authorising the placing on the market of methyl vinyl ether-maleic anhydride copolymer as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

13.12.2014 | EN | Official Journal of the European Union | L 358/47 ---|---|---|--- * * * COMMISSION IMPLEMENTING DECISION of 11 December 2014 authorising the placing on the market of methyl vinyl ether-maleic anhydride copolymer as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2014) 9333) (Only the English text is authentic) (2014/905/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 30 June 2008 the company Reading Scientific Services Ltd made a request to the competent authorities of the Netherlands to place methyl vinyl ether-maleic anhydride copolymer on the market as a novel food ingredient for the use in chewing gum base. ---|--- (2) | On 14 July 2011, the competent food assessment body of the Netherlands issued its initial assessment report. In that report it came to the conclusion that methyl vinyl ether-maleic anhydride copolymer meets the criteria set out in Article 3(1) of Regulation (EC) No 258/97. ---|--- (3) | On 18 August 2011, the Commission forwarded the initial assessment report to the other Member States. ---|--- (4) | Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97. ---|--- (5) | On 12 June 2012, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for methyl vinyl ether-maleic anhydride copolymer as food ingredient in accordance with Regulation (EC) No 258/97. ---|--- (6) | On 10 October 2013 EFSA adopted a Scientific Opinion on the safety of methyl vinyl ether-maleic anhydride copolymer (chewing gum base ingredient) as a novel food ingredient (2), concluding that it is safe under the proposed uses and use levels. ---|--- (7) | The opinion gives sufficient grounds to establish that methyl vinyl ether-maleic anhydride copolymer in the proposed use and use levels in 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 Plants, Animals, Food and Feed, ---|--- HAS ADOPTED THIS DECISION: Article 1 Methyl vinyl ether-maleic anhydride copolymer as specified in the Annex may be placed on the market in the Union as a novel food ingredient to be used in chewing gum base up to a maximum of 2 % in the finished chewing gum product. 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 (including methyl vinyl ether-maleic anhydride copolymer)’ or ‘gum base (including CAS No 9011-16-9)’. Article 3 This Decision is addressed to Reading Scientific Services Ltd, The Lord Zuckerman Research Centre, Whiteknights Campus, Pepper lane, Reading, RG6 6LA, United Kingdom. Done at Brussels, 11 December 2014. For the Commission Vytenis ANDRIUKAITIS Member of the Commission * * * (1) OJ L 43, 14.2.1997, p. 1. (2) EFSA Journal 2013;11(10):3423. * * * ANNEX SPECIFICATION OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER Definition: Methyl vinyl ether-maleic anhydride copolymer is an anhydrous copolymer of methyl vinyl ether and maleic anhydride. Structural formula: Description: Free-flowing, white to white-off powder. Identification: CAS No | 9011-16-9 ---|--- Purity: Assay value | At least 99,5 % in dry matter ---|--- Specific viscosity (1 % MEK) | 2-10 Residual methyl vinyl ether | Not more than 150 ppm Residual maleic anhydride | Not more than 250 ppm Acetaldehyde | Not more than 500 ppm Methanol | Not more than 500 ppm Dilauroyl peroxide | Not more than 15 ppm Total heavy metals | Not more than 10 ppm Microbiological criteria: Total aerobic plate count | Not more than 500 CFU/g ---|--- Mould/yeast | Not more than 500 CFU/g Escherichia coli | Negative to test Salmonella spp. | Negative to test Staphylococcus aureus | Negative to test Pseudomonas aeruginosa | Negative to test * * *