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)
Commission Regulation (EC) No 465/2008of 28 May 2008imposing, 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 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 12(2) thereof,Whereas:(1)Manufacturers and importers of certain substances in the European Inventory of Existing Commercial Chemical SubstancesOJ C 146 A, 15.6.1990, p. 1. 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 1Manufacturers 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 2This 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 CommissionStavros DimasMember of the CommissionANNEX
NoEinecs NoCAS NoSubstance nameTesting/information requirementsTime limit from the date of entry into force of this Regulation
1204-279-1118-82-12,2′,6,6′-tetra-tert-butyl-4,4′-methylenediphenolBioconcentration study on fish(OECD 305 or dietary study)18 months
2239-622-415571-58-12-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoateBioconcentration study on fish(OECD 305 or dietary study)18 months
3222-583-23542-36-7DichlorodioctylstannaneBioconcentration study on fish(to be conducted on substance No 2 (CAS 15571-58-1))18 months
4256-798-850849-47-35-Nonylsalicylaldehyde oximeBioconcentration study on fish(OECD 305 or dietary study)18 months
5281-018-883846-43-9Benzoic acid, 2-hydroxy-, mono-C>13-alkyl derivs, calcium salts (2:1)Enhanced ready biodegradation18 months
6250-702-831565-23-8Di(tert-dodecyl) pentasulphideFurther investigation of potential uptake in fishBioconcentration study on fish (dietary study)18 months
7284-578-184929-98-6Magnesium, bis(2-hydroxybenzoato-O1,O2)-, ar,ar′-di-C>13-alkyl derivsEnhanced ready biodegradation(to be conducted with substance No 5 (CAS 83846-43-9))18 months
8209-136-7556-67-2OctamethylcyclotetrasiloxaneEnvironmental monitoring programme(together with substance No 15 (CAS 541-02-6))18 months
9262-975-061788-44-1Phenol, styrenated21-day Daphnia reproduction test (OECD Guideline 211) conducted on Tristyrenatedphenol (CAS 18254-13-2)Bioconcentration study on fish (dietary study)18 months
10262-967-761788-32-7Terphenyl, hydrogenatedSoil degradation test (OECD 307) for selected hydrogenated terphenylsBioconcentration study on fish for quaterphenylsDepending on the results — study on T criterion(to read across to terphenyls (CAS 26140-60-3))18 months
11222-733-73590-84-9TetraoctyltinBioconcentration study on fish(to be conducted on substance No 2 (CAS 15571-58-1))18 months
12246-619-125103-58-6tert.-DodecanethiolEnhanced biodegradation testBioconcentration study on fish18 months
13248-227-627107-89-72-Ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]-thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoateBioconcentration study on fish(to be conducted on substance No 2 (CAS 15571-58-1))18 months
14250-709-631570-04-4Tris(2,4-di-tert-butylphenyl)phosphiteBioconcentration study on fish (dietary study)18 months
15208-764-9541-02-6DecamethylcyclopentasiloxanScreening: PBT &vPvBEnvironmental monitoring programme(together with substance No 8 (CAS 556-67-2))18 months
16254-052-638640-62-9DIPNReady biodegradation study on marketed material (OECD 301B)18 months