MINUTES OF THE
MEETING OF 5-6 november 2014
Chairperson: Mr. Filipe ramalheira
Note by
the Secretariat[1]
Revision
Contents
1 Adoption of the agenda. 2
2 Implementation and
ADMINISTRATION of the Agreement. 2
2.1 Statements from Members under Article
15.2. 2
2.2 Specific Trade Concerns. 2
2.2.1 Withdrawn concerns. 2
2.2.2 New Concerns. 2
2.2.3 Previously raised Specific Trade
Concerns. 17
2.3 Exchange of Experiences. 64
2.3.1 Preparation of the 7th
Triennial Review.. 64
2.3.2 Transparency. 64
2.3.3 Chairman's Report on the 4 November
2014 thematic session. 67
2.3.4 Good Regulatory Practice (JOB/TBT/119) 67
3 Technical Cooperation
Activities. 71
4 Updating by OBSERVERS. 71
5 report (2014) of the
committee on technical barriers to trade. 72
6 Date of Next Meeting.. 72
1.1. The
Committee adopted the agenda contained in WTO/AIR/4364/Rev.1
2.1. The
Chairman said that the list of statements submitted under Article 15.2
of the TBT Agreement was contained in document G/TBT/GEN/1/Rev.13, dated 25
February 2014. He recalled that this information was available, and regularly
updated, on the TBT Information Management System (the "TBT IMS"). He
stressed that while 129 Members had submitted at least one Statement on
Implementation under Article 15.2, 31 Members had not yet fulfilled this
obligation and he urged them to do so in a timely manner.
2.2. The
representative of Canada
introduced his delegation's proposal on the Article 15.2 Statement - Partnering
Exercise. The aim of this voluntary partnering initiative, he said, was to help
those 31 WTO Members who had not yet fulfilled this obligation by partnering
members who had already submitted statements with those who had yet to do so. A
meeting on the margins of the TBT Committee had been scheduled to see what the
next steps would be.
2.3. The
representative of Uganda thanked Canada for the proposal and noted that
for those Members who had not yet submitted their statement, it was important
that they clearly identify why they had not met this obligation so as to enable
developing country Members to have a strategy to overcome the challenges on a
case-by-case basis as the challenges could vary between Members. He proposed
that the challenges be identified in an "action plan" that would be
prepared by the assisting Member.
2.4. The
representative of the European Union suggested that those Members who
required assistance in fulfilling this obligation flag their need for
assistance and that this assistance be provided under existing technical
assistance frameworks.
2.5. The
representative of New
Zealand agreed with the EU that this be
a demand driven exercise and looked forward to discuss the matter further.
2.6. The
Chairman reported that the following Specific Trade Concerns were
withdrawn from the Agenda at the request of the concerned Member:
a. Chile – Draft Energy Efficiency Analysis and/or
Test Protocol for Electrical Products (G/TBT/N/CHL/248) - withdrawn by the Republic of Korea.
b. Malaysia – Regulation 28, Food Regulations 1985:
Ceramic ware and Guideline on Importation of Ceramic Ware Intended to be used
in the Preparation, Packaging, Storage, Delivery or Exposure of Food for Human
Consumption (G/TBT/N/MYS/40) –
withdrawn by Indonesia.
c. Japan – Wood Use Points Programme
(G/TBT/N/JPN/471 and G/TBT/N/JPN/471/Corr.1) – withdrawn by Indonesia.
2.2.2.1 United States – Tire Identification and Recordkeeping (G/TBT/N/USA/916)
2.7. The
representative of Thailand
noted that the US
measure proposed to increase the plant codes from 2 to 3 digits and require a
blank space 50 mm after the Tire Identification Number (TIN). Thailand was
concerned that this measure could be creating unnecessary obstacles to trade
within the meaning of the TBT Agreement. While Thailand
took note of the US
explanation that it was running out of two symbol plant codes for TINs and was
therefore changing to three symbol codes, the US was asked to consider adopting a
more trade facilitating path available and avoid creating unnecessary burdens
to manufacturers. First, it was clear that TIN was by no means related to the
improvement of quality, safety or efficiency of tyres. Although the US needed to come up with new codes to identify
new tyre plants, there was no need to disrupt the use of the assigned codes
that could thus continue to serve the purpose regardless of the US' proposed
new TINs. The measure's unnecessary trade restrictiveness was evidenced by the
fact that the adoption of new codes would pose additional costs for
manufacturers, and eventually also to consumers, without improving product
quality, efficiency or safety. There was no safety or quality benefit in
requiring the space of 50 mm after TIN on the sidewall either. At present, many
regulations already required markings on the sidewall, and some even specified where
to place the mark. This resulted in little space left on the sidewall. And in
certain cars, tyres were now smaller by design, making it even more difficult
to provide the 50 mm blank space. Since this requirement did not improve
product quality, efficiency or safety, the US was asked to consider removing
it.
2.8. In
case the US nonetheless deemed
it necessary to introduce the changes proposed, Thailand
asked the US
to consider the following: (i) allow existing manufacturers to continue
production under the current TIN without any adjustment. This was because no
duplication of "Plant Code" had been found among the manufacturers who
have been assigned the 2 symbol TIN. Hence, there was no need to add symbol
"1" before the assigned two symbol plant codes, and continued use of
the assigned two symbol plant code should be allowed; (ii) For new
manufacturers, who would need to obtain a plant code, they should be assigned
the 3 symbol plant code immediately after the 2 symbol plant codes had run out.
This would be enough to avoid any duplication and would not impact
manufacturers adversely; (iii) the 50 mm space requirement should be removed;
and (iv) also consider extending the lead time for industry to comply from five
years to ten years.
2.9. To
illustrate its concern, Thailand compared TIN to car license plate numbers
where Thailand had run out of car licence plate number many times. When there
were fewer cars, license plates contained only a few digits. With more cars, a
letter was added in front of the digits, then more letters were needed, and then
more digits were put in front of the letters. To date, this system worked well and
served its purpose. TIN should consider something similar. Thailand understood that the US did need to
make some changes and appreciated its willingness to adopt standardized TINs.
In light of the necessary change, Thailand
proposed that the US
should take the opportunity to consider adopting a more globally beneficial
approach through the Global Technical Regulation (GTR). Thailand believed that the US could
maximize, as well as contribute to the benefits for future models by
harmonizing with the imminent GTR's 15 symbol TIN.
2.10. The
representative of the United States
said that in the 90 days since the US had published the NPRM it had
received 13 comments. The final rule would respond to all of those comments and
serious consideration was being given to making a variety of changes in the
regulation.
2.2.2.2 Russian Federation – Measure affecting imports of Ukrainian juice products
2.11. The
representative of Ukraine
was concerned with the ban on imports of all Ukrainian juice products,
including in the form of baby food, to the Russian Federation, which had been
enacted on 29 July 2014 by the Federal Service on Customers' Rights
Protection and Human Wellbeing Surveillance (Rospotrebnadzor). Russia did not
refer to non-compliance of Ukrainian juice products with any particular effective
Russian or Custom Union's technical regulation as a reason for the ban. A
notice posted in Rospotrebnadzor's website stated that the ban had been imposed
for the reason that "… Ukrainian juice products did not pass state
registration for compliance with the technical regulations of the Customs
Union, but were labelled with an 'EAC' sign - a single sign of the Customs
Union market access". However the Russian authorities had not given any
information as regards particular producers or products which included this
alleged charge. Ukraine emphasized fact that Ukrainian producers had all
necessary certificates confirming compliance of their juice products with the
Technical Regulation for juice products made from fruits and vegetables
(Federal Law of 27 October 2008 No.178-З) and with the Unified Sanitary and
Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and
Epidemiological Supervision (control), approved by Decision of the Commission
of the Customs Union of 28 May 2010 No. 299. According to the
Decision of the Eurasian Economic Commission No. 880, the above Regulations
were in force until 15 February 2015. Ukraine believed that juice products,
including baby food, that had certificates of conformity with the relevant
valid Russian Federation technical regulations and were marked with the sign of
circulation on the market of the Russian Federation and with the appropriate
signs of other importing countries, should be legitimate for importation and
circulation on the market of the Russian Federation at least till mid February
2015.
2.12. Ukraine informed the Committee that, in
accordance with the provisions of Articles 10 and 2.5 of the TBT Agreement, Ukraine had made a request on 15 August 2014 for
relevant information and clarifications through the TBT/SPS Enquiry Point of
the Russian Federation.
However, to date no response has been received. In addition, Ukrainian
producers had also sent inquiries for clarification to the Russian authorities
but the responses they received were quite confusing and vague. Thus, Ukraine requested Russia to provide official detailed
clarification and justification of keeping the measure and its compliance with
the provisions of the TBT Agreement. Ukraine
considered that the ban of import of all juice products, including baby food,
of Ukrainian origin, imposed by Russia
was a discriminatory measure that accorded treatment less favourable than that
accorded to like products of national origin and to like products originating
in other countries. Ukraine
believed that the Russian measure was not justified, applied in a non-transparent
and discriminatory manner and created unnecessary obstacles to trade. Thus, Ukraine
considered that this measure was inconsistent with provisions of Articles 2.1,
2.2 and 5.1 of the TBT Agreement. Russia has not provided any written
official detailed clarification and justification for the measure and the
manner in which it was applied, as required by the provisions of paragraphs 2
to 4 of Article 2 of the TBT Agreement. Thus, in accordance with Articles 10
and 2.5 of the TBT Agreement, Ukraine
requested Russia
to immediately lift the ban since no scientific information existed to justify
the measure.
2.13. The
representative of the Russian Federation
said that Russia had
introduced restrictions on the import of juice products from Ukraine due to
the fact that necessary conformity assessment procedures applied to such
products had not been provided. The Russian regulating authority
(Rospotrebnadzor) had detected that the labelling of Ukrainian juice products
contradicted relevant requirements by providing false information on compliance
with technical regulations of the Custom Union. Moreover, these products were
labelled by sign for the Eurasian Common Economic Space solely, and this fact represented
a violation of the legislation of the Russian Federation and Common
Eurasian Market regulation. The usage of single sign of circulation of products
in the market of member countries of the Customs Union "EAC" for food
products was described in technical regulation of the Custom Union "On
labelling of food products" (which was adopted on 9 December 2011) and
technical regulation of the Custom Union "On safety of food products"
(which was adopted on 9 December 2011). Russia stressed that labelling with
such a sign was allowed only for the goods that had their conformity to the
Common Eurasian requirements attested. The large number of such precedents
appeared to be deceptive practice in internal trade. As the import suspension
of juice products represented a measure taken under implementation of the both
mentioned technical regulations that had been adopted before the accession of
the Russian Federation to the WTO, Russia therefore saw no basis for notifying
it. The measure at issue was, in any case, taken in full compliance with the
WTO rules and in particular with the provisions of the TBT Agreement (Articles
2.9, 2.10, 5.6, 5.7). In order to lift the restriction, the Russian Federation
called the competent authorities of Ukraine responsible for the control of the
products to participate in bilateral consultations at the level of the
competent authorities of both countries. Rospotrebnadzor was thus ready to
develop the procedures, necessary to return such products to the circulation at
the territory of the Russian Federation.
2.2.2.3 Russian Federation – Measure affecting imports of Ukrainian beer
products
2.14. The
representative of Ukraine expressed concern regarding the ban on import
of Ukrainian beer products to the Russian Federation, which has been enacted on
15 of August 2014 by the Federal Service on Customers' Rights Protection and
Human Well-being Surveillance (Rospotrebnadzor). The announced ground for the prohibition
was alleged incompliance with legislation on consumer's rights protection, in
particularly labelling requirements. The measure affected a majority (up to
70%) of imports of Ukrainian beer products to Russia. Yet the measure had been applied
in a non-transparent and unpredictable manner. Ukrainian beer producers had a
long history of credible supply of high quality products to the Russian market.
They had all the necessary certificates of conformity and state registration
that were required by the Russian Federation legislation and technical
regulations. Ukrainian producers effectively applied management systems for
quality and safety of food products in compliance with requirements of ISO 9001
and ISO 22000 and had been accordingly certified.
2.15. However,
and despite the forgoing, on 13 of August 2014, a short and incomplete
publication was posted on Rospotrebnadzor's website regarding the alleged
incompliance by Ukrainian beer producers. Just two days later, all the import
of Ukrainian major producers was stopped. Inquiries were sent immediately to
the Russian authorities with requests for results of laboratory tests and/or
expertise and other relevant information that might be useful to clarify the
reasons for such strict measure. However, Ukrainian producers concerned have
not received any answer with information as yet. Ukraine believed that this Russian
measure was not justified, was applied in non-transparent and unpredictable
manner, and was enacted with a view of creating unnecessary obstacles to trade.
Accordingly, this measure was inconsistent with provisions of the Articles 2.1,
2.2 and 5.1 of the TBT Agreement. The Russian Federation has not provided any
written official detailed clarification and justification for the measure and
the manner in which it was applied, as it was required to do by virtue of the
provisions of the paragraphs 2 to 4 of the Article 2 of the TBT Agreement. Thus,
in accordance with the Articles 10 and 2.5 of the TBT Agreement, Ukraine
requested Russia to immediately lift the ban since no scientific information
was available to justify this measure.
2.16. The
representative of the Russian Federation said that the import suspension
of certain beer products and beer containing beverages produced by some
Ukrainian enterprises had been introduced in the Russian Federation due to
inconsistencies of these products to the technical regulation requirements in
the consumer protection area, particularly due to the incompliance with the
requirements on labelling. The Russian competent authority (Rospotrebnadzor)
detected numerous cases related to such products in the circulation, for which
reason the measures had been introduced to prevent deceptive trade practices,
to maintain the appropriate level of protection the safety and life and health
of population. Russia stressed that the suspension encompassed only certain
Ukraine enterprises, that produce beer, and was not a ban to imports to the
territory of the Russian Federation of all the beer products of Ukraine. Russia
reiterated that the import suspension of beer products of some Ukrainian
companies represented a measure taken under implementation of the existing
technical regulation. There was therefore no basis for notifying it. In order
to resume the supplies of the products from these Ukraine enterprises to the
territory of the Russian Federation, Russia reiterated its call to the competent
authorities of Ukraine responsible for the quality and regulation of such
products, to start consultations at the bilateral basis at the level of the
competent authorities. Rospotrebnadzor was ready to assist in developing the
measures necessary to return such products to the circulation at the territory
of the Russian Federation. Such a work would accelerate the resumption of
Ukrainian beer products imports to the Russian market. The measure at issue was
taken in full compliance with the WTO rules and in particular with the
provisions of the TBT Agreement.
2.2.2.4 France – Proposal to introduce plain packaging of tobacco products
2.17. The
representative of Malawi expressed her delegation's concerns regarding
the consistency of the proposed measure with the TBT Agreement. She also
requested France to abstain from any tobacco plain packaging legislation until
the WTO disputes lodged against Australia's plain packaging measures had been
concluded. Malawi's full statement is contained in G/TBT/W/392.
2.18. The
representative of Ukraine noted that France's Ministry of Social
Affairs, Health and Women's Rights had recently announced that it would develop
an amendment to the Health Bill currently under consideration, which would
include "neutral" packaging requirements for tobacco products.
However, France had not yet released any legislative text or other description
of the proposed "neutral" or "plain" packaging measure. Ukraine
was thus interested to learn from France more details about the measure under
consideration, including what information it has gathered or expects to gather
through a regulatory impact assessment of this proposed measure, and the
timetable of the development of the proposed measure and its notification to
this Committee. Ukraine considered that plain packaging measures raised a host
of concerns under Members' WTO obligations, including the TBT Agreement's
requirement that technical regulations not be prepared, adopted or applied with
a view to or simply "with the effect of" creating unnecessary
obstacles to trade. As set out in Article 2.2 of the TBT Agreement, technical
regulations must fulfil a legitimate objective and be no more trade restrictive
than necessary in so doing.
2.19. As
a preliminary point, Ukraine reiterated that the objective of protecting public
health by reducing smoking prevalence was undoubtedly legitimate and indeed was
an objective shared by Ukraine and France. However, one of the key questions
regarding the consistency of proposed plain packaging measures with the TBT
Agreement was whether the particular means chosen – the eradication of almost
all trademarks and the standardized labelling, marking and packaging
requirements – would actually contribute to the stated legitimate objective.
Even though there were certainly notable differences between France's and
Australia's measures, an analysis of the situation in Australia, the only
Member that has implemented plain packaging to date, was informative. Almost
two years after implementation of plain packaging, evidence from the Australian
market showed that the measure has failed to contribute to the intended
objective and has given rise to a number of unintended consequences. In this
respect, Ukraine noted that as a third party to the dispute with Australia, the
EU, and thus France, has access to all of the evidence that has been submitted
in the context of the dispute on the tobacco plain packaging measure of
Australia showing the lack of actual or potential future contribution of this
type of measure. Ukraine thus hoped that this information would be taken into
consideration in any future regulatory impact assessment as part of the
scientific information available to France.
2.20. In
light of the forgoing considerations, Ukraine was interested to hear from
France regarding the scientific evidence and other data it has considered
before announcing this proposal, or that it was planning to consider, to assess
the impact of the proposed measure on actual smoking behaviour. In this
respect, Ukraine was also interested in hearing from France whether it intended
to undertake a regulatory impact assessment and provide for a public
consultation process regarding the announced "neutral" packaging
measure for tobacco products. Finally, Ukraine would welcome any clarification
from France on the timetable of the development of the proposed measure and its
notification to this Committee. In addition to raising these questions, Ukraine
also encouraged France to reflect on the concerns expressed by Ukraine and
other Members in the context of the recent TRIPS Council meeting. Finally,
given the fact that plain packaging measures for tobacco products were
currently the subject of a WTO dispute, it would appear to be prudent for
France to await the objective assessment of the WTO on all of the relevant
matters of fact and law relating to plain packaging in order to ensure that its
technical regulations would indeed be consistent with its WTO obligations.
2.21. The
representative of Indonesia said that, as one of the complainants in the
dispute against the Australian plain packaging measure, his delegation
considered that plain packaging measures were not only inconsistent with
Articles 2.1 and 2.2 of the TBT Agreement but also the TRIPS Agreement.
Indonesia said that just because tobacco use can be bad for one's health, it did
not follow that any form of tobacco control would be good because such measures
should respect WTO obligations. Indonesia was not challenging the right to use
other forms of tobacco control measures apart from plain packaging. Studies and
empirical evidence has shown no evidence that plain packaging in Australia has
made any contribution towards reducing tobacco use among youth. Indonesia also
asked all Members planning to implement plain packaging to wait until the
Australian dispute had reached its conclusion.
2.22. The
representative of the Dominican Republic associated herself with the
statements made by Malawi, Ukraine and Indonesia.
2.23. The
representative of Honduras expressed her delegation's concerns with the
measure. The full statement is contained in G/TBT/W/399.
2.24. The
representative of Australia said that his delegation welcomed the
announcement by the French Minister for Health to introduce standardised
packaging as part of their proposed comprehensive package of reforms in their
ongoing efforts to combat the burden of disease attributed to tobacco products.
The important steps made by France in tobacco control demonstrated that efforts
to delay the adoption of tobacco plain packaging measures in these countries
had not been successful. Australia looked forward to continuing its support of
France as they proceed with the development and implementation of their own
tobacco plain packaging measures. Australia was of the firm view that Members
had the right to implement measures necessary to protect public health, while
complying with relevant international treaty obligations, including the TBT
Agreement. Tobacco plain packaging was a legitimate measure, designed to
achieve a fundamental objective: the protection of human health. The use of
tobacco plain packaging measure was endorsed by leading public health experts
as well as the World Health Organization and was supported by extensive peer
reviewed research, reports and studies. In this respect, Australia commended
the EU and its Members for the tobacco control measures they have implemented
to date, including the revisions to the Tobacco Products Directive. The revised
EU Directive was a legitimate measure designed to achieve the fundamental
objective of the protection of human health, in particular the protection of
young people against smoking initiation and uptake. Australia's tobacco plain
packaging measure was a legitimate public health measure which was consistent
with the WTO Agreement obligations. Australia was currently defending its
measure in the WTO. It was therefore inappropriate for complainants in the WTO
disputes currently underway against Australia to invoke those proceedings in an
attempt to delay or discourage another Member from developing or implementing
their own legitimate tobacco control measures.
2.25. The
representative of Nigeria associated herself with the concerns expressed
by previous delegations and expressed her delegation's preoccupation with the
effects of plain packaging measures could pose to international trade and the
rights of trademark owners.
2.26. The
representative of Cuba stated that her delegation shared the view that
Members had the sovereign right to regulate to protect public health. It
requested however that France abstain from any tobacco plain packaging
legislation until the WTO disputes lodged against Australia's plain packaging
measures had been concluded. Cuba also asked France to provide detailed
information about the status of the internal process taking place for the
adoption of the measure and urged France to notify this proposed measure to the
WTO as soon as possible.
2.27. The
representative of Nicaragua said that his delegation supported the
position of the five complainants of the current WTO dispute involving
Australia's plain packaging measures. While Members had the sovereign right to
regulate health – and Nicaragua itself was a signatory of various international
instruments on this matter – any such measures had to respect WTO rules,
including the TBT obligation of not being more trade restrictive than
necessary. Concerning plain packaging, Nicaragua believed that this kind of
measure was incapable of attaining its ultimate public health objectives. Given
the important economic and social impact that this kind of measure could cause
in countries like Nicaragua, he urged Members planning to adopt them to wait
until the Australian WTO dispute had been concluded.
2.28. The
representative of Zimbabwe associated his delegation with the concerns
expressed by Malawi, Ukraine, Indonesia, Honduras, the Dominican Republic,
Honduras, Nigeria, Cuba and Nicaragua. While Zimbabwe appreciated the efforts
made by France to protect consumers, the proposal appeared to be inconsistent
with Article 2.2 of the TBT Agreement as this technical regulation would be
more trade restrictive than necessary to fulfil its stated legitimate
objective. There was no scientific evidence that such kind of measure would
influence the behaviour of tobacco consumers or reduce smoking among youth.
Tobacco contributed significantly to Zimbabwe's GDP and was a major export.
These measures would therefore impact negatively on employment, economic
performance and poverty alleviation efforts in Zimbabwe, where tobacco farming
was the major economic activity and source of livelihood for millions of its
citizens.
2.29. The
representative of New Zealand expressed her delegation's support for
France's decision to consider the introduction of plain (or standardised)
packaging requirements for tobacco and tobacco products. There was an extensive
and growing body of international research establishing that plain packaging,
as part of a comprehensive tobacco control programme, would contribute to the
objective of improving public health. To date, there was no credible evidence
proving otherwise. The TBT Agreement recognised the fundamental right of
Members to implement non-discriminatory measures necessary to protect public
health and provided appropriate flexibilities for Members to do so. New Zealand
believed that it was possible for Members to implement a tobacco plain
packaging regime that was consistent with all of their WTO obligations,
including their respective obligations under the TBT Agreement.
2.30. The
representative of Norway expressed her delegation's strong support to
France's effort to combat tobacco use. Smoking was still the single factor with
the greatest negative impact on public health. Norway belied that it was well
within the right of WTO Members to adopt measures necessary to protect public
health insofar as they were consistent with the WTO Agreements. Norway recalled
that plain packaging of tobacco products was the recommended measure under
FCTC. It was the opinion of Norway that the FCTC and the relevant WTO
Agreements were mutually supportive, and that it was possible to introduce
measures for the regulation of tobacco products in line with both sets of
binding obligations.
2.31. The
representative of Canada stressed his delegation's interest to follow
the ongoing international developments regarding the plain packaging of tobacco
products, and how such measures interacted with both international trade and
public health. Canada has been a pioneer in package labelling requirements for
tobacco products, and thus considered these sorts of requirements, as proposed
by France and other Members, a core component of public health.
2.32. The
representative of the European Union informed the Committee that the
French government was currently considering the possibility of introducing
plain packaging for tobacco products. However, the measure was not yet
finalized and it would be duly notified under internal EU procedures as well as
the TBT Agreement. In this context, as the legislative proposal was still in
preparation, the EU considered any discussions on this matter in the TBT
Committee to be premature at the current stage.
2.33. The
representative of the WHO made a statement the full content of which is
contained in G/TBT/GEN/175. It was requested that this statement be considered applicable
to the STCs raised with respect to the plain packaging proposals by Ireland and
the UK as well as Australia's plain packaging measure.
2.2.2.5 Kingdom of Saudi Arabia – Decree of the Saudi Arabian Ministerial
Council on the sale and marketing of energy drinks of 4 March 2014
(G/TBT/N/SAU/669)
2.34. The
representative of Switzerland expressed his delegation's concern with the
Decree of the Saudi Arabian Ministerial Council "on the sale and marketing
of Energy drinks" (N°176; 2/5/1435) of March 4th, 2014. This decree
introduced a specific mandatory statement for "energy drinks", as
well as restrictions on marketing, sponsoring, advertising, including sales
prohibition and constraints. The mandatory statement for so called "energy
drinks" reads as follows: "This product has no health benefits,
having more than 2 cans a day could lead to health damages. Warning - against
taking this product by pregnant and lactating women, people suffering from a
heart condition and high blood pressure and diabetes, youth under 16 of age,
those allergic to caffeine, athletes during sport." Switzerland shared
Saudi Arabia's intents regarding public health and consumer information. While
Switzerland considered that there were grounds to mention the caffeine content
and to raise awareness to pregnant or lactating women and children, a negative
mandatory statement seemed more restrictive than necessary to achieve this
goal. It also seemed to go beyond any relevant international standard. In this
latter respect, he recalled that the CODEX standards on nutrition provided that
declarations on products should not lead consumers to believe that there was exact
quantitative knowledge of what individuals should eat in order to maintain
health, but rather convey an understanding of the quantity of nutrients
contained in the product.
2.35. Given
the forgoing, Switzerland asked Saudi Arabia to inform the Committee what were
the substances that would justify that producers shall mention that a given
product had detrimental effects on health. Additionally, Switzerland asked
which international standards on labelling of nutrients and product claims have
been followed when designing mandatory statements? Switzerland flag its
concerns with the restrictions to sales in educational and government
facilities as well as the requirement on selling such beverages in specifically
designed fridges and shelves. Negative warnings as well as the far reaching
restrictions on sales seemed to go well beyond the criteria of trade
restrictiveness under the TBT Agreement. Without a sound scientific basis, they
could also be seen as arbitrary and discriminatory. Also, as the described
measures differed substantially from previously notified measures, they should
have been also notified.
2.36. The
representative of the European Union noted that the Kingdom of Saudi
Arabia proposal provided for labelling requirements for formulated beverages
with caffeine levels above 14.5 mg per 100 ml. The measure also stated that:
"any energy drink label shall advise that the product is not suitable for
pregnant or lactating women, persons under 16 years, persons with sensitivity
to such products, or those who suffer from diseases that may affect their
health, especially heart patients, arteries, diabetics, and athletes during
exercise." The proposal also required: "labels of energy drinks to
further advise on a maximum intake per day which should not be exceeded by the
consumer and that producers of energy drinks shall be liable for such maximum
consumption recommendation."
2.37. The
EU fully shared Saudi Arabia's public health concerns with these products and
noted that the EU has also implemented legislation in this domain, namely the
EU Regulation 1169/2011. Similarly to Saudi Arabia proposal, this EU Regulation
required labels of beverages which contained caffeine in a proportion in excess
of 150 mg/l to include the following information on the label: "High caffeine
content. Not recommended for children or pregnant or breast feeding women"
followed by a reference in brackets to the caffeine content expressed in mg per
100 ml. The EU Regulation did not require, however, any specific advisory
statement for certain diseases or statements about consumption during physical
exercise. The scientific assessment carried out by the EU did not conclude that
those were necessary. The EU would therefore ask Saudi Arabia to either
withdraw those requirements or to share with the EU its scientific assessment
for including the specific references to physical exercise, illnesses,
cardiovascular patients, and other diseases. As regards the requirement to
provide for a maximum intake per day in the label, it was the EU's view that,
given that caffeine was also consumed from other sources (such as coffee, tea
and chocolate) it would be impossible for the industry to provide for a
scientifically sound specific figure on the label and, more importantly, to
assume strict legal liability for such statement. Therefore, the EU requested
Saudi Arabia to consider the EU labelling requirements in light of the comments
it had just provided when deciding on this measure. Finally, the EU also
expressed concerns regarding the restrictions on advertising and promotion for
energy drinks announced by Saudi Arabia in March 2014. Those measures ban any
sort of advertising for energy drinks, including the sponsoring of any event
and impose several marketing restrictions, including additional warnings. The
EU asked Saudi Arabia to share with this Committee the scientific basis on
which these measures were based.
2.38. The
representative of Kingdom of Saudi Arabia thanked Switzerland and the EU
for their comments and expressed his delegation's wish to discuss this issue bilaterally
with them at the margins of the meeting.
2.2.2.6 Brazil – Draft Technical Resolution nº 69, 9 September 2014,
Regarding the Requirement of Describing the Chemical Composition, in
Portuguese, in the Label of Personal Hygiene Products, Cosmetics and Perfumes (G/TBT/N/BRA/608)
2.39. The
representative of Mexico considered that the proposal in question could
contravene fundamental principles of the TBT Agreement, such as conformity with
international standards, by failing to consider the existence of the widely accepted
International Nomenclature of Cosmetic Ingredients (INCI). The representative
was also concerned at the distinction that was made under the measure between
products from the European Union, and products from Brazil's other trading
partners, in particular those in Latin American, in violation of the MFN
principle. While Mexico reserved the right to submit comments to Brazil on this
measure, the representative submitted a number of requests to Brazil. First,
she asked for an explanation of why the INCI system was not accepted under the
measure, given that this system was widely recognized by regulatory entities
worldwide, as well as by the main product manufacturers and raw material
producers. Second, her delegation requested an explanation or justification as
to the benefits of translating the names of product ingredients into
Portuguese. Bearing in mind that the products used a large number of raw
materials with highly complex technical names, she pointed that lay consumers
were not familiar with such ingredients and were incapable of distinguishing
between ingredients with similar names. Third, Mexico asked Brazil to revoke
the provision in question, or if appropriate, at least modify the wording of
the provision so as explicitly to allow the use of the INCI. She noted that in
the case of Mexico, the use of the INCI was allowed under the Mexican technical
regulation on labelling of such products (NOM 141 SSA1/SCFI 2012), Labelling of
Pre Packaged Cosmetic Products. Health and Commercial Labelling, in force since
2012. Finally, she sought an explanation of the rationale of the measure and
the reasons why it was deemed necessary to translate product ingredients into
Portuguese, in relation to the legitimate objective pursued by Brazil.
2.40. The
representative of Brazil explained that notification G/TBT/N/BRA/608
referred to a draft measure regarding Portuguese language labelling describing
the chemical composition of personal hygiene products, cosmetics and perfumes.
The proposed measure was without prejudice to other applicable requirements. He
highlighted that current legislation determined that the description of
ingredients of personal hygiene products, cosmetics and perfumes was required
to follow the International Nomenclature of Cosmetic Ingredients (INCI).
According to the Brazilian Consumer Protection Code, consumers in Brazil had
the right to clear and appropriate information about products and services
available on the market. He noted that a recent ruling found that the Brazilian
Health Surveillance Agency (ANVISA) shall ensure that information about the
chemical composition of personal hygiene products, cosmetics and perfumes be
made available to consumers in Portuguese. Thus the proposed measure aimed to
bring the requirements on information to consumers in line with applicable
legislation.
2.41. With
respect to the purpose of the INCI, it was the understanding of ANVISA that it
served the purposed of indicating, in a simplified and unequivocal way, the
list of ingredients in the label of cosmetic products. He said this allowed
health professionals to identify technical and scientific information on a
given product, by means of universally accepted quantification. It also enabled
consumers to identify ingredients that they needed to be aware of due to use restrictions
or sensitives, as in the case of allergies or intolerance. The use of INCI
allowed for the identification of any ingredient in a clear, precise and
immediate manner, in any country in the world. From the perspective of sanitary
risks, it simplified actions to protect health in general and also allowed
individual protection in case of emergencies or preventive measures. Brazil
informed that the draft measure was currently under public consultation, and
the final date for comments was 20 January 2015. After the public consultation,
ANVISA would then review the comments received, and it was envisaged that once
the new regulation was approved, a transition period of 180 days would be
provided prior to entry into force.
2.2.2.7 China - National Standard of the P.R.C., Safety Technical
Specifications for Children's Footwear (G/TBT/N/CHN/983)
2.42. The
representative of the European Union thanked China for the
clarifications provided on the Chinese standards and on the restricted chemical
substances referred to in the notified draft. However, the EU still requested
further clarifications on the odour rating requirements. The notified draft set
up five categories of odour ratings for new footwear for children, and the
corresponding testing requirements. In this respect, the EU asked for further
information on the environmental and human health protection issues that were
referred to by the Chinese authorities in the notified draft as justification
for the provisions on odour testing and rating. The EU also requested information
on the practical implications of these ratings and whether the odour rating had
to be indicated on the product. Finally, the EU expressed its doubts that such
odour tests could be conducted by humans, as required in the notified draft and
asked for further information on the requirements for such testing operator
personnel.
2.43. The
representative of China emphasized that China had provided a detailed
written reply to EU comments on 13 January 2014. As this reply had not been
duly received by the EU, China resent the reply to the EU a few days before the
meeting and hoped it would address their concerns. For the additional questions
formulated by the EU, China noted he would refer them back to capital.
