UK REACH Annex 17 and CPNP notification for tattoo ink and PMU
TL;DR: The UK REACH restriction decision of 30 December 2025 inserts a new Annex 17 entry, with substance limits in Appendix 13, for tattoo inks and PMU on the GB market. The amending SI is not yet made, so transition runs from a future entry-into-force date: a 2-year placing-on-market ban then a 3-year use ban. Defra rejected the 19-pigment derogation.
UK REACH Annex 17 and CPNP notification for tattoo ink and PMU
Information, not legal advice. The Defra draft amendment text and Appendix 13 substance table are operative as draft and not yet on legislation.gov.uk as a made SI. Verify the live position with Defra and OPSS before relying on this guide for specific compliance decisions.
Position as at 19 May 2026
Defra published the formal restriction decision on 30 December 2025 and released the draft amendment text on 15 January 2026. The amendment inserts a new entry into Annex 17 of UK REACH Regulation (EC) No 1907/2006 as retained in domestic law, with the substance limits set out in a new Appendix 13.
The decision goes further than the Agency's preferred option. Defra chose stricter concentration limits (RO3) over the Agency's recommended RO2a, and explicitly rejected the proposed derogation for 19 pigments including Pigment Blue 15:3 and Pigment Green 7. Those pigments remain fully in scope of the restriction.
The amending SI itself is not yet on legislation.gov.uk as a final made instrument as at 19 May 2026. Because the SI has not been made, there is no SI number or title to cite yet, and no fixed entry-into-force date. The transition clocks all run from that entry-into-force date, so until the SI is made and dated, specific calendar dates cannot be given.
The operative draft text lives in Defra's "UK REACH draft amendment for substances in tattoo inks and permanent make-up" PDF on the gov.uk announcement page.
The legal scope question
UK REACH and the cosmetics regime are separate frameworks that handle different products. Getting the line between them right matters because the duties are different.
UK REACH covers tattoo ink as a chemical mixture placed on the GB market. The operative restriction sits in Annex 17 with substance-level limits in Appendix 13. Suppliers, importers and downstream users have duties to ensure restricted substances are not present above the relevant concentration limits.
The cosmetics regime is governed by assimilated Regulation (EC) No 1223/2009 on cosmetic products, with enforcement through the Cosmetic Products Enforcement Regulations 2013. The relevant definition of a cosmetic product is one intended to be placed in contact with external body parts mainly to clean, perfume, change appearance, protect, keep in good condition or correct body odours. A consumer cosmetic placed on the GB market must be notified through the Submit Cosmetic Product Notifications service before being made available.
Standard tattoo ink, used for intradermal tattooing, does not obviously meet the cosmetic definition. The product is applied below the skin surface, not in contact with external body parts. Most tattoo ink therefore falls outside the cosmetic notification regime, while still being subject to UK REACH.
Permanent make-up pigment occupies the more difficult middle ground. PMU is marketed mainly to change appearance, applied to the skin in a manner that some would say is intradermal and others would say is partly external. Where a PMU product is sold and marketed as a cosmetic product to consumers, the cosmetic notification duties bite. Where a PMU product is sold only to trained professional practitioners for procedural use, the analysis is more product-specific. See [[uk-reach-for-tattoo-inks]] for the wider ink procurement context.
What Annex 17 actually restricts
The operative draft Annex 17 entry applies to substances that fall within any of four categories.
Category (a) covers substances classified in the GB mandatory classification and labelling list as carcinogen, germ cell mutagen or reproductive toxicant (categories 1A, 1B or 2), skin sensitiser (category 1, 1A or 1B), skin corrosive (category 1, 1A, 1B or 1C), or serious eye damage (category 1).
Category (b) covers substances listed in Annex 2 to the assimilated Cosmetic Products Regulation (the EU cosmetics prohibited list).
Category (c) covers substances listed in Annex 4 to the assimilated Cosmetic Products Regulation for which a condition is specified on product type, body parts, maximum concentration, or other restrictions.
