PI-WIKI-REG-16 · Regulatory · reviewed 2026-10-26
EU REACH Compliance for Body Art: SVHC, Annex XIV & XVII
Critical numbers
RegulationEC 1907/2006 (REACH) [1]
AuthorityEuropean Chemicals Agency (ECHA)
SVHC Threshold0.1% w/w
Article 33 Response45 days max
SCIP Trigger Date5 January 2021
Annex XVII Entry 75Tattoo inks, in force 4 Jan 2022
Annex XVII Entry 27Nickel release, 0.5 / 0.2 µg/cm²/week
Candidate List Updates~6 months (Jan & Jun)
Test Method (Nickel)EN 1811 [7]
BioFlex® PositionNo SVHC > 1 ppm; nickel-free by construction
Entry 75 Second WavePigment Blue 15:3 and Pigment Green 7 banned from 4 January 2023 [3]
Entry 75 Aromatic Amines0,0005 % (5 mg/kg) [3]
Do not
- No monitoring record
- Stale SDS
- Candidate vs Restriction confusion
- Article 33 silence
- Tattoo ink without Entry 75 statement
- Imported jewelry without SCIP confirmation
Applicable standards
- EU REACH (1907/2006) — Substances and articles
- EU Cosmetics (1223/2009) — Aftercare products
- EU MDR (2017/745) — Sterile invasive devices