Novel Foods
Novel foods are regulated under Regulation 2015/2283 which repeals and replaces Regulation 258/97 and Regulation 1852/2001. The latter were in force until 31 December 2017.
The current regulation stipulates that foods belonging to certain categories which have not been used for human consumption to a significant degree within the EU before May 15, 1997 require an authorization before they can be placed on the market.
The responsibility to prove that a food has been consumed to a significant degree before May 15, 1997 lies with the food business operator. Thus, food business operators must provide such proof in their application.
The new regulation established the Union list of novel foods compiling all the authorized novel foods in the European Union up to date.
However, it must not be mistaken with the EU Novel Food Catalogue which solely gives an overview of the currently obtained information regarding history of use and lists mostly botanicals. The list has however no normative status and can therefore only be relied on as an informative instrument. Note that for botanical extracts, the novel food status is particularly complex. This is because in some cases the novel status of an extract only coincides with a specific part of the plant.
Food Compliance Int. has extensive expertise in the field of novel foods. We advise our clients on the novel food status of ingredients and we prepare application dossiers for full authorizations and substantial equivalence authorizations

Success Stories
We represented the world's top dairy producer in a high profile application for the use of the term "probiotic"; in the EU, coordinating the work in several EU countries
01We represented one of the global leaders in the life science markets refuting a forthcoming Spanish policy directly affecting one of their top-grossing ingredients, by filing a complaint before the European Commission
02We represented one of Japan's largest food-processing companies in the impact of new GMO rules for their products in Poland and Russia
03We advised one of the world's leading companies in the healthcare and medical products industry with their communication strategy on health claims on their flagship line of products
04We performed the regulatory due diligence in a multi-million dollar acquisition of a food ingredients producer by an animal by-products processing company
05We represented one of the world's fruit and fruit juice manufacturers on the conformity of the labelling of their new products in several jurisdictions
06We advised the world's number one online food supplement store in their expansion in the EU with their own line of products
07We analyzed composition and labelling of their products, classified them and placed them on several EU countries
08We represented a publicly traded pharmaceutical company based on several food policy issues such as advertising claims, withdrawals and recalls and the placing on the market of novel food
09We advised one of the world's largest food ingredients companies on a high profile, highly confidential issue with one of their top-grossing products in a EU country
10We assisted a food sector association in advocating a policy revision by the European Commission in relation to health claims
11We helped one of the world's leading pharmaceutical companies with the negotiation with the authorities in connection with the withdrawal of one of their flagship products from the market
12We helped several governments to draft several food safety policies
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EU NOVEL
FOOD NEWS
FREQUENTLY ASKED QUESTIONS ON NOVEL FOODS IN THE EU
What is a novel food?
Are there different categories of novel foods?
Are insects considered as novel foods?
How are nanomaterials defined?
How is determined the novel food status of a food?
What is the Union list of novel foods?
What is the Union catalogue of novel foods?
What are the information needed to obtain a novel food authorisation?
Where is the application to be submitted?
Which European institutions are involved in the application review?
How long does it take to obtain an authorization?
If the Commission does not authorized the novel, can the applicant appeal the decision?
Can the applicant request confidential treatment of the information they disclosed during the procedure of application of the novel food?
Can the applicant request data protection of scientific evidence that supported their applicant?
Can a health claim for the novel food benefit from data protection?
Are the authorisations generic?
Are there any compulsory measures in place after the authorisation of the novel food?
Are traditional foods from third countries subjected to the same assessment procedure as novel foods?
Does EFSA take part to the application review of traditional foods?
May Member States take part to the application review of traditional foods?
Can the applicant appeal the decision of the Commission following safety objections?
How long does it take to obtain an authorization?
23. Is data protection applicable to notifications and applications of traditional foods from third countries?
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