Hardy 2025 - UK REACH decision on tattoo and permanent make-up inks

Parliamentary Under Secretary of State Emma Hardy issued this UK REACH decision report on substances in tattoo inks and permanent make-up (PMU) on behalf of the Secretary of State for Environment, Food and Rural Affairs. The report proposes an amendment to Annex 17 of UK REACH after considering the Health and Safety Executive Agency’s Annex 15 dossier and Final Opinion. This is regulatory-context evidence for tattoo/PMU inks; it does not report new finished-product metal concentrations.

Key numbers

• Decision identity: title Substances in tattoo inks and permanent make-up; decision date 30 December 2025; signed by Emma Hardy MP on behalf of the Secretary of State for Defra.
• UK REACH process dates: Defra, with Welsh and Scottish ministerial agreement, requested the Agency’s Annex 15 restriction dossier on 29 April 2021; the Agency’s Restriction Dossier was published on 6 May 2022; the Agency submitted its Final Opinion on 1 June 2023.
• Agency risk statement: the report says hazardous substances in tattoo inks and PMU present a risk to human health and estimates that around 1.8% of people with tattoos develop an adverse reaction severe enough to require a doctor’s consultation.
• Proposed scope, RO2a summary: the Agency’s preferred option covered substances classified in the GB Mandatory Classification and Labelling list for carcinogenicity, mutagenicity, reproductive toxicity, skin sensitisation, skin corrosivity, and eye damage when present in tattoo ink or PMU at or above specified concentration limits.
• Proposed scope, cosmetics crosswalk: RO2a also covered substances restricted from cosmetic products under assimilated Regulation (EC) No. 1223/2009.
• RO2a labelling: the Agency proposed labelling requirements for tattoo inks and PMU, including a unique reference number, ingredient list, and safety instructions; it did not include extra pH-regulator or nickel/chromium (VI) allergen warnings in RO2a.
• RO2a derogations and transition: the Agency’s RO2a included derogations for 19 substances, including pigment Blue 15:3 and pigment Green 7, and proposed a two-year transition period for formulators and suppliers plus an additional one year for tattoo artists and PMU professionals to use up non-compliant inks.
• Secretary of State decision on concentration limits: the report diverges from RO2a and applies the lower, stricter concentration limits described in RO3, stating that unacceptable risk would persist between the RO2a and RO3 concentration limits. The extracted report does not print the numeric RO3 concentration-limit table.
• Secretary of State decision on labelling: the report includes pH-regulator labelling and allergen warnings for tattoo inks and PMU containing nickel or chromium (VI) below their restriction concentration limits.
• Secretary of State decision on pigment derogations: the report rejects the Agency’s recommended derogations and restricts the 19 pigments, including pigment Blue 15:3 and pigment Green 7.

Methods (brief)

This is a UK government regulatory decision report under Article 73 of UK REACH. It summarizes the statutory process, the Agency’s Annex 15 restriction dossier, the Agency’s Final Opinion, and the Secretary of State’s decisions to diverge from the Agency’s preferred RO2a option on concentration limits, labelling, and pigment derogations. The report does not contain a sampling frame, laboratory method, LOD/LOQ values, or product concentration table.

Speciation: nickel is discussed as nickel in allergen-warning labelling. Chromium is specifically chromium (VI) in the allergen-warning labelling clause; this page uses Cr-VI, not total Cr.

Implications

Certification (HMTc): This is A-tier regulatory context for tattoo inks and PMU inks in Great Britain. It supports the tattoo-ink page’s regulatory narrative and species discipline for nickel and Cr(VI), but it should not be used as occurrence evidence or as a source of numeric concentration limits because the extracted decision report does not include the limit table.

Courses: The report is useful for teaching how UK REACH restriction decisions can diverge from an Agency preferred option after socio-economic and risk considerations. It also gives a clean example of why nickel and Cr(VI) allergen warnings must not be generalized into total-metal occurrence values.

App: The source can support a Great Britain tattoo-ink regulatory-status card. It should not be used to present product concentration numbers, brand rankings, or HMTc threshold comparisons.

Wiki pages this source may touch

• tattoo-inks
• nickel
• chromium-hexavalent

Verification notes

• PDF text was extracted with pdftotext -layout to /tmp/mfk_june8_uk_reach_tattoo_restriction.txt. The title block, preliminary matters, Agency Recommendation, Conclusion, and divergence paragraphs 11-13 were checked against this page.
• No DOI is printed in the extracted decision report. Title text, decision date, raw handle MFK_uk-reach-restriction-report-substances-in-tattoo-i, and candidate cite key hardy2025-uk-reach-tattoo-pmu-decision were searched before creation; no existing source page was found.
• Numbers are copied exactly from the extracted report. The page does not import numeric RO3 concentration limits from outside the provided PDF because they are not printed in the extracted text.
• Speciation: the report names nickel and chromium (VI) in the allergen-warning decision. This page does not treat chromium (VI) labelling as total chromium occurrence, and it does not infer arsenic, cadmium, lead, mercury, or other metal limits absent from the extracted report.
• Brand firewall: no product brands or contamination values are reported in the decision report.
• Evidence tier: A because this is a primary UK government regulatory decision under UK REACH, but it is regulatory context only and not a primary occurrence dataset.
• Routing: tattoo-inks exists in the taxonomy snapshot. The current taxonomy has no separate permanent-make-up-ink product slug, so PMU specificity is retained in matrices and body text rather than inventing a product slug.

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.