Commission Implementing Regulation (EU) 2020/157 of 5 February 2020 concerning the authorisation of tartrazine as a feed additive for dogs, cats, ornamental fish, grain-eating ornamental birds and small rodents (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/157
• 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 26 August 2020 in accordance with the rules applicable before 26 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 26 February 2022 in accordance with the rules applicable before 26 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

2a102

Tartrazine

Additive composition

Tartrazine is described as the sodium salt as the principal component

Solid form

Characterisation of the active substance as the sodium salt

Tartrazine consists essentially of trisodium 5- hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole- 3-carboxylate 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

Chemical formula: C 16 H 9 N 4 Na 3 O 9 S 2

Solid form produced by chemical synthesis

CAS number 1934-21-0

Purity criteria:

Colouring matter calculated as the sodium salt: ≥ 85 % (assay)

Subsidiary colouring matter: ≤ 1 %

Organic compounds other than colouring matters ≤ 0,5 %:

—

4-hydrazinobenzene sulfonic acid,

—

4-aminobenzene-1-sulfonic acid,

—

5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid,

—

4,4′-diazoaminodi(benzene sulfonic acid),

—

Tetrahydroxysuccinic acid

Unsulfonated primary aromatic amines: ≤ 0,01 %

Ether extractable matter ≤ 0,2 % under neutral conditions

Analytical method

( 1 )

For the quantification of total colouring matters content of tartrazine in the feed additive:

—

Spectrophotometry at 426 nm (FAO JECFA monographs No 1, Vol. 4 and Commission Regulation (EU) No 231/2012).

For the quantification of tartrazine in feedingstuffs:

—

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

Cats

-

-

433

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.

26.2.2030

Dogs

-

-

520

Small rodents

-

-

2 000

Grain-eating ornamental birds

-

-

63

Category: Sensory additives. Functional group: Colourants. (iii) substances which favourably affect the colour of ornamental fish or birds

2a102

Tartrazine

Additive composition

Tartrazine described as the sodium salt as the principal component.

Solid form

Characterisation of the active substance as the sodium salt

Tartrazine consists essentially of trisodium 5- hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole- 3-carboxylate 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.

Chemical formula: C 16 H 9 N 4 Na 3 O 9 S 2

Solid form produced by chemical synthesis

CAS number 1934-21-0

Purity criteria:

Colouring matter calculated as the sodium salt: ≥ 85 % (assay)

Subsidiary colouring matter: < 1 %

Organic compounds other than colouring matters ≤ 0,5 %:

—

4-hydrazinobenzene sulfonic acid,

—

4-aminobenzene-1-sulfonic acid,

—

5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid,

—

4,4′-diazoaminodi(benzene sulfonic acid),

—

Tetrahydroxysuccinic acid

Unsulfonated primary aromatic amines: ≤ 0,01 %

Ether extractable matter ≤ 0,2 % under neutral conditions

Analytical method

( 1 )

For the quantification of total colouring matters content of tartrazine in the feed additive:

—

Spectrophotometry at 426 nm (FAO JECFA monographs No 1, Vol. 4 and Commission Regulation (EU) No 231/2012).

For the quantification of tartrazine in feedingstuffs:

—

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

Ornamental fish

-

-

1 924

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.

26.2.2030

( 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