CELEX: 32006R0565
Language: en
Date: 2006-04-06 00:00:00
Title: Commission Regulation (EC) No 565/2006 of  6 April 2006  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)

7.4.2006   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 99/3
            
         
      COMMISSION REGULATION (EC) No 565/2006
   of 6 April 2006
   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 Articles 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 20th 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, 6 April 2006.
      
         
            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
               
               
                  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 PEClocal and PECregional
                  
               
               
                  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).