Q&As

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REACH

Inquiry

I submitted my inquiry dossier to ECHA. What happens next?

Once you have submitted your inquiry dossier to ECHA, REACH-IT will execute a series of automatic verifications after which we will manually assess your dossier. The assessment can lead to two different outcomes:

  1. If we are able to process your inquiry dossier, you will receive a communication via REACH-IT providing you with an inquiry number as well as details of available (robust) study summaries, as appropriate. You will also receive a link to the Co-Registrants Page in REACH-IT, which will contain the contact details of the registrants and successful inquirers of the same substance. If you were assigned a list number and a list name, you will need to download the list number in .i6z file format to use it in your registration dossier. At the end of the Submission Report related to your inquiry dossier (in REACH-IT) there is a button that will allow you to download the i6z file to be used when preparing your registration dossier. 
  2. If we are not able to process your inquiry dossier, due to missing and/or inconsistent substance identification information, you will receive a communication via REACH-IT detailing the changes that you need to make to your inquiry dossier. In this case, you will need to submit a new inquiry dossier.
Does the analytical data included in an inquiry dossier have to be generated on the manufactured or imported substance?

In principle, the analytical data included in an inquiry or a registration dossier must reflect the substance as manufactured or imported. Hence, if you are an EU manufacturer, you must submit analytical data generated from a sample that you have manufactured. If you import from outside the EU, you must submit analytical data generated from a sample manufactured by the non-EU manufacturer.

We are aware that this can be problematic if you have to register your substance before taking up manufacture or import. For such cases we may accept submitting analytical data from another source.

For these exceptional cases, you need to explain the following in your inquiry dossier:

  • Why the analytical data cannot be generated on the manufactured substance.
  • Why the substance you intend to manufacture or import will be the same as the one used to generate the analytical data. For example, a statement that the manufacturing process and/or plant specification used to produce the analysed substance will mirror that for the inquired substance.

You also need to provide the following information in your inquiry dossier:

  • The source of the analysed substance i.e. manufacturing site name and address.
  • A short description of the production process and the raw materials for both the inquired substance and the analysed substance.
  • The foreseen manufacturing or import volume for the inquired substance.
  • A statement from the owner of the analytical data indicating that you have their permission to use their analytical data.

You are required to update the substance identification information in the registration dossier within 6 months after the submission to reflect the substance as manufactured or imported. If the registration is not updated, ECHA may initiate a targeted compliance check on substance identity.

How does a Third Party Representative (TPR) function in the inquiry process?

We display on the Co-Registrant page in REACH-IT the contact details of the third party representative (TPR) to registrants and successful inquirers. However, we communicate the result of the inquiry process to the inquirer and not to a designated TPR.

My inquiry could not be processed by ECHA because of missing/inconsistent information. Is there a deadline for submitting a new inquiry dossier?

No. There is no deadline for submitting a new inquiry dossier to ECHA.

What is the timeframe for processing an inquiry dossier?

The REACH Regulation does not impose any timeframe on ECHA for processing an inquiry dossier. Whilst the internal timeframe is 20 working days, we aim to provide the inquiry result as promptly as possible.

I am a potential registrant of an intermediate. Where can I specify this fact in my inquiry dossier?

Inquiry and registration of intermediates are regarded as two distinct processes. For this reason, it is not necessary to specify in your inquiry dossier the type of registration you plan to submit.

I am a potential registrant of an intermediate. Do I have to submit analytical data as part of my inquiry, even though it is not required for the registration?

Yes. Irrespective of the type of registration, you have to submit analytical data as part of your inquiry. The analytical data has to be sufficient to allow ECHA to verify the identity of your substance. This is to enable ECHA to provide you with the contact details of registrants and successful inquirers of the same substance.

Where can I find further information that would help me prepare my inquiry dossier?

When preparing your inquiry dossier, we recommend that you read the following documents:

 

How can I check if my inquiry dossier contains all necessary information to be processed by ECHA?

Before submitting any dossier, we recommend that you use the "Validation Assistant", which will identify the fields of your dossier which deserve particular attention. You can download it via the IUCLID 6 website https://iuclid6.echa.europa.eu/.

