Is SKINIAL cosmetics a medical device or a tattooing product?
This question occupied us for several years from 2011 to 2017, when tattoo removal became increasingly popular. We finalised this question with representatives of the authorities, industry associations and top lawyers for the EU and for most other countries in the world (tattoo removal products do not require FDA approval).
From a legal perspective, there is no reason to doubt the following statement:
- SKINIAL is not a tattooing agent because it is not a colour!
- SKINIAL is not a medical device (see below)
- SKINIAL is a cosmetic product (see below)
SKINIAL IS NOT A TATTOOING AGENT
In Austria in the past and in France in the present, some regional regulatory authorities have claimed that SKINIAL is a tattooing product (tattoo ink) and at the same time refuse to classify it as a tattooing product because, as a colorless liquid, it cannot be a tattooing product according to the law and therefore cannot be approved.
However, SKINIAL has never claimed to be a tattooing product and the authority’s assumption is arbitrary and false. Therefore, no authority has been able to provide evidence for this absurd claim.
SKINIAL IS NOT A MEDICAL PRODUCT
There are three basic reasons against SKINIAL as a medical device
EU law
Cosmetic tattoo removal without laser is considered “chemical tattoo removal”, an activity that is distinguished from medicinal products by two criteria in the “Manual of the Working Group on Cosmetic Products (Subgroup 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 “3.3.22 Tattoo removal products”, two criteria are mentioned that determine whether the product is a cosmetic or a medical/pharmaceutical product.
At least SKINIAL fulfils both criteria and is therefore not banned as a cosmetic product in the EU.
Authorisation body for medical devices
At the request of an Arab country, SKINIAL attempted in 2019 to register the removal products as medical devices with TÜV Süd (Medical and Health Service), a so-called Notified Body. TÜV SÜD PRODUCT SERVICE GMBH is the largest Notified 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 conformity procedure. In the case of SKINIAL, however, this already fails due to the definition in Article 1 of MDD 93/42/EEC or the new MDR, according to which the medicinal product status requires a specific curative or prophylactic function, which is not given. For this reason, the largest notified body in Europe, TÜV SÜD, has refused to accept the products for the standardized procedure. SKINIAL is therefore not a medical device, as it does not qualify for authorization for the medical device procedure according to the criteria.
Safety assessment
In the area of cosmetics, there are also government bodies in the EU that check whether a product fulfils the requirements and is marketable as a cosmetic. There is a consensus that the safety assessment is a suitable instrument for ensuring consumer safety, irrespective of the distinction between cosmetics and functional medicinal products. If a product has an unrestricted safety assessment, it is considered a cosmetic in the EU.
In this respect, the legal question of whether it is a medical device, or a cosmetic has been clearly clarified since 2017 at the latest. However, word was slow to spread. The reason for the tough struggle was, of course, that many medical professionals anticipated the enormous volume of this technology and did not want to leave this market to cosmetics and tattoo artists without a fight.
Fantasies of individual authorities and self-interest of doctors
In Austria, the authorities sometimes use non-EU-compliant national legal standards (e.g. old trade law) to categories SKINIAL as a medical device. However, these regulations clearly violate EU law.
Doctors and some of their professional organizations often claim, without knowing the SKINIAL method or being informed about the current legal situation, that it is a medical method with the consequence that it should be banned for non-doctors. The attempt to prevent competition with this argument may catch on with uninformed private individuals, but it lacks any legal basis.
SKINIAL IS A COSMETIC
A cosmetic remover must fulfil three criteria in the EU:
Safety assessment
For every cosmetic product in the EU, an authorized opinion from a publicly appointed and sworn safety assessor with a correct product information file and a safety assessment, which can often run to several thousand pages, is required. The safety assessment assesses whether the cosmetic product is safe when used as intended and in a foreseeable manner in accordance with Article 3 of the EU Cosmetics Regulation.
A safety assessment is mandatory for all removal products for cosmetic tattoo removal. Products and concepts that come from outside the EU generally do not have this assessment but should have it. Unfortunately, many European products do not have a safety assessment either but are still sold because there are insufficient 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 (EU database) in Brussels. This is a database in which every entrepreneur must enter their cosmetic product according to certain criteria and with the exact composition. The information is checked by the authorities. Only the registering company and the European authorities have access to this database. The purpose of the database is to enable authorities and doctors to quickly obtain a Europe-wide overview of the substances in the event of a hazard.
Every SKINIAL cosmetic product is registered in the CPNP database.
Safety data sheet
A cosmetic product must have a standardized safety data sheet that can be consulted at any time. It contains all chemical components and properties as well as the legally required warnings and the person responsible. It is public.
Every SKINIAL removal product has a safety data sheet, which is available in every studio that works with SKINIAL.
Is there an authorization?
We are often asked whether SKINIAL is permitted. To find out, you need to know what the strange “not prohibited” in the law is all about. The founding fathers of EU legislation originally decided that medical devices must always receive authorization (approval) in a complex, quasi-sovereign procedure, whereas there is basically no authorization for cosmetics. Instead, there are many regulations and prohibitions that a cosmetics manufacturer must comply with, otherwise the cosmetic is banned.
A cosmetic product is therefore authorized in the EU if it is not prohibited. A medical device may only be used and sold if it is authorized.
The fact that everything that is not expressly prohibited is permitted for cosmetics sounds good at first, but it means that cosmetics manufacturers can never be 100% certain that their products do not violate a law and could be banned. Legal certainty is therefore only provided by the safety assessment, in which precisely this is officially tested and certified.
Doctors still have unjustified advantages over beauticians or tattooists
Another difference between the professions is that doctors are not controlled by the authorities. They have their own professional organization that monitors them.
It is certainly more pleasant for the doctors concerned to be monitored by professional colleagues than by the authorities. This is also the reason why it is so difficult to take action against doctors even in cases of justified misconduct.
Although the image of doctors as “gods in white” is increasingly being eroded by scandals, lawsuits, outdated training and the digital revolution, people are more likely to believe a doctor than a beautician or tattoo artist. The fact that doctors are increasingly representing purely commercial interests is often not recognized by end consumers. They are believed and are reluctant to take action against them, even in the case of obvious mistakes, while any subjectively suspected mistake by a beautician or tattoo artist quickly leads to recourse claims.
The status of SKINIAL
SKINIAL is a cosmetic product and fulfils all legal requirements. Until recently, we were the only product in Europe to fulfil all requirements, particularly the submission of a safety assessment.
We are transparent and endeavor to provide as much information as possible in a growing industry that we ourselves helped to found and whose services will in future be a natural part of every studio that works with pigments.
Experiences from many countries around the world
Although EU cosmetics legislation is binding for all EU countries, it is unfortunately implemented differently. As subordinate departments with more or less well-trained staff are responsible for controls, arbitrary bans are repeatedly imposed, but these are always immediately suspended 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 from trainers, supposedly well-informed experts or doctors who either have no idea of the actual legal situation or are pursuing their own interests. These are often competitors or simply opinions that have no basis in fact. Unfortunately, end customers are rarely able to scrutinize such claims. This is one of the reasons why we have decided to provide such comprehensive information here.