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Report EUR 27528 EN

Paola Piccinini, Laura Contor, Sazan Pakalin, Tim Raemaekers, Chiara Senaldi

Report on Work Package 2

Administrative Arrangement N. 2014-33617

Analysis conducted on behalf of DG JUST

2015

Safety of tattoos and permanent

make-up

State of play and trends in tattoo

practices

This publication is a Technical report by the Joint Research Centre, the European Commission's in-house science

service. It aims to provide evidence-based scientific support to the European policy-making process. The scientific

output expressed does not imply a policy position of the European Commission. Neither the European

Commission nor any person acting on behalf of the Commission is responsible for the use which might be made

of this publication.

JRC Science Hub

https://ec.europa.eu/jrc

JRC96808

EUR 27528 EN

ISBN 978-92-79-52789-0 (PDF)

ISSN 1831-9424 (online)

doi:10.2788/924128 (online)

© European Union, 2015

Reproduction is authorised provided the source is acknowledged. All images © European Union 2015, except: [cover page, Kolidzei, image #65391434], 2015. Source: [Fotolia.com]

How to cite: Authors; title; EUR; doi (

Paola Piccinini, Laura Contor, Sazan Pakalin, Tim Raemaekers, Chiara

Senaldi; Safety of tattoos and permanent make-up. State of play and trends in tattoo practices; EUR 27528 EN;

10.2788/924128)

