Background

In 1994 the EU adopted directive 94/27/EC on nickel release, This directive has been replaced, 27 of Annex XVII of REACH shall not be used:

(a) in any post assemblies which are inserted into pierced ears and other pierced parts of the human body unless the rate of nickel release is less than 0,2μg/cm2 /week

(b) 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 coming into direct and prolonged contact with the skin is greater than 0,5μg/cm² /week.

(c) in articles referred to in point (b) where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release not exceed 0,5μg/cm² /week for a period of at least two years of normal use of the article.

In January 15, 2016, the Official Journal of the European Union (OJ) Post 2016 / C 014/04, Publication of titles and references of harmonised standards under entry 27 of Annex XVII of REACH.

Current standard	Superseded standard
EN 1811:2011+A1:2015   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 1811:2011
EN 12472:2005+A1:2009   Method for the simulation of wear and corrosion for the detection of nickel release from coated items	EN 12472:2005
EN 16128:2011   Reference test method for release of nickel from those parts of spectacle frames and sunglasses intended to come into close and prolonged contact with the skin	EN 1811:1998+A1:2008
The new standard EN 16128:2011 takes over from the superseded standard using the same test methods for demonstrating conformity with the conditions of the restriction under entry 27 in Annex XVII of REACH until a new standard for spectacle frames and sunglasses is developed.

RAPEX Notification

In 2015, 22 products have been notified because of nickel release in RAPEX, 86.4%of the notified products originated in China, where some product releases nickel at up to 11μg/cm²/week. Products intended for direct and prolonged contact with the skin are high-risk. Electrical and electronic products need to focus on metal signs or shells.

CTI Suggestion

In recent years the notification of nickel release is increasing, Companies should pay attention to high-risk products, and thier components thus ensuring that product meet the requirements of nickel release, and therefore reducing the risk of the product being recalled.