18th International Fresenius Conference "The Biocidal Products Regulation"

02.04. - 03.04.2019, Novotel Düsseldorf City West/Germany

18th International Fresenius Conference "The Biocidal Products Regulation"

Übersicht Programm Referenten Veranstaltungsort Preise & Leistungen

Übersicht

Highlights

Regulatory Aspects & Market Developments

  • Up-to-date information on Brexit from HSE
  • ECHA’s current activities regarding biocides
  • Cefic: Biocides in 21st century’s Europe

Endocrine Disruptors

  • How to deal with the new ED regulation – authority and industry perspective

Specific Regulatory Areas

  • Ctgb on their experience with biocidal product families
  • Member state experience with in-situ

Current Legal Challenges

  • Dossier preparation for renewals
  • Data sharing under the BPR

Developments Outside Europe

  • Implementation of the Korean BPR and what industry needs to be aware of

Receive the latest information directly from the most relevant regulatory authorities and experts from industry and academia!

Who do you meet?

You will meet authorities, such as directors, heads, managers and consultants of:

  • Legal and regulatory affairs 
  • Registration and authorisation 
  • Research and development 
  • Product safety 
  • Product management 
  • Regulatory science

Sectors taking part: 

  • Chemical and biocides industry 
  • Producers of biocidal products 
  • Industrial and professional users of biocides 
  • Research institutes 
  • Regulatory authorities 
  • Environmental and health risk consultants 
  • Professional associations

Picture Credit: © Gman73 - fotolia.com, © Jacek Fulawka/shutterstock.com

Programm

Get-Together on Monday, 1 April 2019

Will you arrive on Monday? Come into the hotel bar at 8 p.m. and meet other participants and experts in a relaxed atmosphere.

Tuesday, 2 April 2019

8.30 Registration & coffee

9.00 Welcome address by Akademie Fresenius and introduction by the Chair

Samantha Champ, BASF, Germany

Regulatory Aspects & Market Developments

9.10 Biocides in 21st century’s Europe

  • About protection goals
  • Market demands versus regulatory restrictions
  • Challenges for an innovative EU Biocides industry

Camelia Mihai, European Chemical Industry Council (Cefic), Belgium

9.35 Update from the European Commission

  • 21 years since the Biocide Directive – where do we stand?
  • Product authorisations – harmonisation and agreements between member states?
  • Is the BPR proving to be a stimulus for innovation?

Alfonso Las Heras, European Commission, Belgium (preliminarily confirmed)

10.00 Overview of the UK Biocidal Products Regulation following the withdrawal of the United Kingdom from the European Union

  • Basis of the UK legislation
  • Specific requirements needed to obtain an approval/ authorisation or remain on the market in the UK
  • Summary of transitional arrangements

John Bewley, Health and Safety Executive (HSE), United Kingdom

10.25 Coffee break

10.55 ECHA’s current activities regarding biocides

Laura Ruggeri, European Chemicals Agency (ECHA), Finland

11.20 Substantiating claims for biocidal products – what is required and where to find it

  • Guidance available for demonstrating efficacy for disinfection and other product types
  • Efficacy and treated articles

David Ashworth, Klarus Consulting, United Kingdom

11.45 Panel discussion

12.15 Lunch

Endocrine Disruptors

13.45 Endocrine disruption – authority view

  • Practicalities of applying the guidance
  • Experiences on reviewing the first ED assessments
  • Applicant involvement

Stine Jensen, Environmental Protection Agency (EPA), Denmark

14.10 Endocrine disruption – industry view

  • 6 months after implementation – status and influence on the review programme
  • What challenges have arisen?
  • Experiences with the Endocrine Disrupter Expert
  • Group at ECHA
  • What happens after a recommendation of the working group – legal and practical aspects
  • Possibility to address dose response and risk if an ED mode of action has been claimed

Sylvia Jacobi, Albemarle, Belgium

14.35 Panel discussion

15.05 Coffee break

Developments Outside Europe

15.35 Korean BPR – implementation

  • Final text and timelines
  • Submission deadlines
  • Special requirements industry should be aware of

Hyunpyo Jeon, Korea Institute of Science and Technology Europe, Germany

Current Legal Challenges

16.00 Lessons learnt in over five years of data sharing under the BPR

  • Most common data sharing disputes and board of appeal cases
  • Recommendations and upcoming challenges such as Brexit

Flore Cognat, Fieldfisher, Belgium

16.25 BPR renewals – update or rebuild? An industry perspective

  • Timelines for dossier preparation
  • Dossier update work with view to compliance with BPR requirements
  • Feedback from regulatory bodies

Stefan Nave, Lanxess, Germany

16.50 Panel discussion

17.20 End of first conference day

18.30 Departure time for the evening event

As always you are most welcome to attend our evening event, which will take us to the historic district of Dusseldorf. We will enjoy a leisurely dinner at the brewery “Zum Schiffchen”, Dusseldorf´s oldest restaurant that even had Napoleon among its guests. Please join us to continue the day’s interesting discussions in a relaxed and comfortable atmosphere.

Wednesday, 3 April 2019

9.00 Welcome address by the Chair

Flore Cognat, Fieldfisher, Belgium

Specific Regulatory Areas

9.10 In-situ – authority experience

Gerhard Thanner, Environment Agency Austria

9.35 In-situ – industry experience

  • Accepted definitions
  • Data requirements and how are they to be filled?
  • Experience with dossier submissions etc.

Helena Gräf, Ecolab, Germany

10.00 Assessment of halogenated disinfection by-products – current status

  • Scope of work of the DBP Consortium – what we set out to achieve
  • What has been done to date
  • What is still needed and what can we expect during evaluation
  • Lessons learned and how these can be used in assessing DBP for other active substance groups

Sara Kirkham, Arrow Regulatory, United Kingdom

10.25 Challenges in dietary risk and animal safety assessment

  • Identification of relevant scenarios and gathering of data
  • Tools and approaches in exposure assessment
  • Uncertainties in regulatory acceptance

Michael Werner, knoell Germany

10.50 Panel discussion

11.20 Coffee break

11.50 ECHA Forum Biocidal Products Regulation Subgroup (BPRS) coordination of BPR Enforcement

  • Overview on current activities and topics dealt with
  • Upcoming plans
  • Ongoing EU enforcement project on treated articles “BEF-1”
  • Treated articles under the BPR: what is in the focus of enforcers

Eugen Anwander, ECHA BPR Enforcement Forum/ Vorarlberg State Service, Austria

12.15 Biocidal product families: a nightmare or a way forward? – authority perspective

  • Outcome of the working party on the biocidal product families concept
  • Experience of an evaluating competent authority
  • Challenges for the applicant

Rixta Hempenius, Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), The Netherlands

12.45 Biocidal product families – industry perspective

  • Experiences during dossier validation/evaluation
  • What does the future look like?

Ian Watt, DowDuPont, United Kingdom

13.10 Panel discussion

13.40 Lunch and end of the conference

Referenten

Name

Unternehmen

Anwander

Eugen Anwander

ECHA BPR Enforcement Forum/Vorarlberg State Service, Austria

Eugen Anwander has been employed at the Federal State Government Service Vorarlberg in the Institute for Environment and Food Safety and the Chemical Safety Unit since 1992. Being a chemical inspector, he is currently the Chair of the Biocidal Products Regulation Subgroup within the ECHA Enforcement Forum.

mehrweniger
Ashworth

David Ashworth

Klarus Consulting, United Kingdom

David Ashworth is the Managing Director of Klarus Consulting, which advises the biocides and biocidal products community on building and delivering safe and effective claims. He is also Chairman of BluTest, a contract microbiology testing and development company.

mehrweniger
Bewley

John Bewley

Health and Safety Executive (HSE), United Kingdom

John Bewley joined the Health and Safety Executive (HSE) in 2003 and is currently working in the International Chemicals Unit. A key part of his work focusses on the development of the legislation and procedures necessary for the approval and authorisation of biocidal active substances and products following the UK withdrawal from the European Union.

mehrweniger
Champ

Samantha Champ

BASF, Germany

Samantha Champ is currently employed by BASF SE, leading the regulatory affairs team for Biocides Europe, in the company’s Care Chemicals division. Her responsibilities cover all BPR activities, national biocide registration schemes and borderline legislations such as cosmetics and medical products. Since 2014 she is the Vice-chair of the CEFIC European Biocides Product Forum and will become the Chair as of 2018.

mehrweniger
Cognat

Flore Cognat

Fieldfisher, Belgium

Flore Cognat is a Legal Consultant in the competition, regulatory and trade department of Fieldfisher, a law firm in Brussels. Her focus is on regulatory matters involving biocides and chemicals. Previously, she worked for the European Chemical Industry Council (CEFIC) for five years and was leading different biocide policy groups and consortia and providing support, information and advice on implementation of biocide and chemical regulations. Before this, she worked for several years in a regulatory consultancy in Brussels advising industry on compliance with EU and French environmental and health regulatory legislation.

mehrweniger
Gräf

Helena Gräf

Ecolab, Germany

Helena Gräf holds a PhD in food chemistry and toxicology and has been working in the regulatory area of biocides since 2012. After working for a consultancy, she joined Ecolab´s regulatory affairs team in 2016 working with focus on European biocide dossiers and risk assessment for human health.

mehrweniger
Hempenius

Rixta Hempenius

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

Rixta Hempenius holds a PhD in toxicology and has more than 20 years of experience in Regulatory Toxicology. Since 2016 she has been working as Team manager Human Toxicology and Residues at the Dutch competent authority Ctgb.

mehrweniger
Jacobi

Sylvia Jacobi

Albemarle, Belgium

Sylvia Jacobi has been working as Corporate Toxicology Director at Albemarle since 2013. She holds a PhD in pharmaceutical chemistry – pharmacology and is a European registered Toxicologist.

mehrweniger
Jensen

Stine Jensen

Danish Environmental Protection Agency (EPA), Denmark

Stine Jensen is Candidate of Veterinary Medicine and has been working as a Toxicologist at the Danish Environmental Protection Agency since June 2018.

mehrweniger
Jeon

Hyunpyo Jeon

Korea Institute of Science and Technology Europe, Germany

Hyunpyo Jeon received his PhD from Johannes-Gutenberg University in Mainz in 2011, after working at Kumho Laboratory as Senior Researcher in Korea. He has been a member of the Environmetal Safety Group of KIST Europe Forschungsgesellschaft, which is a branch institute of the Korea Institute of Science and Technology for chemical regulation compliance, since 2011.

mehrweniger
Kirkham

Sara Kirkham

Arrow Regulatory, United Kingdom

Sara Kirkham is a Director of Arrow Regulatory, an independent consultancy set up in 2016. She has worked on biocides since 2000, having worked on over 30 active substance applications, in particular in-situ generation systems, and been involved with the assessment of disinfection by-products since 2012.

mehrweniger
Las Heras (preliminarily confirmed)

Alfonso Las Heras (preliminarily confirmed)

European Commission, Belgium

Alfonso Las Heras deals with issues related to product authorisation within the biocides team of Unit E4 in DG SANTÉ. His professional background relates to the regulatory framework of veterinary medicines and to public-private partnership for research on animal health.

mehrweniger
Mihai

Camelia Mihai

European Chemical Industry Council (CEFIC), Belgium

Camelia Mihai obtained a PhD in Sciences at the Vrije Universiteit Brussel. She started her professional career at Cefic, the European Chemical Industry Council in 2009. Since 2016, she leads The European Biocidal Products Forum (EBPF). In this position, she actively follows the regulatory developments of the EU biocides legislation, providing support, information and advice to EBPF members in the area of compliance and implementation.

mehrweniger
Nave

Stefan Nave

Lanxess, Germany

Stefan Nave holds a PhD in organic chemistry. Since 2016, he has been working at Lanxess Deutschland as a global Regulatory Manager for several active substances and biocidal products. His previous experience included working for the German competent authority for biocides and for the biocides department at SCC Consulting.

mehrweniger
Ruggeri

Laura Ruggeri

European Chemicals Agency (ECHA), Finland

Laura Ruggeri joined ECHA’s Biocides Assessment Unit in 2013 and has been the team leader of the human health team since January 2018. She has been the Chair of the ad hoc Biocidal Product Committee Working Group on the Assessment of Residue Transfer to Food (ARTFood) since 2014.

mehrweniger
Thanner

Gerhard Thanner

Environment Agency Austria

Gerhard Thanner is an educated chemist and has been working for several years in the field of organic analysis in the Environment Agency Austria. Since 2010 he has been responsible for the evaluation of biocidal substances and biocidal products. Furthermore, he is alternate member in the Coordination Group for Austria, flexible member in the BPR Working Group on Analytical Methods and Physico-chemical Properties and attends ECHA´s BPR IT user group regularly.

mehrweniger
Watt

Ian Watt

DowDuPont, United Kingdom

Ian Watt is the Global Advocacy and Government Affairs Manager for the Microbial Control business within the Industrial Biosciences division of DowDuPont. Ian has a degree in chemical engineering and a career spanning more than 20 years in biocides, comprising commercial management and regulatory and product stewardship functions. Ian is currently Vice-chair of the CEFIC European Biocidal Products Forum.

mehrweniger
Werner

Michael Werner

knoell Germany

Michael Werner is Chemist and Eurotox registered Toxicologist with an over 20 years track record in hazard, exposure and risk assessments in various regulatory areas including classification and labelling. In his present role as a Senior Expert Regulatory Toxicology at knoell Germany, he provides regulatory and scientific/technical advice to clients for the preparation of biocidal active substance/product dossiers. Another focus of his work is the development of tailor-made dossier strategies for the authorisation of biocidal products/product families in their various and sometimes non-standard applications including animal safety and dietary risk assessment of biocides.

mehrweniger

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