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Biocides Europe 2018
Session 5: ED Criteria
ED criteria: impact on processes and stakeholders
ED properties of biocidal active substances and co-formulants - where to start and how to proceed
- Regulatory background on Endocrine Disruptors: history, criteria and available guidance
- Identification and assessment of ED properties for human health: studies, data bases, QSAR, hazard vs. risk
- Regulatory consequences: implications on active substance approval/renewal, biocidal product authorisation and derogation options
- Assessment of ED properties with a focus on co-formulants and disinfection by-products – possible strategies, issues and implications
Senior Expert Regulatory Toxicology Biocides, knoell GmbH, Germany
Endocrine disruptors and biocides: Where to start? What to expect?
- Brief reminder on ED and exclusion criteria for biocidal active substances
- Entry into force of scientific criteria for identification of ED: implications for active substance approvals and biocidal product authorisations
- Screening, priority setting, conditions for early review of approved substances, procedure and actors
- Harmonisation issues regarding substances in products subject to other legal regimes (ppp, medical devices, veterinary hygiene, cosmetics, …)
- Guidance documents, case law
Session 6: Innovation - development of new biocides and alternatives
5 years BPR – what next?
- BPR aims – where do we stand?
- How is the implementation going?
- Successes, challenges, consequences?
- What next?
Global Advocacy and Government Affairs Manager, Dow Microbial Control
Innovation within consumer-facing preservation markets
- Why the need for innovation in preservation ?
- Multiple stakeholders dictate multiple market preferences
- Innovation is critical across each element of the product lifetime
- Industry is actively committed to meeting current and future needs in sustainable next-generation preservation
Head, Global Marketing Preservation and Laundry, Lonza Consumer Product Ingredients
Session 7: Efficacy
Revision of Efficacy Guidance for PT 14 and PT 19: where are we and what will change
- Revised Technical Guidance for PT 14 in force since January 2017
- Which requirements are new?
- What has changed?
- What needs to be considered for the next renewal?
- Revision of Technical Guidance for PT 19 in progress
- Current status & time frame
- What changes can be expected?
- Which new test methods will be included?
Strategy for efficacy testing for disinfectants in biocidal product families
- A group of products or a biocidal family?
- Testing products or dummy products?
- Worst case testing: check co-formulants!
- Effect of efficacy on the structure of the family
Regulatory affairs biocides, efficacy expert, Knoell NL B.V.
Efficacy Requirements for Product Types 11 and 12
- No available efficacy guidance but will look at the probable efficacy requirements
- Likely requirements for the demonstration of efficacy
- Examine the currently available efficacy tests (including those found outside of the EU) and their fitness for purpose
- Explore what methodologies could be used to provide additional information in support of product claims
Session 8: Enforcement
Developments FORUM subgroup including update on first project REF-6
Senior Scientific Officer, Institute for Environment and Food Safety, Vorarlberg State Service
Session 9: International overviews
Canada - new regulation on treated articles
- Overview/background on past/present status of treated articles
- PMRA communication strategy/risk-based approach to compliance and enforcement
- New regulation publication
- Issues moving forward/next steps
Manager, Regulatory Affairs Group, Dell Tech Laboratories Ltd.
Korea - New Regulation
- Background and current status of K-BPR
- Key provisions
- K-BPR -v- EU BPR
Head Researcher, Korea Testing & Research Institute (KTR), South Korea
Pre recorded presentation - Latest developments in China with regards to biocides and disinfectants regulations
- Regulations for pesticides and disinfectants in China
- Importation requirements for overseas pesticides and disinfectants
- Latest developments and their impact to overseas companies
Head of Agrochemical and Disinfection Products Department, Chemical Inspection and Regulation Service Limited
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