Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (Text with EEA relevance)
Date: 2001-12-03
Institutions: Council of the European Union, European Parliament
Subjects: European standard, food inspection, marketing, product safety, public health

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DIRECTIVE 2001/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 3 December 2001

on general product safety

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(3)

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

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Acting in accordance with the procedure referred to in Article
251 of the Treaty (3), in the light of the joint text approved by
the Conciliation Committee on 2 August 2001,

Whereas:

(1)

(2)

It

Under Article 16 of Council Directive 92/59/EEC of 29
June 1992 on general product safety (4), the Council was
to decide, four years after the date set for the imple-
mentation of the said Directive, on the basis of a report
of the Commission on the experience acquired, together
with appropriate proposals, whether to adjust Directive
92/59/EEC.
is necessary to amend Directive 92/
59/EEC in several respects, in order to complete, rein-
force or clarify some of its provisions in the light of
experience as well as new and relevant developments on
together with the changes
consumer product safety,
made
in Articles 152
concerning public health and 153 concerning consumer
protection, and in the light of the precautionary prin-
ciple. Directive 92/59/EEC should therefore be recast in
the interest of clarity. This recasting leaves the safety of
services outside the scope of this Directive, since the
Commission intends to identify the needs, possibilities
and priorities for Community action on the safety of
services and liability of service providers, with a view to
presenting appropriate proposals.

to the Treaty,

especially

is important

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

is assured.

(4)

(5)

(6)

(1) OJ C 337 E, 28.11.2000, p. 109 and
OJ C 154 E, 29.5.2000, p. 265.

(2) OJ C 367, 20.12.2000, p. 34.
(3) Opinion of

the European Parliament of 15.11.2000 (OJ C 223,
8.8.2001, p. 154), Council Common Position of 12.2.2001 (OJ C
93, 23.3.2001, p. 24) and Decision of the European Parliament of
16.5.2001 (not yet published in the Official
Journal). Decision of
the European Parliament of 4.10.2001 and Council Decision of
27.9.2001.

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

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

In order to ensure a high level of consumer protection,
the Community must contribute to protecting the health
and safety of consumers. Horizontal Community legisla-
tion introducing a general product safety requirement,
and containing provisions on the general obligations of
producers and distributors, on the enforcement of
Community product safety requirements and on rapid
exchange of information and action at Community level
in certain cases, should contribute to that aim.

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 to cover lacunae, in particular pending revision of
the existing specific legislation, and to complement
provisions in existing or forthcoming specific legislation,
in particular with a view to ensuring a high level of
protection of safety and health of consumers, as required
by Article 95 of the Treaty.

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
even if not intended for them. In all these cases the
products under consideration can pose risks for the
consumers which must be
health and safety of
prevented. Certain second-hand goods should neverthe-
less be excluded by their very nature.

(7)

This Directive should apply to products irrespective of
the selling techniques, including distance and electronic
selling.

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(8)

(9)

(10)

(11)

(12)

(13)

(14)

The safety of products should be assessed taking into
account all the relevant aspects, in particular the catego-
ries of consumers which can be particularly vulnerable
to the risks posed by the products under consideration,
in particular children and the elderly.

This Directive does not cover services, but in order to
secure the attainment of the protection objectives in
question, its provisions should also apply to products
that are supplied or made available to consumers in the
context of service provision for use by them. The safety
of the equipment used by service providers themselves
to supply a service to consumers does not come within
the scope of this Directive since it has to be dealt with in
conjunction with the safety of the service provided. In
particular, equipment on which consumers ride or travel
which is operated by a service provider is excluded from
the scope of this Directive.

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

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

the provisions of

If specific Community legislation sets out safety require-
ments covering only certain risks or categories of risks,
with regard to the products concerned the obligations of
economic operators in respect of these risks are those
determined by the provisions of the specific legislation,
while the general safety requirement of this Directive
should apply to the other risks.

The provisions of this Directive relating to the other
obligations of producers and distributors, the obligations
and powers of the Member States, the exchanges of
information and rapid intervention situations
and
dissemination of information and confidentiality apply
in the case of products covered by specific rules of
Community law, if those rules do not already contain
such obligations.

In order to facilitate the effective and consistent applica-
tion of the general safety requirement of this Directive, it
is important to establish European voluntary standards
covering certain products and risks in such a way that a
product which conforms to a national standard trans-
posing a European standard is to be presumed to be in
compliance with the said requirement.

(15) With regard to the aims of this Directive, European
standards should be established by European standardi-
sation bodies, under mandates set by the Commission
assisted by appropriate Committees. In order to ensure
that products in compliance with the standards fulfil the
general safety requirement, the Commission assisted by a
committee composed of representatives of the Member
States, should fix the requirements that the standards
must meet. These requirements should be included in
the mandates to the standardisation bodies.

