CELEX: 32017R2325
Language: en
Date: 2017-12-14 00:00:00
Title: Commission Implementing Regulation (EU) 2017/2325 of 14 December 2017 concerning the authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species and amending Implementing Regulation (EU) 2017/1007 (Text with EEA relevance. )

15.12.2017   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 333/17
               
            COMMISSION IMPLEMENTING REGULATION (EU) 2017/2325
      of 14 December 2017
      concerning the authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species and amending Implementing Regulation (EU) 2017/1007
      (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)
               
               
                  Lecithins were authorised without a time limit in accordance with Directive 70/524/EEC as feed additive for all animal species. These additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
               
            
                  (3)
               
               
                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 an application was submitted for the re-evaluation of preparations of lecithins as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘technological additives’ and in the functional group ‘emulsifiers’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
               
            
                  (4)
               
               
                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 July 2016 (3) that, under the proposed conditions of use, the preparations of lecithins, lecithins hydrolysed and lecithins de-oiled do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations are considered efficacious for use in feed as emulsifiers. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
               
            
                  (5)
               
               
                  The assessment of lecithins liquid, lecithins hydrolysed and lecithins de-oiled shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex I to this Regulation.
               
            
                  (6)
               
               
                  It is considered appropriate to harmonise the characteristics of the lecithins, lecithins liquid, lecithins hydrolysed and lecithins de-oiled and the conditions of use to avoid the distortion of the market, Commission Implementing Regulation (EU) 2017/1007 (4) should be amended accordingly.
               
            
                  (7)
               
               
                  Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
               
            
                  (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 1
      Authorisation
      The additives specified in Annex I belonging to the additive category ‘technological additives’ and to the functional group ‘emulsifiers’, are authorised as additive in animal nutrition, subject to the conditions laid down in that Annex.
      Article 2
      Amendment to Implementing Regulation (EU) 2017/1007
      The Annex to Implementing Regulation (EU) 2017/1007 is replaced by the text in Annex II to this Regulation.
      Article 3
      Transitional measures
      1.   The additives specified in Annex I and premixtures containing those additives which are produced and labelled before 4 July 2018 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
      2.   Compound feed and feed materials containing the additives as specified in Annex I which are produced and labelled before 4 January 2019 in accordance with the rules applicable before 4 January 2018 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.   Compound feed and feed materials containing the additives as specified in Annex I which are produced and labelled before 4 January 2020 in accordance with the rules applicable before 4 January 2018 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 4
      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, 14 December 2017.
         
            
               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 2016;14(8):4561.
      
         (4)  Commission Implementing Regulation (EU) 2017/1007 of 15 June 2017 concerning the authorisation of a preparation of lecithins as feed additive for all animal species (OJ L 153, 16.6.2017, p. 13).
      
         ANNEX I
         
                     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
                  
               
                     mg of lecithins/kg of complete feedingstuff with a moisture content of 12 %
                  
               
                     
                        Category of technological additives. Functional group: emulsifiers
                     
                  
               
                     1c322i
                  
                  
                     —
                  
                  
                     lecithins liquid
                  
                  
                     
                        Additive composition
                     
                     Preparation of lecithins:
                     phospholipids ≥ 48 %,
                     Moisture ≤ 1 %
                     Liquid form
                     
                        Characterisation of the active substance
                     
                     Liquid lecithins (CAS No 8002-43-5) extracted from rapeseeds, sunflower and/or soybean
                     
                        Analytical method
                         (1)
                     
                     For the characterisation of feed additive:
                     Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph ‘Lecithin’ (3)
                         (4)
                     
                  
                  
                     All animal species
                  
                  
                     —
                  
                  
                     —
                  
                  
                     —
                  
                  
                      
                  
                  
                     4 January 2028
                  
               
                     1c322ii
                  
                  
                      
                  
                  
                     hydrolysed lecithins
                  
                  
                     
                        Additive composition
                     
                     preparation of hydrolysed lecithins:
                     phospholipids ≥ 44 %,
                     Moisture ≤ 1 %
                     Liquid form
                     
                        Characterisation of the active substance
                     
                     Liquid hydrolysed lecithins (CAS No 8002-43-5) extracted from sunflowers and/or soybeans
                     
                        Analytical method
                         (1)
                     
                     For the characterisation of feed additive:
                     Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph ‘Lecithin’ (3)
                         (4)
                     
                  
                  
                     All animal species
                  
                  
                      
                  
                  
                      
                  
                  
                      
                  
                  
                      
                  
                  
                     4 January 2028
                  
               
                     1c322iii
                  
                  
                     —
                  
                  
                     Lecithins de-oiled
                  
                  
                     
                        Additive composition
                     
                     Preparation of de-oiled lecithins having a minimum of: phospholipids ≥ 75 %,
                     Moisture ≤ 2 %
                     Solid form
                     
                        Characterisation of the active substance
                     
                     Solid de-oiled lecithins (CAS No 8002-43-5) extracted from sunflowers and/or soybeans and defatted by solvent extraction
                     
                        Analytical method
                         (1)
                     
                     For the characterisation of feed additive:
                     Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph ‘Lecithin’ (3)
                         (4)
                     
                  
                  
                     All animal species
                  
                  
                     —
                  
                  
                     —
                  
                  
                     —
                  
                  
                      
                  
                  
                     4 January 2028
                  
               
            (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
         
            (2)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).
         
            (3)  FAO JECFA Combined Compendium of Food Additive Specifications, ‘Lecithin’, Monograph No 4 (2007), http://www.fao.org/ag/agn/jecfa-additives/specs/monograph4/additive-250-m4.pdf
         
            (4)  FAO JECFA Combined Compendium for Food Additive Specifications — Analytical methods, test procedures and laboratory solutions used by and referenced in the food additive specifications, Vol. 4, http://www.fao.org/docrep/009/a0691e/a0691e00.htm
      
      
         ANNEX II
         ‘
               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
                        
                     
                           mg of lecithins/kg of complete feedingstuff with a moisture content of 12 %
                        
                     
                           
                              Category of technological additives. Functional group: emulsifiers
                           
                        
                     
                           1c322
                        
                        
                           —
                        
                        
                           Lecithins
                        
                        
                           
                              Additive composition
                           
                           Preparation of lecithins having a minimum of:
                           
                                       —
                                    
                                    
                                       phospholipids ≥ 18 %,
                                    
                                 
                                       —
                                    
                                    
                                       lysophospholipids ≥ 11 %,
                                    
                                 Moisture ≤ 1 %
                           
                              Characterisation of the active substance
                           
                           Lecithins (CAS No 8002-43-5) extracted from soybeans
                           
                              Analytical method
                               (1)
                           
                           For the characterisation of feed additive:
                           Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph “Lecithin” (3)
                               (4)
                           
                        
                        
                           All animal species
                        
                        
                           —
                        
                        
                           —
                        
                        
                           —
                        
                        
                           =
                        
                        
                           6 July 2027
                        
                     ’
         
            (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
         
            (2)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).
         
            (3)  FAO JECFA Combined Compendium of Food Additive Specifications, “Lecithin”, Monograph No 4 (2007), http://www.fao.org/ag/agn/jecfa-additives/specs/monograph4/additive-250-m4.pdf
         
            (4)  FAO JECFA Combined Compendium for Food Additive Specifications — Analytical methods, test procedures and laboratory solutions used by and referenced in the food additive specifications, Vol. 4, http://www.fao.org/docrep/009/a0691e/a0691e00.htm