Amended proposal for a Directive of the European Parliament and of the Council on general product safety
Date: 2001-02-02
Institutions: European Commission
Subjects: consumer information, consumer protection, environmental risk prevention, product safety, public health

29.5.2001

EN

Official Journal of the European Communities

C 154 E/265

Amended proposal for a Directive of the European Parliament and of the Council on general
product safety

(2001/C 154 E/24)

(Text with EEA relevance)

COM(2001) 63 final (cid:151) 2000/0073(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 2 February 2001)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

Whereas:

(1) Under Article 16 of Council Directive 92/59/EEC of 29
June 1992 on general product safety (1), the Council was
to decide, four years after the date set for the implemen-
tation of the Directive, on the basis of a report of the
Commission on the experience acquired, together with
appropriate proposals, whether to adjust the Directive.
is necessary to introduce several amendments
Since it
into the Directive,
in order to complete, reinforce or
clarify certain of its provisions taking into account the
experience gained as well as new and relevant devel-
opments on consumer product safety and in the light of
the precautionary principle, Directive 92/59/EEC should
be recast in the interest of clarity.

(2) It

to adopt measures with the aim of
is important
improving the
internal market,
the
functioning of
comprising an area without internal frontiers in which
services and
the free movement of goods, persons,
capital is assured.

(3) In the absence of Community provisions, horizontal legis-
lation of the Member States on product safety, imposing
in particular a general obligation on economic operators
to market only safe products, might differ in the level of
protection afforded to persons. Such disparities, and the
absence of horizontal legislation in certain Member States,
would be liable to create barriers to trade and distortion
competition within the internal market.

(4) In order to ensure a high level of consumer protection,
the Community must contribute to protecting the health
and safety of consumers. Horizontal Community legis-

(1) OJ L 228, 11.8.1992, p. 24.

lation introducing a general product safety requirement,
provisions on the general obligations of producers and
distributors, on the enforcement of Community product
safety requirements and for rapid exchange of information
and action at Community level in certain cases, should
contribute to that aim.

(5) It is very difficult to adopt Community legislation for
every product which exists or which may be developed.
There is a need for a broad-based, legislative framework of
a horizontal nature to deal with such products, and also
in
to cover
existing or forthcoming specific legislation, in particular
with a view to ensuring a high level of protection of
safety and health of persons, as required by Article 95
of the Treaty.

lacunae and to complement provisions

(6) It is therefore necessary to establish at Community level a
general safety requirement for any product placed on the
market, or otherwise supplied or made available to
consumers, intended for consumers, or likely to be used
by consumers under reasonably foreseeable conditions
these cases the
even if not
products under consideration can pose risks for
the
health and safety of consumers which must be prevented.
Certain second-hand goods
should nevertheless be
excluded by their very nature.

intended for them.

In all

(7) The provisions of this Directive should apply to products
irrespective of the selling techniques including distance
and electronic selling.

(8) The safety of products should be assessed taking into
the categories of consumers which can be
account
risks posed by the
to the
particularly vulnerable
products under consideration, in particular children and
the elderly.

(9) Production equipment, capital goods and other products
used in the context of a trade or business should be
covered by this Directive,
they are intended to be
if
used for supplying a service to consumers, as far as
consumer health and safety aspects are concerned. It is
necessary,
this
Directive, that manufacturers ensure that such products
do not pose risks for the safety of consumers when
used under normal or reasonably foreseeable conditions
by service providers.

to achieve the objectives of

in order

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(10) Products which are designed exclusively for professional
use but have subsequently migrated to the consumer
market must be subject
this
Directive because they can pose risks
to consumer
health and safety when used under reasonably foreseeable
conditions.

to the requirements of

(11)

In the absence of more specific safety provisions, within
the framework of Community legislation covering the
products concerned, all the provisions of this Directive
are to apply in order to ensure consumer health and
safety.

(12)

out

legislation sets

specific Community

If
safety
requirements covering only certain safety aspects or
categories of risks with regard to the products concerned,
the obligations of economic operators in respect of the
safety requirements,
including data generation, hazard
identification and risk assessment, should be determined
by those provisions of the specific legislation, while the
general safety requirement of this Directive should apply
to the other aspects.

(13) Where there are specific rules of Community law of the
total harmonisation type, in particular those adopted on
the basis of the new approach, which lay down the safety
requirements applicable to certain products, further obli-
gations should not be imposed on economic operators as
regards the safety requirements to which products must
to be placed on the market.
conform in order
Accordingly,
this
safety requirement of
the general
Directive should not apply in such cases.

the Member

(14) The provisions of this Directive relating to the other obli-
gations of producers and distributors, the obligations and
exchanges of
powers of
information and rapid intervention situations, the dissemi-
nation of information and confidentiality apply in the case
of products covered by specific rules of Community law,
unless these rules contain specific provisions governing
the same aspects and having the same objectives.

States,

the

(15)

the

effective

important

to facilitate

the general safety requirement of
to
is

and consistent
In order
this
application of
Directive,
European
it
voluntary standards covering certain products and risks
in such a way that a product which conforms to a
national standard transposing a European standard is to
be presumed to be
said
requirement.

in compliance with the

establish

(16) With regard to the aims of

this Directive, European
standards should be established by European standard-
isation bodies, under mandates set by the Commission
assisted by a Committee. The mandates should indicate
the objectives that the standards must meet in order to

ensure that products in compliance with the standards
fulfil the general safety requirement.

