Nickel Allergies

Current As Of- February, 1995

CURRENT REGULATIONS

Since 1991, the use of nickel in jewelry has been an issue in many foreign countries, particularly in the countries that comprise the European Union. It is believed that during the piercing process, certain individuals develop a lifetime allergy to nickel and can develop a dennatitis like rash any time that their skin comes into contact with a product containing nickel.

In an effort to control the situation, three countries, Denmark, Sweden and Germany, have established regulations regarding the use of nickel in jewelry. Those regulations are as follows:

SWEDEN Material used for ear piercing or ear jewelry may contain no more than 0.05 percent nickel in an alloy. Shipments are sampled as they enter the country. If a single sample fails during testing, the entire shipment may be rejected.

DENMARK Any metallic jewelry that releases more than 0. 5 ug/cm2/week (micrograms per square centimeter per week) of nickel is banned for sale. This can include ear ornaments, necklaces, bracelets, chains, finger rings, wristwatches, eyeglass frames, hair clips, anklets, watch straps and buckles, garments equipped with - buttons, tighteners, rivets, zippers and other metal items which in normal use, come in close contact with the human skin. Testing conducted by wholesalers and retailers, not manufacturers.

Offenders are subject to penalties and/or imprisonment for up to one year.

GERMANY The government has banned the use of nickel in earring posts and similar consumer products which are designed to remain in the skin of the human body (i.e. ear lobes or nostrils) during the healing process following piercing. Germany also has issued a ruling regarding the labeling of other jewelry which contains nickel. Items which do not come in direct contact with the skin (example: stickpins and brooches) are not required to be labeled.

Effective July 1, 1993, items that come into direct contact with the skin and release more than 5 micrograms of nickel per square centimeter per week (0.5ug/cm2/week), must contain a warning label in the German language. This ruling applies to such items as jewelry, watches, bracelets and eyeglass frames. The German government suggests that as proof of the warning, the customer receipt note the fact that the product contains nickel.

NICKEL-FREE TESTING

DMG - Dimethylglyoxime spot test. The DMG test involves mixing a 1 percent solution of dimethylglyoxime in alcohol with a IO percent solution of ammonium hydroxide in water. Two drops of each solution are placed on a cotton swab and rubbed evenly for 30 seconds against the portion of the piece that will come in contact with the skin. The appearance of a red color, from light pink to strong cerise, indicates that the release of nickel exceeds the legal limit. For pieces that have painted or varnished surfaces, the test shall be made before and after removal of the coating. This test is used in Denmark and Germany.

In Denmark the primary test is Synthetic Perspiration - The item is stored for a period of time, usually a week, in a solution of synthetic perspiration (consisting of 0. 5 percent sodium chloride, 0. I percent lactic acid and 0. I percent urea in deionized water with ammonia added to pH 6.5).

A furnace atomic absorption spectrophotometer is then used to determine the amount of nickel released in the solution in terms of micrograms per square centimeter per week.

In Sweden, the Atomic Absorption test is used. This is done by taking scrape samples of about one milligram from different parts of the item. Samples are placed in a micro-boiling tube, dissolved in acid and diluted to one milliliter. The solution is then analyzed with a flame atomic absorption spectrophotometer to determine how much nickel is released per micrograin, per cubic centimeter, per week.

OUTLOOK FOR THE EUROPEAN COMMUNITY

Because Denmark, Sweden and Germany have adopted different regulations and penalties, this has caused a problem for the European Commission because these regulations introduced a possible barrier to free trade within the European Union (EU).

The European Commission decided to issue a Directive to harmonize the regulations and to ask the Committee for European Standards (CEN) to provide standardized tests for compliance purposes. By the summer of 1997, the test methods should be published in the Official Journal of the European Communities and the directive will become active. Member states will then have six months in which to publish and bring into effect regulations to implement the nickel directive.

Written by the European Union The Council on January 26, 1994 and titled "The Directive 94/ /EC of the European Parliament and of The Council amending for the fourteenth time Directive 76/796/EEC on the approximation of the laws. Regulations and administrative provisions of the member states relating to restrictions on the marketing and use of certain dangerous substances and preparations."

The main points of the Directive are as follows.

Nickel may not be used:

1 . in post assemblies which are inserted into pierced ears and other pierced parts of the human body during epithelization of the wound caused by piercing, whether subsequently removed or not, unless such post assemblies are homogenous and the concentration of nickel to total mass - is less than 0.05%;

2. in products 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 products coming into direct and prolonged skin is greater than 0.5 ug/cm2/week;

3. in products such as those listed in point 2 above where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release from those parts of such products coming into direct and prolonged contact with the skin will not exceed 0.5 ug/cm2/week for a period of at least 2 years of normal use of the product.

Furthermore, products which are the subject of points 1, 2 and 3 above, may not be placed on the market unless they conform to the requirements set out in those points.

For a complete copy of the Directive, call MJSA 401-274-3840.

GUIDELINES FOR THE USE OF THE TERM NICKEL-FREE

Because of the EU Directive which regulates the amount of nickel released from an item, certain manufacturers and distributors have decided to introduce "nickel free" jewelry, some of which is not completely free of nickel, and therefore does not necessarily meet the requirements of the United Kingdom (UK) trades description law.

This UK law is administered by local Trade Standards officers, and their task is to ensure that the description given to a product is not materially different to the product.

When they are in doubt, the have access to the Local Authorities Co-Ordinating Body on Food and Trading Standards (LACOTS) who will issue their interpretation of the law and suggest guidelines to the Trading Standards officers.

In July of 1994, LACOTS issued guidelines for the use of the term nickel free to describe jewelry. They concluded that use of the term "nickel free" should be limited to items and component parts where nickel is present at a concentration of I 00 parts per million or less (ie 0.01%) - significantly lower than the 0.5% proposed for earring posts by the European Directive on nickel.

Please note that this is a guideline and only when a court case has been completed will they know whether this guideline meets the legal requirements of the Trade Description Act.

These guidelines apply to the United Kingdom only and not the entire EU.

SUGGESTED PUBLICATIONS

FOCUS:The Nickel Controversy in Europe 9/92. MJSA Identifies the work of the MJSA Metals Sub-Committee as performing the task of reviewing the European Community situation relative to the issue of the Nickel use in Jewelry.

MEMORANDUM, To All MJSA Members from the Metals SubCommittee, November 23, 1992 regarding the Nickel Situation in the European Community. An update to the FOCUS report issued 9/92 including other developments.

PAPERS

Chairman of the Jewellely Distributors' Association of the United Kingdom, John Milligan. Seminar paper from EXPO New York, March, 1994 on the status of the Directive 76/769/EEC. Contact MJSA, 401274-3840 for a copy.

AJM ARTICLES

What's the Rub?, 8/94 MJSA. This article explains the current regulations, testing methods and a nickel-free plating process.