New Year, New Novel Foods Regime

United KingdomScotland

The future is bright for entrepreneurs and small businesses but securing regulatory approval can cast a shadow. If you are developing a new product and it’s going well, when should you seek approval? Do you invest before you know you have a successful product – and risk losing your investment? Or only once retailers offer you a listing - by which time you will need to have your product in production and as a Food Business Operator (FBO) be able to substantiate your regulatory compliance for the retailer?

If your product is a “novel food” you will need novel foods approval. A novel food is one which has not been “used for human consumption to a significant degree in the EU” before 1997. So if it is just being put on the market now and, for example, contains protein filled insects or simple Chia seeds (neither of which we were consuming in 1997) then it is considered “novel” and needs approval by the European Food Safety Authority (EFSA) – or in the UK by the Advisory Committee on Novel Foods and Processes (ACNFP).

Obtaining such an approval though can be an extremely lengthy process of up to several years. Even under a more simplified process available under certain circumstances, approval can still take up to 18 months to obtain. However, with the introduction of a new Regime in the UK in January 2018 it is hoped that this should reduce the approval time to about 9 months.

Currently there are two processes available. To decide which to adopt, first you must search the list of novel foods authorisations to see if your product specification and use matches an existing approval. If there is no direct match then you must review the applications to see if there is a potentially “equivalent” specification and use. If there are no matches then your use is probably unique and a new application is required. If there is a potentially equivalent use then an application is still required, although this is a simplified application which should take less time.

In the UK an application is made first to the ACNFP, which reviews the application and circulates an opinion to the EU member states. There are various help and guidance documents to tell you how to compile a dossier and what data to include, but the primary concern is Food Safety. It is this two stage process of mutual recognition between member states that can really take time. It means that even if some member states approve the application – others may not.

An example comes from Ocean Spray Cranberries. It made an application back in 2011 and in 2014 and secured French approval. However, other member states disagreed. It went to EFSA’s NDA (Dietetic Products Nutrition and Allergies) panel and in 2015 the panel eventually gave an opinion that if the product was used as intended then the levels were not “nutritionally disadvantageous”. Final approval came earlier this year.

Chia seeds offer another example. They have risen to prominence so quickly that already they can seem mainstream. In regulatory terms they are still novel. There are ANCFP approvals for Chia seeds but their story demonstrates how equivalence can be used – and why a new regime is urgently needed.

In 2003 an FBO applied for approval, which was finally authorised in 2009. In 2009 another FBO then secured authorised use of chia seeds in bread products at a maximum level of 5%. Subsequently, in 2011, The Chia Company then got approval for their 2010 application to use chia seeds in their own bread products on “substantially equivalent bases” to the previous authorisations. In 2011 they applied to extend their approval and final approval was granted under EC 258/97 Novel Food Regulation in January 2013. In 2017 another FBO requested an opinion from the FSA on the “equivalence” of its Chia seeds with the Chia seeds marketed by The Chia Company under the simplified procedure. The application is currently under evaluation (along with several other equivalence applications dating from 2015 and 2016)

You can also use the simplified procedure if your New Product Development (NPD) is based on a food that has a safe use in a third country, provided the data shows compositional and experience of use for at least 25 years in the “customary diet“ of a significant number of people in at least one third country. However, it may be difficult to prove exactly what constitutes a customary diet.

It is these types of examples that are behind the new regime. Currently, whether the route to approval is a new application or to show your use is “substantially equivalent” to an authorised use, it can take years to process and some see this as stifling NPD. The new streamlined regime eliminates the need for individual member state approval and sets out strict timelines for action. In theory this should mean applications taking less time from submission to authorisation and for this reason it should be a much more attractive and commercially viable process. But 9 months is still a long time in the life of a new product and during this time without authorisation the product is illegal. Perhaps more relevantly the product is unlikely to get listed. Or if it is listed it may be vulnerable to a competitor who sees an opportunity to “blow the whistle” or to a customer complaint bringing the product to the attention of Trading Standards (who have power to prosecute).

So a shadow may begin to be lifted in 2018 with the new novel foods regime – although for many the authorisations will still not come fast enough.

Need advice?

If your organisation is grappling with the novel foods regime, or any other Food & Beverage issue, we would be happy to talk it through with you. Feel free to contact Tom Scourfield ([email protected]), Head of Consumer Products at CMS. CMS is the 6th largest law firm globally and has one of the leading Food & Beverage practices in the market. Our specialist team advises on a full range of matters, from regulatory and compliance (including nutrition, health and food information) to GSCOP, product liability issues, contamination and recall, new product launches, labelling, IP and brand protection, marketing and promotions, commercial contracts, food safety, food integrity, and health and safety issues to name a few.