10 Nov 2016

A critical step in the establishment of the new EU novel food Regulations

Continuing with our discussions on the changes to the EU novel food regulations [Regulation (EU) 2015/2283], the European Food Safety Authority (EFSA) has just published the final guidance documents for the new set of regulations on 10 November 2016. Two sets of documents were released:

  • Guidance on the preparation and presentation of an application for authorisation of a Novel Food
  • Guidance on the preparation and presentation of a notification for authorisation of Traditional Foods from third countries (i.e., a country outside of the EU)

As discussed in my previous blog, EFSA launched an open consultation on draft versions of these guidance documents in February 2016 with comments accepted until 21 April 2016. All comments were considered and the guidance documents are now finalized.

The guidance for application for novel foods provides for a much more detailed guidance compared to the guidance document for the original novel foods regulation (i.e., Regulation (EC) No 258/97). In particular, the safety section is in line with the guidance for food additives in that a tiered approached is used to determine the level of safety data that is required for a particular novel food. This guidance document also outlines specific requirements for various types of novel foods including chemical substances, foods produced from microorganisms, foods produced from plants, and foods consisting of engineered nanomaterials etc.

The guidance for a notification for authorisation of Traditional Foods from third countries details the various technical data that is required for specific types of traditional foods including foods from microorganisms, foods from plants, etc. This guidance also outlines the documentation that is required to demonstrate the experience of food use in the third country such as extent of use, cultivation/harvesting, consumption levels, role in the diet, specific population characteristics, and preparation precautions.

While these documents contain much detail, navigating these documents and determining what data is required for a particular novel food will not always be a simple task. Intertek's EU food regulatory experts have been watching the development of these guidance documents closely and are well versed in assisting companies with this daunting task.

In my opinion, as veteran of more than 35 full novel food approvals, and someone that has worked with novel foods since its inception in 1997, this is the best set of guidance yet to come out of EFSA in this area and has been eagerly awaited. We can assist our clients in complying with the new guidance in order to achieve approvals in a more straightforward and time efficient manner.

You may be interested in...