This vision of a regulation was initiated under the need for a common European regulation on tattoo ink ingredients as well as the hygiene requirements during their placement to guarantee a free distribution of products and workers inside the European Union.
This is a first draft meant as a starting point for discussion in multiple phases. We are aware that this draft will also have multiple shortcomings and uncertainties. Exactly this is what we aim to tackle with this first public participation process of building a tattoo legislation where your voice will be heard, and arguments can be discussed and evaluated by reason and rationality.
Our vision of a European Tattoo Regulation shall also ignite a discussion on potential minimal safety testing strategies and short coming on current test applicability to pigments. Currently, it is only possible which pigments are unsafe for use in tattoo inks without giving an advice which to use. In contrast, to the current approach of the European Commission, we strongly advice against a ban of Pigment Blue 15.
This is an experiment, that may result in a fact-based discussion and maybe send a sign that there is a possibility to create legislative measures that are accepted by authorities and a wide range of stakeholders.
The draft of a regulation is limited by the availability of health safety data and the ingredients can therefore only undergo a limited risk assessment. In the past, this data gaps caused a complete absence of any toxicological tests, especially for pigments, required to place the ink into the skin. Therefore, this legislation will substantially improve tattoo safety by covering the basic toxicological profile of the ingredients. Limits of impurities are set to concentrations that are currently technical achievable. Consumers seeking a tattoo have to be clearly informed of the remaining risks of tattoo ink ingredients- as it is common sense with other recreational habits such as smoking and to a minor degree also alcohol.
This vision of a common regulation therefore makes use of negative lists of known harmful substances based on current knowledge in this field as well as giving basic toxicological information that must be available for all ingredients used by a manufacturer.
This draft is based on the ResAP(2008)1, the draft of the REACH restriction on substances used in tattoo inks permanent make-up and valuable comments submitted during public hearing on the REACH restriction. Some points were adapted from the European standard of finger paints, although higher safety standards have to be used since the ink is injected into the body during tattooing.