Date: 2023-03-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/649 of 20 March 2023 concerning the authorisation of L-arginine produced by Corynebacterium glutamicum CGMCC 20516 as a feed additive for all animal species (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/649 authorises L-arginine produced by Corynebacterium glutamicum CGMCC 20516 as a nutritional feed additive for all animal species. The regulation addresses the safety, efficacy, and conditions of use for this additive. It entered into force on April 11, 2023, twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Authorisation:** L-arginine produced by Corynebacterium glutamicum CGMCC 20516 is authorised as a feed additive for all animal species.
* **Additive Category and Functional Group:** Classified as a nutritional additive, specifically an amino acid, its salts, and analogues.
* **Safety Assessment:** The European Food Safety Authority (EFSA) concluded that, under proposed conditions, the additive does not pose a risk to consumer safety, animal health (when supplemented appropriately), or the environment.
* **User Safety:** Exposure by inhalation is possible and the additive may cause eye and skin irritation.
* **Efficacy:** The additive has the potential to be efficacious for all animal species.
* **Post-Market Monitoring:** No specific post-market monitoring requirements are needed.
* **Conditions of Use (Annex):**
* Minimum content: 98.5% L-arginine on a dry matter basis.
* The additive may be used via water for drinking.
* Directions for use must indicate storage conditions, heat stability, and stability in water.
* Labels must advise considering all essential amino acids to avoid imbalances.
* Feed business operators must establish procedures and measures to address potential user risks.
* Appropriate personal protective equipment is required where risks cannot be acceptably reduced.
* **Analytical Method:** Specified analytical methods for identification and determination of L-arginine in feed additive, water, premixtures, and complete feed are provided.
Impact Analysis:
* **Animal Feed Producers/Manufacturers:**
* Impact: Can now use L-arginine produced by Corynebacterium glutamicum CGMCC 20516 in feed for all animal species, provided they adhere to the conditions outlined in the Annex.
* Action Required: Ensure compliance with usage conditions, labelling requirements, and implement safety measures for workers handling the additive.
* **Farmers/Animal Owners:**
* Impact: Can use feed containing the authorised L-arginine additive for their animals.
* Action Required: Follow feeding instructions and ensure appropriate supplementation to avoid nutritional imbalances.
* **Additive and Premix Users:**
* Impact: Potential exposure risks during handling.
* Action Required: Establish operational procedures and use appropriate personal protective equipment (breathing, skin, and eye protection).
* **European Food Safety Authority (EFSA):**
* Impact: Their assessment formed the basis for the authorisation.
* Action Required: No further action specified in this regulation.
* **Commission and Member States:**
* Impact: Responsible for ensuring the regulation is applied and enforced within the Member States.
* Action Required: Implement and monitor compliance with the regulation.
Key Entities Referenced
L-arginine: An amino acid being authorised as a feed additive for all animal species.
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EC) No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
European Food Safety Authority (EFSA): An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Regulation (EC) No 1907/2006: Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency.
Ursula VON DER LEYEN: The President of the European Commission.
Corynebacterium glutamicum CGMCC 20516: The strain of bacteria used to produce L-arginine.
21.3.2023 EN Official Journal of the European Union L 81/13
COMMISSION IMPLEMENTING REGULATION (EU) 2023/649
of 20 March 2023
concerning the authorisation of L-arginine produced by Corynebacterium glutamicum CGMCC 20516
as a feed additive for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003on
additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation
of L-arginine produced by Corynebacterium glutamicum CGMCC 20516. That application was accompanied by the
particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concerns the authorisation of L-arginine produced by Corynebacterium glutamicum CGMCC 20516 as
a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’ and in the
functional group ‘amino acids, their salts and analogues’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 June 2022(2)that, under the
proposed conditions of use, L-arginine produced by Corynebacterium glutamicum CGMCC 20516 does not have an
adverse effect on consumer safety or the environment, or on animal health when supplemented in appropriate
amounts to the diet according to the nutritional needs of the target species and when nutritional imbalances caused
by the simultaneous administration of L-arginine via water for drinking and feed are prevented.
(5) The Authority further concluded that exposure of users by inhalation is possible. The applicant provided the safety
data sheet required in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the
Council(3)which demonstrates that the additive may cause eyes and skin irritation.
(6) The Authority concluded that the additive has the potential to be efficacious for all animal species. The Authority
does not consider that there is a need for specific requirements of post-market monitoring. It also verified the
report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by
Regulation (EC) No 1831/2003.
(7) The assessment of L-arginine produced by Corynebacterium glutamicum CGMCC 20516 shows that the conditions for
authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of
that substance should be authorised. The Commission considers that appropriate protective measures should be
taken to prevent adverse effects on human health, in particular as regards the users of the additive.
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2022;20(7):7427.
(3) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as
Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396,
30.12.2006, p. 1).L 81/14 EN Official Journal of the European Union 21.3.2023
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group
‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition, subject to the conditions laid down
in that Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 March 2023.
For the Commission
The President
Ursula VON DER LEYENANNEX
Minimum Maximum
content content
Identification Species or
Composition, chemical formula, description, analytical Maximum End of period of
number of Additive category of mg of additive/kg of Other provisions
method. age authorisation
the additive animal complete feed with a
moisture content of
12 %
3c365 L-arginine Additive composition All species — — — 1. The additive may be used via water for 11.4.2033
drinking.
≥ 98,5 % L-arginine (on a dry matter basis) and ≤ 1 %
of water 2. The directions for use of the additive
and premixture shall indicate the sto
Solid form
rage conditions, the stability to heat
Characterisation of the active substance treatment and the stability in water
for drinking.
L-arginine ((S)-2-amino-5-guanidinopentanoic acid)
produced by Corynebacterium glutamicum CGMCC 3. The label of the additive and premix
20516 ture shall indicate the following: ‘The
supplementation with L-arginine, in
Chemical formula: C 6H 14N 4O 2 particular via water for drinking,
CAS number: 74–79-3 should take into account all essential
and conditional essential amino acids
Analytical method(1) in order to avoid imbalances.’
For the identification of L-arginine in the feed 4. For users of the additive and premix
additive: tures, feed business operators shall es
tablish operational procedures and
— Food Chemical Codex ‘L-arginine monograph’.
appropriate organisational measures
For the determination of arginine in the feed additive to address the potential risks. Where
and water: risks cannot be reduced to an accep
table level by these procedures and
— Ion-exchange chromatography coupled with
measures, the additive and premix
post-column derivatisation and optical detection
tures shall be used with appropriate
(IEC-VIS).
personal protective equipment, in
For the determination of arginine in premixtures and cluding breathing, skin and eye pro
complete feed: tection.
— Ion exchange chromatography coupled with
post-column derivatisation and optical detection
(IEC-VIS), Commission Regulation (EC)
No 152/2009 (Annex III, F).
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-
reports_en.
21.3.2023
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