Category (d) covers substances listed in Appendix 13 to Annex 17 itself.
Any substance falling into one or more of these categories must not be placed on the market in a tattoo ink, and must not be used in a tattoo ink, where the concentration exceeds the applicable limit set in paragraph 3 of the entry.
General concentration thresholds
Paragraph 3 sets the general concentration thresholds when a substance is not in Appendix 13.
| Hazard classification | Limit (by weight) |
|---|---|
| Carcinogen 1A/1B/2 or germ cell mutagen 1A/1B/2; substances in Annex 2 to Cosmetic Products Regulation; substances in Annex 4 marked "Rinse-off products", "Not to be used in products applied on mucous membranes", or "Not to be used in eye products" | 0.00005% |
| Reproductive toxicant 1A/1B/2 or skin sensitiser 1/1A/1B | 0.001% |
| Skin corrosive 1/1A/1B/1C or serious eye damage 1 (not used solely as pH regulator) | 0.01% |
| Skin corrosive 1/1A/1B/1C or serious eye damage 1 (used solely as pH regulator) | 0.1% |
| Substance listed in Appendix 13 | Limit specified in Appendix 13 |
Where a substance is not in Appendix 13 but falls under more than one hazard category, the lowest applicable limit applies. Where a substance is in Appendix 13 and also falls under one or more general categories, the Appendix 13 limit applies.
Appendix 13 specific substances
Heavy metals, PAHs and methanol
| Substance | EC number | CAS number | Concentration limit |
|---|---|---|---|
| Mercury | 231-106-7 | 7439-97-6 | 0.00005% |
| Nickel | 231-111-4 | 7440-02-0 | 0.0005% |
| Organometallic tin | 231-141-8 | 7440-31-5 | 0.00005% |
| Antimony | 231-146-5 | 7440-36-0 | 0.00005% |
| Arsenic | 231-148-6 | 7440-38-2 | 0.00005% |
| Barium (soluble) | 231-149-1 | 7440-39-3 | 0.05% |
| Cadmium | 231-152-8 | 7440-43-9 | 0.00005% |
| Chromium VI | 231-157-5 | 7440-47-3 | 0.00005% |
| Cobalt | 231-158-0 | 7440-48-4 | 0.00005% |
| Copper (soluble) | 231-159-6 | 7440-50-8 | 0.025% |
| Zinc (soluble) | 231-175-3 | 7440-66-6 | 0.2% |
| Lead | 231-100-4 | 7439-92-1 | 0.00007% |
| Selenium | 231-957-4 | 7782-49-2 | 0.0002% |
| Benzo[a]pyrene | 200-028-5 | 50-32-8, 63466-71-7 | 0.0000005% |
| PAHs classified as carcinogen or germ cell mutagen 1A/1B/2 on the GB mandatory list | , | , | 0.00005% (each) |
| Methanol | 200-659-6 | 67-56-1 | 11% |
Aromatic amines (all at 0.0005% by weight)
Thirty-one aromatic amines and related substances are listed at the 0.0005% threshold, including aniline, benzidine, 2-naphthylamine, o-toluidine, p-toluidine, p-phenylenediamine, 2,4-xylidine, 2,6-xylidine, 3,3'-dichlorobenzidine, 3,3'-dimethoxybenzidine, 4-aminoazobenzene, 4-chloroaniline, 4-chloro-o-toluidine, 4,4'-methylenedianiline, 4,4'-methylenedi-o-toluidine, 4,4'-methylene-bis-2-chloroaniline, 4,4'-oxydianiline, 4,4'-thiodianiline, 4,4'-bi-o-toluidine, 4-methyl-m-phenylenediamine, 4-methoxy-m-phenylenediamine, 6-methoxy-m-toluidine, 2-methyl-p-phenylenediamine, 5-nitro-o-toluidine, 2,4,5-trimethylaniline, sulphanilic acid, 4-amino-3-fluorophenol, 6-amino-2-ethoxynaphthaline, 4-o-tolylazo-o-toluidine, biphenyl-4-ylamine, and o-anisidine. The full verbatim table with CAS and EC numbers is in phase-b-reach-citation-recheck.md.
