CELEX: 51989PC0162
Language: en
Date: 1989-06-07
Title: PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING GENERAL PRODUCT SAFETY

31. 7. 89                                 Official Journal of the European Communities                                No C 193/1
                                                                 II
                                                         (Preparatory Acts)
                                                    COMMISSION
                              Proposal for a Council Directive concerning general product safety
                                                  COM(89) 162 final — SYN 192
                                        (Submitted by the Commission on 27 April 1989)
                                                            (89/C 193/01)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                             Whereas a large number of Community or national rules
                                                                     lay down specific requirements in respect of health and
                                                                     safety of persons for a particular product or product sector;
Having regard to the Treaty establishing the European
                                                                     whereas it must be presumed that products manufactured
Economic Community, and in particular Article 100A
                                                                     in accordance with such rules comply with the general
thereof,                                                             safety requirement; whereas however such presumption
                                                                     does not bar competent national authorities from taking
Having regard to the proposal from the Commission,                   preventive measures in respect of a pro'duct or product
                                                                     sector presenting or likely to present an unacceptable risk
                                                                     for the safety and health of persons;
In cooperation with the European Parliament,
                                                                     Whereas it is impossible to adopt Community legislation
Having regard to the opinion of the Economic and Social              for every product which exists or may be developed;
Committee,                                                           whereas there is a need for a broadly based, horizontal
                                                                     legislative framework to deal with those products, and also
                                                                     to cover lacunae in existing or forthcoming specific
Whereas it is important to adopt measures with the aim of            legislation, in particular with a view to ensuring a high level
progressively establishing the internal market over a period         of protection of safety and health of persons, as required by
expiring on 31 December 1992; whereas the internal                   Article 100A(3);
market is to comprise an area without internal frontiers in
which the free movement of goods, persons, services and
capital is ensured;                                                  Whereas it is appropriate to supplement the duty to observe
                                                                     the general safety requirement by an obligation on
                                                                     economic operators to monitor on a permanent basis the
Whereas some Member States have adopted horizontal                   safety of the products they deal with in the course of their
legislation on product safety, imposing, in particular, a            business;
general obligation on economic operators to produce and
market only safe products; whereas those legislations differ
in the level of protection of persons; whereas such                  Whereas Member States must provide for appropriate
disparities and the absence of horizontal legislation in other       authorities to control the safety of products, which have
Member States are liable to create barriers to trade and             powers to take the appropriate measures;
distortions of competition within the internal market;
                                                                     Whereas Member States must ensure that their competent
Whereas it is therefore necessary to establish on a                  authorities give due consideration to reasoned complaints
Community level a general safety requirement for any                 from the public concerning the safety properties of a
product placed on the market, namely that such products              product;
do not present any unacceptable risks and that potential
users are warned of any remaining risks;
                                                                     Whereas effective supervision of the safety of products
                                                                     requires the setting up at a national and Community level
Whereas the provisions of the Directive are to apply                 of a system of rapid exchange of information on emergency
without prejudice to specific rules of Community Law,                situations in respect of the safety of a product; whereas it is
especially legislation in the agricultural field and legislation     appropriate to give the Commission the power to lay down
on the safety and health of workers at the workplace,                detailed rules for such rapid exchange system at Com-
including consultation on those matters;                             munity level;
 ---pagebreak--- No C 193/2                              Official Journal of the European Communities                                    31. 7. 89
Whereas it is necessary to oblige Member States to restrict        HAS ADOPTED THIS DIRECTIVE:
the marketing of a product representing an unacceptable
risk of an immediate and grave nature;                                                          Article 1
                                                                   1. This Directive applies to the safety of products from
Whereas it is necessary for the preservation of the unity of       the time they are first placed on the market and throughout
the market to inform the Commission of any measure                 their foreseeable time of use.
restricting the conditions of distribution or marketing of a
product; whereas such measures can only be taken in                2. This Directive shall apply without prejudice to
compliance with the provisions of the Treaty, and in               provisions adopted in the framework of more specific rules
particular Articles 30 to 36;                                      of Community law.