The Validation Assistant supports the preparation of your IUCLID 6 dossier in two ways:

  • It performs a check of most of the business rules applied to dossiers in REACH-IT. This enables the user to detect and correct failures before submitting the dossier to ECHA. For further information on the business rule check, please consult the Data Submission Manual - part 4 (How to Pass Business Rule Verification ("Enforce Rules")), available at: http://echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-manuals.
  • It performs a so-called "Substance Identity check", identifying the IUCLID fields of an inquiry dossier that should be filled in or that need particular attention. It is advisable to use the Validation Assistant both for preparing the inquiry substance dataset and the final dossier. We strongly recommend addressing all the reported inconsistencies and shortcomings. Please note that the "Substance Identity check" will not assess whether the information submitted is adequate but only if all required fields are filled in. 

 

Does ECHA disclose or publish the information submitted in an inquiry dossier?

ECHA will not publish any substance identity information submitted as part of an inquiry.

ECHA uses the information submitted for the purposes of inquiry solely to determine whether the same substance has been previously registered or inquired about. We make available the contact details and list of information requirements only within the relevant Co-Registrants page in REACH-IT. The EC/list name, EC/list number and/or EC/list description is the only substance identity information disclosed to registrants and successful inquirers of the same substance.

Do I have to wait for the result of my inquiry before submitting my registration?

Yes. Before submitting your registration, you need to wait until you have received a communication from ECHA which includes the inquiry number. We will also provide you with the link to the relevant Co-Registrants page in REACH-IT, where you will find the details of registrants and successful inquirers of the same substance. This will support you in complying with your obligations to share data and submit a joint registration.

I need to update my registration as a result of a tonnage band increase. Do I need to submit an inquiry?

Yes, but only if you need additional information to update your registration.

My inquiry contains a request for information. How will this information be communicated?
  • Availability of data submitted AT LEAST 12 years previously
    • if the data requested was submitted at least 12 years previously (e.g. under the previous legislation), you will see the comment "attached" and you will receive a copy of the corresponding robust study summary (as attachment to the inquiry annotation);
    • if such data is not available, you will see the comment "not available";
  • Availability of data submitted LESS THAN 12 years previously
    • if the data requested were submitted less than 12 years previously, the name of the company that submitted the data for the given endpoint will be displayed. You can find their contact details in the Co-Registrant Page;
    • if such data is not available, you will see the comment "not available".

    Note that the analysis performed by ECHA of the availability of data is based on the existing registration dossier(s) which passed the check of completeness of the technical dossier.

How can I, as a potential registrant, find the lead registrant of the substance I intend to register?

There are various ways to search for the lead registrant:

 

I am having difficulty cooperating with a previous registrant. What can I do?

It is the common responsibility of the potential and the existing registrant(s) to negotiate and agree on the content of the joint registration dossier, submitted by a lead registrant. In the case of information submitted less than 12 years prior to the inquiry, REACH (as per Article 27(2) and (3)) requires both the potential and previous registrants to make every effort to agree on the sharing of the information and its costs in a fair, transparent and non-discriminatory way. You can find practical advice on data sharing negotiations at: http://echa.europa.eu/support/registration/working-together/practical-advice-for-data-sharing-negotiations

 

In case you fail to reach such an agreement you may, as a last resort, contact ECHA in accordance with Article 27(5) or Article 30(3) of the REACH Regulation. For more details, please find more information at: http://echa.europa.eu/support/registration/working-together/data-sharing-disputes/data-sharing-disputes-in-practice

 

Can I begin vertebrate testing before I receive the result of my inquiry?

No. REACH requires that new testing of a substance involving vertebrate animals can only be carried out as a last resort. Therefore, you need to wait until you have received the communication from ECHA, which states your inquiry number together with the list of the requested (robust) study summaries available to ECHA. This will then allow you to determine which further studies may need to be conducted.

For chemicals manufactured or imported in a quantity of 100 tonnes or more, you are not allowed to conduct any vertebrate testing for the information requirements specified in Annexes IX and X of the REACH Regulation. Instead, you must submit a testing proposal in your registration dossier. We will then evaluate whether the testing proposal is adequate before such a test is performed.

