The directive, first issued in 1992, has been redrafted and extended to cover products not previously listed and to introduce new requirements on the action to be taken whenever products are found to be unsafe.

SCOPE AND DEFINITIONS

The term "product" is defined in the new directive as any product which is intended for consumers (or which is likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them) and which is supplied or made available, whether for consideration or not, in the course of a commercial activity.

It includes for the first time products supplied in the context of providing a service, eg exercise equipment used in a gym. Where products are subject to specific requirements imposed by Community legislation, the directive will apply only to the aspects and risks, or categories of risk, not covered by those requirements. It appears that food products will be covered by the recently adopted general food law directive.

Under article 3 of the directive, producers are obliged to place only safe products on the market. A safe product is defined as:

"Any product which, under normal or reasonably foreseeable conditions of use - including duration and, where applicable, putting into service, installation and maintenance requirements - does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons".

This must take into account the characteristics of the product, its effect on other products when used with them, any information or indication regarding the product, and the categories of consumer at risk when the product is used. The conformity assessment procedures of the existing directive are extended to include compliance with a set of new European standards which will be drawn up under article 4 of the directive.

Products complying with such standards would be deemed to satisfy the product safety requirement. However, compliance would be voluntary and producers would be free to choose other means of compliance.

DEALING WITH UNSAFE PRODUCTS

Producers are obliged to provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks. Producers must also take measures which enable them to be informed of potential product risks and to choose to take appropriate action if necessary. Ways of doing this (batch marking, sample testing, investigating complaints etc) are set out and now include a requirement to keep a register of complaints, if necessary. Such action is to be undertaken either on a voluntary basis, or at the request of the competent authorities. Action to be taken includes: withdrawal from the market; adequate warning of consumers; or recall from consumers. However, recall must be a last resort where other measures are insufficient to prevent risk.

Distributors are required not to distribute products which they know, or which they ought to know, on the basis of the information in their possession and as professionals, to be unsafe. As well as participating in the monitoring of products, forwarding information on risks and co-operating in any action to avoid risks, distributors must now also keep and provide the documentation necessary to trace the origin of products.

In a major new clause, the directive requires that where producers and distributors know, or ought to know, that one of their products is unsafe, they must immediately inform the competent authorities of the member states, giving details of action taken to prevent risk to the consumer. Details of how this notification scheme will work is given in annex 1 to the directive. Both producers and distributors are required under the directive to co-operate with the competent authorities, at the request of the latter, on action taken to avoid the risks posed by their products. The procedures for such co-operation will be established by the competent authorities.

Any restrictions imposed on products must state the appropriate reason on which they are based and be notified as soon as possible to the parties concerned, with an indication of the remedies available. The parties concerned must, whenever feasible, be given an opportunity to submit their views beforehand, or where urgent action is required, after the measure has been implemented. Product withdrawals or recalls must take into consideration the need to encourage distributors, users and consumers to contribute to the implementation of such measures. Measures taken involving restrictions on products must be capable of being challenged before the competent courts.

As regards penalties for non compliance, these will be for each member state to decide, but must be notified to the Commission by 15 January 2004. Penalties must be effective, proportionate and dissuasive.

POWERS OF THE COMPETENT AUTHORITIES

Under the directive, the competent authorities may check any product to assess its safety properties and may require the parties concerned to supply necessary information.

They may ban the marketing of any product found to be dangerous and take measures to ensure the ban is complied with. In the case of a dangerous product already on the market, the authorities may order (or organise) its immediate withdrawal and alert consumers to the risks it presents. They may also organise, together with producers and distributors, the product's recall from consumers and its destruction in suitable conditions. However, any action taken must be proportionate to the seriousness of the risk, taking into account the precautionary principle. In this context they must encourage voluntary action, including where applicable the development of codes of good practice.

MARKET SURVEILLANCE

Member states are required under the directive to undertake effective market surveillance for hazardous products. They are also required to ensure that consumers and others are able to, and know how to, submit complaints to the authorities on product safety and on surveillance and control activities. Complaints must be followed up as appropriate. The Commission, for its part, is tasked with promoting and participating in a European network of competent authorities which will work alongside other EU schemes, such as RAPEX. This network will engage in exchanges of information, joint surveillance operations, co-operation in training activities etc. Member states must inform the Commission of any restrictions imposed, even where the risks are restricted to the national arena. In the latter case, this is only insofar as the information may be of interest to other member states, or involve a new risk not yet reported in other notifications. Serious risks must be notified via the existing RAPEX system, details of which are set out in annex II of the directive. The Commission has the power under article 13 of the directive to require member states to take measures in certain circumstances where it becomes aware of a serious risk to consumers.

Information available to the authorities of the member states, or the Commission, relating to product risks must in general be available to the public, in accordance with the requirements of transparency and without prejudice to the restrictions required for monitoring and investigation activities. In particular, the public must have access to information on product identification, the nature of the risk and the measures taken. Information covered by professional secrecy may be exempt in duly justified cases. Except where it relates to the safety properties of products which must be made public if circumstances so require, in order to protect health and safety.

Information on how the directive is likely to apply in the UK can be found in a DTI consultation paper at: www.dti.gov.uk/CACP/ca/consultation/gpsdcon.pdf

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety. OJ L 11. 15.01.02. pp 4-17