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Manufacture or import do not need to be interrupted during the completeness check of a registration update 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 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.
- In the case of a substance for which the manufacture or import is to be started, the waiting period must be respected. The assignment of the registration number, and the right to manufacture or import the substance, rely on the completeness of the registration dossier after which a registration number is granted by ECHA.
If your dossier is submitted before the compliance check deadline has 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(s).
If you fail TCC for the second time while submitting the requested update, your submission 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.
You can 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.
In the task you have a link to the “Submission page” of the submission. Follow this link and go to the “Key documents” section at the bottom of the page. Here you can download the technical completeness check communication which contains all the relevant information regarding the failure, as well as the steps required by you.
The completeness check is based on REACH Article 20(2). It applies to all registration dossiers submitted to ECHA, (i.e. initial submissions and updates).. 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 "From sbmission 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, if 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, 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. 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.
While the Validation assistant cannot replicate all the checks performed by ECHA, 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 your submission not being accepted by ECHA.
You can find a video tutorials on the use of the IUCLID Validation assistant in the link below:
Please note that 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 manual 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; 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 in the dossier. These warnings will not prevent you from successfully submitting your dossier in REACH-IT. However, leaving quality warnings uncorrected may lead to future clarification requests by ECHA.