Drinks consisting of fruit juice or nectars with added phytosterols. EC No. 60

ReferOctober 2004: Application from Coca-Cola Services S.A to approve fruit juices, fruit nectars and tomato juice with added plant sterols as a novel food. Applicaiton Status: passed to the European Commision.


Plant sterols 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. The phytosterol ingredient is supplied by Cargill Ltd. and the authorities in Finland have issued an opinion on its acceptability as a novel ingredient in various other foods. The applicant proposes to add 0.4% of phytosterols to fruit juices, including tomato juice and nectars. The labelling of Coca-Cola's proposed product will comply with Commission Regulation (EC) 608/2004 on the labelling of food with added plant sterols, and Council Directive 2001/112/EC relating to fruit juices and similar products. Before any novel food product can be introduced on the European market it must be rigorously assessed for safety in accordance with the Novel Foods Regulation (EC) 258/97.

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

Before any new food product can be introduced on the European market, it must be rigorously assessed for safety. In the UK, the assessment of novel foods is carried out by an independent committee of scientists appointed by the Food Standards Agency, the Advisory Committee on Novel Foods and Processes (ACNFP). Following an initial public consultation on the application and the discussion of this application by the ACNFP at the Committee has formulated a positive initial opinion on this refined echium oil. This opinion was passed to the European Commission, however other member states raised objections. 

No authorisation was reached prior to the 1st of January 2018, and the applicaiton was passed tot the European Commission under Novel Food Regulation (EC) 2015/2283.