Commission Implementing Regulation (EU) 2024/750 of 29 February 2024 concerning the renewal of the authorisation of thaumatin as a feed additive for all animal species and repealing Implementing Regulation (EU) No 869/2012

• CELEX: Implementing Regulation (EU) 2024/750
• Articles: 5

Article 1 Renewal of authorisation

The authorisation of the additive specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal of Implementing Regulation (EU) No 869/2012

Implementing Regulation (EU) No 869/2012 is repealed.

Article 3 Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance which are produced and labelled before 21 September 2024 in accordance with the rules applicable before 21 March 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance specified in the Annex, which are produced and labelled before 21 March 2025 in accordance with the rules applicable before 21 March 2024 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substance specified in the Annex, which are produced and labelled 21 March 2026 in accordance with the rules applicable before 21 March 2024 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Article 4 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 feed 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/kg of complete feedingstuff with a moisture content of 12 %

Category: sensory additives. Functional group: flavouring compounds

2b957i

Thaumatin

Additive composition

Thaumatin

Characterisation of the active substance

Proteins thaumatin I and thaumatin II extracted from the arils of the fruit Thaumatococcus daniellii (Benth)

Einecs: 258-822-2

CAS number: 53850-34-3

Specifications

Chemical formula:

Polypeptide of 207 aminoacids

Relative molecular mass: Thaumatin I: 22209, Thaumatin II: 22293

Assay: min 15,1 % nitrogen on the dried basis equivalent to not less than 93 % protein

Purity:

—

Carbohydrates: not more than 3 % expressed on dry weight basis

—

Sulphated ash: not more than 2 % expressed on dry matter basis

—

Aluminium: not more than 100 mg/kg expressed on dry matter basis

Method of analysis

( 1 )

Identification of the thaumatin in the feed additive: Nitrogen content in the food additive Kjeldahl method (JECFA Monograph on Thaumatin. 2006. Thaumatin. Specification Monograph).

All animal species

-

-

-

1.

In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.

2.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12 %: 5 mg.’

3.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 2.

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.

21 March 2034

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en