Agenda
Please note times are in Central European Summer Time (CEST) and to view the event start time in your local time, please click??here.??
-
Registration
-
Welcome and introduction by the moderator
- Session 1: Overviews
-
EU Commission???s general update on regulatory discussions related to product authorisations
- Modification of Regulation 492/2014 on renewal of authorisations under mutual recognition??
- Regulation (EU) No 414/2013 on same biocidal products??
- Cancellation of EU authorisations for products containing iodine and/or PVP iodine??
- Presence of misleading terms in biocidal products trade names, etc??
- Postponement of the active substances review programme beyond 2024??
- Renewal of approval of propiconazole for PT-8, etc??
-
Echa overview
Erik van de Plassche
Chairman of the Biocidal Products Committee, European Chemicals Agency, Finland -
Member State overview from Denmark
-
The BPR ??? practical implementation and the lessons learned
- Reckitt Benckiser ??? an introduction??
- The fast-moving consumer goods industry (FMCG)??
- Practical implementation of the BPR ??? the FMCG lens??
- Moving forward in the right direction??
-
Refreshment break
-
Q&A and panel discussion: What we have learnt from the Covid-19 emergency in the biocides sector and whether there are lessons for the future
- Session 2: The assessment of endocrine disrupting (ED) chemicals under the BPR
-
Identification of EDs in ecotoxicology: an overview of available tests
- Overview of in vivo tests for ED assessment in ecotoxicology: strengths and weaknesses??
- Identification of endocrine modalities and specific modes of action ??
- Limitations in determination of mechanistic parameters??
-
Pepper, a platform supporting the validation process for EDs??
- Addressing the gap between academic research and regulatory needs request validation??
- Pepper???s work supporting a validation process ??
- Validation is a common good so resources must be mutualised??
Philippe Hubert
CEO, Pepper, French platform for the validation of methods for characterization of endocrine disruptors -
Q&A
-
Lunch
-
Chemical Watch demo
- Session 3: Regulatory processes under the BPR
-
Lessons learned from the evaluating competent authority perspective on the DBNPA case
- Importance of the representative uses??
- Public consultation on alternatives??
- Considerations in terms of the derogations????
-
Developments on derogation dossiers under the BPR: are derogation dossiers becoming the rule?
-
The extension of the BPR review programme and its implications for industry
- Current status??
- Legislative changes??
- Practical impacts (resources, guidance, parallel regulatory developments, market distortions???)??
-
Preparing for the 2025 deadline, especially regarding data protection issues
-
Q&A
-
Refreshment break
-
Restrictions imposed at active substance level
-
The mutual recognition process from the perspective of the coordination group
- Role of the coordination group in mutual recognition procedures??
- Procedures and timelines??
- Role of applicants in the process and advice regarding actions by applicants ????
Karolina Pastuszko
Chief Specialist, The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products -
Q&A
-
End of day 1