Legal Assessment of Cosmetic Tattoo Removal
- The beginnings in the year 2000
- Every tattoo removal is an assault
- Is it cosmetic or a medical
- Legal justification – EU law
- Cosmetic requirements
- Safety assessment
- EU database CPNP
- Is there a permit?
- Doctors have better cards than beauticians or tattoo artists
- Experience in many countries of the world
- What about SKINIAL
The beginnings in the year 2000
Before 2005, there was only laser tattoo removal. At that time, cosmeticians and tattoo artists could also work with lasers. After that, one occasionally heard of tattoo artists who claimed to be able to remove tattoos with mysterious liquids. However, there was no disclosure of what these miracle cures consisted of.
The company REJUVI in California was one of the first to become known worldwide with tattoo removal without lasers around 2006. As more and more market participants and dealers used the REJUVI method and its product, several authorities became aware of it, and it was banned in Germany in 2011 because it was classified as hazardous to health due to its high alkalinity.
When SKINIAL began experimenting with lactic acid emulsions in 2009, dermatologists practising laser tattoo removal took notice and claimed that the method was medical and therefore prohibited to be performed by non-medical practitioners. In the years that followed, this dispute was fought out several times in court, with SKINIAL initially losing every case and then gradually winning more and more lawsuits.
In parallel, criteria for cosmetic tattoo removal were included in a European law in 2017, the EUROPEAN COSMETIC DIRECTIVE, which was successively ratified in all EU countries.
In the years 2015 to 2020, new brands appeared almost every month. The sometimes-adventurous concepts were often represented by permanent make-up trainers and sometimes even bore their names. Many companies had a product produced without understanding the complexity of the activity. Since the pandemic, most of SKINIAL’s former competitors have disappeared. Seriously operated cosmetic tattoo removal was increasingly accepted by the market and lost the aura of being special. It was increasingly recognised that cosmetic tattoo removal is not dangerous, but still requires good training for application, as well as compliance with legal regulations and a lot of experience in practice. In addition, the slump in demand caused by the pandemic led to smaller manufacturers in particular withdrawing from cosmetic tattoo removal.
This is a natural development in the product cycle of innovative industries, where only a few specialists remain in the end.
2. Every tattoo removal is an assault
Admittedly, this sounds brutal, but it’s true. Just like any pigmentation, any tattoo removal is legally an assault. However, with the explicit consent of the client, it is without consequence and hassle-free for the practitioner. Consent can be tacit (legally implied), through an action that clearly indicates a certain intention, or through an agreement. This is called a declaration of consent. Jurisprudence has developed several requirements for this consent, which one must be aware of. The client must have been fully and completely informed of all risks.
Although consent can also be given verbally, the practitioner is obliged to provide evidence in case of doubt, which can usually only be proven by a declaration signed by the client.
3. Is SKINIAL now a cosmetic or a medical product?
This question occupied us for several years in 2011 – 2017, when tattoo removal was on everyone’s lips. Many doctors and their professional representatives in several countries claimed that it was a medical method, with the consequence that it had to be banned for non-medical practitioners. Even today, some doctors try to prevent competition with this argument. Even authorities occasionally try to prevent the use by cosmeticians or tattoo artists, sometimes by referring to doctors, sometimes by calling the removal fluid non-compliant with the Tattoo Remedies Regulation, or by citing non-EU-compliant national legal norms. It cannot be said clearly enough. Cosmetics law is EU law. Possible divergent national standards violate higher-ranking EU law.
Basically, there are three reasons why SKINIAL cannot be a medical.
- EU law
As explained below in the section “EU LAW”, there is an EU standard specifically for tattoo removal, compliance with which gives the product a cosmetic purpose.
- Approval body for medical devices
At the request of an Arab country, SKINIAL tried in 2019 to register the removal products as medical devices with the TÜV Süd (Medical and Health Service) of a so-called NOTIFIED BODY. TÜV SÜD PRODUCT SERVICE GMBH is Europe’s largest approval body for medical devices in Germany.
In the preliminary test, the “intended purpose” is used to check whether the product is or can be a medical device. This results in the classification for the choice of the conformity procedure. In the case of SKINIAL, however, it already fails due to the definition of Article 1 of MDD 93/42/EEC or the new MDR, according to which the medicinal product status requires a specific curative or preventive function, which is not given. For this reason, the largest NOTIFIED BODY in Europe, TÜV SÜD, has refused to accept the products for the standardised procedure. SKINIAL is therefore not a medical device because it already fails to qualify for the medical device procedure approval criteria.
- Safety Assessment
On the cosmetics side, too, there are sovereign bodies that check whether a product meets the requirements and is suitable to be sold as a cosmetic product. There is agreement that safety assessment is a suitable instrument for ensuring consumer safety, irrespective of the distinction between cosmetics and functional medicinal products. If a product receives an unqualified safety assessment, it is considered a cosmetic product in the EU.
In this respect, the legal question of whether it is a medical product, or a cosmetic product had been clearly clarified since 2017 at the latest. However, word of this has been slow to get around. The reason for this dogged fight was, of course, that many doctors foresaw the enormous volume for this technology and did not want to leave this market to the cosmeticians and tattooists without a fight.
4. Legal justification – EU law
Cosmetic tattoo removal without laser is considered as “chemical tattoo removal” an activity that is distinguished from medicinal products by two criteria in the “Manual of the Working Group on Cosmetic Producs (Sub-Group on Borderline Products) on the scope of application of the Cosmetics Regulation (EC) No 1223/2009 (Art. 2(1)(A)) in the Version 2.1 (February 2016)”. Under the item “3.3.22 Tattoo removal products” the criteria are mentioned that determine whether the product is cosmetic or medicinal/pharmaceutical. At least SKINIAL fulfils both criteria and is therefore not banned as a cosmetic product in the EU.
