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)

Authorisation

Article 1

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.

Transitional measures

Article 2

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.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEXSupplementary provisions

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: C 18 H 14 N 2 Na 2 O 8 S 2 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