Novel Food Applications

It has always been our belief at The Canna Consultants that there is an absolute need for regulation – one only has to look at some of the scientifically unjustified medical and health claims that are made, in breach of the clear prohibitions, to appreciate that were there no fetter on what a market participant could say about the benefits of their product, then the claims would be evermore outlandish in order to mislead the consumer into making a purchase.

Although unpopular with elements of the industry, it was our view at The Canna Consultants that CBD products were not in any special category and, once the decision was taken that there was no history of significant use prior to 1997, then they should be regulated no differently than any other food product. However, equally we always held the view that the regulation of the industry, given the position which the “un-policed” industry had reached, needed to be proportionate and not stifle or kill the very businesses that had by that time taken root and had the potential to succeed, placing the UK at the forefront of the global CBD industry.

Our Position Paper “The Road to a Better Future” was provided to the UK Food Standards Agency in the Autumn of 2019 and was adopted and implemented by them (with some unfortunate “in-house” amendments) in February 2020. Since then we have submitted multiple Novel Food applications to both the UK FSA and EFSA.

OUR VIEW ON NOVEL FOODS - THEN AND NOW

THE STARTING POINT

THE PRINCIPLE

THE PRACTICAL EFFECT

BY WHOM MUST APPLICATIONS BE MADE?

THE SEQUENCE

TO WHOM ARE APPLICATIONS MADE?

IMPACT OF THE FSA DECISION

HOW LONG DOES VALIDATION TAKE?

WHEN SHOULD AN APPLICATION BE MADE?

OUR VIEW ON NOVEL FOODS - THEN AND NOW

TRANSITION TO COMPLIANCE

At The Canna Consultants we believed that what was required was for each of the organs of the State, whose role it was to ensure compliance with the regulations, to engage with those market participants whose approach was sufficiently credible, in order to ensure that there is open and realistic engagement between themselves and those credible market participants. We believed that that approach is necessary to define the future of the cannabinoid industry for the benefit of all current market participants, current consumers, future market participants and future consumers: for now, for the future, for all.

The inevitable question was: how did one move from the infant industry that we saw – divisive, disjointed, fractious and fragmented – to a future structured, unified, transparent and stable industry that benefits all market participants and all potential consumers?

What was required was a mechanism through which the industry could engage with the Food Standards Agency and make such Novel Food applications as were necessary, whilst continuing to trade in the interim period. There would be little point in making a lengthy and costly Novel Food application if the product was to be starved out of existence during the period that the application was being considered.

To that end we devised a Position Paper, “The Road to a Better Future” and provided it to key Stakeholders in October 2019. The Paper can be read in full here. We challenge you to play “spot the different” between the course advocated in the Paper and that which is being pursued by the Food Standards Agency.

DISEMINATION OF INFORMATION TO MARKET PARTICIPANTS AND CONSUMERS

In order to make all market participants aware of the actions and status of the supply chain, we continue to encourage the Food Standards Agency (in advance of their assumption of responsibility for the assessment of applications for Novel Food Authorisation in January 2021 and thereafter), to maintain and publish, three Registers:

Of Manufacturers of Base Cannabinoid Material (MBCM) who have submitted Novel Food application(s) for their products, including the date of submission and the date of Validation of the same;
Of end products retailed within the UK in respect for which Validated applications have been made by the Manufacturers of Base Cannabinoid Material (MBCM) in the ratio applicable to the retailed end product, such that an independent application for Novel Food Authorisation would not be required; and,
Of end products retailed within the UK in respect of which independent and self-standing applications for Novel Food Authorisation have been made, including the date of submission and the date of Validation of the same.

These would mean that all within the market, participants and (crucially) consumers, would be aware of:

The base ingredients for which Validated applications had been made for Novel Food Authorisation within the required timescale, so as to afford them the benefit from the exemption from enforcement proceedings during the Risk Assessment phase; and,
The products which are currently exempt from enforcement action because of the Validation of an application for Novel Food Authorisation.

NOVEL FOOD AUTHORISATION: THE STARTING POINT

Member States of the European Union are not the only jurisdiction to operate a system which seeks to manage what novel food and novel food ingredients can be made available to their citizens, but they do operate probably the most stringent system and require the most comprehensive data submissions in order to gain successful market authorisation.

A core and critical difference between Member States and other jurisdictions is the location of the “starting point” for their decision-making process. Other jurisdictions, such as the USA, start from the premise that a food or ingredient is safe unless they have cause to believe otherwise.

The European Commission begin with the assumption that the food or ingredient is unsafe and will maintain that position until satisfied, through the provision of independently validated scientific data, that such a position is incorrect and can be relaxed.

While it is tempting to think that these two approaches represent two sides of the same coin, such that they are not that dissimilar, that it is not the case and the manner in which they manifest themselves means that the volume of data required to achieve Market Authorisation will be significantly in excess of that which is likely to be currently in the possession of organisations which may already be marketing their product elsewhere.

NOVEL FOOD AUTHORISATION: THE PRINCIPLE

The premise behind the Authorisation process is that any company who is intending to place on the market a food which falls into certain criteria, must satisfy the European Commission that the food (including the process by which it is created) is safe for consumption by the population.