2.2.2.8 Mexico – Draft Mexican Official Standard PROY NOM 142 SSA1/SCFI
2013: Alcoholic beverages. Health specifications. Health and commercial
labelling (G/TBT/N/MEX/254)
2.44. The
representative of the European Union recalled the comments EU sent to
Mexico on 6 May 2013, and asked Mexico for a written reply. In addition, the EU
reiterated some of its previous specific concerns. With respect to the
definition of ethyl alcohol, the EU expressed its preference for a broader
definition, which would cover all ethyl alcohol of agricultural origin. With
respect to the establishment of minimum and maximum alcohol levels, the EU was
concerned that some EU spirits drinks had alcohol content lower than 25% or
higher than 55% and therefore would not be able to be marketed as spirits
drinks in Mexico. For instance, whisky was filled into wooden casks for
maturation at strength of more than 60%. Some premium, high value whiskies were
bottled at "cask strength" in order to preserve the particular
characteristics of the spirit coming out of the cask and therefore had more
than 55% volume of alcohol. The EU thus requested Mexico to delete this maximum
limit. With respect to the establishment of analytical parameters, the EU was
concerned with how these limits had been set and how they could affect EU
exports to Mexico. In this regard, the EU welcomed further clarifications
regarding the necessity and proportionality of the limits and on how those
limits would relate to the existing 1997 Mexico EU Agreement on the mutual
recognition and protection of designations for spirit drinks. With respect to
the indication of alcohol content, the EU invited Mexico to accept additional
abbreviations for the indication of alcoholic content which were widely
recognised at international level. With respect to the provision of mandatory
information, the EU sought assurances from Mexico that this draft standard did
not require the translation of the spirit drink geographical indication into
Spanish. Finally, with respect to the differentiation established by the latest
available draft between alcoholic drinks depending on their alcoholic content
and the related labelling obligations, the EU noted that according to available
scientific studies, it was the excessive consumption of alcohol that was
harmful for health, regardless of the type of alcoholic beverage. Thus, the
differentiation between high alcohol content and low alcohol content products
with regards to the warning message could mislead consumers, who could conclude
that some alcoholic beverages were more harmful than others.
2.45. The
representative of Chile thanked Mexico for replying to its comments and
for taking them into consideration regarding the definition of tolerance to
alcohol, which was a very important point for Chile to be included in the
standard. Chile asked to inform the next steps regarding the publication of the
standard.
2.46. The
representative of the United States associated herself with the EU's
concerns on this issue and noted that the US would be closely monitoring this
issue.
2.47. The
representative of Mexico noted that it had taken on board all comments
on this measure. She highlighted that the comment requiring that Brandy be
composed 100% of grapes was also taken into account. She also informed the
Committee that a notification containing reference to the publication of the
responses to the comments would be circulated. Mexico promised that all the
comments made at this meeting would also be taken into account and would be
replied to. While she did not have current information on the process, as
requested by Chile, she nonetheless noted that this would be included in the
replies to comments, as well as with the modified draft standard.
2.2.2.9 South Africa – Labelling and advertising of pre-packaged foodstuff (G/TBT/N/ZAF/66/Rev.1)
2.48. The representative of European Union
thanked South Africa for the constructive bilateral meeting where they
presented their concerns on the proposed regulation on labelling and
advertising of pre‑packaged foodstuff. The EU appreciated South Africa's
commitment to take into account EU comments even after of the expiration of the
deadline for comments.
2.49. The
representative of New Zealand noted that it had also engaged bilaterally
with South Africa on this issue, and thanked South Africa for its cooperation
on this issue to date.
2.50. The
representative of South Africa thanked the EU and New Zealand for their
comments and for the bilateral meeting, as well as the US for their written
comments, and promised to share them all with their national regulator. While
the notification that South Africa submitted on 11 June 2014 allowed
for a 60‑day comment period, South African Department of Health was still
considering comments from both domestic producers and trading partners after
the deadline. The purpose of the notification was to allow trading partners the
opportunity to provide comments on provisions of the draft regulation to ensure
there would not constitute unjustified barriers to international trade.
Adoption would only take place after comments were considered, and the
implementation date would be announced after adoption of the regulation. South
Africa therefore welcomed further written comments but asked Members to send
them urgently so that the regulator could still take them into account before
adoption and would be able to provide a reasonable interval before
implementation. South Africa noted that, as indicated in point 8 of the
notification, the regulator had utilised international standards as required by
Article 2.4 of the TBT Agreement. The Department of Health held it
necessary to draft these regulations to provide citizens with adequate
information on product labels and enable them to make informed choices and to
improve health regulation in South Africa.
2.2.2.10 Israel – Resistance to ignition of mattresses, mattress pads, divans
and bed bases (G/TBT/ISR/666 and Add.1)
2.51. The
representative of the European Union referred to an Addendum (G/TBT/N/ISR/666/Add.1)
to the original Israeli notification indicating that the mandatory application
of the notified standard had been postponed and that further scientific
assessments were to be conducted. However, it seemed that at the same time the
notified draft had been declared mandatory by way of Israeli standard SI 5418
as of 15 July 2014. While recognizing the legitimate objective of
human safety and the need for safe home furnishings, the EU was of the view
that the legislation in question created unnecessary barriers to trade for
mattresses and mattress pads tested in accordance with other relevant
standards, such as European standard EN 597‑1 relating to the most
commonly occurring fire safety issue of a cigarette smouldering in a sofa or a
bed. It ensured an equivalent level of protection, adequately fulfilling the
human safety objective pursued by the notified draft, while not requiring the
use of flame retardants containing chemicals, an important characteristic for
consumers who looked for products with fewer chemicals. The EU wished to
receive the results of the investigation mentioned in the Addendum at issue and
the scientific evidence, based on which Israeli standard SI 5418 had been
made mandatory. Furthermore, taking into consideration the extensive use of
other voluntary standards by other WTO Members, the EU asked Israel to
consider recognizing other relevant standards and applying Israeli standard
SI 5418 only in a voluntary manner.
2.52. The
representative of Israel said that although certain parts of voluntary
standard SI 5418 were scheduled to become mandatory on 16 November 2014,
this had not occurred as the regulation had become the subject of court
proceedings at the Supreme Court of Israel. The entry into force of the
regulation could be delayed even further depending on the outcome of the case. The
regulation was an adaptation of British Standard BS 7177 and only parts of the standard
pertaining to mattresses and mattress pads for domestic use were to become
mandatory. In addition, during the last revision of the standard adopted by the
Technical Committee of the Standards Institution of Israel, it had been noted
that two similar standards relating to the same hazard had been adopted by one WTO Member.
Furthermore, the Israeli standard fully adopted the prohibition under the
Stockholm Convention for the use of flame retardant materials. The need for the
standard arose from the real danger stemming from the high ratio of open spiral
heaters used in Israel, which had resulted in a high number of accidents caused
by burning mattresses.
2.2.2.11 European Union – Common Criteria for Information Technology Security
Evaluation (Common Criteria) certification in the EU
2.53. The
representative of China noted with appreciation that in November 2013
one of the Common Criteria testing labs in the EU had issued an
"EAL 4+" certification for a security chip product
developed by a Chinese manufacturer; however, Chinese security chip producers
were still facing obstacles while applying for Common Criteria certifications.
He asked that the EU explain the relationship between Common Criteria
certifications and the market access policies for information security products
in EU countries. According to Article 5 of the TBT Agreement on
conformity assessment procedures, certification procedures needed to apply
equally to domestic and foreign products, be transparent and involve reasonable
costs and processing periods in order to minimize their impact on trade.
Therefore, China urged EU member states involved in the Common Criteria
Recognition Arrangement (CCRA) to treat Chinese security chips with an open and
fair attitude and develop transparent and predictable certification procedures
and evaluation standards.
2.54. The
representative of the European Union said that this concern provided an
opportunity to outline the key differences in approach in this area between the
EU and China. In the EU, "commercial encryption" and "encryption
for national security" were clearly distinguished and handled separately.
In the field of commercial encryption, the required level of certification for
different commercial applications was set by the market and there were no
mandatory certification schemes but only voluntary ones. Neither the EU nor its
member states imposed mandatory cryptography standards for conformity
assessment procedures as a condition for access the EU market. It was up to
individual companies to ensure secure transmission of data over their systems
and networks and procure equipment with the most appropriate technology
available to meet their needs. European voluntary certification schemes were
based on international standards and in particular the ISO/IEC Common Criteria
for Information Technology Security Evaluation standard (ISO/IEC 15408). As
regards the specific concerns raised by China with respect to the alleged
delayed delivery or refusal to deliver voluntary certificates by some
certification bodies in the EU, he invited China to detail these concerns with
supporting evidence. Although these concerns had no connection or relevance
from the point of view of the TBT Agreement, his delegation would be
willing to look into them in good faith and provide feedback to China. He also
underlined that while some Chinese manufacturers had already been participating
in the EU system and receiving certificates, no foreign company had ever
received a commercial encryption licence in China. By the same token, the
Chinese standardization process was closed to foreign companies even if they
had important local investments in China while the EU process was open. The EU
was interested in seeing a balancing of the situation and a level playing field
regarding conditions for access to the market and participation in relevant
standardization work, based on reciprocity.
2.2.2.12 European Union – Limits for hexavalent chromium in toys (2009/48/EC)
2.55. The
representative of China expressed concerns about the existing as well as
proposed limit values for hexavalent chromium in toys or toy components in the
European Toy Safety Directive 2009/48/EC, which officially came into force on
20 July 2013. The annex to the current Directive set the limit values of
hexavalent chromium for three types of toy material at 0.02 mg per kg, 0.005 mg
per kg and 0.2 mg per kg, respectively, which were even more stringent than the
limits specified in the "WHO Guidelines for drinking-water quality"[2]
or in Members’ national standards for foodstuffs. China associated itself with
the EU's goal of enhancing children's protection but wondered at the treatment
of toys on the EU market as if they were for eating or drinking. Moreover, the
EU Scientific Committee on Health and Environmental Risks had proposed a
revision of the existing limit values for hexavalent chromium, which, if
applied as proposed, would result in 21 to 25 times stricter limits and would
make detection impossible or extremely expensive. Referring to the requirement
under Article 2.2 of the TBT Agreement for Members to avoid adopting
regulations which were more trade restrictive than necessary to fulfil a
legitimate objective, he requested the EU to provide scientific evidence
justifying the existing and proposed limit values for hexavalent chromium in
the toy safety Directive. In addition, he said that according to Article 35 of
EU Directive, the revision should not increase the burden or the expenses for
the toy industry, especially for small and medium enterprises. China invited
the EU to verify its compliance to this principle prescribed in its own
Directive. Finally, in accordance with the recently adopted TBT Committee
recommendation on the coherent use of notification formats (G/TBT/35), China
urged the EU to notify the proposed revision of the EU toy safety Directive to
the WTO and open a new comment period.
2.56. The
representative of the European Union said that the concern provided a
good opportunity to explain the context and the functions of the SCHER, one of
the independent non‑food scientific committees that provided the European
Commission with the scientific advice it needed when preparing policy
initiatives and regulatory proposals relating to consumer safety, public health
and the environment. The task of the Committee was to draw the European
Commission's attention to any new or emerging problems, which might pose an
actual or potential threat, and provide a risk assessment, to be distinguished
from risk management, which was the regulator's task. In this particular case,
which was related to chemicals, the task of SCHER was to advise on what could
be considered as a toxicologically sound, virtually safe limit in light of
available evidence. The main trigger for the Commission to request SCHER to
look into this issue was a study related to hexavalent chromium in drinking
water published in July 2011 by the California Office of Environmental Health
Hazard. The aim of SCHER's draft Opinion, which had been available for public
consultation for two months, from 29 July until 28 September 2014,
was to consider whether a revision of the migration limits for hexavalent chromium
in toys or components of toys was necessary in view of new available evidence,
in particular with regard to the carcinogenic effects of chromium VI.
SCHER would finalize its Opinion in the coming months, taking into account all
the comments received from the scientific community and stakeholders. On the
basis of this risk assessment Opinion on the toxicologically safe limits
(calculated on the basis of a risk of one cancer occurrence in a million), the
European Commission, as part of its risk management tasks, would consider
whether the current migration limits for chromium VI set out in paragraph
13 of Annex 2 of Directive 2009/48/EC on the safety of toys needed to be
amended. This evaluation would naturally also take into account available
testing methodologies for the detection of hexavalent chromium in toys. If the
Commission decided to propose a revision of the limits, any such proposal would
be timely and duly notified to the WTO according to TBT Agreement's
notification procedures. He hoped that this intervention clarified the
distinction between the Opinion of the Scientific Committee and a regulatory
proposal which might follow from that scientific opinion.
2.2.2.13 European Union – Standard on safety of household and similar
electrical appliances (EN60335-1:2012)
2.57. The
representative of China said that as of 21 November 2014 all household and
similar electrical appliances placed on the EU market would have to comply with
the EU harmonized standard EN60335-1:2012. China was concerned about the
unnecessary cost the standard would impose on enterprises. In particular, the
additional requirements of this standard would affect compliance of products
previously certified according to EN 60335-1:2002
+A11:2004+A12:2006+A13:2008+A14:2010+A15:2011, as manufacturers would have to
renew certification in accordance with the new requirements even when the
previous certificate remained valid. China requested the EU to provide a
sufficient transition period for the renewal of certificates when upgrading its
standards with a view to avoiding unnecessary barriers to international trade.
2.58. The
representative of the European Union explained that the legal
framework for placing household and similar electrical appliances on the market
was laid down by the Low Voltage Directive 2006/95/EC, which set up
the health and safety requirements for these products. Compliance with the
Directive could be achieved in different ways, including through demonstration
of compliance with the voluntary harmonised EN standards. This provided a
presumption of conformity with the requirements of the Low Voltage Directive,
which did not require third‑party certification. The manufacturer was
responsible for the conformity of the product with the requirements of the
Low Voltage Directive and needed to draw up the technical
documentation, affix the CE marking and sign the Declaration of
Conformity. In cases where the manufacturer chose to comply with the
requirements of the Low Voltage Directive through the EN 60335‑1:2012
standard, compliance with this new standard was needed for products placed on
the market as of 21 November 2014, when it replaced EN 60335-1:2002.
Hence, products, which were in compliance with the previous standard and
already placed on the market, were not affected.
2.2.2.14 European Union – Regulation (EU) No 1169/2011 of the European
Parliament and of the Council on the provision of food information to
consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006, and
repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC,
Commission Directive 1999/10/EC. 2002/67/EC and 2008/5/EC and Commission
Regulation (EC) No 608/2004 (G/TBT/N/EU/143)
2.59. The
representative of Indonesia said that while recognizing the intention
behind the EU Regulation related to environment and health considerations,
Indonesia was concerned that it might pose unnecessary trade barriers to
products from other Members. He requested that the EU provide the risk
assessment and impact analysis related to the implementation of the Regulation
and clarify whether the term vegetable oil therein applied to palm oil only or
also to rape seed oil. Indonesia expected the EU to monitor the implementation
of the Regulation by EU member states and prevent unfair trade practices and
discrimination against particular products such as Indonesian palm oil.
Indonesia was particularly concerned that some companies were putting "no
palm oil" on the label of their products and wished to pursue the
discussions also on a bilateral basis.
2.60. The
representative of the European Union said that EU Regulation 1169/2011
on the provision of food information to consumers, which had been notified to
the WTO in 2008, would enter in force on 13 December 2014. It provided
that the designation "vegetable oils" in the list of ingredients
of food product labels needed to be followed immediately by an indication of
their specific vegetable origin, for instance palm oil, soya oil, olive oil
etc. The relevant provisions respected the principle of non‑discrimination as
they applied to all types of vegetable oils. The Regulation in question did not
require or regulate any form of negative labelling such as "it does not
contain palm oil". Nor did it regulate the manufacturers' freedom to
indicate that an ingredient had not been used in a food product. The European
Commission had produced and updated regularly a Question and Answer document to
help food business operators comply with the Regulation's requirements and was
ready to address any additional question Indonesia might have at bilateral a
level.
2.2.2.15 Russia – Draft of the Eurasian Economic Commission Collegium
decision on amendments to Common sanitary-epidemiological and hygienic
requirements for products, subjected to sanitary-epidemiological supervision
(control) (G/SPS/N/RUS/50)
2.61. The
representative of Indonesia thanked Russia
for their bilateral meeting and noted that under the Eurasian Economic
Commission Collegium decision on amendments to Common sanitary‑epidemiological
and hygienic requirements for products, Russia had tightened the peroxide
content allowed in palm oil to 0.9 millimoles of active
oxygen per kilogram, which also applied in other Eurasian member
states. According to the relevant Codex standard, the good quality of vegetable
oil was determined by the colour, smell and taste, not by the contents of
peroxide, which was permissible up to a limit of 10 millimoles of
active oxygen per kilogram. Although the WTO recognized the right of
governments to implement measures to protect human health, these needed to be
supported by scientific studies and avoid imposing unnecessary trade barriers.
The peroxide content limit of 0.9 millimoles of active oxygen per kilogram
appeared to be set with the intention of curbing imports of palm oil to Russia
as it was unlikely that this requirement could be met by palm oil producers,
especially by those from Indonesia. She requested that Russia provide its risk
assessment and impact analysis regarding the implementation of this regulation
and avoid discriminatory treatment to palm oil from Indonesia.
2.62. The
representative of Ukraine associated herself
with the concerns raised by Indonesia. Ukraine had also raised concerns regarding
this regulation in the SPS Committee and was still waiting for a response
to its enquiry submitted on 5 June for clarifications, in particular
concerning the peroxide level.
2.63. The
representative of the Russian Federation thanked
Indonesia for their bilateral meeting and said that the limits of peroxide
value were fixed in the Unified Sanitary and Epidemiological and Hygienic
Requirements for Goods Subject to Sanitary and Epidemiological Supervision
(Control), approved by the Decision of the Customs Union Commission No. 299
of 28 May 2010, and also in Technical Regulations on oil and fat
products adopted by the Eurasian Economic Commission in 2011. The value of
peroxide specified in both documents was identical, at a maximum level of 10 millimoles
of active oxygen per kilogram, and was in full compliance with CODEX
STAN 210‑1999 as well as Article 2.4 of the TBT Agreement. In
accordance with the Decision of the Board of the Eurasian Commission No. 22
of April 2012, the proposal of the Unified Requirements regarding the
peroxide value should be excluded, so that only the proposal of the Technical
Regulations on oil and fat products applied, with a view to allowing
manufacturers in the Customs Union and exporters in other countries to refer to
only one document. The draft decision providing a maximum limit for peroxide
value of 0.9 millimoles of active oxygen per kilogram was based on
scientific findings regarding its impact on human health and had been notified on
2 April 2014 in document G/SPS/N/RUS/50. However, the adoption of the
amendment regarding the limit of peroxide value had been suspended.
2.2.2.16 Ecuador - Equivalence Agreement N° 14.241 with the European
Union regulations
2.64. The
representative of Mexico thanked the Chairman and referred to the
Agreement No. 14.241 of the Ecuadorian Ministry of Industry and
Productivity, dated 3 June 2014. In this connection, Mexico had
expressed some concerns to Ecuador bilaterally, to which no replies have yet
been received. For this reason, this STC was submitted on the basis of the
following questions: (i) Article 1 of Agreement No. 14 241
stated that "the standards and technical regulations of the European Union
and its member countries were recognized as equivalent". To which
legislation and technical regulations did this refer?; (ii) In the
antepenultimate paragraph of the preamble of the Agreement it was stated that
"the technical report of 30 May 2014 recommends the adoption of
European standards to assist the Ecuadorian industry". Could information
be provided on the way in which it was considered that European standards
assist the Ecuadorian industry? On the basis of the foregoing question, could
Ecuador specify the relationship between European standards and international
standards?; (iii) Did Ecuador agree with the interpretation that the
provisions of Articles 2 and 3 of Agreement No. 14 241, in
relation to conformity assessment procedures, imply a form of discrimination
against products from non‑European countries?
2.65. The
representative of the United States associated herself with the comments
made by Mexico.
2.66. The
representative of Ecuador took note of the concerns expressed and
informed that they would be further discussed bilaterally, given that these
concerns were only recently introduced to the agenda.
2.2.2.17 Ecuador - Draft Technical Regulation of the Ecuadorian
Standardization Institute (RTE INEN) No. 047: "Metal cable tray,
electrical conduit and trunking systems")
2.67. The
representative of Mexico noted that this draft Ecuadorian Technical
Regulation not only established packaging requirements for metal cable tray,
electric conduit and trunking systems, but also contained the requirement to
indicate the country of origin and the name of the importing enterprise. Mexico
considered that, on the basis of Article 2.1 of the TBT Agreement,
this requirement could be discriminatory and protectionist since it applied
solely to imported products. Moreover, these requirements were different from
the ones normally specified for this type of product, which entailed an
increase in their costs. The Regulation also established that products with the
Ecuadorian Standardization Institute (INEN) seal of quality were not subject to
the requirement of a certificate of conformity for marketing purposes; this
seal was only issued for Ecuadorian products, and this, on the basis of
Article 5.1.1 of the TBT Agreement, could also have a discriminatory
effect on imported products. Taking into account the provisions of
Article 2.4 of the TBT Agreement, Mexico considered that the
products covered by the technical regulation in question should be governed
essentially by the provisions of the International Electrotechnical Commission Standard
No. 61537, "Cable tray systems and cable ladder systems for cable
management", rather than Ecuadorian Technical Standard INEN 2486,
which did not have product safety tests as its main objective. Lastly, it
should be noted that the manufacturer or distributor was required to obtain a
raw material conformity certificate; in other words, the raw material
certificate had to be appended to the conformity certificate for the finished
product. This would imply the establishment of requirements that would be in
breach of Article 5.1.2 of the TBT Agreement, as they would generate
unnecessary duplication, given that the finished product certificate was the
document that best served to guarantee that the raw material was suited to the
type of product and that it also met the specific manufacturing standards.
2.68. Accordingly,
Mexico urged Ecuador to: (i) eliminate the specific packaging
requirement for imported products and to make the necessary change to ensure
compliance with the principle of non‑discrimination provided for in the
TBT Agreement; (ii) take international standard IEC 61537 as a
basis for fulfilling the objective pursued by Technical Regulation
No. 047, and if this would not be deemed appropriate, to provide the
necessary justification. In this connection, it was requested that renewed
consideration be given to making compliance with Ecuadorian Technical Standard
NTE INEN 2486 compulsory, for the reasons mentioned earlier;
(iii) eliminate the exemption from requirement of a conformity assessment
certificate for products with the Ecuadorian Standardization Institute (INEN)
quality seal, because of its discriminatory basis; and (iv) eliminate the
requirement for presentation of a raw material conformity assessment
certificate, or if this requirement would be maintained, to provide
justification for its inclusion among the requirements under this regulation.
2.69. The
representative of Ecuador took note of the concerns expressed by Mexico
and said that they would be further discussed bilaterally, given that they had
only recently been introduced on the agenda.
2.2.2.18 Ecuador - (PRTE INEN) No. 111: Energy efficiency, clothes dryers
labelling
2.70. The
representative of Mexico thanked the Chairman and expressed its trade
concern with respect to Ecuadorian Emergency Technical Regulation
(RTE INEN) N° 111, entitled "Energy Efficiency, Clothes Dryers,
Labelling", which was notified by means of document G/TBT/N/ECU/152 of
28 January 2014. Mexico did not find in the regulations any
specification or reference concerning unexpected events of an urgent nature
that might have justified their issuance on an emergency basis. Moreover,
Mexico noted that the Ecuadorian Government took no account of the formal
comments transmitted to Ecuador on 24 February 2014. Mexico also
considered that the technical regulation could imply a violation of the
proportionality principle established in Article 2.2 of the
TBT Agreement by defining excessively high ranges of energy efficiency
which would limit the access of products to the Ecuadorian market (only ranges
"A" and "B" would be admitted). According to information
from industry sources, there were no precedents for such a measure at
international level, since even under schemes such as that of the European
Community, the eco‑design directive for clothes dryers still permitted the
marketing of range "C" products. In this connection, Ecuador was
requested to supply information providing justification for these requirements
in the light of the legitimate objective pursued by Emergency Technical
Regulation RTE INEN 111.
2.71. Mexico
also expressed its concern at two specific requirements included in the
technical regulations ‑ which provided for different certification
schemes, such as certification "by batch" or "by
scheme" ‑ and which were applicable to other household electrical
goods, namely: Emergency Technical Regulations RTE INEN 109 (gas water
heaters); RTE INEN 196 (lighting chains); RTE INEN 077
(washing machines); RTE INEN 124 (washer‑dryers);
RTE INEN 072 (Air conditioners); and RTE INEN 036
(fluorescent lamps). No provision were made, however, for certification
"by type" of product. Mexico requested that these Ecuadorian
technical regulations also admit this latter type of certification or, if
necessary, that justification be provided for it not being admitted. Furthermore,
despite the fact that certificates and test reports on the technical
regulations had been submitted in Spanish, Ecuador has maintained the
requirement that they be authenticated by apostille. Ecuador was thus requested
to provide information justifying this requirement in the light of the
principles contained in Article 5.1 of the TBT Agreement.
2.72. The
representative of Ecuador took note of the concerns expressed by Mexico
and said that they would be further discussed bilaterally, given that they had
only recently been introduced on the agenda.
2.2.3.1 India – Pneumatic tyres and tubes for automotive vehicles (G/TBT/N/IND/20,
G/TBT/N/IND/20/Add.1, G/TBT/N/IND/40 and G/TBT/N/IND/40/Rev.1) - IMS Item No.
133
2.73. The
representative of Japan said that according to Article 10.2 of the
revised "Agreement for granting of BIS licences", tyre manufacturers
outside India were required to pay a bank guarantee fee of USD 10,000,
resulting in unnecessary and different competition conditions for factories
inside and outside India. Japan requested the government of India to consider
amending the regulation. India had explained that the bank guarantee was needed
to recover expenses related to breach of agreement by manufacturers outside
India. Japan requested India to show evidence that such bank guarantee fees
were common internationally. Further, Japan was of the view that the ISI
marking fee in India was more expensive than in other countries and requested
India once again to show evidence that the ISI marking fee in India was
equivalent or not more expensive compared to other countries. Finally, Japan
requested India to consider shortening the time for certification procedures as
it was always taking a long time, around four to five months, to obtain
certification for any tyre size.
2.74. The
representative of the Republic of Korea reiterated concerns about the
Indian Quality Order on Pneumatic Tyres and Tubes for Automotive Vehicles,
regarding which no solution had been found although the issue had been raised
repeatedly by Korea and other Members since 2010. Through bilateral meetings,
Korea and India had made some meaningful progress regarding the ISI mark on
tyres to be exported to third countries. However, there were two outstanding
issues, namely the ISI marking fee and the discriminatory bank guarantees,
which Korea requested India to reconsider and resolve. The marking fee issue
could be resolved easily if the possibility of reciprocal treatment was
considered, namely if Korea required that Indian companies pay a heavy charge
on Indian products with the Korean standard marker heading to other markets.
Korea strongly urged India to reconsider these matters and to provide a
reasonable resolution without any further delay.
2.75. The
representative of the European Union reiterated concerns with regard to
the Indian Quality Order on Pneumatic Tyres and Tubes for Automotive Vehicles,
which introduced a certification procedure with a mandatory marking for tyres.
The EU requested India once again to reconsider its marking fee system, which
currently applied to each ISI-marked tyre and not only to those actually sold
on the Indian market. The EU asked India to remove these royalty fees, which
were extremely burdensome and much more restrictive than necessary, or at least
to limit them to tyres which were sold on the Indian market. Furthermore, as
already indicated in previous meetings, the EU considered that the USD 10,000
bank guarantee that the BIS could use in case of breach of the BIS Agreement
was both discriminatory and an unjustified practice because it applied only to
foreign manufacturers. In fact, pursuant to Article 3.4 of the BIS Agreement,
it appeared that liability for the breach of the Agreement could already be
exerted on the authorized representative of a foreign manufacturer in India.
India was therefore once more invited to explain the rationale for introducing
a new bank guarantee when other legal means already existed in order to ensure
compliance with the BIS Agreement and to remove this provision. Finally, the EU
requested India to confirm that it was possible to get the licences renewed for
two or three years without the need for additional plant inspections.
2.76. The
representative of India said that the "Pneumatic Tyres and Tubes
for Automotive Vehicles (Quality Control) Order, 2009, which applied to both
domestic and foreign manufacturers, had been issued on 19 November 2009 and
entered into force on 13 May 2011. By virtue of this Order, pneumatic tyres
could be imported to India only if they conformed to the specified standards
and bore the Standard Mark of BIS. For this purpose, foreign manufacturers
desiring to export their goods into India were required to enter into an
Agreement with BIS to be granted the BIS licence so that they can use the BIS
Standard Mark on their goods. The foreign manufacturer was also required to
furnish a bank guarantee of USD 10,000 in favour of BIS for due compliance with
the provisions of the BIS Act, rules and regulations, and terms and conditions
of the license. The bank guarantee was necessitated in view of a default by a
foreign manufacturer on its payment of dues to BIS, which could not be realized
even after the matter was taken up with the Embassy of that country. It was
intended to protect the interests of BIS during the tenure of the license and
was invoked only in case of breach of any condition of the agreement signed
between BIS and licensee. It essentially covered any possible loss of revenue
to BIS on account of non‑payment of requisite marking fee dues to BIS and also
took care of legal expenses, if any. In case of any violation of the BIS Act,
rules and regulations, or non‑payment of the marking fee by a domestic
manufacturer, BIS could seek compensation through Court, whereas the law of the
land could not be enforced in foreign countries. During the previous meeting,
one Member had suggested that the liability for the breach of the Agreement
could be exerted on the authorized representative of the foreign manufacturer
in India and that bank guarantee was therefore not needed when other legal
means already existed to ensure compliance with the BIS Agreement. In this
regard, he pointed out that the authorized representative might not have any
control on the manufacturing process of the manufacturer and, as per law, might
not be held responsible for any breach of contract by the manufacturer.
2.77. He
indicated further that the BIS charged a fee on all goods produced and marked
with ISI. Some Members had asked that the marking fee be calculated only on
those goods, which were exported to India. He noted that the marking fee would
not be charged in case the manufacturer supplied their goods to other countries
without the ISI mark, but they were liable to pay a royalty fee to BIS if they
covered that supply with the ISI mark. Moreover, there was a possibility that
the goods sold in overseas market might eventually land in India on a later
date. It was also important to mention that the marking fee was being charged
on domestic manufacturers not only for goods they sold domestically but also
for goods that they exported with the ISI mark. Marking fee was charged at the
same rate on foreign as well as domestic manufacturers and varied from 0.01% to
0.2% of the cost of the product. For example, the cost of a commercial vehicle
tyre was approximately Rs. 20,000 and the marking fee was Rs. 2 per
tyre, which came to 0.01%. Therefore, the marking fee could not be considered
as exorbitant. In the previous meeting, one Member had sought clarification on
the levy of an additional certification fee of USD 90 when a factory
applied for certification for a new tyre size. He explained that a processing
fee of Rs 5,000 in equivalent USD was charged for inclusion of new
varieties of tyres on each occasion irrespective of the number of tyre sizes to
be included. This fee and the renewal application fee of Rs 1,000 were the
same for domestic as well as foreign manufacturers. Other concerns raised by
Members were being forwarded to the capital and a response would be conveyed to
the concerned delegations in due course.
2.2.3.2 India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) - IMS Item
No. 167
2.78. The
representative of the European Union reverted to concerns regarding the
registration of cosmetic products in India, which had entered in force in March
2013. On 2 January 2013, India had issued Guidelines on the Registration of
Imported Cosmetics, establishing that the label of imported cosmetics had to
bear the registration certificate number of the brand and name and address of
the registration certificate holder and that stickering of labels containing
this information may be allowed to be carried out after import at a suitable
place approved by the licensing authority. The EU welcomed the fact that
stickers providing this India-specific information were allowed but also
reiterated its request for India to extend the possibility of providing
information via stickers at customs bonded ware houses to all aspects of
cosmetics labelling, including the list of cosmetic ingredients or any other
information relevant for the consumer. This was a very important trade
facilitating measure that did not jeopardise India's legitimate health and
safety objectives and was particularly relevant for manufacturers that exported
small quantities and found it difficult to adapt the labels to requirements of
different geographical regions. In this respect, on 29 September 2014 the
Office of Drugs Controller General of India had issued a memorandum stating
that "it had been decided under rule 148-A of the drugs and cosmetics
rules, 1945 to permit relabeling or stickering on the label of cosmetics which
have been imported under universal labelling and packaging without concealing
the original label, to conform to the labelling requirements of the said rules
before these are marketed for sale". According to the EU, this latest
memorandum permitted importers to re-label or place a sticker on products to
comply with all Indian labelling requirements and not only the India-specific
ones. The EU asked India to confirm whether this reading was correct.
2.79. On
a related matter, on 16 June 2014 the Indian Central Government had amended the
legal metrology Packaged Commodities Rules 2011 to require that cosmetic
products bear a red or a brown dot at the top of the principal display panel
for products of non-vegetable origin and a green dot for products of vegetable
origin. The rules had not been notified to WTO Members under the TBT Agreement
and had entered into force 15 days after publication. The EU reminded India of
the notification obligations and the absolute need to provide sufficient time
for market operators to adapt to new labelling requirements. In this context,
the EU asked India to notify the measure, provide time for comments and
postpone implementation deadlines. In addition, the EU invited India to clarify
how the vegetarian/non-vegetarian information would need to be provided and
whether stickers would be allowed. Finally, the EU was concerned with the
application of a new importing checklist to check compliance of imported
products with the Indian requirements, which was requiring market operators to
provide data and tests that were not foreseen in the basic Cosmetics Law of
2010. The previous checklist used by DCGI had been in line with the Indian
Cosmetics Law and guidance documents issued in 2013. Regular changes in the
importing procedures and labelling requirements were seriously disrupting trade
flows. In this context, the EU called on India to take the necessary steps to
ensure a predictable business environment in this area and adopt less
restrictive means to fulfil its legitimate objectives.
