Technology can move fast and an update was needed of the 20 year old legislation on novel foods, to simplify the authorisation process and take into account new developments.
Directly applicable EU Regulation 2015/2283 on Novel Foods (the Regulation) came into force on 1st January 2018. Enforcement provisions are provided by Novel Food (England) Regulations that will come into force on 8 March 2018.
The main change is that initial assessments of novel food applications are now undertaken at EU level by the European Food Safety Authority (EFSA) and deadlines have been introduced to improve efficacy.
EFSA recently published guidance on the presentation of new applications pursuant to Article 10 of Regulation (EU) 2015/2283. The Guidance contains a checklist regarding the documentation required by article 10 of Regulation 2015/2283 and tables in order to summarise the accompanying scientific studies .
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. The information required for notifications and applications is provided in further implementation Regulation (2017/2468).
The general criteria for the definition of a novel food is unchanged; a ‘novel food’ is a food or food ingredient which has not been consumed to a significant degree prior to 15 May 1997, but categories of novel foods have been expanded (i.e. insects, vitamins, minerals, food supplements etc.)
A faster and structured notification system for traditional foods from third countries on the basis of a history of safe use is introduced by the Regulation. If the safety of the traditional food can be established from evidence of history of consumption in that third country (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 EU list of novel foods is published in implementing 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. Under the new Regulation all authorisations are generic. This means that any food business operator can place an authorised Novel Food on the EU market, provided the authorised conditions of use, labelling requirements and specifications are respected.
However, alongside this, promotion of innovation is provided by some data protection provisions. The Regulation grants an individual authorisation for a non-renewable five-year period of data protection, if the applicant requests it and the application is based on newly developed scientific evidence and proprietary data.