No C 102/42 Official Journal of the European Communities 18. 4. 91 
the Committee in the macroeconomic dialogue can 
contribute considerably to the Community's policy of 
Done at Brussels, 27 February 1991. 
The Committee generally agrees with the reasons for 
the proposed Regulation, subject to the following com­
ments. 
1. Introduction 
1.1. The proposal in question, based on Treaty 
Article 100A, establishes procedures for standardized, 
Community-level compilation of information on exist­
ing chemical substances and for the evaluation and 
control of the associated environmental and health 
risks. 
1.2. The proposal flows from the Fourth Action 
Programme on the Environment and meets the rec­
ommendations made in the Committee's Opinion on 
that subject (2). The proposal is also compatible with 
the strongly held views voiced in the ESC Opinion 
on the Sixth Amendment to Directive 67/548/EEC (3) 
concerning restrictions on the scope of that Directive. 
(!) OJ No C 276, 5. 11. 1990, p. 1. 
(2) OJ No C 180, 8. 7. 1987, point 2.3.3. 
(3) OJ No C 114, 11. 5. 1977, points 1.5 and 1.6. convergence and thus to greater economic and social 
cohesion in the Community. 
1.3. In this latter Opinion (points 1.5 and 1.6) the 
Committee expressed regret that the Directive's scope 
on notification was limited to new substances and urged 
that all dangerous substances be covered. 
1.4. The present proposal covers the 100 000-odd 
chemical substances listed in the EINECS (European 
inventory of Existing Chemical Substances) inventory 
which were already on the Community market on 
18 September 1981. 
1.5. Because it would be impossible, as the Com­
mission argues in the introduction, to compile infor­
mation on all existing substances and at the same time 
assess the associated risks, a systematic, step-by-step 
approach is proposed, starting with substances whose 
production or import volume exceeds 1 000 tons per 
year per manufacturer/importer and then turning to 
substances whose production or import volume is The Chairman 
of the Economic and Social Committee 
Francois STAEDELIN 
Opinion on the proposal for a Council Regulation (EEC) on the evaluation and the control 
of the environmental risks of existing substances (l) 
(91/C 102/12) 
On 3 October 1990 the Council decided to consult the Economic and Social Committee, 
under Article 100A 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 matter, adopted its Opinion on 
8 February 1991. The Rapporteur was Mr Vidal. 
At its 284th plenary session (meeting of 28 February 1991) the Economic and Social Committee 
adopted the following Opinion unanimously. 
18. 4. 91 Official Journal of the European Communities No C 102/43 
between 10 and 1 000 tons per year per manufacturer/ 
importer. 
1.6. For substances whose production or import vol­
ume is even lower, compilation of information and risk 
evaluation will be carried out on a case-by-case basis. 
1.7. On the basis of information provided by manu­
facturers and importers, and centralized by the Com­
mission, lists of priority substances will be prepared by 
a Management Committee [procedure variant 11(a)] 
working hand in hand with the Commission. The cri­
teria for determining priority substances have not yet 
been laid down but will be adopted under the Regulat­
ory Committee procedure. 
1.8. Work on the priority substances will then be 
divided up amongst the Member States, making full 
use of experience already acquired in this area and 
encouraging new contributions. Rapporteurs will also 
be appointed to deal with each substance so that risks 
can be assessed and appropriate recommendations 
made. 
1.9. These recommendations should be forwarded 
to the Commission and adopted at Community level 
under the procedure laid down in Article 11; once 
adopted, risk evaluation conclusions, together with any 
recommendations made, would be published in the 
Official Journal (Article 8). 
1.10. Where appropriate, the Commission will, on 
the basis of the recommendations, propose measures 
within the framework of Directive 76/769/EEC i}) (on 
the restrictions on the marketing and use of certain 
dangerous substances and preparations), or under other 
existing Community instruments (Article 8.5). 
2. General comments 
2.1. The Committee reiterates the importance it 
attaches to all measures designed to ensure a full and 
reliable flow of information and effective checks so 
that risks can be evaluated, and existing substances 
controlled, in the interests of a high level of human and 
environmental protection. 
2.2. The Committee agrees with the decision to opt 
for a Regulation since this instrument will ensure that 
information on existing chemical substances is com­
piled and evaluated using standardized, cross-Com­
munity procedures and methods, thereby precluding 
fragmentation and distortion of the Community market 
in chemical products. 2.3. The Committee notes with concern, however, 
that five Member States (Ireland, Spain, Portugal, Gree­
ce and Luxembourg) still have no legislation in this 
specific field and recommends that the Commission 
take appropriate steps to help them implement the 
planned measure, so as to ensure that the Regulation 
is applied consistently. 
2.4. In line with the principle of subsidiarity, and in 
order to ensure maximum efficiency, the Committee 
recommends that Member States be actively involved 
in the systematic compilation of data from the outset. 
To this end, the Committee wonders whether it might 
not be preferable for information to be forwarded to 
the relevant national authorities, with the Commission 
being informed, particularly since it is the national 
authorities' responsibility to ensure compliance with the 
Regulation and, where appropriate, to impose sanctions 
(Article 13). 
2.5. In line with the recommendation made in the 
Opinion on the Seventh Amendment (2), the Committee 
would reaffirm the need to ensure that the Com­
mission's programme dovetails with current inter­
national work on chemical substances being carried out 
by UNEP (United Nations Environment Programme), 
WHO (World Health Organization), IPCS (Inter­
national Programme on Chemical Safety) and, in par­
ticular, under the Organization for Economic Co-oper­
ation and Development (OECD) programme. The aim 
is to avoid duplication of work and to use limited 
resources more effectively by spreading the burden of 
risk evaluation around the international community. 
2.6. The Committee therefore calls upon the Com­
mission to tackle the objectives set out in the Explana­
tory Memorandum and to play an active part in the 
OECD programme, and by providing valuable expertise 
and experience, coupled with Community standards 
and regulatory provisions, further the world-wide 
adoption of such standards. 
2.7. The Committee considers that systematic com­
pilation of available data on chemical substances of a 
high production and/or import volume imposes a heavy 
and complex burden on Community firms. To ensure 
that data is both accurate and complete, the Committee 
urges the Commission to review the planned time limits 
in the light of national conditions and the nature of the 
different substances. A period longer than the 6 months 
prescribed in Article 3 of the proposed Regulation 
should be considered, enabling the achievement of satis­
factory and reliable results before the sanctions envis­
aged in Article 13 become applicable. 
2.8. The Commission's step-by-step approach, based 
on the quantities of substances produced or imported 
(J) OJ No L 262, 27. 9. 1976, p. 201. (2) OJ No C 332, 31. 12. 1990. 
No C 102/44 Official Journal of the European Communities 18. 4. 91 
does not necessarily provide absolute guarantees, since 
there is no connection between the quantity and the 
degree of risk presented by substances. 
2.9. While noting that Article 6.2 stipulates that any 
new information indicating that a given substance pre­
sents a risk must be reported immediately, the Commit­
tee wonders whether this is sufficient to offset the 
purely quantitative criterion. 
2.10. In the interests of lightening the workload and 
speeding up completion with regard to the highest-risk 
substances, though should be given to the possibility of 
initially excluding from the data-collection system those 
chemical products generally recognized as being harm­
less or whose potential danger is well known and pla­
cing them on a separate list but without classifying 
them as risk-free substances. 
2.11. Lastly, the Committee emphasizes the need to 
avoid duplicating work on substances already being 
analyzed under international programmes and wel­
comes current cooperation between OECD to provide 
uniform computerized forms for data compilation. 
2.12. The Committee is concernd that the provisions 
of the proposed Regulation may involve an excessive 
number of tests on animals and so be at variance with 
Directive 86/609/EEC on the protection of animals used 
for experimental and scientific purposes. The Commit­
tee therefore recommends as far as possible the accept­
ance of findings already obtained by non-standardized 
testing methods, as well as by screening or other valid 
alternative methods. 
2.13. Finally, the Committee recommends that the 
willingness displayed by the industrial associations 
involved [the European Council of Chemical Manufac-
turers'Federations (CEFIC), the Oil Companies' Inter­
national Study Group for Conservation of Clean Air 
and Water in Europe (CONCAWE), EUROMETAUX, 
etc.] be used to maximum effect in coordinating data 
compilation, so as to reduce the information communi­
cation burden on individual manufacturers/importers. 
Contacts already made in connection with the Manage­
ment Committee referred to in Article 11 should be 
consolidated. 
2.14. On the basis of Articles 8 and 11, the Com­
mission may ask manufacturers/importers to carry out 
further tests on the effects of substances on health and 
the environment. The Committee considers it essential 
that, before any such decision is taken, the Management 
Committee referred to in Article 11 must consult experts 
designated by the parties concerned (manufacturers/ importers, workers' representatives, consumer groups) 
and discuss whether further tests are scientifically 
necessary. 
2.15. The Committee would finally recommend 
maximum guarantees of confidentiality for information 
with a potentially adverse commercial impact; it calls 
for the greatest possible openness in the light of Direc­
tive 90/313/EEC (*) on freedom of access to information 
on the environment and in this connection the Commit­
tee notes that Directive 90/313/EEC does not exclude 
from possible confidential treatment information which 
could, on rare occasions, have commercially adverse 
impact such as the name of the manufacturer or 
importer, or certain physico-chemical data concerning 
the substance in question, which are specifically 
excluded in Article 12 paragraph 1 of the proposed 
Regulation (see Article 3 of Directive 90/313/EEC). 
3. Specific comments 
3.1. Article 2 
3.1.1. A clearer definition of 'substances' and 'prep­
arations' should be made, since the current definition 
could lead to some EINECS entries being considered as 
preparations. 
These definitions are based on those in Directive 67/ 
548/EEC: the matter should therefore be examined in 
conjunction with an amendment to that Directive. 
3.1.2. The definition of 'importing' implies that the 
present Regulation does not cover substances for own 
use imported from outside the Community. The defin-
tion of 'producing' implies that substances for own use 
are covered. 
An inconsistency arises at this point, since in one case 
only substances made available to third parties are 
covered, while in the other, substances which never 
leave the plant are also covered. 
Since this Regulation is based on the European Inven­
tory of Existing Chemical Substances (EINECS) inter­
mediate substances produced but not placed on the 
market should not be covered. 
Producing should therefore be defined as follows: 
"producing' means the production of substances to 
be placed on the market in solid, liquid or gaseous 
form;' 
(*) OJ No L 158, 23. 6. 1990. 
18.^.91 COfficial]ournal of the European communities ^o^ltl^^ 
The definition of^importin^also fails to specify v^heth 
er substances imported for use in preparations are 
covered. In order to malee it clear that these substances 
should be included, the definition of ^importin^ should 
read^ 
^importin^meanssupplyingor making available 
to third parties substances fromoutside the C^om 
munity customs territory ^in the form of substances 
or included in preparations^ ..B 
3.^. ArrA^3 
3.^.1. manufacturers or importers who have exceed 
edathresholdoflOOt^ tons per year, at least ^once in 
the three years preceding adoption of this regulations 
are required to submit information. The committee 
would suggest that^and following^ be added^ this would 
prevent manufacturers or importers whose first pro 
duction or import anLl^FC^listed substance takes 
place after adoption of theR.egulation fromevading 
registration and the consequent contribution to the cost 
of any subsequent tests.^oint^.l and^shouldbe 
amended accordingly. 
3.^BL In line with the comments made in points, 
the committee suggests that the period of si^ months 
following the entry into force of the regulation permit 
ted for data compilation be reviewed. 
3.^.3. Alternatively, the possibility of priority sub 
mission of the information required under 
paragraphsa^,b^,c^ and d^ might be considered,with 
alater deadline being set for the other information. 
3.^. The meaning of^easilyobtainable^finalpara^ 
graphs should be clarified. 
33. ABrA^ 
3.3.1. The comment made in point3.^.1 also applies 
here. 
3B3B^. ^ith regard to the timedimits for the sub 
mission of information on substances produced and 
imported in smaller amounts, the committee notes that 
data compilation will involveafar greater number of 
mainly small and medium^si^edcompanies,which are 
not always able to compile and supply this kind of data 
and therefore require assistance. 
3.^. A^A^oh^ 
3.^.1. Allowance must be made for cases where sup^ pliers are unaware of new uses. 
^ the supplier is aware ofanew use which ..B 
3.eo. Arr^^ 
3.eo.l. In accordance with point ^.9, it should be 
addedthat notification iscompulsory,irrespective of 
the quantity produced or imported. 
3.D. Arr^A^ 
3.^.1. Article 8.1 
Proper reasons must be given if further data or testing 
is required. 
3^ Article 8B^ 
The time limit must take account of the delays involved 
in testing or documentary research. 
3.B. A^^9 
3.^.1. Article 9^ 
m. provide all available information ..B should be 
amended to m.provideall availableinformation rel 
evant to risk analysis.... 
3.^. Article 9.^ 
Ifsome manufacturers supply further information while 
othersdo not, thequestionofwhether all manufacturers 
should be barredfromplacing thesubstanceon the 
market must be clarified. 
3.8. Arr^^ 
3.8.1. This Article shouldingeneraltermsconcur 
with the provisions on confidentiality,tobe defined by 
the council in the seventh Amendment to loirective^^ 
eo^8B^C^. An opportunity must be provided for appeal 
against decisions by the competent authority. 
39. Ar^^^3 
3.9.1. Adequate opportunity for appeal should also 
be provided here. 
3.10. A^^^ 
3.10.1. lOata set for existing substances, point 1.19. 
Use patterns in percentage terms^ 
No C 102/46 Official Journal of the European Communities 18. 4. 91 
A number of important uses are omitted, with the 
result that many products will come under 'other uses'. 
Further important uses, such as 'fuel', should be added. 
3.11. The Regulation is unclear about two cases: 
i) substances with only one EINECS number which may 
Done at Brussels, 28 February 1991. 
1. General comments 
The Committee welcomes the general thrust of the 
Commission proposal, but calls upon the Council to 
take account of the following comments in taking its 
decision. 
1.1. The draft Directive in question is coordinated 
with and subordinated to the draft Council Decision 
on the promotion of energy efficiency in the Community 
(SAVE programme) (2), because the latter lays down 
general standards and specific actions covering the 
problems which this draft Directive seeks to regulate. present varying data, such as those which may be sold 
in differing physical forms and with differing physical 
properties and ii) where a substance is both imported 
and manufactured. In such circumstances, it should be 
made clear whether one or two data sets have to be 
submitted. 
The Chairman 
of the Economic and Social Committee 
Francis STAEDELIN 
1.2. This is the best of introducing a general 
approach to simplify the procedures on action to be 
taken, which would provide certainty for producers, 
safety for consumers, and guarantees for the workers 
who install and maintain the appliances. Another Direc­
tive for liquid fuel appliances, not yet issued, must be 
coordinated with the Directive on gas-fired appliances, 
within the general framework of the Directive on energy 
efficiency. 
1.3. The draft Directive adds to the recent Directive 
90/396/EEC on gas appliances (3), adopted on 29 June 
1990. This directive regulates the performance of gas 
appliances in terms of both safety and the rational use 
of energy (efficiency). The Commission has instructed 
the European Committee for Standardization (CEN) Opinion on the proposal for a Council Directive (EEC) concerning the efficiency requirements 
for new, hot water boilers fired with liquid or gaseous fuels (*) 
(91/C 102/13) 
On 13 November 1990, the Council decided to consult the Economic and Social Committee, 
under Article 100A of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Energy, Nuclear Questions and Research, which was responsible for preparing 
the Committee's work on the subject, adopted its Opinion on 5 February 1991. The Rappor­
teur was Mr Frandi. 
At its 284th plenary session (meeting of 28 February 1991), the Economic and Social Commit­
tee unanimously adopted the following Opinion by a large majority, with 8 votes against 
and 12 abstentions. 
(!) OJ No C 292, 22. 11. 1990, p. 8. 
(2) OJ No C 301, 30. 11. 1990, p. 11. (3) OJ No L 196, 26. 7. 1990, p. 15.