How to prepare a substance in articles notification.
Date: 2016-10-25
Institutions: European Chemicals Agency
Subjects: administrative formalities, chemical element, chemical industry, chemical product, dangerous substance, data transmission, regulation (EU), toxic substance, user guide

How to prepare a 
substance in articles 
notification 

 
 
 
 
 
 
 
 
 
How to prepare a substance in articles 
notification 

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Version 1.0 

Changes to this document 

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Changes 

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Legal notice 

This document aims to assist users in complying with their obligations under the REACH 
Regulation. However, users are reminded that the text of the REACH Regulation is the only 
authentic legal reference and that the information in this document does not constitute legal 
advice. Usage of the information remains under the sole responsibility of the user. The 
European Chemicals Agency does not accept any liability with regard to the use that may be 
made of the information contained in this document. 

Reproduction is authorised provided the source is acknowledged. 

This is a working translation of a document originally produced in English. Please note that 
only the English version, also available on the ECHA website, is the original version. 

Title:  How to prepare a substance in articles notification 

Reference:  ECHA-16-B-16-EN 

Catalogue number: ED-01-16-384-EN-N 

ISBN: 978-92-9247-983-1 

DOI:  10.2823/52449 

Issue date:  April 2016 

Language:  EN 

© European Chemicals Agency, 2016 

Cover page © European Chemicals Agency 

Reproduction is authorised provided the source is fully acknowledged in the form 

“Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written 
notification is given to the ECHA Communication Unit (publications@echa.europa.eu). 

This document will be available in the following 23 languages: 

Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, 
Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, 
Slovenian, Spanish and Swedish 

If you have questions or comments in relation to this document, please send them to ECHA via 
the information request form at the address below, quoting the reference and issue date given 
above: 

http://echa.europa.eu/about/contact_en.asp 

European Chemicals Agency 

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland 

Visiting address: Annankatu 18, Helsinki, Finland 

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Table of Contents 

Changes to this document .......................................................................................................... 2 

Table of Contents ....................................................................................................................... 4 

Table of Figures ......................................................................................................................... 5 

1. 

Introduction ...................................................................................................................... 6 

1.1.  Objective ............................................................................................................................ 6 

1.2.  Overview of the preparation and the submission of a dossier ..................................................... 7 

1.3. 

Information requested for a Substance in Article notification ..................................................... 7 

1.4.  Checks performed by ECHA on the submitted dossiers .............................................................. 8 

1.4.1. 

The Validation assistant .................................................................................................... 8 

1.5.  The functionalities of IUCLID ................................................................................................. 8 

2. 

3. 

Legal entity ....................................................................................................................... 8 

Legal entity site ................................................................................................................ 9 

3.1.  Creating a Legal entity site .................................................................................................... 9 

4. 

Contact.............................................................................................................................. 9 

4.1.  Creating a contact .............................................................................................................. 10 

5. 

6. 

7. 

Downloading pre-filled substance datasets ..................................................................... 10 

Importing a Substance dataset to IUCLID ....................................................................... 10 

How to complete a dataset in IUCLID ............................................................................. 11 

7.1.  Section 1 General information .............................................................................................. 13 

7.1.1. 

Section 1.1 Identification ................................................................................................ 13 

7.1.2. 

Section 1.2 Composition ................................................................................................. 14 

7.1.3. 

Section 1.3 Identifiers .................................................................................................... 15 

7.2.  Section 2 C&L and PBT assessment ...................................................................................... 16 

7.2.1. 

Section 2.1 GHS ............................................................................................................ 16 

7.3.  Section 3 Manufacture use and exposure .............................................................................. 16 

7.3.1. 

Section 3.2 Estimated quantities ...................................................................................... 16 

7.3.2. 

Section 3.3 Sites ........................................................................................................... 17 

7.3.3. 

Section 3.5 Use and exposure information ........................................................................ 18 

7.3.3.1. 

Section 3.5.6 Service life ............................................................................................ 18 

8. 

How to create a Dossier .................................................................................................. 23 

8.1.  Administrative information .................................................................................................. 25 

8.1.1. 

Specific submissions ...................................................................................................... 25 

8.1.2.  Dossier specific information............................................................................................. 25 

9. 

How to export a Dossier .................................................................................................. 25 

10.  Submit Dossier ................................................................................................................ 26 

11.  Update Dossier ................................................................................................................ 26 

Annex 1.  Overview of the business rules checks performed by ECHA on the submitted 

dossiers .......................................................................................................................... 27 

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Table of Figures 

Figure 1:  Selecting the REACH Notification of substance in article template from the picklist 12 

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1.  Introduction 

1.1. 

Objective 

The purpose of this manual is to assist forthcoming notifiers in the preparation of a IUCLID 
Substance in Articles (SiA) notification dossier under the REACH Regulation (EC) No 
1907/2006. More precisely it outlines the IUCLID sections and fields to be further filled-in after 
downloading the substance datasets from the website of the European Chemicals Agency 
(ECHA), in order to prepare a complete SiA notification dossier according to Article 7 (2) of the 
REACH Regulation and submit it successfully. 

This manual assumes that IUCLID has been installed and you have a valid ECHA account. 

More information about the different functionalities in IUCLID and how to use those 
functionalities can be found in the help system built-in IUCLID (see chapter 1.5 
Functionalities of IUCLID). 

In order to help as much as possible potential notifiers, pre-filled IUCLID substance datasets 
are available in the Candidate List of substances of very high concern for Authorisation 
on ECHA website at the following address: http://echa.europa.eu/candidate-list-table. 

Those datasets have been pre-filled with basic information on substance identity, composition 
and classification. ECHA recommends potential notifiers to use them as a starting point. You 
should check and amend if necessary the information included and complete the rest of the 
required information following the instructions given in this manual.  

In principle, producers and importers of articles are required to prepare a SiA notification when 
all conditions of Article 7(2) of REACH are met:  

  The substance is included in the Candidate List of Substances of Very High Concern (SVHC) 

for authorisation (hereafter referred to as Candidate List); 

  The substance is present in articles produced and/or imported above a concentration of 

0.1% w/w; 

  The total amount of the substance present in all articles produced and/or imported, which 

contain more than 0.1% w/w of the substance exceeds 1 tonne per producer and/or 
importer per year. 

A Substance in Articles notification shall be made no later than 6 months after the substance 
has been included in the Candidate List. This obligation has been applicable since 1 June 2011 
for substances included in the Candidate List before 1 December 2010. 

Once a notification has been submitted, notifiers are strongly encouraged to keep their 
notification up-to-date. The notification can be updated in case the notified information 
changes (see chapter 11. Update dossier). 

One notification should concern one substance on the Candidate List. If articles you import or 
produce contain more than one of the substances on the Candidate List, you need to submit a 
separate notification for each substance. If several articles contain the same substance, you 
need to include them all in one notification. 

For more information on Substance in Article (SiA) notifications (Article 7(2) of REACH), 
please consult the dedicated ECHA webpage at 
http://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-
substances-in-articles 

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and the Guidance on requirements for substances in articles at: 
http://echa.europa.eu/guidance-documents/guidance-on-reach 

1.2. 

Overview of the preparation and the submission of a dossier 

A SiA notification IUCLID dossier is a non-editable snapshot file of the substance dataset for 
the Candidate List substance contained in your article. It contains the information to be 
submitted to ECHA. 

The steps below indicate the approach for the preparation of a IUCLID dossier for your SiA 
notification, when a pre-filled substance dataset is available on ECHA’s website: 

Step 1.  Sign-up in REACH-IT and create the Legal entity for the notifier (https://reach-

it.echa.europa.eu/), if necessary. 

Step 2.  Download the pre-filled substance dataset from ECHA’s website (see chapter 5). 

Step 3. 

Import the substance dataset to IUCLID (see chapter 6). 

