Product Liability 2009 - Arnold & Porter LLP

16
Chapter 3
The EU General
Product Safety Regime
Lovells LLP
The regulation of the safety of consumer products in the EU has
changed fundamentally since 15 January 2004, the date for the
implementation of the General Product Safety Directive (2001/95/
EC) (the Directive). The Directive marked the end of the “silent”
recall of consumer products in the EU, imposing onerous new
obligations on suppliers of consumer products to EU markets.
The Directive, which has been implemented in all EU Member
States, has had a significant impact, as evidenced by the substantial
increase in the number of recalls and other notifications of
dangerous products since it came into effect. The greatest number
of recalls has been of toys, electrical products, childcare articles and
motor vehicles. Producers and distributors have had to implement
changes to their systems and processes for managing potential
safety risks, and they have witnessed greater publicity being given
to product safety issues in their industries.
This article:
Considers the key features and provisions of the Directive.
Summarises European Commission (the Commission)
guidance on the notification obligation.
Provides practical advice on risk management and product
recalls in particular.
(References to Articles are to Articles in the Directive unless
otherwise stated.)
General Product Safety
The first directive on general product safety (92/59/EEC) was
adopted in 1992 and introduced into the EU the concept of a
“general product safety obligation” (the “1992 Directive”). Its
purpose was to ensure a consistent, high level of safety in respect of
consumer products throughout the EU; however, it did not have
much of an impact in the Member States, and was criticised for not
going far enough to ensure consumer safety (particularly at an
enforcement level), and for lack of clarity of several of its
provisions.
These criticisms culminated in the revised Directive, which
replaced the 1992 Directive and took the regulation of product
safety in the EU to a new level. The Commission’s objectives in
revising the 1992 Directive were to provide for increased
transparency, more active market surveillance, more effective
enforcement measures and simpler rules for rapid intervention to
remove dangerous products from the market, all with a view to
furthering the primary aim of ensuring a high level of consumer
protection and the proper functioning of the internal market.
The Directive is intended to cover all products that are supplied to
consumers, to the extent that an aspect of their safety is not
regulated by other sector-specific safety regulations. This means
that all consumer products in the EU are fully covered either by the
Directive, or by sector-specific safety regulations, or by a
combination of the two.
Key Changes to the Safety Regime Brought
About by the Directive
The revised Directive introduced several significant changes to the
way the safety of products is regulated.
Producers and distributors have additional obligations to
conduct market surveillance and monitor risks.
Producers and distributors are required to notify national
authorities of product risks.
Producers have an obligation to recall dangerous products.
The range of products covered by the regime is wider.
The application of the regime to “borderline” industries has
been clarified.
National authorities have increased powers and obligations
to enforce product safety laws and prosecute those who fail
to meet their obligations.
National authorities have powers to initiate product recalls of
their own accord.
National authorities have powers to share information with
each other and with the public.
Key provisions
John Meltzer
Rod Freeman
The safety regime under the Directive is built around the “general
safety requirement” (Article 3(1)). A product that does not meet the
definition of a safe product is considered “dangerous” (Article
2(c)).
What is a safe product?
A “safe product” is 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. The following
points in particular should be taken into account:
The characteristics of the product, including its composition,
packaging, instructions for assembly and, where applicable,
for installation and maintenance.
Its effect on other products, where it is reasonably
foreseeable that it will be used with other products.
The presentation of the product, the labelling, any warnings
and instructions for its use and disposal and any other
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