13. 2. 90 Official Journal of the European Communities No C 33/3 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive amending for the seventh time Directive 67/548/EEC on the 
approximation of the laws, regulations and administrative provisions relating to the classifi­
cation, packaging and labelling of dangerous substances 
COM(89) 575 final — SYN 227 
(Submitted by the Commission on 26 January 1990) 
(90/C 33/03) 
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 disparity between the laws, regulations and 
administrative provisions relating to the classification, 
packaging and labelling of dangerous substances and to 
the notification of new substances in the Member States 
may lead to barriers to trade between Member States 
arid may create unequal conditions of competition; 
Whereas disparities in these conditions in the Member 
States directly affect the functioning of the internal 
market; 
Whereas measures for the approximation of the 
provisions of the Member States which have as their 
object the establishment and functioning of the internal 
market shall, in as much as they concern health, safety, 
environmental and consumer protection, take a high 
level of protection as a base and provide, despite existing 
differences in economies of the Member States, for equal 
standards of protection throughout the Community; 67/548/EEC ('), as last amended by Directive 
88/490/EEC (2); 
Whereas it is necessary for these reasons to amend 
Directive 67/548/EEC which currently protects the 
population and in particular the workers using dangerous 
substances, by an adequate classification, packaging and 
labelling of such substances; 
Whereas it is appropriate to reduce to a minimum the 
number of animals used for experimental purposes 
according to the provisions of Council Directive 
86/609/EEC of 24 November 1986 on the approxi­
mation of laws, regulations and administrative provisions 
of the Member States regarding the protection of 
animals used for experimental and other scientific 
purposes (J); 
Whereas Council Directive 87/18/EEC of 18 December 
1986 on the harmonization of laws, regulations and 
administrative provisions relating to the application of 
the principles of good laboratory practice and the verifi­
cation of their application for tests on chemical 
substances (4) specifies the Community principles of good 
laboratory practice which must be followed for tests on 
chemicals; 
Whereas Council Directive 88/320/EEC of 9 June 1988 
concerning the inspection and verification of good 
laboratory practice (5) specifies how the application of 
the principles of good laboratory practice shall be 
verified; 
Whereas in order to ensure the safety of workers and the 
environment, it is opportune that safety data on 
dangerous substances be available to the persons 
responsible for worker safety and environmental safety; 
Whereas to protect man and the environment against (') .OJ No 196, 16. 8. 1967, p. 1. 
potential risks which could arise from the placing on the O OJ No L 259, 19. 9. 1988, p. 1. 
market of new substances, it is necessary to lay down C) OJ No L 358, 18. 12. 1986, p. 1. 
appropriate measures and in particular to reinforce (4) OJ No L 15, 17. 1. 1987, p. 29. 
the recommendations set out in Council Directive (5) OJ No L 145, 11. 6. 1988, p. 35. 
No C 33/4 Official Journal of the European Communities 13. 2. 90 / 
Whereas in order to control the effects on man and the 
environment it is advisable that any new substance placed 
on the market be the subject of a prior study by the 
manufacturer or importer and be notified to the 
competent authorities by means of a notification 
containing certain mandatory information; whereas it is, 
moreover, important to follow closely the evolution and 
use of new substances placed on the market, and 
whereas it is necessary, in order to do so, to institute a 
system which allows all new substances to be listed; 
Whereas, moreover, it is necessary, if the Directive is to 
be properly applied, to draw up an inventory of 
substances on the Community market by 18 September 
1981; 
Whereas it is necessary to provide for measures making 
it possible to introduce a procedure of notification to 
one Member State which is then valid for the 
Community; whereas, it is, moreover, necessary to 
provide that measures relating to the classification and 
labelling of substances may be laid down at Community 
level; 
Whereas in order to ensure an adequate level of 
protection for man and the environment it is necessaiy to 
introduce measures for the packaging and provisional 
labelling of dangerous substances not yet appearing in 
Annex I to Directive 67/548/EEC; and whereas for the 
same reason it is necessary to make the indication of 
safety advice obligatory; 
Whereas Article % of the abovementioned Directive 
classifies substances and preparations as toxic, harmful, 
corrosive or irritant by the use of general definitions; 
whereas experience has shown that it is necessary to 
improve this classification; whereas in the absence, at the 
moment, of specifications necessary. for allocation to 
these classes, it seems appropriate to provide precise 
criteria for classification; whereas, in addition, Article 3 
of the Directive provides for an assessment of risk for 
the environment and it is therefore necessary to 
enumerate certain characteristics and parameters of 
assessment, and to establish a phased study programme, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 67/548/EEC is amended as follows: 
1. Articles 1 to 27 of Directive 67/548/EEC are 
replaced by the following Articles: 
!Article 1 
Objectives and scope 
1. The purpose of this Directive is to approximate 
the laws, regulations and administrative provisions of 
the Member States on: (a) the notification of substances; 
(b) the exchange of information on notified 
substances; 
(c) the assessment of the potential risk to man and 
the environment of notified substances; 
(d) the classification, packaging and labelling of 
substances dangerous to man or the environment, 
which are placed on the market in the Member States. 
2. This Directive does not apply to the provisions 
relating to: 
(a) medicinal products for human use, as defined in 
Directive 65/65/EEC ('), medicinal products for 
veterinary use, as defined in Directive 
81/851/EEC (2), narcotics, as defined in the 
United Nations' Single Convention on Narcotic 
Drugs, 1961, as amended by the 1972 protocol, 
and radioactive substances as defined in Directive 
80/836/Euratom (3); 
(b) the carriage of dangerous substances by rail, road, 
inland waterway, sea or air; 
(c) foodstuffs, in the finished state, intended for the 
final user; 
(d) animal feedingstuffs in the finished state intended 
for the final user; 
(e) plant protection products in the finished state, as 
intended for the final user, which are covered by 
Directive .../.../... (4); 
(f) substances and mixtures of substances in the form 
of waste, which are covered by Directives 
75/442/EEC (5) and 78/319/EEC (6); 
(g) substances in transit which are under customs 
supervision provided they do not undergo any 
treatment or processing. 
Article 2 
Definitions 
1. For the purpose of this Directive: 
(a) 'substances' means chemical elements and their 
compounds in the natural state or obtained by any 
production process, including any additive 
C) OJ No 22, 9. 2. 1965, p. 369. 
O OJ No L 317, 6. 11. 1981, p. 1. 
O OJ No L 246, 17. 9. 1980, p. 1. 
(4) OJ No C 89, 10. 4. 1989, p. 22. COM(89) 34 final — a 
modified proposal for a Council Directive concerning the 
placing on the market of plant protection products. 
(') OJ No L 194, 25. 7. 1975, p. 39. 
(*) OJ No L 84, 31. 3. 1978, p. 43. 
13. 2. 90 Official Journal of the European Communities No C 33/5 
necessary to preserve the stability of the product 
and any impurity deriving inevitably from the 
process used, but excluding any separable solvent; 
(b) 'preparations' means mixtures or solutions 
composed of two or more substances; 
(c) 'notification' means the documents with the 
requisite information presented to the competent 
authority of a Member "State: 
— for substances manufactured in the 
Community, by the manufacturer established 
in the Community who places on the market a 
substance on its own or in a preparation, 
— for substances manufactured outside the 
Community by the legal or natural person 
established within the Community who, for 
the purpose of submitting the notification 
relating to a given substance in conformity 
with this Directive, is designated by the manu­
facturer as being his sole representative. 
The person presenting a notification as described 
above shall hereinafter be referred to as 'the 
notifier'; 
(d) 'placing on the market' means supplying or making 
available to third parties. 
Importation into the Community customs 
territory shall be deemed to be placing on the 
market for the purposes of this Directive; 
(e) 'scientific research and development' means 
scientific experimentation, analysis or chemical 
research carried out under controlled conditions; 
it includes the determination of intrinsic proper­
ties, performance and efficacy as well as scientific 
investigation related to product development; 
(f) 'process-orientated research and development' means 
the phase preceding the full commercialization of 
a substance in the course of which, by means of 
pilot plant or production trials, the technical 
specifications of the substance are modified in the 
light of customer response. 
