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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 2003 on additives for use in animal nutritionnote, 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 and renewing such authorisation.
(2)L-cystine was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 1006/2013note.
(3)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-cystine as a feed additive for all animal species, requesting that additive to be classified in the category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 April 2024note that the use of L-cystine is of no safety concern for the target species, the consumers and the environment. As regards the safety for the user it also concluded that L-cystine is not considered irritant to skin or eyes and is not considered to be a skin sensitiser but that exposure by inhalation of persons handling the additive cannot be excluded. The Authority considered that there is no need for assessing the efficacy of L-cystine, as the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation in this regard.
(5)The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the methods of analysis of L-cystine as a feed additive in the context of the previous authorisation are valid and applicable for the current application. However, the Reference Laboratory subsequently updated the evaluation report submitted in the context of the previous authorisation, in order to take account of scientific and technological developments and to ensure a better suitability of the methods of analysis for official controls. The Authority verified the amended report on the methods of analysis of L-cystine as a feed additive submitted by the Reference Laboratorynote.
(6)In view of the above, the Commission considers that L-cystine satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. As regards the methods of analysis, account should be taken of the updated evaluation report of the Reference Laboratory. It is appropriate to alert the user to take into account that supplementation with L-cystine is to depend on the requirements of the target animals for sulphur-containing amino acids and the level of other sulphur-containing amino acids in the ration. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.
(7)As a consequence of the renewal of the authorisation of L-cystine as a feed additive, Implementing Regulation (EU) No 1006/2013 should be repealed.
(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 1Renewal of the authorisation#
The authorisation of 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 renewed subject to the conditions laid down in that Annex.
Article 2Repeal of Implementing Regulation (EU) No 1006/2013#
Implementing Regulation (EU) No 1006/2013 is repealed.
Article 3Transitional measures#
1.The feed additive L-cystine, as authorised by Implementing Regulation (EU) No 1006/2013 and premixtures containing that additive, which are produced and labelled before 5 September 2025 in accordance with the rules applicable before 5 March 2025, may continue to be placed on the market and used until the stocks concerned are exhausted.
2.Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 5 March 2026 in accordance with the rules applicable before 5 March 2025, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.
3.Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 5 March 2027 in accordance with the rules applicable before 5 March 2025, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.
Article 4Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg/kg of complete feed with 12 % moisture content | ||||||||
| Category: nutritional additives. Functional group: amino acids, their salts and analogues | ||||||||
| 3c391 | L-cystine | Additive compositionL-cystine with a minimum content of 98,5 %Solid form.Characterisation of the active substanceL-cystine produced by hydrolysis of keratin from poultry feathersIUPAC name: (2R)-2-amino-3- [(2R)-2-amino-3-hydroxy-3-oxopropyl] disulfanyl-propanoic acidCAS number: 56-89-3Chemical formula: C6H12N2O4S2Analytical methodnoteFor the identification of L-cystine in the feed additive:Food Chemical Codex L-cystine monographFor the determination of cystine in the feed additive:Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)For the determination of cystine in premixtures:Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 orIon-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)For the determination of cystine in compound feed:Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Regulation (EC) No 152/2009 | All animal species | — | — | — | 1.In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2.The label of the additive and premixtures shall indicate the following:Supplementation with L-cystine shall depend on the requirements of the target animals for sulphur-containing amino acids and the level of other sulphur-containing amino acids in the ration.3.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing protective equipment. | 5 March 2035 |
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