Commission Implementing Regulation (EU) No 1078/2013 of 31 October 2013 concerning the authorisation of fumaric acid as a feed additive for all animal species Text with EEA relevance
Commission Implementing Regulation (EU) No 1078/2013of 31 October 2013concerning the authorisation of fumaric 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 nutritionOJ L 268, 18.10.2003, p. 29., 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/EECCouncil Directive 70/524/EEC of the Council of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1)..(2)Fumaric acid was authorised in accordance with Directive 70/524/EEC as a feed additive, without a time limit, for use on all animal species by Commission Directive 80/678/EECThirty-third Commission Directive 80/678/EEC of 4 July 1980 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (OJ L 185, 18.7.1980, p. 48).. That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.(3)In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of fumaric acid, as a feed additive for all animal species, requesting that additive to be classified in the additive category "technological 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 29 January 2013EFSA Journal 2013; 11(2):3102. that, under the proposed conditions of use, fumaric acid does not have an adverse effect on animal health, human health or the environment and it has the potential to preserve feed. 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 additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.(5)The assessment of fumaric acid shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of fumaric acid should be authorised as specified in the Annex to this Regulation.(6)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.(7)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 1The feed additive specified in the Annex, belonging to the additive category "technological additives" and to the functional group "preservatives", is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2The feed additive specified in the Annex and feed containing that additive, which are produced and labelled before 21 May 2014 in accordance with the rules applicable before 21 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 3This 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, 31 October 2013.For the CommissionThe PresidentJosé Manuel BarrosoANNEX
Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/crl-feed-additivesmg of fumaric acid per kg of milk replacer.Category of technological additives. Functional group: preservatives
Identification number of the additiveAdditiveChemical formula, description, methods of analysisSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
1a297Fumaric acidAdditive compositionFumaric acid 99,5 %Solid formCharacterisation of active substanceFumaric acidC4H4O4CAS no 110-17-8Analytical methodFor the determination of fumaric acid in feed additive: infrared absorption spectrophotometry and titration with sodium hydroxide (Food Chemical Codex 7).For the determination of fumaric acid (as total fumaric acid) in feed premixture and feedingstuffs: ion exclusion High Performance Liquid Chromatography with UV detection (HPLC-UV).Poultry and pigs——20000For safety: breathing protection, glasses and gloves shall be used during handling21 November 2023
Young animals fed with milk replacers——10000
Other animal species———