Phytosterol esters: extension of use. EC No.149

June 2013: Application from Unilever to extend the use of phytosterol esters under the Novel Food Regulation (EC) 258/97. Status: Passed to EU under Regulation (EC) 2015/2283


This is the third application made by Unilever for this novel ingredient and the second one made to the UK. Following an authorisation for the yellow fat spreads with added phytosterol esters, which was assessed for use on the basis that the spreads would not be used for cooking, Unilever submitted an application via the UK to extend the use to ‘milk type’ and ‘yoghurt type’ products which was authorised in 2004. 

This is a new application was prepared by Unilever Research and Development for the extension of use for Phytosterol-Esters in multi-purpose vegetable fat spreads and liquid vegetable fat based emulsions with added phytosterol esters for cooking and baking applications.

The term "phytosterols" covers plant sterols and plant stanols. Plant sterols are naturally occurring substances present in the diet principally as minor components of vegetable oils. Plant stanols, occurring in nature at a lower level, are hydrogenation compounds of the respective plant sterols.

The applicant  states that phytosterol esters are used by the food industry for their cholesterol-lowering properties. It has been shown that these compounds have an effect on lowering low density lipoproteins. Free phytosterols are naturally present at low levels in vegetable oils and in food derived from such sources.

Legal Backgroud

Before a novel food can be marketed legally in EU it requires a pre-market safety assessment under the Novel Food Regulation (EU) 2015/2283, previously 258/97 (EC). This is the Regulation establishes the legal basis for novel foods and the process for submitting a novel food authorisation(s).

One of the major changes under the revised Regulation, was the centralisation of the authorisation process at the EU level. Prior to this, applications for new novel foods were underwent initial assessment in a Member State to achieve an EU wide authorisation. This application was received by the UK under Regulation 258/97 EC and was assessed by our independent experts the Advisory Committee on novel foods and processes.

Application Status: Passed to the EC

The application for Phytosterol-Esters (Extension of Use) was assessed by the UK under Regulation 258/97 (EC). The application was accepted in June 2013 and was reviewed by the Committee to assess it whether the proposed use met the requirements under the regulation. Namely that it is safe, not misleading and would not put consumers as a nutritional disadvantage.

The Committee reviewd the application multiple times, requesting more information. However, even though a draft opinion was formed the assessment was not completed. Resultantly, it was passed tothe EU under regulation 2015/2283, and it has still not been authorised.