CELEX: 32008R0465
Language: en
Date: 2008-05-28 00:00:00
Title: 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)

29.5.2008   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 139/8
            
         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)
   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 the risks of existing substances (1), and in particular Article 12(2) thereof,
   Whereas:
   
               (1)
            
            
               Manufacturers and importers of certain substances in the European Inventory of Existing Commercial Chemical Substances (2) may be required to supply further information which they possess and/or to subject the existing substance to testing where there are valid reasons to believing that the substance presents a serious risk to humans or the environment. Substances that are persistent, bioaccumulating and toxic may present such a risk.
            
         
               (2)
            
            
               The manufacturers and importers concerned should therefore be required to provide the Commission with the information in their possession concerning those substances.
            
         
               (3)
            
            
               The manufacturers and importers concerned should also be required to test the substances in question, to draw up a report on those tests and to forward those reports, together with the results of the tests, to the Commission.
            
         
               (4)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 15 of Regulation (EEC) No 793/93,
            
         HAS ADOPTED THIS REGULATION:
   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.
   
      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 28 May 2008.
      
         
            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).
   
      (2)  OJ C 146 A, 15.6.1990, p. 1.
   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