2.80. The
representative of Canada expressed appreciation for India's willingness
to provide additional clarifications of its Medical Device Regulatory System
during meetings held on the margins of previous TBT Committee meetings as well
as in responding to Canada's questions in the context of the WTO Trade Policy
Review of India in September 2011. However, Canada still had not received
sufficient detail and clarity regarding specific aspects of the regulatory
system and welcomed any additional details on India's future plans for medical
device regulation and the status of the Drugs and Cosmetics (Amendment) Bill,
2013, which as Canada understood, had not been passed by Parliament and contained
provisions for a new medical device regulatory system. Regarding the Guidance
Document on Common Submission Format for Registration/Re-Registration of
Notified Medical Devices in India, which had been published by the Central
Drugs Standard Control Organization (CDSCO) in October 2012 and entered into
force in January 2013, Canada sought information on whether: (i) medical
devices approved by Health Canada would be recognized on the same terms as
those bearing the European Union's CE marking approval; (ii)
certificates/licences needed to be notarized/attested by the Indian Embassy in
the country of origin; and (iii) medical devices needed to be approved for sale
in the country of origin. Canada also welcomed further details on whether
India's requirements for country of origin labelling of medical devices
differed from those of member countries of the former Global Harmonization Task
Force (GHTF).
2.81. The
representative of India indicated that comments had been received from
the capital regarding a suggestion made by a delegation during the previous
Committee meeting that stickers be allowed on imported cosmetics for providing
information on all aspects of cosmetics labelling, including list of
ingredients and any other information for consumers. In this regard, he noted
that as per Rule 129H of the Drugs and Cosmetics Rules, the label of imported
cosmetics shall bear the registration certificate number of the product and the
name and address of the registration certificate holder for marketing the said
product in India. Furthermore, the Guidelines issued on 2 January 2013 allowed
stickering of labels containing the registration certificate number of the
brand and the name and address of the registration certificate holder, after
goods were imported and at a suitable place approved by the Licensing Authority.
Subsequently, on 29 September 2014 (as per Office Memorandum No.
DCGI/MISC/2014(44)), permission had been granted for stickering on the label of
cosmetics, imported under universal labelling and packaging, without concealing
the original label and conforming to the labelling requirements of the said
Rules, before they were marketed for sale. However, only the registration
certificate number of the brand and the name and address of the registration
certificate holder were permitted via stickers; hence stickering of any other
information pertaining to cosmetics labelling, such as list of ingredients, was
not allowed under the Drugs and Cosmetics Rules. If stickers were allowed to
display all mandatory information, such a facility would be liable for misuse
by unscrupulous traders after the goods were cleared into the domestic market.
Thus, the policy objective of informing the consumers would not be properly
served if all requisite information was displayed using stickers on the
packages. He said that concerns raised would be forwarded to the relevant
authorities in the capital and their response would be conveyed to the
interested delegations in due course.
2.2.3.3 China – Provisions for the Administration of Cosmetics Application
Acceptance. Cosmetics Label Instructions Regulations and Guidance for the
Cosmetics Label Instructions (G/TBT/N/CHN/821, G/TBT/N/CHN/937) - IMS Item No.
296
2.82. The
representative of Japan thanked China for its efforts, but reiterated
its concern on two points regarding guidance for application and evaluation of
new cosmetic ingredients ("the Guidance"). Firstly, he noted that
since the implementation of the guidance in May 2011 only four new ingredients
had been registered so far, and there still remained significant resistance to
exports of cosmetic products to China with new ingredients. Japan therefore
asked China to accelerate examination of new ingredients. Secondly, the
guidance required safety evaluation data to be submitted for each single
molecule isolated from plant extracts and fermented solvents. Japan underlined
that such requirement was excessive and trade restrictive because they were not
applied by other Members, such as United States, the European Union or even
Japan. Japan therefore asked China to revise the guidance in a way that
cosmetics manufacturers could register new ingredients without isolation of new
ingredients. In case China did not accept this request, Japan asked China to
share the scientific basis for requiring evaluation of single molecules
isolated from a complex ingredient, as well as the risks that China saw in
evaluating complex ingredients without isolation.
2.83. The
representative of Canada reiterated concern regarding China's Food and
Drug Administration's (CFDA) burdensome approval and registration process for
cosmetic products. He insisted that the lack of progress in approving new
ingredients was a serious barrier to trade. According to Canada, the
"positive list" approach did not ensure an improvement in safety compliance
and was redundant with regulation mechanisms already in place. Canada was
concerned that the "positive list" approach would actually prevent
Chinese consumers' access to safer and more innovative cosmetic products.
CFDA's intention to define what was "a new" vs. "an
existing" ingredient according to a positive list risked a sudden
characterization of thousands of ingredients that were already sold on the
Chinese market as suddenly "new". Canada was also concerned that
domestic cosmetic manufacturers were able to register "new
ingredients" without an additional application process. Further, Canada
was deeply concerned that China applied a different registration process for
its domestic cosmetics manufacturers than it did for importers. He argued that
streamlining the approvals processes for imported cosmetics and applying the
same registration process applied to domestic cosmetic products would create a
fair trade environment for the cosmetic industry, consistent with the TBT
Agreement.
2.84. The
representative of the Republic of Korea underlined his delegation's
respect for China's efforts to protect consumer safety and noted that Korea's
cosmetics manufacturers were trying to comply with the regulation as far as
possible. Regarding the labelling requirements notified under G/TBT/N/CHN/937,
Korea reiterated its concerns that the mandatory regulations of the CFDA and
AQSIQ were overlapping and had even conflicting requirements. He considered
that the Chinese measures conferred unnecessary burden and confusion to many
producers. Therefore, Korea requested China to harmonize the regulation of the
CFDA with the existing regulation of AQSIQ which was based on ISO standards.
2.85. The
representative of the European Union joined the delegations of Japan,
Canada and Korea and asked China to update the Committee on the measures taken
since last meeting to accelerate the procedure for new ingredients
authorisation. The EU was of the opinion that the new registration procedure of
"new ingredients" (G/TBT/N/CHN/1019), was unlikely to deliver the
speed efficiency and predictability essential in the cosmetics sector. She
noted that as several new ingredients were developed per year and only four had
been registered in the last four years, a new system should offer a more efficient
approval of ingredients. The EU mentioned that an authorization system
restricted to only certain ingredients, such as UV filters, colorants and hair
dyes, would be more adequate, as cosmetics were not pharmaceuticals. For the
remaining ingredients, which were the majority of cosmetic ingredients, the
safety characterization and assessment should be done under the responsibility
of the manufacturer. In this context, the EU suggested to China to limit the
procedure for registration of new ingredients to priority substances - i.e.
higher risk substances - and allow a lighter procedure for lower risk
substances; and share the safety responsibility for new ingredients between
China's Food and Drug Administration (CFDA) and the registrant company for low
risk substances.
2.86. The
representative of China reminded the Committee that since the notification of
the measure in July 2011, the CFDA offered specialized training and guidance on
the difficulties enterprises had met in the implementation of this measure. In
addition to cooperation at the governmental level, CFDA had kept bilateral
channels open and formed several working groups on this issue with several
Members. The approving procedure was thus being carried out orderly. She said
that, by 30 September 2014, CFDA had approved 10,367 imported cosmetics
applications, which was more than the average number of the same period last
year. China promised to remain available to discuss the issue bilaterally and
welcomed further cooperation and valuable inputs from interested parties.
2.87. Regarding
Canada's concern on the positive list, China explained that there was no
"positive list" and that the "inventory of used cosmetics
ingredients in China" was still under drafting. China explained that it
was not a "positive list" on cosmetic materials, but instead a list
to distinguish whether a material was used in cosmetics produced or sold in
China. The document designed a sole standard on approving new cosmetic
materials, to prepare for devolving responsibility of managing imported
"normal cosmetic" registrations to provincial level authorities. CFDA
had carried out two rounds of public opinion soliciting, and the industry had
added over 10,000 existing materials to CFDA. Except the materials banned for
safety hazards, all cosmetic materials that were used in the Chinese market
were going to be included in this document. Every kind of material would be
marked by both Chinese and INCI name. Regarding the "Adjustment of
Cosmetic New Ingredient Registration Management" (G/TBT/N/CHN/1019), China
explained it was issued to accelerate the approval procedure of new cosmetic
materials through an adjustment on administration level. As for the
"Cosmetics Label Instructions Regulations and Guidance", China
explained that, due to the adjustment of CFDA's legislation plan, there would
be a new regulation on cosmetics labelling before the end of 2014, which would
be notified to WTO.
2.2.3.4 India – New Telecommunications related Rules (Department of
Telecommunications, No. 842-725/2005-VAS/Vol.III (3 December 2009); No.
10-15/2009-AS-III/193 (18 March 2010); and Nos.
10-15/2009-AS.III/Vol.II/(Pt.)/(25-29) (28 July 2010); Department of
Telecommunications, No. 10-15/2009-AS.III/Vol.II/(Pt.)/(30) (28 July 2010) and
accompanying template, "Security and Business Continuity Agreement") -
IMS Item No. 274
2.88. The
representative of the European Union thanked India for its willingness
to engage in discussions with European Industry and with the EU and said that,
according to his knowledge, following a decision by the Department of
Telecommunications of the Indian Ministry of Communications and IT of 7
July 2014, the entry into force of the in‑country testing of telecom
products for information security reasons was postponed to 1 April 2015.
The EU welcomed this postponement, as they it did not consider the proposed
system as being ready for implementation. Until then, the EU was under the
understanding that a status quo
would apply and that foreign test results would continue to be accepted. The EU
welcomed confirmation by India that relevant tests would have to be carried out
according to international standards, namely the common criteria ISO/IEC 15408 Common
Criteria standard, ISO 27000 for information security management systems, and
the standards developed by the third generation mobile technology partnership
project, 3GPP and 3GPP2, as regards telecom and telecom network elements
problems. He also was under the understanding that India was in the process of
joining the 3GPP2, a step also welcomed by the EU towards ensuring lasting
adherence by India to standards developed by this platform. The EU understood
that test results from laboratories appointed by the Common Criteria Recognition
Arrangement (CCRA) would continue to be accepted also beyond
1 April 2015 for the purpose of the required security assurance,
which would be in line with India's obligations as a full member of the CCRA.
The EU invited India to continue discussing with telecom equipment suppliers to
develop working methods and procedures reflecting international practice. As
for security aspects of mobile telecom elements which were not covered by the Common
Criteria standard, the EU asked that India accept results of qualified foreign
laboratories holding accreditation from ILAC MRA signatories beyond 1 April 2015,
and that India therefore not require exclusively in‑country testing, but
instead continue to accept foreign test results as a basis for any
certification to be issued in India by appointed certification bodies.
2.89. The
representative of the United States welcomed India's positive efforts as
well as the delaying of the implementation to a better time. She associated
itself with the EU's comments, requesting India to accept test results from
accredited laboratories that are ILAC and IAF signatories, and not exclusively
India-based laboratories.
2.90. The
representative of Japan supported the EU and US positions, and confirmed
Japan's interest to the Unified Access Service Licence Agreement.
2.91. The
representative of Canada supported the comments made by the EU, US and
Japan, noting it was not aware of the most recent developments. Up until very
recently they were concerned that the order continued to hinder, and possibly
shut, Canadian exports out of the Indian market, due to delays in registration
and testing. He underlined the relevance of relying on well‑established
international standards for evaluating the competence of conformity assessment
bodies, particularly ISO/IEC17025, and ISO/IEC17065. The ILAC/IAF mutual
recognition agreements (MLAs) also provide for a peer review systems to ensure
the competence of signatory accreditation bodies. They asked India to confirm
they were moving in this direction. He agreed with other concerned Members that
recognition by India of test results by foreign conformity assessment bodies
accredited by the signatories of ILAC and IAF MLAs to test and certify to
India's regulatory requirements would minimise the negative impact on companies
wishing to export to India, while at the same time providing assurance to India
that the recognized conformity assessment bodies are competent. Allowing
accredited foreign conformity assessment bodies to test and certify to India's
regulatory requirements would reduce testing costs and allow exporters to bring
their products to the Indian market more quickly. Finally, Canada noted that
substantive amendments to the Order, such as those with respect to marking and
labelling requirements, should be notified to the TBT Committee, and any
update by India on these points would be welcome.
2.92. The representative of India reiterated that
in‑country security testing of telecom equipment was mandated for
"national security reasons" due to the fact that in modern age
telecommunication equipment was vulnerable to spyware and malware attacks.
Therefore, in May‑June 2011, telecom service providers were instructed by
the Department of Telecommunication that they "shall induct only those
network elements into their telecom network, which have been got tested as per
relevant contemporary Indian or International Security Standards". For
example, IT and IT related elements were to be tested against
ISO/IEC 15408, and Information Security Management System against
ISO 27000 series. These tests were to be conducted from any international
agency/labs of the standards such as Common Criteria Labs in case of
ISO/IEC 15480 standards, until 31 March 2013. As from
1 April 2013, the certification was to be got done only from
authorized and certified agencies/labs in India. This deadline was subsequently
extended from time to time; and the latest extension of 9 months had been
granted from 1 July 2014 to 1 April 2015 for complying with
the mandatory requirement of in‑country testing.
2.93. India
also reiterated its view that the Common Criteria was not sufficient for the
purpose of security testing of telecom equipment because its testing was
limited to IT and IT related products. Moreover, being a process based testing,
while the Common Criteria largely addressed the issues of commercial security
consideration, it did not however address national security issues. Therefore,
in respect of testing of IT products to be used in telecom networks which have
already been tested under CCRA, due leverage would be given to the CC testing.
Additional tests, if required, would be carried out as per the prescribed
systems, processes and standards. Finally, India explained that when an IT
product was used in telecom network, it became a telecom network element where
functional or operational requirements were governed by 3GPP or 3GPP2
standards. India intended to use the 3GPP and 3GPP2 standards also for testing
and certification of telecom equipment. In this regard, India was taking
necessary steps for participating in the exercise of formulating security
standards by 3GPP/3GPP2 Sub-Group.
2.2.3.5 China – Requirements for information security products, including,
inter alia, the Office of State Commercial Cryptography Administration (OSCCA)
1999 Regulation on commercial encryption products and its on-going revision and
the Multi-Level Protection Scheme (MLPS) - IMS Item No. 294
2.94. The
representative of the European Union asked China to provide an
update on the revision of the OSCCA regulation on commercial encryption
products that had been on the agenda of the State Council legislative office
for several years. He also requested China to confirm that there would be a
TBT notification in timely and due manner of the final draft of the
proposed revisions in order to allow Members for a meaningful opportunity to
provide comments. Any update on the substance of the revisions would be
welcome, beyond what the EU already knew, i.e. the fact that the new regulation
would remove the discriminatory provisions that prevented foreign suppliers
from applying for certifications. The EU was also concerned with the
implementation of the multi-Level Protection Scheme (MLPS), in particular the overly
extensive scope of the definition for "critical infrastructure"
and the current restrictions that prevented the procurement of products
incorporating foreign technology for use in critical infrastructure. The EU
also mentioned that standardisation remained another area of concern due to the
impossibility for foreign stakeholders, even if they have investments and were
established in China, to meaningfully participate in this process. This was
compounded by the overall opacity of the process and too short time periods for
comments on draft standards. The EU requested China to ensure that standards
bodies under government control fully comply with the WTO Code of Good
Practice. The EU invited China to make use of relevant international standards
in this field rather than promoting home-grown solutions and to play a full
role in the development of such international standards. Finally, the EU noted
that in the margins of the Government Authorities Meeting of Semi-conductors
(GAMS) meeting held on 14-16 October in Japan, a Seminar on Commercial Encryption
Licensing and Certification took place, with participation from EU, India,
Japan, Korea, the US, among others. This event helped foster exchange of
information about current approaches in the field of encryption and highlighted
the need to step up international cooperation in this area.
2.95. The
EU stressed the importance of international cooperation to address global
issues, and develop resilient systems deploying the best possible technology on
the market. He underlined that it was in no Member's interest to segregate
markets for encryption purposes by foreclosing the possibility of using foreign
technology in their own market against cyber‑attacks that could originate
anywhere in the world. The GAMS endorsed the principle of promoting greater
transparency regarding relevant regulatory policy developments, and the EU
underlined that transparency and cooperation go hand‑in‑hand. The EU stated
that it looked forward to further discussions and dialogue with the Chinese
authorities going forward.
2.96. The
representative of Japan reiterated its support the EU's position and
noted that Japan paid particular attention to various schemes and regulations
within China on information security, and how they could negatively affect
trade of information security products.
2.97. The
representative of China informed that the Regulation on Commercial
Encryption Products was due for revision. This revised version aimed
to ensure equal treatment for foreign and domestic businesses and take the
development of information industry into account. This revision had the
purposes of: (i) protecting information security; (ii) safeguarding
the legitimate rights and interests of citizens, legal persons and other
organisations; and (iii) protecting national security and public
interests. China also continued bilateral and multilateral negotiations with EU
and other Members. The draft had just been submitted to the legal affairs
office of the State Council. OSSCA had been open and transparent, carrying out
reviews and public consultations during the drafting.
2.98.
China also updated the Committee on the state of the revision process of the
Multi-Level Protection Scheme (MLPS). The essence of the Regulation on
Classified Protection of Information Security was to classify the protection on
information systems, aiming at safeguarding the basic information network and
important information systems to ensure national security and public interests.
The security of information systems in banking, education, healthcare,
transportation and other public utilities were all issues to which China
attached great importance, due to their close relationship with citizens'
welfare. Therefore, the "importance" of information systems was not
necessarily decided by the sensitivity of that industry but also by the
possible damage it could cause to, inter alia,
national security, social order, economic development and public interests. In
addition, these systems only covered a very limited portion of all the
information systems in China. Therefore, it seemed very unlikely that the
measure would be able to cause "significant" effects to international
trade. China reiterated that in terms of intellectual property protection and
government procurement, all enterprises within China would be treated equally
in accordance with the non‑discrimination principle of the TBT Agreement.
2.2.3.6 Russian Federation – Draft on Technical Regulation of Alcohol Drinks
Safety (published on 24 October) (G/TBT/N/RUS/2) - IMS Item No. 332
2.99. The
representative of the European Union requested an update on the
status and timeline for adoption of this draft technical regulation, scheduled
to be finalized during summer 2014. It also requested that Russia notify
this new draft to the TBT Committee as it would likely include substantial
change as compared with the text notified in 2012. The EU also noted it had
also submitted detailed written comments in 2013, and encouraged Russia to take
them into consideration. The EU also made various comments on the substance of
the new draft. Concerning wines, the EU welcomed the fact that the use of
''concentrated must'' and ''rectified concentrated must'' were recognized as an
oenological practice in the new version of the draft. In this respect, the EU
asked for the confirmation that wines enriched with ''must'' were not
considered "table wines". The EU also asked for a guarantee that
EU geographical indications (GIs) would be duly protected and
that wines with GIs would continue to be allowed to be bottled in Russia and
maintain the GI designation. Concerning beers, the EU asked for
confirmation that the limit on sugar content of beers would be removed and the
use of fruits as well as additives would not trigger the obligation to label
beers containing such components as "beer beverages". The EU
also requested confirmation that brewery products were still excluded from the
ban on PET packaging.
2.100. The
representative of Mexico recalled that her delegation had sent written
comments to Russia in December 2011 and April 2012, but had not yet
received any formal responses. She also requested Russia to provide updated
information on the state of progress on the elaboration of the regulation and
the current state of play with regard to its final adoption. She also asked
Russia to explain how the Mexican comments were taken into account in relation
to the final text of the regulation in question and to provide a written formal
response to those comments.
2.101. The
representative of Australia reiterated that both Australia and Russia
shared the commitment to adopt internationally accepted standards for alcoholic
products as recommended by the International Organisation of Vine and Wine
(OIV), and to avoid creating unnecessary obstacles to trade in wine. Australia
submitted comments on Russia's notification on 6 February 2013,
focusing on a number of commonly used additives and processing aids that
did not affect the safety of the alcoholic product. Australia noted that
it had been joined in its concerns by a number of other Members who considered
the new measures to be both overly burdensome and repetitive. In the light of
this, Australia once again suggested that Russia consider adopting the OIV list
of approved additives and processing aids, as set out in the
"International Oenological Codex" and the "International Code of
Oenological Practices". Australia remained concerned about the legal
status of wines which conformed to the health warning statement under the previous
legislation, and were in circulation at the time the draft regulation entered
into force. Australia asked again that Russia introduce a six‑month transition
period for these products to enable industry sufficient time to implement the
stated labelling requirements. Australia also reminded Russia of their concerns
over the requirements relating to the bottling location of wines which include
a GI in their description and presentation.
2.102. The
representative of the Russian Federation informed that the internal
adjustment of the draft of the technical regulation on the safety of alcoholic
products was still in process, and that Russia remained open for further
bilateral discussions and willing to keep Members informed of the process.
2.2.3.7 Republic of Korea – Regulation on Registration and Evaluation of
Chemical Material (G/TBT/N/KOR/305) - IMS Item No. 305
2.103. The
representative of the United States said that while her delegation
acknowledged the extensive stakeholder engagement on this issue, the US
remained concerned about the protection of confidential business
information (CBI). The US thus encouraged Korea to develop a strong
definition of CBI so as to include at least the possibility of protecting the
specific chemical identity, composition, and uses, while respecting the
legitimate government interest in allowing for reporting of generic chemical
names, and for providing adequate hazard information to downstream users. The K‑REACH
framework should include additional provisions to help prevent any disclosure
of CBI to the public or other manufacturers and importers. She insisted that
Korea should tighten the definition of "hazardous substance" so
as to avoid confusion and an overly broad application that would de facto
prevent claims of CBI for any substance. Specifically, the US considered that
the phrase "other chemical substances that either pose or raise the
concern of hazard or risk" should be deleted from the definition. The US
also encouraged Korea to give greater consideration to industry requests for a
delay of the implementation date in light of the practical issues that have
been raised. Finally, the US mentioned that the role of the Korean Chemical
Manufacturers Association (KCMA) needed to be defined and it needed to
guarantee a level playing field for domestic and foreign registrants.
2.104. The
representative of Japan associated himself with the US comments.
Regarding products containing around 500 hazardous substances, not less
than 0.1% by weight and not less than 1 ton per year in total, he
said that it would be necessary to notify the authority of the production,
sales and import of them. Japan reiterated its request for Korea to introduce
the regulation by stepwise manner according to the priority of hazardous
substances, as Japan had not received any reply yet. Japan was under the understanding
that the enforcement regulation stipulated the necessary test items for
registration on this regulation, and that the National Institute on
Environmental Research's public notice was the instrument regulating in detail
the conduct of the examination process. However, Japan believed that this would
represent heavy burdens for the Japanese industries, which would have to
carry out a lot of test items on the enforcement regulation. Japan thus
requested Korea to alleviate the mandatory testing in cases where the test
results required further registration under the regulation could reasonably be
estimated from: (i) other test results on the same substance the
registration of which it was applied for; (ii) existing reliable knowledge
on the substance the registration of which it was applied for, such as
published articles, or publically accessible database and documents; and
(iii) publically known test results regarding other substances
constitution of which it was similar to that of the substance the registration
of which it was applied for.
2.105. The
representative of the Republic of Korea informed the Committee that the
Presidential and Ministerial Decrees to the Act on Registration and Evaluation
of Chemical Substances would be published in November 2014. The Act and
the Decrees were scheduled to take effect on 1 January 2015.
Regarding protection of confidential business information (CBI), he
pointed out that CBI including composition and contents of chemical materials
would be excluded from the scope of information to be provided. CBI submitted
during the registration process was going to be protected upon request if CBI
corresponded to that stipulated in the "Unfair Competition Prevention and
Trade Secret Protection Act". In addition, although R&D substances and
low‑concern polymer compounds were exempted from registration, they shall be
applied for exemption as "Toxic Chemicals Control Act (TCCA)"
required it currently. For impurities and by products which were
unintentionally produced, or those which existed in other chemicals, those
substances shall not be registered if they were not commercially distributed or
circulated. He also noted that the Korean Ministry of Environment had already
replied in writing to the United States on 7 April 2014. He
informed that the other issues that had been raised at the present
Committee meeting would be sent to the competent Korean authorities.
2.2.3.8 Indonesia - Technical Guidelines for the Implementation of the
Adoption and Supervision of Indonesian National Standards for Obligatory Toy
Safety (G/TBT/N/IDN/64, G/TBT/N/IDN/64/Add.2) - IMS Item No.328
2.106. The
representative of the European Union expressed regret about the fact
that the new regulation on compulsory testing for toys according to the
Indonesian mandatory standard for toy safety had been implemented on
30 April 2014 without taking into account the substantive concerns
raised by a number of Members and their toy industries. He noted
EU exporters' continuing concerns with the implementation of
Decree No. 24 of Ministry of Industry (and related technical
guidelines), including with the lack of clarity about the process. One area of
remaining concern was the burdensome and discriminatory
conformity assessment procedures between imported and domestically
produced toys. For imported toys testing based on sampling was required for
each batch, which compared unfavourably with tests of samples taken every
six months from the production line for domestic products. Despite some announced
revisions in the sampling procedures, in respect of which the EU requested
further clarifications, the EU exporters still reported difficulties and delays
in getting clearance for their products. The EU therefore invited Indonesia to
reconsider the full issue of conformity assessment and sampling for tests and
testing procedures for imported toys in order to ensure a level playing
field with domestic products. The EU also understood that a technical working
group had been set up in the Ministry of Industry to allow for discussions
between authorities and affected toy manufacturers. The EU welcomed this
development and invited the Indonesian Ministry of Industry to work with the
technical working group to propose amendments to the existing legislation to
address the concerns raised. Regarding testing, he noted that the current 2‑year
grace period allowing the acceptance of foreign tests by laboratories
accredited by ILAC MRA signatories, was due to expire in October 2015.
The EU thus urged Indonesia to extend the acceptance of foreign tests beyond
the expiry of this grace period as the capacity of local laboratories would be
insufficient to deal with the current demands. In this respect, he stressed
that there was no prospect of the capacity to be increased to meet expected
demands by October 2015.
2.107. The
EU also raised concerns regarding the impact on toys of the revised general labelling
requirements (linked to STC ID 436[3]),
which added to the specific marking and labelling requirements prescribed by
Decree No. 24. He noted that in Indonesia toys were subject to two separate
sets of labelling requirements: one stemming from the specific toys regulation,
and another from the mandatory labelling in Indonesian language. Since the
label required under the toys regulation needed to include the shipment tax
number, which could only be obtained after the shipment had reached customs,
the combined application of the two sets of requirements entailed that every
single item had to be handled manually twice: before shipment, according to the
general requirements for labelling in Indonesian language, and after
importation, in order to meet the specific labelling requirements under the toy
regulation. This created a disproportionate burden and cost for foreign toy
manufacturers and importers, as well as unnecessary delays in placing the
products on Indonesian market. In addition, the requirement of permanently
affixing labels on certain types of toys could in itself give rise to safety
concerns. This was so because, as permanent labels could be removed by children
playing with the toys, this could damage the toy and expose the children to
materials not supposed to be accessible for them. The EU also asked Indonesia
to allow enough time for discussions with toy manufacturers on feasible
labelling solutions capable of meeting policy objectives, while ensuring
proportionality and coherence between the two different sets of labelling
requirements applicable to toys, and not compromising toy safety.
2.108. The
representative of the United States associated herself with the
EU concerns. She said that while toy safety was an objective the US shared
with many Members, it nonetheless also noted that Indonesia's toy regulatory
regime included several aspects that were considerably more restrictive than
those adopted by other Members. In this latter respect, the US continued to
have concerns related to laboratory accreditation, testing frequency, sampling,
documentation, and substance restrictions. Despite efforts by both the US Government
and other trading partners, as well as the toy industry coalition, few of these
concerns were addressed prior to the regulation coming into effect at the end
of April 2014. She argued that increased costs and decreased quantity and
variety of safe toys from compliant companies, due to these restrictive requirements,
would cause consumers to look for alternatives in the grey market, thereby
decreasing consumer safety. The US remained interested in working through the
remaining issues of concern with the new Indonesian administration to resolve
these matters and help ensure that Indonesian consumers have access to safe
toys.
2.109. The
representative of Japan reiterated that the Indonesian toy safety
regulation was inconsistent with its obligations under the TBT Agreement,
and regretted that the revised regulation was put into effect although the
concerns remained unsolved. He requested that the new Indonesian administration
would amend the toy regulation so as to make it consistent with TBT Agreement
obligations.
2.110. The
representative of Indonesia informed the Committee that since the new
amendment of the regulation stipulated by Regulation of Minister of Industry
No. 55/M‑IND/PER/11/2013, notified under G/TBT/N/IDN/64/Add.2, there had
been no further changes in this regulation. Information regarding the
availability of regulation was available on Ministry of Industry's website.
Regarding certification procedure, as stated in the technical guidance on the
implementation of toys safety, local and foreign manufactures, could submit
their application to conformity assessments bodies designated by the Minister
of Industry. In addition, foreign manufactures were to appoint their
representative which was functioning as importer or manufacturing importer. On
the issue of testing period for toys, she explained that the current regulation's
requirement for sample‑taking was based on the batches of shipments. A shipment
could consist of several batches which were determined in terms of every
trademark of toys which fell within the same HS code; such an improved
requirement had significantly reduced the time for testing. Regarding
acceptance of test result issued by foreign laboratories, she said that
Indonesia granted a 2‑year grace period for the result to be recognized.
However, this kind of special treatment during this grace period could only be
extended beyond the period if the government of the country where the
laboratories were based already had a mutual recognition agreement with the
Indonesian Government. She further explained that all requirements about
marking and chemical substances contained in toys were set up in the
technical guidance on this matter. The affixing of the label in Bahasa
Indonesia in goods, particularly on toys, could be done through embossed
printing or a firmly attached label on the packages, depending on the
characteristics of the product.
2.2.3.9 European Union – Draft Implementing Regulations amending Regulation
(EC) No. 607/2009 laying down detailed rules for the application of Council
Regulation (EC) No 479/2008 as regards protected designations of origin and
geographical indications, traditional terms, labelling and presentation of
certain wine sector products (G/TBT/N/EEC/264, G/TBT/N/EEC/264/Add.1) - IMS
Item No. 345
2.111. The
representative of Argentina reiterated Argentina's concern with the
unjustified delay in resolving this long standing STC, a conduct it considered
to be inconsistent with the principle of national treatment. Regulations (EC)
No. 479/08 and (EC) No. 607/09, which, on one hand, granted EU member states
the exclusive right to use certain traditional expressions in each of their
respective languages, on the other hand, restricted the right of third states
to use these expressions in their labelling. This seriously affected wine
exports from Argentina to the EU which used the terms "Reserva" and
"Gran Reserva". Argentina believed this legal regime was inconsistent
with the TBT Agreement. In order to help find a practical solution to avoid the
barriers posed by this measure, and at the EU's invitation at this Committee,
Argentina presented a dossier on these terms to the EU in July 2009. This
dossier was then approved in March 2012 by the European Commission's Wine
Management Committee. Although the substantive procedure was completed in March
2012, the final formal step, namely the adoption of the Argentine dossier by
the College of Commissioners and its publication in the Official Journal of the
EU, had not yet been taken. The substantive procedure took two years and seven
months, from July 2009 until the approval of the dossier in March 2012, while
the delay to comply a single administrative act of a formal nature had already
reached two years and eight months, from March 2012 to November 2014. It was
striking that the delay to finalize a merely formal administrative act had
exceeded the time taken to end the substantive procedure that approved the
dossier. It was not coherent that only one formal act required more time than the
total amount of acts of the process, during which Argentina had also responded
to objections by different entities and supplied additional information in
response to requests from the EC for clarifications regarding its
documentation. Argentina insisted that such delay was doubly unjustified:
neither had the process been concluded in a reasonable period of time, nor had
a reasonable explanation been given for the delay. The total delay amounted to
five years and three months. This delay constituted in and of itself an
obstacle to trade. Argentina urged the EU to find a prompt solution.
2.112. Argentina
further argued that the declared aim of not misleading consumers could not be
achieved by the Community's legal regime because there was no uniform and
unequivocal definition of the traditional terms "Reserva" and "Gran
Reserva" at the Community level. The EU could not logically comply with
said objective as there were divergent definitions of these terms at national
level. It was not logical that the EU required third members to comply with
this alleged objective when the EU did not apply the same treatment to its own
members. The pretence of the unequal objective (to not mislead consumers)
constituted a violation of the principle of national treatment. Argentina also
considered that the EU failed to comply with its obligation of national
treatment, as the same conditions of access and marketing were not applied to
wines from outside the Community compared with the conditions enjoyed by
Community wines. Besides, the traditional expressions "Reserva" and
"Gran Reserva" were not provided for at Community level in the case
of Spain. In fact, in the single Annex to Regulation (EC) No. 881/98, entitled
"List of additional traditional terms referred to in Article 3(1)",
the traditional terms "Reserva" and "Gran Reserva" were not
included in relation to Spain, although 14 other expressions were listed for
Spain in that Annex, which made the absence of the terms all the more
noteworthy because the terms "Reserve", "Vieille Reserve"
and "Grand Reserve" in French were listed in the case of Greece.
Argentina therefore questioned why exclusive rights were assigned to Spain for
the use of such Spanish expressions when they were not even provided for
initially.
2.113. Argentina
also noted that the World Wine Trade Group (WWTG) (a grouping of wine producing
countries - Argentina, Australia, Canada, Chile, Georgia, New Zealand, South
Africa and the United States) transmitted four notes to the European
Commission, the first on 4 June 2013, but had not yet received a satisfactory
reply to the request to register and publish the traditional expressions
requested by the non-Community countries, since the undue delays were not
justified from the technical standpoint. Lastly, Argentina recalled that in a
previous TBT Committee meeting, in October 1999 (G/TBT/M/17), the EU had
stated, for instance, that "the purpose was to avoid misleading the
consumer and unfair competition" and "stressed that the legislation
would provide national treatment in that it allowed third countries to use the
terms on similar conditions as applied to EC member States." He noted that
15 years after those statements, the reality still had not changed, despite
continuous flagging of the concern. As the third STC raised in this Committee
in terms of frequency and number of Members raising, Argentina saw this as a
case of clear protectionist policy and urged the EU to eliminate the
unjustified restrictions on exports of quality wines. She insisted that the
Commission address this matter and publish the relevant regulatory act in its
Official Journal.
