Data Submission Manual part 14 – How to Prepare ... - ECHA - Europa

Data Submission 

Manual 

Part 14 - How to Prepare and 

Submit a Request for Use of an 

Alternative Chemical Name for a 

Substance in a Mixture using 

IUCLID 5 

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

2 Data Submission Manual Version: 2.0 

Version Changes 

2.0 Update to reflect changes due to IUCLID and submission web form 

updates (multiple screenshots), redrafting of ch.5.8, addition of ch. 5.9, 

redrafting of ch. 5.2, redrafting of ch. 9.2, web links verified and 

updated, document in new layout, minor textual revision 

1.0 First version 

Part 14 - How to Prepare and Submit a Request for Use of an Alternative Chemical 

Name for a Substance in a Mixture using IUCLID 5 

Reference: ECHA-12-G-36-EN 

Publ.date: July 2012 

Language: EN 

© European Chemicals Agency, 2012 

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 22 languages: 

Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, 

Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovakian, 

Slovenian, Spanish and Swedish 

If you have questions or comments in relation to this document please send them (quote the 

reference and issue date) using the information request form. The information request form 

can be accessed via the Contact ECHA page at: 

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 


Part 14 - How to Prepare and Submit a Request for Use of an Alternative 

Chemical Name for a Substance in a Mixture using IUCLID 5 Release date: July 2012 3 

Table of Contents 

1. INTRODUCTION .................................................................................................................. 6 

2. LEGAL ENTITIES ................................................................................................................. 8 

3. REFERENCE SUBSTANCES ................................................................................................... 10 

3.1. Querying / updating Reference substances in your inventory ................................................... 10 

3.2. Creating a Reference substance .......................................................................................... 13 

4. CREATING A SUBSTANCE DATASET ..................................................................................... 17 

4.1. Create a substance dataset – “CLP alternative name request” template..................................... 17 

4.2. Copy/update from a registered Substance dataset ................................................................. 19 

5. IUCLID 5 SECTIONS TO COMPLETE ..................................................................................... 20 

5.1. IUCLID 5 view mode selector .............................................................................................. 20 

5.2. Information requested for an alternative chemical name request.............................................. 21 

5.3. Information to be provided in IUCLID 5 section 1.1 – Identification (mandatory) ........................ 22 

5.3.1. Identity of the applicant .................................................................................................. 23 

5.3.2. Identification of the substance for which an alternative chemical name is requested................. 23 

5.3.3. Suggested alternative chemical name for the substance....................................................... 27 

5.3.4. Contact person .............................................................................................................. 28 

5.4. Information to be provided in IUCLID 5 section 1.2 - Composition (mandatory).......................... 29 

5.5. Information to be provided in IUCLID 5 section 1.3 - Identifiers (optional)................................. 32 

5.6. Information to be provided in IUCLID 5 section 1.4 - Analytical information (optional)................. 34 

5.7. Information to be provided in IUCLID 5 section 2.1 – GHS (mandatory) .................................... 35 

5.7.1. General information........................................................................................................ 36 

5.7.2. Classification ................................................................................................................. 37 

5.7.3. Labelling ....................................................................................................................... 44 

5.8. Information to be provided in IUCLID 5 section 13 - Assessment Reports (mandatory)................ 47 

5.9. Information to be provided in IUCLID 5 section 14.2 – Alternative name request (mandatory)...... 49 

6. CREATING AN ALTERNATIVE NAME REQUEST DOSSIER ...................................................... 52 

7. EXPORTING YOUR ALTERNATIVE NAME REQUEST DOSSIER ............................................... 59 

8. UPDATING A DOSSIER ........................................................................................................ 62 

8.1. Requested update ............................................................................................................. 62 

8.2. Spontaneous update.......................................................................................................... 63 

9. SUBMITTING AN ALTERNATIVE NAME REQUEST DOSSIER TO ECHA ................................... 64 

9.1. Company sign-up in REACH-IT ............................................................................................ 64 

9.2. Submit a request for an alternative chemical name ................................................................ 64 

9.3. Next steps and final decision on the alternative name request ................................................. 66 

Table of Figures 

Figure 1: Overview of an “alternative name request” dossier creation in IUCLID 5........... 7 

Figure 2: Transfer of a LEO between the IUCLID 5 website and REACH-IT via a LEOX file. 9 



Figure 3: Update link under the Reference substance........................................................ 10 

Figure 4: Query limit reached ............................................................................................ 11 

Figure 5: Query button ...................................................................................................... 11 

Figure 6: Query pick-list .................................................................................................... 11 

Figure 7: Searching for a reference substance................................................................... 12 

Figure 8: Displaying data................................................................................................... 13 

Figure 9: New link under Reference substance.................................................................. 13 

Figure 10: Adding a Reference substance name .................................................................. 14 

Figure 11: Reference substance section .............................................................................. 14 

Figure 12: Searching for a Reference substance.................................................................. 15 

Figure 13: Justification field ................................................................................................ 15 

Figure 14: Completed Reference substance......................................................................... 16 

Figure 15: Uploading the structural formula........................................................................ 17 

Figure 16: Link for creating new substance data set ........................................................... 17 

Figure 17: Name of your substance ..................................................................................... 18 

Figure 18: Assigning a Legal entity...................................................................................... 18 

Figure 19: Expanding the section tree ................................................................................. 18 

Figure 20: Selecting the template from the pick-list............................................................ 19 

Figure 21: Displayed substance in query ............................................................................. 20 

Figure 22: IUCLID 5 view mode........................................................................................... 21 

Figure 23: Legal entity identification in section 1.1 ............................................................. 23 

Figure 24: Type of substance............................................................................................... 23 

Figure 25: Assigning a Reference substance ....................................................................... 24 

Figure 26: Query dialogue box............................................................................................. 24 

Figure 27: Assigning the Reference substance .................................................................... 25 

Figure 28: Button for creating a new Reference substance ................................................. 26 

Figure 29: Name of the Reference substance ...................................................................... 26 

Figure 30: Blue arrow button............................................................................................... 27 

Figure 31: Adding the requested alternative chemical name in the Public name field ......... 28 

Figure 32: Adding the requested alternative chemical name in other EU languages............ 28 

Figure 33: Contact details fields .......................................................................................... 29 

Figure 34: Name and description of composition................................................................. 29 

Figure 35: Degree of purity ................................................................................................. 30 

Figure 36: Typical concentration for each constituent ......................................................... 31 

Figure 37: Additional boxes for the impurities and additives fields ..................................... 31 

Figure 38: Indicate if an impurity is relevant for the C&L of the substance ......................... 31 

Figure 39: Indicate if an additive is relevant for the C&L of the substance.......................... 32 

Figure 40: Add another composition.................................................................................... 32 

Figure 41: Opening section 1.3 in IUCLID 5......................................................................... 33 

Figure 42: Pop-up window “Regulatory programme identifier” ........................................... 34 

Figure 43: Optical activity information ................................................................................ 35 




Figure 44: General information in section 2.1...................................................................... 36 

Figure 45: Linking compositions to the C&L......................................................................... 36 

Figure 46: Entry fields for classification .............................................................................. 39 

Figure 47: Pick-list with reasons for no classification.......................................................... 39 

Figure 48: Specify hazard category and hazard statement for the Physical hazards............ 40 

Figure 49: Specify hazard category and hazard statement for the Health hazards .............. 41 

Figure 50: Specify the affected organ.................................................................................. 42 

Figure 51: Specific concentration limit ................................................................................ 43 

Figure 52: Specify hazard category and hazard statement for the Environmental hazards.. 44 

Figure 53: Specify hazard category and hazard statement for the hazards to aquatic 

environment ....................................................................................................... 44 

Figure 54: Specify a signal word.......................................................................................... 45 

Figure 55: Specify a hazard pictogram ................................................................................ 45 

