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1.
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Notifying
Member: EUROPEAN UNION
If applicable, name of local government involved:
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2.
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Agency
responsible: European Commission,
Health and Food Safety Directorate-General
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3.
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Products
covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers should be provided in addition, where
applicable): Preparations of a kind
used in animal feeding (HS code(s): 2309)
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4.
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Regions
or countries likely to be affected, to the extent relevant or practicable:
[X] All trading partners
[ ] Specific regions or
countries:
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5.
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Title of
the notified document: Draft
Commission Implementing Regulation concerning the denial of the renewal of
the authorisation of Patent Blue V as a feed additive for non‐food producing animals and repealing Implementing Regulation (EU)
No 643/2013 (Text with EEA relevance). Language(s):
English. Number of
pages: 4
https://members.wto.org/crnattachments/2025/SPS/EEC/25_03703_00_e.pdf
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6.
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Description
of content: Patent Blue V was
authorised for a period of ten years as feed additive for non‐food producing animals, in the additive category 'sensory
additives' and the functional group 'colorants, substances that add or
restore colour in feedingstuffs'. An application was submitted for the
renewal of the authorisation of this substance in accordance with article 14
of Regulation (EC) No 1831/2003. Following an inconclusive EFSA opinion, the
applicant chose not to submit supplementary information to address the issues
raised in that opinion. Consequently, considering that the additive does not
satisfy the necessary conditions, the renewal of its authorisation is denied.
A transitional period is included to allow for the withdrawal of the additive
from the market.
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7.
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Objective
and rationale: [X] food safety, [X] animal health, [ ] plant protection, [ ]
protect humans from animal/plant pest or disease, [ ] protect territory from
other damage from pests.
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8.
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Is there
a relevant international standard? If so, identify the standard:
[X] Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text): Code of practice on Good Animal Feeding CAC/RCP 54-2004
[ ] World Organization for Animal Health
(OIE) (e.g. Terrestrial or Aquatic Animal Health Code,
chapter number):
[ ] International Plant Protection
Convention (e.g. ISPM number):
[ ] None
Does this proposed regulation conform to the relevant international
standard?
[X]
Yes [ ] No
If no, describe, whenever possible, how and why it deviates from the
international standard:
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9.
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Other
relevant documents and language(s) in which these are available: Scientific Opinion: Assessment of the feed additive consisting
of Patent Blue V for all non-food-producing animal species for the renewal of
its authorisation (Versele-Laga NV). EFSA Journal, 22(4), e8722. https://doi.org/10.2903/j.efsa.2024.8722 (available in English)
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10.
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Proposed
date of adoption (dd/mm/yy): 4th quarter 2025
Proposed date of publication (dd/mm/yy): 4th quarter 2025
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11.
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Proposed
date of entry into force: [ ] Six months from date of publication, and/or (dd/mm/yy):
This Regulation shall enter into force on the twentieth day following its
publication in the Official Journal
of the European Union.
[ ] Trade facilitating
measure
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12.
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Final
date for comments: [X] Sixty days from the date of circulation of the
notification and/or (dd/mm/yy): 4 August 2025
Agency or authority designated to handle comments: [X] National
Notification Authority, [X] National Enquiry Point. Address, fax number and
e-mail address (if available) of other body:
European
Commission
DG Health and
Food Safety, Unit A4-Multilateral International Relations
Rue Froissart 101
B-1049 Brussels
Tel: +(32 2) 29 54263
E-mail:
sps@ec.europa.eu
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13.
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Text(s) available from: [X] National
Notification Authority, [X] National Enquiry Point. Address, fax number and
e-mail address (if available) of other body:
European Commission
DG Health and Food Safety, Unit A4-Multilateral International
Relations
Rue Froissart 101
B-1049 Brussels
Tel: +(32 2) 29 54263
E-mail: sps@ec.europa.eu
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