CELEX: 32005R0642
Language: en
Date: 2005-04-27 00:00:00
Title: 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

28.4.2005   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 107/14
            
         
      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 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 substances (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 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 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 2
   This 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 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).
   
      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
               
               
                  201-245-8
               
               
                  80-05-7
               
               
                  4,4′-Isopropylidenediphenol (1)
                  
               
               
                  UK
               
               
                  Long-term fish endocrine effects study with investigation of effects on sperm development
               
               
                  18 months
               
            
                  Long-term toxicity study with an appropriate freshwater snail species
               
               
                  18 months
               
            
                  2 generation study with 4,4′-isopropylidenediphenol in mice according to OECD 416 (with some specific modifications)
               
               
                  39 months
               
            
                  2
               
               
                  203-545-4
               
               
                  108-05-4
               
               
                  Vinyl acetate (2)
                  
               
               
                  D
               
               
                  Further data on pattern of polymerisation facilities and information on exhaust air purification techniques for representative facilities
               
               
                  6 months
               
            
                  3
               
               
                  202-627-7
               
               
                  98-01-1
               
               
                  2-Furaldehyde (3)
                  
               
               
                  NL
               
               
                  Long-term toxicity test with fish
               
               
                  6 months
               
            
                  Long-term toxicity test with daphnia
               
               
                  6 months
               
            
                  4
               
               
                  201-622-7
               
               
                  85-68-7
               
               
                  Benzyl butyl phthalate (1)
                  
               
               
                  N
               
               
                  Data about releases into the Wupper from all sources
               
               
                  12 months
               
            
                  Plant fumigation test
               
               
                  12 months
               
            
                  Long-term fish study on reproductive and endocrine effects
               
               
                  12 months
               
            
                  Monitoring study on local air concentrations near flooring production sites and sealant formulation plants
               
               
                  12 months
               
            
                  5
               
               
                  201-329-4
               
               
                  81-15-2
               
               
                  5-Tert-butyl-2,4,6-trinitro-m-xylene (1)
                  
               
               
                  NL
               
               
                  Biodegradation simulation test for determination of half-life in marine environment
               
               
                  18 months
               
            
                  6
               
               
                  200-663-8
               
               
                  67-66-3
               
               
                  Chloroform (3)
                  
               
               
                  F
               
               
                  Environmental exposure information for production and uses
               
               
                  6 months
               
            
                  Two long-term toxicity tests on sediment organisms
               
               
                  6 months
               
            
                  Toxicity tests on micro-organisms:
                  
                              —
                           
                           
                              tests on activated sludge for production sites
                           
                        
                              —
                           
                           
                              nitrification inhibition test
                           
                        
                              —
                           
                           
                              test on the inhibition of methanogenic bacteria
                           
                        
               
                  6 months
               
            
                  7
               
               
                  202-974-4
               
               
                  101-77-9
               
               
                  4,4′-Methylenedianiline (2)
                  
               
               
                  D
               
               
                  Long-term toxicity test on sediment organisms (Chironomus spec.)
               
               
                  6 months
               
            
                  Long-term toxicity test on sediment organisms (Hyalella azteca)
               
               
                  6 months
               
            
                  8
               
               
                  231-152-8
                  215-146-2
               
               
                  7440-43-9
                  1306-19-0
               
               
                  Cadmium (1)
                  
                  Cadmium oxide (1)
                  
               
               
                  B
               
               
                  Ecotoxicity tests under very low water hardness conditions
               
               
                  12 months
               
            
                  Validation of applicability of SEM/AVS concept (bioavailability in sediment compartment)
               
               
                  12 months
               
            
                  9
               
               
                  231-668-3
               
               
                  7681-52-9
               
               
                  Sodium hypochlorite (3)
                  
               
               
                  IT
               
               
                  Whole effluent assessment
               
               
                  9 months
               
            
                  10
               
               
                  247-148-4
               
               
                  25637-99-4
               
               
                  Hexabromocyclododecane (3)
                  
               
               
                  S
               
               
                  Biodegradation simulation test providing valid half-lives as well as identification of metabolites
               
               
                  8 months
               
            
                  11
               
               
                  201-236-9
               
               
                  79-94-7
               
               
                  Tetrabromobisphenol-A (4)
                  
               
               
                  UK
               
               
                  Clarification of use pattern
               
               
                  9 months
               
            
                  Long term toxicity test with Chironomus riparius in sediment
               
               
                  9 months
               
            
                  Long term toxicity test with Chironomus riparius in water
               
               
                  9 months
               
            
                  Toxicity study with molluscs
               
               
                  9 months
               
            
                  Investigation of degradation to bisphenol-A in sediment
               
               
                  9 months
               
            
                  12
               
               
                  287-476-5
               
               
                  85535-84-8
               
               
                  Alkanes, C10-13, chloro (SCCPs) (2)
                  
               
               
                  UK
               
               
                  Environmental exposure information on emissions
               
               
                  3 months
               
            
                  Biodegradation simulation test to determine half-life in the marine environment
               
               
                  18 months
               
            
         (1)  Substance listed in the Annex to Commission Regulation (EC) No 143/97 (OJ L 25, 28.1.1997, p. 13; priority list No 3).
      
         (2)  Substance listed in the Annex to Commission Regulation (EC) No 1179/94 (OJ L 131, 26.5.1994, p. 3; priority list No 1).
      
         (3)  Substance listed in the Annex to Commission Regulation (EC) No 2268/95 (OJ L 231, 28.9.1995, p. 18; priority list No 2).
      
         (4)  Substance listed in the Annex to Commission Regulation (EC) No 2364/2000 (OJ L 273, 26.10.2000, p. 5; priority list No 4).