Step 4.  Enter further information into the substance dataset in IUCLID (see chapter 7). 

Step 5.  Create a REACH notification of Substance in Article dossier in IUCLID (see chapter 

8). 

Step 6.  Export the notification dossier from IUCLID (see chapter 9). 

Step 7.  Submit the notification dossier to ECHA via REACH-IT (see chapter 10). 

In the rare cases where a substance dataset is not available in the Candidate List website, 
you can create one by following the Manual How to prepare registration and PPORD dossiers 
available at http://echa.europa.eu/manuals. 

1.3. 

Information requested for a Substance in Article notification 

The information to be included in the notification is described in the REACH Regulation (Article 
7(4)). The requested information comprises the following (the corresponding IUCLID section is 
indicated in brackets): 

 

 
 

 
 

 

identity of the notifier (i.e. the producer or importer of articles), i.e. name and contact 
details (REACH-IT account and IUCLID section 1.1); 
identity of the notifier and role in the supply chain (IUCLID section 1.1); 
identification of the substance, i.e. substance name, EC number, CAS number, type of 
substance and substance composition (IUCLID sections 1.1 and 1.2): this information is 
provided in the pre-filled substance dataset; 
the registration number of the Candidate List substance, if available (IUCLID section 1.3); 
classification of the Candidate List substance according to the CLP criteria (IUCLID section 
2.1): this information is provided in the pre-filled substance dataset; 
the production site of the notifier, to be filled-in only by producers of articles, not by 
importers of articles (IUCLID section 3.3); 

  a brief description of the use(s) of the substance(s) in the article [technical function(s)] 

 

and of the uses of the article(s) (IUCLID section 3.5); 
the tonnage band of the substance contained in the article(s), i.e. 1-10 tonnes, 10-100 
tonnes, 100-1000 tonnes or ≥1000 tonnes (IUCLID dossier header). 

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Chapter 7. How to complete a dataset in IUCLID describes in detail how you can complete a 
Substance in Article notification in order to fulfil your obligations under Article 7(2) of the 
REACH Regulation. 

1.4. 

Checks performed by ECHA on the submitted dossiers 

All dossiers submitted to ECHA undergo initial technical and administrative checks. Such 
checks are called business rules (BR). 

A dossier will be accepted only if all of the relevant business rules, such as format verification 
and availability of administrative information are satisfied. 

For more information on the business rules check refer to the Annex 1: Overview of the 
business rules checks performed by ECHA on the submitted dossiers. 

1.4.1. 

The Validation assistant 

The Validation assistant (VA) plugin has been developed to enable you to perform some checks 
on the dossier before you submit it to ECHA via REACH-IT. 

Therefore, before the submission, we strongly advise you to use the Validation assistant plugin 
in two steps: 

i.  To check your dataset (before the dossier is created) to be able to correct any 

failures reported at this level. 

ii.  To check the final dossier and address any issues identified in this step. 

Using the plugin in both steps is vital for you to minimise any unnecessary failures and 
potential rejection of your submission.  

For instructions on how to run the Validation assistant, refer to the help system of IUCLID. 

1.5. 

 The functionalities of IUCLID 

The functionalities of IUCLID are described in detail in the help that is built in to the 
IUCLID application. To view the help, press the F1 key anywhere inside the application. The 
help system will try to display the most relevant part of the help content. From there it is 
possible to navigate to the specific help required. For example, if the export wizard of the 
application is open, pressing F1 should open the help content at a description of the Export 
functionality. As an alternative to pressing F1, there are links to help in the application 
interface, wherever there is a help icon in the form of a question mark. 

2.  Legal entity 

Submissions to ECHA are done by Legal entities which have to be defined including contact 
details prior to submission. The contact details of the company are stored as a Legal Entity 
Object (LEO). You can create a LEO both in IUCLID and in the ECHA accounts available at 
http://echa.europa.eu/support/helpdesks/echa-helpdesk/echa-accounts.  

Note that ECHA will use only the contact details of the legal entity that you have registered 
in the ECHA accounts or in REACH-IT. 

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You have already created one legal entity when you installed IUCLID. You can add more legal 

entities by right clicking on Legal entity 
not enforce the consistency between the IUCLID legal entity and the ECHA accounts legal 
entity.  

 on the IUCLID home page. However, ECHA will 

Please note that by the default settings the legal entity is not included in the dossier. If you 
wish to include the legal entity in your dossier, you can change the default settings during the 
dossier creation in the dossier creation wizard (see chapter 8. How to create a Dossier).  

If you include a legal entity in the dossier which will be submitted to ECHA it may be 
beneficial to check if the legal entities in IUCLID and REACH-IT are the same. For further 
information on how to create a Legal Entity Object (LEO) and how to synchronise it between 
IUCLID and REACH-IT, refer to the Manual How to create Registration and PPORD dossiers. 

3.  Legal entity site 

Only producers of articles which produce their articles in the European Union will have to enter 
their production sites. Article importers do not need to fill in this information. A Legal entity 
site is an entry where you, as a producer of articles can indicate the site where production of 
your article takes place. This information includes the name of the site, the address and other 
contact details of the site, and the possibility to include the identifiers of the site under other 
Company/Organisation IT systems. The Legal entity site belongs to only one Legal entity 
owner. 

Note that it is not possible to create a site without linking it to a legal entity, but it is possible 
to modify the link between a site and its legal entity owner by selecting another legal entity 
from your inventory. More than one legal entity site can be associated with the same legal 
entity. 

3.1. 

Creating a Legal entity site 

Step 1.  To create a new site right-click on Legal entity site 

 on the home page and 

select New. 

Step 2.  Provide a name for the site and assign it to the Legal entity owner by clicking on the 

 button.  

Step 3.  Fill as many fields as possible under the General information and Contact address. 

The minimum data required is the Country where the site is located.  

Step 4.  To save the legal entity site information click on 

 from the main menu.  

4.  Contact 

In the Contacts inventory you can insert the contact details of the relevant competent persons, 
such as person responsible for the safety data sheet (SDS), toxicologist, etc, which can be 
attached to the IUCLID dossier. This person may be contacted to provide assistance or ask 
about the information submitted. 

Information on the contact person responsible for your submission must be specified and 
managed in REACH-IT. 

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4.1. 

Creating a contact 

Step 1.  To create a new contact right-click on the Contacts 

 on the home page and 

select New. 

Step 2.  Complete as many fields as possible under the General information. 

Step 3.  To save the contact information click on 

 from the main menu. 

5.   Downloading pre-filled substance datasets 

A Substance in Article notification dossier is prepared for a substance, as defined under Article 
3(1) of the REACH Regulation, which is included in the Candidate List of Substances of Very 
High Concern for authorisation. The information related to the Candidate List substance you 
want to notify, such as the identity of the substance and its composition, is already specified in 
the substance dataset (Substance dataset) created for that substance and  made available to 
download on ECHA's website. The dataset is used as basis for creating a IUCLID dossier.  

Please proceed as follows to download a pre-filled substance dataset for the Candidate List 
substance you want to notify:  

Step 1.  Go to the “Candidate List of Substances of Very High Concern for authorisation” on 

ECHA’s website at http://echa.europa.eu/candidate-list-table 

Step 2.  Under the column IUCLID dataset, in the correspondent row for the Candidate List 

substance you want to notify, click in the symbol 

Step 3.  Download and save the pre-filled Substance dataset file to your computer.  

After downloading and saving to your computer the dataset of the substance you are going to 
notify, please proceed to chapter 6. Importing a substance dataset to IUCLID for instructions. 

