Regulation (EU) No 528/2012 defines a biocidal product as one “consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action”. According to the Cosmetics Regulation (1223/2009), a cosmetic product is any substance or mixture intended to be in contact with external parts of the body or with the teeth and mouth, with the aim of cleaning, perfuming, changing appearance, protecting, keeping in good condition or correcting odours.

Establishing a clear borderline

These definitions identify the product types, and differentiating between them is apparently straightforward. However, some products may have properties matching both definitions. In that case, establishing a clear borderline between a biocidal and a cosmetic product is crucial: it determines the legal framework under which a product can go to market.

Although, in the case of discrepancy, it is the national authorities of each EU member state who decide the product’s classification based on a case-by-case analysis, the initial decision is made by the manufacturer.

One approach could be to register borderline products as biocides, as the regulatory requirements are stricter. But there are financial considerations: registering a biocidal product is complex, time-consuming and more expensive than a cosmetic product. The target consumer may also change depending on how the product is marketed.

If the product is to be marketed as a cosmetic, it must be intended for application to an external part of the body. But even if this requirement is met, if the product contains an ingredient which exceeds the concentration limits specified in the Cosmetics Regulation, it cannot be considered a cosmetic.

If the primary function is cosmetic, this needs to be reflected in the presentation: clear consumer information is crucial. Many cosmetic products – including hand washes, deodorants, etc – contain antibacterial ingredients, and the Cosmetics Regulation allows for secondary biocidal claims. Appropriate positioning of any claims on the label is of utmost importance: font size, illustrations and layout also need to be considered.

If the product is to be classified as a biocide, it must contain a biocidal active substance at an effective concentration. Nevertheless, the inclusion of a biocidal active substance is not necessarily an impediment for its classification as a cosmetic.

Contact national authorities in advance

In the case of discrepancy, the final decision is taken by the national authorities of the EU member states, and a product might be classified as a cosmetic in one and as a biocide in another. So it could be advisable to approach the authorities in advance to establish the classification. This is very important, as an incorrect classification could lead to product recall, a request to redesign the label, a request to reformulate the product or to register it under the appropriate legal framework, all of which have associated costs and delays. Any associated risk to consumer safety also needs to be considered.