Figure 56: Specify labelling hazard statement..................................................................... 45 

Figure 57: Specify a precautionary statement ..................................................................... 46 

Figure 58: Specify a supplemental hazard statement .......................................................... 46 

Figure 59: Specify a note..................................................................................................... 47 

Figure 60: Adding a new endpoint study report................................................................... 48 

Figure 61: Naming of added information ............................................................................. 48 

Figure 62: Attach a document ............................................................................................. 49 

Figure 63: Example on how to fill in the mixture information in section 14.2...................... 50 

Figure 64: Information for the same mixture marketed in different countries .................... 50 

Figure 65: Information provided for an additional mixture containing the same substance 51 

Figure 66: Update the substance ......................................................................................... 52 

Figure 67: Selecting ‘Create dossier’ from the pop-up menu ............................................... 53 

Figure 68: Selecting the dossier template ........................................................................... 54 

Figure 69: Selection of Confidentiality and Regulatory purpose flags .................................. 55 

Figure 70: Inclusion of data from IUCLID 5 sections 1–14 in the dossier ............................ 56 

Figure 71: Verify selected objects ....................................................................................... 57 

Figure 72: Fields for name and administrative information of an initial submission ............ 57 

Figure 73: Success message of dossier creation.................................................................. 58 

Figure 74: Viewing a dossier ............................................................................................... 59 

Figure 75: Exporting a dossier............................................................................................. 59 

Figure 76: Selection of annotations in the export ................................................................ 60 

Figure 77: Save button and location .................................................................................... 60 

Figure 78: Export progress report ...................................................................................... 61 

Figure 79: Selection of the update link ................................................................................ 62 

Figure 80: Dossier creation wizard – Requested update...................................................... 63 

Figure 81: Dossier creation wizard – Spontaneous update is not an allowed submission type 

........................................................................................................................... 63 

Figure 82: Submission of your IUCLID 5 dossier ................................................................. 65 



1. INTRODUCTION 

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 on the label and/or on the Safety Data Sheet (SDS) of the chemical identity of one 

or several substances contained in the mixture(s) 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(s) 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). 

In accordance with Article 24(8) of the CLP Regulation, 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 ECHA, the M/I/DU may use the name that is made 

publicly available over the internet (ECHA website) also on the label and in the 

safety data sheet of the mixture(s). For those substances in a mixture for which 

Article 119(2)(f) or (g) of the REACH Regulation no longer applies, the M/I/DU 

may submit a request to the Agency to use an alternative chemical name. 

The purpose of this manual is to assist in the preparation of a request for use of an alternative 

chemical name for a substance in a mixture and its submission to the European Chemicals 

Agency (ECHA). More particularly it outlines, in chapter 5, the IUCLID 5 sections and fields to 

be filled-in to prepare a request according to Article 24 of CLP. 

It should be noted that the aim of this users’ manual is to help the request submitter to 

identify which of the numerous IUCLID 5 fields are of prime importance for a successful 

submission of a request: all the “mandatory” sections (see chapter 5.2) need to be filled in to 

enable ECHA to process the request. The generated IUCLID 5 alternative name request dossier 

can then be submitted to ECHA using a specific web form (see chapter 9). 

Currently requests for use of an alternative chemical name for a substance in a 

mixture cannot be submitted through REACH-IT. This functionality will become 

available at a later stage. Note that even if the dossier submission is taking place 

through a web form, the request submitter should have a REACH-IT account in any 

case. 

The sections of this manual marked with the symbol to the left indicate information 

essential for the processing of the dossier. 

The manual assumes that IUCLID 5 has been installed and that you have a user account 

assigned to the Legal entity created during the installation of IUCLID 5 (for further 

instructions, see chapter 2). If IUCLID 5 has not yet been installed, please consult the 

IUCLID 5 website available at: http://iuclid.echa.europa.eu 

On this website, you can download the software free of charge, and also find more 

comprehensive guidance about the use of IUCLID 5. 




This manual is prepared to support dossier creation in IUCLID 5.4 and later 

versions. 

If you have been using previous IUCLID 5 versions, the data must be migrated to 

upgrade to the new version. For more information please consult the IUCLID 5 

website available at: http://iuclid.echa.europa.eu. 

For more details (e.g. legal basis and general overview) on the request for use of 

an alternative chemical name for a substance in a mixture, you can consult the 

ECHA website at http://echa.europa.eu/web/guest/alternative-chemical-name-inmixtures. 

The figure below provides a stepwise approach for the preparation and the submission of an 

alternative name request dossier in IUCLID 5: 

Figure 1: Overview of an “alternative name request” dossier creation in IUCLID 5 

If you are already a proficient user of IUCLID 5 and know how to create a Legal 

entity, reference substances and substance datasets, we advise you to go directly 

to chapter 5 of this manual where you will find information on how to fill in your 

alternative name request dossier. 



2. LEGAL ENTITIES 

If you are already a proficient user of IUCLID 5 and have already signed up in 

REACH-IT you are advised to go directly to chapter 5 of this manual where you will 

find information on how to create a substance dataset using the “CLP alternative 

name request” template. 

The “Legal entities” are used in IUCLID 5 to provide contact details on the companies involved 

in processes under REACH. Similarly, in the case of a request for use of an alternative chemical 

name under the CLP Regulation, it is necessary to define the Legal entity of the request 

submitter. Legal entity information is stored in a so-called Legal Entity Object (LEO). 

The most important piece of information in a LEO is the unique “company UUID”. This cannot 

be edited: it is read-only per LEO. REACH-IT uses only the company ID to identify the 

company in all the data processing it carries out. Therefore it is important that the UUID of the 

LEO is identical in all the contexts where the company identity appears (IUCLID 5, REACH-IT, 

any web forms submitted to ECHA). 

An official LEO is required both for signing up in REACH-IT and for the installation of the 

IUCLID 5 application in a local environment. Depending on whether the company has signed 

up in REACH-IT and/or on the IUCLID 5 webpage, the following possibilities exist for ensuring 

LEO synchronisation between both applications (see Figure 2): 

If your company has not yet signed up in REACH-IT or on the IUCLID 5 website, the 

advisable way to create a LEO is on the IUCLID 5 website. The creation of an official 

LEO takes place during the installation and downloading of IUCLID 5 (for more details 

on how to download and install IUCLID 5 refer to http://iuclid.echa.europa.eu). The 

generated LEO XML file (LEOX) can then be imported into your local IUCLID 5 

installation as well as into REACH-IT, ensuring the synchronisation of the information 

(Company name, contact information, UUID). 

If your company already has an active account in REACH-IT but has yet to install 

IUCLID 5, it is advisable to export the LEO XML file (LEOX) from REACH-IT into your 

local IUCLID 5 installation. This is done by going to the tab in the main 

menu of REACH-IT and selecting . The LEOX file will be saved on your local 

computer from where you can import it into IUCLID 5. 

If your company already has installed IUCLID 5 and created an official LEO on the 

IUCLID 5 website, but has yet to sign up in REACH-IT, it is advisable to import the 

existing LEOX file into REACH-IT during the sign-up process. This is done during step 2 

of the signing-up process “Company information”, where the user is asked to upload an 

already existing LEOX. 

If your company has a REACH-IT account and a IUCLID 5 installation, but you are unsure of 

whether the UUIDs between the two applications match, proceed as follows: 

Go to the REACH-IT main menu, and select under the . The second 

row under “Company information” displays the company UUID in REACH-IT. 

In your IUCLID 5 installation, go to “Legal entity” in the main task panel. Select 

“Update” and double-click on the Legal entity of interest in the “Query results” list. The 

UUID of the company is displayed in the “Information” tab at the bottom of the 

IUCLID 5 window. 