Furthermore, what must be proven to be safe is not the novel food/ingredient in its generality but, amongst other things:

that the novel food/ingredient is safe, on its own, in the specific manner in which it is delivered and in which it is intended to be consumed in the manufacturer’s product;
that the novel food/ingredient is safe, on its own, in the specific quantity/volume/strength in which it is delivered and in which it is intended to be consumed in the manufacturer’s product; and,
that the novel food/ingredient is safe, in the context of the delivery mechanism in which it is intended to be consumed, i.e. the manufacturer’s product.

NOVEL FOOD AUTHORISATION: THE PRACTICAL EFFECT

It is therefore necessary to submit scientific data in respect of all aspects of:

the ingredient “simpliciter” (our phrase) and the process through which it was created;
the ingredient in the context of the product and the process through which it was created; and,
the ingredient in the general food environment/consumption context.

Anecdotal “evidence” and contentions that there have been no reported issues raised in other jurisdictions will not necessarily rate highly in the context of the scientific decision concerning the Authorisation application. The decision is based on safety as established through scientific study and evidence, and the data submitted must establish the case in its own merits.

BY WHOM MUST APPLICATIONS BE MADE?

I BUY FROM A CANNABINOID MANUFACTURER; WILL I HAVE TO MAKE AN APPLICATION?

We are aware of White Label suppliers and/or ingredient manufacturers informing purchasers of those products and/or ingredients that they (the Brand) will not need to seek Novel Food Authorisation. Statements such as this have the potential to be very misleading and very economically damaging to the Brand, to the supplier’s benefit.

If the product which the Brand sells is a “pure” White Label product, by which we mean that the Brand does nothing to the product that it purchases, simply labels it and places the product for sale, then it is probably the case that the Brand will not need to make an application (assuming that the supplier is able to pass the Validation process), other than registering the name of the product with the UK FSA as being unchanged from the product which has the benefit of the UK FSA’s marketing exemption granted to the White Label producer (and later the Novel Food Authorisation, assuming that the application successfully proceeds through the Risk Assessment phase and is added to the Union List/UK List).

However, where the Brand:

purchases base ingredients and manufactures the end-product itself (or sub-contracts the manufacture of their product to a third-party); or,
adds ingredients to the White Label base product; or,
does anything else to the White Label base product which changes it,

then it will be a different product than that for which the White Label supplier has submitted an Application/achieved Authorisation and the Brand will need to submit a Novel Food application for their product.

This does not necessarily mean that the Brand will be required to undertake all of the scientific testing which has been undertaken by their White Label and/or ingredient supplier, but the Brand will need to provide their supplier’s data with their own application (assuming that their supplier is willing to permit them access to and use of the proprietary data), plus the Brand’s own data in respect of the product that they themselves have created.

We believe it highly unlikely that bulk manufacturers of cannabinoids and/or cannabinoid ingredients will be willing to submit applications which cover all of the products of their clients where the Brands change the constituent elements of the base product and/or ingredient in order to create a bespoke product.

At The Canna Consultants we believe that it is more likely that:

White Label providers will permit their customers to utilize the non-intellectually protected datasets which they have themselves submitted, but that the customer Brands which amend the chemical composition of the base product will be expected to make their own application for Novel Food Authorisation; and,
Active ingredient providers will permit their customers to utilize the non-intellectually protected datasets which they have themselves submitted, but that the customer Brands which use those active ingredient (in conjunction with any other ingredients), will have to make their own application for Novel Food Authorisation.

We come to this conclusion because with responsibility comes liability and we do not believe that White Label providers and/or ingredient manufacturers will be willing to assume the consequent commercial exposure to all of their customers, who would potentially number in the hundreds.

We refer you back to our previous documents “Be Careful Who You Listen To” (here) and “Be Even More Careful Who You Listen To” (here), which may debunk some of the other misleading statements that we have observed being provided to market participants.

NOVEL FOOD APPLICATIONS: THE SEQUENCE

This sequence describes the current position where an applicant seeks to market their product in any European jurisdiction, including the United Kingdom. Brexit will have an impact upon the application procedure, which is highlighted below, but which cannot presently be incorporated within the sequence because the UK Food Standards Agency has not yet indicated the substance of the procedure that it will invoke from 1st January 2021.

STAGE 1: Confirming the Application and Requesting Information

The Applicant submits their Novel Food Authorisation Dossier to the European Commission.
The Commission send any requests for information to the Applicant as may be necessary for the Commission to address the Validity of the application.
The Applicant provides such information as is requested to the Commission, in order that a decision may be made upon the Validity of the application.

STAGE 2: EU Commission Provides the Application to Member States and EFSA

The Commission seeks to verify whether the application falls within the scope
of the Novel Food Regulations and whether the requirements set out in Article 10(2) and 10(4)(if applicable) of that Regulation (by reference to the associated Guidance) are met, by:
1. Making the application available to the Member States; and,
2. Consulting with the European Food Safety Authority (EFSA) and seeking its opinion as to whether an update to the Union List (of Novel Foods) is liable to have an effect on human health.