2.114. The
representative of the United States recalled its previous concerns and
requested the status of the applications submitted by the US wine industry over
four years ago. The US noted that some US suppliers that currently used the
terms referred to in the EU measure had been unable to ship their products. The
US was also concerned with the lack of transparency in the application process
for the use of traditional terms. This process continued to undermine US exports
of wine to the EU, as companies that used those terms legally in the US and
third markets had been unable to sell their wines to the EU. She thanked the EU
for reconsidering the traditional terms for wine schemes and requested more
information on this review. In this respect, she asked what were the objectives
and parameters of such review, the scope of the stakeholder participation in
the review, and, in particular, whether foreign stakeholders could participate
in the process. The US noted that information about the Wine Advisory Group,
specifically regarding its plans for the approval of the use of Traditional
Terms on wine by the US and other leading wine producing nations, had not been
shared with key trading partners. Furthermore, it appeared that the Wine
Advisory Group had been replaced by a Civil Dialogue Group on Wine. She noted
that key trading partners had not yet received information on the composition
and intentions of this new group regarding traditional terms, further
exacerbating the lack of transparency and undermining trade. The US urged the
Commission to resolve this barrier to trade without further delay.
2.115. The
representative of South Africa showed its support to the statements made
by Argentina and the US. The EU and South Africa could resolve only three
longstanding concerns relating to traditional terms in their economic partnership
agreement negotiations. All other issues, also pertaining to the subject of
this STC, were moved to a rendez-vous
clause to be negotiated at a later stage. As previously stated, South Africa
had been using quite a few of the "traditional terms" referred to by
the EU since the time when European Settlers first started wine production in
the Western Cape province of South Africa in 1685. He noted that these terms
therefore form part of South African valued heritage. As a member of the World
Wine Trade Group, South Africa joined the other Members and cosponsored four
letters to the EU, dated 18 December 2013, 22 May 2014, 4 June 2014, 7 October
2014, sent by the WWTG Chairman to the DG Agriculture and the Rule Development
of the European Commission on the issue of "traditional terms" within
the framework of the European legislation, in particular regarding EC Regulations
478/08 and 607/09. South Africa therefore urged the EU not to use general terms
commonly used in many languages for the description of wine such as "classique" or "reserve"
as a trade barrier. He also asked the EU to engage with concerned Members to
ensure that common solutions could be found.
2.116. The
representative of the European Union informed the Committee that the new
Regulation establishing a common organization of the markets in agricultural
products had been adopted by the European Parliament and the Council in
December 2013 (Regulation (EU) No. 1308/2013). Following its
publication, an internal assessment on "traditional terms" had been carried
out within the EU with stakeholders and experts from the Member States (in
accordance with Article 114(3) of that Regulation). The consultation was
still ongoing and included the conditions and specificities under which these
traditional terms could be used on the labels of products from third
countries. The possible derogations, based particularly on minimum requirements
for production methods and controls under product specifications of the wines
concerned, were covered by this discussion. Nevertheless, after three meetings
no final conclusions were reached and, at this stage, the EU was waiting for
the new Commission to take office before a decision could be made. The EU
promised to continue to make the possible and necessary efforts to bring new elements
into its policy on protection of traditional terms and their indication on the
labels of wines in order to accommodate trade partners' concerns. She assured Members
that their concerns had been taken into account in the assessment process
currently carried out in the EU which was of a complex nature. The procedures
under consideration (whether from EU Member States or third countries) would be
taken once this evaluation was finalized. The EU remained open to discussion
with trade partners bilaterally at expert level.
2.117. The
representative of Argentina underlined again what it saw as a lack of
transparency in the EU's approach since it declared to be attempting to
bring in a new measure which would continue to delay the resolution of
this issue.
2.2.3.10 India – Food Safety and Standards Regulation - Food labelling
requirements - IMS Item No. 298
2.118. The
representative of the European Union recalled that in October 2011 and
January 2014 India issued ad hoc guidelines
under which certain India‑specific information, such as the
vegetarian/non-vegetarian logos and the name and address of the importer, was
considered "rectifiable" information and could be affixed through
stickers by the importer in customs warehouses. However, the guidelines specified
that several compulsory food labelling elements, such as list of ingredients, were
"not rectifiable", which meant that they could not be communicated
by means of stickers but rather had to be printed on the food package. The EU noted
that in most economies worldwide food products could be labelled by means of
stickers provided they were accurate and not easily detachable. She said this was
a very important trade facilitating practice that allowed producers to serve
different regions with different language requirements without the need for
separate production lines, while duly protecting the consumer. In this respect,
she mentioned standard CODEX STAN 1‑1985, relevant to the labelling
of pre‑packaged foods, which states: ''if the language on the original label is
not acceptable, to the consumer for whom it is intended, a supplementary label
containing the mandatory information in the required language may be used
instead of relabeling''. It also states: ''in the case of either relabeling or
a supplementary label, the mandatory information provided shall be fully and
accurately reflect that in the original label.'' For the forgoing reasons the
EU expressed its view that the October 2011 guidelines were too burdensome and were
not therefore in compliance with Articles 2.2 and 2.4 of the TBT Agreement. She
asked India to bring its implementing guidelines in line with CODEX and to
allow all types of labelling information - and not only the India‑specific information
- to be provided by stickers (for example at customs bonded warehouses). This was
a sound alternative to labelling in the country of origin that would allow
India to fulfil its legitimate objectives in a non‑trade restrictive way.
2.119. Concerning
alcoholic drinks, the EU representative noted that Indian legislation
required that the labels to these products contain the full list of ingredients.
As already stated, stickers were not allowed and, in addition, the labels had
to be pre‑registered in different Indian States with the state excise
authorities. In this context, the EU encouraged India to provide more detailed
information to market operators regarding the formulation of ingredients, and
to allow sufficient time for implementation – up to 9‑12 months depending on
the excise cycle. She stressed that approval of labels by State authorities
needed to take place before the implementation date. If this did not occur, the
requirement to list ingredients in the label of alcoholic drinks could result
in a major market access disruption. In addition, and supplemental to the
transition period for implementation, the EU asked India to ensure that all
products presently exported could continue to be marketed until stocks were
exhausted. Finally, the EU was aware that the Food Safety and Standards
Authority was preparing a technical regulation on alcoholic drinks, and
enquired about the envisaged timeframe for notification to WTO.
2.120. The
representative of Switzerland echoed the concerns of the EU and the view
that all labelling information should be "rectifiable" by stickers.
He noted cases of firms pulling out of the Indian market due to these
restrictive measures. Switzerland urged India to bring this measure in line
with CODEX standards.
2.121. The
representative of Japan supported the concerns expressed by the EU. She
noted that certain information (such as the list of ingredients and nutritional
information) were considered as "not rectifiable" and could not
therefore be labelled by means of stickers under the measure. As previously
reported, the implementation of these guidelines has had a significant negative
effect on importation of food product to India from Japan. She cited
Article 2 of CODEX STAN 1‑1985, which defined a label as "any
tag, brand, mark, pictorial or other descriptive matter, written, printed,
stencilled, marked, embossed or impressed on, or attached to, a container of
food." She further cited Article 8.2.1 of this standard, which said:
"if the language on the original label is not acceptable, to the consumer
for whom it is intended, a supplementary label containing the mandatory
information in the required language may be used instead of relabeling";
as well as Article 8.1.1, which said: "labels in pre-packaged foods shall
be applied in such a manner that they will not become separated from the
container." The representative said that this well‑balanced standard
reflected real world practices whereby many countries, including Japan, allowed
food products to be labelled by means of stickers provided they were accurate
and not easily detachable, achieving consumer protection while, at the same
time, avoiding unnecessary trade disruption. Japan stated that India did not
use the CODEX standard as the basis for these guidelines, and asked India to
revise the guidelines so as to bring them in line with the CODEX standard in
accordance with Article 2.4 of the TBT Agreement. Moreover, Japan considered
the guidelines to be overly burdensome, particularly for companies exporting to
India in small quantities. Her delegation believed that the guidelines created
unnecessary barriers to trade in the sense of Article 2.2 of the TBT Agreement,
and asked India to revise them accordingly.
2.122. The
representative of Australia expressed continued concerns with India's
food standards and their enforcement by the Food Safety and Standards Authority
of India (FSSAI). He noted that Australia had previously supported the efforts
of FSSAI to harmonize Indian food standards with CODEX standards, a process
that began in early 2013. Australia had provided extensive information to FSSAI
about Australian food standards and their enforcement. His delegation was
encouraged about recent reports that India was reviewing national food
regulations and requested confirmation as to whether a new review of
regulations had indeed begun or if this simply reflected the ongoing FSSAI
process to harmonize with CODEX standards. If India had indeed begun a new
review, he asked about the scope and objective of the review, which elements of
the food regulations were targeted, and whether the new review would build on
the CODEX harmonization process. And, if not, he asked whether the CODEX
harmonization process would then be abandoned.
2.123. The
representative of New Zealand said her delegation continued to follow
this issue with interest, and had expressed its concerns to India bilaterally.
Like Australia, New Zealand was encouraged by reports of a comprehensive
review of India's Food Safety and Standards Act 2006. She asked about the
parameters of the review, and in particular which aspects of the Act would be
within its scope, the timeframe for the review process, and how interested
parties would be able to engage, to which New Zealand looked forward.
2.124. The
representative of India said that, with respect of food labelling
requirement, the regulatory situation had not changed since the last meeting,
and encouraged interested delegations to refer to India's statement at the
previous meeting. He stressed that if stickers with all mandatory information
were allowed on packages, this may be misused by unscrupulous traders for
manipulating or tampering with the labels of imported food stuff. For instance,
once a package was allowed with sticker declaring sensitive information - such
as "best before date" - this sticker could be easily replaced
with another one with a different "best before date" once the goods
entered into domestic market. Therefore, his delegation did not believe that
allowing use of stickers to declare all mandatory information would properly
serve the policy objective, which was informing consumers of what they were
consuming. Moreover, India did not have track and trace facilities to identify
the source of such food items if a manipulated label was detected at a
subsequent stage in the market. In view of this, India did not see any problem
with maintaining its existing labelling requirements. He said that the queries
raised by some Members regarding a review of existing food labelling
requirements would be forwarded to the capital and a response would be sent to
the interested delegations in due course.
2.125. He
also said that the reason for the labelling requirements of alcoholic beverages
were mandated under the Food Safety and Standards (Packaging and Labelling)
Regulations, which came into effect on 5 August 2011. These regulations were
notified to the WTO in July 2010 at the draft stage. He recalled that paragraph
2.2.2.2 of these regulations mandated that, except for single ingredient food,
a list of ingredients shall be declared on the label. This was also applicable
to alcoholic beverages, if additives - including colour, water and preservatives
- were used in the manufacture of these products and were present in the final
product. He explained that the addition of flavours need not be declared
specifically, but a statement to this effect shall be given on the label. If
the alcoholic beverage was a "single ingredient product", no
ingredient list was required to be declared on the label. Finally, he noted
certain exemptions from specific labelling requirements for alcoholic
beverages, namely: (i) "best before" date shall not be
applicable for wine and liquors, nor for alcoholic beverages containing 10% or
more by volume of alcohol; (ii) declaration of vegetarian/non‑vegetarian was
not required on the label of alcoholic drinks; and (iii) nutritional
information was not required for alcoholic beverages.
2.2.3.11 Chile – Proposed amendment to the Food Health Regulations, Supreme
Decree No. 977/96 (G/TBT/N/CHL/219, G/TBT/N/CHL/219/Add.1, G/TBT/N/CHL/221,
G/TBT/N/CHL/282) - IMS Item No. 370
2.126. While
expressing support for Chile's policy objective of promoting healthy dietary
choices and reducing obesity and related non‑communicable diseases, the
representative of Canada reiterated previous concerns and encouraged
Chile to consider less trade restrictive alternatives. Canada was concerned
that the regulations published on 19 August 2014 deviated from international
standards, were not be based on science, and were likely to be more trade
restrictive than necessary. In addition, Canada was concerned that the
regulation could prohibit the use of trademarked characters, potentially
infringing on intellectual property rights, as well as prohibit the use of
complementary nutritional information, such as Guideline Daily Amounts. He
urged Chile to consider a less trade restrictive alternative to achieve its
policy goals, consistent with international standards and based on science.
Finally, he asked Chile to clarify if and when the 19 August 2014
regulations would enter in force.
2.127. The
representative of Mexico recalled previous concerns with Chile's Food Health
Regulations on the nutritional composition of food and on food advertising
(including labelling), which aim at informing the public of the energy, sugar,
sodium and saturated fat content of the foods they consume. She first noted
that, although the statute establishing the amendment to the Food Health
Regulations (Law No. 20.606) was a technical regulation within the meaning of
Annex 1 to the TBT Agreement, Chile had failed to notify it to the WTO as required
by Article 2.9 of the Agreement, an omission that prevented Mexico from being
able to submit comments on the draft. The representative noted that the
amendment to the Food Health Regulations specified that "it shall be
compulsory to highlight the nutritional characteristics of any type of food or
food product when its energy, sodium, total sugar or saturated fat content is
not the same as in natural form and exceeds the value established in table
No. 1 of this Article". She explained that the table in question
set forth limits on the energy, sodium, sugar and saturated fat content of
foods. Foods that exceeded the established limits were thus required to highlight
this fact by means of the descriptive stamp with the term "EXCESS",
followed by the following terms: "SATURATED FATS",
"SODIUM", "SUGAR" or "CALORIES".
2.128. Mexico
considered that this proposed amendment was inconsistent with the principles of
the TBT Agreement, specifically Article 2.4, because it was not based on
the General Guidelines on Claims of the CODEX Alimentarius (CAC/GL 1 1979, Article
3.5). Moreover, Mexico considered that every food possessed inherent
nutritional characteristics, and for that reason no food could be characterized
as "good" or "bad" in relation to its nutritional content.
Thus the provisions relating to the label "EXCESS" could arouse fear
in consumers by leading them to assume that non‑communicable diseases, such as
obesity, were caused by the consumption of specific foods. Mexico requested
Chile to provide information in support of this provision of the technical
regulation, in the light of the principle of proportionality set forth in Article
2.2 of the TBT Agreement. Furthermore, she observed that the proposed
amendment stipulates that "foods or food products whose nutritional
composition comprises energy, sodium, sugars or saturated fats in amounts
higher than those specified in table No. 1 of Article 120 of the
Regulations (referred to above), may not be advertised in the media or channels
of communication targeting minors aged under 14 […]. This prohibition on
advertising does not apply to foods containing energy, sugars, sodium, or
saturated fats in a natural form, consistent with the Dietary Guidelines of the
Ministry of Health." In this respect, Mexico enquired as to the scientific
or technical evidence justifying this prohibition on advertising to minors aged
14 or less, as well as the exception established for products whose energy,
sugar, sodium or saturated fat content was in a natural form.
2.129. Accordingly,
Mexico requested Chile to conduct a public consultation on the proposed amendments
to the Food Health Regulations, and to harmonize the requirements set forth in
the regulations with the General Guidelines on Claims of the Codex Alimentarius
(CAC/GL 1 1979, Article 3.5). She also asked for an explanation of the
scientific and technical evidence supporting the use of labels bearing the term
"EXCESS" in the light of the legitimate objective pursued by the
amendment to the Food Health Regulations. Chile was also requested to modify
the classification of foods on the basis of a distinction between liquid and
solid foods and, in accordance with international parameters, to classify foods
according to the category to which they belong. The representative further
asked Chile to provide information in support of the prohibition on advertising
certain foods to minors aged 14 or less and to clarify and, if necessary,
eliminate the exemption for foods whose energy, sugar, sodium or saturated fat
content was in natural form. Finally, Mexico asked Chile to consider extending
the date of entry into force of the amendments to the regulations from 6 to 18
months, and to take into account the formal comments made by the Government of
Mexico on the final text of the regulation in question, as transmitted to the
Chilean Government through its enquiry point on 22 October 2014.
2.130. The
representative of the European Union said that her delegation remained
concerned about the lack of notification of Law No. 20.606, an
omission which had seriously curtailed any significant discussion on the
implementing measures. The EU fully shared Chile's policy objectives to combat
obesity and related non‑communicable diseases, and she stressed that her
delegation's intervention in the Committee must be understood as fully
supporting Chile's ultimate aim. Nevertheless, she expressed her delegation's
disagreement on how these objectives could be best met, also noting that the EU
had opted for a different approach which recognised the importance of the
relationship between diet and health and empowered consumers to make informed
choices based on factual information. As a general remark, the EU noted that the
TBT Committee was currently discussing the second draft of these measures. She
regretted that significant time had been spent in the TBT Committee and at
a local level to deal with issues in the first notification only to have Chile reopen
the measure just a few weeks prior to its entry into force. Although the EU
welcomed this new opportunity to provide comments, and hoped for a more
positive outcome, she emphasized concerns regarding legal uncertainty created
by these successive modifications. Moreover, her delegation was concerned that
this new exercise appeared to render these measures more stringent, rather than
enhance their compatibility with the TBT Agreement. The EU requested
Chile's clarifications in this respect.
2.131. The
EU also recalled its previous concerns regarding the lack of scientific basis
for the definition of the maximum levels for the concerned nutrients, noting
the absence of international guidelines backing up this measure. It also
again expressed its doubts on their proportionality and effectiveness. In
particular, the EU was concerned about the use of warning messages, which in
the form of a "stop sign" would bear the inscription "excess of"
sugar, saturated fats, sodium or calories. The EU believed that the use of
these warnings was not in line with CODEX General Guidelines on Claims
(CAC/GL 1‑1979), as it risked arousing fear in consumers regarding
consumption of products that, when consumed in moderation, can be part of a
healthy diet. Furthermore, the use of the term "excess" may lead
consumers to believe that there were limits above which the consumption of
certain nutrients was bad for their health. The EU asked Chile if they had
considered aligning their measure with these international guidelines. In this
regard, the EU recalled that for certain nutrients there was evidence of a
positive association between intake and the risk of developing a disease or
disorder, but there was no scientific evidence suggesting an identifiable threshold
above which the risk existed. She cited the CODEX Guidelines on Nutrition Labelling
(CAC/GL 2‑1985), which stated that the nutrient declaration "should
not lead consumers to believe that there is exact quantitative knowledge of
what individuals should eat in order to maintain health, but rather to convey
an understanding of the quantity of nutrients contained in the product".
Therefore, the EU requested an explanation as to the scientific basis for imposing
the limits in the regulation. This was particularly relevant given that the
established limits would mandate warning icons and messages on a vast majority
of products, leading to a system that would make it difficult for consumers to
identify, among the different food categories, the variants for a healthier
diet. She also requested further information on Chile's assessment as to the
quantity of products that would be affected by these measures, bearing in mind
that if a wide scope of products were affected by the new warnings, its effect
on consumer perceptions might be substantially reduced.
2.132. She
also mentioned additional concerns about the prohibitions on the labelling and
advertising of foods involving, for example, children's characters, animations,
cartoons, animals and toys in relation to products that were protected by
trademarks. The EU asked for Chile's views on how these provisions would impact
such existing and future trademarks. Concerning entry into force, she noted
that while the transition period of 6 months was in line with WTO recommendations,
it might not be sufficient given the extensive re‑labelling procedures that
companies would have to undertake, and which would require significant
investments. For comparison, EU legislation provided for a transitional period
of 3 years. The EU requested that Chile reconsider extending the
implementation deadlines. Finally, she asked Chile to clarify how this new set
of obligations would relate to the provision of voluntary consumer information labelling
schemes, and if such schemes were permitted.
2.133. The
representative of the United States expressed her delegation's strong
support for Chile's public health objectives of reducing obesity and related
non‑communicable disease, and her delegation's appreciation for the extensive
bilateral discussions on this issue. Nevertheless, the US was concerned about
the trade impacts of the proposed measure, particularly for imported pre‑packaged
foods, and implementation some of its provisions. Since the new regulation
covered significantly more food categories, the preliminary estimate from
USDA/FAS was that the regulation could affect USD 250 million worth
of commerce in pre‑packaged food exports to Chile. In the view of US industry, the
current proposal imposed onerous labelling requirements for pre‑packaged foods
and may constitute an unnecessary obstacle to international trade. The US was
therefore interested in exploring less trade restrictive labelling measures
that included flexibility in the placement or shape of the icon, and also
reflected consumer information based on common serving sizes that would help them
achieve a balanced and healthy diet. In this respect, she asked whether Chile had
considered a less stringent labelling approach in combination with a more
comprehensive approach to consumer education in support of its public health
goal, which was an approach strongly supported by her delegation. The US also sought
opportunities to work further with Chile both bilaterally and in the TBT
Committee as the proposal was developed.
2.134. She
noted that the labelling approach of the revised regulations appeared to
strengthen the "warning" element of the icons of the December 2013
final regulation. She asked Chile to explain why the decision was made to
strengthen the warning elements of the regulation, and whether an analysis was
performed on the additional benefits of the new draft approach as opposed to
the December 2013 regulation. She further queried why the proportion of space
occupied by the "excess of" icon varied greatly between
different packages sizes, instead of a fixed ratio. For example, on a package
that was 200 square centimetres the icon would occupy 4.5% of the label
face, but on a package of 75 square centimetres the icon would occupy
8.33% of the label face. She noted that a single food could bear up to
four icons, and for some packages with four icons, between 18% and 42% of
the package surface could be covered.
2.135. She
then asked Chile to explain the basis for the limits for sodium and energy in
solid foods. She noted that Chile's initial nutrient limit for sodium (solids
400 mg/100 g or liquids 100 mg/100 mL) appeared to be based
on 20% of the CODEX Nutrient Reference Values – Non‑communicable Disease (NRV-NCD)
of 2000 mg/day. Chile was proposing to reduce the sodium limit by 5%
per year to 150 mg/100 g. For solid foods, she recalled, CODEX
indicated 2000 kcal as a reference. The regulation's 275 kcal/100 g
limit would translate to roughly 13% of 2000 calorie energy intake
level. Further, the amendment continued to prohibit
(positive) health claims and complementary information for any
product that had to carry the "excess of" icon. In this respect,
the US asked Chile to explain how consumers would benefit from only receiving
information on nutrients to be restricted in
the diet, without also being provided information on nutrients that would be beneficial and encouraged in a healthy diet. She noted that
such prohibition on (positive) claims may impact a consumer's ability to
differentiate nutrient‑reduced foods, such as low‑fat margarine. Chile's
approach, she said, could, in fact, result in "stop‑sign" warnings
for this entire category of products. Also, preventing the inclusion of factual
voluntary claims could decrease the incentives for the food industry to develop
certain foods with an improved nutrient content, if industry could not call
attention to new formulations designed to present consumers with healthier
alternatives.
2.136. She
also enquired as to the basis for setting labelling requirements according to
an across‑the‑board serving size of 100 grams or 100 millilitres. She
observed, for instance, that: 100 grams of butter would amounted to
10 individual serving sizes of butter; 100 grams constituted
approximately 37 sticks of gum; and 100 grams was approximately five
and a half pieces of white bread. This was clearly well about what most people
would consume in one serving, and may make it more confusing for consumers to
identify healthy eating options. Recognizing that CODEX also allowed for the
use of serving sizes, she asked if Chile would instead consider using serving
sizes that reflected the consumption patterns of the Chilean population, which
would adjust the serving size based on the type of product. She suggested Chile
consider labelling which put "consumer advisory icons" in the context
of daily dietary consumption, especially for foods where the average portion of
the consumed food was typically significantly larger or smaller than the
100 grams or 100 ml baseline utilized for the proposed "stop‑signs",
or where the food may provide other valuable nutrients. For example, "food A"
with 275 calories/100 grams that was rich in other key nutrients
- such as calcium, iron, vitamin A and vitamin C - was
very different from "food B" with 275 calories/100 grams
with no other significant nutritional value. She said that the US employed a
multitude of consumer education programs and resources to help consumers
understand how daily intake values related to a healthy diet and to reducing
risks for NCDs. She also noted that WHO had established nutrient intake
recommendations for sodium and sugar; a revised sugar recommendation was in
process. The Codex Committee on Food Labelling and the Committee on Nutrition
and Foods for Special Dietary Uses undertook a work plan to implement the
recommendations of the 2003 WHO Global Strategy regarding
reduction of NCDs. As part of this work plan, she stated, Codex developed
additional claims with respect to nutrients of concern, defined helpful
nutrients like dietary fibre, developed upper limits for claims for healthy
nutrients, and made recommendations to implement mandatory nutritional
labelling. WHO member states had since adopted the WHO "Global Action
Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020"[4],
which included a global target to reduce sodium intake by 30% and actions for
WHO, member states and the private sector related to food labelling.
2.137. Finally,
she also expressed concern with the short implementation timeline for
compliance by July 2015, which may pose difficulties for some US exporters of
pre‑packaged food. She noted that other countries often gave a longer timeline
for compliance with such requirements. For example, when FDA issued two
proposed rules for nutrition labelling (TBT/N/USA/893 and TBT/N/USA/894), a two‑year
implementation timeline from the publication of the final rule was proposed. Once
final requirements were determined, she requested that Chile consider a two‑year
implementation timeframe, especially given that the labelling regulations were
revised two months before the previously scheduled compliance date.
2.138. The
representative of Switzerland reiterated his delegation's previously
expressed concerns, which were still pertinent to the latest notified draft of
the measure, and echoed the statements of other delegations. Switzerland had
submitted comments on the latest draft, and looked forward to engaging
bilaterally with Chile. He asked Chile to explain how the latest draft reduced
restrictive effects on trade as compared to previously notified measures, and
how Chile intended to take into account concerns by Member raised in the TBT
Committee on the latest and previous drafts. While sharing Chile's objective of
reducing the prevalence of NCDs, Switzerland was concerned about the lack of
harmonization to relevant international standards. Several countries were
proposing and enacting nutritional labelling measures, many of which had been
discussed in the TBT Committee, and Switzerland was concerned about the
use of divergent negative messages and pictograms, and the multiplication of
uncoordinated parameters worldwide, for instance, thresholds at which a food
was considered high in a certain nutrient.
2.139. The
representative of Australia expressed support for Chile's right to
implement measures to provide consumers with information to make appropriate
dietary choices and reduce the risk of diet related NCDs, provided such
measures were implemented in a manner consistent with Chile's
WTO obligations. He suggests there may be other measures available to
promote consumer health, which could achieve Chile's objective and which were
being considered by other countries, including Australia. Australia was pleased
that Chile had taken a number of actions in response to concerns raised in the
TBT Committee. He expressed appreciation for the clarification provided by
Chile that the warning label would no longer take the form of an octagonal
"STOP sign" but would instead be a coloured hexagon and its size
would be established in relation to the size of the total area of the products.
Further, he recalled that Chile notified to the WTO, on 13 March 2014
(G/TBT/N/CHL/219/Add.2 and G/TBT/N/CHL/221/Add.1), a compilation of replies to
the comments submitted by Australia and other countries received during the public
consultation period. Australia was also pleased that Chile had changed the
proposed front of pack labelling requirement based on suggestions by other countries,
including Australia. However, he noted that the labelling scheme was still
mandatory for some food categories, including some dairy foods. He additionally
noted certain inconsistencies between the requirements for imported and
domestic products. Finally, he observed that Chile had extended the original
date of entry into force to 30 June 2015, and that Australia looked
forward to working cooperatively with Chile to ensure trade between Australia
and Chile was not disrupted unnecessarily.
2.140. The
representative of Brazil shared the concerns expressed by other
delegations on this measure. His delegation appreciated the bilateral meeting
held that morning with Chile, and would remain engaged in this discussion.
2.141. The
representative of Costa Rica echoed the concerns expressed by Canada and
US, and looked forward to receiving information from Chile on how the concerns
raised by Members would be addressed.
2.142. The
representative of Colombia recalled comments submitted his delegation
submitted comments on the proposed amendment, notified by Chile in
G/TBT/N/CHL/282, and he appreciated the prompt reply from Chile to Colombia's
comments.
2.143. The
representative of Chile said that the Supreme Decree No. 977/96 had been
notified to the WTO as G/TBT/N/CHL/282 on 22 August 2014 and that this
notification replaced all previous notifications and their addenda. The
deadline for comments was 22 October 2014, and Chile received 16 sets of
comments which were transmitted to the relevant regulatory body. She also noted
a public consultation held on the proposed amendment, to which over
300 comments were received from interested parties. The Chilean Government
had also engaged in a nationwide dialogue on the relevance and significance of
the regulation. Chile intended to take all reasonable measures available to
meet its obligations under the TBT Agreement, and to respond to all queries and
provide information to trading partners and WTO Members. The representative
noted that a multisectoral technical committee, led by the Health Ministry,
would be working further on the regulation, and would consider the options
available. She expressed appreciation for support received, and for comments
and questions, all of which would be taken into account in the regulatory
process.
2.2.3.12 India – Electronics and Information Technology Goods (Requirements
for Compulsory Registration) Order, 2012 (G/TBT/N/IND/44, G/TBT/N/IND/44/Add.1,
G/TBT/N/IND/44/Add.2, G/TBT/N/IND/44/Add.3) - IMS Item No. 367
2.144. The
representative of the European Union thanked India for their bilateral
meeting on this issue and commended India for having set up two advisory
committees to allow for discussions between government and industry. This was a
good practice that could be taken as an example by other Members. The first of
these two newly-created committees was a Technical Advisory Committee
to deal with technical matters relating to the implementation of the compulsory
registration for electronics and IT goods (as per a 2012 Order from the
Minister of Communication, in force since 3 April 2014). The second was a Policy Advisory Committee
under the Bureau of Indian Standards to address issues such as marking and
labelling requirements accompanying this scheme. However, the EU still saw
scope for streamlining the current registration scheme, suggesting in
particular: (i) a wide acceptance of test reports issues under the
IECEE CB scheme or by laboratories accredited by ILAC MRA signatories; (ii) limiting
local testing only in cases of suspected non‑compliance of products; (iii) streamlining
the registration requirements by developing an online process with clear
intermediate deadlines for the procedure to move forward in order to reduce
delays to the minimum for completing the registration; (iv) extending the
validity of the certificate from 3 to 5 years thus covering the
life‑cycle of products; (v) extending the validity of test reports from
90 days to at least 12 months, as it was the case in international
practice in order to cover the useful life of each product model; (vi) requiring
that tests should only be repeated if there was a change in design and
components that would affect its safety properties; and (vii) having only one
registration number per product and not per factory, as manufacturing
process was identical among different factories producing the same brands, and
the factories could be traced using serial numbers.
2.145. The
EU also noted that there was a plan to rely further on market surveillance to
check conformity with mandatory standards for these products, and thus requested
India for further information. The EU noted that the requirements concerning
marking and labelling had been amended following consultations with the
industry and that these amendments had been implemented by an order of the
Bureau of Indian Standards of 11 April 2014 (in force on 31 August 2014.
This concerns the modality for the display of the word "self‑declaration"
conforming to the Indian standards on the products. These amendments granted
some flexibility to manufacturers, in particular with regard to products whose
physical dimensions are too small for the affixing of the marking and
labelling on the product itself. A
choice of option had been given as to fixing the labelling on the product or
the packaging. It was too early, he said, to say whether these amendments would
fully address the concerns of industry and fit the nature of the products
concerned, but they seemed to go in the right direction in providing greater
flexibility to manufacturers, and therefore the EU welcomed these developments.
The EU therefore recommended that the Policy Advisory Committee
set up at the BIS continue to be used to discuss any issues concerning
marking and labelling requirements. Finally, the EU noted that on
8 September 2014, on the Indian Gazette, there was a publication of a
public consultation document concerning a proposed expansion of the scope of
the compulsory registration scheme to 15 additional product categories. He
asked India for an update on the state of play and to timely notify any
proposed amendments under the TBT notification procedure to allow the
opportunity for WTO Members to submit comments. The EU mentioned that the
European Industry had submitted comments in this regard hoping they would be
taken into consideration.
2.146. The
representative of the United States associated herself with the EU's
concerns and suggested that rather than requiring additional testing, BIS
should instruct the appointed labs to review and routinely accept a test report
issued by labs approved under the IECEE CB Scheme. The US argued that appointed
labs should only require a product sample unit to conduct verification testing
if the labs cannot resolve a suspected non‑compliance issue from information
exchanges between the certification body issuing the CB Test report and/or
the manufacturer. This would provide immediate relief to manufacturers and
allow India's labs to learn how to correctly perform necessary testing. The US
also required BIS to remove the expiration date from the test report, as no
other national certification agencies had expiration dates on their test
reports. She asked when labs outside of India would be approved to perform the
testing. She also said that the US remained concerned for burdensome over‑labelling
and regulation and requested that the list of products under the
HSE exemption list should be broadened to include more products that
pose little risk to consumers. She noted that industry had raised concerns
regarding the expanded list as it would create disruptions, and asked about the
rationale behind such expansion. She expressed concerns that the expanded list
would create similar problems as under the original product scope, including
delays in testing. The US gathered from informal discussions that a market
surveillance program would be launched, and asked India to notify it to the
TBT Committee with a reasonable comment period.
2.147. The representative of India said that
in October 2012, India had issued the "Electronics and
Information Technology Goods (Requirement for Compulsory Registration) Order,
2012" mandating fifteen categories of electronic items under the
Compulsory Registration Scheme, based on their compliance to specified safety
standards. The Order envisaged manufacturers/importers/sellers/distributors of
the notified goods to conform to the specified standards. The Order was
applicable to both domestic manufacturers and foreign suppliers uniformly.
