3rd Annual European Regulatory Conference on Biocides:

Transcription

1 Event Publication Events for the regulatory community by regulatory people 3rd Annual European Regulatory Conference on Biocides: A Strategy for Product Authorisation 3 February 2015 Sheraton Airport Hotel Brussels, Belgium CONFERENCES TRAINING EVENTS

2 Look at Nature: excellence is built on rules. REACH AGROCHEMICALS COSMETICS EXTRA-EU CLP FEED SDS FOOD BIOCIDES REACH mastery s.r.l. via Giovio 16, Como, Italy Tel

3 Welcome Welcome to the 3rd Annual European Regulatory Conference on Biocides: A Strategy for Product Authorisation As the review programme for active substances progresses slowly we focus our attention on the authorisation of biocide products in our third year in Brussels. Our conference programme looks at the what, how and when of product authorisations with policy, practical advice and experience delivered from experts and practitioners. All packaged neatly into one busy and rewarding day. Topics include a view from the Commission on policy, how product authorisations will be managed by ECHA and related legal issues surrounding the new Regulation. Practical advice will include presentations from industry representatives active in supporting their products across the Union. This will include challenges faced by both large and small organisations. Finally, two topics worthy of attention will be the management of data and untangling treated articles! We sincerely hope you enjoy the conference and look forward to welcoming you to our future events. Dr Louis Wyness Managing Director, TSGE Forum Speaker and Chair Biographies Advertorial - EU Commission develops practical Guides for SMEs on Data Sharing, Letters of Access and Consortia within the context of the BPR Congress Programme Advertorial - A tier 1 screening tool for the assessment of exposure and risk levels of Biocidal Products Page 4 Page 8 Page 9 Page 10 Contents EVENT SPONSORS 3

4 Speaker and Chair Biographies 3RD ANNUAL EUROPEAN REGULATORY CONFERENCE ON BIOCIDES: A STRATEGY FOR PRODUCT AUTHORISATION Pierre Choraine Biocides Team Coordinator DG Environment European Commission Pierre trained as a veterinary surgeon and as a political scientist. He worked successively at IFAH-Europe (then called FEDESA), representing the European animal health industry, at the European Medicines Agency, during its start-up phase, at the Federation of Veterinarians of Europe, as its Executive Director, before joining the European Commission in Since, 2005 he is working on the biocides legislation and became coordinator of the team in charge of that legislation in Nicholas Jarvis Regulatory Affairs Manager Eurofins Regulatory AG Nick Jarvis currently manages a small team of regulatory affairs specialists with particular focus on the biocides and REACH regulations within Europe. Nick received a joint honours degree in chemistry and environmental monitoring & management in 2002 and started his regulatory career at SafePharm in Initially Nick mainly focused on biocidal active substance dossier submission and providing companies with support during the review program. During his time at SafePharm/Harlan, Nick also provided higher tier support for new chemicals/reach risk assessments, support with agrochemical environmental modelling and was responsible for a number of agrochemical Annex III registrations. In 2012 Nick left Harlan to join Eurofins Regulatory as manager of the Biocides and REACH registration group based in the UK and has been working since this time within the company to build up the regulatory capacity to support companies both with active substance support and with product authorisations under both the EU and national transitional schemes. Dr. Sara Kirkham Senior Consultant CEHTRA Sara Kirkham gained her Ph.D. in bio-inorganic chemistry from Nottingham Trent University. She joined Safepharm Laboratories in 1998, working on new chemical substance registrations under NONS. In 2000 she established the Biocides and Existing Substances Registration team. In 2001 she took over management of the group, leading it through the Biocide Existing Active Substances Review Programme, the implementation of REACH and the merger of Safepharm with RCC to form Harlan Laboratories Ltd in She joined CEHTRA UK Ltd as a Senior Consultant in 2011, taking on the lead of the CEHTRA group biocide team, in addition to branching out into new areas of chemicals legislation. Séverine Macke Senior Regulatory Consultant TSGE France Séverine is an expert in regulatory affairs responsible for developing the French market on behalf of the TSGE Group of Companies and for providing consulting and project management services. Prior to joining TSGE, Séverine worked for a manufacturer of bio-active treatments for textiles. She gained experience in defending company business interests, project management, treated articles issues and scientific testing in support of marketing product claims. In addition, she advised manufacturers and retailers on regulatory and registration requirements, SDS drafting and efficacy trials on textiles. She was also the leader of an EU Task Force defending an active substance under BPD. Séverine is a Textile Engineer and studied at U.M.I.S.T. (University of Manchester Institute of Science and Technology). 4

