Biocides Europe 20193-4 DECEMBER 2019 | VIENNA, AUSTRIA

Biocides Europe focuses on key aspects of Regulation (EU) No. 528/2012, otherwise known as the Biocidal Products Regulation (BPR), concerning the approval of active substances and authorisation of biocidal (or antimicrobial) products.

Day one will focus on BPR procedures, authorisation and approval-related processes, the assessment of endocrine disrupting chemicals, and how the BPR has impacted companies throughout Europe.

Day two will start with two break-out sessions in the morning, exploring biocides topics overlapping with other regulations, and the enforcement of biocides. In the afternoon, the expert panel will discuss the sustainability of biocides and the circular economy, as well as testing and modelling.

The latest updates in European biocidal regulations direct from the experts

Why attend?

Who should attend?

• Representatives of authorisation/registration holders

• National competent authorities• Producers, exporters, formulators,

and retailers of biocidal/antimicrobial products, including household cleaning products, preservatives, pharmaceuticals, and pesticides

• Those working in sustainability, EHS, or marine/environmental welfare

• Government regulators• Advisors and consultants• Occupational health professionals• Service providers• NGOs• Other stakeholders in organisations

working with or in biocidal products

Expert panel – listen to senior representatives from European institutions and regulators from member states together with industry representatives from across Europe, for a multi-perspective view on the current landscape of biocidal regulations in Europe.

Current thinking – gain valuable insight into the state of play of the BPR.

Time-efficient – bring yourself up to date with the complex and changeable regulatory landscape concerning biocides over two days.

Q&A panel sessions – have your questions answered at the various Q&A sessions during the conference. You can send any questions you might have for the expert speakers in writing prior to the event.

Focus – an entire conference dedicated to the latest developments of the BPR, with in-depth discussions and practical insights.

Networking – meet and network with biocides professionals from around Europe and further afield, at one of the biggest biocides events in the world.

Day one

Chair: David Dillon, Senior Managing Scientist, Exponent International, UK

08.30 Registration

09.00 CW Welcome

09.10 Keynote Thomas Jakl, Head of Chemical Policy and Biocides, Federal

Ministry of Sustainability and Tourism, Austria

Session 1: Overviews of BPR procedures including the status of transitional regimes

09.25 Update from the Commission: Latest developments in the biocides field

• 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)

Martinus Nagtzaam, Policy Officer, DG Sante, EU Commission, Belgium

09.50 ECHA’s latest updates • General updates on biocides

• Review program action plan

• Lessons learned so far on endocrine disruptors

Simón Gutiérrez, Team Leader, Biocidal Active Substances Unit, Echa, Finland

10.15 Member state overview from Austria• Current situation, achievements

• Challenges

• Possible solutions

• Summary and future perspectives

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

10.40 Industry/consultancy overview• ED assessment of active substances and co-formulants

• Implementation of the new BPF concepts

• Over-conservative risk assessment

Nathalie Hanon, Manager CEHTRA SL - EVP, CEHTRA, Spain

11.05 Q&A

11.20 Refreshments

Session 2: Regulatory issues for authorisation/approval related processes - case studies

11.45 The new Safety Biocidal Family Robert Narquizian, Chief Business Officer, Salveco, France

12.10 The long and winding road to Union Authorisation

• 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 GmbH, Germany

12.35 Mutual recognition lessons learned: Pros and cons of MR in parallel vs in sequence

• 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 Szanto, EU Coordinator for Biocides, National Public Health Centre, Hungary

13.00 Q&A

13.15 Lunch

Session 3: Status of endocrine disruptor assessments for biocides

14.15 The implementation of the guidance for endocrine disruptors from an authority perspective

• 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, Environmental Risk Assessor Biocides, The Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb), the Netherlands

TUESDAY

3DECEMBER2019

14.40 Metabolic effects of Endocrine Disrupting Chemicals: Novel testing METhods and adverse outcome pathways (EDCMET) Project

• 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

15.05 Assessment of potential endocrine disrupting properties of biocidal active substances using in silico tools: First experiences under the new

EU Guidance Document

• 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

15.30 Legal issues raised by ED criteria• Shifting goal posts

• Data demands

• Beyond biocides

Darren Abrahams, Partner, Barrister & Avocat, Steptoe & Johnson LLP, Belgium

15.55 Q&A

16.10 Refreshments

Session 4: How has BPR impacted your company,

and how have you dealt with the challenges posed?

