VIENNA, AUSTRIA 25 - chemicalwatch.com · BIOCIDES 2015 – 18TH ANNUAL CONFERENCE VIENNA, AUSTRIA A unique opportunity to join our expert panel for a two day event in Vienna which

BIOCIDES 2015 – 18TH ANNUAL CONFERENCE

VIENNA, AUSTRIA

A unique opportunity to join our expert panel for a two day event in Vienna which focuses on the latest information and advice on the application of the EU Biocidal Products Regulation (BPR)

Seats Strictly Limited. Book now to avoid disappointment

TWO DAY CONFERENCE + WORKSHOPS

2526NOVEMBER

Brought to you by:

WHY ATTEND?EXPERT PANELListen to senior representatives from European Institutions, Regulators from Member States together with industry representatives from across the EU and elsewhere in the World

CURRENT THINKINGGain valuable insight into the state of play of the BPR

TIME EFFICIENCYBring yourself up-to-date with the complex and changeable regulatory landscape concerning Biocides by attending two conference days and a choice of four workshops

Q&A PANEL SESSIONSHave your specific questions answered by making use of the multiple Q&A sessions. Remember - you can send in any questions you might have in respect of the Biocides’ regime in writing in advance of the conference.

FOCUSBring yourself up-to-date with the BPR since implementation and learn about developments in the rest of the world

FOCUSED WORKSHOPSParticipate in one or two of the four focused workshops to gain a more in-depth understanding of specific developments

BIOCIDES 2015 – 18TH ANNUAL CONFERENCE

25-26 NOVEMBER, VIENNA, AUSTRIA

Who should attend? Authorisation holders Registration holders National Competent Authorities Producers Retailers Formulators Consultants Other Stakeholders

About this eventRegulators, authorities and biocides businesses are continuing to get to grips with the intricacies of the EU Biocidal Product Regulation - putting the provisions into practice and, where necessary, developing further explanation and understanding around application of this hugely complex piece of legislation.

As implementation progresses, more companies, across more industrial sectors, are feeling the effects. Increasingly, downstream users of biocides - in supply chains ranging from pest control, to wood and water treatment, through to consumer goods - need to know their obligations if they are going to remain within the law.

Such companies also need to understand the likely impacts of the regulation on the supply of ingredients that are often critical to the performance of their products, and stay ahead of developments regarding the substitution of biocidal products.

While the BPR takes an overarching view of biocides risk management - through the authorisation of active substances in all product types - important developments are happening elsewhere. The OECD continues to make progress in its internationally-recognised tests and guidance for biocides. And other countries (ie US, China and Japan) are reviewing, revising and introducing new rules.

Providing critical insights on the current state-of-play regarding implementation of the BPR, Biocides 2015 - 18th Annual Conference - sheds light on emerging downstream impacts and also touches on regulatory activity outside of the EU.

09:00 Coffee and Registration

09:30 Chair’s Introduction

SESSION 1: Update from the Regulators

09:40 EU Commission Legislative update• implementation• the recent achievements• on-going works • important deadlines

Ludovic Chatelin, Policy Officer on Biocides, EU Commission, Belgium

10:15 ECHA Update: Latest developments• The new Review Programme Regulation in practice• In situ generated active substances• Article 95: status and next steps• Union Authorisation: status• R4BP 3 and SPC editor: status and next steps

Valerio Spinosi, Scientific Officer, Biocides Assessment Unit, ECHA, Finland

10.40 Q&A

11:00 Refreshments and networking

SESSION 2: Industry response at different supply chain levels

11:15 A) Creosote: Challenges assessing UVCB Biocides• What is creosote• Introduction CCE• Creosote evolvement through the years• UVCB biocides in contrast to most other biocides• Challenges for authorities and industry• Transition BPD/BPR and its challenges• Comparative Assessment• Development of Alternatives• End of life use• Future outlook

Ralph Meulepas, Chairman Technical Committee, Creosote Council Europe, Koppers International B.V.

