Regulation of and Intervention in the Tattoo Business: Surveillance of Tattoo-Related Adverse Events by the EU RAPEX System and by National Monitoring Open Access

The resolution of the Council of Europe in 2008 (ResAP (2008)1) [1] set up the basis for the safety of tattoo products.

This resolution has recommended that the Member States take into account the principles described in the resolution in their national laws and regulations on tattoos and permanent make-up. More specifically, this resolution states which information should be put on the labeling, discusses the safety assessment of tattoo products, and states which substances should not be found. Moreover, vigilance of these products is not specifically addressed.

Nevertheless, despite the lack of European regulations on tattoos to date, a European system for monitoring adverse effects associated with tattoo products does exist. It is presented following this section.

Tattoo products are not covered by any specific regulation or directive. Therefore, the directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety [2] applies to these products by default. This European legislation ensures high and uniform protection of the health and safety of consumers. Products placed on the internal market are subject to general safety requirements. The European Union has also set up a rapid alert system (RAPEX) for products presenting a serious risk to consumers.

According to the decision of 16 December 2009 [3], laying down guidelines for the management of RAPEX, in section 2.1.1, tattoo products are covered by RAPEX.

In the decision of 16 December 2009 [3], it is stated that RAPEX, which was established by Article 12 of the directive on general product safety [2], applies to measures designed to prevent, limit, or control the sale and use of consumer products presenting a serious risk to the health and safety of consumers. Members States are required to participate in the RAPEX system and to inform the European Commission whenever the four criteria below are met:

- the product is a consumer product;

- the concerned product is the subject of measures to prevent, limit, or control its marketing and use;

- the concerned product presents a serious risk to the health and safety of consumers;

- the serious risk has cross-border implications.

When Member States identify products that present a serious risk to health and safety, they pursue rapid intervention measures to protect consumers. In this case, Member States must immediately inform the Commission through the RAPEX system. The purpose of this system is to quickly circulate information about risk and measures between Member States and the European Commission.

There are 2 types of RAPEX notifications:

- ‘Article 12 notification', which responds to the above-mentioned criteria;

- ‘Article 12 notification requiring emergency action', which indicates that the product poses a life-threatening risk and/or that there have been fatal accidents and in other cases where a RAPEX notification requires emergency action by all Member States.

There is also the possibility of receiving ‘notifications for information' when some items are missing in order to complete the notification form correctly. A confirmation of measures may also be required when the notification was sent before measures were adopted. These notifications are subject to different deadlines.

According to the directive 2001/95/CE [2], Member States must provide all available details. In particular, the notification must contain at least

- information enabling the product to be identified;

- a description of the risk involved, including a summary of the results of any tests/analyses and of their conclusions that are relevant to assessing the level of risk;

- the nature and the duration of the measures or action taken or decided on, if applicable;

- information on the supply chains and distribution of the product, and particularly on destination countries.

The decision 2010/15/UE [3] provides an example of Section IV of the notification form of RAPEX.

In Section IV and section 3.2.2, the decision 2010/15 [3] shows the standard notification form to be filled out by Member States. Notifications should be as complete as possible; all sections must be completed. An opportunity to update the notification form is allowed as soon as the information becomes available. The record is then reviewed by the European Commission before being published. The main fields to be filled out on the notification form are described below.

The type of notification is requested: ‘Article 12 notification requiring emergency action', ‘Article 12 notification', ‘Notification for information', or ‘Article 11 notification'. The number, date, and country and the person in charge of notification are also requested.

Many pieces of information are requested: the product category, name, brand, model and/or type number, barcode, batch or serial number, and custom code; a description of the product and its packaging, with pictures of the product, packaging, and labels; and the total number of open items for notification.

Information on the safety requirements applicable to the notified product is requested, including legal provisions (directive, decision, and regulation), standards, means of attestation of conformity, and indication of whether the product is counterfeit or not.

Information establishing the product's origin is requested: the contact details of the manufacturer or its representative, of the exporter(s), of the importer(s), of the distributor(s), and of the retailer(s). Information regarding the product's destination countries is also requested.

A risk category description is required. A summary of test results, legal provisions, and standards (with clauses) against which the product was tested and with which it did not comply must be provided. A risk assessment, conclusions, and information on known incidents and accidents are also required.

