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
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 countries01
We 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 Commission02
We represented one of Japan's largest food-processing companies in the impact of new GMO rules for their products in Poland and Russia03
We 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 products04
We performed the regulatory due diligence in a multi-million dollar acquisition of a food ingredients producer by an animal by-products processing company05
We represented one of the world's fruit and fruit juice manufacturers on the conformity of the labelling of their new products in several jurisdictions06
We advised the world's number one online food supplement store in their expansion in the EU with their own line of products07
We analyzed composition and labelling of their products, classified them and placed them on several EU countries08
We 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 food09
We 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 country10
We assisted a food sector association in advocating a policy revision by the European Commission in relation to health claims11
We 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 market12
We helped several governments to draft several food safety policies13
Conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA
Aug 10, 2022