This article is a continuation of our previous article that explains how the listing for cannabidiol was changed in the Novel Foods catalogue in January 2019 and how this relates across the EU with regards to regulation and enforcement.
It is intended to bring together different opinions and serve as list of resources for those interested parties.
To begin with we share a video from the Hemp & CBD Expo in the United Kingdom. Damien Bove from Adact Medical and Mike Harlington from the CTA UK (Cannabis Trades Association) discuss the changes to the novel food catalogue and why they believe it may not be legal
DG SANTE – DG for Health and Food Safety The Commission’s Directorate-General for Health and Food Safety is responsible for EU policy on food safety and health and for monitoring the implementation of related laws. They contacted Mike after the changes had been made to the novel food catalogue expressing their concerns that the Novel Foods Working Groups, had made changes to the novel food catalogue may have been unlawful. (See video 5:21)
The CTA too legal counsel with London law firm Mackrell Turner Garrett and Jonathan Kirk QC to represent them,
Robert Jappie, Head of Cannabis Law at Mackrell Turner Garrett and Jonathan Kirk QC, of Gough Square Chambers, travelled to Brussels on the 12th March 2019 to make representations to the European Food Safety Authority (EFSA) in respect of the recent decision to reclassify hemp extracts as ‘novel’.
Food supplements with CBD in Germany are classified as Novel
In Germany the BVL (Federal Office for Consumer Protection and Food Safety) recently took a hard line concerning CBD products.
Are dietary supplements marketable with cannabidiol (CBD)?
Classification of products and assessment of marketability is the responsibility of the national authorities responsible for food control.
Therefore, the opinion of the Federal Office for Consumer Protection and Food Safety ( BVL ) on this can only apply subject to a different opinion of the respective competent supervisory authorities in the federal states.
An overview of the state ministries and senate administrations in the federal states can be found on the website of the BVL : www.bvl.bund.de/lebensmittelueberwachungDerBundeslaender
The BVL is currently no case known, according to which cannabidiol (CBD) in food, including in dietary supplements, would be marketable.
From the point of view of the BVL , for products containing CBD before placing on the market either an application for authorization of a medicinal product or a request for authorization of a novel food must be made. Under these procedures, the safety of the product must be demonstrated by the applicant.
The food business operator is primarily responsible for ensuring that its products comply with food law regulations.
On 6th March 2019 the CTA issued a press release
Following a meeting between the Cannabis Trades Association and the Food Standards Agency, the Board of Directors CTA release the following statement:
“After many phone calls with FSA the CTA finally met again on the 4th of March. In attendance were Alison Asquith and Karen Todd from the novel foods team. Tom Whettem, Mike Harlington and Robert Jappie (legal representative from Mackrell Turner Garrett) attended for the CTA.
“We feel it’s fair to say that the FSA seem to be quite misinformed around standard industry practices and accept that they are not conversant with how members products are manufactured. The general impression is the production of CBD oil is achieved through the addition of CBD isolate to a carrier oil. It was not previously understood that CBD oil is created using a full plant extract that is diluted.
“It was not contested by the CTA that isolated individual cannabinoids should be novel. It was also confirmed by the FSA that it was not the extraction process that was considered novel. What was agreed by both parties is that there is a significant amount of doubt by the FSA as to what constitutes a product containing CBD that would fall within the scope of Novel Foods.
“In principle it can be assumed that based on their understanding, it would only be products that are enriched with isolated CBD that would be novel. Which is the position we have presented for almost 2 years now.
What does novel foods actually cover?
Novel Foods regulation in Europe covers two things, consumer rights legislation and guidelines that cover all plant-based food and supplements across the continent. It also covers beauty products. The novel foods catalogue is intended as a resource and guidelines for regulatory authorities to regulate food supplements. It is not a set of laws. EFSA’s Novel Food Catalogue is advisory only, it is relied upon by domestic regulators to protect consumers
What is Novel Food?
Novel Food is defined as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel food came into force.
‘Novel Food’ can be newly developed, innovative food, food produced using new technologies and production processes, as well as food which is or has been traditionally eaten outside of the EU.
Examples of Novel Food include new sources of vitamin K (menaquinone) or extracts from existing food (Antarctic Krill oil rich in phospholipids from Euphausia superba), agricultural products from third countries (chia seeds, noni fruit juice), or food derived from new production processes (UV-treated food (milk, bread, mushrooms and yeast).
The underlying principles underpinning Novel Food in the European Union are that Novel Foods must be:
- Safe for consumers
- Properly labelled, so as not to mislead consumers
- If novel food is intended to replace another food, it must not differ in a way that the consumption of the Novel Food would be nutritionally disadvantageous for the consumer.
Pre-market authorisation of Novel Foods on the basis of an evaluation in line with the above principles is necessary.
Does the extraction method used make a product novel?
According to Damien Bove the extraction method used to manufacture a product does not in itself make a food novel unless it introduces a safety issues. CO2 Extraction has been used for decades for flavouring in the beer Industry, Ethanol extraction has been used for generations and distillation has been used for many centuries. There is no evidence that any of these methods changes the molecular structure of any of the cannabinoids in hemp. This argument is being used by both the Irish and German authorities to classify CO2 extraction of hemp as making it novel in food.
History of use in Europe