CELEX: 32014R0305
Language: en
Date: 2014-03-25 00:00:00
Title: Commission Implementing Regulation (EU) No 305/2014 of 25 March 2014 concerning the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for all animal species other than ruminants, pigs and poultry  Text with EEA relevance

26.3.2014   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 90/12
            
         
      COMMISSION IMPLEMENTING REGULATION (EU) No 305/2014
   of 25 March 2014
   concerning the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for all animal species other than ruminants, pigs and poultry
   (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 propionic acid, sodium propionate and ammonium propionate. 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 propionic acid, sodium propionate and ammonium propionate as feed additives for all animal species to be classified in the additive category ‘technological additives’, functional group ‘silage additives’. The application includes also other uses of the same substances for which no decision has yet been taken. The additive was authorised for 10 years by Commission Implementing Regulation (EU) No 1222/2013 (2) for ruminants, pigs and poultry.
            
         
               (4)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 16 November 2011 (3) that, under the proposed conditions of use, propionic acid, sodium propionate and ammonium propionate do not have an adverse effect on animal health, human health or the environment. It was also concluded that the substances improve the aerobic stability of easy to ensile materials. 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 the substances concerned 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 substances 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 the Food Chain and Animal Health,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   The substances specified in the Annex belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives 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, 25 March 2014.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
         
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  Commission Implementing Regulation (EU) No 1222/2013 of 29 November 2013 concerning the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for ruminants, pigs and poultry (OJ L 320, 30.11.2013, p. 16).
   
      (3)  EFSA Journal 2011; 9(12):2446.
   
      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/kg of complete feedingstuff with a moisture content of 12 %
               
            
                  
                     Category of technological additives. Functional group: silage additives
                  
               
            
                  1k280
               
               
                  —
               
               
                  Propionic acid
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Propionic acid ≥ 99,5 %
                           
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              Propionic acid ≥ 99,5 %
                              C3H6O2 CAS No: 79-09-4
                              Non-volatile residue ≤ 0,01 % when dried at 140 °C to constant weight
                              Aldehydes ≤ 0,1 % expressed as formaldehyde
                              Produced by chemical synthesis
                           
                        
                               
                           
                           
                              
                                 Method of Analysis
                                  (1)
                              
                              Quantification of propionic acid as total propionic acid in feed additive, premixtures, feedingstuffs: ion exclusion High Performance Liquid Chromatography with refractive index (HPLC-RI)
                           
                        
               
                  All animal species other than ruminants, pigs and poultry
               
               
                  —
               
               
                  —
               
               
                  —
               
               
                  
                              1.
                           
                           
                              The simultaneous use of other organic acids at the maximum permitted doses is contraindicated.
                           
                        
                              2.
                           
                           
                              The additive shall be used in easy to ensile material (2).
                           
                        
                              3.
                           
                           
                              Simultaneous use with other sources of the active substance shall not exceed the authorised maximum content.
                           
                        
                              4.
                           
                           
                              For safety: breathing protection, eye protection, gloves and protective clothing shall be used during handling.
                           
                        
               
                  15 April 2024
               
            
                  1k281
               
               
                  —
               
               
                  Sodium propionate
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Sodium propionate ≥ 98,5 %
                           
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              Sodium propronate ≥ 98,5 %
                              C3H5O2Na
                              CAS No: 137-40-6
                              Loss on drying ≤ 4 % determined by drying for two hours at 105 °C
                              Water insoluble ≤ 0,1 %
                              Produced by chemical synthesis
                           
                        
                               
                           
                           
                              
                                 Method of Analysis
                                  (1)
                              
                              Quantification of sodium propionate in feed additive:
                              
                                          (1)
                                       
                                       
                                          ion exclusion High Performance Liquid Chromatography with refractive index detection (HPLC-RI) — for the determination of total propionate; and
                                       
                                    
                                          (2)
                                       
                                       
                                          atomic absorption spectrometry, AAS (EN ISO 6869) — for the determination of total sodium.
                                       
                                    Quantification of sodium propionate as total propionic acid in premixtures, feedingstuffs: ion exclusion High Performance Liquid Chromatography with refractive index (HPLC-RI)
                           
                        
               
                  All animal species other than ruminants, pigs and poultry
               
               
                  —
               
               
                  —
               
               
                  —
               
               
                  
                              1.
                           
                           
                              The simultaneous use of other organic acids at the maximum permitted doses is contraindicated.
                           
                        
                              2.
                           
                           
                              The additive shall be used in easy to ensile materials (2).
                           
                        
                              3.
                           
                           
                              Simultaneous use with other sources of the active substance shall not exceed the authorised maximum content.
                           
                        
                              4.
                           
                           
                              For safety: breathing protection, eye protection, gloves and protective clothing shall be used during handling.
                           
                        
               
                  15 April 2024
               
            
                  1k284
               
               
                  —
               
               
                  Ammonium propionate
               
               
                  
                               
                           
                           
                              
                                 Additive composition
                              
                              Preparation of ammonium propionate ≥ 19,0 %, propionic acid ≤ 80,0 % and water ≤ 30 %
                           
                        
                               
                           
                           
                              
                                 Characterisation of the active substance
                              
                              Ammonium propionate: C3H9O2N
                              CAS No.: 17496-08-1
                              Produced by chemical synthesis
                           
                        
                               
                           
                           
                              
                                 Method of Analysis
                                  (2)
                              
                              Quantification of the ammonium propionate in feed additive:
                              
                                          (1)
                                       
                                       
                                          ion exclusion High Performance Liquid Chromatography with refractive index detection (HPLC-RI) — for the determination of total propionate; and
                                       
                                    
                                          (2)
                                       
                                       
                                          titration with sulphuric acid and sodium hydroxide for the determination of ammonia.
                                       
                                    Quantification of ammonium propionate as total propionic acid in premixtures, feedingstuffs: ion exclusion High Performance Liquid Chromatography with refractive index (HPLC-RI)
                           
                        
               
                  All animal species other than ruminants, pigs and poultry
               
               
                  —
               
               
                  —
               
               
                  —
               
               
                  
                              1.
                           
                           
                              The simultaneous use of other organic acids at the maximum permitted doses is contraindicated.
                           
                        
                              2.
                           
                           
                              The additive shall be used in easy to ensile materials (2).
                           
                        
                              3.
                           
                           
                              Simultaneous use with other sources of the active substance shall not exceed the authorised maximum content.
                           
                        
                              4.
                           
                           
                              For safety: breathing protection, eye protection, gloves and protective clothing shall be used during handling.
                           
                        
               
                  15 April 2024
               
            
         (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
      
         (2)  Easy to ensile forage: > 3 % soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp). Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).