CELEX: 51990PC0259
Language: en
Date: 1990-06-11
Title: AMENDED PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING GENERAL PRODUCT SAFETY

No C 156/8                            Official Journal of the European Communities                                27. 6. 90
                                                             II
                                                     (Preparatory Acts)
                                                COMMISSION
                       Amended proposal for a Council Directive concerning general product safety
                                              COM(90) 259 final — SYN 192
              (Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 11 June 1990)
                                                       (90/C 156/07)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                         Whereas every effort must be made to refer to rules
                                                                 which, if observed, give credence to the assumption that
                                                                 the product in question complies with the general safety
Having regard to the Treaty establishing the European            requirement and to assessment criteria for appraising
Economic Community, and in particular Article 100A               product safety in the absence of such rules;
thereof,
                                                                 Whereas it is impossible to adopt Community legislation
Having regard to the proposal from the Commission,               for every product which exists or may be developed;
                                                                 whereas there is a need for a broadly based, horizontal
                                                                 legislative framework to deal with those products, and
In cooperation with the European Parliament,                     also to cover lacunae in existing or forthcoming specific
                                                                 legislation, in particular with a view to ensuring a high
                                                                 level of protection of safety and health of persons, as
Having regard to the opinion of the Economic and                 required by Article 100A (3) of the Treaty;
Social Committee,
                                                                 Whereas it is appropriate to supplement the duty to
Whereas it is important to adopt measures with the aim
                                                                 observe the general safety requirement by an obligation
of progressively establishing the internal market over a
                                                                 on economic operators to adopt suitable procedures for
period expiring on 31 December 1992; whereas the
                                                                 monitoring the safety of the products they deal with in
internal market is to comprise an area without internal
                                                                 the course of their business;
frontiers in which the free movement of goods, persons,
services and capital is ensured;
                                                                 Whereas Member States must provide for authorities to
Whereas some Member States have adopted horizontal               control the safety of products, which have powers to
legislation on product safety, imposing, in particular, a        take the appropriate measures;
general obligation on economic operators to market only
safe products; whereas those legislations differ in the
level of protection of persons; whereas such disparities         Whereas Member States must ensure that their
and the absence of horizontal legislation in other               competent authorities give due consideration to reasoned
Member States are liable to create barriers to trade and         complaints from the public concerning the safety pro-
distortions of competition within the internal market;           perties of a product;
Whereas it is therefore necessary to establish on a              Whereas effective supervision of the safety of products
Community level a general safety requirement for any             requires the setting-up at a national and Community
product placed on the market;                                    level of a system of rapid exchange of information in
                                                                 emergency situations in respect of the safety of a
                                                                 product; whereas it is appropriate to give the
Whereas it is necessary that potential users are warned of       Commission the power to lay down detailed rules for
any remaining risks;                                             such rapid exchange system at Community level; whereas
                                                                 the procedure laid down by the Council Decision on a
                                                                 Community system for the rapid exchange of infor-
Whereas, in the absence of more specific safety                  mation on dangers arising from the use of consumer
provisions covering the products concerned, the                  products has been adopted in this Directive and the
provisions of this Directive are to apply;                       abovementioned Decision has thereby been repealed;
 ---pagebreak--- 27. 6. 90                              Official Journal of the European Communities                              No C 156/9
Whereas it is necessary to oblige Member States to               Whereas the implementation of this Directive does not
restrict the marketing of dangerous products or to order         affect victims' rights within the meaning of Council
their withdrawal or recall from the market;                      Directive 85/374/EEC of 25 July 1985 on the approxi-
                                                                 mation of the laws, regulations and administrative
                                                                 provisions of the Member States concerning liability for
Whereas it is necessary for the preservation of the unity        defective products (4);
of the market to inform the Commission of any measure
restricting the conditions of distribution or marketing of
a product; whereas such measures can only be taken in
compliance with the provisions of the Treaty, and in             Whereas the procedure for the adoption of measures
particular Articles 30 to 36;                                    applicable to imported products with a view to
                                                                 preventing risks to the safety and health of persons must
                                                                 comply with international obligations,
Whereas this Directive applies without prejudice to
the notification procedures in Council Directive
83/189/EEC of 28 March 1983 laying down a
procedure for the provision of information in the field          HAS ADOPTED THIS DIRECTIVE:
of technical standards and regulations (') and in
Commission Decision 88/383/EEC of 24 February 1988
providing for the improvement of information on safety,
hygiene and health at work( 2 );                                                            TITLE I
                                                                               Objectives, scope and definitions
Whereas it is possible that Member States in applying the
general safety requirement take different decisions with                                   Article 1
regard to a particular product; whereas such differences
can constitute a barrier to intra-Community trade and in          1.   This Directive lays down provisions for the safety
some cases an unacceptable difference in the protection          of marketed products.
