REACH registration dossiers
REACH registration dossiers bring together the technical information and safety assessment needed for chemical substances in the European Union. Their content depends on the substance's registration status and tonnage, and their preparation combines study summaries, hazard and exposure assessment, and electronic submission.
Registration and exemptions
REACH means Registration, Evaluation, Authorisation and restriction of Chemicals. EU manufacturers and importers must register non-exempt chemical substances manufactured or imported at one tonne per year or more. Exemption criteria are in Article 2 and Annexes IV and V, and deciding whether an exemption applies is not always straightforward. Technical writers are usually approached after the non-exemption decision has been made.
The European Chemicals Agency (ECHA), based in Helsinki, handles REACH dossiers and publishes guidance, factsheets, practical guides, webinars and manuals on their format and data summaries.
The regulation's seventeen annexes address the following subjects.
| Annex | Subject |
|---|---|
| I | General provisions for the chemical safety report |
| II | Requirements for compiling safety data sheets |
| III | Criteria for substances registered at 1–10 tonnes per year |
| IV | Registration exemptions under Article 2(7)(a) |
| V | Registration exemptions under Article 2(7)(b) |
| VI | Registration information required under Article 10 |
| VII | Standard information requirements at 1 tonne or more |
| VIII | Standard information requirements at 10 tonnes or more |
| IX | Standard information requirements at 100 tonnes or more |
| X | Standard information requirements at 1,000 tonnes or more |
| XI | Rules for adapting the standard testing regime in Annexes VII–X |
| XII | General provisions for the downstream user's chemical safety report |
| XIII | Criteria for identifying persistent, bioaccumulative and toxic, and very persistent, very bioaccumulative substances |
| XIV | Substances subject to authorisation |
| XV | Dossiers |
| XVI | Socioeconomic analysis |
| XVII | Restrictions on manufacture, placing on the market and use of substances, mixtures and articles |
Annexes are amended as legal interpretations develop and controls on chemicals change.
Dossier components and tonnage
A registration dossier consists of a technical dossier and, at ten tonnes per year or more, a chemical safety report. Higher tonnage requires more test data and hazard and use assessment. The applicable annexes increase by tonnage band.
| Tonnes per year | VI | VII | VIII | IX | X | XI |
|---|---|---|---|---|---|---|
| 1 to below 10 | Yes | Yes, with Annex III | — | — | — | Yes |
| 10 to below 100 | Yes | Yes | Yes | — | — | Yes |
| 100 to below 1,000 | Yes | Yes | Yes | Yes | — | Yes |
| 1,000 or more | Yes | Yes | Yes | Yes | Yes | Yes |
Technical dossier
The technical dossier contains the following information.
- Identity of the manufacturer or importer.
- Identity of the substance and information on its manufacture and use.
- Classification and labelling of the substance.
- Guidance on safe use.
- Study summaries or robust study summaries of intrinsic-property information derived from Annexes VII–XI.
- Whether an assessor has reviewed the manufacture-and-use information, classification and labelling, study summaries or, where relevant, chemical safety report.
- Proposals for further testing, where relevant.
For registrations in the 1–10-tonne band, the technical dossier also includes exposure-related information: main use categories, types of use and significant exposure routes. ECHA's registration guidance explains the templates, information selection, level of detail and type of summary required.
Chemical safety report
The chemical safety report documents four aspects of the substance.
- Intrinsic properties and hazards.
- Manufacturing and use conditions needed to control risks to human health and the environment throughout the substance's life cycle.
- Expected human and environmental emissions and exposure from manufacture and use throughout that life cycle.
- Characterisation of the resulting risks.
The chemical safety assessment forms part of the report: it summarises available environmental and human-health hazard information and, where required, assesses exposure and risk to demonstrate control under specified operational conditions and risk-management measures. Annex I, Section 7 sets out general provisions for the report.
The report should be understandable on its own, documenting the principles, assumptions and conclusions of hazard and exposure assessments and including the key data so that readers need not consult the underlying substance dataset. It may be submitted separately or jointly with other applicants covering the substance's uses.
Electronic format and completeness
The technical dossier must use the International Uniform Chemical Information Database (IUCLID) format under Article 111. IUCLID captures, stores, submits and exchanges substance data using Organisation for Economic Co-operation and Development harmonised templates; other software may prepare the dossier if it produces exactly the same format.
Dossiers are submitted through ECHA's REACH-IT portal. Completeness checking has two parts.
- A technical check that the required information is present.
- A financial check that the fee has been paid.
ECHA recommends using the IUCLID Validation Assistant on both the dataset and final dossier before submission.
Preparation for dossier writing
ECHA provides sample dossiers, practical guides on robust study summaries, weight of evidence and communication during evaluation, and an example chemical safety report for a fictitious substance. Its guidance also covers preparation of the chemical safety report and avoiding common deficiencies.
The overall structure, content and requirements resemble those of pharmaceutical dossiers, so experienced medical writers can develop REACH compilation and writing skills through study and topic-specific training. Courses taught by national dossier evaluators can provide an introduction, practice writing dossier sections and contacts for later questions.