In the case of several Legal entities in IUCLID 5 with the same name but different 

UUID, it may be helpful to keep only the one that matches with REACH-IT as 

“Active trade partner”. To this end, right-click on the Legal entity in the “Query 

results” list and activate/deactivate the Legal entities as appropriate. The “Active 

trade partner” legal entities are displayed in bold text, whereas the inactive ones 

are in standard text. This operation is only for visual assistance and can be 

modified at any point. 

Figure 2: Transfer of a LEO between the IUCLID 5 website and REACH-IT via a 

LEOX file 

The standard way of providing company information to REACH-IT during sign-up is 

to import a ready-made IUCLID 5 LEO in the form of a LEOX (Figure 2). 

On sign-up, if a party does not have a ready-made LEO in a LEOX, REACH-IT can 

create a LEO using information entered manually by the party into the interface of 

REACH-IT (Figure 2). 

For further information on how to create a Legal Entity Object (LEO) and how to 

synchronise it between IUCLID 5 and REACH-IT, please consult the REACH-IT 

“Industry User Manual Part 02 – Sign-up and account management” at: 

http://echa.europa.eu/web/guest/support/dossier-submission-tools 

REACH-IT uses only the company ID to identify the company in all the data 

processing it carries out. Therefore it is important that the UUID of the LEO is 

identical in all the contexts where the company identity appears. 



3. REFERENCE SUBSTANCES 

If you are already a proficient user of IUCLID 5 and know how to create reference 

substances you may go directly to chapter 5 of this manual where you will find 

information on how to fill-in successfully your alternative name request dossier. 

To correctly identify the substance for which you wish to request for an approval to use an 

alternative chemical name in a mixture, it is important to understand the concept of 

Substance, Substance dataset and Reference substance in IUCLID 5. 

The alternative name request dossier is prepared for a substance (a substance is defined under 

Article 2(7) of the CLP Regulation). The definition is identical under REACH. 

In IUCLID 5, the required information related to that substance (such as the identity of the 

substance, its composition, etc) should be specified in the Substance dataset created for that 

substance. 

To insert information on the identity of your substance and its constituents in the Substance 

dataset, you will need to use the concept of a Reference substance. A Reference substance is a 

link to the identity of a chemical substance. The concept of 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 

(e.g. EC number, CAS number) and molecular and structural information, in a central place. 

This information can then be re-used in other datasets without having to retype the 

information. The Reference substance inventory is directly maintained by you, in your local 

IUCLID 5 installation. 

To extend the number of entries in your Reference substance inventory, we recommend you to 

download the ca. 70,000 pre-filled Reference substances from the IUCLID 5 website and 

import them to your local IUCLID 5 installation (unless already done so during the IUCLID 5 

installation). These pre-defined Reference substances have been prepared to improve data 

quality and minimise data entry. 

In addition, you should also download the EC inventory from the IUCLID 5 website (unless 

already done during the IUCLID 5 installation). This inventory consists of a list of substance 

identities which is based on a combination of the following EU inventories: EINECS, ELINCS 

and NLP-list. 

In chapter 3.1 below, you will find the procedure to be followed for searching, updating and 

creating the Reference substances to be assigned to your substance directly from the main 

task panel. Note that it is also possible to create a Reference substance directly from the 

Substance dataset (chapter 4). 

3.1. Querying / updating Reference substances in your inventory 

Click “Update” under “Reference substance” on the main task panel (Figure 3). 

Figure 3: Update link under the Reference substance 




If during the installation of IUCLID 5 you have chosen to download and install the 

Reference substance inventory, you will have approximately 70,000 Reference 

substances stored in your computer. A warning will appear, indicating that the default 

query limit is 500 items (Figure 4). If you answer “Yes”, the query for all Reference 

substances will be skipped the next time you update the inventory. If you answer “No”, 

IUCLID 5 will retrieve the full list of Reference substances the next time you choose to 

update the Reference substance inventory. Either way, you will be redirected to the 

Reference substances screen. 

Figure 4: Query limit reached 

Click the button (Figure 5). 

Figure 5: Query button 

A dialog box will appear. Select “Find Reference substances” from the “Select query” 

pick-list (Figure 6). 

Figure 6: Query pick-list 



Type the search criteria for the substance you are looking for and click . You 

can use the asterisk (*) as a wild card. For example, to get all the substances starting 

with “eth” you would type “eth*”. To get all the substances ending in “amine” you 

would type “*amine” (note that only 2000 results will be shown). 

Figure 7: Searching for a reference substance 

Double click the Reference substance to display the related data (Figure 8). 



Chemical Name for a Substance in a Mixture using IUCLID 5 

Release date: July 2012 13 

Figure 8: Displaying data 

Check the data on the Reference substance. To update/add any information on the 

Reference substance, click the button , edit the information on the 

Reference substance, and save the changes. 

3.2. Creating a Reference substance 

If you do not find in your Reference substance inventory the Reference substance you need, 

you can create it by the following procedure: 

In the Main menu, go to Inventories and click “New” under “Reference substance” 

(Figure 9). 

Figure 9: New link under Reference substance 

Type the name of the Reference substance in the “Reference substance assistant” popup 

window. The box “Active Reference substance” should be checked, as only Reference 

substances marked as “active” can be used during the creation of a Substance dataset. 


14 Data Submission Manual Version: 2.0 

Figure 10: Adding a Reference substance name 

Select the button; the Reference substance is created and an empty 

Reference substance section appears (Figure 11). Click the button. 

Figure 11: Reference substance section 

If the Reference substance is listed in the EC-inventory: 

o assign the EC entry by clicking the button. The query dialog appears, where 

EC inventory entries can be searched (Figure 12); 

o search using any of the criteria listed, such as the EC name of the substance. 

Again, you can use “*” as a wild card; 




Figure 12: Searching for a Reference substance 

o highlight from the list the entry that matches your Reference substance; 

o click the button. The information for this Reference substance will be 

included in your new Reference substance. 

If your Reference substance is not in the EC inventory, select a justification from the 

pick-list proposed under the “No EC information available” section ( 

Figure 13). 

Figure 13: Justification field 

Provide sufficient information in the remaining fields to enable the identification of the 

Reference substance. 

When completing the information for your Reference substance, the following information 

should be submitted: 



- EC number and EC name (if available); 

- CAS number and CAS name (if available); 

- IUPAC name; 

- Description (specify any additional information relevant for the description of the 

Reference substance (i.e. description of the manufacturing process) in this field, if 

necessary); 

- If only the IUPAC name is indicated it is recommended to include the “Molecular 

and Structural formula(s) (including SMILES notation, if available)” or a “Remark” 

in the related field; 

- If only the IUPAC name is indicated it is recommended to include the “Molecular 

Weight” or the “Molecular Weight range”. 

Figure 14: Completed Reference substance 

To include the structural formula (optional), go to “Structural formula”, under 

“Molecular and structural information” and click the button. You can then 

upload an image file with the structural formula (Figure 15). 




Figure 15: Uploading the structural formula 

4. CREATING A SUBSTANCE DATASET 

If you are already a proficient user of IUCLID 5 and know how to create a 

substance dataset you may go directly to chapter 5 of this manual where you will 

find information on how to fill-in your alternative name request dossier. 

4.1. Create a substance dataset – “CLP alternative name request” 

template 

To create an alternative name request dossier in IUCLID 5, you need first to create a 

Substance dataset for the substance for which an alternative chemical name is requested. A 

Substance dataset is the repository of data, which is used as a basis to create the dossier to be 

submitted to ECHA. 

On the IUCLID 5 main screen (Task Panel), under Tasks, select “New” from Substance (Figure 

16). 

Figure 16: Link for creating new substance data set 

Type the name of the substance for which you wish to create an alternative name 

request dossier (Figure 17). The name can be anything, but it is logical to use an 

identifier that you are familiar with such as a trade name or chemical name. 



Figure 17: Name of your substance 

Click the button. Select the Legal entity to be assigned to the Substance 

dataset (Figure 18). 

