Proposal for a Regulation on Novel Food

Presentation by the European Commission during the AGRI Committee meeting on Tuesday 23rd September 2014

This proposal aims to ensure food safety, to protect public health and secure the functioning of the internal market for food, while supporting innovation for the food sector.

Definition of novel food Novel food refers to “all food that was not used for human consumption to a significant degree within the Union before 15 May 1997” (date of the entry into force of the Regulation (EC) 258/97 on novel food and novel food ingredients). Novel food includes:
  1. Food to which a new production process not used for food protection (within the Union before 15 May 1997 – as above) is applied where that production gives rise to significant changes in the composition or structure of food, which affects its nutrition value, the way it is metabolised or the level of undesirable substances
  2. Food containing or consisting of “engineered nanomaterials”
  3. Vitamins, minerals and other substances where a new production process has been applied as referred to the first point
  4. Traditional food from a third country that is derived from primary ingredients with a history of safe use in a third country
The European Commission decided not to include issues related to cloning of farms animals in this proposal deciding instead that this should be addressed in a separate proposal, based on impact assessment. Background information The aim of this proposal is to simplify rules on the authorisation and use of novel food and food ingredients under Regulation (EC) 258/97 on novel food and novel food ingredients in order to foster innovation in the food sector. The European Commission hopes the proposal will reduce the administrative burden, length and costs of the authorisation procedure for the food industry (18 months instead of three years), thus benefitting in particular SMEs. The current framework requires that a Member State food assessment body first assess an application for a pre-market authorisation. The Commission circulates the initial assessment report to all Member States for comments and objections. If no reasoned objections are presented, the novel food may be placed on the market. If, on the contrary, reasoned objections are formulated, the Commission requires an authorisation decision. This includes an additional assessment that is carried out by the Food Safety Authority (EFSA). This new proposal will replace the existing mechanism with a centralised EU-wide procedure, where applicants submit an authorisation to the European Commission, which request a scientific opinion on risk assessment from EFSA. Before taking its final decision to include a novel food in the permitted list of novel foods, the Commission will be assisted by the Standing Committee on the Food Chain and Animal Health (SCOFCAH). The general conditions for including a novel food are that the food:
  • Does not pose a safety risk to human health on the basis of the scientific evidence available
  • Does not mislead the consumer
  • Is intended to replace another food, and does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer
Debate in the European Parliament – 24 September 2014 Members of the Agricultural & Rural Development Committee questioned the European Commission on the following points:
  • Definition of novel food is too vague
EC response: the definition remains vague but it is as a result of negotiations with the Council, and EC does not want to extend the scope of the definition
  • How will labelling of novel food be regulated?
EC response: the new EU Regulation on Food Information for Consumers will contain a specific provision dedicated to the labelling of novel food in order to give consumers freedom of choice
  • How will the safety of novel food be ensured?
EC response: EFSA panel in charge of the risk assessment will be composed of EU scientific experts and representatives of Member States More information Read the European Commission’s proposal for a regulation on novel food here.  

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