United Kingdom has implemented strict restrictions on substances in tattoo ink and permanent make-up products to protect human health, including concentration limits for hazardous chemicals and mandatory labelling for allergens.
UK Sets Strict Limits on Hazardous Chemicals in Tattoo Ink
Importers must respect concentration caps for toxic substances and label allergens.
What changed
Concentration limits apply to carcinogens, mutagens and reproductive toxicants (categories 1A, 1B, 2).
Mandatory labelling required for mixtures containing nickel, chromium (VI) and pH regulators.
Scope limited to HS code 321590, covering inks for tattooing and permanent make-up (excluding printing ink).
Who it affects
Importers of tattoo ink must ensure products meet new concentration limits and carry correct labels.
Manufacturers of permanent make-up must verify formulations against restricted substance lists.
Regulation Analysis: Restrictions on Substances in Tattoo Ink and Permanent Make-Up Products in the UK
The UK has implemented strict controls on hazardous substances in tattoo inks and permanent make-up products under Entry 75 of Annex 17 to UK REACH (as amended by the REACH (Amendment) (No. 3) Regulations 2026). These restrictions include concentration limits for specific hazardous chemicals, mandatory labelling requirements, and phased transition periods for compliance. Below is a structured summary of the key obligations, exemptions, and timelines.
1. Substance Restrictions and Concentration Limits
Tattoo inks containing substances listed below must not be placed on the market or used if they exceed the specified concentration limits by weight. The applicable limits depend on the substance’s classification or listing in regulatory annexes:
| Substance Category | Concentration Limit | Source |
|---|---|---|
| Carcinogens (Cat. 1A, 1B, 2), Germ Cell Mutagens (Cat. 1A, 1B, 2) | 0.00005% (5 ppm) | 1,2 |
| Reproductive Toxicants (Cat. 1A, 1B, 2), Skin Sensitisers (Cat. 1, 1A, 1B) | 0.001% (10 ppm) | 1,2 |
| Skin Corrosives (Cat. 1, 1A, 1B, 1C) or Serious Eye Damage (Cat. 1) (non-pH regulator) | 0.01% (100 ppm) | 1,2 |
| Skin Corrosives (Cat. 1, 1A, 1B, 1C) or Serious Eye Damage (Cat. 1) (pH regulator only) | 0.1% (1,000 ppm) | 1,2 |
| Substances listed in Appendix 13 to Annex 17 of UK REACH | Limit specified in Appendix 13 (e.g., chromium (VI): 0.2 ppm) | 2,1 |
| Substances in Annex 2 or Annex 4 of the Cosmetic Products Regulation (EC 1223/2009) | Limits in column h (maximum concentration) or conditions in column i of Annex 4 apply | 1,2 |
Key Notes:
- If a substance falls under multiple categories, the lowest concentration limit applies1.
- If a substance is listed in Appendix 13, the Appendix 13 limit overrides other category limits1.
- Substances classified for inhalation-only hazards or gases/vapours (except formaldehyde) are exempt1.
2. Labelling Requirements
Suppliers must ensure tattoo ink packaging is marked with the following information, which must be clearly visible, legible, and indelible2,1:
- The statement: "Mixture for use in tattoos or permanent make-up"2,1.
- A batch reference number to uniquely identify the product2,1.
- A list of ingredients in the mixture (excluding impurities)2,1.
- Allergen warnings (e.g., "Contains chromium (VI). Can cause allergic reactions.") if applicable1.
- Safety instructions (e.g., storage conditions, expiration dates, "use by" dates) if necessary for safe use1.
- Other information required under Regulation (EC) No 1272/2008 (CLP Regulation)1.
Exceptions for Small Packaging:
- If the packaging is too small to include all required information (except the statement in point 1), the details must be provided in accompanying instructions for use2,1.
3. User Obligations
Before using compliant tattoo ink, the tattoo artist (user) must provide the person undergoing the procedure with all labelling information required under paragraphs 5 and 6 of Entry 752,1.
4. Exemptions
The restrictions do not apply to:
- Substances classified for inhalation-only hazards under the GB mandatory classification and labelling list1.
- Substances that are gases at 20°C and 101.3 kPa or generate a vapour pressure >300 kPa at 50°C, except formaldehyde (CAS 50-00-0)1.
- Tattoo inks exclusively placed on the market or used as a medical device or accessory under the Medical Devices Regulations 2002 (S.I. 2002/618). If the ink is not exclusively for medical use, both medical device and UK REACH requirements apply cumulatively1.
5. Transition Periods
The restrictions are phased in as follows:
| Requirement | Applies From | Source |
|---|---|---|
| Labelling requirements (paragraphs 5–6) and prohibition on placing non-compliant inks on the market (paragraph 1) | 2 years after entry into force of the Regulations2,1 | |
| Prohibition on using non-compliant inks (paragraphs 2, 7–8) | 3 years after entry into force of the Regulations2,1 |
Note: The entry into force date is specified in the REACH (Amendment) (No. 3) Regulations 2026 (not provided in the sources)2.
6. Definitions
Key terms under Entry 75 include:
- "Tattoo ink": A mixture for intentional insertion into the skin, mucous membrane, or eyeball to create a tattoo or permanent make-up (including micro-blading, micro-pigmentation, and semi-permanent make-up)1.
- "Batch": A specific quantity of tattoo ink produced during a defined manufacturing cycle, expected to be of uniform character1.
- "Ingredient": Any substance added during formulation and present in the ink (excluding impurities)1.
- "pH regulator": A substance altering the pH of the mixture1.
Summary Answer
The UK regulates hazardous substances in tattoo inks and permanent make-up products under Entry 75 of Annex 17 to UK REACH, as amended by the REACH (Amendment) (No. 3) Regulations 2026. Key requirements include:
- Concentration limits for carcinogens, mutagens, reproductive toxicants, skin sensitisers, corrosives, and eye-damaging substances, with the lowest applicable limit taking precedence2,1.
- Mandatory labelling of ingredients, allergen warnings, batch numbers, and safety instructions, with exemptions for small packaging2,1.
- User obligations to provide labelling information to clients before procedures2,1.
- Exemptions for inhalation-only hazards, gases/vapours (except formaldehyde), and medical devices1.
- Transition periods: 2 years for labelling and market placement restrictions, and 3 years for usage prohibitions2,1.
All stakeholders (suppliers, formulators, and tattoo artists) must comply with these rules to avoid penalties under UK REACH. For medical device exclusions, compliance with the Medical Devices Regulations 2002 is also required1.
Sources
- ↩ WTO TBT notification 26-01788 — United Kingdom https://members.wto.org/crnattachments/2026/TBT/GBR/26_01788_00_e.pdf
- ↩ WTO TBT notification 26-03461 — United Kingdom https://members.wto.org/crnattachments/2026/TBT/GBR/26_03461_00_e.pdf