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Safety of Tattoos and Permanent Make-Up State of Play and Trends in Tattoo Practices

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Safety of Tattoos and Permanent Make-Up State of Play and Trends in Tattoo Practices Safety of tattoos and permanent make-up State of play and trends in tattoo practices Report on Work Package 2 Administrative Arrangement N. 2014-33617 Analysis conducted on behalf of DG JUST Paola Piccinini, Laura Contor, Sazan Pakalin, Tim Raemaekers, Chiara Senaldi 2 0 1 5 Testing CIRS|C&K www.cirs-ck.comReport EUR 27528 EN LIMITEDhotline:4006-721-723 DISTRIBUTION Email:[email protected] 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) Testing CIRS|C&K www.cirs-ck.com hotline:4006-721-723 Email:[email protected] Safety of tattoos and permanent make-up State of play and trends in tattoo practices Testing CIRS|C&K www.cirs-ck.com hotline:4006-721-723 Email:[email protected] Testing CIRS|C&K www.cirs-ck.com hotline:4006-721-723 Email:[email protected] 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 (20th 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 Testing i CIRS|C&K www.cirs-ck.com hotline:4006-721-723 Email:[email protected] 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 Testing ii CIRS|C&K www.cirs-ck.com hotline:4006-721-723 Email:[email protected] 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 Testing iii CIRS|C&K www.cirs-ck.com hotline:4006-721-723 Email:[email protected] 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 Testing iv CIRS|C&K www.cirs-ck.com hotline:4006-721-723 Email:[email protected] 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 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 %.
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