How to prepare a request for use of an alternative chemical name for substance in mixture.
Date: 2016-10-24
Institutions: European Chemicals Agency
Subjects: administrative formalities, chemical industry, chemical product, environmental risk prevention, market intervention, product designation, scientific research, technical regulations, toxic substance

How to prepare a 
request for use of an 
alternative chemical 
name for a 
substance in a 
mixture 

 
 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

2 

Version 1.0 

Changes to this document 

Version 

Changes 

1.0 

First version 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

3 

Legal notice 

This document aims to assist users in complying with their obligations under the CLP 
Regulation. However, users are reminded that the text of the CLP 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 request for use of an alternative chemical name for a substance in a 
mixture 

Reference:  ECHA-16-B-12-EN 

Catalogue number: ED-01-16-381-EN-N 

ISBN: 978-92-9247-848-3 

DOI:  10.2823/93208 

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 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

4 

Version 1.0 

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 ..................................................... 6 

1.3. 

Information required for alternative name request dossier ........................................................ 7 

1.4.  Checks performed by ECHA on the submitted dossiers .............................................................. 7 

1.4.1. 

The Validation assistant .................................................................................................... 7 

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

2. 

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

2.1.  How to update and synchronise the LEO information ................................................................ 8 

3. 

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

3.1.  Creating a contact ................................................................................................................ 9 

4. 

5. 

Chemical inventories ......................................................................................................... 9 

Reference substance ....................................................................................................... 10 

5.1.  Creating a reference substance ............................................................................................ 10 

6. 

How to create a Substance dataset ................................................................................. 11 

6.1.  Copy/update from registered Substance dataset .................................................................... 14 

6.2.  Section 1 General information .............................................................................................. 14 

6.2.1. 

Section 1.1 Identification ................................................................................................ 15 

6.2.2. 

Section 1.2 Composition ................................................................................................. 17 

6.2.3. 

(Optional) Section 1.3 Identifiers ..................................................................................... 24 

6.2.4. 

(Optional) Section 1.4 Analytical information ..................................................................... 24 

6.3.  Section 2 Classification & Labelling and PBT assessment ......................................................... 26 

6.3.1. 

Section 2.1 GHS ............................................................................................................ 26 

6.4.  Section 13 Assessment reports ............................................................................................ 34 

6.5.  Section 14 Information requirements .................................................................................... 35 

6.5.1. 

Alternative name request ................................................................................................ 35 

7. 

How to create a Dossier .................................................................................................. 36 

7.1.  Administrative information .................................................................................................. 37 

7.1.1. 

Specific submissions ...................................................................................................... 37 

8. 

9. 

How to export a Dossier .................................................................................................. 38 

Submit Dossier ................................................................................................................ 38 

10.  Update Dossier ................................................................................................................ 38 

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

dossiers .......................................................................................................................... 39 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Table of Figures 

Release date XX 

5 

Figure 1:  An example of selecting the template from the picklist ...................................... 13 
Figure 2:  Degree of purity ........................................................................................... 18 
Figure 3:  Constituent .................................................................................................. 19 
Figure 4:  Unknown impurities ...................................................................................... 20 
Figure 5:  Additive ....................................................................................................... 21 
Figure 6:  Analytical determination ................................................................................ 25 
Figure 7:  Optical activity ............................................................................................. 25 
Figure 3:  Specify the affected organ ............................................................................. 30 
Figure 4:  Specific concentration limits ........................................................................... 31 
Figure 5:  Specify the Environmental hazards ................................................................. 32 
Figure 6:  Labelling for section 2.1 ................................................................................ 33 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

6 

Version 1.0 

1.  Introduction 

1.1. 

Objective 

Under the CLP Regulation, substances and mixtures placed on the market shall be well 
identified. 

However, a manufacturer (M), importer (I) or downstream user (DU) may be concerned that 
disclosure of the chemical identity of one or several substances contained in the mixture(s), on 
the label and/or on the Safety Data Sheet (SDS), puts the confidential nature of their business, 
in particular intellectual property rights, at risk. 

In such cases, the CLP Regulation allows the M/I/DU to submit a request to use an alternative 
chemical name which refers to that substance in a mixture (either by means of a name that 
identifies the most important functional chemical groups or by means of an alternative 
designation). The criteria for approving such a request are defined in the CLP Regulation (Part 
1 of Annex I, point 1.4.1).  

Note that if an M/I/DU wants to request the use of an alternative chemical name for several 
substances in the same mixture(s), a separate request must be prepared for each substance. 

Where a justification claiming confidentiality of the IUPAC name (for substances listed in 
Articles 119(2)(f) and (g) in accordance with Article 10(a)(xi) of the REACH Regulation) has 
been accepted as valid by the European Chemicals Agency (ECHA), the M/I/DU may use the 
name that is made publicly available over the internet, on the ECHA website, also on the label 
and in the SDS of the mixture(s) (Article 24(8), CLP Regulation). However, for substances in a 
mixture where Article 119(2)(f) or (g) of the REACH Regulation no longer applies, the M/I/DU 
may submit a request to use an alternative chemical name to ECHA. 

The purpose of this manual is to assist in the preparation of such a request and its submission 
to ECHA. For example, it outlines the required information, and the IUCLID sections and fields 
to be filled-in to prepare a request according to Article 24 of the CLP Regulation. 

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 in IUCLID (see chapter 1.5 Functionalities of 
IUCLID). The manual also assumes that you have all relevant information available. 

1.2. 

Overview of the preparation and the submission of a dossier 

A IUCLID dossier is a non-editable snapshot file of a substance dataset, containing the 
information to be submitted to ECHA. To generate a dossier and submit it you have to proceed 
through the following steps: 

Step 1.  Sign-up in REACH-IT and create the Legal entity (https://reach-it.echa.europa.eu/) 

Step 2.  Create/find the reference substance in IUCLID for the substance for which an 

alternative chemical name is requested (see chapter 5) 

Step 3.  Create the substance dataset in IUCLID (see chapter 6) 

Step 4.  Enter the required information in the substance dataset in IUCLID (see relevant 

subsections of chapter 6) 

Step 5.  Create a IUCLID dossier (see chapter 7) 

Step 6.  Export the dossier from IUCLID (see chapter 8) 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

7 

Step 7.  Submit the dossier to ECHA via REACH-IT (see chapter 9) 

1.3. 

Information required for alternative name request dossier 

Before you start preparing your alternative chemical name request dossier in IUCLID, make 
sure that you have the required information available. The required information comprises the 
following: 

 

Identity of the request submitter, i.e. name, contact details (REACH-IT account, submission 
web form); 

  The proposed alternative chemical name (IUCLID section 1.1); 
Identity and composition of the substance (IUCLID sections 1.1, 1.2); 
 
Information on the classification and labelling of the substance (IUCLID section 2.1);  
 
  The SDS of the substance for which an alternative chemical name is requested (IUCLID 

section 13); 

  A justification for non-disclosure of the actual substance name, i.e. a justification 

demonstrating that the request submitter has a commercial interest worthy of protection 
(IUCLID section 13);  

  A justification demonstrating that the use of the alternative chemical name meets the need 
to provide enough information for necessary health and safety precautions to be taken in 
the workplace, and that the risks from handling the mixture can be controlled (IUCLID 
section 13); 

  The trade name(s) of the mixture(s) containing the substance for which an alternative 

chemical name is requested (IUCLID section 14); 

  The SDS(s) of the mixture(s) containing the substance (IUCLID section 14). 