                                                                   3. This Directive shall apply without prejudice to other
                                                                   notification procedures in Community legislation and in
Whereas it is possible that Member States in applying the          particular in Council Directive 83/189/EEC of 28 March
general safety requirement take different decisions with           1983 laying down a procedure for the provision of
regard to a particular product; whereas such differences           information in the field of technical standards and
can constitute a barrier to intracommunity trade and in            regulations (3) as well as Commission Decision 88/383/
some cases an unacceptable difference in the protection of         EEC of 24 February 1988 providing for the improvement of
users and consumers;                                               information on safety, hygiene and health at work (4).
Whereas it is, therefore, necessary to provide for an                                           Article 2
adequate mechanism allowing for the adoption of
                                                                   For the purposes of this Directive:
measures applicable throughout the Community in order
to cope with emergency situations of a particular                  (a) 'Product' means any manufactured             product   and
Community concern; whereas because of its emergency                    agricultural product, and includes:
nature, measures adopted under such procedure must be
only of an interim nature and have to be taken by the                  — any part of it such as raw materials, substances,
Commission assisted by a Committee of representatives of                   components and semi-finished products,
the Member States; whereas, for reasons of efficiency, it is
appropriate to provide for a management committee                      — movables incorporated into immovables,
according to procedure II of Council Decision 87/373 (*);
                                                                       — reconditioned products or any other product which
                                                                           is not supplied as new insofar as such supply takes
                                                                           place in the ordinary course of a business.
Whereas public awareness of product safety problems
should be increased by facilitating public debate of such          (b) 'Safe product' means a product that does not present, in
issues;                                                                particular in respect of its design, composition,
                                                                       execution, functioning, wrapping, conditions of as-
                                                                       sembly, maintenance or disposal, instructions for
Whereas it is necessary that Member States provide for                 handling and use, or any other of its properties, an
appropriate means of redress in cases where irregular                  unacceptable risk for the safety and health of persons,
measures are adopted by national authorities;                          either directly or indirectly, in particular through its
                                                                       effect upon other products or its combination there-
                                                                       with.
Whereas the adoption of any measure under this Directive
                                                                   (c) 'Unacceptable risk' is evaluated subject to the appli-
or under more specific legal instruments designed for the
                                                                       cation of more specific rules in respect of health and
same purpose must not, in itself, prejudge further legal
                                                                       safety as mentioned in Article 5, according to the
responsibility with regard to compensation for damages, in
                                                                       following general criteria:
particular under national laws adopted pursuant to
Council Directive 85/374/EEC of 25 July 1985 on the                    (aa) the intended use or consumption of a product
approximation of the laws, regulations and administrative                    according to normal circumstances, including any
provisions of the Member States concerning liability for                     specific representations made by its supplier or on
defective products ( 2 );                                                    his behalf in that respect, and any other reasonably
                                                                             foreseeable use or consumption;
Whereas the adoption of any measures with regard to                    (bb) the foreseeable time of use.
imported products for the purpose of preventing risks to
the safety and health of persons are to be taken in                    Any malfunctioning or defectiveness of a product which
conformity with international obligations,                             does not affect its safety properties as such shall not be
                                                                       taken into consideration.
(!) OJ No L 197, 18. 7. 1987, p. 33.                               (3) OJ No L 109, 26. 4. 1983, p. 8.
(2) OJ No L 210, 7. 8. 1985, p. 29.                                (4) OJ No L 183, 14. 7. 1988, p. 34.
 ---pagebreak--- 31. 7. 89                                 Official Journal of the European Communities                                 No C 193/3
    The feasibility of obtaining higher levels of safety or the      2. Indication of risk shall be made in such a way as to
    availability of other products of the same category,             allow any intended or potential user or consumer to make
    presenting a less degree of risk, shall not constitute, as       his own assessment of the risk, before he acquires a product
    such, ground for considering a risk presented by a               or is otherwise brought into a position to make use of it,
    product as unacceptable.                                         when such indication is an important element for this
                                                                     decision on purchasing or using the product.
(d)'Supplier' means:
    — the manufacturer of a product,
                                                                                                Article 5
    — the importer into the Community from a third
        country,                                                     1. A product which has been manufactured in accordance
                                                                     with specific Community or national rules which lay down
    — distributors and other professionals in the supply             the relevant requirements in respect of health and safety
        chain insofar as their activities may affect the safety      that must be met by that product for being marketed, shall
        properties of a marketed product.                            be presumed to comply with the obligation to place only
                                                                     safe products on the market.
