Commission Implementing Regulation (EU) No 121/2014 of 7 February 2014 concerning the authorisation of L-selenomethionine as a feed additive for all animal species Text with EEA relevance
Commission Implementing Regulation (EU) No 121/2014of 7 February 2014concerning the authorisation of L-selenomethionine 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 2003 on additives for use in animal nutritionOJ L 268, 18.10.2003, p. 29., 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-selenomethionine. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(3)That application concerns the authorisation of L-selenomethionine, an organic compound of selenium, as a feed additive for all animal species, to be classified in the additive category "nutritional additives".(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 2 May 2013EFSA Journal 2013; 11(5):3219. that, under the proposed conditions of use, L-selenomethionine does not have an adverse effect on animal health, human health or the environment and that its use may be considered as an efficient source of selenium 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.(5)The assessment of L-selenomethionine 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 preparation should be authorised as specified in the Annex to this Regulation.(6)The Authority concluded that the limitation of the supplementation with organic selenium established for other organic compounds of selenium should also apply to L-selenomethionine. Furthermore, in case different compounds of selenium are added to the feed, the supplementation with organic selenium should not exceed 0,2 mg per kg complete feed.(7)The applicant delivered supplementary data consequently to the abovementioned opinion of the Authority to prove the stability of the additive once it is incorporated in premixtures containing compounds of trace elements.(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS REGULATION:
Article 1The preparation specified in the Annex, belonging to the additive category "nutritional additives" and to the functional group "compounds of trace elements", is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2This 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, 7 February 2014.For the CommissionThe PresidentJosé Manuel BarrosoANNEX
Details of the analytical methods are available at the following address of the Reference Laboratory:http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspxCategory of nutritional additives. Functional group: compounds of trace elements
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Selenium in mg/kg of complete feed with a moisture content of 12 %
3b815—L-selenomethionineCharacterisation of the additiveSolid preparation of L-selenomethionine with a selenium content < 40 g/kgCharacterisation of the active substanceOrganic selenium in form of L-selenomethionine (2-amino-4-methylselanyl-butanoic acid) from chemical synthesisChemical formula: C5H11NO2SeCAS number: 3211-76-5Crystalline powder with L-selenomethionine > 97 % andSelenium > 39 %Analytical methodFor the determination of L-selenomethionine in the feed additive: high performance liquid chromatography and inductively coupled plasma mass spectrometry (HPLC-ICPMS) after triple proteolytic digestion.For the determination of total selenium in the feed additive: inductively coupled plasma mass spectrometry (ICPMS), or inductively coupled plasma atomic emission spectrometry (ICP-AES).For the determination of total selenium in premixtures, compound feed and feed materials: hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion (EN 16159:2012).All species—0,50 (total)1.The additive shall be incorporated into feed in the form of a premixture.2.For user safety: breathing protection, safety glasses and gloves shall be worn during handling.3.Technological additives or feed materials included in the preparation of the additive shall ensure a dusting potential < 0,2 mg selenium/m3 air.4.In the directions for use of the additive and premixtures, indicate the storage and stability conditions.5.Maximum supplementation with organic selenium:0,20 mg Se/kg of complete feed with a moisture content of 12 %.6.If the preparation contains a technological additive or feed materials for which a maximum content is set or which is subject to other restrictions, the feed additive manufacturer shall provide this information to the customers.28 February 2024