CBD and novel food licence!

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Estimated reading time: 7 minutes

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Introduction

CBD (Cannabidiol) has gained a lot of popularity over the last few years. Becoming a mainstream health product – available in many health stores and grow shops. The law around CBD oil has changed weekly and is different from country to country. Finally, the EU commission has made the decision to regulate CBD products. The novel food status of Cannabidiol (CBD) extracts was confirmed in January 2019. CBD and Novel Food Licence – what does that entail for The Real CBD's future? What is a Novel Food Licence? Let's dig into all of that.

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What is a 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.

The underlying principles of 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.

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How to apply for a Novel Food Licence!

It is a very costly affair to obtain a Novel Food Licence!

The novel food status of Cannabidiol (CBD) extracts was confirmed in January 2019. This means that companies need to apply for authorization of their CBD extracts and isolates using the procedure for full applications.

Part of the application needs to include:

• Identity of the novel food
• Production process
• Compositional data
• Specifications
• The history of use of the novel food and/or of its source
• Proposed uses and use levels and anticipated intake
• Absorption, distribution, metabolism, and excretion
• Nutritional information
• Toxicological information and allergen city
• It should also include a list of all references.

This has to be done for every single product on the products line…..One toxicology reports alone cost thousands of euros.

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The Real CBD and Novel Food Licence

The Real CBD are members of EIHA.

The European Industrial Hemp Association (EIHA) represents the common interests of hemp farmers, producers, and traders working with hemp fibres, shaves, seeds, leaves, and cannabinoids. Their main task is to serve, protect, and represent the hemp sector in the EU and international policy-making.

EIHA covers different areas for the application of hemp, namely its use for construction materials, textiles, cosmetics, feed, food, and supplements.

EIHA will make a joint Novel Food Application for all its members.

So The Real CBD will have its Novel Food Application pre-approval in via EIHA and its partners by 31/3 2021. 

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What is the future for the CBD business?

The world of CBD and cannabis oil have long been a very grey area in many countries. People have tried to make CBD- and cannabis oils at home in their kitchen for years. It all started with Rick Simpson to cure his own cancer.  The consumer never really knew what was in the bottle or if what was stated on the label, was actually in the product.

As EU-commission and the UK Food Standard Agency is taking the first steps to regulate, and make sure the consumer is guaranteed quality products, the whole CBD and cannabis Industry will be filtering all the “cowboys” and homemade products away.

The future CBD consumer will be guaranteed a regulated CBD product! No more crushed paracetamol or morphine hidden in CBD oil for better effect…..

More from our blog:

• Why is a Novel Food Licence for CBD important?
• Law on CBD in Spain and the EU
• CBD oil legal in Scandinavia? Status check
• The Real CBD Product Update October 2019

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Update 1/12 2022 – Novel Food application

CBD products are moving forward in Europe's study of food safety

A memo from the European Industrial Hemp Association (EIHA) said that the novel food group had finished applications for two forms of CBD that will be sent to the European Food Safety Authority (EFSA).

Dosis

In a letter giving consortium members an update, EIHA also said that it had suggested to EFSA that the most CBD a person could take in a day is 17.5 mg. This is because tests showed that CBD had effects on four organs.

“The derived NOAEL (no-observed-adverse-effect level) is lower than we initially expected and lower than what was in the existing literature,” the memo says. The NOAEL level is the amount of exposure of an organism at which there is no increase in the frequency or severity of any bad effects that is biologically or statistically significant.

EIHA says that the applications have been sent to the European Commission's Directorate-General for Health and Food Safety, which will check to see if they are full before sending them to EFSA for risk assessment, which could take up to nine months.

EIHA said that they are still working on a different dossier for full spectrum CBD, which will be finished by the end of the year and sent to EFSA in the first quarter of 2023.

Labeling

EIHA also used the memo to remind consortium members that CBD formulations must have a maximum CBD content of 10%, diluted with hemp seed oil or another food-grade oil, and that the following information should be included on labels, packaging, and any other materials that come with products:

• “Not recommended for children, women who are pregnant, or women who are nursing.”
• “Don't eat anything else made from hemp while you're taking this supplement.”
• “Don't take more than 17.5 mg of CBD per day, and you shouldn't take it with food.”
• “Don't take the supplement at all while on therapy, or talk to your doctor first.”

The European Food Safety Authority (EFSA) gives independent scientific advice and looks at new and current risks in the EU food chain. The agency's voice is important for making sure that foods are accepted and that food laws in Europe are followed in a reasonable way. EFSA lets stakeholders have a say in things like scientific review and communication, while still keeping these processes independent and open to the public. Since 2019, EIHA has been listed as an interested party with EFSA.

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Update 1/7 2023 – Novel Food application

EU Member States have reached a consensus on the EIHA plan, which says that hemp leaves are not new for herbal infusion. After months of talking, Member States have finally reached an agreement.

To change the Catalogue of Novel Foods. This ruling is in line with what EIHA has said for a long time, which is that hemp leaves should be specifically excluded from the Novel

Food Catalogue, which gave them permission to be sold as traditional food for making plant tea. Also, the new item for “Cannabis sativa L.” gives a longer, more detailed list of other hemp goods that are not included of the new rules about food. The change was made to the list on June 2, 2023, and it goes into force right away. Unless a different plan is made. On a national level, the market will be able to sell leaves for herbal infusions.

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