1.4. 

Checks performed by ECHA on the submitted dossiers 

All dossiers submitted to ECHA undergo initial technical and administrative checks in order to 
ensure that they can be handled properly and that the subsequent required regulatory 
processes can be successfully carried out. Such checks are called business rules (BR). 

A dossier can be accepted for processing 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: 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.  

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

8 

Version 1.0 

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. 

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 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 next chapter. 

2.1. 

How to update and synchronise the LEO information 

To register your legal entity you should sign-up into the ECHA accounts where you can enter 
and administer your legal entity information. 

When you create a LEO a numeric identifier called Universal Unique Identifier (UUID) is 
generated. Example of a legal entity UUID: IUC5-a620a92d-32c6-426a-b6ee-fc338cde0932. 

The UUID is different for each LEO, even within the same company in case the company has 
several LEOs.  

You can synchronise the legal entity between IUCLID and REACH-IT by exporting your LEO 
from ECHA accounts or REACH-IT. Then you can import the file to your local IUCLID 
installation. It may be beneficial that the UUID is identical between all the applications where 
the company identity appears (IUCLID, REACH-IT, any web forms submitted to ECHA). 
Alternatively, if you have not yet created your ECHA account, you may export the LEO from 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

9 

your IUCLID installation and import the file to ECHA accounts when you create an account. 
Note that a LEO can be imported to ECHA accounts only while you create an account, and not 
to an existing ECHA account. 

To compare the UUIDs between the applications, you can find them inside each application by 
following the below paths: 

 

IUCLID: Home page > Legal entity > double click your legal entity. The UUID of the 
company is displayed in the Information Panel at the bottom of the IUCLID window.  

  ECHA Accounts: Legal Entity tab > General details > Legal Entity UUID 

  REACH-IT: Menu > Company information > General information > UUID 

For more information on the ECHA account management refer to the ECHA accounts manual 
available at http://echa.europa.eu/support/helpdesks/echa-helpdesk/echa-accounts. 

3.  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. 

3.1. 

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. 

4.  Chemical inventories 

The Chemical inventories contains chemical identifiers, which serve as the basis for defining 
the reference substances. The term inventory is used to compile all the different chemical 
inventories that can be available in IUCLID. Currently, the EC Inventory is the only inventory 
used in IUCLID. 

The EC Inventory is a combination of three individual inventories: 

  EINECS (European Inventory of Existing Commercial Chemical Substances) includes 
substances that were deemed to be on the European Community market between 1st 
January 1971 and 18th September 1981. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
  
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

10 

Version 1.0 

  ELINCS (European List of Notified Chemical Substances) includes substances notified 
under Directive 67/548/EEC, the Dangerous Substances Directive Notification of New 
Substances (NONS) and placed on the market after 18th September 1981. 

  NLP-list (No-Longer Polymers list) includes substances that have been on the European 
Community market between 18th September 1981 and 31st October 1993, and were 
considered to be polymers under the reporting rules for EINECS but were no longer 
considered to be polymers according to the 7th amendment of Dir 67/548/EEC.  

The entries in the EC Inventory consist of a chemical name and a number (EC name and EC 
number), a CAS number1 (if available), molecular formula (if available) and description (for 
certain types of substances). 

5.  Reference substance 

A Reference substance enables you to store 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.  

The Reference substance inventory gives the possibility to use the same information for the 
same chemical identity avoiding to re-type it and to ensure that the data is centrally managed 
and updated. The Reference substance inventory is directly maintained by you, in your local 
installation. Each reference substance can be linked to an unlimited number of substance or 
mixture/product datasets. For updating the information in a reference substance, you can open 
the Reference substance inventory, search for the relevant reference substance and update it. 
The modifications will impact every single dataset linked to that reference substance. 

To extend the number of entries in your inventory, you can search, download and import 
available reference substances from the IUCLID website to your local installation. These pre-
defined reference substances have been prepared to improve data quality and minimise data 
entry. 

5.1. 

Creating a reference substance 

If you do not find a reference substance in the Reference substance inventory, you can create 
a new reference substance. 

There are two types of information that can be reported in a reference substance: 

1.  Information specific to the reference substance: such information exactly corresponds 

to the substance/constituent(s) covered by that reference substance; 

2.  Information related to the reference substance: this information does not accurately 

correspond to the substance/constituent(s) covered by that reference substance for any 
of the following reasons: 

  The information is generic as it also covers other substances/constituents; 
  The information only covers some of the constituents of a reference substance for a 

substance or a group of constituents; 

  The information refers to a similar constituent/substance; 

1 In the case of substances listed in the EC inventory with an EC number starting with 4, there may be no CAS number published even though a 
CAS number may exist for that substance.  This is because under the notification scheme for new substances which existed under the previous 
legislation the CAS number could be claimed confidential and therefore was not published. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
                                           
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

11 

  The information is not the latest available information to identify the 

substance/constituent(s) 

Related information should be reported under the Identifiers of related substances as it may 
create an ambiguity on the identity of substance or constituent(s) which a reference 
substance corresponds to. 

To create a reference substance: 

Step 1.  Right-click on the Reference substance 

 on the home page and select New. 

Step 2.  Enter the name of the reference substance. 

Step 3. 

Step 4. 

If the reference substance is listed in the EC inventory you can assign that 
entry by clicking the Add button. 

If your reference substance is not listed in the EC inventory, select a 
justification from the picklist proposed under the No inventory information available. 

Step 5.  Complete as far as possible the remaining fields of the reference substance.  

The following information, if available and/or applicable, should be submitted for all the known 
constituents and additives: 

IUPAC name, 

  EC Inventory information, 
  CAS number and CAS name, 
 
  Description (Specify any additional information relevant for the description of the reference 
substance in this field. This is important especially when the reference substance does not 
correspond to a well-defined chemical substance. Attached files can be added if 
necessary.), 

  Synonyms, 
 
  Molecular formula (if a molecular formula cannot be derived from the reference substance, 

Identifiers of related substances, 

a justification should be indicated in the Remarks field at the bottom of the section); 

  Molecular weight range, 
  SMILES notation, 
 
  Upload an image file with the Structural formula. 

InChI, 

Step 6.  To save the reference substance click on 

 from the main menu.  

6.   How to create a Substance dataset 

This chapter outlines which information you have to provide through different sections of 
IUCLID, which depends on the type of submission that you wish to do via a IUCLID 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. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

12 

Version 1.0 

To create a IUCLID dossier, you first need to create a substance dataset. A substance 
dataset is a repository of administrative and scientific data for a substance. The information in 
the dataset can be modified: you can add, remove or change information in the dataset. The 
dataset is used as basis for the dossier. The dossier is a snapshot of the dataset at a 
certain moment; the information in the dossier cannot be modified. 

To create a dataset: 

Step 1.  Right-click on the Substance 

 on the IUCLID home page and then select New.  

Step 2.  Fill in the field Substance name. Especially if your IUCLID installation contains 

several datasets, ensure to enter a name that you can easily use to distinguish the 
substance. 

