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REACH-IT

Business Rules

My submission failed business rule 027 (BR027). What is the reason for this failure and what should I do?

Business rule 027 (BR027) failure occurs if the substance identifier in your IUCLID dossier does not match the substance identifier on the REACH-IT joint submission page. To avoid BR027 failure in your future submissions, see the following check list and carry out the steps that apply to your case.

  • Check that you have selected the correct joint submission in REACH-IT when submitting your IUCLID dossier.
  • Check that the EC number in your IUCLID dossier is the same as the EC number of the joint submission in REACH-IT. You can export the assigned EC number either from the REACH-IT joint submission page, from the Pre-SIEF page, or from the inquiry submission report page. Import the EC number into IUCLID and assign it to your reference substance, as specified in Q&A 1258, How do I download the EC number from REACH-IT and import it to IUCLID?.
  • If no EC number exists for your substance yet, check that the spelling of your substance name on the REACH-IT joint submission page is identical to the spelling in your IUCLID dossier section 1.1 IUPAC name. Pay attention to additional spaces and special characters.
  • If your substance is a multi-constituent substance (e.g. a reaction mass of…), make sure that all the constituents indicated in section 1.2 of IUCLID are identical to the constituents included in the REACH-IT joint submission page.
  • If you are a lead registrant of a new joint submission for a substance of Unknown or Variable composition, Complex reaction products or Biological origin (UVCB) with no valid pre-registration or inquiry number, and have tried the above mentioned fixes, please contact ECHA using the ECHA contact form to receive further instructions on how to successfully submit a registration.

While creating your dossier, ECHA advises you to use the IUCLID Validation assistant plug-in to help you to detect any business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392, How can I check my dossier for business rules and technical completeness failures before I submit it to ECHA?. Please address any detected failures before re-submitting your dossier update to ECHA through REACH-IT.

 

My submission failed business rule BR034. What should I do?

Business rule 034 (BR034) failure occurs when you submit a spontaneous update instead of requested update. When your previous submission fails the technical completeness check (TCC), you are expected to submit a requested update. A communication regarding the TCC failure is sent to you via REACH-IT. You also receive an update request under ‘Tasks’ in your REACH-IT account with instructions on how correct the TCC and submit a requested update.

When you create your dossier update, you must tick the boxes 'The submission is an update' and 'Further to a request/decision from a regulatory body’.

Add your last submission number, in this case, the submission that failed the technical completeness check. In the box below, enter the communication number in the ‘Number’ field, as shown in the screenshot.

 

You can find the submission number and the communication number in REACH-IT under ‘Tasks’ and also under ‘Key documents’.

While creating your dossier, we also advise you to use the IUCLID Validation assistant plug-in to help you to detect business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392, How can I check my dossier for business rules and technical completeness failures before I submit it to ECHA?. Please address any detected failures before re-submitting your dossier update to ECHA through REACH-IT.

 

My submission failed business rule BR035. What should I do?

Business rule 35 (BR035) failure occurred because the last submission number you have indicated in your dossier is incorrect. To address the failure, you will need to indicate the last successful submission number for the particular substance in the dossier header in IUCLID, and then re-submit the dossier in REACH-IT.

You can find your previous successful submission number in REACH-IT by going to ‘Substances’ and searching for your registration using the substance name or EC number. The submission number is presented in the results page, as shown in the screenshot below (1).

If you are expected to submit an update due to technical completeness check failure, you need to use the ‘In progress’ submission number (2).

Assign the correct submission number in the IUCLID dossier creation wizard by ticking the box ‘The submission is an update’ and insert the last submission number, as shown in the screenshot (IUCLID desktop view and IUCLID cloud view)below  

 

While creating your dossier, we also advise you to use the IUCLID Validation assistant plug-in to help you to detect business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392, How can I check my dossier for business rules and technical completeness failures before I submit it to ECHA?. Please address any detected failures before re-submitting your dossier update to ECHA through REACH-IT.

My submission has failed business rule BR038. What is the reason for this failure and what should I do?

Your submission has failed business rule 038 (BR038) because you already have a successful submission for the substance and you are expected to submit an update.

To address the failure, you need to assign the last successful submission number of the substance you are submitting the update for in the IUCLID dossier header. Indicate the reason for the update by choosing the appropriate update type, ‘Spontaneous update’ or ‘Further to a request/decision from a regulatory body’.

You can find your last successful submission number in REACH-IT by going to ‘Substances’ and searching for your registration using the substance name or EC number. The last successful submission number is listed on the results page, as shown in the screenshot below. 

 

For a spontaneous update, carry out the following steps, as shown in the screenshot below (Desktop view and IUCLID Cloud view).

  1. Assign the submission number in IUCLID dossier creation wizard by ticking the box ‘The submission is an update’ and inserting the last successful submission number that corresponds to the substance.
  2. Select the type of update, ‘Spontaneous update’.
  3. Select the appropriate justification for the update. Create a block by clicking the button and make a selection from the drop down list. If you select ‘other’, you are required to give the reason in the adjacent free text field.

 

For a requested update, refer to the assessment outcome communication sent to you via REACH-IT. You can find the communication on the submission page under the ‘Key documents’ tab. The communication provides full details on what information is missing from the dossier and a deadline by when you should submit this information.

For a requested update, carry out the following steps, as shown in the screenshot below (Desktop view and IUCLID Cloud view).

  1. Assign the latest submission number in IUCLID dossier creation wizard by ticking the box ‘The submission is an update’ and inserting the last successful submission number, which corresponds to this substance.
  2. Select the type of update, ‘Further to a request/decision from a regulatory body’.
  3. Create a block by clicking the button and insert the annotation number that corresponds to the submission for which further information was requested (e.g. assessment outcome communication number XXX-X-0000000000-00-00/X). In the ‘Remarks’ field, enter your remarks as free text.

 

While creating your dossier, ECHA advises you to use the IUCLID Validation assistant plug-in to help you to detect any business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392, How can I check my dossier for business rules and technical completeness failures before I submit it to ECHA?. Please address any detected failures before re-submitting your dossier update to ECHA through REACH-IT.

My submission failed business rule BR053. What is the reason for this failure and what should I do?

Your submission has failed business rule 053 (BR053) because the EC/list number in section ‘1.1 Identification’ your IUCLID dossier does not match the EC/list number of the inquiry indicated in section ‘1.3 Identifiers’.

To address the failure, you need to ensure that:

  • the substance identification in section ‘1.1 Identification’ of the IUCLID dossier corresponds to the substance identification associated to the inquiry number indicated in section ‘1.3 Identifiers’;
  • the inquiry number indicated in section ‘1.3 Identifiers’ has been copied/typed in the correct format.

To select the EC/list number provided by ECHA as a result of your inquiry assessment, you need to export this EC number from REACH-IT in .i6z format into IUCLID. For instructions on how to export the EC number from REACH-IT to IUCLID, see Q&A 1258: How do I download the EC number from REACH-IT and import it to IUCLID?.

You can find your inquiry number in REACH-IT by going to ‘Substances’ and searching for your inquiry using the substance name or EC number. The inquiry number (e.g. 06-0000000000-00-0000) will be listed on the results page.

While creating your dossier, ECHA advises you to use the IUCLID Validation assistant plug-in to help you to detect any business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392, How can I check my dossier for business rules and technical completeness failures before I submit it to ECHA?. Please address any detected failures before re-submitting your registration dossier to ECHA via REACH-IT.

 

                     

I submitted a lead dossier in REACH-IT but received a business rule BR119 failure message. What should I do?

Business rule 119 (BR119) failure occurs when the lead registrant indicates in their dossier update that they will not provide the optional information (i.e. chemical safety report (CSR) and guidance on safe use (GoSU)) on behalf of its members although in the previous submission they had indicated that they would provide this information.

The following scenarios may trigger BR119 failure:

If the lead registrant initially indicated that they would provide the CSR and/or GoSU on behalf of all members of the joint submission but no longer wishes to do so, they should contact ECHA using the ECHA contact form and request the modification of the joint submission coverage. Before contacting ECHA:

  • The lead registrant should first ensure that the changes will not affect any members of the joint submission.
  • Members relying on the CSR and/or GoSU provided by the lead registrant need to submit a spontaneous update indicating that they will provide individual CSRs and/or GoSUs.

Once ECHA has performed the changes, the lead registrant will need to submit a spontaneous update.

When submitting the spontaneous update, member or lead registrants should indicate in the IUCLID dossier the submission type as ‘spontaneous update’,  the ‘Justification’ select the reason ‘New or update of CSR or guidance of safe use’ as well as entering a clarification in the ‘Remarks’ text box.

While creating the dossier, we advise you to use the IUCLID Validation assistant plug-in to help you to detect business rules and technical completeness check failures in your dataset and dossier. For further instructions on how to use the validation assistant please refer to Q&A 392.

My submission failed business rule BR130. What is the reason for this failure and what should I do?

Business rule 130 (BR130) failure occurs when a lead registrant submits a dossier update in which the joint submission tonnage band indicated is lower than the joint submission tonnage band for the previous submission. The tonnage band of the joint submission is derived from the submission type (IUCLID template) chosen for the substance when the lead dossier was first created.

The individual tonnage band(s) specific to the lead registrant can be indicated in the dossier header.

If the lead registrant wishes to lower their individual tonnage band, they can refer to Q&A 1300 for further instructions.

If the lead registrant wishes to lower the tonnage band of their joint submission, they can refer to the Q&A 1299 for further instructions. 

While creating your dossier, ECHA advises you to use the IUCLID Validation assistant plug-in to help you to detect any business rules and technical completeness check failures in your dataset and dossier, as explained in Q&A 0392, How can I check my dossier for business rules and technical completeness failures before I submit it to ECHA?. Please address any detected failures before re-submitting your registration dossier to ECHA via REACH-IT.

Communication in REACH-IT

How can I be updated with the latest news or the status of REACH-IT?

You are invited to consult the latest news from ECHA webpage. You can also subscribe to our weekly e-News and bimonthly Newsletter at  http://echa.europa.eu/subscribe

A confirmation email will arrive to your email account and after you confirm it your subscription will be activated. 

News on maintenance and other breaks in service will be communicated in the news section in REACH-IT at:

https://reach-it.echa.europa.eu.

What is the difference between Tasks and Messages in REACH-IT?

The "Tasks" tab is used to inform registrants that they need to perform certain action in REACH-IT by a specific deadline. These tasks could be for example a decision that needs to be complied with, an invoice that needs to be paid, etc.

 When a registrant is required to perform a task, it is displayed on REACH-IT home page as follows:

Clicking on the tab will display the task item and clicking on the subject line will open the task. When the task is performed, it can be marked as complete by clicking on the button "Mark as complete". Marking the task as complete ensures that it is not displayed in the tasks list.

 When a task has been read, an icon looking like an open envelope is displayed. You can also view who and when the task was read in the "Task reading history" tab. Important tasks are marked with an exclamation mark.

 Registrants can also search for older tasks by selecting "Tasks" under "I am looking for" field. See screenshot

A page with multiple search criteria is displayed and filling in these fields will enable you to narrow down the results of your search.

Message Tab

All communication between ECHA and the registrant (i.e. account holder) is done through an internal messaging system in REACH-IT. Internal messages are different from emails. They are generated either automatically by the REACH-IT system or when ECHA needs to communicate with the REACH-IT account holders concerning ECHA decisions, relevant information or feedback. These messages are delivered to the user's message box inside REACH-IT.

When ECHA sends a message to a company in REACH-IT, the unread message is displayed on REACH-IT home page as follows:

Clicking on the tab will display the unread message and clicking on the subject line will open the message. You can choose to Archive the message after reading it or you can choose to leave it as it is.

When a message has been read, an icon looking like an open envelope is displayed. You can also view who and when the message was read in the "Message reading history" tab. Important messages are marked with an exclamation mark.

Registrants can also search for older messages by selecting "Messages" under "I am looking for" field. See screenshot

A page with multiple search criteria is displayed and filling in these fields will enable you to narrow down the results of your search.

IMPORTANT: According to the Terms and Conditions of use and service of REACH-IT, messages can trigger deadlines immediately upon notification in REACH-IT. We therefore advise log in to REACH-IT regularly and to open messages immediately.

 

How can I find and communicate with other members or the lead registrant in a SIEF?

Pre-registration

If you submitted a (late) pre-registration (process ended on 31 May 2017), you can find any potential registrants as part of the same pre-SIEF in REACH-IT. Pre-SIEF members should start an active communication within their respective pre-SIEF and take the necessary steps to evolve from pre-SIEF to SIEFs.

To start the communication process within your pre-SIEF(s):

  • Access your REACH-IT account.
  • Select Menu >> Search >> Pre-registrations and pre-SIEFs and select your pre-SIEF.
  • A list of the pre-SIEF members and their contact details is displayed at the bottom.

The first point of contact is the SIEF Formation Facilitator (SFF) (status marked as Facilitator). If no potential registrant volunteered as SFF, any member from the pre-SIEF should actively contribute to form the SIEF.

Inquiry

Currently the only option to get in contact with the co-registrants is via an inquiry, following which ECHA will provide you with the contact details of the lead registrant or early registrants. Once your inquiry has been assessed, a decision will be sent to your REACH-IT message box. The co-registrants page in REACH-IT will give you access to the members of the same SIEF, and the contact details of the lead registrant, if available.

Further information can be found at http://echa.europa.eu/support/dossier-submission-tools/reach-it/inquiry.

What is the next step after a business rule failure?

A dossier is accepted for processing once all the relevant business rules (BR) are satisfied.

When a dossier fails business rules, detailed information is sent through REACH-IT explaining the reason for the failure. A new submission is required depending on whether the submission is an initial or an update (spontaneous or requested).

Dissemination and confidentiality

Can the data disseminated by ECHA be used to prepare SDS?

For downstream users in a supply chain who must generate their own safety data sheets for products procured from within the EEA, the main source of information should be the supplier. Using information from the supplier will ensure that any specific, detailed information is reviewed and included as appropriate.

In addition, use may be made of publicly available information that is not restricted by copyright or any confidentiality protections. It should be noted that, as stated in ECHA's legal notice, reproduction or further distribution of the information from the registration dossiers may be subject to copyright protection and that the use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Moreover, the legal notice emphasises that the Agency cannot guarantee the correctness of the information in the databases and REACH does not permit the Agency to make modifications to the data provided by the owner(s) of the respective information. ECHA's legal notice can be found under this link: http://echa.europa.eu/en/legal-notice .

It should be noted that the supplier of the Safety Data Sheet is responsible for the accuracy of its contents in all cases.

Where can I see the list of registered substances?

Public access to registered substances is provided on ECHA's website, in  http://echa.europa.eu/information-on-chemicals/registered-substances

The information of the registrant of a particular substance can be found under "Administrative data".

How can I check what information in my registration dossier will be published on the ECHA website before I submit my dossier?

The IUCLID Dissemination preview plug-in simulates which information from a registration dossier will be made public on the ECHA website at: http://echa.europa.eu/information-on-chemicals/registered-substances, according to Article 119 of the REACH Regulation.

To use the tool, right click on your dossier → Dissemination preview → follow the wizard. 

Dissemination preview

Can I hide my identity in the registered substances page on the ECHA website using a third party representative?

No. The identity of the registrant will be published unless a confidentiality claim on the identity of the registrant is included in the registration dossier and the justification accepted as valid by the Agency.

A third party representative (TPR) can only be used to represent potential registrants in discussions with other manufacturers, importers and downstream users on data sharing and the joint submission of data as specified in Article 4 of REACH. The identity of the TPR is not published on the ECHA website. It will only be visible in:

  • the potential registrants tab in the REACH-IT co-registrants page, if included in a successful inquiry notification;
  • the registrants tab in the REACH-IT co-registrants page, if included in a successful registration dossier;
  • and in the joint submission, if included during creation (lead registrant) or confirmation (member registrant) of the joint submission in REACH-IT.
When will my company details be included/updated in the registered substances page after a successful registration?

ECHA regularly updates the information received from registration dossiers, but it can take up to four weeks from the date of submission before the information is disseminated on ECHA’s webpage.

Once a registration dossier is considered complete, the information from your dossier will be filtered for confidentiality, aggregated to merge the information from all dossiers of a joint submission into a single dossier and further processed to provide this information in the format of the registered substances page.

