Restrictions of use are set for the 20 substances of FGE.203rev1

Commission Regulation (EU) 2017/378, adopted on 3 March and published on 4 March 2017, amends the EU List of flavouring substances. Restrictions of use are set for the 20 substances of FGE.203rev1


In the European Union (EU), the use of flavouring substances for the purpose of flavouring food is regulated through a positive list (Annex I to Regulation 1334/2008), that was established in 2012 with Regulation EU 872/2012. The European Flavour Association (EFFA) and its members fully support this approach to act in the best interest of consumers and to enable them to enjoy safe and tasty foods & beverages. Now, with the Commission Regulation (EU) 2017/378, the Union List (UL) is amended so as to set conditions of use for twenty flavouring substances.

What are these substances?

The twenty flavouring substances for which conditions of use are set are part of a so-called “Flavouring Group Evaluation” (FGE.203rev1). This group includes some representative substances for which the European Food Safety Authority (EFSA) CEF Panel considered in its opinion from 10 April 2014 that “the safety concern cannot be ruled out” and further concluded that “[…] the substances of this FGE cannot be evaluated through the Procedure”.

Support by the Flavour Industry

EFFA and its members (the flavour industry) fully support the ongoing safety evaluation program of flavourings by EFSA and have therefore, following this EFSA opinion, conducted additional genotoxicity studies for the main substances of this group in order to provide more data that could rule out the safety concern.

All corresponding additional data have been submitted to the EU Commission well in advance of the foreseen legal deadline. All new data submitted supported a conclusion for a lack of genotoxic potential for these substances. According to our findings, they pose no harm to human health (if applied according to current use levels and consumed in food offered in stores across Europe).


Actions from the Commission

Pending the final EFSA opinion based on the new data, the Commission decided to publish the current Regulation to restrict the conditions of use of the substances of this group. This Regulation will freeze the use of these substances to their current uses, based on information provided by the industry.

The proposal was posted on the Directorate-General for Health and Food Safety website and open for public consultation in October 2016, then voted by the Member States in Standing Committee on Plants, Animals, Food and Feed in November.

After the 60 days for WTO-notification, and as anticipated, it was published, under Regulation 2017/378, on the 4th of March 2017 in the EU Official Journal. It will enter into force the 20th day following its publication, i.e. on 24 March 2017. It shall be binding in its entirety and directly applicable in all Member States.

EFFA offers to further support the process and contribute to the best interest of consumers across Europe.

If you have further questions, please do not hesitate to contact EFFA at or a national flavour association, whose contact details are listed in our website.


EFFA Secretariat