In the absence of specific regulations and when the
European standards established under mandates set by
the Commission are not available or recourse is not
made to them, the safety of products should be assessed
taking into account national standards transposing any
other relevant European standards, Commission recom-
mendations or, failing those, national standards, codes of
practice,
the art and the safety which
the state of
consumers may reasonably expect.

It is appropriate to supplement the duty to observe the
safety requirement by other obligations on
general
economic
because
economic
operators is necessary to prevent risks to consumers
under certain circumstances.

operators

action

by

(17)

(18)

(19) The additional obligations on producers should include
the duty to adopt measures, commensurate with the
characteristics of
the products, enabling them to be
informed of the risks that these products may present,
to supply consumers with information enabling them to
assess and prevent risks, to warn consumers of the risks
posed by dangerous products already supplied to them, to
withdraw those products from the market, and, as a last
resort, to recall those products when necessary.

(20) The

on

incumbent

obligations

distributors
In particular,

are
it
proportionate to their responsibilities.
in the framework of charitable
may be impossible,
activities,
to provide the competent authorities with
information and documentation on the possible risks
and origin of
individual
in the case of
the product
second-hand goods supplied by private parties.

in action aimed

safety requirements. Both producers

(21) Distributors must help in ensuring compliance with the
and
applicable
distributors must cooperate with the competent auth-
and
orities
certain
informing
products
conditions
in the
regarding such information should be
Directive to facilitate its effective application, without
placing an excessive burden for the economic operators
and the authorities.

them when they
supplied

at preventing
conclude

dangerous.

risks

that

The

are

set

(22) In order to ensure the effective enforcement of the obli-
gations incumbent on producers and distributors,
the
Member States must establish or designate authorities
which are responsible for monitoring product safety and
have powers to take appropriate measures, including the
power to apply effective proportionate and dissuasive
penalties, and ensure appropriate coordination between
the various designated authorities.

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immediately and efficiently,

(23) It is necessary in particular for the appropriate measures
to include the power for Member States to organise or
the withdrawal of
order,
dangerous products already placed on the market,
to
prohibit the export of dangerous products and as a last
from consumers dangerous products
resort
already supplied to them. Those powers
should be
applied when producers and distributors fail to prevent
risks to consumers in accordance with their obligations.
Where necessary, the appropriate powers and procedures
must be available to the authorities to decide and apply
any necessary measures rapidly.

to recall

(28) Effective

safety requires

supervision of product

the
setting-up at national and Community levels of a system
of rapid exchange of information in situations of serious
risk requiring rapid intervention in respect of the safety of
a product. It is also appropriate for this Directive to set
out detailed procedures for the operation of the system
and to give the Commission, assisted by an advisory
committee, power to adapt them.

(29) It is primarily for Member States, in compliance with the
Treaty and in particular with Articles 28, 29 and 30
thereof,
to take appropriate measures with regard to
dangerous products located within their territory.

enforcement

of Community

(24) The safety of consumers depends to a great extent on the
safety
active
requirements. The Member States
therefore,
establish systematic approaches to ensure the effectiveness
of market surveillance and other enforcement activities
and should ensure their openness to the public and
interested parties.

product

should,

(25) Collaboration between the enforcement authorities of the
Member States is necessary in ensuring the protection
objectives of this Directive. It is, therefore, appropriate
to establish a European Product Safety Network between
the Member States to
the enforcement authorities of
facilitate collaboration at operational
level on market
surveillance and other enforcement activities, in particular
risk assessment, testing of products, exchange of expertise
and scientific knowledge, execution of joint surveillance
projects and tracing, withdrawing or recalling dangerous
products. That Network should involve the authorities in
charge of the specific products and risks concerned.

(26) In conformity with the provisions concerning the appli-
cability of this Directive, the provisions relating to colla-
boration between enforcement authorities should apply
without prejudice to specific collaboration procedures
in
established under
particular in the pharmaceutical sector. The European
Product Safety Network should cooperate with relevant
bodies in which Member States enforcement authorities
collaborate
covered by specific
Community legislation. Systems for Interchange of Data
between Administrations may be used in support of that
cooperation as appropriate.

sectoral Community legislation,

in product

sectors

(30) However,

if

the Member States differ as regards the
approach to dealing with the risk posed by certain
such differences
products,
could entail unacceptable
disparities
in consumer protection and constitute a
barrier to intra-Community trade.

(31)

It may be necessary to deal with serious product-safety
problems requiring rapid intervention which affect or
could affect, in the immediate future, all or a significant
part of the Community and which, in view of the nature
of the safety problem posed by the product, cannot be
dealt with effectively in a manner commensurate with the
degree of urgency of the problem under the procedures
laid down in the specific rules of Community law
applicable to the products or category of products in
question.

