Costs related to the activities Activities of ECHA start immediately after the fee was received by ECHA. Invoicing and financial reconciliation by ECHA AD (0.375 days): € 220 Labour AD desk officer (7 days): € 4 101 Labour AST desk officer (2 days): € 1 172 Support by legal unit (0.375 days): € 220 Total costs per check: € 5 711 that costs will be allocated N: Invoicing and financial reconciliation, evaluation phase CS03 Chemical similarity Legal basis Management Board Decision 31/2013 description Comparison of one source with an active substance (existing or new) under evaluation under BPD or BPR. Temporary reference source does not exist and only one participant has submitted a dossier under the Review Programme for existing active substances or under new active substance approval (Article 7 of the BPR or Article 11 of BPD) Description of the activities performed by ECHA See description for activities on comparison when temporary reference source exists. Costs related to the activities Activities of ECHA start immediately after the fee was received by ECHA. Invoicing and financial reconciliation by ECHA AD staff (0.375 days): € 220 Labour AD desk officer (7 days): € 4 101 Labour AST desk officer (2 days): € 1 172 Support by legal unit (0.375 days): € 220 Total costs per check: € 5 711 Years that costs will be allocated N: Invoicing and financial reconciliation, evaluation phase CS04 Chemical similarity Legal basis Management Board Decision 31/2013 Short description Activities per additional dossier Description of the activities performed by ECHA See description for activities on comparison when temporary reference source exists. Costs related to the activities Activities of ECHA start immediately after the fee was received by ECHA. Labour AD desk officer (2 days): € 1 171 Labour AST desk officer (1 days): € 586 Additional costs per check: € 1 757 Years that costs will be allocated N: Invoicing and financial reconciliation, evaluation phase CS05 Chemical similarity basis Management Board Decision 31/2013 Short description Comparison of two or more sources of an active substance is not yet under evaluation under BPD or BPR. Two datasets submitted for comparison. Description of the activities performed by ECHA See description for activities on comparison when temporary reference source exists.
Maintenance of biocides functionalities for the Portal DashBoard to support national enforcement authorities Only becomes relevant after the development phase Staff costs TA € 57 993 0.41 Other: Outsourcing costs € 40 000 Total cost € 97 993 Table 326 Costs of the management of Biocides activities Activity Costs FTE Management of the Biocides assessment unit Staff costs TA € 360 847 2.55 Total cost € 360 847 Costs related to the development and maintenance of IT tools supporting the internal ECHA biocides processes Other: ECM tools for biocides € 160 000 Total cost € 160 000 Table 327 Costs related to providing technical and scientific guidance and tools for the application of this Regulation by the Commission and Member States' CAs and providing support to national helpdesks Activity FTE Costs for the development of BPR guidance documents per year costs TA € 141 761 1.00 Other: Related expenses € 22 400 Total cost € 164 161 Specific outsourced scientific support to MS Staff costs TA € 90 212 0.64 Other: Outsourcing costs € 100 000 Total cost € 190 212 Development of specific IT tool for scientific purposes (EUSES) (only in 2017) This is a one off activity on which it still has to be decided. costs TA € 515 496 0.91 Outsourcing costs € 450 000 Total cost € 965 496 Maintenance of specific IT tool for scientific purposes (EUSES) (from 2018 onwards) Only relevant after the development phase costs TA € 167 536 0.32 Other: Outsourcing (spread over 2018 and 2019) € 20 000 Total cost € 187 536 Table 328 Other biocides expenses Activity Costs FTE Costs related to legal officers in support of other activities than those specifically identified above (e.g. support to Communication, Helpdesk, IT development, BPC, Coordination Group, access to documents requests, dissemination Staff costs TA € 128 874 Staff costs legal € 117 158 0.91 cost € 246 032
Clothianidin (in combination with pyriproxyfen) 18 The official date of approval is 1 October 2016. As pre-submissions are advised to be made at least 6 months before, submissions can still be made until April. Clothianidin is a candidate for substitution. There were no comments received during the public consultation and the remark was published that there are alternative AS which are already approved. The available data on authorised products of the MSCAs indicates that around 15 BPs containing Clothianidin are currently on the market. These are understimates as the data of the MSCAs are not complete and a number of MS data was not available at this level of detail. Both in our survey and the AISE/EBPF survey the industry reported very low interest in UA for products falling this PT. Only 17% of the products would apply for UA of which only 10% would opt for the BPF option. 