Guidance = Documents

The list below contains all the Guidance Documents which are = available, or=20 will be available, on this website. These documents have been developed = with the=20 participation of many stakeholders (Industry, Member States and NGOs) = within=20 projects managed by the Commission. The objective of these documents is = to=20 facilitate the implementation of REACH by describing good practice on = how to=20 fulfil the obligations.

Some parts of these documents have been or will be translated in all = the=20 European Community languages.

Guidance on the different = processes under=20 REACH

Guidance mainly for = Industry Use

Guidance on registration
Reference name: = Guidance=20 on registration
This document = describes when=20 and how to register a substance under REACH. It consists of two parts: = one on=20 Registration tasks and obligations and the other on the preparation of = the=20 Registration Dossier.
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Guidance on pre-registration
Reference name:=20 Guidance on pre-registration
This document describes = how to=20 identify the substances that can be
pre-registered as well as when = and how to=20 pre-register them.
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Guidance on data sharing
Reference name: = Guidance=20 on data sharing
This document describes data sharing = mechanisms for=20 phase-in and non phase-in substances under REACH. It includes the = communication=20 within the SIEF and the cost sharing guidance. The document also = describes the=20 Confidential Business Information and Competition Law issues in the = context of=20 data sharing.
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Guidance for intermediates =
Reference=20 name: Guidance for intermediates
This document = describes when=20 and how the specific provisions for the registration of intermediates = under=20 REACH can be used.
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Guidance for monomers and polymers
Reference = name:=20 Guidance on polymers
This document describes the = specific=20 provisions for polymers and monomers under REACH.
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Guidance on Scientific Research and Development (SR&D) = and=20 Product and Process Oriented Research and Development=20 (PPORD)
Reference name: Guidance on = PPORD
This=20 document describes specific provisions under REACH for substances = manufactured,=20 imported or used in scientific Research and Development (SR&D) = and=20 Product and Process Oriented Research and Development (PPORD).
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Guidance on Classification and Labelling = notification=20
Reference name: Guidance on C&L = notification
This=20 document describes when and how to notify a classification and labelling = for a=20 substance under REACH.
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Guidance on requirements for substances in=20 articles
Reference name: Guidance for=20 articles
This document assists producers and importers of = articles=20 in identifying whether they have obligations under REACH; in particular = in=20 relation to registration and notification according to Article 7, and in = relation to article supply chain communication according to Article 33. =
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Guidance for Downstream Users
Reference name:=20 Guidance for Downstream Users
This document describes = the=20 roles and obligations of downstream users, and advises them on how to = prepare=20 for the implementation for REACH.
[ download=20 full PDF document ]

Guidance on the preparation of an application for=20 authorisation
Reference name: Guidance on = authorisation=20 application
This document describes how to prepare an = application=20 for authorisation and provides guidance on analysis of the alternatives = and=20 substitution plan. It also describes how third parties may prepare and = submit=20 information on alternatives.
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Guidance mainly for = Authorities=20 Use

Guidance on Dossier and Substance = Evaluation
Reference=20 name: Guidance on evaluation
This document describes = the=20 evaluation tasks to be performed by the Authorities: evaluation of = testing=20 proposals and compliance check by the Agency and substance evaluation by = the=20 Member States Competent Authorities.
[ download full PDF document 3D"pdf ]

Guidance for the preparation of an Annex XV Dossier on = Harmonised=20 Classification and Labelling
Reference name: Guidance = on=20 Annex XV for C&L
This document describes how Member = States=20 Competent Authorities can prepare an Annex XV dossier for a Harmonised=20 Classification and Labelling proposal under REACH.
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Guidance for the preparation of an Annex XV dossier on the=20 identification of substances of very high concern
Reference = name:=20 Guidance on identification of SVHC
This document = describes=20 how the authorities (Member States Competent Authorities or the Agency) = can=20 prepare an Annex XV dossier to identify a substance of very high = concern.
[=20 download full PDF document 3D"pdf ]

Guidance on inclusion of substances in Annex XIV (substances = subject=20 to Authorisation)
Reference name: Guidance on Annex = XIV=20 inclusion
This document describes how the authorities (the = Agency=20 in co-operation with the Member States Competent Authorities) will = include=20 substances in the authorisation system. Guidance is given on the = elaboration of=20 the dossier that supplements each recommendation of a substance for = inclusion in=20 Annex XIV.
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Guidance for the preparation of an Annex XV dossier for = restrictions=20
Reference name: Guidance on Annex XV for=20 restrictions
This document describes how the authorities = (Member=20 States Competent Authorities or the Agency on request from the = Commission) can=20 prepare an Annex XV dossier to propose a restriction under REACH.
[ = download full PDF document 3D"pdf ]

Guidance on the different = methods=20 under REACH

Guidance for identification and naming of substances in REACH =
Reference name: Guidance on substance=20 identification
This document describes how to name and = identify a=20 substance under REACH.
[ download full PDF document 3D"pdf ]

Guidance on how to comply with the provisions of the new = Regulation=20 on Classification, Packaging and Labelling of substances and=20 mixtures
Reference name: Guidance on Classification,=20 Packaging and Labelling
This document aims to assist = industry and=20 authorities to implement the new GHS criteria within the EU which are = based on=20 the UN Globally Harmonised System for the Classification and Labelling = of=20 chemicals (GHS) and to fulfil the relevant procedures.
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Guidance for the preparation of the Chemical Safety Report=20
Reference name: Guidance on Chemical Safety=20 Report
This document aims at assisting industry in = conducting=20 Chemical Safety Assessments and preparing Chemical Safety Reports, when=20 required, as part of a registration dossier (for a substance on its own = or as=20 part of a preparation or as released from an article), as part of an=20 authorisation application or as part of downstream user obligations. It = also=20 sets out the basic principles for authorities preparing a risk = assessment in=20 support of a restriction proposal, and when required as part of a = Substance=20 Evaluation.
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Guidance on information requirements under=20 REACH
Reference name: Guidance on information=20 requirements
This document provides guidance on the = collection and=20 assessment of the available information on the intrinsic properties of = the=20 substances to be registered, on the requirements specified by REACH, on = the=20 identification of data gaps and on the generation of the additional = information=20 required to comply with the Regulation.
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Guidance on Socio Economic Analysis
Reference = name:=20 Guidance on Socio Economic Analysis
This = document=20 assists the different actors in preparing a socio-economic analysis or = input for=20 one as part of the Authorisation and Restriction procedures.
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Guidance on priority setting for = evaluation
Reference=20 name: Guidance on priority setting for = evaluation
This=20 document describes the different priority setting methods developed to=20 prioritise dossiers, testing proposals or substances for evaluation and = gives=20 guidance for the Agency and the Member States Competent Authorities on = the=20 application of these methods.
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Guidance on IUCLID
Reference name: = Guidance on=20 IUCLID
This document describes how to use IUCLID 5 and how = to=20 prepare the dossiers for different REACH requirements.
[ download full PDF document 3D"pdf ]