News – Confirm Your UK Location under GB BPR
Date: 1 December 2021
To maintain access to the market in Great Britain (England, Scotland and Wales), as a GB BPR Authorisation holder or GB Article 95 supplier, biocides companies must:
- be established in the UK (Great Britain or Northern Ireland)
- confirm to the UK authorities (HSE), by the relevant deadline, that you are established in the UK
Companies must confirm HSE that they are established in the UK by:
31 December 2021 if they are existing UK authorisation holders (this includes Union authorisations and simplified authorisations and notifications)
31 December 2022 if they were included on the GB Article 95 List on 1 January 2021
News – Downstream User Notification (DUIN): the deadline has been postponed
Date: 5 November 2021The DUIN deadline expired on October 27, 2021. On HSE’s official website, downstream users are still encouraged to submit a notification, if eligible to do so. HSE has not specified a new deadline yet, but recommends to notify as soon as possible.
We will update you on further DUIN specifications as soon as available. In the meantime please feel free to contact us, if you have any questions.
News – Japan’s MAFF intends to introduce a new requirement within the PP re-evaluation programme
Date: 30 August 2021
The Ministry of Agriculture, Forestry and Fisheries (MAFF) is going to introduce a new requirement for the review of the published literature within the framework of the re-evaluation program of plant protection products.
On August 8 2021, MAFF started a 30-day public comment period for the draft guidance on the literature review. Opinions can be submitted at the eGov website. Following the requirements set out by the European Food Safety Authority (EFSA), the new guidance will request the review of peer-reviewed literature on toxicity, residues, metabolisms and ecotoxicity.
News on dossier evaluation for Annex VII
Date: 23 August 2021
ECHA can now request a combined comet assay (OECD TG 498) and micronucleus test (OECD TG 474) as one study when a positive Ames test and an indication for chromosomal aberration are available and if there are no other adequate and appropriate in vivo genotoxicity data in the dossier.
This approach already applies to compliance checks and testing proposal examinations under REACH annexes VIII, IX and X since 1 July 2020. From now on, registrants can expect requests for a combination study also for Annex VII dossiers.
The proposed combined test is appropriate to investigate gene mutations and chromosome aberrations in vivo and will help to reduce animal testing if combined in one study.
Source: ECHA weekly, Dossier evaluation: request for a combination study at Annex VII, 23rd June 2021 (https://echa.europa.eu/)
EU REACH: upcoming restriction for PFAS, the first example of the "Essential Use Concept"?
Date: 30 July 2021
Per- and polyfluoroalkyl substances (PFAS) are a group of fluorinated substances that have come into the focus of regulators due to their extreme persistence in the environment and widespread presence in animals and humans.
As part of the EU’s chemicals strategy for sustainability (EU Green Deal), a key objective of the EU Commission is to ban all PFAS, unless the European Union deems their use essential. Making the upcoming PFAS restriction the first potential application of the future REACH "Essential Use Concept", even though this new concept is not yet defined and is being developed in parallel.
The intended PFAS restriction on firefighting foams, planned for inclusion into Annex XVII REACH in spring 2023, could serve as the basis for the broad restriction on PFAS, likely to come one to two years later. As a reminder, the five EU Member States preparing the PFAS restriction currently use a very broad group definition of PFAS, that would encompass approximately 4,700 substances.
The REACH competent authorities of these 5 Member States have opened a second consultation to obtain further stakeholder input for their joint restriction proposal covering all PFAS. This latest consultation will stay open until 19 September 2021. It aims at gathering additional data on tonnages, emissions, alternatives, and substitution costs.
In order to further shape and develop the restriction proposal for PFHxA (undecafluorohexanoic acid), ECHA is inviting stakeholder input on SEAC’s draft opinion concerning the restriction proposal from Germany on PFHxA, its salts and related substances. The deadline for comments is 7 September 2021.
“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.
KKDIK regulation now moving into registration phase: important updates on the Lead Registrant selection
Date: 23 February 2021
With the end of the pre-registration phase for KKDIK (‘Turkey REACH’) on 31 December 2020, full attention has now shifted to the actual registration phase, a 3-year window until 31 December 2023.
The Turkish Ministry of Environment and Urbanization (MoEU) recently published a number of updates to inform all actors in the supply chains on important details for the next phase.
Companies that consider becoming Lead Registrant (LR) for a pre-registered substance should clarify their intention soon and be ready to communicate their position with other SIEF members in the coming weeks. The Lead Registrant selection process has started and Lead Registrant candidates need to approach the other SIEF members for acceptance of the LR role. While LR voting is not compulsory, a voting module will be integrated on the SIEF page for the selection of the Lead Registrant in case of SIEF disagreement. The declarations for the Lead Registrant will start on 1 March 2021, simultaneously with the integration of the voting module in the KKS system.
