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REACH is based on the principle that industry should manufacture, import, use substances or place them on the market in a way that, under reasonably foreseeable conditions, human health and the environment are not adversely affected. In order to ensure this, manufacturers and importers1 need to collect or generate data on the substances and assess how risks to human health and the environment can be controlled by applying suitable risk management measures.
To prove that they actually meet these obligations, as well as for transparency reasons, REACH requires manufacturers and importers to submit to the European Chemicals Agency (ECHA) a registration dossier containing:
Substances subject to registration
The registration obligations apply to substances manufactured or imported in quantities of 1 tonne or more per year and manufacturer/importer. Generally, they apply to all individual chemical substances on their own or in preparations. They apply to substances in articles, if the substance is intended to be released during normal and reasonably foreseeable conditions of use or upon request from the European Chemicals Agency (see diagram Requirements for substances in articles).
Substances exempted from registration
Some substances are completely excluded from REACH and therefore from registration: radioactive substances, substances under customs supervision, non-isolated intermediates and substances used in the interest of defence and covered by National exemptions. Moreover, waste is also excluded as it is not a substance, a preparation or an article within the meaning of REACH.
Other substances are specifically exempted from registration where other equivalent legislation applies (substances used in medicinal products, in food or feeding stuff). In addition, certain identified substances or categories of substances and substances from certain identified processes, are exempted from registration. They are considered as causing minimum risk to human health and the environment (substances listed in annexe IV) or their registration is deemed inappropriate or unnecessary (substances or processes listed in annexe V). Polymers are for the time being exempted from registration but manufacturers and importers of polymers may nevertheless be required to proceed with the registration of the monomers or other substances used for the manufacture of polymers (see table Provisions for polymers and monomers). Recycled or recovered substances already registered and re-imported substances are also exempted from registration.
For more information, see table Scope of the REACH regulation.
Substances regarded as registered
Certain substances or uses of substances are regarded as being registered, and therefore no registration is required for these substances for these uses. This applies to:
The information submitted for these substances is equivalent to the registration dossier data. The European Chemicals Agency has been charged with including it into its databases.
Substances with tailored provisions
Isolated intermediates and substances manufactured or imported for the purposes of research and development have tailored provisions within the REACH legislation, including registration, as long as they are used in specified conditions.
Substances falling under the scope of the REACH regulation and not exempted from the registration obligation must be registered before they can be manufactured or imported into the European Union. However, there is a special transition regime for substances which were already being manufactured or imported, under certain conditions, before the entry into force of REACH on 1 June 2007. Such substances are called “phase-in substances”, because they are being subjected to the registration system in different phases over time, rather than immediately in one go. A precondition to benefit from the registration postponement is that the “phase-in substance” is being pre-registered between 1 June 2008 and 1 December 2008. “Non-phase-in substances” or “phase-in substances” which have not been pre-registered, must be registered before manufacture or import starting from 1 June 2008. Note that until then, the previous notification of new substances regulations continues to apply.
Registration dossier completeness check
The European Chemicals Agency is responsible for managing all registration dossiers. The Agency will perform a simple electronic completeness check at the dossier submission stage. The quality of the information submitted may be checked afterwards in the evaluation process.
1. Non-EU manufacturers may appoint “Only Representatives” to fulfil the obligations of importers. Only Representatives are natural or legal persons established in the European Union and having sufficient background in the practical handling of substances and the information related to them. When an Only Representative is appointed, the non-EU manufacturer has the obligation to inform the importer(s) within the same supply chain of the appointment. Following such communication, the Only Representative takes up the role of the EU importers and fulfils their registration obligations.