Products containing cannabidiol (CBD) – overview and enforcement aid
In December, the FOPH and Swissmedic published a new version of the document Products containing Cannabidiol (CBD) (fifth, updated version)
The updated document can be found on the Swissmedic website:
What was changed in the document?
Here is an overview of the changes;
Page 2
Note: This fact sheet does not cover cannabis products with a total THC content of at least 1.0% for medicinal purposes (and follow-up text)
Page 5
Overview of the responsibility of the “Offices” was changed to “Authority” and the text was supplemented by the following section;
The cultivation, processing, production and trade of cannabis for medical purposes with a total THC content of at least 1.0% is subject to the Swissmedic licensing and control system. For food (including food supplements), cosmetics, everyday items and non-smokable tobacco substitutes (e-cigarettes or liquids for electronic cigarettes, tobacco-free snus and snuff substitutes with CBD)...
Page 8
Medical devices – The text has been adapted and some passages have been added;
[Old]: "IX of Directive 93/42/EEC (MDD) 5 , in particular Rule 13 of Annex IX MDD, which states: "All products containing a substance which, when used separately, can be regarded as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which can act on the human body in addition to the effect of the products, are assigned to Class III." The current MepV and MDD will be replaced by new medical device regulations from May 26, 2021 (new MepV and Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices [MDR]). However, the classification of a medical device containing CBD remains unchanged, because according to Rule 14 of Annex VIII MDR, the following still applies:"
[New]: “VIII of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (EU-MDR), in particular Rule 14 of Annex VIII to the EU-MDR, which states:”
Page 9
Products that are offered as food
The following text has been added;
After numerous applications for CBD as a novel food were received in the EU, the EU Commission forwarded them to EFSA for the assessment of the safety of consuming CBD for humans. The EFSA expert panel identified numerous data gaps on the health effects associated with the intake of CBD. Until these data gaps are closed by the applicants, the assessment of CBD as a novel food will therefore be suspended in the EU. Switzerland has also assessed the health risks of CBD as a novel food and published the findings in the "BLV Briefing Letter: Cannabidiol (CBD) in Food and Liver Effects" dated December 3.12.2021, XNUMX. Safety concerns also exist in Switzerland, and the safety of CBD as a food cannot currently be conclusively assessed due to data gaps.
Page 12
Products that are offered as cosmetics
The following text has been added;
As a result of the issuance of the general decree on the denaturation of fragrance oils containing CBD as chemicals on March 29, 2022 and the recent suspension of the assessment of CBD as a novel food in the EU, many CBD oils are currently offered on the market as oral care products with various concentrations. Such products are not in line with the intended purpose of a cosmetic and the risk of misuse is significant. With regard to a safety assessment of these products, no adequate assessment can currently be carried out: to date, no safety report available to the cantonal enforcement authorities has been able to demonstrate safety regarding dermal absorption (insufficient data on absorption through the skin available) and due to data gaps, oral cosmetics pose exactly the same safety concerns as food.
Page 13
change of title;
[Old]: “E-cigarettes) Some e-cigarette shops offer liquids containing CBD.”
[New]: “E-cigarettes, tobacco-free substitutes for snus and snuff) Some e-cigarette shops offer non-smokable tobacco substitutes that contain CBD.”
Page 14
Products that are offered as chemicals
The following text has been replaced and supplemented;
On March 29.3.2022, XNUMX, the Chemicals Registration Office issued a general order requiring that products containing CBD that are placed on the market in accordance with the requirements of chemicals law and are intended for end users must be denatured. This applies, for example, to CBD that is placed on the market as a fragrance oil for room fragrance, but not to CBD for consumption as food (see section "Products offered as food"), medicinal products (see section "Products offered as medicinal products (medicinal products, medical devices)"), cosmetics (see section "Products offered as cosmetics") or as e-liquid for e-cigarettes (see section "Products offered as consumer goods (e.g. liquids containing CBD for e-cigarettes, tobacco-free substitute products for snus and snuff)").
Page 15
Products that are offered as tobacco substitutes for smoking
A few text passages were rewritten and supplemented;
The new Tobacco Products Act passed by Parliament in 2021 also requires that tobacco substitute products smoked be reported. The adopted version of the law is available on the BAG website under Laws.
[Old]: "may impair driving ability."
[New]: "may temporarily impair the ability to drive. In the future Tobacco Products Act, a corresponding warning has therefore been included in Article 14 paragraph 1 letter c number 3."
Page 17
Handling cannabis and cannabis preparations with CBD and a total THC content of less than 1.0%
Text passage changed;
[Old]: “According to the BetmVV-EDI, cannabis resin (hashish) is a prohibited substance regardless of the THC content and therefore always requires an exemption permit from the BAG for handling, regardless of the THC content.”
[New]: "With the amendment to the Narcotics Act of August 1, 2022, cannabis with a total THC content of at least 1.0% for medical purposes is no longer considered a prohibited narcotic and is now subject to Swissmedic's licensing and control system (cf. Art. 8 para. 1 letter d Narcotics Act in conjunction with list a of Narcotics Ordinance-EDI). Further information can be found in the link below."
The entire leaflet can be downloaded at the following link: