Commission Regulation (EC) No 1217/2002 of 5 July 2002 requiring importers or manufacturers of certain Einecs substances to supply certain information and perform certain tests pursuant to Council Regulation (EEC) No 793/93
Date: 2002-07-05
Institutions: European Commission
Subjects: chemical product, dangerous substance, exchange of information, health control, health risk, occupational safety

L 177/6

EN

Official Journal of the European Communities

6.7.2002

COMMISSION REGULATION (EC) No 1217/2002

of 5 July 2002

requiring importers or manufacturers of certain Einecs substances to supply certain information
and perform certain tests pursuant to Council Regulation (EEC) No 793/93

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

(4)

Having regard to Council Regulation (EEC) No 793/93 of 23
March 1993 on the evaluation and control of the risks of
existing substances (1), and in particular Article 12(2) thereof,

be performed by one or more manufacturers or impor-
ters acting on behalf of the others.

The measures provided for in this Regulation are in
accordance with the opinion of the Committee estab-
lished by Article 15 of Regulation (EEC) No 793/93,

Whereas:

(1)

(2)

(3)

A number of Member States have
apprised the
Commission of valid reasons for believing that certain
in the European Inventory of Existing
substances
Commercial Chemical Substances (Einecs) (2) may, due to
the degree of exposure entailed in their production or
use, pose a serious risk to humans or the environment.

The manufacturers and importers concerned should
therefore be required to provide the Commission with
the information in their possession concerning those
substances.

The manufacturers and importers concerned should also
be required to test the substances in question, to draw
up a report on those tests and to forward those reports,
together with the results of the tests, to the Commission,
subject to the possibility provided for by Article 12(3) of
Regulation (EEC) No 793/93 that, where a substance is
produced or imported as such or in a preparation by
several manufacturers or importers, further testing may

HAS ADOPTED THIS REGULATION:

Article 1

Manufacturers and importers of one or more of the Einecs
substances listed in the Annex to this Regulation shall:

(a) provide the Commission with the information specified in

the Annex within the time-limits laid down therein;

(b) perform, in relation to each such substance, the tests indi-
cated in the Annex in accordance with the protocols speci-
fied therein;

(c) provide the Commission with a report on each test,
including the results thereof, within the time-limits laid
down in the Annex.

Article 2

This Regulation shall enter into force on the 20th day following
that of its publication in the Official Journal of the European
Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 July 2002.

For the Commission

Margot WALLSTRÖM

Member of the Commission

(1) OJ L 84, 5.4.1993, p. 1.
(2) OJ C 146 A, 15.6.1990, p.1.

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Official Journal of the European Communities

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The testing/information requirements referred to in this Annex should be addressed to:

ANNEX

European Commission
Directorate-General for Environment
Directorate C — Unit C.3 — Chemicals
B-1049 Brussels

Testing/Information
Requirements

Fertility Study (EC B.34 (1)/
OECD TG 415 (2) or OECD
TG 416 (3))

Months from the
date of entry into
force of this
Regulation)

18

Einecs No

CAS No

Substance name

Reason(s) for concern

1

203-988-3

112-59-4

Diethylene
hexyl ether

glycol mono-

Human
during
exposure
production and use. Disper-
sive use in coatings, printing
inks and cleaning applica-
tions

of

Unavailability of studies on
developmental and fertility
effects
substance
the
causes concern because of
clear reprotoxicity observed
in rodent and non-rodent
studies with some ethylene
glycol ether derivatives

2

263-090-2

61789-80-8 Quaternary

Ammonium
compounds, bis(hydrogena-
ted tallow alkyl) dimethyl,
chlorides

increase

Significant
in
consumption volumes of the
substance which would pose
a potential risk for the envir-
onment

Yearly reports from industry
of the total production and
use volumes of the substance
(period 2000-2002)

