Safety of tattoos and permanent make-up: Compilation of information on legislative framework and analytical methods

This document summarises the work carried out within Working Package 1 of the Administrative Arrangement 33617 on tattoos and permanent make-up, signed with Directorate General Health and Consumers (DG SANCO), now DG Justice (DG JUST). It includes: the description of the project; the description of the recommendations contained in the Council of Europe Resolution (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up; the minutes of the meeting of the Consumer Safety Network Subgroup Tattoos and Permanent Make-up (CSN-STPM), held on 11th November 2014, in Ispra (VA), Italy; a collection of analytical methods that could be useful to implement the recommendations of the Council of Europe Resolution (2008)1, as well as a review of existing legislation/guidelines frameworks for the safety of tattoo and permanent make-up products in the European countries and some other jurisdictions.JRC.I.1-Chemical Assessment and Testin

Safety of tattoos and permanent make-up State of play and trends in tattoo practices

The European Commission launched the 18-month project "Tattoos and Permanent Make-up" with the aim of collecting data about the use, the ingredients, the EU market and possible health problems associated to tattoo and permanent make-up (PMU) inks. The report on work package 1 (2015, Piccinini P. et al.) is available at http://bookshop.europa.eu/en/safety-of-tattoos-and-permanent-make-up-compilation-of-information-on-legislative-framework-and-analytical-methods-pbLBNA27394/ The present report is the outcome of the work package 2 which aims to describe the status of tattoo and PMU practices like tattoo prevalence in the population, including the removal processes, details on service providers and ink manufacturers, tattoo and PMU market, inks' chemical composition, RAPEX notifications and national market surveillance. The information was gathered through questionnaires sent to 32 national authorities (all EU MS and EFTA countries), plus OECD Secretariat, 38 ink manufacturers/distributors/private labels and 23 tattooists/PMU professionals' associations. Replies were collected from 24 EU/EFTA national authorities, 4 non-EU/EFTA countries, 7 ink manufacturers/ distributors/private labels and 10 associations. In addition, we reviewed thoroughly data available from other sources like scientific literature, RAPEX (Rapid Alert System for dangerous non-food products) notifications and national surveillance reports, as of May 2015. The main findings show that: Tattoo and PMU inks are complex chemical mixtures containing several ingredients. The main ingredients are the colorants, pigments in particular; more than 100 of them have been identified in tattoo and PMU inks. These pigments are not produced specifically for such application and a risk assessment taking into account their injection and permanence into the human body is not carried out. An additional identified risk is the presence of impurities; in fact tattoo and PMU inks' purity is on average around 70-90 %. Azo pigments, group to which most of the organic colorants in use belong, are proved to release potentially carcinogenic aromatic amines when exposed to solar, UV or laser irradiation. It is estimated that around 12 % of the whole European population, all ages comprised, are tattooed (estimation based on available data from 14 Member States) and more than 20 % in the United States. Higher tattoo prevalence was reported in young population, including adolescents. While traditionally men were more tattooed than women, figures show that this trend in Europe, Australia and North America is changing. Nowadays in a number of cases the tattoo prevalence in women is higher than in men, particularly in young generations. Most of the tattoo inks used in Europe are imported from the United States, while PMU inks are mostly produced in Europe. The European manufacturers are mainly based in the United Kingdom, Germany, Italy and Spain. With regards to the tattoo artists performing the tattoos, the number of "non-professional tattooists" might represent up to 10 times the number of "registered/professionals" ones. Around 95 % of the 126 RAPEX alerts notified for tattoo/PMU during the last decade related to chemical risks: hazardous chemicals and/or impurities (such as carcinogenic aromatic amines, polycyclic aromatic hydrocarbons, sensitizers, preservatives and heavy metals). The remaining 5% concerned microbiological risks, which are mainly due to the lack of sterility of the inks before opening and from the use of tap water for their dilution. Two thirds of the RAPEX notifications pertain to products imported, with the highest percentages from the United States.JRC.I.1-Chemical Assessment and Testin

Review On Production Processes Of Decabromodiphenyl Ether (DECABDE) Used In Polymeric Applications In Electrical And Electronic Equipment, And Assessment Of The Availability Of Potential Alternatives To DECABDE

In this study commissioned by DG ENV, the JRC-IHCP-ECB has reviewed the production processes of DecaBDE, in particular its NonaBDE content, and explored the availability of potential DecaBDE alternatives used in polymeric applications for EEE (cost of substitution and recyclability of alternatives was outside the scope of the study).JRC.I.3-Toxicology and chemical substance

The European Chemicals Bureau: an Overview of 15 Years Experience in EU Chemicals Legislation

From its creation in 1993, the European Chemicals Bureau (ECB) has played a vital role in the conception, development, implementation and monitoring of European Union (EU) legislation on chemicals and in contributing to the European Commission¿s participation in international chemicals programmes. The ECB has housed much of the European Commission¿s experience, capacity and historical memory in chemical risk assessment and safe chemical management. The contribution of ECB to the drafting, development and implementation of the REACH regulation has been an important one. The provision of scientific/technical expertise to the start-up phase of the newly born European Chemicals Agency (ECHA) has been essential for a swift and effective implementation of REACH. The ECB has contributed to that effort not only by selecting, recruiting and training ECHA staff but also by seconding part of its own key staff to the agency. And finally, during 2008 the ECB is completing the hand-over files and transmitting them to the ECHA, which is taking over responsibility for the operational implementation of EU legislation on chemicals.JRC.I-Institute for Health and Consumer Protection (Ispra

Bisphenol A - and baby bottles: challenges & perspectives

Despite the fact that for more than a decade many toxicological studies were carried out world wide, there is not yet a full understanding of the impact of Bisphenol A (BPA) on human health. As BPA may migrate into infant formula preparations from polycarbonate baby bottles, there is a special concern about its possible effect on the development of infants and young children. The potential endocrine disrupting properties of BPA trigger especially this discussion. Several risk assessment studies have been performed; nevertheless, there is still not yet a full agreement between all the risk assessors and the issue of BPA continues to generate discussion and is at the centre of political debate. Most of the debate arise from diverging opinions concerning the reliability and relevance of studies reporting effects at low doses, often carried out in university laboratories, without following international guideline criteria or good laboratory practices. However, some researchers believe that these criteria should not be used to select best available information. In principle, this controversy might be solved via a new series of globally agreed toxicological studies, possibly to be carried out under the supervision of a panel of independent experts, with the participation of both academic research laboratories and regulatory bodies. To raise the quality and reliability of results, it may be agreed to carry out proficiency testing campaigns prior to the performance of the study. This report provides an overview of the scientific issues which are at the base on the on-going discussions on BPA, by summarising the risk assessment activities carried out so far, having taken into account the latest scientific information available, and considering future challenges, such as the lack of information on some BPAfree plastics which may be used as substitutes for polycarbonate.JRC.DG.I-Institute for Health and Consumer Protection (Ispra