1 1 2 Glutaraldehyde (in combination with CMIT/MIT) 2, 3, 4, 6 The official date of approval is 1 October 2016. As pre-submissions are advised to be made at least 6 months before, submissions can still be made until April. Glutheraldehyde is considered to be a candidate for substitution by being a respiratory sensitiser.Three comments were received during the public consultation of which only one emphasised the essentiality of the AS. In the conclusion it is mentioned that there are other active substances with similar intended uses The available data on authorised products of the indicates that around 800 BPs are currently on the market containing glutaraldehyde. Only a very small number (max. 10) has the combination with CMIT/MIT. Up to 60% of these BPs fall under PT02. These are underestimates as the data of the MSCAs are not complete and a number of MS data was not available at this level of detail. The AS can be used in 3 PT for which the industry declared intention to opt for UA (PT2 in particular but also 3 and 4). No interest declared for UA for PT 6 so far. 1 + 1 family 2 + 1 family 3 + 2 families 18 The official date of approval is 1 July 2016. As pre-submissions are advised to be made at least 6 months before, Both in our survey and the AISE/EBPF survey the industry reported very low interest in UA for products falling under 0 0 0
DCPP 1, 2, 4 The official date of approval is 1 December 2016. Pre-submissions can still be received until 1 June 2016. DCPP is considered to be a candidate for substitution. No comments were received during the public consultation. A comparative assessment is thus required when authorisation is requested. The available data on authorised products of the indicates that around 55 BPs containing DCPP are currently on the market. These are understimates as the data of the MSCAs are not complete and a number of MS data was not available at this level of detail. The AS can be used in 3 PT for which the industry declared intention to opt for UA (PT2 in particular but also 1 and 4). BPs falling under PT02 are only eligible for UA from 2017 onwards. 1 2 3 L-(+)-lactic acid 1 L-(+)- lactic acid is a new active substance under the BPD. L-(+)- lactic acid is not considered a candidate for substitution. New, currently no BPs on the market. There is thus also no deadline for UA applications. Estimates for the year 2017 Table 02 Reasoning supporting estimates for Union Authorisation in 2017 Active substances with deadline in 2017 PTs Outcome RP (based on the Commission Implementing Regulations) Results from MSCA data on approved BPs Results from survey Estimates 2017 2-biphenylol 1,2,3,4,6,13 2-biphenylol is not a candidate for substitution. The available data on authorised products of the indicates that around 250 BPs are currently on the market. This number is an underestimate due the regulatory transition period and The AS can be used in 4 PT for which the industry declared intention to opt for UA (PT2 in particular but also 1,3 and 4). No interest declared for UA for PT 6 and 13 1 + 1 family 2 + 2 family 4 + 3 family
Estimates for the year 2018 03 Argumentation for estimated no. of submissions for UA based on the progress of the Review Programme in 2018 Active substances with deadline in 2018 PTs Results from MSCA data on registered BPs No. of markets the product is on according to the MSCA data Results from our survey and AISE/EBPF survey on appropriateness of the PT the AS falls under for UA Drop out rate based on surveys Ratio BP/BPF based on surveys Estimates 2018 Calcium oxide / lime / burnt lime / quicklime 2, 3 Only in France, 4 under PT02 and 8 under PT03. 1 out of 19 markets For all PTs falling under main group 1, UA is perceived as a valid alternative to NA+MR. 25% A high percentage of products will be placed on the market under BPFs rather than as separate products. According to the AISE/EBPF survey 60% of dossiers will be BPF. 0 0 0 Calcium dihydroxide / calcium hydroxide / caustic lime / hydrated lime / slaked lime 2, 3 Only in France, 13 BPs in total 4 PT02, 5 PT02 and 03 and 4 PT03 1 out of 19 markets For all PTs falling under main group 1, UA is perceived as a valid alternative to NA+MR. 25% A high percentage of products will be placed on the market under BPFs rather than as separate products. According to the AISE/EBPF survey 60% of dossiers will be BPF. 0 0 0 Calcium magnesium tetrahydroxide / calcium magnesium hydroxide / hydrated dolomitic lime 2, 3 Only in France 7 BPs PT02 and Germany 1 BP under PT03 2 out of 19 markets For all PTs falling under main group 1, UA is perceived as a valid alternative to NA+MR. 25% A high percentage of products will be placed on the market under BPFs rather than as separate products. According to the AISE/EBPF survey 60% of dossiers will be BPF. 0 0 0