Step 3.  Assign an existing legal entity to the dataset by clicking on the 

 button. A new 

window opens where you can search for legal entities within your IUCLID installation. 
Enter the search criteria, select the appropriate legal entity from the list, and assign 
it to the substance dataset. 

Step 4.  Save the information by clicking the 

 icon in the main menu.  

For more information on how to fill in the fields in this view, see section 1.1 Identification. 

To complete a dataset: 

Step 1.  Once your substance dataset is created it is displayed in the navigation panel on the 

left part of the screen.  

Step 2.  To open your dataset double-click or right-click and select Open.  

Step 3.  When the dataset is open the Table of contents (TOC) tab is displayed in the 

navigation part of the screen. 

Step 4.  To view the table of contents that is relevant for the type of dossier that you are 

preparing, click on the filled downward arrow (

) in the TOC tab.  

Step 5.  A list of different submission types appears. Select the specific type of submission 

from the list.  

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

13 

Figure 1:  An example of selecting the template from the picklist 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

14 

Version 1.0 

Step 6.  The sections relevant for the submission type are now displayed. Sections including 

mandatory information to complete are marked with the asterisk (
). Note that if 
you are creating a dataset but do not yet know the exact REACH dossier type that 
will be prepared, you can select the option REACH Complete table of contents. This 
will display the table of contents containing all sections that are relevant under the 
REACH Regulation. 

Once you have created a dataset for your substance, you can enter data on the substance in 
this dataset. The following chapters describe what data should be entered into each section of 
IUCLID for the specific type of submission that this manual refers to. The sections are shown 
with their name and the numbering used with the relevant IUCLID table of contents view.  

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. 

6.1. 

Copy/update from registered Substance dataset 

If a Substance dataset has already been submitted for a registration it may contain 
information also relevant for the alternative chemical name request. Thus, the request 
submitter may take advantage of this by copying an existing registration Substance dataset to 
a newly created Substance dataset for an alternative chemical name request. For instance, 
sections 1.1 Identification, 1.2 Composition, 2.1 GHS, and 13 Assessments reports, might 
benefit to be automatically imported from an existing registration Substance dataset. 

The request submitter may then proceed to the appropriate refinement of information 
specifically related to the alternative chemical name request (e.g. not all documents required 
for an alternative chemical name request 13 are in place in section 13 of a registration 
Substance dataset). 

6.2. 

Section 1 General information 

In section 1, General information, enter information on substance identity. 

To fulfil your obligation under Article 24 of the CLP Regulation, Section 1.1 of your IUCLID 
dossier must contain the following minimum information: 

The suggested alternative chemical name of the substance in the mixture(s); AND 

  A Reference substance with an EC number; OR 
  A Reference substance with a CAS number; OR 
  A Reference substance with a IUPAC name AND a Molecular formula AND Molecular 

  weight range AND Structural formula; OR 

  A Reference substance with a IUPAC name and Remarks; OR 
  A Reference substance with a IUPAC name and SMILES notation. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

15 

How to fill in the suggested alternative chemical name for the substance: 

Specify in the Public name field under in section 1.1, the alternative chemical name you are 
requesting to use for the substance in the mixture(s). It is recommended to indicate the 
alternative chemical name in English, if possible. The alternative chemical name can be a name 
referring to the most important functional chemical groups of the substance or an alternative 
designation. 

The Lexicon guide (Part B, Annex VI to the Dangerous Preparations Directive) is recommended 
to be used for establishing the alternative chemical name. It is however not mandatory to use 
this guide. 

In all cases the names chosen must provide enough information to ensure that the mixture(s) 
can be handled without risk and that necessary health and safety precautions can be taken in 
the workplace. 

In case the substance for which an alternative chemical name is requested is marketed in 
more than one EU country, it is recommended to add the alternative chemical name in the 
language(s) of the additional country(-ies) as well, under the Other identifiers field in the Type 
of substance block:  

Step 1.  Click the Add button under the Other identifiers  

Step 2. 

In the dialog box appearing, first choose Alternative name in the picklist under 
Identifier, then the alternative chemical name in the additional language in the 
Identity field, and finally choose the respective country in which the substance is 
marketed in the Country picklist; 

Step 3.  Repeat the same procedure for any other additional country/name. 

Step 4.  Choose the type of substance for which the alternative chemical name is requested in 

the Type of substance picklist.  

For guidance on how to identify substance type, and how to complete the relevant information 
in section 1.1 and 1.2 for each substance type, see sections below. 

6.2.1. 

Section 1.1 Identification 

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

To complete this section, follow the steps: 

Step 1. 

In the Substance name field type the name of the substance for which you are 
preparing the dossier. 

Step 2.  Assign a Legal entity to your substance dataset by clicking on the 

 button (see 

chapter Legal entity).  

Role in the supply chain: 

Step 3.  Select at least one checkbox in this section according to your role in the supply chain 

with regards to this substance. 

Please note that it is not possible to appoint a Third party representative to submit a request 
for use of an alternative chemical name in (a) mixture(s). 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

16 

Version 1.0 

If you are a non-EU manufacturer who wishes to keep certain substance identity details 
confidential to the EU importer of your mixture(s), please contact the ECHA Helpdesk 
(http://echa.europa.eu/web/guest/support/helpdesks/) 

Identification of substance: 

Step 4.  Click the 

 button to assign a reference substance to your substance dataset.  

Step 5.  A query dialog appears. Search for your reference substance. Click Assign. 

If you cannot find your reference substance because it has not been created yet, click New and 
create it (see chapter Reference substance). 

The information to be reported in your reference substance depends on the substance type:  

  Mono-constituent substances: 

A mono-constituent substance is a well-defined substance for which one constituent is 
present at a concentration of at least 80 % (w/w). This constituent is the main constituent of 
the substance. The substance is named according to the chemical name of that main 
constituent.  

If your substance is a mono-constituent substance, assign the reference substance2 
corresponding to the main constituent in section 1.1. 

  Multi-constituent substances: 

A multi-constituent substance is a well-defined substance for which more than one 
constituent is present at a concentration between  10 % and  80 % (w/w).  These 
constituents are the main constituents of the substance. A multi-constituent substance is 
normally named as a reaction mass of the main constituents.3  

If your substance is a multi-constituent substance, assign the reference substance4 
corresponding to the reaction mass of the main constituents of your substance in section 
1.1. 

  UVCB substances: 

UVCB substances (i.e. substances of Unknown or Variable composition, Complex reaction 
products or Biological materials) are substances that cannot be sufficiently identified by their 
chemical composition.  

If your substance is a UVCB substance, assign a reference substance5 corresponding to the 
UVCB substance in section 1.1. 

2 Note that for the reference substance: Molecular formula, Molecular weight range and Structural formula must be provided. In addition, the 
SMILES notation should also be provided if available. 

3 Certain multi-constituent substances corresponding to reaction masses of isomers may sometimes be more conveniently named using a 
chemical name where the isomeric form is not specified rather than as a "reaction mass". 

4 Note that the Molecular formula, Molecular weight range and Structural formula of the reference substance must be provided or a justification for 
not providing this information must be given in the Remarks field. In addition, the SMILES notation should also be provided if available. 

