THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functio
ning 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 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 DL-methionyl-DL-methio
nine as a feed additive. That application was accompanied by the particulars and docu
ments required under Article 7(3) of Regulation (EC) No 1831/2003. (3) That application co
ncerns the authorisation of DL-methionyl-DL-methio
nine as a feed additive for all aquatic animal species, to be classified in the additive category ‘nutritio
nal additives’. (4) The European Food Safety Authority (‘the Authority’) co
ncluded in its opinion of 27 January 2015 (2) that, under the proposed co
nditions of use, DL-methionyl-DL-methio
nine does not have an adverse effect on animal health, human health or the enviro
nment and that it may be co
nsidered an efficacious source of the amino acid L-methio
nine for fish and crustacean species. The Authority does not co
nsider 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. (5) The assessment of DL-methionyl-DL-methio
nine shows that the co
nditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. (6) 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, belo
nging to the additive category ‘nutritio
nal additives’ and to the functio
nal group ‘a(chǎn)mino acids, their salts and analogues’, is authorised as an additive in animal nutrition, subject to the co
nditions 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, 19 August 2015. For the Commission The President Jean-Claude JUNCKER (1) OJ L 268, 18.10.2003, p. 29. (2) EFSA Journal 2015;13(2):4012. ANNEX
Identification number of the additive | ame of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method. | ecies or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
mg/kg of complete feed with a moisture content of 12 % |
Category of nutritional additives. Functional group: amino acids, their salts and analogues |
3c306 | — | DL-methionyl-DL-methionine | Additive composition Crystalline powder from chemical synthesis with a minimum of 93 % DL-methionyl-DL-methionine, a maximum of 3 % DL-methionine and a maximum of 3 % sodium sulphate (on a dry matter basis) Characterisation of the active substance DL-methionyl-DL-methionine (2-[(2-amino-4-methylsulfanylbutanoyl)amino]-4-methylsulfanylbutanoic acid) Chemical formula: C10H20N2O3S2 CAS number: 52715-93-2 Analytical method (1) For the quantification of DL-methionyl-DL-methionine in the feed additive: reversed-phase high performance liquid chromatography coupled to photometric detection at 205 nm (RP-HPLC-UV). For the quantification of DL-methionyl-DL-methionine in premixtures, compound feed and feed materials: ion exchange chromatography coupled with post-column derivatisation and photometric detection at 570 nm (IEC-UV). | Fish and crustaceans | — | | | The moisture content shall be indicated on the labelling. | 9 September 2025 |