Body piercing navigation

Product Specification

We test our products every 6 months:
(30-07-2012, 30-01-2013, 30-07-2013, 30-01-2014)

We do 4 kinds of tests:
  1. Lead test
  2. Nickel release test
  3. Micron plating test
  4. Cadmium test
  1. Lead test = to test the Lead content in each item whether it is under control standard
  2. Nickel release test = to test the nickel content in each product to ensure it is under control standard for which the standard
  3. Micron plating test = the test the thickness of gold plating whether it is 2 microns per our standard
  4. Cadmium test = to test samples for cadmium content under the control standard
We work with:
  1. SGS Testing Korea Co., Ltd for our lead and nickel content test
  2. CNL Plating Systems Co., Ltd for the micron plating test
  3. Intertek Testing Services (Thailand),. Ltd for our Cadmium test

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 for the purpose of adapting its Annex I to technical progress (Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, and Having regard to Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of dangerous substances and preparations (1), and in particular Article 2a thereof,


    Whereas:
  • (1) According to Directive 76/769/EEC as amended by Directive 94/27/EC of the European Parliament and the Council (2), nickel and its compounds are not to be used in certain post assemblies for piercing and certain other products unless they conform to the requirements set out in Directive 76/769/EEC.

  • (2) The risk of sensitisation of humans to nickel by piercing post assemblies has been newly assessed in a targeted risk assessment; the risk assessment concluded that a migration limit for piercing post assemblies would be more appropriate than a content limit.

  • (3) The new rate of nickel release (migration limit) should be adjusted with the multiplication factor specified in EN 1811 to compensate inter-laboratory variations and measuring inaccuracies. The European Committee of Standardisation (CEN) is invited to review EN 1811 in particular regarding the adjustment factor and to prepare a revised standard without adjustment factor, or with a smaller adjustment factor, if appropriate.

  • (4) The risk assessment was referred to the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) for peer review and the CSTEE has confirmed that a nickel migration limit may induce lower risks of sensitisation than a nickel content limit.

  • (5) The provisions laid down by this Directive take into account the current state of knowledge, science and techniques.

  • (6) This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers, in particular Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (3), and Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)

  • (7)The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations,
  • HAS ADOPTED THIS DIRECTIVE:

  • Article 1
  • Annex I to Directive 76/769/EEC is amended as set out in the Annex to this Directive.

  • Article 2
  • 1. Member States shall adopt and publish, by 1 August 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and thisbDirective.They shall apply those provisions from 1 September 2005. When Member States adopt those provisions, these shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

  • 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

  • Article 3
  • This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

  • Article 4
  • This Directive is addressed to the Member States.

Done at Brussels, 27 September 2004.
For the Commission
Olli REHN
Member of the Commission

ANNEX
  • In Annex I to Directive 76/769/EEC, in point 28, Nickel, in the second column point 1 is replaced by the following:
  • 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 ugcm2/week (migration limit).s
Materials:
  • Surgical Steel 316L
    C : 0.03,Mn 2.0,Si 0.75,P 0.045,S 0.03,Cr 18.0,Mo 3.00,Ni 10.00,N 0.10,
  • Titanium ….-ELI (Grade 23)
    C :.08, N :.03, O :.13, H :.0125, V :3.50, Al: 5.50, Fe: 0.25,
  • Silver 925
  • Brass, coated and uncoated
  • Base metal
  • Gold 14K and 18K
  • BioFlex
  • UV Items

TYPES OF PRODUCTS

Our products can be classified in two categories:


Products intended to be used for initial piercing.

  • Surgical Steel 316L (ASTM F138)
  • Titanium Grade 23 Ti6AL4V ELI (ASTM F136)
  • PVD coated Surgical steel and Titanium (ie: Black steel, Black titanium, Zircon gold steel)
  • BioFlex
  • PTFE (Teflon)
  • Gold 14K, 18K and 24K
  • Quartz

Products intended for used in a healed piercing or for fashion jewelry in general.

  • Items from above with bonded (not set) stones
  • Items from above coated with epoxy resin (ie: picture items)
  • Acrylic and other plastic
  • UV
  • Organic materials
  • Silver 925
  • Gold 9K
  • Gold plated surgical steel
  • Pewter (plated with Rhodium, Imitation Rhodium, Black PVD, Gold or steel)
  • Brass (plated with Rhodium, Imitation Rhodium, Black PVD, Gold or steel)
  • Pyrex

STERILIZATION

The main difference between non-sterilization a sterilization items of these two categories is that items intended to be used for initial piercing must be sterilized.

Sterilization refers to any process that effectively kills or eliminates transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) from a surface, equipment, article of food or medication, or biological culture medium.

In the piercing industry, sterilization is usually achieved by moist heat using an autoclave. Autoclaves use steam heated to 121–134 °C (250–273 °F). To achieve sterility, a holding time of at least 15 minutes at 121 °C (250 °F) or 3 minutes at 134 °C (273 °F) is required.

This means that jewelry used for initial piercing must be able to withstand these temperatures without melting or changing in any way.

We sterilize by Ethylene Oxide (E.O.), also called gas sterilization. This system of sterilization is not readily available for the average piercing studio but it allows us to keep jewelry sterile for up to 5 years. Click here to see the results of sterilization for different batches.



