Cannabidiol (“CBD”) does not yet have the status of an approved novel food (“Novel Food”) under Regulation (EU) 2015/2283 on novel foods. This means that products containing CBD in any amount cannot be placed as food or food supplements on the market in Slovakia.
Products containing cannabidiol (CBD) may be placed on the market in Slovakia only as cosmetic products in accordance with Regulation (EU) No 1223/2009 on cosmetic products.
Applicants wishing to place any novel food on the EU market must apply for authorisation from the European Commission. Once the application has been verified, the EU Commission will commission the European Food Safety Authority (“EFSA“) to carry out a scientific assessment on health risks to consumers. The EU Commission decides whether to authorise the novel food and the conditions of its use, taking into account the EFSA’s opinion.
Current status of marketing CBD in foodstuffs and food supplements in Slovakia
The EFSA informed applicants in mid-2022 that it did not have sufficient data on the effects of CBD on the liver, the gastrointestinal tract, the endocrine system, the nervous system and on the psychological well-being of humans. At the same time, animal studies indicate significant adverse effects, in particular in relation to reproduction. This means that it is important to investigate whether these effects are also present in humans.
The EFSA is currently in communication with the applicants to explain how additional information can be provided to help remove uncertainties about the safety of CBD products.
When will CBD be approved in food including food supplements?
It is understood that the EFSA’s time limit for a risk assessment opinion on CBD-containing products being placed on the market – which is nine (9) months from receipt of the application – is suspended until the applicant submits the required additional information and data.
At present, there is no indication that CBD will be approved as a new food anytime soon. There may be some movement during 2023 on authorisation of synthetic CBD in food and dietary supplements. Given the huge number of illegally placed CBD-containing products on the markets in Member States, an opinion from the EU Commission is awaited.
From our practice
In our legal practice, we have received several inquiries from our (mainly foreign) clients, for whom we notify dietary supplements in Slovakia, as to how it is possible that several foreign and Slovak e-shops are offering CBD oils, CBD capsules, CBD candies, CBD gummies or other forms of CBD-containing products on their websites and placing them on the Slovak market, and whether Slovak legislation or the approach of the Slovak authorities (Public Health Office) has changed in this respect.
The answer is no – neither legislation nor the approach of the Public Health Authority has changed in this respect.
Some e-shops and distributors, especially of foreign CBD producers, are trying to circumvent the current ban on placing CBD-containing products on the market by adding information to the consumer information leaflet to the effect that the product is not intended for internal use (yes, despite the fact that they are candies & gummies and capsules, which cannot be ingested other than orally), or that the product is intended for “collecting purposes”.
Additionally, we would like to point out that this practice does not comply with applicable European and Slovak law and that placing food (including food supplements) on the Slovak market in violation of the applicable legislation is punishable by a fine of up to EUR 20,000 in addition to withdrawal of the products from the market.
We therefore advise our clients to wait – that is, not to sell CBD products until CBD is approved at EU level and included in the EU list of novel foods. Approval, if granted, would also list the conditions under which the novel food can be used (i.e., the categories of foods to which CBD can be added, the maximum permissible levels of CBD in those foods, and, where applicable, the specific labelling requirements for those foods).
We are monitoring the situation closely and will let you know as soon as the restrictions on the sale of CBD products in Slovakia are relaxed.
- Act No. 152/1995 Coll. on Foodstuffs, as amended;
- Decree No. 16826/2007-OL of the Ministry of Health of the Slovak Republic and the Ministry of Health of the Slovak Republic; Regulation No. 178/2002, 1924/2006, 1925/2006, 1169/2011, 2015/2283 of the European Parliament and of the Council.