EFSA has published two guidance documents on novel food and traditional food from third countries to help ensure that these foods are safe before risk managers decide whether they can be marketed in Europe. EFSA involved stakeholders closely when developing the guidance.
The new guidance documents explain in detail
- the kind of information applicants need to provide for risk assessment.
and
- how to present this information before EFSA can assess the safety of the novel or traditional food.
EFSA developed the guidance following the adoption of the new European regulation on novel food in November 2015. The regulation, which replaces the previous one from 1997 and comes into effect in January 2018, introduces a centralised assessment and authorisation procedure. EU risk managers will decide on the market authorization of novel foods and may ask EFSA to conduct a scientific risk assessment to confirm their safety.
Applicants submitting novel food applications need to present data describing the product. Dossiers should include the following information:
- data on the compositional, nutritional, toxicological and allergenic properties of the novel food
- information relating to the production process
- the proposed uses and use levels.
EFSA addresses traditional food from third countries (non-EU countries) in a separate guidance document. Applicants need to present evidence of safe use of the traditional food in at least one country outside of the EU for a period of at least 25 years. EFSA and Member States will assess the evidence in parallel procedures.