(32) It

the Community,

is therefore necessary to provide for an adequate
mechanism allowing, as a last resort, for the adoption
of measures applicable throughout
in
the form of a decision addressed to the Member States,
to cope with situations created by products presenting a
serious risk and requiring rapid intervention in the above-
mentioned circumstances and accordingly to ban their
export. Such a decision is not of direct application to
economic operators and must be incorporated into a
national
such a
instrument. Measures adopted under
procedure are interim measures, save when they apply
to
of
products. They should be taken by the Commission
assisted by a committee composed of representatives of
the Member States.

individually

identified

products

batches

or

(27)

It is necessary, for the purpose of ensuring a consistent,
high level of consumer health and safety protection and
the
preserving the unity of
Commission be informed of any measure restricting the
placing on the market of a product or requiring its with-
drawal or recall from the market. Such measures may be
taken only in compliance with the provisions of
the
Treaty, and in particular Articles 28, 29 and 30.

the internal market,

that

(33) Since such rapid intervention measures necessary for the
implementation of this Directive are measures of general
scope within the meaning of Article 2 of Council
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (1), they should be adopted
by use of the regulatory procedure provided for in Article
5 of that Decision.

(1) OJ L 184, 17.7.1999, p. 23.

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(34) In accordance with Article 2 of Decision 1999/468/EC,
the other measures necessary for the implementation of
this Directive should be adopted by use of the advisory
procedure provided for in Article 3 of that Decision. An
Advisory Committee on Consumer Product Safety should
therefore be created without prejudice to the competence
of
the various
aspects of
its application may need to be discussed
between experts from the different national adminis-
trations in charge of enforcement and market surveillance
activities.

the regulatory committee. Moreover,

(35) Public access to the information available to the auth-
orities on product safety should be ensured. However
professional secrecy, as referred to in Article 287 of the
Treaty, must be protected in a way which is compatible
with the need to ensure the effectiveness of market
surveillance activities and of protection measures.

(36) This Directive should not affect victims’ rights within the
meaning of Council Directive 85/374/EEC of 25 July 1985
on the approximation of the laws, regulations and admin-
istrative provisions of
the Member States concerning
liability for defective products (1).

(37)

It is necessary for Member States to provide for appro-
priate means of redress before the competent courts in
respect of measures taken by the competent authorities
which restrict the placing on the market of a product or
require its withdrawal or recall.

(38) In addition,

the

adoption of measures

concerning
imported products with a view to preventing risks to
the safety and health of persons must comply with the
Community’s international obligations.

(39) The Commission should regularly examine how this
Directive is applied and the results obtained, in particular
in relation to the functioning of market surveillance
information and
exchange
systems,
measures at Community level, together with other issues
relevant for consumer product safety in the Community,
and present reports to the European Parliament and the
Council on the subject.

rapid

the

of

(40) This Directive should not affect the obligations of Member
transposition and

States concerning the deadlines for
application of Directive 92/59/EEC,

(1) OJ L 210, 7.8.1985, p. 29. Directive as amended by Directive
1999/34/EC of the European Parliament and of the Council (OJ L
141, 4.6.1999, p. 20).

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

OBJECTIVE (cid:151) SCOPE (cid:151) DEFINITIONS

Article 1

The purpose of

1.
the
products referred to in Article 2(a) placed on the market are
safe.

this Directive is to ensure that

2.
This Directive shall apply only in so far as there are no
specific provisions in rules of Community law governing the
safety of the products concerned.

In particular, where products are subject to safety requirements
imposed by Community legislation specific to those products:

(cid:151) Articles 2(b) and (c), 3 and 4 of this Directive shall not
apply to those products in so far as concerns the risks or
categories of risks regulated by the specific legislation;

(cid:151) the other Articles of this Directive shall apply in so far as
there are no specific provisions in that legislation governing
the aspects covered by the said Articles of this Directive.

Article 2

For the purposes of this Directive:

or

likely,

(a) (cid:145)product(cid:146) shall mean any product which is intended for
consumers,
foreseeable
under
conditions, to be used by consumers even if not intended
for them, and is supplied or made available, whether for
consideration or not, in the course of a commercial activity
and whether new, used or reconditioned.

reasonably

This definition includes products used to provide a service,
in so far as consumer product
safety aspects under
reasonably foreseeable conditions of use of those products
are concerned.

It does not
include second-hand products supplied as
antiques or as products to be repaired or reconditioned
prior to being used, provided that
the supplier clearly
informs the person to whom he supplies the product to
that effect;

(b) (cid:145)safe product(cid:146) shall mean any product which, under normal
or reasonably foreseeable conditions of use, installation and
maintenance, including duration, does not present any risk
or only the minimum risks compatible with the product’s
use, considered as acceptable and consistent with a high
level of protection for the safety and health of persons,
taking into account the following points in particular:

(i) the

characteristics of

composition, packaging,
installation and maintenance,

the product,
instructions

including its
for assembly,

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(ii) the effect on other products, where it is reasonably
foreseeable that it will be used with other products,

(iii) the presentation of

the labelling, any
the product,
instructions for its use and disposal and any other
indication or information provided by the producer
and by distributors,

(iv) the categories of consumers at risk when using the

product, in particular children and the elderly,

(v) the services directly associated with the product
supplied, when these services are provided by the
producer,
in particular the installing and the main-
tenance of the product.

