Phytosterols: Naturis (ACI Group Ltd)

December 2007: Application from Naturis for an opinion on the substantial equivalence of phytosterols as an ingredient in various food categories. Under evaluation.


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

The UK company Naturis is requesting an opinion from the UK Competent Authority, which is the Food Standards Agency, on the equivalence of their phytosterol ingredient derived from soya. The basis of this request is that the applicant's product is equivalent to the phytosterol ingredient marketed by Archer Daniels Midland (ADM) and authorised in 2004 (Commission Decision 2004/333/EC). In accordance with the ADM approval the applicant intends to use their phytosterol ingredient in yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks and cheese type products.

Following an initial public consultation period and the discussion of this application by the Advisory Committee on Novel Foods and Processes at its meetings between January and June, a draft opinion has been formulated suggesting that the phytosterols of Naturis should be accepted as substantially equivalent to the existing phytosterols marketed by ADM.

Any comments on this draft opinion should be sent to the Food Standards Agency by 1 July 2008.

The address to which comments should be sent is: Novel Foods, Room 515B, Aviation House, 125 Kingsway, London WC2B 6NH, or by email to ACNFP Secretariat.

All the views/comments received by the Agency will be made available for public examination. If you would prefer your comments NOT to be made publicly available, please indicate this by fully completing and returning the data protection form (attached below) together with your response.