Novel Food Authorisation in the EU – Taking the Right Steps

Posted 21 April, 2016

The new novel food regulation introduces a centralised authorisation procedure (Regulation 2015/2283). Even though the regulation will only be applicable from the 1st of January 2018, food business operators need to be aware of some crucial changes which the regulation brings.

A choice of two procedures

Two different procedures can be used from the 1st of January 2018 to submit a product for approval in the European Union, each one applicable to a particular case:

  • The authorisation procedure for novel foods
  • The authorisation procedure for traditional foods from a third country

The initial definition of a novel food is ‘any food which was not consumed in the EU to a significant degree before 15 May 1997’. Thus, novel foods can be newly developed or innovative food produced using new manufacturing processes, or food traditionally eaten outside of the EU but not commonly consumed in the EU before 1997.

‘Traditional food from a third country’ is a food derived from primary production with a history of safe use in a third country for at least 25 years. It can be processed or unprocessed food consisting of, isolated from, or produced from:

  • Plants/animals or their parts
  • Micro-organisms, fungi or algae
  • Cell or tissue culture derived from the above

Examples of already authorised novel foods which could have followed this application process are noni fruit juice, chia seeds or baobab dried fruit pulp.

Simplified approval path

With the new process, all applications will be submitted directly to the European Commission (EC), instead of to individual Member States, which until now were carrying out the initial safety assessments. From 2018, EFSA will conduct a scientific risk assessment for novel food applications where necessary.

novel-food-autorisation-clock third-country-authorisation

How to take advantage of the procedure

The authorisation procedure will vary according to the type of novel food seeking approval. This process is dynamic and the underlying dossier must be prepared carefully to ensure that scientific progress and new regulatory requirements are respected in order to avoid unnecessary and costly delays in the evaluation process. Crucial steps include:

  • Drafting a proper and accurate application dossier
  • Opening a dialogue with the authorities and monitoring progress as the application is evaluated
  • Handling ‘additional information requests’ promptly and professionally

Getting it right

It is essential to decide on a realistic strategy to gain authorisation under the new rules. Pen & Tec can help. With over 30 years’ experience of European food regulations and regular contact on behalf of our clients with the EC, EFSA and EU Member States, we work with applicants to identify the most favourable strategy for obtaining authorisation. Our experience also means we can often anticipate questions and potential pitfalls in order to reduce delays before a product can be taken to market.