I registered a substance in the past and today I received an ECHA message informing me of a new potential registrant for the same substance. What do I do next?

This communication is for your information only (as per Article 26(3)), so you do not need to take any action. However, in case your information was submitted 12 years prior to the inquiry, and if a potential registrant requests this information from you, REACH requires that you respond in order to enter into negotiation to reach an agreement on the sharing of this information and their associated costs (as per Article 27(2), (3) and (4)). You are required to make every effort to reach a fair, transparent and non-discriminatory agreement on sharing the data and its cost. You may also consider preparing for the potential request for data sharing by ensuring that you comply with the criteria outlined in the Implementing Regulation on joint submission and data sharing. For more information, see the new draft Guidance on data sharing, Chapter "5. Cost sharing".

How can I find other existing and potential registrants in the co-registrants page?

The co-registrants page helps registrants fulfil their data sharing and joint submission obligation. It is accessible to existing registrants and potential registrants who have successfully inquired. It displays their contact details and, in case of inquirers who requested endpoints data, the list of requested information. Also the role of the registrants within the joint submission is visible for all, so the lead can be easily identified and directly contacted for the purpose of data sharing.

Registrants can see different information depending on their status:

  • Potential registrants, during the 12 months after successfully submitting their inquiry, can see all registrants. However only the leads are identified.
  • Potential registrants, beyond the 12 months of their successful submission and if they have not registered, can only see new potential registrant(s) or registrant(s) that have inquired. They can no longer see the existing registrants that did not inquire.
  • Registrants can see the roles of all co-registrants, i.e. whether they are lead or member and can see the potential registrants.

In case the substance subject to the inquiry process has been pre-registered, inquirers will also be informed about the pre-SIEF members. 

 

How do I know which joint submission to join?

Multiple registrants of the same substance share two main obligations under the REACH regulation: data sharing and joint submission obligations. Registrants can identify who else has registered their substance and therefore shares common obligations under REACH.

It is the common responsibility of all (potential) registrants, yourself included, to form a single joint submission. ECHA strongly recommends that all registrants use this new page as a tool to ensure compliance with these obligations. For example, no role is displayed next to a registrant that has submitted a registration dossier outside of an existing joint submission. They are required to contact the lead registrant, as they share the same responsibility as the other multiple registrants. Registrants of the same substance are obligated to make every effort and to ensure that they are part of the same joint registration dossier. Existing registrants outside the joint submission are required to negotiate access to the joint submission with their co-registrants – regardless whether they need to share data or not.

For further information see Guidance Chapter "6 Registration: Joint Submission" Please also note the partial exceptions applicable for intermediate registrants.

Why are the contact details of a company that notified a substance under the previous legislation (Directive 67/548/EEC) not shown in the Co-Registrants Page?

The contact details of the companies which did not claim a registration number for a substance notified under the previous legislation are not available in REACH-IT and therefore cannot be displayed. Following an inquiry, we send registered mails to those companies that did not claim their registration number to inform them that there is an inquirer for a substance they have notified.

In the Co-Registrants Page, is the Third Party Representative (TPR) or the Only Representative (OR) specific to the inquiry/registration dossier?
Yes. The Third Party Representative (TPR) or the Only Representative (OR) displayed in the Co-Registrants Page is specific to the inquiry/ registration dossier. Consequently, if the same TPR has been nominated in several inquiry or registration dossiers, the same contact details (of the TPR) are displayed multiple times.

This also applies for several non-EU manufacturers: the OR is listed as many times as they have submitted an inquiry/registration for a specific substance.
Can I appoint a Third Party Representative (TPR) after having registered the substance for which I had previously inquired?

Yes. You can appoint or change your Third Party Representative (TPR) by updating your registration dossier.

I intend to register a non-phase-in substance. How can I find out whether a list number is available for my substance?

Before submitting the registration for a non-phase-in substance, you will need to submit an inquiry (Article 26 of the REACH Regulation). Upon the successful processing of your inquiry, ECHA will provide you with a list number which you will be requested to use when submitting your registration.

Please note that you will also need to submit an inquiry for an EINECS-listed substance which you did not pre-register.

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