Common Position (EC) No 11/2001 of 12 February 2001 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council on general product safety
Date: 2001-02-12
Institutions: Council of the European Union
Subjects: approximation of laws, consumer protection, exchange of information, marketing restriction, product safety

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COMMON POSITION (EC) No 11/2001

adopted by the Council on 12 February 2001

with a view to adopting Directive 2001/…/EC of the European Parliament and of the Council
of … on general product safety

(2001/C 93/03)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(3)

Having regard to the Treaty establishing the European Com-
munity, 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),

(4)

Whereas:

(1)

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
implementation 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. It is necessary to amend Directive
92/59/EEC in several respects,
in order to complete,
reinforce or clarify some of its provisions in the light of
experience as well as new and relevant developments on
consumer product safety, together with the changes
made to the Treaty, especially in Articles 152 concerning
public health and 153 concerning consumer protection,
and in the light of the precautionary principle. 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.

(2)

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

(1) OJ C 337 E, 28.11.2000, p. 109.
(2) OJ C 367, 20.12.2000, p. 34.
(3) Opinion of the European Parliament of 15 November 2000 (not
yet published in the Official Journal), Council Common Position
of 12 February 2001 and decision of the European Parliament of
… (not yet published in the Official Journal).

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

In the absence of Community provisions, horizontal
legislation 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 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
legislation introducing a general product safety require-
ment, and containing provisions on the general obli-
gations of producers and distributors, on the enforce-
ment of Community product safety requirements and on
rapid exchange of information and action at Community
level in certain cases, should contribute to that aim.

(5)

(6)

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
health and safety of consumers which must be prevented.
Certain second-hand goods should nevertheless be
excluded by their very nature.

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

a product which conforms to a national standard
transposing a European standard is to be presumed to
be in compliance with the said requirement.

(7)

(8)

(9)

The safety of products should be assessed taking into
account all the relevant aspects, in particular the categor-
ies 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.

(10) 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.

(11)

(12)

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.

(13) 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 dis-
semination 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.

(14)

In order to facilitate the effective and consistent appli-
cation 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

(15) With regard to the aims of this Directive, European
standards should be established by European standardis-
ation 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
standards transposing any other relevant European or
international 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 recommendations may facilitate the
consistent and effective application of this Directive
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)

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.

(18) 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.

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(19) Distributors should help in ensuring compliance with
the applicable safety requirements. The obligations pla-
ced on distributors apply in proportion to their respect-
ive responsibilities. In particular, it may prove imposs-
ible, in the context of charitable activities, to provide the
competent authorities with information and documenta-
tion on possible risks and origin of the product in
the case of isolated used objects provided by private
individuals.

rapid

European network of the enforcement authorities of the
Member States to facilitate, in a coordinated manner
in particular the
with other Community procedures,
Community
system (RAPEX),
information
improved collaboration at operational level on market
surveillance and other enforcement activities, in particu-
lar risk assessment, testing of products, exchange of
expertise and scientific knowledge, execution of joint
surveillance projects and tracing, withdrawing or
recalling dangerous products.

(20) 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 supplied are dangerous. The conditions regard-
ing the provision of such information should be set in
this Directive to facilitate its effective application, while
avoiding an excessive burden for economic operators
and the authorities.

(21)

(22)

In order to ensure the effective enforcement of the
obligations incumbent on producers and distributors,
the Member States should establish or designate auth-
orities 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 coord-
ination 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 pro-
ducers 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.

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

(25)

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.

(26) 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.

(27) This Directive provides for the establishment of non-
binding guidelines aimed at indicating simple and clear
criteria and practical rules which may change, in particu-
lar for the purpose of allowing efficient notification of
measures restricting the placing on the market of
products 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.

(28)

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.

(24) 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

(29) However,

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

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(30)

(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.

It is therefore necessary to provide for an adequate
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 appropri-
ate assessment of the need for, and the best preparation
of such measures, they should be taken by the Com-
mission, assisted by a committee, in the light of consul-
tations with the Member States, and, if scientific ques-
tions are involved falling within the competence of a
Community scientific committee, with the scientific
committee competent for the risk concerned.

