Guidance Notes to The Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2005
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The text of this Internet version of the Guidance Notes to the Statutory Instruments has been prepared to reflect the text as it was Made. The authoritative version of the legislation is the Queen's Printer copy published by The Stationery Office Limited as the The Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2005.
IntroductionThe main objective of The Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2005 is to seek to prevent people becoming sensitised to nickel, which can lead to skin dermatitis. (see the Questions and Answers section for further information). The Regulations come into force on 1st September 2005. Until that time, the Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2000 (1) continue to apply.
This Guide has been prepared in consultation with the Local Authorities Coordinators of Regulatory Services (LACORS) and is intended to help consumers and suppliers of products containing nickel understand how the Regulations affect them.
The Guide seeks to provide practical advice with respect to the Regulations, which put into effect European Directives in the United Kingdom. The Guide does not carry any legal authority and does not replace the provisions of the Regulations. Only the Regulations, as interpreted by the Courts, have force of law.
Background to LegislationTo address the problem of nickel sensitisation, in June 1994 all Member States adopted Directive 94/27/EC (2) (the “Nickel” Directive). This Directive, the 12th Amendment to the “Marketing and Use” Directive, was implemented in the United Kingdom by means of the Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2000.
In September 2004 Directive 2004/96/EC (3) was adopted. This Directive further amended the ”Marketing and Use” Directive in respect of the provision relating to the use of nickel for piercing post assemblies. This amendment is implemented by the new Regulations. When they come into force on 1st September 2005 they will revoke the Dangerous Substances and Preparations (Nickel) (Safety) Regulations 2000.
Products manufactured for export to countries outside the European Economic Area are not affected by these Regulations.
Post AssemblyA post assembly is that part of the item designed and manufactured for insertion into the wound caused by piercing of the human body. The post assembly includes the piece that goes through the wound (a post or stud), plus any faces of the items that hold the piece in and against the wound (the rear of the stud or rear of the decorative part, and any accompanying butterfly).
Nickel Release RateThe Regulations prohibit the supply of all post assemblies (whether they are used during or after the period of healing of the wound caused by piercing) with a nickel release rate of 0.2 micrograms per square centimetre per week, or more (4). This restriction applies to the ear-posts of ordinary earrings, whether or not they are plated with a non-nickel coating.
The Regulations also prohibit the supply of any other products that come into direct and prolonged contact with the skin that have a nickel release greater than 0.5 micrograms per square centimetre per week.
It is the supplier's responsibility to decide which parts of a piece will be in direct and prolonged contact with the skin. Advice can be sought from your Local Authority Trading Standards Department (in Great Britain) or the District Council (in Northern Ireland).
TestingIt is advisable that an appropriately accredited test house carries out tests. Some organisations may prefer to use their own testing facilities; however, it is advisable that an accredited testing house periodically checks in-house measurements. The United Kingdom Accreditation Service can provide details of suitable testing houses – Tel: 020 8917 8400, website: www.ukas.com.
StockWithin the European Community, only compliant products can be placed on the market. You can hold stock which does not comply – for sale outside the EU only – but it is essential to ensure that such stock is clearly identified.
Other DescriptionsDescriptions such as 'nickel free', 'hypo-allergenic', 'nickel safe' etc are not covered by the Regulations and will continue to be covered by the Trade Descriptions Act 1968. If you wish to use such descriptions, it is your responsibility to ensure that they are accurate regarding your product and that you have sufficient evidence to substantiate their use.
You should bear in mind that the obvious message to the consumer in using the term 'nickel free', for example, is that your product contains no nickel and therefore will not promote a nickel allergic reaction. Use of 'nickel free', under the Trade Descriptions Act, is only possible if nickel is present at concentrations that will not be material. What constitutes 'material' is a matter for the Courts to decide. However, evidence suggests that a nickel sensitive reaction is unlikely to occur at concentrations below 100 parts per million or 0.01%.
Test Methods used in the RegulationsRegulation 4(1) provides that conformity with the requirements for nickel release rates under regulation 3 shall be demonstrated using the following specified standards: -
This does not prevent manufacturers from testing their products using other test methods, but it does mean that their products must satisfy the requirements for the nickel release rates under regulation 3 when they are tested using the reference test methods BS EN 1811:1999 or BS EN 12472:1999.
Due DiligenceSuppliers have a duty to ensure their products comply with the relevant legislation, which is known as showing 'due diligence'. If you wish to use the defence of due diligence, you will need to prove that you took all reasonable steps to avoid an offence being committed. What constitutes 'reasonable steps' depends on your circumstances, e.g. the size of your operation. In general, however, taking reasonable steps is likely to involve you setting up a control system that takes regard of the risks involved and covers all regulatory requirements. Such a system should be operated properly, kept under review and amended as necessary.
Further InformationIf you have any further queries, the Jewellery Distributors' Association and the British Jewellers' Association give advice to members free of charge. The Nickel Institute can provide advice on the release of nickel from nickel-containing alloys. Otherwise, you can contact your local Trading Standards office or the Department of Trade and Industry (DTI) DTI will make any amendments the Regulations or supporting Test Standards as required.
AcknowledgementsDTI thanks the Jewellery Distributors' Association and the British Jewellers' Association, along with members of the Nickel Working Group, whose efforts have resulted in this Guide. Thanks also to LACORS for the use of their 'nickel free' and 'due diligence' guidance notes, and to LGC Ltd for their technical input.
(1) SI 2000/1668, available from HMSO or online at http://www.opsi.gov.uk/si/si2000/20001668.htm
(2) European Parliament and Council Directive 94/27/EC of 30 June 1994 amending for the 12th time Directive 76/769/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. [OJ L188, 22.7.1994, p.1.]
(3) 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 1 to technical progress. [OJ L301, 28.9.2004, p.51]
(4) Until 1st September 2005, the nickel content of post assemblies intended for use during the period of epithelization (healing) of the wound caused by piercing must be less than 0.05% by mass. The British Standard Specification BE EN 1810:1998 is the reference test method for the measurement of nickel content.
Questions and Answers
Consumer & Competition Policy Directorate
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Last Updated 9th November 2011