New rules on the marketing of “novel foods” will be introduced across the entire European Union as soon as 1 January 2018. This is the effective date of Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods.

Novel food is any food or ingredient that was not used for human consumption to a significant degree within the Union before 15 May 1997, when the first EU novel foods regulation entered into force (Regulation 258/97). Then novel foods were defined to include not only foods produced via novel processes and as such not existing before (e.g. baker’s yeasts undergoing UV treatment to increase vitamin D content), but also certain foods which have been consumed for ages in other countries of the world (e.g. chia seeds).

The general structure of the novel food definition remains unchanged. Novel foods continue to be foods that have been newly developed or are innovative or produced using new technologies, as well as foods originating from third countries if they have a proven history of safe use. However, given the scientific and technological developments since 1997, it became necessary to review, clarify and update food categories falling within the definition. The Union legislature has decided that these categories should include, for example, insects and their parts and food with a new or intentionally modified molecular structure.

The major change is that it will be procedurally easier to authorise novel foods to be placed on the market.

The long wait time to obtain marketing authorisation for novel foods has been the biggest challenge for food business operators so far. Efficiency and transparency are to increase thanks to the introduction of deadlines for safety review and food authorisation procedures.

Novel food applications will be dealt with by the European Commission. Authorisation will depend, inter alia, on safety evaluation by the European Foods Safety Authority (EFSA).

The new regulation also introduces the EU list of novel foods authorised by the Commission. Only foods from that list can be placed on the market within the Union.

The regulation lays down a faster and more proportionate system for the safety review of traditional foods from third countries (which are novel foods in the EU). To be considered traditional, those foods should have been consumed in at least one third country for at least 25 years as a part of the customary diet of a significant number of people. If such a traditional food has a proven history of safe use and no Member State submits any safety objections, it can be placed on the market on the basis of a notification.

 

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Check what we refer to:

  • Regulation (EU) 2015/2283 of the European Parliament and of the Council  of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 – see here;
  • Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients – see here.