Overview
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.
Related Pages
- Risk of sensitisation of humans to nickel by piercing post assemblies
- Nickel
- EN 1811 Nickel Release Testing
References
Works cited in this page’s text, in first-appearance order. This is not the full corpus for this page; it is only what the prose above draws on. The complete set of sources is listed under Sources below. Each title links to its source record, which carries the ingest receipt, the extracted values, and the file hash of the document it was built from.
Update history
The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git. When DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.
| Commit | Date | Change | Description |
|---|---|---|---|
| a8052bb | 2026-08-09 | major | 1 source added; contamination-profile values revised; 7 sections added |