CELEX: 32018R0338
Language: en
Date: 2018-03-07 00:00:00
Title: Commission Implementing Regulation (EU) 2018/338 of 7 March 2018 concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets (holder of the authorisation BASF SE) (Text with EEA relevance. )

8.3.2018   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 65/17
               
            COMMISSION IMPLEMENTING REGULATION (EU) 2018/338
      of 7 March 2018
      concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets (holder of the authorisation BASF SE)
      (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 a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770). 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 the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) as a feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all avian species for fattening or growing or reared for laying and weaned piglets to be classified in the additive category ‘zootechnical additives’.
               
            
                  (4)
               
               
                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 September 2017 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) does not have an adverse effect on animal health, human health or the environment, and that it improves the zootechnical performance and/or phosphorus utilisation in the target 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 the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) 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 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 ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, 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, 7 March 2018.
         
            
               For the Commission
            
            
               The President
            
            Jean-Claude JUNCKER
         
      
      
         (1)  OJ L 268, 18.10.2003, p. 29.
      
         (2)  EFSA Journal 2017; 15(11)5024.
      
         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
                  
               
                     Units of activity/kg of complete feedingstuff with a moisture content of 12 %
                  
               
                     
                        Category of zootechnical additives. Functional group: digestibility enhancers
                     
                  
               
                     4a27
                  
                  
                     BASF SE
                  
                  
                     6-phytase
                     EC 3.1.3.26
                  
                  
                     
                        Additive composition:
                     
                     Preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) with a minimum content of:
                     Solid form: 5 000  FTU (1)/g
                     Liquid form: 5 000  FTU/g
                     
                        Characterisation of the active substance:
                     
                     6-phytase produced by Aspergillus. niger (DSM 25770)
                     
                        Analytical method
                         (2):
                     For the quantification of phytase activity in the feed additive:
                     
                                 —
                              
                              
                                 colorimetric method based on the enzymatic reaction of phytase on the phytate
                              
                           For the quantification of phytase activity in premixtures:
                     
                                 —
                              
                              
                                 colorimetric method based on the enzymatic reaction of phytase on the phytate — VDLUFA 27.1.3
                              
                           For the quantification of phytase activity in feedingstuffs:
                     
                                 —
                              
                              
                                 colorimetric method based on the enzymatic reaction of phytase on the phytate — EN ISO 30024
                              
                           
                  
                     Pigs for fattening
                     Sows
                     Minor porcine species for fattening or for reproduction
                  
                  
                     —
                  
                  
                     100 FTU
                  
                  
                      
                  
                  
                     
                                 1.
                              
                              
                                 In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
                              
                           
                                 2.
                              
                              
                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.
                              
                           
                                 3.
                              
                              
                                 For use in weaned piglets up to 35 kg.
                              
                           
                  
                     28.3.2028
                  
               
                     Weaned piglets
                  
                  
                     125 FTU
                  
               
                     Chickens for fattening
                     Chickens reared for laying
                  
                  
                     750 FTU
                  
               
                     Turkeys for fattening
                     Turkeys reared for breeding
                     All other avian species (excluding laying birds)
                  
                  
                     125 FTU
                  
               
            (1)  1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °C
         
            (2)  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