# L_2011343EN.01012101.xml

| 23.12.2011 | EN | Official Journal of the European Union | L 343/121 |
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23.12.2011

EN

Official Journal of the European Union

L 343/121

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COMMISSION IMPLEMENTING DECISION

of 21 December 2011

authorising the placing on the market of a novel chewing gum base as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2011) 9680)

(Only the English text is authentic)

(2011/882/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:

| (1) | On 10 October 2007 the company Revolymer Ltd made a request to the competent authorities of the Netherlands to place a novel chewing gum base on the market as a novel food ingredient. |
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(1)

On 10 October 2007 the company Revolymer Ltd made a request to the competent authorities of the Netherlands to place a novel chewing gum base on the market as a novel food ingredient.

| (2) | On 23 April 2009 the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that the novel chewing gum base can safely be used as a food ingredient. |
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(2)

On 23 April 2009 the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that the novel chewing gum base can safely be used as a food ingredient.

| (3) | The Commission forwarded the initial assessment report to all Member States on 30 April 2009. |
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(3)

The Commission forwarded the initial assessment report to all Member States on 30 April 2009.

| (4) | Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision. |
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(4)

Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections to the marketing of the product were raised in accordance with that provision.

| (5) | Therefore the European Food Safety Authority (EFSA) was consulted on 2 July 2010. |
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(5)

Therefore the European Food Safety Authority (EFSA) was consulted on 2 July 2010.

| (6) | On 25 March 2011, EFSA in the ‘Scientific Opinion on the safety of a “novel chewing gum base (REV-7)” as a novel food ingredient’ (2) came to the conclusion that the novel chewing gum base was safe at the proposed conditions of use and the proposed levels of intake. |
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(6)

On 25 March 2011, EFSA in the ‘Scientific Opinion on the safety of a “novel chewing gum base (REV-7)” as a novel food ingredient’ (2) came to the conclusion that the novel chewing gum base was safe at the proposed conditions of use and the proposed levels of intake.

| (7) | The novel chewing gum base complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. |
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(7)

The novel chewing gum base complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

| (8) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(8)

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

HAS ADOPTED THIS DECISION:

Article 1

The novel chewing gum base as specified in the Annex may be placed on the market in the Union as a novel food ingredient for the use in chewing gums up to a maximum of 8 %.

Article 2

The designation of the novel chewing gum base authorised by this Decision on the labelling of the foodstuff containing it shall be ‘gum base (1,3-butadiene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono-Me ether)’.

Article 3

This Decision is addressed to Revolymer Ltd, 1 Newtech Square, Deeside Industrial Park, Deeside, Flintshire CH5 2NT, United Kingdom.

Done at Brussels, 21 December 2011.

For the Commission

John DALLI

Member of the Commission

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(1)  
  OJ L 43, 14.2.1997, p. 1.

1

(2)  
  EFSA Journal 2011; 9(4):2127.

2

EFSA Journal

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ANNEX

Specifications of the novel chewing gum base

Description

The novel food ingredient is a synthetic polymer (patent number WO2006016179). It has a white to off-white colour.

It consists of branched polymers of monomethoxypolyethylene glycol (MPEG) grafted onto polyisoprene-graft-maleic anhydride (PIP-g-MA), and unreacted MPEG (less than 35 % by weight).

Molecular structure of MPEG grafted PIP-g-MA

Image 1

Image 2

| Characteristics of mono methoxy polyethylene glycol |
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| Moisture | less than 5 % |
| Ash | less than 5 mg/kg |
| Residual anhydride | less than 15 μmol/g |
| Polydispersity index | less than 1,4 |
| Isoprene | less than 0,05 mg/kg |
| Ethylene oxide | less than 0,2 mg/kg |
| Free maleic anhydride | less than 0,1 % |
| Total oligomeres (less than 1 000 Dalton) | not more than 50 mg/kg |

Characteristics of mono methoxy polyethylene glycol

Moisture

less than 5 %

Ash

less than 5 mg/kg

Residual anhydride

less than 15 μmol/g

Polydispersity index

less than 1,4

Isoprene

less than 0,05 mg/kg

Ethylene oxide

less than 0,2 mg/kg

Free maleic anhydride

less than 0,1 %

Total oligomeres (less than 1 000 Dalton)

not more than 50 mg/kg

| Impurities from raw materials |
| --- |
| Ethylene glycol | less than 200 mg/kg |
| Diethylene glycol | less than 30 mg/kg |
| Monoethylene glycol methyl ether | less than 3 mg/kg |
| Diethylene glycol methyl ether | less than 4 mg/kg |
| Triethylene glycol methyl ether | less than 7 mg/kg |
| 1,4-Dioxane | less than 2 mg/kg |
| Formaldehyde | less than 10 mg/kg |

Impurities from raw materials

Ethylene glycol

less than 200 mg/kg

Diethylene glycol

less than 30 mg/kg

Monoethylene glycol methyl ether

less than 3 mg/kg

Diethylene glycol methyl ether

less than 4 mg/kg

Triethylene glycol methyl ether

less than 7 mg/kg

1,4-Dioxane

less than 2 mg/kg

Formaldehyde

less than 10 mg/kg

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