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, 
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 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; 
Whereas it is necessary that potential users are warned of 
any remaining risks; 
Whereas, in the absence of more specific safety 
provisions covering the products concerned, the 
provisions of this Directive are to apply; 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 
requirement and to assessment criteria for appraising 
product safety in the absence of such rules; 
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) of the Treaty; 
Whereas it is appropriate to supplement the duty to 
observe the general safety requirement by an obligation 
on economic operators to adopt suitable procedures for 
monitoring the safety of the products they deal with in 
the course of their business; 
Whereas Member States must provide for 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 pro­
perties 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 in 
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 Community level; whereas 
the procedure laid down by the Council Decision on a 
Community system for the rapid exchange of infor­
mation on dangers arising from the use of consumer 
products has been adopted in this Directive and the 
abovementioned Decision has thereby been repealed; 
27. 6. 90 Official Journal of the European Communities No C 156/9 
Whereas it is necessary to oblige Member States to 
restrict the marketing of dangerous products or to order 
their withdrawal or recall from the market; 
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 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 
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); 
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 intra-Community 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 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 
by the Commission assisted by a committee of represen­
tatives 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 (3); 
Whereas the Commission, acting in accordance with the 
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 
consumers; 
Whereas steps should be taken to protect the legitimate 
interests of the individuals concerned when doubts are 
publicly cast on product safety features; 
Whereas it is necessary that Member States provide for 
appropriate means of redress in cases where irregular 
measures are adopted by national authorities; 
(') 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. Whereas the implementation of this Directive does not 
affect victims' rights within the meaning of Council 
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 
defective products (4); 
Whereas the procedure for the adoption of measures 
applicable to imported products with a view to 
preventing risks to the safety and health of persons must 
comply with international obligations, 
HAS ADOPTED THIS DIRECTIVE: 
TITLE I 
Objectives, scope and definitions 
Article 1 
1. This Directive lays down provisions for the safety 
of marketed products. 
2. The provisions of this Directive apply insofar as 
there are no more specific provisions, in rules of 
Community law, governing the safety of the concerned 
products. 
Article 2 
For the purposes of this Directive: 
(a) 'product' shall mean any manufactured, processed 
or agricultural product supplied whether for 
consideration or not in the course of a business, and 
whether new, used or reconditioned; 
(b) 'safe product' shall mean any product which, during 
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 
consistent with a high standard of protection for the 
safety and health of persons: 
— given its composition, execution, wrapping, pre­
sentation and labelling, conditions of assembly, 
maintenance or disposal, instructions for 
handling and use and its direct or indirect effect 
upon or in combination with other products, 
(4) OJ No L 210, 7. 8. 1985, p. 29. 
NoC 156/10 Official Journal of the European Communities 27. 6. 90 
— when used for its intended use or in a manner 
which may reasonably be foreseen, having 
regard, inter alia, to any specific statement made 
by its supplier or on his behalf in that respect 
and, in particular, to the normal behaviour of 
children. 
The feasibility of obtaining higher levels of safety or 
the availability of other products presenting a lesser 
degree of risk shall not constitute grounds for 
considering a product to be 'not safe' or 'dangerous'; 
(c) 'dangerous product' shall mean any product which 
does not meet the definition of 'safe product' 
according to point (b) of the present Article; 
(d) 'supplier'shall mean: 
— the manufacturer of the product, when he is 
established in the Community, and any person 
presenting himself as the manufacturer by 
affixing to the product his name, trademark or 
other distinctive mark, 
— the manufacturer's authorized agent, when the 
manufacturer is not established in the 
Community, or, if no such agent exists, the 
importer of the product, 
— distributors and other professionals in the supply 
chain in so far as their activities may affect the 
safety properties of a marketed product, 
— the commercial supplier of used and/or recondi­
tioned products. 
TITLE II 
General safety requirement 
Article 3 
1. Suppliers are under an obligation to place only safe 
products on the market. Member States shall incorporate 
in their legislation all necessary measures to ensure that 
suppliers meet this obligation. 
