Commission Implementing Regulation (EU) 2020/228 of 19 February 2020 concerning the authorisation of erythrosine as a feed additive for dogs and cats (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/228
• 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 11 September 2020 in accordance with the rules applicable before 11 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 11 March 2022 in accordance with the rules applicable before 11 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 .

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

2a127

Erythrosine

Additive composition:

Erythrosine described as the sodium salt as the principal component.

Solid form

Dogs

Cats

-

-

-

-

16

13

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.

11.3.2030

Characterisation of the active substance as the sodium salt:

Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3- oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulphate as the principal uncoloured components.

The calcium and the potassium salts are also permitted.

Chemical formula: C 20 H 6 I 4 Na 2 O 5 ·H 2 O

CAS number: 16423-68-0

Solid form produced by chemical synthesis.

Purity criteria

—

Total colouring matters, calculated as the anhydrous sodium salt ≥ 87 % (assay)

—

Inorganic iodides ≤ 0,1 % (calculated as sodium iodide)

—

Water insoluble matter ≤ 0,2 %

—

Subsidiary colouring matters (except fluorescein) ≤ 4,0 %

—

Fluorescein ≤ 20 mg/kg

—

Organic compounds other than colouring matters:

—

Tri-iodoresorcinol ≤ 0,2 %

—

2-(2,4-dihydroxy-3,5-diiodobenzoyl) benzoic acid ≤ 0,2 %

—

Ether extractable matter from a solution of pH from 7 through 8 ≤ 0,2 %

Analytical method

( 1 )

For the quantification of erythrosine in the feed additive:

—

spectrophotometry at 526 nm (Commission Regulation (EU) No 231/2012 refers to FAO JECFA monographs n. 1 (Vol. 4))

For the quantification of erythrosine in feedingstuffs:

—

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

( 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