Commission Implementing Regulation (EU) 2023/1682 of 29 June 2023 concerning the renewal of the authorisation of dimethylglycine sodium salt as a feed additive for chickens for fattening (holder of the authorisation: Taminco BV) and repealing Implementing Regulation (EU) No 371/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1682
• Articles: 5

Article 1 Renewal of the authorisation

The authorisation of the substance specified in the Annex, belonging to the additive category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives: (improvement of performance parameters)’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal of Implementing Regulation (EU) No 371/2011

Implementing Regulation (EU) No 371/2011 is repealed.

Article 3 Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 24 March 2024 in accordance with the rules applicable before 24 September 2023 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 24 September 2024 in accordance with the rules applicable before 24 September 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for chickens for fattening.

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 additive

Name of the holder of authorisation

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 additive/kg of complete feedingstuff with a moisture content of 12%

Category of zootechnical additives. Functional group: other zootechnical additives (improving performance parameters).

4d4

Taminco BV.

Dimethylglycine sodium salt

Additive composition

Dimethylglycine sodium salt with a purity of at least 97 %

Solid form

Characterisation of the active substance

Sodium N,N-dimethylglycine produced by chemical synthesis.

Dimethylaminoethanol (DMAE)≤ 0.1 %

Chemical formula: C 4 H 8 NO 2 Na

CAS number; 18319-88-5

EINECS number: 242-206-5

Analytical method

( 1 )

For the determination of dimethylglycine sodium salt in the feed additive and premixtures:

liquid chromatography (HPLC) with diode array detection (DAD), detection at 193 nm.

For the determination of the active substance in compound feed:

gas chromatography (GC) using pre-column derivatisation and flame ionisation detection (FID).

Chickens for fattening

—

1 000

1 000

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 eye and skin protective equipment.

24 September 2033

( 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.