Navigating Cosmetic and Medicinal Borderlines (EU/UK)
Claims to avoid on your cosmetic products (EU/UK)!
When marketing cosmetic products, it’s essential to understand the boundary between cosmetic and medicinal functions to ensure your products remain compliant and within your intended regulatory classification. Medicinal functions, such as those suggesting a product treats or heals the body, are not permitted on cosmetics and could put your product at risk of being challenged by the UK Medicines and Healthcare products Regulatory Agency (MHRA) or by EU Member States authorities as an unlicensed medicine, risking prosecution and removal from sale.
To market your product in the cosmetic space, you should ensure that your product delivers a cosmetic function as its primary function and also ensure you use cosmetic claims to highlight any additional benefits that your product gives to your consumers.
We have collected together a few non-compliant claims (according to UK MHRA interpretation) that should be avoided or carefully assessed within the product context to ensure your product does not stray into the medicinal category. Although those principles are all applicable within the EU as well, some EU Member States may have different interpretations.
Please note that product classification should always be done taking into consideration the overall presentation of the product. The table below is not exhaustive and should be assessed in accordance with the overall presentation and specific context of the claim.
* Article 1 of Directive 2001/83/EC as amended defines a “medicinal product” as:
“Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; [the first/presentational limb]
Any substance or combination of substances which may be used in, or administered to, human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis” [the second/functional limb]
Sayali Garud and Sofia Nuzzo