Industry needed to get goods tested with laboratories recognized by BIS. On
meeting requisite standards, BIS granted a unique registration number. Industry
needed to mark a self‑declaration of conformity on their products in a
prescribed manner, followed by Registration numbers.
2.148. On the
issue of accepting CB test reports for the purpose of ascertaining
compliance of goods, India informed the Committee that the matter had been
deliberated in detail during a visit of a senior delegation of IECEE to New
Delhi in the month of October 2013. The Indian delegation pointed out that
while India was not opposed to acceptance of CB test reports, the
Compulsory Registration Order was an act of the regulator which was completely
independent, and even Indian CB test labs had to follow the rules. CB test
reports were accepted for granting provisional clearance of goods covered under
the Scheme. India was accepting IECEE Certificates and Test Reports for the
Safety Critical Components being used for products under the Compulsory
Registration Scheme. Based on these deliberations, a Communiqué, issued jointly
by IECEE and the Government of India on 24 March 2014, declared that
India had not made any infringement of the rules of IECEE. A copy of this Joint
Communiqué was available on IECEE's website at: http://www.iecee.org/. India's
position in this matter had also been voted for in the meeting of Certification
Management Committee of IECEE CB held in 2014.
2.149. On
the concerns expressed by some delegations regarding the new labelling
requirement issued on 11 April 2014, India informed the Committee
that the requirement was subsequently revised on 31 July and its
implementation was postponed until 31 August 2014. The process of
revision was carried out through a series of intensive
stakeholder consultations. Further, the draft amendment was placed on BIS
website seeking comments from all stakeholders before it was finalised. He
explained that the new labelling requirement was quite flexible and allowed for
mandatory marking along with other markings, such as ratings, specification or
model number, on the data plate or on the product itself.
2.150. India
referred to the need expressed by some delegations for expanding the validity
period of test reports. The representative noted that as per the BIS Rules, the
test reports issued by BIS recognized labs had to be submitted along with
application for grant of registration. For this purpose a period of
90 days had been specified in the BIS Rules. India maintained that
90 days was a sufficient time period for the submission of test reports
along with application for registration. On the issue of Highly Specialized
Equipment (HSE), raised by some delegations in the previous meeting, India
noted that the process of their exemption had already been simplified. There
was no longer a need for a HSE certificate issued by the Department of
Electronics and Information Technology, and a declaration of specification from
manufacturer was enough for customs clearance.
2.151. For
testing purposes, India maintained that the authorized labs were well on track.
A list of recognized labs was available on websites of DeitY and BIS. He
underlined that these labs were well‑equipped, and worked under International
Safety Certification program. In fact, three of the recognized labs had parent
companies of foreign origin (e.g. UL India Pvt Ltd., in Bangalore and Inter
Tech Pvt Ltd., in New Delhi). Concerned authorities had no feedback of any
delay in testing. In respect of allowing other labs for testing purposes, India
said that the laboratories aspiring to test under the scheme would have to seek
recognition from the BIS. However, he insisted that there were no capacity
constraints in the authorized labs. On the registration side, he said that as
of 28 October 2014, more than 1200 registrations had been
granted without facing any implementation related problem. Finally, India
considered it premature to discuss the proposed review of the Compulsory
Registration Order for expanding the list of products.
2.2.3.13 Peru – Act to Promote Healthy Eating Among Children and Adolescents -
IMS Item No. 383
2.152. The
representative of Canada said that while Canada supported Peru's
objective of reducing obesity and other non‑communicable diseases, it was
nonetheless still concerned that this measure could be more trade restrictive
than necessary to achieve this objective. Canada asked Peru to clarify whether
the proposed regulations were based on international standards, and when would
they come into force. Canada encouraged Peru to provide a transition period so
as to allow industry time to adjust to any new labelling requirements.
2.153. The
representative of Switzerland endorsed the comments made by Canada while
also lending its support Peru's efforts to combat diet related non‑communicable
diseases. He noted that his delegation had submitted comments on previous
versions of the measure, and looked forward to engaging with Peru on a
bilateral basis to understand better which international standards were used to
determine the food categories that would be subject to compulsory labelling for
being "high in" certain nutrients. He asked what was being done
to ensure that consumers understood the fat content of foods, and whether
stickers could be used for compliance. He also recalled that several countries
were proposing and enacting nutritional labelling measures, many of which had
been discussed in the TBT Committee. Switzerland was therefore concerned
about the use of divergent negative messages and pictograms, and the
multiplication of uncoordinated parameters worldwide. Switzerland encouraged
Members to follow relevant international standards to promote harmonization of
approaches.
2.154.
The representative of Costa Rica echoed the concerns expressed by
Canada and recalled that at last the meeting Peru reported that the measure
would be revised based on comments received by the deadline of
18 August 2014. He asked to what extent the comments would be taken
into account and whether Peru would be notifying a new draft.
2.155. The
representative of Guatemala reiterated past concerns on this issue, and
noted comments submitted by her delegation during the public comment period.
Guatemala looked forward to receiving a reply from Peru, and asked when Peru
would notify new draft legislation.
2.156. The
representative of Peru said the regulation was aimed at promoting
healthy eating amongst children and adolescents, and was notified as
G/TBT/N/PER/59 on 23 May 2014, with a comment period ending on
18 August 2014. All comments received were forwarded to the Health
Ministry, which was still in the process of evaluating them in order to see how
they could be taken into account. If, as a result of this process, a decision
would be made to the effect that substantial changes to the measure would be
necessary, a new draft would be developed and the WTO would be notified.
2.2.3.14 Indonesia – Ministry of Health Regulation 30/2013 on the inclusion
of sugar, salt and fat content information, as well as health messages on the
label of processed foods (G/TBT/N/IDN/84) - IMS Item No. 389
2.157. The
representative of Canada supported Indonesia's objective of reducing the
risk of non‑communicable diseases, but was nevertheless concerned that the
regulatory proposals may have a significant impact on trade and were likely to
be more trade restrictive than necessary. He recalled that Canada had raised
this issue with Indonesia at the March 2014 TBT Committee meeting. At that
time, Indonesia indicated that testing for sugar, salt and fat content had to be
conducted by accredited in‑country laboratories. He asked if Indonesia had
considered opening up such testing to foreign laboratories, and if not,
whether this would be considered. Finally, he asked when the Regulation would
enter into force and what type of transition period would be provided for
industry to adapt.
2.158. The
representative of the European Union said that her delegation looked
forward to the implementing provisions for the Regulation that would be issued
by the Indonesian Ministry of Health and which would address product coverage
in detail – as indicated in a written response to the EU comments. She
recalled its request that the implementing regulations be notified to the
TBT Committee while still in draft form, and Members be provided
sufficient time to comment on them. The EU was also interested knowing more
about the guidelines of the Indonesian Ministry of Health and the National
Agency for Drugs and Food which would address other details of the Regulation – as
also indicated in a written response to the EU comments. The EU also reiterated
its concerns with respect to the mandatory warning message on salt, sugar and
fat content that would have to be included on the label of all processed food
products. In this respect, Indonesia was invited to consider whether the
objectives of the Regulation could be achieved with less trade‑restrictive
means. Some issues which, in the EU's view, still required Indonesia's
clarification were: (i) the placement of nutrition information and related
health warnings; (ii) testing methods for nutrition levels; and, (iii) the
conduct of risk assessment related to non‑communicable diseases. She noted the
EU was informed about a study on total diet being undertaken by the Indonesian
Ministry of Health, with the aim to determining types of food to be included in
the high risk and low risk classifications. She expressed her delegation's
interest in the results of this study.
2.159. Referring
to Indonesia's written response to the EU comments, she said the EU was
still interested in receiving more detailed information on how the Indonesian
authorities would address a possibility of acceptance of test results issued by
laboratories other than those accredited by the Indonesian National
Accreditation Body (KAN). The EU also restated that compliance with the CODEX
Alimentarius Guidelines on Nutrition Labelling would require the amount of
saturated fat and sodium or salt to also be labelled when the nutrition
labelling was provided. Finally, her delegation welcomed Indonesia's written
confirmation that the use of stickers would be allowed for labelling. However, she
stressed the importance of having the possibility to place the stickers on
products after importation, and before being placed on the market in Indonesia
– for instance, in customs warehouses – as means to show compliance
with the Regulation. The EU was of the view that this was a sound alternative
to labelling in the country of origin that would allow Indonesia to fulfil its
legitimate objectives in a non‑trade restrictive way.
2.160. The
representative of the United States endorsed the EU comments, while
also supporting Indonesia's regulatory and public health efforts to
improve nutritional literacy and raise awareness among Indonesians about
healthy lifestyles. She thanked Indonesia for notifying the Regulation in
January 2014, but also expressed her delegation's concern that the
notification had occurred after the measure had been adopted, and given the
lack of a public comment period, she said this called into question whether
alternate approaches or potential challenges for implementation were considered.
The US also wondered how Members' concerns would be addressed, given the
limited flexibility at this stage of Indonesia's rule making process. She
recalled the US submitted comments on 6 March 2014. Her delegation
was concerned that the Ministry of Health Decree lacked clear guidance on how
to implement and comply with the new labelling regulations. Moreover, the need
for laboratory testing to establish label conformity seemed excessive given the
relatively low risk posed by the inclusion of nutrition information. Lastly,
she asked if there was a more definite timeline as to when the Ministry of
Health would issue further technical guidance for implementation, as promised
during previous discussions in the Committee, especially since the measure had
already become effective.
2.161. The
representative of Australia said that his delegation recognised and
supported Indonesia's right to implement measures to provide consumers with
information to make appropriate dietary choices and reduce the risk of diet‑related
non‑communicable diseases. However, it was important that such measures were
not more trade‑restrictive than necessary to achieve this objective. Australia
supported the harmonisation of labelling standards to help reduce the cost and
complexity of imports and exports particularly for small to medium enterprises,
and urged Indonesia to consider the negative impact of this Regulation. He
noted the fact that Indonesia would be one of the first countries in the world
to implement a mandatory scheme for foods containing sugar, salt and fat and,
in this respect, stressed that there were other less‑restrictive measures
available to promote consumer health being considered by other countries,
including Australia. He asked Indonesia to clarify why it considered a mandatory
scheme necessary to achieve its objectives of public health and informed
consumer choice. He noted the Decree was published in the Official Gazette on
16 April 2013, entering into force three years after
promulgation. The Decree, however, was not notified to the WTO until
13 January 2014. He encouraged Indonesia to notify any further
amendments and guides on the operation of the Decree through the WTO TBT
transparency process. Indonesia had indicated at the previous Committee meeting
that an implementing Decree for this Regulation would be issued. Australia thus
requested that this Decree be notified to the TBT Committee in a timely manner
so that WTO Members would have sufficient time to provide comments.
2.162. The
representative of Switzerland echoed previous concerns, in particular
concerning the need for approval of the label by Indonesian authorities.
Switzerland had presented comments to Indonesia on this regulation, and in
reply to a question on the difference between the Regulation and the CODEX Guidelines
on Nutrition Labelling (CAC/GL 2-1985). Indonesia's explanation to that
question was that the inclusion of nutrition values in absolute numbers was not
related to health, but that, nevertheless, consumers would pay more attention
to such absolute numbers. While Switzerland shared Indonesia's objective of
protecting health, it seemed confusing to provide consumers with information
that did not pertain to health. More generally, Switzerland was concerned about
developments relating to negative messages, and asked for an update from
Indonesia on the measure.
2.163. The
representative of Indonesia restated that the labelling requirements
involved "health messages", not "health warnings".
Further, the Regulation did refer to the Codex Standard for Labelling. Indonesia
also clarified that it did not intend to prevent or prohibit the public from
consuming particular foods. The legitimate objective of the Regulation was,
instead, to increase consumers' awareness on the importance of knowing the
amount of sugar, salt and fat in the processed food they consumed and the
recommended daily intake. Such awareness was important to control the risk factors
that contributed to non‑communicable diseases. Indonesia was still in the
process of preparing technical regulation for guidance on implementation of this
Regulation. Other subsequent arrangements would be included in this technical
regulation. To ensure transparency, the implementation regulation would be
notified to the WTO.
2.164. Regarding
conformity assessment procedures, Indonesia explained that, as previously
stated, the Regulation required testing of sugar, salt and fat content, as well
as other quality parameters, to be conducted by laboratories accredited by
Indonesian National Accreditation Body (KAN), or by other competent
institutions that had mutual recognition arrangements with KAN. Such test
results must be provided by producers when they registered (or re‑registered)
with the National Agency of Drugs and Foods Controls (BPOM), or when they
formulated ingredient lists. The possibility to accept test results from other
laboratories, including in the country of origin, would be addressed at a later
stage. With respect to the amount of saturated fat and sodium for processed
food, this was stipulated in the Regulation of the National Agency of Drugs and
Foods Controls, on the Control of Claim on Processed Food Labelling and
Advertisement, notified as G/TBT/N/IDN/58. She expressed willingness to
continue discussions with concerned Members bilaterally.
2.2.3.15 European Union – Revised Proposal for the Categorization of
Compounds as Endocrine Disruptors of 19 February 2013 by DG Environment - IMS
Item No. 393
2.165. The
representative of the United States noted that the EU had published an
internal notice to assess, classify and regulate endocrine disruptors, which
she believed could significantly disrupt trade, particularly of agricultural
products. The US thanked the European Commission for informing the TBT
Committee of the launch of the public consultation on defining criteria for
identifying endocrine disruptors. In this respect, they requested an
explanation of how comments from WTO Members would be taken into account. The
US also appreciated that the EU extended the usual consultation period,
allowing a total of 16 weeks for interested parties to comment. She
mentioned that a long consultation period would be appropriate in this case,
which involved complicated scientific issues and with significant potential for
disruptive effects on agricultural trade.
2.166. The
representative of Mexico reiterated her delegation's interest in the
pesticide registration process provided for in Regulation (EC)
No. 1107/2009. She said that Mexico was preparing comments to be submitted
to the public consultation process which was informed by the EU. She expressed her
delegation's hope that the result of this consultation process and the
provision published by the EU would duly respect the principles enshrined in
the TBT Agreement.
2.167. The
representative of the European Union reiterated its intention to
carry out a comprehensive impact assessment to analyse different options
for defining criteria for the identification of endocrine disruptors and their
corresponding health, socio‑economic and environmental effects, once
incorporated in different pieces of EU legislation. In this context, the
European Commission published in mid‑June 2014 a roadmap setting out
the scope of such impact assessment and presenting the policy options that
would be assessed. She explained that at least two studies supporting the
impact assessment were needed. The first one had already started and would
assess the chemicals that might be identified as endocrine disruptors under
each of the various options for the criteria. The second one would then assess
the socio‑economic, health and environmental impacts of the implementation of
the various options for the criteria into the relevant legislations. As part of
this impact assessment process, on 26 September 2014 the European
Commission launched a public consultation on the definition of criteria for
identifying endocrine disruptors in the context of the implementation of the
EU's plant protection products regulation and the biocidal products regulation.
This public consultation would provide information relevant to the impact
assessment. The public consultation was meant to last until
16 January 2015. The usual consultation period of 12 weeks had
been extended to allow all stakeholders sufficient time to provide input. The
EU called on all interested stakeholders, including WTO Members, to actively participate
in this public consultation. She explained that once the consultation was
closed a feedback report would be issued with an assessment of all replies
received. Such factual, quantitative report would feed into the work for the
impact assessment whose outcome would not prejudge or constitute the
announcement of any position on the part of the European Commission, but would
allow the Commission to take an informed decision as regards further EU
legislative work as appropriate. The EU promised to present proposals for the
establishment of scientific criteria to identify endocrine disruptors in the
EU's plant protection products regulation and biocidal products regulation only
after the conclusion of the impact assessment. The EU would continue updating
the Committee on this matter.
2.2.3.16 Ecuador – Resolution establishing the "General conformity
assessment framework for Ecuador" and the "Handbook of procedures to
be observed prior to all stages of the customs clearance, marketing and market
surveillance of manufactured, imported and marketed goods subject to Ecuadorian
technical regulations (G/TBT/N/ECU/44, G/TBT/N/ECU/44/Add.1,
G/TBT/N/ECU/44/Add.2, G/TBT/N/ECU/44/Add.3) - IMS Item No. 398
2.168. The
representative of the United States said that some US exporters have
been unable to obtain Ecuadorian Certificates of Conformity and Certificates of
Recognition, that trade continued to be disrupted, and that many companies had
therefore decided to withdraw from the Ecuadorian market entirely. The US noted
that Ecuadorian certification bodies' lack of capacity to meet the demand for
conformity assessment. Moreover, US certifying bodies asserted that they could
not issue the requisite certifications. The US further noted that Ecuador
already had in place stringent measures to control the quality of goods
entering its market. She therefore asked if Ecuador could explain what benefits
additional attestations of conformity would confer. She also asked Ecuador to
explain the legitimate objectives of requiring additional certification
requirements for each product.
2.169. The
representative of Brazil shared the concerns expressed by the US delegation
and informed the Committee of ongoing bilateral negotiations on this issue.
2.170. The
representative of Ecuador recalled that the TBT Agreement recognized the
legitimate objectives of addressing safety, the protection of life, human and
animal health, plant health, the protection of the environment as well as the
protection of the consumer. It was to apply these objectives and protect
consumers against damaging practices and certain food practices that an
Inter-ministerial Committee on Quality of Ecuador was, according to article 9.1
of the law on the Ecuadorian System of Quality, established as the body in
charge of formulating the policies on the basis of which products would have to
comply with technical regulations and conformity assessment procedures before
they were traded. Inter-ministerial Committee on Quality of Ecuador established
the resolution 001 about the General conformity assessment framework for
Ecuador and the Handbook of procedures. This resolution established guidelines
for the trading of products according with the requirements of the technical
regulations, and the way in which they would be applied. To this end, the
procedure required that the import of
goods produced outside the country or the marketing of products in the case of
domestic production of goods were subject to
Ecuadorian technical regulations, would have to comply with Ecuadorian
assessment framework regulations, or the equivalent compulsory regulations. The
certification of conformity or inspection would have to be carried out by a
body recognized by the Ecuadorian authorities. The importer, before the
importing of the goods subject to such technical regulations, must obtain a
certification of conformity assessment. The assessment document would have to
prove the validity and the scope of the accreditation of the certification
bodies or of the inspection body within a period of 5 days after reception of
the technical documentation. The national institute of standardisation, on the
basis of these certification documents, would issue, through the Ecuadorian
bodies, a recognition certificate for the product which would then be marketed.
This certificate of recognition would then be issued within a period of 5 days
from reception of the document. All this process was electronic and fell within
the framework of trade facilitation.
INEN could suspend or cancel any recognition certificate if it was
proved that the document presented had been tampered with or when it was
established that the product did not conform with the requirements of the
technical regulations, without prejudging the administrative sanctions to be
applied. Ecuador underlined that the measures adopted were not a restriction to
imports, but a useful process to establish conformity with Ecuadorian technical
regulations. She also noted that they had been notified as required by the TBT
Agreement.
2.2.3.17 Russian Federation – Measure affecting import of Ukrainian confectionary
products - IMS Item No. 399
2.171. The
representative of Ukraine reiterated her delegation's concerns with the
ban on imports of Ukrainian confectionery products to the Russian Federation
that had also been extended to the transit of Ukrainian confectionery products
to the occupied territory of the Autonomous Republic of Crimea. She noted that
initially this ban concerned major producers and was enacted on 29 July 2013
by the Decision of the Federal Service on Consumers' Rights Protection and
Human Well-being Surveillance of the Russian Federation (Rospotrebnadzor).
However, she said, on 5 September 2014 this unjustifiable and
discriminatory import ban had been expanded to all confectionery products of
Ukrainian origin. With regard to the reason for imposing this restrictive
measure, she recalled that the Russia had referred vaguely to its legislation
on consumer rights concerning labelling requirements (Federal Law No.
2300-1, of 7 February 1992). As its modus operandi,
Russia applied its measures in a non‑transparent manner, limiting relevant
information to very general notices on the Rospotrebnadzor
website and failing to respond to enquiries of Ukrainian producers and
authorities concerning specifics of alleged inconsistencies. She stressed that
no evidence concerning violation of legislation on consumer protection was
officially submitted to Ukraine. Ukraine also emphasized that official results
of the inspection of Ukrainian factories conducted in October 2013 had not yet
been provided to the producers and authorities. Ukraine further highlighted the
lack of cooperative and constructive communication from Russian authorities in
resolving this particular concern, including disregarding information provided
by the Ukrainian authorities.
2.172. She
also noted that Ukraine had not yet received any written response to additional
questions raised under this STC at previous meetings. She recalled that Russia
was asked to provide: (i) a clear explanation of the reasons why the ban
was introduced, including transmission of laboratory test results; (ii) an
official detailed clarification and justification for measure and how it
complied with Articles 2.1 and 2.2 of the TBT Agreement; and
(iii) the official results of the inspection of Ukrainian factories that
was conducted in October 2013. She further noted that according to Russian
Federation legislation (Articles 14.7, 14.8, 14.15, 14.43 of the Code on
Administrative Offences), violation of requirements on consumer protection would
result in a fine for Russian producers, but no ban on the placing on the market
was envisaged. Thus, she stated the import ban for Ukrainian producers was
clearly inconsistent with national treatment provisions of Article 2.1 of the
TBT Agreement. Ukraine believed that the measure was not justified, and
was discriminatory as well as applied in non‑transparent manner with a view to
creating unnecessary obstacle to trade. Ukraine also noted the significant
economic impact of this ban, which resulted in a reduction of 480 million
US dollars per year of trade in these goods – which were traditionally
exported to Russia – representing 45% of the total export of confectionary
products from Ukraine. In accordance with the Articles 10 and 2.5 of the TBT Agreement,
Ukraine therefore requested the Russian Federation to immediately lift the ban
since no scientific information was available to justify the measure.
2.173. The
representative of the Russian Federation indicated that the measure
affecting confectionery products of the Ukrainian company Roshen
was introduced due to inconsistencies of these products with Russian labelling
requirements. Labelling requirements for food products were established in 2011
by the Customs Union Technical Regulations on Food Product Labelling. The
circulation in the territory of the Customs Union of food products not in
compliance with the provisions of the technical regulation was prohibited. In
2013, the Russian regulating authority Rospotrebnadzor
had detected that the labelling of confectionary produced by the company Roshen had contradicted relevant requirements by providing
false information on the content of proteins fat and carbohydrates in the
products. The measure at issue was introduced to protect consumer rights for
valid information and to prevent deceptive trade practices. He reiterated that the import suspension of
confectionary produced by the company Roshen
represented a measure taken under the existing technical regulation. Hence,
Russia did not see any basis for notification. With regard to concerns about
national treatment, his delegation did not see any basis for such concerns and
stated that the legislative requirements and their enforcement were applied in
a manner fully compliance with the national treatment principle.
2.174. Russia
also said that after the detection of the first violation of the Technical
Regulations on Food Product Labelling by Ukrainian producers, Rospotrebnadzor had paid closer attention to Ukrainian
products and that this had revealed many additional violations. As a result, as
from 5 September 2014, a prohibition on importation of all Ukrainian
confectionary products was introduced due to inconsistency with labelling
requirements. The results of test were shared with Ukrainian authorities
at bilateral meetings held in August, October and December 2013. The
majority of tested products did not meet the requirements of the technical
regulation. During the December 2013 bilateral meeting, the State Inspection of Ukraine for Protection
of Consumers' Rights recognized the inconsistencies. In the process of
consultation, an agreement was reached that would allow the trade of
confectionary products of Roshen to be resumed.
Unfortunately, the Ukrainian side has still not taken steps to implement the
agreement reached. In order to lift the ban, Russia called on the competent
authorities of Ukraine to participate in bilateral consultations with the
competent authorities of the Russian Federation.
2.2.3.18 Ecuador – Resolution No. 116 of the Foreign Trade Committee of
Ecuador of 19 November 2013 and Technical Regulation of the Ecuadorian
Standardization Institute RTE INEN 022 on the labelling of processed and
packaged food products (G/TBT/N/ECU/19/Add.3, G/TBT/N/ECU/19/Add.5,
G/TBT/N/ECU/19/Add.6, G/TBT/N/ECU/19/Add.8) - IMS Item No. 411
2.175. The
representative of Canada said that while his delegation supported
Ecuador's objective of reducing the risk of non‑communicable diseases, it was
nonetheless still concerned that the regulatory proposals could have a significant
impact on trade and were likely to be more trade restrictive than necessary.
Given reports that the measure had entered into force on 29 May 2014,
Canada asked Ecuador to clarify the status of the measure. If the measure had
indeed entered into force, Canada was concerned that Ecuador had not provided
trading partners the appropriate transition period prior, which was required under
the TBT Agreement. He recalled that when this issue was last raised with
Ecuador at the March 2013 TBT Committee meeting, Ecuador had
indicated that it was taking WTO Members' concerns into consideration when
amending the regulation. Canada thus asked Ecuador for an update regarding any
such amendments.
2.176. The
representative of Costa Rica recalled concerns about the difficulties
faced by Costa Rican food product exporters to comply with Ecuador's
conformity assessment procedures. He was pleased to report that these
difficulties had been overcome according to reports from the Costa Rican food
industry. Nevertheless, his delegation remained concerned about provisions
relating to "traffic light" labelling for fat, sugar and sodium
content. These were set forth in the Ecuadorian Technical Regulation
(RTE INEN) No. 022 "Labelling of processed and packaged
food products", adopted by Resolution No. 14413 of
22 August 2014 of the Under‑Secretariat for Quality of the Ministry
of Industry and Productivity. In this respect, Canada expressed the
view that this "traffic light" system was not based on
scientific evidence nor was it covered by any CODEX reference standard. Given that
it was not based on any recognized international practice, he stressed that
such labelling requirement would have a considerable impact on trade, including
the fact that exporters would have to adapt product labelling specifically for
the Ecuadorian market. He additionally expressed ongoing concerns about the labelling
requirements for food products manufactured from transgenic ingredients. Costa Rica
questioned the scientific basis and proportionality of these requirements in
relation to the provisions of Article 2.2 of the TBT Agreement. He
asked to be informed of the terms in which these matters were regulated in the
final regulations and of the way in which concerns expressed by various
delegations at previous meetings of the Committee had been taken into account.
2.177. The
representative of Mexico reiterated its overarching concerns about
Resolution No. 116 of the Ecuadorian Foreign Trade Committee, by which the
"certificate of recognition" requirement was established for a series
of documents listed in the same document. She noted that this topic had been
the subject of bilateral dialogue with Ecuador, in which the following was
requested from Ecuador: (i) the notification of the measure in question to
the TBT Committee; and (ii) the provision of information to justify
the establishment of this requirement for a wide range of products. Given the
variety of products covered by Resolution No. 116, Mexico requested
Ecuador to provide information on the contribution made by the new requirement
to fulfilment of the legitimate objectives pursued by the different technical
regulations governing the specifications of the various products covered.
2.178. Mexico
also reiterated its continued concerns about Ecuador's draft revision,
PRTE INEN 022 (1R) of the Ecuadorian Standardization Institute
Technical Regulation, entitled "Labelling of processed and packaged food
products", which was notified to Members in document G/TBT/N/ECU/19/Add.8.
With respect to this notification, her delegation was concerned that Ecuador
had failed to comply with transparency obligations laid down in Article 2.9
of the TBT Agreement since this measure was a technical regulation and
Ecuador had not provided Members with the opportunity to submit comments. On
the specific provisions of the draft revision of PRTE INEN 022, Mexico
considered that the definitions of "food", "processed
food", "nutritional claim", as well as the system of colour
coded charts, all may contravene the provisions of Article 2.4 of the
TBT Agreement, as they were not based on relevant international standards,
such as the "General Standard for the Labelling of Pre‑Packaged
Foods" of the CODEX Alimentarius (CODEX STAN 1 1985, point 2).
She said the same point applied for labelling with references to non‑caloric
sweeteners and transgenic contents. Mexico argued that the system of colour
coded charts (showing "high", "medium" and "low"
concentration of total fats, sugars and salts) may contravene the principle of
proportionality provided for in Article 2.2 of the TBT Agreement by
not constituting the least restrictive alternative necessary to fulfil the
desired legitimate objective. She was concerned that the system did not help
the consumer make an appropriate choice of products for consumption; rather,
the messages could instead arouse fear in the consumer. Further, the measures
on advertising, which prohibited the use of images of real or fictitious
persons and animals in labelling, could be contrary to the provisions of the TRIPS Agreement,
which governed the protection countries were required to provide for the owners
of an intellectual or industrial property right.
2.179. The
representative reiterated a series of requests to Ecuador. First, she called on
Ecuador to notify the "Sanitary regulations for the labelling of processed
foods for human consumption", in accordance with the provisions of the TBT Agreement,
so that comments on the regulations could be submitted. Second, she requested
that PRTE INEN 022 be amended so that concepts such as
"food" and "nutritional claim" coincided with the
provisions of the CODEX Alimentarius, and that the difference between
"food" and "processed food" was eliminated. Third,
Mexico asked for an explanation of the justification and scientific evidence
for the colour coded system of charts specifying the "high",
"medium" or "low" concentration of three components: total
fats, sugars and salts, respectively. Fourth, she requested that justification
be provided for – or if appropriate, consideration be given to eliminating
the requirement of – including the term "transgenic" on the label,
in case of transgenic content. Fifth, Mexico asked that the restrictions on
advertising in labelling be reconsidered.
2.180. The
representative of the European Union echoed concerns expressed by other
delegations on PRTE INEN 022 on the labelling of processed and
packaged food products. This technical regulation imposed nutrition food labelling
obligations comprising "high in" warnings and a traffic light
warning system. While the EU fully shared Ecuador's public health objectives
regarding the provision of adequate nutritional information to consumers, the
representative expressed doubt that the approach taken in the notified draft was
neither the best way to achieve these objectives, nor proportional to the aim
pursued, which should be to empower consumers to make an informed choice in
order to foster effective competition and consumer welfare. The EU recalled
previous interventions on this specific trade concern regarding the lack of
proportionality of the measure, its departure from CODEX guidelines, and
the use of the "high in" warnings, which were well recorded in
the minutes of the last meeting of this Committee, document G/TBT/M/63.
2.181. The
representative of the United States supported concerns raised by other
Members on Ecuador Foreign Trade Committee Resolution 116 , and referred
Members to comments made by her delegation under another STC concerning an
equatorial measure (Ecuador – Resolution establishing the "General
conformity assessment framework for Ecuador" and the "Handbook of
procedures to be observed prior to all stages of the customs clearance,
marketing and market surveillance of manufactured, imported and marketed goods
subject to Ecuadorian technical regulations).
2.182. The
representative of Brazil shared the concerns raised by other
delegations, expressed appreciation for the bilateral dialogue with Ecuador on
this matter, and said Brazil would remain engaged in this discussion.
2.183. The
representative of Colombia recalled that his delegation had sent
comments to PRTE INEN 022 (G/TBT/N/ECU/19/Add.8) on 26 August 2014,
but to date had not received a response for Ecuador. He requested that Ecuador
provide a prompt reply.
2.184. The
representative of Ecuador explained that Foreign Trade Committee (COMEX)
with Resolution No. 116, adopted on 19 November 2013, was not a technical
regulation, but rather was an administrative measure for customs which outlined
the product headings which were subject to the requirement to submit a
certificate of recognition.. She also stressed that the measure was not an
unnecessary barrier to trade, and was consistent with multilateral trade rules.
2.185. With
respect to RTE INEN 022, she explained that the Ministry of Public Health had
carried out a national survey on health and nutrition, which revealed some
worrying trends. In light of this situation, the Ministry of Public Health
adopted a comprehensive policy taking certain measures to promote health and to
improve the living standards of the population, including this measure on
"Health regulation labelling of processed food for human consumption".
In Article 12 of the measures, it was specified that any processed food for
human consumption must comply with the requirements of RTE INEN 022, including
a colour coded bar with graphics. On 26 January 2014, the Regulatory Agency on
Health made available to users a data processing system to access the new
labelling system. Several workshops were held throughout the territory to make
firms aware of the labelling system, including visit from technical personnel
to ensure correct implementation. On 12 March 2014, Ecuador notified this
measure in document G/TBT/N/ECU/19/Add.4. Aware that firms needed some
additional time to comply and adapt to the requirements, the national authority
brought the measure into force in a staggered was accordance to the size of the
firms. She noted that SMEs were given additional time to meet the labelling
requirements.
2.186. The
representative noted that Ecuador had taken on many of the comments and
concerns raised by other Members, including with respect the placement of the
label, the prohibition of depictions of animals and children, and the use of
stickers. To date, according to the monitoring carried out by Ministry of
Public Health, more than 80% of firms had brought their labelling in line with
the requirements, and the remaining firms still had additional time to do so.
On this basis, she concluded that firms had managed to adapt to the new
requirements.
2.2.3.19 France – Recycling Triman Mark: "Draft Decree on a common set
of symbols informing the consumer about recyclable products subject to a system
of extended producer responsibility associated with waste sorting
instructions" (G/TBT/N/FRA/153) - IMS Item No. 420
2.187. The
representative of the United States asked the European Union for an
update on the revision of the draft decree, which the US understood would
provide more flexibility to industry in meeting the labelling requirements,
including the option of posting recycling information on a website. She asked
how companies would be made aware of these requirement changes. Without this
revision, she said, foreign manufacturers could incur significant costs. She
asked that France continue consultation with producers and manufacturers on
alternative less costly options that would still increase recycling rates, such
as a consumer education programme. The US welcomed the exemption of glass from
the proposal in the law published on 2 January 2014, but asked whether
aluminium/plastic closures would still be subject to the recycling logo
requirement. In the event that there would not be a revision to the draft
decree, she said it was unclear how companies would comply with some of the
labelling requirements. It was their understanding that if there were "significant
and disproportionate economic, regulatory or technical obstacles", the
information could be provided by placing the label on either the packaging or
the manual of the product. However, it was not clear how this option would provide
the appropriate information to the consumer.
