Commission Regulation (EC) No 565/2006 of  6 April 2006  imposing testing and information requirements on the importers or manufacturers of certain priority substances in accordance with Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances   (Text with EEA relevance)
Date: 2006-04-06
Institutions: European Commission
Subjects: chemical product, dangerous substance, disclosure of information, health control, health risk, toxic substance

7.4.2006

EN

Official Journal of the European Union

L 99/3

COMMISSION REGULATION (EC) No 565/2006

of 6 April 2006

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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 Articles 10(2) thereof,

Whereas:

(1)

(2)

The rapporteurs designated by the Member States in
accordance with Article 10(1) of Regulation (EEC) No
793/93 have evaluated the information submitted by
the manufacturers and importers in respect of certain
priority substances. After consultation of those manufac-
turers and importers, the rapporteurs have determined
that it is necessary for the purposes of the risk evaluation
to require those manufacturers and importers to submit
further information and carry out further testing.

The information needed to evaluate the substances in
question is not available from former manufacturers or
importers. The manufacturers
and importers have
checked that
tests on animals cannot be replaced or
limited by using other methods.

mation and carry out further testing of those substances.
The protocols
to the
Commission should be used for performing those tests.

submitted by the rapporteurs

(4)

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

HAS ADOPTED THIS REGULATION:

Article 1

The manufacturers and importers of the substances listed in the
Annex, 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 and shall deliver the results to the
relevant rapporteurs.

The tests
specified by the rapporteurs.

shall be performed according to the protocols

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

Article 2

(3)

It is therefore appropriate to request manufacturers and
importers of priority substances to submit further infor-

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

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

Done at Brussels, 6 April 2006.

For the Commission

Stavros DIMAS
Member of the Commission

(1) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

L 99/4

EN

Official Journal of the European Union

7.4.2006

ANNEX

No

Einecs No

CAS No

Substance name

Rapporteur

Testing/Information requirements

Time limit from the
date of entry into
force of this Regu-
lation

1

214-604-9

1163-19-5

Bis(pentabromophenyl)ether (1)

UK/F

Developmental neurotoxicity study in rats
or mice

24 months

human

bio-monitoring

Suitable
pro-
gramme, including breast milk and blood,
and the need for a trend analysis over a
certain period

Environmental monitoring
programme
including birds, sewage sludge, sediment,
and air to establish time trends for the
substance and its more toxic and bioaccu-
mulative degradation products over
a
period of ten years

Annual reporting
over a period of
10 years

Annual reporting
over a period of
10 years

2

3

4

5

237-158-7

13674-84-5

Tris(2-chloro-1-methylethyl)
phosphate (2)

UK/IRL

Data on releases and use pattern of certain
life cycle stages

3 months

237-159-2

13674-87-8

Tris[2-chloro-1-(chloromethyl)
ethyl] phosphate (2)

UK/IRL

Data on releases and use pattern of certain
life cycle stages

3 months

Sediment-water Chironomid
using spiked sediment (OECD 218)

toxicity

test

6 months

Sediment-water Lumbriculus
using spiked sediment

toxicity test

6 months

Sediment-water Hyallella toxicity test using
spiked sediment

6 months

253-760-2

38051-10-4

2,2-Bis(chloromethyl)
trimethylene bis (bis(2-
chloroethyl) phosphate (2)

UK/IRL

Data on releases and use pattern of certain
life cycle stages

3 months

231-111-4
232-104-9
222-068-2
231-743-0
236-068-5

7440-02-0
7786-81-4
3333-67-3
7718-54-9
13138-45-9

Nickel (3)
Nickel sulphate (3)
Nickel carbonate (2)
Nickel dichloride (2)
Nickel dinitrate (2)

232-104-9

7786-81-4

Nickel sulphate (3)

231-111-4

7440-02-0

Nickel (3)

DK

Information on ecotoxicity and bioavail-
ability of nickel in laboratory studies

3 months

Information on ecotoxicity, fate and bio-
availability from field studies

6 months

Information on toxicity of nickel in various
soil types

6 months

Development and validation of a chronic
Biotic Ligand Model for Rainbow trout

3 months

Development and validation of a chronic
Biotic Ligand Model for algae and inverte-
brates

3 months

Exposure information for derivation of
PEClocal and PECregional

6 months

Monitoring data of European surface waters 6 months

Two-year oral carcinogenicity study with
nickel sulphate in rats (OECD 451 — B32)

30 months

Two-year inhalation carcinogenicity study
with elemental nickel metal powder in rat
(OECD 451 — B32)

30 months

7.4.2006

EN

Official Journal of the European Union

L 99/5

No

Einecs No

CAS No

Substance name

Rapporteur

Testing/Information requirements

Time limit from the
date of entry into
force of this Regu-
lation

6

221-221-0

3033-77-0

2,3-Epoxypropyltrimethyl
ammonium chloride (3)

7

222-048-3

3327-22-8

(3-Chloro-2-hydroxypropyl)
trimethyl ammonium
chloride (3)

8

202-453-1

95-80-7

4-Methyl-m-phenylene-
diamine (1)

FIN

FIN

D

Simulation test Aerobic sewage treatment,
Activated sludge units (OECD 303A)

6 months

Environmental exposure information

3 months

Simulation test Aerobic sewage treatment,
Activated sludge units (OECD 303A)

6 months

Environmental exposure information

3 months

Sediment-water Lumbriculus
using spiked sediment

toxicity test

6 months

(1) Substance listed in the Annex to Commission Regulation (EC) No 1179/94 (OJ L 131, 26.5.1994, p. 3; priority list 1).
(2) Substance listed in the Annex to Commission Regulation (EC) No 2364/2000 (OJ L 273, 23.10.2000, p. 5; priority list 4).
(3) Substance listed in the Annex to Commission Regulation (EC) No 143/97 (OJ L 25, 27.1.1997, p. 13; priority list 3).