Registration requirements reflect responsibilities in the form of documents. Manufacturers and importers are required to provide the following documents: Provide technical records for substances with a total amount of 1 ton or more; Provide chemical safety reports for substances with a total amount of 10 tons or more.
Technical files include material properties, usage and classification information, and safety guidelines for use. To obtain information on the nature of the chemical, it is necessary to proceed from the test attachment according to the tonnage of the produced or imported substance and the need for chemical safety assessment. The content of the information needs to be adjusted according to the tonnage, as this marks the potential exposure of the substance. New testing is only required when it is impossible to obtain information using any of the licensing methods. The implementation of new tests ensures the quality of the information. The GLP (Pharmaceutical Non-clinical Research Quality Management Practice) applies only to toxicological and ecotoxicological experiments and analyses.
Technical files include material properties, usage and classification information, and safety guidelines for use. To obtain information on the nature of the chemical, it is necessary to proceed from the test attachment according to the tonnage of the produced or imported substance and the need for chemical safety assessment. The content of the information needs to be adjusted according to the tonnage, as this marks the potential exposure of the substance. New testing is only required when it is impossible to obtain information using any of the licensing methods. The implementation of new tests ensures the quality of the information. The GLP (Pharmaceutical Non-clinical Research Quality Management Practice) applies only to toxicological and ecotoxicological experiments and analyses.
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