(16)

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 such standards, the safety of products should be
assessed taking into account in particular national stan-
dards transposing any other relevant European or inter-
national standards, Commission recommendations or
national standards,
international standards, codes of
good practice, the state of the art and the safety which
consumers may reasonably expect. In this context, the
Commission's
the
recommendations may
facilitate
this Directive
consistent and effective application of
pending the introduction of European standards or as
regards the risks and/or products for which such stan-
dards are deemed not to be possible or appropriate.

(17) Appropriate independent certification recognised by the
competent authorities may facilitate proof of compliance
with the applicable product safety criteria.

(18)

(19)

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

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 them when necessary, which may
involve, depending on the provisions applicable in the
Member States, an appropriate form of compensation,
for example exchange or reimbursement.

(20) Distributors should help in ensuring compliance with
the applicable safety requirements. The obligations
placed on distributors apply in proportion to their
it may prove
respective responsibilities.
impossible,
to
provide the competent authorities with information and
documentation on possible risks and origin of
the
product in the case of isolated used objects provided by
private individuals.

in the context of charitable activities,

In particular,

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(21)

(22)

(23)

(24)

(25)

Both producers and distributors should cooperate with
the competent authorities in action aimed at preventing
risks and inform them when they conclude that certain
products
conditions
supplied are dangerous. The
regarding the provision of such information should be
set in this Directive to facilitate its effective application,
while avoiding an excessive burden for economic opera-
tors and the authorities.

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

It is necessary in particular for the appropriate measures
to include the power for Member States to order or
organise, immediately and efficiently, the withdrawal of
dangerous products already placed on the market and as
a last resort to order, coordinate or organise the recall
from consumers of dangerous products already supplied
to them. Those powers should be applied when produ-
cers and distributors fail to prevent risks to consumers
in accordance with their obligations. Where necessary,
the appropriate powers and procedures should be avail-
able to the authorities to decide and apply any necessary
measures rapidly.

The safety of consumers depends to a great extent on
the active enforcement of Community product safety
requirements. The Member States should,
therefore,
establish systematic approaches to ensure the effective-
ness of market surveillance and other enforcement activ-
ities and should ensure their openness to the public and
interested parties.

Collaboration between the enforcement authorities of
the Member States is necessary in ensuring the attain-
ment of the protection objectives of this Directive. It is,
therefore, appropriate to promote the operation of a
European network of the enforcement authorities of the
in a coordinated manner
Member States to facilitate,
in particular the
with other Community procedures,
Community Rapid
System (RAPEX),
Information
improved collaboration at operational level on market
surveillance and other enforcement activities, in partic-
ular risk assessment, testing of products, exchange of
expertise and scientific knowledge, execution of joint
surveillance projects
and tracing, withdrawing or
recalling dangerous products.

(26)

(27)

(28)

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

Effective supervision of product safety requires 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 in 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.

This Directive provides for the establishment of non-
binding guidelines aimed at indicating simple and clear
criteria and practical rules which may change, in partic-
ular for the purpose of allowing efficient notification of
measures restricting the placing on the market of prod-
ucts in the cases referred to in this Directive, whilst
taking into account the range of situations dealt with by
Member States and economic operators. The guidelines
should in particular include criteria for the application of
the definition of serious risks in order to facilitate
consistent implementation of the relevant provisions in
case of such risks.

(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.

(30) However,

if the Member States differ as regards the
approach to dealing with the risk posed by certain prod-
ucts, such differences could entail unacceptable dispari-
ties 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, under the procedures laid down
in the specific rules of Community law applicable to the
products or category of products in question.

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(32)

is therefore necessary to provide for an adequate
It
mechanism allowing, as a last resort, for the adoption of
measures applicable throughout the Community, in the
form of a decision addressed to the Member States, to
cope with situations created by products presenting a
serious risk. Such a decision should entail a ban on the
export of the product in question, unless in the case in
point exceptional circumstances allow a partial ban or
even no ban to be decided upon, particularly when a
system of prior consent is established. In addition, the
banning of exports should be examined with a view to
preventing risks to the health and safety of consumers.
Since such a decision is not directly applicable to
economic operators, Member States should take all
necessary measures for its implementation. Measures
adopted under such a procedure are interim measures,
save when they apply to individually identified products
or batches of products. In order to ensure the appro-
priate assessment of the need for, and the best prepara-
tion of such measures, they should be taken by the
Commission, assisted by a committee,
in the light of
consultations with the Member States, and, if scientific
questions are involved falling within the competence of
a Community scientific committee, with the scientific
committee competent for the risk concerned.

which restrict the placing on the market of a product or
require its withdrawal or recall.

