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CBD, hemp products and novel foods

Health products

In short
Applicant for novel food authorisation, or a cosmetics responsible person for topical products

Who has to appoint one

Anyone placing CBD products on the EU market. Oral CBD products are treated as novel foods requiring authorisation, and no authorisation has yet been granted, which means they cannot lawfully be sold as food in the Union. Topical cosmetics containing CBD from lawful hemp sources are a different and more workable route.

Thresholds and exemptions

THC content is decisive and is regulated nationally, with limits varying between member states. Exceeding the national threshold makes the product a controlled substance rather than a regulatory infringement.

What must appear on the label

For cosmetics: the full cosmetic labelling with the responsible person, the INCI ingredient list and the CPNP notification. Medicinal claims are prohibited in every route, and 'not for oral consumption' does not save a product designed to be ingested.

Marketplace fields

Marketplaces have removed oral CBD products across the Union, and payment providers frequently decline the category. Advertising platforms prohibit it outright in most member states.

Documentation you must hold

For a novel food route, the authorisation application with toxicological data, which is a multi-year process. For cosmetics, the Product Information File, safety report and CPNP notification, plus documentation showing the extract derives from lawful hemp varieties.

Standards and testing

Cannabinoid profiling including THC quantification by a validated method, heavy metals, pesticide residues and solvent residues from extraction.

Language requirements

Labelling in the language of each member state of sale.

When it applies

Novel food authorisation must precede sale, and none currently exists for oral CBD extracts.

How long records are kept

Ten years for the cosmetic Product Information File.

What happens if you do not comply

Seizure, withdrawal and, where national THC limits are exceeded, criminal proceedings for controlled substances. The legal position differs sharply between member states, so a single EU approach is not available.

Who enforces it

National food safety authorities, cosmetics authorities, and police and customs for controlled substance aspects.

Where the boundary lies

The Court of Justice has held that CBD lawfully produced in a member state is not a narcotic drug, but that does not make it an authorised food: the novel food requirement remains. Topical cosmetics are the practical route, and medicinal claims destroy it immediately.

Questions we are asked

Can we sell CBD oil as a food supplement?
Not lawfully in the Union today. Oral CBD extracts are novel foods without authorisation, and member states remove them from the market.
Is a CBD cream easier?
Yes, as a cosmetic with a responsible person, a safety report and CPNP notification, provided no medicinal claims are made and the THC content complies with national law.
Cosmetics responsible person where applicable · on request

Who signs for you
EU representative Europe Services, SE — Na Čečeličce 425/4, Smíchov, 150 00 Praha 5, Czech Republic
UK representative REP27 LTD — Unit 82a James Carter Road, Mildenhall, Suffolk IP28 7DE, United Kingdom

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