(32) 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).

(33)

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.

(35) 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 provisions of the Member States
concerning liability for defective products (2).

(36)

(37)

It is necessary for Member States to provide for appropri-
ate 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.

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
Community’s international obligations.

(38) The Commission should periodically examine the man-
ner 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
information 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.

(39) This Directive should not affect

the obligations of
Member States concerning the deadline for transposition
and application of Directive 92/59/EEC,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

Objective — Scope — Definitions

Article 1

The purpose of this Directive is to ensure that products

1.
placed on the market are safe.

(34) 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.

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 Community law governing the safety of the products
concerned.

(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).

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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:

(c)

(d)

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

(b) Articles 5 to 22 shall apply except where there are specific
provisions governing the aspects covered by the said
Articles with the same objective.

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
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.

This definition shall not apply to 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)

‘safe product’ shall mean any product which, under
normal or reasonably foreseeable conditions of use
including duration and, where applicable, putting into
service, installation and maintenance requirements, does
not present any risk or only the minimum risks compat-
ible 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 product,

including its
the characteristics of
composition, packaging, instructions for assembly
and, where applicable, for installation and mainten-
ance;

(ii)

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

(iii)

the presentation of the product, the labelling, any
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’;

‘dangerous product’ shall mean any product which does
not meet the definition of ‘safe product’ in (b);

‘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)

(ii)

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;

the manufacturer’s representative, when the manu-
facturer 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, in so far as
their activities may affect the safety properties of a
product;

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

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

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

(f)

(g)

(h)

CHAPTER II

General safety requirement, conformity assessment cri-
teria and European standards

Article 3

Producers shall be obliged to place only safe products on

1.
the market.

2.
A product shall be deemed safe, as far as the aspects
covered by the relevant national legislation are concerned,
when,
in the absence of specific Community provisions
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.

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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 European standards, the references of which have
been published by the Commission in the Official Journal of the
in accordance with Article 4. The
European Communities
Member States shall publish the references of such national
standards.

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 Euro-
pean standards other than those referred to in para-
graph 2;

(b)

the standards drawn up in the Member State in which the
product is marketed;

(c) Commission recommendations setting guidelines on

product safety assessment;

(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.

4.
Conformity of a product with the criteria designed
to ensure the general safety requirement, in particular 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 withdrawal from the market or
recall where there is evidence that, despite such conformity, it
is dangerous.

Article 4

For the purposes of this Directive, the European stan-
1.
dards 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 28 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 standardisation bodies to draw up standards
which satisfy these requirements;

(c)

on the basis of those mandates, the European standard-
isation bodies shall adopt the standards in accordance
with the principles contained in the general guidelines for
cooperation between the Commission and those bodies.

2.
The Commission shall publish in the Official Journal of
the European
the European Communities the references of
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.

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.

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 estab-
lished by Article 5 of Directive 98/34/EC. The Commission
shall notify the Member States of its decision.

CHAPTER III

Other obligations of producers and obligations of
distributors

Article 5

1. Within the limits of their respective activities, producers
shall provide consumers with the relevant information to
enable them to assess the risks inherent in a product through-
out 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:

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

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

(a)

be informed of risks which these products might pose;

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(b)

choose to take appropriate action including, if necessary
to avoid these risks, withdrawal
from the market,
adequately and effectively warning consumers or recalls
from consumers.

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.

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

(a)

(b)

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

in all cases where appropriate,
the carrying out of
sample testing of marketed products, investigating and, if
necessary, keeping a register of complaints and keeping
distributors 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.

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 risks, keeping and providing the
documentation necessary for tracing the origin of products,
and cooperating in the action taken by producers and com-
petent authorities 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
particular, of action taken to prevent risk to the consumer.

Producers and distributors shall, within the limits of their
4.
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.

