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.
2004/336/EC: Commission Decision of 31 March 2004 authorising the placing on the market of yellow fat spreads, milk based fruit drinks, yoghurt type products 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) 1246)
Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β
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.
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. The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.
This Decision is addressed to Teriaka Ltd., Siirakuja 3, 01490 Vantaa. 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.
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. Milk based fruit drinks, yoghurt type products and cheese type products (fat content <= 12 g per 100 g) where milk fat and or protein has been partly or fully replaced by vegetable fat and/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 % Γ’-sitosterol < 15 % Γ’-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.
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