2. In particular, within the limits of their respective 
activities, suppliers shall: 
— provide the potential user or consumer with the 
relevant information to enable him to assess the risks 
presented by a product when such risks are 
acceptable as such but are not immediately obvious 
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 
constitute a means of escaping the general safety 
requirement nor a defence when the product proves 
to be dangerous, — adopt appropriate measures to ensure suitable moni­
toring of the safety of the products, taking account 
of their particular characteristics, with a view to 
being properly informed of risks which these 
products might present, assessing this information 
and taking appropriate action including, if necessary, 
recalling the product in question or withdrawing it 
from the market to avoid these risks. 
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 
subsequently be identified, sample testing of 
marketed products and the institution of systematic 
procedures for assessing and investigating complaints 
made. 
3. Distributors and other professionals in the supply 
chain who are not suppliers are required to act with due 
care in order to contribute to ensuring compliance with 
the general safety requirement. In particular, within the 
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 
cooperating in the action taken to avoid these risks. 
Article 4 
1. Suppliers shall be deemed to have complied with 
the general safety requirement when the product 
conforms: 
— with the specific rules of Community law laying 
down the health and safety requirements which the 
product must satisfy in order to be marketed, 
— if there are no Community rules, with the specific 
rules of national law of the Member State on whose 
territory the product is in circulation, such rules 
being drawn up in conformity with the Treaty and in 
particular Articles 30 and 36 thereof and laying down 
the health and safety requirements which the product 
must satisfy in order to be marketed. 
2. In order to assess the conformity of a product with 
the rules mentioned in paragraph 1, reference shall also 
be made to national voluntary standards giving effect to 
a European standard or, when they exist, Community 
technical specifications or, failing these, safety and health 
standards for the products concerned drawn up in the 
Member State in which the product is in circulation. 
3. In the absence of any more specific rule, the 
conformity of a product or category of products with the 
general safety requirement shall be assessed by reference 
to the state of the art, to the state of scientific and 
27. 6. 90 Official Journal of the European Communities NoC 156/11 
technical knowledge, having regard to practical feasi­
bility, and to the codes of good practice in respect of 
safety and health in the sector concerned and to the 
safety which users or consumers may reasonably expect. 
4. Conformity of a product with the rules mentioned 
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 
to require its withdrawal from the market where there is 
evidence that despite such conformity it is dangerous to 
the health and safety of users or consumers. 
TITLE III 
Obligations and powers of the Member States 
Article 5 
Member States shall take the necessary regulatory and 
administrative measures so that suppliers comply with 
their obligations under this Directive to prohibit the 
placing of dangerous products on the market and to 
enable them to be withdrawn or recalled. 
In particular, Member States shall: 
(a) establish and/or nominate 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 standards; 
(c) make the authorities known to the Commission; the 
Commission shall pass this information to the other 
Member States; 
(d) make the authorities known to the public; 
(e) ensure that the authorities collect and systematically 
analyse information on the real or probable existence 
of a risk associated with a product and data on 
accidents and harmful effects imputable to products; 
(f) ensure that the authorities give due consideration to 
reasoned complaints about the safety properties of a 
product; 
(g) ensure that the authorities have the necessary powers 
to take the appropriate measures incumbent upon 
them under this Directive; 
(h) provide, without prejudice to the common criminal 
law provisions made under national legislation, for 
suitable sanctions in the event of failure to comply 
with the obligations deriving from this Directive. Article 6 
1. For the purposes of Article 5 (g), the Member 
States have the necessary powers, acting in accordance 
with the degree of risk and in conformity with the 
Treaty and in particular Articles 30 and 36 thereof, to 
adopt appropriate measures with a view to: 
(a) organizing appropriate checks on the safety pro­
perties of products, even after their first being placed 
on the market as being safe, on an adequate scale, 
up to the stage of end use or final consumption or, if 
appropriate, their disposal; 
(b) requesting all relevant information from parties likely 
to be concerned; 
(c) requesting samples of a product or a product line, 
