Any substance produced or imported by a manufacturer or importer in a quantity exceeding one tonne per year is subject to registration. This means that every company based in the EU that manufactures or imports chemical substances in or into the EU in quantities exceeding one tonne per year is bound by this obligation.
Importers of mixtures (e.g. paints, varnishes, adhesives, cleaning agents, etc.) are also bound by the registration obligation. Thus, when importing mixtures into the EU, each ingredient contained that exceeds the tonnage threshold of one tonne per year must be registered by the importer.
If, on the other hand, a company produces a mixture within the EU that comprises different substances, it is not bound by the registration obligation – unless a new substance, within the meaning of chemicals laws, is produced in the mixture. Under the terms defined by the REACH Regulation, such a "formulator" of mixtures is a downstream user and not a manufacturer.
Each manufacturer or importer is fundamentally responsible for registering "their" chemical substance. The companies concerned are, however, required to combine forces in so-called consortia and jointly register the substance where the individual substances are the same. In principle, it should be noted that the registration obligation applies to each individual legal entity: If, for example, several companies within the same group produce or import the same substance in a quantity greater than one tonne per year, each "individual company", as a separate legal entity, is formally subject to the registration obligation!
- The obligation to register substances lies with the manufacturers and importers. REACH does not provide for any registration by a downstream user. This regulation essentially serves to protect the downstream user.
- The downstream user is equally not permitted to register or pre-register substances in place of their supplier. It is the manufacturer’s or importer’s duty to comply with this obligation if they wish to continue to be allowed to bring their substances and mixtures to market.
- If a downstream user has pre-registered a substance, they cannot transfer the resulting benefits to their supplier.
- If they intend to manufacture or import a phase-in substance themselves after 1 December 2008, they may avail of the extended registration obligations by pre-registering after this date (Article 28(6)).
- Downstream users may provide information to support the preparation of a registration.