The IUCLID pre-filled substance datasets for Candidate List substances, available on ECHA’s 
website, are provided as a support for companies preparing notifications for Substances in 
Articles. The notifying company remains, however, solely responsible for the appropriateness 
and correctness of the information submitted in the notification. The pre-filled substance 
datasets contain the correct substance identifiers in section 1.1 and 1.2, together with relevant 
classification information in section 2.1. Please note that despite the presence of certain 
required information in the above mentioned IUCLID sections, you are required to enter 
further information as described in chapter 7. How to complete a dataset in IUCLID of this 
Manual (e.g. the Legal entity in section 1.1).  

A Substance dataset is a repository of administrative and scientific data for a substance. In 
IUCLID, the identification information on a given substance or a given constituent of a 
substance, such as chemical names (EC name, CAS name, IUPAC name, synonyms, etc.), 
identity codes (EC number, CAS number), molecular and structural information are stored as a 
Reference substance. The information in the Substance dataset can be modified: you can add, 
remove or change information in the dataset. You can find more detailed information on 
reference substance and on how to manage a substance dataset in the Manual How to prepare 
registration and PPORD dossiers available at http://echa.europa.eu/manuals. 

6.   Importing a Substance dataset to IUCLID 

To create a Substance in Articles notification dossier in IUCLID, you need first to import to your 
local IUCLID installation the previously downloaded Substance dataset (see chapter 5).  

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The steps below show how to import the downloaded pre-filled Substance dataset for the 
Candidate List substance you want to notify to IUCLID: 

Step 1.  On the IUCLID home page, click on the Import 

, which will launch the Import 

assistant.  

Step 2.  On the Import assistant window, click on Add files button. A new window will open.  

Step 3.  Select the substance dataset file (.i5z/.i6z) from the folder where you have saved it 

during the download process in your hard drive. Then, click on the Open button. 

Step 4.  Press the Finish button in the Import assistant window. 

Step 5.  When the import is complete a popup notification appears on the bottom right-hand 
corner of the IUCLID screen. You can click on this or the flashing red circle to show 
the Background job console.  

Step 6.  Once your substance dataset is imported, you can retrive it from the Substance 

inventory by clicking on the Substance 

 on the IUCLID home page.  

Step 7.  All available substances are displayed in the navigation panel on the left part of the 
screen. To open your dataset by double-click or right-click on it panel select Open.  

For more information on Import function refer to the help system of IUCLID. 

After importing the pre-filled Substance dataset to IUCLID, you are now ready to complete it 
with further information as explained in the next chapter, in order to prepare your SiA 
notification IUCLID dossier.  

7.  How to complete a dataset in IUCLID 

This chapter outlines which information you must provide through the different sections of the 
IUCLID to prepare a Substance in Articles notification dossier. 

When entering your data you can use the help system of IUCLID which is built inside the 
application. To view the help, press the F1 key anywhere inside the application and the most 
relevant information will be displayed in the help window. 

Once you have downloaded and imported a pre-filled Substance dataset for your substance, 
you can modify the information in the dataset: you can add, remove or change information in 
the dataset. The dataset will be used to create the SiA notification IUCLID dossier.  

The steps below show how you can complete the pre-filled Substance dataset for your 
substance: 

Step 1.  Retrieve the Substance dataset you have already imported to IUCLID (see chapter 

6), by clicking on the Substance button 
 on the IUCLID home page under Main 
tasks. The Substance dataset is displayed in the navigation panel on the left part of 
the screen (under Search tab). 

Step 2.  Open the Substance dataset by double-clicking on it or right-clicking and select 

Open; 

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Step 3.  After opening the Substance dataset, to view the Table of contents (TOC) that is 

relevant for the SiA notification dossier, click on the TOC tab in the navigation panel 

and then on the filled downward button (

) in the right side of the TOC tab;  

Step 4.  Select the REACH Notification of substance in article option from the picklist of 

different submission types and then click the OK button;  

Figure 1:  Selecting the REACH Notification of substance in article template from 

the picklist 

Step 5.  The sections relevant for a SiA notification dossier are now displayed in the 

navigation panel on the left part of the screen. Sections including mandatory 
information to complete are marked with the asterisk (

);  

Step 6.  Complete the Substance dataset by checking and entering the required information 

for a SiA notification in this dataset, into each section of IUCLID, as described in 

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detail in the next sections of this chapter. The sections are shown with their name 
and the numbering used in IUCLID. 

When filling in the different parts of a dataset it is important, that: 

  when you create many rows in a table, you must fill in the relevant information in each 

row, 

  when other is selected in a picklist the adjacent text field marked with 'Other' must be 

completed, 

when a field is associated with a unit, this must be filled in. 

7.1. 

Section 1 General information 

In section 1, General information, of IUCLID specify the information on substance identification 
and the identity of the notifier, as required under Article 7(4) of the REACH Regulation, as 
explained below.  

7.1.1. 

Section 1.1 Identification 

Section 1.1 contains information on the identity of the notifier, the role in the supply chain, 
identification of the substance, and the type of (reference) substance. 

To complete this section, follow the steps: 

Step 1. 

Step 2. 

In the Substance name field, type the name of the Candidate List substance for 
which you are preparing the SiA notification dossier. 

If you have any confidentiality concerns about the substance name, you need to fill 
in the Public name field. In this field you have to indicate a generic name suitable for 
publication, which appropriately describes the substance. 

More information on how to derive a public name for a substance for use under the REACH 
Regulation, you can find at http://echa.europa.eu/manuals. 

Step 3.  Assign a Legal entity to your substance dataset by clicking on the 

 button (see 

chapter 2. Legal entity). 

You can NOT appoint a Third party representative for a notification of substances in articles. 

Role in the supply chain: 

Step 4.  Select the checkbox Manufacturer (for producer of articles), Importer (of articles) or 
Only representative in this section according to your role in the supply chain. If you 
are both a producer and an importer of articles containing the same Candidate List 
substance then tick both boxes: Manufacturer and Importer. 

Identification of substance and Type of substance: 

Information on substance identification is pre-filled in the Substance dataset that you 
downloaded. The information given is sufficient to identify the substance and there is no 

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need to provide any further information. If you agree with the pre-filled information we 
recommend you to skip this section.  

The following information is pre-filled: 

  The field Reference substance is filled with the name of the reference substance and the 

EC Number/EC name and/or CAS number/CAS name and/or the IUPAC name. 

  The field Type of substance is filled in (mono-constituent, multi-constituent or UVCB). 

In addition to these minimum requirements, you have the possibility to also provide all the 
information specified in section 2.1 to 2.3.4 of Annex VI to the REACH Regulation as 
mentioned in REACH Article 7(4)c. For that, please refer to the Manual How to prepare 
registration and PPORD dossiers. 

An update of a notification successfully submitted (i.e. the notification has received a reference 
number) must always specify an EC number in the Reference substance section of IUCLID 
section 1.1. Please use the EC number or provisional EC number granted to your previous 
successful notification submission for this substance. 

Contact person: 

Step 5.  You can add information of the contact person(s) for that specific substance in the 

Contact persons field from the previously defined contacts (see chapter 4. Contact). 

To enter your data click on the 

 button. 

Step 6.  Click on the chain button

to assign a contact from your inventory. 

Step 7.  To save the information click 

 from the main menu. 

7.1.2. 

Section 1.2 Composition 

Section 1.2 of IUCLID is used for describing the identity of the substance at a compositional 
level. This section should indicate the identity, degree of purity and concentration of the 
constituents in the substance, including any impurities and additives. The state and form of the 
substance must also be specified in this section. 

Information on substance composition is pre-filled in the Substance dataset that you 
downloaded. The information given on substance composition is sufficient and there is no 
need to provide any further information. If you agree with the pre-filled information, we 
recommend you to skip this section. However, if you have more detailed information that 
you would like to provide, then please follow the instructions below. 

The following information is usually pre-filled: 

  The fields Name, Type of composition and State/form contain the information regarding 

the name and type of the composition, as well as the physical state or form. 

