Download European Product Safety Regime: Long Awaited

Innovation
MARCH 2013
Product Liability and Product Safety Group
European Product Safety Regime:
Long Awaited Reform Now Within
Touching Distance
On 13 February 2013 the European Commission (“the Commission”)
proposed new rules to improve the safety of products circulating in the
European Union (“the Union”) and to improve market surveillance.
The 2008 adoption of a New Legislative Framework1 on the marketing of products and other
measures has meant that the product safety regime has been in need of an overhaul, in order
to ensure better integration of the legislative tools in the area of consumer product safety.
The February 2013 proposal comprises a “package” of the following measures:
»» A proposal for a new Regulation on Consumer Product Safety.
»» A proposal for single Regulation on Market Surveillance for products.
»» A communication for safer and compliant products for Europe, setting out a
multi-annual plan for market surveillance.
»» A report on the implementation of Regulation (EC) No. 765/20082 , including a
financial valuation.
The focus of this briefing note is on the two new proposed Regulations, which, once implemented,
will be directly binding on Member States. The two proposed Regulations will operate in the
same way as the Revised General Product Safety Directive i.e. the measures contained in the draft
Regulations will apply where there is no sector-specific regime.
This document contains a general
summary of developments and is not
a complete or definitive statement of
the law. Specific legal advice should
be obtained where appropriate.
1
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out
the requirements for accreditation and market surveillance relating to the marketing of products and
repealing Regulation (EEC) No 339/93; Decision No 768/2008/EC of the European Parliament and
of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing
Council Decision 93/465/EEC; Regulation (EC) No 764/2008 of the European Parliament and of the
Council of 9 July 2008 laying down procedures relating to the application of certain national technical
rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC.
2
Ibid.
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1. Proposed New Regulation on Consumer
Product Safety
This proposed new Regulation concerns all non-food consumer
products, with certain clearly defined exceptions, such as
medicinal products for human or veterinary use, food and
feed3. It is intended to replace Directive 2001/95/EC, the
Revised General Product Safety Directive, which is currently
the “cornerstone” of product safety legislation in the Union
and which is implemented at a national level by the various
Member States.
The Commission’s explanatory memorandum accompanying
the draft Regulation states “the proposed regulation requires that
consumer products must be “safe”, sets out certain obligations on
economic operators and contains provisions for the development
of standards and support of the general safety requirement. The
operation of the proposed regulation and its interface with other union
legislation will be significantly streamlined and simplified whilst
maintaining a high level of protection of the health safety of consumers”.
Of note is the fact that the proposed Regulation does not refer
to “producer” unlike the current legislation, but instead to
“economic operator” and identifies obligations in relation
to specific roles in the supply chain, such as “manufacturer”,
“authorised representative” and “distributor”.
Key elements of the proposed Regulation on Consumer
Product Safety
»» Article 2 confirms that the new regulation expands upon
the previous rules in that it applies to products to which
consumers are exposed in the context of a service provided
to them.
»» Article 4 states that economic operators shall make
available on the Union market, only safe products (known
as the “general safety requirement”).
»» Article 5 states that a product will be presumed to be in
compliance with the general safety requirement if it
conforms with Union harmonisation legislation, as regards
the risks covered by the requirements designed to protect
human health and safety (within sector specific regimes).
»» Article 7 requires that products (or packaging /
accompanying documentation) must bear country of
origin indications.
»» Article 8 places an obligation on manufacturers to draw up
technical documentation (including an analysis of risks)
and retain this for a period of 10 years after the product has
been placed on the market and also to make this available
to Market Surveillance Authorities on request. This Article
also provides that products should provide a type / batch /
serial number and full contact details of the manufacturer.
»» Articles 9, 10 & 11 set out detailed responsibilities
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of manufacturers, authorised representatives, importers
and distributors, including an obligation to notify Market
Article 2 of the draft Regulation sets out a full list.
Surveillance Authorities of risks. There are certain
exemptions from the obligation to inform Market
Surveillance Authorities set out in Article 13, for
example, “only a limited number of well identified
products are not safe”, or “the manufacturer, importer or
distributor can demonstrate that the risk has been fully
controlled and cannot any more endanger the health and
safety of persons”.
