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Commission Implementing Regulation (EU) 2020/197Show full title

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)

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ANNEX

a

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

Identification number of the additiveAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd 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
2a129Allura 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 a

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

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