seizure or sequestration of products and, if appro­
priate, obtaining access to commercial premises; 
(d) ensuring compliance with the provisions concerning 
suitable monitoring of products; 
(e) warning, in an appropriate form, of the risks arising 
from a product, in particular by public notices, distri­
bution of notices to all persons liable to be exposed 
to the risk in question and by providing the products 
in question with warning notices to make them safe; 
(f) imposing appropriate restrictions as to the conditions 
of distribution and marketing and, if appropriate, of 
disposal of a dangerous product; 
(g) requesting appropriate changes in a product or 
product line in order to make it safe; 
(h) temporary or definitive prohibition of the manu­
facture or marketing of a product; 
(i) organizing the withdrawal or recall of a dangerous 
product already on the market and, if appropriate, 
its destruction, under appropriate conditions; 
(j) when there are strong and corroboratory indications 
that a product is dangerous and presents a risk of an 
immediate and grave nature: 
— seizure of the product concerned at any stage of 
manufacture or distribution for the period, not 
exceeding three months, required to have the 
necessary analysis carried out to investigate the 
matter, 
— serving of a notice prohibiting those on whom it 
is served, for a period ending not more than 
three months after the date of the notice as is 
specified therein, from supplying, offering to 
supply or exhibiting the product concerned. 
NoC 156/12 Official Journal of the European Communities 27. 6. 90 
2. The measures to be taken by the competent auth­
orities of the Member States under this Article shall be 
addressed, as appropriate, to 
(a) the supplier; 
(b) within the limits of their respective activities, to 
distributors and/or other professionals in the supply 
chain, and in particular to the party responsible for 
the first stage of distribution on the national market, 
who are not covered by the definition of the supplier 
in Article 2 (d); 
(c) when appropriate, to final users and/or consumers, 
or any other person in possession of the product, 
especially with regard to cooperation in the action 
taken to avoid risks. 
TITLE IV 
Notification and exchange of information 
Article 7 
1. Where a Member State has taken measures, 
pursuant to Article 6 (e) to (j), which restrict the placing 
of a product on the market 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, immediately inform the 
Commission of any such measures, together with the 
reasons for adopting them. This obligation shall not 
apply where the measures relate to an event which is 
local in effect, in any case limited to the territory of the 
concerned Member State. 
The Commission shall enter into consultations with the 
parties concerned as quickly as possible. When the 
Commission concludes, after such consultations, that the 
measure is justified, it shall immediately inform the 
Member State which initiated the action and the other 
Member States. When the Commission concludes after 
these consultations that the measure is not justified, it 
shall immediately inform the Member State which 
initiated the action and the manufacturer or his auth­
orized agent established in the Community. 
2. Where a Member State has information about the 
existence or the likely existence of a grave and 
immediate risk which has or may have effects outside its 
territory, it shall immediately inform the Commission 
thereof, and of the measures it has taken or intends to 
take, unless equivalent procedures are required under 
specific Community legislation applying to the products 
or category of products in question. 
The Commission shall ensure that such information is 
passed to the other Member States and they in turn shall 
inform the Commission of any outcome. Specific detailed procedures for rapid exchange of this 
information between Member States and the 
Commission shall be adopted in accordance with the 
procedure laid down in Article 11 (1) and (5). 
TITLE V 
Action at Community level 
Article 8 
Whenever the Commission has knowledge, whether 
through information provided or notification by the 
Member States, in particular under Article 7, 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 be adequately dealt with, especially 
with a view to the urgency and/or complexity of the 
product safety issue in question, under the other 
procedures laid down under any specific Community 
legislation governing the product or category of 
products concerned, and 
(c) which can only be eliminated effectively by adopting 
appropriate measures applicable throughout the 
Community, in order to ensure the best possible 
protection of persons and the proper functioning of 
the Common Market, 
— the Commission shall either initiate the consultation 
and investigation procedure as set out in Article 9, 
— or, if one or more Member States has decided to 
take or implement one of the measures mentioned in 
Article 6 (e) to (j), 
it shall ask the Member States to take appropriate 
temporary measures to prevent the risk, in accordance 
with the procedure laid down in Article 11. 
