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Manufacture or import does not need to be interrupted during the completeness check of a dossier when the dossier is submitted to update an existing registration, which already has a registration number assigned, for the following reasons: (i) when the reason for the update is to respond to an ECHA communication or decision requesting additional information; or (ii) the registrant has new and relevant information about the substance, and its uses and properties. However, if the update is made to increase the scope of the registration (e.g. increase of tonnage band, or change from an Article 17/18 registration to an Article 10 registration), the new scope cannot be applied in the manufacture/import until the dossier has successfully passed the completeness check.
For new dossiers submitted to obtain a registration number, the following scenarios exist:
- In the case of a non phase-in substance for which the manufacture or import is to be started, the waiting period must be respected as the assignment of the registration number, and the right to manufacture or import the substance, rely on the submission of a complete registration dossier to ECHA and the granting by ECHA of a registration number.
- In the case of a phase-in substance which was pre-registered, and for which the relevant registration deadline has not yet passed, there is no requirement to interrupt manufacture of import during the completeness check. Such substances may be manufactured and imported until their relevant registration deadline without a registration number. If a dossier for a pre-registered substance is submitted immediately before its relevant registration deadline, but fails the completeness check, ECHA will set a deadline by when the dossier has to be completed. The manufacture or import of the substance may continue during this time even if the registration deadline is passed. However, if the dossier is not completed by the set completeness check deadline, ECHA will issue a decision rejecting the registration. If the relevant registration deadline has passed at this moment, the registrant cannot continue manufacture or import until they successfully submit a new registration dossier and receive a registration number for the substance.
In the case that you submitted your dossier before the compliance check deadline had passed, you may follow the deadline given in the TCC letter. ECHA will not continue with the Evaluation process before you have submitted the requested update for the technical completeness check failure.
Should also your second submission fail the TCC, the combination of your two submissions in response to the compliance check decision will be rejected. If at this point the compliance check deadline has already passed, it means that ECHA has not received a response to the compliance check decision and may proceed with further regulatory actions. It is therefore advisable not to leave the submission of updates to regulatory requests to the last moment.
This Q&A does not apply if your submission in response to an ECHA decision under compliance check was made after the deadline indicated in that decision. In such a case you should update the incomplete dossier without delay and inform ECHA about not meeting the compliance check deadline via the contact form: https://echa.europa.eu/contact
- To be legally on the market from 31 May 2018 onwards, any registrant (lead or member) that intends to benefit from the phase-in scheme of this particular registration deadline must have submitted a registration dossier to ECHA by this deadline. A dossier is considered to be submitted if it has been uploaded in REACH-IT and passed the business rules step, as long as it has not been rejected due to incompleteness caused by non-payment of the fee, or second failure of the technical completeness check. Please note the following in relation to a TCC failure close to the registration deadline:
- A member registrant cannot submit a dossier before the dossier of the lead registrant of that substance has been submitted. As soon as the lead registrant submits a dossier to ECHA (uploads it in REACH-IT and passes the business rules step), member registrants of that joint submission can submit their dossiers.
- Member registrants cannot receive their registration numbers before the lead dossier is found to be complete. This means that submitted member dossiers are ‘parked’ in the submission pipeline until a decision is taken on the completeness of the lead dossier.
- If a registration dossier fails the completeness check, ECHA informs the registrant of the missing/incomplete information and grants a deadline by which the registrant has one attempt to complete the information. If the registrant submits all the requested information to ECHA within the deadline, the dossier will receive a registration number and the registration date will be the date of the first submission. If this dossier is the lead registrant dossier, all submitted member dossier for that joint submission will be released from being ‘parked’ and will be processed for completeness.
- Should also the second submission result in a failure of the completeness check then the combination of the first and second submissions will be rejected and no registration number is issued for that registrant. In case the rejected submission is the lead registrant dossier, a registration number is also not issued for any member registrant of that joint submission.
