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PUBLICATION OF TITLES AND REFERENCES OF HARMONISED STANDARDS UNDER ENTRY 27 OF ANNEX XVII OF REACH

2016-02-23 72

Background

In 1994 the EU adopted 94/27 / EC of nickel release directives ,  The 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/cm 2 /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 0,5 μg/cm 2 /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/cm 2 /week for a period of at least two years of normal use of the article.


Main Requirement

On 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. 

Reference and title of the standard

Reference of superseded standard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The new standard EN 16128:2011 takes over from the superseded standard the same test methods for demonstrating conformity with the conditions of the restriction under entry 27 in Annex XVII of REACH until a new standard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 will be developed


RAPEX Notification 

In 2015, 22 products has been notified because of  nickel release in RAPEX, 86.4%of the notified products are origining from China,The product releases nickel up to 113 g/cm/week.Products intended to 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, components, ensure that products meet the requirements of nickel release control, Reduce the risk of the product being punished.