Figure 18: Assigning a Legal entity 

Click the button. You have now created a Substance dataset. 

The section tree of your Substance dataset is displayed in the navigation part of the 

screen (Figure 19) (to see the complete tree view, click the button and select 

“expand all” from the pop-up menu). 

Figure 19: Expanding the section tree 

IUCLID 5 also offers the possibility of highlighting sections that are suggested for 

completion to assist in the preparation of various types of dossiers. For alternative 




chemical name request, click the button and select “CLP alternative name request” 

from the pick-list (Figure 20). 

Figure 20: Selecting the template from the pick-list 

4.2. Copy/update from a registered Substance dataset 

A Substance dataset already submitted for a registration 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 alternative name 

request Substance dataset. 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 related documents to 

be attached in Section 13 are in place in a registration Substance dataset). 

Further instructions on how to create a copy of a Substance dataset can be found in 

chapter D.4.10 of the IUCLID 5 End User Manual at: 

http://www.iuclid.eu/index.php?fuseaction=home.documentation&type=public#usermanual 

Particular attention should be paid to compatibility between different versions of IUCLID 5: 

migration tools and information about them are available at the IUCLID 5 website at: 

http://iuclid.echa.europa.eu 



5. IUCLID 5 SECTIONS TO COMPLETE 

This chapter outlines which information must be provided through the different sections of the 

IUCLID 5 tree and within the dossier header. 

Once you have created a Substance dataset for your substance and assigned it to the Legal 

entity of the request submitter, you can enter data on the substance in this dataset. 

To retrieve the Substance dataset you have already created, click “Update” under “Substance” 

in the main task panel (see Figure 16), and select your substance from the list by double 

clicking it (note: to facilitate the retrieval of your Substance dataset, you may either use the 

filtering system by typing the name (or part of it) of the substance in the query field or use the 

query system by clicking the button) (Figure 21). 

Figure 21: Displayed substance in query 

Once the substance is displayed in the data entry pane, expand the section tree (by clicking 

the “Section tree” tab) and proceed to complete the necessary sections. Double click in each 

section to display it, and click the button in the upper part of the screen to 

complete the fields. 

5.1. IUCLID 5 view mode selector 

When the Substance dataset is opened, you can select the specific view mode “CLP alternative 

name request” by clicking on the black arrow indicated in Figure 22. 




Figure 22: IUCLID 5 view mode 

Once the desired view mode is selected in the drop-down list, the section tree changes in such 

a way that the leaf or book symbol preceding the IUCLID 5 sections are coloured in red 

for required sections or in green for optional sections. 

Keep in mind that this view mode selector is merely a tool to help in determining 

which sections to fill in. However, the present manual prevails upon this view 

mode selector regarding the requirements for a request for an alternative chemical 

name under the CLP Regulation. The conformity of the dossier will be checked by 

ECHA, which may request further data to bring it into conformity with the 

requirements of Article 24 of the CLP Regulation. 

5.2. Information requested for an alternative chemical name request 

This chapter of the manual describes in detail how to fill in the relevant IUCLID 5 sections and 

provides some general administrative/practical information which is needed for a proper 

processing of your request by ECHA. 

Before you start preparing your alternative name request dossier in IUCLID 5, make sure that 

you have available the minimum information requested. 



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 5 – section 1.1); 

- identity and composition of the substance (IUCLID 5 – sections 1.1, 1.2); 

- information on the classification and labelling of the substance (IUCLID 5 – section 

2.1) 

- the SDS of the substance for which an alternative chemical name is requested 

(IUCLID 5 section 13); 

- demonstration that the request submitter has a commercial interest worthy of 

protection for non-disclosure of the actual substance name (IUCLID 5 – section 

13); 

- the trade name(s) of the mixture(s) which contain the substance for which an 

alternative chemical name is requested (IUCLID 5 – section 14.2); 

- the SDS of the mixture(s) which contains the substance (IUCLID 5 – section 14.2). 

The subsequent chapters of this manual describe in details how to fill in a IUCLID 5 “CLP 

alternative name request” dossier according to the Article 24 of the CLP Regulation. 

The following information is not specifically requested. You can nevertheless 

provide it on a voluntary basis in the relevant IUCLID 5 sections (indicated in 

brackets): 

- reference(s) to a REACH registration or CLP notification if relevant 

(IUCLID 5 – section 1.3); 

- information on optical activity and typical ratio of (stereo) isomers if 

relevant (IUCLID 5 – section 1.4). 

5.3. Information to be provided in IUCLID 5 section 1.1 – Identification 

(mandatory) 

Use this section to specify the identity of the applicant, and the identity of the 

substance for which you request an alternative chemical name. 

To fulfil your obligation under Article 24 of the CLP Regulation, the section 1.1 of 

your IUCLID 5 dossier shall 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. 

5.3.1. Identity of the applicant 

Although the Legal entity is available in REACH-IT as part of the sign-up process and in 

the context of the alternative name request web form (see chapter 9), it is also 

necessary to indicate a Legal entity in the IUCLID 5 dossier. This information must be 

provided in the block “Substance identification” (Figure 23). 

Figure 23: Legal entity identification in section 1.1 

It is not possible to appoint a third party representative for a request for use of an 

alternative chemical name. 

The Legal entity (Legal entity of the submitting applicant) should have already 

signed up in REACH-IT (with the same Company Universal Unique Identifier, 

UUID). 

5.3.2. Identification of the substance for which an alternative chemical name 

is requested 

Although not mandatory, it is recommended to select the appropriate type of substance 

among the different types proposed in the composition pick-list (Figure 24). 

Figure 24: Type of substance 



In “Reference substance” click the button to assign a “Reference substance” to your 

substance (Figure 25). In this block, a Reference substance must always be linked. In 

case of a mono-constituent substance, the same Reference substance must be linked in 

section 1.1 and the block “Constituents” of IUCLID 5 section “1.2 Composition”. 

Figure 25: Assigning a Reference substance 

A query dialog box appears. Search for your “Reference substance” using the 

appropriate identifier (Figure 26). 

Figure 26: Query dialogue box 

Highlight the Reference substance from the result list and click (Figure 27). 




Figure 27: Assigning the Reference substance 

It is possible that the Reference substance already exists but you have not set it as 

“Active”. In this case, un-tick the “Show only active values” checkbox to display 

both the Reference substances marked as active and inactive. Right-click the non 

activated substance you want to assign. Click the to 

activate it. Then click . 

If you cannot find your Reference substance because it has not been created yet: 

o click to create a new Reference substance (Figure 28); 



Figure 28: Button for creating a new Reference substance 

o you will be redirected to the “Reference substance assistant”; 

o type the name of the Reference substance you need to create and click the 

button (Figure 29); 

Figure 29: Name of the Reference substance 

o to specify the information on the new Reference substance, click the blue arrow 

button (Figure 30); 




Figure 30: Blue arrow button 

o you will be redirected to the screen for the new Reference substance. Complete 

the fields as described in chapter 3 “Creating a Reference substance" (SMILES 

notation, molecular formula, molecular weight range, structural formula…); 

o click the button; 

o click the button to go back to the substance (save when requested). 

For multi-constituent substances you are advised to indicate the name of the 

substance in the IUCLID 5 section “1.1 Identification” in the field “IUPAC name” 

(e.g. Reaction mass of [main constituent 1 (IUPAC name) and main constituent 2 

(IUPAC name) etc]). 

Each main constituent should be included with its respective reference substance 

in the IUCLID 5 section “1.2 Composition”. 

For UVCB substances you are advised to indicate the name of the UVCB substance 

in the IUCLID 5 section “1.1 Identification” in the field “IUPAC name” (e.g. 

Reaction products of [names of the starting materials]), while the process 

description, refinement process, etc. should be indicated in the field “Description” 

of section 1.1. 