New EU Fertiliser Regulation – notifying body for Germany and Nando
Date: 16 February 2021
The new EU Fertiliser Product Regulation 2019/1009 of the European Parliament and of the Council of 5 June 2019 is intended to create harmonized conditions for the supply of fertilisers across the internal market and to define general principles for CE marking.
HSE is operating an independent PPP active substance renewal programme for Great Britain
Date: 12 February 2021In its newsletter on 11 February, HSE informs about a PPP active substance renewal programme for Great Britain that is independent of the EU and in operation from 1 January 2021. You can find the list of active substances, their expiry dates and the relevant renewal application deadlines on the HSE website.
SCC GmbH strengthens its management and sets its course for the future with two new CEOs: Monika Hofer and Martin Weiser
Date: 4 February 2021
Dr Monika Hofer and Dr Martin Weiser joined the management board of SCC Scientific Consulting Company on 1 January 2021.
Monika Hofer is a chemist and toxicologist and has been in a leading position at SCC for more than 20 years. She has significantly contributed to the growth and success of our company in her role as Head of the Regulatory Science business unit and through her work as SCC's Vice President.
Martin Weiser is a pharmacist and pharmacologist and has gained extensive experience in a number of executive positions in the pharmaceutical industry, most recently serving as CEO of the German Medicines Manufacturers’ Association in Bonn.
Dr Friedbert Pistel, the Founder of SCC and its President since 1989, will step back from the company’s operational business by 31 March 2021 to become the Chair of the Pistel Family Foundation (Pistel-Familienstiftung).
As of 1 April 2021, the new management board will comprise Monika Hofer, Martin Weiser and Florian Pistel, who has been responsible for administration, finance and human resources since 2019.
In addition to the changes in the management board, SCC will be expanding its existing portfolio of regulatory services. Alongside its current services in the fields of agrochemicals, chemicals, biorationals, biocides, cosmetics, feed additives, GMOs, and environmental protection, the company will be expanding its pharmaceuticals and medical devices offering and also aims to focus on further international market expansion and innovative targets.
If you have any questions, please contact your partner at SCC.
SCC and GBK are cooperation partners offering consolidated expertise and bundled services
Date: 2 February 2021
With the newly enhanced cooperation, SCC and GBK bundle their vast expertise in legal, environmental, health, safety and regulatory issues to offer their customers versatile and integrated services across the world.
SCC supports its international customers with cost-efficient tailored solutions for their scientific and regulatory needs in the fields of agrochemicals, and biorationals, fertilisers, chemicals and biocides, feed and food additives, food contact materials, cosmetics and consumer products, medical devices, pharmaceuticals and legal services (provided by SCC Legal).
GBK GmbH Global Regulatory Compliance, Ingelheim, is an international consulting company providing a hands-on expertise in the fields of environment, health and safety to their more than 1,250 global customers in the chemical, food, pharmaceutical and automotive industries. GBK’s core services include product-registration in chemical inventory lists in Europe, USA and Asia, EHS auditing and dangerous goods services, including worldwide EMTEL emergency phone service for hazardous materials transportations as well as seminars and trainings. For more information on GBK, please visit GBK’s website.
Transparancy Regulation: Practical Arrangements
Date: 15 January 2021
Following the Transparency regulation, EFSA has finally published the long expected Practical Arrangements. The arrangements are legally binding and intend to help interpreting and implementing the legal framework provided by the Transparency regulation. Currently, three Practical Arrangements are available on the EFSA homepage:
- The Practical Arrangement on confidentiality sets out the rules how confidentiality can be claimed and how such claims will be assessed within the need to make data publicly available according to the Transparency regulation.
- The Practical Arrangement on pre-submission phase and public consultations sets out time lines and proceedings for the newly established pre-submission advice phase and the notification of studies.
- The Practical Arrangement concerning transparency and confidentiality stipulates proceedings for proactive transparency and confidentiality. Its Annex provides a list of items for which confidentially requests may be submitted and gives the legal basis for them.
All three Practical Arrangements contain important insights on how the Transparency regulation will impact the regulatory framework and the depended proceedings such as approval and renewal of active substances.
We are preparing further updates on this issue and will share them with you soon.
EU's Green Deal – a brief overview
Date: 13 January 2021
Our biorationals experts Dr Lars Huber and Dr Jasmin Philippi closely examined EU's Green Deal and its impact on the crop protection industry, taking a glance at recent regulatory developments, on the one hand, and agricultural practice, on the other. The full analysis can be found in the IHS Markit Top 20 issue 2020 or you can also download it here.