“Comply with UK REACH”: Important update on the Lead registration (2)
Date: 21 July 2021
The Health and Safety Executive (HSE), the responsible agency for UK REACH, announced that the functionality to ‘claim the lead’ in the “Comply with UK REACH” service is available from 22 July 2021.
The lead registrant is the main contact for substance registration with the HSE. The lead role should be claimed once the registrant has a dossier ready for submission in compliance with all recommendations under UK REACH.
Please remember you can only ‘claim the lead’ when you have access to the Substance Group. Access to the Substance Group is only granted when you grandfathered your registration or submitted an Article 26 inquiry for your substance. Hence, if you pursue to claim the lead role for a substance under UK REACH and you do not have access to the Substance Group yet, you should act now and submit an Article 26 inquiry.
“Comply with UK REACH”: Important updates on Lead registration and tonnage update processes
Date: 15 June 2021
On 1st January 2021 the UK REACH regulation became effective. To re-cap, the two key deadlines in 2021 are the Grandfathering deadline on 30th April and the DUIN deadline on 27th October.
According to British authorities it should be possible to claim the Lead registration of a substance directly after the recently passed Grandfathering deadline. Against their initial plan the function has not been activated yet because of the feedback from stakeholders. The HSE is now considering the most suitable time to make the Lead functions available in the UK REACH tool in order to best manage this crucial and complex stage of forming groups and making joint submissions.
Although the lead function is not yet available, we recommend submitting an Article 26 inquiry as soon as you know that you will have to register a certain substance. Then the access to the substance group will immediately give you the possibility to begin discussions about data sharing and agreeing the contents of the joint submission.
If you intend to update the tonnage band of a grandfathered substance you can currently use the ‘update’ button in the “Comply with UK REACH” service. To stay compliant it is important to also request an invoice and pay the respective fee. The deadline for the full information requirements will then automatically become relevant for the new tonnage band.
Very encouraging: While UK REACH is still in its infancy, the British authorities are open to feedback and do their best to support stakeholders.
Biopesticide registration in EU – implications of the General Food Law and EU’s Green Deal
Date: 10 June 2021
Recent months have brought some significant changes for plant protection products in general and biopesticides in particular in the EU. In his latest editorial contribution for the Crop Science Biologicals 2021, Dr Lars Huber scrutinises the current regulatory developments in the EU and describes which impact they have on the biopesticides market. Click here to download the full article.
New EN ISO 10993-1 has been published
Date: 3 May 2021
The new EN ISO 10991-1:2020 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) has recently been published in several European member states as national standard, based on the ISO 10993-1:2018.
According to the introduction of the new standard, “it is not intended that this document provide a rigid set of test methods, including pass/fail criteria, as this might result in either an unnecessary constraint on the development and use of novel medical devices, or a false sense of security in the general use of medical device. … ISO 10993 series is intended for use by professionals, appropriately qualified by training and experience, who are able to interpret its requirements and judge the outcome of the evaluation for each medical device, taking into consideration all the factors relevant to the medical device, its intended use and the current knowledge of the medical device provided by review of the scientific literature and previous clinical experience.”
In line with Appendix B.2.2 (The biological evaluation plan) of ISO 10993-1:2018, risk management activities must be planned in advance. Since biocompatibility is a risk management activity, it requires a biological evaluation plan drawn by qualified experts. It is emphasised that simply planning to conduct testing against all of the aspects of biocompatibility identified in Annex A does not meet the requirements.
Important updates on UK REACH: Inquiry rational and Lead Registrant selection
Date: 18 March 2021
Inquiry after DUIN explained by HSE
At the end of December 2020, the UK REACH authorities, HSE, indicated that the Downstream User Import Notification (DUIN) for UK based importers or distributors has to be followed by an Article 26 inquiry. However, there was a general lack of clarity regarding the purpose of this inquiry. Recently the HSE has published new guidance explaining the function of the inquiry step.
A successful DUIN entitles the notifier to defer the registration of their substance until the end of the relevant registration deadlines. The DUIN therefore allows the continued placing on the market and use of the notified substance in the UK for another 2, 4 or 6 years after the DUIN deadline of October 27, 2021.
The Article 26 inquiry step ensures that potential registrants have been assigned to the correct substance groups after notification. For example, importers might have submitted a DUIN for substances that they do not need to register. Having the inquiry step ensures the substance groups only comprise of potential registrants who are required to be in these groups.