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Amendment to Nickel Release Standard Published - EN 1811:2011 + A1:2015

An amendment to EN 1811:2011 has been published. This amendment clarifies the compliance/non-compliance criteria for release of nickel from jewellery and other metal components, which may be in direct and prolonged contact with the skin. The new criteria will make it easier to assess product for compliance with the REACH Annex XVII requirements for nickel release.

The standard EN 1811:2011 introduced a ‘measurement of uncertainty’ into the test procedure for metal items in contact with the skin. It specified three categories of results; “compliant, non compliant and no decision”. The ‘no decision’ for results which were situated around the 0.50 μg/cm2/week compliance requirement of the Directive created a level of ambiguity for results in the ‘no decision’ range. A similar problem was faced for post assemblies around the 0.28 μg/cm2/week.

The new amendment simplifies the requirement for compliance by removing the ‘No decision” category and provides a ‘PASS’ compliance level of 0.88μg/cm2/week for articles intended to come into prolonged and direct contact with the skin, and 0.35μg/cm2/week for post assemblies.

The Table below summarises the change resulting from this amendment to the standard

  Post assemblies and body piercings Other Components in direct and prolonged contact with the skin
Result (μg/cm2/wk)

Under 0.11

0.11 to 0.35 Over 0.35 Under 0.28 0.28 to 0.88 Over 0.88
Old Criteria

Pass

No Decision Fail Pass No Decision Fail
New Criteria Pass Fail Pass Fail

In this situation, it clarified the acceptance criteria that compliance limit for post assemblies and other components in direct and prolonged contact with skin are 0.35 μg/cm2/wk and 0.88 μg/cm2/wk respectively, taking account of measurement of uncertainty and adopted the upper threshold, with the REACH requirements unchanged. That means it would be easier to assess the compliance of the product to REACH regulations.

Note: The “post” is the part of an earring [or other piercing jewellery] which penetrates into the skin

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