Skip to Menu Skip to Search Contact Us Skip to Content

SAFEGUARDS | Consumer Products NO. 155/15

2 girls wearing jewelry

The European Committee for Standardization (CEN) has recently published the standard ‘EN 1811:2011+A1:2015’ for nickel release. The amendment provides important changes to conformity assessment procedures.

In 2011, the European Standard EN 1811:2011 ‘Reference test method for release of nickel from all post assemblies which are inserted into pierce parts of the human body and articles intended to come into direct and prolonged contact with the skin’ was published by the Comité Europeén de Normalisation (CEN, European Committee for Standardisation). This standard was harmonised [1] in 2012 by the EU Commission for presumption of conformity with nickel release in entry 27 under ANNEX XVII of REACH and has been effective since March 2013.

On 20 July 2015, the CEN approved Amendment 1 to the standard for nickel release. This standard, EN 1811:2011+A1:2015, is now available on a commercial basis at the national standards organizations such as the British Standards Institute (BSI). [2]

The new standard EN 1811:2011+A1:2015 also applies the combined measurement uncertainty of 46% into consideration for conformity assessment but has a number of important changes, including

  • Eliminating measured migration values in the ‘inconclusive’ category
  • ŸA non-body piercing article that is obliged to meet the migration limit of 0.5 μg/cm²/week is deemed to be compliant if the measured migration value is less than 0.88 μg/cm²/week
  • ŸA body piercing article that is obliged to meet the migration limit of 0.2 μg/cm²/week is deemed to be compliant if the measured migration value is less than 0.35 μg/cm²/week

The above changes have in effect translated the measured migration values in the ‘inconclusive’ category under EN 1811:2011 A/C:2012 to a ‘Pass’ or ‘Compliant’ in the new standard.

According to the European Standard EN 1811:2011+A1:2015, conflicting standards shall be withdrawn by January 2016 at the latest.

Highlights of the new standard, including a comparison with the existing standard method ‘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

Title

Reference 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

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 μg/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 under ANNEX XVII of REACH)

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

Remark

Conflicting national standards to be withdrawn by January 2016

In force

Throughout our global network of laboratories, we are able to provide a range of services, including analytical testing and consultancy, for nickel and other restricted substances in consumer products for the European and international markets. Please do not hesitate to contact us for further information.

For enquiries, please contact:

Hing Wo Tsang
Global Toys and Juvenile Products
t: +852 2774 7420

© SGS Group Management SA – 2015– All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.