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Related Experiment Videos

Nickel dermatitis: how much nickel is safe?

D J Gawkrodger1

  • 1Department of Dermatology, Royal Hallamshire Hospital, Sheffield, UK.

Contact Dermatitis
|November 1, 1996
PubMed
Summary

The European Union's Nickel Directive sets limits on nickel content and release from products in contact with skin. Many jewelry items exceed these limits, requiring manufacturers to reformulate their products to comply with new regulations.

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Area of Science:

  • Materials Science
  • Toxicology
  • Regulatory Affairs

Background:

  • The European Union's Nickel Directive, effective 1996, regulates nickel in consumer products.
  • Nickel is a common allergen, necessitating restrictions in items with prolonged skin contact.

Purpose of the Study:

  • To review data on nickel allergy thresholds and release levels from consumer products.
  • To assess compliance of current nickel-containing materials with the Nickel Directive.

Main Methods:

  • Analysis of existing data on nickel sensitivity thresholds.
  • Evaluation of nickel release rates from various alloys and jewelry items.
  • Comparison of release levels against the 0.5 microgram/cm2/week limit set by the directive.

Main Results:

  • The directive limits nickel concentration to 0.05% in post assemblies and release to 0.5 microgram/cm2/week for skin-contact products.
  • Many nickel-containing alloys and jewelry, particularly high-sulfur stainless steel, exceed the permissible nickel release levels.
  • The 0.5 microgram/cm2/week limit, while protective for many, may not safeguard all nickel-sensitive individuals.

Conclusions:

  • Manufacturers must modify jewelry composition to meet the Nickel Directive's stringent release standards.
  • Compliance with the Nickel Directive requires significant changes in materials used for jewelry and other skin-contact items.
  • The directive aims to reduce nickel allergy prevalence by limiting exposure from consumer goods.

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