2. The following substances and preparations are 
'dangerous' within the meaning of this Directive: 
(a) explosive: 
substances and preparations which may explode 
under the effects of a flame or upon heating or 
which are very sensitive to shocks or friction; (b) oxidizing: 
substances and preparations which give rise to a 
highly exothermic reaction in contact with other 
substances, particularly flammable substances; 
(c) extremely flammable: 
substances and preparations having an extremely 
low flash point and a low boiling point; 
(d) highly flammable: 
— substances and preparations which may 
become hot and finally catch fire in contact 
with air at ambient temperature without any 
application of energy, 
or 
— solid substances and preparations which may 
readily catch fire after brief contact with a 
source of ignition and which continue to burn 
or to be consumed after removal of the source 
of ignition, 
or 
— liquid substances and preparations having a 
very low flash point, 
or 
— substances and preparations which, in contact 
with water or damp air, evolve highly 
flammable gases in dangerous quantities; 
(e) flammable: 
liquid substances and preparations having a low 
flash point; 
(f) very toxic: 
substances and preparations which, if they are 
inhaled or ingested or if they penetrate the skin, 
may involve extremely serious, acute or chronic 
health hazards and even death; 
(g) toxic: 
substances and preparations which, if they are 
inhaled or ingested or if they penetrate the skin, 
may involve serious, acute or chronic health 
hazards and even death; 
(h) harmful: 
substances and preparations which, if they are 
inhaled or ingested or if they penetrate the skin, 
may involve limited health hazards; 
(i) corrosive: 
substances and preparations which may, on 
contact with living tissues, destroy them; 
No C 33/6 Official Journal of the European Communities 13.^2. 90 
(j) irritant: 
non-corrosive substances and preparations which, 
through immediate, prolonged or repeated 
contact with the skin or mucous membrane, can 
cause inflammation; 
(k) sensitizing: 
substances and preparations which, if they are 
inhaled or if they penetrate the skin, are capable 
of eliciting a reaction of the immune system 
(hypersensitization) such that on further exposure 
to the substance or preparation, characteristic 
adverse effects are produced; 
(1) carcinogenic: 
substances or preparations which, if they are 
inhaled or ingested or if they penetrate the skin, 
may induce cancer or increase its incidence; 
(m) mutagenic: 
substances and preparations which, if they are 
inhaled or ingested or if they penetrate the skin, 
may induce heritable genetic defects or increase 
their incidence; 
(n) toxic for reproduction: 
substances and preparations which, if they are 
inhaled or ingested or if they penetrate the skin, 
may produce, or increase the incidence of, 
non-heritable adverse effects in the progeny and 
or an impairment of male or female reproductive 
functions or capacity; 
(o) dangerous for the environment: 
substances and preparations which, should they 
enter the environment, present or may present an 
immediate or delayed danger for one or more 
compartments of the environment. 
Article 3 
Testing and assessment of the properties of substances 
1. The physico-chemical properties of the 
substances and preparations shall be determined 
according to the methods specified in Annex V Part 
A ('); their toxicity shall be determined according to 
the methods specified in Annex V Part B (') and their 
ecotoxicity according to those specified in Annex V 
Part C 0). 
Laboratory tests shall be carried out in compliance 
with the principles of good laboratory practice 
provided for in Directive 87/18/EEC (2) and the 
(') See the following adaptations to technical progress: 
— Oj No L 251, 19. 9. 1984, p. 1, 
— OJNoL 133, 30. 5. 1988, p. 1. 
O OJNoL 15, 17. 1. 1987, p. 29. provisions of Directive 86/609/EEC (J) regarding the 
protection of animals used for experimental and other 
scientific purposes. 
2. The real or potential enviromental risk shall be 
assessed on the basis of the elements set out in 
Annexes VII and VIII and taking into account any 
existing internationally recognized procedures. 
Article 4 
Classification 
1. Substances shall be classified on the basis of 
their intrinsic properties according to the categories 
laid down in Article 2 (2). 
2. The general principles of the classification and 
labelling of substances and preparations shall be 
applied according to the criteria in Annex VI ("), save 
where contrary requirements for dangerous prepa­
rations are specified in separate Directives. 
3. Annex I (5) contains the list of substances 
classified in accordance with the principles outlined in 
Article 4 (1) and (2) together with their harmonized 
classification and labelling. The decision to place a 
substance in Annex I together with the harmonized 
classification and labelling shall be taken in 
accordance with the procedure laid down in Article 
24. 
4. The dangerous substances listed in Annex I 
shall, where appropriate, be characterized by concen­
tration limits or any other parameter enabling the 
health or environmental hazard of preparations to be 
assessed. 
Article 5 
Duties of the Member States 
1. The Member States shall take all the measures 
necessary to ensure that, without prejudice to Article 
8, substances cannot be placed on the market on their 
own or in preparations unless the substances have 
been: 
— notified to the competent authority of one of the 
Member States in accordance with this Directive, 
O OJNoL 358, 18. 12. 1986, p. 1. 
(4) See also OJ No L 257, 16. 9. 1983, p. 1. 
(5) See also the following adaptations to technical progress: 
— OJ No L 360, 30. 12. 1976, p. 1, 
— OJ No L 88, 7. 4. 1979, p. 1, 
— OJNoL 351, 7. 12. 1981, p. 5, 
— OJ No L 106, 21. 4. 1982, p. 18, 
— OJNoL 257, 16. 9. 1983, p. 1, 
— OJNoL 247, 1.9. 1986, p. 1, 
— OJ No L 239, 21. 8. 1987, p. 1, 
— OJ No L 259, 19. 9. 1988, p. 1. 
13. 2. 90 Official Journal of the European Communities No C 33/7 
— packaged and labelled in accordance with Articles 
18 to 20 and with the criteria in Annex VI, and in 
accordance with the results of the tests provided 
for in Annexes VII and VIII, save in the case of 
preparations where provisions exist in separate 
Directives. 
In addition, the Member States will take all the 
measures necessary to ensure that the provisions 
concerning safety data sheets as laid down in Article 
21 are respected. 
2. The measures referred to in the second indent of 
paragraph 1 of Article 5 (1) shall apply until the 
substance is listed in Annex I or until a decision not to 
list it has been taken in accordance with the 
procedure laid down in Article 24. 
Dangerous substances not yet appearing in Annex I 
but included in the list referred to in Article 16 (1) or 
already on the market before 18 September 1981 
must, in so far as the manufacturer, whether or not 
established in the Community, may reasonably be 
expected to be aware of their dangerous properties, 
be packaged and provisionally labelled by the manu­
facturer or his representative in accordance with the 
rules laid down in Articles 17 to 20 and with the 
criteria in Annex VI. 
Article 6 
Duties of the notifier 
1. Without prejudice to Articles 1 (4), 7 (1), 8 (1) 
and 11 (1), any notifier of a substance shall be 
required to submit to the competent authority 
referred to in Article 11 (1) of the Member State in 
which the substance is manufactured, or in the case of 
a manufacturer located outside the Community, the 
Member State within which the notifier is established, 
a notification including: 
— a technical dossier supplying the information 
necessary for evaluating the foreseeable risks, 
whether immediate or delayed, which the 
substance may entail for man and the envi­
ronment, and containing all available relevant data 
for this purpose. As a minimum the dossier shall 
contain at least the information and results of the 
studies referred to in Annex VII Part A, together 
with a detailed and full description of the studies 
conducted and of the methods used or a biblio­
graphical reference to them, 
— a declaration concerning the unfavourable effects 
of the substance in terms of the various uses 
envisaged, — a proposal for a safety data sheet, 
— in the case of a manufacturer located outside the 
Community the notifier shall include a statement 
from the manufacturer to the effect that, for the 
purpose of submitting a notification for the 
substance in question, he is designated as the 
manufacturer's sole representative, 
— if so desired, a statement by the notifier requesting, 
with justification, that the notification be 
exempted from the provisions of Article 10 (2) for 
a maximum period which shall not in any case 
exceed one year following the date of notification. 
2. The notifier need not supply the information 
required for the technical dossier in Annex VII Part A 
with the exception of items 1 and 2 if: 
(i) the data were originally submitted at least ten 
years previously; 
or 
(ii) the substance has been submitted previously by 
the notifier for approval as an active substance 
for use in plant protection products in 
conformity with the provisions of Directive 
O; 
or 
(iii) the substance has been submitted previously by 
the notifier for approval as an additive, or a 
substance for use, in animal feedingstuffs in 
accordance with the provisions of Directive 
70/524/EEC (2). 
3. The substance may be placed on the market only 
when the notifier has received a written acknowl­
edgement from the competent authority that the noti­
fication has been accepted as being in conformity with 
the Directive, and in any case not earlier than 60 days 
after the date of receipt of the notification by the 
authority. 
4. Without prejudice to Article 9 any notifier of a 
substance already notified shall inform the competent 
authority: 
— when the quantity of the substance placed on the 
market reaches 10 tonnes per year per manu­
facturer or when the total quantity placed on the 
market reaches 50 tonnes per manufacturer; in 
this case, the competent authority may require 
some or all the additional tests/studies laid down 
in Annex VIII, level 1 to be carried out within a 
time limit it will determine, 
— the proposed classification and labelling of the 
substance in accordance with this Directive, (') COM(89) 34 final. OJ No C 89, 10. 4. 1989, p. 22. 
(2) OJ No L 270, 14. 12. 1970, p. 1. 