If your registration dossier has gone through all these steps successfully, the information from your registration dossier will appear on the registered substances page at:

http://www.echa.europa.eu/information-on-chemicals/registered-substances.

 

 

How is the total tonnage band calculated for registered substances published on the ECHA website?

The total tonnage band displayed in the registered substances page is aggregated data calculated from all dossiers in a joint/individual submission. Tonnage data is considered only from full registrations where the tonnage band is not claimed confidential. Tonnage data is extracted from the last year reported in section 3.2 of the IUCLID dossier and is the sum of manufactured + imported tonnage - tonnage directly exported – tonnage immediately used as intermediate.

For dossiers that contain full and intermediate registrations, the tonnage data extracted will be the sum of the reported manufactured plus imported tonnage fields, minus the tonnage immediately used as intermediates. Tonnage data will be summed for all dossiers in a joint/individual submission, and will be displayed as:

  • A tonnage band range, i.e., 100 000 – 1 000 000 tonnes, if no dossier contains a confidentiality claim on tonnage band;
  • Open tonnage band, i.e., 1 000+ tonnes, when at least one dossier contains a confidentiality claim on tonnage band;
  • "Tonnage data confidential", when all dossiers aggregated have claimed their tonnage band as confidential, REACH Articles 119(2)(b); and
  • "Intermediate use only", when only intermediate registration dossiers are present in the joint submission.
What information in a NONS dossier can be claimed confidential under REACH?

REACH has extended the number of information for which a confidentiality claim can be made as compared to previous legislations. Additional data can, therefore, be claimed confidential under REACH which was not possible under NONS, such as:

  • The name of the notifier (which under REACH is considered to be part of the information contained in the safety data sheet)
  • The information contained in the safety data sheet (including registration number, uses and uses advised against).
  • The trade name of the substance.
  • If essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous.

ECHA gives the same possibilities for claiming confidentiality to NONS notifiers as to other REACH registrants. Therefore, if your company considers that some information should not be published on the ECHA website, you can claim such information confidential. The confidentiality claims need to be properly justified and a fee for claiming this information confidential in accordance with article 119(2) will be issued.

Additional Question and Answers on NONS can be found here.

Why doesn’t the registered substance page contain information on commercially available products?

REACH applies to chemical substances and therefore only information about chemicals are disseminated on the ECHA webpage. It does not contain information about chemical preparations, formed by mixing different chemical substances, nor about articles containing chemicals.

In other words, you can find information about methanol or butane, but not for example about a shampoo, cleaning products or pencils.

Why can’t I find the substance I am looking for?

If the substance you are looking for has not been registered, it is not available on ECHA’s webpage. Substances are included to the database within 4 weeks after the ECHA has received a registration dossier for this substance.

Can I trust the data provided in the registered substance page?

The information disseminated on ECHA’s webpage originates from registration dossiers submitted by companies. Companies have the obligation to provide accurate and up-to-date information in their registration dossiers.

Due to the high volume of data and the large number of chemicals, all information on chemicals is automatically processed. ECHA's IT systems can verify that all information has been submitted, but cannot evaluate the quality and correctness of the submitted information. ECHA can therefore not guarantee the correctness or adequacy of the information or that the dossiers are compliant with REACH.

Where can I send questions regarding the registered substance page?
If you are a registrant, and you have questions about dissemination, please contact the ECHA helpdesk.
If you are a journalist, please contact the ECHA Press Office (press (at) echa.europa.eu).
For any other questions contact the ECHA Information Desk
 

To leave feedback, please use the feedback form on the portal.

In the case of an only representative, what name will appear on the dissemination page: the non-EU company or the only representative?

The table below defines which legal entity will be disseminated on ECHA’s webpage depending on information provided in sections 1.1 and 1.7 of your IUCLID dossier.

Further information can be found in the manual Dissemination and confidentiality under the REACH Regulation at: http://echa.europa.eu/manuals

I made a request of confidentiality under art. 119(2) of REACH Regulation. Will ECHA send an official confirmation on the acceptance/rejection of my claim?

Yes. ECHA sends a communication of confirmation/rejection of a confidentiality claim via REACH-IT, at the end of the assessment procedure. While processing the confidentiality claim, the information requested confidential is not disseminated on the ECHA website.

After the assessment procedure, the confidentiality claims considered valid will remain so. However, the rejected confidentiality claims will be disseminated on the ECHA website.

For further information on the assessment procedure please read section 3.8. Assessment of the Confidentiality Request by ECHA of the “Dissemination and Confidentiality under REACH Regulation” manual at the following link: https://echa.europa.eu/documents/10162/22308542/manual_dissemination_en.pdf/7e0b87c2-2681-4380-8389-cd655569d9f0.

 

Functionalities

Which web browsers are supported by REACH-IT?

REACH-IT has been tested with:

  • Google Chrome 48.0 and higher on a Microsoft Windows platform
  • Internet Explorer 11.0 and higher on a Microsoft Windows platform
  • Mozilla Firefox 44.0 and higher on a Microsoft Windows platform

The use of untested browsers may reduce REACH-IT functionalities and cause application errors in REACH-IT. Using an older version of the browsers, or different software platform, may cause incompatibility issues with REACH-IT functionalities. Therefore, users are advised to upgrade their internet browser as mentioned above.

How do I sign up in REACH-IT if my company has different roles and/or acts as an only representative?

If you are an only representative (OR) who represents more than one non-EU/EEA manufacturer, you will have to register separately for each non-EU/EEA manufacturer you represent. It is not possible to have one common account in REACH-IT used by multiple legal entities. However, it is possible to use same company information (e.g. name, VAT, address, etc.). You may consider adding a numerical or other identifier to your company name when signing up in REACH-IT, to facilitate the management of different legal entity accounts.

A user with the "Legal entity manager role" can use a "Foreign user" to access multiple legal entities. More information on how to do this can be found in chapter 6.7 of the ECHA Account manual.

Note that in the "Company Size" information, you must indicate the size of the non-EU/EEA manufacturer you are representing and not the size of your own legal entity. ORs can provide different contact details for each account.

If you made a mistake when indicating the company size of your company (or the one you represent as an OR) in REACH-IT when submitting a registration dossier or after a registration number is provided to you, refer to the page related to Small and Medium-sized Enterprises on ECHA website to find out more about how to correct this mistake.

 

What format of attachments does REACH-IT and IUCLID support?

REACH-IT and IUCLID support the following file types: jpg, jpeg, pdf, doc, docx, rtf, txt, tiff, mol, png and gif.

If you attach a file, which is unsupported by REACH-IT or IUCLID, you could be contacted by the Agency with a request to update your submission.
 
How do I download the EC number from REACH-IT and import it to IUCLID 6 desktop?

The EC number can be downloaded from REACH-IT either from the Joint submission Object, the Inquiry or the Pre-SIEF page.

  1. Log in to REACH-IT, go to the relevant submission page and click on the button ‘Export assigned EC number or Export EC substance’, as shown below:


  2. Once the assigned EC number has been exported, go back to the IUCLID home page and click on ‘Import’ as shown below.


  3. Once the assigned EC number has been imported go back to the IUCLID home page and click on ‘Reference substance’ as shown below.


  4.  Click on the icon ‘New’ as shown below.


  5. Add’ the newly uploaded reference number to the reference number inventory as shown below.


  6. Fill in the reference substance identity information and save the entry.
How do I communicate that I ceased manufacture/import?

You can cease manufacture due to the following scenarios:

  • You ceased manufacture/import due to commercial reasons according to Article 50(2) of the REACH Regulation. The registered volume in your registration is updated to zero and the status of your registration is changed to "inactive". If you restart manufacture/import of the substance, you should inform ECHA via the 'Restart manufacture or import' button available on the reference number page in REACH-IT.
  • You ceased manufacture following a draft decision according to Article 50(3) of the REACH Regulation. The status of your registration will be changed to "Revoked". A new registration must be submitted if you wish to restart manufacturing/importing your substance.

Before ceasing manufacture, we recommend that you read Q&A 0054 that explains the duties of registrants that cease manufacture and import.

Below are the steps on how to cease/restart manufacture in REACH-IT.

 

You should use the functionality ‘restart manufacture or import’ to reactivate the reference number, when a substance is manufactured/imported again.