11:40 B) BPR impact in the nonwovens industry• Introduction to EDANA, the international association

serving the nonwovens and related industries• The use of biocides in the nonwovens industry• EDANA’s main priorities: treated articles and borderline issues• Conclusion: Outlook

Bernd Heinken, Head of Technical Support Department SAI, Schuelke & Mayr GmbH, on behalf of EDANA, Belgium

12:05 C) A short Overview of how SMEs deal with the BPR: Challenges, Worries and OpportunitiesMarko Sušnik, Advisor, UEAPME, Austria

12:30 Round Table (all morning speakers With CA representative, Marcel Hulsman, CTGB, NL, Prof. Ralph Cooney, University of Auckland, NZ and NGO (tbc)

13:15 Lunch and networking

SESSION 3: More detailed updates

14:15 Article 95 Enforcement• Background Art. 95 of the BPR• Compliance scenarios• Enforcement issues• Experience, recent developments• Communication in the supply chain• In situ generated active substances

Paul Krajnik, Deputy Director, Waste Management, Chemicals Policy and Green Technology Division V/5, Chemicals Policy and Biocides, Federal Ministry, Forestry, Environment and Water Management - Austria

14:40 Enforcement or Compliance? Article 95 BPR• Industry Situation end 2014 – uncertainty about effect of art 95• Current industry situation – enforcement by NL authorities• In-situ biocides compliance

Chuchu Yu, Consultant Scientific & Regulatory Affairs, NVZ - Dutch Detergents Association

15:05 Developments on in-situ Biocides and the Impact on the Supply Chain• Regulation if in situ biocides under the BPR – where we are

and how we got here• In situ biocides and the BPR Review Programme• In situ biocides and Article 95• Consequences for suppliers of precursors, active substances

and biocidal products• Some current examples of supply chain scenarios

Mike Baldry, Regulatory Affairs Consultant, Antec International Ltd. (Chemours Chemical Solutions)

15:30 Q&A

15:45 Refreshments and networking

16:00 Consequences of treated article regulations for the coatings industry• Art 95 contains a limited set of biocides useable in paint

formulations• Biocide regulations could affect sustainability• Facilitate entry of new biocides

Anthonie Stuiver, R&D Manager, Exterior Woodcare, AkzoNobel

16:25 Master batches• What is a Masterbatch?• Is a Masterbatch incorporating an active substance a

biocidal product?• In which case is an article made of a resin which

incorporated a Masterbatch of an active substance a Treated article?

• Proposed way forward

Anna Gergely, Director, EHS Regulatory, Steptoe & Johnson LLP, Belgium

DAY 1: 25 November 2015

16:50 Mandatory Data Sharing under the BPR – prospects and risks for data owners, data submitters and new market entrants• The impact of mandatory data sharing on existing data

access, transfer and licensing agreement• How to solve conflicts between mandatory data sharing

and freedom of contract• Legal consequences for future contract design• Recent case law

Gunnar Sachs, Lawyer, Clifford Chance Deutschland LLP, Germany

17:15 BPR fees: impact on the future of biocidal productsElodie Cazelle, Technical and Regulatory Affairs Manager, A.I.S.E., Belgium

17:40 Q&A

18:00 Close of Day One

09:15 Keynote: The NZ Biocides Toolbox• The research objective: to develop a toolbox of new greener

synthetic and natural biocides with reduced environmental and health impacts

• The Research Team: high quality interdisciplinary research team of chemists, microbiologists and engineers from a consortium of 4 research provider organisations

• The commercial objective: to work with international and NZ companies to develop greener biocides which have greater consumer acceptance

• The economic objective: to enable NZ manufacturing companies in the biocide relevant sectors to grow their business through export

• The biocide relevant sectors: Construction, Healthcare, Consumer Products, Air and Water Quality, Packaging etc

