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Restricted Substances Testing

Nickel Release Testing

Nickel (Ni) is a kind of element that easily leads to allergy. Ni will be absorbed by skin in touch with the material containing Ni releasing. The most common allergy is that sweating makes Ni release in touchable parts. According to statistics, 20% of people have the Ni allergy. Clothing, jewelry and some commodity exporting to Europe are required to test Ni release commonly if the contents have metal accessories containing Ni.
EU the REACH Regulation No.1907/2006 XVII Safety Requirements
Nickel usually exists in plating, stainless steel and other alloys. Prolonged contact with excessive nickel may cause severe sensitization and lead to Dermatitis. In order to reduce these risks, the Nickel release was prescribed in Nickel Directive94/27/EC. Not until July 20 1999, EU published three standard—EN1810, EN1811 and EN12472 to state more accurate analysis method for nickel release , which shows precise quantitative analysis will be made to Nickel release. These procedures particular for specific group of metal products are list as below:

Standard

Scope

Limit

EN1810

Body-piercing assemblies

<0.05%Ni

EN1811

Body-piercing assemblies

<0.2μg/cm2/Week

Products directly prolonged contacting  with skin

<0.5μg/cm2/Week

EN12472

Coated items directly prolonged contacting with skin

<0.5μg/cm2/Week

Requirements of the Directive: For the following products, shall not be placed on the market unless they conform to the requirements.
(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 from such post assemblies is less than 0.2 μg/cm 2 /week (migration limit);
(b.) in articles intended to come into direct and prolonged contact with the skin such as:
—earrings
—necklaces, bracelets and chains, anklets, finger rings
—wrist-watch cases, watch straps and tighteners,
—rivet buttons, tighteners, rivets, zippers and metal marks
when these are used in garments, 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/cm2/week.
General methods for the Detection: according to the requirements of Directive 94/27/EC, items should be tested in accordance with the appropriate European harmonised standard(s), the references of which have been published by the European Commission in the Official Journal of the European Communities. , these are EN1811 and EN12472. The standards specify a quantitative method for the release of nickel from articles.
Procedure of the Detection: The item to be tested for nickel release is placed in an artificial sweat test solution for one week. The concentration of dissolved nickel in the solution is determined by atomic absorption spectrometry, inductively-coupled plasma spectrometry or other appropriate analytical method. The nickel release is expressed in micrograms per square centimetre per week (mg/cm2/week).
Nickel Testing and Analysis for Jewellery, Watches and Metals
PTS Testing Service nickel testing services
PTS Testing Service can carry out nickel testing in leather and textile products and samples:
Nickel release testing BS EN 1811:2011+A1:2015 and BS EN 12472:2005+A1:2009
Fast Nickel release IHM 35 based on BS EN 1811:2011+A1:2015
What products should undergo nickel testing?
Nickel is most commonly used in jewellery and apparel as the major use of nickel is in the preparation of alloys, however PTS Testing Service recommends that the following products should undergo nickel testing to ascertain whether the consumer product contains compliant levels of nickel:
Jewellery (including plated jewellery)
Accessories
Watches
Clothing and apparel
Footwear
Metallic coatings
Children’s toys
Metal items that will be in prolonged contact with the skin
Nickel alloys
How does nickel affect the skin?
Although not toxic, the exposure to nickel in certain products which are intended to come into direct and prolonged skin contact, such as jewellery, watches and accessories, may cause sensitization of humans to nickel and may lead to allergic reactions, known as the nickel itch in sensitized individuals.
Why test jewellery, watches and metals for nickel?
European standard EN 1811 is the internationally recognised nickel testing and analysis method used to determine the rate of nickel release from jewellery, metals and other items. The nickel test was devised to assess whether articles comply with the requirements of the EU Nickel Directive.
Nickel Directive
What is the Nickel Directive?
The nickel directive is a European Union directive regulating the use of nickel in jewellery and other consumer products designed to come into direct and prolonged skin contact. Nickel released is regulated under EC 1907/2006 REACH Annex XVII, Item 27.
EN 1811 is the internationally recognised test method for determining the rate of nickel release from jewellery, spectacle frames and other items. The test was devised to assess whether articles comply with the requirements of the EU Nickel Directive.
Following lengthy consideration by a European CEN Steering Group, BS EN 1811: 1988+A1:2008, the legal standard for testing articles for nickel compliance, has been revised. The new version BS EN 1811:2011, incorporated into REACH, is effective in the UK from 31st March 2013.
BS EN 1811:2011 is applicable to articles intended to come into prolonged and direct contact with the skin and all post assemblies inserted into body piercings, but does not apply to spectacle frames and sunglasses. Various changes to the method will make results more consistent and repeatable.
What are the limits for Nickel under the directive?
BS EN 1811:2011 will be used to verify the conformity of the products to the regulation. The limits set out in this test method are:
Any post assemblies which are inserted into pierced ears and other pierced parts of the human body: 0.2 µg/cm2/week.
Articles intended to come into direct and prolonged contact with the skin such as: necklaces, watch straps, bracelets etc: 0.5 µg/cm2/week.
Do I comply with the Nickel Directive?
In order to ensure that your products are compliant, they should be tested by a UKAS accredited laboratory. The new standard is not effective until March 2013; however EU Member States may choose to withdraw BS EN 1811:1998 and introduce the revised 2011 standard immediately. The combined use of the two standards may cause confusion for those trading in several EU countries and so compliance with the revised 2011 standard is the safest option.
Why do I need to comply with the directive?

The presence of nickel in certain products which are intended to come into direct and prolonged skin contact, such as jewellery, may cause sensitization of humans to nickel and may lead to allergic reactions. Compliance with the nickel directive will help to ensure protection to the consumer as well as maintaining your business reputation and brand image.
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