No C 33/8 Official Journal of the European Communities 13. 2. 90 
— when the quantity of the substance placed on the 
market reaches 100 tonnes per year per manu­
facturer or when the total quantity placed on the 
market reaches 500 tonnes per manufacturer; in 
this case, the competent authority shall require the 
additional tests/studies laid down in Annex VIII, 
level 1 to be carried out within a time limit it will 
determine, unless the notifier can justify that a 
given test/study is not appropriate or an alter­
native scientific test/study would be preferable, 
— when the quantity of a substance placed on the 
market reaches 1 000 tonnes per year per manu­
facturer or when the total quantity placed on the 
market reaches 5 000 tonnes per manufacturer; in 
this case, the competent authority shall draw up a 
programme of tests/studies according to Annex 
VIII, level 2, to be carried out by the notifier 
within a time limit it will determine. 
5. When additional testing is carried out in 
accordance with the requirements of paragraph 4 
above the notifier shall provide the competent 
authority with the results of the studies carried out. 
Article 7 
Reduced notification requirements for substances 
placed on the market in quantities less than one tonne 
per annum per manufacturer 
1. Without prejudice to Article 1 (4), 8 (1) and 
11 (1), any notifier of a substance placed on the 
Community market in quantities less than one tonne 
per annum per manufacturer shall be required to 
submit to the competent authority referred to in 
Article 11 (1) of the Member State in which the 
substance is manufactured, or in the case of a manu­
facturer located outside the Community, the Member 
State within which the notifier is established, a notifi­
cation including: 
— a technical dossier supplying the information 
necessary for evaluating the foreseeable risks, 
whether immediate or delayed, which the 
' substance may entail for man and the envi­
ronment, and containing all available relevant data 
for this purpose. As a minimum the dossier shall 
contain at least the information and results of the 
studies referred to in Annex VII Part B, together 
with an indication of the methods used or a 
bibliographical reference to them, 
] 
— a declaration concerning the unfavourable effects 
of the substance in terms of the various uses 
envisaged, 
— the proposed classification and labelling of the 
substance in accordance with this Directive, — in the case of a manufacturer located outside the 
Community the notifier shall include a statement 
from the manufacturer to the effect that, for the 
purpose of submitting a notification for the 
substance in question, he is designated as the 
manufacturer's sole representative, 
— if so desired a statement by the notifier requesting, 
with justification, that the notification be 
exempted from the provisions of Article 10 (2) for 
a maximum period which shall not in any case 
exceed one year following the date of notification. 
Moreover, when the quantities to be placed on the 
market are below 100 kilograms per year per manu­
facturer the notifier may, without prejudice to Article 
11 (1), restrict the information for the technical 
dossier of the notification referred to above to that 
provided for in Annex VII Part C. 
2. The notifier need not supply the information 
required for the technical dossiers of Parts B or C of 
Annex VII with the exception of items 1 and 2 
thereof if: 
(i) the data were originally submitted at least ten 
years previously; 
or 
(ii) the substance has been submitted previously by 
the notifier for approval as an active substance 
for use in plant protection products in 
conformity with the provisions of Directive 
or 
(iii) the substance has been submitted previously by 
the notifier for approval as an additive, or a 
substance for use, in animal feedingstuffs in 
accordance with the provisions of Directive 
70/524/EEC (2). 
3. In the absence of any indication to the contrary 
from the competent authority, the substance may be 
placed on the market 15 days after the receipt of the 
dossier by the competent authority subject to any 
conditions which may subsequently be imposed by the 
authority. 
4. In the case of a notifier who has submitted a 
reduced notification dossier in conformity with the 
second subparagraph of paragraph 1 then 15 days 
before the quantity of the substance placed on the 
market reaches 100 kilograms per year per manu­
facturer or before the total quantity placed on the 
market reaches 500 kilograms per manufacturer, the 
notifier shall provide the competent authority with the 
additional information necessary to complete the 
technical dossier to the level of Annex VII Part B. 
— a proposal for a safety data sheet, (') OJ No C 89, 10. 4. 1989, p. 22. 
(2) OJ No L 362, 31. 12. 1985, p. 8. 
13. 2. 90 Official Journal of the European Communities No C 33/9 
Similarly when a notifier has submitted a reduced 
notification in conformity with the first subparagraph 
of paragraph 1 above then before the quantity of the 
substance placed on the market reaches 1 tonne per 
annum per manufacturer, or before the total quantity 
placed on the market reaches 5 tonnes per manu­
facturer, the notifier shall submit a full notification 
according to the requirements of Article 6. 
5. The substances notified in conformity with 
paragraph 1 and the first subparagraph of paragraph 4 
must, in so far as the notifier may reasonably be 
expected to be aware of their properties, be packaged 
and provisionally labelled in accordance with the rules 
laid down in Articles 17 to 20 and with the criteria 
imposed in Annex VI. In accordance with the prin­
ciples set out in Article 18, the label should bear, in 
addition to the label deriving from the tests already 
carried out, the warning 'Caution—substance not yet 
fully tested'. 
Article 8 
Exemptions 
1. The following substances are exempted from the 
provisions of Articles 6, 7, 9 and 10: 
— substances which appear in the inventory referred ' 
to in Article 16 (1), 
— from the date of entry into force of Directive 
'on the placing of plant protection 
products on the market' to active > substances 
intended for exclusive use in such products and as 
covered by the above Directive, 
— additives and substances for exclusive use in 
animal feedingstuffs as covered by Directive 
70/524/EEC and by Directive 82/471/EEC (2), 
— substances used exclusively as additives in food­
stuffs as covered by Directive 89/107/EEC (3). 
2. The substances listed below, shall be considered 
as having been notified within the meaning of this 
Directive when the following conditions are fulfilled: 
— polymerizates, polycondensates and polyadducts 
except those containing 2 % or more of any 
substance not listed in the inventory referred to in 
Article 16 (1), 
(') OJ No C 89, 10. 4. 1989, p. 22. 
(2) OJ No L 213, 21. 7. 1982, p. 8. 
C) OJ No L 40, 11. 2. 1989, p. 27. — substances placed on the market in quantities less 
than 10 kilograms per annum per manufacturer, 
— substances placed on the market in limited quan­
tities, and in any case not exceeding 100 kilograms 
per manufacturer per annum, and intended solely 
for purposes of scientific research and devel­
opment carried out under controlled conditions, 
— any manufacturer or importer making use of this 
exemption must maintain written records 
containing the identity of the substance, labelling 
data, quantities and a list of customers; this infor­
mation shall be made available upon request to the 
competent authorities of each Member State 
where the manufacture, importation, or scientific 
research and development takes place, 
— substances placed on the market for the purposes 
of process-orientated research and development 
with a limited number of registered customers in 
quantities which are limited to the purpose of 
process-orientated research and development. 
These substances shall qualify for an exemption 
for a period of one year provided that the manu­
facturer or importer communicates their identity, 
labelling data, quantity, the justification for the 
quantity and a list of customers to the competent 
authorities of each Member State where the 
manufacture, importation or process orientated 
research and development takes place and 
complies with any conditions imposed by these 
authorities on such research and development. 
After this period these substances will normally be 
subject to notification. 
The manufacturer or importer shall also give an 
assurance that the substance or the preparation in 
which it is incorporated will be handled only by 
customers' staff in controlled conditions and will not 
be made ^available at any time either on its own or in 
preparation to the general public. 
The one-year exemption period referred to above may 
in exceptional circumstances be extended for a further 
year if the notifier can demonstrate to the satisfaction 
of the competent authority that such an extension is 
justified. 
3. The substances referred to in paragraph 2, must, 
in so far as the manufacturer may reasonably be 
expected to be aware of their dangerous properties, 
be packaged and provisionally labelled by the manu­
facturer or his representative in accordance with the 
rules laid down in Articles 17 to 20 and with the 
criteria imposed in Annex VI. 
If is not possible to label completely because the 
results of tests provided for in Annex VII Part A are 
No C 33/10 Official Journal of the European Communities 13. 2. 90 
not all available and in accordance with the principles 
set out in Article 18, the label should bear, in addition 
to the label deriving from tests already carried out, 
the warning: 'Caution — substance not yet fully 
tested'. 
4. Where a substance as referred to in paragraph 2, 
labelled in accordance with the principles set out in 
Article 18, is very toxic or toxic, the manufacturer or 
importer of such a substance must transmit to the 
competent authority any appropriate information as 
regards Annex VII Part A, points 2.3, 2.4 and 2.5. 
