2006/58/EC: Commission Decision of 24 January 2006 authorising the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ingredients pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2006) 42) (Text with EEA relevance)

• CELEX: Regulation (EC) No 258/97
• Articles: 5

Article 1

Foods and food ingredients as described in Annex I with added phytosterols/phytostanols as specified in Annex II, 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 maximum 3 g (in case of one portion per day) or maximum 1 g (in case of three portions per day) of added phytosterols/phytostanols.

Article 3

This Decision is addressed to Pharmaconsult Oy, Riippakoivunkuja 5, FIN-02130 Espoo.

Schedules & Appendices

ANNEX I

ANNEX I

PRODUCTS REFERRED TO IN ARTICLE 1

Rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) and ≤ 30 % wheat; and with ≤ 4 % added sugar but no fat added.

ANNEX II

ANNEX II

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

< 15 % β-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.