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 ingredients1, 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 Council3, Directive 2009/39/EC of the European Parliament and of the Council4 and Directive 2009/54/EC of the European Parliament and of the Council5.

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

ANNEX ISPECIFICATIONS 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