The feasibility of obtaining higher levels of safety or the
availability of other products presenting a lesser degree of
risk shall not constitute grounds for considering a product
to be (cid:145)unsafe(cid:146) or (cid:145)dangerous(cid:146);

(c) (cid:145)dangerous product(cid:146) shall mean any product which does not

meet the definition of (cid:145)safe product(cid:146) in point (b);

(d) (cid:145)producer(cid:146) shall mean:

(i) the manufacturer of the product, when he is estab-
lished in the Community, and any other person
presenting himself as the manufacturer by affixing to
the product his name, trade mark or other distinctive
mark, or the person who reconditions the product,

(ii) the manufacturer’s representative, when the manu-
if
facturer is not established in the Community or,
the
there
Community, the importer of the product,

representative

established

no

in

is

(iii) other professionals in the supply chain,

in so far as
their activities may affect the safety properties of a
product placed on the market;

(e) (cid:145)distributor(cid:146) shall mean any professional in the supply chain
whose activity does not affect the safety properties of a
product;

(f)

(cid:145)recall(cid:146) shall mean any measures aimed at achieving the
return of a dangerous product
that has already been
supplied or made available to consumers by the producer
or distributor.

CHAPTER II

GENERAL SAFETY REQUIREMENT, CONFORMITY
ASSESSMENT CRITERIA AND EUROPEAN STANDARDS

Article 3

Producers shall be obliged to place only safe products on

1.
the market.

2. Where there are no specific Community provisions
governing the safety of the products in question, a product
shall be deemed safe when it conforms to the specific rules
law of the Member State in whose territory the
of national
product is lawfully produced or marketed, such rules being
drawn up in conformity with the Treaty, and in particular
Articles 28 and 30 thereof, and laying down the health and
safety requirements which the product must satisfy in order to
be marketed. The product shall be deemed safe in so far as the
aspects covered by the rules of national law are concerned.

Products in conformity with voluntary national standards trans-
posing European standards, the references of which have been
published by the Commission in the Official
the
European Communities in accordance with Article 4 shall be
presumed to be in conformity with the general
safety
requirement of this Directive, in so far as the aspects covered
by those standards are concerned. The Member States shall
publish the references of such national standards.

Journal of

assessed having regard, where

In the absence of specific rules or national standards
3.
transposing European standards as referred to in paragraph 2
or when recourse is not made to such standards,
the
to the general safety requirement
conformity of a product
shall be
to
they exist,
to other relevant
voluntary national standards giving effect
European standards, to Commission recommendations setting
guidelines on product safety assessment or, failing these, to
standards drawn up in the Member State in which the
product is lawfully produced or marketed, to the codes of
good practice in respect of health and safety in the sector
concerned or to the state of the art and technology and to
the safety which consumers may reasonably expect.

4.
Conformity of a product with the provisions mentioned
in paragraphs 2 or 3, shall not bar the competent authorities of
the Member States from taking appropriate measures to impose
restrictions on its being placed on the market or to require its
from the market where there is evidence that,
withdrawal
despite such conformity,
it is dangerous to the health and
safety of consumers.

Article 4

1.
For the purposes of this Directive, the Commission shall
establish the mandates to the European standardisation bodies
and publish in the Official Journal of the European Communities
the references of European standards. Where there is evidence
that a standard does not ensure compliance with the general
safety requirement of
the Commission shall
this Directive,
withdraw such publication in whole or in part, in accordance
with paragraph 4.

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The mandates shall be established in accordance with Directive
98/34/EC of the European Parliament and of the Council (1).
The Commission shall ensure coordination with the Advisory
Committee on Consumer Product Safety referred to in Article
15(1) of this Directive.

The mandates shall define the objectives that the standards
to ensure that products conforming to such
must meet
safety
standards
requirement of this Directive.

in compliance with the

general

are

The standards referred to in paragraph 1 shall be adopted
2.
by European Standardisation Bodies,
in accordance with the
principles contained in the general guidelines for cooperation
between the Commission and those Bodies.

3.
The Commission, after consulting the Committee estab-
lished by Article 5 of Directive 98/34/EC, may decide to
publish in the Official Journal of the European Communities the
references of European standards relating to products covered
by this Directive which were adopted by European Standard-
isation Bodies before the entry into force of this Directive.

safety

general

4. Where a Member State or the Commission considers that
a European standard referred to in Article 3(2) does not satisfy
the
the
requirement of
Commission or the Member State shall refer the matter to
the Committee established by Directive 98/34/EC, setting out
the
its
Commission shall notify the Member States whether or not
the
to be
withdrawn from publication as referred to in Article 3(2) of
this Directive.

receiving the Committee’s opinion,

standard concerned or

this Directive,

reasons. After

thereof has

a part

CHAPTER III

OTHER OBLIGATIONS OF PRODUCERS AND OBLIGATIONS
OF DISTRIBUTORS

Article 5

1. Within the limits of their respective activities, producers
information to
shall provide consumers with the relevant
enable them to assess
in a product
inherent
the normal or reasonably foreseeable period of
throughout
its use, where such risks are not
immediately obvious
without adequate warnings, and to take precautions against
those risks.

the risks

Provision of warnings does not, however, exempt any person
from compliance with the other requirements laid down in this
Directive.

Also within the limits of their respective activities, producers
shall adopt measures commensurate with the characteristics of

(1) OJ L 204, 21.7.1998, p. 37. Directive as amended by Directive

98/48/EC (OJ L 217, 5.8.1998, p. 18).

the products which they supply, to enable them to be informed
of risks which these products might present and to take appro-
priate action including, if necessary to avoid these risks, with-
drawing the products in question from the market, adequately
and effectively warning consumers of the risks posed by the
products, or,
in the last resort, recalling from consumers
products already supplied to them when other measures
would not suffice to prevent the risks involved.

The measures shall for example include, whenever appropriate,
marking of the products or product batches in such a way that
they and their producers can be identified, sample testing of
marketed products, investigating complaints made and keeping
distributors informed of such monitoring.

