uni en 1811:2011 standard on nickel release - legor · pdf filenickel release •nickel in...
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UNI EN 1811:2011 standard on nickel release
Andrea Friso, Master Alloy Division
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REACH Regulation 1907/2006
(point 27, Annex XVII)
Nickel is one of the substances recognised asbeing harmful to human health.
Its use has therefore been subject to precise restrictions.
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Nickel release
• Nickel in contact with skin can generate allergies, skin rashes e dermatites
• UNI EN 1811 born in 1998 for EuropeanUnion (27 UE member states)
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Nickel release
UNI EN 1811 first born in 1998…
Applied throughout all EuropeanUnion (27 UE member states)
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EN1811:2011, a reference standard
«A method for simulating the release of nickel from all items inserted into pierced parts of
the ear or other parts of the human body and from objects designed to come into direct and
prolonged contact with the skin.»
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Relevant points
• Applicable on precious and non-preciousmetals
• Defines the maximum amount of nickel released after reaction on skin
• Does not prohibit nickel in alloys!!
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Relevant points
…Why not prohibiting nickel completely??
…In other sectors Ni-based alloys are extremely important!
- Steel watches
- Eyewear
- Fashion materials…
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Enforced in EU on April 1°, 2013
Correction factor eliminated: tests are now 10 times stricter!!
Uncertainty factor of 46% introduced
Artificial sweat solution modified, slightly more aggressive
EN1811:2011: what has changed
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EN1811:2011 artificial sweat corrosion test
Cleaning and degreasing
Maintain for 168 h (7 days) in a solution of artificial
sweat at 30°C
Analyzing via ICP the quantity of nickel dissolved in the solution
(i.e.: released from the jewel)
Non-coated items
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If the object is coated:
Release value must not exceed 0.5µg/cm²/week for a period of 2 years of normal use of the
object before it is placed on the market
The method for simulating 2 years of normalwear is defined by the EN12472:2009 standard
Coated items
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EN12472:2009 before EN1811:2011
Cleaning and degreasing
Corrosion treatment50C, 2h
Wearing treatment 30 rpm, 5h
Woods and abrasive pastes
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EN12472:2009 – The wearing test machine
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EN12472:2009 – The wearing test machine
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REACH point 27 annex XVIINickel and related compounds
Items designed to come intodirect and prolonged contact
with the skin(0.5µg/cm²/week)
Uncoated
Wearing testEN12472:2009
Ni release testEN1811:2011
Coated
Items inserted into piercedparts of the ear
(0.2µg/cm²/week)
Uncoated Coated
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Ni release valueLimit according
to newEN1811:2011
Result
Effective limitaccording to
oldEN1811:2008
(µg/cm²/week) (µg/cm²/week) (Uncertainty of 46%) (µg/cm²/week)
<0,11 0,2 (for objectsinserted into
pierced parts ofthe body)
Compliant
0,11 ÷ 0,35 Non-conclusive0.05% in weight;
2.0 µg/cm²/week after
the 1st april 2005
>0,35 Non-compliant
<0,280,5
Compliant0,28 ÷ 0,88 Non-conclusive 5,0
>0,88 Non-compliant
Comparing EN1811:2011 e EN1811:2008
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Relevant points
• To be on the safe side do not exceed:
– 0.28 µg/cm²/week (non-pierced skin)
– 0.11 µg/cm²/week (pierced skin)
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Weak points
Doesn’t take into account individualsthat are sensitized to nickel
• After a first allergy rash, lessstimulus is needed to trigger it again
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Weak points
• Extended statistical uncertainty:
– Analysis method parameters
– Surface area measurement
– Kind of sample
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What changes now?
• It is prohibited to produce or to commercialize items that are non-compliant, in any of the 27 UE member States
• The sole responsible in front of the end customer is the jewelry manufacturing company
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SANCTIONS
Art. 16 – D. Lgs. September 14°, 2009, n. 133[Extract from italian regulation]
[…] punishment with arrest until threemonths or fine between 40.000 and150.000 euros.
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Consequences• Zero Ni release only on Ni-free alloys
• Ni release test becomes mandatory(just like fire assay!)
• Necessary to have a reliable statistic for each production process
• The risk of possible allergic reactions can never be totally excluded!