PI-WIKI-NI-15 · Materials Science · reviewed 2026-10-27
Nickel Allergy & Sensitization
Critical numbers
EU Nickel Release Limit (post)<0.2 μg/cm²/week (EN 1811:2023) [1]
EU Nickel Release Limit (skin)<0.5 μg/cm²/week (EN 1811:2023) [1]
Population Sensitization RateMedian about 9% of adults (range 1–28%); far higher in women
Sensitization RiskDepends on dose, duration and occlusion; fresh piercings are high risk
Elicitation Dose (sensitised, patch test)About 0.8 μg/cm² reacts in 1 in 10 nickel-allergic people
Titanium Grade 23 Nickel Content<0.05% (effectively nickel-free)
BioFlex® Nickel ContentNone (polymer, contains no metal)
REACH RegulationAnnex XVII Entry 27, current wording set by Regulation (EC) 552/2009 [2]
Reference Test MethodEN 1811:2023, harmonised 20 Dec 2023 (OJ C/2023/1604), supersedes EN 1811:2011+A1:2015 [11]
Coating Durability RequirementLimit must hold for at least 2 years of normal use; wear simulated by EN 12472 [2]
Patch Test Reading Times48 h (patch removal) and 72–96 h (the reading that separates allergic from irritant)
Piercing / Nickel Allergy AssociationOR 5.9 (95% CI 3.6–9.4) in the general population, 2025 meta-analysis [5]
Do not
- Calling it an infection and reaching for antibiotics
- Trusting the phrase "surgical steel"
- Assuming a coating makes a piece safe
- Leaving the channel empty after removing the jewelry
- Re-piercing a sensitised client with the same alloy family
- Not recording nickel status anywhere durable
Applicable standards
- European Union / EEA — REACH (EC) 1907/2006, Annex XVII entry 27
- United Kingdom — UK REACH since 1 January 2021
- United States — No federal nickel release limit for jewelry or body jewelry