Temporary washable tattoos are often viewed by consumers as fun, decorative items applied to the skin for cosmetic purposes. According to the European regulatory framework, temporary washable tattoos and other products that create a drawing, stamp, or sticker on the skin are typically considered cosmetic products. This classification is based on their intended use—to enhance appearance, similar to traditional makeup or body art. As a result, these products are subject to the same safety and regulatory requirements as other cosmetics under Regulation (EC) No 1223/2009.
Regulatory Foundations: Why Are Washable Tattoos Cosmetics?
The definition of a cosmetic product under EU law includes substances or mixtures intended to be placed in contact with the external parts of the human body, such as the skin, with the aim of cleaning, perfuming, changing appearance, protecting, or keeping them in good condition. Washable tattoos fulfill the “changing appearance” criterion, as their primary role is to temporarily modify the visible characteristics of the skin. Unlike medical products or devices, they do not penetrate the skin or provide therapeutic benefits. This clarity in definition ensures that any manufacturer or distributor of temporary tattoos remains compliant with the comprehensive and strict safety requirements outlined in the Cosmetics Regulation.
Key Considerations for Compliance and Safety
For brands and formulators, several critical considerations apply when bringing temporary washable tattoos to market:
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- Safety Assessment: All ingredients in temporary tattoo products must undergo a Cosmetic Product Safety Report (CPSR) by a qualified assessor.
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- Labelling Obligations: The product’s packaging must include a full ingredient list, usage instructions, warnings, and the responsible person’s name and address.
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- Good Manufacturing Practice: Production must comply with industry-standard GMP to avoid contamination and ensure consistent quality.
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- Responsible Person: A responsible person established within the EEA must ensure the product’s compliance and safety before it is placed on the EU market.
Possible Classifications of Temporary Tattoos
While most temporary washable tattoos fall squarely under cosmetics, there are occasional overlaps or borderline cases. For example, if a product is marketed or intended for use in a way that has a therapeutic aim—such as delivering active pharmaceutical ingredients or claiming medical benefits—it may instead be regulated as a medicinal product or medical device. Similarly, tattoos that are not meant to come into contact with the skin, like stickers for application to objects, fall outside the scope of cosmetic regulation. Therefore, the precise classification depends on both the intended use and claims presented to consumers. For most brands selling traditional, decorative temporary tattoos, adherence to cosmetic regulations ensures legal compliance across the EU market .
