2004/335/EC: Commission Decision of 31 March 2004 authorising the placing on the market of milk type products and yoghurt type products with added phytosterol esters as novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2004) 1245)

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

Article 1

Foods and food ingredients as described in Annex 1 with added phytosterol esters as specified in Annex 2, hereinafter called the products, may be placed on the market in the Community.

Article 2

The products shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3g (in case of one portion per day) or a maximum of 1g (in case of three portions per day) of added phytosterol esters (calculated as free sterols/stanols).

The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.

Article 3

This Decision is addressed to Unilever, London Road, Purfleet, Essex RM19 1SD, United Kingdom.

Done at Brussels, 31 March 2004.

For the Commission

David Byrne

Member of the Commission

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

(2) OJ L 97, 1.4.2004, p. 44.

Schedules & Appendices

ANNEX 1

Products referred to in Article 1

Milk type products, such as semi-skimmed and skimmed milk type products, yoghurt type products, and milk/yoghurt type products where the milk fat has been partly or fully replaced by vegetable fat.

ANNEX 2

Specifications of phytosterols and phytostanols for the addition to foods and food ingredients

Definition:

Phytosterols and phytostanols are sterols and stanols that are extracted from plants and may be presented as free sterols and stanols or esterified with food grade fatty acids.

Composition (with GC-FID or equivalent method):

< 80 % â-sitosterol

< 15 % â-sitostanol

< 40 % campesterol

< 5 % campestanol

< 30 % stigmasterol

< 3 % brassicasterol

< 3 % other sterols/stanols

Contamination/Purity (GC-FID or equivalent method)

Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants, best ensured by a purity of more than 99 % of the phytosterol/phytostanol ingredient.