The technical completeness check (including manual checks) is in general performed on each dossier within three weeks of its submission date. However, for phase-in substances submitted in the course of the two-month period immediately before the relevant registration deadline, the completeness check may take up to three months after the deadline. Registrants who wish to have the outcome of the completeness check in advance of the 2018 registration deadline may consider these timelines.
The completeness check is based on REACH Article 20(2). It applies to all registration dossiers submitted to ECHA; both dossiers submitted to obtain a new registration number, as well as dossiers submitted as updates of existing registrations. The completeness check consists of two parallel verifications: (i) the technical completeness check, in which ECHA verifies that all the required elements have been provided in the registration dossier; and (ii) the financial completeness check, in which ECHA verifies that the registration fee has been paid, if applicable to that submission.
If during the technical completeness check the registration dossier you submitted is found incomplete, ECHA will issue a deadline by which you have only one attempt to submit the missing or incomplete information. If you do not provide the requested information by the set deadline in the form of an update dossier, the submission will be rejected. In such a case, any registration fee you had paid in relation with this submission will not be refunded or otherwise credited.
You can find more information about the registration process on the REACH 2018 registration deadline pages: https://echa.europa.eu/support/registration/from-submission-to-decision
We also recommend you to have a look at our webinar on the technical completeness check process:
There is no need to change the data waiving justification from free text to an available picklist phrase. A free text justification will be considered equally complete to a picklist value, whenever it is in line with column 2 of REACH Annexes VII-X, or sections 2-3 of Annex XI.
However, when preparing a dossier in IUCLID 6 from IUCLID 5 data, please review the selection in the field ‘Endpoint’ in particular for IUCLID sections where different information requirements can be addressed (e.g. 4.13, 7.8.1) to ensure that you have clearly indicated that the appropriate requirement is being waived.
The manual verification applies to all registration dossiers submitted to ECHA. The manual checks focus on ensuring that registrants who waive or deviate from the standard information requirements provide justifications foreseen by the legislation. Therefore the extent of the verification depends on whether the dossier contains waiving of standard information or deviations from substance identification conventions, as well as on the specific requirements that apply to the registration type (i.e. lead, member, individual registration) and the registration scope (tonnage band, isolated intermediate).
For further information, please refer to the document Information on manual verification at completeness check available at: https://echa.europa.eu/manuals.
As a first step, ensure to prepare your registration/PPORD dataset and dossier according to the advice given in the manual How to prepare registration and PPORD dossiers available at: http://echa.europa.eu/manuals. Annexes 1-3 of the manual also give an overview of the business rules and technical completeness check rules that apply to registration and PPORD dossiers.
Next, use the IUCLID Validation assistant plug-in to help you detect business rules and technical completeness check failures present in your dataset and dossier. While the Validation assistant cannot replicate all the checks performed by ECHA (see below), it simulates the majority of the verifications done and helps you minimise the chance of failure during submission. It is important to keep in mind that any failure in the Validation assistant Submission checks tab that is left uncorrected before submitting your dossier in REACH-IT will lead to that your submission will not be accepted by ECHA.
To run the Validation assistant, right click on your dataset in the Navigation panel → Validate → follow the steps in the wizard. The same validation should be performed on the dossier to make sure that no failures have been introduced during dossier creation.
You can find a video tutorials on the use of the IUCLID Validation assistant in the link below :
If the Validation assistant does not indicate any failures, this is not an automatic confirmation of that your dossier is complete. As of 21 June 2016, the technical completeness check includes additional verifications of the registration dossier by ECHA staff. These checks cannot be replicated using the Validation assistant plug-in; the related completeness issues cannot be displayed by the tool.
Information on the areas of the additional verifications can be found in the following location; the document is regularly updated with advice based on the experience gained with incoming registrations: https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf.
We also recommend you to have a look at our webinar on the completeness check process: https://echa.europa.eu/-/completeness-check-preparing-a-registration-dossier-that-can-be-successfully-submitted-to-echa.
The quality rules warn the user of common inconsistencies and shortcomings. These warnings will not prevent you from successfully submitting your dossier in REACH-IT; however leaving quality warnings uncorrected may lead to later clarification requests by ECHA.