of users and consumers;
                                                                 2.    The provisions of this Directive apply insofar as
Whereas it is therefore necessary to provide for an              there are no more specific provisions, in rules of
adequate mechanism allowing for the adoption of                  Community law, governing the safety of the concerned
measures applicable throughout the Community in order            products.
to cope with emergency situations of particular
Community concern; whereas, by reason of their
urgency, measures adopted under such a procedure can
be no more than interim measures that have to be taken                                     Article 2
by the Commission assisted by a committee of represen-
tatives of the Member States; whereas, for reasons of            For the purposes of this Directive:
efficiency, it is appropriate to provide for a management
committee according to procedure II of Council
Decision 87/373 (3);                                             (a) 'product' shall mean any manufactured, processed
                                                                     or agricultural product supplied whether for
                                                                     consideration or not in the course of a business, and
Whereas the Commission, acting in accordance with the                whether new, used or reconditioned;
powers vested in it, is continuing to look into the possi-
bility of setting up an advisory committee on product
safety to include representatives of the various interested
parties, and in particular of the suppliers, users and           (b) 'safe product' shall mean any product which, during
consumers;                                                           its foreseeable time of use, does not present any risk
                                                                     or only those reduced to such a level, taking account
                                                                     of the product's use, considered as acceptable and
Whereas steps should be taken to protect the legitimate              consistent with a high standard of protection for the
interests of the individuals concerned when doubts are               safety and health of persons:
publicly cast on product safety features;
                                                                     — given its composition, execution, wrapping, pre-
Whereas it is necessary that Member States provide for
                                                                          sentation and labelling, conditions of assembly,
appropriate means of redress in cases where irregular
                                                                          maintenance or disposal, instructions          for
measures are adopted by national authorities;
                                                                          handling and use and its direct or indirect effect
                                                                          upon or in combination with other products,
(') OJ No L 109, 26. 4. 1983, p. 8.
(2) OJ No L 183, 14. 7. 1988, p. 34.
O OJ No L 197, 18. 7. 1987, p. 33.                               (4) OJ No L 210, 7. 8. 1985, p. 29.
 ---pagebreak--- N o C 156/10                           Official Journal of the European Communities                                    27. 6. 90
    — when used for its intended use or in a manner              — adopt appropriate measures to ensure suitable moni-
         which may reasonably be foreseen, having                     toring of the safety of the products, taking account
         regard, inter alia, to any specific statement made           of their particular characteristics, with a view to
         by its supplier or on his behalf in that respect             being properly informed of risks which these
         and, in particular, to the normal behaviour of               products might present, assessing this information
         children.                                                    and taking appropriate action including, if necessary,
                                                                      recalling the product in question or withdrawing it
    The feasibility of obtaining higher levels of safety or           from the market to avoid these risks.
    the availability of other products presenting a lesser
    degree of risk shall not constitute grounds for
    considering a product to be 'not safe' or 'dangerous';            The measures to be taken to monitor products speci-
                                                                      fically include, whenever appropriate, marking of the
                                                                      products or product lots in such a way that they can
(c) 'dangerous product' shall mean any product which                  subsequently be identified, sample testing of
    does not meet the definition of 'safe product'                    marketed products and the institution of systematic
     according to point (b) of the present Article;                   procedures for assessing and investigating complaints
                                                                      made.
