Novel Food
The term “Novel Food” refers to novel foods and novel food ingredients which had not been used for human consumption to a significant degree before 15 May 1997 and which fall under one of the following categories:
- foods and food ingredients with a new or intentionally modified primary molecular structure;
- foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
- foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals (except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use);
- foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.
- Examples of Novel Foods are fruit juices like noni juice, milk or yoghurt enriched with phytosterols or phytostanols, …
Tools to prove that a food or food ingredient is not a novel food (.PDF)
1) Regulation
The rules with regard to the marketing of Novel Foods have been harmonised at European level through the Regulation (EC) No 258/97 of 27 January 1997 concerning novel foods and novel food ingredients (.PDF).
Novel Foods must not present a danger for the consumer, mislead the consumer or have adverse effects.
This Regulation shall not apply to food additives, flavourings and extraction solvents used in the production of foodstuffs.
Since the date of applicability (18 April 2004) of Regulation (EC) No 1829/2003 on genetically modified food and feed, genetically modified organisms (GMOs) intended for use as food or feed no longer fall within the scope of Regulation No 258/97 either.
2) Authorisation procedure
Before Novel Foods may be placed on the market, they must be subjected to a scientific assessment. This assessment will determine whether an authorisation will be granted for the marketing of the product in question in the Community.
The authorisation procedure as described in Regulation (EC) No 258/97 lays down that authorisation applicants must submit a file to the competent authorities of the member state where the product will be marketed for the first time. The member state in question has to make an initial assessment of the product, decide whether an additional risk assessment may be needed and submit its assessment report to the European Commission and the other member states.
In Belgium, it is the Superior Health Council that carries out the scientific assessment of Novel Foods.
If neither the European Commission nor the other member states make remarks with a view to the marketing of the new product and no additional assessment is needed, the product may be placed on the market.
In all other cases, the European Commission shall take an authorisation decision after consulting the Standing Committee on the Food Chain and Animal Health. This authorisation decision (EC Decision) mentions the scope of the authorisation and, if necessary, the conditions of use, the designation of the product and its specifications as well as specific labelling requirements.
More information about the European legislation on Novel Foods can be found on the website of the European Commission - DG SANCO (WEB).
That website also provides you a list of the applications for Novel Foods (WEB) that have been submitted since May 1997 as well as a list of the authorisations that have been granted for Novel Foods (WEB).
3) Notifications
Besides the general authorisation procedure described above a simplified procedure is provided for, which only requires a notification. This procedure only applies to specific Novel Foods which, on the basis of the scientific evidence available and generally recognised or on the basis of an opinion delivered by a competent body, are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein.
Here you will find a list of the Novel Foods that have been notified (DG SANCO) (WEB).
4) Services
The competent authority for Novel Foods in Belgium is the Department for Foods, Animal Foods
and Other Consumption Products (DG for Animals, Plants and Foodstuffs). This Department (see ‘Contact’) can:
- provide general information about Novel Foods and their legislative basis
- provide practical information with regard to the authorisation application or the notification of a product
- have an exploratory consultation with the applicants
- assess your file
- examine whether a product should be considered as a novel food or not.
- …
- Of course, all information will be treated confidentially.
Learn more in the: Information brochure on Novel Food (.PDF)
Published on 04/10/2012 – Page last updated on 04/10/2012
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