UK: Double Trouble: Supplying Dangerous Products Can Give Rise To Both Criminal And Civil Liability

Last Updated: 13 March 2008
Article by John D. Colahan and Mark Clarke

Businesses which fail to comply with the General Product Safety Directive face an increased risk of both criminal and civil liability. This article provides an overview of businesses' obligations under the General Product Safety Directive and considers some of the product liability implications of failing to comply with the safety standards that it imposes.

The Regime

The General Product Safety Directive (2001/95/EC) (the GPSD) has been implemented by each of the Member States of the European Union (EU). The GPSD introduced a new safety regime to the EU and, through the various national implementing measures, has imposed new obligations on producers, suppliers and distributors of consumer products. Certain consumer products, such as toys, cosmetics and electrical appliances, are covered by sectoral Directives. Where a product is subject to specific safety requirements imposed by a sectoral Directive, the GPSD will only apply to the aspects and risks or categories of risks not covered by the sectoral Directive.

The General Safety Requirement

The GPSD provides for a primary obligation for producers and distributors of consumer products to place only safe products on the market. A "safe" product is one which, under normal or reasonably foreseeable conditions of use, does not present any risk to consumers, or only the minimum risks compatible with the product's use. All other products are deemed to be "dangerous" products.

Supporting Obligations

This general safety requirement is supported by various secondary obligations which require producers and distributors of consumer products to share and report information concerning risk, and to take appropriate action to manage such risk, including, if appropriate, recalling the products.

In particular, producers and distributors must immediately notify a competent enforcement authority where a product is known to pose a risk to consumers that is incompatible with the general safety requirement. Such businesses must also immediately inform the competent authority of any action they have taken to prevent risks to consumers.

If a competent authority considers the risk to consumers to be "serious" (i.e., requiring rapid intervention), it is obliged to notify the European Commission (the Commission) with "due dispatch". The Commission will then share this information with other Member States through RAPEX, its Rapid Alert System for dangerous consumer products (including consumer products that are covered by sectoral Directives, but excluding food and medical devices or pharmaceuticals). Sharing the information via RAPEX will discharge any obligation to notify other national authorities in the RAPEX area.

The competent authorities are obliged to promote and encourage voluntary action, but where a competent authority has reasonable grounds for believing that a product is dangerous and the voluntary action taken by a business has not been sufficient to minimise the risk to consumers, it can order the business to take appropriate measures, including, as a last resort, recalling the product (sometimes at very short notice).

Liability Under the GPSD

Failure to comply with the obligations arising under national laws implementing the GPSD can result in significant reputational damage for a business, particularly in the event of a product recall (whether instigated by the business itself or by a competent authority). Further, breaches of the GPSD can give rise to criminal liability under national laws. In England and Wales, the penalty for each offence can be a fine of up to £20,000 and/or up to 12 months of imprisonment. The GPSD does not, however, require Member States to provide for the compensation of consumers who are injured by dangerous products or as a result of other breaches of the GPSD.

Civil Liability

On a European level, civil liability for injury caused by dangerous products is provided for by the Directive on Liability for Defective Products (85/374/EEC) (the Product Liability Directive). The Product Liability Directive provides for a strict liability regime, pursuant to which, even in the absence of fault, a supplier is liable to pay compensation for damage caused by a defective product. Under the Product Liability Directive, a product is "defective" if it does not "provide the safety which a person is entitled to expect". Businesses may be subject to additional civil liability regimes at a national level, for example, in England and Wales, in negligence or for breach of contract or statutory duty.

Whilst the concepts of "dangerousness" and "defectiveness" under the two Directives are different, it is likely that a product which is proven to be "dangerous" under the GPSD would not be considered to provide the safety which a person is entitled to expect and, as such, would also be "defective" under the Product Liability Directive. In such a case, the supplier of the product would be at risk of both criminal prosecution and of civil liability for damages. (It is interesting to note, however, that although a supplier may be able to invoke a complete defence under the Product Liability Directive, such as the "development risk defence", this would not remove its potential criminal liability under the GPSD.)

Similarly, although failure to comply with the supporting obligations provided for by the GPSD will not incur a civil liability for damages, proof of such failure may, and in England and Wales can, be adduced as evidence of a business's negligence or breach of statutory duty.

Further, since the GPSD provides for a number of routes through which producers and distributors of consumer products can or must provide product safety information in writing to enforcement authorities and/or the Commission (both of which can require the production of reports as a compulsory measure), such businesses must be mindful, to the fullest extent possible, about the creation of adverse or sensitive documents in this context. Enforcement authorities are obliged to make such information available to the public and, where an enforcement authority considers there to be a serious risk, it must notify the Commission, which will share the information with the other Member States.

The corollary is that product risk information is now disseminated more quickly and widely than ever before and the greater the availability of information about potentially dangerous or defective products, the greater the risk of civil claims. Added to which, in the event of a civil claim in England and Wales, such information as has been communicated to the enforcement authorities would probably fail to be disclosed in the civil proceedings (and this is likely to include information that has been communicated to the enforcement authorities under cover of "professional secrecy").

Practical Guidance

The GPSD has considerably reduced the discretion of producers and distributors of consumer products with respect to when to issue warnings or share information concerning the risks which such products might present and when corrective measures, including recalls, should be implemented. This reduction in discretion has increased the level of corrective activity and, with it, the risk of civil claims for damages. The best way for businesses to avoid the double exposure to criminal and civil liability is to prevent product safety risks before they occur. This can be most easily effected at the time of procurement, when any product which a business proposes to import and/or supply should be assessed against the relevant regulatory requirements and industry best practice.

In any event, all businesses that produce, import and/or supply consumer products must comply with the safety standards prescribed by both the GPSD and the Product Liability Directive. Together, these Directives impose a significant obligation on such businesses to ensure the safety of consumer products in the EU and failure to do so presents real business risks.

That being so, all such businesses should carefully evaluate their internal systems for quality assurance and the management of risk. In particular, where businesses import products directly from markets with histories of product safety concerns, it is their duty to ensure that such products are safe and the various obligations provided for by the GPSD are complied with. Such businesses should not, therefore, simply rely upon warranties from non- European manufacturers that products have been adequately tested, but must ensure independently that appropriate quality controls are in place and that their products are safe. Moreover, in the light of recent highly publicised disputes along supply chains, it is advisable to review existing contractual documentation to make sure that it has a clear delineation of responsibility for failures of quality assurance, as well as robust dispute resolution provisions.

Accordingly, producers, importers and/or suppliers of consumer products should, as appropriate:

  • document their quality control system and regularly update it;
  • conduct sample testing;
  • investigate, record and follow-up any product related complaints;
  • maintain appropriate warnings and instructions on their products;
  • establish and maintain a document retention policy;
  • establish relationships with relevant trade associations;
  • train personnel on product safety issues; and
  • monitor technological developments relating to product safety.

Additionally, given the speed with which producers and distributors of consumer products are now expected to report risks arising in relation to their products and the corrective they have taken to minimise the risk to consumers, it has never been more important to establish a rapid response system to deal with information concerning risk and implement a crisis management plan to enable swift and thorough product recalls. Whilst these steps may not extinguish the possibility of civil claims, they are likely to reduce the likelihood of the same.

Finally, the impact caused by action in the EU needs to be considered in the light of regimes and liability that can arise elsewhere, notably in the US.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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