- 1 Cannabidiol gets reclassified as a novel food in the EU
- 2 What is a Novel Food?
- 3 Proof of CBD & Hemp Use Pre-1997 in the EU
- 4 Implications of the Novel Food Reclassification of Hemp Products
- 5 The Cannabis Trade Association
- 6 The Cannabis Trade Association will not be submitting a Novel Food Application
For centuries, people have used plants as a part of there diet and to balance their health. With plant-based diets and supplements rising in popularity as more people pursue a healthy lifestyle, reduce risk of disease, and seek the best quality of life.
Gaining worldwide attention in these pursuits is CBD, or cannabidiol, a compound that is extracted from the cannabis sativa plant; in Europe, CBD is extracted from the hemp plant and mixed with oil for convenient dosing of CBD. CBD extracted from hemp contains less than 0.2% concentration of tetrahydrocannabinol (THC).
These products have generally been classified as traditional foods or food supplements, until recently.
Cannabidiol gets reclassified as a novel food in the EU
In January 2019, there was a significant change to Cannabidiols’s classification by the European Food Safety Authority (EFSA) in the novel foods catalogue. The EFSA stated, “products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated.” As a result, CBD went from being a permitted food in Europe to being a fully unauthorized novel food.
Novel Food Authorisation
While this isn’t necessarily a negative thing, since operators can still place novel foods on the market, companies must first apply for premarketing authorization, a practice which has been inconsistently enforced across Europe. An authorization will be given only if it’s shown to be safe, not nutritionally disadvantageous, and won’t mislead the customer through claims.
Restrictions on Sale of Cannabidiol
Some EU member states are left confused by the regulation change and are placing restrictions on the sale of CBD as a result of the new classification. At the same time, consumers are left in the dark as to which CBD products have authorization by the EFSA and the EU member state regulatory bodies.
What is a Novel Food?
A novel food is defined by the European Food Safety Authority as “food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of the Member States to the Union.” A novel food can be;
- a newly developed innovative food.
- food produced using new technologies and production processes
- food which is or has been traditionally eaten outside of the EU.
This is where it becomes a bit tricky for CBD, as new innovations and extraction methods have changed the way Cannabidiol is produced, yet it cannot be proven that CBD oil and hemp-based products were not in use before 1997 in the EU.
Proof of CBD & Hemp Use Pre-1997 in the EU
Hemp has been a rich part of Europe’s history for centuries. Not only has it been used as a food supplement, but it’s also been lauded as a healer, medicine, and source of protection against disease.
Here are some mentions of hemp in Europe’s history:
· 1220 (Italy) – Inscriptions on the Tower of Escape in Bologna reads, “Canabis Protectio”, which translates to “Cannabis is Protection”;
· 1475 (Italy) – A cookbook describes a recipe for “a health drink of cannabis nectar”;
· Medieval Germany – a recipe appears in a cookbook for monks for hemp soup
· Medieval Poland – analysis of Polish diets at the time show that hemp was in great stock and regularly consumed;
· 1945-1958 (Italy) – Dr. Carlo Erba focuses his studies on two hemp extracts, quoting its use by contemporary British and French chemists;
· 1894 (Sweden) – The World Exhibition in Antwerp features various food industries, including a company called Maltos Cannabis;
· Prior to 1997 – it is shown that there have been hundreds of thousands of tonnes of products produced in Austria, Germany, and The Netherlands in the form of hemp seeds, hemp seed oil, ready-made products containing hemp, hemp-infused beverages, and snacks containing hemp.
Implications of the Novel Food Reclassification of Hemp Products
Dr. Hemp Me takes the stand that hemp and CBD should not be classified as a novel food.
- There was little to no communication as to why the EFSA reclassified hemp and CBD as a novel food. For centuries, hemp and hemp-extracted cannabinoids have been used as a food and food supplement. With the whole plant containing a degree of cannabinoids, and CBD specifically, it is not possible to extract anything from the hemp plant without it containing cannabinoids.
- If a product has no added isolates or synthetic cannabinoids, and contains less than 0.02% THC, and is from an approved hemp cultivator or non-cannabis source, it should remain to be considered a traditional food, rather than a novel food requiring premarketing authorization.