(d) 'supplier'shall mean:
    — the manufacturer of the product, when he is                 3.    Distributors and other professionals in the supply
         established in the Community, and any person             chain who are not suppliers are required to act with due
         presenting himself as the manufacturer by                care in order to contribute to ensuring compliance with
         affixing to the product his name, trademark or           the general safety requirement. In particular, within the
         other distinctive mark,                                  limits of their respective activities, they shall participate
                                                                  in monitoring the safety of marketed products, for
                                                                  example by passing on information on product risks and
    — the manufacturer's authorized agent, when the
                                                                  cooperating in the action taken to avoid these risks.
         manufacturer      is not     established   in   the
         Community, or, if no such agent exists, the
         importer of the product,
                                                                                             Article 4
    — distributors and other professionals in the supply
                                                                  1.     Suppliers shall be deemed to have complied with
         chain in so far as their activities may affect the
                                                                  the general safety requirement when the product
         safety properties of a marketed product,
                                                                  conforms:
    — the commercial supplier of used and/or recondi-
         tioned products.                                         — with the specific rules of Community law laying
                                                                      down the health and safety requirements which the
                                                                      product must satisfy in order to be marketed,
                           TITLE II
                 General safety requirement                       — if there are no Community rules, with the specific
                                                                      rules of national law of the Member State on whose
                            Article 3                                 territory the product is in circulation, such rules
                                                                      being drawn up in conformity with the Treaty and in
1.    Suppliers are under an obligation to place only safe            particular Articles 30 and 36 thereof and laying down
products on the market. Member States shall incorporate               the health and safety requirements which the product
in their legislation all necessary measures to ensure that            must satisfy in order to be marketed.
suppliers meet this obligation.
2.    In particular, within the limits of their respective        2.     In order to assess the conformity of a product with
activities, suppliers shall:                                      the rules mentioned in paragraph 1, reference shall also
                                                                  be made to national voluntary standards giving effect to
— provide the potential user or consumer with the                 a European standard or, when they exist, Community
    relevant information to enable him to assess the risks        technical specifications or, failing these, safety and health
    presented by a product when such risks are                    standards for the products concerned drawn up in the
    acceptable as such but are not immediately obvious            Member State in which the product is in circulation.
    and are not insignificant, and to take precautions
    against these risks throughout the forseeable time of
    use of the product; provision of a warning does not           3.     In the absence of any more specific rule, the
    constitute a means of escaping the general safety             conformity of a product or category of products with the
    requirement nor a defence when the product proves             general safety requirement shall be assessed by reference
    to be dangerous,                                              to the state of the art, to the state of scientific and
 ---pagebreak--- 27. 6. 90                             Official Journal of the European Communities                              N o C 156/11
technical knowledge, having regard to practical feasi-                                     Article 6
bility, and to the codes of good practice in respect of
                                                                 1.    For the purposes of Article 5 (g), the Member
safety and health in the sector concerned and to the
                                                                States have the necessary powers, acting in accordance
safety which users or consumers may reasonably expect.
                                                                with the degree of risk and in conformity with the
                                                                Treaty and in particular Articles 30 and 36 thereof, to
4.     Conformity of a product with the rules mentioned         adopt appropriate measures with a view to:
in paragraphs 1 and 2 shall not bar the competent auth-
orities of the Member States from taking action to
impose restrictions on its being placed on the market or        (a) organizing appropriate checks on the safety pro-
to require its withdrawal from the market where there is             perties of products, even after their first being placed
evidence that despite such conformity it is dangerous to             on the market as being safe, on an adequate scale,
the health and safety of users or consumers.                         up to the stage of end use or final consumption or, if
                                                                     appropriate, their disposal;
                         TITLE III                              (b) requesting all relevant information from parties likely
                                                                     to be concerned;
       Obligations and powers of the Member States
                                                                (c) requesting samples of a product or a product line,
                          Article 5                                  seizure or sequestration of products and, if appro-
Member States shall take the necessary regulatory and                priate, obtaining access to commercial premises;
administrative measures so that suppliers comply with
their obligations under this Directive to prohibit the
                                                                 (d) ensuring compliance with the provisions concerning
placing of dangerous products on the market and to
                                                                     suitable monitoring of products;
enable them to be withdrawn or recalled.
