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

27.11.2012 | EN | Official Journal of the European Union | L 327/49 ---|---|---|--- * * * COMMISSION IMPLEMENTING DECISION of 22 November 2012 authorising the placing on the market of dihydrocapsiate as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2012) 8391) (Only the English text is authentic) (2012/726/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 6 August 2010 the company Ajinomoto Co. Inc., Japan made a request to the competent authorities of the United Kingdom to place dihydrocapsiate on the market as novel food ingredient. ---|--- (2) | On 10 March 2011 the competent food assessment body of the United Kingdom issued its initial assessment report. In this report it came to the conclusion that dihydrocapsiate will not present a health risk to consumers. ---|--- (3) | The Commission forwarded the initial assessment report to all Member States on 13 April 2011. ---|--- (4) | Within the 60 day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections were raised in accordance with that provision. ---|--- (5) | Therefore the European Food Safety Authority (EFSA) was consulted on 9 November 2011. ---|--- (6) | On 28 June 2012 in their ‘Scientific opinion on dihydrocapsiate’ (2) EFSA came to the conclusion that dihydrocapsiate is safe under the proposed uses and use levels. ---|--- (7) | Dihydrocapsiate 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, ---|--- HAS ADOPTED THIS DECISION: Article 1 Dihydrocapsiate as specified in the Annex I may be placed on the market as a novel food ingredient for the uses defined and at the maximum levels established in Annex II, and without prejudice to the provisions of Regulation (EC) No 1925/2006 of the European Parliament and of the Council (3), Directive 2009/39/EC of the European Parliament and of the Council (4) and Directive 2009/54/EC of the European Parliament and of the Council (5). Article 2 The designation of dihydrocapsiate authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘Dihydrocapsiate’. Article 3 This Decision is addressed to Ajinomoto Co. Inc., 15-1, Kyobashi, Chuo-ku, 1-choume, 104-8315, Tokyo, Japan. Done at Brussels, 22 November 2012. For the Commission Maroš ŠEFČOVIČ Vice-President * * * (1) OJ L 43, 14.2.1997, p. 1. (2) EFSA Journal 2012; 10(7):2812. (3) OJ L 404, 30.12.2006, p. 26. (4) OJ L 124, 20.5.2009, p. 21. (5) OJ L 164, 26.6.2009, p. 45. * * * ANNEX I SPECIFICATIONS OF DIHYDROCAPSIATE Definition Dihydrocapsiate is synthesised by enzyme-catalysed esterification of vanillyl alcohol and 8-methylnonanoic acid. Following the esterification dihydrocapsiate is extracted with n-hexane. The enzyme Lipozyme 435 was approved by the Danish Veterinary and Food Administration. Description: Viscous colourless to yellow liquid Chemical formula: C18H28O4 Structural formula: CAS No: 205687-03-2 Physical-chemical properties of dihydrocapsiate Dihydrocapsiate | more than 94 % ---|--- 8-Methylnonanoic acid | less than 6 % Vanillyl acohol | less than 1 % Synthesis related substances | less than 2 % * * * ANNEX II USES OF DIHYDROCAPSIATE Food category | Maximum use levels ---|--- Cereal bars | 9 mg/100 g Biscuits, cookies and crackers | 9 mg/100 g Rice based snacks | 12 mg/100 g Carbonated drinks, dilutable drinks, fruit juice based drinks | 1,5 mg/100 ml Vegetable drinks | 2 mg/100 ml Coffee based drinks, tea based drinks | 1,5 mg/100 ml Flavoured water — still | 1 mg/100 ml Precooked oatmeal cereal | 2,5 mg/100 g Other cereals | 4,5 mg/100 g Ice cream, dairy desserts | 4 mg/100 g Pudding mixes (ready to eat) | 2 mg/100 g Products based on yoghurt | 2 mg/100 g Chocolate confectionery | 7,5 mg/100 g Hard candy | 27 mg/100 g Sugar-free gum | 115 mg/100 g Whitener/creamer | 40 mg/100 g Sweeteners | 200 mg/100 g Soup (ready to eat) | 1,1 mg/100 g Salad dressing | 16 mg/100 g Vegetable protein | 5 mg/100 g Ready to eat meals Replacement meals | 3 mg/meal Meal replacement drinks | 1 mg/100 ml * * *