Distributors shall be required to act with due care to help
2.
to ensure compliance with the applicable safety requirements,
in particular by not supplying products which they know or
should have presumed, on the basis of the information in their
possession and as professionals, do not comply with those
requirements. Moreover, within the limits of their respective
activities, they shall participate in monitoring the safety of
products placed on the market, especially by passing on
information on product
safeguarding and providing
documentation necessary for tracing the origin of products,
and cooperating in the action taken by producers and
competent authorities to avoid the risks.

risks,

that

they have placed on the market

3.
Producers and distributors shall immediately inform the
competent authorities of the Member States if they conclude
that a product
is
dangerous. They shall in particular inform the authorities of
the action taken to prevent risks to consumers and voluntary
additional measures which they intend to take or have already
taken. Specific requirements for this information are set out in
Annex I. They shall be adapted by the Commission acting in
accordance with the procedure referred to in Article 15(2).

4.
their
Producers and distributors, within the limits of
respective activities, shall collaborate with the competent auth-
orities, at the request of the latter, on action taken to avoid the
risks posed by products which they supply or have supplied.
The competent authorities shall define the procedures for such
collaboration,
for dialogue with the
producers and distributors concerned on issues related to
consumer product safety enforcement.

including procedures

CHAPTER IV

SPECIFIC OBLIGATIONS AND POWERS OF THE MEMBER
STATES

Article 6

States

shall
comply with

and
1. Member
distributors
this
Directive in such a way that products placed on the market
are safe.

that
obligations

producers
under

ensure
their

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In particular, Member States shall establish or nominate
2.
authorities competent to monitor the compliance of products
with the obligation to place only safe products on the market
and arrange for such authorities to have the necessary powers
and responsibility to take the appropriate measures incumbent
upon them under this Directive.

(f)

temporarily prohibiting, for the period required to carry
out the various checks, verifications or safety assessments,
anyone from supplying, offering to supply or exhibiting,
certain products whenever there are precise and consistent
indications that they could be dangerous;

The Member States shall define the tasks, organisation
3.
the various
the authorities competent
and powers of
product categories, risk aspects and surveillance activities, as
well as the appropriate arrangements for the exchange of
information, coordination and collaboration between such
authorities and shall notify the Commission thereof, as well
as any subsequent modification thereto. The Commission
shall pass on such information to the other Member States.

for

Article 7

to infringements of

lay down the rules on penalties
The Member States shall
applicable
the national provisions
adopted pursuant to this Directive and shall take all measures
necessary to ensure that they are implemented. The penalties
provided for must be effective, proportionate and dissuasive.
to the
The Member States
Commission by the date specified in Article 20(1) at
the
latest and shall also notify it, without delay, of any subsequent
amendment affecting them.

shall notify those provisions

(g) prohibiting the placing on the market of dangerous
products and establishing the accompanying measures
needed to ensure that the ban is complied with;

(h) organising or ordering, in cooperation with the producers
and distributors, the effective and immediate withdrawal of
dangerous products already on the market, the warning of
consumers on the risks posed by dangerous products, the
recalling from consumers of
already
supplied, and the destruction of the products in question
under appropriate conditions, if necessary, in cases where
action by producers and distributors to the same aims, in
conformity to their obligation under this Directive, is not
satisfactory or is insufficient.

those products

In particular, the competent authorities shall have the
2.
to apply
necessary powers and take the necessary action,
with due
those
mentioned in paragraph 1(d) to (h), in the case of products
posing a serious risk which requires rapid intervention.

appropriate measures

rapidity

among

Article 8

In order to achieve the objectives of this Directive and in
1.
particular for the purposes of Article 6, the competent auth-
orities of the Member States shall have the necessary powers,
and take the necessary action in accordance with the degree of
risk and in conformity with the Treaty, and in particular
Articles 28 and 30 thereof, to adopt appropriate measures
with a view to:

(a) organising appropriate checks on the safety properties of
products, even after their being placed on the market as
being safe, on an adequate scale, up to the final stage of use
or consumption;

3.
The measures to be taken by the competent authorities
under paragraphs 1 and 2 shall be addressed, as appropriate,
to:

(a) the producer;

(b) within the limits of their respective activities, distributors
and in particular the party responsible for the first stage of
distribution on the national market;

(c) any other person, where necessary, with regard to coop-
eration in action taken to avoid risks arising from a
product.

(b) requiring all necessary information from the parties

concerned;

Article 9

(c) taking samples of products and subjecting them to safety

checks;

(d) subjecting product marketing to prior conditions designed
to ensure product safety and requiring that suitable clearly
worded, easily comprehensible warnings,
in the official
language or languages of the Member State in which the
product is marketed, be affixed regarding the risks which
the product may present;

1.
The approaches established by the Member States for
operating effective market surveillance, including the working
procedures and the procedures for exchanging information and
coordination and collaboration between the various authorities
concerned, shall aim at guaranteeing a high level of consumer
health and safety protection.

