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anses

French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 06/09/2016

Novel foods and food ingredients

Definition, regulatory framework and presentation of the Agency's role

Keywords : Nutrition, Novel foods, Nutrivigilance

Novel foods are foods or food ingredients that were not used for human consumption in the European Community before 1997. They can be of plant or animal origin, resulting from scientific and technological research, or from the food traditions or cultures of third countries.Find out what these foods are and the role played by ANSES in their assessment.

What do we mean by novel foods?

"Novel foods" are foods or food ingredientsthat were not consumed, or only in negligible quantities, in the European Union before 15 May 1997. To belong to this category, they must also have one or more of the following characteristics:

  • have a new or deliberately modified primary molecular structure;
  • consist of or be isolated from micro-organisms, fungi or algae;
  • consist of plant matter or be isolated from plants or animals (unless they are obtained by traditional propagating or breeding practices and have a history of safe food use);
  • be produced by a process which is not commonly followed (where that process gives rise to significant changes in their nutritional value, metabolism or content in undesirable substances).

Novel foods are defined in European Regulation EC no.258/97, currently being revised.

This Regulation does not apply to food additives, flavourings and extraction solvents

Examples from among the wide diversity of ingredients or foods covered by this Regulation include magnolia bark extract, phytosterols, guar gum, noni juice, dehydrated baobab fruit pulp, etc.

 

Marketing Authorisation: the European system and the role of ANSES

The marketing of novel foods in Europe requires prior authorisation after a national investigation by the Member States’ health authorities, subject if necessary to arbitration at EU level on the basis of an Opinion by the European Food Safety Authority (EFSA).

The system is designed to ensure consumer safety concerning:

  • the potential toxicity of the product
  • any potential nutritional imbalance that could result from introducing it into the overall diet.

Manufacturers submit applications for marketing authorisation to a Member State. The Member State is required to submit an initial assessment report to the European Commission.The other Member States contribute any remarks in the form of a secondary assessment report. The European Commission takes the final decision, after consulting EFSA if it chooses to do so.

If the Commission's decision is favourable, the novel food can be sold throughout the European Union. The authorisation issued only concerns the product assessed: any use of the same ingredient in a different food matrix must undergo a new assessment.

In France, ANSES is the competent organisation for carrying out initial and secondary assessments, at the request of the DGCCRF (Directorate General for Competition, Consumer Affairs and Fraud Control).

On the basis of a re-evaluation or new data, a Member State may, temporarily, restrict or suspend the marketing authorisation for a novel food within its territory, if it has reason to believe that its consumption presents a risk. The Member State notifies the European Commission, which consults EFSA and, ultimately, decides whether or not to validate the restriction on marketing.