CELEX: 32019R0049
Language: en
Date: 2019-01-04 00:00:00
Title: Commission Implementing Regulation (EU) 2019/49 of 4 January 2019 concerning the authorisation of sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine as feed additives for all animal species (Text with EEA relevance.)

14.1.2019   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 10/2
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2019/49
         of 4 January 2019
         concerning the authorisation of sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine as feed additives 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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
                  
               
                     (2)
                  
                  
                     Sodium selenite was authorised without a time limit as a feed additive for all animal species in accordance with Directive 70/524/EEC. This substance was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
                  
               
                     (3)
                  
                  
                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of sodium selenite as a feed additive for all animal species. In the framework of the re-evaluation an application was submitted also for a coated granulated form of sodium selenite.
                  
               
                     (4)
                  
                  
                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of zinc-L-selenomethionine as a feed additive for all animal species.
                  
               
                     (5)
                  
                  
                     The applicants requested that sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine be classified in the additive category ‘nutritional additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
                  
               
                     (6)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 20 October 2015 (3), 28 January 2016 (4), 8 March 2016 (5) and 20 February 2018 (6) that, under the proposed conditions of use, sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine do not have adverse effects on animal health, human health or the environment. With respect to the limitation of the supplementation with organic selenium established for other organic compounds of selenium, the Authority concluded that it should also apply to zinc-L-selenomethionine. Moreover, the Authority concluded that sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine may be considered as efficient sources 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 reports on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
                  
               
                     (7)
                  
                  
                     The assessment of sodium selenite, coated granulated sodium selenite and zinc-L-selenomethionine shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
                  
               
                     (8)
                  
                  
                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substance sodium selenite, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
                  
               
                     (9)
                  
                  
                     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
            Authorisation
            The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.
         
         
            Article 2
            Transitional measures
            
               1.   Sodium selenite and premixtures containing that substance, which are produced and labelled before 3 August 2019 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted.
            
            
               2.   Feed materials and compound feed containing sodium selenite which are produced and labelled before 3 February 2020 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
            
            
               3.   Feed materials and compound feed containing sodium selenite which are produced and labelled before 3 February 2021 in accordance with the rules applicable before 3 February 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
            
         
         
            Article 3
            Entry 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.
         
         
            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 4 January 2019.
            
               
                  For the Commission
               
               
                  The President
               
               Jean-Claude JUNCKER
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
         
            (3)  EFSA Journal 2015;13(11):4271.
         
            (4)  EFSA Journal 2016;14(2):4398.
         
            (5)  EFSA Journal 2016;14(3):4442.
         
            (6)  EFSA Journal 2018;16(3):5197.
      
      
         
            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
                        
                     
                  
                        3b801
                     
                     
                         
                     
                     
                        Sodium selenite
                     
                     
                        
                           Characterisation of the additive
                        
                        Sodium selenite, as a powder, with a minimum content of 45 % selenium
                        
                           Characterisation of the active substance
                        
                        Sodium selenite
                        Chemical formula: Na2SeO3
                        
                        CAS number 10102-18-8
                        Einecs number 233-267-9
                        
                           Analytical method
                            (1)
                        
                        For the characterisation of sodium selenite:
                        
                                    —
                                 
                                 
                                    Titrimetry — European Pharmacopoeia Monograph 01/2008:1677; and/or
                                 
                              
                                    —
                                 
                                 
                                    Gravimetry
                                 
                              For the quantification of total sodium in sodium selenite:
                        
                                    —
                                 
                                 
                                    Atomic Absorption Spectrometry (AAS) - EN ISO 6869:2000; or
                                 
                              
                                    —
                                 
                                 
                                    Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN:15510:2007
                                 
                              For the quantification of total selenium in premixtures feed materials and compound feed:
                        
                                    —
                                 
                                 
                                    Hydride Generation Atomic Absorption Spectrometry (HGAAS) after microwave digestion — EN 16159:2012
                                 
                              
                     
                        All species
                     
                     
                        —
                     
                     
                         
                     
                     
                        0,50 (total)
                     
                     
                        
                                    1.
                                 
                                 
                                    Sodium selenite may be placed on the market and used as an additive consisting of a preparation.
                                 
                              
                                    2.
                                 
                                 
                                    The additive shall be incorporated into feed in the form of a premixture.
                                 
