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