Personal Care Compliance — Where the Rules Are the Same but the Stakes Are Different

Personal care products occupy a grey area that catches brands out more often than any other category. The regulatory requirements are clear. The categorisation of products is often less so.

The distinction between a cosmetic product and a medicinal product is based primarily on intended use and claims. Cosmetic products are intended to clean, perfume, change appearance, protect, keep in good condition, or correct body odours. Products that claim to treat or prevent disease, or to restore, correct, or modify physiological functions, may fall within the scope of medicines regulation. In practice, borderline cases can arise where product positioning and claims require careful assessment. This is a frequent source of compliance issues, particularly for products making functional or performance-related claims.

Incorrect classification can lead to regulatory action. In the UK, products that fall within the scope of medicines legislation are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), which operates under a different and more stringent regulatory framework than cosmetics.

Where the Line Is Drawn

Claims are a key factor in determining product classification. A moisturiser that claims to hydrate or maintain the condition of the skin is typically considered a cosmetic. A product that claims to treat conditions such as eczema may fall within the scope of medicines regulation. Classification is based on the product’s intended purpose, presentation, and claims. In some cases, similar or even identical formulations may fall under different regulatory frameworks depending on how the product is positioned.

For this reason, claims compliance is not only a labelling consideration. It is a regulatory decision that should be addressed before a product is placed on the market.

What Arcus Covers

Product classification advice. We assess your product’s intended use, composition, and claims to determine the applicable regulatory framework and the resulting compliance requirements.
CPSR and PIF for cosmetic products. Safety assessments conducted by appropriately qualified assessors, along with full Product Information File structuring and maintenance.
Claims review. We assess claims against available evidence and applicable UK and EU cosmetic claims frameworks to support compliant product positioning.

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