(e) 'Foreseeable time of use' means the time that can be
    reasonably expected a product may be used in normal              2. In the absence of any specific rules, compliance with
    circumstances and for the use for which it is intended.          the general safety requirement of a particular product or
                                                                     product family shall be examined having regard to the state
                                                                     of the art, the state of scientific and technical knowledge
                                                                     including its practical feasibility and good business
                           Article 3
                                                                     practices in respect of safety and health in the product
                                                                     sector concerned.
Member States shall take all necessary measures in order to
ensure that only safe products are placed on the market,
irrespective of the commercial conditions of such placing
on the market.                                                                                  Article 6
These measures shall extend to such activities as may affect
                                                                     The measures which Member States are required to take in
the safety of a product, in particular its treatment,
                                                                     accordance with Article 3 shall include ensuring that the
processing, packaging, storage, transport, installation and,
                                                                     supplier of a product makes appropriate arrangements for
where necessary, its disposal.
                                                                     permanent monitoring, such as mentioned in the indicative
                                                                     list in Annex 1, of the safety of the products supplied by
                                                                     him, with a view to being properly informed about any
                           Article 4                                 unacceptable risk which such products may be likely to
                                                                     present and to assess such information with a view to
1. The measures which Member States are required to                  further avoiding such risk. In the case of distributors or
take pursuant to Article 3 shall include those necessary to          professionals other than the manufacturer or importer, the
ensure that, where a product because of its nature or for            duty of monitoring shall extend only to their activities and
technical and/or economic reasons presents a significant             insofar as they may affect the safety of the product.
risk which is acceptable as such, such risk is appropriately
indicated in order to make the potential user or consumer
aware of such risk, and in a way which
                                                                                                 Article 7
(a) takes into account, in particular:
                                                                     1.    Member States shall:
    — the intended use, consumption, packaging, transport
        and storage of a product according to normal                 (a) establish and/or nominate appropriate authorities to
        circumstances, including any specific represen-                  control the compliance of products with the obligation
        tations made by its supplier or on his behalf in that            to place only safe products on the market;
        respect, and any other reasonably foreseeable use or
        consumption,
                                                                     (b) ensure, at the same time, the technical competence and
    — the perception and knowledge that can reasonably                    the impartiality of the authorities, where applicable on
        be expected from the intended or potential user or                the basis of the relevant harmonized European stan-
        consumer, and                                                     dards ;
(b) ensures that any relevant warning can be duly perceived,         (c) ensure that the authorities have the necessary powers to
    where necessary at all stages of use, consumption and                 take the appropriate measures incumbent upon them
    disposal, and, if necessary, throughout the foreseeable               under this Directive; an indicative list of such powers is
    use time of a product.                                                set out in Annex 2;
 ---pagebreak--- No C 193/4                                Official Journal of the European Communities                                     31. 7. 89
 (d) ensure that the authorities are in a position to take                                       Article 9.
     account of and, where necessary, collect relevant data,
     on a permanent and regular basis, from sources which            1. Each Member State shall take all necessary measures to
     may supply indications for the likely existence of any          ensure that information about the existence or the likely
     risk of products, in particular based on evidence from          existence of an unacceptable risk presented by a product
     accidents, cases of sickness or any other personal injury:      marketed or likely to be marketed on their territory, in
                                                                     cases where such risk is or is likely to be grave and
                                                                     immediate, is rapidly exchanged between its own com-
     — which are likely to be related to any of the properties       petent authorities with a view to gathering and assessing all
         of a product,                                               relevant information in the most effective way.
         which are of a serious nature and which are likely to       2. Where a Member State has information about the
         recur and                                                   existence or the likely existence of a grave and immediate
                                                                     risk having not only local effects, it shall immediately
                                                                     inform the Commission thereof and of the measures it has
     — which are not due to an obvious or unforeseeable              taken or envisages to take, in particular those within the
         misuse of the product or the non-observance of an           meaning of Article 10. The Commission shall, where
         appropriate instruction or warning;                         appropriate, ensure the rapid transmission of such
                                                                     information to the other Member States.
     ensure that the authorities give due consideration to           This obligation shall not apply to products which, under
     reasoned complaints about the safety properties of a            other Community instruments, are the subject of equi-
     product, in particular from consumer organizations,             valent notification procedures.
     business associations and workers as well as their
     representatives;
                                                                     3. Detailed procedures for the transmission of the
                                                                     information within the meaning of paragraph 2 shall be
(f) notify the Commission of the authorities. The Commis-            adopted by the Commission in agreement with the
     sion shall communicate this information to the other            competent authorities of the Member States.
