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)

• CELEX: Implementing Decision (EU) 2016/1190
• Articles: 4

Article 1

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

2.   The labelling of food supplements containing trans -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.

Schedules & Appendices

ANNEX

ANNEX

SPECIFICATION OF TRANS -RESVERATROL

Definition:

Chemical name

5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol

Chemical formula

C 14 H 12 O 3

Molecular weight

228,25 Da

CAS No

501-36-0

Description:

Trans -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