Reference source : Departamento Agencia Nacional de Medicamentos
Chile’s Institute of Public Health (ISP) has introduced a new sanitary control regime for tattoo inks, marking the first time the country formally categorises how these products should be regulated. The decision was published in a newly issued Resolución Exenta E 6717/25.
According to the ISP, tattoo inks, including permanent or temporary pigments inserted into the dermis, do not fall under the regulatory categories of pharmaceuticals, cosmetics or medical devices. This conclusion is based on their mechanism of action and intended purpose, which is predominantly aesthetic, though occasionally linked to reconstructive or medical uses. Despite not being classified as medical or cosmetic products, the inks must still comply with stringent colourant requirements established for pharmaceutical products in Chile. Only dyes listed on the official “Nómina de colorantes permitidos en productos farmacéuticos” may be used.
Under the new resolution, tattoo inks must comply with all regulatory expectations applied to authorised pharmaceutical colourants, such as:
The ISP also clarified that the decision applies not only to inks currently on the market but also to any substances that may be introduced in the future and that share the same characteristics and intended use.
The resolution reiterates existing prohibitions under Chile’s Sanitary Code on misleading advertising. Any form of promotion suggesting unauthorised health benefits or medical value for tattoo inks will be prohibited. Authorities warn that such claims could mislead the public or pose a risk to collective health.
The resolution orders that the new classification be published in the Official Gazette and on the ISP’s website. As of its signing on 6 October 2025, the new regime is now fully in effect.
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