CELEX: 32020R1370
Language: en
Date: 2020-10-01 00:00:00
Title: Commission Implementing Regulation (EU) 2020/1370 of 1 October 2020 concerning the authorisation of a preparation of lanthanide citrate as a feed additive for weaned piglets (holder of authorisation Treibacher Industrie AG) (Text with EEA relevance)

2.10.2020   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 319/5
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1370
         of 1 October 2020
         concerning the authorisation of a preparation of lanthanide citrate as a feed additive for weaned piglets (holder of authorisation Treibacher Industrie AG)
         (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 lanthanide citrate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
                  
               
                     (3)
                  
                  
                     The application concerns the authorisation of the preparation of lanthanide citrate as a feed additive for weaned piglets to be classified in the additive category ‘zootechnical additives’.
                  
               
                     (4)
                  
                  
                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 16 April 2013 (2), 20 April 2016 (3) and 12 November 2019 (4) that, under the proposed conditions of use, the preparation of lanthanide citrate does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that although the acute respiratory toxicity data indicate that the dust is of low toxicity, prolonged or repeated exposure to the additive should be avoided. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive has the potential to be efficacious in improving the growth of weaned piglets. The Authority did 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 lanthanide citrate 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 ‘other zootechnical additives’, 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, 1 October 2020.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 268, 18.10.2003, p. 29.
         
            (2)  EFSA Journal 2013; 11(5):3206.
         
            (3)  EFSA Journal 2016; 14(5):4477.
         
            (4)  EFSA Journal 2019; 17(12):5912.
      
      
         
            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 additive/kg of complete feedingstuff with a moisture content of 12 %
                        
                     
                  
                        
                           Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters).
                        
                     
                  
                        4d21
                     
                     
                        Treibacher Industrie AG
                     
                     
                        Lanthanide citrate
                     
                     
                        
                           
                              Additive composition
                           
                        
                        Preparation of lanthanide citrate containing:
                        Lanthanide citrate ≥ 65 %
                        Sodium 8-12 %
                        Chloride 8-12 %
                        Water < 10 %
                        Solid form
                     
                     
                        Weaned piglets
                     
                     
                        -
                     
                     
                        250
                     
                     
                        250
                     
                     
                        
                                    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 skin, eyes and breathing protection.
                                 
                              
                     
                        
                           22.10.2030
                        
                     
                  
                        
                           
                              Characterisation of active substance
                           
                        
                        Lanthanide citrate
                        Lanthanum 8,5 ± 0,9 %
                        Chemical formula C6H5LaO7
                        
                        CAS-Number: 3002-52-6
                        Cerium 16,3 ± 1,6 %,
                        Chemical formula: C6H5CeO7
                        
                        CAS-Number: 512-24-3
                        Citrate 40 ± 5 %.
                        Chemical formula: C6H5O7
                        
                        CAS number: 126-44-3
                     
                     
                        -
                     
                  
                        
                           
                              Analytical method
                           
                            (1)
                        
                        For the quantification of citrate salts: Titration – European Pharmacopeia Monographs 0400 and 0412
                        For the quantification of total lanthanum and total cerium: Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)
                     
                  
               (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