31. 12. 90 Official Journal of the European Communities No C 332/9 
Opinion on the proposal for a Council Directive amending for the seventh time Directive 
67/548/EEC on die approximation of the laws, Regulations and administrations provisions 
relating to the classification, packaging and labelling of dangerous substances (*) 
(90/C 332/02) 
On 8 February 1990 the Council decided to ask the Economic and Social Committee, under 
Article 100A of the EEC Treaty, for an Opinion on the abovementioned proposal. 
The Section for Protection of the Environnement, Public Health and Consumer Affairs, 
which was responsible for the preparatory work, adopted its Opinion on 10 July 1990. Mr 
Beltrami was Rapporteur. 
At its 279th plenary session (meeting of 19 September 1990) the Economic and Social 
Committee unanimously adopted the following Opinion. 
1. Aims of the Commission proposal 
1.1. Directive 67/548 (2) is the basic Directive with 
which the Commission began a systematic classification 
and regulation of dangerous substances culminating in 
Directive 79/831/EEC(3) which amended the original 
Directive for the sixth time and laid down harmonized 
standards on: 
a) the classification, packaging and labelling of 
dangerous substances in the Community; and 
b) the notification of new chemicals. 
1.2. In the light of experience during the implement­
ing period for Directive 79/831/EEC (sixth amend­
ment), which took effect in the Member States in Sep­
tember 1981, the Commission now finds it necessary to 
amend the directive for the seventh time with the two­
fold aim of removing discrepancies that have arisen 
since 1981 and ensuring more effective implementation 
of the basic directive. 
1.3. This proposal is in line with the Resolution 
adopted by the Council of the European Communities 
and the representatives of the governments of the Mem­
ber States at the Council meeting of 19 October 1987, 
as well as the fourth environmental action programme 
(1987-1992) (4) and the relevant ESC Opinion (5). 
1.4. In adapting and supplementing the sixth amend­
ment (Directive 79/831/EEC) the Commission proposal 
is a further step towards preventive action to protect 
man and the environment. It reinforces the comprehen­
sive, coordinated framework formed by the set of pre­
vious regulating the notification, classification, packag­
ing and labelling of dangerous substances. 
1.5. The proposal also strives for greater harmoniza­
tion between the provisions adopted by the individual 
(!) OJ No C 33, 13. 2. 1990, p. 3. 
(2) OJ No L 196, 16. 8. 1967. 
(3) OJ L. 259, 15. 10. 1979; ESC Opinion of 31 March 1977, OJ 
No C 114, 11. 5. 1977. 
(4) OJ No C 328, 7. 12. 1987. 
(5) OJ No C 180, 8. 7. 1987. Member States—a prerequisite for the attainment of 
the Single Market and the free movement of goods. 
1.6. In the proposed directive the Commission has 
amplified the aims set out in Article 1 to include assess­
ment of the potential risk to man and the environment 
of notified substances [Article 1 (l)(c)], thereby placing 
greater emphasis on this aspect than in the sixth amend­
ment. 
1.7. This innovation, combined with the change in 
the safeguard clause (Article 26), more specifically fits 
the seventh amendment to act as more effective instru­
ment for assessing substances and collecting data. 
1.8. In the light of the aims being pursued, the fol­
lowing changes are also proposed: 
a) harmonization of the notification procedure and 
the contents of the technical dossier to be supplied 
to the authorities in respect of new substances pla­
ced on the market in quantities of less than one ton 
per annum (Article 7); 
b) imposition of similar conditions on Community and 
non-Community manufacturers; the latter must des­
ignate a legal person established in the EEC as sole 
representative for notification purposes with a view 
to automatic monitoring of the quantities placed on 
the Community market (Article 6); 
c) clarification and clearer identification of certain 
categories of placing on the market based on new 
definitions of scientific research and development 
and process-orientated research and development 
(Articles 2 and 8); 
d) introduction of procedures governing relations 
between the first and subsequent notifiers and the 
competent authority to avoid, as confirmed by 
Directive 86/609/EEC, unnecessary testing on ver­
tebrate animals (Articles 6 and 10); 
No C 332/10 Official Journal of the European Communities 31. 12. 90 
e) introduction of criteria and definitions regarding 
two new categories of danger: 'sensitising' and 
'dangerous for the environment' (which is 
accompanied by a new symbol) (Article 2); 
f) new labelling conditions, including the requirement 
that the label must bear the EEC No (inventory 
or notification number) even in the case of non-
dangerous substances (Article 18); 
g) introduction of a savety data sheet to be supplied 
to clients; specific regulations will be framed on 
this point in a future Community legal instrument 
(Article 21). 
