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REACH stipulates that substances produced in the EU or imported into the EU in volumes of one or more metric tons per year must be registered. (Substances already on the market – referred to as phase-in substances – were subject to transition periods. Producers and importers affected by this had to initially pre-register their substances by December 1, 2008. Actual registration of these substances then needed to take place in phases within fixed periods by 2018 and is now completed.)
Companies file information on substances electronically with the European Chemicals Agency (ECHA) in Helsinki in the form of technical dossiers and chemical safety reports. They submit the necessary data for evaluation and must be able to demonstrate that the substances are safe to handle and do not compromise the health of processors or consumers or the environment. The relevant substance is given a registration number by the ECHA to indicate that the submitted dossier has been accepted. The authorities decide whether additional information is required during dossier or substance evaluation.
The registration of all phase-in substances only represents one part of REACH, as REACH encompasses registration, evaluation, authorization, and restriction of chemicals. In the future new substances will always need to be registered prior to production or import. This applies to quantities of one or more metric tons per year and per company (legal entity).
Some substances are also subjected to extensive approval procedures. Laws similar to REACH with comprehensive registration requirements for the production and import of all chemicals are now also in place in South Korea, Taiwan, and Turkey. Further countries are planning corresponding legislative changes. Experiences from Europe are very useful in the implementation of these regulations.
REACH aims to ensure safe handling of substances across all areas of application, which requires continuous exchange of suitable information between all those involved in a supply chain. REACH has intensified the exchange of information on substance applications, conditions of use, and risk management measures between manufacturers/importers, processors, and users, which has increased transparency and thus ensures greater safety throughout the entire product chain:
Few chemical substances do not need to be registered. The obligation to register does not apply to some natural substances, active ingredients for pharmaceuticals, biocides, and crop protection for which there are already applicable rules, and polymers.
The REACH obligation to register does not apply to polymers. Instead, the monomer components of polymers need to be registered, which is the responsibility of the monomer manufacturer. When polymers are imported into the EU, the polymer importer needs to register their monomer components, provided these make up two or more percentage points of the polymer weight and the total imported volume of the monomer exceeds one metric ton per year.