5 Note that the Molecular formula, Molecular weight range and Structural formula of the reference substance must be provided or a justification for 
not providing this information must be given in the Remarks field. In addition, the SMILES notation should also be provided if available. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
                                           
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

17 

Type of substance: 

Step 6.  Select the appropriate Type of substance from the picklist.  

We also recommend you to read the Guidance for identification and naming of substances 
under REACH and CLP available at http://echa.europa.eu/guidance-documents/guidance-on-
reach.  

Step 7.  Select the Origin, e.g., organic or inorganic, from the picklist. 

Step 8.  You can include additional identifiers for your substance under Other identifiers. 

Step 9.  You can add information of the contact person(s) for this substance from the 

previously defined contacts (see chapter Contact). 

Step 10.  To save the information click 

 from the main menu. 

6.2.2. 

Section 1.2 Composition 

Section 1.2 is used for describing the identity of your substance at a compositional level. In 
this section, you will report the identity and concentration of the constituents of the 
composition, including any impurities and additives. The state and form of your composition(s) 
is reported in this section. 

You are advised to ensure that the information included in IUCLID section 1.1 and section 1.2 
is sufficient to clearly report your substance identity and is consistent between both sections. 
In particular, this information reported may not be so generic that it would describe more than 
one substance. 

Each substance dataset must contain at least one composition record which refers to the 
composition manufactured, imported or used by the registrant/notifier/applicant. Depending on 
the type of substance and dossier to be prepared, it may be necessary to report more than one 
composition. This is in particular the case where compositional differences affect the hazard 
profile and classification of the substance.  

Each composition is reported as a record in IUCLID. To create a new record: 

Step 1.  Right-click on the 1.2. Composition in the TOC from the navigation panel on the left 

part of the screen. 

Step 2.  From the picklist select New record. 

Step 3.  A new record to report a new composition is created. 

Next, fill in the information on your substance composition. 

General information: 

Step 1.  Provide a descriptive Name for the composition. This is especially relevant if you 

report multiple compositions. 

Step 2.  The default selection in the Type of composition field is legal entity composition of 
the substance. This refers to a composition manufactured, imported or used by the 
registrant/notifier/applicant. Each dataset should contain at least one composition of 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

18 

Version 1.0 

this type. Only modify this value where you intend to report a composition with a 
different purpose. For more information on what composition types that can be 
reported for that submission please refer to the specific instructions for the 
submission type that you are preparing. 

Step 3. 

Indicate the physical State/form of the composition by selecting the appropriate  
value in the picklist. Where the substance covers different physical states or forms, a 
separate composition should be created for each of them.  

Step 4.  You can give more detailed information on the composition under the Description of 

composition. This is particularly important when several compositions are reported in 
order to clarify the differences between the compositions. Providing further 
considerations on how the composition has been defined is also advisable when the 
composition covers wide concentration ranges or polymorphs or isomers. For 
substances that cannot be described with well-defined and quantified constituents 
(e.g. UVCB substances), further information to identify the composition is provided in 
this field, including the identity of the starting materials and a description of the 
production process used to manufacture the substance. 

Step 5.  You can provide supporting attachments under the Attached description. 

Step 6. 

In the Justification for deviations field, provide where relevant, the justification for 
deviating from the rules for reporting the composition of substances as specified in 
the legal text and indicated in the Guidance for identification and naming of 
substances under REACH and CLP available at 
http://www.echa.europa.eu/web/guest/guidance-documents/guidance-on-reach. 

Degree of purity: 

Step 7.  Provide the degree of purity of the composition, together with the unit of 

measurement. For instance, a substance with a purity of between 95-98% (w/w) will 
be given as shown below. 

Note: The degree of purity should correspond to the overall concentration of the 
(main) constituents in the composition. 

Figure 2:  Degree of purity 

Constituents: 

Step 8. 

Include the constituents for the composition by clicking the 
composition must have, as a minimum, one constituent. The number of constituents 
to be reported will depend on the type of substance. To add more constituents, click 
the 

, and then the new repeatable blocks will appear.  

 button. Each 

Step 9.  Assign a reference substance to the newly created constituent by clicking the 

button. Search for the appropriate reference substance and add it by selecting it and 
clicking Assign; alternatively, create a new reference substance to specify the 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

19 

constituent (see Reference substance). Ensure that the reference substance contains 
a chemical name in the IUPAC name field, and the appropriate EC and CAS 
identifiers, as available. 

Step 10.  Indicate the Typical concentration and the Concentration range (minimum and 
maximum values, and unit of measurement) for every constituent. 

Figure 3:  Constituent 

Impurities and additives: 

Step 11.  To complete the information regarding Impurities and Additives follow the same 

procedure. 

Step 12.  Where the impurity or additive is considered relevant for classification and labelling 

of the substance, the relevant box must be ticked.  

Step 13.  The function of each additive has to be provided by making a selection in the picklist 

Function. Only selections beginning with the word stabiliser are applicable under 
REACH and CLP.  

To report unknown impurities, create a generic reference substance (see Reference 
substance) and insert in the IUPAC name field the phrase unknown impurities. In the Remarks 
field of the impurity block, specify the nature, number and relative amounts of the impurities 
as far as possible. Also provide the Typical concentration (with unit of measurement) and 
Concentration range (with unit of measurement) for the unknown impurities. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

20 

Version 1.0 

Figure 4:  Unknown impurities 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Figure 5:  Additive 

Release date XX 

21 

When reporting information on the composition, where there is any deviation from the rules 
for identifying a mono-constituent, multi-constituent or UVCB substance, you will need to 
provide explanations for the deviations in the field Justification for deviations. Such 
deviations include, for example, reporting a mono-constituent composition that includes a 
main constituent with a concentration of less than 80 %. 

The composition to be reported depends on the substance type: 

Mono-constituent substances: 

For mono-constituent substances, you have to complete the following information: 

  Report only the main constituent under the Constituents in section 1.2. Assign the same 

reference substance for this constituent as in section 1.1. 

  Report individually any impurities under the Impurities in section 1.2. 

  Report any additive necessary to stabilise your composition under the Additives in section 

1.2. Specify the stabilising function of the additive from the picklist Function. 

  Report the concentration range (both minimum and maximum values) and the typical 

concentration for the main constituent, any impurity and any additive. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

22 

Version 1.0 

Note: The typical concentration and concentration range values reported for the main 
constituent of a mono-constituent substance should normally not be less than 80% (w/w).6 

  Report a degree of purity for your composition corresponding to the concentration range of 

the main constituent. 

Multi-constituent substances: 

For multi-constituent substances, you have to complete the following information: 

  Report the main constituents under the Constituents in section 1.2.  

Note: The main constituents should be the same for all compositions reported. 

  Report any other constituent below 10% under Impurities in section 1.2. 

  Report any additive necessary to stabilise your composition under Additives in section 1.2. 

Specify the stabilising function of the additive from the picklist Function. 

  Report the concentration range (both minimum and maximum values) and the typical 

concentration for the main constituents, any impurity and any additive. 
Note: The typical concentration and concentration range values of each main constituent 
should normally be  10 and  80%.7 

  Report a degree of purity for the composition corresponding to the overall concentration 

range of the main constituents. 

