Information Letter 059 – May 2019

Subject: Recent European Developments on Cannabis Derivatives

Dear All,

Cannabis derivatives such as Hemp seed oil and Cannabidiol (CBD) are very fashionable those last days and many cosmetic brands pay attention to this new market trend. As usual, new developments, new technologies and new practices raise legal questions and the European Authorities start to raise questions (and sometimes concerns) about these Cannabis derivatives.

Following a meeting at the European Commission level on December 10th, 2018, it was confirmed that a note on the status of Cannabis in cosmetics would be published. Regulatory developments can take quite a lot of time in the EU and, in the meantime, BIORIUS can shed some light on this topic:

Cosmetic Regulation (EC) n° 1223/2009:
In Annex II of the regulation, concerning prohibited substances, entry 306 mentions narcotics. It is specified that these are all the substances listed in Tables I and II of the Single Convention on Narcotic Drugs signed at New York on March 30th, 1961.

The New York Convention of March 30th, 1961:
This convention defines the term cannabis as the floriferous or fruiting heads of the cannabis plant (excluding seeds and leaves that are not accompanied by the luminaries) whose resin has not been extracted, whatever their application.

Cannabis, cannabis resin, cannabis extracts and tinctures are listed in Table I of the Convention, the same table referred to in Annex II to the Cosmetic Regulation.

It should therefore be concluded that seeds and leaves not accompanied by flower heads are not included in the substances prohibited by Regulation (EC) No 1223/2009.

Cannabidiol:

Cannabidiol:
Cannabidiol is a cannabinoid derivative (CBD) that does not appear to have a psychoactive effect, unlike Tetrahydrocannabinol (THC). It therefore seems that it can be used in cosmetic products under certain conditions:

  • It must not induce a significant physiological effect by exerting a pharmacological or metabolic action (as defined in the cosmetic regulation),
  • The Cannabidiol extract used must only come from unaccompanied seeds and leaves (1961 New York Convention)
  • The THC content must be determined according to the Community method and must not exceed 0.20% in the raw material used (e.g. French Decree of August 22nd, 1990, R. 5132-86 Public health code),
  • The presence of THC in finished products, regardless of its rate, is prohibited.
  • The presence of THC becomes by definition an impurity, so it will be appropriate for the safety assessor to assess its presence with regard to the safety of the finished product.

National provisions:
To the best of our knowledge, there are no national provisions related to Cannabis derivatives in the countries of the EU. Some countries like Sweden, France and Lituania made some reports on this topic. To the best of our knowledge, these reports do not prevent cosmetic brands from using Cannabis in cosmetics provided that the conditions reported above are fulfilled.

However, BIORIUS learned that drug squad in France controlled the product labels of several cosmetic brands. At this occasion, the French Authorities reminded that it is prohibited to display pictures or drawings ofCannabis leaves on product labels and any other marketing communications. We recommend that our Clients be cautious with the use of these symbols and try to avoid them until clarifications are provided by the European Commission.
We stay at your disposal for any questions related to this topic.

Best regards,
Dr. Fred Lebreux