In less than 10 days, the UK finally faces its departure from the European Union. Come 1^st February 2020, we will enter a year of transition before the separation becomes absolute. This will be a time of great legislative uncertainty. Despite having drawn all existing EU laws into the UK law books in an effort to ensure business continuity, there will be huge pressure from multiple directions and right now it’s anyone’s guess what the regulatory scape will look like for most business sectors in a few years’ time. Food, health and agriculture are all key areas that will become hotbeds for lobbyists – ourselves included.  

One of the most important legislative areas for the natural health sector is that of novel foods. That’s because classifying a food or food ingredient as novel puts a barrier in the way of getting it to market, one that must be negotiated, involving pre-market authorisation. On one hand, that may help protect the safety of consumers if the food is something lab-grown or genetically modified, to which humans have never been exposed. But if the food is intrinsically safe, the barrier may be too costly for some players to bring to market. Or it might take years to negotiate the regulatory obstacle course, denying consumers access to products that deliver important health benefits. Novel food classification, in short, can be used covertly by the corporatocracy to protect certain vested interests, while denying others.

While the new novel food regulatory framework, passed in the EU in 2015 (Reg 2015/2283), provides a clear, simplified route for foods and ingredients that have had over 25 years safe use in countries other than the EU, e.g. fruits and botanicals from Asia, there is still a significant financial burden in creating the dossier required for a novel food application.

With Brexit, however, the UK can no longer rely on assessments carried out by the European Food Safety Authority (EFSA). The UK’s Food Standards Agency (FSA) must now pick up the baton of assessor for novel foods that plan to be sold in the UK.

To find out the latest views from the FSA, Meleni Aldridge attended a Westminster Forum seminar last week to find out what companies and citizens can expect now that UK authorities assume control of this often controversial area of food law.

The first pill that the trade and consumers will need to swallow is that there will now be a need to process a separate UK application if a novel food is to be sold in the UK, and, if the product or food is also to be sold in the EU, a second application will have to be submitted for assessment by EFSA. Whilst much of the supporting data will be able to be used for both, it will increase the cost of the overall process, posing yet another barrier for smaller companies. Whilst the FSA will try to minimise the burden to companies by continuing to use EU tools and data sets, where appropriate, it will be more locally focused, UKcentric and not necessarily make

Check out Rob Verkerk and Meleni Aldridge’s log cabin chat in which they talk through some of the salient points about how the UK plans to handle novel foods post-Brexit.

Applying for novel foods in the UK

In the UK, it’s the Food Standards Agency (FSA), satellite scientific committees and laboratories that will be handling different aspects of novel food applications. The key focus will inevitably be on safety, the burden of proof being placed fairly and squarely on the applicant. This will require in-depth toxicological, consumption and safety data from countries where the ingredient/food might have been on sale and correlation of evidence of experience elsewhere and how that risk might be best managed in the UK. There is now also a need to profile all proteins in the product using mass spectroscopy given the link between proteins and allergenic reactions.

The new fast track process is described as ‘light touch’, as opposed to ‘no touch’, relative to the very elaborate applications of the past, but will still be a costly process. The FSA claims that this ‘light touch’ risk analysis process is going to require around 140 new personnel, made up largely of risk assessors and risk managers.

One of the very controversial areas relates to products containing cannabidiol (CBD) isolates, that have been classified as novel foods in the UK as well as at EU level, despite hundreds of brands still being on the market, technically illegally. Most are small producers who just don’t have the funds to jump through novel food legislative hurdles. The FSA were unequivocal on this point and we are awaiting release of a much-awaited report detailing how they are planning to handle the situation.

For further information on this area, please check out Rob Verkerk’s detailed article on CBD in this week’s newsletter and we will update you when the FSA’s report is published.

Novel trends

Application trends in the pipeline are in some of the following areas:

• Healthy foods, as components of a healthy diet or those that provide higher levels of ingredients e.g. algae oil with concentrated levels of fatty acids, botanicals for the for the mind (nootropics)
• Enriched foods e.g. vitamin D enriched mushrooms
• Ingredients thought to have a positive health effect e.g. Asian herbs that are still considered foods because they don’t meet the definition of a medicine
• New sources of protein e.g. insects (e.g. larvae of black sulphur flies), cultured meat, new protein isolates. The FSA is clear that it will be diligent in assessing risks and how they might impact vulnerable groups with special concern over the risk of allergenic reactions
• Biotech foods and products derived from gene editing (otherwise known as genetically modified organisms or GMOs)
• Products that benefit the circular economy and sustainability, e.g. ‘waste’ products (coffee berries, coffee leaves, grape vine leaves) and secondary products used in a new way
• Products that involve high pressure processing, ultra-violet treatment, new technologies and engineered nanoparticles.

What’s next?

If there is any good news, it’s that the UK is planning to process applications in 18 months as against 3 years for the EU. But of course it’s only good news for companies wanting to sell at least initially only in the UK, and it could present unique challenges if dual applications are in. Larger companies with deep pockets are seeing this fast track route as a way of bringing many products to market that consumers or the regulations have prevented to date.

There are clearly many biotech (including genetically modified) products waiting in the wings, as well as meatless ‘fermented’ products. More palatable perhaps, is the protein derived from insect proteins. Here there are companies who have sunk large sums of money into insect production plants only to find that the regulators have classified insects retrospectively as novel foods, and that the foods allowed to be given to insects are tightly regulated too. They too, like the CBD industry, are playing a waiting game to find out if a group classification may be possible given the financial barrier to the smaller companies. That said, there are insect protein-containing products already on sale and in their favour, is the fact that insects have been, and are, a normal part of the diet for many people in other countries.

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