How do I download the EC number from REACH-IT and import it to IUCLID cloud?

The EC number can be downloaded from REACH-IT either from the Joint submission Object, the Inquiry or the Pre-SIEF page.

  1. Log in to REACH-IT, go to the relevant submission page and click on the button ‘Export assigned EC number’.
  2. Download the file from REACH-IT and save it in your local disk (e.g. desktop). Open IUCLID Cloud, go to the dashboard where the ‘Import IUCLID file(s) to Cloud’ section is located, and drop or upload the file.
  3. Create the substance data set by clicking on ‘New’ from the substance box in the Dashboard.
  4. Insert the name of the new substance and click on ‘Create’.
  5. Open the new substance, click on section 1.1. 

    Click on ‘Edit’ button on the top right corner of the page.

  6. Go to ‘Identification of substance’ section and click on ‘Select item’ to link the reference substance.

    If the reference substance is not listed in the window on the right side of the page, you can create your reference substance using the ‘Create’ button on the top right corner of the window.
  7. Add the ‘Inventory number’ previously imported in IUCLID and complete all the relevant fields, as shown below.
Joint submission

A. Joint submission creation/deletion

Deleting a joint submission

To delete a joint submission search for your joint submission in REACH-IT and use the ‘Delete joint submission’ functionality.

You can only delete the joint submission if:

  • There are no members in the joint submission (active or inactive)
  • There are no submissions linked to it (failed or passed)

If the above options do not apply, ECHA can delete the joint submission upon your request. In order to do so, please contact ECHA using the contact form.

Please take into account that once the deletion has taken place, ECHA will not be able to revert the action.

Creating a joint submission by manually selecting the substance identity

The joint submission is created by the lead registrant using the pre-registration number, inquiry number or the registration number.

When none of these identifiers are available, or the pre-registration number refers to a submission that does not correctly define the substance identity, you should proceed as follows: Select Menu >> joint submission >> Create new.

Read carefully the information provided on the right side of the page. If you are certain that you do not have any reference number, click on the link ‘substance identity manually’ and follow the wizard.
create submission

Creating a joint submission for a UVCB substance without numerical identifiers (EC/CAS)

When forming a joint submission, you are required to first agree on the substance’s chemical name with all of your co-registrants. Therefore, we recommend that you first read ECHA's "Guidance for identification and naming of substance under REACH and CLP" chapter 4.3. UVCB substances. Also consult our Sector-specific support for substance identification, on certain UVCB substance types (e.g. oleochemicals, essential oils, metals, etc.).

The chemical name of the UVCB substance must be reported in the ‘IUPAC name’ field of the reference substance in section 1.1. of your IUCLID dossier. This applies even if the naming conventions for UVCB substances do not follow the IUPAC nomenclature.

The spelling of the chemical name is important, the name needs to be identical both in your joint submission in REACH-IT and in IUCLID dossier section 1.1 ‘Identification’. This is important in order to pass the business rules check. The name should not contain spelling errors or additional spaces between words or characters.

Creating a joint submission

  1. Start your registration by creating a new joint submission. Use the ‘insert the substance identity manually’ link, found in the checklist of joint submission creation wizard (see picture).


     
  2. In the next step, search for your substance name and then create the joint submission by its ‘chemical name’ (see picture).


     
  3. Select ‘other name’ or ‘IUPAC name’ depending on the naming convention of your substance as the ‘chemical name type’ and insert the derived name of your UVCB substance into the field and click continue (see picture). This will be the name of your substance in REACH-IT.



     
  4. REACH-IT might suggest other already pre-registered or registered constituents with similar names; please ensure that you select ‘your constituent’ at the bottom of the page and click ‘continue’ (see picture).



     
  5. The name has now been added to the section ‘selected constituents’ (see picture). Click ‘continue’ and confirm you substance identity and continue with the joint submission creation wizard.



     

Prepare and submit your dossier as part of the joint submission you created.

Remember to report all the identified constituents of your UVCB substance in IUCLID dossier section 1.2 ‘composition’. For further information on composition requirements for UVCB substances consult our guidance “How to prepare registration and PPORD dossiers.” on page 32. Also, fill in the ‘Description’ in section 1.2 including the identity of the starting materials and a description of the production process used to manufacture the substance. For Manufacturing process description see Q&A 1199.

Once you have submitted your dossier

A numerical identifier will be issued to your substance once it has passed the business rules check. Export the EC number from the joint submission page and use it in the reference substance in any future updates. Members submitting after the lead has passed the business rules check should export the issued EC number from the joint submission page and use the numerical identifier and the correct IUPAC name in section 1.1 of the IUCLID dossier. Instructions on how to download and export the EC number can be found in Q&A 1258.

 

B. Joint submission management - lead registrant

How can I transfer the lead registrant role in REACH-IT to another member of the joint submission?

If the current lead registrant does not want to continue in their role as lead, it is up to the SIEF members to choose a new member, who will take over the lead role. In order to transfer the role, the following shall be observed:

  • The current and the future lead registrant need to agree on the handover. Then, the following actions must be performed within the Joint Submission in REACH-IT:
    • The current lead registrant will need to assign the lead role to the future lead registrant using the ‘Assign New Lead’ button. The future lead registrant, should already be a member of the joint submission.

      assign new lead

    • Then, the future lead registrant should accept the assignment by clicking ‘Confirm Lead’ button and subsequently become the lead registrant in the Joint Submission.

      assign new lead

  • The new lead registrant needs to submit a lead dossier containing all the information to be provided on behalf of the joint submission. If the new lead registrant has previously submitted a registration dossier for this substance, the lead dossier should be submitted as a spontaneous update.
The initial lead registrant is still technically considered as the lead registrant of the joint submission until all above mentioned technical steps are carried out.
How can I increase the Joint Submission’s tonnage band?

To increase the Joint Submission tonnage band, the Lead Registrant needs to submit a spontaneous update. Please note, that the increase of tonnage band of the Joint Submission may require additional data to be provided in the Lead Dossier.

In Dossier Creation Wizard

Step 1

The tonnage band indicated in submission type (IUCLID 6 template) represents the tonnage band of the Joint Submission. Please pick the same submission type as was used from the last successful submission at a higher tonnage band.
step 1


step 2

 

Step 2

The administrative information of the dossier represents the data of the Lead Registrant. The tonnage band indicated in this step represents the tonnage band of the Lead Registrant’s own registration.

Keep in mind that the lead registrant can have his tonnage band different from the tonnage band of the Joint Submission, while the information required for the lead dossier is based on the highest tonnage band of any Joint Submission member. If the Lead Registrant increases his own registration’s tonnage band, a new invoice will be triggered.

Mark the dossier as an update, add the last successful submission number and chose ‘change of tonnage band’ from the drop-down menu as justification for the spontaneous update.

How can I decrease the Joint Submission’s tonnage band?

Step 1

Before decreasing the Joint Submission tonnage band, the Lead Registrant needs to make sure that all members of the Joint Submission, except for the Lead himself, have the tonnage band equal or below the decreased (new) JS’s tonnage band. Members can update their own tonnage band by submitting a spontaneous update.

The tonnage band of Intermediate registrations do not affect the tonnage band of the full joint submission, therefore, a member with an intermediate registration can have a higher tonnage band than the decreased Joint Submission.

Step 2

The Lead Registrant has to contact ECHA via the contact form and request that ECHA performs the decrease of the Joint Submission tonnage band.

If a consultant is representing the Lead Registrant, a signed request by the Lead Registrant needs to be submitted.

Step 3

After ECHA has decreased the Joint Submission tonnage band, the Lead Registrant has to submit a spontaneous update using the same submission type (IUCLID template) that was used for the last successful submission, but at a decreased tonnage band.

In the same update, the Lead Registrant has to update its own registration’s tonnage band (administrative information) to be equal or lower than the decreased tonnage band.

step 3

Mark the dossier as an update, add the last successful submission number and chose ‘change of tonnage band’ from the drop-down menu as justification for the spontaneous update.

step 3

Please note: If a final decision from ECHA was sent to the Joint Submission members, they will need to comply with such decision even after the tonnage band decrease.

 

Can the tonnage band of the lead registrant be below the Joint Submission tonnage band?