Pigments and dyes (all at 0.1% by weight)
Forty-four pigments and dyes are listed at the 0.1% threshold, including the 19 pigments that the Agency had recommended for derogation. The minister rejected the derogation. So Pigment Blue 15:3 (CAS 147-14-8, CI 74160), Pigment Green 7 (CAS 1328-53-6, CI 74260), and the other 17 pigments in that group are now fully restricted at the same 0.1% limit as the rest of the list. Other named substances at the 0.1% threshold include Solvent Red 1, Solvent Red 23, Acid Orange 24, Acid Red 73, Acid Red 26, Acid Green 16, Acid Violet 17, Basic Red 1, Disperse Blue 35/106/124, Disperse Orange 37, Disperse Red 1/17, Disperse Yellow 3/9, Pigment Violet 3/39, Solvent Yellow 2, and a range of Pigment Red, Pigment Orange and Pigment Yellow entries by Colour Index number. The full verbatim list is in phase-b-reach-citation-recheck.md.
Label triggers below the limit
Two substances trigger mandatory allergen warnings even when present BELOW the Appendix 13 limit.
"(e) if the mixture contains nickel below the concentration limit specified in Appendix 13, the statement 'Contains nickel. Can cause allergic reactions.'; (f) if the mixture contains chromium (VI) below the concentration limit specified in Appendix 13, the statement 'Contains chromium (VI). Can cause allergic reactions.';"
In practical terms, a "compliant" ink that contains any detectable nickel or chromium(VI) below the restriction threshold must still carry the relevant allergen statement on the label.
UK is stricter than EU
The UK regime intentionally departs from EU REACH Entry 75 in two ways.
First, Defra chose RO3 over the Agency's preferred RO2a. RO3 carries stricter concentration limits across multiple substance categories.
Second, Defra rejected the proposed derogations for 19 pigments that the Agency had recommended for temporary continued use. Pigment Blue 15:3 and Pigment Green 7 (the two most politically-contested EU restriction items) are fully restricted under UK REACH from the outset.
The practical effect is that an EU REACH compliance declaration is not sufficient for GB compliance. A supplier selling into GB must evidence UK REACH compliance specifically, against the operative Appendix 13 limits.
Transition framing
The draft entry sets two transition triggers, both measured from the entry-into-force date of the eventual SI. In the draft text the two trigger dates are left blank, with drafting notes confirming the intent: the placing-on-the-market provisions (a 2-year transition) take effect 2 years after the SI enters into force, and the use provisions (a 3-year transition) take effect 3 years after the SI enters into force.
So:
- 2 years after SI entry-into-force: the placing-on-the-market ban starts. Suppliers cannot place non-compliant ink on the GB market.
- 3 years after SI entry-into-force: the use ban starts. Professional artists cannot use non-compliant ink in a tattoo procedure.
The gap between the two dates is a 1-year window where suppliers can no longer sell non-compliant stock but artists can still use stock that was lawfully placed on the market before the placing ban.
Because the SI has not been made, its entry-into-force date is not yet fixed, so the calendar end-dates for the placing-on-market ban and the use ban cannot be stated yet. Both clocks are anchored to that entry-into-force date.
Pre-30 December 2025 stock has no special legacy clause
There is no grandfather rule for stock placed on the market before the decision date. Compliance is determined purely by whether the mixture is being placed on the market or used after the respective transition dates, and whether the mixture meets the Appendix 13 concentration and labelling conditions.
A studio holding pre-decision stock cannot rely on the purchase date as a defence. The question is whether the ink will be lawfully used at the point of the procedure, which depends on the use-ban date and the substance composition.
