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Novel foods and food ingredients

The rules for authorising novel foods and food ingredients are harmonised at European level. Before they are placed on the market, tests carried out by the European Food Safety Authority must demonstrate that these products do not pose any risk to health or the environment.


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 amending act(s)].


The novel foods and food ingredients concerned by this Regulation are those which are not yet currently used for human consumption.

Novel foods and food ingredients

This Regulation applies to foods and food ingredients in the following categories:

  • foods and food ingredients which present a new or modified primary molecular structure;
  • foods and food ingredients which consist of micro-organisms, fungi or algae;
  • foods and food ingredients which consist of or are isolated from plants and ingredients isolated from animals;
  • foods and food ingredients whose nutritional value, metabolism or level of undesirable substances has been significantly changed by the production process.

The Regulation is not applicable to food additives, flavourings, extraction solvents, nor to food enzymes (which are the subject of Regulation (EC) No 1332/2008).

Genetically Modified Organisms (GMOs) are no longer covered by this Regulation, but by Regulation (EC) No 1823/2003 instead.

Furthermore, foods and food ingredients covered by this Regulation must not:

  • present a danger for the consumer;
  • mislead him/her;
  • be nutritionally disadvantageous for him/her.

Evaluation procedure

The foods and foods ingredients referred to in the Regulation must undergo Community assessment before being placed on the market.

Under the assessment procedure, the competent body of the Member State which receives an application must make an initial assessment and determine whether or not an additional assessment is required. If neither the Commission nor the Member States raise an objection, and if no additional assessment is required, the Member State informs the applicant that he may place the product on the market. In other cases an authorisation decision is required. This decision is adopted in accordance with the measures proposed by the Commission within the Committee on Food Safety and Animal Health.

The decision defines the scope of the authorisation and specifies, as appropriate, the conditions of use, the designation of the food or food ingredient, its specification and the specific labelling requirements.

Any decision or provision concerning a novel food or food ingredient which is likely to have an effect on public health must be referred to the Scientific Committee for Food.


The Regulation lays down specific requirements concerning the labelling of novel food and food ingredients which have been added to the European general requirements on food labelling.

Without prejudice to the general requirements of European legislation concerning the labelling of foodstuffs, the labelling of novel food and food ingredients must mention:

  • any characteristics such as composition, nutritional value or the intended use of the foodstuff;
  • the presence of materials which may have implications for the health of some individuals;
  • the presence of materials which give rise to ethical concerns.

Suspension procedure

Member States are authorised to suspend or restrict provisionally the marketing and use in their territory of any novel food or food ingredient if they believe that its use constitutes a health hazard or a risk to the environment. They inform the Commission, which takes steps in accordance with the procedure regarding authorisations for placing products on the market.


ActEntry into forceDeadline for transposition into the Member StatesOfficial Journal
Regulation (EC) No 258/97



OJ L 43 of 14.2.1997

Amending act(s)Entry into forceDeadline for transposition in the Member StatesOfficial Journal
Regulation (EC) No 1829/2003



OJ L 268 of 18.10.2003

Regulation (EC) No 1882/2003



OJ L 284 of 31.10.2003

Regulation (EC) No 596/2009



OJ L 188 of 18.7.2009

The successive amendments and corrections to Regulation (EC) No 258/97 have been incorporated into the original text. This consolidated version is of documentary value only.

Last updated: 20.01.2011
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