Information on the measures taken, the category (withdrawal from the market, recall from consumers), the scope and date of entry into force, and the duration of the measures must be provided.

Indication of whether the entire notification or part of it and/or its attachment(s) are covered by confidentiality must be provided. A request for confidentiality must always be accompanied by a justification clearly stating the reasons for such a request.

Member States are encouraged to obtain and provide information on the supply chains of the notified product in non-EU countries that cooperate closely with the EU on product safety.

RAPEX notifications are available on the website of the European Commission at the following address: http://ec.europa.eu/consumers/safety/rapex/alerts/main/index.cfm?event=main.list Notifications&selectedTabIdx=1.

To illustrate the work of Members States at the European level, it is interesting to consider tattoo ink notifications. The following is a review of all notifications on tattoo inks presenting a serious risk to human health from 2005 to September 30th, 2014. The research based on the European database was performed using the word ‘tattoo' in the field ‘product'. The results regarding Rapex notifications review from 2005 to end of September 2014 are presented in table 1.

The main notifying countries are Germany and Italy. The main origin countries of tattoo inks presenting a serious risk to human health are the USA and China. Nevertheless, it is noted that in several cases, the origin country is unknown.

The main types of risk reported concern the presence of heavy metals, aromatic amines released by azo dyes, or polycyclic aromatic hydrocarbon. Few notifications indicate microbiological contaminations. The standard claimed in most of the notifications is the resolution of the Council of Europe in 2008 [1]. The measures taken by Member States are either compulsory measures, such as import rejection at the border, a ban of the product from the market, withdrawal of the product from the market, or recall of the product from end users, or voluntary measures, such as withdrawal of the product from the market or destruction of the product.

An example of the French vigilance system for tattoo products is explained below.

Up to 2004, there was no French regulation on tattoo products. France adopted a regulation on tattoos on August 9th, 2004, by the publication of Law n°2004-806. This law, and particularly article 149 [4], relates to public health policy regarding tattoo products other than medical devices in the regulatory framework for public health. Tattoos were then added to the field missions of the competent authority of the French National Agency for Medicines and Health Products Safety (ANSM).

We can distinguish technical and administrative requirements.

French regulations establish technical requirements for tattoo products:

- a definition: tattoo products are any substance or preparation intended for coloring by cutaneous effraction to create a mark on the external parts of the human body, except for products that are medical devices;

- tattoo products do not require any authorization to be put on the market;

- a tattoo product can be put on the market if it meets certain regulatory requirements, and particularly the absence of harm to the health of the consumer, meaning that manufacturers are responsible for the safety of the product and that tattoo products should not affect human health;

- tattoo products must comply with the definition;

- the composition of tattoo products must comply with the lists of substances;

- tattoo products must meet the labeling requirements.

French regulations also establish administrative requirements:

- reporting by the responsible person to the competent authority is required;

- technical documentation must be kept available to the control authorities;

- the manufacture of tattoo products must be conducted in accordance with Good Manufacturing Practices;

- safety assessment of the human health effects of tattoo products must be performed in compliance with Good Laboratory Practice.

To ensure safety of tattoo products, the French competent authority (ANSM) organizes a vigilance system to monitor the risk of side effects from the use of tattoo products. Vigilance is directed toward all products once they are on the market.

Vigilance of tattoo products always involves monitoring of the adverse effects resulting from their use. It is directed toward all tattoo products once they are available on the market.

This vigilance includes

- reporting of all adverse events and collecting information about them;

- registration, evaluation, and use of the information related to those effects for the purpose of prevention;

- performance of all studies on the safety of use of tattoo products;

- implementation and monitoring of corrective actions if necessary.

French regulations provide the following definitions:

Undesirable Effect: This adverse effect is a harmful and unintended reaction that occurs during the normal use of a tattoo product in humans or results from its misuse.

Serious Undesirable Effect: This effect is defined as an undesirable effect that results in hospitalization, temporary or permanent functional incapacity, a disability, an immediate vital risk, death, an anomaly, or a birth defect.

Misuse: This is incorrect use of a product during routine use, with special precautions mentioned in 7° of article R.513-10-5.

In the French regulation [5], many actors can be identified: the responsible person, the health professional, the person making tattoos, and the consumer.

