European Commission: each country must decide whether CBD is a medicine or a food supplement

Taking into account the current uncertainty in Portugal regarding Cannabidiol (CBD) — whether or not it is considered a food supplement — and in the absence of publication of the regulation of the Medicinal Cannabis Law by Infarmed, Cannapress sent some questions to EFSA (European Food Safety Agency), which forwarded all responses to the European Commission.

After forwarding the questions to several departments, this was the answer we received from Anca Paduraru, spokesperson for the European Union (EU) projects on Health, Food Safety and Energy.

“CBD (Cannabidiol) can be classified in many ways — as a medical product (medicinal products), food or food supplement. The classification of a product as a medicinal product, as a food or a food supplement is a national competence. As such, each Member State must decide whether CBD can be sold as a medicine or food supplement in its territory, taking into account all the characteristics of the product. If it is classified as a medicine, EU legislation requires that a marketing authorization (MA) be issued by the competent authority before it is placed on the market.

Therefore, regarding the status of CBD in Portugal or any other specific questions regarding access to CBD oil in Portugal, our advice is that you contact the competent authorities in Portugal that are in the best position to answer these questions.

[perfectpullquote align=”right” bordertop=”false” cite=”” link=”” color=”” class=”” size=””]”Each Member State must decide whether CBD can be sold as a medicine or food supplement in its territory, taking into account all the characteristics of the product”[/perfectpullquote]

Regarding the use of CBD as a food supplement, the use of this substance in food supplements is not harmonized at EU level (only the use of vitamins and minerals). Member States can therefore regulate the use of this substance in food supplements, under the terms of Article 36 of the Treaty on the Functioning of the European Union. This, without prejudice to the legislation relating to the “novel food”.

As for the possible classification of CBD as a novel food, Article 4 of Regulation (EU) 2015/2283 on novel foods requires food business operators to verify whether or not the food they intend to place on the EU market falls within the scope of application of the new Regulation (EU) 2015/2283 on food matters. That is, whether or not the food is new. If, having taken into account all available information, food business operators are still unsure whether a food is novel, they should consult the competent authorities of the Member State where they first intend to place the food on the market. Commission Implementing Regulation (EU) 2018/456 sets out the information that has to be included in the consultation request, and includes provisions on the confidentiality of the request and the steps in the consultation process that operators must follow.

Discussions are currently taking place between the EC and the relevant authorities in Member States on the novel food status of cannabidiol and other cannabinoids.

The Czech Republic considered CBD in food supplements as a novel food under the previous Novel Food Regulation and therefore an application for authorization was submitted to the Czech authorities. As this application had not yet been completed as of 31 December 2017, the application is being considered under the requirements of the new novel food regulation.”

Cannapress sent requests for clarification to Infarmed and DGAV — General Directorate of Food and Veterinary Medicine. Paula Cruz de Carvalho, Deputy Director General of DGAV, sent the following explanation to Cannapress by email:

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INFARMED has not sent any response to date.

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