(38)

(39)

In addition,
the adoption of measures concerning
imported products, like those concerning the banning of
exports, with a view to preventing risks to the safety and
health of consumers must comply with the Communi-
ty's international obligations.

The Commission should periodically examine
the
manner in which this Directive is applied and the results
obtained, in particular in relation to the functioning of
market surveillance systems, the rapid exchange of infor-
mation and measures adopted at Community level,
together with other issues relevant for consumer product
safety in the Community, and submit regular reports to
the European Parliament and the Council on the subject.

(40)

This Directive should not affect
the obligations of
Member States concerning the deadline for transposition
and application of Directive 92/59/EEC,

(33)

The measures necessary for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (1).

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

(34)

In order to facilitate effective and consistent application
of this Directive, the various aspects of its application
may need to be discussed within a committee.

Objective — Scope — Definitions

(35)

(36)

Public access to the information available to the authori-
ties 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.

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
administrative
States
concerning liability for defective products (2).

the Member

provisions

of

Article 1

The purpose of this Directive is to ensure that products

1.
placed on the market are safe.

2.
This Directive shall apply to all the products defined in
Article 2(a). Each of its provisions shall apply in so far as there
are no specific provisions with the same objective in rules of
the products
Community law governing the
concerned.

safety of

Where products are subject
to specific safety requirements
imposed by Community legislation, this Directive shall apply
only to the aspects and risks or categories of risks not covered
by those requirements. This means that:

(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

(a) Articles 2(b) and (c), 3 and 4 shall not apply to those
products insofar as concerns the risks or categories of risks
covered by the specific legislation;

(1) OJ L 184, 17.7.1999, p. 23.
(2) 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).

(b) Articles 5 to 18 shall apply except where there are specific
provisions governing the aspects covered by the said
Articles with the same objective.

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Article 2

For the purposes of this Directive:

(a) ‘product’ shall mean any product — including in the
context of providing a service — which is intended for
consumers or likely, under reasonably foreseeable condi-
tions, to be used by consumers even if not intended for
them, and is supplied or made available, whether for
in the course of a commercial
consideration or not,
activity, and whether new, used or reconditioned.

This definition shall not apply to second-hand products
supplied as antiques or as products to be repaired or recon-
ditioned prior to being used, provided that the supplier
clearly informs the person to whom he supplies the
product to that effect;

(b) ‘safe product’ shall mean any product which, under normal
or reasonably foreseeable conditions of use including dura-
tion 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,
taking into account the following points in particular:

(i) the characteristics of the product, including its compo-
sition, packaging, instructions for assembly and, where
applicable, for installation and maintenance;

(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,
warnings and instructions for its use and disposal and
any other indication or information regarding the
product;

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

product,

in particular children and the elderly.

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 ‘dangerous’;

(c) ‘dangerous product’ shall mean any product which does

not meet the definition of ‘safe product’

in (b);

(d) ‘serious risk’ shall mean any serious risk, including those
the effects of which are not immediate, requiring rapid
intervention by the public authorities;

(e) ‘producer’ 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 manufac-
turer is not established in the Community or, if there is
no representative established in the Community, the
importer of the product;

(iii) other professionals in the supply chain, insofar as their
activities may affect the safety properties of a product;

(f) ‘distributor’ shall mean any professional in the supply chain
whose activity does not affect the safety properties of a
product;

(g) ‘recall’ shall mean any measure aimed at achieving the
that has already been
return of a dangerous product
supplied or made available to consumers by the producer
or distributor;

(h) ‘withdrawal’ shall mean any measure aimed at preventing
the distribution, display and offer of a product dangerous
to the consumer.

CHAPTER II

General

safety

requirement,

conformity
criteria and European standards

assessment

Article 3

Producers shall be obliged to place only safe products on

1.
the market.

A product shall be deemed safe, as far as the aspects
2.
legislation are concerned,
covered by the relevant national
when,
specific Community provisions
in the absence of
governing the safety of the product in question, it conforms to
the specific rules of national law of the Member State in whose
territory the product is 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.

A product shall be presumed safe as far as the risks and risk
categories covered by relevant national standards are concerned
when it conforms to voluntary national standards transposing
the references of which have been
European standards,
published by the Commission in the Official
the
European Communities
in accordance with Article 4. The
Member States shall publish the references of such national
standards.

Journal of

3.
In circumstances other than those referred to in para-
graph 2, the conformity of a product to the general safety
requirement shall be assessed by taking into account
the
following elements in particular, where they exist:

(a) voluntary national standards transposing relevant European
standards other than those referred to in paragraph 2;

(b) the standards drawn up in the Member State in which the

product is marketed;

(c) Commission recommendations
product safety assessment;

setting

guidelines on

(d) product safety codes of good practice in force in the sector

concerned;

(e) the state of the art and technology;

(f) reasonable consumer expectations concerning safety.