Responsible persons must notify the competent authority, without delay, of all serious undesirable effects. Moreover, the responsible persons must notify the competent authority about other undesirable effects. In the latter case, there is no concept of time. A lack of reporting of serious undesirable effects as soon as responsible persons have knowledge and by any means is punishable by 2 years' imprisonment and a penalty of EUR 30,000.

Health professionals and persons making tattoos must notify the competent authority, without delay, of all serious undesirable effects. Moreover, health professionals and persons making tattoos must notify the competent authority of other undesirable effects, with no concept of time. In his notification, the health professional specifies if the undesirable effect results from misuse and describes the conditions under which the tattoo has been applied. A lack of reporting of serious undesirable effects as soon as health professionals or persons making tattoos have knowledge and by any means is punishable by 2 years' imprisonment and a penalty of EUR 30,000.

Consumers can report undesirable effects, indicating any misuse and describing the conditions under which the tattoo was applied.

Manufacturers or their representatives and the persons on whose behalf tattoo products are manufactured are notably required to report all undesirable effects contrary to the requirement of safety of tattoo products to the General Directorate for Competition Policy, Consumer Affairs, and Fraud Control (DGCCRF).

ANSM has developed a notification form for an undesirable effect occurring after the realization of a tattoo. On this form, it is stipulated that tattoo products with an undesirable effect must be kept for at least 3 months. This notification form can be downloaded from the ANSM website and then sent to the vigilance department of ANSM.

This notification form includes several fields to fill out:

All person involved in the reporting system for vigilance of tattoo products are indicated: responsible persons, health professionals (physicians, pharmacists), tattooists, tattooed persons, and other. It is advisable to write the full name, telephone number, and e-mail address of the person designated above. The date of issue of the notification form is requested.

It is requested that the date of birth of the tattooed person, the person's gender, and whether there is a current pregnancy be specified.

The following information on tattoo products is requested: the name of the product(s), the batch number, and the color index of the colorants inside the tattoo product(s). The address and local contact details of suppliers, distributors, and/or manufacturers must also be provided.

Completion of the fields regarding the address and local contact details of the tattooist is requested. The notifier should indicate if the notification concerns a monochrome tattoo or a polychrome tattoo. The colors constituting the tattoo and the date of the realization of the tattoo must be clarified. The body area where the tattoo was performed is worth mentioning. If associated products are used, such as anaesthetic, antiseptic, etc. they may be included. At last, the date of occurrence of the adverse effect is requested.

Many fields are available: consulting a physician; consulting a pharmacist; social inconvenience (specify); work stoppage; urgent medical intervention; hospitalization; sequelae, disability, or incapacity; and other (specify).

Specification of professional use or misuse and if there are old tattoos is requested.

Clarification of whether the effect of the events took place at or away from the area of the realization of the tattoo is requested.

In the notification form, an open field is left available to the notifier, to describe the adverse effect and the occurence time of the effect.

Information on whether the person has allergies and/or skin diseases or other diseases is requested.

The development of the undesirable effect is investigated, such as if there was a spontaneous resolution of the effect and whether local and/or a general treatment was carried out.

Information on whether further investigations were carried out is requested, such as microbiological sampling, blood assessment, a biopsy, or an allergy survey. Finally, which final diagnosis was made and whether there is a causal link between the effects observed and the realization of the tattoo must be indicated.

The vigilance of tattoo products is led by the French competent authority, or ANSM, which defines the approach and leads and coordinates the action of different stakeholders, including

- notification of the undesirable effect and collection of information about it;

- registration, evaluation, and use of this information for the purpose of prevention, with the information analyzed while taking into account the available data on the sales and use practices of tattoo products;

- realization of all studies and all work on safety regarding tattoo products;

- realization and monitoring of corrective actions;

- possibly also research and analysis of data contained in the file of the finished product.

In terms of market surveillance, ANSM works in strong coordination with DGCCRF to monitor the implementation of the text. Given the collaboration agreement between the two French competent authorities, ANSM and DGCCRF, in France, tattoo inks were subject to a survey from 2012 to 2013. In total, 35 tattoo inks were examined by ANSM. Sterility tests were performed on 26, and research on aromatic amines was carried out on 28 samples. The DGCCRF laboratory focused on finding heavy metals. Three products were found to be nonsterile, and the presentation and/or labeling of 11 products were considered noncompliant with regulations [6].