Article 1
Open ↗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.
Source
2004/845/EC: Commission Decision of 12 November 2004 on authorising the placing on the market of milk based beverages 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) 4289)
2004/845/EC: Commission Decision of 12 November 2004 on authorising the placing on the market of milk based beverages 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) 4289)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
Open ↗The products shall be presented in such a manner that they can easily be divided into portions that contain either a maximum of 3 g (in case of one portion per day) or a maximum of 1 g (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.
Article 3
Open ↗This Decision is addressed to Forbes Medi-Tech Inc., 750 West Pender Street, Vancouver BC V6C 2T8, Canada.
Supplementary provisions
ANNEX 1Supplementary provisions
Open ↗ANNEX 1 Products referred to in Article 1 Milk type products, such as semi-skimmed and skimmed milk type products, where the milk fat has been partly or fully replaced by vegetable fat.
ANNEX 2Supplementary provisions
Open ↗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 % β-sitosterol < 35 % β-sitostanol < 40 % campesterol < 15 % 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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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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