Annexes to COM(2005)340 - Authorisation of the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ingredients under Regulation 258/97

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dossier COM(2005)340 - Authorisation of the placing on the market of rye bread with added phytosterols/phytostanols as novel foods or novel food ...
document COM(2005)340 EN
date January 24, 2006
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

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.