5 Speaker and Chair Biographies 3RD ANNUAL EUROPEAN REGULATORY CONFERENCE ON BIOCIDES: A STRATEGY FOR PRODUCT AUTHORISATION Koen Van Maldegem Partner fieldfisher Koen s practice focuses on EU regulatory, business and competition law, with an emphasis on chemicals, pesticides, biocides and cosmetics. He advises international and Belgian companies on regulatory compliance and free movement of products throughout the EU. His expertise covers regulatory counselling at the EU and Member State level regarding data protection, data sharing and data compensation, task force formation and management, distribution and supply agreements for pesticides, biocides and chemicals, and he is specialized in solving the antitrust issues that may arise in these areas. He also handles product defence litigation before European and national courts. Koen authored articles on biocides, data sharing and antitrust legislation and for many years has been a frequent speaker at conferences for the pesticides, biocides and chemicals industry. He obtained his B.A. at the Gent (Belgium) University in 1987 and obtained his Sc.B in Economics at the Leuven (Belgium) University in Camelia Mihai Sector Group Manager Biocides Cefic Camelia obtained a PhD in Sciences at the Vrije Universiteit Brussel. She started her professional career at Cefic, the European Chemical Industry Council, coordinating the regulatory activities of several REACH and biocides active substance consortia. Since 2012, she has lead several groups within the Cefic sector group of European producers of biocidal active substances and products The European Biocidal Products Forum (EBPF). In this position, Camelia actively follows the regulatory developments of the EU biocides legislation, providing support, information and advice to Cefic members in the area of compliance and implementation. She represents Cefic in the Coordination Group and BPC WG Meetings regarding the implementation of the BPR. Chiara Pecorini Junior Scientific Officer ECHA Chiara Pecorini holds a degree in Veterinary biotechnology and a PhD in Biotechnology applied to veterinary and zootechnical sciences from the Veterinary Medicine Faculty of the University of Milano (Italy), where she also worked as a post-doctoral fellow. She collaborated with the French National Institute for Agricultural Research (INRA) in Jouy-en-Josas and was a visiting research associate at the Anschutz Medical Campus, Department of Physiology and Biophysics, University of Colorado Denver (USA). Her research activity focused on in vitro and in vivo models in the field of biology of lactation. She started working on the toxicological risk assessment of biocidal active substances in the Chemical Assessment and Testing Unit at the European Commission Joint Research Centre (JRC) in Ispra (Italy). As of January 2013, she is junior scientific officer in the Biocides Assessment unit at the European Chemicals Agency (ECHA), where she is the process coordinator of Union authorization of biocidal products. She is also the chair of the Ad hoc Working Group on Human Exposure and a member of the Human Health team supporting the activities of the Biocidal Products Committee (BPC) and its working groups, focusing in particular on human exposure assessment. 5

6 Speaker and Chair Biographies 3RD ANNUAL EUROPEAN REGULATORY CONFERENCE ON BIOCIDES: A STRATEGY FOR PRODUCT AUTHORISATION Perminder Rupra Technical Director PAL International Perminder is currently Technical Director at Pal International where he is responsible for driving Operational, Product Development & Regulatory strategies. He graduated at Nottingham Trent University in 2001 gaining BSc (Hons) in Microbiology & Environmental Management. During , Perminder supported the Quality & Technical teams at Nestlé s Rowntrees division whilst at University. This included development support for Polo smoothies and implementation of an Environmental management procedure for the Leicester site. After Graduating in 2001 Perminder joined Pal International who specialise in manufacturing disinfectant wipes and single use personal protective equipment for the food and healthcare professional markets. As Technical Manager he helped develop wipes in to new geographies by registering disinfectant wipes across a large portfolio of countries within and outside the EU. In 2006 Perminder left Pal and joined Rockline Industries who are the largest manufacturer of wet wipes globally. At Rockline he was a key member of the global product development team continuously developing products for brands and retailers across the globe focusing mainly on US, EU & Asia Pacific markets. In 2012 Perminder returned to Pal and is now driving the development of the biocidal products strategy and is instrumental in the current resurgence at Pal. Registration Open June 2015 Barceló Praha Hotel Prague, Czech Republic Delegate Price: 350+VAT This two-day programme will have expert speakers from Competent Authorities and practitioners delivering material designed to help your organisation manage the complexity of European biocide regulations. It will provide a great opportunity for service providers to exhibit and for all to network with the wide spectrum of organisations. The programme committee chairpersons include: The Prague Biocide Conference 2015: Staying on the EU Market - Regulatory Challenges in the Supply Chain Dr. Edmund Plattner Consultant (former Austrian Ministry for Environment) Dr. Viktor Prachar TSGE Slovakia (former Unit Head Biocides, Centre for Chemical Substances and Preparations, Slovak Republic) You can register now by visiting our website or contact us for general enquiries, exhibition or sponsorship opportunities on: T +44 (0) E enquiries@tsgeforum.com 6 8