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Conformity of a product with the criteria designed to
4.
ensure the general safety requirement, in particular the provi-
sions mentioned in paragraphs 2 or 3, shall not bar the
competent authorities of the Member States from taking appro-
priate measures to impose restrictions on its being placed on
the market or to require its withdrawal from the market or
recall where there is evidence that, despite such conformity, it
is dangerous.

In the cases referred to in the second and third subparagraphs,
the Commission shall, on its own initiative or at the request of
a Member State, decide in accordance with the procedure laid
down in Article 15(2) whether the standard in question meets
the general safety requirement. The Commission shall decide to
publish or withdraw after consulting the Committee established
by Article 5 of Directive 98/34/EC. The Commission shall
notify the Member States of its decision.

Article 4

1.
For the purposes of this Directive, the European standards
referred to in the second subparagraph of Article 3(2) shall be
drawn up as follows:

(a) the requirements intended to ensure that products which
conform to these standards satisfy the general safety
requirement shall be determined in accordance with the
procedure laid down in Article 15(2);

(b) on the basis of those requirements, the Commission shall,
in accordance with Directive 98/34/EC of the European
Parliament and of the Council of 22 June 1998 laying
down a procedure for the provision of information in the
field of technical standards and regulations and of rules on
information society services (1) call on the European stand-
ardisation bodies to draw up standards which satisfy these
requirements;

(c) on the basis of those mandates, the European standardisa-
tion bodies shall adopt the standards in accordance with
the principles contained in the general guidelines for
cooperation between the Commission and those bodies;

(d) the Commission shall report every three years to the Euro-
pean Parliament and the Council, within the framework of
the report referred to in Article 19(2), on its programmes
for setting the requirements and the mandates for standar-
disation provided for in subparagraphs (a) and (b) above.
This report will, in particular, include an analysis of the
decisions taken regarding requirements and mandates for
standardisation referred to in subparagraphs (a) and (b) and
regarding the standards referred to in subparagraph (c). It
will also include information on the products for which the
Commission intends to set
the requirements and the
mandates in question, the product risks to be considered
and the results of any preparatory work launched in this
area.

2.
The Commission shall publish in the Official Journal of the
European Communities the references of the European standards
adopted in this way and drawn up in accordance with the
requirements referred to in paragraph 1.

If a standard adopted by the European standardisation bodies
before the entry into force of this Directive ensures compliance
with the general safety requirement,
the Commission shall
decide to publish its references in the Official Journal of the
European Communities.

If a standard does not ensure compliance with the general
safety requirement, the Commission shall withdraw reference
to the standard from publication in whole or in part.

(1) OJ L 204, 21.7.1998, p. 37. Directive amended by Directive 98/

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

CHAPTER III

Other obligations of producers
distributors

and obligations of

Article 5

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

The presence of warnings does not exempt any person from
compliance with the other requirements laid down in this
Directive.

Within the limits of their respective activities, producers shall
adopt measures commensurate with the characteristics of the
products which they supply, enabling them to:

(a) be informed of risks which these products might pose;

(b) choose to take appropriate action including, if necessary to
avoid these risks, withdrawal from the market, adequately
and
from
consumers.

effectively warning

consumers or

recall

The measures referred to in the third subparagraph shall
include, for example:

(a) an indication, by means of the product or its packaging, of
the identity and details of the producer and the product
reference or, where applicable, the batch of products to
which it belongs, except where not to give such indication
is justified and

(b) in all cases where appropriate, the carrying out of sample
testing of marketed products, investigating and, if neces-
sary, keeping a register of complaints and keeping distribu-
tors informed of such monitoring.

Action such as that referred to in (b) of the third subparagraph
shall be undertaken on a voluntary basis or at the request of
the competent authorities in accordance with Article 8(1)(f).
Recall shall take place as a last resort, where other measures
would not suffice to prevent the risks involved, in instances
where the producers consider it necessary or where they are
obliged to do so further to a measure taken by the competent
authority. It may be effected within the framework of codes of
good practice on the matter in the Member State concerned,
where such codes exist.

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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 infor-
mation on product risks, keeping and providing the documen-
tation necessary for tracing the origin of products, and cooper-
ating in the action taken by producers and competent authori-
ties to avoid the risks. Within the limits of their respective
activities they shall take measures enabling them to cooperate
efficiently.

3. Where producers and distributors know or ought
to
know, on the basis of the information in their possession and
as professionals, that a product that they have placed on the
market poses risks to the consumer that are incompatible with
the general safety requirement, they shall immediately inform
the competent authorities of the Member States thereof under
the conditions laid down in Annex I, giving details, in partic-
ular, of action taken to prevent risk to the consumer.

