Restriction on articles containing Nickel - ECHA draft guideline open for comments

Following a request of the European Commission, a draft guideline has been prepared by ECHA providing non-exhaustive lists of articles and subtypes of articles falling within the scope of the restriction entry. The restriction entry restricts the use of nickel  and nickel compounds in articles intended to come into direct and prolonged contact with the skin if the rate of nickel release from the parts of these articles is greater than 0,5 µg Ni/cm²/week. The Member States have agreed on the scientific based interpretation of the “prolonged contact with the skin” and with the guideline the aim is to give practical examples of articles and parts of articles that are covered by or are out of the scope of the restriction entry. This guideline is based on information received during a survey conducted from February to April 2015, the case reports in open literature and other scientific literature. However, due to lack of information on precise contact times of articles, the guideline uses reasonable assumptions as a basis for division of articles falling and not falling under the scope of the restriction. 

The objective of this call for comments is to: 

1. Gather any available information that would contribute to further exemplify and clarify which articles or parts of articles fall under the scope of the restriction, when using interpretation of prolonged contact with the skin. This should help to further develop the existing list of examples of articles and parts of articles that have not been considered so far in the analysis (in particular, reflecting “borderline” cases).
2. Request feedback on the guidance document and, in particular, whether there are any omissions in the document that would be helpful to cover.

The guideline, after consideration by the Member State Competent Authorities, is envisaged to be published on ECHA’s website to serve as a tool that will provide the stakeholders and enforcement authorities with essential guidance on the scope of this restriction.

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