# L_2012327EN.01004901.xml

| 27.11.2012 | EN | Official Journal of the European Union | L 327/49 |
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27.11.2012

EN

Official Journal of the European Union

L 327/49

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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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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, |
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(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

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(1)  
  OJ L 43, 14.2.1997, p. 1.

1

(2)  
  EFSA Journal 2012; 10(7):2812.

2

EFSA Journal

(3)  
  OJ L 404, 30.12.2006, p. 26.

3

(4)  
  OJ L 124, 20.5.2009, p. 21.

4

(5)  
  OJ L 164, 26.6.2009, p. 45.

5

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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:

Image 1

CAS No: 205687-03-2

Physical-chemical properties of dihydrocapsiate

| Dihydrocapsiate | more than 94 % |
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| 8-Methylnonanoic acid | less than 6 % |
| Vanillyl acohol | less than 1 % |
| Synthesis related substances | less than 2 % |

Dihydrocapsiate

more than 94 %

8-Methylnonanoic acid

less than 6 %

Vanillyl acohol

less than 1 %

Synthesis related substances

less than 2 %

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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 |

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

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