Nickel Release: Definition of ‘Prolonged Contact with the Skin’ and Enlargement of the Article Spectrum The European Chemicals Agency (ECHA) has published a definition of ‘prolonged contact with the skin’ for the requirement of nickel release in articles. This definition clarifies the requirements about nickel release according to REACH Annex XVII but also enlarged the spectrum of affected articles. Background Nickel is a well-known contact allergen and is used in several metal alloys. The nickel release is regulated under Annex XVII in the REACH regulation in Europe. Entry 27 postulates the restriction of nickel if the rate of nickel release in articles intended to come into direct and prolonged contact with the skin is greater than 0,5 μg/cm²/week. According to the regulation, examples of these articles are earrings, necklaces, bracelets, watch straps, rivet buttons, zippers and metal marks, when these are used in garments. Due to unclear definition of ‘direct and prolonged contact with the skin’ misunderstandings about the applicability of nickel restriction have been occurred. Therefore the European Chemicals Agency (ECHA) has published a statement about the definition for ‘prolonged contact with the skin’. For the nickel release ‘prolonged contact with the skin’ is defined as contact with the skin of nickel of potentially more than: 10 minutes on three or more occasions within two weeks, or 30 minutes on one or more occasions within two weeks. This definition has consequences for articles which until now do not fall under the requirement for the nickel release. According to the definition more articles fall under this restriction like: Mobile telephones (a statement that mobile telephones fall under this requirement has been published by the EU previously) Small electrical devices like cameras, camcorders, MP3 players and tablets Household appliances like hairdryers and vacuum cleaners Binoculars Personal care and home goods like manicure and pedicure sets, scissors, hairdryers Writing utensils (according to different entries in RAPEX) Tools Further information Statement of the ECHA : http://echa.europa.eu/documents/10162/13641/nickel_restriction_prolonged_contact_skin_en.pdf Bureau Veritas Solutions and Services Bureau Veritas offers a wide range of chemical management solutions to help you overcome the challenges of complying with the REACH Regulation. To find out how we can assist you in meeting REACH requirements as related to your business, visit: www.bureauveritas.de/cps, www.bureauveritas.co.uk/cps , www.bureauveritas.fr/cps, or email: [email protected] Bureau Veritas Consumer Products Services, Inc. (“BVCPS”) provides the information in this client bulletin as a resource of general information. It does not replace any applicable legal or regulatory requirements and is provided “as is.” BVCPS will not be liable for any indirect, special, punitive, consequential or other damages (including without limitation lost profits) of any kind in connection with this client bulletin. BVCPS DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, IN CONNECTION WITH THIS CLIENT BULLETIN. Copyright © 2014 Bureau Veritas Consumer Product Services, Inc. All Rights Reserved. Bureau Veritas Consumer Products Services • December 2014, 14B-044 www.bureauveritas.de /cps
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