     Member States, and shall publish it in the Official
     Journal of the European Communities.                           4. Whenever the Commission has knowledge of the
                                                                    possible existence of a risk within the meaning of
                                                                    paragraph 1, without having received information pursu-
2. Compliance of a product with any of the criteria for              ant to paragraph 2, the Member State concerned, upon
assessment established in Article 5, and in particular the          request from the Commission, shall immediately supply all
specific rules mentioned in paragraph 1 shall not bar               relevant information about the matter which such Member
competent authorities of the Member States from adopting,           State disposes of or which it can obtain.
under the applicable procedures, any of the preventive
measures set out in this Directive, or any further measure
                                                                    5. Member States shall designate the competent authority
provided for under specific legislation governing a
                                                                    which is entitled and adequately equipped to ensure
particular product or product sector, where there is
                                                                    effective cooperation with the Commission according to
evidence that a product, despite such compliance, is or is
                                                                    paragraphs 2 and 4 as well as the expeditious carrying out
likely to present an unacceptable risk.
                                                                    of measures adopted under the procedure laid down in
                                                                    Article 14. Member States shall inform the Commission
                                                                    thereof.
                            Article 8
                                                                                                Article 10
1. Where a Member State intends to take or has taken
measures, pursuant to Article 7 and 10, which restrict the           1. (a) Where the appropriate authority in a Member State
placing of a product onto or require its withdrawal from                     has reasonable grounds for suspecting that a product
the market, the Member State shall, to the extent that such                  presents an unacceptable risk of an immediate and
notification is not required under any specific Community                    grave nature, it shall serve a notice prohibiting those
legislation governing the particular product or product                      on whom it is served, for such a period ending not
sector concerned, immediately inform the Commission of                       more than three months after the date of the notice
any such measure, indicating the reasons for adopting it.                    as is specified therein, from supplying, offering to
This obligation shall not apply where the measure has only                   supply, agreeing to supply or exposing the product
local effect.                                                                concerned.
                                                                         (b) The notice referred to in (a) may impose require-
2. National measures which have been notified according                      ments as regards labelling or other notifications
to paragraph 1 shall be examined pursuant to the                             accompanying the product, as a condition for the
procedure laid down in Article 14; the Commission may                        resumption of the supplying of the product on the
submit a draft of any appropriate measure.                                   market.
 ---pagebreak--- 31. 7. 89                                Official Journal of the European Communities                               No C 193/5
    (c) Any person having an interest in any product in             — examine the need for adopting appropriate measures
        respect of which a notice has been served may apply             applicable throughout the Community.
        to the appropriate authorities for an order setting
        aside the notice.                                           3. Member States shall adopt, upon request from the
                                                                    Commission, any measures necessary and appropriate for
2. Where the appropriate authority in a Member State                the purpose of this procedure, in particular those
finds that a product presents an unacceptable risk of an            mentioned in Annex 2 (2) (a), (b) and (c) to obtain
immediate and grave nature it shall take all appropriate            appropriate information. Member States shall com-
measures to withdraw those products from the market or              municate forthwith the findings and results of such
to prohibit or restrict their being placed on the market.           mesasures to the Commission.
                                                                    4. The Commission shall communicate to the Member
                           Article 11                               States the results of the investigation.
Whenever the Commission has knowledge, whether
through information provided by Member States, in                                            Article 13
particular under Article 9, or by reason of a notification
from Member States, in particular under Article 8, of the           The Commission shall be assisted by a Committee on
possible existence of a grave and immediate risk related,           Product Safety Emergencies, hereinafter called 'the
directly or indirectly, to the safety properties of a product,      Committee', composed of the representatives of the
                                                                    Member States and chaired by the representative of the
(a) which does or is likely seriously to affect, directly or        Commission.
