Substance in Articles

How to comply with REACH
Substances, preparations ("mixtures") and articles are subject to different provisions under REACH. Meanwhile, non-EU companies and EU companies have different obligations

Advice for EU Manufacturers(M)/Importers(I) of Chemicals and Preparations

  • Prior to manufacture/import, M/I shall pre-register/register substances manufactured /imported over 1 ton per year with the European Chemical Agency (ECHA);
  • Companies who import/manufacture substances exceeding 1t per year for the first time after 1st December 2008 can complete a Late Pre Registration;
  • EU importers will be exempt from REACH registration if their non-EU suppliers have registered by appointing Reach Only Representative (OR); however, importers need to confirm with their suppliers' OR that they are on the inventory of importers and their tonnage and uses are covered by the registrations of OR. This can be done by asking for Reach Compliance Certificate from the only representative.
  • EU importers shall ask for the latest Safety Data Sheet (SDS) according to REACH and CLP standards if the substances or preparations meet the criteria for classification as dangerous;
  • Manufacturers and importers shall communicate information about the safe use of chemicals (risk management measures) along the supply chain in the format of SDS/exposure scenario;
  • Manufacturers and importers may fulfill more obligations such as authorization and restriction under REACH.
  • Prior to exporting their substance to the EU, non-EU companies need to pre-register or register their substance with the European Chemical Agency if the quantity of the substance exported into the EU exceeds 1 ton per year (unless their importers have registered);
  • Non-EU Companies who export their substance to the EU with the volume of the substance exceeding 1t per year for the first time after 1st December 2008 can submit a late pre-registration (LPR);
  • Non-EU companies generally need to appoint an Reach Only Representative to submit (pre-) registrations to ECHA because only EU-based legal entities are allowed to 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;

Advice for Downstream Users (DU)

A downstream user is any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. If non-EU suppliers have appointed a REACH Only Representative, EU importers covered by the OR will be regarded as Downstream Users.
  • Downstream users of substances generally do not have registration obligations;
  • Downstream users have the right to make their uses known to their suppliers, so that the suppliers can include these uses in their chemical safety assessments as “identified uses" as part of registration dossier;
  • Downstream users must prepare their own chemical safety reports (including the development of exposure scenarios) if their use is not included in the registration dossier;