European Union REACH
REACH is the EU regulation governing the manufacture and import of chemical substances. REACH is an acronym for the “registration, evaluation and authorization of chemicals” and has been in force in all EU Member States since June 1, 2007. It also applies in Iceland, Lichtenstein, and Norway.
In general, REACH requires the registration of chemical substances manufactured or imported into the EU in quantities exceeding 1 metric ton per year. This requirement applies per substance and per manufacturer or importer (as appropriate). Registration applies to chemical substances as such, in preparations (also called “mixtures”) and, under certain conditions, to articles (finished products) incorporating those substances.
REACH assigns the obligation to register on the EU based manufacturer or EU based importer. Many U.S.-based companies prefer to appoint an “only representative” to register their product(s) rather than rely on their EU-based customers to do so. Only Representatives are commonly referred to by the acronym “OR”. Registrations are submitted to the European Chemicals Agency (ECHA)
Bearing in mind that the cost and burden of registering can be daunting, the EU exempted a limited number of substances from the registration requirement. These exemptions apply to:
There are two aspects to the REACH evaluation process: dossier evaluation and substance evaluation.
For dossier evaluation, ECHA is statutorily required to perform a compliance check on at least 5% of the dossiers submitted for registration. Dossier evaluation focuses on completeness and quality of information. ECHA will notify the registrant of any deficiencies.
For substance evaluation, each year ECHA and the EU Member States select 30 chemical substances for placement on the “Community Rolling Action Plan”, commonly referred to as “CoRAP”, for further evaluation. The Members States focus on those chemical substances that are manufactured/imported in large quantities and which are persistent and prone to bioaccumulation.
Each Member State has a designated agency that performs the evaluation; it is not performed by ECHA. Chemical substances placed on the CoRAP may eventually be subject to authorization or restriction.
U.S. companies that wish to export or use within the EU chemical substances identified as a “substance of very high concern” (SVHC) must ensure that a use-authorization has been obtained. The policy objective of this requirement is to ensure adequate control and progressive replacement of these substances.
The restriction is another means under REACH that allows the European Commission to control the use of dangerous chemical substances circulated within the common market. Any chemical substance on its own, in a preparation or in an article may be subject to EU-wide use restrictions that limit or prohibit its production or use.
REACH's effect on companies:
REACH impacts on a wide range of companies across many sectors, even those who may not think of themselves as being involved with chemicals.
In general, under REACH you may have one of these roles:
Manufacturer: If you make chemicals, either to use yourself or to supply to other people (even if it is for export), then you will probably have some important responsibilities under REACH.
Importer: If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be individual chemicals, mixtures for onwards sale or finished products, like clothes, furniture or plastic goods.
Downstream users: Most companies use chemicals, sometimes even without realising it, therefore you need to check your obligations if you handle any chemicals in your industrial or professional activity. You might have some responsibilities under REACH.
Companies established outside the EU: If you are a company established outside the EU, you are not bound by the obligations of REACH, even if you export their products into the customs territory of the European Union. The responsibility for fulfilling the requirements of REACH, such as registration lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union.
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