Registration dossier/technical dossier

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Requirements concerning the registration dossier
Source: IFA

A registration dossier always contains a technical dossier. Should you manufacture or import a substance in quantities of ten tons or more per year, your registration dossier must be accompanied by a chemical safety report.

The registration dossier must be created by means of the IUCLID software and submitted to ECHA from a REACH-IT account.

Technical dossier

The technical dossier contains information and data on the substance to be registered and information on risk management measures.

Article 10 and Annex VI of the REACH Regulation set out the minimum requirements for the information to be provided in the technical dossier. This includes:

  • the identity of the manufacturer or importer, general information on the registrant ;
  • identification of the substance;
  • information on manufacture and use(s), including by downstream users (Annex VI, Section 3);
  • classification and labelling of the substance ;
  • guidance on safe use of the substance(Annex VI, Section 5);
  • summaries of study reports on physicochemical properties, toxicology and ecotoxicology (REACH, Article 12).

Further requirements for information are graded according to the quantities produced or imported per year. You can find them in Annexes VII to X of the REACH Regulation:

Annual quantity Annex
1 ton or more VII
10 tons or more VIII
100 tons or more IX
1,000 tons or more X