Θέλετε αναζητήσετε τη σχετική ερώτηση και απάντηση στη γλώσσα σας; Αλλάξτε τη γλώσσα στο αναπτυσσόμενο μενού ανωτέρω.
- 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.
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
Once you have submitted your inquiry dossier to ECHA, REACH-IT executes a series of verifications. After these are completed, for most already registered or successfully inquired substances, ECHA directs inquirers to the relevant Co-Registrants page in REACH-IT where they can find contact details of other registrants and potential registrants of the same substance.
In contrast, for substances where no registrants or potential registrants exist or with ambiguous identifiers, ECHA verifies the substance identity information. In that case, the assessment can lead to two outcomes:
- If ECHA is able to process your inquiry dossier, you will receive the following:
- A communication in REACH-IT with the inquiry number as well as details of available (robust) study summaries, as appropriate.
- 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 (see Q&A 1485).
- If ECHA is not able to process your inquiry dossier, due to missing and/or inconsistent substance identity information, you will receive a communication in REACH-IT describing the necessary changes to submit a successful inquiry dossier. In this case you will need to address the described issues in the substance dataset and then submit a new inquiry dossier.
The REACH Regulation does not impose any timeframe on ECHA for processing an inquiry dossier. However, ECHA aims to provide the inquiry outcome in 20 working days.
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.
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".
The analysis performed by ECHA of the availability of data is based on the existing registration dossier(s) which passed the completeness check of the technical dossier.
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.
If a potential registrant has 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 the example screenshot below and watch the explanation in this YouTube video
If a potential registrant has not 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 registrant has not 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:
- They submit an inquiry to ECHA. Instructions on how to submit an inquiry can be found in the manual ‘How to prepare an inquiry dossier’ at: https://echa.europa.eu/manuals.
- They contact other registrants of the same substance. The contact information can be found by searching the dissemination page at: https://echa.europa.eu/information-on-chemicals/registered-substances.
Here you can find further information on how to find your co-registrants.
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 helps registrants fulfil their data sharing and joint submission obligations. It is accessible to existing 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 negotiations.
Registrants can see different information depending on their status:
- Potential registrants, during the 1 year after successfully submitting their inquiry, can see all registrants. However only the leads are identified.
- Potential registrants, beyond the 1 year 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.
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.
Yes. The Third Party Representative (TPR) or the Only Representative (OR) 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.
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.