2007/343/EC: Commission Decision of 15 May 2007 authorising the placing on the market of oil enriched with phytosterols/phytostanols as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2007) 2073)

Regulation (EC) No 258/97 · Decision · 5 articles

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 1

Oil enriched with phytosterols/phytostanols as specified in Annex 1 may be placed on the market in the Community as a novel food ingredient for use in the foods specified in Annex 2.

Article 2

The products containing the novel food ingredient shall be presented in such a manner that they can be easily 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. Spicy sauces and salad dressings including mayonnaise shall be packed as single portions.

Article 3

This Decision is addressed to Enzymotec, 5 Hataasi ST, Ramat Gabriel Industrial Park, Migdal HaEmeq, Israel 23 106.

Supplementary provisions

ANNEX ISupplementary provisions

ANNEX I Specifications of oil enriched with phytosterols/phytostanols Definition: Oil enriched with phytosterols/phytostanols is composed of an oil fraction and a phytosterol fraction. Substance/Parameter Content Acylglycerol Distribution: Free fatty acids (expressed as oleic acid) Not more than 2 % Monoacylglycerols (MAG) Not more than 10 % Diacylglycerols (DAG) Not more than 25 % Triacylglycerols (TAG) Making up the balance Phytosterol fraction: β-sitosterol Not more than 80 % β-sitostanol Not more than 15 % campesterol Not more than 40 % campestanol Not more than 5 % stigmasterol Not more than 30 % brassicasterol Not more than 3 % other sterols/stanols Not more than 3 % Others: Moisture and volatile Not more than 0,5 % Peroxide value (PV) < 5 meq/kg Trans fatty acids Not more than 1 % Contamination/Purity (GC-FID or equivalent method) of phytosterols/phytostanols 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 %.

ANNEX IISupplementary provisions

ANNEX II Foods referred to in Article 1 Spreadable fats, as defined by Council Regulation (EC) No 2991/94 ( 1 ) Annex, points B and C, excluding cooking and frying fats and spreads based on butter or other animal fat. Milk based products, such as products based on semi-skimmed and skimmed milk products, possibly with the addition of fruits and/or cereals, products based on fermented milk such as yoghurt and cheese based products (fat content ≤ 12 g per 100 g), where possibly the milk fat has been reduced and the fat or protein has been partly or fully replaced by vegetable fat or protein. Soya drinks. Spicy sauces and salad dressings including mayonnaise. ( 1 ) OJ L 316, 9.12.1994, p. 2 .

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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