                                                                 (e) warning, in an appropriate form, of the risks arising
In particular, Member States shall:
                                                                     from a product, in particular by public notices, distri-
                                                                     bution of notices to all persons liable to be exposed
(a) establish and/or nominate authorities to control the             to the risk in question and by providing the products
     compliance of products with the obligation to place             in question with warning notices to make them safe;
     only safe products on the market;
                                                                 (f) imposing appropriate restrictions as to the conditions
(b) ensure, at the same time, the technical competence
                                                                     of distribution and marketing and, if appropriate, of
     and the impartiality of the authorities, where
                                                                     disposal of a dangerous product;
     applicable on the basis of the relevant harmonized
     European standards;
                                                                 (g) requesting appropriate changes in a product or
(c) make the authorities known to the Commission; the                product line in order to make it safe;
     Commission shall pass this information to the other
     Member States;
                                                                 (h) temporary or definitive prohibition of the manu-
                                                                     facture or marketing of a product;
(d) make the authorities known to the public;
(e) ensure that the authorities collect and systematically       (i) organizing the withdrawal or recall of a dangerous
     analyse information on the real or probable existence           product already on the market and, if appropriate,
     of a risk associated with a product and data on                 its destruction, under appropriate conditions;
     accidents and harmful effects imputable to products;
                                                                 (j) when there are strong and corroboratory indications
(f) ensure that the authorities give due consideration to            that a product is dangerous and presents a risk of an
     reasoned complaints about the safety properties of a            immediate and grave nature:
     product;                                                        — seizure of the product concerned at any stage of
                                                                          manufacture or distribution for the period, not
(g) ensure that the authorities have the necessary powers                 exceeding three months, required to have the
     to take the appropriate measures incumbent upon                      necessary analysis carried out to investigate the
     them under this Directive;                                           matter,
                                                                     — serving of a notice prohibiting those on whom it
(h) provide, without prejudice to the common criminal                     is served, for a period ending not more than
     law provisions made under national legislation, for                  three months after the date of the notice as is
     suitable sanctions in the event of failure to comply                 specified therein, from supplying, offering to
     with the obligations deriving from this Directive.                   supply or exhibiting the product concerned.
 ---pagebreak--- N o C 156/12                            Official Journal of the European Communities                                 27. 6. 90
2.     The measures to be taken by the competent auth-            Specific detailed procedures for rapid exchange of this
orities of the Member States under this Article shall be          information      between     Member     States   and      the
addressed, as appropriate, to                                     Commission shall be adopted in accordance with the
                                                                  procedure laid down in Article 11 (1) and (5).
(a) the supplier;
                                                                                             TITLE V
(b) within the limits of their respective activities, to
     distributors and/or other professionals in the supply                         Action at Community level
     chain, and in particular to the party responsible for
     the first stage of distribution on the national market,                                 Article 8
     who are not covered by the definition of the supplier
     in Article 2 (d);                                            Whenever the Commission has knowledge, whether
                                                                  through information provided or notification by the
                                                                  Member States, in particular under Article 7, of the
(c) when appropriate, to final users and/or consumers,            possible existence of a grave and immediate risk related,
     or any other person in possession of the product,            directly or indirectly, to the safety properties of a
     especially with regard to cooperation in the action          product:
     taken to avoid risks.
