21.7.2016

Official Journal of the European Union

L 196/53

COMMISSION IMPLEMENTING DECISION (EU) 2016/1190

of 19 July 2016

authorising the placing on the market of

trans

-resveratrol as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2016) 4567)

(Only the English text is authentic)

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 8 November 2012, the company DSM Nutritional Products Ltd made a request to the competent authorities of Ireland to place

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-resveratrol on the market as a novel food ingredient within the meaning of point (f) of Article 1(2) of Regulation (EC) No 258/97.

(2) On 28 June 2013, the competent food assessment body of Ireland issued its initial assessment report. In that report it came to the conclusion that

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-resveratrol meets the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97.

(3) On 4 September 2013, the Commission forwarded the initial assessment report to the other Member States.

(4) Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.

(5) On 3 April 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for

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-resveratrol as novel food ingredient in accordance with Regulation (EC) No 258/97.

(6) On 11 December 2015, EFSA concluded in its opinion on the safety of synthetic

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-resveratrol as a novel food(2), that

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-resveratrol used in food supplements intended for adults is safe under the proposed conditions of use.

(7) That opinion gives sufficient grounds to establish that

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-resveratrol as a novel food ingredient complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(8) In its opinion, EFSA also indicated that

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-resveratrol may interact with specific medicines therefore, it is necessary to inform the consumers when consumed in combination with medicines.

(9) Directive 2002/46/EC of the European Parliament and of the Council(3) lays down requirements for food supplements. The use of

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-resveratrol should be authorised without prejudice to that legislation.

(10) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION:

Article 1

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-resveratrol as specified in the Annex to this Decision may be placed on the market in the Union as a novel food ingredient to be used in food supplements in capsule or tablet form intended for adult population only with a maximum dose of 150 mg per day without prejudice to the provisions of Directive 2002/46/EC.

Article 2

1. The designation of

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-resveratrol authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘

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-resveratrol’.

2. The labelling of food supplements containing

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-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.

Article 3

This Decision is addressed to DSM Nutritional Products Ltd, Heanor Gate Ind. Est. Heanor, Derbyshire, United Kingdom.

Done at Brussels, 19 July 2016.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

(1)

OJ L 43, 14.2.1997, p. 1

(2)

EFSA Journal

2016;14(1):4368.

(3) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (

OJ L 183, 12.7.2002, p. 51

ANNEX

SPECIFICATION OF

TRANS

-RESVERATROL

Definition:

Chemical name	5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol
Chemical formula	C14H12O3
Molecular weight	228,25 Da
CAS No	501-36-0

Description:

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-resveratrol is off-white to beige crystals.

Purity:

Trans-resveratrol	Not less than 99 %
Total by-products (related substances)	Not more than 0,5 %
Any single related substance	Not more than 0,1 %
Lead	Not more than 1 ppm
Mercury	Not more than 0,1 ppm
Cadmium	Not more than 0,5 ppm
Arsenic	Not more than 1 ppm
Loss on drying	Not more than 0,5 %
Sulphated ash	Not more than 0,1 %
Diisopropylamine	Not more than 50 mg/kg