Commission Regulation (EC) No 465/2008 of 28 May 2008 imposing, pursuant to Council Regulation (EEC) No 793/93, testing and information requirements on importers and manufacturers of certain substances that may be persistent, bioaccumulating and toxic and are listed in the European Inventory of Existing Commercial Chemical 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 139/8

EN

Official Journal of the European Union

29.5.2008

COMMISSION REGULATION (EC) No 465/2008

of 28 May 2008

imposing, pursuant to Council Regulation (EEC) No 793/93, testing and information requirements
on importers and manufacturers of certain substances that may be persistent, bioaccumulating and
toxic and are listed in the European Inventory of Existing Commercial Chemical Substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

a report on those tests and to forward those reports,
together with the results of the tests, to the Commission.

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 12(2) thereof,

Whereas:

(4)

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,

HAS ADOPTED THIS REGULATION:

Article 1

(1)

(2)

Manufacturers and importers of certain substances in the
European Inventory of Existing Commercial Chemical
Substances (2) may be required to supply further infor-
mation which they possess and/or to subject the existing
substance to testing where there are valid reasons to
believing that the substance presents a serious risk to
humans or
are
persistent, bioaccumulating and toxic may present such
a risk.

environment. Substances

that

the

of

Inventory

Manufacturers and importers of one or more of the substances
that may be persistent, bioaccumulating and toxic, listed in the
European
Existing Commercial Chemical
Substances and set out in the Annex to this Regulation shall
provide the Commission with the information specified in the
Annex within the time limits laid down therein and perform,
with regard to each such substance, the tests indicated in the
Annex in accordance with the protocols specified therein.

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

They shall also provide the Commission with a report on each
test,
including the results thereof, within the time limits laid
down in the Annex.

Article 2

(3)

The manufacturers and importers concerned should also
be required to test the substances in question, to draw up

This Regulation shall enter into force on the day following that
of 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).
(2) OJ C 146 A, 15.6.1990, p. 1.

29.5.2008

EN

Official Journal of the European Union

L 139/9

ANNEX

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

18 months

18 months

18 months

18 months

No

Einecs No

CAS No

Substance name

Testing/information requirements

1

2

204-279-1

118-82-1

2,2′,6,6′-tetra-tert-butyl-4,4′-
methylenediphenol

Bioconcentration study on fish
(OECD 305 or dietary study)

239-622-4

15571-58-1

2-ethylhexyl 10-ethyl-4,4-
dioctyl-7-oxo-8-oxa-3,5-dithia-
4-stannatetradecanoate

Bioconcentration study on fish
(OECD 305 or dietary study)

3

222-583-2

3542-36-7

Dichlorodioctylstannane

Bioconcentration study on fish
(to be conducted on substance No 2
(CAS 15571-58-1))

Bioconcentration study on fish
(OECD 305 or dietary study)

Enhanced ready biodegradation

18 months

256-798-8

50849-47-3

5-Nonylsalicylaldehyde oxime

281-018-8

83846-43-9

Benzoic acid, 2-hydroxy-,
mono-C>13-alkyl derivs,
calcium salts (2:1)

4

5

6

7

250-702-8

31565-23-8

Di(tert-dodecyl) pentasulphide

Further investigation of potential uptake in fish
Bioconcentration study on fish (dietary study)

284-578-1

84929-98-6 Magnesium, bis(2-hydroxy-

benzoato-O1,O2)-, ar,ar′-di-C>13-
alkyl derivs

Enhanced ready biodegradation
(to be conducted with substance No 5
(CAS 83846-43-9))

8

209-136-7

556-67-2

Octamethylcyclotetrasiloxane

9

262-975-0

61788-44-1

Phenol, styrenated

10

262-967-7

61788-32-7

Terphenyl, hydrogenated

11

222-733-7

3590-84-9

Tetraoctyltin

12

246-619-1

25103-58-6

tert.-Dodecanethiol

13

248-227-6

27107-89-7

2-Ethylhexyl 10-ethyl-4-[[2-[(2-
ethylhexyl)oxy]-2-oxoethyl]-
thio]-4-octyl-7-oxo-8-oxa-3,5-
dithia-4-stannatetradecanoate

Environmental monitoring programme
(together with substance No 15
(CAS 541-02-6))

21-day Daphnia reproduction test (OECD Guideline
211) conducted on Tristyrenatedphenol
(CAS 18254-13-2)
Bioconcentration study on fish (dietary study)

Soil degradation test (OECD 307) for selected
hydrogenated terphenyls
Bioconcentration study on fish for quaterphenyls
Depending on the results — study on T criterion
(to read across to terphenyls (CAS 26140-60-3))

Bioconcentration study on fish
(to be conducted on substance No 2
(CAS 15571-58-1))

Enhanced biodegradation test
Bioconcentration study on fish

Bioconcentration study on fish
(to be conducted on substance No 2
(CAS 15571-58-1))

18 months

18 months

18 months

18 months

18 months

18 months

18 months

18 months

14

250-709-6

31570-04-4

Tris(2,4-di-tert-
butylphenyl)phosphite

Bioconcentration study on fish (dietary study)

18 months

15

208-764-9

541-02-6

Decamethylcyclopentasiloxan
Screening: PBT &vPvB

Environmental monitoring programme
(together with substance No 8 (CAS 556-67-2))

18 months

16

254-052-6

38640-62-9

DIPN

Ready biodegradation study on marketed material
(OECD 301B)

18 months