The authorisation and use of novel foods and food ingredients have been harmonised in the European Union since 1997 when Regulation EC 258/1997 on novel foods and novel food ingredients was adopted. In 2013, the Commission presented a proposal for a new regulation on the matter. The co-legislators the European Parliament and the Council have reached an agreement with the new Regulation EU 2015/2283.
An applicant who intends to place on the EU market a novel food should submit an application to the European Commission. After having verified its validity, the European Commission makes it available to the Member States and mandates EFSA for a scientific assessment (Article 10).
The Authority shall adopt its opinion within nine months from the date of receipt of a valid application from the EC.
An applicant who intends to place on the EU market a traditional food from a third country, may opt to submit a notification of that intention to the European Commission (Article 14). In this event and after having verified its validity, the Commission shall forward the notification to the Member States and to EFSA. Within four months from this date the Member State or the Authority may submit to the EC duly reasoned safety objections to the placing on the market of the traditional food concerned. If duly reasoned safety objections have been submitted to the Commission the traditional food concerned shall not be authorised for its placing on the market (Article 15). In that case, the applicant may submit an application to the Commission including the documented data relating to the safety objections raised (Article 16).
EFSA will issue an opinion within 6 months from receipt of a valid application. Such procedure shall apply as of 1 January 2018.