This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
(This note is not part of the Regulations)
These Regulations implement European Parliament and Council Directive 94/27/EC (OJ No. L 188, 22.7.94, p.1).
The Regulations prohibit the supply of post assemblies intended to be inserted into a pierced part of the human body during epithelization of the wound caused by such piercing and containing nickel or a nickel compound unless the concentration of nickel is less than 0.05% (regulation 3(1)).
The supply of products containing nickel or a nickel compound which are intended to come into direct and prolonged contact with the skin is prohibited unless the rate of nickel release will not exceed the rate of 0.5μg/cm2/per week (regulation 3(2)). This requirement does not apply to products which have a non-nickel coating.
The supply of products containing nickel or a nickel compound and which have a non nickel coating and which are intended to come into direct and prolonged contact with the skin is also prohibited. Products are excepted from this prohibition if the non nickel coating ensures that the rate of nickel release will not exceed 0.5μg/cm2/per week for a period of at least two years of normal use, (regulation 3(3)).
Regulation 3(5) provides that the British Standard BS EN 1810, BS EN 1811, BS EN 12472, shall be used to demonstrate whether products satisfy the requirements of the Regulations.
A Regulatory Impact Assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies are also available from the Consumer Affairs Directorate of the Department of Trade and Industry, Room 433, 1 Victoria Street, London SW1H 0ET.
Copies of the British Standards BS EN 1810, BS EN 1811 and BS EN 12472, can be obtained from the British Standards Institution, 389 Chiswick High Road, London W4 4AZ.
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