The latest Regulation , also named “REACH”, was adopted by EU in 2007 to improve the protection from the risks related to the use of chemical substances.
It applies to any substance, not only those involved in the industrial processes.
Companies must identify and manage the risks linked to the substances they produce an sell across the EU proving that they can be used safety and indicating the risk management measures to the users as indicated in the Regulation below.
REACH sets the procedures to collect and to assess the information about the substances properties and the hazards. The applicant of a substance should submit all the required information in a registration dossier consisting of 2 main sections: a technical dossier and a Chemical Safety Report (CSR).
Producers and importers must find all existing available information regarding substance intrinsic properties, its manufacturing process, the use and the exposure. The technical dossier includes information about substance identity, directions on its safety use, classification and labelling, proposals on further tests, if relevant. The main aim of the Chemical Safety Assessment (CSA) is to define the conditions of use (operating conditions and risk management) by which the risks can be controlled. The 3 principal steps are: hazard evaluation, exposure evaluation and risk characterization where the levels of exposure are compared with the threshold levels for each effect.
ECHA receives and evaluates the conformity of the individual registrations based on the principle that a single substance corresponds to a single registration.
The unambiguous and correct identification of the substance is a pre-requisite that allows information sharing avoiding duplication of tests on animals and unnecessary costs.
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