Article 9 
Follow-up information 
Any notifier of a substance already notified in 
conformity with Articles 6 (1) or 7 (1) shall be 
responsible on his own initiative for informing the 
competent authority to which the initial notification 
was submitted of: 
— changes in the annual or total quantities placed on 
the market by him in accordance with the tonnage 
range laid down in Annex VII Parts A, B or C, 
point,2.2.1, 
— new knowledge of the effects of the substance on 
man and/or the environment of which he may 
reasonably be expected to have become aware, 
— new uses for which the substance is placed on the 
market of which he may reasonably be expected to 
have become aware, 
— any change in the composition of the substance as 
given in Annex VII Parts A, B or C, point 1.3, 
— any change in his status, such as manufacturer or 
importer. 
Article 10 
Re-notification of the same substance and avoidance 
of duplicating testing on vertebrate animals 
1. In the case of a substance which has already 
been notified in accordance with Articles 6 (1) or 7 
(1), the competent authority may agree that the 
subsequent notifier of that substance may, for the 
purposes of items 3, 4 and 5 of Parts A and B of 
Annex VII and items 3 and 4 of Annex VIII Part C, 
refer to the results of the tests/studies carried out by 
the first notifier, insofar as the subsequent notifier can 
provide evidence that the substance renotified is the 
same as the one previously notified, including the 
degree of purity and the nature of impurities. The 
first notifier must give his agreement in writing to the 
reference to the results of the tests/studies he has 
carried out before such reference can be made. 2. Before carrying out testing on vertebrate animals 
for the purpose of submitting a notification in 
conformity with Articles 6 (1) or 7 (1), and without 
prejudice to Article 10 (1), prospective notifiers shall 
enquire of the competent authority of the Member 
State within which they intend subsequently to notify, 
as to 
(a) whether or not the substance they intend to notify 
has already been notified; 
(b) the name and address of the first notifier. This 
enquiry shall be supported by evidence that the 
prospective notifier has the intention to place the 
substance on the market and of the quantities he 
intends to place on the market. 
In the event 
(a) that the competent authority receiving the enquiry 
is satisfied that the prospective notifier has the 
intention to place the substance on the market in 
the quantities stated; 
and 
(b) that the substance has been notified previously; 
and 
(c) that the first notifier has not requested and been 
granted a temporary exemption from the 
provisions of this Article, 
the competent authority shall provide the prospective 
notifier with the name and address of the first notifier 
and will at the same time inform the first notifier of 
the name and address of the prospective notifier. 
The first notifier and the prospective notifier shall 
take all reasonable steps to reach an agreement on the 
sharing of information so as to avoid the duplication 
of testing on vertebrate animals. 
3. Notifiers of the same substance who have agreed 
to share information relating to Annex VII in 
accordance with the provisions of paragraphs 1 and 2 
shall also take all reasonable steps to reach an 
agreement on the sharing of, information concerns 
testing on vertebrate animals submitted in conformity 
with Article 6 (4). 
Article 11 
Rights and duties of the competent authorities 
1. Member States shall appoint the competent 
authority or authorities responsible for receiving the 
information provided for in Articles 6 to 9 and 
examining its conformity with the requirements of the 
Directive. 
13. 2. 90 Official Journal of the European Communities No C 33/11 
Moreover, if it can be shown to be necessary for the 
evaluation of the risk which may be caused by a 
substance, the competent authority may ask for 
further information, supplementary testing and verifi­
cation/confirmatory tests concerning the substances 
or their degradation products (metabolites), of which 
they have been notified or have received information 
under this Directive; this may also include requesting 
any of the information referred to in Annex VIII 
earlier than provided for in Article 6 (4). 
Additionally, the competent authority may: 
— carry out such sampling as is necessary for control 
purposes, 
— take appropriate measures relating to safe use of a 
substance pending the introduction of Community 
provisions. 
2. For notifications submitted in conformity with 
Article 6(1) the competent authority shall only accept 
the notification dossier when it is in full conformity 
with the Directive and shall inform the notifier in 
writing of this acceptance. The authority shall at the 
same time advise the notifier of the official number 
which has been allocated to his notification. 
3. For notifications submitted in conformity with 
Article 7 (1) the competent authority shall, within a 
period of 15 days following receipt of the notification, 
decide whether the notification is in conformity with 
the Directive and, in the event that the notification is 
adjudged not to be in conformity, inform the notifier 
accordingly. In the event that the notification is in 
conformity with the Directive, the authority shall, 
within the 15-day period following receipt of the 
dossier, advise the notifier of the official number 
which has been allocated to his notification. 
4. The procedure laid down in Article 24 shall be 
followed in confirming or amending proposals for 
classification and labelling. 
5. Without prejudice to Article 14 (1), Member 
States and the Commission shall ensure that any 
information concerning commercial exploitation or 
manufacturing is kept secret. 
Article 12 
Involvement of the Commission in the notification 
procedure 
When a Member State has received the notification 
dossier referred to in Articles 6 (1) and 7 (1) or infor­
mation on the supplementary testing carried out in 
accordance with Article 6 (4) and 7 (3) or follow-up 
information submitted in conformity with Article 9, it 
shall forthwith send to the Commission a copy of the 
dossier/further information or a summary thereof. In the case of the further information referred to in 
Article 11 (1) the competent authority shall notify the 
Commission of the tests chosen, the reasons for their 
choice, the results and, if appropriate, an assessment 
of the results. In the case of the information received 
in conformity with Article 8 (2) competent authorities 
shall forward to the Commission such elements as 
would be of common interest for the Commission and 
the other competent authorities. 
Article 13 
Duties of the Commission 
1. On receipt of the dossiers/information referred 
to in Article 12, the Commission shall forward copies 
to the Member States. I addition, the Commission 
may also forward any other relevant information it 
has collected pursuant to this Directive, as it sees fit. 
2. The competent authority of any Member State 
may consult direct the competent authority which 
received the original notification, or the Commission, 
on specific details of the data contained in the dossier 
required under this Directive; it may also suggest that 
further tests or information be requested. If the 
competent authority which received the original noti­
fication fails to comply with the suggestions of other 
authorities regarding further information, confir­
mation tests or amendments in the study programmes 
provided for in Annex VIII, it shall give its reasons to 
the other authorities concerned. Should it not be 
possible for the authorities concerned to reach 
agreement and should any one authority feel, on the 
basis of detailed reasons, that additional information, 
confirmation tests or amendments in the study 
programmes are nevertheless really necessary to 
protect man and the environment, it may ask the 
Commission to take a decision in accordance with the 
procedure laid down in Article 24. 
Article 14 
Confidentiality of data 
1. If he considers that there is a confidentiality 
problem, the notifier may indicate the information 
provided for in Articles 6 to 9 which he considers to 
be commercially sensitive and disclosure of which 
might harm him industrially or commercially, and 
which he therefore wishes to be kept secret from all 
persons other than the competent authorities and the 
Commission. Full justification must be given in such 
cases. 
With respect to the notifications and information 
submitted in conformity with Articles 6 (1), 6 (4), 7 
(1) and 7 (3), industrial and commercial secrecy shall 
not apply to: 
No C 33/12 Official Journal of the European Communities 13. 2. 90 
(a) the trade name of the substance; 
(b) the name of the manufacturer and the notifier; 
(c) physico-chemical data concerning the substance in 
connection with Annex VII, point 3; 
(d) the possible ways of rendering the substance 
harmless; 
(e) the summary results of the toxicological and 
ecotoxicological tests; 
(f) if appropriate in the context of classification and 
labelling for the purpose of introducing the 
substance into Annex I, the degree of purity of 
the substance and the identity of impurities 
and/or additives which are known to be 
dangerous within the meaning of Article 2 (2); 
(g) the recommended methods and precautions 
referred to in Annex VII, point 2.3 and the 
emergency measures referred to, in Annex VII, 
points 2.4 and 2.5; 
(h) the information contained in the safety data sheet. 
If the notifier, manufacturer or importer himself 
discloses previously confidential information, he shall 
inform the competent authority accordingly. 
2. The authority receiving the notification/infor-
mation shall decide on its own responsibility which 
information is covered by industrial and commercial 
secrecy in accordance with paragraph 1. 
3. For substances appearing in the list provided for 
in Article 16 (2) and which are not classified as 
dangerous within the meaning of this Directive, the 
name may be included in the form of its trade name 
in those cases where the competent authority to which 
the notification has been submitted so requests. 
Normally, such substances may be included in the list 
in the form of their trade name for a maximum of 
three years. However, if the competent authority to 
which the dossier was submitted considers that the 
publication of the chemical name in the IUPAC 
nomenclature itself would reveal information 
concerning commercial exploitation or manufac­
turing, the name of the substance shall be recorded 
under its trade name alone for as long as this 
competent authority sees fit. 
Dangerous substances may, at the request of the 
competent authority receiving the notification, be 
entered on the list in the form of the trade name 
alone until such time as they are introduced into 
Annex I. 
4. Confidential information brought to the 
attention either of the Commission or of a Member 
State shall be kept secret. 
