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A substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Regulation (EC) N. 1907/2006, also named REACH, entered into force in June 2007 and it was adopted by European Union (EU) to improve the protection of human health and the environment from the risks related to the use of chemical substances. It is applied to any substance not only those involved in the industrial processes. It is responsibility of the Companies to identify and manage the risks linked to the substances they produce and place on the market across the EU proving that they can be used safety and indicating the risk management measures to the users.
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 required for all the substances subject to registration and a Chemical Safety Report (CSR) requested if the amount of substance produced/imported is higher than 10 tons/year. The registration dossier has to be prepared by the software IUCLID 5 and, once created, must be submitted to the European Chemicals Agency (ECHA) via REACH-IT platform.
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.