Our products meet or exceeds the European Union Nickel Directive* 94/27/EC
Our Medical Grade Titanium products provide the maximum safety and comfort for people with known nickel allergies.Our Stainless Steel and 24ct Gold Plated product line use Medical Grade Stainless Steel as the base metal for user comfort and safetyNickel Directive
The Nickel Directive was a European Union directive regulating the use of nickel in jewellery and other products that come into contact with the skin. Since 1 June 2009, it has been subsumed into the REACH Regulation, specifically item 27 of Annex XVII to that regulation. Nevertheless, the term Nickel Directive is still used to refer to the restrictions on nickel usage and the prescribed test method for quantifying nickel release from products EN 1811.
Allergy to nickel is a common cause of contact dermatitis, with roughly 10% of the population in Western Europe and North America being sensitive to nickel. Initial sensitization frequently occurs from jewellery such as ear studs and other body piercings, and nickel allergy is more prevalent among women than men. Once sensitized, an individual can develop contact dermatitis from shorter term contact with nickel-containing products: this is a particular problem given the use of nickel in coinage, such as the European one- and two-euro coins and the Canadian five-cent piece. This led to moves by two European countries to prevent the initial sensitization of jewellery wearers by limiting the use of nickel in piercing studs and other products which are in prolonged contact with the skin, and then to the European Union Nickel Directive in 1994.
The Nickel Directive imposes limits on the amount of nickel that may be released from jewellery and other products intended to come into direct and prolonged contact with the skin. These limits, known as migration limits, are:
• 0.2 µg/cm2/week for post assemblies which are inserted into pierced ears and other pierced parts of the human body;[note 1]
• 0.5 µg/cm2/week for other products intended to come into direct and prolonged contact with the skin.
Nickel release is measured by a test method known as EN 1811, which involves placing the object in an artificial sweat solution for one week, then measuring nickel by atomic absorption spectroscopy or any other appropriate technique (e.g. ICP-MS). Other, equivalent test methods may also be accepted. Wear and corrosion can be simulated by a method known as EN 12472.
THE EUROPEAN PARLIAMENT AND OF THE COUNCIL DIRECTIVE 94/27/EC28. Nickel
CAS No 7440-0-20 EINECS No 2311114 and its compoundsMay not be used:
1)in all post assemblies which are inserted into pierced ears and other pierced parts of the human body unless the rate of nickel release from such post assemblies is less than 0,2 µg/cm2/week (migration limit);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 contact with the skin is greater than 0.5 µg/cm²/week;3) in products 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 µg/cm²/week for a period of at least two 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.Each business must comply with the Nickel laws over the EU by law.
Why Do We Need The Nickel Directive?
In Europe approximately 10% of women and 1% of men suffer from an allergy to nickel caused by skin absorption of nickel ions, released from nickel containing materials.
The EC Nickel Directive was brought in to combat this by specifying the release rate of nickel in articles which have direct and prolonged contact with the skin.The Directive covers jewellery along with belt buckles, jeans studs, sunglasses and metal poppers on babies garments etc.EC Nickel Directive 2004/96/EC; SI 2005 No 2001
EC Directives regarding nickel first became law in July 2001 and have enjoyed many revisions in subsequent years.With effect from March 2013, new legislation has come into force regarding ear and body piercing jewellery.
However, most of these changes apply to the testing methods and results.As per the EC Nickel Directive 2204/96/EC; SI 2005 No 2001 (published 28/09/04) the jewellery itself should not emit nickel at a rate greater than 0.2 microgrammes/cm2/week.This has not changed.
What Piercing Jewellery Conforms to the Directive?
For Initial Piercings (unhealed): We recommend using titanium body jewellery for initial piercings.However, 316L Steel, PVD coated Titanium or Steel can also be used.
For Healed Piercings; we recommend using titanium, 316L steel, PVD on steel or titanium, Sterling silver, steel-silver, gold plate, acrylic, PTFE, bioplast, silicone, pyrex or organic body jewellery for healed piercings.
TDi – Conforming To The Nickel Directive
Since 1999, TDi bodyjewellery has been working with the Sheffield Assay Office, Analytical Services, sample testing all jewellery.
TDi operates a ‘due diligence’ system, as recommended by the Assay Office, to ensure it conforms to the requirements of the ‘Nickel Directive’.