7 Let us make life simpler for your REACH regulatory testing Contact us at - PHYSICAL CHEMISTRY PROPERTIES - ANALYTICAL SERVICES đŏlc-ms/ms, GC/MS, LC-ICP/MS - ECOTOXICOLOGY đŏaquatic toxicity đŏterrestrial toxicity đŏenvironmental fate - IN VITRO AND IN VIVO TOXICOLOGY đŏacute and in vitro testing đŏlocal tolerance / sensitisation đŏmutagenicity đŏrepeated dose toxicity đŏreproductive toxicity including screening, DART, one and multigeneration studies đŏtoxicokinetics đ Carcinogenicity studies đ Inhalation toxicology đ QSAR analysis 7

8 Advertorial EU Commission develops practical Guides for SMEs on Data Sharing, Letters of Access and Consortia within the context of the BPR Koen Van Maldegem Partner fieldfisher, Boulevard Louis Schmidt 29, 1040 Brussels - Belgium At the end of August 2014, the European Commission awarded three contracts for the drafting of EU guidance documents (Guides) under the Biocidal Products Regulation (BPR). The Guides are intended to assist SMEs with practical advice on data sharing, consortiums and letters of access. The contracts were awarded to a consortium led by Fieldfisher and further composed of CEFIC (the European Chemical Industry Council), UEAPME (the European Association of Craft, Small and Medium-sized Enterprises) and AISE (the International Association for Soaps, Detergents and Maintenance Products). The drafting of the Guides is in the final stages and release is expected in February The aims of the BPR are ambitious and will have a significant impact upon affected industries, SMEs in particular, which has already started to manifest itself. This is most obvious for the so-called existing active substances (that were on the market on 14 May 2000 and are part of the ongoing review programme initiated under the Biocidal Products Directive (BPD)). Recital 58 of the BPR states: a level playing field should be established [for] existing active substances, taking account the objectives of reducing unnecessary tests and costs to the minimum, in particular for SMEs, of avoiding the establishment of monopolies, of sustaining free competition, between economic operators and or equitable compensation of the costs borne by data owners. These aims are to be achieved by, amongst other things, the introduction of innovations; in other words, new rules on: letters of access, mandatory data sharing, and consortiums. The Guides are directly concerned with these three innovations. The principal aim is to provide assistance to all parties involved in data sharing under the BPR to come to data sharing agreements. The word data is commonly used to refer to scientific tests and studies, including, but not limited to, those involving vertebrate animals. The BPR places parties under an obligation to use every effort - in good faith - to reach an agreement on the sharing of data. If no agreement is reached, in certain circumstances for certain types of data, the Agency can help the parties by granting permission to refer to the requested data. The Guides give practical guidance on (i) what prospective applicants and data owners should do in practice to prepare themselves for data sharing; (ii) the way that negotiations should be conducted between parties, and (iii) the possible outcomes of the negotiations. They provide tips and guidance on how parties should make every effort in their negotiations so that a fair, transparent and non-discriminatory sharing of data and their costs is reached between them and on how this can be implemented in a letter of access, or how data sharing can be handled among companies within a consortium and what forms the latter can take. Each of the Guides has been discussed with a sample of SMEs, the European Chemicals Agency (the Agency ), the Member State Competent Authorities ( MSCAs ), representative associations, law firms and technical consultancies. The Guides should in particular help companies to achieve a timely inclusion on the so-called Article 95 BPR List of relevant substance or product suppliers within the regulatory deadline of 1 September

