Foods and food ingredients that have not been used for human consumption to a significant degree in the EU before 15 May 1997 are "novel foods" and "novel food ingredients".

Novel foods and novel food ingredients must be:

• Safe for consumers;
• Adequately labelled to not mislead consumers.

Regulation EC 258/97 sets the rules for the marketing of novel foods and novel food ingredients.

Risk assessment

Companies must apply for authorisation and present the scientific information and safety assessment report to market a novel food or novel food ingredient to an EU country authority.

Novel foods and novel food ingredients are assessed before they reach the market.

• A EU country's competent authority assesses the application and decides if additional assessment is necessary;
• It allows the marketing of the product if no additional assessment is necessary and if the Commission and EU countries do not object.

All other cases require an authorisation decision.

Before the approval The Commission otherwise asks for an opinion in the Standing Committee on Food Chain and Animal Health .

The Commission sends decisions on a novel food or ingredient likely to affect public health to the Scientific Committee for Food.

The scope of the authorisation:

• Establish conditions of use,
• Designation of novel food or novel food ingredient,
• Where appropriate specification and labelling requirements.

In certain cases a novel food or a novel food ingredient may be placed on the market under a "simplified procedure". A company may notify the Commission about their placing on the market of a novel food or a novel food ingredient based on an opinion of a Food assessment body concerning the "substantial equivalence".

Safeguard measure (Art 12 of the Regulation EC 258/97)

If new information or re-assessment becomes available so that an EU country has reason to consider that a novel food or a novel food ingredient poses a risk to human or environmental health the EU country may suspend or temporarily restrict the marketing and use of any novel food or novel food ingredient on their territory.

They inform the Commission who after consideration of the case will take the measures either to extend the Member State's measure to all EU countries or to request that Member State to repeal its measure.

Excluded from the rules for marketing novel foods or novel foods ingredients are foods and food ingredients for which an approval system exists:

• Food additives within the scope of Directive 89/107/EEC - approximating EU countries' laws on food additives;
• Flavourings for use in foods within the scope of Directive 88/388/EEC - approximating EU countries' laws on flavourings.
• The use of foods and/or food ingredients in the EU exclusively as, or in, food supplements would not be considered to be significant human consumption within the meaning of Regulation (EC) N° 258/97. Therefore, other food uses, i.e. ";non-food supplement" use, would require authorisation under the Regulation;
• Extraction solvents used in the production of foods within the scope of Directive 88/344/EEC - approximating EU countries' laws.
• Regulation (EC) No 1829/2003 on genetically modified organisms for food and feed
• Food supplements are subject to Directive 2002/46/EC - approximation of laws on food supplements.

Requirements for labelling of novel food and ingredients are in addition to the European general requirements on food labelling. Where appropiate and without prejudice to those, the labelling of novel food and novel food ingredients may mention:

• Characteristics - composition, nutritional value, intended use of the foodstuff;
• Presence of materials which may affect the health of some individuals;
• Presence of materials that give rise to ethical concerns.

Recommendation 97/618/EC - application rules

Applications for authorisation of a novel food; Updated 16-09-2011

Notifications of novel foods; Updated 12-09-2011

Related Opinions of the Scientific Committee on Foodstuffs on novel foods.