CELEX: 32022R0271
Language: en
Date: 2022-02-23 00:00:00
Title: Commission Implementing Regulation (EU) 2022/271 of 23 February 2022 correcting Implementing Regulation (EU) 2020/1760 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)

24.2.2022   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 43/10
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2022/271
         of 23 February 2022
         correcting Implementing Regulation (EU) 2020/1760 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S)
         (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)
                  
                  
                     The use of Bacillus subtilis DSM 25841 as a feed additive was authorised for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets by Commission Implementing Regulation (EU) 2020/1760 (2) for a 10-year period.
                  
               
                     (2)
                  
                  
                     In the Annex to Implementing Regulation (EU) 2020/1760, a wrong identification number was inserted in the column ‘Identification number of the additive’.
                  
               
                     (3)
                  
                  
                     Implementing Regulation (EU) 2020/1760 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to that Implementing Regulation by the corrected version thereof.
                  
               
                     (4)
                  
                  
                     In order to allow feed business operators to adapt the labelling of the additive and feed containing it to the corrected terms of the authorisation, a transitional period should be provided for as regards the placing on the market of those products.
                  
               
                     (5)
                  
                  
                     In order to preserve the legitimate expectations of the interested parties in relation to the terms of the authorisation of the additive, this Regulation should enter into force as a matter of urgency.
                  
               
                     (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 Annex to Implementing Regulation (EU) 2020/1760 is replaced by the Annex to this Regulation.
         
         
            Article 2
            
               1.   The preparation specified in the Annex and premixtures containing that substance, which are produced and labelled before 25 August 2022 in accordance with the rules applicable before 25 February 2022 may continue to be placed on the market until the existing stocks are exhausted.
            
            
               2.   Feed materials and compound feed containing the preparation and premixtures referred to in paragraph 1 which are produced and labelled before 25 February 2023 in accordance with the rules applicable before 25 February 2022 may continue to be placed on the market until the existing stocks are exhausted.
            
         
         
            Article 3
            This Regulation shall enter into force on the 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 February 2022.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  Commission Implementing Regulation (EU) 2020/1760 of 25 November 2020 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S) (OJ L 397, 26.11.2020, p. 6).
      
      
         
            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
                     
                     
                        Minimum content
                     
                     
                        Maximum content
                     
                     
                        Other provisions
                     
                     
                        End of period of authorisation
                     
                  
                        CFU/kg of complete feedingstuff with a moisture content of 12 %
                     
                     
                        CFU/l of water for drinking
                     
                  
                        
                           Category of zootechnical additives. Functional group: gut flora stabilisers
                        
                     
                  
                        4b1902
                     
                     
                        Chr. Hansen A/S
                     
                     
                        
                           Bacillus subtilis
                        
                        DSM 25841
                     
                     
                        
                           Additive composition
                        
                        Preparation of Bacillus subtilis DSM 25841 containing a minimum of 1,25 × 1010 CFU/g of additive
                        Solid form
                        
                           Characterisation of the active substance
                        
                        Viable spores of Bacillus subtilis DSM 25841
                        
                           Analytical method
                            (1)
                        
                        For identification of Bacillus subtilis DSM 25841: Identification: Pulsed Field Gel Electrophoresis (PFGE)
                        For enumeration of Bacillus subtilis DSM 25841 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar – EN 15784
                     
                     
                        All porcine species, including sows,
                        other than lactating sows in order to have a benefit in suckling piglets
                     
                     
                        -
                     
                     
                        5 × 108
                        
                     
                     
                        -
                     
                     
                        1,7 × 108
                        
                     
                     
                        -
                     
                     
                        
                                    1.
                                 
                                 
                                    In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
                                 
                              
                                    2.
                                 
                                 
                                    The additive may be used in water for drinking.
                                 
                              
                                    3.
                                 
                                 
                                    For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.
                                 
                              
                                    4.
                                 
                                 
                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use: a potential respiratory sensitiser, potential skin irritant and potential eyes or dermal sensitiser. 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.
                                 
                              
                     
                        16.12.2030
                     
                  
               (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