All cosmetic products in Europe must be safety assessed and registered in the CPNP.
5. Requirements for a Cosmetic
For each cosmetic product in the EU, an authorised opinion from an officially sworn safety assessor is also required with a correct product information file and a safety assessment, which can often take up a volume of several thousand pages. The safety assessment evaluates whether the cosmetic product is safe for both the intended use and the foreseeable use, according to Article 3 of the EU Cosmetics Regulation.
A safety assessment is mandatory for all removal products in cosmetic tattoo removal. Products and concepts coming from outside the EU usually do not have this certification, but they should. Unfortunately, many European products do not have a safety assessment either but are still sold because there are no sufficient controls in many countries.
All SKINIAL removal products are safety rated.
EU database CPNP
Cosmetic products sold in the EU must be registered in the CPNP in Brussels. This is a database in which every entrepreneur must register his cosmetic product according to certain criteria and with the exact composition. The information is controlled by the authority. Only the registering entrepreneur and European authorities have access to this database. The purpose of the database is that authorities and doctors can get a quick overview of the substances in case of danger throughout Europe.
Every SKINIAL cosmetic product is registered in the CPNP database.
6. Is there a permit?
We are often asked whether SKINIAL is authorised. To do this, one must know what the strange reasoning in the law is “not prohibited”. The fathers of the EU laws originally decided that medical devices always must obtain approval (authorisation) in an extensive formal, quasi-sovereign procedure, whereas there is basically no approval for cosmetics. Instead, there are many regulations and prohibitions that a cosmetic manufacturer must comply with, otherwise the cosmetic is banned.
A cosmetic product is therefore allowed in the EU if it is not prohibited. A medical device may only be used and sold if it is authorised.
It sounds good at first, but it means that cosmetics producers can never be 100% sure that their products do not violate any law and could be banned. Therefore, legal certainty can only be created by a safety assessment in which exactly this is checked and certified by the authorities.
7. Doctors have the better cards than beauticians or tattoo artists
Another difference between the professions is that medical professionals are not controlled by authorities. They have their own professional organisation that monitors them. This is certainly a more pleasant solution for doctors than for tattooists and beauticians, who are supervised by the authorities. The supervision by the authorities often leads to the fact that regulations are interpreted very restrictively by the authorities, to the detriment of cosmeticians and tattooists. The reasoning is as simple as it is annoying for those affected. Authorities want to avoid being exposed to claims for damages at all costs, so they tend to overshoot the target of a regulation with their measures. Tattoo artists and beauticians do not usually defend themselves against unreasonable measures taken by authorities.
Although the “gods in white” image of doctors is increasingly eroding due to scandals, lawsuits, outdated training and the digital age, people are still more likely to believe a doctor than a beautician or tattoo artist. The fact that doctors occasionally represent purely business interests is often not perceived by end consumers. People believe them and are reluctant to take action against them even in the case of obvious mistakes, whereas every subjectively suspected mistake by a cosmetician or tattoo artist quickly encourages claims for recourse.
8. Experience in many countries of the world
Although the EU cosmetics law is mandatory for all EU countries, it is unfortunately implemented differently. Since subordinate departments with well-trained employees are responsible for the controls, there are always arbitrary bans, which are, however, always suspended immediately when the authorities are made aware of the applicable legal situation. On the other hand, there are countries that have not yet effectively implemented the EU standards in our area.
In Western Europe, we are often confronted with wild claims by trainers, supposedly well-informed professionals, or doctors who either have no clue about the actual legal situation or are pursuing their own interests. These are often competitors or simply opinions, which, however, lack any basis. Unfortunately, end customers are rarely able to question such claims. This is also one reason why we have decided to provide such extensive clarification here.
In our blog “Public Authorities Worldwide” we go into detail about our experiences in many EU countries but also on other continents.
9. What about SKINIAL
SKINIAL is a cosmetic and meets all legal requirements. We are transparent and strive for maximum education in a growing industry that we ourselves founded and whose services will become a natural part of every studio working with pigments in the future.
Natural cosmetic tattoo and PMU removal will become the dominant removal and correction technique. Laser will retain its justification in a niche, namely large-area removals.
Laser tattoo removal will be offered by fewer and fewer doctors in the future because it is too complex, expensive to purchase, difficult to use and unsatisfactory, especially for doctors. Laser tattoo removal is hardly economically viable, even for university institutions. The high acquisition and maintenance costs are out of proportion to the low remuneration. Another aspect, however, disturbs the medical profession far more. The treatment is painful and lengthy. Nevertheless, the results are often very unsatisfactory. Doctors are not used to being criticised by patients for their work. However, laser removal meets patients’ expectations far less than cosmetic removal. This is very unsatisfactory for doctors and will lead to dermatologists increasingly withdrawing from laser tattoo removal or at least offering cosmetic methods in addition.
Few specialists who have several of the latest lasers and sufficient experience will still specialise in laser tattoo removal. These are usually found in large university clinics but also some private practices. However, these specialists will increasingly use cosmetic methods for sensitive areas, different colours that cannot be removed by the laser and cover-ups.
The simple-minded religious war will end, because the only interest of specialists will be to remove unwanted pigmentation from clients or patients as gently, quickly, painlessly, and comprehensively as possible.
Don’t be put off until the time comes. Recent economic history is full of protectionist agitations discrediting new, disruptive technologies. In the long run, more advanced technology has still prevailed.