Novel foods in Europe: Towards a simpler approval process?

There has long been a clear desire among both industry and the authorities for a revision of the European Union's Novel Foods Regulation. Manufacturers confused as to why certain nutritional products, which can be marketed in most regions of the world, face restrictions in the European Union (EU), will often find that their product contains an ingredient regarded as novel in the EU. The EU Novel Foods Regulation 258/97 applies to food and food ingredients that were not used to a significant degree for human consumption in the EU before 15 May 1997. It includes plant/algae, fungi/micro-organism and animal derived foods, and foods with a significant change in composition or structure. Since the Regulation entered into force in 1997 around 30 novel foods have been approved (such as phospholipides from egg yolk, rye bread with added phytosterols/phytostanols, and diacylglycerol oil of plant origin) out of more than 80 applications.

In January, the European Commission published its proposal to amend the Novel Foods Regulation — a proposal that has been several years in the making. It hopes to resolve some of the shortcomings in the Regulation, such as the administrative burden and lengthy process of the EU Member State first carrying out an assessment of the novel food application, and then choosing to forward the application on to EFSA for a further assessment (drawing out the process for up to three years); and the rigid approval process for traditional food from non-EU countries, which must currently undergo the same novel foods assessment as fairly new — and possibly unsafe — food ingredients.

The Commission's revision aims to dramatically simplify the procedure (reducing the timeframe for novel food applications from an estimated three years to ideally around one year) with the proposal that the Member State assessment be omitted so that the European Food Safety Authority (EFSA) can immediately assess the application. In this way double work is avoided. It also proposes that:

  1. A specific category for traditional food from non-EU countries should be created. The new category would enable these foods to be approved within a few months following simply a notification procedure with the Commission — on the condition that data showing a history of safe food use is available.
  2. Most authorisations will have generic status.
  3. The possibility of data protection should be allowed in justified cases, for example, for newly developed scientific evidence and/or proprietary data. A successful application would then give the company concerned a five-year exclusivity period, meaning that no other company will be allowed to use the approved food/food ingredient in that period.

The Commission's proposal is largely based on discussions with industry and stakeholders, and the next stage is for it to be discussed between the European Parliament and the Council to reach agreement and adopt a final text. As the process slowly moves forward, working within the provisions of the new Novel Foods Regulation may eventually become possible after 2010.

Article by Pieter Lagae, Regulatory Adviser, EAS, 50 Rue de l'Association, 1000 Brussels, Belgium. Tel: (+32 2) 218 14 70, Fax: (+32 2) 219 73 42, email [email protected], visit

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