GRS News

 

The European Commission (representing all the Member States) announced in January 2019 that CBD was a novel food.  Since then CBD companies have been beavering away, gathering data and conducting toxicity and stability studies to compile their Novel Food Application dossiers for submission to the European Commission (EC).  The EC’s role is to validate these dossiers before going to EFSA for the safety assessment.  So finally, CBD ingestibles are regulated and the sector has clarity on what needs to be done to ensure good quality and safe products for the consumer.  Correct?

 

Well, not quite!  Recently, the EC has ‘paused’ their assessment of all CBD novel food applications because they are deliberating whether, in fact, CBD is a narcotic (and therefore, a controlled drug) and not a novel food.  This ‘change’ seems to have come about because the International Narcotic Convention refers to ‘extracts and tinctures’ from the Cannabis plant as being narcotic.  The Narcotic Convention does not cite CBD specifically but as we can see, CBD is implied because ‘extracts and tinctures’ is stated.  Since the Narcotic Convention was agreed, things have changed so it could be argued that it is ‘no longer fit for purpose’.  This does seem to be the general view because the UN is considering the removal of ‘extracts and tinctures’ from the Narcotic Convention and also to confirm an acceptable limit for THC.  The final decision, however, won’t be made until circa December 2020.

 

In practical terms what does this mean to the European CBD Industry?

 

If you have already submitted your CBD novel food dossier to the EC, you will have probably received a response by now that they will not validate the dossier until a decision has been reached on whether CBD is a narcotic or a novel food.

 

If your target market is the UK, the EC’s response may well have put you in a panic.  Why?

 

Well, how on earth can you get your dossier validated by the EC in time for the 31 March 2021 deadline set by the UK Food Standards Agency (FSA)?  This date is important because having a validated dossier by 31 March 2021 ensures that, if your product is already on the UK market, you can keep your product on the market.

 

Don’t panic!

 

Below is a summary of a telephone call I had with Paul Tossell, Head of Radiological, GM, Novel Foods and Feed Additives Team at the UK FSA:

 

Whilst the UK is in transition (i.e. in the process of Brexit), the FSA cannot formally (or legally) accept Novel Food dossiers.  Companies must continue to submit to the European Commission (EC) up until 31 December 2020 because this is the legal pathway.  The FSA, however, can informally accept dossiers until the end of 2020.  If a company does informally share their dossier with the FSA, the FSA will review the dossier and provide feedback on where improvements can and should be made.  This will then give companies time to update their dossiers and formally submit a good quality dossier to the FSA in January 2021. A good quality dossier (especially under the guidance of FSA) means that it is possible to speed up the time from submission to approval.

 

If the applicant wants to launch their product throughout Europe then they must submit to the EC.  It is a commercial decision as to whether the company makes a submission to the EC now knowing that it will be ‘paused’ whilst the EC determines if CBD is a narcotic or not.  The advantage of submitting to the EC now is that your dossier will already be in the queue for validation should they determine CBD is not a narcotic.  Companies may prefer, however, to focus on the UK market only, for now, whilst the EC is ‘sorting itself out’.  

 

If the UK is the only target market, companies are still encouraged to submit their dossier informally to the FSA this year for their feedback and to act as an informal pre-notification that they will be making a formal submission via the online portal in January 2021.

 

For any novel food application (i.e. not just CBD), assuming the application makes it through to the European Food Safety Authority (EFSA) by the end of 2020 then the FSA will respect EFSA’s determination of the application going forwards i.e. FSA is very much in line with EFSA and the novel food regulation i.e. they will mirror what the EFSA do.

 

The FSA will not extend the 31 March 2021 deadline for dossiers to be validated. Paul Tossell was very definite about this and also definite that the FSA has the capacity to validate dossiers in time for the 31 March 2021 deadline.  To help meet this deadline, however, companies should informally submit their dossiers to the FSA by 31 December 2020 and ideally, as soon as possible.

 

Paul Tossell confirmed the formal submission process for the UK is as follows:

 

• From 1 January 2021 onwards, formal submission to be made via the online portal.
• The FSA will undertake a quick administration check of the dossier to ensure that all sections are complete (this takes about 1 week).
• Assuming the administration check is okay, it’ll take about 1 month to validate the dossier i.e. to check that there is “enough information of the right sort of data” to move the dossier through to the safety assessment.

 

I raised the question about the possible risk of the Home Office re-classifying CBD as a narcotic and the ‘influence’ of the Narcotic Convention.  It was made clear that, in this instance, National legislation overrides the Narcotic Convention and that the decision as to whether or not something is a narcotic is made at local level.  It’s important to note that the Home Office has confirmed that CBD (without any psychoactive properties) is not a narcotic and therefore, not a controlled drug.  The MHRA has confirmed that CBD (without any psychoactive properties) and without any medical claims, is not a medicine.  This means that all that is left, is classification as a ‘food’ and because there is no history of use prior to May 1997, CBD is a novel food.

 

So … for those companies with product already on the market in the UK, they must informally submit their dossiers to the FSA within the next few months and definitely by end of this year.  The FSA will provide informal feedback to improve applications so that good quality dossiers are formally submitted to them via the online platform as from 1^st January 2021.  From the above, I am estimating that companies should allow 6-8 weeks to get their dossiers validated by the FSA in time for the deadline of 31 March 2021.

 

I believe the position for the UK and CBD as a novel food is now clear.  It means that CBD companies should be able to be compliant with FSA requirements and have a viable business in the UK.  This will help to buy them time if their ultimate goal is to launch EU-wide.  Of course, this assumes that the EC’s determination will be that CBD is a novel food and not a narcotic! 

 

If you'd like to know more or need further clarity, please don't hesitate to reach out to me.

 

Author: Greer Deal, Director of Global Regulatory Services Limited

Email: greer @ globalregulatoryservices.com