UVCB substances: 

For UVCB substances, you have to complete the following information: 

  Report the description of the manufacturing process, as well as other information relevant 

for the substance identification, in the field Description of the composition. 
Note: To facilitate the reporting of the manufacturing process, suggestions as to what to 
enter are provided in a free text template for the field Description of composition. To open 
the free text template, click on the icon that shows the letter A with an arrow at the bottom 
right, 
copy the text from the template to the field, click on the button labelled Insert. The text 
should then be edited so that it contains only the relevant data. 

. A pop-up window appears. Click Option 2: composition of a UVCB substance. To 

  Report the appropriate individual constituents or groups of constituents under Constituents.  

Note: To provide information on the constituents or groups of constituents in your 
substance, you must not reuse, in section 1.2, the reference substance already assigned 
for your substance in section 1.1.  

6 Any deviation from the "80% rule" should not be applied, unless a valid justification is provided. This justification  should be provided in the 
Justification for deviations field for each composition where such a deviation is applied. 

7 Any deviation from the "80% rule" should not be applied, unless a valid justification is provided. This justification  should be provided in the 
Justification for deviations field for each composition  where such a deviation is applied. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
 
 
 
                                           
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

23 

  Do not report any constituent under the Impurities header of the composition (impurities 

are not considered relevant for UVCBs). 

  Report any additive necessary to stabilise your composition under the Additives header. 

Specify the stabilising function of the additive. 

  Report the concentration values of the individual constituents, groups of constituents and 

any additive as a concentration range (both minimum and maximum values) and typical 
concentration. 

  Report the appropriate degree of purity for your UVCB substance (the degree of purity 

should normally be 100% for UVCBs which do not include any additive, as the concept of 
impurity is not considered relevant for these substances).  

Reporting the characterisation of nanomaterials: 

This sub-section is filled in when solid: nanomaterial has been selected in the State/form 
picklist for that composition. It includes fields to report key characteristics of compositions that 
are nanoforms. 

Step 14.  Select the Shape of the nanoform from the available options in the picklist.  

Step 15.  Provide size ranges for the three Dimensions x, y, z and the unit of measurement 

(e.g. nm). Provide the Percentile (e.g. D50) of the size distributions to which the size 
ranges refer to. Additional information on shape of the nanoform can be provided in 
the Remarks field. 

Step 16.  Provide the ranges of specific surface areas of the nanoform, together with the unit. 

Step 17.  Under Surface treatment applied, indicate whether surface treatment was applied, 

and the type of treatment as relevant. 

Step 18.  Where surface treatment was applied, provide information on the treatment. Click on 

 button to create a surface treatment block and indicate a name for the 

the 
surface treatment.  

Step 19.  Next, in the table Surface treatment report the identity of the surface treatment 

agents layer-by-layer. Click on the Add button to create a new row for each layer. 
This action will open a dialogue window, where you indicate the layer number, and 
link a reference substance that describes the surface treatment agent applied by 

clicking the 

 button.  

Step 20.  Indicate the nature of the External layer by selecting one of the options available in 
the picklist. Provide the % (w/w) Total fraction of core particle that is representative 
of this nanoform. This value refers to the weight fraction of the core particle relative 
to the total weight of the surface-treated particle. Any supporting information, such 
as illustrations of the particle structure can be attached. 

Note that several surface treatment blocks can be created within the same composition. This 
refers to the situation where several nanoforms with similar surface treatment exist, but where 
the dossier submitter has determined that this does not impact the chemical identity or the 
hazard profile of this composition. 

When the nanoforms of the substance vary significantly in shape, specific surface area or 
surface treatment applied, then separate composition records are created to reflect these 
differences.  

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

24 

Version 1.0 

Step 21.  To save the information click 

 from the main menu. 

6.2.3. 

 (Optional) 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, 
REACH pre-registration number, REACH inquiry number, notification number (NCD), CLP 
notification number. 

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. 

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. 

6.2.4. 

(Optional) Section 1.4 Analytical information 

Section 1.4 is for the inclusion of analytical information such as spectra or chromatograms to 
enable the identity of your substance to be verified, including the compositions specified in the 
dossier. It is also the place to include the descriptions of the methods used to generate this 
information.  

In this section you can create several records to include analytical information you consider 
sufficient to verify the identity of your substance. To create a new record: 

Step 1.  Right-click on 1.4 Analytical information in the TOC from the navigation panel on the 

left part of the screen. 

Step 2.  From the picklist select New record. 

Step 3.  A new record to report the analytical information is created. 

To complete this section, follow the steps: 

Methods and results of analysis: 

Use the table Analytical determination to provide analytical information used to verify the 
identity of the substance.  

Step 1.  Click on the Add button and then the pop-up window appears. 

Step 2.  Fill in the information on the analytical methods and results. 

For each analytical determination: enter the purpose for which the analysis was carried out, 
select the Analysis type (e.g. spectral, chromatographic), Type of information provided, and 
any Remark you consider relevant. For each method, you should attach the file containing the 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

25 

method and the result of the analysis. If you cannot provide results for the indicated analysis 
type, select the reason from the picklist Rationale for no results and fill in the explanation in 
the Justification field. Note that several analysis types can be reported for one determination. 

You can choose to enter identification or quantification as purpose of an analysis. Both 
identification and quantification analyses are expected to be submitted to verify the 
composition of a substance. 

Identification refers to any analysis carried out to establish the identity of the constituents, 
including their chemical functionalities, present in the composition of a substance. Examples 
of analyses used for identification are spectroscopic analyses such as UV, IR, NMR, MS or 
XRD. 

Quantification refers to any analysis carried out to establish the concentration of the 
constituents in the composition. Examples of analyses used for quantification are 
chromatographic analyses, elemental analyses, titration. 

Some analyses may be carried out both for identification and quantification purposes. 

Figure 6:  Analytical determination 

Step 3. 

Indicate whether your substance is optically active by selecting the appropriate value 
from the picklist. 

Step 4.  Provide information on the optical activity, whenever applicable in the Remarks field. 

Figure 7:  Optical activity 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

26 

Version 1.0 

Related composition(s): 

Step 5.  You can link the reported analytical information to the relevant Composition from 
section 1.2 by clicking the Add button. This is especially relevant when you have 
reported several compositions in section 1.2. 

6.3. 

Section 2 Classification & Labelling and PBT assessment 

6.3.1. 

Section 2.1 GHS 

Use this section to specify the Classification and Labelling (C&L) information of your substance 
resulting from the application of the criteria of the CLP Regulation.  

It is highly recommended to consult Annex I of the CLP Regulation for the classification 
criteria and the following guidance document for more detailed instructions on the 
application of the C&L criteria available at http://echa.europa.eu/web/guest/guidance-
documents/guidance-on-clp.  

In this section you can create several records to indicate more than one C&L for different 
compositions and forms of a substance. Note that when a new record is created you must fill in 
the data in all requested fields. 

To create a new record: 

Step 1.  Right-click on the section 2.1 GHS in the TOC from the navigation panel on the left 

part of the screen. 

Step 2.  From the picklist select New record. 

Step 3.  A new record to report the classification and labelling information is created. 

