What Is Novel Food Regulation?

If you’ve read up on less common food products or wanted to introduce one as a merchant, you’ve doubtlessly encountered the term “novel food regulation” or “EU novel food regulation.”

Whether you’re looking to offer a particular food type in your inventory or are merely interested in the topic, this article will explain the gist of the novel food regulation standard.

What Is It?

Before explaining anything else or getting into more detail on the subject, let’s see what this food regulation is all about.

All foods and consumables that haven’t been widely consumed by UK- or EU-based citizens prior to May 1997 fall subject to the “novel foods” categorisation.

Before being introduced to a vendor’s catalogue on the EU or UK markets, these foods will require authorisation.

What Does This Include?

This involves foods that don’t have a so-called “history of consumption” here. But which foods fall under this category? Here are some examples:

Traditional foods – Even if some products have been a part of a diet in various countries worldwide, they may still have to go through an authorisation process in the EU and the UK. We’re talking about foods like baobab and chia seeds, which may be familiar to most UK citizens in this day and age, but weren’t a part of regular UK and EU diets back in 1997.

New foods – To perform, for instance, cholesterol reduction, various new food types are used, such as phytosterols and phytosterols. These also fall under the “novel foods” category.

Foods from new processes – Old food concepts are often met with new creation methods nowadays. For instance, to increase the vitamin D levels present in bread, some manufacturers use UV (ultraviolet) treatment on their bread products. This increases the levels of vitamin D in these foods and makes them subject to the EU novel foods regulation.

There are various similar examples of other food products that fall under the category in question.

The Two Authorisation Routes

To authorise a particular product under the novel foods regulation, you can take two different routes – the traditional food notification and the full application.

Traditional Food Notification

This is a more straightforward route that doesn’t require too much of your time. The data requirements are lower than with the full application method. Expect a four-month review period, however. If there are no objections about the product in a review, the applicant is notified, and the product is placed on the list of authorised novel foods. This process covers the food products that have been in use in countries outside of the UK and EU for 25 or more years.

Full Applications

If you are trying to authorise a product that doesn’t meet the 25-year condition of EU or UK use, you’ll need to take the full application route.

For this, the applicant needs to share a more comprehensive array of information. For one, all the administrative data, including various information about the applicant. Then, the information on the particulars regarding the novel food in question needs to be displayed. This includes info such as the production process, specifications, food identity, nutritional information, toxicology, proposed uses, levels of anticipated take, the food source and history, etc.

Finally, the applicant has to round up the glossary of terms throughout the dossier, complete study reports, copies or reprints of pertinent scientific data, scientific opinions in terms of national or international regulatory bodies, as well as all related certificates (recommended).

Brexit-Related Changes

Since we’re talking about the EU novel foods regulation, it is clear which organisation the whole movement originated from. This, however, doesn’t mean that the UK is exempted here.

The application process hasn’t changed much due to Brexit (although looking into the details is required if you want a consumable product authorised). Given that the authorisation process can take up to four months, what has happened during this transitional period?

As of 1 January 2021, many rules and regulations have started to change. The ongoing applications of novel foods have been subject to this. Take note that if the assessment process that began before 1 January 2021 hasn’t been completed until the said date, you will be required to apply again.

Upon completing the application form, you’ll be prompted to provide the EFSA question number assigned to you before.

Be aware that the existing authorisations that the European Commission has approved prior to 1 January 2021 will remain in place. You don’t need to reapply.

What About CBD?

There is a lot of confusion regarding the legality of cannabidiol (CBD) within the UK. Fortunately for CBD enthusiasts, CBD is entirely legal in the United Kingdom, so long as it has a derivate of an EU-approved industrial hemp strain or has originated from outside of the EU.

That said, CBD is very much considered a “novel food” and, as such, falls under the same requirements as other products of the type. The “novel food” status for CBD was confirmed back in January 2019.

To be precise, since CBD hasn’t been officially used as a regular consumable in any country for 25 or more years, it can’t be authorised via the traditional food notification route. In other words, it has to be processed via a full application, where the applicant needs to provide a variety of related documents (as mentioned earlier).

Keep in mind that the applicant needs to apply for CBD extract and isolate authorisation. Of course, if your application hasn’t been resolved by 1 January 2021, you need to apply for it once again. Other than that, CBD regulation hasn’t undergone any vital changes as a result of the ongoing Brexit transition.

Novel Food Regulation Basics

In most cases, when it comes to novel foods, permission is granted. Even if we’re talking about consumables such as CBD, as long as you follow the UK guidelines, your request is likely to be accepted.

Keep the 25-year condition in mind, though. Applying the standard method with a product that doesn’t meet this condition will result in wasted time, at the very least. Always look into the terms and conditions before applying.