Safety of tattoos and permanent

make-up

State of play and trends in tattoo

practices i

Table of contents

Abstract 1

1. Introduction 3

2. Tattoos and Permanent Make-up Project 4

3. Methodology 5 3.1 Questionnaires 5

3.2 Web search 7

3.3 RAPEX notifications 7

3.4 National studies and surveys 8

3.5 Literature 8

3.6 Presentations 8

4. Work Package 2: State of play 9 4.1. Meeting of the Consumer Safety Network Subgroup Tattoos and Permanent

Make-up (20

th April 2015) 9

4.2. Statistics about tattoo and PMU practices 9

4.2.1. Introduction 9

4.2.1.1. Definition and uses 9

4.2.1.2. Tattoo as an art 9

4.2.2. Prevalence of tattoos and PMU 10

4.2.2.1. General population 10

4.2.2.2. Influence of age and gender 12

4.2.2.3. Age of getting the first tattoo/PMU 16

4.2.3. Exposure 18

4.2.3.1. Tattoo size, location and gender 18

4.2.3.2. Tattoo number and gender 20

4.2.3.3. Tattoo colours 23

4.2.4. Tattoo regrets and removals 23

4.2.5. Tattoo market 24

4.2.5.1. Tattoo studios and artists 24

4.2.5.2. Tattooist associations 25

4.2.5.3. Ink production and imports 27

4.2.5.4. Quality measures 32

4.2.5.5. Labelling 33

4.2.5.6. Ink containers 33

4.2.6. Additional comments provided by the respondents to the

questionnaires 34

4.2.6.1. General issues 34

4.2.6.2. Regulatory issues 35

ii

4.2.6.3. Market surveillance 36

4.3. Ingredients of tattoo and PMU inks and their fate 37

4.3.1. Introduction 37

4.3.2. Colorants 39

4.3.2.1. Red colorants 40

4.3.2.2. Yellow colorants 43

4.3.2.3. Blue colorants 45

4.3.2.4. Orange colorants 46

4.3.2.5. Violet colorants 47

4.3.2.6. Brown colorants 48

4.3.2.7. Green colorants 49

4.3.2.8. Black colorants 49

4.3.2.9. White colorants 50

4.3.3. Ingredients other than colorants 50

4.3.4. Fate of colorants 52

4.4. RAPEX notifications and market surveillance 56

4.4.1. RAPEX notifications related to tattoo and PMU products 56

4.4.2. Market surveillance in MS and results of test analysis from other

sources 59

5. Conclusions 66

6. References 68 6.1. Literature and national reports 68 6.2. Oral Presentations 76

List of abbreviations 77

List of figures 79

List of tables 80

ANNEX I - meeting of the Consumer Safety Network Subgroup Tattoos and Permanent

Make-up (20 April 2015) 82

Minutes 83

Table A: Agenda 91

Table B: List of participants 93

ANNEX II - Questionnaires 94

Table A: Questionnaire on statistical data 95 Table B: Questionnaire on ingredients 96 ANNEX III - Replies to questionnaires - Statistical data 97 Table A: Prevalence of tattoos and PMU inside and outside Europe 98 Table B: Tattoo procedures, regrets and removals 99 Table C: Age of individuals for their first tattoo or PMU 100 iii Table D: Number of tattoos/person 101 Table E: Number of tattoo artists and studios according to Member States'

Authorities 102

Table F: Number of tattoo artists and studios according to tattooist associations 103
Table G: List of tattooist associations 104 Table H: Ink and instrument purchase 106 Table I: Tattoo and PMU ink importers 107 Table J: Tattoo and PMU ink production countries 109 Table K: List of manufacturers according to Member States' Authorities 110 Table L: Manufacturers producing volume 111 Table M: Manufacturers quality features 112

Table N: Label composition 113

Table O: Size of ink containers 114

Table P: Manufacturers client feed-back 115

Table Q: General issues 116

Table R: Regulatory issues 118

Table S: Health problems 119

Table T: Market surveillance 120

ANNEX IV - Replies to questionnaires - Ink ingredients 121 Table A: List of colorants in use in tattoo inks and found in market surveillance activities 122 Table B: List of colorants in use in PMU inks and found in market surveillance activities 125 Table C: List of additives, both auxiliaries and preservatives, in use in tattoo inks and found in market surveillance activities 128 Table D: List of additives, both auxiliaries and preservatives, in use in PMU inks and found in market surveillance activities 132 ANNEX V - Analysis of tattoo and PMU inks - Test results 136 Table A: Summary of chemical analysis results from all sources 137 Table B: Summary of microbiological analysis results from all sources 158 ANNEX VI - Statistical data from literature and national reports 159 Table A: Prevalence of tattoos inside and outside Europe 160 Table B: Regrets, removals and motivations for removal 163 Table C: Age of individuals for their first tattoo 164 Table D: Size and localisation of tattoos 165

Table E: Colours of tattoos 166

Table F: Skin exposure 167

Table G: Tattooed individuals and their number of tattoos 168

Table H: Number of tattooists 169

iv Table I: Problems and non-compliances 170 ANNEX VII - Ink ingredients from literature and national reports 171 Table A: List of colorants in use in tattoo and PMU inks 172 Table B: List of additives, both auxiliaries and preservatives, in use in tattoo and

PMU inks 176

ANNEX VIII - RAPEX notifications 179 Table A: RAPEX notifications related to microbiological risks 180 Table B: RAPEX notifications related to chemical risks 180 ANNEX IX - Pigment structures and fate 185 Table A: List of all colorants identified through all sources with their chemical structure 186

Table B: Fate of pigments 192

1

Abstract

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. 1 The report on work package 1 (2015, Piccinini P. et al.) is available at 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

1 Administrative Arrangement 33617 "Tattoos - Permanent Make-up", signed by the Directorate General Joint

Research Centre (DG JRC), Unit I.1 Chemical Assessment and Testing, and the Directorate General Health and

Consumers (DG SANCO), Unit B.3 Product and Service Safety, as from 1 st January 2015 Directorate General Justice and Consumers (DG JUST), Unit E.3 Product and Service Safety. 2 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. 3

1. Introduction

With the substantial increase in use of tattoos and permanent make up during the last years, concerns have been growing about the potential health problems they might cause, due to the possible presence of hazardous chemicals in their ingredients, or to the lack of strict hygiene conditions during their application.quotesdbs_dbs1.pdfusesText_1

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