                              
                                    3.
                                 
                                 
                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.
                                 
                              
                     
                        3 February 2029
                     
                  
                        3b802
                     
                     
                         
                     
                     
                        Coated granulated sodium selenite
                     
                     
                        
                           Characterisation of the additive
                        
                        Coated granulated preparation of Sodium selenite with
                        
                                    —
                                 
                                 
                                    a selenium content of 1 % - 4,5 % and
                                 
                              
                                    —
                                 
                                 
                                    coating agents and dispersants (polyoxyethylene (20) sorbitan monolaurate (E 432), glycerol polyethyleneglycol ricinoleate (E 484), polyethyleneglycol 300, sorbitol (E 420ii) or maltodextrin) up to 5 %
                                    and
                                 
                              
                                    —
                                 
                                 
                                    granulating agents (calcium magnesium carbonate, calcium carbonate, corn cobs) up to 100 % w/w.
                                 
                              Particles < 50 μm: below 5 %
                        
                           Characterisation of the active substance
                        
                        Sodium selenite
                        Chemical formula: Na2SeO3
                        
                        CAS number 10102-18-8
                        Einecs number 233-267-9
                        
                           Analytical method
                            (1)
                        
                        For the quantification of total selenium in the feed additive (film granulated preparation):
                        
                                    —
                                 
                                 
                                    Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES); or
                                 
                              
                                    —
                                 
                                 
                                    Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
                                 
                              For the quantification of total sodium in the feed additive (film granulated preparation):
                        
                                    —
                                 
                                 
                                    Atomic Absorption Spectrometry (AAS) - EN ISO 6869:2000; or
                                 
                              
                                    —
                                 
                                 
                                    Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) - EN:15510:2007
                                 
                              For the quantification of total selenium in premixtures, feed materials and compound feed:
                        
                                    —
                                 
                                 
                                    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 users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.
                                 
                              
                     
                        3 February 2029
                     
                  
                        3b818
                     
                     
                        —
                     
                     
                        Zinc-L-selenomethionine
                     
                     
                        
                           Characterisation of the additive
                        
                        Solid preparation of Zinc-L-selenomethionine with a selenium content of 1-2 g/kg
                        
                           Characterisation of the active substance
                        
                        Organic selenium in form of zinc L-selenomethionine
                        Chemical formula: C5H10ClNO2SeZn
                        Crystalline powder with
                        
                                     
                                 
                                 
                                    L-selenomethionine > 62 %,
                                 
                              
                                     
                                 
                                 
                                    selenium > 24,5 %,
                                 
                              
                                     
                                 
                                 
                                    zinc > 19 % and
                                 
                              
                                     
                                 
                                 
                                    chloride > 20 %
                                 
                              
                           Analytical method
                            (1)
                        
                        For the determination of selenomethionine in the feed additive:
                        
                                    —
                                 
                                 
                                    high performance liquid chromatography with fluorescence detection (HPLC-FLD)
                                 
                              For the determination of total selenium in the feed additive:
                        
                                    —
                                 
                                 
                                    inductively coupled plasma-atomic emission spectrometry (ICP-AES); or
                                 
                              
                                    —
                                 
                                 
                                    inductively coupled plasma-mass spectrometry (ICP-MS)
                                 
                              For the determination of total selenium in premixtures, feed materials and compound feed:
                        
                                    —
                                 
                                 
                                    hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion – EN 16159
                                 
                              For the quantification of total zinc in the feed additive:
                        
                                    —
                                 
                                 
                                    inductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN 15510; or
                                 
                              
                                    —
                                 
                                 
                                    inductively coupled plasma-atomic emission spectrometry after pressure digestion, (ICP-AES) – EN 15621
                                 
                              
                     
                        All species
                     
                     
                        —
                     
                     
                         
                     
                     
                        0,50 (total)
                     
                     
                        
                                    1.
                                 
                                 
                                    The additive shall be incorporated into feed in the form of a premixture.
                                 
                              
                                    2.
                                 
                                 
                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.
                                 
                              
                                    3.
                                 
                                 
                                    In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.
                                 
                              
                                    4.
                                 
                                 
                                    Maximum supplementation with organic selenium:
                                    0,20 mg Se/kg of complete feed with a moisture content of 12 %.
                                 
                              
                     
                        3 February 2029
                     
                  
               (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports