Changes in approval of novel foods
By Alison Sharper - 12 February 2018
The new Novel Foods Regulation (2015/2283) applies from 1 January 2018 and revoked the previous legislation that had been in force for 20 years. So what changes does this bring to the definition of novel food and its authorisation process?
The previous regulation (258/97) was updated to simplify the authorisation procedures and to take account of technological progress. The general criteria for the definition of a novel food remains unchanged - a ‘novel food’ is a food or food ingredient which has not been consumed to a significant degree prior to 15 May 1997. Due to developments in science and new food sources, the EU has reviewed and updated the categories of novel food, including, for example, nanomaterials and whole insects.
If you are unsure whether a food or ingredient is novel, you should consult the Member State where you first intend to market the novel food. The Member State may consult other Member States and the Commission. The implementing Regulation - yet to be adopted by the Commission - will detail how Member States can consult other Member States and the Commission on the status of a novel food
Once it has been determined that a food or ingredient is novel, it must be evaluated. Deadlines for the safety evaluation and authorisation procedure have been laid down to encourage innovation and improve the efficiency of the authorisation process.
One of the main changes is that the approval procedure has been centralised - safety evaluations will now be carried out by the European Food Safety Authority instead of Member States. A further implementation Regulation (2017/2469) describes the information required when submitting an application.
Foods that have only been considered novel since the introduction of the new rules and which have been on sale from 1 January 2018 may remain on the market until a decision is taken on their authorisation. Applications must be submitted by January 2019 and a decision will be made by January 2020 at the latest.
A faster and structured notification system for traditional foods from third countries has been introduced on the basis of a history of safe use. If the safety of the food can be established on this basis (i.e. consumed in at least one third country for at least 25 years and as part of the customary diet of a significant number of people in at least one third of the country) and there are no safety concerns raised by Member States or EFSA, the traditional food may be placed on the EU market. If safety concerns are raised, the applicant must submit an application. The information required for notifications and applications is provided in a further implementation Regulation (2017/2468).
All authorisations are generic unlike the applicant-specific, restricted novel food authorisations under the old regime. As a result, you may place an authorised novel food on the market, as long as the conditions for use and the labelling requirements are respected. However, an applicant can benefit from data protection provisions which are introduced in the Regulation. The newly developed scientific evidence and proprietary data provided in support of a novel food application will receive a non-renewable five-year period of data protection, if the applicant requests it.
The Union list of novel foods has now been published in Regulation (2017/2470) and includes the details of possible conditions of use, additional specific labelling requirements and relevant specifications. Any newly approved novel foods will be added to this list.