Registration, Evaluation, Authorisation and Restriction of Chemicals [REACH]

Guidance Documents

The list below contains all the Guidance Documents which are available, or will be available, on this website. These documents have been developed with the participation of many stakeholders (Industry, Member States and NGOs) within projects managed by the Commission. The objective of these documents is to facilitate the implementation of REACH by describing good practice on how to fulfil the obligations.

Some parts of these documents have been or will be translated in all the European Community languages.

Guidance on the different processes under REACH

Reach Directive-EC1907-2007

Guidance Mainly for Industry Use

Guidance on registration

Reference name: Guidance on registration

This document describes when and how to register a substance under REACH. It consists of two parts: one on Registration tasks and obligations and the other on the preparation of the Registration Dossier.

[ download full PDF document ] ( Updated 26/05/08 )

Guidance on pre-registration

Reference name: Guidance on pre-registration

This document describes how to identify the substances that can be pre-registered as well as when and how to pre-register them.

[ download full PDF document ]

See also the new ECHA web site on pre-registration

Guidance on data sharing

Reference name: Guidance on data sharing

This document describes data sharing mechanisms for phase-in and non phase-in substances under REACH. It includes the communication within the SIEF and the cost sharing guidance. The document also describes the Confidential Business Information and Competition Law issues in the context of data sharing.

[ download full PDF document ]

Guidance for intermediates

Reference name: Guidance for intermediates

This document describes when and how the specific provisions for the registration of intermediates under REACH can be used.

[ download full PDF document ] ( Updated 18/02/08 )

Guidance for monomers and polymers

Reference name: Guidance on polymers

This document describes the specific provisions for polymers and monomers under REACH.

[ download full PDF document ] ( Updated 29/05/08 )

Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD)

Reference name: Guidance on PPORD

This document describes specific provisions under REACH for substances manufactured, imported or used in scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD).

[ download full PDF document ] ( Updated 18/02/08 )

Guidance on Classification and Labelling notification

Reference name: Guidance on C&L notification

This document describes when and how to notify a classification and labelling for a substance under REACH.

[ download full PDF document ]

Guidance on requirements for substances in articles

Reference name: Guidance for articles

This document assists producers and importers of articles in identifying whether they have obligations under REACH; in particular in relation to registration and notification according to Article 7, and in relation to article supply chain communication according to Article 33.

[ download full PDF document ] ( 26/05/08 )

The dissenting views of some member states on this guidance document are available for information.

[ download PDF document ]

Guidance for Downstream Users

Reference name: Guidance for Downstream Users

This document describes the roles and obligations of downstream users, and advises them on how to prepare for the implementation for REACH.

[ download full PDF document ] ( Updated 29/01/08 )

Guidance on the preparation of an application for authorisation

Reference name: Guidance on authorisation application

This document describes how to prepare an application for authorisation and provides guidance on analysis of the alternatives and substitution plan. It also describes how third parties may prepare and submit information on alternatives.

[ download full PDF document ]

Guidance on Socio-Economic Analysis – Authorisation

Reference name: Guidance on Socio-Economic Analysis - Authorisation

This document assists applicants making an application for an authorisation to prepare a socio-economic analysis. Further, it assists interested parties in providing information related to socio-economic impacts during the handling of the application.

[ download full PDF document ]

Guidance Mainly for Authorities Use

Guidance on Dossier and Substance Evaluation

Reference name: Guidance on evaluation

This document describes the evaluation tasks to be performed by the Authorities: evaluation of testing proposals and compliance check by the Agency and substance evaluation by the Member States Competent Authorities.

[ download full PDF document ]

Guidance for the preparation of an Annex XV Dossier on Harmonised Classification and Labelling

Reference name: Guidance on Annex XV for C&L

This document describes how Member States Competent Authorities can prepare an Annex XV dossier for a Harmonised Classification and Labelling proposal under REACH.

[ download full PDF document ]

Guidance for the preparation of an Annex XV dossier on the identification of substances of very high concern

Reference name: Guidance on identification of SVHC

This document describes how the authorities (Member States Competent Authorities or the Agency) can prepare an Annex XV dossier to identify a substance of very high concern.

[ download full PDF document ]

Guidance on inclusion of substances in Annex XIV (substances subject to Authorisation)

Reference name: Guidance on Annex XIV inclusion

This document describes how the authorities (the Agency in co-operation with the Member States Competent Authorities) will include substances in the authorisation system. Guidance is given on the elaboration of the dossier that supplements each recommendation of a substance for inclusion in Annex XIV.

[ download full PDF document ]

Guidance for the preparation of an Annex XV dossier for restrictions

Reference name: Guidance on Annex XV for restrictions

This document describes how the authorities (Member States Competent Authorities or the Agency on request from the Commission) can prepare an Annex XV dossier to propose a restriction under REACH.

[ download full PDF document ]

Guidance on Socio-Economic Analysis - Restrictions

Reference name: Guidance on Socio-Economic Analysis - Restrictions

This document assists Member State Competent Authorities and the Agency (on a request from the Commission) in preparing and using a socio-economic analysis when developing an Annex XV dossier for Restriction. Further, it assists interested parties in preparing a socio-economic analysis or providing information in order to contribute to one.

[ download full PDF document ] ( Updated 05/05/08 )

Guidance on the different methods under REACH

Guidance for identification and naming of substances in REACH

Reference name: Guidance on substance identification

This document describes how to name and identify a substance under REACH.

[ download full PDF document ]

Guidance on how to comply with the provisions of the new Regulation on Classification, Packaging and Labelling of substances and mixtures

Reference name: Guidance on Classification, Packaging and Labelling

This document aims to assist industry and authorities to implement the new GHS criteria within the EU which are based on the UN Globally Harmonised System for the Classification and Labelling of chemicals (GHS) and to fulfil the relevant procedures.

[ download full PDF document ]

Guidance on information requirements and chemical safety assessment

Reference name: Guidance on information requirements and chemical safety assessment

This package of documents provides guidance on the collection and assessment of the available information on the intrinsic properties of the substances to be registered, on the requirements specified by REACH, on the identification of data gaps and on the generation of the additional information required to comply with the Regulation. The documents also aim at assisting industry in conducting Chemical Safety Assessments and preparing Chemical Safety Reports, when required, as part of a registration dossier (for a substance on its own or as part of a preparation or as released from an article), as part of an authorisation application or as part of downstream user obligations. It also sets out the basic principles for authorities preparing a risk assessment in support of a restriction proposal or a proposal to include substances into the authorisation regime, and when required as part of a Substance Evaluation.

[ download full PDF document ] ( Updated 29/05/08 )

Guidance on priority setting for evaluation

Reference name: Guidance on priority setting for evaluation

This document describes the different priority setting methods developed to prioritise dossiers, testing proposals or substances for evaluation and gives guidance for the Agency and the Member States Competent Authorities on the application of these methods.

[ download full PDF document ]

Guidance on IUCLID

Reference name: Guidance on IUCLID

This document describes how to use IUCLID 5 and how to prepare the dossiers for different REACH requirements.

[ download full PDF document ]