Phytosterol application: Prima Pharm

September 2005: Application from Prima Pharm requesting an opinion on the equivalence of phytosterols to be used in yellow fat spreads, milk based fruit drinks, yoghurt type products, cheese type products, soya drinks, milk and fermented milk type products. Awaiting notification.

Regulation (EC) No 258/97 includes a simplified procedure where a novel food is considered substantially equivalent to a food that is already on the market. In this case, the applicant can submit a notification to the European commission after obtaining an opinion on equivalence from an EU Member State.

The basis of this request for an opinion is that the applicant's product is equivalent to 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 in July and October 2004 (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').

Following an initial public consultation period and the discussion of this application at the 29 September 2005 meeting of the Advisory Committee on Novel Foods and Processes (ACNFP), the UK Competent Authority was content that the applicant's phytosterol ingredient meets the criteria for equivalence as defined by Article 3(4) of Regulation (EC) No 258/97. The UK's opinion can be accessed below.

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.