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.
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