# L_2017049EN.01000401.xml

| 25.2.2017 | EN | Official Journal of the European Union | L 49/4 |
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25.2.2017

EN

Official Journal of the European Union

L 49/4

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COMMISSION REGULATION (EU) 2017/324

of 24 February 2017

amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards specifications for Basic methacrylate copolymer (E 1205)

(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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 14 thereof,

Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(5) thereof,

Whereas:

| (1) | Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008. |
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(1)

Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.

| (2) | Those specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application. |
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(2)

Those specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.

| (3) | On 21 November 2014, an application was submitted for the amendment of the specifications concerning the food additive basic methacrylate copolymer (E 1205). The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
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(3)

On 21 November 2014, an application was submitted for the amendment of the specifications concerning the food additive basic methacrylate copolymer (E 1205). The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

| (4) | The applicant has requested the definition of the food additive to be amended with regard to the short description of the manufacturing process due to a modernization of the manufacturing process. Following a thorough review of the particle size in the current specification, the applicant has requested a change in the particle size of the powder. |
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(4)

The applicant has requested the definition of the food additive to be amended with regard to the short description of the manufacturing process due to a modernization of the manufacturing process. Following a thorough review of the particle size in the current specification, the applicant has requested a change in the particle size of the powder.

| (5) | The European Food Safety Authority (‘the Authority’) adopted an opinion on the safety of the proposed amendment of the specifications for basic methacrylate copolymer (E 1205) as a food additive (4). Based on the data provided by the applicant and taking into account the original evaluation of the substance in 2010 (5), the Authority concluded that the proposed amendments to the specifications of the food additive Basic methacrylate copolymer (E 1205) are not of a safety concern. |
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(5)

The European Food Safety Authority (‘the Authority’) adopted an opinion on the safety of the proposed amendment of the specifications for basic methacrylate copolymer (E 1205) as a food additive (4). Based on the data provided by the applicant and taking into account the original evaluation of the substance in 2010 (5), the Authority concluded that the proposed amendments to the specifications of the food additive Basic methacrylate copolymer (E 1205) are not of a safety concern.

| (6) | Regulation (EU) No 231/2012 should therefore be amended accordingly. |
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(6)

Regulation (EU) No 231/2012 should therefore be amended accordingly.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EU) No 231/2012 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of 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, 24 February 2017.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  
  OJ L 354, 31.12.2008, p. 1.

2

(3)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

3

(4)  
  EFSA Journal 2016;14(5):4490, p. 13.

4

EFSA Journal

(5)  
  EFSA Journal 2010;8(2):1513, p. 23.

5

EFSA Journal

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ANNEX

In the Annex to Regulation (EU) No 231/2012, the entries for food additive E 1205 Basic methacrylate copolymer are amended as follows:

| (1) | the entry for the definition is replaced by the following:






  ‘Definition | Basic methacrylate copolymer is manufactured by thermic controlled polymerisation of the monomers methyl methacrylate, butyl methacrylate and dimethylaminoethyl methacrylate (dissolved in propan-2-ol), by using a free radical donor initiator system. An alkyl mercaptane is used as chain modifying agent. The polymer solution is extruded and granulated under vacuum to remove residual volatile components. The granules resulting are commercialized as such or undergo a milling step (micronisation).’ |
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(1)

the entry for the definition is replaced by the following:

‘Definition

Basic methacrylate copolymer is manufactured by thermic controlled polymerisation of the monomers methyl methacrylate, butyl methacrylate and dimethylaminoethyl methacrylate (dissolved in propan-2-ol), by using a free radical donor initiator system. An alkyl mercaptane is used as chain modifying agent. The polymer solution is extruded and granulated under vacuum to remove residual volatile components. The granules resulting are commercialized as such or undergo a milling step (micronisation).’

| (2) | the entry for the particle size is replaced by the following:






  ‘Particle size of the powder (when used forms a film) | < 50 μm at least 95 %
  < 20 μm at least 50 %
  < 3 μm not more than 10 %’ |
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(2)

the entry for the particle size is replaced by the following:

‘Particle size of the powder (when used forms a film)

< 50 μm at least 95 %

< 20 μm at least 50 %

< 3 μm not more than 10 %’

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