3. Member States shall define the tasks, powers, organis-
ation and cooperation arrangements of the competent auth-
orities. They shall keep the Commission informed, and the
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 ... (*) and shall
also notify it, without delay, of any amendment affecting them.

(*) Two years after the date of entry into force of this Directive.

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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
point (a) and in points (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
properties, 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, clear-
ly worded and easily comprehensible warnings, in
the official languages of the Member State in which
the product is marketed, on the risks it may present;

(ii)

to make its marketing subject to prior conditions so
as to make it safe;

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

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
practice 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,
points (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.

(c)

for any product that could pose risks for certain persons:

The measures to be taken by the competent authorities

4.
under this Article shall be addressed, as appropriate, to:

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

(a)

the producer;

(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:

(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 to
cooperation in action taken to avoid risks arising from a
product.

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

Article 9

(f)

for any dangerous product already on the market:

to order or organise its actual and immediate
withdrawal, and alert consumers to the risks it
presents;

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

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

(a)

establishment, periodical updating and implementation
of sectoral surveillance programmes by categories of
products or risks and the monitoring of surveillance
activities, findings and results;

(i)

(ii)

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(b)

(c)

follow-up and updating of scientific and technical know-
ledge concerning the safety of products;

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.

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 in so far 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.

2. Member States shall ensure that consumers and other
interested parties are given an opportunity to submit com-
plaints 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 pro-
cedures established to that end.

Article 10

The Commission shall promote and take part in the
1.
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,
particularly RAPEX. Its objective shall be,
in particular, to
facilitate:

(a)

(b)

(c)

(d)

the exchange of information on risk assessment, danger-
ous products, test methods and results, recent scientific
developments as well as other aspects relevant for control
activities;

the establishment and execution of joint surveillance and
testing projects;

the exchange of expertise and best practices and cooper-
ation in training activities;

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

In accordance with the procedure laid down in Article 15(3)
of this Directive, the Commission shall, while ensuring the
effectiveness and proper functioning of the system, adopt the
guidelines 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 subpara-
graph.

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, it shall immediately inform the Member State which
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

CHAPTER V

Exchanges of information and rapid intervention
situations

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.

Article 11

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

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
of the voluntary measures laid down in Article 5 of this
Directive taken by producers and distributors.

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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.

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(3).

4.
Access to RAPEX shall be open to applicant countries,
non-member countries or international organisations, within
the framework of agreements between the Community and
those countries or international organisations, according to
arrangements defined in these agreements. Any such agree-
ments shall be based on reciprocity and include provisions
on confidentiality corresponding to those applicable in the
Community.

Article 13

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

3.
Export from the Community of dangerous products
which have been the subject of a decision referred to in
paragraph 1 shall be prohibited unless the decision provides
otherwise.

4. Member States shall
take all necessary measures to
implement 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.
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 competence of a Community scientific committee, the
scientific committee competent to deal with the 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 among those
listed in Article 8(1)(b) to (f) if, at one and the same time:

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)

(b)

the measures referred to in Article 4 concerning standards
adopted by the European standardisation bodies;

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

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

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).

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
procedures laid down by the specific Community legis-
lation applicable to the products concerned; and

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
functioning 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.

Article 15

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.

(a)

(b)

(c)

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CHAPTER VII

Final provisions

Article 16

1.
Information available to the authorities of the Member
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 trans-
parency 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
relevant for ensuring the effectiveness of market monitoring
and surveillance activities. The authorities receiving infor-
mation covered by professional secrecy shall ensure its protec-
tion.

Article 17

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

Article 18

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

Measures requiring the withdrawal of a product or its recall
shall take into consideration the need to encourage distribu-
tors, 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 this Directive and
3.
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.

2.
Every three years following ... (*), the Commission shall
submit a report on the implementation of this Directive to the
European Parliament and the Council.

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, standardis-
ation 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 relevant issues,
in particular 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 Com-
mission with all the necessary assistance and information for
carrying out the assessments and preparing the reports.

Article 20

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary in order to comply
with this Directive with effect from ... (*). 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
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by
Member States.