Each known constituent should be included with its respective reference substance 

in the IUCLID 5 section “1.2 Composition”. 

It is also recommended to read the “Guidance for identification and naming of 

substances under REACH and CLP”, available at: 

http://echa.europa.eu/web/guest/guidance-documents/guidance-on-reach 

5.3.3. Suggested alternative chemical name for the substance 

Specify in the “Public name” field under “Substance identification” (Figure 31), the 

alternative chemical name you are requesting to use for the substance in 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) can 

be used for establishing the alternative chemical name. It is not however 

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. 



Figure 31: Adding the requested alternative chemical name in the Public name field 

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 names” field 

(Figure 32). 

o in the “Other names” field click ; 

o in the dialog box appearing, add the alternative chemical name in the additional 

language by indicating first the “Name Type” (i.e. Alternative name), then the 

alternative chemical name in the additional language and finally the respective 

country in which the substance is marketed; 

o repeat the same procedure for any other additional country/name. 

Figure 32: Adding the requested alternative chemical name in other EU languages 

5.3.4. Contact person 

You can also indicate the information details of the contact person(s) for that specific 

substance (Figure 33). Complete as many of the fields as possible. In case you leave these 

fields empty, REACH-IT will use, by default, the contact information you have specified in your 

REACH-IT account. However please note that in any case ECHA will use the information details 

as specified by the applicant in REACH-IT for any further communication. 




Figure 33: Contact details fields 

5.4. Information to be provided in IUCLID 5 section 1.2 - Composition 


Use this section to specify the composition of the substance for which you request 

an alternative chemical name. 

At least one composition must be indicated to identify the substance for which an alternative 

chemical name is requested. 

Ensure that a Reference substance exists or has been created for the constituent(s) (see 

chapter 3), and optionally for each impurity (if any) or additive (if any). If possible it is 

recommended to fill in the fields “Typical concentration” and/or “Concentration range”, and the 

unit indicated. 

Double click section 1.2 (Composition) and click the button (Figure 34). 

Click the button . 

Enter the name and a brief description of the composition. 

Figure 34: Name and description of composition 

Complete the “Degree of purity” section (Figure 35). The degree of purity to be 



specified should correspond to the concentration of the main constituent(s) in the 

substance. The drop-down list box allows you to pick symbols or units from a pick-list, 

and the boxes allow you to type numbers. In this part you can give the normal range of 

purity for the substance. For instance, a substance with purity between 95-98% (w/w) 

will be given as shown below. It is necessary to specify the unit to complete this 

section. You can indicate ranges if exact information on the degree of purity is not 

accessible to you. 

Figure 35: Degree of purity 

Create a repeatable block for “Constituents” by clicking the green button. 

At least one constituent should be indicated for the composition. 

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 . Create the Reference substance you need if it was not created in 

advance. See chapter 3 for more details. 

In case the substance is a mono-constituent, then the first composition block in 

section 1.2 of the IUCLID 5 dossier should contain only one constituent. The 

Reference substance linked to this constituent must be the same as the one 

specified in section 1.1. 

If the substance is a multi-constituent the Reference substance assigned in 

section 1.1 cannot be any of the Reference substances specified for the individual 

constituents in section 1.2. 

If the substance is a multi-constituent or a UVCB substance, then all constituents 

of one composition block in IUCLID 5 section 1.2 must represent distinct substance 

identities. 

For example the following case: 

- constituent 1 identifies "formaldehyde" as a IUPAC name; 

- constituent 2 identifies "200-001-8" as the EC number (the EC number 

of formaldehyde); 

will be considered invalid. 

Indicate the “Typical concentration” and/or the “Concentration range” for every 

constituent in the same manner as indicated below (Figure 36). You can indicate ranges 

if the exact or typical concentration of the constituent is not accessible to you. 




Figure 36: Typical concentration for each constituent 

If you need to specify more than one constituent, click the button in the 

relevant section, and more boxes will appear. 

If applicable, follow the same procedure to complete the impurities and additives fields 

by including a reference substance for each known impurity and additive (Figure 37). 

Figure 37: Additional boxes for the impurities and additives fields 

In case of unknown impurities, you may account for them by creating a new Reference 

substance and indicating in the IUPAC name field "Unknown impurities". You should 

also specify the number of these unknown impurities in the “Remarks” field. 

Indicate concentration ranges if the total (typical) concentration of the unknown 

impurities is not accessible to you. 

If an impurity or additive is considered relevant for classification and labelling of a 

substance, the corresponding checkbox should be ticked (Figure 38 and Figure 39). 

Figure 38: Indicate if an impurity is relevant for the C&L of the substance 



Figure 39: Indicate if an additive is relevant for the C&L of the substance 

Multiple compositions: 

It is possible to specify more than one composition for a substance. This may be relevant if 

you have more than one supplier for the same substance and differences in the composition 

exist. When differences in the composition need to be reported, additional repeatable 

composition blocks can be added (Figure 40). 

If several “Substance composition” blocks are created in section 1.2 then every 

block must be completed. 

Click the button under “Substance composition” in IUCLID 5 section 1.2 and more 

boxes will appear (Figure 40). 

Figure 40: Add another composition 

5.5. Information to be provided in IUCLID 5 section 1.3 - Identifiers 

(optional) 

Section 1.3 of the substance dataset is relevant for providing information on other 

related requests or regulatory processes. You can include in this section the C&L 

notification number (in case you have notified this substance in the past) and the 

REACH registration number(s) of the substance, if available (e.g. from the SDS 

provided by the supplier of the substance). Registration numbers without the last 

four digits are accepted in case you are not the actual registrant of the substance 

and you are not aware of them (e.g. in the SDS of your supplier the last four digits 

of the registration number are missing). 

Open the section 1.3 of the IUCLID 5 Substance dataset by double clicking on “1.3 Identifiers” 

from the section tree view and click the button (Figure 41). 




Figure 41: Opening section 1.3 in IUCLID 5 

In the “Regulatory programme identifiers”, select “Add” to edit the list of identifiers. A 

pop-up window entitled “Regulatory programme identifier” appears on the screen 

(Figure 42). 

To specify C&L notification and registration numbers, complete the fields as follows in 

the “Regulatory programme identifier” column (Figure 42): 

o select “CLP notification number”; 

o select “REACH Registration number”; 

o the numbers shall be specified in the “ID” field. 



Figure 42: Pop-up window “Regulatory programme identifier” 

5.6. Information to be provided in IUCLID 5 section 1.4 - Analytical 

information (optional) 

Use Section 1.4 of IUCLID 5 to further specify, if available, the information on the 

identity of your substance. 

In the section tree of your substance dataset, double-click Section 1.4 (Analytical information) 

and click the button. 

In the “Optical activity” field (Figure 43), provide information on the optical activity and typical 

ratio of (stereo) isomers, if available and applicable. 




Figure 43: Optical activity information 

5.7. Information to be provided in IUCLID 5 section 2.1 – GHS 


Use section 2.1 of IUCLID 5 to specify the classification according to CLP criteria of 

the substance for which you request an alternative name. 

Open the section 2.1 of the IUCLID 5 Substance dataset by double-clicking on “2.1 GHS”. 

In this section you provide the Classification and Labelling (C&L) information of the substance 

for which the alternative name is requested. 

The GHS block is repeatable so that you can indicate more than one C&L for a substance 

having several compositions. To do so, click the button. 

In case of multiple repeatable blocks it must be noted that information will be 

checked for all the blocks created. 

It is highly recommended to consult Annex I to the CLP Regulation for the 

classification criteria and the related guidance 

(http://echa.europa.eu/web/guest/guidance-documents/guidance-on-clp) for more 

detailed instructions on the application of the Classification and Labelling rules. 

Special attention should be given to Part 1.4 of the CLP Annex I, where specific 

criteria for “requests for use of an alternative chemical name under Article 24” are 

illustrated. 

