Specialised Products

CBD & Hemp Cosmetics

CBD and hemp sit at the intersection of cosmetics law, narcotics control and medicines law. The Annex II prohibition on cannabis extracts, the permitted synthetic and seed-derived forms, the THC and controlled-cannabinoid limits, and why the source decides legality.

CBD and hemp are among the most sought-after ingredients in skincare, and among the most legally complicated. They sit where cosmetics law, narcotics control and medicines law overlap, and the single most important fact is that the exact form of the ingredient, not the word β€œCBD”, decides whether a product is legal.

The narcotics prohibition

Entry 306 of Annex II to the Cosmetics Regulation prohibits cannabis, cannabis resin, and extracts and tinctures of cannabis, reflecting the 1961 Single Convention on Narcotic Drugs. The direct consequence is that cannabidiol prepared as an extract or tincture of the cannabis plant is not permitted in cosmetics, regardless of how it is marketed. This is the trap many brands fall into, because a great deal of commercial CBD is exactly that, a cannabis extract.

The permitted forms

Compliant CBD comes from forms that fall outside the prohibition. Synthetically produced cannabidiol has its own entry in the CosIng database and is permitted, and CBD supplied as an isolate that is not the prohibited extract or tincture is treated separately from entry 306. Ingredients from the seeds and stems rather than the flowering tops, Cannabis sativa seed oil, seed extract, seedcake and stem-derived materials, are permitted, provided the tetrahydrocannabinol (THC) content stays within the hemp limit of 0.2%. The Court of Justice confirmed in its 2020 Kanavape ruling that lawfully produced CBD is not in itself a narcotic, but that ruling did not override the Annex II prohibition on the specific cannabis derivatives, so a brand has to work within the CosIng entries rather than rely on the judgment alone.

THC and controlled cannabinoids

THC and other controlled cannabinoids bring a second layer of law. In the UK the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 apply, and a CBD cosmetic must qualify as an β€œexempt product”, meaning its controlled-cannabinoid content stays within the regulatory limit. The practical difficulty is that extracting CBD tends to co-extract trace controlled cannabinoids, so a certificate of analysis verifying THC and controlled-cannabinoid levels is essential evidence, not an optional extra.

Not a novel food, and no medicinal claims

The novel-food regime that causes so much difficulty for CBD applies to ingestible products, not to topical cosmetics, so a CBD cream or balm needs a CPSR, a Responsible Person and a notification rather than novel-food authorisation. What it must not do is make medicinal claims: a claim to treat pain, inflammation or a skin disease moves the product into the medicines regime and out of cosmetics entirely.

How we help

We make sure the CBD source is a compliant one, synthetic or seed and stem derived rather than a prohibited extract, verify the THC and controlled-cannabinoid content against the limits using certificate-of-analysis data, prepare the safety report and act as Responsible Person, and set the claims firmly on the cosmetic side of the medicines line. The result is a CBD product that can actually be sold, not one that is withdrawn at the first enforcement check.

Relevant services

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CPSR

From Β£70 Β· 2 to 3 days

The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.

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Responsible Person

From Β£149 Β· per product, per year

Oxford Biosciences acts as your Responsible Person in the UK and the EU under a single quality management system, holding the regulatory obligation: PIF maintenance, SCPN and CPNP notification, labelling oversight, and cosmetovigilance.

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Claims Testing

From Β£5,000 Β· 3 to 5 months

Clinical efficacy studies that generate the measured evidence a cosmetic claim needs, to a standard a regulator or a broadcaster will accept. For anti-ageing, brightening and other performance claims.

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Frequently asked questions

Is CBD legal in cosmetics in the EU and UK?

In the EU and UK, it depends on the source. Cannabidiol prepared as an extract or tincture of cannabis is prohibited under Annex II entry 306, but synthetically produced CBD and CBD isolate outside that prohibition are permitted. The product must also stay within THC and controlled-cannabinoid limits and make no medicinal claims.

Is hemp seed oil allowed in cosmetics?

In the EU and UK, yes: Cannabis sativa seed oil and other seed- and stem-derived ingredients are permitted in cosmetics because they come from the seeds and stems rather than the prohibited flowering tops, provided the THC content stays within the hemp limit of 0.2%.

What is a CPSR?

A Cosmetic Product Safety Report (CPSR) is the safety assessment required by Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product is placed on the UK or EU market. Annex I sets out two parts: Part A, the cosmetic product safety information (composition, physico-chemical and microbiological characteristics, stability, exposure and the toxicological profile of each substance), and Part B, the safety assessment, in which a qualified assessor states and reasons the conclusion on safety. It is the pivotal scientific document held within the Product Information File.

When is a product a cosmetic and when is it a medicine in the EU and UK?

In the EU and UK, a cosmetic is defined by Article 2 of Regulation 1223/2009. A product becomes a medicinal product under Directive 2001/83/EC either by presentation (its claims) or by function (a pharmacological, immunological or metabolic action), and where it could be both, the medicines regime takes precedence.

What safety data does a new cosmetic ingredient need?

In the EU and UK, a toxicological dossier built to the SCCS Notes of Guidance (12th revision, SCCS/1647/22): the core endpoints including genotoxicity, skin sensitisation, repeated-dose toxicity and dermal absorption, generated by non-animal methods, with a margin of safety calculated from the exposure.

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