Prof. Ralph Cooney, University of Auckland, New Zealand

SESSION 4: Borderline Issues

09:30 Borderline issues of the BPR: Medical Devices, Medicinal Products and Cosmetics• Background and provisions of the BPR• Experiences and views on the changed conditions under

the BPR• Borderline to medical devices, cosmetic products, medicinal

products and veterinary medicinal products• Borderline between biocide product types

Dr. Ludger Grunwald, Dir. Regulatory Affairs EMEA,

ECOLAB Deutschland GmbH

09:55 Q&A

10:10 Refreshments and networking

SESSION 5: Implications of substitution decisions

10:25 Identifying challenges for the procedure of comparative assessment• Overview of the provisions concerning the comparative

assessment• Main aspects of the assessment procedure• Experiences and current challenges

Jessica Jordan, Scientific Officer, BAuA, Germany

10:50 Developing a strategy for dealing with substitution decisions• Reviewing the scope of substitution criteria• Public Consultation - experiences• Putting the theory into practise• Impacts on registration strategies and costs

Samantha Champ, Head of Regulatory Affairs - Biocides, BASF SE, Germany

11:15 Pest Control - Effect of the active ingredient withdrawals and use restrictions• Short introduction of Babolna• Short outlook to areas governed by other regimes• Pest control reshaped by legislation:• Reduced portfolio of actives (Withdrawals)• Restrictions

- substitution – comparative assessment - Non-inclusions - only professional use - restricted field of use

• The effect on practice of some pest control areas and highlights of some special aspects

Sandor Karikas, Development Engineer, Babolna Bio Ltd., Hungary

11.40 Q&A

12:00 Lunch and networking

SESSION 6: Safer/Sustainable Biocides

13:00 EU Report on the Sustainable Use of Biocides• the study prepared • a state of play on the report to be sent to Council and EU

Parliament

Ludovic Chatelin, Policy Officer on Biocides, EU Commission, Belgium

13:30 Substitution made easy - The WIDES Data Base for Disinfectants• Why `Green Public Procurement´ of disinfectants?• Purpose and structure of the developed WIDES Database

(www.wides.at/en)• Lessons learned - Experiences of users and results in Vienna• Some suggestions for the sustainable use of biocides in Europe

Marion Jaros, Official, Vienna Ombuds-Office for Environmental Protection, Austria

13:55 Anti-microbial Conducting Polymers• The research objective: To develop new anti-microbial

polymers based on functionalized polyaniline technology• The outcomes: new polymeric biocides, microbiological

testing and mechanisms

Day 2: 26 November 2015

OPTIONAL WORKSHOPS

• The research team: materials chemists and microbiologists from the University of Auckland, Victoria University Wellington, Scion Research Ltd and Industrial Research Ltd

• The commercialization team including industry and start-up executives leading commercialization strategy

• The industry engagement strategy: Joint technology Planning

Prof.Ralph Cooney, University of Auckland, New Zealand

14:20 The US EPA Safer Choice Program (formerly Design for the Environment- DfE)• Program background• What does the label mean?• Product review process• Safer Chemical Ingredients List (SCIL)• CleanGredients• Preservatives• DfE for Antimicrobial Products Pilot

Melanie Vrabel Adams, Senior Environmental Protection Specialist, US Environmental Protection Agency

14:55 Q&A

15:10 Refreshments and networking

SESSION 7: Global Regulation Update

15:40 China non-agricultural pesticide registration system• Development of China Pesticides Industry• Authority for China Pesticides registration• China Pesticides registration system• Requirements for Non-Agricultural Pesticides Registration

Yong Jiang, Project Director, Product Registration and Compliance Department, China National Chemical Information Centre, China

16:05 Biocides in Asean - a brief overview of biocide management in• Thailand• Malaysia• Philippines• Singapore• Indonesia• VietnamIncluding information on your obligations, responsibilities and enforcement.

Deirdre Lawler, Head of Industrial Chemicals & Biocides, Regulatory Affairs, Dr Knoell Consult GmbH, Germany

16:30 US Regulatory Update

16:55 The Role of the OECD Task forceLeon van der Wal, Policy Analyst, OECD, France

17:20 Final Q&A panel session

17:45 Close of Conference

One Day Workshops

Workshop 1 – Pre-conference, 24 November, 09.30-17.00

A Practical Introduction to the BPR: • Brief overview: main principles and role of Echa, the

Commission, member states• Authorisation of active substances • Authorisation of biocidal products • Treated articles • Overview of interlinks between BPR and other legislations• Costs, data protection and data sharing provisions• Available Guidance

Workshop Leaders: Darren Abrahams, Partner, Steptoe & Johnson LLP, Belgium; Christian Gruendling, Technical Director, FCIO, Association of the Austrian Chemical Industry

Workshop 2 – Post-Conference, 27 November, 09.30-17.00

IT Tools for Biocide Authorisation - Hands on Workshop (Please have IUCLID preloaded on your laptop!)

• Tools Overview: IUCLID, SPC Editor & R4BP 3• Create active and basic substance datasets• Create a biocidal product dataset• Generate a biocidal product dossier• Produce an SPC• Create an ECHA account via R4BP 3

Workshop Leader: Rita Sookrit, Training Manager, ReachCentrum, Belgium

Half Day Workshops

Workshop 3 – 27, November, 09:00-12.30 Consortia under BPR:

• Biocidal Product Regulation Overview - Biocidal Product Family - Regulation 414 of 2013

• Consortium Structure• Consortium Management

- Obligation - Communication - Data & Cost Sharing - LoA

Workshop Leader: Magda Kornacka, Project Manager Reach & Biocide, ReachCentrum, Belgium

Workshop 4 – 27, November, 13.30-17.00 Planning a biocidal product family authorisation

• Considerations for forming a biocidal product family (BPF) and the use of meta SPC

• What to include in the family and when; future proofing? • Justifying a BPF product grouping• Determination of a test programme• Preparing the dossier and SPC• A Competent Authority viewpoint

Workshop Leaders: Sara Kirkham, Senior Consultant, EHTRA UK Ltd., and Alice Brousse, Consultants, Toxicologist Specialist, Cehtra EU; Marcel Hulsman, Account Manager Biocides, CTGB,

3 WAYS TO REGISTER

LOCATION & TIMINGS

chemicalwatch.com/biocideshub/biocidesconference2015

[email protected] +44(0)1743 818293

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PRICES

25/26 NOVEMBER 2015 TWO-DAY CONFERENCE €895 +VAT (22%)

PRE-CONFERENCE WORKSHOP 24 NOVEMBER 2015 €545 +VAT (22%)

POST-CONFERENCE WORKSHOPS WORKSHOP (3) €295 +VAT (22%)

POST-CONFERENCE WORKSHOPS WORKSHOP (2) €545 +VAT (22%)

POST-CONFERENCE WORKSHOPS WORKSHOP (4) €295 +VAT (22%)

Payment options:

1. Invoice payable by bank transfer, credit card or check made payable to CW Research Ltd

2. Online using our secure order-form

Austria Trend HotelsHOTEL SAVOYEN VIENNA Rennweg 16, 1030 WienTel: +43-1-20633-9105 Fax: +43-1-20633-9111

www.austria-trend.at/ Hotel-Savoyen-ViennaWe have arranged a special bedroom rate for Conference participants at the Hotel Savoyen Vienna.

Standard rooms = €120Delegates will be sent a special link to make reservations directly with the hotel.

EVENT TIMINGS:

Tuesday 24 November Workshop 1 09.30-17.00

Wednesday 25 November Conference Day 1 09.00-18.00

Thursday 26 November Conference Day 2 09.15-17.45

Friday 27 November Workshop 2 09.30-17.00

Friday 27 November Workshop 3 09:00-12.30

Friday 27 November Workshop 4 13.30-17.00

Payment must be made before the event starts

Reservations: chemicalwatch.com/biocideshub/biocidesconference2015Email: [email protected] Tel: +44(0)1743 818293