Article 9 
1. Within the limits arising from circumstances and 
from the urgency of the product safety issue in question, 
the Commission may decide to initiate a consultation 
and investigation procedure with the Member States to 
obtain further information on the nature and scale of the 
risk, its causes and possible means of prevention so that 
it can consider thoroughly whether it is necessary 
to adopt appropriate measures directly applicable 
throughout the Community. 
2. When the Commission decides to initiate such a 
procedure, it shall immediately inform the Member 
States, providing a summary of the evidence available. 
27. 6. 90 Official Journal of the European Communities NoC 156/13 
3. Upon request from the Commission, the Member 
States shall take the appropriate measures, in particular 
those mentioned in Article 6 (a) to (c), in order to obtain 
the necessary information. 
Member States shall inform the Commission of the 
findings and results of such measures. 
4. The Commission shall inform the Member States of 
the results of the investigation. 
Article 10 
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 a representative of the 
Commission. 
Article 11 
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 but which may 
not exceed one month. The opinion shall be delivered by 
the majority laid down in Article 148 (2) of the Treaty 
for adoption of decisions by the Council 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 adopted 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 paragraph 1 of this 
Article shall be valid for no longer than six months. It 
may be prolonged under the same procedure. 
3. Member States shall take all necessary measures in 
order to implement the decisions adopted under this 
procedure within 10 days. 
4. The competent authorities of the Member States 
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. 5. The period for the adoption of detailed procedures 
of the rapid exchange of information system established 
in Article 7 (2) shall be one month. 
TITLE VI 
Miscellaneous and final provisions 
Article 12 
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 the competent authorities, is 
kept confidential, except for the information which must 
be made public in order to ensure effective protection of 
health and safety of persons, as may be necessary under 
the circumstances. 
Article 13 
This Directive shall be without prejudice to Directive 
85/374/EEC of 25 July 1985 on the approximation of 
laws, regulations and administrative provisions of the 
Member States concerning liability for defective 
products ('). 
Article 14 
1. Any decision adopted under this Directive and 
involving restrictions on the placing of a product on the 
market, or requiring its withdrawal from the market, 
shall state the exact grounds on which it is based. It shall 
be notified a 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 has not been done in advance, 
because of the urgency of the matter, such opportunity 
shall be given, in due course, after the measure has been 
implemented. 
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, 
shall be entirely without prejudice to assessment of the 
responsibility of the party concerned in the light of the 
national criminal law applying in the case in question. 
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. 
These measures may, if appropriate, include replacement 
of the product or reimbursement of its cost. 
(') OJ No L 210, 7. 8. 1985, p. 29. 
No C 156/14 Official Journal of the European Communities 27. 6. 90 
2. Member States shall provide in their legislation that 
any person, natural or legal, who publicly calls into 
question the safety properties of a product or a category 
of products for the sole purpose of increasing public 
awareness of health and safety problems, shall not be 
held liable for the economic consequences which public 
debate might entail, provided such statements are 
intended to be truthful and accurate and are made in 
good faith. 
3. Member States shall establish the necessary admin­
istrative and legal mechanisms for ensuring that suppliers 
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 
by the competent authorities, involving restrictions on 
the placing of a product on the market, or requiring its 
withdrawal from the market, can be challenged before 
the courts. 
Article 15 
Every two years, the Commission shall submit a report 
on the implementation of this Directive to the Parliament 
and the Council. Article 16 
1. Member States shall bring into force the laws, 
regulations and administrative provisions, including 
adequate 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 17 
Council Decision .../.. ./EEC of on a Community 
system for the rapid exchange of information on dangers 
arising form the use of consumer products, is repealed. 
Article 18 
This Directive is addressed to the Member States.