2.
In order to achieve the objective referred to in paragraph
1, the Member States shall ensure that appropriate and effective
means and procedures are put in place, which may include in
particular:

(e) making arrangements to ensure that persons who might be
exposed to a risk from certain products are informed in
good time and in a suitable manner of the said risk by, inter
alia, the publication of special warnings;

(a) the establishment, periodical updating and implementation
surveillance programmes by categories of

of
sectoral
products or risks;

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(b) the

follow-up and updating of

scientific knowledge
concerning the safety of products publicly available, peri-
odical reports on surveillance activities, findings and results
achieved;

(c) periodical reviewing and assessments of the functioning of
the
if
necessary, revision of the surveillance approach and organi-
sation put in place.

control activities and their

effectiveness, and,

3.
The Member States shall ensure that consumers and other
interested parties may present complaints to the competent
authorities on product safety and on surveillance and control
activities and that these complaints are considered, followed up
as appropriate and answered. The Member States shall actively
inform consumers and the other interested parties of
the
procedures established to that end.

Article 10

The Commission shall promote the establishment and
1.
operation of a European Product Safety Network between the
authorities of
for market
surveillance of consumer products and involving also the
Commission.

the Member States competent

The Network shall cooperate with relevant bodies in
2.
product
sectors covered by the legislation referred to in
Article 1(2) and shall have as its objectives, in particular, to
facilitate:

(a) the exchange of information on risk assessment, dangerous
products,
the recent scientific
developments as well as other aspects relevant for control
activities;

test methods and results,

(b) the establishment and execution of joint surveillance and

testing projects;

(c) the exchange of expertise and best practices and colla-

boration in training activities;

(d) coordination at Community level of
and recall of dangerous products.

tracing, withdrawal

CHAPTER V

EXCHANGES OF INFORMATION AND RAPID INTERVENTION
SITUATIONS

Article 11

legislation,

inform the Commission of

to (h), the Member State shall, to the extent that such notifi-
required under Article 12 or any specific
cation is not
Community
the
measures, specifying its reasons for adopting them. Where
the notifying Member State considers that the measures relate
to an event which is local in effect and in any case limited to
its territory, the notification will specify it. It shall also inform
the Commission of any modification or withdrawal of such
measures.

The guidelines referred to in Annex II, point 8, shall define the
contents and standard form for the notifications provided for
in this Article. In particular the guidelines shall provide criteria
for determining which measures related to purely local events
must not be notified because they are not relevant for the aims
of this Article.

The Commission shall

2.
forward the notification to the
other Member States, unless it concludes, after examination,
that the measure does not comply with Community law. In
immediately inform the Member State
such a case,
which initiated the action.

it shall

Article 12

1. Where a Member State adopts or decides to adopt,
recommend or agree with manufacturers,
importers and
distributors, whether on a compulsory or voluntary basis,
measures or actions to prevent, restrict or impose specific
conditions on the possible marketing or use, within its own
territory, of products by reason of a serious risk for the health
and safety of consumers which requires rapid intervention, it
shall immediately inform the Commission thereof through the
Community Rapid Information System (RAPEX). The Member
States shall also inform the Commission without delay of any
modification or withdrawal of such measures or actions.

If the notifying Member State considers that the effects of the
risk do not or cannot go beyond its territory, the notification
shall indicate it taking into account the relevant criteria estab-
lished in the guidelines referred to in Annex II, point 8.

Without prejudice to the first subparagraph, Member States
may pass on to the Commission any information in their
possession regarding the existence of a serious risk requiring
rapid intervention before deciding to adopt the measures or
action in question.

On receiving this information,

the Commission shall
2.
check whether it complies with the requirements applicable
to the
to the functioning of RAPEX, and shall
other Member States, which,
immediately
in turn,
inform the Commission of any measures adopted.

forward it
shall

1. Where a Member State takes measures which restrict the
placing on the market of products or require their withdrawal
from the market, or the recall
those
products already supplied, as provided for in Article 8(1)(d)

from consumers of

3.
Detailed procedures for RAPEX are set out in Annex II.
They shall be adapted by the Commission in accordance with
the procedure referred to in Article 15(2).

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Access to RAPEX shall be open to candidate countries,
4.
third countries or
international organisations, within the
framework of agreements between the Community and those
countries
to
modalities defined in these agreements. Any such agreements
shall be based on reciprocity and include provisions on confi-
dentiality corresponding to those applicable in the Community.

organisations,

international

according

or

Article 13

1.
If the Commission becomes aware of a serious risk from
certain products to the health and safety of consumers in
it may, after
various Member States requiring rapid action,
consulting the Member States, adopt a decision, in accordance
with the procedure laid down in Article 14(1),
requiring
Member States to take measures from among those listed in
Article 8(1)(d) to (h) if:

(a) Member States differ on the approach to deal with the risk;

(b) the risk cannot be dealt with, in view of the nature of the
safety issue posed by the product and in a manner
compatible with the degree of urgency of the case, under
other procedures laid down by the specific Community
legislation applicable to the products concerned; and

(c) the risk can be eliminated effectively only by adopting
in
appropriate measures applicable at Community level,
order to ensure a consistent and high level of protection
of the health and safety of consumers and the proper func-
tioning of the internal market.

2.
Decisions referred to in paragraph 1 shall be valid for a
period not exceeding one year and may be confirmed, under
the same procedure, for additional periods of one year.

However, decisions concerning specific, individually identified
products or batches of products, shall be valid without a time-
limit.

Export

3.
from the Community of products for which
Member States have been required to take measures among
those listed in Article 8(1)(f), (g) and (h) shall be prohibited.

The Member States shall take all necessary measures to
4.
implement the decisions referred to in paragraph 1 within less
than 10 days, unless a different period is specified in those
decisions.

