# L_2011102EN.01000601.xml

| 16.4.2011 | EN | Official Journal of the European Union | L 102/6 |
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16.4.2011

EN

Official Journal of the European Union

L 102/6

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COMMISSION IMPLEMENTING REGULATION (EU) No 371/2011

of 15 April 2011

concerning the authorisation of dimethylglycine sodium salt as feed additive for chickens for fattening (holder of the authorisation Taminco N.V.)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
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(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of dimethylglycine sodium salt. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of dimethylglycine sodium salt. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of dimethylglycine sodium salt as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of dimethylglycine sodium salt as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 December 2010 (2) that dimethylglycine sodium salt, under the proposed conditions of use, does not have an adverse effect on animal health, consumer health or the environment, and that this additive has the potential to significantly improve body weight gain and feed to gain ratio in chickens for fattening. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the European Union Reference Laboratory for Feed Additives set up by Regulation (EC) No 1831/2003. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 December 2010 (2) that dimethylglycine sodium salt, under the proposed conditions of use, does not have an adverse effect on animal health, consumer health or the environment, and that this additive has the potential to significantly improve body weight gain and feed to gain ratio in chickens for fattening. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the European Union Reference Laboratory for Feed Additives set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of dimethylglycine sodium salt shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of dimethylglycine sodium salt shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 April 2011.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  EFSA Journal (2011); 9(1):1950.

2

EFSA Journal (2011); 9(1):1950

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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 |
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| mg/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: other zootechnical additives (improvement of zootechnical parameters) |
| 4d4 | Taminco N.V. | Dimethylglycine sodium salt | | Additive composition

  Dimethylglycine sodium salt with a purity of at least 97 % |

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

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

4d4

Taminco N.V.

Dimethylglycine sodium salt

Additive composition

Dimethylglycine sodium salt with a purity of at least 97 %

| | Active substance

  Sodium N,N-dimethylglycine
  C4H8NO2Na, produced by chemical synthesis. |
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Active substance

Sodium N,N-dimethylglycine

C4H8NO2Na, produced by chemical synthesis.

| | Analytical methods
   (1)

  For the determination of the active substance in the additive and premixtures: liquid chromatography (HPLC) with diode array detection (DAD), detection at 193 nm.
  For the determination of the active substance in feedingstuffs: gas chromatography (GC) using pre-column derivatisation and flame ionisation detection (FID). |
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Analytical methods
   (1)

For the determination of the active substance in the additive and premixtures: liquid chromatography (HPLC) with diode array detection (DAD), detection at 193 nm.

For the determination of the active substance in feedingstuffs: gas chromatography (GC) using pre-column derivatisation and flame ionisation detection (FID).

Chickens for fattening

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1 000

| 1. | For safety: glasses and gloves shall be used during handling. |
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1.

For safety: glasses and gloves shall be used during handling.

| 2. | Minimum recommended dose: 1 000  mg/kg of complete feedingstuff with a moisture content of 12 %. |
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2.

Minimum recommended dose: 1 000  mg/kg of complete feedingstuff with a moisture content of 12 %.

6 May 2021

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(1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/eurl-feed-additives

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