Series of industry case studies

16.35 SME perspective: How to best apply resources for dealing with the BPR

• 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, Regulatory Affairs Manager, I-Tech AB, Sweden

16.50 Manufacturer’s perspective Ilona den Hartog, Senior Regulatory Specialist, Nouryon

(forrmerly AkzoNobel), Netherlands

17.05 Impact of the BPR: Formulator’s perspective• Practical experience

• Changes in strategy

• Financial adjustments

• Uncertainties

• Lessons for the future

Alice Ngosso, Regulatory Affairs Manager, Vinck Chemicals GmbH & Co. KG, Germany

17.20 Distributor’s perspective• 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

17.35 Panel and Q&A 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

18.00 Close of day one

Day one TUESDAY

3DECEMBER2019

Day two

Session 5: Choice of two break-out sessions:

A: Biocides topics overlapping with other legislation

B: Enforcement of biocides

5A: Biocides topics overlapping with other legislation

Chair: Camelia Mihai, Sector Group Manager, European Biocidal Product Forum - Cefic, Belgium

09.00 Is my product a cosmetic, biocide, or both ? –assessment criteria for the borderline

Gerald Renner, Director Technical, Regulatory & International Affairs, Cosmetics Europe, Belgium

09.25 Does the BPR promote innovations in disinfection?• Probiotics

• Super-oxidised water

• Re-formulated hydrogen peroxide

• Chemical leasing

Manfred Klade, Environmental Engineer, Bureau for Chemical Engineering TB-Klade, Austria

09.50 BPR and other legislative regimes• The legislators’ original intention

• Legislative overlaps and conflicts

• Classification and labelling

• Treated articles

• Impact for global industries:

• a ‘road to nowhere’ or

• a ‘highway to hell’

Koen van Maldegem, Partner, FieldFisher LLP, Belgium

10.15 Q&A

5B: Enforcement of biocides

Chair: David Dillon, Senior Managing Scientist, Exponent International, UK

09.00 Developments FORUM subgroup including update on first project REF-6/BREF-1

Eugen Anwander, Senior Scientific Officer, Institute for Environment and Food Safety, Vorarlberg State Service, Austria & Chair of ECHA BPR Enforcement FORUM, Finland

09.25 Enforcement of treated articles in Sweden• The legislation in Sweden regarding treated articles

• Enforcement organisation in Sweden

• Sanctions

• Results and conclusion from enforcement projects in Sweden

Jenny Karlsson, Technical Officer, Enforcement of Rules - Pesticides and Articles, Swedish Chemicals Agency, Sweden

09.50 In situ nitrogen: A case study on enforcement and Art. 55 (3) BPR derogations

Henning Krueger, Lawyer, JurSolution Law Firm, Germany

10.15 Q&A

10.30 Refreshments

10.55 Moderators’ feedback

Chair: David Dillon, Senior Managing Scientist, Exponent International, UK

Session 6: Sustainability of biocides and circular economy

11.05 Efficacy assessment and sustainability• As little as possible – as much as necessary

• The fear of bacteria and the ”precautionary principle”

• A highly regulated market versus a consumer’s free choice

• The quest for easy

• Efficacy as necessary base for using a biocide

• Beyond efficacy… (Efficacy necessary but not sufficient)

Ulrike Frank, Senior Scientific Advisor, Swedish Chemicals Agency, Sweden

11.30 New active substance, sustainable uses – the case for chlorine dioxide• Chlorine dioxide – a sustainable treatment alternative

• Methods of generation – enough to cover everything?

• An alternative delivery system (ex situ)

• Case examples of sustainable uses

Sjef Swinkels, European Market Development Manager WT & Corrugated Board, Brenntag, Germany

11.55 The contribution of biocides to sustainable economies• Benefits of biocides within the regulatory framework

• Case examples of the value of biocides to sustainable economies

• The past, the present and the future –a compelling need for change

Ian Watt, Regulatory Sciences and Product Sustainability, Microbial Control, DuPont Specialty Products Division, UK

WEDNESDAY

4DECEMBER2019

12.20 Silver leaching: A report on silver in sportswear Anders Finnson, Senior Environmental Advisor, Swedish Water

and Waste Water Association, Sweden

12.45 Q&A

13.00 Lunch

Session 6: Sustainability of biocides and circular economy continued

14.10 Substitution of chemicals of concern – Promoting innovation by facilitating partnerships• The Europe Enterprise Network and the Partnership

Opportunities Database (what they are, how they work)

• Project’s objectives and what we have done

• Market segments (companies’ needs and attitudes towards substitution, how to further support them and how to reach them)

• Lessons from the biocidal product market

Meg Postle, Director, Risk & Policy Analysts, RPA Ltd., UK & Marco Camboni, RPA Europe srl, Italy

14.35 Not only biocides: a contribution from microbial-based systems for infection and antimicrobial resistance (AMR) control• Healthcare-associated infections are a global concern:

persistent microbial contamination and AMR of pathogens are major causes

• Microbial-based sanitation approaches can be very efficient in stably abating pathogens and their AMR

• Results of our studies (published research)

• Further innovations and future perspectives

Elisabetta Caselli, Associate Professor of Clinical Microbiology, Department of Chemical and Pharmaceutical Sciences, University of Ferrara, Italy

15.00 Panel with Q&A• What does sustainable use of biocides entail?

• What is the role of biocides in a circular economy?

• How to define a workable regulatory framework for substitution of substances?

15.25 Refreshments

Session 7: Testing and modelling

15.50 Guidance development overview from German efficacy expert

Juliane Fischer, German Environment Agency, Germany

16.15 Impact of substance ID on read-across, data sharing and testing, and its strategic implication for registrations• Background to substance identity (focus on UVCB

substances)

• Interplay between REACH, BPR and PPP Regulations – how to ensure consistency of approach

• How should UVCB substances be named and identified under the BPR and who should be involved

• Redefinition of active substances

• The balance between unnecessary animal testing and correct hazard assessment

• source versus composition-based naming

• narrow substance definition versus broad substance definition

• The grey area of when two compositions are the same or not – substance sameness

• What to do when substance id/substance definition causes practical problems for data sharing under biocides

Steve Buchanan, Senior Chemistry & REACH Consultant, TSG, UK

16.40 Recent developments and technical issues with the testing of in situ generated active substances and products• Background around in-situ actives and the BPR

• Overview of current guidance on data requirements

• Technical issues faced by in-situ actives

Emma Miller, Managing Chemistry Consultant, Yordas, UK

17.05 Q&A

17.20 Close of conference

Day two WEDNESDAY

4DECEMBER2019

Prices Payment options:• Invoice payable by bank transfer,

credit card or cheque made payable to Chemical Watch

• Online using our secure order form• Payment must be made before the

event starts

We have arranged a special bedroom rate for conference attendees at the Radisson Blu Park Royal Palace Hotel. Attendees will be sent a link for booking hotel accommodation directly with the hotel.

Event timings

2 December (Workshop one): 9:00 - 16:30

2 December (Workshop two):12:00 - 17:00

3 December: 8:30 - 18:00

4 December: 9:00 - 17:20https://chemicalwatch.com/biocides-europe-2019

events@chemicalwatch.com

+44(0)1743 818 293

Three ways to register

Venue

Radisson Blu Park Royal Palace Hotel

Schlossallee 8, Vienna 1140, Austria

Tel: +43 1 89 11 0

Email: info.parkroyalpalace.vienna@radissonblu.com

Conference - 3-4 December

Chemical Watch members – €945

Early-bird discount for members – €845

Full price (for non-members) – €995

Early-bird discount for non-members – € 895

Early-bird discount expires Friday 11 October

Workshop 1 – Full price €495

Members €445

Workshop 2 – Full price €395

Members €345

Event sponsorship: +44 (0) 1743 818 292

If your organisation would like to sponsor or exhibit at this event – gaining access to our high quality delegates over the course of the two days – please contact our sales team today on the number below.

Sponsoring this event

Biocides Europe 2019

Workshop 2 – A Practical Introduction to the Biocides Product Regulation

Workshop Leaders: Darren Abrahams, Partner, Steptoe, Brussels

Eleonore Mullier, Senior Associate, Steptoe, Brussels

Nathalie Hanon, CEHTRA

Cyril Durou, CEHTRA

12.00 Registration and lunch

12.30 Introduction to the BPR and key stakeholders (Commission, ECHA and Member States), interaction with other regimes

14.00 Active substances: general procedure, update on the review program, timetable, etc.

Biocidal products: Authorisation procedures (single product & BPF) and tools

15.00 Refreshments

15.15 National product registration under transitional rules and poison centre notifications

Data sharing principles and disputes

Treated articles

16.30 Endocrine disruptors

17.00 Close

Workshop 1 – Physical Chemical Properties and Analytical Methods for Biocidal Products

Workshop leader: Peter Liney, Managing Scientist - Chemistry, Exponent, UK

Registration from 08:45 - 09:15

09:15 Background and Introduction

09:30 Physical and chemical properties requirements for formulated biocidal products• Overall review of physical, chemical and technical properties

data requirements

• Appropriate testing methods

• In-depth discussion of storage stability requirements

• Group Exercise

11:00 Refreshment break

11:15 Physical Hazard (CLP) requirements for formulated biocidal products• Overall review of physical hazard data requirements

• Appropriate testing methods for CLP compliance

• Waiver possibilities

• Group exercise

12:30 Lunch

13:30 Complex biocidal product submissions • Biocidal product families

• In-situ generation systems (ISGS)

• Carriers

• Formulation type specific requirements

• Group exercise

15:00 Refreshment break

15:15 Analytical method validation requirements for formulated biocidal products• Method for the active substance in the formulated product

• Method for relevant impurities in the formulated product

• Monitoring methods

• Validation criteria

• Group exercise

16:30 Questions and close of day

Optional pre-conference workshopsMONDAY

2DECEMBER2019