Regulation on detailed data required in documentation concerning introduction of a new substance, necessary to evaluate risk caused by the substance to human health and to environment.

This Regulation of the Minister of Health, which is composed of seven Paragraphs and four Annexes, establishes the information that shall be compulsorily included in the the documentation on the introduction of a new susbtance when: the foreseen amount of turnover is more than 1 tone per year (Annex 1); the foreseen amount of turnover is less than 1 tone per year but at least 100 kg per year (Annex 2); the foreseen amount of turnover is less than 100 kg per year (Annex 3); the substance is a polymer (Annex 4); at least ten years have passed from the first registration of the substance.