    indirectly, the safety and health of an indeterminate
    number of persons in more than one Member State; and
                                                                                             Article 14
(b) which cannot adequately be dealt with, especially with a
    view to the urgency and/or complexity of the product
    safety issue in question, under other procedures for            1. The representative of the Commission shall submit to
    information, consultation, concertation and decision-           the Committee a draft of the measures to be taken. The
    making and related powers where so laid down under              Committee shall deliver its opinion on the draft within a
    specific Community legislation governing the product            time limit which the chairman may lay down according to
    or product sector concerned; and                                the urgency of the matter. The opinion shall be delivered by
                                                                    the majority laid down in Article 148(2) of the Treaty in the
                                                                    case of decisions which the Council is required to adopt on
(c) which can only be coped with appropriately by                   a proposal from the Commission. The votes of the
    adopting adequate measures applicable throughout the            representatives of the Member States within the Committee
    Community, in order best to ensure protection of                shall be weighted in the manner set out in that Article. The
    persons and the proper functioning of the common                chairman shall not vote.
    market,
                                                                    The Commission shall adopt the measures which shall
it shall either initiate the consultation and investigation         apply immediately. However, if these measures are not in
procedure as set out in Article 12 or directly take                 accordance with the opinion of the Committee, they shall
appropriate temporary measures to prevent the risk                  be communicated by the Commission to the Council
involved, such as those mentioned in Annex 2 (d) to (i) in          forthwith. In that event, the Commission may defer
accordance with the procedure laid down in Article 14.              application of the measures which it has decided for a
                                                                    period of five working days from the date of such
                                                                    communication.
                           Article 12
                                                                    The Council, acting by a qualified majority, may take a
1. Where the Commission decides to initiate a procedure             different decision within the time limit referred to in the
under this Article, it shall immediately communicate such           previous paragraph.
decision to the Member States with a summary of the
evidence available.                                                 2. Any measure adopted under this procedure shall be
                                                                    valid for no longer than six months. It may be prolonged
2. The purpose of the procedure is, within the limits               under the same procedure.
imposed by the circumstances and the urgency of the
product safety issue in question, to                                3. Member States shall take all the necessary measures in
                                                                    order to implement the decisions adopted under this
— obtain full information about the nature and scope of             procedure within 10 days.
    the risk,
                                                                    4. Enforcement authorities of Member States which carry
— identify its causes and assess possible means of                  out measures adopted under this procedure shall give,
    prevention,                                                     within one month, to any party concerned, an opportunity
 ---pagebreak---  No C 193/6                                 Official Journal of the European Communities                                      31. 7. 89
 to submit its views, and shall inform the Commission                      Measures requiring the withdrawal of a product shall
 accordingly.                                                              include provisions aiming to increase the readiness of any
                                                                           holder of such product, in particular distributors and end
                                                                           users or final consumers, to facilitate its withdrawal.
                             Article 15                                   2. Member States shall provide in their legislation that
                                                                          any person, natural or legal, who publicly puts into
 Member States shall take all necessary measures to ensure
                                                                          question the safety properties of a product or a category of
 that any information covered by professional secrecy
                                                                          products, for the sole purpose of promoting public
 relating to the safety properties of a product, which has
                                                                          awareness of health and safety issues, shall not be held
 been revealed to competent authorities, is kept confiden-
                                                                          liable for the economic consequences which such public
 tial, except for the information which must be made public
                                                                          debate might entail, provided such statements are substan-
 in order to ensure adequate protection of health and safety
                                                                          tially relevant, made in good faith and without discrimi-
 of persons, as may be necessary under the circumstances.
                                                                          nation, represented in an objective way and supported by
                                                                          serious argument.
                             Article 16                                   3. Member States shall establish the necessary adminis-
                                                                          trative and legal mechanisms for ensuring that suppliers of
 This Directive shall be without prejudice to Directive 85/               products, the safety of which is put in question in a manner
 374/EEC.                                                                 not in conformity with paragraph 2, have appropriate
                                                                          means of redress.
                                                                          4. Member States shall ensure that any irregular measure
                             Article 17                                   taken by the enforcement authorities, involving restrictions
 1. Any decision adopted under this Directive and                         on placing a product on the market, can be reviewed by the
involving restrictions on the placing of a product on the                 Courts.
market or requiring the withdrawal of a product from the
market shall state the exact grounds on which it is based. It                                        Article 18
shall be notified as soon as possible to the party concerned,
                                                                          1. Member States shall bring into force the laws,
who shall at the same time be informed of the remedies
                                                                          regulations and administrative provisions including ad-
available to him under the laws in force in the Member
                                                                          equate sanctions to comply with this Directive by
State in question and of the time limits applying to such
                                                                          1 January 1991 at the latest. They shall forthwith inform
remedies.
