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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.

 

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.

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.

 

 

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 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.

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.

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.
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

Pre-registrations

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.


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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