In all cases such information: — may be brought to the attention only of the auth­
orities whose responsibilities are specified in 
Article 11 (1), 
— may, however, be divulged to persons directly 
involved in administrative or legal proceedings 
involving sanctions which are undertaken for the 
purpose of controlling substances placed on the 
market. 
This Article and Article 15 shall not oblige a Member 
State whose legislation or administrative practices 
impose stricter limits for the protection of industrial 
and commercial secrecy than those laid down in these 
Articles to supply information, where the State 
concerned does not take steps to comply with these 
stricter limits. 
Article 15 
Exchange of the summary dossier 
1. The data supplied in accordance with Articles 12 
and 13 (1) may be forwarded to the Commission and 
the Member States in summary form. 
In such cases and in the context of Article 13 (2), the 
competent authorities of a Member State and the 
Commission shall have access to the notification 
dossier and the additional information at all times. 
2. For the purpose of the exchange of information 
referred to in Articles 12 and 13 (1), the Commission 
shall develop a common format. This format shall be 
adopted by the procedure laid down in Article 24. 
Article 16 
Lists of existing and new substances 
1. The Commission shall, on the basis in particular, 
of information provided by the Member States, draw 
up an inventory of substances on the Community 
market by 18 September 1981 ('). This inventory shall 
be drawn up in accordance with the guidelines laid 
down in Commission Decision 81/437/EEC (2). 
2. The Commission shall keep a list of all 
substances notified under this Directive. This list shall 
be complied in accordance with the provisions of 
Commission Decision 85/71/EEC (}). 
(') The inventory will be published in the Official Journal of 
the European Communities early in 1990. 
(2) OJ No L 167, 24. 6. 1981, p. 31. 
(3) OJ No L 30, 2. 2. 1985, p. 33. 
13. 2. 90 Official Journal of the European Communities No C 33/13 
3. The Commission shall allocate a number (EEC 
number) to each substance contained in the inventory 
referred to in paragraph 1 and the list referred to in 
paragraph 2. 
Article 17 
Packaging 
1. Member States shall take all necessary measures 
to ensure that dangerous substances cannot be placed 
on the market unless their packaging satisfies the 
following requirements: 
(a) it shall be so designed and constructed that its 
contents cannot escape; this requirement shall not 
apply where special safety devices are prescribed; 
(b) the materials constituting the packaging and 
fastenings must not be susceptible to adverse 
attack by the contents, or liable to form 
dangerous compounds with the contents; 
(c) packaging and fastenings must be strong and solid 
throughout to ensure that they will not loosen 
and will safely meet the normal stresses and 
strains of handling; 
(d)-containers fitted with replaceable fastening 
devices shall be so designed that the packaging 
can be refastened repeatedly without the contents 
escaping. 
2. The Member States may also prescribe that: 
— packages shall be closed initially with a seal in 
such a way that when the package is opened for 
the first time the seal is irreparably damaged, 
— containers with a' capacity not exceeding three 
litres which contain dangerous substances 
intended for domestic use shall have child-
resistant fastenings, 
— containers with a capacity not exceeding one litre 
which contain very toxic, toxic or corrosive liquids 
intended for domestic use shall carry a tactile 
warning of danger. 
3. Any technical specifications which may be 
necessary with regard to. the devices referred to in 
paragraph 2 shall be adopted by the procedure in 
Article 24 and shall be given in Annex IX, in 
particular: 
— in Annex IX Part A relating to child-resistant 
fastenings, 
I 
— in Annex IX Part B relating to tactile warnings of 
danger. Article 18 
Labelling 
1. Member States shall take all necessary measures 
to ensure that dangerous substances cannot be placed 
on the market unless the labelling on their packaging 
satisfies the following requirements. 
2. Every package shall show clearly and indelibly 
the following: 
— the name of the substance, 
— the origin of the substance, 
— the danger symbol, when laid down, and indi­
cation of the danger involved in the use of the 
substance, 
— standard phrases indicating the special risks arising 
from such dangers, 
— standard phrases indicating the safety advice 
relating to the use of the substance, 
— the EEC number (when known) or the official 
number of the notification dossier allocated by the 
competent authority or the words 'substance 
falling under Article 8 (2) of Directive 
67/548/EEC'. 
In addition, for substances appearing in Annex I the 
label shall also include the words 'approved EC label 
in accordance with Directive 67/548/EEC'. 
(a) The name of the substance shall be one of the-
terms listed in Annex I; if .this is not the case the 
name must be given in accordance with inter­
nationally recognized nomenclature. 
(b) The indication of origin shall include the name 
and address of the manufacturer, the distributor 
or the importer established in the Community. 
(c) The symbols shall conform to those in Annex 
II ('); they shall be printed in black on an orange-
yellow background. 
The use of the symbols and indications of danger 
is specified in Annex VI. 
(d) The special risks involved in using the substances 
shall be indicated by one or more of the standard 
phrases which, in accordance with the references 
contained in the list in Annex I, are set out in 
(') See the following adaptations to technical progress: 
OJ No L 257, 16. 9. 1983, p. 1, and OJ No L 247, 
1.9. 1986, p. 1. 
No C 33/14 Official Journal of the European Communities 13. 2. 90 
Annex III ('). In the case of a substance not listed 
in Annex I, the reference to the special risks 
attributed to the dangerous substances shall 
comply with appropriate indications given in 
Annex III. 
The phrases 'extremely flammable' or 'highly 
flammable' need not be indicated where they 
repeat the wording of an indication of danger 
used in accordance with (c) above. 
(e) The safety advice relating to the use of the 
substances shall be indicated by standard phrases 
which, in accordance with the references 
contained in the list in Annex I, are set out in 
Annex IV (2). 
The packaging shall be accompanied by the safety 
advice required by the above paragraph where it 
is materially impossible for this to be given on the 
label or package itself. 
In the case of a substance not listed in Annex I, 
the safety advice relating to the dangerous 
substances shall comply with appropriate indi­
cations given in Annex IV. 
(f) The EEC number shall be obtained either from 
the inventory or from the list referred to in Article 
16. The official number of the notification dossier 
shall be obtained from the competent authority as 
provided for in Article 11 (2) and (3). 
(') See the following adaptations to technical progress 
— OJ No L 360, 30. 12. 1976, p. 1; 
— OJ No L 88, 7. 4. 1979, p. 1; 
— OJ No L 257, 16. 9. 1983, p. 1; 
— OJ No L 247, 1. 9. 1986, p. 1. 
(2) See the following adaptations to technical progress 
— OJ No L 360, 30. 12. 1976, p. 1; 
— OJ No L 88, 7. 4. 1979, p. 1; 
— OJ No L 257, 16. 9. 1983, p. 1. (g) Indications such as 'non-toxic', 'non-harmful' or 
any other similar indications must not appear on 
the label or packaging of substances subject to 
this Directive. 
3. In the case of irritant, highly flammable, 
flammable and oxidizing substances, an indication of 
special risks and safety advice need not be given 
where the package does not contain more than 125 
ml. This shall also apply in the case of the same 
volume of harmful substances not retailed to the 
general public. 
4. When more than one danger symbol is assigned 
to a substance: 
— the obligation to indicate the symbol T makes the 
symbols X and C optional, unless Annex I 
includes provision to the contrary, 
— the obligation to indicate the symbol C makes the 
symbol X optional, 
— the obligation to indicate the symbol E makes the 
symbols F and O optional. 
5. In addition to the provisions for the labelling of 
dangerous substances specified above, Member States 
shall also take all necessary measures to ensure that 
any substance appearing in the inventory referred to 
in Article 16(1) or notified in accordance with 
Articles 6 and 7 or covered by Article 8 (2) cannot be 
placed on the market unless the labelling or packaging 
includes the EEC number (where known) or the 
official number of the notification dossier allocated by 
the competent authority or the words 'substance 
falling under Article 8 (2) of Directive 67/548/EEC'. 
The EEC number shall be obtained either from the 
inventory or the list referred to in Article 16. The 
official number of the notification dossier shall be 
obtained from the competent authority as provided 
for in Article 11 (2) and (3). 
Article 19 
Implementation of labelling requirements 
1. Where the particulars required by Article 18 appear on a label, that label shall be firmly 
affixed to one or more surfaces of the packaging so that these particulars can be read hori­
zontally when the package is set down normally. The dimensions of the label shall be as 
follows: 
Capacity of the package Dimensions (in millimetres) 
not exceeding three litres if possible, at least 55 x 78 
greater than three litres but not exceeding 50 litres at least 78 x 110 
greater than 50 litres but not exceeding 500 litres at least 110 x 155 
greater than 500 litres at least 155 x 221 
13. 2. 90 Official Journal of the European Communities No C 33/15 
Each symbol shall cover at least one tenth of the surface area of the label but not be less than 
1 cm2. The entire surface of the label shall adhere to the package immediately containing the 
substance. 