  The field Degree of purity is filled by default as ≤ 100 %. 
  For mono-constituent substances the field Constituents contains the information filled 

under Reference substance in section 1.1 Identification. 

  The field Typical concentration field is pre-filled by default as ≤ 100%. 
  For multi-constituent substances the field Constituents contains the identification 

information of the various constituents. 

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  The field Concentration range is filled by default as > 10% and < 80 %. 

Use this section to specify some of the information requested under Article 7(4) of the REACH 
Regulation, on the identity of the substance to be notified at a compositional level that you 
may have available. 

Each substance dataset must contain at least one composition which refers to the substance to 
be notified. Each composition is a new record in IUCLID. To create a new record and fill in the 
information on your substance composition, please refer to the Manual How to prepare 
registration and PPORD dossiers. 

7.1.3. 

Section 1.3 Identifiers 

In this section you can insert identifiers for regulatory programmes. In particular, this section 
should be used to report the following identifiers when available: REACH registration number 
and REACH substance in article notification number (in case of notification update, see below). 

To enter your data, you must first create a new record by right-clicking on the section name 
and selecting a new fixed record. 

Step 1.  Press Add button to add a new identifier to the Regulatory programme identifiers 

table. 

Step 2.  Depending on the type of submission, select the appropriate identifier from the 

Regulatory programme picklist. 

Step 3.  Enter the relevant number in the ID field, the REACH registration number has the 

following format: 01-XXXXXXXXXX-CC-XXXX. 

Step 4.  Click on OK and the added regulatory programme identifiers will appear in the table.  

Step 5. 

If you need to provide more than one programme identifier, create a new row by 
repeating the previous steps. 

Step 6.  To save the information click 

 from the main menu. 

Importers of articles may not have access to a registration number of the substances in the 
article. Producers of articles, incorporating the Candidate List substance into the article 
themselves, should normally have access to the registration number via the Safety Data 
Sheet (SDS) of the substance. However, in that case the article producer should verify that 
his use is covered by the registration, in which case he is exempted from the notification 
obligation. 

For notification updates: 

In this section you should add the reference number (notification number) that has been 
already granted to your substance, in case you want to submit a Substance in Articles 
notification update, by following the steps above, taking into account the following: 

  From the Regulatory programme picklist, select REACH substance in article notification 

number; 

  Please note that a notification number has the following format: 03-XXXXXXXXXX-CC-

XXXX.  

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7.2. 

Section 2 C&L and PBT assessment 

There are two sections in IUCLID for entering information relating to classification and labelling 
(C&L), 2.1 GHS and section 2.2 DSD - DPD. In addition, the section 2.3 PBT assessment allows 
to store the outcome of the PBT assessment performed under the REACH Regulation.  

The subchapter below contains relevant information for your SiA notification on the section 2.1 
GHS of IUCLID. For more information on this section and its subsections in IUCLID, please 
refer to the Manual How to prepare registration and PPORD dossiers. 

7.2.1. 

Section 2.1 GHS 

The Classification and Labelling information is in the pre-filled Substance datasets available 
for download from web-page of the Candidate List. Therefore, that information is pre-filled in 
the Substance dataset that you downloaded. It contains sufficient information on 
classification and labelling. However, if you would like to provide more detailed information 
or a Substance dataset is not available for the substance you want to notify, then please 
follow the instructions below.  

Supporting information for each substance can be found on the Candidate List of substances 
of very high concern for Authorisation on ECHA’s webpage by clicking the  Details button 
in the specific substance row of the web-page of the Candidate List: 
http://echa.europa.eu/candidate-list-table  

The classification and labelling information in the pre-filled Substance datasets was taken 
from the Annex VI to the CLP Regulation, where available: 
http://echa.europa.eu/regulations/clp/legislation 

Information on how to fill in Section 2.1 of IUCLID can be found in the Manual How to prepare 
registration and PPORD dossiers. 

7.3. 

Section 3 Manufacture use and exposure 

7.3.1. 

Section 3.2 Estimated quantities 

In this section you have the possibility to provide information on the tonnage of the Candidate 
List substance present in the article. 

To insert information on the tonnage, please proceed through the following steps: 

Step 1.  Create a new record by right-clicking on the section name (3.2 Estimated quantities) 

and selecting a New record. 

Step 2.  Fill in the Year field with the calendar year for which the tonnage calculation has 

been made. 

Step 3.  Under Tonnages relevant for registration/notification of substances in articles, please 

provide information on tonnage (tonnes/year) that is relevant to your articles:  

 

 

tonnage of the Candidate List substance contained in the imported articles in the field 
Tonnage imported in articles  

and/or 

tonnage of the Candidate List substance contained in the produced articles in the field 
Tonnage in produced articles. 

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You can calculate and provide (for both cases mentioned above) the total tonnage of the 
Candidate List contained in the articles. The Guidance on requirements for Substances in 
Articles available at http://echa.europa.eu/guidance-documents/guidance-on-reach gives you 
some advice on how to carry out the calculations. 

Step 4.  To save the information click 

 button from the main menu. 

For articles which have been produced/imported for at least three consecutive years, the 
tonnage to be reported should correspond to the average tonnage produced/imported during 
these three full years (or average of two full years if the article has been produced/imported 
for two full years). Otherwise the tonnage will be calculated based on the previous calendar 
year only and no averaging will be made. 

In case production/import of the article starts in the current year and it is expected that the 
article producer/importer will fall under the notification obligation (the 1 tonne threshold has 
been or will be exceeded) you are advised to notify as soon as the 1 tonne threshold has 
been reached. In that case, please indicate an expected tonnage for the whole year. 

You have the possibility to indicate the tonnage that you have provided in this section as 
confidential. In that case a justification has to be provided, please proceed as follows: 

Step 1.  To add confidentiality to the flag of this section, on the top of the section, click on 

the no flag is set 

 button.  

Step 2.  On the set flags window under confidentiality, click on the downward button 

 to 

open the picklist. On the list, select one of the reasons for confidentiality: CBI, IP or 
No PA.   

Step 3.  Enter the required justification it into the field Justification, which is a free text field. 

After confidentiality is set, the flag icon in this section will appear as confidentiality 

flag ( 

). 

Step 4.  To save the information click 

 button from the main menu. 

For more information on indicating information as confidential, please refer to manual on 
confidentiality requests and dissemination available at http://echa.europa.eu/manuals. 

7.3.2. 

Section 3.3 Sites 

Only producers of articles will have to enter their articles production sites. Importers of articles 
do not need to fill in this information.  

To enter your data create a new record by right-clicking on the section name (3.3 Sites) and 
selecting a New record. To include a production site in this record, first create a site using the 
same Legal entity that you used for the creation of the dataset (see chapter 3 Legal entity 
sites). To specify the information on your articles production sites, you can create several 
records (one for each site) and each of them must have one of the existing Legal entity sites 

linked to it by the chain button 
expected to be the same as the country of the submitting Legal entity. 

. When reporting the production site, the country is 

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7.3.3. 

Section 3.5 Use and exposure information 

The section 3.5 is composed of a number of sub-sections corresponding to the different life 
cycles stages of a substance. In the context of a notification for substance in articles, only the 
subsection 3.5.6 Service life must be completed. In this sub-section you have to describe the 
article(s) and its use(s).  

It is recommended to follow the principles explained in the Guidance on information 
requirements and chemical safety assessment, Chapter R.12: Use description (available at 
http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-
chemical-safety-assessment). 

7.3.3.1.  Section 3.5.6 Service life 

The steps described below show how the different fields should be filled in. Detailed 
information on the expected content of each field can be accessed clicking the help button. 

Step 1.  Right-click on Service life and select New record. A service life record is then created. 
When creating a new record you can re-name it by pressing F2 button and inserting, 
as needed (cf. examples below) the name assigned to each article or each use of the 
article you wish to describe. 