(*) Two years after the date of entry into force of this Directive.

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

Article 22

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

Article 21

Directive 92/59/EEC is hereby repealed from ... (*), with
effect from the date mentioned in the first subparagraph of
Article 20(1), without prejudice to the obligations of Member
States concerning the deadlines for transposition and appli-
cation of the said Directive as indicated in Annex III.

Article 23

This Directive is addressed to the Member States.

Done at ...

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

For the European Parliament

For the Council

The President

The President

(*) Two years after the date of entry into force of this Directive.

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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.

2.

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.

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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ANNEX II

PROCEDURES FOR THE APPLICATION OF RAPEX AND GUIDELINES FOR NOTIFICATIONS

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, it must, before deciding to adopt measures, inform the Commission within 45 days whether it
confirms or modifies this information.

5.

6.

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.

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:

(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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(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
including any differing assessment of risk or any other special

circumstances, stating the reasons,
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/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.

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

action(s) in question.

8.

9.

The Commission shall prepare a summary 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.

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

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ANNEX III

PERIOD FOR THE TRANSPOSITION AND APPLICATION OF THE REPEALED DIRECTIVE

(Referred to in the first subparagraph of Article 21)

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 21)

Article in this Directive

Article in Directive 92/59/EEC

1

2

3

4

5

6

7

8

9

10

11

12

13

14 + 15

16

17

18

19

20

21

22

Annex I

Annex II

Annex III

Annex IV

1

2

4

—

3

5

5(2)

6

—

—

7

8

9

10

12

13

14

15

17

18

19

—

Annex

—

—

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STATEMENT OF THE COUNCIL’S REASONS

I.

INTRODUCTION

On 17 May 2000 the Commission submitted to the Council a proposal for a Directive of the
European Parliament and of the Council on general product safety, based on Article 95 of the
Treaty (1).

The European Parliament gave its opinion on 15 November 2000 (2).

The Economic and Social Committee gave its opinion on 20 September 2000 (3).

On 12 February 2001, the Council adopted its Common Position in accordance with Article 251 of
the Treaty.

II. OBJECTIVE

The proposal is intended to recast Directive 92/59/EEC of 29 June 1992 on general product safety.
It introduces clearer and more efficient rules designed to ensure that only safe products are placed
on the market.

Key features of the revision are increased transparency, more active market surveillance, stronger
collaboration between Member States, a better definition of the responsibilities of producers and
distributors, reinforced criteria to assess product safety, and more efficient rules for removing
dangerous products from the market and prohibiting their export when banned at EU level. The
proposal also strengthens the operation of the EU’s rapid alert system (RAPEX).

III. ANALYSIS OF THE COMMON POSITION

1.

General

The text of the Common Position strikes a fair balance between the need, on the one hand, to
ensure that products placed on the market are safe and, on the other hand, to ensure, as regards
the practical implications, feasibility and effectiveness.

The Commission has accepted the Common Position agreed by the Council.

2.

Parliament amendments

The Council adopted in full or in part, or in their substance, 21 of the 30 amendments
proposed by the European Parliament.

In particular, the Council:

(a)

adopted six amendments in full: 5, 10, 12, 17, 20 (with a slight rewording) and 25;

(b)

introduced in the Common Position 15 amendments in part or in substance as follows:

(1) OJ C 337 E, 28.11.2000, p. 109.
(2) OJ C ...
(3) OJ C 367, 20.12.2000, p. 34.

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Amendments 1, 8, 18 on charity shops and street markets: recital 19 now clarifies that, in
the context of charitable activities, it may prove impossible to provide information on the
origin of the product and on its possible risks. In relation to Article 5 this recital also
explains that
the general obligation applicable to distributors to help in ensuring
compliance with the applicable safety requirements applies only in proportion to their
respective responsibilities.

Amendment 2 on transparency is introduced (with a slight rewording) in recital 13.
However the mention of confidentiality, as it is not incompatible with the need for
transparency, is also retained.

