Compliance with REACH - a service from the ITIA
Dossier Update
Further to the successful registration of all the substances by the Lead Registrants covered by the Tungsten Consortium and in accordance with Article 22(1) of the REACH Regulation, registrants are responsible to update their registrations with relevant new information and submit it to ECHA in a timely manner.
To ensure up-to-date registration dossiers (including CSR and SDS), reflecting the most accurate and recent knowledge on the substances, an annual review process will be performed. The Tungsten Consortium Dossiers will be reviewed and updated, if necessary, to include any new data on tungsten and its compounds registered by the Consortium.
These guidelines describe the scenarios requiring an update of the registration dossier and the way it will be done. The responsibilities to update the individual part and the joint-submission part of the dossier are explained in Part (A); and in case of an update-requirement caused by a decision made by ECHA or the commission are described in Part (B). Part (C) depicts procedures for the annual review of the dossiers and their update, if necessary, conclude these guidelines.
(A) Updates of the Registration Dossiers on Registrants Own Initiative
Registrants are required to inform ECHA on their own initiative about any new relevant and available data on the registered substance and update their registration dossiers accordingly. If the information to be updated is part of jointly submitted information, it is recommended that the Lead Registrant updates his registration on behalf of all Registrants.
The following table identifies when a registrant should update the registration dossier on his individual details and when Lead Registrants should update the Joint-Submission part of the dossiers on behalf of all registrants:
| Updates on Individual Part of Dossiers | Updates on Joint-Submission Part of Dossiers |
|---|---|
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| The above registrant-specific updates have to be reported by individual registrants. Registrants will be responsible for any fees associated with such updates. Click to view details of applicable fees and levels Members should contact their national REACH helpdesk, if assistance is needed. |
The above updates will be reported to ECHA by Lead Registrants on behalf of all Registrants. Consultation and support will be collected from both Consortium and SIEF members (including Downstream Users). Technical and legal support will be provided by the Tungsten Consortium. According to Article 5 of Fees Regulations specifically states that ECHA shall not levy a fee for certain updates, including changes in the composition of the substance, information on new uses including uses advised against, and a change in the Chemical Safety report. |
(B) Updates as consequence of a decision made by ECHA or the Commission
Registrants may be required to update their registration as a consequence of ECHA's or the Commission's decision under the evaluation procedure. These updates have to be performed within the deadline specified by ECHA/Commission in the relevant decision. The registrant should also consider updating his registration taking into account any decision made in accordance with Article 60 (Granting of authorisation) and Article 73 (Commission decision on Restrictions).
Such updates will be the responsibility of each of the registrant, unless Tungsten Consortium takes a decision to assist when / if necessary.
(C) Procedure for the Annual Review and Update of Registration Dossiers
As an on-going exercise the Consortium Secretariat collects requests from SIEF Members (covering Consortium Members, LoA Purchasers, possible Registrants and their Downstream Users) on new uses, use descriptors, new compositions of substances, which may trigger updates. Members must report their details of new uses and/or use descriptors by completing and returning request form for new uses and exposure data to the Consortium Secretariat by 31 January (each year) to ensure new details are included in the dossier for the next update of that year.
Please note that the next cut-off date for requests of dossier updates is 31 December 2019.
The Consortium Secretariat will first verify that such details are not covered elsewhere or the new uses are not similar to an already identified use. If the reported use/use descriptor is similar to an already identified use with a GES, the Technical Committee may consider grouping the two together and modifying it accordingly. Notes: The Downstream Users/Producer must remain available to actively participate in the drafting and approval of the new use and descriptor codes.
The following table summarises the process and timing for the annual updates:
| Time | Activity | Responsibility |
|---|---|---|
| 31 Jan | Cut-off date for requests to be addressed and included in the next Update on the Joint-Submission parts of Dossier as listed on the above table. | SIEF Members (including Consortium Members, LoA Purchasers and DU) |
| Feb | The Consortium Secretariat will provide a summary of all requested updates together with quarterly reports on literature for relevant results which may affect the registration dossiers to the Technical Committee for review and comments | Consortium Secretariat |
| Feb to Mar | Reviewing the requested updates. Preparing the updates, if recommended by the Technical Committee | Technical Committee and Consortium Secretariat |
| Mar to Apr | The Consortium Secretariat will submit updates outline on how to prepare the updates to the Technical Committee. This is an Agenda item for the April meetings. | Consortium Secretariat |
| Apr to May | Formal approval for updates to be made by the Technical and Steering Committee. Notify all Members (Consortium and SIEFs) about updates in the Joint-Submission Part of the Registration Dossiers to be made by the Consortium this year. | Technical and Steering Committees Consortium Secretariat |
| Jun to Jul | Drafting of the approved dossier updates | Consortium Secretariat |
| Aug | - Submitting draft documents to the Technical Committee - Reviewing and commenting on the draft documents |
-Consortium Secretariat -Technical Committee |
| Sept | Final review and approval of the draft updates by the Technical Committee | Technical Committee |
| Oct | Notifying all Members on the updates will be performed this year. Inclusion of updates in CSR/IUCLID |
Consortium Secretariat |
| Nov | - Sending final Dossier to Lead Registrants - Submitting the update to ECHA |
Consortium Secretariat Lead Registrant |
New developments on worldwide regulation and relevant scientific literature will be monitored by the Consortium Secretariat and the Technical Committee will be informed on a quarterly basis, if there is new data available, which may be relevant to the Registration Dossiers and related documents.
Updates, such as responses to:
- new knowledge of risks of substance to human and or the environment,
- any change in classification and labelling
- new developments on EU regulations
will follow a similar procedure (as the annual update process), but will be done more quickly with the aim to perform such updates within three months and/or to comply within the time frame as recommended by ECHA.