3

203-481-7

107-31-3

Methyl formate

4

200-864-0

75-35-4

1,1-dichloroethene

Production Volume

High
Chemical

Acute inhalation exposure of
experimental animals to the
substance has resulted in eye
and respiratory tract
irrita-
tion

and

Uncertainty
impossi-
bility of establishing a scien-
tifically based OEL (SCOEL)
due to lack of data

Lack of data on prolonged
exposure for the establish-
ment of safe exposure level

Production Volume

High
Chemical

system disfunc-
Nervous
term
upon long
tioning
exposure well below present
Occupational
Exposure
Limits (OELs)

6
(volumes
year 2000)
18
(volumes
year 2001)
24
(volumes
year 2002)

18

Subchronic Inhalation Toxi-
city Study: 90-day repeated
inhalation dose study (EC
B.29 (3)/OECD TG 413 (4))

18

Subchronic Inhalation Toxicity
Study: 90-day repeated inhala-
tion dose
(recovery
study
period of 4-6 weeks) with
special neurological parameters
(EC B.29 (3)/OECD TG 413 (6)
and OECD TG 424 (5)).
General pathology may be
waived if this information is
available in other studies.

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EN

Official Journal of the European Communities

6.7.2002

Einecs No

CAS No

Substance name

Reason(s) for concern

Testing/Information
Requirements

Months from the
date of entry into
force of this
Regulation)

and

Special neurological para-
meters:
— Functional observational
motor

battery
activity assessment;
— Assessment of behavioural
visual
perfor-

performance
discrimination
mance);

(e.g.

5

211-309-7

637-92-3

2-ethoxy-2-methylpropane

Data poor substance

Growing potential for wide
dispersive
the
use
substance due to its potential
use as a substitute for MTBE

of

Adverse effects may occur
upon prolonged exposure

— Assessment of cognitive
delayed
(e.g.
function
alternation, Morris water
maze).

All relevant information and
full study reports necessary
for evaluation of the hazard
potential of the substance

Information on annual pro-
duction and import volumes

Acute Toxicity for Daphnia
(EC C.2 (3)/OECD TG 202 (6))

Growth Inhibition Test
for
Algae (EC C.3 (3)/OECD TG
201 (7))

Developmental
Study (OECD TG 414 (8))

Toxicity

All relevant information and
full study reports necessary
for evaluation of the hazard
potential of the substance

18

Fertility Study (OECD TG
416 (5))

24

(1) In accordance with Annex V of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the

classification, packaging and labelling of dangerous substances (OJ 196, 16.8.1967, p.1).

(2) OECD's Guidelines for the Testing of Chemicals - Section 4 - Health Effects TG No 415: ‘One-Generation Reproduction Toxicity Study ’ (Original Guideline, adopted 26 May 1983).
(3) OECD's Guidelines for the Testing of Chemicals - Section 4 - Health Effects TG No 416: ‘Two-Generation Reproduction Toxicity Study’ (Updated Guideline, adopted 22 January

2001).

(4) OECD's Guidelines for the Testing of Chemicals - Section 4 - Health Effects TG No 413: ‘Subchronic Inhalation Toxicity: 90-day Study’ (Original Guideline, adopted 12 May 1981).
(5) OECD's Guidelines for the Testing of Chemicals - Section 4 - Health Effects TG No 424:
(6) OECD's Guidelines for the Testing of Chemicals - Section 2 - Effects on Biotic Systems TG No 202: ‘Daphnia sp. Acute Immobilisation Test and Reproduction Test’ (Updated

‘Neurotoxicity Study in Rodents’ (Original Guideline, adopted 21 July 1997).

Guideline, adopted 4 April 1984).

(7) OECD's Guidelines for the Testing of Chemicals — Section 2 — Effects on Biotic Systems TG No 201: ‘Alga, Growth Inhibition Test’ ( (Updated Guideline, adopted 7 June 1984).
(8) OECD's Guidelines for the Testing of Chemicals - Section 4 - Health Effects TG No 414: ‘Prenatal Developmental Toxicity Study’ (Updated Guideline, adopted 22 January 2001).