                                                                  (a) which does or is likely seriously to affect, directly or
                                                                       indirectly, the safety and health of an indeterminate
                            TITLE IV                                   number of persons in more than one Member State,
                                                                       and
         Notification and exchange of information
                                                                  (b) which cannot be adequately dealt with, especially
                            Article 7                                  with a view to the urgency and/or complexity of the
                                                                       product safety issue in question, under the other
 1.    Where a Member State has taken measures,                        procedures laid down under any specific Community
pursuant to Article 6 (e) to (j), which restrict the placing           legislation governing the product or category of
of a product on the market or require its withdrawal                   products concerned, and
from the market, the Member State shall, to the extent
that such notification is not required under any specific         (c) which can only be eliminated effectively by adopting
Community         legislation,   immediately    inform    the          appropriate measures applicable throughout the
Commission of any such measures, together with the                     Community, in order to ensure the best possible
reasons for adopting them. This obligation shall not                   protection of persons and the proper functioning of
apply where the measures relate to an event which is                   the Common Market,
local in effect, in any case limited to the territory of the
concerned Member State.
                                                                  — the Commission shall either initiate the consultation
                                                                       and investigation procedure as set out in Article 9,
The Commission shall enter into consultations with the
parties concerned as quickly as possible. When the                — or, if one or more Member States has decided to
Commission concludes, after such consultations, that the               take or implement one of the measures mentioned in
measure is justified, it shall immediately inform the                  Article 6 (e) to (j),
Member State which initiated the action and the other
Member States. When the Commission concludes after                it shall ask the Member States to take appropriate
these consultations that the measure is not justified, it         temporary measures to prevent the risk, in accordance
shall immediately inform the Member State which                   with the procedure laid down in Article 11.
initiated the action and the manufacturer or his auth-
orized agent established in the Community.
                                                                                             Article 9
                                                                  1.    Within the limits arising from circumstances and
2.     Where a Member State has information about the
                                                                  from the urgency of the product safety issue in question,
existence or the likely existence of a grave and
                                                                  the Commission may decide to initiate a consultation
immediate risk which has or may have effects outside its
                                                                  and investigation procedure with the Member States to
territory, it shall immediately inform the Commission
                                                                  obtain further information on the nature and scale of the
thereof, and of the measures it has taken or intends to
                                                                  risk, its causes and possible means of prevention so that
take, unless equivalent procedures are required under
                                                                  it can consider thoroughly whether it is necessary
specific Community legislation applying to the products
                                                                  to adopt appropriate measures directly applicable
or category of products in question.
                                                                  throughout the Community.
The Commission shall ensure that such information is              2.    When the Commission decides to initiate such a
passed to the other Member States and they in turn shall          procedure, it shall immediately inform the Member
inform the Commission of any outcome.                             States, providing a summary of the evidence available.
 ---pagebreak--- 27. 6. 90                            Official Journal of the European Communities                             N o C 156/13
3.    Upon request from the Commission, the Member             5.     The period for the adoption of detailed procedures
States shall take the appropriate measures, in particular      of the rapid exchange of information system established
those mentioned in Article 6 (a) to (c), in order to obtain    in Article 7 (2) shall be one month.
the necessary information.
Member States shall inform the Commission of the                                         TITLE VI
findings and results of such measures.
                                                                             Miscellaneous and final provisions
4.    The Commission shall inform the Member States of                                   Article 12
the results of the investigation.
                                                               Member States shall take all necessary measures to
                                                               ensure that any information covered by professional
                        Article 10                             secrecy relating to the safety properties of a product,
                                                               which has been revealed to the competent authorities, is
The Commission shall be assisted by a Committee on             kept confidential, except for the information which must
Product Safety Emergencies, hereinafter called 'the            be made public in order to ensure effective protection of
committee', composed of the representatives of the             health and safety of persons, as may be necessary under
Member States and chaired by a representative of the           the circumstances.
Commission.
