EU REACH – Amended Nickel Release Standard Published in List of Harmonised Standards – EN 1811:2011 + A1: 2015
The amended nickel standard EN 1811:2011 + A1:2015 has been adopted in the list of harmonised standards published on 15 January 2016 in the EU official journal.
This means that the amended standard is to be used to demonstrate compliance with the REACH requirement in Annex XVII for nickel release from jewellery and other metal components that may be in direct and prolonged contact with the skin, as the standard clarifies the compliance/non-compliance criteria.
The new criteria will make it easier to assess product for compliance with the REACH Annex XVII requirements for nickel release. Similarly, the methods EN 12472:2005+A1:2009 and EN 16128:2011 are adopted as the recognised test methods.
A link to the publication in the Official Journal is below:
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2016.014.01.0110.01.ENG&toc=OJ:C:2016:014:TOC
The original 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 that were situated around the 0.05 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 to 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
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Other components in direct and prolonged contact with the skin
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|
Result (μg/cm2/wk)
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Under 0.11
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0.11 to 0.35
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Over 0.35
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Under 0.28
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0.28 to 0.88
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Over 0.88
|
|
Old Criteria
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Pass
|
No Decision
|
Fail
|
Pass
|
No Decision
|
Fail
|
|
New Criteria
|
Pass
|
Fail
|
Pass
|
Fail
|
The standard, EN 1811:2011 + A1:2015, provides a much simpler results reporting process of results for suppliers, manufacturers and retailers testing to the nickel release standard. Laboratories will be able to provide results which that will be reported as either ‘compliant’ or ‘non compliant’ or ‘PASS’ and ‘FAIL.’.
The publication in the Official Journal means that the amended standard is to be used to demonstrate compliance with the REACH requirement in Annex XVII for nickel release from jewellery and other metal components which may be in direct and prolonged contact with the skin.
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