Data Submission Manuals

The aim of the Data Submission Manuals (DSMs) is to support industry to prepare and create IUCLID dossiers and to submit notifications, inquiries, registrations, requests and claims using REACH-IT. Step-by-step instructions for completing the process of each submission are provided in the manuals alongside overviews of the processes, concepts, and legal contexts involved. The manuals are not in sequential order because some older manuals have been removed from the DSM series.

The current manuals will not be valid from 21 June onwards due to the new release of IUCLID 6 and the new version of REACH-IT. The new manuals can then be found at the new Manuals page.

 

DSM 1: How to prepare and submit a PPORD notification

 

Description

This manual gives instructions on how to prepare, create and update a PPORD notification using IUCLID and how to submit a PPORD dossier in REACH-IT. The manual also outlines the importance of the reference substance inventory and EC inventory for creating a substance dataset in IUCLID. The manual highlights how these steps require you to install IUCLID and to create a legal entity during or after the installation of IUCLID.

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Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare registration and PPORD dossiers.

You can already access the relevant manual for creating dossiers using IUCLID6:

 

DSM 2: How to prepare and submit an inquiry dossier

 

Description

This manual gives instructions on how to prepare, create and update an inquiry using IUCLID and how to submit an inquiry dossier in REACH-IT. The manual also outlines the importance of the reference substance inventory and EC inventory for creating a substance dataset in IUCLID. These steps require you to install IUCLID and to create a legal entity either in IUCLID or REACH-IT.

Download full PDF document

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Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare an inquiry dossier.

You can already access the relevant manual for creating dossiers using IUCLID6:

 

DSM 4: How to pass business rule verification ("Enforce Rules")

 

Description

This manual aims to provide a Business Rule Navigator to help industry users pass the initial business rules step performed by ECHA which checks and screens all incoming dossiers. The manual gives detailed guidance on the most crucial aspects of preparing and creating a dossier which must be completed correctly for the dossier to pass the business rules check as well as giving a basic understanding of business rules verification as distinct from the technical completeness check.

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Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare registration and PPORD dossiers.

You can already access the relevant manual for creating dossiers using IUCLID6:

 

DSM 5: How to complete a technical dosser for registrations and PPORD notifications

 

Description

This manual aims to guide industry users in the preparation and creation of PPORD and registration dossiers to pass the technical completeness check (TCC). The manual highlights what IUCLID sections must be completed for the different dossier types in order for a TCC to be passed and the importance of the Validation Assistant plug-in. The manual also provides guidance on the re-submission of dossiers which have failed the TCC and updates to dossiers which have to undergo another TCC.

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Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare registration and PPORD dossiers.

You can already access the relevant manual for creating dossiers using IUCLID6:

 

DSM 12: How to prepare and submit a classification and labelling notification using IUCLID

 

Description

 

The manual gives instructions on how to use IUCLID for preparing, creating and updating a Classification and Labelling (C&L) notification and how to submit this type of C&L notification in REACH-IT. The manual briefly outlines two other means of preparing and submitting a C&L notification using either the bulk XML tool or using the C&L notification tool online. The manual also shows how to transfer a Legal Entity Object between the IUCLID website and REACH-IT using an LEO XML file.

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Languages
 

 

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Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare a classification and labelling notification.

You can already access the relevant manual for creating dossiers using IUCLID6:

 

DSM 14: How to prepare and submit a request for use of an alternative chemical name for a substance in mixture using IUCLID 5

 

Description

This manual aims to help industry to use IUCLID to prepare and create a request under the CLP Regulation for the use of an alternative chemical name for a substance in a mixture. The manual also shows how to submit this request in REACH-IT. The manual supports industry to update such requests as this requires additional information over and above that required in the initial request.

Download full PDF document

Languages
 

 

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Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare a request for use of an alternative chemical name for a substance in a mixture.

You can already access the relevant manual for creating dossiers using IUCLID6:

 

DSM 15: How to determine what will be published on the ECHA website from the registration dossier

 

Description

This manual outlines the process of disseminating information from an initial and completed REACH-IT submission. The manual also describes what a confidentiality claim is, what information can be claimed as confidential by a registrant, as well as listing what information is disseminated on ECHA's website and the eChem Portal.