STAGE 3: EFSA Provides its Views on the Suitability/Validity to the Commission, or Requests further information from the Applicant

EFSA, within a period of 30 working days following the receipt of the consultation request (and full supporting documentation, whichever is the latter), provides the Commission with its views on whether the application fulfils the relevant requirements set out in Article 10(2) and 10(4)(if applicable) of the Regulation; or,
EFSA requests such further information as it desires in order for it to make its assessment of the suitability and Validity of the application.
Upon (a) above being satisfied, whether on the first occasion (or subsequent occasions), EFSA confirm that the application is suitable and Valid.

STAGE 4: Risk Assessment Performed by EFSA, or EFSA requests further information from the Applicant concerning the Risk Assessment being Undertaken

EFSA, within 9 months from the date of the receipt of the Valid application (and full supporting documentation, whichever is the latter), performs the risk assessment and provides its opinion; or,
EFSA requests such further information as it desires in order for it to make its Risk Assessment on the application.
Upon (a) above being satisfied, whether on the first occasion (or subsequent occasions), EFSA informs the Commission of its opinion as to whether the Union List should, or should not, be updated to include the food which is the subject of the application.

STAGE 5: Risk Management

From the date of publication of EFSA’s opinion, the EU Commission then has
7 months to draft an implementing act authorizing the placing on the market within the European Union of a novel food and updating the Union List accordingly.

TO WHOM ARE APPLICATIONS MADE?

TO WHOM ARE NOVEL FOOD SUBMISSIONS MADE?

The Novel Food (Amendment) (EU Exit) Regulations 2019 (SI 2019/702) indicate that submissions should be made to the Food Standards Agency (as regards England, Wales and Northern Ireland) and Food Standards Scotland (as regards Scotland). These Regulations state that they come into force on “Exit Day”.

The European Union (Withdrawal Agreement) Act 2018 defined “Exit Day” as 31/1/20, however, the similarly named Act of 2020 introduced the concept of the “Implementation Period”, which saves EU authority until the “Implementation Period completion day”. The “IP completion day” is 31st December 2020.

Thus, presently (and at least until 31/12/20), Novel Food submissions can only be made to the EU Commission. After that date submissions will need to be made to the UK FSA for products intended for sale in England, Wales and Northern Ireland, to Food Standards Scotland for products intended for sale in Scotland and to the EU Commission for products intended for sale in the European Union.

We say presently because it may be that the date from which the FSA will adopt responsibility will move backwards depending upon the progress of the politico-economic Brexit negotiations.

IMPACT OF THE FSA DECISION

THE IMPACT OF THE FSA ANNOUNCEMENT AND CHANGE IN RESPONSIBILITY/LIABILITY FOR RECEIPT AND ASSESSMENT OF NOVEL FOOD APPLICATIONS

As currently defined, in order to benefit from the UK FSA exemption (which is applicable only to the UK), any application must be “Validated” by 31/3/21 (i.e. reach Stage 3(c) as identified above).

Any submission made before 31/12/20 has to be a submission to the EU Commission, who will have responsibility for the validation assessment. For applications made after 31/12/20 then the UK FSA is responsible for the validation process, and the duration of that process.

The UK FSA is currently inviting organisations who make submissions to the EU Commission to provide a copy to the FSA:

“In addition to submitting them to the European Commission as usual, we strongly recommend businesses also send them to us to allow us to consider them. We can then give businesses guidance and answer any queries we may have, in order to ensure they progress at pace through our UK authorisation process from 1 January 2021.”

HOW LONG DOES VALIDATION TAKE?

HOW LONG DOES THE VALIDATION PROCESS TAKE?

What can be seen from the process Stages identified above is that the applicant can be asked to provide additional data during the Validation Stage, and so in some senses the maximum period is uncertain and case-specific.

Perhaps what is most relevant in the current circumstances is what is the shortest duration over which the Validation Stage can take place, because at present this would inform potential applicants as to the date by which they must submit their application in order for it to be Validated by 31st March 2021?

WHEN SHOULD AN APPLICATION BE MADE?

THE BIG QUESTION: WHEN SHOULD AN APPLICATION BE MADE AND WHY?

At The Canna Consultants we believe that those intending to submit applications for Novel Food Authorisation, whether to the EU or the UK FSA, should assume that the Validation process will take at least three months from the date of submission.

Therefore, in order to benefit from the enforcement exemption period offered by the UK Food Standards Agency, an application should aim to be made no later than 1st January 2021 – the first date upon which applications could be made directly to the UK regulator. If there is an indication from the UK FSA that the Validation stage will proceed quicker than that, then the applicant suppers no prejudice, but despite what some voices say, the matter cannot be left until March 2021.

We repeat what is necessarily becoming our well-worn phrase:

Be Careful Who You Listen To.

When you conclude that you need to control your Brand’s destiny and you want to explore more, then contact those who know what it takes to make an Application, and have the resources and relationships to make your Application the best that it can be, so that you can gain market and Brand advantage, contact The Canna Consultants.