CELEX: 32017R0066
Language: en
Date: 2016-12-14 00:00:00
Title: Commission Implementing Regulation (EU) 2017/66 of 14 December 2016 concerning the authorisation of tannic acid as a feed additive for all animal species (Text with EEA relevance. )

17.1.2017   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 13/259
               
            COMMISSION IMPLEMENTING REGULATION (EU) 2017/66
      of 14 December 2016
      concerning the authorisation of tannic acid as a feed additive 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 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).
               
            
                  (2)
               
               
                  Tannic acid was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
               
            
                  (3)
               
               
                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of tannic acid as a feed additive for all animal species. The applicant requested that additive to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
               
            
                  (4)
               
               
                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 September 2014 (3) that, under the proposed conditions of use in feed this substance does not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of tannic acid in feed is similar to that on food. The Authority has already concluded that for food tannic acid is efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed.
               
            
                  (5)
               
               
                  Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.
               
            
                  (6)
               
               
                  The Authority concluded that in the absence of data on user safety tannic acid should be considered as potentially hazardous to the respiratory tract, skin, eyes and mucous membranes. Consequently, appropriate protective measures should be taken. 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.
               
            
                  (7)
               
               
                  The assessment of the substance 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 tannic acid should be authorised as specified in the Annex to this Regulation.
               
            
                  (8)
               
               
                  Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for tannic acid, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
               
            
                  (9)
               
               
                  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 substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.
      Article 2
      Transitional measures
      1.   The substance specified in the Annex and premixtures containing those substances, which are produced and labelled before 6 August 2017 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
      2.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 6 February 2018 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
      3.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 6 February 2019 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
      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, 14 December 2016.
         
            
               For the Commission
            
            
               The President
            
            Jean-Claude JUNCKER
         
      
      
         (1)  OJ L 268, 18.10.2003, p. 29.
      
         (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
      
         (3)  EFSA Journal 2014;12(10):3828.
      
         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 active substance/kg of complete feedingstuff with a moisture content of 12 %
                  
               
                     
                        Category: Sensory additives. Functional group: Flavouring compounds
                     
                  
               
                     2b16080
                  
                  
                     —
                  
                  
                     Tannic acid
                  
                  
                     
                        Additive composition
                     
                     Tannic acid
                     
                        Characterisation of the active substance
                     
                     Tannic acid
                     Produced by extraction from different plants.
                     Purity: min. 93 % on dry matter basis
                     Chemical formula: C76H52O46
                     
                     CAS number 72401-53-7
                     FLAVIS No: 16.080
                     
                        Method of analysis
                         (1)
                     
                     For the determination of tannic acid, in the feed additive:
                     Qualitative colorimetric or precipitation tests (Ph. Eur. 6th edition, monograph 1477) and quantitative gravimetric method (FAO JECFA tannic acid monograph).
                     For the identification of tannic acid (as gallic acid) in the premixture of flavourings:
                     Reversed Phase High Performance Liquid Chromatography coupled to UV detector(RP-HPLC-UV).
                  
                  
                     All animal species
                  
                  
                     —
                  
                  
                     —
                  
                  
                     —
                  
                  
                     
                                 1.
                              
                              
                                 The additive shall be incorporated into the feed in the form of a premixture.
                              
                           
                                 2.
                              
                              
                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
                              
                           
                                 3.
                              
                              
                                 The recommended maximum content of the active substance shall be: 15 mg/kg of complete feedingstuff with a moisture content of 12 %.
                              
                           
                                 4.
                              
                              
                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:15 mg/kg’.
                              
                           
                                 5.
                              
                              
                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 15 mg/kg.
                              
                           
                                 6.
                              
                              
                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. 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 safety glasses and gloves.
                              
                           
                  
                     6 February 2027
                  
               
            (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