Commission Regulation (EC) No 642/2005 of 27 April 2005 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 substancesText with EEA relevance
Commission Regulation (EC) No 642/2005of 27 April 2005imposing 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 establishing the European Community,Having regard to Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of risks of existing substancesOJ 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)., and in particular Article 10(2) thereof,Whereas:(1)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 manufacturers 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.(2)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.(3)It is therefore appropriate to request manufacturers and importers of priority substances to submit further information and carry out further testing of those substances. The protocols submitted by the rapporteurs to the Commission should be used for performing those tests.(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 1The 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.
Article 2This Regulation shall enter into force on the twentieth 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, 27 April 2005.For the CommissionStavros DimasMember of the CommissionANNEX
Substance listed in the Annex to Commission Regulation (EC) No 143/97 (OJ L 25, 28.1.1997, p. 13; priority list No 3).Substance listed in the Annex to Commission Regulation (EC) No 1179/94 (OJ L 131, 26.5.1994, p. 3; priority list No 1).Substance listed in the Annex to Commission Regulation (EC) No 2268/95 (OJ L 231, 28.9.1995, p. 18; priority list No 2).Substance listed in the Annex to Commission Regulation (EC) No 2364/2000 (OJ L 273, 26.10.2000, p. 5; priority list No 4).
NoEinecs NoCAS NoSubstance nameRapporteurTesting/information requirementsTime limit from the date of entry into force of this Regulation
1201-245-880-05-74,4′-IsopropylidenediphenolUKLong-term fish endocrine effects study with investigation of effects on sperm development18 months
Long-term toxicity study with an appropriate freshwater snail species18 months
2 generation study with 4,4′-isopropylidenediphenol in mice according to OECD 416 (with some specific modifications)39 months
2203-545-4108-05-4Vinyl acetateDFurther data on pattern of polymerisation facilities and information on exhaust air purification techniques for representative facilities6 months
3202-627-798-01-12-FuraldehydeNLLong-term toxicity test with fish6 months
Long-term toxicity test with daphnia6 months
4201-622-785-68-7Benzyl butyl phthalateNData about releases into the Wupper from all sources12 months
Plant fumigation test12 months
Long-term fish study on reproductive and endocrine effects12 months
Monitoring study on local air concentrations near flooring production sites and sealant formulation plants12 months
5201-329-481-15-25-Tert-butyl-2,4,6-trinitro-m-xyleneNLBiodegradation simulation test for determination of half-life in marine environment18 months
6200-663-867-66-3ChloroformFEnvironmental exposure information for production and uses6 months
Two long-term toxicity tests on sediment organisms6 months
Toxicity tests on micro-organisms:tests on activated sludge for production sitesnitrification inhibition testtest on the inhibition of methanogenic bacteria6 months
7202-974-4101-77-94,4′-MethylenedianilineDLong-term toxicity test on sediment organisms (Chironomus spec.)6 months
Long-term toxicity test on sediment organisms (Hyalella azteca)6 months
8231-152-8215-146-27440-43-91306-19-0CadmiumCadmium oxideBEcotoxicity tests under very low water hardness conditions12 months
Validation of applicability of SEM/AVS concept (bioavailability in sediment compartment)12 months
9231-668-37681-52-9Sodium hypochloriteITWhole effluent assessment9 months
10247-148-425637-99-4HexabromocyclododecaneSBiodegradation simulation test providing valid half-lives as well as identification of metabolites8 months
11201-236-979-94-7Tetrabromobisphenol-AUKClarification of use pattern9 months
Long term toxicity test with Chironomus riparius in sediment9 months
Long term toxicity test with Chironomus riparius in water9 months
Toxicity study with molluscs9 months
Investigation of degradation to bisphenol-A in sediment9 months
12287-476-585535-84-8Alkanes, C10-13, chloro (SCCPs)UKEnvironmental exposure information on emissions3 months
Biodegradation simulation test to determine half-life in the marine environment18 months