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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 Certificate of Compliance from the only representative. Click here to find more REACH compliance tips for EU importers;
  • EU importers shall ask for or prepare the latest Safety Data Sheets according to REACH and CLP regulation if the substances or preparations meet the criteria for classification as hazardous;
  • M/I shall communicate information about the safe use of chemicals (risk management measures) along the supply chain in the format of SDS/exposure scenario;
  • M/I may fulfill more obligations such as authorization and restriction under REACH.

Please note: Companies also need to comply with CLP regulation.

Advice for Non-EU chemical Companies

  • 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';
  • 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 register;
  • Non-EU companies are obligated to inform their EU importers of the appointment of the Only Representative;
  • Non-EU companies are required to provide Safety Data Sheets 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;
  • Non-EU companies may transfer only representative if they are unhappy with the current only representative;

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.

  • 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;
  • Downstream users shall ask for REACH & CLP compliant SDSs from their suppliers and follow corresponding risk management measures.

Advice for Article Suppliers and Importers

  • Registration: Article 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;
  • Substance Identification: Article suppliers or article importers shall identify possible substances of very high concern(SVHC) and restricted substances in their product. They may do so by carrying out testing by themselves or asking their suppliers to carry out testing.
  • 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;

Contact

  • Europe Office
    Unit 1 Ardee Business Park, Hale Street, Ardee, Co. Louth, Ireland
    Tel : +353 41 9806 916 | Fax : +353 41 9806 999
    Email: service@cirs-reach.com