Geert DANCET. Executive Director ECHA. Joined ECHA in 2007

Transcription

1 Geert DANCET Executive Director ECHA Joined ECHA in 2007 Head of the REACH unit in the European Commission s Directorate General for Enterprise and Industry from 2004 to 2007 Joined the European Commission in 1986

2 Opening address Biocides Stakeholders Day 26 September 2016 Geert Dancet Executive Director European Chemicals Agency

3 180 PARTICIPANTS 140 COMPANIES 20 MEMBER STATES 30 COUNTRIES 50SMEs

4 Your picks to our programme today Endocrine disruptor criteria Biocidal product families Working in consortia In situ substances Treated articles Enforcement IT tools separate hands-on session

5 Share with us Send questions and give us feedback online: slico.com with #BiocidesDay Share on social media: #BiocidesDay Do you know of a biocides success story? Share it with us.

6 2018 what will be new? Five years of BPR Brexit Endocrine disruptors New executive for ECHA

7 I wish you the best of success. Follow our news News: echa.europa.eu/subscribe LinkedIn: European Chemicals Agency YouTube: EUchemicals

8 Jack DE BRUIJN Director of Risk Management ECHA Joined ECHA in 2007 Manages and coordinates ECHA s scientific evaluations and assessments under the Biocidal Products Regulation

9 Interact with us 1. Go to slido.com and type event code: BiocidesDay 2. Send your questions and give a thumbs-up to the best ones we will ask them in that order 3. Give us feedback after each session

10 Martinus NAGTZAAM DG Health and Food Safety European Commission Acting Head of Biocides Sector with more than 20 years of experience in regulatory and technical fields of the biocides and agchem business Chairman of the CEFIC European Biocidal Products Forum and active in a number of biocidal product working groups at European and global level

11 Biocides Stakeholders' Day Future outlook on biocides ECHA, Helsinki, Finland 26 September 2017 Mario Nagtzaam European Commission DG SANTE, Unit E.4

12 Introduction I. Access to market II. Safety III. Transparency IV. Monitoring V. Controls and alert systems VI. Legal certainty EDs

13 I.- Access to market 1.- Biocidal products 2. Union authorisation 3. IT 4. SMEs

14 II.- Safety 1. Review programme 2. Interim MRL approach 3. Renewals 4. CLP 5. EDs 6. Treated articles 7. Research and development

15 III.- Transparency 1. Expert group 2. Dissemination 3. Feed back mechanism 4. Public consultations

16 IV.- Monitoring 1. UA report 2. Art 65 report 3. Better Regulation- evaluation

17 V.- Controls and alert systems 1. Subgroup biocides Forum 2. Fipronil

18 VI.- Legal certainty 1. Scientific guidance 2. Regulatory guidance 3. Implementing and delegated acts Commission notices 4. Article 3(3) decisions 5. Referrals

19 EDS-IMPLEMENTATION CA NOTES FOR AGREEMENT ED CRITERIA SECONDARY LEGISLATION AND REGULATORY GUIDANCE TECHNICAL AND SCIENTIFIC GUIDANCE

20 EDS - SECONDARY LEGISLATION AND REGULATORY Active substances (ASs) GUIDANCE Approval of ASs Technical guidance note (art. 11) Renewal of ASs Implementing act (art. 16) Review of approved ASs Implementing act (art. 16) Review programme Delegated act (art 89) Biocidal products (BPs) Authorisation of BPs Technical guidance note (art. 24) Renewal of BPs Technical guidance note (art. 40) Cancellation or amendment of BPs Implementing act (art. 51) Data requirements Adaptation of data requirements Delegated act (art. 85) for ASs and BPs to scientific and technical progress

21 Thank you for your attention For further information : Commission website : CIRCABC expert group documents: sante-biocides@ec.europa.eu ECHA website & Helpdesk on Biocides :

22 Hugues KENIGSWALD Biocides Assessment Unit ECHA Joined ECHA in 2012 Head of Biocides Assessment Unit His unit supports the Biocidal Product Committee s working groups and the coordination group. The unit is also responsible for most of the technical and scientific assessment activities for biocides and R4BP 3

23 Upcoming developments Biocides Stakeholders Day 26 September 2017 Hugues Kenigswald Head of Unit - Biocides Assessment European Chemicals Agency

24 Main points 1. Core work 2. New hurdles 3. Progressing together

25 Main points 1. Core work 2. New hurdles 3. Progressing together

26 Active substances approval Review Programme Still 70% of active substance and product-type combinations to be assessed ~ 40 opinions foreseen in 2018 (like 2016 & 2017) New active substances 10 opinions foreseen in 2018 In situ generated and Articles 93 and 94 active substances applications expected

27 Union authorisations: ramping up Towards 70 applications by end 2017 Same biocidal products also growing: over 30 applications by end 2017 First 2 Biocidal Products Committee opinions in December Biocidal Products Committee opinions foreseen in 2018

28 Main points 1. Core work 2. New hurdles 3. Progressing together

29 Foreseen impact of endocrine disruptor criteria New data needed to assess ED properties: what and when? Active substances: delays several years? Authorisation of biocidal products: how to deal with co-formulants? Already approved active substances: a specific review programme or waiting for renewal? Increased workload and impact on resources

30 Brexit: uncertain consequences UK as evaluating authority (active substances and Union authorisations) UK as ref Member State for mutual recognition in parallel UK companies operating in the EU Future situation in UK for UK and EU companies Many uncertainties: depends on the negotiations and the political choices of the UK government Check new Q&As:

31 Need for clarifying product families Note for guidance by Commission (2014) Topics that need to be further clarified Very complex families Issues for applicants and for Member States Coordination group working party starts

32 Main points 1. Core work 2. New hurdles 3. Progressing together

33 R4BP 3: making your life easier Enhancing the workflows Refining summary of product characteristics comparison Improving the user interface Increasing the performance Preparing for Brexit

34 Guidance and user support Updating guidance on the technical equivalence More guidance for products: Efficacy Human exposure Environmental exposure Translation of frequent sentences for summary of product characteristics - covering further product types: 6, 7, 9, 10, 11, 12, 13

35 EUSES Tool for harmonised environmental exposure assessment Upgrading the current version Consulting the users Preparing for a sustainable future Reference:

36 Making data available Dissemination of product authorisations with summary of product characteristics (SPC) Advanced searches Improving dissemination of active substances Get your SPCs ready!

37 Conclusions Starting the 5 th year of the BPR Some new hurdles Some processes with limited experience Resources under pressure Positive expectations for the future Union authorisation is developing More experience gained by all Improving further support and cooperation

38 Your feedback is important Follow our news Newsletter: echa.europa.eu/subscribe LinkedIn: European Chemicals Agency YouTube: EUchemicals

39 Simón GUTIÉRREZ ALONSO ECHA Joined ECHA in 2015 Leads the environmental team in the Biocides Assessment Unit and is deputy chair of the Biocidal Products Committee working group on environment

40 Endocrine disruptors where are we Biocides Stakeholders Day 26 September 2017 Simón Gutiérrez Alonso Biocides Assessment Unit, ECHA

41 Content Delegated act and scientific criteria, where are we? Scientific guidance, where are we? Expected impact in different processes Take home messages

42 Content Delegated act and scientific criteria, where are we? Scientific guidance, where are we? Expected impact in different processes Take home messages

43 Biocides Delegated act and scientific criteria, where are we? Agreement at CA meeting on delegated act 12 July 2017 Adoption process involving EP and council Sept Nov 2017 Delegated act entry into force January 2018 Criteria applicable July 2018

44 Content Delegated act and scientific criteria, where are we? Scientific guidance, where are we? Expected impact in different processes Take home messages

45 Drafting team and consultation group Drafting team: ECHA, EFSA, JRC ECHA ED expert group Consultation group Member State pesticide experts & other stakeholders

46 Guidance timelines First draft (Jan 2017) First EXPERTS consultation (Apr-May 2017) Second draft Second EXPERTS consultation (July-Aug 2017) Draft guidance for public consultation (Nov 2017) Guidance on ED assessment (Jun 2018)

47 Content Delegated act and scientific criteria, where are we? Scientific guidance, where are we? Expected impact in different processes Take home messages

48 Expected impact on different processes Active substances under evaluation COM note March 2017 competent authorities meeting Biocidal products COM note July 2017 competent authorities meeting Active substances already approved Note to be prepared by COM

49 Procedure for active substances ACTIVE SUBSTANCES ( 300) ACTIVE SUBSTANCE/PRODUCT-TYPE ( 600) Not approved 5 % Not approved 3 % Approved 26 % Approved 43 % Under review 52 % Under review 71 %

50 Commission note on ongoing evaluations Refers to draft delegated act: criteria applicable 6 months after entry into force Distinction between dossiers before/after 1 Sept 2013 Exclusion and substitution criteria depends on HH or ENV All BPC opinions will need to have ED properties assessed according to the new criteria Opinion is adopted but no decision at the Standing Committee COM return opinion to ECHA Cooperation ECHA-EFSA

51 Notes for applicants Delays are foreseen in the process 45 active substances maybe on hold pending additional data Limited experience of all parties Additional information may be needed, possibly iteratively Start reviewing the data available and engage in discussions with evaluating authority Consider the guidance (when available) Plan resources and expertise to support your active substances

52 Procedure for products Name Function CAS no. Content (%) AS 1 AS 2 Active substance Active substance Non-AS 1 Surfactant Non-AS 2 Solvent Pigment 1 Pigment Perfume 1 Perfume

53 Commission note on products (1/3) ED criteria also to non-active substances (socalled "co-formulants") A product is ED if it contains an active substance and/or non-active substance(s) with ED properties Member State authorities can request additional information but should respect the overall 3-year deadline laid down in BPR

54 Commission note on products (2/3) Substances also under REACH. To avoid work duplication and ensure consistency, the evaluating body: Checks whether the potential ED properties of the coformulant already have been or are assessed under REACH (e.g. substance evaluation or SVHC identification) If not, consider triggering evaluation with the Member State responsible for REACH If running in parallel, the regulatory consequences do not apply

55 Commission note on products (3/3) For products where the evaluation has finalised but the product is not yet authorised, Member State competent authority may still request further information if needed For already authorised products, the BPR sets the rules to amend or cancel an authorisation

56 Observations from ECHA Information on co-formulants is limited Data ownership Evaluation of co-formulants may challenge the deadlines

57 Notes for applicants Review the co-formulants you use in your products Start discussing with the substance suppliers in relation to data available or on-going regulatory processes (e.g. under REACH) Contact your Member State authority to discuss your case Plan resources and expertise to support your products

58 Procedure for already approved active substances Approx. 130 active substances already approved Additional information may be needed If evaluation needed before renewal, a specific work programme has to be put in place; discussions between COM and ECHA on-going

59 Sorting substances for assessment Enough information to exclude ED properties Suspicion of ED properties Not enough information available to draw preliminary conclusions

60 Observations from ECHA Need to start ASAP to sort and evaluate (high time pressure) Additional resources needed Sorting the substances Coordination activities Evaluation stage by IND and MSCAs Impact on BPC-WG and ED-EG

61 Notes for applicants Contact the evaluating competent authority for the active substance if new information is available Plan resources and expertise to support your already approved active substances

62 Content Delegated act and scientific criteria, where are we? Scientific guidance, where are we? Expected impact in different processes Take home messages

63 Take home messages The application of the new ED criteria will have an impact on timelines and resources for industry, MSCAs and ECHA Industry should consider the scientific guidance when available Industry and Member State competent authorities should start reviewing the data available Be aware that co-formulants should also be considered for ED properties

64 Links Information on actual guidance development status Outline of Draft Guidance Document for the Implementation of the Hazard-based Criteria to Identify Endocrine Disruptors outline/64736dc fc8-d aa76f2137 Endocrine disruptor expert group EU COM on Endocrine disruptors

65 Thank you simon.gutierrez(at)echa.europa.eu Follow our news Newsletter: echa.europa.eu/subscribe LinkedIn: European Chemicals Agency YouTube: EUchemicals

66 Questions and feedback 1. Go to slido.com 2. Enter event code: BiocidesDay 3. Send your question & give us feedback

67 We are on a break and will return shortly

68 Christel MUSSET Director of Registration ECHA Joined ECHA in 2007 Responsible for all activities related to the registration process under REACH Before ECHA she worked at the European Chemicals Bureau (ECB) of the Joint Research Centre (JRC) where she coordinated the development of IT systems for REACH

69 Valerio SPINOSI Biocides Assessment Unit ECHA Joined ECHA in 2010 Scientific and Regulatory Officer in the Biocides Assessment Unit Leads a team that deals with IT, communication and support

70 IT tools and support Biocides Stakeholders Day 26 September 2017 Valerio Spinosi Biocides Assessment Unit European Chemicals Agency

71 Content IT update Making data available Guidance update New layout for website Helpdesk

72 Message filters and archive 71

73 New communication - Industry

74 Case and asset relation diagram 73

75 Multi-select and export 74

76 Content IT update Making data available Guidance update New layout for website Helpdesk

77 Making biocides data available Improved biocides dissemination pages available by end of 2018 Extended search functionalities (e.g. by hazards and uses, Review Programme substances, Annex I substances) More detail on biocidal products (dedicated detailed pages) Preview of Summary of Product Characteristics (web SPC) Access to current and historical data on previous lifecycles of active substance approvals and products authorisations (initial applications and subsequent renewal data) Biocidal product comparison

78 Biocidal product extended search Product trade names Authorisation holder Authorisation type C&L data (hazards) Product uses o Field of use o User category o Target organisms o Application method

79 Biocidal product factsheet Comprehensive overview of product details Authorisation details Assessment history

80 Product comparison Compare up to five products based on: Product uses o Product-type o Target organisms o Field of use o User category o Application method Active substances Hazard statements

81 Content IT update Making data available Guidance update New layout for website Helpdesk

82 BPR GUIDANCE Diagram in 2013 BPR GUIDANCE Diagram 2017 [

83 Already available Part A Part B (AS) Part A

84 Upcoming for Vol I Identity, PhysChem, analytical methodology Parts B+C to be added to Part A Vol II Efficacy Part A to be brought in line with Parts B+C B+C PT5 updated following ECHA disinfectants project B+C PT8 new appendix on Annex A of EN-599 Vol III Human Health New section Livestock exposure (ARTFood Project 1) New section Dietary risk/non-professional users (ARTFood Project 2) Vol IV Environment Add guidance on Part B on BPs, add Part C and add SoC

85 To be started this year Vol II Efficacy B+C PT11, 12 and 19 updates Vol IV Environment Update to address flagged issues from currently ongoing update Vol V Technical equivalence Update following experience since first published in 2013 Consultation to start in 2018 for publication in 2019

86 Pay also attention to ts_for_biocides_en.pdf/4280fdc4-dfb0-405e-898e-70f3cdf62ce2 Coming in October 2017: New web page for superseded versions of BPR guidance documents

87 Content IT update Making data available Guidance update New layout for website Helpdesk

88 New layout for ECHA s website thanks to your feedback. Coming soon, stay tuned!

89 Content IT update Making data available Guidance update New layout for website Helpdesk

90 Helpdesk what you ask most about Union authorisation In situ generated active substances Phase-out periods Redefinition of active substances On-going notification process Technical equivalence IT Submissions (2 381)

91 Contact us we are here to help

92 Thank you valerio.spinosi(at)echa.europa.eu Follow our news Newsletter: echa.europa.eu/subscribe LinkedIn: European Chemicals Agency Youtube: EUChemicals

93 An GHEKIERE ARCHE Consulting Joined ARCHE Consulting in 2006 and has been responsible for the biocides team since 2010 Since 2014, has developed, together with her biocides team, a new consortium management service for biocidal products

94 Wo r k i n g i n a c o n s o r t i u m An Ghekiere 26 September 2017, ECHA Biocides Stakeholders Day

95 Outline Why are consortia for biocidal products new? Strategy Steps in consortium building Pre-consortium phase Consortium phase General findings Conclusions

96 Why are consortia for BP new? Biocidal Products Directive (BPD) Consortia for AS but not BP Frame formulation limitations of grouping Cost not so high under transitional measures (limited AS approved yet) In general dossier preparation not so complex Biocidal Products Regulation (BPR) Consortia for AS and BP Biocidal product family more flexibility for grouping Cost very high Often no in house knowledge or capacity for complex dossier preparation Amended SBP Regulation 11 October 2016

97 STRATEGY

98 Dossier Submission Each consortium member own authorisation number via Same biocidal products application, Regulation (EU) No 414/2013 Reference Dossier submitted by ARCHE Consortia UA or NA SBP SBP SBP Member 1 Member 2 Member 3

99 Reference dossier submitted for UA Amended SBP regulation 414/2013 (11 October 2016) makes the following options possible: Reference dossier SBP SBP 1 SBP SBP

100 Reference dossier submitted for NA ARCHE Consortia Reference dossier to eca MR country A MR country B Members 1 SBP SBP Members 2 SBP SBP MR Fees can be shared among members SBP independent when approved

101 DIFFERENT STEPS IN CONSORTIUM BUILDING

102 Different steps in consortium building Call of interest AS or combination of AS Pre-consortium phase Consortium phase

103 Pre-consortium phase Questionnaire Product data Processed data Decision joining consortium Preliminary data gap analysis + grouping

104 Consortium agreement Drafted by legal partner Review by members during pre-consortium phase Agreement between members Indicates the start of the consortium

105 Consortium: structure Secretary Consortium management Accountancy Consortium management Drafting consortium agreement Anti-trust compliance Legal partner Manufacturers Importers Distributors Consortium Members Technical service provider Dossier preparation Steering Committee Technical Committee

106 Consortium: steps dossier preparation Data gap analysis Inventory of tests Review of existing data Waivers/expert statements Testing Develop testing strategy Selection of labs Testing IUCLID dossier Risk assessment SPC Input studies/waivers Administrative data requirements Attachments Environmental Human SoC Product assessment report Creation metaspcs/product SPCs

107 Timeline Dossier preparation Call of interest Start Preconsortium Start Consortium Submission BPC opinion +/- 2 years Date of AS approval

108 Ongoing ARCHE consortia NaOCl Call of interest NaCl Permethrin H 2 O 22 Pre-consortium phase Consortium phase In situ PAA Consortia Peracetic NaCl acid Submitted Chlorine Peracetic cid acid Permethrin See next slide

109 Call of interest Will be published beginning of October 2017: Active substance PT BPC opinion expected Expected submission Sodium dichloroisocyanurate dihydrate (NaDCC) 2, 3, 4, 5 April 2018 April 2020 Pyrethrins and pyrethroids 18, 19 June 2018 June 2020 Hydrogen peroxide 11, 12 June 2018 June 2020

110 GENERAL FINDINGS

111 General findings Consortia for BP still new, need some explanation Little reaction of MS MS ask additional information for MR (templates LoA AS and products) Additional LoA to the AS dossier required for reference dossier although all members have an individual AS LoA Pre-submission meeting is very important and must be duly prepared

112 General findings MR fees higher than expected Many avoid UA due to high annual ECHA fee Current discussions on similar use, composition & risk and acceptable size of BPFs can result in even higher fees and bigger administrative burden for companies and authorities Flexible evaluation fees based on the size of the family or on actual time spent good approach for BPF dossiers

113 CONCLUSIONS

114 Conclusions Consortia are highly cost saving SME often only option Still many uncertainties (big BPF, requirements) Consortia BPF - UA SBP still new, but is supported by EC, ECHA and MS Reduces the high workload for authorities

115

116 Brigitte van NOORLOOS Board for the Authorisation of Plant Protection Products and Biocides, the Netherlands Project manager in the field of biocides Among other BPR projects, involved in the assessment of in situ generated active substances

117 Applications for the approval of free radicals and other in situ generated substances: experiences and challenges Brigitte van Noorloos, MSc Project Manager Biocides Ctgb (Dutch competent authority) ECHA Biocides day, 26 September, 2017

118 Outline of presentation What are in situ generated substances In situ generated substances in Review Programme and Art. 93 Challenges Art. 93 in situ generated substances Challenges & experiences free radicals Practical recommendations

119 What are in situ generated substances (1) In situ generated active substance (CA-May12- Doc.6.2a): active substance that is not directly supplied to the user generated intentionally via a chemical reaction, or other means such as electrolysis and electrical generation, as a result of direct manipulation on the site of use prior to or during its intended application, from one or several other substances, called precursor substances. In situ generation on site formulation

120 What are in situ generated substances (2) Methods for the in situ generation of active substances: Chemical reaction monochloramine from ammonium sulphate and a chlorine source Electrolysis and electrical generation sodium chlorite generating chlorine dioxide via electrolysis Formation of the in situ generated active substance during use Single precursor under use conditions such as heating aluminium phosphide released from phosphine Hydrolysis to form an acid-base pair - addition or dilution of the precursor to water - precursor and a.s. are related as an acid-base pair. Substituted hydantoins hydrolysing to hypophalous species

121 What are in situ generated substances (3) Recommendation of the BPC Working Groups In situ generated active substances Risk assessment and implications on data requirements for active substances generated in situ and their precursors

122 Review Programme: re-definition (1) Substances that were already included in the Review Programme have been re-defined (CA-March15- Doc.5.1-Final) precursor => a.s. generated from precursor Bromine chloride => Active bromine generated from bromine chloride precursor 1 => a.s. generated from precursor 1 and precursor 2/3 Sodium bromide: => Active bromine generated from sodium bromide and sodium hypochlorite/ calcium hypochlorite/chlorine/ by electrolysis. a.s. => a.s. from precursor with acid Chlorine dioxide => chlorine dioxide generated from sodium chlorate and hydrogen peroxide in the presence of a strong acid

123 Review Programme: re-definition (2) New precursor/active substance combinations could be added to the existing ones New PT s could be added to the existing ones Notification deadline: 27 april 2016 Dossier submission of dossier max. 2 yrs after acceptance Overview of notifications: notifications_en.pdf/e39a07ea-52dd-4562-a8e5-eab6be898312

124 BPR Article 93 (1) Substances that did not fall within the scope of the BPD (9/8/EC), but do fall under the scope of the BPR Art. 93 substances : - Free radicals (ambient air/water/coating) incl. singlet oxygen - Ozone from ambient air - Active chlorine from (sea)water - Monochloramine from ammonia/ ammonium salts + 2nd precursor - Reaction mass of TiO2 and silver chloride - Silver phosphate glass Article 93 list published by ECHA 08_en.pdf/0bafa033-c600-aa f383e20e26ac

125 BPR Article 93 (2) A.s.-dossier submitted by 1 Sept 2016: - products remain under transitional law (deadlines Art. 89) - new products: LoA to a.s. dossier needed - LoA needed for BPR authorisation (after a.s. approval) No a.s. dossier submitted by 1 Sept 2016: - transitional law until 1 Sept. 2017

126 BPR Article 93 (3) Timelines Art. 93 substances 1 Sept 2016? 1-X-2021?? 1-X-2024? Transitional law BP Dossier preparation Active substance dossier submission 1 Sept 2017 No a.s. dossier submitted => no use or sales Decision for approval Approval date = Biocidal product dossier submission deadline No product dossier => grace period max. 180 /365 d Deadline for authorisation

127 Art. 93 in situ generated substances: applications

128 Free radicals: status in NL Pre-submission meetings with applicants Most validations finalised, evaluations started Active substance part mainly empty (data waivers) Evaluation and discussion needed to determine data gaps

129 Art. 93 substances: Challenges (1) Several applicants for one substance in several countries Example: Free radicals generated in situ from ambient air or water 1 substance approval 3 eca s 9 PT s 10 applicants with very different systems Similar cases for ozone, active chlorine from (sea)water Only one CAR Coordinated by ECHA project manager Free radicals: 1st telcon in May

130 Challenges (2) What is to be assessed at a.s. level/ at product level - No precursors - Different systems - approval should also cover/allow future new system - treated articles Assessment of precursors Composition of ambient air or water

131 Challenges (3) Disinfection By-Products (DBP) Guidance on the Biocidal Products Regulation Volume V, Guidance on Disinfection By-Products (January 2017) Classification: Exclusion, substitution/annex I listing: based on properties of the in situ generated active substance only

132 Challenges (4) What should be authorised at product level? - substance(s) or mixture generating the active substance - the a.s. generated from substances/mixtures which cannot themselves be authorised as biocidal products (CA-March15-Doc.5.1-Final) Equipment?

133 Challenges: free radicals (1) Levels and identity of free radicals: Information needed about the relation between electric discharge/coating concentration/. and the amount of radicals/oxidising potential How is over- and underdosing prevented/ specification of apparatus? Humidity, temperature, light intensity, composition of ambient air or water/pollution

134 Challenges: free radicals (2) Disinfection By-Products (DBP): theoretical approach possible? Analysis of air outlet; of filters? Efficacy: few standard tests for these types of applications (no European standards)

135 Practical recommendations Always include data or data waivers Include a clear description of the system If a.s. application for several PT s, indicate differences between dossiers Reports in English Draft assessment in Word Do not delete paragraphs/annexes from template: explain why not relevant Include study reports in IUCLID

136 Guidance See ECHA website In situ generated substances New: Recommendation of the BPC Working Groups In situ generated active substances Risk assessment and implications on data requirements for active substances generated in situ and their precursors In preparation: BSM (new annex): How to report, in IUCLID, active substance(s) generated in situ

137 Thank you for your attention!

138 Free radicals: guidance (bonus) Guidance: CA-May16-Doc.5.1 Final Definition: free radicals generated in situ from ambient air or water No further definition of the radicals - Water treatment - Air treatment - Surface treatment/ coated articles Testing in most cases not necessary/possible Risk assessment: - DBP - emission during handling/application of product - emission during handling of treated articles

139 Caroline HALL Evonik Nutrition and Care Toxicologist (ERT) within Product Stewardship of Evonik Nutrition & Care GmbH, Hanau, Germany Started her career as study director within the field of genetic toxicology at a Contract Research Organization Since 2012, has been involved in different active substance approvals as well as biocidal product authorisations

140 Union Authorization for a Biocidal Product Family ECHA s Biocides Stakeholders Day 26 September 2017 Caroline Hall

141 Content 1. Introduction 2. Why choosing Union Authorization of a Biocidal Product Family? 3. Challenges from an industry perspective 4. Issues during dossier preparation 5. Concluding remarks C Hall September 26, 2017 Union Authorization for a Product Family

142 Evonik s Involvement in Biocides Business within EU Evonik Nutrition & Care Products for use in the areas consumer goods, nutrition and health Evonik Resource Efficiency Environmentally friendly and energy efficient systems as solutions for several industries Biocidal Actives Ampholyt, Chlorhexidine digluconate Products Types 1, 2, 3 & 4 Current activities for UA-BPF Ampholyt Products Types 2, 3 & 4 Biocidal Actives Hydrogen Peroxide, Peracetic Acid, Silicon dioxide Products Types 1, 2, 3, 4, 5, 6, 11, 12 & 18 Current activities for UA-BPF Hydrogen Peroxide & Peracetic Acid Products Types 2, 3, 4 & 5 C Hall September 26, 2017 Union Authorization for a Product Family

143 Why choosing Union Authorization of Biocidal Product Families? General benefits of union authorizations of biocidal product families (UA-BPF): Route from market in single countries to the entire EU Secure marketability of active substances Future business opportunities via change procedures Cost effective way for SMEs to gain access to the market Well defined process C Hall September 26, 2017 Union Authorization for a Product Family

144 Key steps of UA-BPF Business decision Development of family structure Pre-submission meeting with eca ECHA Pre-submission meeting Dossier preparation Evaluation and authorization Concept with or without onboarding of customers formulations Collection of information on products, uses and applications Generation of efficacy and physical-chemical data Focus on applications, family concept and data gap filling Advise on further development of family concept by eca Declaration of intention by Applicant Clarity on family concept by ECHA and MS Risk assessment based on efficacy and hazard of active substances and co-formulants Discussions with eca and customers C Hall September 26, 2017 Union Authorization for a Product Family

145 Challenges from industry perspective Set-up of an developmental project with clear responsibilities: Contractual framework requires legal resources (letter of access, further contracts etc.) High demand on internal regulatory and R&D expertise Choice of partners: consultants and external labs with high level of expertise and capacities needed Intense communication with customers and end-users on products, uses & applications Product development based upon regulatory needs at a late stage Labs Data Service provider/ end user R&D ECHA Distributor/ Formulator Project eca Regulatory Consultant (Eco-) Toxicology C Hall September 26, 2017 Union Authorization for a Product Family

146 Issues during dossier preparation (1/2) Topics Efficacy of Disinfectants Co-Formulants / Substances of Concern (SoC) Dietary risk assessment Information on applications Fogging Problems New comprehensive guidance requires new efficacy testing. Frequently, available data does not fit to the intended application and claims. How to discriminate a 2 nd active from a clever formulation? Definition of SoC and consequences for risk assessment, storage stability, analytics etc. Appropriate guidance for professional applications is lacking. Detailed information on end use is needed, but frequently not known. Efficacy testing of the system consisting of the active and the apparatus requires multiple testing for different systems. C Hall September 26, 2017 Union Authorization for a Product Family

147 Issues during dossier preparation (2/2) Topics Wet wipes Classification & Labelling Exposure models Problems Carrier material requires an own metaspc even though risk to humans and environment is lower or the same as for liquids. Product classification strongly influences family structure. BUT in some cases RAC decision on harmonized classification of active substances is missing. Many exposure models are more than 10 years old, extremely conservative and not reflecting currents operational procedures. Furthermore, some models do not exist at all (eg. foam spraying). IT tools Publication of SPC Several IT tools and data formats have to be used (R4BP3, IUCLID, SPC editor, PAR). Continuous alignment of tools, formats and labels necessary. Details of SPC publication may contradict confidential business information. C Hall September 26, 2017 Union Authorization for a Product Family

148 Most important are the product applications - You can t be early enough to discuss with your customers and your active substance supplier! Industry and Authorities are learning side-by-side. High workload & costs By the time you get closer to the solution you understand the complexity of the problem. Game changer UA-BPF is a well defined process coordinated by ECHA. Informed customers are crucial for success. Work in progress Open and clear communication between eca and Applicant needed. Key role of eca Challenge are the IT tools. Fees are an extremely high burden. C Hall September 26, 2017 Union Authorization for a Product Family

149 Thanks! I wish to express my personal thanks to all colleagues for their contributions - especially Wolfgang Leonhardt for his ideas and valued efforts. C Hall September 26, 2017 Union Authorization for a Product Family

150

151 Abbreviations eca IUCLID MS PAR RAC R4BP3 R&D SME SoC SPC UA-BPF Evaluating Competent Authority International uniform chemical information database Member State Product Assessment Report Committee for Risk Assessment Register for biocidal products Research and development Small and medium-sized enterprise Substance of concern Summary of product characteristics Union authorization of a biocidal product family C Hall September 26, 2017 Union Authorization for a Product Family

152 Questions and feedback 1. Go to slido.com 2. Enter event code: BiocidesDay 3. Send your question & give us feedback

153 We are on a break and will return shortly

154 Jukka MALM Deputy Executive Director ECHA Joined ECHA in 2008 Director of Regulatory Affairs In charge of the overall coordination of regulatory decision making and opinion forming of the Agency

155 Chiara PECORINI Biocides Assessment Unit ECHA Joined ECHA in 2013 Process coordinator of union authorisation of biocidal products Before joining ECHA she worked in the Chemical Assessment and Testing Unit at the European Commission

156 How to do a successful Union authorisation application Biocides Stakeholders Day 26 September 2017 Chiara Pecorini Biocides Assessment Unit European Chemicals Agency

157 Overview 1. How did the process go so far 2. What is important for successful applications 3. Where are we heading to

158 Overview 1. How did the process go so far 2. What is important for successful applications 3. Where are we heading to

159 Steps and actors in the process Preparatory discussions Pre-submission consultation Submission of application Overall timeline: at least 2.5 years ECHA acceptance Validation and evaluation May request additional information Biocidal Products Committee opinion Commission decision

160 Applications in the ECHA s pipeline Union authorisations (UA) Same biocidal products 39 applications expected to be submitted in About 90% product families Update 18 September 2017 Disinfectants (>70%), insecticides and preservatives

161 How did the process go so far (1/2) Pre-submission 92% of UA applications with pre-submission 95% of positive outcomes 93% of outcomes with additional comments Submission and checks by ECHA Overall, smooth submissions of applications In general, applications passed ECHA checks

162 How did the process go so far (2/2) Validation and evaluation Effective cooperation with evaluating authorities 3 evaluations submitted to ECHA BPC opinion 3 working group discussions so far 2 BPC opinions foreseen in December 2017

163 Overview 1. How did the process go so far 2. What is important for successful applications 3. Where are we heading to

164 Tips for pre-submission Discuss technical or methodological questions with your evaluating authority Describe clearly the uses in the Summary of Product Characteristics (SPC) Justify that co-formulants do not contribute to efficacy Make a pre-submission at the latest 6 months before the intended date of submission

165 Requirements for pre-submission Mandatory SPC (English;.xml) Supporting document Recommended Agreement signed by the evaluating authority R4BP 3 Where relevant Overview of the family

166 Tips for Union authorisation applications Discuss with the evaluating authority to prepare a good quality dossier Have your SME status verified before submission Apply as early as possible before the deadline Monitor your case in R4BP 3 Pay attention to deadlines Payment of the fees Resubmission of requested information

167 Requirements for UA applications Mandatory IUCLID dossier SPC (English;.xml) Agreement signed by the evaluating authority Outcome of presubmission consultation or rationale about similar conditions of use Where relevant Overview of the family Supporting document for provisional authorisation R4BP 3

168 Tips for same product New possibilities after amendments to Same Products Regulation Only administrative changes accepted Examples of administrative changes relevant for same product applications Change of the name of the product Addition of trade names Different authorisation holder

