CBD products: European legal situation

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Galway Daily life & style Growing trend in Ireland of CBD Oil for humans and dogs

CBD products are flooding the market: CBD oil, CBD flowers, CBD tea and many more. The hype surrounding the non-psychoactive cannabinoid cannabidiol (CBD) can hardly be stopped.  But is it all legal at all?

CBD experts went looking for clues and spoke to the official representatives to tell you more about the good CBD flower you can now easily buy online on the best sites!

CBD and novel food: classification as novel food?

When evaluating products containing hemp, it should be ensured that these are not foods that are “novel” in the sense of the Novel Food Regulation (Regulation (EU) 2015/2283). They were not used for human consumption to any significant extent in the European Community before May 15, 1997.

The cannabis Sativa plant is listed in the EU Commission's public novel food catalogue as generally “not novel”. In the information in the Novel Food Catalog, there is no restriction of permissibility to certain parts of the plant. At least not as long as regulations have been made in other legal bases.

However, the single substance CBD is rated as a novel in the Novel Food Catalogue. Thus, CBD requires approval according to the Novel Food Regulation. Since CBD has not yet been approved as a novel food, such products are so far not marketable (as a non-approved novel food).

The EU Commission has received an application for approval of CBD as a novel food. However, to approve a product as a novel food, the applicant must demonstrate that the substance does not pose a risk to human health. We currently have no further information on the status of the approval process.

Classification as unsafe food

According to Article 14 of Regulation (EC) No. 178/2002, food must not be unsafe. The THC is primarily responsible for the psychoactive effects of cannabis products. Further prominent representatives of the cannabinoids occurring in the plant are cannabinol (CBN) and CBD.

Except for seeds and roots, the entire hemp plant has glandular hairs that produce a cannabinoid- containing resin. Consequently, THC is an ingredient in products containing hemp, consisting of hemp leaves and possibly hemp flowers. Against this background, it must be ensured for foods based on industrial hemp that the guideline values ​​for THC in foods containing hemp are not exceeded.

And what does that mean now?

Manufacturers have to guarantee the safety of food – especially concerning possible effects on health. Since products with cannabidiol can have drug properties, a distinction must be made with the inclusion of drug monitoring.

If there are no drug properties, classification as a novel food is possible. It may have to be checked on a case-by-case basis using specifications for the manufacturing process, extraction process or composition (e.g. degree of enrichment).

According to the EU Commission’s novel food catalogue, cannabidiol is already classified as “novel” and therefore requires approval following Regulation (EU) 2015/2283. For various CBD products, advertisements were submitted to the BVL under Section 5 of the Food Supplements Ordinance. However, such a display does not mean that a CBD product is also marketable as a dietary supplement.

The Consumer Protection and Food Safety does not certify the displayed product’s marketability, but only confirms receipt of the advertisement. Like most CBD oils, dietary supplements do not require any approval because they are part of the food. However, an application following the Novel Food Regulation is necessary if the CBD content is higher than in the original plant.

The person who puts food on the market as the responsible distributor is responsible for ensuring that the product is safe and that all legal requirements for composition and labelling comply.

The official food control checks compliance with the relevant legal requirements on a random basis. The assessment of products is always an individual decision.

Cannabis sativa extracts (hemp extracts)

In the case of plant extracts, it is generally always necessary to check whether the extraction method used leads to a targeted enrichment (or depletion) of certain substances.

If the specific extract in the respective composition were not consumed to a significant extent as a food in the European Community before May 15, 1997, it would be regarded as a novel food within the meaning of the Novel Food Regulation.

Accordingly, hemp extracts would be classified as novel as soon as CBD was specifically
enriched there. For concentrations of this magnitude, there are currently insufficient studies on possible effects on health.

Besides, there are always changing proportions of THC in such CBD preparations. These preparations could consequently not be marketable due to the narcotics regulations.

CBD, cannabis, medicine … advance in the EU?

In February 2019, the EU Commission passed a resolution to promote cannabis in medicine. (19) The EU Member States should remove obstacles to research on medical cannabis and promote related projects. Doctors should be able to prescribe officially approved cannabis-based drugs to patients. The Hemp Association described this resolution as a sham package. (20) So far, there is only one drug with CBD in the EU called Sativex. Dronabinol and medicinal extracts such as THC25, currently available in some pharmacies, would not comply with this resolution any more than CBD flowers.

Conclusion

As already mentioned at the beginning of the article, the legal situation regarding CBD products is very complicated, as different laws, ordinances and regulations apply here.

Although CBD flowers are illegal and CBD oils are not marketable, there is always a way for sellers. Especially when it comes to CBD oils, each product has to be considered individually.

Ultimately, the individual state authorities have to check whether a CBD product can be sold or not. However, you are not liable to prosecution if you buy CBD oil – if the THC content is below 0.2 per cent.