Harmonised classification has to be respected and you should not modify any of those 
harmonised hazard classes/differentiations, unless you have data based on which a stricter 
classification (hazard classes and/or differentiations) applies. Therefore, if your substance 
has a harmonised classification for some hazard classes/differentiations, you should classify 
for other hazards according to available and reliable data. 

To complete this section, follow the steps: 

General information: 

Step 1.  Enter a descriptive Name for the GHS record. This is particularly relevant in the case 

that multiple GHS records are created, to easily distinguish the different records.  

Step 2.  Select a composition(s) in the Related composition field for which the GHS record is 

relevant by clicking the Add button.  

If you have several compositions (several records in section 1.2) and several GHS records (i.e. 
several classification and labelling pairs), then it is mandatory that you link each GHS record to 
the related composition(s) by using the Related composition field. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

27 

Several compositions can be linked to the same C&L record if they have the same 
classification.  

Classification: 

In this block you must select a Hazard category and Hazard statement for each hazard class of 
differentiation, otherwise, you must fill in the Reason for no classification. 

Special attention should be given to Part 1.4 of the Annex I to the CLP Regulation, where 
specific criteria for “requests for use of an alternative chemical name under Article 24” are 
illustrated. 

Requests for the use of an alternative chemical name under Article 24 of the CLP Regulation 
may be granted when the substance is exclusively classified as one or more of the hazard 
categories listed below: 

Hazard class or 

differentiation 

Hazard 
category 

Hazard statement 

Physical Hazard classes 

All 

All 

Acute toxicity - oral 

Category 4 

H302: Harmful if swallowed 

Acute toxicity - dermal 

Category 4 

H312: Harmful in contact 
with skins 

Acute toxicity - inhalation 

Category 4 

H332: Harmful if inhaled 

Skin corrosion/irritation 

Category 2 

H315: Causes skin irritation 

Serious eye damage/eye irritation  Category 2 

Specific target organ toxicity — 
Single exposure 

Category 2 

H319: Causes serious eye 
irritation 

H371: May cause damage to 
organs <or state all organs 
affected, if known> <state 
route of exposure if it is 
conclusively proven that no 
other routes of exposure 
cause the hazard> 

Specific target organ toxicity — 
Single exposure 

Category 3 

H335: May cause respiratory 
irritation 

Specific target organ toxicity — 
Single exposure 

Category 3 

H336: May cause drowsiness 
or dizziness 

Specific target organ toxicity — 
Repeated exposure 

Category 2 

H373: May cause damage to 
organs <or state all organs 
affected, if known> through 
prolonged or repeated 
exposure <state route of 
exposure if it is conclusively 
proven that no other routes 
of exposure cause the 
hazard> 

Hazardous to the aquatic 
environment — Chronic 

Category 3 

H412: Harmful to aquatic life 
with long lasting effects 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

28 

Version 1.0 

Hazardous to the aquatic 
environment — Chronic 

Category 4 

H413: May cause long lasting 
harmful effects to aquatic life 

The  Reason for no classification should be selected according to the following principles: 

  data lacking should be selected if you do not have relevant data or other adequate and 

reliable information that can be compared with the classification criteria; 

 

 

inconclusive should be selected if you have data or other information which is not reliable 
(e.g. data of poor quality) or if you have several equivocal study results or information. In 
these cases, the available data/information cannot be regarded as a firm basis for 
classification; 

conclusive but not sufficient for classification should be selected in cases where a substance 
is tested with the appropriate high quality reflected in the study or where other high quality 
information is available, and based on that, it is concluded that the classification criteria are 
not fulfilled. 

Note that the CLP regulation foresees certain waivers: 

If a substance is classified for certain physical hazards, it does not need to be classified for 
certain others. For example: explosives, organic peroxides, self-reactive substances and 
mixtures as well as pyrophoric or oxidising solids should not be considered for classification 
as flammable solids since flammability is an intrinsic hazard in these classes. 

If a substance has a particular physical state, e.g. it is a gas, it does not need to be 
classified for hazards that are only associated with other physical states, e.g. as an oxidising 
solid or corrosive to metals. 

In case of the above classification waivers apply, you should select conclusive, but not 
sufficient for classification as a reason for no classification. 

and interconnections: 

If a substance is classified for Skin corrosion Category 1, the risk of severe damage to eyes 
is considered implicit (but not the vice versa). In this case, the substance should be 
classified for Eye damage Category 1. 

  Classification - Physical hazards: 

Step 3.  Specify the Hazard category (e.g. Expl. Div. 1.1) and Hazard statement (e.g. H201: 
Explosive; mass explosion hazard) for the Physical hazards by selecting the 
appropriate values from the picklists. 

The CLP Regulation implements the Globally Harmonized System of Classification and Labelling 
of Chemicals (GHS). However, not all the hazard categories and corresponding hazard 
statements from the GHS have been implemented into the CLP regulation. Therefore, please 
note when populating IUCLID section 2.1 - GHS that not all the available entries are relevant 
for CLP (e.g. Flammable liquids/Flammable liquid 4/H227: Combustible liquid). 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

29 

  Classification - Health hazards: 

Step 4.  Specify Hazard category (e.g. Acute Tox. 4) and Hazard statement (e.g. H302: 

Harmful if swallowed) for the Health hazards by selecting the appropriate values 
from the picklists. 

For more instructions on the selection of these codes, please consult the guidance on the 
application of the CLP criteria available at http://echa.europa.eu/web/guest/guidance-
documents/guidance-on-clp.   

Step 5.  For the following hazard class or differentiation: Specific target organ toxicity - single 

exposure (STOT SE) and Specific target organ toxicity - repeated exposure (STOT 
RE) you should fill in Hazard category, Hazard statement and Affected organs, 
otherwise, the field Reason for no classification should be filled in.  

It is recommended to include no more than three primary target organs for practical reasons 
and because the classification is for specific target organ toxicity. If more target organs are 
affected it is recommended that the overall systemic damage should be reflected by the phrase 
damage to organs. 

If the affected organ is unknown, indicate unknown in the field Affected organs. For these and 
other classes/differentiations, you are also advised to indicate the Route of exposure, where 
applicable. 

You can specify more than one STOT SE /STOT RE by adding additional blocks by clicking on 

the 

 symbol.  

The route of exposure should only be specified if it is conclusively proven that no other route 
of exposure causes the hazard. Supporting evidence can be attached in section 13 (unless it 
is already specified in Annex VI to the CLP Regulation). 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

30 

Version 1.0 

Figure 8:  Specify the affected organ 

The CLP Regulation implements the Globally Harmonized System of Classification and Labelling 
of Chemicals (GHS). However, not all the hazard categories and corresponding hazard 
statements from the GHS have been implemented into the CLP regulation. Therefore, please 
note when populating IUCLID section 2.1 - GHS that the following entries under the health 
hazards are not relevant for CLP.  

Hazard class 

Hazard category 

Hazard statement 

Acute toxicity - oral 

Acute Toxicity 5 

Acute toxicity - dermal 

Acute Toxicity 5 

Acute toxicity - inhalation 

Acute Toxicity 5 

Skin corrosion / irritation 

Skin Mild Irritation 3 

Serious eye damage / eye 
irritation 

Eye Irritation 2A 

Eye Irritation 2B 

Aspiration hazard 

Asp. Toxicity 2 

H303 

H313 

H333 

H316 

H320 

H305 

  Classification - Specific concentration limits: 

Step 6. 