169 Requirements for same product Mandatory Reference case number SPC (English;.xml) Supporting document Where relevant Letter of access Ensure consistency between supporting document and SPC R4BP 3

170 Union authorisation

171 ECHA procedures

172 SPC Linguistic review of the translations of the summary of product characteristics (SPC) for Union Authorisation applications

173 R4BP 3.9 New functionalities for Union authorisation Grouped administrative changes Notification of unexpected or adverse effects

174 Overview 1. How did the process go so far 2. What is important for successful applications 3. Where are we heading to

175 Outlook to 2018 First Union authorisations granted First same product authorisations granted 18 BPC opinions adopted Fine-tuning the process in light of experience

176 Conclusions Making the process as effective as possible More templates and procedures available More experience acquired by all the actors Cooperation as the key to success Continuous improvement thanks to your feedback

177 Thank you chiara.pecorini(at)echa.europa.eu Follow our news Newsletter: echa.europa.eu/subscribe LinkedIn: European Chemicals Agency Youtube: EUChemicals

178 Ulrike FRANK Swedish Chemicals Agency, KEMI Biologist involved in regulatory hazard and risk assessment for many years Involved in the risk assessment of active substances for biocides and in the development and interpretation of the biocides legislation

179 The tricky rules for Treated Articles: Ulrike Frank Biocides Stakeholder s Day, Helsinki September

180 Content What is a treated article and what is not? Obligations connected with treated articles For the purpose approved substances If a claim is made. What is a biocidal function? What is a claim? Consumer information

181 Treated articles new kids on the block Treated articles first time regulated with Biocidal Products Regulation (BPR) from 1. September 2013 What is a treated article? anything treated with a biocide But

182 What is not a treated article? If the treated article has a primary biocidal function, it is a Biocidal product! If the treated article is a mixture and has a biocidal function, it is a Biocidal product!

183 What is not a treated article? If the treated article contains (small) leftovers from a production process and the biocidal function was only intended for the production process, it is Out of Scope (i.e. not regulated by the BPR) Note: This is an interpretation of a guidance document

184 What is a treated article? An article which as a whole or of which parts have been treated with a biocide with the intention to impart a biocidal function to the article or parts of the article To protect the article/material from deterioration, or To protect humans or animals using the article from unwanted effects of harmful organisms

185 What are the obligations for treated articles? When articles are treated with biocides, only for the purpose approved active substances may be used If a claim is made To label the product with information on the active substance, what biocidal property the article has, instructions for use, precautonary measures, etc. Consumers have to be provided on request with the information about the biodical treatement of the article

186 For the purpose approved active substances What does this mean? During substance approval, the purpose of the treatment has to be stated and tests which demonstrate efficacy for that purpose have to be provided. the substance needs to be approved for the right PT* the substance needs to be approved for the right use* *see Art. 58(2) BPR

187 For the purpose approved active substances? Example1: A substance is approved as a PT 6 (in-can-preservative). It must not be used for applications where the dry paint needs to be protected (e.g. house facades, PT 7), or where humans need to be protected (e.g. from mold on walls, PT 2)

188 For the purpose approved active substances? Example 2 (from HelpDesk): Copper is under review in PT 2. The approved use is as a ionisation system with the purpose to disinfect liquids (e.g. swimming pools, spas). Copper shall be used in pulverised composite materials, applied to objects (e.g. door handles) to protect users from bacterial contamination (PT 2) this use is different, it has not been assessed during substance evaluation and is not approved

189 If a claim is made. What is a claim? Basically, any statement that the article has a biocidal function. What is a biocidal function? the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. (Art. 3a)

190 .biocidal function requires: 1. A chemical is involved 2. Intention 3. The damage is caused by harmful organisms

191 Biocidal function? 1. Is a chemical involved? 2. Is there intention to destroy? 3. Is the damage (bad smell) caused by harmful organisms? No biocidal product!

192 a claim is made Examples Durable mildew and algae resistance (facade paint) Anti-odour, neutralizes bad odour, anti-odour-technology, odourless, etc. (sportswear) Antibacterial, reduces the spreading of bacteria, removes xx% bacteria, bacteria-resistent, antimicrobial, etc. (any article) Preserves, protects, impregnates (wood preservative) Pressure treated, impregrated (wood)

193 Mixtures with biocidal functions..are biocidal products! Paint Durable mildew and algae resistance

194 When does a claim not trigger BPRrequirements? when the biocidal function is not caused by an added chemical preservative/disinfectant Example: certain clothes (wool, bambus, etc.) which are claimed to be naturally antibacterial when the damage being prevented/cured is not caused by organisms when the claim is based on a mechanical action

195 If a claim is made labelling obligations follow. These include: statement that the article incorporates biocidal products The biocidal property attributed to the article The (chemical) name of all active substances Possible nanomaterials contained (their name) Instructions for use, including precautions In case of silent treatement (example in-can preservatives) no labelling is necessary.

196 Consumer information on request OBS: concerns all treated articles, also silently -treated ones The supplier has to provide information on biocidal treatment, on request, within 45 days* Precondition: Information on biocidal treatment (why, what, how?) has to be handed down the supply chain. *Art. 58 (5)

197 Market survey on articles treated with biocides ( PM 6/16) Scope: To find out whether the provisions for treated articles are followed by market participants 1. Are TA labelled correctly if a claim is made? 2. Is information to consumers given on request? 3. Do Member States Competent Authorities agree how to interpret the rules?

198 Conclusions Distinction between treated articles, biocidal products and articles out of scope is important but complex. Only active substances approved for the right PT and use are permitted in TA. A claim triggers labelling obligations; important to know about the organisms which cause the damage which shall be prevented and about the effect of the BP used (on target and non-target organisms). This information is also necessary to inform consumers on request.

