CELEX: 32016R2023
Language: en
Date: 2016-11-18 00:00:00
Title: Commission Implementing Regulation (EU) 2016/2023 of 18 November 2016 concerning the authorisation of sodium benzoate, potassium sorbate, formic acid and sodium formate as feed additives for all animal species (Text with EEA relevance )

19.11.2016   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 313/14
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2016/2023
   of 18 November 2016
   concerning the authorisation of sodium benzoate, potassium sorbate, formic acid and sodium formate as feed additives for all animal species
   (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. Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives.
            
         
               (2)
            
            
               In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, sodium benzoate was entered in the Register of Feed Additives as existing product belonging to the functional group of silage additives, for all animal species.
            
         
               (3)
            
            
               In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, application was submitted for the authorisation of sodium benzoate and in accordance with Article 7 of Regulation (EC) No 1831/2003 applications were submitted for the authorisations of potassium sorbate, formic acid and sodium formate. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
            
         
               (4)
            
            
               Those applications concern the authorisations of sodium benzoate, potassium sorbate, formic acid and sodium formate as feed additives for all animal species to be classified in the category ‘technological additives’.
            
         
               (5)
            
            
               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 June 2012 (2) that, under the proposed conditions of use, sodium benzoate does not have an adverse effect on animal health, human health or the environment; however it was considered as a potential sensitizer and a risk for inhalation cannot be excluded. The Authority also concluded that the additive has a potential to improve the production of silage by reducing the pH and increasing the preservation of dry matter in easy, moderate difficult and difficult to ensile material.
            
         
               (6)
            
            
               The Authority concluded in its opinion of 18 June 2013 (3) that, under the proposed conditions of use, potassium sorbate does not have an adverse effect on animal health, human health or the environment; however it was considered irritant for skin and eyes and potential irritant to respiratory tract. The Authority also concluded that the additive has a potential to improve the aerobic stability of silage in easy and moderate difficult to ensile material.
            
         
               (7)
            
            
               The Authority concluded in its opinion of 11 September 2014 (4) that, under the proposed conditions of use, formic acid does not have an adverse effect on animal health, human health or the environment; however it was considered corrosive for skin and eyes and respiratory tract. The Authority also concluded that the additive has a potential to improve the ensiling process and the quality of the silage in aerobic stability of silage in easy, in moderate difficult and difficult to ensile material.
            
         
               (8)
            
            
               The Authority concluded in its opinion of 11 March 2015 (5) that, under the proposed conditions of use, sodium formate does not have an adverse effect on animal health, human health or the environment; however the liquid form was considered corrosive for skin and eyes and to respiratory tract. The Authority also concluded that the additive has a potential to improve the preservation of nutrients by reducing the dry matter loss in easy, moderate and difficult to ensile material.
            
         
               (9)
            
            
               For sodium benzoate, potassium sorbate, formic acid and sodium formate, 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
            
         
               (10)
            
            
               The assessments of sodium benzoate, potassium sorbate, formic acid and sodium formate show that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those additives should be authorised as specified in the Annex to this Regulation.
            
         
               (11)
            
            
               Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of sodium benzoate, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
            
         
               (12)
            
            
               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
   Authorisation
   The additives 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
   Transitional measures
   The sodium benzoate specified in the Annex and feed containing it, which are produced and labelled before 9 June 2017 in accordance with the rules applicable before 9 December 2016 may continue to be placed on the market and used until the existing stocks are exhausted.
   Article 3
   Entry into force
   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, 18 November 2016.
      
         
            For the Commission
         
         
            The President
         
         Jean-Claude JUNCKER
      
   
   
      (1)  OJ L 268, 18.10.2003, p. 29.
   
      (2)  EFSA Journal 2012;10(7):2779.
   
      (3)  EFSA Journal 2013;11(7):3283.
   
      (4)  EFSA Journal 2014;1(10):3827.
   
      (5)  EFSA Journal 2015;13(5):4056.
   
      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
                  
               
            
                  1k301
               
               
                  —
               
               
                  Sodium benzoate
               
               
                  
                     Additive composition
                  
                  Sodium benzoate ≥ 99,5 %
                  Solid form
                  
                     Characterisation of the active substance
                  
                  Sodium benzoate ≥ 99,5 %
                  C7 H5 Na O2
                  
                  CAS no 532-32-1
                  Produced by chemical synthesis
                  
                     Analytical method
                      (1)
                  
                  For the determination of sodium benzoate: titrimetric method (01/2008:0123 of European Pharmacopoeia).
               
