Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products

Transcription

1 NL STORM Secure PT 14 BIJLAGE II bij het besluit d.d. 8 maart 2018 tot verlenging van de toelating van het middel STORM Secure, toelatingnummer NL Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products PRODUCT ASSESSMENT REPORT OF A BIOCIDAL PRODUCT FOR THE RENEWAL OF A NATIONAL AUTHORISATION Product identifier in R4BP STORM Secure Product type(s): Active ingredient(s): Case No. in R4BP Asset No. in R4BP Evaluating Competent Authority 14 (Rodenticide) Flocoumafen Storm Secure: BC-RJ NL NL Internal registration/file no Date (renewal) 1 / 223

2 NL STORM Secure PT 14 Table of content 1 Conclusion Summary of the product assessment Administrative information Composition and formulation Classification and Labelling according to the Regulation (EC) No 1272/ Use(s) appropriate for further authorisation General directions for use Assessment of the product Use(s) considered appropriate for authorisation after former assessment (uses currently under authorisation) Physical, chemical and technical properties Physical hazards and respective characteristics Methods for detection and identification Efficacy against target organisms Risk assessment for human health Risk assessment for animal health Risk assessment for the environment Assessment of a combination of biocidal products Comparative assessment Confidential annex (Access level: Restricted to applicant and authority) Methods for detection and identification Full composition of the product / 223

3 NL STORM Secure PT 14 1 Conclusion The first authorisation of STORM Secure was as a rodenticide product against rats and house mice in and around buildings by professionals and non-professionals, and as product against brown rats in sewers by professionals only. For the renewal of the product the intended use is as a rodenticide against rats and house mice in and around buildings by (trained) professionals and against brown rats in sewers by trained professionals only. Use of the product by non-professionals is no longer intended. This is due to the fact the product is classified with Repr. 1B after application of the 9 th ATP on March 01, Non-professional use will not be permitted after this date. The Dutch CA considers the information provided for the first authorisation sufficient for the renewal of the product. Therefore, the first renewal authorisation of STORM Secure will be as rodenticide against rats and house mice in and around buildings by (trained) professionals and against brown rats in sewers by trained professionals only. Use(s) considered appropriate for authorisation after former assessment (uses currently under authorisation) 1 Rats and house mice (in and around buildings, professionals and non-professionals) 2 Brown rats (Rattus norvegicus) (sewer, professionals) Use(s) appropriate for further authorisation (first renewal authorisation) 1 Rats and house mice (indoor, trained professionals) 2 Rats and house mice (outdoor around buildings, trained professionals) 4 House mice (indoor, professionals) 5 Rats (indoor, professionals) 6 Rats and house mice (outdoor around buildings, professionals) 3 Brown rats (Rattus norvegicus) (sewer, trained professionas) Some restrictions in use are necessary to prevent access of children and non-target animals to the product, please refer to the SPC (Summary of product characteristics). Prior to renewing the approval of anticoagulant active substances and renewing the authorisations of the respective products discussions took place at EU-level to harmonise use instructions and risk mitigation measures to the greatest possible extent. As an outcome of these discussions a set of three standard SPCs compiling the relevant sentences for the uses that may be authorised for each of the three user categories (general public, professionals and trained professionals) has been produced (for details please refer to document CA-Nov16-Doc.4.1.b Final). The SPC for renewal of STORM Secure has been updated with the relevant sentences accordingly. 3 / 223

4 NL STORM Secure PT 14 National specific regulations in the Netherlands: Due to Dutch national specific regulations in the Netherlands only trained professionals and nonprofessionals are allowed to apply rodenticides (no professional use). Only trained professionals with additional IPM training are allowed to apply rodenticides outdoors. In addition, the use against house mice is restricted to use in buildings, and for both house mice and rats, use in covered and protected bait points is not allowed (derogations based on art 37 BPR). Therefore, in the Netherlands authorised use of this product will consist of: - use in buildings against house mice (Mus musculus) and rats (Rattus norvegicus and Rattus rattus) by trained professionals, - use against brown rats (Rattus norvegicus) in sewers by trained professionals - use around buildings against rats (Rattus norvegicus and Rattus rattus) by trained professionals with additional IPM training. 4 / 223

5 NL STORM Secure PT 14 2 Summary of the product assessment 2.1 Administrative information Identifier in R4BP STORM Secure Manufacturer(s) of the product Name of manufacturer BASF Agro B.V. Arnhem (NL) Freienbach Branch Address of manufacturer Huobstrasse Pfäffikon SZ Switzerland Location of manufacturing sites BASF plc St. Michael s Indrustrial Estate WA88TJ Widness, Cheshire United Kingdom Manufacturer(s) of the active substance(s) Active substance Name of manufacturer Flocoumafen BASF Agro B.V. Arnhem (NL) Freienbach Branch Address of manufacturer Huobstrasse Pfäffikon SZ Swittzerland Location of manufacturing sites Vertellus Specialities UK Ltd. Lower Road, Halebank WA8 8NS Widnes, Cheshire United Kingdom 5 / 223