»» Article 15 sets out specific requirements for traceability
(including electronic traceability) for certain products
which, due to their specific characteristics, or specific
conditions of distribution or usage are susceptible to bear a
serious risk to the health and safety of consumers.
»» Article 18 deals with penalties and allows for Member
States to lay down the rules on infringement which are
to be notified to the Commission 3 months prior to the
date of application of the Regulation. Of note is the
provision that the penalty should have regard to the
size of the business and whether the economic operator
has committed a previous similar infringement. Criminal
sanctions may apply for serious infringement.
2. Proposed New Regulation on
Market Surveillance
The Commission’s explanatory memorandum accompanying
this draft Regulation highlights that market surveillance
has not kept pace with developments in the Union’s general
regulatory framework and ought to be coordinated and capable
of reacting rapidly over a large geographical area. It recognises
that there is a large overlap between the various pieces of
existing legislation in terms of the market surveillance rules
and obligations on economic operators. The Commission finds
that this has led to confusion on the part of both economic
operators and national authorities.
The new Regulation will apply consumer and non-consumer
products with certain exceptions, such as, for example, food, for
which there is a separate market surveillance regime in place4.
Key elements of the proposed Regulation on
Market Surveillance
»» Article 5 provides that each Member State is to designate
Market Surveillance Authorities and define their duties,
powers and organisations.
»» Article 6 states that Market Surveillance Authorities shall
perform appropriate checks on an “adequate scale” and
with “adequate frequency” by means of documentary
checks and physical and laboratory checks where necessary.
»» Article 9 provides for Market Surveillance Authorities to
carry out risk assessment and sets out obligations on
economic operators to rectify formal non-compliance with
legislation in relation to e.g. CE marking or labelling.
4
Other exceptions are, e.g. medicinal products for human and
veterinary use, medical devices, transportable pressure
equipment. Article 2 sets out a full explanation as to scope.
EUROPEAN PRODUCT SAFETY REGIME: LONG AWAITED REFORM NOW WITHIN TOUCHING DISTANCE
MARCH 2013
Where Market Surveillance Authorities find that a
product does present a risk they shall, without delay,
specify the necessary corrective action to be taken
by the economic operator to address the risk within
a specified period. This corrective action can be
recommended or agreed with the economic operator.
Types of corrective action to be taken by economic
operators in circumstances where a product presents a
risk include affixing warnings, temporary prevention
from placing on the marking pending a risk assessment,
withdrawing or recalling the product and alerting the
public to the risk presented.
»» Article 10 gives Market Surveillance Authorities the power to take “all necessary measures” to deal with the risk presented by the product in circumstances where the economic operator cannot be identified or, has not
taken the necessary corrective action within the time
frame specified. This Article also provides that in cases
where Market Surveillance Authorities consider a product presents a serious risk, they shall take “all necessary measures” without first requiring the economic
operator the opportunity to take corrective action.
»» Articles 14-18 set out detailed measures for control of
products entering the Union.
»» Articles 19 & 20 deal with workings of the RAPEX system
(Rapid Information Exchange System). This is currently
a provision of the Revised General Product Safety Directive
and the fact that it is proposed that this now be housed
within the proposed Market Surveillance Regulation,
demonstrates that both this and the proposed Consumer
Product Safety Regulation, are intended to operate in close
conjunction with one another.
»» Article 25 establishes a European Market Surveillance
Forum to meet at regular intervals. Tasks of this body
will include the exchange of expertise and best practises
and organising joint market surveillance and joint
testing programmes.
Summary
These proposed new pieces of legislation represent a significant
revision of the current status quo. Both economic operators and
Market Surveillance Authorities will have to adapt to the new
regime within a relatively short lead in time, once both draft
Regulations have been finalised.
The proposals will now be discussed by the European
Parliament and the Council. The proposed new legislation is
expected to come into effect in 2015. We will report further
with any changes to the proposals as matters develop.
Contacts
If you would like further details please speak to your usual Arthur Cox contact or any of the persons listed below.
Isabel Foley
Partner
Orla Clayton
Associate
+353 (0)1 618 0450
[email protected]
+353 (0)1 618 0437
[email protected]
Dublin
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