You can create several service life records if needed.  

In general it is advised to describe separately (i.e. in different Service life records) the 
different articles containing the same Candidate List substance. Similar articles should however 
be grouped together and the information provided only in one record. To this aim you should 
decide which articles are similar enough to be described together. This can be done based, 
namely, on all the following conditions: 

 
 
 

 

the articles have the same use/function; and 
the Candidate List substance has the same technical function; and 
the Candidate List substance is located in the same (integral) part/material of the article; 
and 
the use conditions of the articles can be expected to be similar.  

Example 1: The Candidate List substance is contained in the single seat and back rest piece of 
chairs. The seat and back rest piece is an article made of a plastic material. This article exists 
in different designs, sizes and colours. These variants should however all be considered as the 
same ‘type of article’. Articles that only differ in design, size or colour, can be grouped 
together in the same Service life record. 

Example 2: The Candidate List substance is used as waterproofing agent in textile fabrics 
made of polyester fibres. In one case the substance is used in very low concentration in the 
fabrics for everyday clothing, where frequent skin contact and regular cleaning with releases to 
the environment, e.g. during washings, are expected . In the other case the substance is used 
in high concentration for fabrics used to produce boat sails, where limited skin contact and no 
frequent cleaning are expected. However, during use there are releases to the environment. 
These articles should not be grouped in the same Service life record, because their 
uses/functions and use conditions are different which means that not all conditions above are 
met. 

The following (types of) articles, where relevant, should be described in separate Service life 
records:   

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  articles only used by workers; 
  articles with high potential release of the Candidate List substance during use. 

Step 2.  Under Registration/Notification status for the use, click on the dropdown button (

) 
and choose from the picklist: use of substance in articles notified according to REACH 
Article 7(2). Then, click OK. This selection will narrow down the list of fields to be 
filled in. Indeed, not all fields initially displayed when creating a record under Service 
life are relevant for substance in articles notification. 

Step 3.  Provide a Service life number for the service life record, if deemed useful for your 

own purpose. 

Step 4.  Provide the service life name (or name/use of your article). Insert, in the Service life 
name field, a short name. The name should be concise but descriptive of the specific 
article you are describing and of its use, e.g. insulation element, computer cables 
etc.  

Step 5.  Provide further description of the article and of its use(s). In the field Further 

description of use, provide more information on the article and its use(s).  

Please fill in this section, for example, by including the information below: 

  description of the article and its different (integral) parts/materials, when applicable;  
information in which part(s)/materials the Candidate List substance is present and its 
 
maximum concentration (w/w); precise technical function of the Candidate List substance 
in the article or part(s)/materials of the article;  

  description of all the different foreseen ‘uses’ during the service life (e.g. processing into 

finished article (for semi-finished articles), installation, maintenance and use of the finished 
article, disposal). Highlight to the extent possible where releases can be expected; 
Indicate if the article is intended to be used by vulnerable populations (e.g. babies, 
children, pregnant women); 
In the case you are grouping similar articles, we advise you to describe the different 
characteristics of those articles. 

 

 

Example 3: Single seat and back rest plastic piece of a chair 

The article is a single seat and back rest piece of a chair made of polypropylene (PP). It 
contains 3% w/w of a Candidate List substance used as a flame retardant. The chair, and 
therefore its seat and back rest piece, is mainly for indoor use, but there may be some outdoor 
use. When sitting on the chair, this plastic article will come into contact with skin or clothing.  

If the article is exposed to heat or a flame, the PP used can burn and melt and generates a 
highly exothermic combustion reaction. The Candidate List substance is added to PP, in order 
to disrupt its combustion. 

Example 4: Sewer pipe 

The article is a sewer pipe made of Polyvinyl chloride (PVC). The PVC sewer pipe contains 1% 
w/w of a Candidate List substance, which was used as heat stabiliser in the production of the 
pipe. The pipe will be handled and mounted by workers. It is foreseen for outdoor use. The 
pipe comes into contact with the soil and with sewage water from homes/buildings and 
industrial sites and therefore the Candidate List substance can be released to the environment. 

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The Candidate List substance is used to prevent thermal degradation of PVC during 
manufacture and when processed. 

Example 5: Semi-finished textile fabric 

The article is a semi-finished textile fabric made of polyester fibres. It contains 3% w/w of a 
Candidate List substance, used as flame retardant. The fabric will be further processed in 
finishing activities, including washing processes and/or curing processes under elevated 
temperature. Releases to the environment from these processes are expected, as well as 
inhalation of vapours and particles by workers.  

The finished fabric is used for the production of clothes and home textile articles. Further 
releases to the environment are expected during washings of these final articles. Contact with 
skin while wearing the clothing article can be expected. Inhalation of released particles or 
vapours  during use of the final article, in particular from home textiles with large surface 
areas. 

Example 6: Insulated electric wires in a TV 

The articles are insulated electric wires contained in an imported TV. The insulated electric 
wires were made by insulating the copper wire, through extrusion, using a PVC liquid mixture 
containing 10% w/w of the Candidate List substance. The Candidate List substance is used as 
plasticiser and its maximum concentration in the insulated wires is 4% w/w.  

The insulated wires containing the Candidate List substance in the TV were grouped together 
because they are similar, even if having different diameters, code colours, and being bundled 
in cables. 

When disposed, the TV should be treated as electronic waste, which includes the insulated 
electric wires in it. 

Step 6.  Where several compositions of the Candidate list substance are reported in the 

section 1.2 (see subchapter 7.1.2), you can link the compositions that are related to 
this particular use in the table Related composition by clicking on Add and selecting 
the relevant composition(s). 

Step 7. 

Indicate by whom the article is foreseen to be used. In the field Article used by, 
please indicate if the article is foreseen to be used by workers, or by consumers (i.e. 
by the general public) by clicking on dropdown button (
both workers and consumers within one service life record. 

). You should not select 

Article foreseen to be used by consumers (e.g. screw, hammer) can also be used by workers. 
It is enough to report these articles as article used by consumers if the use conditions are 
generally the same.  

Step 8. 

In the field Article category (AC), you should select the type of article(s) into which 
the Candidate List substance has been incorporated from a list of standard articles 
categories (e.g. wood articles, plastic articles). In case of an article with various 
(integral) parts/materials (e.g. painted paper clip), please choose the article category 
describing the part of the article where the Candidate List substance is present.  
Select the article category (AC) from the pick list, by clicking on dropdown button (
). 

The Article Categories (AC) are listed in the Table R.12-14 in the Appendix R.12.4. of the 
Guidance on information requirements and chemical safety assessment, Chapter R.12: Use 

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description. The Table also includes explanations and examples, as well as suitable TARIC 
chapters, for some AC. 

If you cannot identify a suitable article category (or you wish to be more specific), please 
select AC0: Other and provide explanation in the adjacent field. If applicable, you can select a 
code (and the corresponding phrasing) from the TARIC system 
(http://ec.europa.eu/taxation_customs/dds2/taric/taric_consultation.jsp)  

In principle, articles that are assembled or joined together remain articles, therefore, articles 
categories AC1 to AC3 are recommended to be used in combination with the relevant material-
based article categories AC4 to AC13 or AC0.  

Step 9.  Describe the use of the articles from the perspective of release to the environment.  

i.  Create one Contributing activity / technique for the environment, by clicking the 

 button. 

ii.  Under the field Name of activity / technique briefly characterise with your own 

words the use of the articles from an environmental perspective. 

iii.  Under Environmental release category (ERC), select from the standardised list of 
environmental release categories (ERCs) the one(s) that best describe the use of 
the articles, by clicking on dropdown button (
). It is possible to choose several 
ERCs, if appropriate. 

