European Standards Developed in Support of the European Union Nickel Directive

  • Martin Baker


As a result of the increasing prevalence of nickel allergy arising from exposure to consumer articles, the European Union introduced the Nickel Directive in 1994. The purpose of this legislation was to establish a nickel release limiting value, which would prevent primary nickel sensitisation. The limiting value specified was 0.5 μg/cm2/week, which is applicable to nickel-containing consumer articles having prolonged and direct contact with the skin. For articles inserted into pierced parts of the body, the nickel release limiting value is 0.2 μg/cm2/week. Consumer articles coming into these two categories are not allowed onto the market place unless they conform to their respective limiting values.

The European standards required to prove conformity with this directive were developed by various technical committees belonging to the European Committee for Standardisation. Various revisions and amendments have been made to these standards since they were published in 1998. The European Standard 1811 provides a method for the quantitative measurement and compliance assessment of the nickel release from consumer articles. For coated articles, European Standard EN 12472 provides a method to simulate the accelerated wear and corrosion that can occur to an article. A qualitative indication of the nickel release can be obtained by applying the dimethylglyoxime screening test CR 12471.


  1. 1.
    Blaschko A. Die Berufsdermatosen der Arbeiter. Ein Beitrag zur Arbeitshygiene. I Das Galvaniseur-Ekzem. Dtsch Med Wochenschr. 1889;15:925–7.CrossRefGoogle Scholar
  2. 2.
    Schittenhelm A, Stockinger W. Über die Idiosynkrasie gegen Nickel (Nickel-Krätze) und ihre Beziehung zur Anaphylaxie. Z Gesamte Exp Med. 1925;45:58–74.CrossRefGoogle Scholar
  3. 3.
    Burckhardt W. Beiträge zur Ekzemfrage III. Mitteilung. Die Rolle der Alkalischädigung der Haut bei der experimentellen Sensibilisierung gegen Nickel. Arch Dermatol Syphilol. 1935;173(3):262–6.CrossRefGoogle Scholar
  4. 4.
    Calnan CD. Nickel dermatitis. Br J Dermatol. 1956;68(7):229–36.CrossRefGoogle Scholar
  5. 5.
    McAlester AW Jr, McAlester AW 3rd. Nickel sensitization from white gold spectacle frames. Am J Ophthalmology. 1931;14(9):925–6.CrossRefGoogle Scholar
  6. 6.
    Boss A, Menne T. Nickel sensitisation from ear piercing. Contact Dermatitis. 1982;8(3):211–3.CrossRefGoogle Scholar
  7. 7.
    Brandrup F, Larsen SF. Nickel dermatitis provoked by buttons in blue jeans. Contact Dermatitis. 1979;5(3):148–50.CrossRefGoogle Scholar
  8. 8.
    Wöhrl S, Jandl T, Stingl G, Kinaciyan T. Mobile telephone as new source for nickel dermatitis. Contact Dermatitis. 2007;56(2):113.CrossRefGoogle Scholar
  9. 9.
    Bonnevie P. Der klinische Wert der Ekzempropen an der Nickelidiosynerasie erläutert. Acta Derm Venereol. 1936;17:376–88.Google Scholar
  10. 10.
    Marcussen PV. Ecological considerations on nickel dermatitis. Br J Ind Med. 1960;17:65–8.PubMedPubMedCentralGoogle Scholar
  11. 11.
    Menne T, Rycroft R. Nickel contact dermatitis from consumer products. In: European environmental and contact dermatitis research group 10th meeting; 1990.Google Scholar
  12. 12.
    Menne T, Rasmussen K. Regulation of nickel exposure in Denmark. Contact Dermatitis. 1990;23(1):57–8.CrossRefGoogle Scholar
  13. 13.
    Liden C. Nickel in jewellery and associated products. Contact Dermatitis. 1992;26(2):73–5.CrossRefGoogle Scholar
  14. 14.
    Proposal for a council directive amending for the fourteenth time Directive 76/769/EEC 27 April 1993. Off J Euro Communities. 1993;C116:18.Google Scholar
  15. 15.
    Common position (EC) No 12/94 adopted by the Council on 4 March 1994. Off J Euro Communities. 1994;C137:60–64.Google Scholar
  16. 16.
    European parliament and council directive 94/27/EC of 30 June 1994. Off J Euro Communities. 1994;L188:1–2.Google Scholar
  17. 17.
    Liden C. Report from CEN/TC 283 WG4 Health and safety aspects with special reference to nickel allergy; 1993.Google Scholar
  18. 18.
    Liden C, Menne T, Burrows D. Nickel-containing alloys and platings and their ability to cause dermatitis. Br J Derm. 1996;134:193–8.CrossRefGoogle Scholar
  19. 19.
    ISO 3160–3. Watch cases and accessories – gold alloy coverings – part 3: abrasion resistance tests of a type of coating on standard gauges; 1993.Google Scholar
  20. 20.
    Liden C. Report from CEN/TC 283 WG4 Health and safety aspects with special reference to nickel allergy; 1994.Google Scholar
  21. 21.
    Commission communication 20.7.1999 in the framework of the implementation of Parliament and Council Directive 94/27/EC of 30 June 1994. Off J Euro Communities. 1999;C205:5.Google Scholar
  22. 22.
    Regulation (EC) No 1907/2006 of the European parliament and of the council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).Google Scholar
  23. 23.
    Commission communication as regards restrictions on the marketing and use of nickel. Off J Euro Union. 2007;C60:2.Google Scholar
  24. 24.
    Commission communication in the framework of the implementation of Regulation (EC) No 1907/2006 (REACH). Off J Euro Union. 2012;C142:8.Google Scholar
  25. 25.
    Risk of sensitisation of humans to nickel by piercing post assemblies Contract No. ETD/FIF.2001592. LGC Limited; 2003.Google Scholar
  26. 26.
    Opinion of the scientific committee on toxicity, ecotoxicity and environment on risks of sensitization of humans to nickel by piercing post assemblies; 2003.Google Scholar
  27. 27.
    Commission Directive 2004/96/EC of 27 September 2004 amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of nickel for piercing post assemblies. Off J Euro Union. 2004;L301:51.Google Scholar
  28. 28.
    EN 71–3 Safety of Toys Part 3 Migration of certain elements; 1994.Google Scholar
  29. 29.
    Use of uncertainty information in compliance assessment Eurachem/Citac Guide; 2007.Google Scholar
  30. 30.
    Commission Communication in the framework of the implementation of Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Off J Euro Union. 2016;C14:110.Google Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Agosi, Allgemeine Gold- und Silberscheideanstalt AGPforzheimGermany

Personalised recommendations