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The General Product Safety Directive (GPSD) Summary This directive applies to the supply of all new and secondhand products to consumers for personal use, whether they were intended for use by consumers or not. The directive either applies entirely to a product, if no CE marking directives apply, or partially, if CE marking directives do apply to a product. Therefore, the General Products Safety Directive applies, at least partially, to all products used by consumers. The directive contains specific requirements for suppliers, including manufacturers, importers, retailers, distributors, those who rework, repair or modify, service providers etc. Personal transactions are excluded from the directive. In the UK, this directive is primarily enforced by local Trading Standards Authorities and Environmental Health Officers. The maximum penalty for failure to comply is a 12 month prison sentence and/or a 20,000 pound fine. Authorities also have the power to force a recall and replacement of faulty products. Contents Purpose The General Product Safety Directive 2001/95/EC supports two objectives laid out in the EC Treaty: 1) Article 100a for creating a single European market in goods and services with the objective of providing producers and consumers with the benefits of economies of scale that this offers, and 2) Article 129a for ensuring consumer protection. The effect of the directive has been to introduce identical requirements for consumer product safety in every country within the European Economic Area (EEA). In the UK, it has been implemented into United Kingdom law by Statutory Instrument (S.I.) 2005/1803: The General Product Safety Regulations 2005. The Directive applies to the supply of all new and second hand products to consumers for personal use. It also applies to products that have migrated from professional to consumer user, either through the distribution of new products or resale of second-hand products. Products include all goods placed on the market, including during the provision of a service. "Supply" includes selling, leasing, hiring, lending and part exchanging. The Directive does not apply to products for use in the workplace by employees or for those which are to be exported outside the EU. Where safety related requirements for a product are dealt with by other directives (such as CE marking directives), their requirements shall take precedence over the corresponding GPSD requirements. The GPSD places additional requirements on the supplier though - see Relationship between the GPSD and CE marking directives for more details. The Regulations are generally enforced in the United Kingdom by local authorities, primarily local Trading Standards Authorities and Environmental Health Officers. For certain products, enforcement will be undertaken by other authorities, such as VOSA for vehicles and MHRA for medical devices. There is also a provision, for the first time, for the European Commission to impose a ban on a product without a member state's request. In the UK, the maximum penalty for the supply of non-compliant products is 12 months imprisonment and/or a £20 000 fine. More importantly, the regulations also give the authorities the power to force manufacturers to recall or replace faulty product - potentially a far more onerous penalty. Under the regulations, authorities are given the powers to enter premises, test products and seize records and products. The authorities have various measures available to them, i.e.
One of the main requirements is for products to be safe. Obviously, safety is subjective and there are a number of ways presented to assess safety. Where existing specific product directives exists for the products, these are applicable. In the absence of existing directives, the GPSD has provision for using harmonised European standards listed as supporting the GPSD to provide a presumption of conformity with the requirements, in the same way as CE marking directives. Where such standards do not exist, recourse to other harmonised European standards, national standards, codes of practice and the state of the art etc. can be used to support claims of compliance with the safety requirements. It should be noted that International standards are given no special status in the regulations. The Directive applies to all suppliers of products used by consumers, whether intended for them or not. It only applies to the supply of goods as part of a commercial activity, so personal sales are not covered. The Directive distinguishes between producers and distributors: Producers are those who manufacture or otherwise bring the product to market, such as an importer. It also covers those whose activities affect the safety of the product, such as repairers. Distributors are those whose activities do not affect the safety of the product, such as wholesalers, retailers etc. The regulations place an obligation on suppliers for their products to be safe. They are required to provide consumers with all relevant safety information for safe use and to keep themselves informed of the risks. Suppliers are required to inform the authorities when they discover that they have placed an unsafe product on the market. The relevant authority will depend on the product and would, in most cases, be the local authorities. The producer is specifically required to:
Such measures may include:
Obligations on the Distributor A distributor should act with due care and must not supply products which as a professional he knows or should have presumed to be dangerous. They should maintain records, as far as possible, to enable unsafe products to be traced back to their origins. This is only applicable within the limits of his activity. The requirement could be viewed as an obligation for a distributor to maintain the chain that enables tracing of products. It should be notes that enforcement action by an enforcement authority concerning the maintenance of records would only be contemplated if there is a safety issue with the product.
The European Commission have a special section on the GPSD with a great deal of useful information on their EUROPA server. This includes the full text of the directive, lists of the current harmonised standards as well as guidance and interpretative documents. The UK government's Department for Business, Enterprise and Regulatory Reform (BERR) publishes a number of useful guides on the Directive and these are available for download. As with all directives, the actual requirements for any piece of equipment under the directive are complex and dependent on not only the design but also the type of user, the intended use and what is claimed in the instructions or sales literature. For further advice specific to your products, please contact us at Conformance and we will be pleased to discuss your needs.
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