Yes. If the lead registrant wants to lower his tonnage band below the tonnage band of the Joint Submission, the Lead needs to submit a spontaneous update.

In Dossier Creation Wizard

Step 1.

The tonnage band indicated in submission type (IUCLID template) represents the tonnage band of the Joint Submission and should remain the same as used during the last successful submission.

Step 2.

The administrative information of the dossier represents the data of the Lead Registrant. The tonnage band indicated in this step represents the tonnage band of the Lead Registrant’s own registration, which can be equal or lower than the tonnage band of the Joint Submission, indicated in submission type.

How do I change the registration type of my Joint Submission?

If there is full agreement among the members of a Joint Submission and there is no Joint Submission of the different type, the lead registrant can send a formal request to ECHA so that ECHA can apply the necessary changes.

N.B. A Joint Submission type can change from full to intermediate only if there are no full members present.

How can a lead registrant of an intermediate joint submission change their registration from intermediate to full or add a full registration to their current intermediate registration dossier?

Registrants of the same substance are required to register the substance jointly regardless of the use (e.g. intermediate and non-intermediate). However, due to the reduced information requirements applicable to intermediates (used under strictly controlled conditions), registrants of intermediates may choose for practical reasons to either form a joint submission together with the registrants of non-intermediate (full) or to form one parallel joint submission for intermediate use only.

Before changing your registration, please consider the following flowchart:

Please note that since registrations for: i) full, ii) transported intermediate and iii) an on-site intermediate are each considered as a separate registration and have separate fees, this update may trigger an invoice.

Data sharing negotiations.

In addition to the applicable administrative expenses, all members of a joint submission (including the lead) have to contribute to the costs of the data they need. If only one member needs additional studies, they alone will need to pay for the cost of that data. Consequently, if a registrant is planning to submit a full opt-out dossier, they are only required to share the costs related to the administration expenses of the joint submission.

Further information: How to transfer the lead role to the member of a joint submission: https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/ids/0380.

C. Joint submission management - member registrant

How can I confirm my membership in a Joint Submission in REACH-IT before I submit my member registration dossier?

The lead registrant of a joint submission will provide you with a combination of joint submission name and security token outside of the REACH-IT environment (e.g. by email, phone). To confirm your membership, log in to REACH-IT and use the ‘Join existing Joint Submission’ functionality and follow the wizard.
joint submission

Member registrants will also need to indicate their membership to a joint submission by adding the joint submission name during the submission of their registration dossier in REACH-IT.

Member registrants are able to indicate their membership to a joint submission in section 1.5 of IUCLID 6 registration dossier. This information can be used for your own administrative purposes, but will not be verified against the information derived from REACH-IT.

Member registrants cannot submit their dossiers until the lead dossier has been accepted for processing by ECHA. The status of the lead dossier can be checked in the joint submission in REACH-IT.

How do I change from an individual to a joint submission?

An individual registrant who wants to become part of a joint submission needs to submit a spontaneous update and indicate that their registration is part of a joint submission. Before submitting, they have to confirm membership of the joint submission, in this case the lead registrant needs to provide the joint submission name and the security token.

Once you have the information required, you can confirm membership by signing in to REACH-IT >> Select Menu >> Joint Submission >> Join existing and enter the joint submission name and security token and follow the wizard.

When updating the dossier in IUCLID pay attention to the following:

  • Enter the registration number in section 1.3 of your substance dataset
  • Create the registration dossier by right-clicking the substance and selecting "create dossier" and follow the wizard
  • Choose the template "REACH Registration member of a joint submission –general case/ - intermediate" depending on your submission.
  • Indicate the reason for update as "Change from individual to joint submission"
My submission failed business rules verification, stating that I should submit my registration jointly. What does this mean?

Following the entry into force of the ‘Commission Implementing Regulation (EU) 2016/9 on Joint Submission of Data and Data Sharing', new checks were put in place to ensure that all submissions are in line with the ‘one substance, one registration' (OSOR) principle. According to the OSOR principle there can only be one joint registration per substance per registration type (full or intermediate).

Furthermore, if an active joint submission already exists (i.e. the lead registrant has successfully submitted the lead dossier), individual registrants (i.e. not part of the joint submission) for the same registration type (full or intermediate) are blocked from updating their dossiers, unless they become members of the joint submission.

ECHA advises you to take the following steps:

  • Find your co-registrants.
  • Establish substance sameness and negotiate on data sharing.
  • For the scenarios described in QA 1171, you can partially or fully opt-out from information submitted jointly by your co-registrants. However, your submission still has to be in the framework of the joint submission. Therefore, certain administrative fees may be applicable towards the joint submission.
  • If you cannot agree on the data and cost sharing, you can file a data-sharing dispute with ECHA. The dispute mechanism should be used as a last resort and you will need to demonstrate that you have made every effort to reach a voluntary agreement.
  • If you wish to submit a partial or full opt-out, but cannot come to a voluntary agreement with the lead registrant on the conditions for joining the joint submission, you can also use the above-mentioned dispute mechanism.

 

What are the constraints for updating my registration dossier under the ‘one substance, one registration' (OSOR) rules?

If you are an individual registrant and no other company has registered the same substance, you will not face any constraints when updating your registration. If there are other registrants for the same substance, you will have to fulfil certain criteria to be able to update. Below you can find the scenarios of your case:

  • A joint submission exists for the same substance and same registration type and your registration is outside of this: You cannot update your dossier, until you join the joint submission.
  • A joint submission exists for the same substance and same registration type and your registration is part of it: You can update your registration without any limitation, as long as you are not changing the type of your registration. For intermediate joint submissions, changing your registration to both intermediate and full or only full is only possible if there is no full joint submission already created for the substance, or there are no full registrations outside of a joint submission.
  • No joint submissions exist for the same substance and for the same registration type (full or intermediate), but other individual registrations have been submitted: You can update your registration without any limitation, as long as you are not changing the type of your registration or until a joint submission is created. For intermediate registrations, changing your registration to both intermediate and full or only full is only possible if there is no full joint submission already created for the substance, or there are no full registrations outside of a joint submission
Under what circumstances can a registrant submit partially or fully separate data from other members of the joint submission?

Registrants must always submit their information within the framework of a joint submission. However, registrants can submit some information separately, if: 

  • it would be disproportionately costly for them to submit some information jointly, or
  • submitting the information jointly would lead to the disclosure of commercially sensitive information that would likely cause substantial commercial detriment, or
  • they disagree with the lead registrant on the selection of information.

Registrants who fall under any of the above circumstances can submit some or all data on their own: these are respectively called partial and full opt-out. Technical implementation of the opt-out is described in Q&A 396.

 

 

 

Can I update my individual dossier without creating/joining a joint submission, even though multiple registrants exist?

As long as your registration fulfils the criteria listed below, you are allowed to update it, even if there are other individual registrations in the system:

  • There are only individual registrants and no joint submission exists in REACH-IT.
  • lYou are not changing your registration type with your update. For intermediate registrations, changing your registration to both intermediate and full or only full is only possible if there is no other full and intermediate registrant (either as part of a joint submission or as individual registrant).

If any potential or existing registrant creates and submits a joint registration, this joint registration will block all the individual registrants of the same substance and same registration type from being able to update their dossiers, until they join the joint submission.

Can I update my joint registration even though another joint submission for the same substance exists?

We highly encourage you to start negotiating with the other joint submission on merging into one, as in the future it will be unavoidable.

However, for the time being, you are still allowed to update your dossier without any limitations, as long as you are not changing the type of your registration. For intermediate joint submissions, changing your registration to both intermediate and full or only full is only possible, if there is no full joint submission already created for the substance, or there are no full registrations outside of a joint submission.

I submitted an individual registration and ECHA has requested that I update my dossier. Can I make the update without creating/joining a joint submission?
  • If there is a joint submission for the same substance you will need join the joint submission in order to submit the update.
  • If there is no joint submission, but there are individual registrants for the same substance, you should create a joint submission and take up the role as lead registrant before submitting the update.
  • If there is no joint submission and you are the only individual registrant, you can update your registration without creating the joint submission.
  • None of the above applies, if the update requested is linked to a technical completeness check (TCC) failure. In this case you submit an update as individual member.
How can I find other joint submissions in REACH-IT?