You will find the list of ERCs together with explanation and examples in the Tables R.12-12 and 
R.12-13 of the Guidance on information requirements and chemical safety assessment, 
Chapter R.12: Use description (see Appendix R.12.4.). Please also refer to the figure R.12.7 in 
this appendix for a decision tree for the ERC assignment.  

If the articles described within a use have different conditions of uses from an environmental 
perspective, this can be indicated by creating several contributing activities/techniques for the 
environment. Additional contributing activities can be created by clicking on the 

 button.  

Step 10.  Describe the use of the articles from the human health exposure perspective. 

 

 

If you have indicated that your article is used by consumers in the field Article used by, 
you will have the possibility to create Contributing activity / technique for consumers; 

If you have indicated that your article is used by workers in the field Article used by, 
you will have the possibility to create Contributing activity / technique for workers. 

Contributing activities/techniques are created by clicking the 

 button. 

i.  Under the field Name of activity / technique briefly characterise with your own 

words the specific use of the article from an human health exposure perspective.  

ii.  If you have selected consumers under article used by: under Article category 

(AC), select from the standardised list of articles categories in the picklist menu 
the one(s) that best characterise the article from an exposure perspective (e.g. 
AC6a –leather articles, large surface area articles) by clicking on dropdown button 
(
). If you cannot identify a suitable article category please select AC0: Other 
and provide explanation in the adjacent field. 

iii.  If you have selected workers under article used by: under Process categories 

(PROC), select from the standardised list of process categories available in the 
picklist menu the appropriate one(s) by clicking on dropdown button (

), 

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e.g.PROC 21:Low energy manipulation of substances bound in materials and/or 
articles. 

iv.  If none of the specific PROC categories seems applicable, you can tick the box 

PROC0: Other and describe in the adjacent field, the foreseen tasks, application 
techniques or process types in your own words. 

A process category for articles used by workers describes the tasks, application techniques or 
process types defined from the occupational perspective. You can find the name, explanation 
and examples of these PROCs in Table R.12-11 in the Appendix R.12.4. to the Guidance on 
information requirements and chemical safety assessment, Chapter R.12: Use description.  

v.  In the field Percentage (w/w) of substance in mixture / article (%), please provide 
the concentration (% w/w) of the Candidate List substance present in the article 
as imported or produced. In the field Details on the percentage of substance in a 
mixture / article, you can provide more detailed information on the concentration 
reported. The obligation to notify applies when this concentration is above 0.1 % 
(w/w). This concentration threshold applies to each article of an imported object 
made up of more than one article, which were joined or assembled together. 

If the articles described within a use have different conditions of uses from a human health 
exposure perspective, this can be indicated by creating several contributing activities / 

techniques. Additional contributing activities can be created by clicking on the 

 button. 

Step 11.  Provide a description of the use(s) – as technical function - of the Candidate List 

substance in your article.  

Under Technical function of the substance during use select the appropriate technical 
function of the substance in the article from the picklist, by clicking on dropdown 
button (
and does not have any function in the article, you can select from the picklist no 
technical function. Further explanation can be provided in the field Further 
description of use (see step 5).  

). If the substance remains in the article from a preceding life cycle stage, 

The technical function (TF) of the substance in the article describes the role that the substance 
fulfils when it is used (what it actually does in an article). The technical function is therefore 
focused on substances, and it is not meant to convey information on the type of article. 

The list of specific TFs are listed in Table R.12-15 in the Appendix R.12.4. to the Guidance on 
information requirements and chemical safety assessment, Chapter R.12: Use description. If 
none of the listed technical functions (TF) seems applicable, you may describe it in your own 
words, instead of assigning a specific available TF. In that case you should tick the box Other 
and provide the relevant description in the adjacent field. 

Step 12.  In the field Tonnage of substance for this use (tonnes/year), please report the 

tonnage (tonnes/year) of the Candidate List substance contained in the article you 
are describing, e.g. 1.5 (tonnes/year in the sewer pipe). As a minimum requirement, 
the tonnage range of the Candidate List substance has to be provided in the IUCLID 
dossier header (Chapter 8). In the next field, you have the possibility to provide 
more detailed information on the tonnage if you so wish. 

Step 13.  The field Details on tonnage reported can be filled with more detailed information on 
the tonnage reported in the field above, if necessary, e.g. how the tonnage value has 
been calculated. Note that the checkbox Total EU tonnages for this use is not 
relevant for the SiA notification and should NOT be selected.  

Step 14.  In the Remarks field you can provide additional information you consider relevant for 

the Substance in Article notification dossier, in particular further information related 

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to exposure resulting from the use of the article (considering the service life of the 
article including disposal), e.g. results from a chemical safety assessment of article 
service life. You may also consider to include information for safe and proper 
use/handling of the article, as well as appropriate instructions for its disposal that 
you communicate down the supply chain in accordance to Article 33 of REACH 
Regulation. 

Step 15.  To save the information click 

 button from the main menu. 

If you need to notify more than one type of article or use containing the same Candidate List 
substance, you need to create several records under the Service life following steps 1 to 15 
above. 

You have the possibility to indicate the information on use that you have provided in this 
section as confidential. In that case, proceed as follows: 

Step 1.  To add confidentiality to the flag of this section, on the top of the section, click on 

the no flag is set 

 button.  

Step 2.  On the set flags window under confidentiality, click on the downward button 

 to 

open the picklist. On the list, select one of the reasons for confidentiality: CBI, IP or 
No PA.  

Step 3.  Enter the required justification it into the field Justification, which is a free text field. 

After confidentiality is set, the flag icon in this section will appear as confidentiality 

flag ( 

). 

Step 4.  To save the information click 

 button from the main menu. 

8.  How to create a Dossier 

Once you have included all relevant information in your substance dataset, the next step is 
to create a dossier. 

Before creating a dossier you are advised to check the completeness of your substance 
dataset by running the Validation assistant. For more information on how to run the 
Validation assistant refer to the help system of IUCLID. 

This may also be a good time to verify if the quality of the dataset can be improved before 
creating a dossier, please check the webpage How to improve your dossier on the ECHA 
website: http://echa.europa.eu/support/how-to-improve-your-dossier 

Step 1.  To create a dossier open the list of available substance datasets by clicking on the 

Substance 

 on the IUCLID home page. 

Step 2.  All available substances (within the limits of the search results managed in the user's 
preferences) are displayed in the navigation panel on the left part of the screen. If a 
substance does not appear in the list you can search for it using the search panel. If 
the list is very long, you can also filter by typing (part of) the name of the substance 
in the filter field. 

Step 3.  Select the substance for which you want to create a dossier. 

Step 4.  Right-click on the substance in the query results list. From the pop-up menu select 

Create dossier. 

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Step 5.  After selecting the Create dossier option the dossier creation wizard is displayed. 

Follow the steps in the dossier creation wizard. 

Only two steps are displayed in the dossier creation wizard as the default option: Select 
submission type (1) and Complete the dossier header (5). If you wish to change the default 
settings to have more options you can select the checkbox Use advanced settings. 

Step 1.  Select the submission type. Choosing the correct dossier template by selecting 
the submission type is essential for a successful submission. Before exporting your 
dossier you have to make sure that the selected template corresponds with the 
intended submission. 
When the checkbox Use advanced settings is selected follow the steps 2-4, if the 
default settings are kept (recommended approach), go to step 5 directly. 

Step 2.  Define the confidentiality level by selecting the data protection flags. If you have 

included any confidentiality or regulatory programme flags in your substance 
dataset, please make sure that the relevant information is included in your dossier 
by selecting the appropriate flags in this step. If you are unsure it is recommended 
to select the defaults option 'all fields - including confidential test material'. ECHA will 
assess the confidentiality of the information and the justifications provided. You can 
find more information on the publication of part of the dossier on the ECHA website 
at http://echa.europa.eu/manuals. 

Step 3.  Select whether the annotations should be included in the dossier. 

