The Commission considers foods and food ingredients that have not been used for human consumption to a significant degree in the EU before 15 May 1997 novel foods and novel food ingredients.
They must be:
- Safe for consumers;
- Properly labelled to not mislead consumers.
Risk assessment before the marketing of novel foods and ingredients
To market a novel food or ingredient, companies must apply to a EU country authority for authorisation, presenting the scientific information and safety assessment report.
- The competent authority 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.
- Before approving, the Commission asks the Standing Committee on Food Chain and Animal Health for an opinion.
- Conditions of use,
- Designation of novel food or novel food ingredient,
- Specification and labelling requirements.
Simplified procedure - notification
A novel food or ingredient may be marketed through a simplified procedure called "notification". The company notifies the Commission about their marketing a novel food or ingredient based on the opinion of a food assessment body that has established "substantial equivalence".
The Commission sends decisions on a novel food or ingredient likely to affect public health to the Scientific Committee for Food.
Requirements for labelling of novel food and ingredients are additional to the general EU requirements on food labelling. Where necessary, labelling of novel food and novel food ingredients may mention:
- Characteristics - composition, nutritional value, intended use;
- Materials which may affect the health of some individuals;
- Materials that give rise to ethical concerns.
If a EU country considers a novel food or ingredient a risk to human or environmental health because of new information, it may suspend or temporarily restrict the marketing and use of any novel food or ingredient on their territory.
The country informs the Commission which either extends the national measures to all EU countries or asks that they are repealed.
Regulation EC 258/97 – Article 12
What the Novel Food Regulation does not cover
The Regulation does not cover foods and ingredients for which an approval exists:
- Food additives within Regulation EC 1333/2008;
- Flavourings for use in foods within Regulation EC 1334/2004;
- Extraction solvents used in the production of foods within Directive 2009/32/EC - approximating EU countries' laws;
GMOs for food and feed - Regulation EC 1829/2003;
- If foods and/or food ingredients were used exclusively in food supplements, new uses in other foods require authorisation under the Novel Food Regulation e.g. food fortification require authorisation.
Authorisations and refusals for marketing of novel foods and ingredients
Applications for authorisation and their status Updated 25-06-2012
Notifications of novel foods Updated 29-04-2013
Opinions of the Scientific Committee on Foodstuffs on novel foods.
Recommendation 97/618/EC - application rules.
This information has been collected since the Novel Food Regulation entered into force.