New legislation and guidance on novel foods

Food technology is moving fast, with insect-based foods, foodstuffs from cloned animals and foods based on single-celled organisms being proposed as ways to address the problems of feeding a growing world population, and new ingredients and supplements under development. But promoting innovation needs to go hand in hand with ensuring consumer safety.

European legislation defines novel food as foods that have not been consumed to a significant degree by humans before 15 May 1997. This apparently arbitrary cut-off date reflects the fact that the original EU legislation came in in that year. The 1997 law has now been replaced by new EU Regulation 2015/2283, in force from the start of 2018.  Enforcement provisions for England (the Novel Food (England) Regulations) took effect from 8 March 2018.

The aim of the changes is to enable business to bring innovative foods to the market efficiently, while maintaining high levels of safety for consumers. The categories of novel foods covered have been expanded. There are now ten categories, including:

• food with a new or intentionally modified molecular structure
• food consisting of, isolated from or produced from microorganisms, fungi or algae
• food consisting of, isolated from or produced from cell culture or tissue culture
• food consisting of engineered nanomaterials. This category includes materials with dimensions of 100 nm or less, or larger structures that retain nanoscale properties, such as large specific surface area. This definition is subject to review and updating.

Insects and food from cloned animals are included within the categories of novel foods from animal sources. Note that GMOs do not fall within this regime. They are dealt with under separate legislation.

Initial assessments of novel food applications will now be undertaken at EU level by the European Food Safety Authority (EFSA) with new deadlines to improve efficiency.

EFSA recently published guidance on the presentation of new applications pursuant to Article 10 of Regulation (EU) 2015/2283, with checklists of the documentation required Regulation 2015/2283 and tables in order to summarise the accompanying scientific studies. 

The EU list of novel foods is published in an Implementing Regulation (2017/2470). This includes the details of conditions of use, additional specific labelling requirements and relevant specifications. Any newly approved novel foods will be added to this list.

A potential concern for innovative businesses is the non-proprietary nature of the authorisations. In contrast to the old system, any producer will be able to market an authorised novel food, provided that the conditions of use, labelling requirements and specifications are followed.

However, there is some protection for innovation. Newly developed scientific evidence and data cannot be used for the benefit of another application for five years after a novel food has been authorised without the innovator’s consent. To access this protection, the innovator must designate the data as proprietary when making its original application. And, of course, innovators can make use of intellectual property rights such as patents, trade secrets, plant variety rights, branding etc, to protect their investment.