Biocides Europe 2019

• EDs (including update of Annexes II and III and early review),
• Authorisation of in situ generated products
• Union authorisations
• Fact finding missions
• Art 65 reporting
• Art 55(3) derogation (in situ nitrogen)

Mario Nagtzaam

Policy Officer, European Commission, Belgium

• General updates on biocides
• Review program action plan
• Lessons learned so far on endocrine disruptors

Simón Gutiérrez Alonso

Scientific Officer, European Commission, Joint Research Centre

• Current situation, achievements
• Challenges
• Possible solutions
• Summary and future perspectives

Nina John

Policy Officer, Federal Ministry for Sustainability and Tourism, Competent Authority, Austria

• ED assessment of active substances and co-formulants
• Implementation of the new BPF concepts
• Over-conservative risk assessment

Nathalie Hanon

Executive Vice President & Head of Biocides, CEHTRA

• Desire and reality: the gap from a consultant’s point of view
• Data requirements: the moving target
• ECHA process flow: the circle of comments, discussions & revisions
• Deadlines: the challenge
• Pitfalls: the do's and don´ts

Silvia Wagner

Managing Director, spectra Consult, Germany

• National authorisation, mutual recognition definitions
• Mutual recognition in parallel: pros and cons
• Mutual Recognition in sequence: pros and cons
• Renewal of an authorisation in accordance with Commission Delegated Regulation (EU) No 492/2014

Emese Szántó

EU coordinator for biocidal products, National Public Health Centre, Hungary

• History - where does this ED issue come from?
• How we deal with ED assessment at Ctgb
• Consequences of our work
• Lacunas observed so far

Peter Okkerman

Scientific assessor, The Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands

• Metabolic disorders an increasing cause of health concern 
• Current ED testing tools do not focus on effects related to the disruption of metabolic processes
• Several EU funded projects on the overarching “New testing and screening methods to identify endocrine disrupting chemicals” within the “Horizon 2020” framework
• EDCMET - “Metabolic effects of Endocrine Disrupting Chemicals: novel testing METhods and adverse outcome pathways” 
• Overarching objective to develop novel testing methods for regulatory purposes, to assess the metabolic effects of EDs 

Albert Braeuning

Head of Unit Effect-based Analytics and Toxicogenomics, German Federal Institute for Risk Assessment, Germany

• The new ED guidance – why in silico screening
• What are in silico methods
• Reflection on present situation on ED-models
• ED - in silico screening in practice

Antje Gerloff-Elias

Expert Regulatory Ecotoxicologist and Head of QSAR team, Knoell Consult, Germany

• Shifting goal posts
• Data demands
• Beyond biocides

Darren Abrahams

Partner, Barrister & Avocat, Steptoe International (UK) LLP

• Approved active and the choices made to get there
• What now?
• Product approvals and new uncertainties
• Re-registration; the cycle starts over
• Business aspects of BPR for SMEs

Cecilia Ohlauson

Head of Regulatory Affairs, I-Tech AB, Sweden

• Practical experience
  • Changes in strategy
  • Financial adjustments
  • Uncertainties
• Lessons for the future

Alice Ngosso

Regulatory Affairs Manager, Vink Chemicals GmbH & Co. KG, Germany

• Communication in the supply chain for chemicals with potential biocidal use, such as hydrogen peroxide
• Timely decision making process for product authorization
• for the distributor
• for the supplier
• for the customers
• Finding the right partners and agreeing a business model
• Implementation of biocides supply chains

Kai Mann

European Product Manager Biocides, Brenntag, Germany

Impact of new BPR requirements for ongoing and future approval/renewal procedures

• EDs as actives/non-actives
• Updates Annexes II & III BPR
• Change of BPF concept