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 1U.K.
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 2U.K.
The designation of dihydrocapsiate authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘Dihydrocapsiate’.
Article 3U.K.
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
ANNEX IU.K. SPECIFICATIONS OF DIHYDROCAPSIATE
Definition U.K.
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.
:
Viscous colourless to yellow liquid
:
C18H28O4
:
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 IIU.K.
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 |
EFSA Journal 2012; 10(7):2812.