Juices and Nectars with Phytosterols. EC No. 60

Coca-Cola Service's application to approve fruit juices, fruit nectars and tomato juice with added plant sterols as a novel food. Application Status: passed to the European Commission.


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. 

Legal Background

Before a novel food can be marketed legally in the 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 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 assessed for safety. In the UK, the assessment of novel foods is carried out by the Advisory Committee on Novel Foods and Processes.

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 application was passed to the European Commission under Novel Food Regulation (EC) 2015/2283.