Mike Prince EUOTA Unit 3 Regents Court South Way, Walworth Business Park Andover Hampshire SP10 5NX United Kingdom 16 April 2015

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1 CENTRE FOR CHEMICAL REGULATION AND FOOD SAFETY CENTRE FOR CHEMICAL REGULATION AND FOOD SAFETY The Lenz, Hornbeam Business Park, Harrogate. HG2 8RE UK T (+44) F (+44) info@uk.exponent.com 1 Pride Park Drive, Pride Park, Derby, DE24 8BX. UK T (+44) info@uk.exponent.com Mike Prince EUOTA Unit 3 Regents Court South Way, Walworth Business Park Andover Hampshire SP10 5NX United Kingdom 16 April 2015 Dear Mike Please find below answers to the questions which were raised during our meeting at Harrogate on 3 rd March 2015 and further information (shown in blue font from 16 March and in green font from 16 April 2015) which has been incorporated based upon your e mail dated 16 March 2015 and the updated DGA following a review of additional information, dated 8 April IDENTIFIED DATA GAPS The data gap analysis which was conducted to assess the data requirement for Ozone as a biocidal active substance with a representative product (reported 13 February 2015), highlighted the following data gaps which may require the generation of additional data to fulfil the endpoint:- Table 1: Identified Data Gaps Section No. Information, test or study required for Active Substance 2.8 Method of manufacture (syntheses pathway) of active substance including information on starting materials and solvents including suppliers, specifications and commercial availability 2.9 Specification of purity of the active substance as manufactured in g/kg, g/l or %w/w (v/v) as appropriate, providing inclusively the upper and lower limit Comments The identity of any impurities including degradation products and un-reacted products. Analytical profile of at least five representative batches (g/kg active substance) including information on content of the impurities. Information on the precursor(s) of the active substance Note, generation from ambient air will not require this Typical cost to conduct study 5 Batch analysis = 10,000-50,000 GBP (dependent upon the complexity of the analysis and number of impurities) Note:- This study will be required even if a LOA is purchased for the ORG data package as technical equivalence must be demonstrated for every source. Page 1 of 8

2 Section No. Information, test or study required for Active Substance 2.10 The identity of any impurities and additives including byproducts of synthesis and unreacted starting materials 2.11 Analytical profile of at least five representative batches (g/kg active substance) including information on content of the impurities referred to in Absorption spectra data (UV/VIS, IR, NMR) and a mass spectrum, molar extinction coefficient at relevant wavelengths, where relevant 5.1 Analytical methods including validation parameters for the determination of active substance as manufactured and where appropriate, for relevant residues, isomers and impurities of the active substance and additives (e.g. stabilisers) For impurities other than relevant impurities this only applies if they are present at 1 g/kg Comments information. Please note that each member of the TF will need to disclose their source (which will be treated in confidence and included in the confidential section of the dossier) and a 5 batch analysis will be required for each source. Where members have the same source only one report will be required and Exponent can assist in organizing this to ensure confidentiality. Members could then share the costs for the total number of sources required. UV-vis spectra required for each source of Ozone, to confirm identity. Analytical methods are required to measure the active substance as manufactured and where appropriate, for relevant residues and impurities of the active substance. The methods must include validation parameters (in accordance with the criteria outlined in the ECHA document entitled, Guidance on the BPR: Volume I. Part A Chapter II: Requirements for Active Substances Version 1.1 November Typical cost to conduct study Include as part of the 5 batch analysis Include as part of the 5 batch analysis Page 2 of 8

3 Section No. Information, test or study required for Active Substance 5.3 Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor articles treated with it come into contact with food-producing animals, food of plant or animal origin or feeding stuffs) Comments It is considered that methods will be present in the IOA database. Typical cost to conduct study The price to validate a method of analysis for foodstuff - crops (4 crop types) = 16,000-20,000 GBP and animal (5 matrices) = 18,000-22,000 GBP Further supporting data may be required for foodstuffs if direct exposure is anticipated. Total cost to conduct the studies Worst case 44,000 92,000 GBP Best case 10,000 50,000 GBP Note, it has been assumed that efficacy data will be supplied by the task force members. 2 SUBMISSION FEES 2.1 ACTIVE SUBSTANCE DOSSIER The fees to submit a new active substance dossier are shown in the table below. From discussions it is understood that there could be up to 4 product types which will need to be authorised. Table 2: Fees to Submit a New Active Substance Dossier Agency Description of Task Fee (Euros) ECHA Fee required 2016 Evaluating Member State Germany 1 Fee required 2016 Fee for the first product-type for which that active substance is approved Additional fee per additional product-type = 40,000 Assuming 4 Product types (40,000 * 3 = 120,000) Fee for the first product-type for which that active substance is approved (with potential additional fees) Additional fee per additional product-type = 47,500 Assuming 4 Product types (47,500 * 3 = 142,500) 120, ,000 (40,000 * 3) 189, ,500 (47,500 * 3) Total for an active substance and representative dossiers for 4 product types 572,300 1 Splitting payments into several instalments is negotiable on a case-by-case basis; CA-Nov14-Doc.7.2 Page 3 of 8

4 2.2 PRODUCT AUTHORISATION There are three options for gaining Product Authorisation (PA) and/or Mutual Recognition in one or multiple Member States (MS). (i) and (ii):- Application to one MS as lead country with mutual recognition by all (or selected) others, either in sequence or in parallel (iii) a Union Authorisation submitting to the European Chemicals Agency (ECHA). National authorisation (Art. 29) Submit to one lead (Reference) member state Gain PA in lead member state Authorisation will take at least 455 days AND (i) Mutual recognition in sequence (Art. 33) National authorisation already granted by the Reference member state Submit a mutual recognition application to each member state concerned including a translation of the PA granted by the reference member state Authorisation likely to take 180 days OR (ii) Mutual recognition in parallel (Art. 34) Submit an application to the Reference MS for PA at the same time as each of the concerned MSs for which mutual recognition is applied Authorisation likely to take at least 515 days (iii) Union Authorisation (Art ) a. Application to ECHA b. Higher fee than authorisation through a lead member state, but gain PA in all Member States. The fee per product payable to ECHA will be 80,000 if the product is not identical to the representative product submitted with the active substance dossier. Where the product is identical the fee will be 40,000. If the Task Force s products can be grouped into a biocidal product Family (see below for further details) the fee will be 150,000. In addition, ECHA will charge an annual maintenance fee for a biocidal product of 10,000 and an annual maintenance fee for a Biocidal Product Family of 20,000. A MS will be allocated to review the application and will charge an additional fee for the evaluation in order to recoup their costs. If, for example the UK was chosen the fee is likely to be ca 10,000 GBP. c. Authorisation could take ca. 700 days Union Authorisation (UA) allows companies to place their biocidal products on the market throughout the entire European Union, without the need to obtain a specific national authorisation Page 4 of 8

5 and gives the same rights and obligations in all the Members States as those provided by national authorisations. The submission strategy chosen will depend upon the number of Member States where authorisation is required and the cost of authorisation I each country. Biocidal Product Family It may be possible to group similar products into a biocidal product Family for which a single authorisation can be sought by either National or Union Authorisation. The BPR (Art. 19) defines a biocidal product family as: a group of biocidal products having similar uses, the same active substances, similar composition with specified variations and similar levels of risk and efficacy. An assessment will be made of which products are sufficiently similar to form a Biocidal Product Family (BPF). Information to be assessed includes proposed label text, claims and detailed instructions for use. Table 3: Member State Product Authorisation and Mutual Recognition fees - various options considered (Fees likely to be required 2019/2020 i.e. at least 2 years for active substance approval then 18 months to submit product dossiers) Option 2 Fees (Euros) per product Fees (Euros) per BPF 3 Member States (Lead PA in DE; MR in UK, IE) 6 Member States (Lead PA in DE; MR in UK, IE, IT, ES, FR) 9 Member States (Lead PA in DE; MR in UK, IE, IT, ES, FR, BE, AU, NL) All Member States (28 MS) Union authorisation 56,890 (50, , ,500) 74,050 (50, , , , , ,000) 90,205 (50, , , , , , ) 140,000 (80,000 ECHA + 60,000 Germany) 86,890 (75,000; 4,390; 7,500) 122,050 (75,000; 4,390; 7, , , ,000) 147,805 (75,000; 4,390; 7, , , , ) 240,000 (150,000 ECHA + 90,000 Germany) 2 The fees differ for each Member State as they attempt to recoup their individual costs. The Member States listed are for illustrative purposes only and the fees are subject to change. Page 5 of 8