Harmonised classification (included in Annex VI to the CLP Regulation) has to be 

respected and you should not modify any of those hazard classes and/or 

differentiations. If the substance has a harmonised classification for some hazard 

classes/differentiations you should self-classify for other hazards using relevant 

and available data (Title II of the CLP Regulation). 



5.7.1. General information 

Provide information in as many fields as possible (Figure 44). 

Figure 44: General information in section 2.1 

Indicate the state/physical form of the substance by selecting the appropriate term 

from the pick-list. This information may be useful in justifying different classifications 

for your substance. 

If you have several compositions (several blocks in IUCLID section 1.2) and several 

Classification and Labelling blocks in section 2.1, then you should link each C&L block to 

its related composition(s) by using the field "Related composition" (Figure 45). 

Several compositions can be linked to the same C&L block. In case of multiple compositions 

and multiple C&L blocks, each composition block must be linked to at least one C&L block 

(Figure 45). 

If multiple repeatable blocks are created in IUCLID section 2.1 then all of these blocks must be 

complete. 

Figure 45: Linking compositions to the C&L 




If your substance is not included in the list of harmonised classifications and does 

not meet the criteria for classification in any of the hazard categories, you should 

tick the box “Not classified” and then you do not need to specify anything else 

(Figure 44). Note, however, that if the substance does not meet the criteria for 

classification in any hazard class, there is no need to apply for an alternative 

chemical name. 

5.7.2. Classification 

For each hazard class or differentiation either the two fields, “Hazard category” and 

“Hazard statement” must be indicated, otherwise, the field “Reason for no classification” 

must be filled in (Figure 46). 

In case a substance is classified in some but not all hazard classes you have to 

indicate the “Reason for no classification” for the other hazard classes or 

differentiation. 

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 

Physical Hazard classes All All 

Hazard statement 

Acute toxicity - oral Acute Toxicity 4 H302: Harmful if swallowed 

Acute toxicity - dermal Acute Toxicity 4 H312: Harmful in contact with 

skins 

Acute toxicity - inhalation Acute Toxicity 4 H332: Harmful if inhaled 

Skin corrosion/irritation Category 2 H315: Causes skin irritation 

Serious eye damage/eye irritation Category 2 H319: Causes serious eye 

irritation 

Specific target organ toxicity — Single 

exposure 


exposure 


exposure 

Specific target organ toxicity — 

Repeated exposure 

Hazardous to the aquatic environment 

— Chronic 

Hazardous to the aquatic environment 

— Chronic 

Category 2 H371: May cause damage to 

organs 

Category 3 H335: May cause respiratory 

irritation 

Category 3 H336: May cause drowsiness or 

dizziness 

Category 2 H373: May cause damage to 

organs through 

prolonged or repeated exposure 

 

Category 3 H412: Harmful to aquatic life 

with long lasting effects 

Category 4 H413: May cause long lasting 

harmful effects to aquatic life 




Figure 46: Entry fields for classification 

The field “Reason for no classification” is pre-filled indicating “data lacking” by default. You can 

update the “Reason for no classification” by selecting the appropriate reason for that hazard 

class/differentiation from the pick-list (. 

Figure 47). In case a “Hazard category” is selected, the field “Reason for no classification” is 

automatically set to the “empty field”. 

Figure 47: Pick-list with reasons for no classification 



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 

but which is not reliable (e.g. data of poor quality) or if you have 

several equivocal study results or information. The available 

data/information can not 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 

study or where other high quality information is available, and based 

on that, it is concluded that the classification criteria are not fulfilled. 

There are certain classification waivers in CLP: 

- if a substance is classified for certain physical hazards, it does not need 

to be classified for certain others; 

- if a substance has a particular physical state, e.g. it is a gas, it does not 

need to be classified for hazards requiring another physical state, e.g. 

as an oxidising solid or as corrosive to metals. 

In case of such classification waivers you should select “conclusive but not 

sufficient for classification” as a reason for no classification. 

5.7.2.1. Classification - Physical hazards 

For all hazard classes indicated in the block “Physical hazards”, either the two first fields (i.e. 

the field “Hazard category” (e.g. expl. Div. 1.1) and the field “Hazard statement” (e.g. 

explosive; mass explosion hazard)) shall be filled in, or the field “Reason for no classification” 

shall be filled in (Figure 48). 

Figure 48: Specify hazard category and hazard statement for the Physical hazards 




5.7.2.2. Classification - Health hazards 

For all hazard classes and differentiations indicated in the block “Health hazards”, either 

the two first fields (i.e. fields “Hazard category” and “Hazard statement”) should be 

filled in or the field “Reason for no classification” should be filled in (Figure 49). 

Figure 49: Specify hazard category and hazard statement for the Health hazards 



For more instructions on the selection of these codes, please consult the Guidance on the 

application of the CLP criteria which can be found on the ECHA website. 

For the “Specific target organ toxicity - Single exposure” and “Specific target organ 

toxicity - Repeated exposure” hazard classes, you have to indicate in the field “Affected 

organs” the primary target organs. 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” ( 

Figure 50). 

If the affected organ is unknown indicate “unknown” it in the field “Affected 

organs”. 

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 

to section 13 of IUCLID 5 in a separate endpoint study record (unless it is already 

specified in Annex VI to the CLP Regulation or justified in the SDS provided by the 

supplier). 

Two routes of exposure can be specified. This means that in case all three routes 

of exposure cause the hazard, the route of exposure field shall remain empty. 

Figure 50: Specify the affected organ 

For “Specific target organ toxicity – single” and “Specific target organ toxicity – 

repeated” either the three fields “Hazard category” and “Hazard statement” and 

“Affected organs” should be filled in, or the field “Reason for no classification” 

should be filled in ( 

Figure 50). 

Substances which have a harmonised classification, or are fulfilling the criteria for 

classification, as carcinogenic, mutagenic, reproductive toxicants or substances 

fulfilling the criteria for STOT-SE or STOT-RE Category 1 do not qualify for an 

alternative chemical name. 

5.7.2.3. Classification – Specific concentration limit 

Harmonised classification has to be applied: if your substance has harmonised specific 

concentration limit(s), you shall specify it in this IUCLID 5 block ( 

Figure 51). 

If you propose to set specific concentration limit(s) under the strict condition of Article 




10 of the CLP Regulation, it is recommended to provide a scientific justification 

accordingly. The scientific justification can be attached to section 13 of IUCLID 5 in a 

separate endpoint study record (unless already specified in CLP Annex VI or in the SDS 

provided by the supplier). 

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

o a concentration range (at least one of the two range fields); 

o at least one hazard statement related to the SCL. 

You can specify more than one hazard statement by clicking on the green cross 

. 

Figure 51: Specific concentration limit 

5.7.2.4. Classification - Environmental hazards 

For all hazard classes indicated in the block “Environmental hazards”, either the two 

first fields (i.e. fields “Hazard category” and “Hazard statement”) should be filled in, or 

the field “Reason for no classification” should be filled in (Figure 52). 



Figure 52: Specify hazard category and hazard statement for the Environmental 

hazards 

Note that only substances fulfilling the criteria for environmental classification as 

Hazardous to the aquatic environment – Chronic, Category 3 or 4, can qualify for 

the use of an alternative chemical name ( 

Figure 53). Specifying the M-Factor shall not be applicable for these categories. 

Figure 53: Specify hazard category and hazard statement for the hazards to aquatic 

environment 

5.7.3. Labelling 

5.7.3.1. Signal word 

“Danger”, “Warning” or “No signal word” should be selected in the field “Signal word” 

(Figure 54). 




Figure 54: Specify a signal word 

5.7.3.2. Hazard pictograms 

If applicable, you can select a hazard pictogram from the pick-list (Figure 55). 