Download full PDF document

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Additional annexes and templates
a.) Technical Annex for IUCLID sections 1, 2, 3
  1. General information
  2. Classification & Labelling and PBT assessment
  3. Manufacture, use and exposure

 

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b.) Technical Annex for IUCLID section 4

  1. Physical and chemical properties

 

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c.) Technical Annex for IUCLID section 5

  1. Environmental fate and pathways

 

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d.) Technical Annex for IUCLID section 6

  1. Ecotoxicological information

 

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e.) Technical Annex for IUCLID section 7

  1. Toxicological information

 

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f.) Technical Annex for IUCLID section 8, 11, 12, 13

  1. Analytical methods
  2. Guidance on safe use
  3. Literature search
  4. Assessment reports

 

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New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual Dissemination and confidentiality under the REACH Regulation.

You can already access the relevant manual for creating dossiers using IUCLID6:

 

DSM 16: Confidentiality claims: How to make confidentiality claims and how to write Art 119 (2) confidentiality claim justifications

 

Description

This manual describes when a confidentiality claim can be made, information about the fees charged for a claim, and the process for preparing and making a claim. The manual outlines the legal basis for ECHA's assessment of confidentiality claims and the process which ECHA follows during the assessment. The manual also recommends how to justify and write a confidentiality claim and the criteria for what these recommendations are based on.

Download full PDF document

Languages
 

 

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  • lt
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Additional annexes and templates
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual Dissemination and confidentiality under the REACH Regulation.

You can already access the relevant manual for creating dossiers using IUCLID6

 

DSM 17: How to derive a public name for a substance for use under the REACH Regulation

 

Description

 

This manual advises industry users on how to create a suitable public name for a substance where the IUPAC name is claimed as confidential in a registration dossier.

Download full PDF document

Languages
 
Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual Dissemination and confidentiality under the REACH Regulation.

You can already access the relevant manual for creating dossiers using IUCLID6:

 

DSM 18: How to report the substance identity in IUCLID 5 for registration under REACH

 

Description

This manual outlines what substance identity is and how to identify a substance. The manual also gives instructions on how to report and manage substance identification in a IUCLID dossier and gives specific answers to common questions on this process. The manual also clarifies the role of REACH-IT in the verification of a substance identity.

Download full PDF document

Languages
 

 

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  • lt
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  • pt
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Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare registration and PPORD dossiers.

You can already access the relevant manual for creating dossiers using IUCLID6:

Please note that some of the Questions and Answers (Q&As) included in DSM 18 have been transferred to ECHA's Q&A support web pages. Please check the Q&As with IDs 1154-1160.

 

DSM 19: How to submit a chemical safety report as part of a joint submission

 

Description

This manual guides registrants (whether submitting as a lead or a co-registrant) on how to prepare and submit a chemical safety report.

Download full PDF document

Languages
 
Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare registration and PPORD dossiers and the revised Guidance on Information Requirements and Chemical Safety Assessment Part D: Framework for exposure assessment (available draft currently under consultation).

You can already access the relevant manual for creating dossiers using IUCLID6 and the Guidance document:

 

DSM 20: How to prepare and submit a substance in articles notification using IUCLID

 

Description

This manual guides industry users on how to prepare, create and submit a substance in articles notification to ECHA for substances found in the Candidate List of substances of very high concern. The manual also shows how to identify the substance and which IUCLID fields are of prime importance to increase the likelihood of a successful submission. The manual is structured to cater for different levels of experience and expertise in using IUCLID.

Download full PDF document

Languages
 

 

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Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare a substance in articles notification.

You can already access the relevant manual for creating dossiers using IUCLID6:

 

DSM 21: How to prepare and submit a downstream user report using IUCLID 5

 

Description

This manual describes the scenarios when a downstream user will prepare a chemical safety report and when the chemical safety report does not need to be created. The manual shows how to prepare, create and submit a chemical safety report as a downstream user and which IUCLID fields are of prime importance to increase the likelihood of a successful submission.

Download full PDF document

Languages
 

 

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Additional annexes and templates
 Template on conditions of use [PDF] [EN]
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare a downstream user report.

You can already access the relevant manual for creating dossiers using IUCLID6:

 

DSM 22: How to prepare and submit an application for authorisation

 

Description

This manual gives an overview as well as detailed guidance on how to prepare, create and submit an application for authorisation to ECHA. The manual concentrates on the IUCLID sections and fields that need to be filled in by the applicant and is structured to cater for different levels of experience and expertise in using IUCLID.

Download full PDF document

Languages
 

 

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  • lt
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  • nl
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  • pt
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Additional annexes and templates
 
New manual

After the launch of REACH-IT 3 on 21 June 2016, this manual will be replaced by the manual How to prepare an application for authorisation.

You can already access the relevant manual for creating dossiers using IUCLID6:

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