COMMISSION IMPLEMENTING REGULATION (EU) 2020/197

14.2.2020 | EN | Official Journal of the European Union | L 42/4 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) 2020/197 of 13 February 2020 concerning the authorisation of allura red AC as a feed additive for cats and dogs (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(2) of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2): ---|--- (2) | Allura red AC was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for dogs and cats belonging to the group ‘colourants, including pigments’ under the heading ‘colouring agents authorised for colouring foodstuffs by Community rules’. The 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 thereof, an application was submitted for the re-evaluation of allura red AC as a feed additive for dogs and cats. The applicant requested the additive to be classified in the additive category ‘sensory additive’ and in the functional group ‘colourants’. The 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 opinions of 24 April 2012 (3), 15 May 2013 (4) and 20 October 2015 (5) that, under the proposed conditions of use, allura red AC does not have an adverse effect on animal health or the environment. It also concluded that the substance should be considered potentially harmful for the user of the additive as a result of skin, eye, or inhalation exposure. 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. In accordance with Commission Regulation (EC) No 429/2008 (6), phase I of the environmental risk assessment has determined that allura red AC, as an additive intended for non-food producing animals, is exempted from further assessment due to the unlikelihood of a significant environmental effect, there being no scientifically-based evidence for concern having been identified by the Authority in its above-mentioned opinions. The Authority further concluded that the additive concerned is effective in adding colour to feedingstuffs. 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 allura red AC 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 additive 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 of the substance concerned, 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 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 ‘colourants’, is authorised as an 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 that substance, which are produced and labelled before 5 September 2020 in accordance with the rules applicable before 5 March 2020 may continue to be placed on the market and used until the existing stocks are exhausted. 2\. Feed materials and compound feed containing the substance specified in the Annex which are produced and labelled before 5 March 2022 in accordance with the rules applicable before 5 March 2020 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, 13 February 2020. For the Commission The President Ursula VON DER LEYEN * * * (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 2012; 10(5):2675. (4) EFSA Journal 2013;11(6):3234. (5) EFSA Journal 2015; 13(11):4270. (6) Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1). * * * ANNEX Identification number of the additive | 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 of kg of complete feedingstuff with a moisture content of 12 % Category: Sensory additives. Functional group: Colourants. (i) substances that add or restore colour in feedingstuffs 2a129 | Allura Red AC | Additive composition Allura Red AC described as the sodium salt as the principal component. Solid form (powder or granules) Characterisation of the active substance as the sodium salt Allura Red AC consists essentially of disodium 2-hydroxy-1-(2- methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. The calcium and the potassium salts are also permitted Solid form (powder or granules) produced by chemical synthesis Chemical formula: C18H14N2Na2O8S2 CAS number: 25956-17-6 Purity criteria Content not less than 85 % total colouring matters, calculated as the sodium salt (assay) Water insoluble matter: ≤ 0,2 % Subsidiary colouring matters: ≤ 3 % Organic compounds other than colouring matters: | — | 6-hydroxy-2-naphthalene sulfonic acid, sodium salt: ≤ 0,3 % ---|--- — | 4-amino-5-methoxy-2- methylbenezene sulfonic acid: ≤ 0,2 % ---|--- — | 6,6-oxybis (2-naphthalene sulfonic acid) disodium salt: ≤ 1 % ---|--- Unsulfonated primary aromatic amines: ≤ 0,01 % (calculated as aniline) Ether extractable matter: ≤ 0,2 % from a solution of pH 7 Analytical method (1) For the quantification of Allura Red AC in the feed additive: — | spectrophotometry at 504 nm (Commission Regulation (EU) No 231/2012 referring to FAO JECFA monographs n. 1 (Vol. 4)) ---|--- — | For the quantification of Allura Red AC in feedingstuffs: ---|--- — | high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) ---|--- Cats | - | - | 308 | | 1. | In the directions for use of the additive and premixture, 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 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. ---|--- 5.3.2030 Dogs | - | - | 370 * * * (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 * * *