9 Conference Programme 3RD ANNUAL EUROPEAN REGULATORY CONFERENCE ON BIOCIDES: A STRATEGY FOR PRODUCT AUTHORISATION Chair: Koen van Maldegem fieldfisher Registration Introduction to the Conference The Biocidal Products Regulation - Policy perspectives Union authorisation of biocidal products: challenges and expectations Koen van Maldegem fieldfisher Pierre Choraine European Commission DG SANCO Chiara Pecorini ECHA Break and networking Legal issues surrounding product authorisations Exploring Product Authorisation, a multidimensional process Koen van Maldegem fieldfisher Camelia Mihai EBPF, CEFIC Q & A session Lunch and networking steps that SMEs must take to ensure efficient product authorisation Product authorisation; determining the data requirements Perminder Rupra PAL International Dr. Sara Kirkham CEHTRA Break and networking Complex biocidal product families Treated article or biocidal product: the case of textiles Nicholas Jarvis Eurofins Regulatory AG Séverine Macke TSGE France Panel discussion and Q & A Close of Conference

10 Advertorial A tier 1 screening tool for the assessment of exposure and risk levels of Biocidal Products Dr. Cyril Durou Senior Ecotoxicologist CEHTRA France SAS, Rue Laroque, 33560, Sainte Eulalie, Bordeaux, France Key Words: exposure, risk, tailor-made, tool. EHT The Biocidal Products Regulation (528/2012) (BPR) has been in force since 1 September Any biocidal product, other than those eligible for the simplified authorization procedure, shall be authorised if the following criteria are fulfilled: sufficiently effective, no unacceptable resistance, no immediate or delayed unacceptable effects on the human health via direct or indirect exposure, no unacceptable effect on the environment. Both Annex II; Information requirements for active substances and Annex III; Information requirements for biocidal products, specify that as part of the determination of whether an active substance or product fulfills the criterion of no unacceptable effects a draft risk assessment must be performed. Although the BPR Annex VI lists the common principles for the evaluation of dossiers for biocidal products, including a summary of the risk assessment principle, it does not provide guidance on how applicants should perform the assessment. Whilst there is existing technical guidance developed under the Biocidal Products Directive (98/8/EC) and the REACH Regulation (1907/2006), the specific BPR guidance documents are still in preparation. This means that any applicant may face multiple questions at the initiation, or during the course of the preparation of an application dossier for which they may need to consult several sets of documents to try and find a solution. Which (chemical) entity shall be addressed in the risk assessment part of an applicant product dossier? The regulation always requires that a risk assessment (RA) be performed on the active substance (AS) contained in any biocidal product (BP) to be marketed on the EU market. Besides this provision for the AS, an additional risk assessment, to the same standard as for the AS, shall be carried out for the precursor(s) of in-situ generated AS and for any 10

11 Advertorial substance of concern (SoC). In other words, the risks are assessed for any relevant individual components of a BP. The results from these assessments shall be integrated to produce an overall risk assessment for the BP. Finally, the assessment shall take into account any cumulative or synergistic effects. However, the legal text is quite vague on the definition of a SoC and/or a relevant constituent. The key starting questions may include the typical and maximal content in the BP, whether or not the substance/component exceeds the generic threshold to contribute to the hazard classification of the BP or the function of the substance/component in the BP. What is the scope and purpose of the RA? The exposure assessment must address both the typical use claimed on the product label alongside a realistic, worst-case, use scenario. For human health the RA covers any population potentially exposed: industrial workers, professional workers and the general population exposed via the environment for the different effects (e.g. acute toxicity, sensitization) that an AS/SoC may exhibit and also via the different routes of exposure (inhalation, dermal, oral). For the environment, the following compartments have to be taken into account: aquatic and sediment (freshwater, marine), aquatic food chain (freshwater predator, marine predator, and marine top predator), sewage treatment plants, air, soil (agricultural), ground-water and the soil food chain. With such a wide range of potential exposure scenarios, the number of exposure estimations and calculated risk values required to complete a quantitative risk assessment can be numerous. The possibility to reduce the scope of any risk assessment requires a sound knowledge of the use pattern and the acceptability of any modifications to the risk assessment process; even then a preliminary exposure assessment may be required to support a conclusion of no unacceptable risk for a use. With so many points to assess, is there a viable pragmatic approach? A tiered approach to the exposure and risk assessment is recommended, with the priority focused on the AS present in the BP. Any additional RA on SoC/relevant component should only be started after existing data suitable for use in the risk assessment have been identified, i.e. relevant and reliable hazard data, typical and maximum content. What does a risk assessment consist of? The risk assessment is split into three sections; a) Hazard data on the active substance and those threshold values needed to compare with exposure values, i.e. AEL, ARfD, PEC b) Information on the use of the biocidal product and the exposure calculations. The exposure calculations are initially performed using generic model scenarios (Emission Scenario Documents (ESD), EUBEES, OECD). This is a Tier 1 screening assessment. If the assessment fails at Tier 1, modifications can be introduced to the exposure estimation to make the scenario more realistic. This is termed a Tier 2 assessment. c) Risk characterization; the hazard threshold is compared with estimates of exposure. If exposure is greater than the hazard threshold the use is considered to be unacceptable. d) Risk assessment is an iterative process, with information constantly being fed back into the process to gradually make the assessment more realistic and typical of the use so the end result is a true indication of the level of risk of using the product in accordance with the instructions on the label. 11

