Piccinini et al. 2016 - EU/JRC safety report on tattoo and permanent make-up inks

Piccinini, Pakalin, Contor, Bianchi, and Senaldi prepared this JRC Science for Policy report for the European Commission on tattoo and permanent make-up (PMU) ink safety. The report is not a single primary laboratory survey; it synthesizes legislation, analytical methods, RAPEX notifications, national market-surveillance campaigns, literature, questionnaires, and expert input. This page records the tattoo/PMU ink heavy-metal surveillance and comparator data only, with brand names suppressed and Cr(VI), total Cr, total Hg, and other species kept separate.

Key numbers

• Report identity: JRC Science for Policy report EUR 27947 EN, JRC101601, Administrative Arrangement N. 2014-33617; PDF DOI 10.2788/011817.
• Scope: the report states that 12% of Europeans have tattoos and that tattoo/PMU inks use more than 100 colorants and more than 100 additives; over 80% of colorants in use are organic and more than 60% are azo-pigments.
• Executive-summary surveillance percentages: among analysed tattoo/PMU ink samples, PAH issues were detected in 43%, primary aromatic amines in 14%, heavy metals in 9%, preservatives in 6%, and microbiological contamination in 11%.
• CoE ResAP(2008)1 impurity comparator, Cr(VI): the report states that the recommended 0.2 ppm (parts per million, mg/kg) limit applies to chromium (VI), not to total chromium, so analytical methods must speciate chromium and separate chromium (VI) and (III).
• CoE ResAP(2008)1 impurity comparator, soluble Cu: 25 ppm is the recommended limit for soluble copper after extraction to an aqueous solution with pH 5.5.
• CoE ResAP(2008)1 total-element comparators: total barium, tin, and zinc 50 ppm; cobalt 25 ppm; arsenic, lead, selenium, and antimony 2 ppm; mercury and cadmium 0.2 ppm. These are source-side regulatory comparators, not HMTc limits.
• RAPEX search frame: during 2005-2015, week 15, 126 alerts related to tattoo and PMU inks were reported.
• RAPEX risk split: of the 126 notifications, 120 were chemical risks (109 tattoo inks and 11 PMU inks) and 6 were microbiological risks.
• RAPEX chemical classes: notifications were mainly for primary aromatic amines (40%), polycyclic aromatic hydrocarbons (30%, including 10% benzo[a]pyrene), and heavy metals (28%).
• RAPEX metals: among all notifications, 28% had heavy-metal contents above CoE ResAP(2008)1 threshold values. The alerts were related to total As, Ba, Cd, Cr(VI), soluble Cu, Pb, Ni, and Zn.
• RAPEX concentration maxima: high Ba and soluble Cu concentrations reached 7800 mg/kg and 4310 mg/kg, respectively. Ni levels reported in RAPEX notifications ranged from 12 to 9690 mg/kg.
• Major market-surveillance campaigns summarized in Table 8.1: Switzerland 2009-2014 approximately 600 samples; Germany 2007-2014 approximately 1000; Italy 2007-2014 approximately 300; Netherlands 2004-2015 approximately 3000.
• Market-surveillance PAH context: considering all information sources, 43% of 358 inks analysed for total PAHs were above the 0.5 mg/kg CoE ResAP(2008)1 comparator, with reported values 0.5-55000 mg/kg.
• Market-surveillance benzo[a]pyrene context: 24% of 300 samples analysed exceeded 0.005 mg/kg, with reported values 0.005-6.8 mg/kg.
• Market-surveillance PAA context: 14% of 3282 products analysed for total PAAs contained carcinogenic PAAs, with measured concentrations from 0.1 to 6900 mg/kg.
• Market-surveillance metals: overall, 9% of tattoo and PMU products analysed exceeded recommended maximum concentrations for metals; percentages ranged from 1.4% to 32% depending on the metal. The report says it was not possible to estimate percentages for Ni and Cr(VI) because Ni lacked a numerical CoE limit and many studies reported only total Cr even though the comparator applies to Cr(VI).
• Market-surveillance microbiology context: more than 3800 tattoo/PMU products were considered for microbiological contamination, and 11% of bottles were not sterile.