2.188. The
representative of Canada supported comments made by the US and invited
Members to refer to the comments made by Canada on this issue at previous
Committee meetings.
2.189. The
representative of the European Union informed the Committee that the
requirement regarding the affixing of the TRIMAN logo had been changed. With
regard to the waste sorting instructions, the TRIMAN logo should be affixed, preferably
on the product, on the accompanying product manual if it would not be possible
to do so on the product itself, or on any supporting documentation (including
dematerialised forms), if the other means had not been used. The obligation to
label a product with the TRIMAN logo was now on those placing the product on
the French market for the first time.
2.2.3.20 Russian Federation – Safety of products for children and adolescents
- IMS Item No. 418
2.190. The
representative of the European Union reiterated concerns sent to the
Russian authorities on 28 February 2014, and also raised in previous Committee
meetings, in particular the issue concerning the definition of "synthetic
or artificial leather" and the abolishment of the ban on the use of
synthetic or artificial materials in the products for children and adolescents.
He asked Russia to provide more detailed information on the possible changes of
the notified amendments and on the timeline foreseen for their adoption and
entry into force.
2.191. The
representative of Norway associated her delegation with the statement
and concerns raised by the EU and looked forward to updates and written replies
from Russia.
2.192. The
representative of the Russian Federation thanked the EU and Norway for
their comments on the amendments to the Customs Union technical regulation on
the safety of products for children and adolescents which entered into force on
1 July 2012, with a transitional period for implementation which expired on 15
February 2014. Subsequent amendments to the technical regulation were notified
to the WTO in G/TBT/N/RUS/29. Public hearings on amendments to the technical
regulation started in December 2013 and, based on requests from WTO Members,
were extended until April 2014. Comments from interested parties had been
received and were being considered in the draft amendments being developed. He
added that procedures for the introduction of amendments to technical
regulations were similar to those for the introduction of the regulation
itself. In answer to the EU request for a timeline, he stated that the
amendments would most likely not be adopted before January 2015, with entry
into force no earlier than July 2015. Until then the existing technical
regulation would continue to be applied. He said the use of artificial and/or
synthetic material in the lining of footwear for children and adolescents
(Annexes 14 and 15 to the technical regulation) was not prohibited.
2.2.3.21 China – Regulations for the Supervision and Administration of
Medical Devices (Order No. 650 of the State Council) (G/TBT/N/CHN/1022,
G/TBT/N/CHN/1023, G/TBT/N/CHN/1024, G/TBT/N/CHN/1025, G/TBT/N/CHN/1026,
G/TBT/N/CHN/1029) - IMS Item No. 428
2.193. The
representative of Canada expressed his delegation's continued concerns
with the far- reaching effects of this measure on the medical device industry
in China as well as foreign suppliers of medical devices. Given the number of
implementing regulations related to Order No. 650 that had been issued in
recent months, more time would be required to fully comprehend the potential
impact for foreign medical devices companies. He asked whether there were plans
to hold debriefing or training sessions in China. He also requested
clarification on certain aspects of the new implementing regulations, in
particular Order No. 4 (Medical Device Registration Administration Methods),
and Order No. 5 (In Vitro Diagnostic Products Registration Administration
Methods). He noted that Article 13 of Order No. 4 and Article 15
of Order No. 5 stated that imported products for which registration or
listing applications were being made "should have obtained permission to
be entered into the market and sold in the country (region) where the applicant
registered or produced the product". Did this this mean that imported
medical devices and in vitro diagnostic products had to have prior approval in
their country of origin? He said such a requirement might be difficult for
Canadian exporters who may not necessarily seek regulatory approval
domestically. Could applications be made for Canadian‑originating medical
devices or in vitro diagnostic products which had received approval in other
leading jurisdictions, such as the US or EU, but which were not approved in
Canada? Additionally Orders No. 4 and No. 5 required the applicant to
provide registration inspection samples of Class II and III medical
devices and in vitro diagnostic products. This form of duplicative type
testing appeared to be unnecessary and burdensome for imported devices that had
already been approved in other markets. Canada requested China to clarify
whether foreign clinical trial data was applicable or whether the trials had to
be conducted in China as this was not clear from Article 22 of Order
No. 4, which only stated that clinical trials should be conducted for
Class II and III medical devices. Canada also had concerns with
Article 35 of Order No. 5, which specifically stated that, for
in vitro diagnostic products, a focused clinical evaluation should be
conducted in China, which constituted an unnecessary and duplicative clinical
trial requirement for Canadian exporters that had received prior regulatory
approval in other leading foreign jurisdictions, including Canada. He said this
duplicative requirement would result in additional time and expense being
incurred by Canadian medical device exporters wishing to enter the Chinese
market. Canada asked whether China intended to issue additional implementing
regulations concerning medical devices in the future and looked forward to
receiving a detailed response to its questions.
2.194. The
representative of the European Union welcomed the efforts made by
Chinese authorities to amend the regulations on medical devices, and the
constructive dialogue between the Chinese and EU authorities. However, like
Canada, the EU still had some concerns with the regulations, and in particular
Article 17 of Order 650, which stated that if the safety and
effectiveness of the medical device could be proven by using data obtained from
the clinical trial of similar products or during clinical applications, then
the product was exempted from clinical trials and listed in a catalogue. Did
this mean that that Medical Devices not listed in the catalogue would have to
be subject to clinical trials conducted in China? The EU also had concerns that
the draft lists of Class II and Class III devices exempted from clinical trials
were too limited. She asked CFDA to put in place a robust system that allowed
for swift updates of exemption catalogues, as experience had shown that the
pace of the regulatory mechanism to update such lists sometimes lagged
significantly behind the pace of innovation.
2.195. She
also noted that for products not listed in the catalogues duplicative and
redundant clinical trials would have to be conducted in China. The EU was of
the view that due consideration should be given to studies that had taken place
outside China, especially where the studies had been conducted in a
jurisdiction which, like China, was a member of the International Medical
Device Regulators Forum (IMDRF). The study results might then only require
small bridging studies to ensure its relevance to China. She reiterated the
importance of avoiding any duplication of clinical trials which would cause
additional delays in placing products on the Chinese market, without any added
benefit. Excessive trials, she said, also presented ethical problems. The EU
failed to understand the rationale for the requirement to register medical
devices in the country of origin, as all medical devices marketed in China
(whether already registered in the country of origin or not) needed to comply
with comprehensive Chinese authorization requirements.
2.196. Finally,
concerning the Electromagnetic Compatibility (EMC) testing, the EU reiterated
its request that CFDA accept test reports from foreign laboratories accredited
by accreditation bodies that were members of ILAC, as an alternative to in‑country
testing in China. The EU also stressed that the registration certificate should
exclude the potentially confidential "Product Technical Requirements"
documentation. Finally, the EU requested that Chinese authorities provide a
transitional period of three years as these new provisions introduced major
changes. Further guidelines, she said, would also be welcome.
2.197. The
representative of the United States supported comments made by Canada
and the EU. While appreciating China's efforts in notifying the implementing
regulation of CFDA's overall medical devices regime, Order No. 650
did not appear to provide sufficient transition periods for industry to fully
adjust to the multiple new requirements, in particular for Class I medical
product conformity assessment procedures. She asked whether China would take
into account comments received from industry on the necessity of a transition
period of two to three years.
2.198. The
representative of China informed the Committee that CFDA had
communicated directly with relevant foreign and domestic enterprises and
associations on the measures and had taken comments into account, including
those received from the EU and US chambers of commerce in China. Prior to
implementation, she said, CFDA had held specialized training sessions to help
enterprises and organizations to understand better the measures. Comments from
stakeholders and interested parties would continue to be taken into account.
2.2.3.22 Egypt – Bottled water - IMS Item No. 421
2.199. The
representative of Turkey reiterated concerns regarding exports of
bottled water to Egypt. Turkish exporters of bottled water still could not obtain
permission for importation from the Supreme Committee for Water of Egypt's
Ministry of Health. He recalled that in previous Committee meetings Egypt had argued
that Egyptian Standard No. 2007/1589 was in conformity with the relevant
Codex Standards and WHO Guidelines, and was equally applied to domestic bottled
water companies. However, in previous discussions, in June 2013, Egyptian
authorities had informed his delegation that the mandatory Egyptian Standards were
being revised according to "Codex Standard 227‑2001" and
the "WHO Guidelines for Drinking‑Water Quality, 2011". The
representative sought clarification as to whether the Egyptian Standard was in
conformity with these two relevant documents and asked Egypt to explain why it
had initiated such a revision of the standard. Turkey also requested Egypt to
provide any additional information on the current status of the revision
initiated by Egyptian authorities.
2.200. With
respect to Egypt's argument that domestic and imported products were accorded equal
treatment, he reminded the Committee of the fact that Turkish exporters of
bottled water could not obtain permission for importation from the Supreme
Committee for Water. The explanation given by Egypt was that periodic control
of its source could not be maintained based on Egyptian Standard No. 02007/1589.
In this respect, in April 2014 Turkey had invited a technical committee of
Egyptian officials to conduct inspection visits and to control the water source
of Turkish exporter firms of bottled water on‑site. When no reply was received
to this request, on 14 October 2014, Turkey had reiterated this meeting
request to the relevant Egyptian authorities. Turkey had not yet received a
reply to either request.
2.201. He
also recalled that at the last Committee meeting, Egypt had stated that the
requirement limiting importation of bottled water to those producers with an EU
reference applying the HACCP system had been removed. His delegation considered
this to be a positive development, since such requirement was a clear violation
of Egypt's WTO MFN obligations. Turkey requested additional information
from Egypt as to how the requirement was removed and how its effective
implementation would be ensured. Furthermore, in reference to the decisions of
the Supreme Committee for Water, Turkey posed the following questions: (i) what
were the requirements for exporting bottled water to Egypt; (ii) from
which countries did Egypt allow importation of bottled water; (iii) how did
Egyptian authorities maintain periodic control of the source of the bottled water
coming from these countries; and, (iv) whether they conducted inspection
visits, or required test reports or certificates? Turkey again expressed its
readiness to invite a technical committee from Egypt to conduct inspection
visits and control the water source if this was the requirement applied by
Egypt to its other trading partners. His delegation continued to believe that
Egypt's policies and practices constituted an unnecessary obstacle to Turkey's
bottled water exports to Egypt. He asked Egypt to cooperate with Turkey to find
a mutually satisfactory solution to this issue and once again recalled Egypt's
existing obligations under WTO Agreements in general, and the TBT Agreement in
particular.
2.202. The
representative of Egypt stated that imports of bottled water were
subject to Egyptian Standard No. 2007/1589, mandated by Ministerial Decree
No. 130‑2005, which was notified to the TBT Committee as
G/TBT/N/EGY/1. This standard was publicly available at the premises of the
Egyptian Organization for Standardization in Cairo, as well as online.[5]
The Egyptian Standard requirements included that authorities conduct regular
checks on water resources, along with all other specifications requested. In
this regard, she underlined that in 2012 the Egyptian government had suspended
seven bottled water companies due to non‑compliance with the standard's
requirements. Egypt applied this decree equally to domestic and foreign bottled
water companies, and was therefore fully compliant with Article 2.1 of the
TBT Agreement. She further stated the Egyptian standard was in conformity
with relevant CODEX standards and WHO guidelines. Finally, she stated
the Egyptian Standard was not more trade restrictive than necessary, as the
measure was necessary for consumer health, safety and protection. The
representative said she would convey all other requests for clarification from
Turkey to her capital, and would reply in due time.
2.2.3.23 India – Labelling Regulations for Canola Oil - IMS Item No. 413
2.203. The
representative of Canada said that until February 2014,
canola oil had entered India since 2007 without incident, and was marketed
as canola oil and labelled as "Ingredients: Imported Refined Canola
Oil". In July 2014, India's Food Safety and Standards Authority of India
(FSSAI), which had apparently banned the marketing and labelling of canola oil,
published an import clearance notice reaffirming India's position that the
product must be labelled and marketed as "Imported Refined Rapeseed Oil ‑ Low
Erucic Acid." Canada said that such sudden and seemingly irrevocable
decision to apply such labelling requirements to canola oil shipments without
notice, directly and immediately affected exports, marketing and sales of
canola oil in India. Canada was of the view that India was therefore in
violation of its WTO obligations for having failed to notify Members of
changes to its labelling regulations. Moreover, he said India's regulation
could be more trade restrictive than necessary to achieve its legitimate
objective of food safety, which would be a violation of Article 2.2 of the
TBT Agreement.
2.204. Canada
was also concerned that the labelling requirements for canola oil, contained in
India's Food Products and Food Additives Regulations 2011, did not conform to
the relevant guidelines recommended by CODEX Alimentarius, as CODEX Standard 210‑1999
deems "canola oil" and "rapeseed oil – low erucic acid'
as synonyms. He said India's labelling requirements appeared to discriminate
against the legitimate term "canola oil", which was of equivalent
status to "low erucic acid – rapeseed oil" according to CODEX
Alimentarius guidelines. Despite claims to contrary by FSSAI, Canada reiterated
that "canola oil" was not a trademark name but rather an
internationally recognized vegetable oil applauded for its health benefits.
Since India's regulation differed from the international standard, in this case
the CODEX standard, Canada was of the view that India's regulation may violate
Article 2.4 of the TBT Agreement. Furthermore, he noted that the
Bombay High Court ruled in favour of an importer, by issuing a stay order
against the FSSAI labelling guidelines for "canola oil". Canada
encouraged India to consider an alternative measure to the currently enforced
labelling requirements for "canola oil", which would follow CODEX
Alimentarius guidelines, and would not create an unnecessary barrier to trade.
2.205. The
representative of Australia considered the requirement to use the term "rapeseed
oil – low erucic acid", as specified by India in its Food Products and
Food Additives Regulations 2011, and only permitting the use of the term "canola oil"
as a secondary term, as an unnecessary labelling burden for Australian
exporters of refined "canola oil" to India. His delegation believed
this regulation contradicted CODEX Alimentarius Standard for named vegetable
oils, which permitted the use of synonym descriptors for
"rapeseed oil", including "canola oil" (Codex Standard
210 ‑ 1999, section 2.1.16). Australia understood that the term
"canola oil" was often used to describe domestic products that were
available for local sale in India. He said India's Plant Quarantine Order 2003,
which outlined India's import quarantine requirements for plants and plant
products, allowed the use of the alternative terms "rape and canola".
Australia continued to express support for FSSAI's initiative of harmonising
India's food standards with CODEX that commenced in early 2013.
2.206. The
representative of India said "canola oil" was an edible
vegetable oil produced from "rapeseed bearing low erucic acid".
"Canola oil" had been imported to India for several years, mostly
from Canada, and India believed that "canola oil" was a given
trade name. He noted that in the CODEX standard the product was listed as
"rapeseed oil, low erucic acid". In accordance with
the CODEX, India's Food Safety and Standards (Packaging and Labelling)
Regulations 2011 required that the product be labelled and marketed as "Imported
Refined Rapeseed Oil- Low Erucic Acid". He stated the manufacturer may, if
desired, write "Canola Oil" in parenthesis. He said that in an e‑mail
message from FSSAI, dated 26 May 2014, the Canadian High Commission
in New Delhi was informed about this labelling requirement. It was also noted
that the labelling of canola oil should conform to Food Safety and Standards
(Packaging and Labelling) Regulations 2011, which was effective from 5 August
2011. This regulation, he reminded Members, was duly notified to the WTO in
July 2010 and Members were given 60 days for comments. The objective of the
marking requirements was to ensure protection of the interests of consumers and
to provide a basis for consumers to make informed choices in relation to the
foods they consumed. The representative noted that it entailed only a simple
change of product declaration on the labels. Instead of writing the
"brand name", he explained suppliers were henceforth required to
declare the "generic name" on the product labels for the sake of
consumer information. He stressed that this measure could not be characterized
as more trade restrictive than necessary.
2.2.3.24 Thailand – Draft Notification of the Alcoholic Beverages Control,
Re: Rules, Procedure and condition for Labels of Alcoholic Beverages, issued
under B.E. (G/TBT/N/THA/437) - IMS Item No. 427
2.207. The
representative of Canada recognized Thailand's right to impose measures
to protect consumer health and safety, and provide consumers with adequate
information to make informed choices. He expressed appreciation for Thailand's
briefing at the margins of the Committee meeting, and applauded its efforts to
reduce youth consumption of alcohol. Canada was, however, concerned that
Thailand's proposed labelling regulations may be more trade restrictive than
necessary to meet their objective, and in turn, may have an undue impact on the
trade of Canadian alcoholic beverages to Thailand. He noted that
Clause 2(2) and Clause 3(1‑6) of the proposed rules prohibit the use
of wine labels that contained: (i) images of athletes, artists, singers or
cartoons; and (ii) messages that were affiliated with activities such as
sport, music, and contests. Seeing some of the images displayed by Thailand
during the briefing session, Canada understood Thailand's concerns. However,
some of the definitions in the regulations were unclear and might be overly
injurious to certain labels considered as "cartoons". For instance, some
Canadian wine labels portrayed images which were not, however, intended to
appeal to children or promote irresponsible alcohol consumption. His delegation
understood that the amended proposed regulation of September 2014 had been
expanded to consider the use of graphic warning labels and messages unique to
Thailand. He asked for further information about next steps on this regulatory
proposal. He also noted that the amended proposed regulation had not been
notified to the TBT Committee, and therefore encouraged Thailand to make that
notification and to comply with the related entry into force obligations under
the TBT Agreement.
2.208. The
representative of Mexico thanked Thailand for the information session
and for meeting with her delegation bilaterally. Mexico reiterated concerns with
this Thai measure, notified to the TBT Committee on 28 March 2014 in document
G/TBT/N/THA/437. Her delegation was concerned that Thailand may be contravening
basic principles of the TBT Agreement with respect to the preparation of
technical regulations, such as those relating to: (i) non‑discrimination,
as contained in Article 2.1 of the TBT Agreement; (ii) proportionality, as
contained in Article 2.2; and (iii) conformity with international standards,
as contained in Article 2.4. She noted that the technical regulation established
an exception for beverages manufactured in Thailand or imported for re‑export,
or for those prepared for purposes of non‑commercial sampling, analysis, or
research within the country. In this respect, Mexico asked Thailand to adhere
to the TBT principle of non‑discrimination Mexico also asked Thailand to ensure
compliance with the TBT principle of proportionality in the light of the
legitimate objective pursued by this regulation. She recalled that the
regulation imposed graphic warning labels on the harmfulness and toxicity of
alcoholic beverages, using colour coded graphics authorized by the Alcohol
Control Committee of the Department of Disease Control. In addition, the
regulation imposed prohibitions on the labelling of alcoholic beverages (such
as messages on product quality or characteristics), instead of promoting
measures to help the public obtain accurate information on the effects of alcoholic
beverage consumption, so that consumers could make informed choices. Bearing in
mind the obligations in Article 2.2 of the TBT Agreement, Mexico asked
Thailand for information on the justification or scientific evidence supporting
the labelling proposal, including the aforementioned prohibitions, in light of
the legitimate objective pursued by the regulation. Similarly, she requested information
on the alternatives considered by Thailand to achieve the objective defined by
the technical regulation, such as the use of public information campaigns on
the effects of excessive alcohol consumption.
2.209. Furthermore,
Mexico considered that these measures could constitute violations of the TRIPS
Agreement due to the wide range of prohibitions established on the use of
images (athletes, artists, singers and cartoon pictures), which could
unjustifiably encumber the use of trademarks in the ordinary course of trade.
Accordingly, Thailand was requested to take due account of the provisions of
Section 2 of Part II of the TRIPS Agreement. Finally, Mexico
reserved the right to submit formal comments to the government of Thailand and,
in the meantime, expressed continued concerns that the measures proposed could
be considered as restrictive and discriminatory, which could lead to the
creation of parallel markets for unrecorded alcohol and give rise to adverse
economic effects as well as health problems, including for Thai citizens.
2.210. The
representative of the European Union reiterated concerns regarding the
draft on Alcoholic Beverages Control notified by Thailand on 28 March 2014
(G/TBT/N/THA/437), intended to replace the old measure dated 21 January 2010
(G/TBT/N/THA/332). The notified draft law laid down requirements for labelling
of alcoholic products, including mandatory text warning statements. The EU
thanked Thailand for the presentation organized on the margins of the meeting,
and for the clarifications provided. In particular, the EU welcomed Thailand's commitment
to re‑notify the measure if a decision would be taken to re‑introduce graphic
health warning labels. The EU requested confirmation on this point from
Thailand, and considered that the substantial changes to the March 2014 draft
in the area of graphic health warnings should be re‑notified to the WTO, and
that sufficient time should be allowed for comments. Thailand was currently
carrying out a public consultation on the Alcoholic Beverages Control and the amended
March 2014 draft, as available online, included provisions on graphic health
warning labels. In that respect, the EU requested Thailand to clarify how
previous EU comments had been taken into account and also clarify the status of
the most recent amended draft. She recalled that her delegation submitted
comments on 23 May 2014, and was still looking forward to receiving Thailand's
reply. With respect to graphic warning health messages, the EU saw the recent
online draft (which had not been notified) as a step backwards. The draft
notified to the WTO by Thailand in 2010 (G/TBT/N/THA/332) contained similar requirements
which were eventually not adopted and which were not present in the March 2014
draft following the comments submitted by various WTO Members, including the
EU. She reiterated the request to Thailand whether they could take into
consideration less trade restrictive measures or, failing this, clarify on
which basis and evidence Thailand concluded that different, less costly and
burdensome alternatives than the indication of a graphic health warning, would
be insufficient to address the objective pursued.
2.211. Furthermore,
the EU remained concerned about the strict labelling requirements proposed in
the notified draft and its departure from international standards. In
particular, referring to Article 2.4 of the TBT Agreement, the EU invited
Thailand to clarify the reasons for a deviation from the definition of a label
and a container as provided in the text of CODEX STAN 1‑1985. She
reiterated concerns regarding the lack of clarity of the provisions of the
notified draft relating to messages on the labels which may lead to
inconsistent interpretations by economic operators. Finally, the EU believed
that the administrative complexity of the label approval process (intended to
be dealt with by two separate government agencies), and the short
implementation deadlines for compliance, constituted serious market access
barriers. In this respect, she reiterated the request for Thailand to allow the
sale of all products existing on the market until stocks had been exhausted.
She requested that Thailand take these comments into account and respond to
them before the adoption of the draft regulation.
2.212. The
representative of the United States echoed comments of other Members,
and expressed concerns with Thailand's most recent proposal requiring graphic
labels and warning statements on all alcoholic beverages sold in Thailand. The
US submitted comments to the notification of the original text notified by
Thailand in March 2014, as G/TBT/N/THA/437. The US was particularly concerned
that Thailand had made substantive updates to its March 2014 proposed measure,
but that it had not yet notified those amendments to the WTO for comment by
other Members. These updates included drafts of Thailand's proposals for the
graphic labels and warning statements that would be required on any alcoholic
beverage sold in Thailand. In line with WTO customary practice, and taking into
account the recommendation of the TBT Committee on "Coherent use of
notification formats" (G/TBT/35), she urged Thailand to notify the
amendments to its March 2014 proposal immediately and to delay implementation
of this measure until after Members had an opportunity to submit comments. She
emphasized that this measure, as proposed, entailed unnecessary obstacles to
trade with significant potential impact on US and other Members' exports to
Thailand. She urged Thailand to take into account the serious concerns
expressed by Members over this issue, and to consider less trade alternatives
as a means of achieving its policy objectives. Once the final requirements were
determined, she asked Thailand to consider flexibility regarding implementation,
including adequate transition periods to facilitate industry's adjustment to
the new labelling scheme, and the possibility to allow sale of products on the
market until exhaustion.
2.213. The
representative of Australia recognised the right of governments to take
measures necessary to protect public health, provided that such measures
complied with relevant international trade obligations. He welcomed information
provided by Thailand to date, and looked forward to receiving further
information on the proposed measure.
2.214. The
representative of Chile supported the statements of other Members, and
expressed significant concerns about the provisions and implementation of the
proposed measure. While Chile agreed with the objective pursued by Thailand to
safeguard consumer health and safety, she believed that this measure was more
trade restrictive than necessary within the meaning of Article 2.2 of the
TBT Agreement. She asked Thailand to consider alternative measures to achieve
their policy objective, which were common international practice. In
particular, Chile was concerned about implications of the measure for various declarations
about the quality and characteristics of the product normally displayed on
labels of wines and other alcoholic beverages, such as "reserve",
"grand reserve", "special", amongst others. For instance,
she noted the importance of such terms for differentiating qualities of Pisco; special Pisco; reserve Pisco; gran reserve Pisco.
She also cited possible implications for geographic indications and
appellations of origin, and highlighted their importance for helping consumers identify
a product as originating in a certain territory with a certain quality and
reputation, and other characteristics which could be attributed directly or
indirectly to the geographic origin. Her delegation expressed concern that the
Thai measure may not allow for such information on labels, denying consumers
important information. Furthermore, there was a lack of clarity on the
prohibition on using images. Chile did not understand how various evocative
images, such as of sculptures, angles, abstract pictures or images relating to
sport or caricatures, could incite alcohol consumption. Chile enquired as to
the scientific basis for such prohibitions. She also sought clarification about
how the rule would be applied in the period prior to entry into force, and the
sanctions for non‑compliance. Finally, she urged Thailand to take account of
the various concerns expressed by Members.
2.215. The
representative of New Zealand thanked Thailand for the briefing session.
New Zealand acknowledged and supported Thailand's right to adopt new
regulations to address public health concerns, and appreciated that in seeking
to address the harmful use of alcohol, the draft technical regulation was
directed towards achieving a legitimate public health objective. New Zealand
appreciated Thailand's recent request by its Ministry of Health for public
comment on its draft regulation. However, New Zealand requested that Thailand
notify this regulation to the TBT Committee in accordance with its WTO
obligations, as Thailand has previously done on previous versions of the
regulation. In this light, she welcomed recent comments that Thailand intended
to notify the revised version of the regulation in due course, and requested
that Thailand provide reasonable time for Members to provide comments as per
WTO obligations.
2.216. New
Zealand also reiterated concerns that the labelling requirements were
unnecessarily trade restrictive and was particularly concerned that the new
version of the regulation envisaged a more restrictive approach than the
regulations previously notified in March 2014. She asked for an explanation of
the rationale behind the change in this revised draft regulation. New Zealand
was particularly concerned that Clauses 2 and 3 of the draft regulation were
subjective and open to interpretation that could lead to uncertainties for
manufacturers and importers as to whether certain labels were consistent with
the regulation. New Zealand also asked for clarity regarding the interpretation
of the provisions on pictures of athletes, artists and singers, and the
definition of "recreation". Finally, she noted that the draft
regulation allowed labels used before the entry into force of the regulation to
be used for a transition period of 180 days after the regulation came into
force. This was a positive inclusion that would limit the impact on trade. However,
she was concerned that the period may not be appropriate for alcoholic
beverages such as wines and spirits with a longer shelf life, and asked
Thailand to consider extending it.
2.217. The
representative of South Africa thanked Thailand for bilateral
discussions. South Africa shared concerns outlined by other Members, but also
understood the need to inform consumers about the danger of alcohol abuse. His
delegation was concerned that Thailand had not officially stated in its draft
regulation (G/TBT/N/THA/437) which graphic depictions would need to be included
in the health warning. South Africa understood that it would be the picture of
a drunk‑driving accident. Furthermore, the draft regulation, as notified, did
not state the content of the other warning statement that would need to be
included in the label. Therefore, South Africa requested Thailand to provide
further details regarding the photo and the content of the warning statement,
and to provide further opportunity to allow trading partners to provide
comments on these labelling requirements before implementation. Finally,
Thailand was requested to provide a reasonable period of at least 6 months
between adoption and entry into force of the regulation to allow producers time
to adapt.
2.218. The
representative of Thailand was of the view that the Draft Ministerial
Announcement was in clear conformity with TBT Agreement obligations. The draft
regulation pursued the objective of consumer information consistent with
Article 2.2 of the TBT Agreement. The regulation would apply equally to
both imported and local products, as per Article 2.1 of the Agreement.
Moreover, Thailand had properly notified the draft in accordance with Article
10.6 of the Agreement, allowing a comment period of 60 days. The representative
stated that all comments had been taken into consideration by the Disease
Control Department of the Ministry of Public Health. She also informed Members
that prior to the meeting, Thailand convened a plurilateral discussion with
representatives of concerned Members, which provided an opportunity for Thai
experts (from the Disease Control Department and International Health Policy
Programme of the Ministry of Public Health) to explain the rationale for the
measure, and which made clear that the regulation was only about addressing
concerns of Thai population. Regarding the draft regulation on graphic health
warnings raised by Members, she informed the Committee that Thailand had first
collected in‑country comments. The comments of internal stakeholders would then
be carefully considered, and a decision would be taken on the question of
pictorial warning labelling, which in any event would serve the purpose of
consumer protection and comply with the TBT Agreement. However, Thailand
assured Members that further details about the content of the photo and warning
statement would be provided by notifying to the TBT Committee without delay.
She assured Members that all other comments received would be forwarded for
consideration by the Department of Disease Control of the Ministry of Public
Health.
2.219. The
Thai representative of the International Health Policy Programme said that
alcohol consumption was the leading national health risk factor, and that
control of alcohol‑related health problems was firmly on the Thai national
agenda. She said alcohol consumption caused serious social problems, and harmed
socio‑economic development. Most importantly, while there was low risk and high
risk alcohol consumption, risk free alcohol consumption did not exist.
Therefore, Thailand did not regard alcohol as an ordinary commodity. She
reported that the Ministry of Public Health had been tasked with protecting
society from alcohol, with particular concern for the young generation. To
achieve this goal, and as recommended by the WHO, Thailand pursued a
comprehensive policy framework including a variety of interventions aiming at
different target groups through different mechanisms in sustainable ways.
Alcohol marketing was the most powerful determinant of alcohol consumption. She
said marketing was effective with consumers by shaping attitudes to products
and the decision to purchase and drink. Evidence had shown that packaging and
labelling of alcoholic beverages could increase appeal to consumers, including
drinkers and potential drinkers. It could also minimize and distract from
potential harm caused by the product.
2.220. Due
to legal loopholes, she explained that alcohol packaging and labelling had been
used aggressively as a marketing channel in Thailand. There were many pictures
of celebrities, athletes and singers on alcohol containers and packages. These
were not only attractive labels in their own right; they were also cunningly
used as creative marketing tools by linking to ongoing promotions campaigns or
activities. A 2011 study carried out in Thailand showed that more than half of
the Thai respondents found the containers, packages and labels of alcoholic
beverages to be colourful, attractive, and persuasive to purchase and consume.
Therefore, the Thai government could not take the sport and music marketing
strategy of the alcohol industry for granted, and needed effective tools to
control it to and protect citizens. In line with the principle of consumer
protection, and taking account of the recommendations of the WHO's "Global
Strategy to Reduce Harmful Use of Alcohol" on controlling alcohol beverage
labels to reduce the negative impacts of drinking and intoxication, Thailand
developed this draft notification with the aim of reducing attractiveness and
appeal of alcohol to drinkers, especially young people. The prohibition on
displaying images of celebrities, athletes, film stars, singers, and cartoons
on alcohol beverage labels were intended to eliminate the positive attitude
towards alcohol products. The representative said the draft regulation did not
aim to block responsible communication, or the right to show trademark names or
the symbol of the company, but to work as an extension of the Alcohol Beverages
and Control Act 2008.
2.2.3.25 Indonesia – Regulation of Minister of Trade No. 10/M-DAG/PER/1/2014
concerning Amendment of Regulation of Minister of Trade No.
67/M-DAG/PER/11/2013 concerning Affixed Mandatory Label in Indonesian Language
for Goods (G/TBT/N/IDN/85) - IMS Item No. 436
2.221. The representative of the European Union
said the EU continued to have concerns with the burdensome, time‑consuming and
costly compulsory registration procedure for sample labels as a precondition
for obtaining the labelling certificate (SKPLBI). The overall requirements for
the labelling and label content were more restrictive than necessary to fulfil
the stated objective of consumer protection and prevention of deceptive
practices. The EU asked whether the same objectives could be achieved through a
general requirement for local and foreign manufacturers/importers to submit a
sample label for information to Indonesian authorities prior to first placing
of a product on the Indonesian market. The EU considered the requirement for
permanently affixed labels through, for instance engraving or embossing, as
well as the prohibition to affix labels in the form of stickers while products
were still in Indonesian customs, to be excessively constraining for many
products and not in tune with market reality for globally traded products.
Concerning automotive spare parts labelling requirements, the EU pointed out
that international practice did not require, in addition to the homologation
markings, any specific printings on the tyres themselves. Therefore, the EU
invited Indonesia to consider that for automotive spare parts, and in
particular tyres, a marking attesting conformity to UNECE regulations be
accepted on the Indonesian market without further requirements at customs.
Further labelling requirements could be applied at the point of sale, without
requiring any marking on the product itself, such as affixing labels to the
packaging of tyres or by providing the required information by signs, brochures
or other similar ways. Finally, he reminded the Committee that the EU had
already raised concerns with respect to the application of these labelling
requirements for toys, under STC ID 328.[6]
2.222. The
representative of the United States associated her delegation with the
comments made by the EU. She said the US continued to have concerns with the
Indonesian practice of notifying measures after adoption
and reminded Indonesia of the transparency requirements of the TBT Agreement,
in particular allowing time for comments to be taken into account. She queried
whether products already on the market would have to meet these labelling
requirements.
2.223. The
representative of Japan supported the comments made by previous
delegations and invited Indonesia to ensure that the regulation was not more
trade-restrictive than necessary.