These dimensions are intended solely for provision of the information required by this 
Directive and if necessary of any supplementary health or safety indications. 
2. A label is not required where the particulars are clearly shown on the package itself, as 
specified in paragraph 1. 
3. The colour and presentation df the label — or, in the case of paragraph 2, of the package 
— shall be such that the danger symbol and its background stand out clearly. 
4. Member States may make the placing on the market of dangerous substances in their 
territories subject to the use of the official language or languages in respect of the labelling 
thereof. 
5. For the purpose of this Directive, labelling requirements shall be deemed to be satisfied: 
(a) in the case of an outer package containing one or more inner packages, if the outer 
package is labelled in accordance with international rules on the transport of dangerous 
substances and the inner package or packages are labelled in accordance with this 
Directive; 
(b) in the case of a single package, if such a package is labelled in accordance with inter­
national rules on the transport of dangerous substances and with Article 18 (2) (a), (b), (d), 
(e) and (f). 
Where dangerous substances do not leave the territory of a Member State, labelling may be 
permitted which complies with national rules instead of with international rules on the 
transport of dangerous substances. 
Article 20 
Exemptions from labelling and packaging 
requirements 
1. Articles 17 to 19 do not apply to the provisions 
governing: 
(a) the following dangerous gases, compressed, 
liquefied or under pressure, or any mixture 
thereof: butane, propane, oxygen, hydrogen, 
acetylene; 
(b) aerosols which comply with the requirements of 
Council Directive 75/324/EEC ('); 
(c) munitions and explosives placed on the market 
with a view to producing a practical effect by 
explosion or a pyrotechnic effect. 
2. In addition, Member States may: 
(a) permit the labelling required by Article 18 to be 
applied in some other appropriate manner on 
packages which are either too small or otherwise 
unsuitable for labelling in accordance with Article 
19(1) and (2); 
(') OJ No L 147, 9. 6. 1975, p. 40. (b) by way of derogation from Articles 18 and 19 
permit the packaging of dangerous substances 
which are not explosive, very toxic or toxic to be 
unlabelled or to be labelled in some other way if 
they contain such small quantities that there is no 
reason to fear any danger to persons handling 
such substances or other persons. 
3. If a Member State makes use of the options 
provided for in paragraph 2, it shall inform the 
Commission thereof forthwith. 
Article 21 
Safety data sheet 
1. At or, if appropriate, before the first delivery of 
a dangerous substance or preparation, any manu­
facturer, importer or distributor shall communicate to 
the recipient the information necessary for protection 
of man and the environment by the means of a safety 
data sheet. This data sheet may be communicated on 
paper or electronically. Subsequently, the manu­
facturer, importer or distributor shall forward to the 
recipient of the safety data sheet any new relevant 
information on the substance or preparation which 
has become known to him. 
No C 33/16 Official Journal of the European Communities 13. 2. 90 
2. Detailed regulations on the elaboration, distri­
bution, contents and format of the safety data sheet 
referred to in paragraph 1 will be the subject of a 
future Community legal instrument. 
Article 22 
Adaptation to technical progress 
The amendments necessary for adapting the Annexes 
to technical progress, shall be adopted in accordance 
with the procedure laid down in Article 24. 
Article 23 
Committee for adaptation to technical progress 
1. A Committee (hereinafter called 'the Com­
mittee') is hereby set up to adapt to technical progress 
the Directives concerning the elimination of technical 
barriers to trade in dangerous substances and prepa­
rations. It shall consist of representatives of the 
Member States, with a Commission representative as 
chairman. 
2. The Committee shall adopt its own rules of 
procedure. 
Article 24 
Procedure for adaptation to technical progress 
1. Where reference is made to the procedure laid 
down in this Article, the matter shall be referred to 
the Committee by its chairman, either on his own 
initiative or at the request of the representative of a 
Member State. 
2. 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. 
3. (a) The • Commission shall adopt the measures 
envisaged if they are in accordance with the 
opinion of the Committee. 
(b) If the measures envisaged are not in 
accordance with the opinion of the Committee, 
or if no opinion is delivered, the Commission 
shall without delay, submit to the Council a 
proposal relating to the measures to be taken. 
The Council shall act by a qualified majority. (c) If, on the expiry of a period to be laid down in 
each act to be adopted by the Council under 
this paragraph but which may in no case 
exceed three months from the date of referral 
to the Council, the Council has not acted, the 
proposed measures shall be adopted by the 
Commission. 
Article 25 
Free circulation clause 
The Member States may not prohibit, restrict or 
impede the placing on the market of substances which 
comply with the requirements of this Directive, on 
grounds relating to notification, classification, 
packaging or labelling within the meaning of this 
Directive. -
Article 26 
Safeguard clause 
1. Where, for substances appearing in the inventory 
referred to in Article 16(1) or notified in accordance 
with Articles 6 or 7 or falling under Article 8 (2), a 
Member State has detailed evidence that, although 
satisfying the requirements of this Directive, the 
substance nevertheless constitutes a danger for man or 
the environment, it may temporarily prohibit the 
placing on the market of that substance or subject it 
to special conditions in its territory. It shall 
immediately inform the Commission and the other 
Member States of such action and give reasons for its 
decision. 
2. The Commission shall consult the Member 
States within six weeks, then give its view without 
delay and take the appropriate measures. 
3. If the Commission considers that 
— technical adaptations to the Annexes of this 
Directive are necessary, such adaptations shall be 
adopted, either by the Commission or by the 
Council, in accordance with the procedure laid 
down in Article 24, 
— harmonized measures are necessary concerning 
restrictions on the marketing and use of certain 
dangerous substances it will submit a proposal 
within the framework either of Directive 
76/769/EEC or other appropriate Community 
measures concerned with restrictions on marketing 
and use. 
In both cases the Member State which has adopted 
the safeguard measures rtiay maintain them until the 
adaptations enter into force. 
Article 27 
Reports 
1. Every three years, Member States shall forward 
to the Commission a report on the implementation of 
13. 2. 90 Official Journal of the European Communities No C 33/17 
this Directive in their respective countries. The first 
report shall be submitted three years after the 
implementation of this Directive. 
2. Every three years, the Commission shall prepare 
a composite report based on the information referred 
to in paragraph 1, which shall be forwarded to the 
Member States.' 
2. The Annexes are amended as follows: 
— Annex II is modified by the addition of a symbol 
for 'dangerous for the environment' as in Annex I 
to this Directive, 
— Annex VI Part 1 (A) is replaced by Annex II to 
this Directive, 
— Annex VII is replaced by Annex III to this 
Directive, 
— Annex VIII is replaced by Annex IV to this 
Directive. 
Article 2 
The following Directives are amended as follows: 
1. Directive 73/173/EEC ('): 
— replace 'Article 6' by 'Article 18' in Article 5 (2) 
(c), 
— replace 'Article 8 (c)' by 'Article 24' in Articles 9 
(2) and 10; 
2. Directive 77/728/EEC ('): 
— replace 'Article 6' by 'Article 18' in Article 6 (2) 
(c), 
— replace 'Article 8 (c)' by 'Article 24' in Articles 10 
(3) and 11; 
3. Directive 78/631/EEC: 
— replace 'Article 6' by 'Article 18' in Article 6 (2) 
(g)> 
— replace 'Article 8 (c)' by 'Article 24' in Articles 10 
(3) and 11. 
4. Directive 88/379/EEC: 
— replace the reference to Directive 79/831/EEC by 
a reference to the present Directive in the second 
and eighth recitals, 
— replace 'carcinogenic, mutagenic and teratogenic 
effects' by 'carcinogenic and mutagenic effects and 
effects on reproduction' in Article 3 (3), 
(') Directives 73/173/EEC and 77/728/EEC will cease to 
apply on 8 June 1991 on the date of entry into force of 
Directive 88/379/EEC. — replace 'Article 8 (2) of Directive 67/548/EEC' by 
'Article 8 (3) of Directive 67/548/EEC' in Article 
3 (5), 
— replace 'teratogenic' by 'toxic for reproduction' 
and replace 'teratogenic substances' with 
'substances toxic for reproduction' in Article 3 (5) 
(0)> 
— replace 'teratogenic' with 'toxic for reproduction' 
and replace 'teratogenic substances' with 
'substances toxic for reproduction' in Article 3 (5) 
(p)> 
— replace Article 15 (1) by Article 17 (1) in Article 
16 (1) (a), 
— replace Article 21 by Article 24 in Article 6 (3), 
— replace Article 11 (4) by Article 14 (4) in Article 7 
(1) (c) (ii), 
— replace Article 16 (2) (c) by Article 18 (2) (c) in 
Article 7 (1), 
— replace Article 21 by Article 24 in Articles 10, 14 
(2) and 15. 
