Last updated 25 September 2020
As a result of the ACI’s latest communication with the UK Food Standards Agency (FSA), what new information do we have?
On Monday 14th September the FSA made it clear to the ACI that toxicology safety study data is a prerequisite for a validated Novel Food Application by the 31st March 2021 and literature-based information is not sufficient.
There has been speculation in the industry that organisations can rely on existing data in the public domain in order to gain a validated novel food application. We can now confirm that this is not the case, and further toxicology studies are required in order to gain novel foods authorisation.
Why do I need a risk dossier to gain Novel Food Validation?
A risk dossier is important to ensure the safety of the product and recommended dose for the consumer. The risk dossier is viewed alongside ADME, bioavailability, genotoxicity testing etc. to ensure the overall safety. Once we have generated this data, this can then be included in consortium member’s Novel Food Applications alongside the additional stability testing required.
My manufacturer has told me they are doing the Novel Food Application and I don’t need to do anything, is this true?
No. You must ensure that your finished products are included in your manufacturer’s Novel Foods Application or they will not be authorised for sale.
Furthermore, it is not enough to “take the word” of your supplier. You MUST start asking your manufacturer questions about their application and understand that your finished products are covered.
If you are buying isolate, distillate or materials which will be made into a finished product by your organisation then you cannot go ahead under your manufacturer’s application unless their Novel Food dossier covers the exact manufacturing process and ingredients which are used in your finished product. If not you must do your own application.
The key is to challenge your supplier and ask to see evidence of their data generation activities.
My manufacturer has said they are doing the application, but they are not giving me updates and I am concerned. Can I still join the consortium?
Yes, you can join the consortium subject to the product information you have generated so far and it meets the consortium requirements. Please contact with the ACI team to discuss this further.
What is the Consortium and why should I join?
The ACI Safety Data Consortium is the ACI’s proposal to help CBD companies share the costs of generating the required data for a novel food dossier. The consortium includes a selection of companies from around the world that have bought into the ACI’s strategy of delivering a successful novel foods programme.
From the outset, the consortium has always maintained that generating new toxicity data would be crucial for a validated, and then authorised CBD novel foods dossier; the FSA’s scientific advisory committee, the Committee on Toxicity (COT), expressed concerns over the safety profile of CBD, especially in regards to hepatotoxicity (liver damage).
Hence, the ACI have engaged a contract research organisation (CRO) to conduct a 90-day rodent study in order to meet these concerns directly. The study is in line with the FSA’s advice to follow EFSA’s guidelines – namely, the toxicity study is required to meet OECD 408 standards.
The consortium’s strategy includes generating all the data required, including absorption studies, genotoxicity, amongst other requirements. Without generating toxicity data on your product, you will not have your novel food dossier validated.
Contact us now to find out more about how you can be part of this industry-first consortium, save on cost, and ensure your products remain on the shelves after the deadline.
I buy a white label product, what do I need?
You need the data from key CBD raw material toxicology testing, extended toxicology testing and many other pieces of research and evidence which have been presented in previous webinars. Here is a link to the webinar and accompanying presentations from Dr Parveen Bhatarah, ACI Regulatory and Compliance Lead, and Mark Bowes-Cavanagh, Managing Director of ADSL (partner lab for the safety data consortium). This will give a detailed overview of how the ACI is helping its members save cost and navigate this subject. This webinar is aimed at those with a technical and/or regulatory background.
I manufacture multiple products for my clients – can the consortium help with the data requirements and novel food dossier?
Yes, we are working with many manufacturers on generating all the data, and through our consultancy services, compiling the dossier for them. Through our partnership with ADSL, we can offer the most competitive and comprehensive package for manufacturers with multiple product lines.
Contact us for a quote today.
How do I know my supplier is generating the necessary data?
Challenge them. If you don’t see evidence that your supply chain is having these conversations, then you can’t be certain that your products will remain on the shelves after the March 31 2021 deadline.
For consortium members, how does the ACI intend on supporting suppliers in confirming that they are part of this data generation and are doing their Novel Food Application?
