The legislation originates from a European Directive in 1994, and applies to products inserted into a body piercing, and those intended to come into direct and prolonged contact with the skin. This was finally adopted into UK Law as "The Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2000". The 2000 Regulations have since been revoked and replaced with “The Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2005”, enforceable from 1st September 2005.

The major change in the 2005 legislation is that now piercing post assemblies must comply with a more rigorous release test, rather than a stipulated nickel content.

This is important legislation which has implications for all of the jewellery, watch and fashion industry.

Under the 2005 legislation any manufacturer, importer, wholesaler or retailer in the supply chain will commit an offence if:

They sell a post assembly intended to be inserted into a pierced part of the human body unless the rate of nickel release from the post assembly is less than 0.2 μg/cm2/week;
They sell jewellery items, including certain metal clothing fasteners, if the rate of nickel release from those parts of the product which come into direct and prolonged contact with the skin is greater than 0.5 μg/cm2/week.
They sell any jewellery items, including certain metal clothing fasteners, where these have a non-nickel coating unless the coating is sufficient to ensure that the rate of nickel release from those parts of the product which come into direct and prolonged contact with the skin does not exceed 0.5 μg/cm2/week for a period of at least two years normal use of the product.

TEST STANDARDS

In order to ensure that products comply, they are tested to the relevant British Standards stipulated in the legislation i.e. BS EN 1811 and BS EN 12472. Other screening tests are a useful part of a due diligence procedure, but legally all items must pass the relevant test stipulated in the Regulations.

Key points from the regulations

To read the key points from the regulations click here

Supply Chain Responsibilities
Anyone wishing to place items on the market must recognize that they have a legal obligation to ensure that items meet the requirements of the Regulations. The responsibility for ensuring that all items conform is placed upon retailers, importers, wholesalers and manufacturers.

The onus is on the supplier to take all reasonable steps and exercise “all due diligence” to ensure that their product complies. Note the word “all” in these statements. The supplier needs to be able to prove, through a paperwork audit trail that they have complied with the legislation. This will entail obtaining certification from suppliers to guarantee compliance and also “appropriate” random testing of the products being sold.

The UK legislation is enforced by local Trading Standards Officers who will respond to any consumer complaints and also have the power to randomly check product supplied by UK importers, wholesalers and retailers to ensure their products comply. If a product causes a problem to a customer, or is found not to comply during a routine random check, the supplier will need to be able to prove that he took “all reasonable steps” and exercised “all due diligence” to avoid committing an offence. .

Carrying out a few tests at random or the production of an unaccredited test certificate will not be accepted as fulfilling the requirements of ‘Due Diligence’, in the event that a product on the market is subsequently found not to meet the criteria set out in the legislation.

It is only possible to establish a ‘Due Diligence Defence’ if all of the following are met:

The supplier has a Preventative System in place to demonstrate that all reasonable and practical steps have been taken to ensure that products comply with legislation. This should include clear specifications of your requirements and some product testing to ensure products conform.
The supplier can demonstrate that the Preventative System has been regularly monitored to ensure that it remains effective in order to avoid an offence being committed.
There is a reasonable and innocent explanation as to how the offence occurred.
The supplier of a product which is found not to comply with the Nickel Regulations is committing an offence under the Consumer Protection Act. There may also be financial penalties in terms of personal injury claims and damage to the reputation of the business.

GUIDANCE NOTES
Guidance Notes to the regulations providing further background to areas such as due diligence and exempt stock regulations have now been published by the Department for Business Enterprise and Regulatory Reform. These are available on their website: www.berr.gov.uk under Regulatory Guidance in the Consumer Protection and Product Safety section.