Commission Regulation (EC) No 466/2008 of 28 May 2008 imposing testing and information requirements on the importers and 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: 2008-05-28
Institutions: European Commission
Subjects: chemical product, dangerous substance, disclosure of information, health control, health risk, testing, toxic substance

L 139/10

EN

Official Journal of the European Union

29.5.2008

COMMISSION REGULATION (EC) No 466/2008

of 28 May 2008

imposing testing and information requirements on the importers and 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 the risks of
existing substances (1), and in particular Article 10(2) thereof,

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,

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, in accordance with Article 10(5) of Regulation
tests on animals cannot be
that
(EEC) No 793/93,
replaced or limited by using other methods.

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 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, 28 May 2008.

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).

29.5.2008

EN

Official Journal of the European Union

L 139/11

ANNEX

No

Einecs No

CAS No

Substance name

Rapporteur

Testing/information requirements

1

247-759-6

26523-78-4

Tris (nonylphenyl) phosphite

FR

2

237-410-6
239-148-8

13775-53-6
15096-52-3

Trisodium
hexafluoroaluminate

DE

3

266-028-2

65996-93-2

Pitch, coal tar, high temp

NL

4

246-690-9

25617-70-8

2,4,4-trimethylpentene

DE

Acute toxicity test with Daphnia magna
Information on structure of TNPP
Information on water solubility
Log Kow determination
Hydrolysis test
Sediment test with Lumbriculus variegatus
Monitoring data for sites with PEC/PNEC > 1
Long-term Daphnia test depending on outcome of
acute Daphnia test

Information on downstream uses
Information on emissions to the aquatic compartment
for all lifecycle stages
Information on emissions to the atmosphere for all
lifecycle stages
Information on hardness of receiving water body for
two producers
Information on fraction of cryolite in particulate
emissions of aluminium smelters
Dissolution study

Information on the release of the 16 EPA PAHs to the
different environmental compartments from the use of
CTPHT in the production and use of binder for coal
briquetting clay pigeons and heavy-duty corrosion
protection

into wastewater

from production and
treatment plants,

Information on emissions
processing sites
surface water and sediment
Activated sludge respiration inhibition test (OECD 209)
Long-term Daphnia magna reproduction test (OECD
211)

Time limit
from the date
of entry into
force of this
Regulation

4 months

4 months

4 months

4 months

5

231-111-4

7440-02-0

Nickel

DK

Sediment toxicity testing

12 months

232-104-9

7786-81-4

Nickel sulphate

222-068-2

3333-67-3

Nickel carbonate

231-743-0

7718-54-9

Nickel dichloride

236-068-5

13138-45-9 Nickel dinitrate

6

7

8

287-477-0

85535-85-9 Alkanes, C14-17, chloro

202-696-3

98-73-7

Nitrobenzene

202-679-0

98-54-4

4-Tert-butylphenol

UK

DE

NO

Fish bioaccumulation study (OECD TG 305)

6 months

Local lymph node assay (OECD TG 429/B42)

6 months

Local exposure information on the releases from two
processing sites (5 and 6) into wastewater treatment
plants
and
marine)

compartment

and aquatic

(freshwater

4 months

9

200-915-7

75-91-2

Tert-butyl hydroperoxide
(TBHP)

NL

Repeated dose (28 day)
412 — B8)

toxicity (inhalation)

(OECD

12 months

COMET assay on respiratory tissue

15 months