Legal Week
October 20, 2005


With the General Product Safety Regulations 2005 now in force [in the
UK], producers and suppliers of consumer products are under scrutiny
to deliver safety, with heavy fines and penalties for abuse.

By Rod Freeman

On 1 October, 2005, the General Product Safety Regulations 2005
(GPSR) came into force, marking a fundamental change in the way
consumers are protected from product safety risks in the UK.

The new regulations enhance the level of consumer protection by
imposing onerous new obligations on producers and suppliers of
consumer products, by giving new powers and responsibilities to
enforcement authorities and by increasing the risks and penalties for
businesses that do not comply.

The GPSR applies to all categories of consumer products except to the
extent that their safety is governed by sector legislation at European
Union (EU) level. In practice, this means that the GPSR will apply --
at least in part -- to all consumer products except for food and
(arguably) pharmaceuticals, which are both covered by their own
comprehensive sector-specific safety regulations.

The GPSR implements, albeit belatedly, Directive 2001/95/EC on general
product safety.

This new directive itself is a reworked version of an earlier General
Product Safety Directive (92/59/EEC), with the new provisions
intended to increase the level of consumer protection provided by
these measures.

The deadline for implementation of the new directive was, in fact, 15
January, 2004. The UK is one of the last member states to implement
it, ahead only of The Netherlands and Luxembourg.

The general safety requirement

The GPSR are based around a 'general safety requirement', that is, the
obligation on producers and distributors of consumer products to place
only 'safe' products on the market.

A 'safe' product is defined in terms of it presenting no risks, or
presenting 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.

Factors such as the provision of instructions and warnings, and
whether particularly vulnerable categories of consumers are at risk,
are to be taken into account.

This is a demanding test, and sets a low threshold for when the risks
presented by a product will be considered to be unacceptably

New obligations for producers and distributors

Producers are now required to mark products with details of their name
and address (unless it is not reasonable to do so) and in most cases
they must maintain a register of complaints about the safety of their
products. In many cases, producers will also be expected to have a
programme for conducting sample testing of marketed products.

They will also need to have taken reasonable steps to be in a position
to be able to trace products and undertake effective corrective action
if an unexpected risk does arise.

Product recall

For the first time in the UK, producers of products will be under a
direct legal obligation, where justified by the circumstances, to
recall dangerous products. Where they neglect to do so, the
authorities will have the power to conduct the recall and claim the
costs back from the producer.

One of the most important innovations of the new directive is the
obligation on producers to immediately notify the competent
authorities when they become aware that they have put an unsafe
product on the market. This is the first time such an obligation has
been imposed generally on producers and distributors of consumer
products in the UK. It is a strict obligation and has proved to be one
of the most difficult aspects of the new regime for producers and

The Department of Trade and Industry (DTI) has published guidelines
which, in line with guidance published by the European Commission
(EC), suggest that the term 'immediately' means no later than 10
calendar days from the date of knowledge of the potential risk (three
calendar days for 'serious' risks). This is, in itself, a very short
time frame to assess a risk, particularly where knowledge of it
emerges over time.

The guidance published by the EC also seeks to provide some assistance
on how to determine when the notification obligation arises by setting
out a 'risk assessment methodology'. This methodology, while finding
some acceptance with enforcement authorities in the EU, has been met
with criticism, and there are already moves to produce a more workable
risk assessment model.

Nevertheless, the implications of a failure to notify can be
significant, and the tight time frames for notification, combined with
the uncertainty surrounding what is a proper approach to risk
assessment for this purpose, highlight the need for producers and
distributors to call upon the right level of both technical and
specialist legal expertise as an urgent matter, as soon as a potential
risk is identified.

The possible implications of a notification to national authorities
are amplified by the enhanced information-sharing procedures in the EU
that accompany the new directive. These ensure that notified
information about 'serious' risks is promptly communicated the EC and
the other member states via the Rapid Alert System for Non-Food
Products (RAPEX) system. Such information is also made public on the
EC's website.

The EC has also, this year, entered into an agreement with the
Consumer Product Safety Commission in the US for the sharing of
information about product risks.

Practical difficulties with pan-European recalls

The new notification obligation presents challenges for producers and
distributors that market their products in more than one member state,
and may therefore have to ensure all relevant authorities are notified
'immediately' in accordance with the local implementing laws.

Systems to create a central notification system are still being
developed, but in practice, producers that are concerned about
protecting their reputation in local markets will wish to liaise
directly with national authorities in each country where the product
has been marketed. This process does not have to be unduly onerous,
but it does require careful planning, management, and usually the
involvement of a network of local counsel experienced in liaising with
the local safety authorities.

The new directive requires member states to ensure that the safety
requirements are enforced adequately. The GPSR therefore provides a
range of powers to trading standards authorities, including powers to
withdraw products from the supply chain, to oblige producers to
provide warnings/instructions and to conduct product recalls.

Controversially, in determining what action is appropriate in relation
to a particular risk, the authorities are now required to take account
of the 'precautionary principle'.

The GPSR provide for increased penalties for non-compliance, with the
more serious offences attracting penalties of up to u20,000 and/or 12
months' imprisonment.

Some aspects of the new directive are similar to those that have
operated for some years in the US under the Consumer Product Safety
Act and which have been particularly burdensome for producers and
suppliers of consumer products in that jurisdiction.

The European model will present similar challenges. Indeed, the
European regime is, in some important respects, more difficult for
producers because the threshold for notifying authorities of risks is
lower, there is less protection for confidential information
and,unlike in the US, there is no centralised system of enforcement.

With more than 18 months' experience of the new regime in some member
states, there are some trends that are now starting to emerge. There
is a marked trend in the number of dangerous products being reported
to the EC through the RAPEX system. Generally, safety authorities
across the EU are becoming increasingly active in scrutinising any
potential safety risks that may arise for consumers within their

Producers and distributors across the EU have generally been actively
reviewing their systems and contracts to make the adjustments required
of them. For those producers that have had to deal with unexpected
product risks in the EU over the past 18 months, the need to be
properly prepared has been already brought home in no uncertain terms.
Unsurprisingly, product safety lawyers have seen a significant
increase in the demand for compliance and regulatory advice from their
clients as the obligations and risks of the new regime are starting to
become understood.

Now that the new regulations are in force in almost every member
state, the next phase will almost certainly involve a period of
increased enforcement activity by the authorities. As has been the
experience in the US, one might expect that this will be accompanied
by a few high-profile and well-publicised prosecutions of some
producers which have not responded sufficiently quickly to the
requirements of the new regime, and which have been caught out by the
enhanced enforcement measures that now exist in the UK and throughout
the rest of the EU.

Rod Freeman is a partner at Lovells and a specialist in product
liability and product safety law.