Once a potential member of the joint submission has pre-registered, registered or inquired about a substance, they can find the Joint Submission and the Lead Registrant’s details by using the Joint Submission functionality and by ticking the option ‘Show other joint submissions’, (see example screen shot below).

Joint submission

If a potential member of the joint submission has not pre-registered, registered or inquired about a substance, and the Lead registrant accepts to publish their contact information, they will be able to find the name of the Lead registrant on our website: https://echa.europa.eu/registration-statistics-infograph. The List of the lead registrants can be downloaded at the bottom of the info graphic.

If a potential member of the joint submission has not pre-registered, registered or inquired about a substance and the Lead registrant does not accept to publish their contact information, they can only find the Joint Submission and the Lead Registrant’s details if:

The above process is also explained in a YouTube video: https://www.youtube.com/watch?v=JLzCqj7xIlQ.

A member registrant wants to increase their own tonnage band above the current tonnage band of the Joint Submission. What procedure should we follow?
  1. The member has to communicate their intention to upgrade their tonnage band to the lead registrant.
  2. The lead registrant submits a dossier update using the IUCLID template corresponding to the higher tonnage band (submission type). The dossier will include all data required for the higher tonnage band. When creating the dossier, in the dossier header, the lead registrant should indicate their own tonnage band, which will in this case be lower than the used template (administrative information).
  3. Once the lead has successfully submitted the lead dossier, the member can submit their updated member dossier indicating the new, higher tonnage band in the dossier header (administrative information) and pay the corresponding fee.

In addition to the applicable administrative charges, all members of a joint submission (including the lead registrant) have to contribute to the costs of the data they need. If only one member registrant needs additional studies, they alone will need to pay for the cost of that data.

There is no cost linked to the increase of the joint submission tonnage band, there is only for the increase of the tonnage band of a registration. Therefore, as long as the lead registrant only increases the tonnage band of the joint submission, but not their own registration, they will not incur any additional fee. On the other hand, when the member registrant submits their updated dossier at an increased tonnage band, they will receive a new invoice.

In case the data that is required for the higher tonnage band is only available for the specific member registrant, who wishes to update their dossier, they can decide not to share it with the lead registrant, but instead include it in their own dossier and submit an opt-out for the higher tonnage band.

Note that, by submitting an opt-out dossier you will not be entitled to the reduced joint submission fees. Furthermore, any registrant who in the future wishes to update their registration to this higher tonnage band would have to include the data in their dossier separately. For this reason, ECHA recommends that the lead registrant’s dossier contains all information, regardless of their tonnage band. Alternatively, and only if the majority of SIEF members supports it, the member registrant can take over the lead role of the joint submission.

How can a member registrant of an intermediate joint submission change their registration from intermediate to full or add a full registration to their current dossier?

Registrants of the same substance are required to register the substance jointly regardless of the use (e.g. intermediate and non-intermediate). However, due to the reduced information requirements applicable to intermediates (used under strictly controlled conditions), registrants of intermediates may choose for practical reasons to either form a joint submission together with the registrants of non-intermediate (full) or to form one parallel joint submission for intermediate use only.

Before changing the member registration, please consider the following flowchart:

Please note that since registrations for: i) full, ii) transported intermediate and iii) an on-site intermediate are each considered as a separate registration and have separate fees, this update may trigger an invoice.

Data sharing negotiations

In addition to the applicable administrative expenses, all members of a joint submission (including the lead) have to contribute to the costs of the data they need. If only one member needs additional studies, they alone will need to pay for the cost of that data. Consequently, if a registrant is planning to submit a full opt-out dossier, they are only required to share the costs related to the administration expenses of the joint submission.

D. List of lead registrants

How can I be sure there is no confidential material published on the List of lead registrants

ECHA removes all confidential information before compiling the list of lead registrants. Joint Submission information are not published if the substance identity has been claimed confidential in all JS registrations dossiers. The information on the List of lead registrants mirrors the information published on ECHA’s dissemination webpage.

Why are some Lead names on the List of lead registrants marked as ‘Available in REACH-IT’?

When creating a Joint Submission the lead registrant can refuse to publish their contact details.
contact details
In this case, the contact details of the lead registrant will not be publicly available on the List of lead registrants and the entry will be marked ‘Available in REACH-IT’’.

This means that only companies, that have registered, pre-registered or inquired about this substance will be able to find the contact details in REACH-IT. (See Q&A 1220).

 

I am a Downstream User and my substance is not on the List of lead registrants. Will I be able to buy the substance if none of my suppliers has a valid registration?

A supplier, who has a valid pre-registration, can manufacture/import the substance below 100 tonnes per year without a registration until the registration deadline on 31 May 2018. After this day the supplier will only be able to manufacture/import your substance above 1 tonne per year, if they have a valid registration.

There can be a number of reasons, why your substance is not on the List of lead registrants:

  • The substance is still in the pre-SIEF stage and no lead registrant has been appointed
  • Suppliers are still gathering data and have not formed the Joint Submission yet
  • There is a joint submission, but all members have claimed their substance identity confidential.
  • Your supplier is an individual registrant and no Joint Submission will be created for your substance
  • The annual quantity of the substance manufactured or imported by the individual suppliers is below 1 tonne per year (so there is no 2018 registration requirement)

We advise you to contact your supplier(s) to find out what they are doing to ensure your supply.

What is the List of lead registrants?

When creating a Joint Submission the lead registrant can accept to publish their contact details.

ECHA publishes the contact details of these lead registrants on the List of lead registrants. The list includes the substance identity, registration type and creation date and whether or not the lead dossier has been submitted.

The lists is available both in pdf and excel and can be found at:

https://echa.europa.eu/regulations/reach/registration/registration-statistics.

Why is my substance not listed in the List of lead registrants?

There may be several reasons, why a substance has not been included to the List of lead registrants:

  • The substance is still in the pre-SIEF stage and no lead registrant has been appointed.
  • The lead registrant has been appointed, but has not created the Joint Submission in REACH-IT.
  • There is a joint submission, but all members have claimed their substance identity confidential.
  • There is only an individual registrant and no Joint Submission has been created for your substance.
  • The annual quantity of the substance manufactured or imported by the individual suppliers is below 1 tonne per year.

2008 preregistered substances

All registered substances

Legal entity

A. Legal entity management

How can I update and synchronise my legal entity (LEO) information?

There is no need to synchronise the company details in REACH-IT and IUCLID. The legal entity information is always extracted from the information in REACH-IT.

However, if you wish to do so, we recommend updating the information in REACH-IT, and later exporting it to your IUCLID 6. If you update your LEO information in your IUCLID 6 application, remember also to update your LEO information in REACH-IT.

Step by step instructions on how to update and synchronise the LEO information can be found in chapter 2.1 of ‘How to prepare registration and PPORD dossiers’ manual at: http://echa.europa.eu/manuals.

 

 

How do I update my company size in REACH-IT?

The company size can be updated in REACH-IT via the ‘Company size’ functionality from the main menu and selecting the ‘Update company size’ functionality. 

update company size

This will open a wizard that will guide you through the process of updating the company size. Read carefully the instructions and have the documentary evidence at hand to substantiate the companies involved in the ownership structure.

Note: By declaring that your company is an SME, you become eligible to an SME fee reduction. ECHA routinely verifies the SME status of legal entities who self-identify as SMEs. We recommend that you keep your company size information up-to-date in your REACH-IT account.

B. Legal entity change

What documentary evidence is considered adequate if a legal entity change involving a total "sale of assets" occurs? Does ECHA verify the adequacy of the submitted documentation?

The final decision on what documentation is considered adequate evidence of a ‘sale of assets’ is determined on a ‘case by case' basis in accordance with the relevant national principles of private and corporate law of the Member State where the entity is established. For this reason ECHA Practical Guide 8 – How to report changes in identity of legal entities limits itself to the general example of the asset sales agreement and does not provide further information in this regard.

The relevant documents should be presented to the national enforcement authorities upon request. Ultimately, the REACH duty holders bear responsibility for the submission of adequate documentary evidence. To ensure that it complies with the national legal order they may seek legal advice from in-house or private practice lawyers, for example.

More information on changes in identity of legal entities can be found in the aforementioned Practical Guide 8 – available at http://echa.europa.eu/practical-guides.

