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 shall be performed according to the protocols specified by the rapporteurs.
The results shall be delivered within the time limits laid down in the Annex.
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union .
ANNEXSupplementary provisions
ANNEX
No
Einecs No
CAS No
Substance name
Rapporteur
Testing/Information requirements
Time limit from the date of entry into force of this Regulation
1
214-604-9
1163-19-5
Bis(pentabromophenyl)ether ( 1 )
UK/F
Developmental neurotoxicity study in rats or mice
24 months
Suitable human bio-monitoring programme, including breast milk and blood, and the need for a trend analysis over a certain period
Annual reporting over a period of 10 years
Environmental monitoring programme including birds, sewage sludge, sediment, and air to establish time trends for the substance and its more toxic and bioaccumulative degradation products over a period of ten years
Annual reporting over a period of 10 years
2
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
3
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 toxicity test using spiked sediment (OECD 218)
6 months
Sediment-water Lumbriculus toxicity test using spiked sediment
6 months
Sediment-water Hyallella toxicity test using spiked sediment
6 months
4
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
5
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 )
DK
Information on ecotoxicity and bioavailability of nickel in laboratory studies
3 months
Information on ecotoxicity, fate and bioavailability 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 invertebrates
3 months
Exposure information for derivation of PEC local and PEC regional
6 months
Monitoring data of European surface waters
6 months
232-104-9
7786-81-4
Nickel sulphate ( 3 )
Two-year oral carcinogenicity study with nickel sulphate in rats (OECD 451 — B32)
30 months
231-111-4
7440-02-0
Nickel ( 3 )
Two-year inhalation carcinogenicity study with elemental nickel metal powder in rat (OECD 451 — B32)
30 months
6
221-221-0
3033-77-0
2,3-Epoxypropyltrimethyl ammonium chloride ( 3 )
FIN
Simulation test Aerobic sewage treatment, Activated sludge units (OECD 303A)
6 months
Environmental exposure information
3 months
7
222-048-3
3327-22-8
(3-Chloro-2-hydroxypropyl) trimethyl ammonium chloride ( 3 )
FIN
Simulation test Aerobic sewage treatment, Activated sludge units (OECD 303A)
6 months
Environmental exposure information
3 months
8
202-453-1
95-80-7
4-Methyl-m-phenylenediamine ( 1 )
D
Sediment-water Lumbriculus toxicity test using spiked sediment
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).
