The new Novel Foods Regulation ((EU) 2015/2283) went live on January 1, 2018. Its aim is to improve the conditions of food business operators bringing new and innovative foods to the EU market while maintaining a high level of food safety for European consumers.
The new Regulation replaces the former system of national authorizations for a simple, faster, centralized EU-procedure. On December 20, 2017, the long-awaited core element of the new regulation, the Union List of Novel Foods, was agreed upon and laid down in Implementing Regulation (EU) 2017/2470. From now on, all authorizations under the previous regulation (EC) 258/97 are generic. The Union list provides the specifications and conditions of use for these foods and food ingredients. Food business operators can directly market their products, provided that they meet the specifications in the Union List, and that the authorized conditions of use are observed. For the most recent version of the Union list (20 December 2017) click here. The list will be updated regularly. Whether and how these updates also include corrections of mistakes and inconsistencies needs to be seen.
The transition from product- and business-operator specific to generic authorizations is a big relief for many in the food business, but some manufacturers of very innovative products are probably deeply disappointed. One issue is that data protection for proprietary data under article 26 and 27 of (EU) 2015/2283 does not apply to those applications that only recently got their Novel Foods authorization under the former regulation. Applications that have not been finalized under the old regulation will be further processed pursuant to (EU) 2015/2283, but may now have the opportunity to request data protection under these articles.
In order to get an overview on the nutrition industry verdict about the new Novel Foods regulation, please read the following press release. As our expert Dr Steffi Dudek points out: “The new regulations certainly represent progress for traditional foods from third countries or for relatively simple products – exotic berries for example. But manufacturers of innovative synthetic or fermented ingredients who got authorisation under the old regulation after investing heavily in research will be disappointed that their proprietary data is not respected in the way they had hoped. I’m also concerned that some products that should be subject to their own authorisation might enter the EU market under a generic authorisation. It remains to be seen how companies will take the responsibility to assess the status of their products.”
On January 5th, the Commission launched an electronic submission form that has to be used for all types of future novel food applications. Applicants have to register on EU login website prior to first use. The e-submission allows applicants to follow-up their applications from the submission until the outcome, improving transparency. To support applicants in this application procedure, there is a user guide available. Make sure you have a look at it before you start!
If you have any question or would like our support, please get in touch with our expert in Novel Foods – Dr. Steffi Dudek: firstname.lastname@example.org.
Don’t miss any Regulatory News by signing up for our free monthly news digest: