Key takeaway
What This Development Means
ANSES has proposed a Category 1B reproductive toxicity and lactation hazard classification for cannabidiol (CBD). If adopted, this would impact industries using CBD in pharmaceuticals, cosmetics, and food products, requiring new labelling, compliance measures, and risk assessments. A public consultation is open until 16 May 2025, with potential long-term regulatory consequences.
What does the proposed CBD classification mean for manufacturers?
If adopted, manufacturers will need to update labelling, Safety Data Sheets (SDS), and risk management measures. Some products may face reformulation or market restrictions, particularly in pharmaceuticals, cosmetics, and food sectors.
How can businesses provide input on the CBD classification proposal?
Companies can participate in the public consultation via ECHA’s website. Submissions must be made before 16 May 2025, providing scientific evidence, industry impact assessments, or regulatory feedback.
Source basis: https://echa.europa.eu/harmonised-classification-and-labelling-consultation
The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) has proposed a harmonised classification for cannabidiol (CBD) under the CLP Regulation. If adopted, this classification could significantly impact industries using CBD in pharmaceuticals, cosmetics, and food products.
What You Need To Know About ANSES’ CBD Classification Proposal
The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) has submitted a proposal to the European Chemicals Agency (ECHA) for a new harmonised classification of cannabidiol (CBD) under Regulation (EC) No 1272/2008 (CLP Regulation). The proposal recommends classifying CBD as:
Reproductive Toxicity Category 1B (H360FD) – May damage fertility or the unborn child.Lactation Hazard (H362) – May cause harm to breastfed children.
A public consultation has been launched, running from 17 March 2025 to 16 May 2025. Stakeholders across the pharmaceutical, cosmetic, food, and chemical industries should review the proposal and submit comments.
Potential Impact On Key Industries
Pharmaceuticals & Medical Use
CBD is widely used in prescription medications such as Epidyolex, authorised for treating epilepsy. A Category 1B reproductive toxicity classification could lead to tighter regulations, requiring additional risk assessments and potentially affecting market availability.
Cosmetics & Personal Care
CBD is a common ingredient in skincare and wellness products. A stricter classification could result in additional labelling requirements, possible restrictions on formulations, and re-evaluation of safety data under the Cosmetics Regulation (EC) No 1223/2009.
Food & Beverage Industry
While CBD-infused food and supplements remain a grey area under EU law, this classification could further delay novel food approvals. The European Food Safety Authority (EFSA) has already paused CBD novel food applications due to safety concerns.
Regulatory Next Steps & Industry Response
The Committee for Risk Assessment (RAC) will review comments submitted during the public consultation, after which the European Commission may decide to adopt the classification into Annex VI of the CLP Regulation. If adopted, companies handling CBD will need to reassess risk management measures, update Safety Data Sheets (SDS), and comply with new labelling requirements.
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