2. General comments 
2.1. The Committee basically endorses the Com­
mission arguments underpinning the proposed Direc­
tive, subject to the following comments. 
2.2. The Committee reiterates its keen interest in all 
measures designed to promote a high level of infor­
mation and safety for purposes of protecting workers 
in all activities related to manufacturing, transport and 
the use of dangerous substances. 
2.3. It would therefore ask the Commission to press 
ahead with coordination of the various rules which it 
has framed on the different aspects of the above matter. 
2.3.1. It asks the Commission to see that the present 
high standards of the rules in force in the Community 
are not diminished. 
2.3.2. It recommends that the Commission guarantee 
where necessary the highest possible degree of harmon­
ization between Community provisions and those 
adopted or being prepared within other international 
organizations or forums [(e.g. the Organization for 
Economic Co-operation and Development (OECD), the 
United Nations Environment Programme (UNEP), the 
International Labour Organization (ILO), the World 
Health Organization (WHO), and the Food and Agri­
culture Organization of the United Nations (FAO)]. 
2.4. The Commission is also requested to note that 
this issue forms a composite whole and that a close 
watch must be kept on the potential direct and indirect 
implications of certain provisions for the competitive 
position of Community firms vis-a-vis firms in non-
EEC countries, bearing in mind possible discrepancies 
compared with the rules applied by major competitors 
such as the United States, Japan, Canada, USSR, etc. 
3. Specific comments 
3.1. Article 2—Definitions 
3.1.1. For purposes of clarifying interpretation of 
ambiguous cases, the Committee advocates that 'articles' too should be defined and provision made for 
specific exemptions from the rules. 
3.1.2. Article 2(1 )(c) (Notification) 
3.1.2.1. The Committee realizes that the Com­
mission aims to place Community and non-Community 
manufacturers on an equal footing as regards notifi­
cation requirements and to reduce the volume of paper­
work necessitated by several different notifications. 
However, it will be difficult to achieve automatic moni­
toring over quantities of substances placed on the Euro­
pean market by requiring non-Community manufac­
turers to designate a single official representative 
authorized to submit the notification. 
3.1.2.2. A single representative would in practice be 
unable to shoulder the responsibility of checking all 
possible ways of placing a substance on Community 
markets (possibly via three-cornered operations or 
inclusion in preparations) by firms other than the orig­
inal manufacturer. 
3.1.2.3. The Committee thinks it should also point 
out that the sectors concerned fear that the sole official 
representative for notification may, over time, be 
transformed into a real exclusive right from the com­
mercial point of view, with inevitable negative conse­
quences. 
3.1.2.4. The Committee therefore considers that the 
safest way of ensuring effective prevention of the risks 
connected with substances originating from non-EEC 
countries is for notification to remain, as at present, 
the responsibility of the importer who thus assumes all 
the attendant responsibilities. 
3.1.2.5. To control the extra paperwork involved in 
presenting additional studies and evidence and avoid 
unnecessary repetitions of notification, use could be 
made of modern office automation systems and a pro­
cedure like that used for managing Community quotas. 
3.1.3. Article 2(2)(n) (Toxic for reproduction) 
The definition of 'toxic for reproduction' refers in the 
English version to 'adverse effects'. The Committee 
feels that 'dangerous effects' would be more logical. 
3.2. Article 4(4) (Classification) 
3.2.1. The Committee proposes the deletion of 'or 
any other parameter' since all substances listed in 
Annex I will be subject to concentration limits. 
3.2.2. For the sake of clarity, the Committee pro­
poses the insertion of 'containing such substances' after 
'preparations'. 
31. 12. 90 Official Journal of the European Communities No C 332/11 
3.3. Article 6(1) (Duties of the notifier) 
3.3.1. First line: 'Articles 1(4)' to read 'Articles 1(2)'. 
3.3.2. Fifth indent: to be deleted, for the reasons 
indicated in point 3.1.2. 
3.3.3. Sixth indent: for the sake of clarity, this pass­
age should be reworded as follows: 
'in the event of a new substance being notified 
for the first time, the notifier may request, with 
justification, that the notification be exempted 
from...'. 
3.4. Article 6(2) (Duties of the notifier), Article 7(2) 
(Simplified procedure) 
3.4.1. The Committee endorses the Commission pro­
posal to exempt active plant protection substances and 
additives/ingredients in animal feedingstuffs from hav­
ing to supply the information required for the technical 
dossier (see Annex VIIA) when authorization for use 
in compliance with the relevant Directives has been 
requested. 
3.4.2. The Committee considers that the same argu­
ments hold good and therefore requests the Com­
mission to extend the exemption to active pharmaceuti­
cal substances and additives/ingredients in food for 
human consumption. 