               
                  All animal species
               
               
                  —
               
               
                   
               
               
                  2 400 
               
               
                  
                              1.
                           
                           
                              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. 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, safety glasses and gloves.
                           
                        
                              2.
                           
                           
                              The mixture of different sources of sodium benzoate shall not exceed the permitted maximum contents.
                           
                        
               
                  9 December 2026
               
            
                  1k202
               
               
                  —
               
               
                  Potassium sorbate
               
               
                  
                     Additive composition
                  
                  Potassium sorbate ≥ 99 %
                  Solid form
                  
                     Characterisation of the active substance
                  
                  Potassium sorbate ≥ 99 %
                  C6 H7 KO2
                  
                  CAS no 24634-61-5
                  Produced by chemical synthesis
                  
                     Analytical method
                      (1)
                  
                  For the determination of potassium sorbate in feed additive: titration with perchloric acid (European Pharmacopoeia, monographs 6.0 method 01/2008:0618).
                  For the determination of potassium sorbate in premixture and feedingstuffs: ion exclusion High Performance Liquid Chromatography with UV detection (HPLC-UV).
               
               
                  All animal species
               
               
                   
               
               
                   
               
               
                  300
               
               
                  
                              1.
                           
                           
                              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. 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, safety glasses and gloves.
                           
                        
                              2.
                           
                           
                              The additive shall be used in easy and moderate difficult to ensile materials. (2)
                              
                           
                        
               
                  9 December 2026
               
            
                  1k236
               
               
                  —
               
               
                  Formic acid
               
               
                  
                     Additive composition
                  
                  Formic acid (≥ 84,5 %)
                  Liquid form
                  
                     Characterisation of the active substance
                  
                  Formic acid ≥ 84,5 %
                  H2CO2
                  
                  CAS no 64-18-6
                  
                     Analytical method
                      (1)
                  
                  For the determination of formic acid: ion chromatography method equipped with electrical conductivity detection (IC-ECD).
               
               
                  All animal species
               
               
                  —
               
               
                   
               
               
                  10 000 
               
               
                  
                              1.
                           
                           
                              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. 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, safety glasses and gloves
                           
                        
                              2.
                           
                           
                              The mixture of different sources of formic acid shall not exceed the permitted maximum content in complete feedingstuffs.
                           
                        
               
                  9 December 2026
               
            
                  1k237
               
               
                  —
               
               
                  Sodium formate
               
               
                  
                     Additive composition
                  
                  Solid form
                  Sodium formate ≥ 98 %
                  Liquid form
                  Sodium formate ≥ 15 %
                  Formic acid ≤ 75 %
                  Water ≤ 25 %
                  
                     Characterisation of the active substance
                  
                  Sodium formate ≥ 98 % (solid form)
                  NaHCO2
                  
                  CAS no 141-53-7
                  formaldehyde ≤ 6,2 mg/kg
                  acetaldehyde ≤ 5 mg/kg
                  butylaldehyde ≤ 25 mg/kg
                  Sodium formate ≥ 15 % (liquid form)
                  Formic acid ≤ 75 %
                  Produced by chemical synthesis
                  
                     Analytical method
                      (1)
                  
                  Determination of sodium in feed additives: EN ISO 6869: atomic absorption spectrometry (AAS) or EN 15510: inductively coupled plasma atomic emission spectrometry, (ICP-AES).
                  Determination of total formate in feed additives: EN 15909 reverse phase HPLC with UV detection (RP-HPLC-UV).
                  Determination of total formate in premixtures and feedingstuffs: Ion-exclusion high performance liquid chromatography with UV or with refractive index detection (HPLC-UV/RI) or Ion chromatography method equipped with electrical conductivity detection (IC-ECD).
               
               
                  All animal species
               
               
                  —
               
               
                   
               
               
                  10 000 
                  (formic acid equivalent)
               
               
                  
                              1.
                           
                           
                              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. 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, safety glasses and gloves.
                           
                        
                              2.
                           
                           
                              The mixture of different sources of formic acid shall not exceed the permitted maximum contents in complete feedingstuffs.
                           
                        
               
                  9 December 2026
               
            
         (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
      
         (2)  Easy to ensile forage: > 3 % soluble carbohydrates in fresh materials. Moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in fresh materials. Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).