Comply with REACH
How to comply with REACH
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 1 ton 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 1 ton per year for the first time after 1st December 2008 can submit a late pre-registration (LPR);
•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 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.
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 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
suppliers/importers shall register substances in articles if the
substances are intended to be released during normal and reasonable
foreseeable conditions of use and the total amount of the substance
present in the articles with intended releases exceeds 1 tonne per year.
For example, ink in a marker or paint in a tube needs to be registered;
In such situation the substance specific requirements for the substance
in article – and similar deadlines for registration is applicable for
pre-registration, Late pre-registration may yet be possible in specific
cases – Please contact us for further advise.
• Substance Identification: Article suppliers or article importers shall identify possible Substance of Very High Concern (SVHC) and restricted substances in their product. They may do so by SVHC assessments followed by selective testing by themselves or asking their suppliers to so.
• Communication Requirement: If a SVHC is present in the article with a concentration above 0.1% (w/w), article suppliers and importers are obliged to inform the recipients of the article along the supply chain about the chemical name(s) and how the article can be safely used. REACH further requires this information be made available within 45 days upon consumer request;
• Notification: Notification to European Chemical Agency (ECHA) is required if any SVHC present in the article has a concentration above 0.1% (w/w) and the total amount of the SVHC exceeds 1 tonne per annum per producer or importer. The SVHC candidate list will be regularly updated from time to time.
• Authorization: Those listed SVHCs in Annex XIV of REACH will not be allowed to be used, placed on the market or imported into the EU after a date to be set unless the company is granted an authorization