EU Updates Reference of Nickel Release Standard EN 1811 for Compliance with Entry 27 of Annex XVII to REACH Regulation
On 20 December 2023, the European Commission published Communication C/2023/1604 on the latest references of standards for nickel release testing under Entry 27 of Annex XVII to EU REACH Regulation (EC) No 1907/2006.
The reference of standard (harmonised standard) for the 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, has been updated from EN 1811:2011+A1:2015 to EN 1811:2023.
Compared to its 2015 version, the standard EN 1811:2023 has the following important updates:
- Clarified that the nickel release result of each sample has to be compliant with the migration limit when more than one sample of the same article is tested (Clause 9.2.2.1)
- Clarified that both test methods should be applied (EN 1811 without and with EN 12472) when uncertainty exists about the presence of nickel in the outer coating (Annex B.3);
For more details on updates in the standard EN 1811:2023, please further refer to Intertek Insight:
https://www.intertek.com.cn/eninfo_itemid_1645716624709259264_lcid_40.html
With immediate effect (from 20 December 2023), the list of nickel release test methods for demonstrating conformity with Entry 27 of Annex XVII to REACH shall become as follows:
| Harmonised Standards for EU REACH Annex XVII Entry 27 Nickel Release |
EN 1811:2023
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 12472:2020
Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items |
EN 16128:2015
Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release |
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