Figure 55: Specify a hazard pictogram 

5.7.3.3. Hazard statements 

You should select at least one hazard statement from the pick-list and type in the free 

text fields where applicable (Figure 56). 

Figure 56: Specify labelling hazard statement 

If no hazard statement applies to your substance, then you can select “No hazard 

statement” from the pick-list. This statement is located at the real end of the picklist. 

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

. 



5.7.3.4. Precautionary statements 

This information is not requested under the CLP Regulation, nevertheless you can select 

a precautionary statement from the pick-list (Figure 57). 

Figure 57: Specify a precautionary statement 

You can specify more than one precautionary statement for the labelling by 

clicking on . 

It is recommended to not apply more than 10 precautionary statements on a 

labelling. 

5.7.3.5. Additional Labelling requirements 

If applicable, you can select a supplemental hazard statement from the pick-list (Figure 

58). 

Figure 58: Specify a supplemental hazard statement 

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

clicking on . 

5.7.3.6. Notes 

This information is not requested under the CLP Regulation, nevertheless you can select 

note(s) from the pick-list (Figure 59). 




Figure 59: Specify a note 

5.8. Information to be provided in IUCLID 5 section 13 - Assessment 

Reports (mandatory) 

IUCLID 5 section 13 is an endpoint study record–type section in which different 

assessment reports can be attached covering information not documented in other 

IUCLID 5 sections. 

This section should be used in order for the request submitter to provide some of the needed 

documents in order for his alternative name request dossier to be processed by ECHA. The 

documents that are mandatory to be attached 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 name: 

A document demonstrating that the request submitter has a commercial interest worthy of 

protection of the actual substance name should be provided here. In the document it should be 

justified why the disclosure of the information would cause potential commercial harm to the 

submitter or to a third party. 

You need to attach the before mentioned documents in IUCLID 5 as part of the Substance 

dataset as follows: 

Right-click section “13 Assessment Reports” and select “New endpoint study record” 

(Figure 60). 



Figure 60: Adding a new endpoint study report 

A “New endpoint study record” section appears. Re-name the new endpoint record to 

“SDS of Substance X” or “Commercial interest justification”, as appropriate and click 

the button (Figure 61). 

Figure 61: Naming of added information 

In the next screenshot, shown below, from the pick-list under “Type of report” select 

“Safety data sheet” for attaching the SDS of the substance or “other” for attaching the 

commercial interest justification. 

In the “document” field click the button and the button that appears. You 

may be requested to save at this stage, which you should do. You can then attach the 

relevant document (Figure 62). Use the “Remarks” field to specify further the nature of 

the document. 




Figure 62: Attach a document 

All alternative name requests must contain at least the following endpoint study 

records in IUCLID 5 section 13: 

- the Safety Data Sheet (SDS) of the substance for which an alternative 

chemical name is requested; 

- demonstration that the request submitter has a commercial interest 

worthy of protection for non-disclosure of the actual substance name. 

5.9. Information to be provided in IUCLID 5 section 14.2 – Alternative 

name request (mandatory) 

In this section the request submitter needs to provide the SDS of the mixture(s) that contains 

the substance for which an alternative chemical name is requested. 

Open the section 14.2 of the IUCLID 5 Substance dataset by double-clicking on “14.2 

Alternative name request”. 

The “information on mixtures” block is repeatable so that you can indicate several mixtures in 

case the substance for which an alternative chemical name is requested is contained in more 

than one mixture. To do so, click the button (Figure 65). 

Indicate in the field “Mixture name” the name of the mixture. 

In the “Trade names and safety data sheets of the mixture” table, select “Add” to 

create a row and indicate the required mixture information. A pop-up window entitled 

“Trade name and safety data sheet information” appears on the screen (Figure 63). 

To identify the mixture in which the substance is contained, complete the fields in the 

pop-up window as follows (Figure 63): 

o indicate the “Trade name” of the mixture in the country that this mixture is 

marketed; 

o choose from the drop-down list the country in which this mixture is marketed; 

o remarks (if any); 



o attach the SDS of the mixture (preferably in English language and if not 

available in any other EU/EEA language). 

Figure 63: Example on how to fill in the mixture information in section 14.2 

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 (no repeatable block is required for 

information on the same mixture). The SDS of the mixture should be attached only once 

regardless of the number of countries specified in the same table (Figure 64). 

Figure 64: Information for the same mixture marketed in different countries 

All alternative name requests must contain at least the following information/fields 




in IUCLID 5 section 14.2: 

- Name of the mixture ('Mixture name' field); 

At least one row in the table 'Trade names and safety data sheets of 

the mixture'. 

At least one row in each table must contain: 

- Trade name AND Country AND mixture SDS attached. 

Remaining rows in the same table (if existing) must contain at least: 

- Trade name AND Country. 

For every additional mixture you need to create a new block in the IUCLID section 

14.2, provide the requested information for all the countries that this mixture is 

marketed and attach the related SDS (the same recommendation as above 

regarding the language of the SDS applies) (Figure 65). 

Figure 65: Information provided for an additional mixture containing the same 

substance 



6. 

CREATING AN ALTERNATIVE NAME REQUEST DOSSIER 

On the IUCLID 5 main screen (Task Panel), select “Update” under Substance (Figure 

66). 

Figure 66: 

Update the substance 

All available substances are displayed; select the substance for which you want to 

create the alternative name request dossier. 

Right-click the appropriate substance in the “Query results” list. From the pop-up menu 

select “Create Dossier” (Figure 67). 




Figure 67: Selecting ‘Create dossier’ from the pop-up menu 

The “Dossier creation wizard” is displayed. 

Step 1: Select the Dossier template “CLP alternative name request” (Figure 68). 



Figure 68: Selecting the dossier template 

Step 2: Select all Confidentiality and Regulatory purpose flags (Figure 69). Note that 

any section in your IUCLID 5 Substance dataset containing a Confidentiality or 

Regulatory purpose flag that is not selected at this stage will be omitted from the final 

dossier. It is recommended to select all flags when creating the dossier in order to 

avoid omission of any relevant information. 




Figure 69: Selection of Confidentiality and Regulatory purpose flags 

Step 3: Leave the default settings as they appear. At this stage, please make sure that 

all the necessary sections for your “CLP alternative name request” dossier appear 

ticked, as only these documents will appear in your dossier (Figure 70). The relevant 

IUCLID 5 sections for alternative name requests are 1.1, 1.2, 1.3 (as appropriate), 1.4 

(as appropriate), 2.1, 13 and 14.2. 



Figure 70: Inclusion of data from IUCLID 5 sections 1–14 in the dossier 

It is normal that section 13 does not appear on this screen; it will be checked in 

step 5 of the dossier creation wizard. 

Step 4: Select the appropriate “Detail level of endpoint fields”. 

Step 5: Verify that all the appropriate endpoint study/summary records are selected for 

the final dossier (Figure 71). You have to ensure at this step that the section 13 

assessment reports (e.g. the SDS of the substance and the demonstration of 

commercial interest) are included in the final dossier. It is not possible to deselect the 

Legal entity, Substance, or Reference substance records. 




Figure 71: Verify selected objects 

Step 6: In the field “Name”, enter an appropriate name which enables you to easily 

identify the dossier when searching or exporting it from IUCLID 5. It may be useful to 

refer to the substance name and the dossier version, in case several were created 

(Figure 72). 

Figure 72: Fields for name and administrative information of an initial submission 

A window informs about the success of the dossier creation. When clicking the


dossier> button, the dossier will be displayed (Figure 73). 

Figure 73: Success message of dossier creation 

Verify that sections 1.1, 1.2, 1.3 (if appropriate), 1.4 (if appropriate), 2.1, 13 and 

14.2 were included in the generated dossier and are correctly filled out. If a 

missing/incomplete section is detected, proceed to amend the substance dataset 

and generate a new dossier. 