                                                                                         Article 13
                        Article 11
                                                               This Directive shall be without prejudice to Directive
 1.   The representative of the Commission shall submit         85/374/EEC of 25 July 1985 on the approximation of
to the committee a draft of the measures to be taken.           laws, regulations and administrative provisions of the
The committee shall deliver its opinion on the draft            Member States concerning liability for defective
within a time limit which the chairman may lay down            products (').
according to the urgency of the matter but which may
not exceed one month. The opinion shall be delivered by
the majority laid down in Article 148 (2) of the Treaty                                  Article 14
for adoption of decisions by the Council on a proposal          1.    Any decision adopted under this Directive and
from the Commission. The votes of the representatives of        involving restrictions on the placing of a product on the
the Member States within the committee shall be                 market, or requiring its withdrawal from the market,
weighted in the manner set out in that Article. The             shall state the exact grounds on which it is based. It shall
chairman shall not vote.                                        be notified a soon as possible to the party concerned,
                                                               who shall at the same time be informed of the remedies
The Commission shall adopt the measures, which shall            available to him under the laws in force in the Member
apply immediately. However, if these measures are not in        State in question and of the time limits applying to such
accordance with the opinion of the committee, they shall        remedies.
be communicated by the Commission to the Council
forthwith. In that event, the Commission may defer             The parties concerned, whenever feasible, shall be given
application of the measures which it has adopted for a          an opportunity to submit their views before the adoption
period of five working days from the date of such               of the measure. If this has not been done in advance,
communication.                                                  because of the urgency of the matter, such opportunity
                                                                shall be given, in due course, after the measure has been
The Council, acting by a qualified majority, may take a         implemented.
different decision within the time limit referred to in the
previous paragraph.                                             Any decision taken by virtue of this Directive and
                                                                involving restrictions on the placing of a product on the
                                                                market, or requiring its withdrawal from the market,
2.    Any measure adopted under paragraph 1 of this             shall be entirely without prejudice to assessment of the
Article shall be valid for no longer than six months. It        responsibility of the party concerned in the light of the
may be prolonged under the same procedure.                      national criminal law applying in the case in question.
3.    Member States shall take all necessary measures in        Measures requiring the withdrawal of a product shall
order to implement the decisions adopted under this             include provisions aiming to increase the readiness of
procedure within 10 days.                                       any holder of such product, in particular distributors and
                                                                end users or final consumers, to facilitate its withdrawal.
                                                                These measures may, if appropriate, include replacement
4.    The competent authorities of the Member States            of the product or reimbursement of its cost.
which carry out measures adopted under this procedure
shall, within one month, give to any party concerned an
opportunity to submit its views, and shall inform the
Commission accordingly.                                         (') OJ No L 210, 7. 8. 1985, p. 29.
 ---pagebreak--- No C 156/14                           Official Journal of the European Communities                                27. 6. 90
2.     Member States shall provide in their legislation that                                 Article 16
any person, natural or legal, who publicly calls into
question the safety properties of a product or a category        1.    Member States shall bring into force the laws,
of products for the sole purpose of increasing public           regulations and administrative provisions, including
awareness of health and safety problems, shall not be           adequate sanctions, to comply with this Directive by
held liable for the economic consequences which public           1 January 1991 at the latest. They shall forthwith inform
debate might entail, provided such statements are               the Commission thereof.
intended to be truthful and accurate and are made in
good faith.
3.     Member States shall establish the necessary admin-        2.    The provisions adopted pursuant to paragraph 1
istrative and legal mechanisms for ensuring that suppliers      shall make express reference to this Directive.
of products, the safety of which is called into question in
a manner not in conformity with paragraph 2, have
appropriate means of redress.
4.     Member States shall ensure that any measure taken                                     Article 17
by the competent authorities, involving restrictions on
                                                                 Council Decision . . . / . . ./EEC of    on a Community
the placing of a product on the market, or requiring its
                                                                 system for the rapid exchange of information on dangers
withdrawal from the market, can be challenged before
                                                                 arising form the use of consumer products, is repealed.
the courts.
                        Article 15
Every two years, the Commission shall submit a report                                        Article 18
on the implementation of this Directive to the Parliament
and the Council.                                                This Directive is addressed to the Member States.