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Regulatory review of the European Commission on the safety of tattoos, body piercing and related practices

Norman Noah (Norman.Noah@lshtm.ac.uk), London School of Hygiene and Tropical Medicine, England

With the increasing popularity of body adornment and piercing, regulations to ensure the safety of such practices are welcome. Concerns have recently been expressed by Member States and the European Parliament about the safety of tattoos and body piercing and the absence of legislation in the European Union (EU) and elsewhere (1).

The preliminary version of this paper is a step in a series of actions by the European Union’s Institute for Health and Consumer Protection and Physical and Chemical Exposure Unit (2). A technical working group of experts from EU member states are developing several working papers in collaboration with other experts and organisations. These proposed papers include a regulatory review, and others of chemicals used in tattoos/piercings, health effects and risks, assessment of risk, authorisation and registration, education and skills and hygiene practices. There will also be a status report on the current situation, nature and size of the problem in the EU.

The European Commission’s Joint Research Centre (JRC) was asked by the Directorate-General for Health and Consumer Protection (DG SANCO) to collect and assess all necessary information for establishing a common knowledge basis for future legislation in the EU.

The main objectives were to:

	Assess the prevalence in the EU of tattooing and body piercing
	Review the existing regulations on tattooing/body piercing in the EU and elsewhere
	Review the safety data on tattooing dyes and pigments, piercing, tattooing/body piercing practices and the extent of any problems related to these activities
	Review the professional aspects of these activities, such as training requirements and hygiene standards.

The ultimate goal is to assess the need for, and, if appropriate, make proposals to regulate and harmonise these activities across the EU. In this undertaking, the JRC and DG SANCO are working together with the Council of Europe, which is preparing a resolution on tattoos and permanent make up.

After three meetings of the technical working group, which were held between December 2002 and March 2003, the following policy options were agreed:

	provisions on authorisation/registration of the activity
	provisions on skills/education of the practitioners
	provisions on the equipment/space
	provisions on hygienic practices
	provisions on sterility of products/equipment/practices
	request for risk assessment
	introduction of a negative list of substances
	introduction of a positive list of substances.

The Working Paper then goes on to describe the rationale and objectives of the project, lists a Directory of existing legislation and current regulatory actions taking place in each of the EU member states, as well as Canada, Australia and the United States (described in more detail later in the document), and gives a summary of various work that has been done in the member states. Some of the problems are highlighted. Some of the dyes used in tattooing for insertion into the skin are not permitted to be used as cosmetics on the skin. Little is known about the toxicology or even the composition of some of the dyes.

The draft resolution then goes on to cover proposals for tattooing and permanent make up (PMU). These include ensuring sterility of products used, hygienic practices of the practitioner, appropriate labelling of the product, and pre-market safety assessment.

The risks and health effects from tattooing, body piercing and related practices are described in an accompanying document (3). The health effects include both infectious and non-infectious risks.
As a result of the review, a list of recommendations has been made:

These include

	analysing the substances used for tattoos and body piercing and undertaking a systematic risk assessment;
	raising the awareness of both practitioner and customer of the health risks;
	developing a list of substances and materials which are permissible [positive list] or which may lead to adverse health effects (‘negative list’);
	proper labelling of ingredients used in colours and licensing safe colours and materials;
	regulating hygiene standards of studios;
	regularising training and accrediting practitioners;
	and further epidemiological studies on the hazards of these practices.