FSA News Item, 9 September 2005

NOVEL FOODS - Application from Prima Pharm for an opinion on the equivalence of phytosterols as novel food approval.

The basis of this request for an opinion is that the applicant's product is comparable with the Diminicol phytosterol ingredient marketed by Teriaka , Finland , that was authorised in 2004. (Commission Decision 2004/336/EC).

Teriaka subsequently obtained authorisation for additional food categories on the basis of substantial equivalence (Opinions of the Novel Food Board (FIN) 'on substantial equivalence in the case of a milk and soya drink with added Diminicol Ingredient' and 'of fermented milk products with added Diminicol').

Background

Phytosterols are used by the food industry for their cholesterol-lowering properties. They are naturally present at low levels in vegetable oils and in food derived from such sources.

Any comments on this application should be sent to the ACNFP Secretariat by 29 September 2005 and will be passed to the Committee for consideration during its assessment of this novel food ingredient.