 

 

What is the outcome of a legal entity change?

The legal successor should observe the following when a legal entity change is validated in REACH-IT:

Transferred items (i.e. registrations/notifications)

If a registration/notification for a substance is transferred from the legal initiator to the legal successor, who already has a valid registration/notification for the same substance, the status of the transferred registration/notification will be marked ‘Annulled’, because a legal entity can only have one registration for the same substance.

Tonnage band update

For transferred registrations when the originating legal entity has registered the same substance as the legal successor and the tonnage of the originating legal entity is higher than the registered substance of the legal successor, the system will keep track of the legal successor's right to a higher tonnage band. The legal successor will still need to submit a spontaneous update to indicate the higher tonnage band. For transferred pre-registrations, the tonnage band will not be updated when a legal entity change is completed for the same pre-registered substance. In this case, the legal successor will have to modify the pre-registration as explained in Q&A 345.

Joint Submission

Transfer of joint submission roles linked to Registrations: Where the initiating legal entity has submitted registrations as part of a joint submission, the joint submission role (e.g. Member or Lead registrant) are transferred together with the registrations to the legal successor.

If no registrations were submitted, the roles are not transferred. The legal successor need to confirm their membership to the joint submission. 

Transfer of joint submission roles linked to Pre-registrations: Where the initiating legal entity has confirmed membership to a joint submission based on his pre-registration, the joint submission role (e.g. Member or Lead registrant) is not transferred together with the pre-registration.

Pre-SIEF

When a legal successor enters the pre-SIEF contact details during the validation of a legal entity change, these details will be updated in the pre-SIEF of all the pre-registrations of that legal successor. The pre-SIEF contact details will however need to be updated if you wish to add additional contact persons in the transferred pre-registrations once the transfer is complete. Pre-SIEF contact details will not be updated if you already have a successful registration for a pre-registration with the same substance identification.

Invoicing

The Agency will issue an invoice for the legal entity change pursuant to Commission Regulation (EC) No 340/2008 Article 5 (Fee regulation) if the item list contains one or more payable items.

  • Items that trigger a fee during a legal entity change are: Registrations, Registration of on-site isolated intermediate, Registration of transported isolated intermediate.
  • Items that do not trigger a fee during a legal entity change are: Pre-registrations, Product and Process Oriented Research and Development (PPORD) notifications, Classification and Labelling (C&L) notifications, Inquiry notifications.

Where an invoice is needed (i.e. the legal entity change includes at least one payable item), only one invoice will be issued per legal entity change.

Invoices are issued to the legal successor. The company size of the legal successor after the change of legal personality will determine the fee. Pursuant to Commission Regulation (EC) No 340/2008 Annex III Table 3, a reduced fee will be invoiced to SMEs.

Only once the invoice is paid in full, will the transfer of items take place and the legal entity change be completed in REACH-IT. If the invoice is not paid within the extended due date the legal entity change is deleted from the system and items will not be transferred.

Information about the fee regulation can be found at http://echa.europa.eu/regulations/reach/legislation.

Practical information on how to report changes in identity under REACH and CLP can be found in How to report changes in identity under
REACH and CLP
-guide

How can I download the dossier that I acquired via a legal entity change?

You can use the ‘Request IUCLID file’ functionality to download the dossier in REACH-IT. The IUCLID file can be downloaded from the REACH-IT submission report page. You can get to the submission report page, by clicking --> Menu --> Search --> Submissions.

request IUCLID file

When a legal entity change (LEC) takes place, a new submission number is created and assigned to each transferred asset. This is done for technical reasons to keep track of the legal entity transfer, and is not linked to any new submission.

Therefore, when the legal successor submits a request for a dossier download, they should request the download for a submission that is linked to an ‘Initial submission’ or a ‘Submission update’, and not to the Event ‘Legal entity change’. The submission numbers with the related Events can be checked at the Reference number page, ‘Reference number history section’

You can get to the Reference number history section, by clicking Menu → Search → Reference number → click on the reference number displayed in the results page to open the Reference number page → click on the Reference number history section → click on the submission number under ‘Initial submission’ or ‘Submission update’. (see screenshot below)

Reference number history

Please note that it is not possible to download a NONS registration under Directive 67/548/EEC that was successfully claimed if no registration dossier update has been submitted. The owner of the NONS registration needs to contact the appropriate Member State competent authority to receive the files in IUCLID 5 format if the successfully claimed NONS registration needs to be updated. The list of MSCA contact details is available at National Helpdesks page.

B. SME Verification

What documents are needed in REACH-IT for SME fee reductions under REACH?

Under REACH, registrants and applicants can benefit from reduced fees established for micro, small and medium enterprises (SMEs).

Companies declare their SME size at the time of dossier submission, based on which ECHA issues an invoice. At a later stage, ECHA carries out an ex-post assessment, to verify the correctness of the company size. The SME verification process is important to ensure that only genuine SMEs benefit from the reduced fees and that correct fees are collected.

Before declaring the SME status in REACH-IT, companies should be familiar with the rules set by the Commission Recommendation 2003/361/EC on SME definition.

Companies should upload documentary evidence to their REACH-IT account to support SME status claims. This is only required for those submissions, which are related to SME fee reductions.

The documentary evidence should include:

  • Information about the ownership structure (upstream, downstream) at the time of the submission.
  • The financial statements (consolidated, if available) together with accompanying notes for the two latest accounting periods before the time of the submission.
  • Official certificate/information confirming the average number of employees for each of the two latest accounting periods before the time of submission.

The documents listed above shall be provided for all partner and linked enterprises, as defined by Article 3 of the aforementioned Commission Recommendation.

In case of Only Representatives, the assessment on whether the SME reduction applies is done by reference to the headcount, turnover and balance sheet information of the non-EU company represented and its linked and partner enterprises.

All documents uploaded to REACH-IT are treated confidentially by ECHA and used exclusively for size verification purposes. For transparency and traceability reasons, documents cannot be deleted. It is, however, possible to add supplementary documentation to your REACH-IT account at a later stage. The documentation is not assessed immediately, but only once the size verification process has been initiated.

The list of documentary evidence accepted by ECHA can be found in SME verification -page.

Instructions on how to upload documents and other useful information about REACH-IT can be found at Discover REACH-IT -guide.

More information on company’s size assessment and links to the relevant legislation can be found at SME fees under REACH and CLP -page

When do the documents submitted for SME verification require a certified translation?

If the original version of any document is not in one of the official languages of the European Union, a certified translation should be provided.

Legal basis for certified translations is Article 13(3) of the amended Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Please see it at: 

http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:079:0007:0018:EN:PDF

A certified translation is the one which is accompanied by a signed statement that the translator is competent in the source and target languages (a sworn translator) and that the translation is an exact and accurate translation of the source document. The certified translator should have a certificate or a stamp that identifies the services provider and his qualification.

How does a cessation of manufacturing or import of substances affect the SME verification process?

The SME verification process relates to your information obligations at the time of submitting your registration, which includes the obligation to inform ECHA about the eligibility for a fee reduction in accordance with Article 13(1) of Regulation (EC) No 340/2008. Ceasing to manufacture or import of substances have no consequence on that obligation.

If after registering a substance, you have decided to stop manufacturing or importing it, you should still pay the applicable registration fee in full in case ECHA found that you were not eligible for the claimed SME fee reductions. Once the registration fee is paid and, therefore, your registration can be considered complete, you can indicate in REACH-IT that you have ceased the production or import of a substance. If at a later stage you decide to restart manufacturing or importing it, you would only need to report it again in REACH-IT and the registration would still be valid. Otherwise, you would need to submit a new registration and pay a new registration fee.

In case the balance to the correct registration fee is not paid, such registration will be de-activated in ECHA’s database and the rejection of the registration will be communicated to you by a decision.

How does termination of the Only Representative (OR) contract with non-EU enterprise affect the SME verification process?

The SME verification process relates to your information obligations at the time of submitting your registration, which includes the obligation to inform ECHA about the eligibility for a fee reduction in accordance with Article 13(1) of Regulation (EC) No 340/2008. The termination of the OR agreement has no consequence on that obligation.