Icaridine 19 The available data shows that around 500 BPs containing Icaridine are on the market. 10 out of 19 markets In both surveys none of the respondents expressed interest in UA for their products falling under PT19. 30% Around 70% would choose for BPF. 0 0 0 Azamethiphos 18 The available data shows that around 230 BPs containing azamethiphos are on the market 12 out of 19 markets Both in our survey and the AISE/EBPF survey the industry reported very low interest in UA for products falling under this PT. Only 17% of the products would apply for UA. 40% Around 70% would choose for BPF. 0 0 0 Mixture of cis- and trans-p-menthane-3,8 diol (Citrodiol) 19 The available data shows that around 100 BPS containing citriodiol are currently on the market 5 out of 19 markets In our survey none of the respondents expressed interest in UA for their products falling under PT19. 30% Around 70% would choose for BPF. 0 0 0 Pyrethrins and Pyrethroids 18, 19 The available data shows that around 1750 BPs containing pyrethrins and pyrethroids are currently on the market 12 out of 19 markets Both in our survey and the AISE/EBPF survey the industry reported very low interest in UA for products falling under this PT. Only 17% of the products would apply for UA. 40% Around 70% choose for BPF. 1 1+1 2 Chrysanthemum cinerariaefolium 18 The available data shows that around 300 BPs containing chrysanthemum cinerariaefolium are currently on the market 4 out of 19 markets Both in our survey and the AISE/EBPF survey the industry reported very low interest in UA for products falling under this PT. Only 17% of the products would apply for UA. 40% Around 70% would choose for BPF. 0 0 0
Estimates for the year 2020 Table 05 Argumentation for estimated no. of submissions for UA based on the progress of the Review Programme in 2020 Active substances with deadline in 2020 PTs Results from MSCA data on registered BPs No. of markets the product is on according to the MSCA data Results from our survey and AISE/EBPF survey on appropriateness of the PT the AS falls under for UA Drop out rate based on surveys BP/BPF based on surveys Estimates 2020 Cyphenothrin PT18 18 The data available shows that there are currently around 220 BPs containing cyphenothrin are on the market 5 out of 19 markets Both in our survey and the AISE/EBPF survey the industry reported very low interest in UA for products falling under this PT. Only 17% of the products would apply for UA. 40% Around 70% would choose for BPF. 0 0 0 Geraniol PT18 18,19 The data available shows that there are currently around 1400 BPs containing cyphenothrin are on the market 11 out of 19 markets Both in our survey and the AISE/EBPF survey the industry reported very low interest in UA for products falling under this PT. Only 17% of the products would apply for UA. 40% Around 70% choose for BPF. 1 family 1+1 family 2+2 families Sodium cacodylate PT18 18 The available data shows that there are only 9 BPs currently registered on the market in Germany. 1 out of 19 markets Both in our survey and the AISE/EBPF survey the industry reported very low interest in UA 40% Around 70% would choose for BPF. 0 0 0
for products falling under this PT. Only 17% of the products would apply for UA. 8 AS 3 For all PTs falling main group 1, UA is perceived as a valid alternative to NA+MR. 15% A high percentage of products will be placed on the market under BPFs rather than as separate products. According to the AISE/EBPF survey 60% of dossiers will be BPF. 1 family 2 + 2 families 5 + 4 families 15 AS 4 For all PTs falling under main group 1, UA is perceived as a valid alternative to NA+MR. 40% A high percentage of products will be placed on the market under BPFs rather than as separate products. According to the AISE/EBPF survey 1 + 1 families 4 + 4 families 7 + 8 families
60% of dossiers will be BPF. 2 5 For all PTs falling main group 1, UA is perceived as a valid alternative to NA+MR. 20% A high percentage of products will be placed on the market BPFs rather than as separate products. According to the AISE/EBPF survey 60% of dossiers will be BPF. 1 1 2 + 2 families 5 1 For all PTs falling under main group 1, UA is perceived as a valid alternative to NA+MR. 25% A high percentage of products will be placed on the market BPFs rather than as separate products. According to the AISE/EBPF survey 60% of dossiers will be BPF. 2 families 3 families 5+7 families
NL € 18.500,00 € 22.000,00 No € 1.195 PL € 5.957,10 € 5.957,10 € 1.477,90 € 1.477,90 No PT € 3.078,00 € 1.539,00 No RO - - - - - - SK € 70.750,00 € 7.500,00 € 9.750,00 No Between €300 - €750 SL € 13.500,00 € 25.800,00 € 2.500,00 € 3.700,00 No ES € 2.436,90 € 2.436,90 € 1.160,40 € 1.160,40 No SE € 32.619,70 € 65.239,40 € 13.047,90 € 26.095,80 Yes, instalments UK € 12.495,20 € 5.013,40 No Yes, not specified TOTAL € 114.524,70 € 149.116,60 EU € 40.000 – 80.000 € 150.000 - Yes, 60% (medium) -40% (small) (micro) Not yet, national annual fees be implied Figure 06. Overview of MS fees for product authorisation Source: European Commission - CA-March15-Doc.7.2