Novelty Act – change in novel foods regime

United Kingdom

London’s first insect bar recently opened. The bar offers products such as bug based ice cream and brownies. To most of us this sounds rather radical and new but insects actually have a long history of human consumption. St John famously consumed locusts and honey.

It seems that insect consumption may be having a come back as part of the development of new innovative products. For example, most of the products available at the insect bar are made with newly developed cricket flour. In addition cutting edge technologies such as nanotechnology are now being applied to food to develop new and exciting products.

Interestingly both insect and foods using nanotechnology are governed by the same regime. This is known as the novel foods regime. There is a change in the regulation of novel foods which is due to come into effect from 1 January 2018. The new regime is intended to address some of the uncertainties in the current regime and promote innovation. However, as with all regime changes there can often be unintended consequences and Food Business Operators (FBOs) should start preparing early for the change.

Under the current system the definition of a “novel food” is one which has not been “used for human consumption to a significant degree” in the EU before 15 May 1997. Unfortunately for FBOs in the business of selling insect based products it seems consumption by St John does not qualify as consumption for the purposes of the novel food regulation. In addition “consumption to a significant degree” is a rather subjective definition and in some cases, such as Moringa Pods, even the Food Standards Agency (FSA) is unsure if a food needs authorisation before it can be sold to consumers. This means that any FBO currently selling a product containing Moringa Pods risks being found to have sold a novel food contrary to regulation. In which case they would almost certainly have to remove the product from the market and apply for an authorisation. Industry insiders estimate approval under the current system takes on average 36 months which is likely to mean existing stock would be unsaleable in the EU as it is likely to go out of date before the authorisation is granted. In addition less than half (44%) of all novel food applications have been approved so there is a risk that an FBO may find they invest the time and money in an application only to find they have to withdraw from the market entirely.

The new regime is intended to bring some much needed clarity about what is a novel food and also speed up the approval process. Both of which should be good news for FBOs. However, there are some elements of the new regulation that may be less advantageous to FBOs.

Some categories which are excluded from the current regime are explicitly included under the new regulation for example whole insects. This means that any FBO currently selling products containing whole insects should review if these would meet the criteria of “used for human consumption to a significant degree” in the EU before 15 May 1997. If not, one of the unintended consequences is that when the new regime comes into force on 1 Jan 2018 the FBO is likely to need an authorisation to continue to sell the product. Even under a new streamlined process authorisation is presumably not going to be instantaneous and any FBO in this situation should plan for the possibility of a period during which they can not sell in the EU.

Another significant issue is the move from individual company authorisations to industry wide authorisations. Under the current system only the FBO that applied for the authorisation can use it and details of the application was kept confidential. This meant that a FBO could protect any propriety information about where an ingredient was sourced or how it was developed confidential. In addition since only they could use the authorisation the FBO had an EU monopoly on sales until another authorisation was granted. The monopoly would last at least until another FBO applied for their own authorisation (potentially on the basis that their product is “substantially equivalent” to an approved novel food). As this application is likely to take some years FBOs could invest in research and development of novel foods with an expectation of being first to market and having a substantial period of exclusivity during which they could re-coup their investment in research and development.

Under the new system authorisations will be industry wide, so even though one FBO will apply, all FBOs will be able to make use of any resulting approval. There is a system in place to protect propriety scientific data used in the application for five years which will at least give the applicant a head start but it may not protect FBOs if a competitor reverse engineers their product and then sells the product using the authorisation. In addition five years is a relatively modest protection for scientific data as it may have commercial value past this point. The protections available to developers of novel foods seem out of line with those available to inventors under other regimes such as patents (a patent gives 20 years protection).

These concerns may discourage FBOs from investing in development of novel foods. Given that there are already industry concerns about lack of innovation in areas such as alternative vegetarian proteins it is far from ideal to bring in a regime that may further discourage development of new products.

It goes without saying that this new regime is an EU initiative and therefore will in force until the UK leaves the EU. Presumably it will be at least initially preserved in its new form when the Great Repeal Act is passed. However, one of the proposed pillars for the UK’s new industrial strategy mentioned in the recently published Industrial green paper was research & innovation. Perhaps once the UK has left the EU there may be scope to review the novel foods regime and see if it really promotes the development of new innovative new products.