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Home > Data on substances > Information requirements for registration Information requirements for the technical dossier for registration |
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The technical dossier contains information on the properties and classification of a substance as well as on uses and guidance on safe use. Information on the intrinsic properties of a substance to be registered Under REACH, registrants are obliged to collect all available relevant information on the intrinsic properties of a substance to be registered, regardless of the quantity manufactured or imported. However, the type and quantity of information that is required as a minimum to meet the obligations of the REACH regulation depends on the quantity that is manufactured or imported into the European Union. Annexes VII to X of REACH specify the minimum data requirements for a given substance according to its tonnage.
1. For the lowest tonnage band (1 to 10 t per year per manufacturer or importer), the required minimum information is confined to the physico-chemical data: As each new tonnage level is attained, the requirements of the next corresponding REACH annexe must be addressed. Exposure information Information on the manufacture (if within the European Union), use, handling and disposal of the substance (i.e. covering its whole life cycle) or of articles containing the substance, should be gathered to obtain insight into populations and compartments exposed, as well as the nature of the exposures, i.e. route, frequency and duration (annexe VI of REACH, sections 3 and 5 and, for substances in quantities between 1 and 10 tonnes per year per registrant, annexe VI, section 6). This information guides data requirements on the intrinsic properties of a given substance: e.g. if limited and well controlled human exposure is only taking place at the workplace during a few days a month, long-term repeated toxicity studies may not be needed. For substances manufactured or imported in quantities between 1 and 10 tonnes per year and per manufacturer/importer, this information will be used to conclude on dispersive or diffuse use of the substance.
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