Methods (brief)

The JRC project gathered evidence from an international webinar, CSN-STPM meetings, questionnaires, national legislation and guideline texts, harmonized analytical methods, literature, national studies and surveys, web searches, RAPEX notifications, and meeting presentations. The RAPEX database was searched for tattoo/PMU ink notifications from 2005 through 2015 week 15. The market-surveillance synthesis drew on multiple documents and campaigns rather than a single study or publication; the report explicitly warns that the Figure 8.6 percentages derive from several documents considered during the project.

Speciation: arsenic in the CoE comparator and RAPEX alerts is reported as arsenic/As with no inorganic-arsenic speciation, so this page treats it as total arsenic (tAs). Mercury is reported as mercury with no methylmercury speciation, so this page treats it as total mercury (tHg). Cr(VI) is reported where the report names Cr(VI); the report separately notes that many surveillance studies measured only total Cr, which is not interchangeable with Cr(VI).

Implications

Certification (HMTc): This is A-tier regulatory-surveillance context for tattoo inks and PMU inks, especially for source-side comparators, RAPEX notification patterns, and market-surveillance exceedance proportions. It should not be treated as a single primary occurrence dataset for percentile pooling without returning to the underlying national studies and RAPEX records.

Courses: The report is useful for teaching surveillance synthesis, regulatory comparators, and species discipline. It gives a clear example where Cr(VI) limits cannot be applied to total-Cr measurements without speciation, and where a metal such as Ni may have an “as low as technically achievable” requirement rather than a numeric limit.

App: This source can support tattoo-ink context cards about EU/JRC surveillance and method gaps. It should not be used for brand ranking; the report names brands in the RAPEX section, but this page suppresses those names and reports only aggregate notification and product-form information.

Wiki pages this source may touch

• tattoo-inks
• arsenic-total
• barium
• cadmium
• cobalt
• chromium
• chromium-hexavalent
• copper
• mercury-total
• nickel
• lead
• antimony
• tin
• zinc

Verification notes

• PDF text was extracted with pdftotext -layout to /tmp/mfk_june8_tattoo_pmu_final_report.txt. The title page, Executive summary, Methodology section, CoE impurity-limit discussion, RAPEX section 8.1, and market-surveillance section 8.2 were checked against this page.
• Identity checks before creation found no existing wiki/sources/piccinini2016-tattoo-pmu-safety.md, no DOI hit for 10.2788/011817, no raw-handle hit for MFK_safety-of-tattoos-and-permanent-make-up-final, and no title/report-code hit for JRC101601 or EUR 27947 EN.
• Units are copied as reported (ppm, mg/kg, and ppb/µg/kg in the source-side comparator note); no conversions were performed.
• Speciation: the page keeps Cr(VI) separate from total Cr, total arsenic separate from inorganic arsenic, and total mercury separate from methylmercury. The report itself says the Cr(VI) comparator does not apply to total chromium measurements unless chromium is speciated.
• Brand firewall: the RAPEX section names three brands and gives their shares among products not in line with recommendations/legislation. Those brand names and shares are intentionally omitted here because they attach brands to noncompliance/contamination values.
• Evidence tier: A because the report is a European Commission JRC regulatory synthesis with transparent DOI/report identifiers, RAPEX and national surveillance inputs, and explicit method/scope discussion. It is context/surveillance evidence rather than a primary laboratory dataset.
• Routing: products: ["[[products/tattoo-inks]]"] uses the closed taxonomy slug. The taxonomy snapshot has no distinct permanent-make-up-ink product slug, so PMU specificity is retained in matrices and body text rather than inventing a product slug. Selenium appears in the source’s total-element comparator and frontmatter metal list as Se, but there is no [[metals/selenium]] wiki page in the current taxonomy snapshot, so no selenium page link is listed.

Page history

The five most recent substantive edits to this page. The full version history lives in git; when DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.