CELEX: 32022R0270
Language: en
Date: 2022-02-23 00:00:00
Title: Commission Implementing Regulation (EU) 2022/270 of 23 February 2022 correcting Implementing Regulation (EU) 2021/1410 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds (holder of authorisation Huvepharma NV) (Text with EEA relevance)

24.2.2022   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 43/7
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2022/270
         of 23 February 2022
         correcting Implementing Regulation (EU) 2021/1410 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds (holder of authorisation Huvepharma NV)
         (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 a preparation of Bacillus licheniformis DSM 28710 as a feed additive was authorised for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds by Commission Implementing Regulation (EU) 2021/1410 (2) for a 10-year period.
                  
               
                     (2)
                  
                  
                     In the Annex to Implementing Regulation (EU) 2021/1410, an incorrect identification of the species, for which the additive is authorised, which excluded turkeys for breeding, was inserted in the column ‘Species or category of animal’.
                  
               
                     (3)
                  
                  
                     Implementing Regulation (EU) 2021/1410 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to that Implementing Regulation.
                  
               
                     (4)
                  
                  
                     In order to allow feed business operators to adapt the labelling of the additive and feed containing it to the corrected terms of 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) 2021/1410 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) 2021/1410 of 27 August 2021 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds (holder of authorisation Huvepharma NV) (OJ L 304, 30.8.2021, p. 8).
      
      
         
            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
                     
                  
                        CFU/kg of complete feedingstuff with a moisture content of 12 %
                     
                  
                        
                           Category: zootechnical additives. Functional group: gut flora stabilisers
                        
                     
                  
                        4b1828
                     
                     
                        Huvepharma NV
                     
                     
                        
                           Bacillus licheniformis DSM 28710
                     
                     
                        
                           Additive composition
                        
                        Preparation of Bacillus licheniformis DSM 28710
                        containing a minimum of:
                        3,2 × 109 CFU/g of additive
                        Solid form
                        
                           Characterisation of the active substance
                        
                        Viable spores of Bacillus licheniformis DSM 28710
                        
                           Analytical method
                            (1)
                        
                        For the enumeration of Bacillus licheniformis DSM 28710 in additive, premixture and feedingstuffs:
                        
                                    —
                                 
                                 
                                    Spread plate method EN 15784
                                 
                              For the identification of Bacillus licheniformis DSM 28710:
                        
                                    —
                                 
                                 
                                    Pulsed Field Gel Electrophoresis (PFGE)
                                 
                              
                     
                        Laying hens
                        Minor poultry species for laying
                        Poultry species for breeding
                        Ornamental birds
                     
                     
                        -
                     
                     
                        1,6 × 109
                        
                     
                     
                        -
                     
                     
                        
                                    1.
                                 
                                 
                                    In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
                                 
                              
                                    2.
                                 
                                 
                                    May be used in feed containing the following permitted coccidiostats: diclazuril and lasalocid A sodium.
                                 
                              
                                    3.
                                 
                                 
                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalation or eyes exposure cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including skin, eyes and breathing protection.
                                 
                              
                     
                        19.9.2031
                     
                  
               (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