2004/333/EC: Commission Decision of 31 March 2004 authorising the placing on the market of yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks and cheese type products with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2004) 1243)

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

Article 1

Foods and food ingredients as described in Annex 1 with added phytosterols/phytostanols 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 phytosterols/phytostanols.

Salad dressings shall be packed as single portions.

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

Article 3

This Decision is addressed to Archer Daniels Midland Company, 4666 Faries Parkway, Decatur, IL. 62526-5666, USA.

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

Yellow fat spreads, as defined by Council Regulation (EC) No 2991/94(1), excluding cooking and frying fats and spreads based on butter or other animal fat.

Salad dressings including mayonnaise.

Milk type products such as semi skimmed and skimmed milk type products, possibly with the addition of fruits and/or cereals, fermented milk type products such as yoghurt, soya drinks, and cheese type products (fat content <= 12 g per 100 g), where the milk fat and/or protein has been partly or fully replaced by vegetable fat or protein.

(1) OJ L 316, 9.12.1994, p. 2.

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.