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
(2) EFSA Journal 2012; 10(7):2812.
(3) OJ L 404, 30.12.2006, p. 26.
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 |