5.
The competent authorities responsible for carrying out
the measures referred to in paragraph 1 shall, within one
month, give the parties concerned an opportunity to submit
their views and shall inform the Commission accordingly.

CHAPTER VI

COMMITTEE PROCEDURES

Article 14

The Commission shall be assisted by a Regulatory
composed of
Product
the Member States and chaired by a

1.
Committee on Consumer
representatives of
representative of the Commission.

Safety,

2.
In cases where reference is made to this paragraph, the
regulatory procedure laid down in Article 5 of Decision
1999/468/EC shall apply, in compliance with Article 7(3) and
Article 8 thereof. The period provided for in Article 5(6) of
Decision 1999/468/EC shall be fifteen days.

Article 15

1.
The Commission shall be assisted by an Advisory
Committee on Consumer Product Safety composed of represen-
tatives of the Member States and chaired by the representative
of the Commission.

2. Where reference is made to this paragraph, the advisory
procedure laid down in Article 3 of Decision 1999/468/EC
shall apply,
in compliance with Article 7(3) and Article 8
thereof.

3.
The Advisory Committee on Consumer Product Safety
shall also assist the Commission in preparing standardisation
mandates in compliance with Aricle 4(1) and in examining any
question concerning the application of
in
particular issues related to enforcement and market surveillance
activities.

this Directive,

CHAPTER VII

MISCELLANEOUS AND FINAL PROVISIONS

Article 16

Information available to the authorities of the Member
1.
to consumer
States or
the Commission relating to risks
in general be
health and safety posed by products shall
available to the public in line with the requirements of trans-
parency.
to
the public
information on product identification, the nature of the risk
and the measures taken.

In particular

shall have

access

to disclose

However, the Member States and the Commission shall take the
steps necessary to ensure that their officials and agents are
the
required not
purposes of this Directive which, by its nature, is covered by
professional
for
information relating to the safety properties of products
which must be made public if circumstances so require,
in
order to protect the health and safety of consumers.

information obtained for

justified cases,

in duly

secrecy

except

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Protection of professional secrecy shall not prevent the
2.
dissemination to the competent authorities of
information
relevant for ensuring the effectiveness of market surveillance
and
receiving
information covered by professional secrecy shall ensure its
protection.

enforcement

authorities

activities.

The

Article 17

This Directive
85/374/EEC.

shall be without prejudice

to Directive

Article 18

Any measure adopted under this Directive and involving
1.
restrictions on the placing of a product on the market, or
requiring its withdrawal from the market, or its recall from
consumers must state the appropriate reasons on which it is
It shall be notified as soon as possible to the party
based.
concerned and shall indicate the remedies available under the
provisions in force in the Member State in question and the
time limits applying to such remedies.

The parties concerned shall, whenever feasible, be given an
opportunity to submit their views before the adoption of the
measure. If this has not been done in advance because of the
urgency of the measures to be taken, such opportunity shall be
given in due course after the measure has been implemented.

its

from the
Measures requiring the withdrawal of a product
market or
into
take
consideration the need to encourage distributors, users and
such
consumers
measures.

to contribute to the implementation of

from consumers

recall

shall

2. Member States shall ensure that any measure taken by the
competent authorities involving restrictions on the placing of a
product on the market or requiring its withdrawal from the
market or recall from consumers can be challenged before the
competent courts.

Any decision taken by virtue of

this Directive and
3.
involving restrictions on the placing of a product on the
market or requiring its withdrawal
from the market or its
recall from consumers shall be without prejudice to assessment
of the liability of the party concerned,
in the light of the
national criminal law applying in the case in question.

tation of this Directive to the European Parliament and the
Council.

2.
The report shall in particular include information on the
the functioning of market
safety of consumer products,
surveillance, standardisation work, the functioning of RAPEX
and Community measures taken on the basis of Article 13. To
this end the Commission shall conduct assessments of
the
the approaches, systems and
in particular
relevant
practices put in place in the Member States,
in the light of
the requirements of this Directive and the other Community
legislation relating to product safety. The Member States shall
provide the Commission with all the necessary assistance and
information for performing the assessments and preparing the
reports.

issues,

Article 20

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive with effect
from 1 January 2003. They shall
forthwith inform the Commission thereof.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of
their official publication.
Member States shall determine how such reference is to be
made.

2. Member States shall communicate to the Commission the
text of the provisions of national law which they adopt in the
field covered by this Directive.

Article 21

Directive 92/59/EEC is hereby repealed with effect
from
1 January 2003 without prejudice to the obligations of
Member States concerning the deadlines for transposition and
for application of the repealed Directive as indicated in Annex
III.

References to the repealed Directive shall be construed as
references to this Directive and shall be read in accordance
with the correlation table in Annex IV.

Article 19

Every three years following the date referred to in Article
1.
20(1), the Commission shall submit a report on the implemen-

Article 22

This Directive is addressed to the Member States.

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ANNEX I

REQUIREMENTS CONCERNING INFORMATION ON DANGEROUS PRODUCTS TO BE PROVIDED TO
COMPETENT AUTHORITIES BY PRODUCERS AND DISTRIBUTORS

1. The information must be provided in cases where producers or distributors conclude, based on data, test results or
other information which become available to them, that a product which they supply is not safe, within the meaning
of Article 2(b) or, as appropriate, in the light of the specific safety requirements set in rules of Community law
applicable to the product considered.

