The Legal status of Cannabis and Cannabis Extracts in cosmetic products.

THE LEGAL STATUS OF CANNABIS AND CANNABIS EXTRACTS IN COSMETIC PRODUCTS

Can CBD be used legally in cosmetic products in the UK and EU?

Written by Amanda Isom, Compliance Manager, the Cosmetic, Toiletry & Perfumery Association (CTPA).

The use of cannabis extracts in cosmetic products has seen a notable increase recently although hemp seed oil has been a common ingredient in cosmetics for some years. With the multi-faceted rules and regulations that apply to such products, it can be a landscape that is challenging to navigate.

As the trade association for the UK cosmetics industry, the CTPA is often asked about the legal status of using cannabis extracts in cosmetic products and we hope that the following information will help businesses navigate the complexities connected with this area.

In the UK (and EU), products classified as cosmetics are regulated by Regulation (EC) No. 1223/2009 (the Cosmetic Products Regulation (CPR)). The main purpose of the CPR is human safety. The law applies to products intended for sale and those given away for free. As always, ignorance of the law is no excuse and no defence; and the penalties for non-compliance can be severe such as heavy fines and even periods of imprisonment.

Principal requirements of the CPR include composition, safety assessment, labelling, notification, a product information file, Good Manufacturing Practice, claim substantiation and monitoring adverse reactions.

Cosmetics containing cannabis extracts, including those containing CBD, have to comply with the same legal obligations as other cosmetics which are placed on the market. However, particular consideration should also be given to whether the product is classified as a cosmetic and the status of the ingredient used under both the national drug legislation and the CPR.

Product classification

Before ensuring the compliance of a product under the CPR it is important to firstly establish whether this is the correct legislative framework for the product. Cannabis-containing products can fall under several regulatory frameworks (e.g. medicinal products, general products, food

supplements, cosmetics) depending on where they are applied, how they will be used and the function of the product.

In order for a product to be classified as a cosmetic, it must fall within scope of the definition of a cosmetic product provided in Article 2 of the CPR:

Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

All parts of the definition must be fulfilled. Therefore, a topical product, such as a cream, can sometimes fall within scope of other frameworks and not be deemed a cosmetic. For example, a product without one of the named cosmetic functions within the definition, cannot be considered a cosmetic. Similarly, a product which has a function such as treating an adverse condition, will also not be considered a cosmetic but could be classified as a medicinal product.

In the UK, a medicinal product is defined as a product that:

• is presented as having properties to treat or prevent disease in human beings; or

• is administered to human beings with a view to restoring, correcting or modifying physiological functions or by exerting a pharmacological, immunological or metabolic action.

Borderline between cosmetics and medicines

A product marketed to treat or prevent disease falls within the definition of a medicinal product and, therefore, cannot be a cosmetic product. Similarly, claiming to cure or heal a specific adverse condition will also be regarded as a medicinal claim. A product can be a medicine or a cosmetic but it cannot be both.

The Cosmetic Products Regulation envisages that a cosmetic product may have a secondary preventative purpose but the primary purpose must be cosmetic and there must be no claim or function to cure a disease or adverse condition. Particular care should be taken if referring to the endocannabinoid system in relation to a product.

A cosmetic product may have a secondary preventative purpose but the primary purpose must be cosmetic and there must be no claim or function to cure a disease or adverse condition. Particular care should be taken if referring to the endocannabinoid system in relation to a product.

National control of cannabis

For cosmetic products and cannabis ingredients it is necessary to also look beyond the specific sector legislation. Whilst many countries around the world implement the International Single Convention on Narcotic Drugs 1961, variations in the way the controls are applied, both between different regions and countries, leads to practical challenges when formulating and developing a product destined for a range of regional or global markets.

UK 1971 Drugs Act and 2001 Regulations

In the UK, cannabis and cannabis resin, cannabinol and cannabinol derivatives are Class B drugs under the Misuse of Drugs Act 1971. Any preparations or products (including cosmetics) containing these substances are also deemed to be controlled as Class B drugs. Only cannabis, cannabis resin, cannabinol and cannabinol derivatives falling outside of the scope of the controls of the UK Drugs Act and Regulations are exempt from the controls.

Cannabis extracts as a cosmetic ingredient

The Annexes to the CPR provide restrictions, prohibitions and permissions for use for specific cosmetic ingredients. Annex II (the list of prohibited substances) contains a direct reference (entry 306) to any substance listed in tables 1 and 2 of the Narcotics Convention. Thereby prohibiting the use in cosmetic products of listed narcotics.

Specifically:

• Cannabis and Cannabis Resin - and extracts and tinctures of cannabis

Where: “Cannabis” means the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin hasnot beenextracted, by whatever name they may be designated.

“Cannabis plant” means any plant of the genus Cannabis

“Cannabis resin” means the separated resin whether crude or purified, obtained from the Cannabis plant.

The listing does not distinguish between hemp and non-hemp varieties and excludes from scope any extracts obtained from the leaf and seed.

Substantiating claims

Beyond the product composition, another key aspect of compliance with the CPR is claim substantiation. Any claim made about a cosmetic product, either on the product label, in advertising or online, must comply with the requirements of Article 20 of the CPR and the ‘Common Criteria’ for cosmetic claims. In essence, this means that claims must be true, honest and fair and be supported with appropriate evidential proof. Under these provisions, many ‘free from’ claims cannot be made. For example, claims such as ‘free from parabens’ are not permitted if they imply a denigrating message based on a presumed negative perception of a safe and permitted ingredient.

Can CBD be used legally in cosmetic products in the UK/EU?

For the reasons outlined above, the simple answer, under current interpretations of the law, is yes. BUT...

For plant-derived CBD:

• the CBD should be in pure form and notcontain any controlled substances suchas specific controlled cannabinoids;

• all three limbs of the ‘exempt productdefinition’ in the 2001 Regulations mustbe met including the limit of 1mg forcontrolled substances (e.g.tetrahydrocannabinol, cannabinol); and

• the CBD must not be derived from theflowering or fruiting tops of the plant orthe whole plant where the flowering orfruiting top remains intact for processing(including hemp varieties).

CBD must not be derived from the flowering or fruiting tops of the plant or the whole plant where the flowering or fruiting top remains intact for processing (including hemp varieties).

The CTPA represents all typesof companies involved in making, supplying and selling cosmetic and personal care products and, as the voice of the UK industry, we promote best practice and advise companies about the strict legal framework for cosmetics. Representing industry views to the UK Government and external stakeholders we also provide information to the media on issues relating to thesafety ofcosmetic products.

The CTPA also has a dedicated consumer website, www.thefactsabout.co.uk, which explains the laws governing cosmetic products and the science behind them. Written in everyday language, the site has a section ‘What’s in my cosmetic?’ to explain about the ingredients and terms used to help dispel myths and encourage people to research the facts.

CTPA

Written by Amanda Isom, Compliance Manager, the Cosmetic, Toiletry & Perfumery Association (CTPA).