- The scenarios that a (potential) registrant may encounter
- (potential) registrant’s obligation to submit an inquiry dossier
- the type of inquiry to be specified in section 14 of the IUCLID dossier.
|My situation||Should I submit an inquiry?||Type of inquiry|
|I am planning to register a substance||There is always an obligation to make an inquiry before registering a substance, in accordance with Article 26(1) of the REACH Regulation.This guarantees that you are put in touch with all previous registrants of the substance as well as other potential registrants.||Inquiry for a substance before its registration (Type 3)|
|I am the Lead registrant and I want to increase the tonnage band of the joint submission||Yes, an inquiry should be made in situations when a registrant reaches the next tonnage threshold (Article 12(2)).||Inquiry for tonnage band increase (Type 4)|
|I am a member of a joint submission and I want to update my registration from intermediate to full||Yes, an inquiry should be made to transition between the information requirements of Article 17(2) or 18(2) to the information requirements stemming from Article 10.||Inquiry for tonnage band increase (Type 4)|
|I am a member of a joint submission and I want to increase my tonnage band within the tonnage band covered by the joint submission but I don't have data||Yes, in accordance with Article 12(2||Inquiry for tonnage band increase (Type 4)|
|I am a member of a joint submission and I want to increase my tonnage band within the tonnage band covered by the joint submission||If the information is available in the joint submission and there is an agreement in place on sharing additional data you might want to contact directly the lead registrant. Otherwise, submit an inquiry to ECHA.||Inquiry for tonnage band increase (Type 4)|
|I am a registrant with an individual registration, and I want to increase the tonnage band of my registration or change the registration type from “Intermediate” to “Full”.||Yes, in accordance with Article 12(2), if you need to comply with new (higher) data requirements for the update.||Inquiry for tonnage band increase (Type 4)|
|I am the Lead registrant and I want to change the registration type of the joint submission from “Intermediate” to “Full”.||Yes, in accordance with Article 12(2), if you need to comply with new (higher) data requirements for the update.||Inquiry for tonnage band increase (Type 4)|
Further details on the inquiry procedure can be found on ECHA’s website.
The Inquiry process aims to put potential registrants and previous registrants in contact with each other to share data so that the joint submission obligations can be met.
Studies involving vertebrate animals should not be repeated and available studies need to be shared. By doing so, it reduces registration costs and avoids unnecessary testing, especially on vertebrate animals.
Further details on the inquiry procedure can be found on ECHA’s website at: http://echa.europa.eu/regulations/reach/substance-registration/inquiry.
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.
Inquiry dossier should be prepared the same way regardless it is for intermediate or for full registration. The purpose of the inquiry process is to ensure data sharing by all registrants and potential registrants of the same substance, so that the joint submission obligations are met. Thus, despite of the type of registration you plan to submit (full or intermediate) it should contain sufficient analytical information to ensure the accurate identification of the substance.
An inquiry dossier should contain:
- Information about the potential registrant.
- Information about the identity of the inquired substance. The analytical data (qualitative and quantitative data) provided in the inquiry dossier should be sufficient to verify the identity and composition of the substance.
- Information requirements where the potential registrant would need to carry out new studies, including those involving vertebrate animals.
As a result of submitting an inquiry the potential registrant is put in contact with previous registrants and other potential registrants of the substance. By doing so, we ensure that data is shared by all registrants of the same substance and that the joint submission obligations are met.
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, you can consult the Manual How to prepare registration and PPORD dossiers, available at: https://echa.europa.eu/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.
If you are uncertain about your substance’s identity, do not include any numerical identifiers (i.e. EC, CAS) in the reference substance of your inquiry dossier. Instead, write “tentative name” followed by a proposed representative chemical name in the IUPAC name field (e.g. tentative name, Reaction mass of A and B). Refer to any other relevant identifier in the "Other substance identifiers” field. See screenshot for clarity.
After receiving the appropriate identifiers for your substance as part of the inquiry outcome, make sure you update the IUPAC name field accordingly when preparing the registration dossier.
If you have unambiguously identified your substance, you should include any available numerical identifiers (i.e. EC or CAS) in the reference substance field of your inquiry dossier. After your inquiry is assessed, ECHA will grant you full access to the Co-registrants page of your substance.
If the EC number is not available to you and the substance does not have a CAS number but you are already in contact with the lead registrant, you can request the identifier from the lead. Otherwise, you may request the identifier from ECHA using the web form: http://echa.europa.eu/en/web/guest/contact
ECHA does not check the completeness of the substance identity information submitted as part of the inquiry process. The completeness check will only be performed on the registration dossier, in accordance with Article 20 (2) of the REACH Regulation.
However, you can minimise the risk of failures before you submit the registration dossier by using the IUCLID Validation assistant tool. We advise you to validate the dossier and correct the information by following the advice reported in the tool.
If the Validation assistant does not indicate any failures, it is not an automatic confirmation that your dossier is complete, since the technical completeness has been complemented with additional verifications done by ECHA staff that are not displayed in the Validation assistant report. Information on the areas of the additional verifications can be found at: https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf
- Contact details: names and addresses of the previous registrants and, if appropriate, other inquirers (potential registrants).
- Studies: a list of submitter’s contact details for each endpoint and the UUIDs of the (robust) study records which have been submitted more than 12 years earlier. This information enables the potential registrant to request the sharing of existing data from the previous registrants.
- Contact details: names and addresses of the previous registrants and, if appropriate, other inquirers (potential registrants).
- Studies: a list of the submitters’ contact details for each endpoint and the UUIDs of the (robust) study summaries which have been submitted more than 12 years earlier. This information enables the potential registrant to request these robust study summaries directly from the previous registrants.
No. There is no deadline for submitting a new inquiry dossier to ECHA.
No. 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.
- a list of submitter’s contact details for each endpoint
- the UUIDs of the (robust) study summary which have been submitted more than 12 years earlier.
No. 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. REACH requires that new testing of a substance involving vertebrate animals can only be carried out as a last resort.
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 REACH. Instead, you must submit a testing proposal in your registration dossier. We will then evaluate whether the testing proposal is adequate before allowing you to perform the test.
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.
Each time a new potential registrant successfully inquires about a substance or a registrant requests for additional information for a substance, an email notification is sent to all co-registrants in REACH-IT, informing them that a new member registrant is potentially entering the market. The new member will most likely only interact with the lead registrant, but for transparency reasons, all co-registrants are informed about it (see screenshot below).
The co-registrants page (CoRP) helps registrants fulfil their data sharing and joint submission obligations. It is accessible to registrants and potential registrants who have successfully inquired about a substance. 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 negotiations.
Different information is displayed depending on their status:
- Potential registrants, within 1 year after successfully submitting their inquiry, can see all registrants and potential registrant(s). However only the leads are identified.
- Potential registrants, beyond 1 year of their successful submission and if they have not registered, they can no longer see any registrant(s) or any other potential registrant(s).
- Registrants can see the roles of all co-registrants, i.e. whether they are lead or member and can see the potential registrants.
They are not shown in the case where the notifying company did not claim a registration number for the notified substance. For such cases, only the company name and the country are displayed.
The co-registrant page shows only the contact details of those companies who did claim the registration number.
Yes. The Third Party Representative (TPR displayed on 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.