28. 7. 86 Official Journal of the European Communities No C 189/1 
II 
(Preparatory Acts) 
ECONOMIC AND SOCIAL COMMITTEE 
Opinion on the proposal for a Council Directive on the approximation of the laws, 
regulations and administrative provisions of the Member States relating to the classification, 
packaging and labelling of dangerous preparations ('). 
(86/C 189/01) 
On 16 September 1985 the Council decided to consult the Economic and Social Committee, under 
Article 100 of the Treaty establishing the European Economic Community, on the abovementioned 
proposal. 
The Section for Protection of the Environment, Public Health and Consumer Affairs, which was 
responsible for preparing the Committee's work on the subject, adopted its opinion on 
4 March 1986, in the light of the report by Mr Romoli. 
At its 236th plenary session (meeting of 23 April 1986), the Economic and Social Committee 
adopted the following opinion with no dissenting votes but with one abstention. 
1. General comments 
1.1. The Committee endorses the rationale behind the 
proposal, prepared by the Commission following an 
express request from the Council to regulate those areas not 
covered by existing Directives. 
1.2. The proposal is in line with the position of the 
European Parliament and of the ESC opinion on the 'paints 
and varnishes' draft Directive of 27 November 1975' (2). 
1.3. The Committee recognizes the need to harmonize 
the classification, packaging and labelling of all the 
dangerous preparations on the Community market, as part 
of the elimination of technical barriers to trade. The 
Committee also feels it wise to supplement and harmonize 
the rules governing dangerous preparations, laid down by 
the 1967 'dangerous substances' Directive 67/548/EEC (3) 
and by the Directives on solvents (73/173/EEC) (4), paints 
and varnishes (77/728/EEC) (5) and pesticides (78/631/ 
EEC) (6). All these Directives have been updated and 
amended several times. 
1.4. The Committee notes that the desire for harmoniz­
ation and standardization justifies the use of a single overall 
(!) OJ No C 211, 22. 8. 1985, p. 3. 
(2) OJ No C35, 16.2. 1976. 
(3) OJ No L 196, 16. 8. 1967, p. 1. 
(4) OJ No L 189, 11. 7. 1973, p. 7. 
(5) OJ No L 303, 28. 11. 1977, p. 23. 
(6) OJ No L 206, 29. 7. 1978, p. 13. Directive, even though for some preparations the same 
result might perhaps have been achieved by amending and 
supplementing the existing Directives. 
1.5. The Committee recognizes that the Commission 
proposal seeks to make Community rules more consistent 
by correcting potential disparities in the basic criteria, and 
including certain groups of preparations which have to date 
not been subject to control. The need for consistency is 
particularly great, in that Directive 67/548/EEC on 
dangerous substances — the parent instrument for all the 
Directives on preparations — has certain shortcomings, 
more especially as regards the criteria for classifying and 
packaging existing substances, which in practice are left to 
the discretion of the manufacturer. 
1.6. The Committee points out the huge scale of the 
problem: the Commission has so far classified around 
1 200 dangerous substances, while the number of subst­
ances for assessment in the EEC inventory is 95 000. 
Preparations deriving from these and in circulation are 
reckoned to number about 500 000. 
1.7. The Committee therefore stresses the need to allow 
a sufficient period of time, with suitable implementing 
arrangements, for the transition to the new single Directive. 
This will give the sectors involved — particularly those 
which already respect the existing provisions — a chance to 
change their packing and labelling procedures. 
1.8. At the very least, amendment of the current 
provisions on classification, packaging and labelling must 
NoC 189/2 Official Journal of the European Communities 28. 7. 86 
not mean a reduction in existing information and safety 
levels for workers and consumers. 
2. Specific comments 
2.1. Article 1 (field of application) 
2.1.1. The Committee agrees with the Commission 
proposal to exclude certain groups of preparations 
(medicinal products, radioactive substances, cosmetics, 
etc.) provided that they are covered by specific provisions at 
Community or international level guaranteeing adequate 
worker and consumer protection. 
2.1.2. The Committee would point out here that other 
sectors (such as approved farm pesticides and flavourings 
for foodstuffs) feel that they are in a similar position which 
would justify their exclusion. To ensure that Community 
provisions remain consistent and unified, the Committee 
suggests that the Commission consider the possibility of 
retaining the specific features of sectoral arrangements and 
incorporating them in the overall Directive. 
2.2. Article 3 (criteria for classifying the dangerousness 
of the preparations) 
2.2.1. The Committee notes that the Commission 
proposal employs a correct technical scientific approach, 
using 12 parameters to gauge the toxicity of each substance 
as shown by scientific tests. 
2.2.2. However, the Committee fears that these pro­
cedures may prove too complicated and thus risk being 
misapplied. This would adversely affect the degree of 
information and safety for workers and consumers. 
2.2.3. The persons preparing or blending the substances 
— mainly small or medium-sized firms with limited 
technical and specialist resources — are very likely to 
encounter difficulties or uncertainties in following the 
precepts of the Directive, in so far as it is they who are to 
make the scientific assessment of the data provided by the 
manufactures of the substances. 
2.2.4. The Committee therefore feels it worth restating 
the aim of the Directive: to protect workers and consumers 
by means of exhaustive, unambiguous information on the 
risks which the use of the preparations entails. 