2.224. The
representative of Indonesia thanked the EU, US and Japan for raising
their concerns, and also thanked the EU for their bilateral meeting. This
labelling regulation, he said, ensured that consumers were properly informed on
products purchased. The new regulation and its amendments on the affixing of
labels in Indonesian language contained several improvements on the previously
notified regulation on obligatory labelling (G/TBT/N/IDN/47). He mentioned the
following as examples of such improvements: (i) the increase in the number
of products covered, from 103 to 127; (ii) adjustments in the HS codes;
and (iii) the requirement for permanent labelling through embossed print
or firmly attached labels. He explained that importers or producers of products
not listed in the attachment of the regulation may put labels in the Indonesian
language, adjusted to the characteristics of the products. Those listed in the
attachment of the regulations, and who had their products already distributed
on the Indonesian market, were granted a transitional period until 24 December
2014 so as to adjust to the required label. For new products, the regulation
applied since 24 June 2014. He observed that some types of products were exempt
from this regulation, such as basic materials for production processes,
products in bulk, temporary imported products and several other categories. Exemption
was also given to producers, trademark holders, general importers and suppliers
of automotive products who submitted a "letter of exemption" to the
Directorate of Consumer Empowerment of the Ministry of Trade. Indonesia
welcomed bilateral discussion with Members on more specific aspects of the
regulation.
2.2.3.26 Kingdom of Saudi Arabia – Certificate of Conformity (not notified)
and GSO marking requirements for toys - IMS Item No. 435
2.225. The
representative of the European Union thanked Saudi Arabia for their
extensive replies to concerns raised at the previous meeting of the Committee,
and for the bilateral meeting which had taken place and looked forward to
future bilateral discussions. He reiterated his delegation's support for the
harmonization efforts being made within the Gulf region on toy safety and said
the EU was willing to exchange experiences and provide any clarification
regarding the EU's own experience with technical harmonization in the toy or
other sectors as this may help in ensuring more uniform implementation across
the region. The EU's main concerns were with inconsistencies in implementation
practices of individual Gulf States. There were differing interpretations of
the requirements on the fixing of the "G mark", and on the registration
number placed next to the "G mark" – for example, whether labels were
to be permanent or non‑permanent. Secondly, there appeared to be a trend in
some Gulf States to introduce additional duplicative conformity assessment
requirements, for example the Saudi Certificate of Conformity (CoC) or the Abu
Dhabi Trustmark. More positively, he noted that foreign laboratories that were
ILAC accredited to ISO17025 were allowed to perform the required testing.
Concerning the process whereby each toy model was assigned a registration
number which had to be fixed next to the "G mark", the EU understood
that GSO was considering ways to facilitate the registration process allowing
registration numbers to be assigned to each manufacturer or importer rather
than to each model. He understood a guidance document was being prepared which,
he said, was being eagerly awaited by industry.
2.226. The
representative of the United States also thanked Saudi Arabia for their
bilateral discussions and for the document they had provided which helped
clarify the use of the "G mark" for toys. The US continued to look
forward to working with both the GCC and the individual members as the
"G mark" was being further implemented for toys and other
products.
2.227. The
representative of Canada appreciated the technical harmonization efforts
undertaken by Saudi Arabia and other Gulf Cooperation Council (GCC) members
through the GCC Standardization Organization (GSO). Nonetheless, his delegation
shared some of the concerns expressed by the EU and the US regarding transparency
issues on notifications by GCC members of regional GSO technical regulations.
Differences in notification practices by GCC members over the same regional
technical regulation, including non‑notification or variations in content or
timeframe, could lead to difficulties for all members reviewing those
notifications. To this end, Canada had written to the GSO, copying Saudi
Arabia, on the subject of notification practices by GCC members on the same
regional technical regulations. Canada appreciated that the GSO itself, in its
presentation at the Thematic Session on Transparency at the June 2014 meeting,
acknowledged the potential for confusion on this issue. Canada encouraged GCC members
to streamline and coordinate their regional notification efforts where
possible.
2.228. The
representative of the Kingdom of Saudi Arabia thanked delegations for
their comments and looked forward to continuing discussions bilaterally. All
comments would be sent to capital where full answers would be prepared and
relayed to Members.
2.2.3.27 China – Safety Requirement for Lithium Ion Cells and Batteries used
in Portable Electronic Equipment (G/TBT/N/CHN/1016) - IMS Item No. 425
2.229. The
representative of the Republic of Korea thanked China for their
bilateral meeting and looked forwarded to continued cooperation so as to
resolve the concerns. Many Members, including Korea, adopted technical
regulations on lithium ion cells and batteries which were harmonized with
international standards. However many of China's test requirements for their safety
regulation did not correspond with either the current IEC62133 or its draft
revision. He requested that China harmonize those requirements with
international standards. For those that were not, China should provide the
scientific rationale and background. Concerning Article 11, he asked that
China eliminate the requirement from the National Standard or exclude it from
mandatory requirements since the safety requirement for system protection
circuit could be complied by portable electronic equipment manufacturers rather
than cells and batteries manufacturers.
2.230. The
representative of China said that as lithium batteries were the cause of
many injuries and even death, China had drafted a national standard safety
requirement in order to protect consumer's health and safety. An ad hoc
working group established in 2008 developed this standard. This working group
was consisted by more than 40 lithium producers and science research
institutes, both domestic and abroad, including many foreign enterprises. After
three years of in‑depth discussion and industry surveys, and three rounds of
requests for comments, a final version of the draft standard was formulated.
She said that, due to a different scope of application, the Chinese standard
did not directly correspond to IEC62133. It adopted the relevant criteria of
IEC62133, when appropriate, and improved the IEC standard according to the
characteristics of the lithium battery. A number of proposals based on this
Chinese standard had been adopted by the IEC, which illustrated its
effectiveness. Therefore, the Chinese standard, based on the relevant
international standard, did not violate any TBT Agreement provision or
principle.
2.2.3.28 Russian Federation – Measure affecting import of Ukrainian dairy
products - IMS Item No. 426)
2.231. The
representative of Ukraine informed the Committee that on 7 April 2014
the Russian Federation imposed an import ban on dairy products from 6 Ukrainian
producers. The ban was imposed on the ground of alleged noncompliance with
requirements of the "Technical regulation on milk and dairy
products", approved by Federal Law No. 88 FZ. Since that time, this ban
was expanded to 27 Ukrainian producers. She said that this measure was being
applied in a non-transparent manner as producers were still unaware of the
specifics of their alleged noncompliance and have not received any documents
regarding the results of the tests conducted by the relevant authority of the
Russian Federation (Rospotrebnadzor). She noted that all producers affected by
the ban held certificates of conformity in accordance with the requirements of
the Technical Regulation on milk and dairy products. These certificates were
issued by accredited certification bodies listed in the register of the
certification bodies of the Customs Union. For the purposes of ensuring safety
and quality of their products, she explained that these producers additionally
achieved: (i) voluntary certification for their dairy products in the
accredited regional centres in Ukraine for standardization, metrology and
certification; (ii) control for product safety and quality by the Ukrainian
State laboratories of veterinary medicine, in accordance with requirements of
the ISO/IEC 17025:2006; and, (iii) certified management systems for safety and
quality of food products based on Hazard Analysis and Critical Control Points
(HACCP) principles.
2.232. Ukraine
considered that Russia was applying this measure with a view to, and with the
effect of, creating unnecessary obstacles to trade, in violation of Article 2.2
of the TBT Agreement. In addition, Ukraine believed that the unpredictability
and the lack of transparency in respect of this measure made the measure
inconsistent with national treatment and MFN provisions of the Article 2.1 of
the Agreement. She informed Members that Ukrainian dairy products, some of them
from international global companies with decades of excellent standards, had
been traditionally exported to the Russian Federation for many years. Some of
the producers exported up to 70% of their production to the Russian market.
Through these measures, however, Russia had effectively cut by half the imports
of Ukrainian dairy products. Finally, she urged Russia to immediately lift the
ban in accordance with the Articles 10 and 2.5 of the Agreement, since no
scientific information was available to justify the measure.
2.233. The
representative of the Russian Federation said that the import suspension
of dairy products of some Ukrainian companies was introduced due to
inconsistencies of these products with the technical regulation of the Russian
Federation. He reported that requirements for dairy products were established
in 2008 by the provisions of Federal Law of the Russian Federation
"Technical regulation on milk and dairy products" that was adopted on
12 June 2008. As of 1 May 2014, the technical regulation of the Customs Union
"on safety milk and dairy products" (adopted by Decision of the
Council of Eurasian Economic Commission No. 67 on 9 October 2013) entered into
force. Circulation within the territory of the Russian Federation of food
products that were not in compliance with the provisions of the technical
regulation was prohibited. In 2014, he explained, the Russian regulating
authority (Rospotrebnadzor) had detected that the dairy products produced by
the some Ukrainian companies contradicted relevant requirements on fat,
proteins and moisture content.
2.234. He
further explained that the measure at issue was introduced to protect consumer
rights for valid product information and to prevent deceptive trade practices.
Given that the decision to suspend dairy products imports from some Ukrainian
companies was taken as part of the enforcement of the existing technical
regulation, Russia saw no basis for notifying such decision to the TBT
Committee. In addition, the import suspension applied to specific products
manufactured by specific Ukrainian companies. In any event, he said, the
decision at issue was taken in full compliance with the WTO rules, in
particular with the provisions of the TBT Agreement. The representative reported
that Rospotrebnadzor was ready to assist the competent authorities of Ukraine
in developing the measures necessary to resume the circulation of the at issue
products in the territory of the Russian Federation. He said this would lead to
the quickest resumption of the trade in Ukrainian dairy products on the Russian
market. The competent authorities were also ready to discuss the questions on a
bilateral basis in order to avoid any restrictions in the future.
2.2.3.29 Ecuador – Draft Technical Regulation of the Ecuadorian
Standardization Institute (PRTE INEN) No. 189: "Labelling of alcoholic
beverages" - IMS Item No. 433
2.235. The
representative of Canada noted that the new customs regulation on
spirits imports covering whisky, vodka, tequila and rum had been approved on 9
August 2013, published in the official registry on 23 September 2014 with entry
into force 30 days later. This regulation only appeared to apply to imported
spirts and required labels to be affixed in the country of origin, which was
contrary to standard practice in the internationally traded spirits industry.
The usual practice was to apply, in the country of production, generic front
labels providing mandatory information and to affix, in the import market any
other market specific information on the back or secondary label. He asked
Ecuador to explain how this requirement was not more trade restrictive than
necessary to fulfil a legitimate objective and therefore a violation of Article
2.2 of the TBT Agreement. He also asked Ecuador to provide an update with
respect to any revisions to the regulation.
2.236. The
representative of Mexico expressed concern with the fact that the
measure did not provide for any possibility of labelling or relabeling in the
primary area of the product. She was also concerned with the requirement that
the name of the Ecuadorian importer be affixed on the label. She said that
Mexico considered that these requirements could be in contravention of the TBT
Agreement, specifically Article 2.2, as it was debateable whether this measure
constituted the least restrictive alternative to fulfil the legitimate
objective pursued. She requested that the requirement of a label of origin with
the name of the importer in Ecuador be removed, and that Ecuador reply to the
comments formally submitted by Mexico on 2 July 2014.
2.237. The
representative of Ecuador informed the Committee that this draft
regulation on the requirements for the labelling of alcoholic drinks was to
protect human health and safety, and prevent deceptive practices. This measure
applied to both domestically produced and imported to beverages. National and
importing producers had to prove compliance through the submission of an
inspection certificate. This certificate could only be accepted in Spanish. She
said the competent authorities were looking at revising the measure in view of
the comments received
2.2.3.30 European Union – Proposal for a Directive of the European Parliament
and of the Council amending Directive 96/53/EC of 25 July 1996 laying down for
certain road vehicles circulating within the Community the maximum authorised
dimensions in national and international traffic and the maximum authorised
weights in international traffic (COM(2013) 195 final) (G/TBT/N/EU/109) - IMS
Item No. 434
2.238. The
representative of the United States thanked the EU for the bilateral
discussion on this issue, in particular the EU's confirmation that the proposal
allowed for derogations from the fixed dimensions. Her delegation appreciated
that the EU had noted the US concern that any technical specifications developed
for type approval include the ability to use an aerodynamic cabin to qualify
for such derogations. She also appreciated that industry would be able to
participate in stakeholder meetings on this subject.
2.239. The
representative of the European Union thanked the US and looked forward
to continued discussions bilaterally.
2.2.3.31 Ireland – Proposal to introduce standardised/plain packaging of
tobacco products in Ireland (G/TBT/N/IRL/1, G/TBT/N/IRL/1/Add.1) - IMS Item No.
380
2.240. The
representative of Malawi expressed her delegation's concerns regarding
the consistency of the proposed measure with the TBT and TRIPS Agreements. She
also requested Ireland to abstain from any tobacco plain packaging legislation
until the WTO disputes lodged against Australia's plain packaging measures had
been concluded. Malawi's full statement is contained in G/TBT/W/393.
2.241. The
representative of Ukraine said that this proposed plain packaging
measure raised concerns under WTO law, including Article 2.2 of the TBT
Agreement requiring that technical regulations be not be more trade restrictive
than necessary to fulfil a legitimate objective. While protecting public health
by reducing smoking prevalence was unquestionably a legitimate objective,
Ukraine also believed that the available scientific evidence and data indicated
that plain packaging did not contribute to that objective and would, in fact,
have unintended consequences against the attainment of this objective. She also
said that, as a third party to the dispute Ukraine and four other Members have
lodged against Australia over its plain packaging measure, the EU, and thus
Ireland, would have already seen the evidence showing the lack of contribution
the Australia measure was able to make towards its stated objective. Ukraine
therefore reiterated its concern that plain packaging measures, such as the one
proposed by Ireland, appeared to violate Ireland's obligations under the TBT
and TRIPS Agreements. Further, Ukraine understood that a number of EU member
states have registered objections with the European Commission regarding the
impact of the proposed Irish measure on the EU Common Market. Given this state
of affairs, Ukraine would appreciate an update on the internal EU process and
the impact this process may have on the Irish proposal in terms of substance
and timing. Finally, Ukraine considered that it would be prudent for Ireland to
await the recommendations and rulings of the Dispute Settlement Body in the
dispute over Australia's similar measure to ensure that its proposed technical regulation
would be adopted in line with its WTO obligations.
2.242. The
representative of the Dominican Republic associated herself with the
statements made by Malawi and Ukraine and urged Members that were planning to
implement tobacco plain packaging measures to wait until the conclusion of the
Australian disputes.
2.243. The
representative of Australia reiterated his delegation's strong support
for the decision by Ireland to legislate for the mandatory plain packaging of
tobacco products. In particular, Australia welcomed the presentation of
implementing legislation to the Irish Parliament in June 2014. The important
steps made by Ireland in tobacco control demonstrated that efforts to delay the
adoption of tobacco plain packaging measures in these countries have not been
successful. Australia firmly believed that Members had the right to implement
measures necessary to protect public health, while complying with relevant
international treaty obligations, including the TBT Agreement. Tobacco plain
packaging was a legitimate measure designed to achieve a fundamental objective:
the protection of human health. The adoption of tobacco plain packaging
measures was a policy choice endorsed by leading public health experts as well
as the World Health Organization and was supported by extensive credible peer
reviewed research, reports and studies. Australia's own tobacco plain packaging
measure, currently being litigated in the WTO, was consistent with Australia's
obligations under the WTO Agreements. It was inappropriate for complainants in
these disputes underway against Australia to invoke those proceedings in an
attempt to delay or discourage another Member from developing or implementing
their own legitimate tobacco control measures.
2.244. The
representative of Guatemala stated that while her delegation shared
Ireland's policy objectives related to public health and tobacco control; it
was nevertheless concerned with the proposed legislation and encouraged Ireland
to consider less trade restrictive alternative measures.
2.245. The
representative of Cuba stated that while her delegation shared the view
that Members had the sovereign right to regulate to protect public health, such
measures had to be drafted respecting Members' WTO obligations. Cuba continued
to have reservations with respect to the usefulness of plain packaging and was
concerned with its trade restrictiveness. She also requested Ireland to abstain
from any tobacco plain packaging legislation until the WTO disputes lodged
against Australia's plain packaging measures had been concluded.
2.246. The
representative of Honduras stated her delegation's concern that Ireland
was introducing a measure – tobacco plain packaging - similar to a measure, by
Australia, currently being challenged by five disputes before the DSB, and
which had also been object of concerns from many Members in this Committee as
well as other WTO bodies. Honduras informed the Committee that, as a
complainant in the Australian dispute, it had submitted its first written
submission to the Panel on 8 October 2014, which included concrete evidence
showing that this kind of measure was not reducing tobacco consumption in the
Australian population. Honduras also reiterated that it was not calling into
question Members' right to adopt measures to protect public health; but only
that, in as far as they do so, such measures needed to be based on solid
scientific evidence and comply with WTO rules. Honduras therefore urged Ireland
to reconsider the introduction of this measure which lacked scientific basis,
was unnecessarily trade restrictive and also constituted a violation of
intellectual property rights such as trademarks and geographical indications.
In this context, Honduras asked Ireland to wait for the conclusion of the
Australian plain packaging WTO dispute before taking a decision on its own
similar measure.
2.247. The
representative of Indonesia requested Ireland to abstain from any
tobacco plain packaging legislation until the WTO disputes lodged against
Australia's plain packaging measures had been concluded.
2.248. The
representative of Zimbabwe associated himself with the concerns
expressed my Malawi, Ukraine, Dominican Republic, Cuba, Honduras and Indonesia.
2.249. The
representative of Uruguay was of the view that the proposed Irish plain
packaging measure was compatible with WTO rules and fell within the sovereign
rights Members had to legislate to promote public interests. Such a right was
reaffirmed by the "Punta de Este Declaration", adopted during the
FCTC's 2010 COP, and the "Moscow Declaration", adopted during the
FCTC's 2014 COP. In implementing such a measure, Ireland would be thus merely
exercising its sovereign right to protect public health by giving effect to the
obligations it had undertaken as a party to the WHO FCTC, in particular its
Article 11 and relevant implementing guidelines, which were adopted by
consensus. Uruguay requested that this statement to be equally applicable to
the subsequent SCTs on the plain packaging measures by the UK and Australia.
2.250. The
representative of Norway referred Members to her delegation's previous
statement made under the new STC with respect to the proposed tobacco plain
packaging measure by France. She also rejected the view that other Members
should wait the end of the Australian dispute before implementing their own
plain packaging measures.
2.251. The
representative of New Zealand supported Ireland's decision to commence
the process of introducing a plain packaging regime for all tobacco products.
She also referred Members to her delegation's previous statement made under the
new STC with respect to the proposed tobacco plain packaging measure by France.
2.252. The
representative of Nigeria expressed her delegation's concern that plain
packaging for tobacco could serve as a dangerous precedent for other heavy
regulated products, like foods and carbonated drinks, in particular due to
their effects to the intellectual property rights related to these products.
She also requested Ireland to abstain from adopting any tobacco plain packaging
legislation until the WTO disputes lodged against Australia's plain packaging
measures had been concluded.
2.253. The
representative of Nicaragua said that the statement his delegation made
in the present meeting in the context of the STC on France's proposed plain
packaging measure was equally applicable to this STC as well as the next two
concerns involving similar measures by the UK and Australia.
2.254. The
representative of the European Union noted that tobacco products have
being recognised as having harmful effects on human health. In this sense,
Article 2.2 of the TBT Agreement included the protection of human health as a
legitimate objective. The Agreement also recognised that any measure pursuant
to this legitimate objective must not be more trade restrictive than necessary
and create unnecessary obstacles to international trade. It should also be
noted that Article XX(b) of the GATT 1994 emphasised the importance of public
health by justifying measures "necessary to protect human … health".
She called Member's attention to the Irish Government's statement that the Bill
aimed at further reducing the smoking prevalence in Ireland by reducing the
attractiveness of tobacco products, especially among young people, and that the
measures were a response to the packaging design strategies developed by
tobacco companies in recent years, which were aimed at young people, including
young women. The notified draft constituted the latest strand of a
comprehensive range of tobacco control legislation already in place in Ireland aimed
at decreasing tobacco consumption. Such other measures under existing Irish law
included the following: (i) a comprehensive smoke free legislation; (ii) a ban
in place on smoking at the workplace; (iii) a ban on tobacco advertising and
sponsorship; and (iv) a ban on the display of tobacco products in shops. In
addition, all tobacco products placed on the Irish market must display combined
text and graphic health warnings. Certain types of sale promotions were also
prohibited. Further, the smoking of tobacco products in vehicles where children
were present would also be prohibited by a law to be enacted by the end of
2014.
2.255. In
addition to the notified draft, Ireland made available to TBT Committee
Members, through a TBT notification, an explanatory memorandum that detailed
the rationale of the measure and its expected health impacts, a regulatory
impact analysis and several scientific studies on the impact of plain packaging
on smoking prevalence. In parallel with the WTO notification, Ireland has also
notified the proposed measure to the European Commission in accordance with
internal EU requirements for notification of draft national technical
regulations under Article 8 (1) of Directive 98/34/EC and under Article 24 (2)
of the Tobacco Products Directive 2014/40/EU. Under these internal EU
procedures, Ireland received detailed opinions and comments from some EU member
states. These comments were currently being analysed and considered by the
Irish authorities. As regards comments that may be received from WTO Members
under the WTO TBT notification procedure, these would be equally examined and
written replies be provided in due course.
2.2.3.32 United Kingdom – Proposal to introduce plain packaging of tobacco
products (G/TBT/N/GBR/2) - IMS Item No. 424
2.256. The
representative of the Dominican Republic expressed her delegation's
concerns regarding the consistency of the proposed measure with the TBT and
TRIPS Agreements. The full statement of the Dominican Republic is contained in
G/TBT/W/397, the content of which it, by their request, is to be equally
applicable to the following STC on Australia's plain packaging measures.
2.257. The
representative of Malawi expressed her delegation's concerns regarding
the consistency of the proposed measure with the TBT and TRIPS Agreements. She
also requested the UK to abstain from any tobacco plain packaging legislation
until the WTO disputes lodged against Australia's plain packaging measures had
been concluded. Malawi's full statement is contained in G/TBT/W/394.
2.258. The
representative of Australia reiterated its delegation's strong support
for the decision by the UK to legislate for the mandatory plain packaging of
tobacco products. Australia welcomed, in particular, the UK's release of draft
regulations on standardised packaging of tobacco products for public
consultation. This followed the findings of an independent review that
concluded that "standardised" packaging of tobacco products would be
very likely to reduce the rate of children taking up smoking and have a
positive impact on public health. In the interest of efficient use of time,
Australia said that it would not repeat in full its earlier statements, but
rather refer Members to the comments it have made on similar issues, and in
particular: (i) that Members had the right to take action in the interest of
public health concerns; (ii) that measures be based on credible evidence; and
(iii) Australia's firm belief that plain packaging measures were fully
compliant with Members' WTO commitments. Australia welcomed the references to
the DSB proceedings on its own measures. However, as these proceedings were
still ongoing, he suggested that the correct approach under Article 14 of the
TBT Agreement was to leave substantive discussion of Australia's measures to
that specific WTO body.
2.259. The
representative of Ukraine stated her delegation's concern that plain packaging
measures were more trade restrictive than necessary to fulfil their health
protection objective as they failed to actually contribute to reducing smoking
while being trade restrictive. Such measures therefore appeared to be contrary
to Article 2.2 of the TBT Agreement. With respect to the UK's proposed measure,
Ukraine would appreciate to receive from the UK an update on the status of the
proposal. Since the last meeting of this Committee, the UK conducted a public
consultation on the proposed measure. Ukraine would be particularly interested
to know when the results of this consultation process would be released. In
closing, Ukraine would like also to suggest that it would be prudent for the UK
to await the recommendations and rulings of the DSB in the dispute over
Australia's measure to ensure that this proposed technical regulation would be
consistent with its WTO obligations.
2.260. The
representative of Honduras expressed her delegation's concern with the
proposed measure's inconsistencies with the TRIPS and TBT Agreements. While
Honduras fully shared the aim of protecting human health, it also considered
these measures to be more trade restrictive than necessary for achieving these
objectives. Honduras recalled that in its first written submission as a complainant
in the Australian dispute, it had made it clear that the plain packaging
measures at issue were not based on sufficient scientific evidence and were an
unnecessarily trade restrictive, and also that they were affecting Honduras'
intellectual property rights, which were key elements for the economic
development of a country. Honduras urged the UK to await the conclusion of the
Australian dispute before implementing its own plain packaging measure.
2.261. The
representative of Cuba expressed concern regarding the consistency of
the proposed measure with the WTO Agreements, in particular the TBT and TRIPS
Agreements. Cuba considered that the proposed measure lacked scientific basis
and was more trade restrictive than necessary to the attainment of its stated
public health objective. It also requested the UK to abstain from implementing
any tobacco plain packaging legislation until the WTO disputes lodged against
Australia's plain packaging measures had reached a conclusion and the results
could be assessed.
2.262. The
representative of Indonesia supported the concerns raised by the
Dominican Republic and Malawi and asked Members intending to implement plain
packaging measures to wait until the conclusion of the Australian dispute.
Indonesia also referred to the arguments it had made in the present meeting
with respect to the STCs raised with respect to the proposed plain packaging
measures by France and Ireland.
2.263. The
representative of Guatemala supported the concerns raised by the
Dominican Republic and Malawi and said that, while her delegation acknowledged
the legitimate rights the UK government had to protect public health, it
nevertheless considered that this had to be done in a less trade restrictive
way possible. Guatemala asked Members intending to implement plain packaging
measures to wait until the conclusion of the Australian dispute. Guatemala
asked these points to be also equally applicable to the next STC on Australia's
plain packaging measures.
2.264. The
representative of Norway referred Members to its previous statements
under the STCs raised with respect to the proposed plain packaging measures by
France and Ireland and commended the UK on its measures to combat the tobacco
epidemic.
2.265. The
representative of Nigeria stated its concerns with the negative impact of
the proposed measure on branding and consumers as well as on the Nigerian
economy, given that Nigeria is an important producer of tobacco leaves, a
sector that provides income to its farmers. Nigeria considered that this
proposal would be in breach of the EU's WTO obligations, including under the
TRIPS and TBT Agreements.
2.266. The
representative of New Zealand lent support to the EU decision to
introduce further controls on the packaging of tobacco products. She also noted
the recent findings of the independent review into the public health effects of
standardised packaging of tobacco products, commissioned by the UK Government. In
particular, she quoted the following conclusion of Sir Cyril Chantler's report:
"… after a careful review of all of the relevant evidence before me I am
satisfied there is sufficient evidence derived from independent sources that
the introduction of standardised packaging as part of a comprehensive policy of
tobacco control measures would be very likely over time to contribute to a modest
but important reduction in smoking prevalence especially in children and young
adults. Given the dangers of smoking, the suffering that it causes, the highly
addictive nature of nicotine, the fact that most smokers become addicted when
they are children or young adults and the overall cost to society, the
importance of such a reduction should not be underestimated."
2.267. The
representative of Zimbabwe shared the concerns expressed by the
Dominican Republic, Malawi, Ukraine, Honduras, Cuba, Indonesia, Guatemala and
Nigeria, and stated that Zimbabwe's statement was equally applicable to the
next concern on Australia's plain packaging measure.
2.268. The
representative of the European Union noted that tobacco products have
being recognised as having harmful effects on human health. In this sense,
Article 2.2 of the TBT Agreement included the protection of human health as a
legitimate objective. The Agreement also recognised that any measure pursuant
to this legitimate objective must not be more trade restrictive than necessary
and create unnecessary obstacles to international trade. It should also be
noted that Article XX(b) of the GATT 1994 emphasised the importance of public
health by justifying measures "necessary to protect human … health".
She said that the UK's decision to proceed with the Regulations had not yet
been made. If taken forward, she said, the UK draft Regulation on Standardised
Packaging of Tobacco Products aimed at further reducing the smoking prevalence
in the UK by: (i) discouraging uptake of tobacco use by young people; (ii)
encouraging and supporting tobacco users who want to quit; and (iii) reducing
people's exposure to second hand smoke. The proposed UK measure would form the
latest strand of a comprehensive range of tobacco control legislation already
in place in the UK aimed at decreasing tobacco consumption. Under such existing
legislation, there were already: (i) a ban on advertising tobacco products to
the general public; (ii) a ban of tobacco sponsorship to sports and cultural
events; and (iii) a prohibition for companies to give out free samples of
tobacco. Furthermore, pictorial warnings on tobacco products were also required
in the UK and the sale of these products from vending machines was prohibited,
including, as from 2015 on, tobacco displays in all shops being prohibited.
2.269. In
addition to the notified draft, the UK made available to TBT Committee Members,
through a TBT notification, an explanatory memorandum that detailed the
rationale of the measure and its expected health impacts, a regulatory impact
analysis and several scientific studies on the impact of plain packaging on
smoking prevalence. In parallel with the WTO notification, the UK has also
notified the proposed measure to the European Commission in accordance with
internal EU requirements for notification of draft national technical
regulations. Under these internal EU procedures, the UK received detailed
opinions and comments from some EU member states. These comments were currently
being analysed and considered by the UK authorities. As regards comments that
may be received from WTO Members under the WTO TBT notification procedure,
these would be equally examined and written replies be provided in due course.
2.2.3.33 Australia – Tobacco Plain Packaging Bill 2011 (G/TBT/N/AUS/67, G/TBT/N/AUS/67/Add.1,
G/TBT/N/AUS/67/Add.2) – IMS Item No. 304
2.270. The
representative of Ukraine explained that the reason why Ukraine
requested that this "old" agenda item be reintroduced the Committee
agenda was to allow Ukraine to provide a brief update to the Committee on the
facts relating to this measure, which was currently the subject of a WTO
dispute settlement proceeding. This update was mainly a matter of courtesy and
transparency for the whole of the WTO membership, given that the parties and
third parties to the disputes have now seen the full presentation of Ukraine's
evidence and arguments in its first written submission in the context of that
dispute. Ukraine considered that it would be useful for all Members to be
informed of developments in respect of the concerns that Ukraine previously
raised over Australia's measure from the perspective of the TBT Agreement, now
almost two years after its entry into force. The evidence available to date,
which has been submitted in the context of the dispute settlement process,
showed that the Australian tobacco plain packaging measure was not contributing
to the stated objective of improving public health by reducing smoking
prevalence in Australia. The measure, however, was already distorting
competition in the market and it was highly realistic that the perverse market
dynamic that this measure set in motion would continue, leading to the opposite
result than the intended objective of reducing smoking. The quantitative and
qualitative evidence available to Ukraine demonstrated that this measure was an
unnecessary obstacle to trade because it restricted trade without making any
contributing to the fulfilment of its legitimate objective (and, actually, it
even went against that objective). Ukraine looked forward to the WTO Panel's
objective assessment of the evidence presented by Ukraine as well as to the
Panel's analysis of the legal arguments. Australia would, of course, be able to
present its case to the WTO Panel as well and that was the way concerns over measures
covered by the WTO Agreements were to be resolved in accordance with the rules
of the DSU. In this respect, Ukraine informed the Committee that this dispute
settlement process should move forward in the most expeditious way possible.
2.271. The
representative of Honduras shared the concerns expressed by Ukraine with
regard to the possibility that other Members would follow Australia's example
and adopt legislation on plain packaging for tobacco products. As one of the co
complainants of the ongoing dispute lodged against Australia's plain packaging
measure, Honduras had presented its first written submission to the Panel. In
that submission, Honduras included expert and empirical evidence with regard to
the effects of the measure in the Australian market. This evidence demonstrated
that plain packaging was an experiment that had failed. The empirical data
following the implementation of the measure in December 2012 confirmed that
plain packaging had not reduced tobacco use in Australia. Instead of this, this
measure had in fact led to a phenomenon, known as "substitution
effect", which made that consumers replaced high priced brands by cheaper
brands. In its written submission to the Panel, Honduras had made it clear that
the dispute was not whether smoking was a danger or whether it affected public
health. Clearly, the response was yes for both questions. Honduras also shared
Australia's objective to reduce the use of tobacco and this was why Honduras
itself also had various strict tobacco control rules. On the other hand, in
Honduras's view, Australia's measure on plain packaging was an unprecedented
instrument that resulted in the elimination of all registered trademarks used in
a product that was legally sold in Australia. As Honduras had explained to the
Panel, Australia had at its disposal various less trade restrictive alternative
measures. The existence of alternative measures that could contribute to the
declared public health objectives in the same level as plain packaging,
confirmed the unjustifiable and unnecessary character of plain packaging. For
the forgoing reasons, the Australian measures violated its obligations under
the TRIPS and TBT Agreements. Finally, Honduras urged other Members planning to
introduce similar plain packaging measures to wait until the Australian dispute
would be over and the compatibility of its measures with WTO disciplines had
been reviewed by the DSB.
2.272. The
representative of Canada expressed his delegation's support for the
efforts of France, Ireland, UK and Australia with respect to tobacco control.
Tobacco use was a very significant problem in Canada and in the world. In
Canada alone 37,000 people died annual from tobacco use, making it Canada's
leading cause of preventable deaths by disease. Tobacco products were also the only
goods that were subject to a legally binding international treaty, the WHO's
FCTC. Canada believed that Members should engage in these discussions bearing
in mind the complete economic picture regarding tobacco control, including the
question whether tobacco constituted a net "economic drain" for many
countries with respect to its health costs. Canada was interested in the
further discussions on the appropriate balance between regulation,
international trade and public health.
2.273. The
representative of Cuba said that her delegation supported the statements
made by its other fellow co complainants in the Australian dispute, Ukraine and
Honduras. She also said that the statements Cuba made in this meeting in
context of the other STCs involving plain packaging proposed measures were
equally applicable to this STC.
2.274. The
representative of Indonesia said that, as the other co-complainants in
the Australian dispute, his delegation had also presented to the Panel its own
first written submission on 8 October 2014. Indonesia believed that public
health regulations should not be more trade restrictive than necessary. More
specifically, Indonesia noted that after two years in force, the Australian
measure was not working as intended. Indonesia also asked all Members currently
planning to implement similar plain packaging measures to wait until the
Australian dispute was over. Finally, Indonesia asked this statement to be
considered as equally appliance to the other STCs discussed in this meeting
involving proposed plain packaging measures by France, Ireland and the UK.