Step 4.  Verify and select which documents and entities will be included in your dossier. To 
this end, select in the Entities list the substance entity which will be preceded by  . 
The documents and entities connected to the substance will be listed in the 
References to window; documents to be included are already checked. Certain 
documents, such as section 1.1, will always be included in a dossier, and cannot be 
excluded in this step. Likewise, depending on the submission type, some documents 
will not appear in the list and cannot be included as they are not relevant for the 
selected submission type. If you are unsure of the information to be included, you 
can select Next and rely on the default settings for that submission type. 

Step 5.  Complete the dossier header by entering additional administrative information. 

Information contained in the dossier header is crucial for business rules checking when you 
submit your dossier. Missing or incorrect information can result in that your submission 
cannot be accepted for further processing and will be automatically removed from the 
system. In this case you need to create a new dossier with corrected information and submit 
it again. For more information refer to the Annex: Overview of the business rules checks 
performed by ECHA on the submitted dossiers. 

The following subchapters describe how to fill in the administrative information in the dossier 
header. 

Note that In the particular case of SiA notification, you should select REACH Notification of 
substance in article template in the Dossier creation wizard. 

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8.1. 

Administrative information 

Enter a Dossier name, which enables you to easily identify it in your database. You are advised 
not to use confidential information in the dossier name, as it will be seen by anyone you share 
the dossier with.  

When relevant, enter a Dossier submission remark. This remark can include further 
information on the reason for the submission (e.g. detail which information has been updated). 

8.1.1. 

Specific submissions 

By default the dossier is created for an initial submission, in case of an update you should 
select the checkbox The submission is un update. 

For your spontaneous update, you must select the checkboxes The submission is an update 
and Spontaneous update. Additionally, select an appropriate Justification from the picklist, 
which is reporting the update reasons for a SiA notification.  

If the reason for the spontaneous update is not listed in the picklist, then you are required 
select other and indicate the information about the reason in the corresponding field. 

If you need to indicate more than one reason for updating the dossier, you should create an 
additional repeatable block for each reason by clicking on the 
 button. Please note that a 
Justification has to be provided in all the blocks. 

See also chapter 11. Update Dossier. 

8.1.2.  Dossier specific information 

This part of the dossier header allows giving more general information on the IUCLID SiA 
notification dossier submitted. 

In the field Tonnage band you must select your own tonnage band (i.e. 1-10 tonnes, 10-100 
tonnes, 100-1000 tonnes or ≥1000 tonnes). 

Confidentiality claim on tonnage band and its Justification fields must to be filled in case you 
want to claim the relevant data confidential. For tonnage band, this is the only way to request 
the confidentiality.  

The checkbox for the Confidentiality claim on the tonnage band is the only location in the 
dossier where you can request confidentiality on your tonnage band. The confidentiality flag 
in IUCLID section 3.2 relates to the actual tonnage manufactured/imported, which is always 
treated as confidential information 

The checkbox Reviewed by an assessor is not required, but if it has been reviewed by an 
assessor it may be indicated here.  

9.  How to export a Dossier 

To start the export process, first search for the Dossier 
IUCLID application. When the Dossier is shown in the list of search results, right-click on its 
entry, and then select Export from the menu. 

 in the navigation panel of the 

For details on the export wizard, see the help that is built in to the IUCLID application. 

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10. Submit Dossier 

To submit your dossier to ECHA you must sign-up in REACH-IT with the legal entity details of 
the submitting entity, and follow the instructions provided there for your specific type of 
submission. 

You can access REACH-IT from ECHA website: http://www.echa.europa.eu/ or go directly to 
the REACH-IT website: https://reach-it.echa.europa.eu/. 

11. Update Dossier 

If you need to update your dossier, you do not need to re-type again all your substance data. 
Instead you can update the information in the substance dataset. To edit the substance 
dataset, select it from the navigation panel and fill in or update the relevant data. When the 
dataset is ready you can create a dossier (see chapter How to create a Dossier). 

It is strongly recommended to keep the SiA notification up to date. You should consider 
updating your notification if the information you have included in it changes. Reasons for 
updating could be a change in the tonnage range, in the characteristics of the article 
produced/imported (description, use(s)) etc. In all these circumstances, updating your 
notification is strongly recommended. Keeping your notification up to date will help document 
your REACH compliance towards national enforcement authorities.  

Do not forget to specify in section 1.3 of IUCLID the reference number (notification number) 
that has been already granted to your substance, in case you want to submit a notification for 
Substance in Articles update (see chapter 7.1.3. Identifiers). 

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Annex 1.  Overview of the business rules checks performed 

by ECHA on the submitted dossiers 

Business rules are a set of dossier format and administrative pre-requisites that must be 
fulfilled before ECHA can establish that the dossier can be handled properly. Business rules do 
not assess the completeness or compliance of the data provided. If the dossier submission fails 
at the business rule level, the dossier will be automatically removed from the system, and a 
new submission is required. You can see the outcome of the business rules check in the 
submission report in REACH-IT. 

This document will guide you through the basic requirements of creating the substance dataset 
and the IUCLID dossier header. In addition, it is recommended to use the IUCLID Validation 
Assistant plugin on the substance dataset and also on the final dossier before exporting it from 
IUCLID and submitting it to REACH-IT. Right-click on your substance dataset or on the dossier 
in the IUCLID navigation panel and select Validate. This plugin will check most of the business 
rules. However, some of the business rules depend on the information that is stored within the 
REACH-IT database, and therefore the plugin cannot simulate all the business rules checked by 
the Agency. 

Business Rules applicable for Substance in Article notifications 

Location 
(IUCLID/REACH-IT) 

IUCLID  
substance dataset 

IUCLID 
substance dataset 

IUCLID 
section 1.1 – Identification 

IUCLID 
section 1.1 – Identification;  
section 1.2 – Composition 

Rule description 

A REACH dossier must be created from a substance 
dataset. It cannot be created out of a mixture or product 
dataset.  

Relevance 

All dossier types 

When creating a dossier where a category will be included, 
the dossier has to be created out of a substance dataset 
that is linked to a category. 

Substance in Articles 
notification 

A reference substance must exist in section 1.1 

All dossier types 

All dossier types 

Each reference substance in section 1.1 and 1.2 must 
contain a substance identifier. An acceptable substance 
identifier is: 
- EC/List number 
- CAS number 
- IUPAC name 

Any EC/List number defined in section 1.1 and 1.2 of 
IUCLID must exist in the REACH-IT EC inventory. 

If you use a reference substance to report unknown 
constituents/impurities, they must be “identified” by 
inserting “Unknown constituent/impurity” in the IUPAC 
name field. 

If categories are used, this rule is applied to all the 

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IUCLID 
section 1.1 – Identification 

category member substances. 

At least one of the following fieldsmust be provided for 
the reference substance in section 1.1: 
- EC/List number 
- CAS number 
- Molecular formula AND molecular weight AND structural 
formula 
- SMILES notation 
- Remarks 

Substance in Articles 
notification 

IUCLID 
section 1.1 – Identification  

In an update submission, the substance must be identified 
by an EC/List number. 

Substance in Articles 
notification 

IUCLID 
section 1.1 – Identification 

IUCLID 
section 1.1 – Identification; 
section 3.3 - Sites 

The reference substance must be marked as one of the 
following: 
- Mono constituent substance 
- Multi constituent substance 
- UVCB 

When ‘Manufacturer’ is selected as a role in the supply 
chain then at least one manufacturing site must be 
provided in section 3.3. To this end, you must create a 
record in section 3.3 and assign a 'Site' to this record. In 
addition you must assign at least one manufacture use 
from section 3.5.1 using the field 'Related 
manufacture/own use'. 