                                                                         the Commission thereof.
                                                                         2. The provisions adopted pursuant to paragraph 1 shall
The parties concerned, whenever feasible, shall be given an              make express reference to this Directive.
opportunity to submit their views before the adoption of
the measure. If this is not possible, in particular because of                                       Article 19
the urgency of the matter, such opportunity shall be given,
in due course, after the implementation of such measure.                 This Directive is addressed to the Member States.
                                                                 ANNEX    1
                 ILLUSTRATIVE LIST OF APPROPRIATE ARRANGEMENTS FOR MONITORING IN THE SENSE
                                                              OF ARTICLE 6
               (a) Appropriate marking of a product or a lot of products allowing for identifying it at a later stage.
               (b) Regular or random testing of a product in respect of its safety properties.
               (c) Appropriate agreements with other suppliers and professional customers and with general business
                   organizations of the product sector(s) concerned in order to receive and exchange, on a regular basis,
                   relevant information on safety issues in the product sector(s) concerned.
               (d) Systematic assessment and evaluation of complaints about a product or reasons for returns, even when they
                   are not directly founded on its safety properties.
 ---pagebreak--- 31. 7. 89                                Official Journal of the European Communities                                        No C 193/7
          (e) Keeping of adequate records on a regular basis of any such arrangements and their results.
          (f) Where necessary for effective monitoring, nomination of a person or service especially in charge of
              organizing such arrangements and supervising their proper functioning.
                                                             ANNEX      2
                               INDICATIVE LIST OF POWERS OF NATIONAL AUTHORITIES
          1. Powers for the adoption of appropriate measures for:
              — the organization of appropriate checks on the safety of products, even after their first being placed on the
                  market as being safe, on an adequate scale and especially with a view to the remaining risk, up to the
                  stage of end use or final consumption and, in the event, their disposal,
              — the control on the respect of the provisions on permanent monitoring by suppliers.
          2. Powers for the adoption of adequate preventive measures such as
              (a) the request of all relevant information from parties likely to be concerned such as suppliers and where
                  necessary, from any other natural or legal person;
              (b) the request of samples of a product or of a production line, seize or sequestrate products and, where
                  necessary, the penetration into premises or any other locality for that purpose;
              (c) the increase of the number and scope of controls, checks, tests, analyses or the like which are normally
                  foreseen for the particular product or product sector concerned, or the carrying out of such measures ad
                  hoc;
              (d) the publication through appropriate media and in an appropriate form of public warnings addressed to
                  those parties who, in normal circumstances, can be supposed to be users or consumers of the product
                  concerned, but where necessary, to the public in general as well;
              (e) the request addressed to manufacturers, importers and, where necessary, to any other professional, and,
                  in the event, to end users or final consumers as well, to disseminate adequate warnings to all persons
                  likely to be exposed to the risk involved, including, where necessary, the public in general;
              (f) the request addressed to manufacturers to add appropriate warning notices to the product in question;
                  where necessary, such request may also be addressed to distributors or other professionals;
              (g) the imposition of appropriate restrictions as to the conditions of distribution and marketing and, in the
                  event, of disposal, of a product;
              (h) the request of appropriate changes in a product or production line or the prohibition, either temporarily
                  or definitively, of its further manufacture or marketing or, in the case of raw material, substance,
                  component, semi-product of any other part, the prohibition of its use, integration into or association
                  with certain categories or types of products;
              (i) the withdrawal of a product already placed on the market — even where it is already in the possession of
                  an end user or final consumer — and, where necessary, its destruction under appropriate conditions;
                  according to the circumstances, Member States' authorities may:
                  (aa) invite a manufacturer to voluntarily recall, in the most effective way, the product concerned;
                  (bb) order manufacturers to recall, in the most effective way, the product concerned;
                  (cc) seize the product concerned at any stage of the manufacturing process and the distribution chain,
                        and, where necessary, at the premises or homes of end users or final consumers.