CEN has published the latest qualitative method for detecting the presence of nickel in articles. This standard can be considered as effective immediately.
In February 2022, the European Committee for Standardization (Comité Européen de Normalisation, CEN) published CEN/TR 12471:2022 as a cost-effective qualitative method for detecting the presence of nickel in articles. This is a completely revised and restructured edition of CR 12471:2002 ‘Screening tests for nickel release from alloys and coatings in items that come into direct and prolonged contact with the skin.’
This latest screening method is based on the formation of a red colored metal complex when nickel ions react with dimethylglyoxime in the presence of ammonia. It contains a pretreatment step where artificial sweat and heat are used to induce corrosion of the surface to increase the sensitivity of the test, and a detailed procedure for confirmation of the presence of nickel using dithiooxamide.
CEN/TR 12471:2022 contains several important points:
- Clarifies that the reference method for nickel release is EN 1811 (or EN 16128 for spectacle frames and sunglasses)
- Emphasizes that a quantitative test using EN 1811, or EN 12472 followed by EN 1811, can be carried out to verify compliance with entry 27 to Annex XVII of Regulation (EC) 1907/2006 (REACH,SafeGuardS 57/21 and references therein)
- Advises that a positive result in the screening test may not be compliant with the respective nickel release limits falling under entry 27 to Annex XVII of REACH
Highlights of test result interpretations from the new screening test standard are summarized in Table 1.
CEN/TR 12471:2022 ‘Screening for the presence of nickel in articles which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin’ | ||
|---|---|---|
| Test Method | Result | |
| Dimethylglyoxime | Dithiooxamide | |
| Light pink to strong cerise red | Black-violet | Positive for nickel1 |
| Pink to cerise red | Not black-violet | Uncertain2 |
| Another color | No testing required | Uncertain2 |
| To change in color | No testing required | Negative |
| 1Positive results are considered as confirmed when a second test on a different area of the test surface indicates a positive result. If the repetition is negative, the result is considered as ‘uncertain’ 2Testing using EN 1811 is recommended for samples with ‘uncertain’ results | ||
Table 1
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