12 Advertorial Why perform a Tier 1 assessment? The first Tier 1 calculation should be run at the data gap analysis stage. The purpose of this initial run is to check the level of risk and to ascertain how much effort may be required to reach an acceptable risk. For example, risk management measures required to reduce exposure or additional hazard data needed to refine the threshold value. What tools are available for Tier 1 assessment? Various tools have been developed to assess the exposure of chemicals for the environment. Among these EUSES has been the most extensively used during the BPD/BPR Review Program of Existing Active Substances. Under the Review Program generic product type exposure scenarios have been developed (RIVM/EUBEES Program/OECD) and some of these biocide uses are incorporated in EUSES version (2012). However, there are problems with some of the ESDs in the program; some ESDs contain errors, new use patterns added to old ESDs are not included as they were developed after the last update of EUSES, or the ESD has been modified but not updated in EUSES. As an example, for disinfectants used in food and feed areas (Product Type 4), a generic ESD is publicly available but has not been included in EUSES. For many biocide uses, no ESD (Product-type 3 or 19 as examples) has been developed and will require tailor-made scenarios to be performed. The EUSES model also makes it very difficult to modify the ESD scenarios already included in the model. These issues therefore restrict the use of EUSES for preparing risk assessments for biocidal product authorisation, where many products do not fit into the standard use types covered by the ESDs. The CEHTRA screening tool. CEHTRA, using Microsoft Excel, has developed a unique Tier 1 tool which allows us to perform the concurrent assessment of both the environmental exposure and risk assessment of multiple substances in a single BP. In addition, the tool, unlike EUSES, has been developed to be flexible so it can be adapted to meet the needs of BP whose uses are not covered by any existing or newly developed generic ESD. The tool has been validated and its ease of use compared against the existing tools. For formulators the new screening model offers not only economic benefits in reducing the time needed to perform exposure calculations, and the ability to perform rapid reiteration of calculations when needed for determining safe use concentrations and dosing regimens, but can also be effective during development of new formulations in helping to identify safe concentration levels of both active substance and SoC in products. It can also offer formulators a simple method of comparing different formulation compositions, useful when faced with comparative assessment. By maintaining the flexibility of the tool it is possible to develop new use scenarios, and to modify the generic ESD to cope with Tier 2 refinements making the tool useful for the complete environmental risk assessment. 12

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15 Events for the regulatory community by regulatory people CONFERENCES TRAINING EVENTS Upcoming events for your diary rd Annual Eastern Europe Regulatory Conference: Registration of Plant Protection Products Budapest, Hungary April 2015 Delegate Price: 500+VAT The Prague Biocide Conference 2015: Staying on the EU Market - Regulatory Challenges in the Supply Chain Prague, Czech Republic June 2015 Delegate Price: 350+VAT Managing the Challenges of the EU Cosmetic Regulation: Guidance, Practical Advice, Industry Updates and Networking with Experts London, UK 7 July 2015 Delegate Price: 380+VAT The BCPC Congress 2015 Brighton, UK 6-7 October 2015 Delegate Price: 550+VAT (Early Bird Rate) The European REACH Congress 2015 Düsseldorf, Germany November 2015 Delegate Price: 500+VAT (Early Bird Rate) For further information, to register or discuss sponsorship and exhibition opportunities, please contact us: T +44 (0) E enquiries@tsgeforum.com

16 Events for the regulatory community by regulatory people