Tattoo ink and permanent makeup companies have to adapt to the new law before January

Spanish tattoo ink and permanent makeup manufacturing companies have just one month to adapt to Commission Regulation (EU) 2020/2081 of December 14, 2020, which will enter into force on December 4. January and that modifies annex XVII of Regulation 1907/2006 of the European Parliament and of the Council, regarding the registration, evaluation, authorization and restriction of chemical substances and mixtures with regard to substances contained in inks for tattoos or permanent makeup .

This was specified by the Spanish Agency for Medicines and Health Products (Aemps) in a statement in which it stressed that the new regulation establishes the restriction of the use of more than 4,000 dangerous chemical substances and introduces maximum concentration limits for individual substances or groups of substances used in tattoo inks or permanent makeup, among which certain dyes, metals or methanol stood out.

This regulation also requires that mixtures intended for tattoos and permanent makeup mention this use on their labels, which, in turn, must include a list of ingredients and the relevant safety statements, according to the agency, in charge of grant prior authorization for its commercialization as an aesthetic product in Spain.

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Furthermore, to also guarantee the protection of people in the long term, Regulation 2020/2081 automatically limits chemicals that are classified in the EU as carcinogens, germ cell mutagens or toxic to reproduction in various categories, but excluding substances of this type classified due to inhalation exposure only.

Skin sensitizers, skin corrosives, skin and eye irritants of different categories are also limited, as well as certain substances that cause serious eye injuries and prohibited substances cannot be used in cosmetic products or those whose use is prohibited for application in mucous membranes and eyes according to the Regulation on cosmetic products (EC) 1223/2009.

The Aemps pointed out that, in the case of the blue pigment 15:3 and the green pigment 7, the new standards will be applied at the European level as of January 4, 2023 and advanced that it will periodically update a list with the products for permanent makeup (micropigmentation) and tattoo that are authorized.