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Regulatory
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Europe
Posted By:
Trace One
Trace One GmbH, in order to stay compliant, monitors and implements regulatory updates related to Annex VIII CLP Regulation and Annex II REACH Regulation in the Prosisoft HSM product line for Hazardous Substance Management in Microsoft Dynamics NAV and 365 Business Central.
Regarding these regulations, new functionalities and necessary updates are currently specified, programmed, and tested. Here we announce when they will be available for installation.
Annex VIII requirements
The notification contents and technical requirements are not yet fixed finally. The adoption of the 2nd amendment to Annex VIII is not expected until the end of October 2020. A change in the IUCLID format should also be issued by ECHA at quite the same time. The application date of January 1 2021 regarding products for consumers and commercial users makes this situation a real challenge for the software manufacturer.
As announced in a previous Trace One newsletter, we will complete and provide the Annex VIII module in two steps:
- End of August: the functions for UFI generation and management of your UFI portfolio, important for affixing the UFI to the label, also: collection of data already available in HSM resp. possibility of entering other data required to create the PCN,
- End of this year: the functions for creating the PCN files and their transmission as well as the system-to-system functions (S2S) required for automation.
In view of the complexity of the requirements - alone with regard to the numerous options the regulation itself offers - the setup and integration into your operational processes is a demanding undertaking. Therefore, we will support this process through intensive coordination and advice, in particular through workshops with our individual customers.
Annex II REACH Regulation
On June 26 2020 the EU Regulation 878/2020 on amending Annex II "Guide to the compilation of Safety Data Sheets” of the REACH Regulation was published in the EU Official Journal. The changes mainly affect Section 1 (output of the UFI), new information in Section 3, Section 9 and Sections 11 and 12, as well as information on nanomaterials and endocrine disruptors in various sections.
We have already analyzed the changes by the amending regulation. Introducing them in HSM won’t be a problem. However, we will not begin implementation until 2021, as we have a number of more urgent tasks ahead of us (including the delivery of the above-mentioned Annex VIII functions).
Fortunately, according to Article 2 of the new regulation, SDSs not yet compliant with the regulation may continue to be made available until December 31 2022. There is general agreement in the pronouncements of consulting companies, help desks and associations such as the VCI that the currently valid SDS format according to EU Regulation 2015/830 may be used until December 31, 2022, both with regard to the update and the new creation of Safety Data Sheets.
We will keep you up to date with all the latest developments.
Newsletter 134