3.5. Article 6(3) (Duties of the notifier) 
3.5.1. In the Committee's view, the Commission pro­
posal whereby a new substance may be placed on the 
market only when written acceptance of notification 
has been received from the competent authority, is a 
change from the sixth amendment and imposes a new 
constraint on the notifier. 
3.5.2. The absence of any time limit for the com­
petent authorities' reply can generate delays that are 
potentially damaging to the notifier. 
3.5.2.1. The Committee therefore proposes setting a 
maximum time limit after reception of notification, 
within which the authority has to reply. 
3.53. As the competent authority only has to check 
that the notification formally complies with the terms 
of the directive, the Committee considers it excessive 
to have to wait 60 days after the date of receipt of the 
notification by the authority before placing a substance 
on the market. 
3.5.3.1. It therefore asks that the present limit of 45 
days be retained. 
3.5.4. In any event the possibility of adopting the 
requisite safety measures is guaranteed by all the infor­mation to be supplied by the notifier in the technical 
dossier for the purpose of assessing the foreseeable 
risks, whether immediate or delayed, which the substan­
ce may entail for man or the environment. 
3.6. Article 7 (Simplified procedure) 
3.6.1. The Committee endorses the proposed intro­
duction of a standardized simplified procedure for 
quantities less than one ton per annum per manufac­
turer. 
3.6.2. It welcomes the elimination of the divergencies 
to be observed in current national provisions and the 
ending of the requirement that separate notification 
must be presented in each Member State. 
3.6.3. However, supply of the information specified 
in Annex VIIB seems an undue burden, especially in 
view of the relevant procedures applicable in the United 
States and Japan. 
3.6.4. The Committee therefore proposes that, in the 
case of quantities less than one ton per annum per 
manufacturer, the technical dossier to be presented 
should contain the information indicated in Annex 
VIIC, except that, in accordance with Article 11(1), the 
competent authorities may ask for further information, 
supplementary testing and verification tests when this 
appears necessary to assess the risks of a given sub­
stance. 
3.7. Article 7(1) (Simplified procedure) 
3.7.1. First paragraph: 'Article 1(4)' to read 'Article 
1(2). 
3.7.2. Fifth indent: for the reasons indicated in point 
3.1.2, this entire passage should be deleted. 
3.7.3. Sixth indent: for the sake of clarity, to be 
reworded as follows: 
'in the event of a new substance being notified 
for the first time, the notifier may request, with 
justification, that the notification be exempted 
from...' 
3.8. Article 7(5) (Simplified procedure), Article 8(3) 
(Exemptions) 
3.8.1. Relevant to the Italian version only. 
No C 332/12 Official Journal of the European Communities 31. 12. 90 
3.9. Article 8 (Exemptions) 
3.9.1. The Committee supports the proposed intro­
duction of exemptions graded according to whether the 
new substances are intended for scientific research and 
development or process-orientated research and devel­
opment. 
3.9.2. However, bearing in mind that requirements 
of the various commodity sectors differ, in several cases 
100 kg per annum is not sufficient for scientific research 
and development carried out in laboratories. 
3.9.3. The Committee therefore advocates an 
increase in the quantity set out in the proposal to a 
minimum of 500 kg per annum per manufacturer. 
3.9.4. Article 8(1): The Committee welcomes the 
exemptions granted for active plant protection sub­
stances, additives/ingredients in animal feedingstuffs 
and substances to be used as additives in foodstuffs. 
For the reasons underlying these exemptions, it rec­
ommends that active pharmaceutical substances should 
also be exempted. 
3.9.5. Article 8(2). First indent: The Commission has 
retained the conditions laid down in Article 8(1) of the 
sixth amendment (Directive 79/831/EEC). Bearing in 
mind the particular properties of such products and the 
technical advances made in the meantime, the Commit­
tee asks the Commission to note that it would be more 
appropriate to develop a specific testing programme for 
polymers. This programme should include the possi­
bility of a reduced 'package of tests' for less dangerous 
polymers. 
3.9.6. Article 8(2), fourth indent: relevant to the Ital­
ian version only. 
3.10. Article 10 (Renotification of the same substance) 
3.10.1 Article 10(1): 'Annex VIII' to read 'Annex 
VIF. 
3.11. Article 11(2) and (3) (Rights and duties of the 
competent authorities) 
3.11.1. The Committee points out that no time-limit 
is indicated for replies to notifications under Article 
6(1) whereas, in the case of notifications submitted in 
conformity with Article 7(1), the competent authority 
has to decide and the notifier within a period of 15 
days following receipt of the notification whether the 
notification is in conformity with the directive. 3.11.2. For the reasons indicated in point 3.5.2, the 
Committee considers that it is also essential in the case 
of notifications submitted in conformity with Article 
6(1) for the competent authority to take a decision and 
inform the notifier by a set time-limit, proposed as 45 
days from receipt of notification. 
