The definition of substance with REACH legal text is ‘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’
Every substance manufactured or imported in the quantities more than 1 tonne per annum needs to be pre-registered / registered with the European Chemical Agency (ECHA) and it can be done by the European legal entity.
If you are manufacturer within the European community then you can pre-register / register using your company details.
If you are a importer then you can also pre-register / register by your self otherwise buy the substances from the REACH complaint non European companies
If you manufacture outside the European countries and export to you Europe, the REACH compliance can be achieved with the help of Only Representative (OR).
Companies who import/manufacture/export substances exceeding 1 ton per year for the first time after 1st December 2008 can complete a Late Pre Registration;
Non-EU companies generally need to appoint an Only Representative to submit (pre-) registrations to ECHA because only EU-based legal entities are allowed to pre-register and subsequently register;
Non-EU companies are obligated to inform their EU importers of the appointment of the Only Representative; EU buyer (Importer) will also request a certificate of Reach Compliance from you OR;
Non-EU companies are required to provide Safety Data Sheet (SDS) according to REACH and CLP standards at the first delivery of a substance or preparation if the substances or preparations meet the criteria for classification as dangerous;
Non-EU companies may fulfill more obligations such as authorization and restriction, etc;