(Regulation (EC) No 1907/2006)
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is an EU regulation that came into force on 1 June 2007 creating one single system for regulation of chemicals.
Under REACH a manufacturer or importer of a substance into the EU, in quantities of 1 tonne or more per year, must register their substance with ECHA.
Only legal entities based in Europe can register. Non European companies must appoint an ‘Only Representative' if they register under their own name. European companies can appoint Third Party Representative if they wish to maintain confidentiality and identity.
REACH registration involves: the submission of toxicological and eco-toxicological information; risk assessment; decisions on how to manage identified risk; and proposals for classification and labelling. It is also likely to include CSR with exposure scenarios and guidance for safe use.
The deadline for registering depends upon the type and quantity of substance that needs to be registered. There are various tonnage bands under with a substance can be registered.
ECHA (European Chemical Agency) introduced scheme of extended registration deadline by prioritizing substance registration based on tonnage and toxicity.
The process begins with a declaration known as a pre-registration, which is made to ECHA. By 1 December 2008 all companies manufacturing or importing a substance into the EU at 1 tonne or more per annum and who wished to take advantage of the extended registration deadline scheme should have pre-registered that substance with ECHA.
Potential registrants who manufacture or import for the first time a phase-in substance in quantities of one tonne or more per year after 1 December 2008, can submit a late pre-registration if they met both criteria
- At the latest 6 months after manufacturing or importing a substance above the 1 tonne threshold per year; and
- At least 12 months before the relevant transitional deadline for registration.
Once late pre-registered manufacturers/importers can take advantage of the phased deadlines set by ECHA for registration.