199 Francesca RAVAIOLI Ministry of Health, General Directorate on medical devices and pharmaceutical service, Italy Vice-Chair and the Italian representative in the ECHA FORUM - Biocidal Products Regulation sub-group Coordinator in the Ministry of Health, Italy, for the surveillance and monitoring of biocidal products and treated articles placed on the market and the risk involved in the use of biocides

200 WHAT TO EXPECT FROM ENFORCEMENT Francesca RAVAIOLI, BPR-SG Vice-Chair Ministry of Health Italy General Directorate on medical devices and pharmaceutical service Biocides Stakeholders Day September 2017

201 Key issues from stakeholders day 2016 Enforcement essential for: Citizens: public health Environment and sustainable use Companies: fair competition Compliance and enforcement: a shared responsibility Non-compliance from unintentional to deliberate Need harmonization and proportionality Treated articles a big challenge Biocides enforcement group BPRS

202 Forum BPR Subgroup (BPRS) In February 2017, EU COM officially handed over to ECHA (according art 76 (l ) BPR) the coordination of MSs' enforcement authorities and control activities on biocidal products ECHA established a new body under the FORUM: BPR Subgroup of the Forum for Exchange of information on Enforcement All the BPRS members have been appointed via the Permanent Representations Election of the BPRS Chair: Eugen ANWANDER (AT) & Vice Chairs: Dominik PISAREK (PL) & Francesca RAVAIOLI (IT) EU COM representative: Martinus NAGTZAAM The ECHA Forum Secretariat organized the meetings of the BPRS at ECHA: three meetings a year ~ March, June and November

203 BPRS identity BPRS has been established as a subgroup of the FORUM: firm commitment to seek synergies and work in close coordination with the Forum for REACH, CLP and PIC in particular work on common activities & joint outputs (back-to-back meetings) Strong link with European Commission Purpose of the group is to share experience, create synergies, identify tools for information exchange

204 BPRS tasks [REACH Reg. art 77 (4)] The Forum shall undertake the following tasks: (a) spreading good practice and highlighting problems at Community level; (b) proposing, coordinating and evaluating harmonised enforcement projects and joint inspections; (c) coordinating exchange of inspectors; (d) identifying enforcement strategies, as well as best practice in enforcement; (e) developing working methods and tools of use to local inspectors; (f) developing an electronic information exchange procedure; (g) liaising with industry, taking particular account of the specific needs of SMEs, and other stakeholders, including relevant international organisations;

205 Enforcement process

206 BPRS-1 and -2 key results Working Group on Prioritization of the BPR enforcement projects Join the Forum Task Force on Best Practice Documents to develop the BPR Essential requirements for enforcement Join the Forum WG REACH-EN-FORCE-6 to implement a project focused on the Classification and Labelling of biocidal products Set the BPRS priorities by revising the Forum Multiannual Work Programme to include BPRS priorities Take over the Forum WG Implementation of Portal Dashboard for biocides allowing inspectors access to data submitted to ECHA Revise the Forum Rules of Procedure

207 Priorities for BPR enforcement BPRS WG Prioritisation of the BPR enforcement projects The WG is working on defining the scope of the first BPRS project a) Defining clear policy objectives and priorities b) Creating the necessary organization in order to be able to achieve effective, efficient, transparent and systematic enforcement of the Regulations. c) Performing actual enforcement measures, including compliance promotion, compliance enforcement d) Development and implementation of procedures for periodic progress monitoring and measurement e) Development and implementation of procedures for review, evaluation and update of the enforcement strategy, based on the monitoring procedures.

208 Training for Trainers 2018 Forum WG Training for enforcement trainers BPRS is considering to organise training for trainers who will train the BPR inspectors. The WG is defining the scope of such training, which may take place already in 2018.

209 Implementation of PD-NEA BPRS WG on Implementation of PD BPR Objective: Support the implementation of the PD BPR allowing inspectors access to data submitted to ECHA Future timelines for expanding PD-NEA will be communicated in 2018 Priority was given to the ECHA biocides dissemination project

210 Next steps Prioritisation of the next BPR enforcement project Update on the preparation of REF-6 & best practice documents Multiannual Work Programme BPRS activities Update on IT tools for BPR NEAs EU Commission Report in accordance with Article 65(3) of the BPR

211 THANK YOU FOR YOUR ATTENTION ANY QUESTIONS? Francesca RAVAIOLI, BPR SG Vice-Chair

212 Questions and feedback 1. Go to slido.com 2. Enter event code: BiocidesDay 3. Send your question & give us feedback

213 Closing remarks Jack de Bruijn Director of Risk Management ECHA

214 Thank you for sharing with us 140 here in person from 30 countries 260 online 35 one-to-one sessions use the networking session to ask more reach for our hashtag #BiocidesDay 70 questions online

215 Today s material online Presentations there - video recording tomorrow Give us feedback today via Slido (BiocidesDay) For unanswered questions, contact our helpdesk Tomorrow IT tool training welcome back IUCLID, R4BP 3 and SPC Editor No live stream but main parts will be recorded and made available after the event

216 Complexities Legislation and implementing procedures IT tools and their further development Union authorisation biocidal product family Working in consortia In situ generated substances Treated articles vs biocidal products 215

217 Challenges you raised Timelines for evaluations how to speed up Endocrine disruptor criteria how to adapt Risk assessment under biocides and REACH how to avoid unnecessary overlap Who advises on what Member State vs ECHA Plea for open and clear communication between applicant and evaluating authority How to find consortia and deal with letters of access Level of the fees

218 Keep an eye out for these Public consultation for endocrine disruptor guidance Deadlines to apply for Union authorisation Brexit check our website for Q&As

219 Note down in your calendar REACH 2018 conference January 2018 Biocides 5 years conference October 2018