Commission Regulation (EC) No 2592/2001 of 28 December 2001 imposing further information and testing requirements on the manufacturers or importers of certain priority substances in accordance with Council Regulation (EEC) No 793/93 on the evaluation and control of the risk of existing substances
Date: 2001-12-28
Institutions: European Commission
Subjects: consumer protection, dangerous substance, exchange of information, health control, health risk, import

29.12.2001

EN

Official Journal of the European Communities

L 345/25

COMMISSION REGULATION (EC) No 2592/2001

of 28 December 2001

imposing further information and testing requirements on the manufacturers or importers of
certain priority substances in accordance with Council Regulation (EEC) No 793/93 on the evalu-
ation and control of the risk of existing substances

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Regulation (EEC) No 793/93 of 23
March 1993 on the evaluation and control of risks of existing
substances (1), and in particular Article 10(2) thereof,

Whereas:

Article 12(3) of Regulation (EEC) No 793/93 provides
that in the case of a substance produced or imported as
such or in a preparation by several manufacturers or
importers, the further testing may be performed by one
manufacturer/importer acting on behalf of
the other
manufacturers or importers concerned. In that case, the
other manufacturers or importers are to make reference
to the tests carried out and make a fair and equitable
contribution to the cost.

(1)

(2)

(3)

(4)

The Member States designated as rapporteur pursuant to
certain priority
Regulation (EEC) No 793/93 for
substances undergoing risk evaluation activities have
evaluated the information submitted by the manufac-
turers or importers in respect of those substances. After
importers
the manufacturers
consultation
concerned,
the
they have determined whether,
purposes of the risk evaluation, it is necessary to require
those manufacturers or importers to submit
further
information and/or to carry out further testing.

for

or

of

those substances,

The manufacturers and importers have checked whether
the information needed to evaluate the substances in
question is not available from former manufacturers or
importers of
in accordance with
Article 10(5) of Regulation (EEC) No 793/93. The manu-
facturers and importers have also checked, in consulta-
tion with the Member States designated as rapporteur,
whether tests on animals cannot be replaced or limited
by using other methods.

The Commission has been informed by the Member
States designated as rapporteur of the need to request
further information and testing from the manufacturers
or importers of those substances.

(6)

The provisions of this Regulation are in accordance with
the opinion of the Committee established by Article 15
of Regulation (EEC) No 793/93,

HAS ADOPTED THIS REGULATION:

Article 1

The manufacturer(s) and importer(s) of the substances listed in
the Annex to this Regulation, who have submitted information
in accordance with the requirements of Articles 3, 4, 7 and 9
of Regulation (EEC) No 793/93, shall provide the information
and perform the tests indicated in the Annex to this Regulation
and shall deliver the relevant results to the Member States
designated as rapporteur.

The tests shall be performed according to the protocols speci-
fied by the Member States designated as rapporteur.

The results shall be delivered within the time limits laid down
in the Annex.

Article 2

The Member States designated as
rapporteur have
submitted to the Commission the protocols on the
requested further testing.

This Regulation shall enter
into force on the 20th day
following 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, 28 December 2001.

For the Commission

Margot WALLSTRÖM

Member of the Commission

(1) OJ L 84, 5.4.1993, p. 1.

Einecs No

CAS No

Substance name

Rapporteur

Testing information requirements

Months from the date of entry
into force of this Regulation

ANNEX

1

200-539-3

62-53-3

Aniline (1)

D

Data about formation of aniline from caoutchouc chemicals

Data about the releases into the waste water and waste water treatment which
are representative for the European caoutchouc industry

Data about releases into the atmosphere and the applied exhaust air purification
techniques in caoutchouc industry

Plant fumigation toxicity test

Long-term toxicity tests on Lumbriculus variegatus and Chironomus riparius with
preincubated sediment

Bioaccumulation test with Lumbriculus variegatus with preincubated sediment

Terrestrial effect tests with princubated soil

Terrestrial bioaccumlation tests with preincubated soil

9

9

9

6

6

6

depends on the results of
testing of 3,4-
the actual
dichloroaniline
(terrestrial
effects) and the results of
of
the
aniline

sediments

tests

2

3

4

5

6

201-557-4

84-74-2

Dibutyl phthalate (1)

202-627-7

98-01-1

2-Furaldehyde (2)

202-974-4

101-77-9

4,4(cid:1)-Methylenedianiline (1)

204-211-0

117-81-7

Bis(2-ethylhexyl) phthalate (2)

204-825-9

127-18-4

Tetrachloroethylene (1)

NL

NL

D

S

UK

Plant toxicity test

In vivo gene mutation test

Long-term toxicity test on Lumbriculus variegatus

Multigeneration fish study in freshwater

Environmental monitoring program for tetrachloroethylene and tricholoroacetic
acid in the EU

14C isotope fingerprinting analysis on the trichloroacetic acid found in soil from
at least one site with high levels

Test for the possible natural formation of thichloroacetic acid in soil from at
least one site under natural conditions, and determination of the potential flux
from this source

12

12

6

18

18

L

3
4
5
/
2
6

E
N

O

f
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2
9
1
2
2
0
0
1

.

Einecs No

CAS No

Substance name

Rapporteur

Testing information requirements

Months from the date of entry
into force of this Regulation

7

214-604-9

1163-19-5

Bis(pentabromophenyl) ether (1)

F/UK

Developmental toxicity study

Testing of debromination:

— anaerobic degradation,

— photodegradation

28-day sediment toxicity study in Lumbriculus variegatus

Plant growth test

Earthworm reproductive toxicity test

Activated sludge respiratory inhibition study

8

9

10

11

231-152-8

7440-43-9

Cadmium (3)

B

Determination of the dissolution/transformation of the substance in water

231-765-0

7722-84-1

Hydrogen peroxide (2)

FIN

90-day repeated dose inhalation study

247-148-4

25637-99-4

Hexabromocyclododecane (2)

S

90-day repeated dose toxicity study

251-087-9

32536-52-0

Diphenyl ether, octabromo deriva-
tive (1)

F/UK

90-day inhalation study with examination of reproductive organs and immuno-
toxicity parameters

Testing of debromination:

— anaerobic degradation,

— photodegradation

or equivalent information

28-day sediment toxicity study in Lumbriculus variegatus

Plant growth test

Earthworm reproductive toxicity test

Activated sludge respiratory inhibiton study

3

3

6

6

6

6

6

3

24

6

3

6

18

6

6

6

6

.

2
9
1
2
2
0
0
1

.

E
N

O

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L

3
4
5
/
2
7

Einecs No

CAS No

Substance name

Rapporteur

Testing information requirements

Months from the date of entry
into force of this Regulation

12

287-477-0

85535-85-9

Alkanes, C14-17, chloro (3)

UK

28-day sediment toxicity study in Lumbriculus variegatus

28-day toxicity test on a Chironomus midge species

Long-term plant growth test

Earthworm reproductive toxicity test

6

6

6

6

(1) Substance listed in the Annex to Commission Regulation (EC) No 1179/94 (OJ L 131, 26.5.1994, p. 3).
(2) Substance listed in the Annex to Commission Regulation (EC) No 2268/95 (OJ L 231, 28.9.1995, p. 18).
(3) Substance listed in the Annex to Commission Regulation (EC) No 143/97 (OJ L 25, 28.1.1997, p. 13).

L

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.

2
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1
2
2
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0
1

.