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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) 2025/1395 of 15 July 2025 correcting and
amending Implementing Regulation (EU) 2020/997 as regards the terms of the
authorisation of L-lysine base, liquid, as a feed additive for all animal
species (Text with EEA relevance). Language(s):
English, French and Spanish. Number of pages: 9
https://members.wto.org/crnattachments/2025/SPS/EEC/25_04976_00_e.pdf
https://members.wto.org/crnattachments/2025/SPS/EEC/25_04976_00_f.pdf
https://members.wto.org/crnattachments/2025/SPS/EEC/25_04976_00_s.pdf
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6.
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Description
of content: The additive covered by
this Act is currently authorised for a period of ten years as a feed additive
for all animal species in the additive category 'nutritional additives' and
in the functional group 'amino acids, their salts and analogues'. An application
was submitted for the modification the authorisation of this additive in
accordance with article 13 of Regulation (EC) No 1831/2003. The modification
consists of the addition of a new production strain, Corynebacterium glutamicum NRRL B-68248.
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 authorisation of this additive is amended under certain
conditions detailed in the Annex to the Act.
In addition,
the additive covered by this Act was erroneously referred to in Commission
Implementing Regulation (EU) 2020/997 as an active substance, while it is
actually a preparation. Implementing Regulation (EU) 2020/997 is therefore
corrected accordingly by this Act.
A
transitional period is included for the interested parties to meet the
requirements resulting from those amendment and correction.
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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:
Modification of the terms of authorisation regarding the additive consisting
of liquid l-lysine base produced with Corynebacterium
glutamicum NRRL B‑67439 and NRRL B-67535 for all animal species
(ADM specialty ingredients (Europe) B.V.)
EFSA Journal, 22(7), e8950. https://doi.org/10.2903/j.efsa.2024.8950
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10.
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Proposed
date of adoption (dd/mm/yy): 15 July 2025
Proposed date of publication (dd/mm/yy): 16 July 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.
[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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