EUROPEAN NICKEL DIRECTIVE

The main legislation affecting body piercing jewelry (initial piercing jewelry and replacement piercing jewelry) is the European Nickel Directive. It is important to understand that this law changed in 2004.

The original nickel directive (76/769/EEC - now Council Directive 94/27/EC), that became law on January 20th 2000, prohibited the presence of nickel in any material used in the piercing of the body unless such materials we0re homogeneous and the concentration of nickel, expressed as mass of nickel to total mass, was less than 0,05%. Surgical steel 316L with its 9-12 % of nickel was not allowed to be used for initial piercing

Additionally, any piece of jewelry coming in direct and prolonged contact with the skin had to have a rate of nickel release of less than 0.5 micrograms per square centimeter per week (0.5ug/cm2/week).

In 2004, an amendment came into effect (Commission directive 2004/96/EC). Under this new directive, any post assembly in contact with body piercings shall not emit nickel at a rate greater than 0.2 micrograms per square centimeter per week (0.2ug/cm2/week).

For regular jewelry in contact with unbroken skin, the rate of nickel release permissible remains unchanged at 0.5 micrograms per square centimeter per week (0.5ug/cm2/week).

These new limits replaced the requirement for nickel content of less than 0.05% for materials used for initial piercing.

See the official text of the amendment by clicking here



THE LEAD ISSUE

While Europe led the way in regards to the nickel issue, America has been at the forefront in regards to the lead issue.

California enacted the Lead-Containing Jewelry Law to limit the amount of lead in jewelry, including children’s jewelry and body piercing jewelry. High amounts of lead, a persistent and toxic metal, have been found in jewelry, especially inexpensive children’s jewelry. Exposures to lead can cause a host of health effects ranging from behavioral problems and learning disabilities to organ failure, and even death. Children 6 years old and under are most at risk because their bodies are growing quickly.

The law separates jewelry in 3 classes of materials and states what are the lead content limits for each class of materials.

Class 1 materials can be commercialized without problems. The materials included in Class 1 are the following:

  • Stainless or surgical steel.
  • Karat gold.
  • Sterling silver.
  • Platinum, palladium, iridium, ruthenium, rhodium, or osmium.
  • Natural or cultured pearls.
  • Glass, ceramic, or crystal decorative components, including cat's eye, cubic zirconia, including cubic zirconium or CZ, rhinestones, and cloisonné.
  • A gemstone that is cut and polished for ornamental purposes.
  • Elastic, fabric, ribbon, rope, or string, unless it contains intentionally added lead and is listed as a class 2 material.
  • All natural decorative material, including amber, bone, coral, feathers, fur, horn, leather, shell, wood, that is in its natural state and is not treated in a way that adds lead.
  • Adhesive.

Materials from class 2 must contain less than a specified amount of lead. The materials included in Class 2 are the following:

  • Electroplated metal with less than 6 percent lead by weight that is electroplated with suitable under and finish coats.
  • Unplated metal with less than 1.5 percent lead that is not otherwise listed as a class 1 material.
  • Plastic or rubber, including acrylic, polystyrene, plastic beads and stones, and polyvinyl chloride (PVC) that contains less than 0.02 percent (200 parts per million) lead by weight.
  • A dye or surface coating containing less than 0.06 percent (600 parts per million) lead by weight.

Class 3 materials are any material not covered by Class 1 and Class 2 that contain less that 0.06 percent (600 parts per million) lead by weight.

Additionally, The US Federal government enacted a law in 2009 in regards to lead in children products as well as paint. (CPSIA Section 101)

The new law will, by August 14th 2011 reduce the permissible amount of lead in jewelry intended for children under 12 years old to less than 0.01 percent (100 parts per million).
From February 2010 onward, the lead content limit will be 0.03 percent (300 parts per million)
Lead in paint will have to be less than 0.009 percent (90 parts per million) by the same date.
Some products are exempted from being tested for lead contents due to the fact that by their nature, they will never exceed the lead content limits. These products are Pearls, woods, bone, amber, horn, sterling silver (925 and above), gold (10 K and above), titanium and surgical steel.


WHAT WE TEST AND HOW DO WE TEST

As part of our internal quality policies, we regularly test our products.

Nickel release tests are performed on the following items by test method BS EN12472:2005 that simulates wear and corrosion for the detection of nickel release from coated items or by test method BS EN 1811:1999 for the detection of Nickel release in products intended to come in direct and prolonged contact with the skin:

  • Surgical Steel 316L (ASTM F138)
  • Titanium Grade 23 Ti6AL4V ELI (ASTM F136)
  • PVD coated surgical steel and Titanium (ie: Black steel, Black titanium, Zircon gold steel)
  • Gold plated surgical steel
  • Base metal, Brass and Silver jewelry
  • Gold 9K, 14K, 18K and 24K
  • Items from above coated with epoxy resin (ie: picture items)
  • Brass (plated with Rhodium, Imitation Rhodium, Black PVD, Gold or steel
  • Silver 925
  • UV Items

Lead content tests are performed on the following products by test method US EPA 3050B

  • Gold 9K
  • Brass, coated and uncoated
  • Pewter, coated and uncoated
  • Gold plated surgical steel
  • Acrylic and other plastic items
  • Stones we use in the manufacture of jewelry
  • Organic materials that are painted
  • Jewelry using epoxy resin
  • BioFlex
  • Items from above coated with epoxy resin (ie: picture items)
  • Silver 925
  • UV Items
AE
indicator