If your substance has harmonised Specific concentration limits, you need to specify 
them by filling in at least one of the two range fields in the Concentration range (%) 
and in addition, you also need to indicate the relevant Hazard categories.  

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

31 

You can specify more than one concentration limit by adding additional blocks by 

clicking on the 

 symbol. 

If you propose to set specific concentration limit(s) under the strict condition of Article 10 ofthe 
CLP Regulation, you have to provide a scientific justification in section 13.  

For each specific concentration limit (SCL), you should specify: 

  a concentration range (at least one of the two range fields); 
  at least one hazard statement related to the SCL. 

Figure 9:  Specific concentration limits 

The CLP Regulation implements the Globally Harmonized System of Classification and Labelling 
of Chemicals (GHS). However, not all the hazard categories and corresponding hazard 
statements from the GHS have been implemented into the CLP regulation. Therefore, please 
note when populating IUCLID section 2.1 - GHS that the following hazard categories under the 
specific concentration limits are not relevant for CLP. 

Hazard category 

Flammable Liquid 4 

Acute Toxicity 5 

Skin Mild Irritation 3 

Eye Irritation 2A 

Eye Irritation 2B 

Asp. Toxicity 2 

  Classification - Environmental hazards: 

Step 7.  Specify Hazard category (e.g. Aquatic Acute 3) and Hazard statement (e.g. H412) for 

the Environmental hazards by selecting the appropriate values from the picklists.  

The CLP Regulation implements the Globally Harmonized System of Classification and Labelling 
of Chemicals (GHS). However, not all the hazard categories and corresponding hazard 
statements from the GHS have been implemented into the CLP regulation. Therefore, please 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

32 

Version 1.0 

note when populating IUCLID section 2.1 - GHS that the following entries under the 
environmental hazards are not relevant for CLP. 

Hazard class 

Hazard category 

Hazard statement 

Hazardous to the aquatic 
environment 

Aquatic Acute 2 

Aquatic Acute 3 

H401 

H402 

Figure 10:  Specify the Environmental hazards 

Labelling: 

Step 8.  Specify the Signal word by selecting the appropriate value from the picklist. If no 

signal word applies to your substance, then you need to select No signal word from 
the picklist. 

Step 9. 

If applicable, please select a Hazard pictogram from the picklist. You can select more 

than one pictogram by clicking on 

. 

Step 10.  You should select at least one Hazard statement from the picklist and provide 

Additional text where applicable or, if no hazard statement applies to your substance, 
then you need to select No hazard statement.  

You can always specify more than one hazard statement for the labelling by clicking 

on 

.  

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Figure 11:  Labelling for section 2.1 

Release date XX 

33 

The principles of precedence for the hazard pictograms are stated in Art. 26 of CLP Regulation, 
for example, if the hazard pictogram 'GHS06' applies, the hazard pictogram 'GHS07' shall not 
appear on the label. Please consult CLP Regulation and/or the guidance on the application of 
the CLP criteria to ensure consistency of the between the classification and labelling sections. 

According to Art. 27 of CLP Regulation, some hazard statements are not required in the label 
because of redundancy. For additional information please consult the guidance on the 
application of the CLP criteria.  

The CLP Regulation implements the Globally Harmonized System of Classification and Labelling 
of Chemicals (GHS). However, not all the hazard categories and corresponding hazard 
statements from the GHS have been implemented into the CLP regulation. Therefore, please 
note when populating IUCLID section 2.1 - GHS that the following hazard statements for 
labelling are not relevant for CLP. 

Hazard statement (in Labelling section): 

H227: Combustible liquid 

H303: May be harmful if swallowed 

H305: May be harmful if swallowed and enters airways 

H313: May be harmful in contact with skin 

H316: Causes mild skin irritation 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

34 

Version 1.0 

H320: Causes eye irritation 

H401: Toxic to aquatic life 

H402: Harmful to aquatic life 

H303+H313: May be harmful if swallowed or in contact with skin 

H303+H333: May be harmful if swallowed or if inhaled 

H313+H333: May be harmful in contact with skin or if inhaled 

H303+H313+H333: May be harmful if swallowed, in contact with skin or inhaled 

H315+H320: Causes skin and eye irritation 

Step 11.  If applicable, please select a Precautionary statements from the picklist.  

Step 12.  If applicable, please specify the Additional labelling requirements.  These include 

supplemental CLP hazard statements and additional labelling elements resulting from 
the application of CLP Article 25. Please consult the CLP Regulation and Guidance for 
further information on the additional  labelling requirements. 

Notes: 

Step 13.  If applicable, you can select note(s) from the picklist.  

6.4. 

Section 13 Assessment reports 

Section 13 is an endpoint study record–type section in which different assessment reports can 
be attached, covering information not documented in other IUCLID sections. This section 
should be used by the request submitter to provide some of the required documents for the 
alternative name request dossier.  

The documents that are mandatory to be attached in section 13 are: 

Safety Data Sheet (SDS) of the substance: 

The SDS of the substance for which an alternative chemical name is requested should be 
attached in this section. The SDS should be in one of the EU/EEA languages (recommended in 
English, if applicable and possible) and according to the format specified in Annex II to the 
REACH Regulation.  

Commercial interest for requesting an alternative chemical name: 

A document demonstrating that the request submitter has a commercial interest worthy of 
protection should be provided. In the document it should be justified why the disclosure of the 
actual substance name would cause potential commercial harm to the submitter or to a third 
party.  

Use of the alternative chemical name provides enough information for safe use: 

A document demonstrating that the use of the alternative chemical name provides enough 
information for safe use should be provided. In this document a demonstration that the use of 
the alternative chemical name meets the need to provide enough information for necessary 
health and safety precautions to be taken in the workplace and that the risks from handling 
the mixture can be controlled should be included in the request should be included. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

35 

You need to attach the before-mentioned documents in IUCLID as part of the Substance 
dataset as follows: 

Step 1.  Right-click section 13 Assessment Reports from the navigation panel on the left part 

of the screen. 

Step 2.  From the picklist select New record. 

Step 3.  A new endpoint study record section appears.  

To complete this section follow the steps: 

Step 1. 

Step 2. 

In the Type of report picklist, choose the relevant document type, e.g. CLP 
justification for requesting an Alternative name, safety data sheet (SDS) or other 
(and write "Justification for safe use" in the adjacent text field). 

In the Document/report field click the 
Browse, find the relevant document, and attach it. Use the Remarks field to specify 
further the nature of the document. Then click OK.  

 button. In the pop-up window, click 

Step 3.  Repeat the procedure for every required document. 

6.5. 

Section 14 Information requirements 

6.5.1. 

Alternative name request 

In this section the request submitter needs to provide the trade name(s) and the SDS(s) of the 
mixture(s) in which they request to use an alternative chemical name. You can indicate several 
mixtures, if the substance for which alternative chemical name is requested is contained in 
more than one mixture, by creating a new record for each of them.  

To create a new record: 

Step 1.  Click on the section 14 Information from the navigation panel on the left part of the 

screen and select Alternative name request. 