6 2.3 SUMMARY OF SUBMISSION FEES It is important to distinguish between the (i) necessary submission of an active substance dossier with the minimum number of representative products across the relevant PTs (to demonstrate a safe use in each PT) and (ii) subsequent Product Authorisation (PA) submissions (registrations of products or product families by each member of the TF (or as joint submissions), once ozone a.s. is authorised). To summarise the regulatory fees, if for example product authorisations need to cover 4 product types that incorporate 8 product families requiring authorization throughout Europe utilising the Union Authorisation procedure, the costs are likely to be as follows:- Table 4: Example summary of submission fees utilising the Union Authorisation procedure Reference Description of Task Fee (Euros) Total (Euros) Payable by Table 2 Table 3 (i) Total fee for the active substance plus first product-type for which that active substance is approved (ECHA and Evaluating Member State e.g. Germany) Additional fee per additional product-type i.e. fee (87,500 * 3) (assumes 4 Product Types) (ii) All Member States (28 MS) Union authorization 240,000 (150,000 ECHA + 90,000 Germany) per BPF As there are 8 BPF = 240,000 * , ,300 EUOTA (Fees required 2016) 262,500 1,920,000 (240,000 for 1 BPF) 1,920,000 (240,000 for 1 BPF) Individual members of EUOTA, cost share dependent on extent of product authorisation sharing (fees likely to be required 2019/2020) Due to the significant variation in costs between the Member States, the most appropriate approach to be taken is assessed on a case by case basis i.e. National Authorisation or Union Authorisation. 3 CONSULTANCY FEES Detailed below are approximate consultancy fees required to prepare and submit both the active substance dossier with representative products supporting 4 product types, and subsequently also 8 biocidal product family dossiers (BPF) across up to 4 product types. Once the full details of the proposed families are known, together with the intended 3 It is considered unlikely that there will need to be as many as 8 BPFs in order to cover all of the in situ generated ozone uses. Page 6 of 8

7 countries where authorisation will be sought, a more accurate quotation can be provided. It may not be necessary to generate 8 BPF dossiers to cover the proposed uses across 4 PTs. Table 5: Consultancy Fees Stage Exponent Task Fee (GBP) Active Substance Product Authorisation Phase Fee to prepare active substance dossier with representative product dossier supporting 4 product types. (Fees required 2015/2016) The definition of a biocidal product family (BPF) is as follows:- biocidal product family means a group of biocidal products having: (i) similar uses; (ii) the same active substances; (iii) similar composition with specified variations; and (iv) similar levels of risk and efficacy; The fee to prepare 8 Biocidal Product Family dossiers supporting 4 product types. Data gap analysis per product family ca GBP per BPF 4 Preparation of IUCLID dossier including product specific physical chemistry and efficacy data ca 5,500 GBP per BPF Preparation of risk assessments for Human Health and the Environment ca 5,000-7,500 GBP per BPF (utilising as much of the representative products risk assessments as possible) Submission of the dossiers via R4BP GBP per BPF Note:- The representative product dossiers will be used as the basis for the product dossiers but considerably more data will be required for product authorization, in particular, efficacy data. It has been assumed that the exposure and risk assessments included in the active substance dossier will represent the worst-case scenarios and further refinements will not be required other than to make the exposure scenarios specific for the products contained within the families. (Fees likely to be required 2018/2019) 109,000 to 137,000 GBP 105,600 to 132, Note:- this price is dependent upon the amount of additional product data i.e physical chemistry and efficacy data. 5 Depending upon the product uses and the amount of additional data submitted it may be possible to readacross between the biocidal product families thus introducing cost savings. Page 7 of 8

8 We hope we have addressed all of the questions raised and if you have any further questions, please do not hesitate to contact me. Yours sincerely Alison McGuire Senior Managing Scientist Regulatory (Biocides) Exponent International Limited Page 8 of 8