— replace 'teratogenic effects' by 'effects on repro­
duction' in the title of Annex I Part 6, 
. — replace 'teratogenic substances' by 'substances 
toxic for reproduction' in Annex I Table VI. 
Article 3 
1. No later than 1 January 1992 the Member States 
shall adopt and publish the laws, regulations and admin­
istrative provisions necessary to comply with this 
Directive. They shall immediately inform the 
Commission thereof. 
2. The measures adopted pursuant to the first 
paragraph shall make express reference to this Directive. 
3. The Member States shall communicate to the 
Commission the text of the provisions of national law 
which they adopt in the field covered by this Directive. 
Article 4 
This Directive is addressed to the Member States. 
No C 33/18 Official Journal of the European Communities 13. 2. 90 
ANNEX I 
Annex II to Directive 67/548/EEC is modified by the addition of the following symbol 
dangerous for the 
environment' 
ANNEX II 
Annex VI part 1 (A) to Directive 67/548/EEC is replaced by the following: 
'General classification and labelling requirements for dangerous substances 
PARTI 
A. Save where otherwise provided for in the separate Directives on dangerous preparations, the 
substances and preparations shall be classified as very toxic, toxic or harmful according to the 
following criteria: 
(a) classification as very toxic, toxic or harmful shall be effected by determining the acute toxicity 
of the commercial substance or preparation in animals, expressed in LDS0 of LC50 values with 
the following parameters being taken as reference values: 
Category LD50 absorbed 
orally in rai 
mg/kg LD50 percutaneous 
absorption in rat or rabbit 
mg/kg LC50 absorbed by 
inhalation in rat 
mg/litre/four hours 
Very toxic < 25 S 50 < 0,25 
Toxic 25 — 200 50 — 400 0,25 — 1 
Harmful 200 — 2 000 400 — 2 000 1 — 5 
(b) if facts show that for the purposes of classification it is inadvisable to use the LD50 or LC50 
values as a principal basis because the substances or preparations produce other effects, the 
substances or preparations shall be classified according to the magnitude or these effects.' 
13. 2. 90 \ 
Official Journal of the European Communities No C 33/19 
ANNEX IIIA 
Annex VILA to Directive 67/548/EEC 
Information required for the technical dossier Chase set') referred to in Article 6 (1) 
If it is not technically possible or if it does not appear scientifically necessary to give information, the 
reasons shall be clearly stated and be subject to acceptance by the competent authority. 
The name of the body or bodies responsible for carrying out the studies shall be mentioned. 
0. IDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER 
1. IDENTITY OF THE SUBSTANCE 
1.1. Name 
1.1.1. Names in the IUPAC nomenclature 
1.1.2. Other names (usual name, trade name, abbreviation) 
1.1.3. CAS number (if available) 
1.2. Molecular and structural formula 
1.3. Composition of the substance 
1.3.1. Degree of purity (%) 
1.3.2. Nature of impurities, including isomers and by-products 
1.3.3. Percentage of (significant) main impurities 
1.3.4. If the substance contains a stabilizing agent or an inhibitor or other additives, specify: 
nature, order of magnitude: .. . ppm; ... % 
1.3:5. Identification data (UV, IR, NMR or mass spectrum, HPLC, GC) 
1.4. Methods of detection and determination. 
A full description of the methods used or the appropriate bibliographical references 
2. INFORMATION ON THE SUBSTANCE 
2.0. Production 
2.0.1. Technological process used in production 
2.0.2. Exposure estimates related to production: 
— working environment 
— environment 
2.1. Proposed uses 
2.1.1. Types of use: description of the function and the desired effects 
2.1.1.1. Technological process(es) related to the use of the substance (where known) 
2.1.1.2 Exposure estimate(s) related to use (where known): 
— working environment 
— environment 
2.1.1.3. Form under which the substance is marketed: substance, preparation, product 
2.1.1.4. Concentration in marketed preparations and products 
2.1.2. Fields of application with approximate breakdown 
— industries 
— farmers and skilled trades 
— use by the public at large 
No C 33/20 Official Journal of the European Communities 13. 2. 90 
2.1.3. Where known and where appropriate the identity of the recipients of the substance 
2.2. Estimated production and/or imports for each of the anticipated uses or fields of application 
2.2.1. Overall production and/or imports in tonnes per year 
— the first calendar year 
— the following calendar years 
2.2.2. Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a 
percentage 
— the first calendar year 
— the following calendar year 
2.3. Recommended methods and precautions concerning: 
2.3.1. handling 
2.3.2. storage 
2.3.3. transport 
2.3.4. fire (nature of combustion gases or pyrolysis, where proposed uses justify this) 
2.3.5. other dangers, particularly chemical reaction with water 
2.4. Emergency measures in the case of accidental spillage 
2.5. Emergency measures in the case of injury to persons (e.g. poisoning) 
2.6. Packaging 
3. PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE 
3.0. State of the substance at 20 C and 101,3 kPa 
3.1. Melting point 
3.2. Boiling point 
3.3. Relative density 
3.4. Vapour pressure 
3.6. Water solubility 
3.7. Fat solubility 
3.8. Partition coefficient (n-octanol/water) 
3.9. Flash point 
3.10. Flammability 
3.11. Explosive properties 
3.12. Self ignition temperature 
3.13. Oxidizing properties 
4. TOXICOLOGICAL STUDIES 
4.1. Acute toxicity 
4.1.1. Administered orally 
4.1.2. Administered by inhalation (particle size and vapour pressure are among the criteria to be 
taken into account for the choice of this route of administration) 
4.1.3. Administered cutaneously (percutaneous absorption) 
4.1.4. Substances other than gases shall be administered via two routes at least, one of which 
should be the oral route. The other route will depend on the intended use and on the 
physical properties of the substance. 
Gases and volatile liquids should be administered by inhalation, 
4.1.5. Skin irritation 
4.1.6. Eye irritation 
4.1.7. Skin sensitization 
4.2. Repeated dose 
4.2.1. Repeated dose toxicity (28 days) 
13. 2. 90 Official Journal of the European Communities No C 33/21 
4.2.2. The route of administration should be the most appropriate having regard to the intended 
use, the acute toxicity and the physical and chemical properties of the substance. In the 
absence of contra-indications, the oral route is usually the preferred one. 
4.3. Other effects 
4.3.1. Mutagenicity (including carcinogenic pre-screening test) 
The substance should be examined initially by means of a series of two tests, one of which 
should be a bacteriological test (reverse mutation test) with and without metabolic activation, 
and one a non-bacteriological test to detect chromosome abberations or damage. In the 
event of a positive result in either test further testing according to the strategy described in 
Annex V should be carried out. 
4.3.2. Teratogenicity: pre-screening test 
5. ECOTOXICOLOGICAL STUDIES 
5.1. Effects on organisms 
5.1.1. Acute toxicity for fish 
5.1.2. Acute toxicity for daphnia 
5.1.3. Growth inhibition test on algae 
5.2. Degradation 
— biotic 
— abiotic: 
— if the substance is not readily biodegradable then consideration should be given to the 
need to carry out the following tests: 
— hydrolysis as a function of pH 
— photodegradation screening test 
5.3. Adsorption/desorption screening test 
6. POSSIBILITY OF RENDERING THE SUBSTANCE HARMLESS 
6.1. For industry/skilled trades 
6.1.1. Possibility of recycling 
6.1.2. Possibility of neutralization of unfavourable effects 
6.1.3. Possibility of destruction: 
— controlled discharge 
— incineration 
— water purification station 
— others 
6.2. For the public at large 
6.2.1. Possibility of recycling 
6.2.2. Possibility of neutralization of unfavourable effects 
6.2.3. Possibility of destruction 
— controlled discharge 
— incineration 
— water treatment station 
— others 
No C 33/22 Official Journal of the European Communities 13. 2. 90 
ANNEX IIIB 
Annex VIIB to Directive 67/548/EEC 
Information required for the technical dossier referred to in Article 7 (1) 
If it is not technically possible or if it does not appear scientifically necessary to give information, the 
reasons shall be clearly stated and be subject to acceptance by the competent authority. 
The name of the body or bodies responsible for carrying out the studies shall be mentioned. 
0. IDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER 
1. IDENTITY OF THE SUBSTANCE 
1.1. Name 
1.1.1. Names in the IUPAC nomenclature 
1.1.2. Other names (usual name, trade name, abbreviation) 
1.1.3. CAS number (if available) 
1.2. Molecular and structural formula 
1.3. Composition of the substance 
1.3.1. Degree of purity (%) 
1.3.2. Nature of impurities, including isomers and by-products 
1.3.3. Percentage of (significant) main impurities 
1.3.4. If the substance contains a stabilizing agent or an inhibitor or other additives, specify: 
nature, order of magnitude: ... ppm; ... % 
1.3.5. Identification data (UV, IR, NMR or mass spectrum, HPLC, GC) 
1.4. Methods of detection and determination 
A full description of the methods used or the appropriate bibliographical references 
2. INFORMATION ON THE SUBSTANCE 
2.0. Production 
2.0.1. Technological proces$(es) used in production 
2.0.2. Exposure estimate related to production: 
— working environment 
— environment 
2.1. Proposed uses 
2.1.1. Types of use: description of the function and the desired effects 
2.1.1.1. Technological process(es) related to the use of the substance (where known) 
2.1.1.2. Exposure estimate(s) related to the use of the substance (where known): 
— working environment 
— environment 
2.1.1.3. Form under which the substance is marketed: substance, preparation, product 
2.1.1.4. Concentration in marketed preparations and products 
2.1.2. Fields of application with approximate breakdown 
— industries 
— farmers and skilled trades 
— use by the public at large 
2.1.3. Where known and where appropriate the identity of the recipients of the substance 
13. 2. 90 Official Journal of the European Communities No C 33/23 
2.2. Estimated production and/or imports for each of the anticipated uses or fields of application 
2.2.1. Overall production and/or imports in tonnes per year 
— the first calendar year 
— the following calendar years 
2.2.2. Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a 
percentage 
— the first calendar year 
— the following calendar years 
2.3. Recommended methods and precautions concerning: 
2.3.1. handling 
2.3.2. storage 
2.3.3. transport 
2.3.4. fire (nature of combustion gases or pyrolysis, where proposed uses justify this) 
2.3.5. other dangers, particularly chemical reaction with water 
2.4. Emergency measures in the case of accidental spillage 
2.5. Emergency measures in the case of injury to persons (e. g. poisoning) 
2.6/ Packaging 
3. PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE 
3.0. State of the substance at 20 C and 101,3 kPa 
3.1. Melting point 
3.2. Boiling point 
3.6. Water solubility 
3.8. Partition coefficient (n-octanol/water) 
3.9. Flash point 
3.10. Flammability 
4. TOXICOLOGICAL STUDIES 
4.1. Acute toxicity 
4.1.1. Administered orally 
4.1.2. Administered by inhalation (particle size and vapour pressure are criteria for the choice of 
this route of administration) 
4.1.3. Administered cutaneously (percutaneous absorption) 
4.1.4. For the acute toxicity test, one route of administration is sufficient. For substances other than 
gases, the route shall depend on the intended use and on the physical properties of the 
substance 
Gases and volatile liquids should be administered by inhalation 
4.1.5. Skin irritation 
4.1.6. Eye irritation 
4.1.7. Skin sensitization 
4.3. Other effects 
4.3.1. Mutagenicity: bacteriological test with and without metabolic activation (reverse mutation 
test) 
5. ECOTOXICOLOGICAL STUDIES 
5.2. Degradation 
— biotic 
No C 33/24 Official Journal of the European Communities 13. 2. 90 
ANNEX IIIC 
Annex VIIC to Directive 67/548/EEC 
Information required for the technical dossier referred to in Article 7 (2) 
If it is not technically possible or if it does not appear scientifically necessary to give information, the 
reasons shall be clearly stated and be subject to acceptance by the competent authority. 
The name of the body or bodies responsible for carrying out the studies shall be mentioned. 
0. IDENTITY OF MANUFACTURER AND THE NOTIFIER IF THESE ARE NOT THE SAME 
1. IDENTITY OF THE SUBSTANCE 
1.1. Name 
1.1.1. Names in the IUPAC nomenclature 
1.1.2. Other names (usual name, trade name, abbreviation) 
1.1.3. CAS number (if available) 
1.2. Molecular and structural formula 
1.3. Composition of the substance 
1.3.1. Degree of purity (%) 
1.3.2. Nature of impurities, including isomers and by-products 
1.3.3. Percentage of (significant) main impurities 
1.3.4. If the substance contains a stabilizing agent or an inhibitor or other additives, specify: 
nature, order of magnitude: . .. ppm; ... % 
1.3.5. Identification data (UV, IR, NMR or mass spectrum, HPLC, GC) 
1.4. Methods of detection and determination. 
A full description of the methods used of the appropriate bibliographical references. 
2. INFORMATION ON THE SUBSTANCE 
2.0. Production 
2.0.1. Technological process(es) used in production 
2.0.2. Exposure estimate related to production: 
— working environment 
— environment 
2.1. Proposed uses 
2.1.1. Types of use: description of the function and the desired effects 
2.1.1.1. Technological process(es) related to the use of the substance (where known) 
2.1.1.2. Exposure estimate(s) related to the use of the substance (where known): 
— working environment 
— environment 
2.1.1.3. Form under which the substance is marketed: substance, preparation, product 
2.1.1.4. Concentration in marketed preparations and products 
2.1.2. Fields of application with approximate breakdown 
— industries 
— farmers and skilled trades 
— use by the public at large 
2.1.3. Where known and where appropriate the identity of the recipients of the substance 
13. 2. 90 Official Journal of the European Communities No C 33/25 
2.2. Estimated production and/or imports for each of the anticipated uses or fields of application 
2.2.1. Overall production and/or imports in tonnes per year 
— the first calendar year 
— the following calendar year 
2.2.2. Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a 
percentage 
— the first calendar year 
— the following calendar year 
2.3. Recommended methods and precautions concerning: 
2.3.1. handling 
2.3.2. storage 
2.3.3. transport 
2.3.4. , fire (nature of combustion gases or pyrolysis, where proposed uses justify this) 
2.3.5. other dangers, particularly chemical reaction with water 
2.4. Emergency measures in the case of accidental spillage 
2.5. Emergency measures in the case of injury to persons (e.g. poisoning) 
2.6. Packaging 
3. PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE 
3.0. State of the substance at 20 C and 101,3 kPa 
3.9. Flash point 
3.10. Flammability 
4. TOXICOLOGICAL STUDIES 
4.1. Acute toxicity 
4.1.1. Administrated orally 
ANNEX IV 
Annex VIII to Directive 67/548/EEC 
Additional information and tests required pursuant to Article 6 (4) 
If it is not technically possible or if it does not appear scientifically necessary to give information, the 
reasons shall be clearly stated and be subject to acceptance by the competent authority. 
The name of the body or bodies responsible for carrying out the studies shall be indicated. 
LEVEL 1 
Toxicological studies 
— Fertility study (one species, one generation, male and female, most appropriate route of adminis­
tration). 
If there are equivocal findings in the first generation, study of a second generation is required. 
Depending upon the dosing schedule it may be possible in this study to obtain an indication of 
teratogenicity. A positive indication should be examined in a formal teratology study. 
— Teratology study (one species, most appropriate route of administration) 
This study is required if teratogenicity has not been examined in the fertility study. 
No C 33/26 Official Journal of the European Communities 13. 2. 90 
— Sub-chronic and/or chronic toxicity study, including special studies (one species, male and female, 
most appropriate route of administration) shall be required if the results of the repeated-dose study in 
Annex VII or other relevant information demonstrate the need for further appropriate investigation. 
The effects which would indicate the need for such a study could include for example: 
(a) serious or irreversible lesions; 
(b) a very low or absence of a 'no effect' level: 
(c) a clear relationship in chemical structure between the substance being studied and othfer substances 
which have been proved dangerous. 
— Additional mutagenesis studies and/or screening study(ies) for carcinogenesis as prescribed in the 
testing strategy described in Annex V. 
When both tests in the base set were negative, one test for a,different end point in another organism 
should be performed as supplementary study. 
When a test or both tests were positive in the base set, a supplementary study should include the same 
or different end points in other in vivo test methods. 
— Basic toxicokinetic information. 
Ecotoxicology studies 
— Prolonged toxicity study with Daphnia magna (21 days) 
— Test on higher plants 
— Test on earthworms 
— Prolonged toxicity study with fish 
— Tests for species accumulation; one species, preferably fish. 
— Supplementary biodegradation study(ies), if sufficient degradation has not been proved by the studies 
laid down in Annex VII 
Further studies on adsorption/desorption dependent upon the results of the investigations laid down in 
Annex VII. 
LEVEL 2 
Toxicological studies 
The test programme shall cover the following aspects unless there are strong reasons to the contrary, 
supported by evidence, that it should not be followed: 
— chronic toxicity study, 
— carcinogenicity study, 
— fertility study (e.g. three-generation study); only if an effect on fertility has been established at level 1, 
— developmental toxicity study on peri and postnatal effects, 
— teratology study (especies not employed in the respective level 1), 
additional toxicokinetic studies which cover biotransformation, pharmacokinetics, 
— additional tests to investigate organ or system toxicity. 
Ecotoxicity studies 
— Additional tests for accumulation, degradation, mobility and absorption/desorption 
— Further toxicity studies with fish 
— Toxicity study with birds 
— Additional toxicity studies with other organisms.