The Commission shall,
in accordance with the procedure
referred to in Article 15(3), adapt the specific requirements
relating to the obligation to provide information laid down in
Annex I.

4.
Producers and distributors shall, within the limits of their
respective activities, cooperate with the competent authorities,
at the request of the latter, on action taken to avoid the risks
posed by products which they supply or have supplied. The
procedures for such cooperation,
including procedures for
dialogue with the producers and distributors concerned on
issues related to product safety, shall be established by the
competent authorities.

CHAPTER IV

Specific obligations and powers of the Member States

Article 6

1. Member States shall ensure that producers and distribu-
tors comply with their obligations under this Directive in such
a way that products placed on the market are safe.

2. Member States shall establish or nominate authorities
competent to monitor the compliance of products with the
general safety requirements and arrange for such authorities to
have and use the necessary powers to take the appropriate
measures incumbent upon them under this Directive.

Commission shall pass on such information to the other
Member States.

Article 7

Member States shall lay down the rules on penalties applicable
to infringements of the national provisions adopted pursuant
to this Directive and shall take all measures necessary to ensure
that they are implemented. The penalties provided for shall be
effective, proportionate and dissuasive. Member States shall
notify those provisions to the Commission by 15 January 2004
and shall also notify it, without delay, of any amendment
affecting them.

Article 8

1.
For the purposes of this Directive, and in particular of
Article 6 thereof, the competent authorities of the Member
States shall be entitled to take, inter alia, the measures in (a) and
in (b) to (f) below, where appropriate:

(a) for any product:

(i) to organise, even after its being placed on the market
as being safe, appropriate checks on its safety proper-
ties, on an adequate scale, up to the final stage of use
or consumption;

(ii) to require all necessary information from the parties

concerned;

(iii) to take samples of products and subject them to safety

checks;

(b) for any product that could pose risks in certain conditions:

(i) to require that

it be marked with suitable, clearly
in the
languages of the Member State in which the

worded and easily comprehensible warnings,
official
product is marketed, on the risks it may present;

(ii) to make its marketing subject to prior conditions so as

to make it safe;

(c) for any product that could pose risks for certain persons:

to order that they be given warning of the risk in good
time and in an appropriate form, including the publication
of special warnings;

(d) for any product that could be dangerous:

for the period needed for the various safety evaluations,
checks and controls, temporarily to ban its supply, the offer
to supply it or its display;

(e) for any dangerous product:

to ban its marketing and introduce the accompanying
measures required to ensure the ban is complied with;

(f) for any dangerous product already on the market:

(i) to order or organise its actual and immediate with-
drawal, and alert consumers to the risks it presents;

3. Member States shall define the tasks, powers, organ-
isation and cooperation arrangements of the competent author-
ities. They shall keep the Commission informed, and the

(ii) to order or coordinate or, if appropriate, to organise
together with producers and distributors its recall from
consumers and its destruction in suitable conditions.

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2. When the competent authorities of the Member States
take measures such as those provided for in paragraph 1, in
particular those referred to in (d) to (f), they shall act in
accordance with the Treaty, and in particular Articles 28 and
30 thereof, in such a way as to implement the measures in a
manner proportional to the seriousness of the risk, and taking
due account of the precautionary principle.

In this context, they shall encourage and promote voluntary
action by producers and distributors, in accordance with the
obligations incumbent on them under this Directive, and in
particular Chapter III thereof, including where applicable by the
development of codes of good practice.

If necessary, they shall organise or order the measures provided
for in paragraph 1(f) if the action undertaken by the producers
and distributors in fulfilment of their obligations is unsatisfac-
tory or insufficient. Recall shall take place as a last resort. It
may be effected within the framework of codes of good prac-
tice on the matter in the Member State concerned, where such
codes exist.

3.
In particular, the competent authorities shall have the
power to take the necessary action to apply with due dispatch
appropriate measures such as those mentioned in paragraph 1,
(b) to (f), in the case of products posing a serious risk. These
circumstances shall be determined by the Member States,
assessing each individual case on its merits, taking into account
the guidelines referred to in point 8 of Annex II.

The measures to be taken by the competent authorities

4.
under this Article 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 a view to coopera-
tion in action taken to avoid risks arising from a product.

Article 9

1.
In order to ensure effective market surveillance, aimed at
guaranteeing a high level of consumer health and safety protec-
tion, which entails cooperation between their competent
authorities, Member States
that approaches
employing appropriate means and procedures are put in place,
which may include in particular:

ensure

shall

(a) establishment, periodical updating and implementation of
sectoral surveillance programmes by categories of products
or risks and the monitoring of surveillance activities, find-
ings and results;

(b) follow-up and updating of scientific and technical knowl-

edge concerning the safety of products;

(c) periodical review and assessment of the functioning of the
control activities and their effectiveness and, if necessary,
revision of the surveillance approach and organisation put
in place.

