CBD and reproductive toxicity: where the 1B listing stands

ANSES proposed an EU-wide harmonised classification of cannabidiol in the class "reproductive toxicity, category 1B". Two hazard statements come with it:

• H360FD: "May damage fertility. May damage the unborn child."
• H362: "May cause harm to breast-fed children."

The file relies on studies in monkeys, rats and mice. They show effects of CBD on sperm production, fertility, deaths around birth and brain development. The agency stresses that the process concerns "only" the assessment of hazards and does not, at this stage, set the measures that apply to products.

The CLP Regulation sorts reproductive toxicants into three levels. Category 1A covers substances known to affect human reproduction, mainly on the basis of human data. Category 1B covers presumed reproductive toxicants, mainly on the basis of animal studies. Category 2 covers suspected ones, where the evidence is weaker.

CBD is therefore proposed at the middle level. This means the animal studies were judged clear enough, without direct proof in humans. H362 is a separate category: it covers effects on or via breastfeeding.

A classification describes what a substance can do, not what it does at a given dose. That is the difference between hazard and risk. A classified substance can remain usable if exposure is low and controlled, which the rules of each sector then decide.

A harmonised classification follows a route set by Article 37 of the CLP Regulation. The ANSES file went to public consultation on the website of the European Chemicals Agency (ECHA) from 17 March to 16 May 2025. ECHA's Risk Assessment Committee, known as RAC, then has 18 months to give its opinion.

It has done so: according to the Belgian federal health service, which reported it on 5 May 2026, RAC adopted an opinion to classify CBD as toxic for reproduction. The opinion covers fertility, the unborn child and breast-fed children.

The political step remains. If the European Commission finds the classification appropriate, it prepares without undue delay a draft entry in Annex VI of the CLP Regulation, which goes to the member states. The regulation sets no deadline for this decision, and adoption is not automatic.

The CLP Regulation does not itself require hazard labels on finished consumer products. Its Article 1 excludes, among others, medicines, cosmetics and foods. The effects come through the rules of each sector, which refer to the classification.

Cosmetics are the clearest case. Article 15 of Regulation (EC) No 1223/2009 bans from cosmetics any substance classified as carcinogenic, mutagenic or toxic for reproduction in category 1A or 1B. An exemption remains possible under four cumulative conditions: compliance with food safety requirements, no suitable alternative, a specific use with known exposure, and a favourable opinion from the Scientific Committee on Consumer Safety. Our article on claims for CBD cosmetics describes the current framework.

For foods, the classification changes nothing in practice. No CBD food has received the authorisation required under the novel food regulation, as our overview of CBD regulation in 2026 explains.

The classification does not say that a CBD flower or oil makes people infertile. It says that animal studies show effects on reproduction clear enough to presume a hazard in humans. The actual risk depends on the dose, the duration and the person.

Two opinions point the same way for exposed groups. EFSA concluded on 9 February 2026 that the safety of CBD cannot be established for pregnant and breastfeeding women, people under 25 and people on medication. For other adults, it sets a provisional safe level of about 2 mg a day for 70 kg. Our article on CBD, pregnancy and breastfeeding brings the agencies' positions together.

If you are pregnant, breastfeeding or trying to conceive, the careful course is not to use CBD and to talk to a doctor or midwife. Beyond that, the file is a matter of regulatory watch: our page on CBD side effects sums up the known data.