The five-question supplier audit
A studio that wants to manage UK REACH compliance risk should put five direct questions to every ink and PMU supplier.
First, ask for a current UK REACH compliance statement that names the exact product, batch or formulation. A generic "REACH compliant" statement on a website is not enough. The statement should name the product code, the relevant Annex 17 entry, and the supplier's basis for compliance against Appendix 13.
Second, ask for a substance-level Certificate of Analysis or equivalent laboratory report, mapped to the Appendix 13 substance list with concentration measurements. If any of the substance groups in the substance table appear in the formulation, the report should show concentration against the relevant limit.
Third, ask for a UK-facing Safety Data Sheet and confirmation of who is the GB importer or responsible economic operator for the product. Post-Brexit, an EU-based responsible person does not automatically cover GB market obligations. There needs to be a UK-based party.
Fourth, ask directly whether the supplier classifies the product as a standard tattoo ink, a PMU-only pigment, or a consumer cosmetic product. The classification controls whether SCPN notification is required.
Fifth, ask for written confirmation on transition stock status. Whether the supplier intends to continue placing the product on the GB market through to the 2-year placing-on-market ban, and whether the supplier will provide any use-up advice for stock at the 3-year use-ban date.
CPNP notification process
The GB cosmetic notification portal is Submit Cosmetic Product Notifications (SCPN), run for the Office for Product Safety and Standards. The service requires notification of every cosmetic product made available to consumers in GB, with core information including ingredients, certain nanomaterials, a poisons-service contact, and the responsible person. The portal currently shows no fee.
The responsible person is normally the GB importer where the product is brought into GB from outside, unless a UK-based person is designated in writing. A UK PMU artist or studio importing a cosmetic PMU product directly from a non-GB supplier may find that they have become the responsible person by default, with the associated notification, labelling, and post-market surveillance duties.
Enforcement is real. The SCPN landing page states that failure to notify can lead to a fine and up to three months' imprisonment. The fine can be unlimited in England and Wales, or up to £5,000 in Scotland and Northern Ireland.
A practical compliance timeline for studios
The steps below anchor to the SI entry-into-force date (call this date "T"). The SI has not yet been made, so T is not yet fixed and no specific calendar dates can be given. The timeline is therefore expressed as offsets from T, which you convert to real dates once the SI is made and dated on legislation.gov.uk.
T (SI entry-into-force, once Defra makes the SI): restriction is law. Two-year clock starts on the placing ban; three-year clock starts on the use ban.
T + 6 months: identify every ink and PMU SKU in stock. Request UK REACH compliance statements against Appendix 13. Separate cosmetic PMU items from non-cosmetic tattoo inks.
T + 12 months: stop buying from suppliers that cannot produce UK-specific Appendix 13 evidence.
T + 18 months: rotate non-compliant or unclear stock out of procurement lists. Lock down batch traceability.
T + 24 months (placing-on-market ban): suppliers cannot lawfully place non-compliant ink on the GB market. Stock already on the market remains usable in studios until the use-ban date.
T + 36 months (use ban): artists cannot lawfully use non-compliant ink in a tattoo procedure, regardless of when the stock was acquired.
UK-facing supplier ranges that are clearly labelled as REACH-compliant from early 2026 include Dynamic, World Famous, and Eternal lines, according to Killer Ink's January 2026 guidance. Compliant inks from UK suppliers reportedly carry a 10 to 25 per cent premium over pre-restriction stock. See [[cost-of-starting-out-uk]] and [[supplier-audit-framework]].
Northern Ireland is its own conversation
The Windsor Framework keeps NI goods rules aligned with EU-facing rules in several areas, including the EU REACH tattoo-ink restriction under EU 2020/2081 (in force since 4 January 2022, with Pigment Blue 15:3 and Green 7 restricted from 4 January 2023).
The UK REACH restriction in this guide applies to Great Britain. NI continues to apply EU REACH for tattoo inks.
