Rules for cosmetic tattoo removal
Unlike medical products, cosmetic products do not need to be approved in the EU. Cosmetic tattoo removal products only have to comply with legal requirements. If the authorities cannot prove a violation of a law, the cosmetic product is allowed. Cosmetic law in the EU (incl. Switzerland) is regulated in the EUROPEAN COSMETIC DIRECTIVE. SKINIAL fulfils all conditions.
Germany
In Germany, after initially unclear wording in a 2011 press release about an alleged acid removal from 2007 (several years before SKINIAL was founded), the BfR (Federal Office for Risk Assessment) clarified to SKINIAL that they had never claimed that the SKINIAL method was illegal or not allowed. Therefore, there has never been a licensing problem in Germany.
Austria
In Austria, some provincial authorities (Hauptmannschaften) claim that tattoo removal without laser may only be done by medical professionals because it is a medical treatment. However, this is wrong. TÜV SÜD (Europe’s largest approval body for medical products) formally rejected the application for approval of SKINIAL as a medical product because it is definitely a cosmetic product. The requirements of an “aesthetic treatment” in the sense of the ÄstOpG are also not met. As an alternative legal basis, some provincial governors cite Austrian trade law, which, however, is in collision with higher-ranking European law. A substantive investigation of the SKINIAL method and products has never been carried out despite several offers on our part. In recent times, the authorities have deviated from their strict prohibition and recommend at least having a pigmentation training or naming a doctor friend as a sponsor. Nevertheless, no SKINIAL studio in Austria has ever been formally legally banned. It would be illegal in any case and would also violate EU antitrust law.
Switzerland
In Switzerland, courts already saw no danger from cosmetic tattoo removal in 2011 and ruled in favor of the SKINIAL treatment studios.
In France, a study entitled “Risques des produits et pratiques de taouage et de détaouage” was prepared by the renowned HCSP in July 2018 and published on 15 December 2020, in which a commission of temporary experts with little expertise in the field of laser removal and no expertise in the field of cosmetic tattoo removal gave partly abstruse opinions on the subject, which were legally flawed and very superficially researched. As a result, not surprisingly, laser treatment was glorified and alternative methods, without knowing them, were strictly rejected. In their own interest, many doctors also claim that tattoo removal without laser is forbidden for non-doctors. However, such a general ban would be illegal and would also violate anti-trust law. Some local surveillance authorities (ARS) are bothered by the products during sporadic routine inspections of studios, out of ignorance of the new method, but so far have had to back down each time after clarification. There has not yet been a single legally binding ban on SKINIAL tattoo removal without laser for a studio in France.
Italy
In Italy, a lawsuit filed in 2014 by a client in Turin, who allegedly had a scar because of a treatment and also filed criminal charges against the treating studio, led to a nationwide four-year provisional treatment ban by a well-known, overzealous public prosecutor. The trial ended after four years without a conviction and the treatment ban was lifted again because the authorities could not prove any danger from the new technique.
Holland
In Holland, after a year-long intensive investigation, the Ministry of Youth and Health confirmed in writing to SKINIAL in June 2018 that both the treatment and the removal products were harmless and that treatment could be carried out without any problems.
European Union
Although laser treatments are generally prohibited for cosmeticians in the EU, there are many countries even in the EU that hardly monitor these rules. Therefore, the use of lasers outside medical practices is still common there.
United States
In the USA, completely different rules apply, and cosmetics are not subject to the FDA and therefore lasers are still often used there, even in cosmetic studios.
South America and Asia
The situation is similar in South America and Asia, where there are hardly any restrictions on laser removal by cosmeticians.
Africa
In Africa, the focus of the authorities is predominantly on hygiene and not on the removal method.
Recommendation
Do not be unsettled. Recent economic history is full of protectionist agitations by interest groups to discredit new, disruptive technologies. In the long run, however, more advanced safer technology has still prevailed.