Commission Implementing Regulation (EU) 2015/489 of 23 March 2015 concerning the authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R645 as a feed additive for all animal species  Text with EEA relevance
Date: 2015-03-23
Institutions: European Commission
Subjects: animal feedingstuffs, food safety, food supplement, market approval




L_2015078EN.01000501.xml










24.3.2015   


EN


Official Journal of the European Union


L 78/5








            COMMISSION IMPLEMENTING REGULATION (EU) 2015/489
of 23 March 2015
         
concerning the authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R645 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 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 selenomethionine produced by Saccharomyces cerevisiae NCYC R645. 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 a preparation of 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 3 July 2014 (2) that, under the proposed conditions of use, selenomethionine produced by Saccharomyces cerevisiae NCYC R645 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 selenomethionine produced by Saccharomyces cerevisiae NCYC R645 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 selenomethionine produced by Saccharomyces cerevisiae NCYC R645. 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 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 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 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, 23 March 2015.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  
            EFSA Journal 2014; 12(7):3797.




ANNEX














Identification number of the additive


Name of the holder of authorisation


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




Selenium in mg/kg of complete feed with a moisture content of 12 %





Category of nutritional additives. Functional group: compounds of trace elements






3b817


—


Selenomethionine produced by Saccharomyces cerevisiae NCYC R645
(Selenised yeast inactivated)



Characterisation of the additive:

Preparation of organic selenium:






 


Content of selenium: 2 000  to 2 400  mg Se/kg










 


Organic selenium > 98 % of total selenium










 


Selenomethionine > 70 % of total selenium





Characterisation of the active substance:







 


Selenomethionine produced by Saccharomyces cerevisiae NCYC R645










 


Chemical formula: C5H11NO2Se





Analytical method
 (1):
For the determination of selenomethionine in the feed additive:






—


reversed phase high performance liquid chromatography with UV detection (RP-HPLC-UV), or










—


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 atomic emission spectrometry (ICP-AES), or










—


inductively coupled plasma mass spectrometry (ICPMS).




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 %.






13 April 2025






(1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx