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.
Next steps for polymer registration in South Korea
Date: 24 November 2020
After taking a close look at the new guidance on polymer registration in South Korea, SCC's and TSafeG's regulatory experts in their feature article for Chemical Watch provide a concise summary of the most crucial and critical parts of the guidance from defining a polymer and specifying the data requirements to identifying potential challenges. Read the full article.
How does South Korea's simplified K-BPR approval process work?
Date: 26 October 2020
Ji Yeong Kim, our Asia regulatory affairs expert, provided in her focus feature for Chemical Watch an overview of South Korea's newly adopted simplified K-BPR approval process. There she explains which active substances are subject to the simplified approval and gives useful information, such as the required data, the timing of the procedure and other insights helpful for those submitting biocidal active substances for approval under this new process. Read the full article on the simplified K-BPR approval process here.