3.12. Article 12 (Involvement of the Commission in 
the notification procedure) 
3.12.1. First paragraph: 'Article 7(3)' to read 'Article 
7(4)'. 
3.13. Article 14(1) (Confidentiality of data) 
3.13.1. Article 14(1) second paragraph: 7(1) and 
7(3)' to read 7(1) and 7(4)'. 
3.14. Article 18(2) (Labelling) 
3.14.1. The Committee thinks it should point out 
how the proposed new labelling rules will cause prob­
lems in the sectors concerned because of the Com­
mission's intended twofold objective for labelling, i.e.: 
a) immediate information for users on the risks 
involved in using a substance and precautions to be 
taken; and 
b) the provision of an extra means for carrying out 
cross-checks. 
The Committee fully agrees with the aims of point a) 
and considers essential the requirements laid down in 
the first five indents of Article 18(2). 
3.14.2. But it is puzzled by the additional require­
ments, such as: 
— the EEC number (when known) or the official 
number of the notification dossier or the words 
'substance falling under Article 8(2) of Directive 
67/548/EEC, and 
— for substances appearing in Annex I the words 
'approved EC label in accordance with Directive 
67/548/EEC. 
It considers that these provisions: 
— provide no essential safety information, 
— needlessly clutter up labels and make difficult to 
locate basic information right away, 
— provide support for the Commission's proposal to 
make labels bigger, and 
— require the re-writing of all existing labels. 
31. 12. 90 Official Journal of the European Communities No C 332/13 
3.15. Article 18(5) (Labelling) 
3.15.1. Here the Commission proposes to introduce 
a labelling requirement, albeit restricted to indication 
on the label of the EEC number or the notification 
number, even in the case of non-dangerous substances 
already on the market. 
3.15.2. Regardless of the fact that the proposed 
Directive is concerned with dangerous substances, the 
Committee would point out that the practical appli­
cation of this requirement raises major difficulties and 
would be a lengthy process, since approximately 
100 000 EINECS-listed substances existed on the mar­
ket on 18 September 1981. 
3.15.3. In addition, dangerous substances listed in 
this inventory (EINECS), and not yet included in Annex 
I, are already subject to labelling requirements under 
Articles 15 to 18 and to the criteria laid down in Annex 
VI to Directive 79/831/EEC 
3.15.4. Information is therefore already guaranteed 
for the purpose of adopting the requisite safety measur­
es for all dangerous substances. 
3.15.5. While bearing in mind the Commission's 
intention of reinforcing arrangements for cross-checks, 
the Committee would point to the desirability of recon­
ciling efficient safety precautions with simple measures 
and procedures that are easy and reliable to implement, 
bearing in mind the very different types of firms that 
will have to comply (E.G. small and medium-sized 
businesses (SMB), wholesalers, retailers, importers, 
etc.). 
3.15.6. It therefore asks the Commission to re-exam­
ine Article 18(2) and (5) in the light of the comments 
made in point 3.14, to remove the rules on quoting EEC 
numbers or dossiers and referring to the basic Directive, 
and to seek instead ways of including checks in the 
documents that normally accompany commercial trans­
actions. 
Done at Brussels, 19 September 1990. 3.16. Article 21 (Safety data sheet) 
3.16.1. To standardize company behaviour and take 
account of market realities, the Committee proposes 
that updated sheets should be sent to customers no later 
than twelve months after the dispatch of the previous 
sheet. 
3.17. Annex 111 A (concerning Annex VIIA to Directive 
67/548/EEC) 
3.17.1. Point 2.0.1: The Committee regards the data 
concerning the 'technological process used in pro­
duction' required in Annex VIIA, B and C as one of 
the producer's most important secrets and thinks that 
it must be protected. 
In view of the Commission's explanation that the infor­
mation being asked for only concerns any risks that 
such processes might pose for the staff involved or for 
the environment, the Committee asks the Commission 
to make the appropriate changes to point 2.0.1 of Annex 
VIIA, B and C. 
3.17.2. Points 4.3.2 and 5.3: Since no testing method 
has yet been developed for the: 
— teratogenicity-pre-screening test, and the 
— adsorption/desorption screening test, 
the Committee asks that such tests will be required by 
the Directive after the relevant methods have been 
adopted. 
3.17.3. Point 5.1.3: Relevant to the Italian version 
only. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE