COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(91) 469 final - SYN 276 
Brussels, 5 December 1991 
Amendment to the proposal for a 
COUNCIL REGULATION (EEC) 
On the Evaluation and the Control of the 
Environmental Risks of Existing Chemicals 
(presented by the Commission pursuant to Article 149(3) 
of the EEC-Treaty) 
^ 
EXPLANATORY MEMORANDUM 
1. In September 1990, the Commission submitted a proposal for a 
Council Regulation on the evaluation and the control of the 
environmental risks of existing substances. (Com (90) 227 final 
SYN-276) under Article 100A of the Treaty. 
2. After the first reading, the European Parliament adopted an opinion 
on the above proposal for a Regulation on 9th October 1991, 
approving a number of amendments to the text proposed by the 
Commission. In Its legislative resolution, the European Parliament 
called on the Commission to amend its proposal accordingly pursuant 
to Article 149(3) of the EEC Treaty. 
3. The Commission having considered the amendments approved by the 
European Parliament, agreed to Incorporate a number of them in a 
mod IfIed proposa I. 
4. Recital 12 has been amended to fix a deadline for the establishment 
of the first annual priority list of chemicals. 
5. Recital 16 has been modified to emphasize the importance of using 
alternative test methods wherever possible. 
6. A new recital 16 has been added, again to ensure that existing data 
is given consideration even if it has not to be generated according 
to established testing methods. 
7. Recital 17 has been modified to clarify that tests conducted before 
the advent of Good Laboratory Practice would not be discounted. 
8. The objectives laid down in Article 1 have been modified to make It 
clear, that man, in the context of this Regulation, includes 
workers and consumers. 
9. The definition of Importation in Article 2(c) has been clarified. 
10. Articles 3 and 4 have been modified to make It clear that 
substances incorporated in preparations are also to be taken into 
account in this Regulation. In addition, the reference period for 
determining the obligation to report has also been clarified. 
Finally changes designed to avoid anima H testing have also been 
Included in these articles. 
11. Article 7.1 now includes a requirement to establish the first 
priority lists within one year of the adoption of the Regulation. 
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12. Article 8.1 has been changed to Include the obligation for wider 
consultation of Member States and Industry. Article 8.2 clarifies 
that further Information/testing can only be required If this 
serves to Improve the protection of man or the environment. 
13. Article 9.3. now takes Into account substances incorporated in 
préparât ions. 
14. Article 9.4 now stipulates that punitive sanctions can only be 
taken against companies that do not comply with the additional 
requirements imposed by the Regulation. 
15. Article 12 has been amended to clarify a number of concerns 
relating to confidentiality. 
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Modified Proposal for a Council Regulation on the evaluation and the 
control of the environmental risks of existing substances. 
The Commission, on the basis of the opinion delivered by the European 
Parliament in Its first reading on 9th October 1991, modifies Its 
original proposal (J.O. C 276, 5.11.1990, p. 1) pursuant to Article 
149(3) of the E.C. Treaty as follows : 
- Recital 12 to now read 
Whereas on the basis, In particular of the information and data 
submitted by manufacturers and Importers and of specific proposals by 
Member States, it is necessary to draw up, at Community level, lists of 
priority substances which require special environment, and whereas to 
expedite this work, the Commission shall, not later than One Year 
fol lowing the entry Into force of this Regulation, submit an initial 
priority list based on existing priority lists In the Member States. 
- Recital 16 to now read : 
Whereas In the Implementation of this Regulation, It is appropriate to 
reduce to a minimum the number of animals used for experimental 
purposes in accordance with the provision of Council Directive 
86/609/EEC of 24 November 1986 on the Approximation of law regulations 
and administrative provisions of the Member States regarding the 
protection of animals used for experimental and other scientific 
purposes, and whereas wherever possible and In consultation with the 
European Centre for Alternative Testing Methods, the use of animals 
will be avoided by recourse to validated alternative procedures. 
- Recital 16a (new) 
Whereas, when evaluating existing data, results obtained using test 
methods other than those described In Annex V to Directive 67/548/EEC 
should also be taken Into consideration. 
- Recital 17 to now read : 
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 verification of their application for tests on 
chemical substances specifies the Community principles of good 
laboratory practice which must be followed for tests on chemicals to be 
carried out In the context of this Regulation. 
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ABJJUCLES 
- Article 1. to now read : 
The purpose of this Regulation is to approximate the laws, regulations 
and administrative provisions of the Member States on : 
a) the collection of Information on existing substances; 
b) the evaluation and the control of the risks of existing substances 
to man, including workers, and consumers, and the environment 
which are listed in the European Inventory of Existing Commercial 
Substances EINECS. 
This Regulation shall apply without prejudice to specific Community 
legislation concerning the safety and the protection of the health of 
workers at work. 
- Article 2 point (c) to now read : 
"c) importing means supplying, making available or using substances 
from outside the Community territory." 
- Article 3 to now read 
importer who 
either on_I Any manufacturer who has produced or any 
existing substance appearing In Annex 1 
préparât Ion. In quantities exceeding 1000 tonnes per year 
In the three years preceding and/or one year following 
this Regulation, must submit to the Commission the 
Information, in accordance with the data set laid down in 
within six months of the Regulation entering Into force : has imported an 
ts own or In a 
at least once 
the adopt Ion of 
fol lowing 
Annex I i, 
(a) 
(b) 
(c) 
(d) the name of the substance and the number on the EINECS inventory; 
the quantity of the substance produced or imported; 
the classification of the substance according to Annex I to 
Directive 67/548/EEC or the provisional classification according to 
Directive 67/548/EEC, including the class of danger, the danger 
symbol, the risk phrases and the safety phrases; 
information on uses of the substances which are reasonably 
foreseeable 
(e) data on physico-chemical properties of the substance; 
(f) data on environmental fate and pathways; 
(g) data on the ecotoxoclty of the substance; 
(h) data on the acute and sub-acute toxicity of the substance; 
(I) data on the carcinogenicity, mutagenicity and/or toxicity 
reproduction of the substance; 
(j) any other Indication relevant to the risk evaluation of 
substance. to 
the 
Manufacturers and Importers are required to taKe all reasonable efforts 
to obtain the data referred to under poJnla l^LJo_CJJ^a^ov^x^oj«ej^ejifc 
out additional tests on animals for the purpose of submitting these 
slala.. 
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- Article 4 to now read : 
1. Any manufacturer who has produced or any importer who has Imported 
a substance appearing In the EINECS inventory but not listed In 
Annex I, either on Its own or In a preparation in quantities 
exceeding 1000 tonnes per year, at least once In the three years 
preceding and every year following, the adoption of this 
Regulation, must submit to the Commission the information referred 
to In Article 3, in accordance with the data set laid down In Annex 
II, within 18 months of the Regulation entering Into force. 
2. Any manufacturer who has produced or any Importer who has Imported 
a substance appearing In EINECS, either on Its own or In a 
preparation, in quantities exceeding 10 tonnes per year, but no 
greater than 1000 tonnes per year, at least once in the three years 
preceding and/or every year following the adoption of this 
Regulation, must submit to the Commission the following 
Information, in accordance with the declaration form laid down in 
Annex III within a period of 18 months, to start once the 
Regulation has been in force for three years : 
(a) the name of the substance and the number on the EINECS inventory; 
(b) the quantity of the substance produced or Imported; 
(c) the classification of the substance according to Annex I to 
Directive 67/548/EEC or the provisional classification according to 
Directive 67/548/EEC, including the class of danger, the danger 
symbol, the risk phrases and the safety phrases; 
(d) Information on uses of the substance which are reasonably 
foreseeable. 
3. The Commission, in consultation with the Member States, will 
determine the cases in which It is necessary to request the 
producers and importers of the substances declared In pursuance of 
paragraph 2, to submit additional information, in the framework of 
Annex II, on the physico-chemical properties, exposure, toxicity, 
and ecotoxicity of the substance and any other aspect relevant to 
the risk evaluation of the substance, provided that no recourse 
need be had to further animal experiments. The specific Information 
to be submitted and the procedure to be followed for this 
submission will be determined In accordance with the procedure laid 
down In Ar t i cIe II. 
- Article 7.1 to now read : 
1. On the basis of the information submitted by the manufacturers and 
importers in accordance with Articles 3 and 4, and on the basis of 
the national lists of priority substances, the Commission, in 
consultation with Member States, shall regularly draw up lists of 
priority substances or groups of substances requiring special 
attention because of the possible effects they may pose to man or 
the environment. These lists will be adopted in accordance with the 
procedure laid down in Article 11 and will be published by the 
Commission, In the first Instance within 1 year of the entry into 
force of this Regulation. 
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- Article 8.1 to now read : 
1. For each substance on the priority lists, an appropriate Competent 
Authority of a Member State will be Identified as rapporteur for 
that substance after consultation with the Member State concerned. 
The rapporteurs will be designated in accordance with the procedure 
laid down In Article 11. 
The duty of the rapporteur will be to evaluate the Information 
submitted by the manufacturer(s) or importer(s) pursuant to the 
requirements of Articles 3, 4 and 6 and any other available 
Information, and to Identify, after hearing the parties concerned, 
whether, for the purpose of the risk evaluation, It would be 
necessary to require manufacturer(s) or Importer(s) of priority 
substances to submit further data and/or to carry out further 
testing. 
- Article 8.2 to now read : 
2. In the case where the Competent Authority, acting as rapporteur, 
Identifies the need for further information and/or testing, In 
order to protect man and/or the environment from the harmful 
effects QÎ tùfi substances concerned. it shall inform the 
Commission. The Commission will then submit, to the Management 
Committee referred to In Article 11, a proposal to request further 
Information and/or testing specifying the time limit within which 
the further Information and/or the results of the further tests 
shall be supplied. The decision to Impose such a request on 
manufacturer(s) or Importer(s) will be adopted in accordance with 
the procedure laid down in Article 11. 
- Article 9.3 to read : 
3. in the case of a substance either on Its own or In a preparation 
produced or imported by several manufacturers or importers, the 
testing in pursuance of paragraphs 1 and 2 may be performed by one 
or more manufacturer(s) or Importer(s) acting on behalf of the 
other concerned manufacturer(s) or importer(s). The other concerned 
manufacturers or importers shall make reference to the tests 
carried out by that or those manufacturer(s) or Importer(s) and 
shall share the costs on a fair and equitable basis. 
- Article 9.4 to read : 
4. in the event that the further Information and/or the results of the 
further testing are not supplied within the 11 me limits specified 
In Article 8(2) and adopted In accordance with the procedure laid 
down in Article 11, a decision to suspend the further marketing and 
use of the substance on the Community market will be adopted in 
accordance with the procedure laid down In Article 11 In respect of 
UPdertaKlngs Which have failed to submit the above-mentioned 
Information or test results and will remain in force until such 
time as the additional Information and/or the results of the 
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further testing are supplied. The Commission will periodically 
review the cases of substances whose marketing and/or use has been 
suspended in accordance with this paragraph with a view to making 
proposals for harmonized permanent measures concerning restrictions 
on marketing and/or use in the framework of either Directive 
76/69/EEC or other appropriate Community measures. 
- Article 12.1 now read : 
Industrial and commercial secrecy shall not apply to : 
the name of the substance, as given In EINECS, 
the name of the manufacturer or Importer, 
the physico-chemical data concerning the substance, 
the summary results of the toxlcological and ecotoxIcologlcal 
tests, 
any Information relating to the safety of the substance and the 
emergency measures, 
- any Information which, if withheld. miant isad LQ animal 
experiments being carried out or repeated unnecessarily. 
KSN 0254-1475 
COM(91) 469 final 
DOCUMENTS 
EN 14 
Catalogue number : CB-CO-91-543-EN-C 
ISBN 92-77-78060-6 
Office for Official Publications of the European Communities 
Lr2985 Luxembourg