Step 2.  From the picklist select New record. 

Step 3.  A new record to report information on mixtures appears. 

To complete this section, follow the steps: 

Step 1. 

Indicate the name of the mixture in the field Name or trade name of mixture product 

Step 2.  Under the Safety data sheets of mixture / product field, select Add to create a row 

and indicate the required mixture information.  

Step 3.  A pop-up window appears on the screen. 

Step 4.  Select the Country in which this mixture is marketed from the picklist. 

Step 5. 

In the Remarks field, indicate the trade name of the mixture in the country in which 
it is marketed; 

Step 6.  Click on the 

 button to attach the SDS of the mixture (preferably in English 

language, or, if not available, in any other EU/EEA language) in the same way as 
done for the SDS of the substance, see section Assessment reports. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

36 

Version 1.0 

In case the mixture is marketed in more than one EU/EEA country, you need to specify the 
additional country in another row but in the same table by following the steps above again (i.e. 
do not create a new record). The SDS of the mixture should be attached only once regardless 
of the number of countries specified in the same table. 

All alternative name requests must contain at least the following information/fields in IUCLID 
section Alternative name request, for each mixture covered by the request:  

  Name of the mixture (Name or trade name of mixture / product field): 
  At least one row in the table Safety data sheets of mixture / product. 
  At least one row in each table must contain: Country AND mixture SDS attached. 
  Remaining rows in the same table (if applicable) must contain at least Country. 

For every additional mixture included in the request, you need to create a new record in the 
section Alternative name request and complete the steps described above. 

7.  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. 

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 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

37 

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. 

7.1. 

Administrative information 

Enter an appropriate Dossier name which enables you to easily identify the dossier when 
searching and exporting it from IUCLID. 

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). 

7.1.1. 

Specific submissions 

When creating your updated dossier on request of ECHA, the checkboxes The submission is an 
update and Further to a request/decision from a regulatory body must be selected.  

The Last submission number and the annotation (communication) number in the request letter 
must be entered in their respective adjacent fields. 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

38 

Version 1.0 

Do not select Spontaneous update for this submission type. This type of update is not 
allowed and will not be processed by ECHA. 

Please ensure that the checkbox Spontaneous update is not selected.  

8.  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. 

9.  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/. 

10. 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). 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

39 

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 and that the 
required regulatory processes can be successfully carried out. 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 before any regulatory processes can be initiated.  

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. 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 submission context (e.g., validity of reference number, duplicate 
submissions, etc.), and therefore the plugin cannot simulate all the business rules checked by 
the Agency.  

Business rules applicable for a request for use of an alternative chemical name 
for a substance in a mixture (CLP alternative name request) 

Location 
(IUCLID/REACH-IT) 

IUCLID  
substance dataset 

Rule description 

Relevance 

A CLP alternative name request dossier must be created from 
a substance dataset. It cannot be created out of a mixture or 
product dataset.  

CLP alternative name 
request 

IUCLID  
section 1.1 – Identification 

Any entry, in the table 'Other names' in section 1.1, indicated 
as 'Alternative name' must contain also the 'Name' and the 
'Country'. 

CLP alternative name 
request 

IUCLID  
section 1.1 – Identification 

The field ‘Public name’ cannot be empty. The requested 
alternative name has to be provided in this field. 

CLP alternative name 
request 

IUCLID  
section 1.1 – Identification 

IUCLID  
section 1.2 – Composition 

IUCLID 
section 1.2 – Composition 

A reference substance must exist in section 1.1. 

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 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”.  

CLP alternative name 
request 

CLP alternative name 
request 

CLP alternative name 
request 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

40 

Version 1.0 

IUCLID  
section 1.1 – Identification; 
section 1.2 – Composition 

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

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 
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. 

CLP alternative name 
request 

IUCLID  
section 1.1 – Identification; 

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

CLP alternative name 
request 

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 with the 
reference substance in section 1.1. 

CLP alternative name 
request 

IUCLID  
section 1.1 – Identification; 
section 1.2 – Composition 

If the substance is defined as a multi-constituent substance, 
the reference substance 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. 

CLP alternative name 
request 

IUCLID  
section 1.2 – Composition 

All constituents of a multi-constituent or of a UVCB substance 
must identify distinct reference substances, e.g. it is not 
allowed to have constituent 1 identified with IUPAC name 
"formaldehyde" and constituent 2 identified with the EC 
number 200-001-8 (the EC number of formaldehyde). 

CLP alternative name 
request 

IUCLID  
section 2.1 – GHS 

IUCLID  
section 2.1 - GHS 

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

CLP alternative name 
request 

CLP alternative name 
request 

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  
section 2.1 - GHS 

For each 'Specific concentration limit' block that is created 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, 

CLP alternative name 
request 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

Release date XX 

41 

at least one selection must be made under 'Hazard categories'.  

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 2.1 - GHS 

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.  

CLP alternative name 
request 

IUCLID  
section 2.1 - GHS 

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

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’.  

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

CLP alternative name 
request 

IUCLID  
section 13 – Assessment 
reports 

The following two documents must be attached to the dossier 
in section 13: 
Safety Data Sheet (SDS)  
Justification for the alternative name request (to be included 
as report type “Other” 

CLP alternative name 
request 

IUCLID  
section 14 - Alternative name 
request  

IUCLID  
section 14 - Alternative name 
request 

Information on the mixture must be included in section 14 of 
the substance dataset. 

CLP alternative name 
request 

CLP alternative name 
request 

In section 14 of the dossier, each block created under 
'Information on mixtures' must contain: 
the 'Mixture name' 
at least one row in the table 'Trade names and safety data 
sheets of the mixture' indicating a trade name, country and an 
attached document and/or a remark. 

At least one mixture safety data sheet must be attached in 
section 14. 

IUCLID  
section 14 - Alternative name 
request  

When submitting a requested update, the number of mixtures 
indicated in section 14 has to match with the information in 
the initial submission. 

CLP alternative name 
request 

IUCLID 
dossier template 

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

CLP alternative name 
request 

IUCLID  

A CLP alternative name request has to be submitted as an 

CLP alternative name 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
How to prepare a request for use of an 
alternative chemical name for a 
substance in a mixture 

42 

Version 1.0 

dossier header 

initial submission, unless the Agency has requested an update. 
In this case the dossier should be marked as a requested 
update. 

request 

IUCLID  
dossier header 

REACH-IT 

REACH-IT 

REACH-IT 

Spontaneous updates are not valid submission types for CLP 
alternative name requests. 

When submitting an update following a request from the 
Agency, the dossier header should contain the following 
information: 
The correct last submission number. 
The correct annotation number indicated in the 
communication from the Agency. 

CLP alternative name 
request 

The same IUCLID dossier cannot be submitted more than 
once. 

CLP alternative name 
request 

You cannot submit a CLP alternative name request while 
another submission is still pending in the system for the same 
substance. 

CLP alternative name 
request 

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.  

CLP alternative name 
request 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 
 
 
 
 
 
 
EUROPEAN CHEMICALS AGENCY 
ANNANKATU 18, P.O. BOX 400, 
FI-00121 HELSINKI, FINLAND 
ECHA.EUROPA.EU