The ACI and ADSL have agreed to provide evidence through a letter of intent and a declaration letter that a supplier is taking the necessary steps to work towards the upcoming regulation. This can be shown to clients (brands) and retail partners looking to stock your products. We will also be providing weekly updates to ensure organisations know what stage their product is at with testing.
Be aware that the safety study is just for isolate and broad spectrum CBD. Secondary finished products will need to be filed by members which can include the core date we are generating. The ACI can assist members with these applications so please contact us if you need assistance or further clarification.
I’m a CBD brand who grows our own hemp and processes this to make our own CBD which we include in our products that are selling throughout the UK. We were under the impression that having toxicology safety data was not necessary for our novel food application. What must we do to stay on the market after the FSA deadline?
There are companies like this who have already submitted their novel food application using a literature-based submission based on information which is already in the public domain. It must be clarified that the information in the public domain is from a pharmaceutical product, Epidiolex, hence the data is not applicable for a Novel Food Application. The Committee on toxicology (COT) have clearly indicated that there are a lot of gaps in the publicly available literature, and the FSA have made it clear that this data will not suffice.
I have already submitted my application without this data, can I still join the consortium and add to my application?
Yes. It is not too late to join the consortium and add this data to your application. Contact us ASAP to process this in time.
OECD408: What, why, and how?
You will have heard us mention an OECD408 which is an abbreviation for a toxicological rodent study. This has to comply with certain parameters and requirements to be suitable for its purpose. This is a 90 day study through oral administration, because it is for food, including pathology testing, blood testing and other tests. The “408” refers to the EFSA published guidance on what should be in that study and what it should look like.
Although this is a 90 day test, it is much more than that. It’s a high intensity study of long duration to meet the requirements and parameters as set out by the EFSA, it can take up to 6 months. This test alone can cost upwards of £300k without the additional studies. These studies are not easy to book especially due to COVID-19 so through the ACI you can be assured that this testing will be done ethically and on time as we have already secured the OECD408 lab and had protocols approved.
What about after the study?
We offer support to our members throughout this process, including regular updates on testing, updating the relevant authorities, and compiling the actual dossier itself. Contact us now to see how we can help you through this process.
I’m CEO of a multinational CBD raw material manufacturer. Our novel foods application is already being processed. At the time of submission it was not clear whether tox data was required so we relied upon data that already existed in the public domain.
- How will FSA recent confirmation impact our application?
- The FSA are not just a regulatory body, they have an ethical and moral duty to keep the consumers safe. They have a team of experts which make up the Committee of Toxicity who are an internationally recognised body. In the case of CBD, the COT position is that there are gaps in the toxicological data which make it impossible to give a full evaluation of CBD safety. The FSA position is that we should follow EFSA guidance from a toxicology view to guide how we complete the Safety Study. They have been quite clear that without this information you will not gain a validated application. If you are a major supplier of a CBD product for end users, the application that you would put in cannot be solely literature and it is not too late to change this.
What about animal studies? We are an ethical brand and do not believe in harming animals.
As part of the Novel Food Application they have spoken about reproductive & carcinogenic issues, as part of our study we have taken samples to make sure that we don’t have to do any more animal testing than the OECD 408 studies. This means that we have made our procedure as ethical as possible when it comes to animal testing. Also, by using a consortium approach we are doing one study rather than each individual brand doing their own – keeping animal testing to a minimum.
3 reasons why joining the ACI & the Safety Study Consortium might be your only option to keep trading:
- Regulatory Framework – By joining this study you will enter the market with the regulatory framework needed to run a strong, ethical and legal business across the UK.
- Competitive Pricing – This work is being completed at a shared cost which means instead of spending hundreds of thousands, you’re looking at tens of thousands.
- FSA are clear on how the dossier should look – The FSA have made it clear that this process should follow structured protocol with ethical bearing. We are working under the guidance of the Scientific Leads in the Cannabinoid & Novel Foods Industry, we are taking advice from COT to ensure clarity at every stage and we are the only trade body working towards a safer, regulated industry with the desires of our members at the core of our work.
The Bottom Line:
ALL brands need a Novel Food Application, some of the data can be cross-referenced from your supplier’s Novel Foods Application but ONLY if they are generating the relevant Safety Study data.
Join the ACI Now.