EU Nickel Directive 94/27/EC
This page records the Nickel Directive requirements as described in LGC 2003. It is a historical/source-grounded regulation page, not a current consolidated REACH legal-status page.
Requirements Preserved From Source
| Product category | Requirement described by LGC 2003 | Method / basis |
|---|---|---|
| Post assemblies inserted into pierced ears or other pierced body parts during epithelization | Homogeneous post assemblies with nickel concentration less than 0.05% by mass | Nickel content requirement; EN 1810 discussed as reference method. |
| Products intended to come into direct and prolonged contact with the skin | Nickel release must not be greater than 0.5 µg/cm2/week | EN 1811 artificial-sweat release method discussed as reference method. |
| Coated products intended for direct and prolonged skin contact | Coating must keep nickel release at or below 0.5 µg/cm2/week for at least two years of normal use | Release-rate requirement over coating service life. |
LGC 2003 Recommendation
The report recommends replacing the 0.05% m/m nickel-content requirement for piercing post assemblies with a migration limit:
| Recommended limit | Scope | Method |
|---|---|---|
| 0.2 µg/cm2/week | All post assemblies | EN 1811 |
The recommendation is grounded in two report findings: finished/polished stainless steel articles released very low nickel in the tested conditions, and where nickel release was measurable, urine and blood plasma released about twice as much nickel as artificial sweat. The authors therefore recommended a lower artificial-sweat EN 1811 limit for post assemblies than the 0.5 µg/cm2/week skin-contact-product limit.
Category 1 Boundary
This regulation page is relevant to nickel hazard, dermal sensitisation, and consumer-product contact materials. It is not a food contaminant limit and must not be used as a concentration benchmark for infant formula, baby foods, or other Category 1 food products.