Q&As

Want to search for the relevant question and answer in your own language? Change the language in the dropdown menu above.

Back

Back

REACH-IT

Joint submissions

A. General

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 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).
  2. Once the lead has successfully submitted the lead dossier, can the member submit their updated member dossier indicating the new, higher tonnage band in the dossier header (administrative information).
  3. 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.
  4. There is no cost linked to the increase of the joint submission tonnage band, 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 also, 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.

General questions

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. The information provided in section 1.5 of the IUCLID 6 registration dossier can be used for your own administrative purposes, but this information 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 can a joint submission be deleted in REACH-IT?

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 JS (active or inactive)
  • There are no submissions linked to the JS (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.

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 create a joint submission by selecting manually 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

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"
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.
  • You are not changing your registration type with your update. For intermediate registrations, changing your registration to mixed or full is only possible if there is no other mixed/full registrant (either as part of a joint submission or as individual registrant).

Any potential or existing registrant can create and submit 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 mixed or 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.
 

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.

How can a lead registrant create 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.

 

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.

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.

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:

  • Suppliers are still gathering data and have not formed the Joint Submission yet
  • 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.
  • Your supplier is 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.

Link to 2008 preregistered substances: https://echa.europa.eu/information-on-chemicals/pre-registered-substances

Link to all registered substances: https://echa.europa.eu/information-on-chemicals/registered-substances

One substance, one registration

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 mixed or 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 mixed or 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.

 

 

 

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.
Submitting an opt out dossier

How can I opt out of a Joint Submission?

In case there is a disagreement regarding a specific endpoint, potential registrant may opt-out of information according to Article 11(3) (or 19(2) in case of intermediates) if:

  • it is disproportionately costly to submit this information jointly; or
  • it would lead to the disclosure of information which he considers to be commercially sensitive and may cause substantial detriment; or
  • there is disagreement on the selection of this information.

In such cases, you can partially or fully opt-out of the joint submission and include all endpoints you want to opt out of to your member dossier. An opt-out (partial or full) does not allow submitting a registration dossier outside the framework of the joint submission. Even if you fully opt-out, you may still be requested to participate in the cost sharing of the relevant administrative fees associated with the management of the joint submission.

In case of an opt-out, you are required to:

  • remain part of the joint submission
  • submit your own information to cover the data requirement
  • submit a clear and reasoned justification for opting out
  • include opt-out information in section 14 of IUCLID 6 dossier

REACH registration dossier of a member registrant

  • Sections 2, 4, 5, 6, 7 and 8 of the member dossier should be left empty if the member registrant relies on the information provided in the lead dossier.
  • If a member registrant submits a dossier with any of these sections filled in, the submission is regarded as an opt-out (see picture below).

opt out

Please note, when a member only opts out of IUCLID section 2 (Classification and Labelling), the opt out status in the joint submission page will be marked as ‘no’. The opt out status is only marked as ‘yes’, when the member opts out of data requirements other than Classification and Labelling.

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

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.

Nota bene: 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.

Categories Display