Guidance on registration - ECHA - Europa

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56 <strong>Guidance</strong> on registration Version 2.0 May 2012 9 Ecotoxicological information 9.1.3 Short-term aquatic toxicity to fish 9.1.4 Activated sludge respiration inhibition test 9.2.2.1 Hydrolysis as a function of pH 9.3.1 Adsorption/desorption screening ANNEX IX (100 tonnes or more) 7 Information on the physicochemical properties of the substance 7.15 Stability in organic solvents and identity of relevant degradation products 7.16 Dissociation constant 7.17 Viscosity 8 Toxicological information 8.6.1 Short-term repeated dose toxicity test (28 days) 8.6.2 Sub-chronic toxicity (90 days) 8.7.2 Pre-natal developmental toxicity 8.7.3 Two-generation reproductive toxicity 9 Ecotoxicological information 9.1.5 Long-term aquatic toxicity on invertebrates (Daphnia) 9.1.6 Long-term aquatic toxicity on fish 9.2.1.2 Ultimate degradation in surface water 9.2.1.3 Soil simulation testing 9.2.1.4 Sediment simulation testing 9.2.3 Identification of degradation products 9.3.2 Bioaccumulation in aquatic species (fish) 9.3.3 Further information on adsorption/desorption 9.4.1 Short-term terrestrial toxicity on invertebrates 9.4.2 Effects on soil micro-organisms 9.4.3 Short-term terrestrial toxicity to plants ANNEX X (1000 tonnes or more) 8 Toxicological information 8.6.3 Long-term repeated dose toxicity (≥ 12 months) 8.7.2 Developmental toxicity 8.7.3 Two-generation reproductive toxicity 8.9.1 Carcinogenicity 9 Ecotoxicological information 9.2 Further biotic degradation testing 9.3.4 Further information on the environmental fate and behaviour of the substance and/or degradation products 9.4.4 Long-term terrestrial toxicity to invertebrates Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
<strong>Guidance</strong> on registration Version 2.0 May 2012 57 9.4.6 Long-term terrestrial toxicity to plants 9.5.1 Long-term toxicity to sediment organisms 9.6.1 Long-term or reproductive toxicity to birds 3.1.2 Use of information from other assessments As stated under REACH, ‘Available information from assessments carried out under other international and national programmes shall be included. Where available and appropriate, an assessment carried out under Community legislation (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the development of, and reflected in, the chemical safety report. Deviations from such assessments shall be justified’ (Annex I Section 0.5). Therefore registrants need to take into account and to use these already available assessments to prepare their registration dossier. This includes in particular assessments carried out under other EU programmes such as the Existing Substances Risk Assessment Programme, assessments of active substances under the Biocidal Products Directive or the Plant Protection Products Directive when such substances are covered by REACH. Another important source of information is the OECD HPV (Organisation for Economic Cooperation and Development High Production Volume) Chemicals Programme where a lot of similarities exist with REACH. Those similarities should be taken into account when preparing a registration dossier where a dossier for the OECD HPV Chemicals Programme is available. 3.2 Registration dossier 3.2.1 Structure of the registration dossier The registration dossier is the set of information submitted electronically by a registrant for a particular substance. It consists of two main components: a technical dossier, always required for all substances subject to the registration obligations; a chemical safety report, required if the registrant manufactures or imports a substance in quantities of 10 tonnes or more per year. The technical dossier contains a set of information about: (i) the identity of the manufacturer/importer; (ii) the identity of the substance; (iii) information on the manufacture and use of the substance; (iv) the classification and labelling of the substance; (v) guidance on its safe use; (vi) study summaries of the information on the intrinsic properties of the substance; (vii) robust study summaries of the information on the intrinsic properties of the substance, if required; (viii) an indication as to whether the information on manufacture and use, the classification and labelling, the (robust) study summaries and/or, if relevant, the chemical safety report has been reviewed by an assessor; (ix) proposals for further testing, if relevant; Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
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Guidance on registration - ECHA - Europa

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