- Regulation (EC) No 1907/2006 — REACH, entry 75 of Annex XVII
- Regulation (EC) No 1272/2008 — CLP
Who has to appoint one
Manufacturers and sellers outside the Union placing tattoo or permanent make-up inks on the EU market.
Thresholds and exemptions
None. The REACH restriction applies to any quantity placed on the market.
What must appear on the label
'Mixture for use in tattoos or permanent make-up', the reference number of the mixture, the full list of ingredients, batch number, and the supplier's EU contact details.
Marketplace fields
Marketplaces suppress inks that do not show the mandatory statement and ingredient list.
Documentation you must hold
Compositional analysis against the concentration limits of entry 75, safety data sheet, and poison centre notification with a UFI.
Standards and testing
Analytical testing for restricted substances including specific pigments, aromatic amines and heavy metals.
Language requirements
The mandatory statements and ingredient list in the language of each member state of sale.
When it applies
The restriction has applied since 4 January 2022.
How long records are kept
10 years.
What happens if you do not comply
Withdrawal and fines. Several member states run coordinated sweeps of this category.
Who enforces it
National chemicals and consumer product authorities.
Where the boundary lies
Pigments Blue 15:3 and Green 7 remain among the most contested substances in this restriction, and product claims that an ink is 'EU compliant' need analytical evidence behind them.
Questions we are asked
- Is a supplier declaration enough?
- No. You need analysis against the limits, because enforcement tests the ink itself.
Who signs for you
EU representative Europe Services, SE — Na Čečeličce 425/4, Smíchov, 150 00 Praha 5, Czech Republic
UK representative REP27 LTD — Unit 82a James Carter Road, Mildenhall, Suffolk IP28 7DE, United Kingdom