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)

Article 1

Manufacturers and importers of one or more of the substances that may be persistent, bioaccumulating and toxic, listed in the European Inventory of 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.

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

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

ANNEX

ANNEX
No
Einecs No
CAS No
Substance name
Testing/information requirements
Time limit from the date of entry into force of this Regulation
1
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)
18 months
2
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)
18 months
3
222-583-2
3542-36-7
Dichlorodioctylstannane
Bioconcentration study on fish
(to be conducted on substance No 2 (CAS 15571-58-1))
18 months
4
256-798-8
50849-47-3
5-Nonylsalicylaldehyde oxime
Bioconcentration study on fish
(OECD 305 or dietary study)
18 months
5
281-018-8
83846-43-9
Benzoic acid, 2-hydroxy-, mono-C>13-alkyl derivs, calcium salts (2:1)
Enhanced ready biodegradation
18 months
6
250-702-8
31565-23-8
Di(tert-dodecyl) pentasulphide
Further investigation of potential uptake in fish
Bioconcentration study on fish (dietary study)
18 months
7
284-578-1
84929-98-6
Magnesium, bis(2-hydroxybenzoato-O1,O2)-, ar,ar′-di-C>13-alkyl derivs
Enhanced ready biodegradation
(to be conducted with substance No 5 (CAS 83846-43-9))
18 months
8
209-136-7
556-67-2
Octamethylcyclotetrasiloxane
Environmental monitoring programme
(together with substance No 15 (CAS 541-02-6))
18 months
9
262-975-0
61788-44-1
Phenol, styrenated
21-day Daphnia reproduction test (OECD Guideline 211) conducted on Tristyrenatedphenol (CAS 18254-13-2)
Bioconcentration study on fish (dietary study)
18 months
10
262-967-7
61788-32-7
Terphenyl, hydrogenated
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))
18 months
11
222-733-7
3590-84-9
Tetraoctyltin
Bioconcentration study on fish
(to be conducted on substance No 2 (CAS 15571-58-1))
18 months
12
246-619-1
25103-58-6
tert.-Dodecanethiol
Enhanced biodegradation test
Bioconcentration study on fish
18 months
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
Bioconcentration study on fish
(to be conducted on substance No 2 (CAS 15571-58-1))
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

Schedules & Appendices

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