Product 3

QQQQ copy.gif

Directive on Nickel Release – 2004/96/EC – EU Directive relating to restrictions on the marketing and use of nickel for piercing post assemblies

Requirements of the Directive

Piercing post assemblies

Nickel migration ≤ 0.2 mg/cm²/week

Products intended to come into direct and prolonged contact with human skin

Nickel migration ≤ 0.5 mg/cm²/week

Test Methods

BS EN 1811:1999 is the reference test method for release of nickel from products intended to come into direct and prolonged contact with the skin.

BS EN 12472:2005 is the reference test method for the simulation of wear and corrosion for the detection of nickel release from coated items.

Scope of the Directive

The Directive covers any products intended to come into direct and prolonged contact with the skin, including (but not limited to):

• earrings

• necklaces, bracelets, chains, anklets and finger rings

• wrist-watch cases, watch straps and tighteners

• rivet buttons, tighteners, rivets and zippers and metal marks contained in or intended to be used in garments

Questions and Answers

1. Why is nickel a problem?

Nickel can cause allergic contact dermatitis (ACD). Signs of ACD range from dryness, chapping and inflammation of the skin to eczema and blisters.

Nickel sensitivity affects approximately 10% of women and 1% of men in western countries. It is not an inherited condition but is related to direct and prolonged skin contact with the substance. Nickel ACD was first noticed in industries where soluble forms of nickel came into contact with workers' skin, e.g. electroplating and battery manufacture.

Nickel sensitivity outside of occupational industries was first noticed in people who had skin contact with clothing buckles, zips and clasps that had been nickel-plated. ACD has increased with the use of nickel-plated jewellery and particularly with the practice of body-piercing.

2. How does nickel sensitisation happen?

When an item containing nickel comes into direct and prolonged contact with the skin, sweat can act on it to release release nickel ions. Sensitisation can take between one and three weeks of such contact. The quantity of nickel ions required to induce it varies with individuals. Skin condition, other allergies, gender and age can all be factors. Some nickel-sensitised

people may develop ACD with further exposure.

3. How long does nickel sensitisation last?

Nickel sensitisation lasts for life. However, some nickel-sensitised people display no symptoms (such as allergic skin rashes), either because they are minimally exposed or because relatively high amounts of nickel ions are required in them to cause ACD.

Short-term contact with nickel-releasing items such as keys, coins and tools is unlikely to lead to nickel allergy in non-sensitised people or cause ACD in those who are nickel sensitised.

4. How is nickel ACD treated?

Simply avoiding direct and prolonged exposure to nickel-releasing materials is often a sufficient remedy. ACD may also be treated with anti-inflammatory topical skin creams or ointments, e.g. cortisone-based skin moisturisers.

5. Why has a maximum nickel content limit allowed in piercing post assemblies been replaced by a restriction on nickel release?

It is not known precisely what concentration of nickel can cause sensitisation. Therefore a maximum nickel content was originally set at the lowest possible level to ensure protection from the risk of sensitisation. However, studies since have shown that certain types of stainless steel with a high nickel content do not elicit an allergic response in the majority of people who are already sensitised to nickel. When tests for migration (see Question 6) were performed on these stainless steels, very low levels of migrated nickel were detected, or could not be detected at all. Therefore, while the requirement of a maximum nickel content would remove any possibility of sensitisation, it was decided that this was not proportionate to the risk of sensitisation from products containing nickel that migrate little or none of the substance.

6. What is migration and how is it measured?

Migration is the measure of release of a substance from the surface of an object, usually into a liquid, over a period of time. For the purposes of testing under EN 1811, the media used is an artificial sweat solution which simulates human sweat. This standard requires a post assembly

of known surface area to be immersed into a known volume of artificial sweat solution for a period of 1 week.

7. Does the 0.2 micrograms per square centimetre per week limit only apply to piercing post assemblies used during the period of healing of the wound caused by piercing?

No, the limit applies to all piercing post assemblies, whether they are used during or after the period of healing of the wound caused by piercing.

8. Will the 0.2 and 0.5 micrograms per square centimetre per week limits prevent nickel sensitisation?

These limits are confidently expected to reduce new incidences of nickel

sensitisation, as experience in Denmark has shown.

9. Will these limits prevent elicitation of nickel ACD in sensitised individuals?

Unfortunately, even these extremely low levels of nickel release will not prevent all cases of elicitation of nickel allergy in people already sensitised to nickel.

10. Is it permissible for piercing post assemblies to be plated with a non-nickel coating?

Yes. Such post assemblies must comply with the 0.2 micrograms per square centimetre per week limit for nickel release as determined by the reference test method EN 1811