Since your represented company benefited from reduced SME fee at the time of registration, therefore you, as the appointed OR at that time, are still liable to demonstrate the eligibility for the SME fee reduction obtained, once ECHA initiates the verification of your represented company size. The failure to provide complete documentation would result in ECHA finding your represented enterprise as non-eligible for the claimed SME fee reductions. In such case, the OR would be liable for the difference between the fee already paid and the correct registration fee, as well as the applicable administrative charge.

Pre-registrations

How can I update the information in my pre-registration?

You can modify all information, except for the substance identity (see also QA 1142) and the legal entity assigned to that pre-registration. You can modify:

  • Contact information (both internal contact of the owner and possible third party representative).
  • The remarks field for the pre-SIEF if needed.
  • Similar substance fields.
How do I delete/deactivate my pre-registration?

A pre-registration cannot be deleted, but it can be deactivated in REACH-IT. To deactivate the pre-registration look for your substance in the pre-SIEF section of REACH-IT and use the ‘Deactivate’ functionality.


The Status column that describes the status of your participation in the pre-SIEF will turn to ‘Inactive’. You can reactivate you pre-registration at any time by using the ‘Activate ’ functionality. If you update your pre-registration while the status is inactive, the system will automatically reactivate your pre-registration.

The deactivation of a preregistration signals to other pre-SIEF members, that you are not interested in an active participation in the SIEF discussion. Note, however, that even as a non-active participant to the pre-SIEF you may still be asked to share data in the SIEF.

Note also, that the pre-registration and potential future registration of your substance are not affected by the deactivation from the pre-SIEF forum. You can benefit from the extended registration deadline if you have a valid preregistration, irrespective of its status (active or inactive).

The ‘Deactivate’ button is disabled if a third party representative was appointed for a particular pre-registration. In this case, the deactivation can only be performed by the third party representative and not by the potential registrant.

Can downstream users check online if their suppliers have pre-registered?

No, downstream users should make appropriate contractual arrangements with their suppliers to ensure that they comply with REACH.

Where can I see the list of substances that have been pre-registered?

Pursuant to Article 28(4) of the REACH Regulation, ECHA published a list of pre-registered substances on its website by 1 January 2009. The list includes all substances that were pre-registered by 1 December 2008. For each substance the following information is given:

  • Substance identification: EC number, CAS number and name of the substance
  • Substance identification of the similar substances, if applicable
  • First envisaged registration deadline

This list does not mention the names of the companies who pre-registered the substances. You are invited to check the list on our website at: http://echa.europa.eu/information-on-chemicals/pre-registered-substances

What should I do if I am in the wrong pre-SIEF?

If during pre-registration of your substance, you entered your substance name in a different way than the other manufacturers and importers, or if you realise during discussions on the sameness of your substance that you do not have the same substance as the other pre-registrants in the pre-SIEF, you may want to look for and join another SIEF. Whether you find a more suitable SIEF or not, you must register your substance with the correct identifiers, which have to be consistent with the analytical data on your substance.

A useful tool when looking for a more suitable SIEF is the list of pre-registered substances. This list contains all pre-registered substances, with the available identifiers, such as EC number, CAS number and chemical name with synonyms. The list is available at:

http://echa.europa.eu/information-on-chemicals/pre-registered-substances. You can also search the list of registered substance available at https://echa.europa.eu/information-on-chemicals/registered-substances.

Once you have examined the list of pre-registered and/or registered substances, the following scenarios are possible:

1) You found a more suitable pre-SIEF for your substance

You can find the lead registrant in the list of lead registrants on the ECHA website. Contact the lead to join the SIEF. If the substance is not listed or no lead is mentioned, you can use REACH-IT to update your pre-registration. If you add the more suitable substance as a similar substance you will have access to this substance pre-SIEF page. As you will not be listed as a member of this pre-SIEF, you will have to take the initiative and get in contact with the pre-registrants therein to explain that you wish to join the SIEF. It is also possible for you to set up the joint submission and to become the lead registrant. For instructions on how to update your pre-registration to view a different pre-SIEF in REACH-IT, see Q&A 1142.

2) You did not find a suitable pre-SIEF for your substance

Most likely you will have to become the lead registrant for the substance. In any case, you should include your pre-registration number in Section 1.3 of your IUCLID dossier, even though it previously corresponded to different substance identifiers (see Q&A 293)In addition, you should keep any relevant documentation that demonstrates the phase-in status of your substance in case it is requested by the enforcement authorities.

How can I join a more suitable pre-SIEF in REACH-IT?

Once you have found a more suitable or more specific identifier for your substance, you can find the pre-SIEF of your substance (here bismuth tetroxide) in REACH-IT and use the functionality ‘Edit pre-registration’ to update your pre-registration (as advised in Q&A 377). 

In the next step of the wizard, you should add the more suitable substance in the ‘Similar substances’ tab.

When this is done, you will be able to navigate from the pre-SIEF page of your substance to the pre-SIEF page of the similar substance using the ‘Read across to’ tab. You will not be listed as a member of this pre-SIEF, which means that you will be able to see the members of the pre-SIEF, but they will not be able to see you. For this reason, you will have to take the initiative and get in contact with them to explain that you wish to join the SIEF.

The ‘Similar substances’ functionality was designed for pre-registrants to list substances with similar chemistry, for which data may be used for grouping or read-across in the registration, in accordance with Annex XI of REACH. So not all substances listed in the ‘Similar substances’ tab concern registrants that want to refine their substance identity.

The ‘Similar substances’ functionality should not be used to fulfil the registration obligations for a substance other than the substance originally intended to be covered in the registration. The new identifier can therefore only refine the identity of the substance initially concerned; it cannot correspond to an entirely different substance.

How can I become the SIEF Formation Facilitator (SFF) in REACH-IT and what are the tasks?

The SFF (SIEF Formation Facilitator) is the person initiating communication with other pre-SIEF participants to start working together and ultimately submit the data in a joint submission. The SFF is visible in the pre-SIEF page in REACH-IT and is marked with the letter F for Facilitator.

To take the role of SFF, use the ‘Become facilitator’ button from the Pre-SIEF page in REACH-IT. If the button is not available, it means that someone else is already the SFF.

If you are the SFF and you no longer wish to facilitate discussions among co-registrants, you should discuss with your co-registrants if anyone is willing to take up the role of facilitator. You can delete your role as facilitator by using the ‘Stop facilitator’ button.

For further info on the tasks of the SFF, see Q&A 99.

Can I still pre-register my substance?

According to Article 28(6) of the REACH Regulation, potential registrants who for the first time manufacture or import a phase-in substance in quantities of one tonne per year or more after 1 December 2008 can submit a late pre-registration within six months of first manufacturing or importing the substance above one tonne per year and at least 12 months before the relevant registration deadline.

The last registration deadline for tonnage bands between 1-100tpa is on 31.May 2018. This means that the deadline to late pre-register a new substance and benefit from the extended deadline expired on 31.May 2017.

If you are a potential registrants who for the first time manufacture or import a phase-in substance in quantities of one tonne per year or more you have submit your inquiry dossier to ECHA. For further information, see Q&A 444.


C. SME verification

Do I need to take into account any linked or partner non-EEA companies, when determining the SME status?

Yes, according to Article 12 of the Fee Regulation (EC) No 340/2008 and the references therein to the definitions concerning micro, small and medium-sized enterprises as set out in the Annex to the European Commission Recommendation 2003/361/EC, both EEA and non-EEA companies are to be considered for the classification of partner and linked enterprises during the determination of the SME status of a company. Moreover, the non-EEA company is the very entity under consideration, in case when a submission is made by an Only Representative, as specified in Article 12 of the Fee Regulation.

If a dossier submission is rejected after the second technical completeness check, what are the consequences?
In case the registrant fails to complete his/her registration for the second time within the deadline set, the Agency will reject the registration and the registration fee will not be reimbursed. According to Article 5 of the REACH Regulation, substances may not be manufactured, or placed on the market unless they have been registered. By virtue of Article 23(1), 23(2) or 23(3) of REACH, as applicable, neither Article 21 nor Article 5 apply to the registration dossiers for substances benefiting from the extended registration deadlines of Article 23 of REACH until the respective deadline in question. This means that if a registration is rejected before the respective deadline in Article 23 of REACH, manufacturing or importing of this substance within the EEA can continue until this deadline.

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