2013/49/EU: Commission Implementing Decision of 22 January 2013 authorising the placing on the market of synthetic zeaxanthin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2013) 110)

• CELEX: Regulation (EC) No 258/97
• Articles: 4

Article 1

Synthetic zeaxanthin as specified in the Annex may be placed on the market in the Union as a novel food ingredient in food supplements at the maximum intake recommended by the manufacturer of up to 2 mg per day.

Article 2

The designation of synthetic zeaxanthin authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘synthetic zeaxanthin’.

Article 3

This Decision is addressed to DSM Nutritional Products, Alexander Fleminglaan 1, 2613 AX Delft, The Netherlands.

Schedules & Appendices

ANNEX

ANNEX

SPECIFICATIONS OF SYNTHETIC ZEAXANTHIN

Definition Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid. Synthetic zeaxanthin is produced by a multi-step chemical synthesis from smaller molecules.

Synthetic zeaxanthin is presented either as a spray-dried powder of gelatin or starch base (‘beadlets’) with added α-tocopherol and ascorbyl palmitate or as a corn oil suspension with added α-tocopherol

Description:

Orange-red crystalline powder with little or no odour

Chemical formula:

C 40 H 56 O 2

Structural formula:

CAS No:

144-68-3

Molecular weight:

568,9 daltons

Physical-chemical properties of synthetic zeaxanthin

Loss on drying

less than 0,2 %

All-trans zeaxanthin

more than 96 %

Cis-zeaxanthin

less than 2 %

Other carotenoids

less than 1,5 %

Triphenylphosphine oxid

(CAS No 791-28-6)

less than 50 mg/kg