2. This requirement applies in the case of product lines or batches, not for individual dangerous products.

3. The information to be provided shall include at least:

(cid:151) the details that permit a precise identification of the product or product batch in question;

(cid:151) full description of the risk posed by the products concerned;

(cid:151) all available information, useful to trace the product;

(cid:151) description of action taken to prevent risks to consumers.

4. The information shall be provided to the authorities designated for that purpose in the Member States where the

products in question are or have been placed on the market or otherwise supplied to consumers.

ANNEX II

PROCEDURES FOR THE APPLICATION OF THE COMMUNITY RAPID INFORMATION SYSTEM (RAPEX)
PROVIDED FOR IN ARTICLE 13 AND GUIDELINES FOR NOTIFICATIONS REFERRED TO IN ARTICLES 12
AND 13

1. The system covers products as defined in Article 2(a) of this Directive that present a serious risk to the health and

safety of consumers which requires rapid intervention.

Pharmaceuticals, which come under Directives 75/319/EEC and 81/851/EEC, are excluded from the application of
the RAPEX system.

2. The system is essentially aimed at a rapid exchange of information in the event of a serious risk to the health and
safety of consumers requiring rapid intervention. In this regard, the national authorities will judge each individual
case on its merits taking into account the guidelines referred to in point 8 which will define specific criteria for
identifying serious risks requiring rapid intervention.

3. Member States notifying under Article 12 of this Directive shall give all available details. In particular, the notifi-

cation shall contain the information stipulated in the guidelines referred to in point 8 and at least:

(a) information to identify the product;

(b) a description of the danger involved, including a summary of the results of any tests/analyses and of their

conclusions which are relevant to assessing the level of risk;

(c) the nature and the duration of the measures or action taken or decided on, if applicable;

(d) information on supply chains and distribution of the product.

Such information must be transmitted, using the special standard notification form and by the means stipulated in
the guidelines referred to in point 8.

When the measure notified pursuant to Article 11 or Article 12 seeks to limit the marketing or use of a chemical
substance or preparation, the Member States shall provide as soon as possible either a summary or the references of
the relevant data relating to the substance or preparation considered and to known and available substitutes, where
such information is available. They will also communicate the anticipated effects of the measure on consumer health
and safety together with the assessment of the risk carried out in accordance with the general principles for the risk
evaluation of chemical substances as referred to in Article 10(4) of Regulation (EEC) No 793/93 in the case of an
existing substance or in Article 3(2) of Directive 67/548/EEC in the case of a new substance. The guidelines referred
to in point 8 shall define the details and procedures for the information requested in that respect.

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4. When a Member State has informed the Commission, according to Article 12(1), third subparagraph, about a
serious risk, before deciding to adopt measures it must inform the Commission within a deadline of 45 days
whether it confirms of modifies this information.

5. The Commission shall verify, in the shortest time possible, the conformity with the provisions of this Directive of
the information received under this rapid information system and, when it considers it to be necessary and in order
to assess product safety, may carry out an investigation of its own motion. In the case of such an investigation
Member States shall supply the Commission with the requested information to the best of their ability.

6. Upon receipt of a notification the Member States are requested, to inform the Commission, at the latest within the

set period of time stipulated in the guidelines referred to at point 8, of the following:

(a) whether the product has been marketed in their territory and if they have adopted or intend to adopt the same
or different measure(s) or action(s) adapted to their own circumstances or they consider it is not necessary to
adopt measure(s) or action(s) for the product concerned in view of their own circumstances and explain why;

(b) supplementary information they have obtained on the danger involved, including the results of any tests/analyses

carried out to assess the level of risk;

(c) whether they disagree with the measure(s) or action(s) in question and explain why;

(d) whether they consider that no follow-up is necessary and they explain why;

(e) whether it is unnecessary to adopt measures or take action for the products concerned under their circumstances

and why.

The guidelines referred to in point 8 shall specify how to deal with notifications concerning risks which are
considered by the Member State notifying not to go beyond its territory.

7. Member States shall immediately inform the Commission of any modification, or withdrawal of the measure(s) or

action(s) in question.

8. Guidelines concerning the operation of the exchange of information system by the Commission and the Member
States, shall be prepared and regularly up-dated by the Commission assisted by the Advisory Committee set up
under Article 15(1).

9. The Commission may inform the national contact points regarding products posing risks requiring rapid action,

imported to or exported from the European Community and the European Economic Area.

10. The responsibility for the accuracy of the information provided and the liability for it lie with the notifying Member

State.

11. The Commission shall ensure the proper functioning of the system.

ANNEX III

REPEALED DIRECTIVE AND DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW AND FOR
APPLICATION

Repealed Directive (referred to in Article 21): Council Directive 92/59/EEC; Deadlines for transposition and for
application (referred to in Article 21): 29 June 1994.

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ANNEX IV

CORRELATION TABLE

This Directive

Directive 92/59/EEC

1

2

3

4

5

6

7

8

9

10

11

12

13

14 and 15

16

17

18

19

20

21

22

Annex I

Annex II

Annex III

Annex IV

1

2

4

(cid:151)

3

5

5, second paragraph

6

(cid:151)

(cid:151)

7

8

9

10

12

13

14

15

17

18

19

(cid:151)

Annex

(cid:151)

(cid:151)