Phytosterol Ester

Last updated:
10 January 2017
January 2017 - An application from X'ian Healthful Biotechnology for an opinion on equivalence of their phytosterol ester compared with phytosterol ester ingredients marketed by Archer Daniels Midland. 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 in food derived from such sources.

Regulation (EC) 258/97 makes provision for novel foods or ingredients that are substantially equivalent to an existing product to be placed on the market once the applicant has informed the European Commission. In all cases to date, the Commission has required that the applicant first obtains an opinion on substantial equivalence from a Member State. X'ian Healthful Biotechnology has requested such an opinion from the UK Competent Authority on  the equivalence of its phytosterol ester to the authorised phytosterol ester marketed by Archer Daniels Midland and authorised in 2004 (Commission Decision 2004/333/EC)

The applicant's phytosterol ester will be used in the same products as those for which approval has been granted for Archer Daniels Midland (yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks and cheese type products).

On 23 June, the EU referendum took place and the people of the United Kingdom voted to leave the European Union. Until exit negotiations are concluded, the UK remains a full member of the European Union and all the rights and obligations of EU membership remain in force. During this period the Government will continue to negotiate, implement and apply EU legislation. The Government, under the Prime Minister, has begun negotiations to exit the EU. The outcome of these negotiations will determine what arrangements apply in relation to EU legislation and funding in future once the UK has left the EU.

Any comments on this opinion should be emailed to the ACNFP Secretariat at  by 12 July 2017. The comments will be passed to the Committee for consideration in finalising its assessment of this novel food ingredient.

All views/comments received by the FSA will be made available for public examination as part of the Committees consideration of the application. If you would prefer your comments not to be made publically available, please indicate this in your response.