2.2.5. The Committee feels that this basic aim could be 
achieved with less complicated procedures. It therefore 
asks the Commission to consider whether it could simplify 
the number of parameters and the procedures for defining 
them, without falling short of Community safety stan­dards. Consequently, 'simplified' methods should not be 
used when toxological data are available; these data will in 
any case have to be disclosed to ensure the necessary 
harmonization. 
2.2.6. In addition to this, the Committee urges greater 
clarity as to responsibility, particularly the responsibility to 
each other, and to the final user, of the manufacturer, 
importer of retailer of the 'substances' and the manu­
facturer, importer of retailer of the 'preparations'. 
2.3. Article 4 (communication of the information to the 
authorities) 
2.3.1. The Committee is concerned by the fact that 
harmonization work on the classification of substances for 
inclusion in Annex I of Directive 67/548/EEC is a very 
lengthy process. Furthermore, administrative problems are 
likely to be created by the sheer volume of data to be 
forwarded and assessed at national and Community level 
on the hazardousness of the substances contained in 
preparations. 
2.4. Article 7 (packaging and labelling of certain 
preparations) 
2.4.1. Whilst recognizing that labelling provides an 
initial direct source of information for the user, the 
Committee underlines the urgent need for campaigns to 
teach the public — particularly children and domestic users 
— how to use these products safely. 
2.4.2. Turning to the special arrangements for various 
categories of dangerous preparations intended for the 
general public, the Committee sees a need to speed up work 
on safe fastening systems which will protect children and 
the visually handicapped. 
2.5. Article 8 (indication of contents on the label) 
2.5.1. The Committee notes that this clause is based on 
provisions currently applying to solvents, paints and 
varnishes, and pesticides. The Committee reiterates that 
the basic aim is to provide workers and consumers with 
ciear information on the risks involved and on how to use 
the preparation safely. The use of 'symbols', 'risk phrases' 
and 'safety advice' as in the Directives already operative 
seeks to achieve the aim. Indication of the chemical name of 
ingredients would provide additional information, but 
would raise the problem of industrial property rights. 
28. 7. 86 Official Journal of the European Communities No C 189/3 
Manufacturers would be obliged to reveal the chemical 
content of their products — the result of costly and lengthy 
research. This information could be unfairly used by 
competitors. 
2.5.2. The Committee therefore feels that where the 
manufacturer proves such a disadvantage to be a genuine 
possibility, he should be allowed to indicate the presence of 
a dangerous ingredient by a single designated term agreed 
by the national authority. The national authority should be 
informed in confidence of the chemical identity of the 
ingredient. Industrial property rights could thus be 
safeguarded without compromising health protection. 
2.5.3. Alternatively, the label could list only the 
particular ingredients which make the product dangerous. 
2.5.4. The Committee feels that in any case companies, 
anti-poison centres and industrial medical officers could 
work together to find an effective, pragmatic solution to the 
question of indicating consistuents on the label as an aid to 
emergency treatment after accidents. Anti-poison centres 
are at present geared mainly to consumer risks; they should 
also be in a position to meet the needs of companies. 
2.5.5. Here the Committee would recall the opinion on 
occupational cancer (J) adopted unanimously by the 
Committee on 29 May 1985 in which attention is drawn to 
the importance of adequately informing those concerned, 
particularly through labelling: 
'Labels should inform those at the workplace of the 
name of the substance they have to work with, the 
carcinogenic propeties and potency, the concentration of 
agents in them, the preventive measures to be taken, and 
the possible effects.' 
2.5.6. However, the Committee wonders whether this 
information could perhaps be regulated by a specific 
Directive on the protection of workers exposed to 
carcinogens. 
(!) OJ No C 188, 29. 7. 1985. 
Done at Brussels, 23 April 1986. 2.6. Article 11 (relations with anti-poison centres) 
2.6.1. The Committee agrees with the Commission on 
the need to set up an information system on the substances 
contained in preparations, and particularly on the medical 
treatment to be given in cases of emergency. The Member 
States are to appoint the appropriate bodies. However, the 
Committee points out that some Member States do not 
currently have suitable machinery for carrying out these 
tasks. The programme will therefore have to be phased in 
gradually. 
2.6.2. These bodies will have to be able to handle a large 
amount of information from all Member States, at the same 
time ensuring the utmost confidentiality for the reasons 
given in 2.5 above. 
2.7. Article 15 (entry into force of the Directive) 
2.7.1. The above comments will entail some major 
changes to the proposal. The Committee therefore asks the 
Commission to reconsider the implementation dates, and 
ensure that they are feasible. 
2.8. Annex I (method of defining health hazard para­
meters) 
2.8.1. In view of the comments made in 2.2 above, the 
Committee feels that the method for defining parameters 
(Annex I) is in need of revision and clarification, inter alia 
with reference to the guide to labelling in Directive 83/467/ 
EEC (2). One solution might be to ensure that, when 
labelling, the formulatory industries are able to refer to the 
indicators of hazardousness of the constituents used in the 
preparations. These indications can be taken from the 
substance labelling which the producer or importer is to 
carry out under Directive 67/548/EEC. 
(2) OJ No L 257, 16. 9. 1983. 
The Chairman 
of the Economic and Social Committee 
Gerd MUHR