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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: Commission
Implementing Regulation (EU) 2025/1795 of 9 September 2025 concerning the
authorisation of riboflavin (vitamin B2) produced with Bacillus subtilis CGMCC 7.449 and a
preparation of riboflavin produced with Bacillus
subtilis CGMCC 7.449, as feed additives for all animal species
(Text with EEA relevance). Language(s):
English, French and Spanish. Number of pages: 4
https://members.wto.org/crnattachments/2025/SPS/EEC/25_06076_00_e.pdf
https://members.wto.org/crnattachments/2025/SPS/EEC/25_06076_00_f.pdf
https://members.wto.org/crnattachments/2025/SPS/EEC/25_06076_00_s.pdf
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6.
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Description
of content: This Regulation
authorises for the first time in the European Union and for a period of
ten years riboflavin (vitamin B2) produced with Bacillus subtilis CGMCC 7.449 and a preparation of
riboflavin produced with Bacillus subtilis
CGMCC 7.449 as feed additives belonging to the additive category 'nutritional
additives' and in the functional group 'vitamins, pro-vitamins and chemically
well-defined substances having similar effect' for all animal species. This
authorisation is based on the favourable conclusions of a scientific
assessment of the dossier submitted by the applicant, conducted by the
European Food Safety Authority (EFSA). The terms of the authorisation are
detailed in the Annex to the Act.
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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: Safety and efficacy of feed additives
consisting of vitamin B2 (98%) and vitamin B2 (80%) produced with Bacillus subtilis CGMCC 7.449 for all
animal species (Chifeng Pharmaceutical Co., Ltd.): EFSA Journal 2025;23:e9249, https://doi.org/10.2903/j.efsa.2025.9249 (available in English)
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10.
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Proposed
date of adoption (dd/mm/yy): 9 September 2025
Proposed date of publication (dd/mm/yy): 10 September 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 that of
its publication in the Official Journal of the European Union.
[X] Trade facilitating
measure
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12.
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Final
date for comments: [ ] Sixty days from the date of circulation of the
notification and/or (dd/mm/yy): Not applicable
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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