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SAFEGUARDS | Consumer Products NO. 022/16

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The EU has recently updated the list of standards for demonstrating compliance with nickel release under ANNEX XVII of REACH. This revised list contains three European standards, including amendment 1 to EN 1811, and takes effect immediately.

In September 2015, we informed you [1] that the Comité Europeén de Normalisation (CEN, European Committee for Standardization) published EN 1811:2011+A1:2015 as a test standard for nickel release. This standard has a number of important changes, including

  • Eliminating measured migration values in the 'inconclusive' category
  • Translating the measured migration values in the 'inconclusive' category under EN 1811:2011 A/C:2012 to a 'Pass' or 'Compliant'

According to EN 1811:2011+A1:2015, conflicting national standards are to be withdrawn by January 2016 at the very latest.

On 15 January 2016, Commission Communication 2016/C 014/04 [2] was published in the Official Journal of the EU (OJEU) harmonizing the list of standards for demonstrating presumption of conformity with nickel release under entry 27 of ANNEX XVII of REACH [3]. This revised list contains the following three harmonized standards:

  • EN 1811:2011+A1:2015 'Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin'
  • EN 12472:2005+A1:2009 'Method for the simulation of wear and corrosion for the detection of nickel release from coated items'
  • EN 16128:2011 'Reference test method for release of nickel from those parts of spectacle frames and sunglasses intended to come into close and prolonged contact with the skin'

EN 16128:2011 [4] is technically unchanged as compared to EN 1811:1998+A1:2008 and has been harmonised for demonstrating presumption of conformity with nickel release since May 2012. The substantially revised standard, EN 16128:2015 [5], is anticipated to become a harmonised standard for presumption of conformity with nickel release by November 2018.

These harmonised standards are European standards developed by a recognised European Standards Organisation following a request from the European Commission. Manufacturers, other economic operators, or conformity assessment bodies can use these harmonised standards to demonstrate that affected products comply with nickel release under Annex XVII of REACH.

Commission Communication 2016/C 014/04 does not indicate an effective date but can be considered as immediate; 15 January 2016.

Highlights of the result interpretation for EN 1811:2011+A1:2015 and the superseded standard, EN 1811:2011 A/C:2012 are summarized in Table 1.

Table 1



Standard Method

EN 1811:2011+A1:2015

EN 1811:2011 A/C:2012

Result interpretation

(consideration of 46% uncertainty)

0.5 μg/cm²/week limit (non-body piercing)

Compliant

< 0.88 μg/cm²/week

Non-compliant

≥ 0.88 mg/cm²/week

0.5 μg/cm²/week limit (non-body piercing)

Compliant

≤ 0.28 μg/cm²/week

Inconclusive

> 0.28 but < 0.88 μg/cm²/week

Non-compliant

≥ 0.88 μg/cm²/week



< 0.2 μg/cm²/week limit (body piercing)

Compliant

< 0.35 μg/cm²/week

Non-compliant

≥ 0.35 μg/cm²/week

< 0.2 μg/cm²/week limit (body piercing)

Compliant

< 0.11 μg/cm²/week

Inconclusive

> 0.11 but < 0.35 μg/cm²/week

Non-compliant

≥ 0.35 μg/cm²/week

Requirement (Entry 27, ANNEX XVII of REACH)

  • ≤ 0.5 μg/cm²/week (non-body piercing)
  • Ÿ< 0.2 μg/cm²/week (body piercing)

Effective date for harmonisation

15 January, 2016

Withdrawn

SGS will follow up and inform interested parties as developments on REACH regulation occur. Our expertise combined with consultancy services and experience in consumer product supply chains provides a central point of contact for global solutions. If you would like to learn more about how SGS can support your REACH compliance activities please visit www.sgs.com/reach.

For enquiries, please contact:

Hing Wo Tsang
Global Hardlines
t: +852 2774 7420

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