Before submitting your dossier through the web form (see chapter 9), it is strongly 

recommended to run the latest version of the IUCLID 5 Technical Completeness 

Check (TCC) plug-in, which incorporates several Business Rules. In addition it is 

strongly recommended to run the latest version of the IUCLID 5 Fee Calculation 

plug-in, to estimate the fee associated to your alternative chemical name request. 

Both plug-ins are available free of charge at the IUCLID 5 webpage: 

http://iuclid.echa.europa.eu. Installation is simple, and a user manual is 

downloaded together with the plug-ins. 




7. EXPORTING YOUR ALTERNATIVE NAME REQUEST DOSSIER 

The alternative name request dossier needs to be exported before it can be submitted 

to ECHA. 

In the main task screen of your IUCLID 5 installation, click on the dossier icon or the 

“View” link (Figure 74). 

Figure 74: Viewing a dossier 

Select your “CLP alternative name request” dossier, right-click it and select “Export” 

(Figure 75). 

Figure 75: Exporting a dossier 

The export assistant will ask you if you wish to include your annotations in the dossier. 

Normally, select “Export without annotations” (unless you have included relevant 

information as annotations in your dossier) and click the button (Figure 76). 



Figure 76: Selection of annotations in the export 

In the next step specify the location where you want to store your dossier by clicking 

the button (Figure 77). You also need to indicate a name for the exported dossier in 

the “File Name” field. To avoid confusion, it is advisable to indicate the same name you 

specified when creating the dossier. 

Figure 77: Save button and location 

Now click the button. The dossier has now been exported to the location you 

specified; a confirmation message will appear (Figure 78). 



Chemical Name for a Substance in a Mixture using IUCLID 5 

Release date: July 2012 61 

Figure 78: Export progress report 



8. UPDATING A DOSSIER 

This section provides instructions on how to submit further information requested by ECHA 

according to Article 24(3) of the CLP Regulation. 

If you need to update your Alternative name request dossier, you do not need to re-type again 

all your substance data; instead you can update the information in your Substance dataset. 

In the main screen go to tasks, and click “Update” under “Substance” (Figure 79). 

Figure 79: Selection of the update link 

Select from the list the substance for which you wish to submit the updated information 

and double click it. From the Substance dataset Section tree pane, select the section(s) 

that you wish to update. Edit the necessary IUCLID 5 dossier sections by clicking the 

button . 

When creating your dossier, specify the type of specific submission in step 6 of the 

dossier creation wizard (dossier header). 

To create and export the dossier, please refer to chapters 6 and 7 of this manual. 

8.1. Requested update 

When creating your updated dossier on request of ECHA, the button “The submission is an 

update” and the checkbox “Further to a request/decision from regulatory body” must be 

selected. The last submission number and the annotation number in the request letter must be 

entered in their respective adjacent fields (Figure 80). 




Figure 80: Dossier creation wizard – Requested update 

8.2. Spontaneous update 

This type of update is not allowed and will not be processed by ECHA. 

Please ensure that the box “Spontaneous update” is not ticked ( 

Figure 81). 

Figure 81: Dossier creation wizard – Spontaneous update is not an allowed 

submission type 



9. SUBMITTING AN ALTERNATIVE NAME REQUEST DOSSIER 

TO ECHA 

9.1. Company sign-up in REACH-IT 

If you already have a REACH-IT account you can skip this step. 

If you do not have an account in REACH-IT, please refer to the Industry User Manual – 

Part 2, located at: http://echa.europa.eu/web/guest/support/dossier-submission-tools 

It is important that the company size, contact information, and the company 

address indicated under the tab “Company information” in REACH-IT are correct. 

ECHA will use the company size to determine the fee for your request. 

9.2. Submit a request for an alternative chemical name 

To submit an alternative name request dossier go to the webpage “Submit a Request for use of 

an alternative chemical name for a substance in a mixture” (located at 

https://comments.echa.europa.eu/comments/clp24.aspx), where you will find the relevant 

web form to upload your IUCLID 5 dossier. 

Enter the relevant identification details of the request submitter (“Identification of Legal Entity” 

field) and upload the IUCLID 5 dossier (Figure 82). 

Enter the Legal entity UUID and the Legal entity name of your company, as these 

appear in your REACH-IT account. 

The Legal entity name and the Legal entity UUID indicated in the web form must 

be identical with the corresponding data in the request submitter’s REACH-IT 

account. The Legal entity name and UUID can be found under the “Company 

information” tab in REACH-IT. 

Enter your REACH-IT account user name. ECHA needs to verify if this username belongs 

to an existing user with submission rights; therefore it shall be a user with either a 

“Company Manager” or “Company User” role (not “Company Reader”). 

Enter a valid email address. A preliminary confirmation of your request submission will 

be sent to this email address. 

You may enter a purchase order number as your own reference for invoicing purposes. 

This purchase order number will be referenced on the invoice. 

Under “Upload application file” click on to open a dialogue box which allows 

you to select the dossier file (.i5z file) you want to upload. 

The alternative name request dossier should have already been created in 

IUCLID 5.4 (or onwards version) and have the extension ‘i5z’. 

The upload of dossiers with file size above 20 MB has first to be approved by ECHA. 

Please contact the ECHA Helpdesk before submitting a larger file, providing a 

justification at http://echa.europa.eu/web/guest/contact 




Before submitting the dossier, the request submitter needs to type the text visible in 

the user identification box (CAPTCHA) and confirm that he agrees with the declaration 

illustrated at the bottom of the web form by ticking the related box. 

Click the button to submit your “Request for Use of an Alternative 

Chemical Name for a Substance in a Mixture”. 

Figure 82: Submission of your IUCLID 5 dossier 

After submitting the IUCLID 5 dossier to ECHA, you will receive an acknowledging e-mail, 

including a .PDF file summarising the information provided in the web form (summary form). 

The uploaded dossier will go through a virus check. Additionally, ECHA will make some 

preliminary checks to ensure the consistency of the information provided in the web form. In 

case of any inconsistencies, you will receive a notification by e-mail to the e-mail address 

provided in the web form. 



9.3. Next steps and final decision on the alternative name request 

After the alternative name request dossier has successfully passed the preliminary checks, the 

Business Rules check is initiated. 

The request submitter will receive the outcome of this check as an internal message to his 

REACH-IT account (as specified in the web form), including the submission number, or an 

explanation on the failing rules. 

After the Business Rules check has been passed (i.e. dossier accepted for processing), ECHA 

will determine the fee for the request. The fees are defined in the Commission Regulation (EU) 

No 440/2010, and depend on the number of mixtures included in the request. Small and 

medium sized companies (SMEs) can benefit from reduced fees. 

The invoice is sent to all the REACH-IT accounts of the specific Legal Entity UUID (as specified 

in the web form) via REACH-IT. Following a successful payment of the invoice, a message will 

be sent via REACH-IT, acknowledging the “date of receipt” of the request. 

The date of receipt will mark the beginning of a six weeks period during which ECHA will assess 

the alternative name request and make a decision on accepting or rejecting the request. The 

six weeks countdown starts from the day on which the fee has been received in full by ECHA. 

In case further information will be requested by ECHA (with a certain deadline given to submit 

the updated alternative name request dossier), the six-week countdown stops. Following the 

submission of the updated dossier, a letter acknowledging the new date of receipt (provided 

that the updated dossiers will pass the Business Rules check) will be sent to the request 

submitter and a new six-week period starts. 

If ECHA raises no objection within six weeks of the alternative name request (or within six 

weeks of the receipt of further required information in case of a requested update), the use of 

the requested alternative name shall be deemed to be allowed. 


EUROPEAN CHEMICALS AGENCY 

ANNANKATU 18, P.O. BOX 400, 

FI-00121 HELSINKI, FINLAND 

ECHA.EUROPA.EU

Data Submission Manual part 14 – How to Prepare ... - ECHA - Europa

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