- The EFSA gave little to no transition period for the reclassification, significantly jeopardizing the operations and productions of hemp-derived CBD products. As a result of this reclassification:
- The EU becomes less competitive in the global CBD market. The global cannabis industry (which includes CBD and hemp-derived products) is expected to be worth US$130 billion by 2029;
- Companies and products are forced to go from a regulated market into a “grey market”, and consumers are faced with the decision to purchase CBD products even if they’re not deemed as fully legal;
- Loss of jobs in production, operations, and sales.
- A reduced grip on market control as the consumer cannot differentiate products that have and have not been classified as “novel foods”;
- Products containing hemp in Europe may remain under antiquated extraction technologies while the rest of the world continues to innovate in cannabinoid extraction
For these reasons, Dr. Hemp Me supports the efforts to have the EFSA overturn the reclassification of CBD as a novel food in order to continue to provide members of the EU access to quality products and allow the EU to remain competitive in the global CBD market.
The Cannabis Trade Association
Dr. Hemp Me also supports the initiatives put forth by the Cannabis Trades Association for the further regulation and licensing of all cannabis and cannabinoid products in the EU.
The Cannabis Trade Association (CTA) is the largest membership-based Hemp and Cannabis Association in Europe. It works with the Government to establish legislation to ensure the industry has effective and practical guidance and is adequately regulated.
The Cannabis Products Directory
A new initiative has been formed called the Cannabis Products Directory (CPD) which aims to ensure product transparency, quality and customer satisfaction across the industry. The CPD is a framework for the regulation and licensing of all cannabis and cannabinoid products in Europe. The initiative was developed in conjunction with the Food Standards Agency (FSA) and the Medicines and Healthcare products Regulatory Agency (MHRA) with the CPA at the leadership.
The CPD means that growers, producers, manufacturers and sellers will all have to be registered, as will each product. Inspections and laboratory testing of products will occur at regular intervals.
Each product will have a Cannabis Product Information File (CPIF) and an assigned ‘Responsible Person’ who will ensure that the product remains compliant and updates the CPIF.
Benefits to the Consumer
The CPD means that consumers will now be empowered with information about their cannabis and CBD products, as they’ll be able to see what products have been produced and tested in accordance with regulations and will be assured of quality and safety.
Dr. Hemp Me believes that the European Union is well equipped to become global leaders in hemp CBD. We support that the EFSA overturns classifying CBD as a novel food while supporting the development of structures and processes such as the CPD that will advance the industry as a whole while keeping the interests of consumers top of mind.
The Cannabis Trade Association will not be submitting a Novel Food Application
The CTA have confirmed in a press release dated the 2nd of September 2019 that they do not intend to put forever an application for Cannabis extracts to be novel food authorised. If the CTA were to do this all Cannabis extract products would have to be taken down from physical and online stores until the novel food process was completed which can take anything from 18 months to two years.
The CTA confirmed;
- It is our opinion that cannabis extracts are not novel
- There have been no legally binding determinations on the status of cannabis extracts and their Novel Food status
- All statements pertaining to the Novel status made by the European Food Standards Agency and Member States are currently only opinion
- Any opinions made by the EFSA cannot be legally relied upon to secure a prosecution for breach of the NFR
- The Novel Food Regulations state it is the Food business operator’s responsibility to determine a food falls within the scope of the Regulation
- We put forward that there is no requirement to submit an application for a Novel Food as it’s our opinion cannabis extract are not Novel
- The risk of submission of an application could result in products coming off the market until such a time as an authorisation is granted.
While Cannabis extracts should not be considered novel food there is a need for the Cannabis/CBD market to be regulated. Currently the CTA are regualting each one of its memebers including Dr. Hemp Me. As part of this process the CTA have brought in a panel of independent experts called TrustCanna.
TrustCanna is a product certification process which will allow consumers to see which products have been verified and safe to use for the end user.
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Is CBD oil classed as a Novel Food?
In January of 2019, CBD was reclassified as a novel food by the EFSA, stating “products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated.”
What is a Novel Food?
European Food Safety Authority (EFSA) definition of a novel food is “food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of the Member States to the Union.”
Why should CBD not be considered a Novel Food?
Cannabis extract containing CBD oil has been used for thousands of year and should not come under the assumption that CBD has not been used before 1997.