Substance in Articles 
notification 

Substance in Articles 
notification 

IUCLID 
section 1.1 – Identification 

The ‘Only representative’ as a role in the supply chain 
cannot be marked together with ‘Manufacturer’ or 
‘Importer’. Separate legal entities and 
registrations/notifications are required for each non-EU 
manufacturer represented. 

Substance in Articles 
notification 

IUCLID 
section 1.2 – Composition 

At least one composition must be defined in section 1.2. 
The following requirements are also to be fulfilled: 
- All created compositions must contain at least one 
constituent. 
- All constituents must be linked to a reference substance. 

All dossier types 

IUCLID 
section 1.2 – Composition 

All dossier types 

All compositions created in section 1.2 must have the 
composition type indicated. At least one of the 
compositions in section 1.2 must reflect the composition 
of the substance manufactured/imported by the 
registrant. This composition must be marked as the “Legal 
entity composition of the substance”.  

If the composition type “other” is selected from the list, 
the relevant information must be provided in the adjacent 
free text field. 

IUCLID 
section 1.1 – Identification;  
section 1.2 – Composition 

If the substance is defined as mono-constituent, the first 
‘legal entity composition of the substance’ in section 1.2 
has to have a matching substance identity when compared 

All dossier types 

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How to prepare a substance in articles 
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with the reference substance in section 1.1. 

IUCLID 
section 1.1 - Identification;  
section 1.2 – Composition 

If the substance is defined as a multi-constituent 
substance, the reference substance in section 1.1 cannot 
be identical to any of the constituents defined in the first 
composition of type ‘legal entity composition of the 
substance’ in section 1.2. 

All dossier types 

IUCLID  
section 1.2 – Composition 

All constituents of a multi-constituent or of a UVCB 
substance must identify distinct reference substances. 

All dossier types 

IUCLID 
section 1.2 - Composition 

If the substance is classified, a ‘Hazard category’ and a 
‘Hazard statement’ must be provided, or a ‘Reason for no 
classification’ for each hazard class in IUCLID section 2.1 
should be indicated.  

Substance in Articles 
notification 

If the substance is not classified, the tick box 'Not 
classified' should be marked and no classification should 
be provided in that record. 

IUCLID 
section 1.2 - Composition 

If the substance is classified, at least one block for 'Specific 
target organ toxicity - single' and 'Specific target organ 
toxicity - repeated' must be provided in IUCLID section 2.1. 
For each block, a ‘Hazard category’, a ‘Hazard statement’, 
and 'Affected organs' must be provided, or indicate a 
‘Reason for no classification’.  

Substance in Articles 
notification 

If the substance is not classified, the tick box 'Not 
classified' should be marked and no classification. 

IUCLID 
section 1.3 - Identifiers 

When a registration number is provided in section 1.3 it 
has to refer to the same substance as indicated in section 
1.1. 

Substance in Articles 
notification 

IUCLID 
section 1.3 – Identifiers 

For an update submission, a reference number must be 
given in IUCLID section 1.3.  

Substance in Articles 
notification 

IUCLID 
section 2.1 - GHS 

The classification and labelling information must be 
provided in the GHS format in section 2.1 - GHS. 

Substance in Articles 
notification 

IUCLID 
section 2.1 - GHS 

Substance in Articles 
notification 

If at least one classification is provided in a C&L record in 
section 2.1 then: 
- a ‘Signal word’ must be provided in the ‘Labelling’ block 
of the same record. 
- a ‘Hazard statement’ or a ‘CLP supplemental hazard 
statement’ must be provided in the ‘Additional labelling 
requirements’ block of the same record. 

If no classification is provided, the tick box ‘Not classified’ 
should be selected and no hazard statements and no 
signal words should be provided. 

IUCLID 

For each 'Specific concentration limit' block that is created 

Substance in Articles 

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section 2.1 - GHS 

in a C&L record in IUCLID section 2.1, at least one of the 
two fields under 'Concentration range (%)' must be 
provided. In addition, at least one selection must be made 
under 'Hazard categories'.  

notification 

If no classification is given in a C&L record, the tick box 
'Not classified' should be marked and no specific 
concentration limits should be indicated in that record. 

IUCLID 
section 3.3 - Sites 

Assign a site to each record in IUCLID section 3.3. You must 
also provide a contact address for the site; 'Country' is the 
minimum information required. 

Substance in Articles 
notification 

IUCLID 
section 3.5.6 – Service life 

Substance in Articles 
notification 

At least one record in section 3.5.6 has to be included, 
containing the following information:  
- 'Service life name' 
- 'Article used by' 
- 'Further description of use' 
- at least one 'Contributing activity / technique for the 
environment' described with the appropriate 
'Environmental release category (ERC)' codes 
- 'Technical function of the substance during use' 

In addition:  
- if the article is used by workers, the appropriate 'Article 
category (AC)' codes must be provided. 
- if the article is used by consumers, at least one 
'Contributing activity / technique for consumers' must be 
provided described with the appropriate 'Article category 
(AC)' codes.  

-If 'other:' is selected in any of the picklists then the 
adjacent free text field must be filled in. 

IUCLID 
dossier header 

IUCLID  
dossier header  

Once a reference number for a registration/notification is 
granted, it is not allowed to submit another initial 
submission for the same substance from the same legal 
entity. If you need to modify/add data, an update 
submission is required. 

Substance in Articles 
notification 

All dossier types - 
Updates 

Updates can be submitted in the following cases: 
- Following the successful registration / notification of this 
particular substance, after having received a reference 
number (spontaneous update). 
- Following a technical completeness check (TCC) failure 
(requested update). 
- Following a request for further information by the 
Agency (spontaneous or requested update as specified in 
the request). 

In any other case, an initial submission is required. 

IUCLID 
dossier header 

If you wish to submit a spontaneous update then the 
following conditions must be fulfilled: 

Substance in Articles 
notification 

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How to prepare a substance in articles 
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- In the dossier header tick the boxes 'The submission is an 
update' and 'Spontaneous update'. 
- Insert the submission number to the last successful 
submission as the ‘Last submission number’. 
- Select an appropriate justification for updating by first 
creating a block under 'Spontaneous update' and then 
making a selection in the pick-list. If you selected ‘other:’, 
you are required to give the reason in the adjacent free 
text field.  

IUCLID 
dossier header 

Legal entity change cannot be performed by submitting 
and update to the dossier. The ‘Legal entity change’ 
module in REACH-IT is to be used to carry out the 
administrative changes related to ownership of the 
registration/notification. 

Substance in Articles 
notification 

IUCLID  
dossier template 

The dossier template used in IUCLID must correspond with 
the intended submission type in REACH-IT. 

All dossier types 

REACH-IT 

REACH-IT  

REACH-IT 

REACH-IT 

REACH-IT 

REACH-IT 

REACH-IT 

A new dossier cannot be submitted when the previous 
submission for the same substance is still being processed. 

All dossier types - 
Updates 

No submissions can be made from the account of a legal 
entity, which at the time of submission undergoes the 
legal entity change (merge) process.  

All dossier types  

Legal entity change functionality is available in REACH-IT. 

Parallel submissions are not allowed for the same 
annotation number. You cannot submit a dossier quoting 
the same annotation number while another dossier is still 
being processed. 

Substance in Articles 
notification 

It is not allowed to submit a notification when when a 
registration dossier for the same substance from the same 
submitting legal entity is currently under processing by the 
system. 

Substance in Articles 
notification 

If an active registration already exists for the substance by 
the submitting legal entity then it is not allowed to submit 
a notification. 

Substance in Articles 
notification 

The same IUCLID dossier cannot be submitted more than 
once. 

Substance in Articles 
notification 

It is not allowed to update a dossier that is being 
deactivated or has been revoked. 

Substance in Articles 
notification 

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EUROPEAN CHEMICALS AGENCY 
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FI-00121 HELSINKI, FINLAND 
ECHA.EUROPA.EU