Amendment 3 is taken partly into account by rewording recital 20, although the Council,
which supports the concept of preventing excessive burden for economic operators and
the authorities, has not deleted this wording altogether as the amendment proposes.

Amendment 6 on possible future action in the field of safety of services: this concern is
fully reflected in a declaration to be published in the Official Journal, whereby the
Commission intends to identify the requirements, possibilities and priorities concerning
Community action on the safety of services and the liability of service providers and to
make suitable proposals in this connection.

Amendment 7 on clarification of the scope is integrated in Article 1(2) which is now more
explicit in this respect.

Amendment 42 requesting the mention of installation and maintenance in the definition
of ‘safe product’ (Article 2(b)) is covered in substance.

Amendment 13 on the mention of the precautionary principle in Article 3 has been
integrated in recital 1, which now mentions this principle explicitly.

Amendments 15 and 26 on the need for consulting the committee are covered in substance
by the new version of Articles 4 (on European standards), 14 and 15 (on comitology)
while the Council wishes a regulatory committee procedure instead of an advisory one.

Amendment 21 on withdrawal and recall of products already on the market has been
integrated in its first part. The second part of the amendment was not taken on board
because it is incompatible with the ambition of the Directive to encourage business in
taking proactive measures on their own initiative.

Amendment 22 on information of national authorities of voluntary measures taken by
producers and distributors has been integrated, in substance, in Article 5(3).

Amendment 23 on damage compensation: the principle of compensation is introduced in
recital 18, taking into account that Article 17 ensures that the Directive will apply without
prejudice to Directive 85/374/EEC concerning liability for defective products.

Amendment 27 on availability of information on the risks has been included in part in
Article 16, while the need for restrictions in case of monitoring and investigation activities
is also mentioned. The specification of the risks concerned, to be ‘duly established in
accordance with the provisions of the Directive’, was considered to be too restrictive and
has not been integrated in the text.

(c)

did not include nine amendments (4, 11, 14, 16, 19, 24, 28, 29 and 37) in the Common
Position: the Council followed in this respect the arguments of the Commission, which
has not accepted these amendments.

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3. Most important innovations introduced by the Council

Article 2 (definitions): the definitions of ‘product’ and ‘safe products’ are modified in order to
better clarify the scope of the Directive, particularly in relation to products provided in the
context of services.

Additional definitions for ‘serious risk’ and ‘withdrawal’ are introduced to improve the clarity
of the text.

Article 3 (general safety requirement and conformity assessment criteria): the presentation of
this Article is changed, without modification of the original proposal in its substance.

Article 4 (European standards): a three-stage procedure is defined for the drawing up of
European standards for the purposes of the Directive, in accordance with the regulatory
committee procedure.

Article 5 (Other obligations of producers and distributors): the presentation of the Article is
changed, and wording aimed at encouraging a more proactive role of producers and
distributors, including the possible use of codes of good conduct, is introduced.

Article 8 (Specific obligations and powers of the Member States): modifications of this Article
are aimed at achieving a better match between the actions to be taken and the type/degree of
risks presented by the product. As in Article 5, the proactive role of producers and distributors
is encouraged.

Article 11 (Exchanges of information): modifications of this Article are aimed at better defining
the scope of the notifications which must be made by Member States to the Commission of
restriction measures taken for reasons other than those of serious risks requiring rapid
intervention, particularly those involving purely local events, in order to avoid overburdening
of the exchange of information system.

Article 12 (Community rapid information system — RAPEX): introduction of the obligation for
Member States to notify the Commission, in case of serious risks, also of measures taken on a
voluntary basis by producers and distributors.

Article 13 (Rapid intervention situations): two main changes are introduced:

1.

2.

the consultation process prior to which the Commission can require Member States to
take restrictive measures for products posing serious risks is reinforced;

the export ban for products for which the Member States have been required to take
restriction measures is maintained in principle, but a different decision can be taken case
by case.

Articles 14 and 15 (Committee procedures) are adapted to the new comitology rules.