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REACH-IT

Business Rules

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.

 

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.

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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