top of page
Writer's pictureDaniel Jiménez

Cannabidiol in Europe: New Regulation on the Horizon

Updated: Sep 30

The European Chemicals Agency (ECHA) has published a key proposal for the cosmetics industry in Europe: the classification of Cannabidiol (CBD) as a CMR Reprotoxic substance. This proposal, promoted by France , seeks to include CBD among the chemical substances subject to strict regulation due to its potential effects on human reproduction.





What is Cannabidiol?

Cannabidiol (CBD) , identified by its CAS number 13956-29-1 , is a non-psychoactive compound derived from cannabis that has gained relevance in recent years, especially for its therapeutic benefits in cosmetic products. It is credited with soothing, anti-inflammatory and antioxidant properties, which has made it a popular ingredient in products such as creams, oils and serums.


However, the use of CBD in European cosmetics is surrounded by strict regulations. According to Regulation (EC) No 1223/2009 , CBD can only be used in cosmetics if:


  • It is of synthetic origin .

  • It comes from parts of the cannabis plant that are not considered narcotics , such as the seeds and leaves not attached to the flowering tops.


Furthermore, CBD must not contain Tetrahydrocannabinol (THC) , the psychoactive substance present in cannabis, as it is prohibited in cosmetics. However, the regulation allows the presence of traces of THC if they are technically unavoidable, as stipulated in Article 17 of the aforementioned regulation.


The Proposal for Classification of CBD as a CMR

In September 2023, France took a step forward in regulating CBD by proposing its classification as a substance CMR Reprotoxic , i.e. as a chemical that can negatively affect human reproduction. If this classification is approved, CBD would enter the list of prohibited substances in cosmetic products under European regulations, unless a specific exemption is granted.


This potential change has raised concerns in the cosmetics industry, which has seen CBD as a highly valuable ingredient due to its wide acceptance and multiple beneficial applications.


Currently, CBD is not explicitly regulated in Regulation (EC) No 1223/2009 , except when it is considered a narcotic, and it is also not present in the Annex VI of Regulation 1272/2008 (CLP) , which regulates the classification and labelling of hazardous substances. However, this proposed classification could mark a significant change in its future use.


Impact on the Cosmetics Industry

If CBD is classified as a CMR substance, its use in cosmetic products would be banned across the EU unless an exemption is in place. This regulation would affect a wide range of products currently containing CBD, forcing manufacturers to reformulate their products or, in some cases, withdraw them from the market.


The public consultation on CBD classification is ongoing, giving stakeholders, including businesses and industry associations, the opportunity to voice their concerns and provide input before a final decision is made.


Conclusion

The possible classification of Cannabidiol as a CMR substance represents a significant challenge for the European cosmetics industry. While CBD has been a star ingredient in numerous products due to its beneficial properties, this new proposal could drastically limit its use. It is essential that companies remain attentive to the development of this regulation and take the necessary measures to comply with any regulations that may arise.


As the public consultation progresses, and pending the final decision of ECHA and the European Commission , the cosmetics industry must prepare for possible changes in its formulations and commercial strategies. Staying up to date and being ready to adapt to emerging regulations is key to ensuring compliance and competitiveness in the European market.


References

  1. Regulation (EC) No 1223/2009 on cosmetic products.

  2. Regulation 1272/2008 (CLP) on classification, labelling and packaging of substances and mixtures.

  3. Proposal from the European Chemicals Agency (ECHA) for the classification of Cannabidiol.

Comments


Belab Services

Hire Cosmetic Safety Assessment Experts

With over 10 years of experience in cosmetic safety assessments and regulation, BELAB SERVCES offers a comprehensive and reliable solution to effectively verify and register cosmetic products.

Our solution, based on a deep knowledge of legislation, has a team of scientific consultants and advanced IT tools, making it the fastest and most reliable way to access the European market.


Don't wait any longer and ask us for more information.

bottom of page