France submitted its intention to classify Cannabidiol (CBD) as toxic to reproduction

France intends to classify Cannabidiol (CBD) as Toxic to Reproduction

Date of publication: 07/06/2023

On June 7 2023, the European Chemicals Agency (ECHA) published the intent from France of harmonized classification and labelling (CLH) for CBD, for its reproductive toxic potential. If the process is concluded, CBD would be listed as a carcinogenic, mutagenic and toxic for reproduction (CMR) substance and therefore prohibited in cosmetic products in Europe.

BACKGROUND

Cannabidiol (CBD) (CAS 13956-29-1) is one of many different cannabinoids found and extracted from hemp (Cannabis sativa or Cannabis indica). Cannabidiol is normally located in the aerial parts of the plants (flowers, stems and leaves) and not in the roots or seeds. Although CBD is chemically similar to Tetrahydrocannabinol (THC), Cannabidiol does not cause a psychoactive effect (e.g. euphoric effects). Cannabigerol (CBG), another cannabinoid extracted from the plant, is a precursor molecule that can converted into other cannabinoids (like THC and CBD) during plant growth and is gaining more and more attention by consumers and the cosmetic industry.

Cannabidiol is used in cosmetics and personal care products as an antioxidant, anti-sebum, skin conditioning, and skin-protecting ingredient. It is not currently regulated by the EU Cosmetics Regulation No. 1223/2009, but it is subject to a consultation by the European Commission which issued a call for data on Cannabidiol in cosmetic products at the beginning of June. This call aims to gather scientific information relevant to the safety assessment of Cannabidiol and its potential contaminants, including trans-Δ⁹-tetrahydrocannabinol (THC or delta-9-THC), in pure form or as extracts.

WHAT’S NEW?

On June 7 2023, the European Chemicals Agency (ECHA) published the intent from France of harmonized classification and labelling (CLH) for CBD, for its reproductive toxic potential. If the process is concluded, CBD would be listed as a carcinogenic, mutagenic and toxic for reproduction (CMR) substance and therefore prohibited in cosmetic products in Europe.

WHAT NOW?

When France prepares the dossier for Cannabidiol, it will undergo an acceptance check by ECHA. In case the dossier is accepted, data provided to support the CMR (Carcinogenic, Mutagenic, and Toxic to Reproduction) classification, and specifically the Toxic to Reproduction classification, will undergo an assessment by Risk Assessment Commitee (RAC). The outcome of this assessment might lead to an official CMR classification of Cannabidiol.

Therefore, depending on the outcome of the RAC opinion, the future use of Cannabidiol in cosmetics may face potential threats, because cosmetic ingredients classified as CMR substances, specifically those falling under category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008, are prohibited in cosmetic products. Additionally, cosmetic ingredients classified as CMR substances in category 2 may also face prohibition, unless they have undergone evaluation by the Scientific Committee on Consumer Safety (SCCS) within the new classification framework and have been deemed safe for use in cosmetic products.

References:

European Commission – Call for data on ingredients used in cosmetic products

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