2.275. The
representative of Nigeria stated its concerns with the negative impact
of the proposed measure on international trade and asked that her delegation's
previous statements with respect to the other STCs on proposed plain packaging
to be considered as equally applicable to this particular STC.
2.276. The
representative of Australia noted the continued interest of other
Members in its initiative to require the plain packaging of tobacco products,
and acknowledged the significant amount of support it has received for this
important measure. As other Members were aware, Australia's measure was
currently before the DSB for resolution following the initiation of dispute
settlement proceedings by Ukraine, Honduras, Indonesia, the Dominican Republic,
and Cuba. In this respect, he draw Members' attention to Article 14 of the TBT
Agreement, which stated that the settlement of disputes "with respect to
any matter affecting the operation of this Agreement shall take place under the
auspices of the [DSB]". Australia was therefore both disappointed and
surprised to see this issue raised again in the TBT Committee. Australia did
not consider it appropriate for Ukraine to raise this measure as a STC for
discussion as Australia's measure was no longer a matter for the TBT
Committee's consideration. Discussion of Australia's tobacco plain packaging
measure in this Committee would create a "parallel process" alongside
the ongoing dispute settlement proceedings, which would undermine the rules and
procedures for participation of Members in those disputes, particularly for the
41 Members that have requested participation in the related tobacco plain
packaging disputes as third parties. Australia's tobacco plain packaging
measure has already been raised as a STC and been the subject of detailed
debate at several previous TBT Committee meetings in 2011 and 2012, prior to
the commencement of dispute settlement proceedings. It was clear from the fact
that the measure was now subject to dispute settlement proceedings that the
views of Members raising this measure as a concern remain unchanged. Re
consideration of this measure by the TBT Committee was therefore unnecessarily
duplicative, and was contrary to Rule 27 of the Rules of Procedure for Meetings
of the TBT Committee, which provided that: "Representatives should make
every effort to avoid the repetition of a full debate at each meeting on any
issue that has already been fully debated in the past and on which there
appears to have been no change in Members' positions already on record."
Australia expressed its hope that such unnecessary use of this Committee's time
would not be repeated in the future.
2.2.3.34 Ecuador – Proposed Motor Vehicle Safety Regulatory Requirements (RTE
INEN 034) (G/TBT/N/ECU/32, G/TBT/N/ECU/32/Add.1, G/TBT/N/ECU/32/Add.2,
G/TBT/N/ECU/32/Add.3, G/TBT/N/ECU/32/Add.4, G/TBT/N/ECU/32/Add.6) - IMS Item
No. 409
2.277. The
representative of Mexico said that despite bilateral discussions (held
in 2003), Mexico's observations had not been incorporated in the most recent
publication of RTE INEN 034. Mexico considered that Ecuador had
failed to comply with Article 2.4 of the TBT Agreement because its
proposed technical regulation was only based on the requirements established
by the United Nations Economic Commission for Europe (UNECE) without also
considering as valid references the other existing standards, such as those
from of the United States, Japan or Korea. With respect to the
"third party" certification requirement, under the measure' section
dealing with conformity assessment procedures, Mexico considered that Ecuador
should bear in mind that third party certification must be exceptional in
the automotive sector, given that this was a sector regulated
internationally with vehicles normally being certified at the origin.
Regarding the transition period for the entry into force of the regulation, a
period of 180 days (six months) was established for implementation of
the compulsory safety provisions. Mexico considered, however, that this was an
insufficient period for producers to be able to introduce the requested
changes. On the basis of the foregoing, Mexico requested Ecuador: (i) to
extend to 2‑years transition period for implementation of the changes envisaged
in the technical regulation, as from the date of its publication;
(ii) with regard to the safety requirements, to accept the conformity
assessment in accordance with the rules of the United Nations Economic
Commission for Europe (UNECE), as well as the regulations of the United States
("Federal Motor Vehicle Safety Standards" – FMVSS), Japan (SRRV), the
Republic of Korea ("Korea Motor Vehicle Safety Standards" – KMVSS)
and Brazil ("National Transit Council" – CONTRAN); and
(iii) with regard to the assessment of conformity with the technical
regulation in question, it was requested that the alternative process of
"self‑certification" be allowed, since bearing in mind the specific
characteristics of the automotive sector (a sector regulated internationally),
the reports of tests carried out by the manufacturer could be recognized as
valid.
2.278. The
representative of Brazil said that his delegation was following this
concern very closely and that it shared the concerns raised by Mexico.
2.279. The
representative of Ecuador said that her delegation took note of the
points made by Mexico and Brazil, which would be also included in their next
bilateral meetings given that they had only recently been introduced on the
agenda.
2.280. The Chairman recalled that the
Committee was scheduled to complete the Seventh Triennial Review at its
3-5 November 2015 meeting in line with the Article 15.4 of the TBT
Agreement. He stressed that, as usual, the Review would be based on substantive
proposals – and he encouraged Members to submit these as soon as possible. The
following timeline[7]
was agreed:
a.
4-6 November
2014: TBT Committee meeting (discussion on approach and any
substantive proposals submitted);
b.
End-February 2015:
circulation by Secretariat of outline compiling relevant information available
to the review;
c.
17-19 March
2015: TBT Committee meeting (discussion of substantive proposals);
d.
1 June 2015: deadline for
the submission of substantive proposals by Members;
e.
16-18 June
2015: TBT Committee meeting (discussion of substantive proposals);
f.
July 2015: circulation by
Secretariat of first draft report of the Review;
g.
End-August 2015: submission
of written comments from Members on the first draft;
h.
End-September 2015:
circulation of second draft report of the Triennial Review;
i.
3-5 November
2015: TBT Committee meeting (adoption of the Seventh Triennial
Review).
2.281. The
representative of El Salvador thanked the Chairman for having provided a
clear timeline for the 7th Triennial Review process and stressed the
importance her delegations attributed to the Committee's triennial review
mandate.
2.282. The
Chairman proposed that the thematic sessions in 2015 focus on proposals
made in the context of the 7th Triennial Review. He suggested that
the time scheduled for the thematic sessions (informal mode) be used to discuss
specific proposals from Members and also to reflect on how to address relevant
existing recommendations. This would not preclude discussion on other topics if
Members came forward with specific proposals. This would mean that the first
thematic session for 2015 (scheduled for 17 March 2015) would focus
on any 7th triennial review proposals tabled by then.[8]
It was so agreed.
2.283. The representative of Canada
introduced his delegation's proposal contained in document JOB/TBT/109. He
stressed that the objective of the proposal was to enhance transparency and
dissemination of existing information pertaining to all WTO Members' domestic
regulations that can impact trade. It was Canada's view that the information
available through the WTO Secretariat could be better disseminated to
interested entities inside and outside Member governments. In this way, rather
than 160 national systems, there would be only one
system managed through the WTO Secretariat. There would be a "push"
email system which would allow users to identify countries or sectors that they
would be interested in monitoring. The service would consolidate on a daily
basis the most recent TBT notifications posted on the WTO website and would
send it in an automatic e‑mail to subscribers (it would include relevant
information, such as: dates, links to texts). While he acknowledged that
several Members had created such national systems (e.g., US, EU, Kenya) there
would clearly be efficiencies from the WTO developing a single
global export alert system for existing TBT notifications.
2.284. The representative of El Salvador
asked if this would system be implemented on a voluntary or mandatory basis.
2.285. The representative of Chile noted
that Canada had raised a fundamental issue in the area of transparency.
Currently, different Members were making efforts to improve procedures aimed at
alerting the public and private sector about TBT measures, and, in particular
their potential impact on exports. While there might be duplication, the WTO
was in a good place to establish a system which would be more efficient and
this would be of particular importance to those developing countries that did
not have the resources to set up their own systems. It was also important to
bear in mind that public consultations had little effect if the TBT
notifications did not reach the interested stakeholders at the right time. In
this regard, the WTO Secretariat could deliver a better service than the one
rendered currently. Canada's proposal therefore needed to be maintained on the
work programme of the Committee.
2.286. The representative of Mexico
recognized that the aim of the Canadian proposal was to develop a common, joint
platform – improving on the existing system – to optimize resources aimed at
creating national systems for alerts. This would, in Mexico's understanding,
represent a new mechanism for dialogue between regulators, private sector and
other stakeholders involved in the implementation of the TBT Agreement. Mexico
stressed the importance of reviewing this proposal in the Committee.
2.287. The representative of Uganda
supported the Canadian proposal and made substantive additional suggestions.
His detailed statement is reflected in full in document G/TBT/GEN/176.
2.288. The representative of the United States
noted that the Canadian proposal could be particularly important for those
countries that did not already have their own alert systems. She expressed her
delegation's concern that, while the Canadian proposed system was intended as a
complement, the development of a WTO‑based system could negatively impact
Members which already had such a system in place, or those which were currently
either planning for a new system or for upgrading existing ones. Members with
existing alert systems might have to face a situation of possible reductions in
subscribers, confusion among stakeholders, a potential a loss of data on
subscriber activity, increased circumvention of enquiry points to submit
comments, and reduced contacts between Members, industry and various
stakeholders. The US also stressed dependence of existing systems on the
current version of the IMS and Docs-Online and warned that possible changes to
the current system – because of the development of a new one – could
have a negative impact. Nevertheless, the US supported efforts to increase
awareness among stakeholders of measures notified to the TBT Committee. She
informed the Committee that the US was currently in the process of developing
an updated version of its own alert system.
2.289. The representative of Switzerland
characterized the instrument proposed by Canada as an inclusive public good,
crucial for the adequate functioning of the TBT notification procedures – and
at the heart of how to better involve the private sector. He said that the current
WTO IMS would benefit from an upgrade and that it needed to be made more user‑friendly.
In this regard, he recalled the contributions made to the Committee's 6th
Triennial Review and, in particular, the proposal tabled by the European Union[9]
which, among other things, called for an enhancement of current WTO IT
information systems.[10]
Switzerland proposed that the Committee request an upgrade of current systems
in the context of the Committee's upcoming 7th Triennial Review.
2.290. The representative of Brazil welcomed
the Canadian proposal and considered it a helpful contribution that would
be useful for both governments and the private sector. Brazil viewed this
proposal complementary to national initiatives, such as Brazil's own alert
system (Alerta Exportador[11]);
in other words, the systems could live side-by-side. Brazil stressed the
importance of making available, as suggested in paragraph 2.6 of Canada's
proposal, the full regulatory text (e.g., via a hyperlink). He stressed the
importance of such texts being made available for download in an accessible
file format that could be processed by translation tools.
2.291. The representative of China asked who
would be responsible for daily maintenance of alert system, whether it would
use only the WTO working languages, and whether there would be a budget for the
project.
2.292. The representative of the European Union
recalled, like Switzerland, the Committee's previous discussion in the context
of the 6th Triennial Review on how to improve the TBT IMS,
including the initial discussions on an alert system. He also recalled that in
that occasion the Committee had concluded that any improvement on TBT IMS
would be beneficial to those who did not have resources to develop their own
web‑based applications. In general, the EU expressed its interest in engaging
in a discussion of further improvements to IMS, particularly on with respect to
increase the system's user‑friendliness. Like the United States, he noted,
however, that some Members had already invested significant financial and human
resources in developing their own national alert systems. Thus, the
implications of future WTO-based alert system for existing systems needed to be
carefully considered. He also pointed out that national systems could, to some
extent, be even better than a global one at reaching certain categories of
stakeholders. He said that the EU would give serious consideration to the
Canadian proposal and noted that the Committee could – along with the
topic of transparency and IT more broadly - discuss it further at the upcoming
thematic session on the 7th triennial review in March 2015.
2.293. The representative of Ukraine
supported the Canadian proposal and noted the benefits it could have for
stakeholders. She was of the view that to have a common platform, operated by
the WTO, could be the optimal solution for many enquiry points and notification
authorities considering their own limited resources. Nevertheless, further
consideration and discussion was necessary in the Committee.
2.294. The representatives of Chinese Taipei,
Cuba, the Dominican Republic, Guatemala, the Philippines
and Trinidad and Tobago welcomed the Canadian initiative as it built on
the transparency provisions of the TBT Agreement. The importance of an
efficient and effective alert system that facilitated a dissemination of
information to stakeholders, in particular in developing countries, was noted.
The representative of Chinese Taipei informed the Committee that its
notification authority would join the TBT on‑line notification system (TBT‑NSS)
on 1 January 2015.
2.295. The representative of Canada
responded to a number of issues raised. With respect to the voluntary or
compulsory nature of the proposal, he stressed that the proposal was not
intended to create any additional requirements on Members; rather, it was
intended to make existing information more readily available and interpretable
for stakeholders or governments. It was about "packaging" the
information, not requesting more of it. Canada further noted that UN DESA
was currently considering a similar initiative aimed at least developed
countries (LDCs) and that synergies could be explored. With respect to the role
of national initiatives, Canada drew the Committee's attention to paragraph 2.9
of its proposal which suggested that Members' Enquiry points could login to the
alert notification system that would filter and provide Enquiry Point staff
with a database of subscribers registered in their country – this could
actually enhance the information provided and make the proposed system more
relevant. On China's point about operation, working languages and budget – this
would have to be discussed subsequently.
2.296. The Secretariat noted that it was
open to enhancing the existing TBT IMS and that it had done so previously
on a step‑by‑step basis in response to Committee recommendations. Should the
Canadian proposal further evolve and a mandate be established by the Committee,
for instance in the form of a recommendation, the feasibility of implementing
the project would be assessed, including with respect to resources needed.
2.297. The Chairman noted that there was
substantial interest for the Canadian proposal and that several ideas were on
the table, including a number of substantive, procedural and budgetary issues
that remained to be addressed. He encouraged further discussion in the
Committee to find a common understanding and noted that the Committee could
build on this work in the forthcoming triennial review.
2.298. The Chairman presented his report on
the thematic session held on 4 November 2014 on the topics of conformity
assessment procedures, and technical assistance and special and differential
treatment. The full report, including a brief summary of each presentation, is
contained in G/TBT/GEN/174.
2.299. The Chairman reported on his
consultations and work related to the list of voluntary mechanisms and related
principles of Good Regulatory Practice (GRP). He recalled the mandate before
the Committee[12]
and noted that this work had been going on for some time. He further recalled
that after the September 2014 informal meeting the Committee had agreed on a
two‑track approach. Under the first track, and on the one hand, he had – as
Chairman – addressed substantive issues in the text of the document itself. In
this vein, a new round of comments had been opened and several comments were
received from Members. The Chairman stressed that in this process he had used a
minimalist approach when taking into account the comments received, i.e. he
reflected those comments which sought to clarify the text and that did not
substantially change its meaning. He explained that he had done this because
the text that the Committee had considered in June 2014 had already been deemed
quite stable. His proposals were eventually issued as JOB/TBT/119 on
27 October 2014. In parallel, the second track involved a process of
consultations on systemic issues, namely those relating to the legal status of
the document.
2.300. The chairman stressed that, for the current
meeting, the time had come to merge the two tracks he had just outlined. He had
therefore circulated a Room Document (in all three languages) containing an
only slightly revised version which incorporated only six changes compared to
the original proposal (JOB/TBT/119). He also said that a "track change
version" had been made available for Members so that they could see
exactly what modifications had been made. The Chairman stressed that the
Committee had spent quite some time debating the issue at hand and, in his
view, everyone's positions were clear. The document, he said was the result of
a compromise, a delicate balance. In opening the floor he recalled a quote by
the renowned Portuguese poet Fernando Pessoa, who said: We worship
perfection because we can't have it; if we had it, we would reject it.
Perfection is inhuman, because humanity is imperfect.[13]
2.301. The representative of India thanked
the Chairman and the Secretariat for a draft text which took into account the
sensitivities of all Members and said that, in his delegation's view, the
Committee was on the verge of a final balance. He said India could only offer
some preliminary comments since the revised draft proposal had only been issued
late the previous day and more time would be required to examine some intricate
changes. India considered that there were a few loopholes in paragraph 3 that
needed to be rectified. First, what had originally been three sentences of a
legal disclaimer had been merged into one. It needed to be considered whether a
different meaning had been conveyed, in particular with respect to the word
"thereof" at end of the second sentence in paragraph 3. He asked if
this word qualified the phrase "TBT Agreement" or only the phrase
"any other WTO agreement". He noted that the Committee had started
with two clear sentences for a disclaimer as the basis for discussion. India's
intention was to ensure that the list did not constitute any interpretation of
the TBT Agreement. He also expressed his delegation's doubts with the meaning
of the word "list". Did it refer to the complete table? Or, instead,
did it refer only to the list of "possible steps and examples of
mechanisms", i.e., not including the third column of the table? This was
not clear because the first sentence in paragraph 3 only referred to the
"list of possible steps and examples of mechanism". He explained that
the third column, which contained references to articles and sub-articles of
TBT Agreement, was also required to be taken into account while examining the
interpretative value. India was also of the view that the disclaimer needed to
stand alone as it had done before – and not be merged as this added to
ambiguity and confusion.
2.302. Second, the Indian delegation did not
endorse the use of the word "authoritative" as this was subjective.
Moreover, if used, it would imply that there were some other kinds of
interpretations that were still possible which would not be authoritative. In
this regard, the basic purpose of the document was to list voluntary mechanisms
and related principles of GRP for the purpose of assisting policy makers in
implementing the Agreement; it was not for deriving any legal interpretation of
the Agreement. More work was therefore necessary to finalize the document,
particularly the “legal disclaimer”.
2.303. The representative of China shared
the concerns expressed by India. He thanked the Chairman and Secretariat for
the consultative process and the positive progress that had been made. However,
he regretted that not all his concerns had been clearly reflected. First, he
noted that in the e mail conveyed to Members by the Secretariat on the evening
before the current meeting, six changes had been incorporated in the latest
version of paper. China regretted that a seventh suggestion by China[14]
– the deletion of the word "may" – had not been reflected. While this
was not a "life or death" issue for China, it was an important one
because it helped reinforce the relatively weak Special and Differential
Treatment mechanisms in the GRP paper and thus would bring some comfort to
developing country Members, and particularly LDCs. He asked other Members
whether for them this change was so important that it could be characterized as
a "life or death" issue.
2.304. The disclaimer (paragraph 3) was, in China's
view, one of the core issues that divided Members. While China was pleased with
the information session held on 4 November 2014 to educate delegations about
WTO Committee documents referenced to in WTO Panel and Appellate Body reports,
it was now necessary to take some time to digest the Secretariat's compilation.
China would provide better-informed thoughts and comments on the GRP paper
containing the recently proposed legal disclaimer at a later time. China was
seeking more clarity on the language regarding "authoritative
interpretation" and its added value. According to Article IX:2 of the WTO
Agreement (on Decision-Making), the "Ministerial Conference and the
General Council shall have the exclusive authority to adopt interpretations of
this Agreement and of the Multilateral Trade Agreements" – this included
the TBT Agreement. The language contained in the proposed legal disclaimer
meant the same thing. As the GRP paper would be adopted by the TBT Committee
rather than as a Ministerial Declaration or as General Council document, it
went without saying that this document did not constitute an interpretation by
the Ministerial Council or the General Council. Thus the language did not have
any added value. The mechanisms could still be used by a WTO Panel to interpret
the relevant provisions of the TBT Agreement. Preliminarily, the Chinese
delegation said that they could manage with a language similar to that of the
SPS document; that is: replacing "constitute an authoritative
interpretation" with the language "provides any interpretation".
2.305. The representative of the United States
said that it was unfortunate that India and China did not feel that the
compromises that had been struck during the informal consultations had been
enough. The US delegation, together with other delegations, had worked very
hard to come up with a compromise solution that would make everyone
comfortable. In light of the many concessions that it had already made, the US
was not therefore comfortable with further changes to the document.
2.306. The representative of the European Union
thanked the Chairman for consultations that had been well‑handled and had
proved effective. They were effective because the number of open issues had
been reduced to only a few – and the Committee did, indeed, have a largely
agreed outcome document. The attainment of such small number of outstanding
issues (currently reduced to the term "may", mentioned by China) was
possible because all other requests from China, India and other delegations had
been considered and accommodated in the text, including their requests:
(i) to add elements on special and differential treatment in various
places of the text; and (ii) to clarify certain provisions in order to
make them appear less "burdensome" (there were in any case voluntary
in nature) for developing countries. In other words, some Members had made
genuine efforts to bridge positions and to accommodate the requests of others,
and the EU had made a number of compromises and concessions on the originally
proposed text. It was therefore unfortunate and regretful that this had been
met with inflexibility.
2.307. He said that the EU nevertheless still
remained persuaded that the document did not require any disclaimer in the
first place. For instance, every second line of the text contained language
such as "may", "non‑prescriptive",
"illustrative", "for example", "according to
administrative capacity", or "depending on the level of economic
development". And yet, reluctantly, the EU had accepted the compromise put
forward by the Chairman. The EU was not willing to go any further. Now it was
up to other Members who had not shown flexibility to take responsibility for
the Committee not being able to adopt the document. The EU also noted that the
majority of Members looked forward to the document because it was considered to
contain useful guidance, especially for developing countries in the process of
setting up regulatory systems, administrative procedures, and processes for
rule‑making. Indeed, it was a useful compendium of existing practices – basically
a menu of tools which each Member could pick and choose from depending on
whether it would fit their systems or not.
2.308. The EU further noted that the presentation
at the informal information session had also demonstrated that in no case had a
Panel or Appellate Body used a Committee document as the basis for their
interpretation. They reached the interpretation of specific provisions
according to other criteria, and then they looked at Committee documents to see
if there was anything that would contradict their interpretation or could
confirm their interpretation. But in no way – regardless of various disclaimers
used – was a recommendation used or rejected as a possible source of
interpretation of provisions in Agreements. Hence, the issue of legal interpretative
value had been overly exaggerated in the context at hand. What was currently on
the table was a very balanced document.
2.309. The representative of Argentina noted
that the main point of contention appeared to be the disclaimer. One
possibility was to accept paragraph 3 as it currently stood (leaving it
unchanged) and eliminate column three in the document (where articles of the
TBT Agreement were quoted).
2.310. The representative of China insisted
that his delegation had been constructive throughout the process, but it was
important to address legitimate concerns of developing Members and LDCs. China
drew the Committee's attention to discussions in the SPS Committee where
delegations had been discussing a simple working definition for "private
standards" for more than three years without consensus. Part of the reason
for the failure to achieve consensus on such definition in that Committee was
the fact that some large Members had insisted on including a strong legal
disclaimer to that simple working definition. If the EU was asking about
responsibility for failure, the representative of China wished to turn that
same question back: who should take responsibility for a lack of consensus in
the SPS context? Moreover, China could not agree with the reading of Panel and
Appellate Body reports that the EU had provided, particular the US Tuna II Reports. In this case the WTO Panel and Appellate
Body had clearly regarded the TBT Committee document on the "Six
Principles"[15] as
a "subsequent agreement". The Appellate Body had thus used this
decision to interpret what constituted an international standard. This
justified China's concern and that of other Members.
2.311. The representative of Brazil thanked
China, India and other Members for raising an important systemic discussion. As
had the Chair, he also mentioned the Portuguese poet Fernando Pessoa, who, he
recalled, wrote a book called "The Book of Disquiet,"[16]
a title that also described how he felt with these discussions. He wished to
comment on the discussion from two different points of view. It was a given
that Members must be fully aware and cognisant of what they do and decide in
WTO Committees in which they participate. It was also important that they be
careful and cautious about implications and the impact of what they together
agreed in a document. On that same side of the equation, he recalled – as China
and others had done – that some disclaimers had been inserted in several
documents; there were two or three important precedents in the
SPS Committee with somewhat different language used in each case. This
needed to be taken into account. On the other hand, the Committee would do well
to take time to ponder the implications of the reinforcement of this precedent,
namely: the insertion of all kinds of disclaimers in the work of all Committees
in which we Members participate. Delegations needed therefore to ask
themselves: what room would be left for the work of Committees, which convened
and worked according to Article III of the Marrakesh Agreement (on the
Functions of the WTO), to further the objectives of the Agreements and to
facilitate their operation and administration? If the Committee would decide to
insert – without prejudice as to whether this was right or wrong, good or bad –
a very strong disclaimer language in a document called a voluntary
"list", then the representative of Brazil would venture to say that
all other documents that came out of the Committee that were more than a list
would have to have a disclaimer.
2.312. The representative of Brazil stressed that he
was not making any particular affirmation; rather, he was simply calling for
thoughtful consideration. As regards the list of Panel and Appellate Body
Reports presented at the Committee's informal information session (4 November
2014), he noted that 20 were Panel Reports and 4 were Appellate Body
Reports. With respect to the Appellate Body decision in US – Tuna II,
while, of course, it could be said that the Appellate Body went too far, the
real question was another one: what should we (the TBT Committee) do about it
this? What should be done when such a decision was not to the Committee's
liking? Do we put a disclaimer on all we do? Another option was to tell the
Appellate Body that it was not a good
decision. This could be done in future cases, in a statement in the DSB – there
were several ways of influencing future decisions. All this needed to be
considered so that the Committee could find an acceptable path that would not
haunt or hobble its future work.
2.313. The representative of India
associated himself with the points made by the delegation of China. India could
also support the proposal made by Argentina. On the issue of taking
responsibility, India noted that this was about bridging the few remaining
gaps, a goal India was ready to work towards to. At the same time the gaps were
ambiguous, as already articulated by India, and needed further work. It was
important not to delve in constructive or deliberate ambiguity in trying to
achieve a compromise.
2.314. The representative of the European Union
appreciated the statement by Brazil. Consequences of disclaimers needed to be
considered. What would happen if the Committee started to put into question
what it did by adding disclaimers to what had been agreed? He stressed that the
document was part of an overall package, it was a balanced compromise. On the
point made by China, the EU stressed that there was an important difference
with the work done in the SPS context on private standards. He explained that
in the SPS context the document being discussed would have given the impression
that there was agreement that private standards fell within the scope of the
SPS Agreement. The disclaimer had, in that case, been a precondition by the EU
to accept a discussion of private standards in the SPS context. GRP in TBT context
was an altogether different matter as there was no question about GRP being an
important component of the effective implementation of the TBT Agreement. There
was consensus about this and the matter had been reiterated since the Second
Triennial Review – thus the contexts were not comparable.
2.315. The representative of Mexico thanked
the Chairman and the Secretariat for the transparent process of the negotiation
on the document. Moreover, the informal information session of 4 November 2014
had been very useful. She expressed her delegation's disappointed with the lack
of agreement. Clearly, the document was not perfect – but it came close and the
Committee had worked on it for a long time and had a mandate to do so. Mexico
remained convinced that the use of disclaimers would have repercussions further
down the line. She thanked Brazil for their intervention in this regard. Mexico
was not fully comfortable with the use of a disclaimer but, in the spirit of
compromise, had accepted the Chairman's text. She expressed Mexico's doubts on
what the next step should be. Mexico could accept the text as it stood, as a
package. Mexico would therefore feel uncomfortable with the idea of introducing
more changes to the document.
2.316. The Chairman thanked all Members for
their interventions. He said that the discussion had been useful in that at
least there was agreement on the whole text, except for the disclaimer (in
paragraph 3) and for the word "may" in the middle of page 6.[17]
He noted that no other issue had been raised by delegations. To the contrary,
many delegations stressed the value of the document. It was, after all, a list
aimed at deepening the understanding of the ways in which Members could
implement the TBT Agreement. Also, eventually, it was important to show that this
organization could agree – albeit at a different level (this was not the DDA) –
but agree nonetheless on a document, by consensus. It was important to reflect
if the issue of the disclaimer (having it or not having it) was so important as
to block the adoption of the document. He also stressed that he was not taking
any side on this; he was simply trying to facilitate an agreement. With respect
to the comments made on whether or not drafting suggestions by Members had been
taken into account, he noted that this was always difficult. When one Member's
comments were taken into account another had to concede. The negotiation of the
text could be described as a formula for an "equal distribution of
pain". The Chairman promised therefore to continue to "distribute pain".
For now, and for clarity, he asked that the Committee confirm: the text was closed except for the disclaimer (in paragraph 3) and
the word "may" (on page 6). It was so agreed.
3.1. The
Secretariat updated the Committee on technical assistance activities
undertaken and planned for the 2014‑2015 biennium, which contained an intense TA
agenda, due to, in great part, a large number of national TBT‑specific
activities: 20 (10 undertaken in 2014, and 10 planned for 2015). He said that demand
has been particularly high from Latin America from which almost half (8) of
such requests came from. Many of the requests for national and regional
activities (10 in total) were for joint TBT‑SPS activities. Such joint
activities were organized in partnership with SPS colleagues from the
Agriculture Division. The Secretariat has also organized (or planned to
organize) 6 TBT‑specific regional activities. He highlighted that some of the
workshops, in particular, regional workshops, were organized in partnership
with the host country. In this respect, he took the opportunity to thank the
Brazilian Government, in particular Inmetro, for the financial, logistical, and
intellectual support given at the IADB/WTO workshop for Latin American countries
that had taken place in Brazil in September 2014. The Secretariat also
informed the Committee that the Fifth Advanced Course on the TBT Agreement
would take place in March 2015, where 25 participants would be selected to
attend the two week course. She encouraged developing country Members to submit
candidatures. A document containing information on the Secretariat's technical
assistance activities was made available.[18]
3.2. The
representative of Brazil thanked the WTO Secretariat for the assistance
provided in the organization of the national workshop on TBT held back to back
with the regional workshop in September 2014. This event, he said, was attended
by government officials and stakeholders and provided a highly qualified forum
for TBT related issues.
3.3. The
representative of El Salvador thanked the WTO Secretariat for its
support at a national workshop on the TBT and SPS Agreements which had taken
place in September 2014, attended by officials from technical regulations body,
the consumer defence committee and the Ministry of Agriculture.
3.4. The
representative of Paraguay expressed his delegation's interest in
holding a national workshop in 2015.
3.5. The
representative of the IEC updated the Committee on its technical
assistance related activities[19],
including the Conformity Assessment Committee (CAC) launched by the African
Electrotechnical Standardization Commission (AFSEC), a two day training seminar
in Paraguay on IECEE conformity assessment activities and a new technical
mentoring partnership between Uruguay. He also informed the Committee that the
78th General Meeting would take place in Tokyo from 10-14 November.
3.6. The
representative of the BIPM informed the Committee that the BIPM, along
with OIML had participated in the AFRIMETS Legal Metrology School in Tunisia in
October 2014. He also said that the BIPM would be proposing to extend its
current practice of allowing staff from national metrology institutes from
developing countries to spend time at BIPM so as to have a better understanding
of metrology.
4.1. The
representative of ISO informed the Committee that a new publication on
using and referencing ISO and IEC standards to support public policy and
technical regulations was now available.[20]
He also highlighted the continued development of the ISO Academy[21]
which pulled together numerous training and development initiatives to build
the capacity of members to meet their commitment to good standardization
practices. Further updates on courses and partnering initiatives with members
would be made available in the coming months.
4.2. The
representative of the BIPM informed the Committee that Sudan and Yemen
had recently become associates, bringing participation to 56 member states and
41 associate states and economies. He said the General Conference would take
place from 18-20 November, the agenda of and related documents of which were on
the BIPM website.[22]
Concerning the scientific progress towards the revision of the international
system of units (SI), he said this would bring significant future proofing to
the scientific community, but that the changes were not expected to have an
impact on the trade community.
4.3. The
representative of UNECE informed the Committee that WP6 recently had
recommendations on references to standards and education related standards,
both of which would be the focus of the annual session taking place on 24-26
November.[23]
4.4. The
representative of the Kingdom of Saudi Arabia proposed that the
Committee accept the application for observer status submitted by the GCC
Standardization Organization (GSO). The proposal was supported by Qatar,
Egypt, United States, Jordan and Canada.
4.5. The
Committee agreed to grant ad hoc
observer status to the Gulf Cooperation Council Standardization Organization
(GSO).
5.1. The
Committee adopted its 2014 Report to the Council for Trade in Goods
(G/L/1092).
6.1. The next regular meeting of the Committee is
scheduled for 18-19 March 2015. It will be
preceded by a thematic session to be held on 17 March.
__________
[1] This document has been prepared under the Secretariat's own
responsibility and is without prejudice to the positions of Members or to their
rights and obligations under the WTO.
[3] Indonesia – Regulation of Minister of Trade No.
10/M-DAG/PER/1/2014 concerning Amendment of Regulation of Minister of Trade No.
67/M-DAG/PER/11/2013 concerning Affixed Mandatory Label in Indonesian Language
for Goods.
[6] Indonesia - Technical Guidelines for the Implementation of the
Adoption and Supervision of Indonesian National Standards for Obligatory Toy
Safety (G/TBT/N/IDN/64, G/TBT/N/IDN/64/Add.2)
[8] For more detail see the Chairman's follow-up communication of
4 December 2014 (sent by fax to all Members).
[9] G/TBT/W/354, dated 12 June 2012.
[10] See, in particular, the recommendations contained in paragraphs 17
and 18 of G/TBT/32.
[12] Paragraph 4 of G/TBT/32.
[13] Autobiografia sem Factos, p. 249
[14] Shown highlighted in yellow in the middle of page 6 of
JOB/TBT/119/Rev.1.
[15] G/TBT/1/Rev.11, Annex 2, page. 45.
[16] "Livro
do Desassossego: Composto por Bernardo Soares, ajudante de guarda-livros na
cidade de Lisboa)",
published posthumously in 1982, 47 years after Pessoa's death.
[17] Highlighted in yellow and within square brackets in
JOB/TBT/119/Rev.1 (circulated subsequent to the meeting, on 4 December 2014).
[18] G/TBT/GEN/171/Rev.1.