2. Member States shall ensure that consumers and other
interested parties
are given an opportunity to submit
complaints to the competent authorities on product safety and

on surveillance and control activities and that these complaints
are followed up as appropriate. Member States shall actively
inform consumers and other interested parties of the proced-
ures established to that end.

Article 10

1.
The Commission shall promote and take part in the
operation in a European network of the authorities of the
Member States competent for product safety, in particular in
the form of administrative cooperation.

2.
This network operation shall develop in a coordinated
manner with the other existing Community procedures, partic-
ularly RAPEX. Its objective shall be, in particular, to facilitate:

(a) the exchange of information on risk assessment, dangerous
products, test methods and results, recent scientific devel-
opments as well as other aspects relevant for control activi-
ties;

(b) the establishment and execution of joint surveillance and

testing projects;

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

tion in training activities;

(d) improved cooperation at Community level with regard to
the tracing, withdrawal and recall of dangerous products.

CHAPTER V

Exchanges

of

information

and

rapid

intervention

situations

Article 11

1. Where a Member State takes measures which restrict the
placing on the market of products — or require their with-
drawal or recall — such as those provided for in Article 8(1)(b)
to (f), the Member State shall, to the extent that such noti-
fication is not required under Article 12 or any specific
Community legislation, inform the Commission of the meas-
ures, specifying its reasons for adopting them. It shall also
inform the Commission of any modification or lifting of such
measures.

If the notifying Member State considers that the effects of the
risk do not or cannot go beyond its territory, it shall notify the
measures concerned insofar as they involve information likely
to be of interest to Member States from the product safety
standpoint, and in particular if they are in response to a new
risk which has not yet been reported in other notifications.

In accordance with the procedure laid down in Article 15(3) of
this Directive, the Commission shall, while ensuring the effec-
tiveness and proper functioning of the system, adopt the guide-
lines referred to in point 8 of Annex II. These shall propose the
content and standard form for the notifications provided for in
this Article, and, in particular, shall provide precise criteria for
determining the conditions for which notification is relevant
for the purposes of the second subparagraph.

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The Commission shall forward the notification to the
2.
other Member States, unless it concludes, after examination on
the basis of the information contained in the notification, that
the measure does not comply with Community law. In such a
case,
immediately inform the Member State which
it shall
initiated the action.

Article 12

1. Where a Member State adopts or decides to adopt,
recommend or agree with producers 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,
immediately notify the
Commission thereof through RAPEX. It shall also inform the
Commission without delay of modification or withdrawal of
any such measure or action.

it shall

If the notifying Member State considers that the effects of the
risk do not or cannot go beyond its territory, it shall follow the
procedure laid down in Article 11, taking into account the
relevant criteria proposed in the guidelines referred to in point
8 of Annex II.

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

In the case of a serious risk, they shall notify the Commission
this
the voluntary measures laid down in Article 5 of
of
Directive taken by producers and distributors.

2.
On receiving such notifications, the Commission shall
check whether they comply with this Article and with the
requirements applicable to the functioning of RAPEX, and shall
forward them to the other Member States, which, in turn, shall
immediately inform the Commission of any measures adopted.

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

Access to RAPEX shall be open to applicant countries,
4.
third countries or international organisations, within the frame-
work of agreements between the Community and those coun-
tries or international organisations, according to arrangements
defined in these agreements. Any such agreements shall be
based on reciprocity and include provisions on confidentiality
corresponding to those applicable in the Community.

Article 13

1.
If the Commission becomes aware of a serious risk from
certain products to the health and safety of consumers in
various Member States, it may, after consulting the Member
States, and, if scientific questions arise which fall within the
the
competence of
Scientific Committee
risk
concerned, adopt a decision in the light of the result of those
consultations, in accordance with the procedure laid down in
Article 15(2), requiring Member States to take measures from

a Community Scientific Committee,
to deal with the

competent

among those listed in Article 8(1)(b) to (f) if, at one and the
same time:

(a) it emerges from prior consultations with the Member States
that they differ significantly on the approach adopted or to
be adopted to deal with the risk; and

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

(c) the risk can be eliminated effectively only by adopting
appropriate measures applicable at Community level,
in
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.
The 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 none of which shall
exceed 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 dangerous products
which have been the subject of a decision referred to in para-
graph 1 shall be prohibited unless the decision provides other-
wise.

