Approximately 15% of women and 2% of men suffer from nickel allergic contact dermatitis (NACD).
Many chemical agents and some metals - including nickel - can provoke allergic contact dermatitis.
HOW DOES NICKEL ALLERGY OCCUR?
For NACD reactions to occur there needs to be three conditions present simultaneously:
Direct contact between a nickel-releasing object and the skin
Contact must be continuous and prolonged on the same area of skin
A sufficient amount of nickel ions must be released and absorbed into the skin.
It is the quantity of nickel released, rather than the level of nickel content, which determines the potential to provoke nickel allergy or NACD reactions.
NICKEL RESTRICTION IN THE EU
There has been EU legislation for many years restricting nickel release in articles intended for direct and prolonged skin contact. This was first established by Directive 94/27/EC (the so-called ‘Nickel Directive’) and subsequently incorporated into REACH (Annex XVII, Entry 27). The aim of the legislation is to prevent the general population from becoming sensitised to nickel and to reduce NACD reactions in the majority of nickel-sensitised individuals.
The Regulation states that “Nickel and nickel compounds shall not be used:
In any post assemblies that are inserted into pierced ears and other pierced parts of the human body [body piercings] unless the nickel release […] is less than 0.2μg/cm²/week
In articles intended to come into direct and prolonged contact with the skin such as: earrings, necklaces, bracelets and chains, anklets, finger rings, wristwatch cases, watch straps and tighteners, rivet buttons, rivets, zippers and metal marks, when these are used in garments, if the nickel release rate from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0.5μg/cm²/week”
Articles cannot be placed on the EU market unless they comply with this requirement, in accordance with the relevant CEN standards on nickel-release testing (e.g. EN 1811; EN 12472; EN 16128). Since the introduction of this restriction, the prevalence of nickel allergy in the European population has fallen. This suggests that where the legislation is complied with and enforced, it is effective.
Following a mandate from the European Commission, the European Chemicals Agency (ECHA) has been developing additional guidance on implementing the EU’s restrictions on nickel. In 2014, ECHA adopted a guidance interpretation of what constitutes ‘prolonged contact’.
THE NICKEL INSTITUTE VIEW
The Nickel Institute supports the objectives of the EU's nickel restriction in preventing allergy and NACD.
It is essential to use appropriate materials in those applications requiring direct and prolonged contact with the skin. In these circumstances, using low nickel-releasing materials will help prevent sensitisation or NACD.
To be targeted, effective and proportionate, the restriction should apply to:
Items with a similar type of exposure to those already listed in the restriction (Entry 27, Annex VII, REACH); or
Items where there is clinical evidence that the items cause nickel allergy and NACD among the general population.
THE NICKEL INSTITUTE'S RECOMMENDATIONS
Increase education and awareness
Eliminate the leading causes of nickel sensitisation through the use of appropriate materials in appropriate applications
Improve enforcement of existing legislation to aid compliance.
Similar provisions to the EU nickel restriction are in place in other countries. For example, China adopted a standard (GB 28480-2012) in 2012 that restricts the release of nickel in body piercing (0.2μg/cm²/week) and in articles intended to come into direct and prolonged skin contact, such as jewellery items (0.5μg/cm²/week). These limits are in line with the EU nickel restriction.
In 2020 China issued a standard (GB/T 39498-2020) on “Guidelines for the use and control of key chemical substances in consumer products”. This standard, effective since June 2021, confirms the release limits set by GB 28480-2012 for nickel in body piercings and articles in direct and prolonged skin contact.
Other countries, such as the United States and Canada have no specific legislation to restrict the release of nickel in articles. However, there are a number of standards that provide important references for manufacturers of relevant products:
ASTM Standard on Consumer Safety Specification for Adult Jewellery (Designation: F2999-13)
ASTM Standard on Children’s Jewellery (F2923-14)
These ASTM Standards include specifications for nickel in metal components. They list, amongst others, surgical stainless steel as one of the approved materials for body-piercing jewellery in both adults and children.