Commission Implementing Regulation (EU) 2020/173 of 6 February 2020 concerning the authorisation of brilliant blue FCF as a feed additive for cats and dogs (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/173
• Articles: 4

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 27 August 2020 in accordance with the rules applicable before 27 February 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 27 February 2022 in accordance with the rules applicable before 27 February 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 .

Schedules & Appendices

ANNEX

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

2a133

Brilliant Blue FCF

Additive composition:

Brilliant Blue FCF described as the sodium salt as the principal component.

Solid form (powder)

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Characterisation of the active substance as the sodium salt:

Disodium α-(4-(N-ethyl-3-sulphonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulphonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2- sulphonate

The calcium and the potassium salts are also permitted.

Chemical formula: C 37 H 34 N 2 Na 2 O 9 S 3

Solid form (powder) produced by chemical synthesis

CAS number: 3844-45-9

Purity criteria

Content not less than 85 % total colouring matters, calculated as the sodium salt (assay)

Water insoluble matter: ≤ 0,2 %

Subsidiary colouring matters: ≤ 6 %

Organic compounds other than

colouring matters:

—

Sum of 2-, 3- and 4-formyl benzene sulfonic acids: ≤ 1,5 %

—

3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid: ≤ 0,3 %

Leuco base: ≤ 5 %

Unsulfonated primary aromatic amines: ≤ 0,01 % (calculated as aniline)

Ether extractable matter: ≤ 0,2 % from a solution of pH 7

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Analytical method

( 1 )

For the quantification of total colouring matters content of brilliant blue FCF in the feed additive:

Spectrophotometry at 630 nm and titration with Titanous chloride as described in:

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Commission Regulation (EU) No 231/2012 referring to FAO JECFA Combined Compendium for Food Additive Specifications (Analytical methods Vol. 4); and the Monograph No 1 (2006) ‘Brilliant Blue FCF’.

For the quantification of brilliant blue in feedingstuffs:

—

high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)

Cats

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278

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 eye, skin and breathing protection.

27 February 2030

Dogs

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334

( 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