Detailed dual-compliance guidance for studios operating across the GB/NI border (for example mobile artists, conventions, and wholesale suppliers) is not yet published by Defra or HSE as at May 2026, so the practical detail below is the general framework rather than official border-specific guidance.
The general framework: a GB supplier selling into NI must meet EU REACH for the NI portion of stock; a NI supplier selling into GB must meet UK REACH for the GB portion. Larger UK wholesalers operate dual-regime documentation. Smaller studios that cross the border occasionally should ask suppliers explicitly which regime their compliance documentation covers.
Common misconceptions
"Every tattoo ink must be notified on CPNP." Tattoo ink is generally not a cosmetic product. CPNP applies to cosmetics. PMU classification is the place this question actually bites.
"EU REACH compliance is the same as UK REACH compliance." UK REACH chose stricter limits than EU REACH (RO3 over RO2a) and rejected the 19-pigment derogations the Agency had recommended. An EU 2020/2081 compliance statement does not prove UK compliance.
"Pigment Blue 15:3 and Pigment Green 7 are derogated for a few more years in GB." They were recommended for derogation by the Agency. The minister rejected that recommendation in the 30 December 2025 decision. Both pigments are fully restricted under UK REACH at the 0.1% limit in Appendix 13.
"The 2-year transition means studios cannot use anything after year 2." The 2-year clock is for placing on the market (the supplier ban). The use ban is at 3 years. Artists can use lawfully-placed stock through to the year-3 cutoff.
"There is no enforcement risk for studios using non-notified cosmetic PMU products." OPSS publishes that non-notification of a cosmetic product is a criminal offence. The risk is real even if rarely enforced against individual studios.
"NI and GB follow the same notification route." They do not. Windsor Framework keeps NI cosmetic and goods rules largely EU-aligned. NI artists work under EU 2020/2081 for tattoo inks and EU CPNP rules for cosmetics.
Open questions
A few points are not yet settled in public sources as at May 2026, because the SI has not been made:
- SI number and title. The amending SI for the Annex 17 tattoo-ink entry is not yet on legislation.gov.uk, so there is no SI number or short title to cite yet.
- Entry-into-force date. The exact entry-into-force date is not yet fixed; the draft leaves the trigger dates blank because they depend on when the SI is made. Every transition clock runs from that date.
- Northern Ireland border detail. Detailed dual-compliance guidance for cross-border GB/NI operation is not yet published by Defra or HSE, so studios should ask suppliers directly which regime each compliance document covers.
- BS EN 17169:2020 status. There is no public evidence as at May 2026 that BS EN 17169:2020 has been elevated to a statutory benchmark under the Health and Care Act 2022 section 180 cosmetic procedures licensing scheme.
The verbatim Annex 17 entry text and Appendix 13 substance table ARE retrievable from the Defra draft amendment PDF on gov.uk, and are reproduced in phase-b-reach-citation-recheck.md and summarised above.
Sources
- GOV.UK, UK REACH restriction for tattoo inks and permanent make-up, 30 December 2025 decision page (decision report PDF + draft amendment PDF).
- GOV.UK, Submit cosmetic product notifications landing page.
- Cosmetic Products Enforcement Regulations 2013, legislation.gov.uk.
- Assimilated Regulation (EC) No 1223/2009 on cosmetic products.
- UK REACH Regulation (EC) No 1907/2006, as retained in domestic law.
- HSE Annex 15 restriction dossier and Agency Final Opinion.
- GB CLP (assimilated Regulation (EC) No 1272/2008) and the GB mandatory classification and labelling list.
- Medical Devices Regulations 2002 (SI 2002/618).
- Killer Ink, REACH compliance guidance (January 2026).
Information, not legal advice. Always verify product classification, REACH compliance evidence and CPNP notification status directly with the supplier and, where uncertain, with OPSS and Defra, before placing or selling stock.