Phytosterol-esters in 'milk' and 'yogurt' type products. EC No. 39

August 2002: Application from Unilever for approval of phytosterol-esters to be included as a cholesterol-lowering ingredient in 'milk' and 'yogurt' type products. Authorised March 2004.


This is an application submitted by Unilever for an extension of use for phytosterol-esters.  Previously, they submitted an application of use of phytosterol-esters in Yellow Fat Spreads, which was approved under Commission Decision 2000/500/EC of 24 July 2000.

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.

Here, the extension of use would include The 'milk' type products including skimmed, semi-skimmed and vegetable oil based milk variants. The 'yogurt' type products include a range of natural and fruit flavoured yogurts. It is understood that, under EU milk legislation (EC Directive 95/2) and the varying national legislation across member states covering yogurt, the addition of phytosterol-esters, and other ingredients required to stabilise the products, will prevent the use of the term 'milk' and 'yogurt', to describe these Novel Foods.

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: Authorised

The application for an externsion of use for phytosterol-esters in milk and yougurt types products which was assessed by the UK under Regulation 258/97 (EC). The application was accepted in  August 2002 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 completed its assessment and published its positive opinion. This opinion was shared with the other Member States resulting in the product being authorised by the EU subject to the conditions specified in the authorisation. This extension of use was authorised under Commission Implementing Decision (2004/335/EC).