4. Member States shall take all necessary measures to imple-
ment the decisions referred to in paragraph 1 within less than
20 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

1.
The measures necessary for the implementation of this
Directive relating to the matters referred to below shall be
adopted in accordance with the regulatory procedure provided
for in Article 15(2):

(a) the measures referred to in Article 4 concerning standards

adopted by the European standardisation bodies;

(b) the decisions referred to in Article 13 requiring Member
States to take measures as listed in Article 8(1)(b) to (f).

2.
The measures necessary for the implementation of this
Directive in respect of all other matters shall be adopted in
accordance with the advisory procedure provided for in Article
15(3).

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Article 15

available under the provisions in force in the Member State in
question and the time limits applying to such remedies.

1.

The Commission shall be assisted by a Committee.

2. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at 15 days.

3. Where reference is made to this paragraph, Articles 3 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

4.

The Committee shall adopt its rules of procedure.

CHAPTER VII

Final provisions

Article 16

Information available to the authorities of the Member
1.
States or the Commission relating to risks to consumer health
and safety posed by products shall in general be available to
the public, in accordance with the requirements of transpar-
ency and without prejudice to the restrictions required for
monitoring and investigation activities. In particular the public
shall have access to information on product identification, the
nature of the risk and the measures taken.

However, Member States and the Commission shall take the
steps necessary to ensure that their officials and agents are
required not to disclose information obtained for the purposes
of this Directive which, by its nature, is covered by professional
secrecy in duly justified cases, except 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.

Protection of professional secrecy shall not prevent the
2.
dissemination to the competent authorities of information rele-
vant for ensuring the effectiveness of market monitoring and
surveillance activities. The authorities receiving information
covered by professional secrecy shall ensure its protection.

Article 17

This Directive shall be without prejudice to the application of
Directive 85/374/EEC.

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, they shall be given such
opportunity in due course after the measure has been imple-
mented.

Measures requiring the withdrawal of a product or its recall
shall take into consideration the need to encourage distributors,
users and consumers to contribute to the implementation of
such measures.

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 or recall can
be challenged before the competent courts.

Any decision taken by virtue of

3.
this Directive and
involving restrictions on the placing of a product on the
market or requiring its withdrawal or its recall 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.

Article 19

1.
The Commission may bring before the Committee
referred to in Article 15 any matter concerning the application
of
this Directive and particularly those relating to market
monitoring and surveillance activities.

Every three years,

2.
the
Commission shall submit a report on the implementation of
this Directive to the European Parliament and the Council.

following 15 January 2004,

The report shall in particular include information on the safety
of consumer products, in particular on improved traceability of
products, the functioning of market surveillance, standardisa-
tion work, the functioning of RAPEX and Community meas-
ures taken on the basis of Article 13. To this end the Commis-
sion shall conduct assessments of the relevant issues, in partic-
ular the approaches, systems and 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 carrying out
the
assessments and preparing the reports.

Article 18

Article 20

1.
Any measure adopted under this Directive and involving
restrictions on the placing of a product on the market or
requiring its withdrawal or recall must state the appropriate
reasons on which it is based. It shall be notified as soon as
possible to the party concerned and shall indicate the remedies

The Commission shall
identify the needs, possibilities and
priorities for Community action on the safety of services and
submit to the European Parliament and the Council, before 1
January 2003, a report, accompanied by proposals on the
subject as appropriate.

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Article 21

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary in order to comply
with this Directive with effect from 15 January 2004. They
shall forthwith inform the Commission thereof.

When Member States adopt those measures, they shall contain
a reference to this Directive or be accompanied by such refer-
ence on the occasion of their official publication. The methods
of making such reference shall be laid down by Member States.

2. Member States shall communicate to the Commission the
provisions of national
in the field
covered by this Directive.

law which they adopt

References to Directive 92/59/EEC shall be construed as refer-
ences to this Directive and shall be read in accordance with the
correlation table in Annex IV.

Article 23

This Directive shall enter into force on the day of its publica-
tion in the Official Journal of the European Communities.

Article 24

This Directive is addressed to the Member States.

Article 22

Done at Brussels, 3 December 2001.

Directive 92/59/EEC is hereby repealed from 15 January 2004,
without prejudice
to the obligations of Member States
concerning the deadlines for transposition and application of
the said Directive as indicated in Annex III.

For the European Parliament

For the Council

The President

N. FONTAINE

The President

F. VANDENBROUCKE

ANNEX I

REQUIREMENTS CONCERNING INFORMATION ON PRODUCTS THAT DO NOT COMPLY WITH THE
GENERAL SAFETY REQUIREMENT TO BE PROVIDED TO THE COMPETENT AUTHORITIES BY PRODUCERS
AND DISTRIBUTORS

1. The information specified in Article 5(3), or where applicable by specific requirements of Community rules on the
product concerned, shall be passed to the competent authorities appointed for the purpose in the Member States
where the products in question are or have been marketed or otherwise supplied to consumers.

