07/07/2015
From the Nickel Directive to the
REACH restriction
Workshop on the EU Nickel restriction.
Articles in direct and prolonged contact
with the skin”
25 June 2015
Enrique García John
Policy officer - Unit D1 - REACH
Directorate-General for Internal Market,
Industry, Entrepeneurship and SMEs
European Commission
Nickel-induced Contact Dermatitis
• Nickel metal is classified a Cat 1 Skin sensitiser
• Nickel was, and still is, the major cause of contact
dermatitis amongst EU population
• 10 – 20% of women are sensitised. 1-3% men. Large
variation amongst countries
• There is evidence that indicates that in some
countries (DK, SE, DE) the incidence, at least for some
age groups, has decreased
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Looking back – the first Directive
• Nickel in articles was first regulated in the EC in 1994
by EP and Council Directive 94/27/EC
– 12th amendment of Directive 76/769/EEC on restriction of the
marketing and use of certain dangerous substances and preparations
– Inspired by Danish measure of 1991 which restricted nickel
– Published on 22 July 2004
• The directive established limitations to the use of
nickel and its compounds in:
– post assemblies which are inserted into pierced ears or other pierced
parts of the human body (during epithelisation of wound). Material
must be homogeneous and Ni content (by mass) must be < 0,05%
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Looking back – the first Directive (II)
– in products intended to come into direct and prolonged contact with the
skin such as:
•
•
•
•
Earrings,
Necklaces, bracelets and chains, ancklets, finger rings
Wrist-watch cases, watch straps and tighteners
Rivet buttons, tighteners, rivets, zippers and metal marks, when these are
used in garments
– The rate of metal release from the parts of the products coming in direct
and prolonged contact with the skin must be < 0,5 µg/cm2/week.
– Products such as the above, with a non-nickel coating, are also
prohibited unless the coating proves to meet the nickel release limit for a
period of at least two years of normal use of the product.
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Looking back – the first Directive (III)
“Whereas the presence of nickel in certain objects coming into direct and
prolonged contact with the skin may cause sensitization of humans to nickel
and may lead to allergic reactions; whereas for these reasons the use of nickel
in such objects should be limited” (preamble of Dir. 94/27/EC)
• The migration limit of 0,5 µg/cm2/week was established based
on all available studies at the time, including study of Menne
(1987) of nickel alloys in nickel sensitive individuals
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Looking back – the first Directive (IV)
“The available data suggests that a release rate of 0.5 μg Ni/cm2/week is
sufficient to protect against sensitisation of non-sensitised individuals in a
substantial part of the population exposed to direct and prolonged contact
with nickel and nickel alloys"
"The available data suggests that whilst the release rate of 0.5 μg
Ni/cm2/week after direct and prolonged contact is sufficient to protect against
elicitation of an effect in a substantial part of the population, complete
protection for the most sensitive sensitised persons may only be achieved at
levels that could be an order of magnitude lower"
(RAR Nickel, Danish EPA, 2009)
Aim was to protect the majority, but not all, of those sensitized
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Review by Directive 2004/96/EC
– The Directive was reviewed in 2004. Published 28.09.2004
• Release limit of 0,2 µg/cm2/week adopted for post-assemblies. Content
limit was removed
• Based on targeted RA study performed on LGC report “Risks of
sensitisation of Humans to Nickel by piercing post-assemblies” (2003)
• Based on the recognition that it was an anomaly that piercing materials
made of high-grade stainless steels used in surgical implants (ISO 5823)
would not meet the content limit of 0,05%
• Appropriateness of migration limit ratified by CSTEE opinion of November
2003
• Recital 3 recognises “adjustment factor” of 0,1 applied on migration result
measured according to EN 1811:1998 to compensate inter-laboratory
variation and invites CEN to review standard so as to reduce this factor.
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Annex XVII to REACH
– The nickel restriction was taken up as entry 27 in Annex
XVII to the REACH regulation
– Annex XVII entered into force on 1 June 2009
– Annex XVII as amended by Regulation (EC) No 552/2009 of
22 June 2009 entered into force on 27.06.2009
– No changes with respect to the text of Directive
76/769/EEC except for change of term “products” to
“articles” in coherence with REACH nomenclature
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Test Methods
In 1993 the Commission mandated CEN to develop methods in
support of the restriction, which resulted in:
• EN 1810:1998 - Body piercing assemblies – referenced test method
for determination of nickel content by flame absorption spectrometry
• EN 1811:1998 - Reference test method for the release of nickel from
products intended to come into direct and prolonged contact with
the skin
• EN 12472:1998 - Method for the simulation of wear and corrosion
for the detection of nickel release from coated items. Modified in
2005 and 2009.
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Test Methods (II)
EN 1811:2011 replaced 1998 version. Revision of 2014 with
expected adoption in 2015
CR 12471 – “Screening tests for nickel release…”.
(Dimethylglyoxime method). August 2002. Not suitable for
determing compliance.
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 (identical to
EN 1811:1998)
Formal vote EN 16128:2015 begins on 11 June 2015
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Direct & prolonged contact (I)
The restriction has since 1994 has a “narrative” description of its scope, based
on “direct and prolonged contact with the skin” and exemplified by a nonexhaustive list of articles. (..such as)
http://echa.europa.eu/qa-display//qadisplay/5s1R/view/ids/663
COM already provided
a clarification following
reports related to
sensitisation due to
use of mobile phones.
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Direct & prolonged contact (II)
• Meaning of “prolonged” in the context of entry 27 was
discussed in CARACAL-6 in October 2010. In paper
CA/85/2010 the Commission proposed the following
definition:
• “the term prolonged should be understood as covering a
daily overall contact with the skin of more than 30 minutes
continuously or 1 hour discontinuously”
• The Member States requested further scientific basis to any
proposal for a definition
• The Commission requested ECHA, in February 2011 to
further assess ther matter and propose a definition
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Direct & prolonged contact (III)
•
ECHA proposed definition and associated report presented
to MSs and stakeholders in CARACAL-13 (November 2013)
•
ECHA considered all available information on rate of release
of Ni from alloys, on nickel take-up via the skin and on how
sensitised individuals react to different doses of nickel.
•
Comments received from MSs and NIPERA. Some requests
for further guidance and expanded list of articles covered.
•
Definition, in the form of a Q&A was endorsed by CARACAL14 in April 2014.
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Direct & prolonged contact (IV)
http://echa.europa.eu/qa-display/-/qadisplay/5s1R/view/reach/restrictions
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Nickel Guidelines project
•
COM requested ECHA to prepare guideline, with concrete
examples, to support implementation of Ni restriction, on
13 October 2014
•
Consultation of industry stakeholders and health care
providers, via questionnaires (survey Feb – April 2015)
•
Comments received from 12 industry stakeholders, 3 health
care institutions and from CEC German mirror- committee
for CEN/TC 347
•
ECHA currenty working in preparation of draft guideline
•
Further consultation expected to begin late August 2015
•
Potential endorsement by CARACAL in early 2016
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For further information please visit:
http://ec.europa.eu/growth/sectors/chemicals/reach
/index_en.htm
http://ec.europa.eu/environment/chemicals/index_e
n.htm
http://echa.europa.eu
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Disclaimer
All views expressed are purely personal and should not be considered as representative of the
European Commission’s official position. Neither the European Commission nor any person
acting on behalf of the Commission is responsible for the use which might be made of the
following information.
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