2. The Commission, assisted by the Committee referred to in Article 15, shall define the content and draw up the
standard form of the notifications provided for in this Annex, while ensuring the effectiveness and proper functioning
of the system. In particular,
it shall put forward, possibly in the form of a guide, simple and clear criteria for
determining the special conditions, particularly those concerning isolated circumstances or products, for which
notification is not relevant in relation to this Annex.

3. In the event of serious risks, this information shall

include at least the following:

(a) information enabling a precise identification of the product or batch of products in question;

(b) a full description of the risk that the products in question present;

(c) all available information relevant for tracing the product;

(d) a description of the action undertaken to prevent risks to consumers.

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PROCEDURES FOR THE APPLICATION OF RAPEX AND GUIDELINES FOR NOTIFICATIONS

ANNEX II

1. RAPEX covers products as defined in Article 2(a) that pose a serious risk to the health and safety of consumers.

Pharmaceuticals, which come under Directives 75/319/EEC (1) and 81/851/EEC (2), are excluded from the scope of
RAPEX.

2. RAPEX is essentially aimed at a rapid exchange of information in the event of a serious risk. The guidelines referred

to in point 8 define specific criteria for identifying serious risks.

3. Member States notifying under Article 12 shall provide all available details. In particular, the notification shall contain

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

(a) information enabling the product to be identified;

(b) a description of the risk 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,

in particular on destination countries.

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 (3) in the case of an
existing substance or in Article 3(2) of Directive 67/548/EEC (4) 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.

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

5. The Commission shall, in the shortest time possible, verify the conformity with the provisions of the Directive of the
information received under RAPEX and, may, when it considers it to be necessary and in order to assess product
safety, carry out an investigation on its own initiative. 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 referred to in Article 12, the Member States are requested to inform the Commission,
at the latest within the set period of time stipulated in the guidelines referred to in point 8, of the following:

(a) whether the product has been marketed in their territory;

(b) what measures concerning the product in question they may be adopting in the light of their own circumstances,
stating the reasons, including any differing assessment of risk or any other special circumstance justifying their
decision,

in particular lack of action or of follow-up;

(c) any relevant supplementary information they have obtained on the risk involved, including the results of any tests

or analyses carried out.

The guidelines referred to in point 8 shall provide precise criteria for notifying measures limited to national territory
and shall specify how to deal with notifications concerning risks which are considered by the Member State not to go
beyond its territory.

(1) OJ L 147, 9.6.1975, p. 13. Directive as last amended by Commission Directive 2000/38/EC (OJ L 139, 10.6.2000, p. 28).
(2) OJ L 317, 6.11.1981, p. 1. Directive as last amended by Commission Directive 2000/37/EC (OJ L 139, 10.6.2000, p. 25).
(3) OJ L 84, 5.4.1993, p. 1.
(4) OJ 196, 16.8.1967, p. 1/67. Directive as last amended by Commission Directive 2000/33/EC (OJ L 136, 8.6.2000, p. 90).

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

in question.

8. The Commission shall prepare and regularly update, in accordance with the procedure laid down in Article 15(3),

guidelines concerning the management of RAPEX by the Commission and the Member States.

9. The Commission may inform the national contact points regarding products posing serious risks, imported into or

exported from the Community and the European Economic Area.

10. Responsibility for the information provided lies with the notifying Member State.

11. The Commission shall ensure the proper functioning of the system, in particular classifying and indexing notifications
according to the degree of urgency. Detailed procedures shall be laid down by the guidelines referred to in point 8.

ANNEX III

PERIOD FOR THE TRANSPOSITION AND APPLICATION OF THE REPEALED DIRECTIVE

(REFERRED TO IN THE FIRST SUBPARAGRAPHE OF ARTICLE 22)

Directive

Period for transposition

Period for bringing into application

Directive 92/59/EEC

29 June 1994

29 June 1994

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ANNEX IV

CORRELATION TABLE

(REFERRED TO IN THE SECOND SUBPARAGRAPH OF ARTICLE 22)

This Directive

Directive 92/59/EEC

Article 1

Article 2

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8

Article 9

Article 10

Article 11

Article 12

Article 13

Articles 14 and 15

Article 16

Article 17

Article 18

Article 19

Article 20

Article 21

Article 22

Article 23

Annex I

Annex II

Annex III

Annex IV

Article 1

Article 2

Article 4

—

Article 3

Article 5

Article 5(2)

Article 6

—

—

Article 7

Article 8

Article 9

Article 10

Article 12

Article 13

Article 14

Article 15

—

Article 17

Article 18

Article 19

—

Annex

—

—