6 NL STORM Secure PT Composition and formulation Table 1 Common name IUPAC name Function CAS number Flocoumafen 4-hydroxy-3- Active [(1RS,3RS;1RS,3RS)- substance 1,2,3,4-tetrahydro-3- [4- (4- trifluoromethylbenzyloxy) phenyl]-1- naphthyl]coumarin The product contains a bittering agent and a dye. EC number Content (%) (pure active) Information on the full composition is provided in the confidential 1 annex (see chapter 4). According to the information provided the product contains no nanomaterial as defined in Article 3 paragraph 1 (z) of Regulation No. 528/2012: Information on the substance(s) of concern No substance of concern was identified upon initial assessment (the application for authorisation was submitted and the assessment took place before the Biocidal Products Regulation 528/2012 entered into force). At renewal the substance of concern guidance was followed and citric acid (CAS: ), being active substance for product type 02, is considered as a substance of concern Candidate(s) for substitution Flocoumafen is considered a candidate for substitution in accordance with Article 10(1)(a) and 10(1)(e) of Regulation (EU) No 528/2012 according to the BPC opinion for flocoumafen adopted on June 16, 2016 (ECHA/BPC/115/2016) Type of formulation RB (ready for use bait) Bait blocks of 20 gram. 1 Access level: Restricted to applicant and authority 6 / 223

7 NL STORM Secure PT Classification and Labelling according to the Regulation (EC) No 1272/2008 Table 2 Classification Hazard classes, Hazard categories Repr. 1B STOT RE 2 Hazard statements H360D H373 (blood) Table 3 Labelling Pictograms Code GHS08 Pictogram / Wording Signal word - Danger Hazard statements Supplemental hazard information - Supplemental label elements - H360D May damage the unborn child. H May cause damage to the blood through prolonged or repeated exposure. Precautionary statements P101 If medical advice is needed, have product container or label at hand. Note - P102 P201 P280 P P501 Keep out of reach of children. Obtain special instructions before use. Wear protective gloves. IF exposed or concerned: Call a POISON CENTER or doctor/physician. Dispose of contents/container to hazardous or special waste collection point. 2.4 Use(s) appropriate for further authorisation For national specific regulations in the Netherlands see Conclusion 7 / 223

8 NL STORM Secure PT 14 Table 4 Use(s) considered appropriate for authorisation after former assessment (uses currently under authorisation) 1 Rats and house mice (in and around buildings, professionals and non-professionals) 2 Brown rats (Rattus norvegicus) (sewer, professionals) Use(s) appropriate for further authorisation (first renewal authorisation) 1 Rats and house mice (indoor, trained professionals) 2 Rats and house mice (outdoor around buildings, trained professionals) 4 House mice (indoor, professionals) 5 Rats (indoor, professionals) 6 Rats and house mice (outdoor around buildings, professionals) 3 Brown rats (Rattus norvegicus) (sewer, trained professionas) Use 1 appropriate for further authorisation House mice and rats- trained professionals- indoor Product Type(s) 14 Where relevant, an exact description of the use Target organism(s) (including development stage) Adult and juvenile: Rattus norvegicus (Norway rat / brown rat), Rattus rattus (roof rat/black rat), Field(s) of use Application method(s) Mus musculus (house mouse) Indoor Pulsed baiting Bait formulations: - Ready-to-use bait to be used in tamper-resistant bait stations Application rate(s) and frequency - Covered and protected baiting points (as long as they provide the same level of protection for non-target species and humans as tamper-resistant bait stations). Bait products: Mice: 1 block (20 g) per bait station. Rats: 2-3 blocks (40 g 60 g) per bait station. 8 / 223

9 NL STORM Secure PT 14 Pulsed baiting technique: Replace eaten bait only after 3 days and then at maximum 7 day intervals. Move any untouched bait to active areas. At each visit, replace eaten bait. Place bait throughout the infested area, in tamper-resistant bait boxes or at covered and protected bait points. If control is not achieved, survey site again to establish reasons and consider re-siting or increasing the number of bait points. Category(ies) of users Pack sizes and packaging material Trained professionals Either loose bait blocks (20 gram each) or PE/PP/PET/HDP laminated sachets containing 60 g bait, further packaged in: Plastic container: 3 kg 10 kg, PP or HDPE or PET, closure: lid of PP or PE Reclosable bag: 3 kg 10 kg, paper laminate, re-closable flexible bags Lined reclosable cardboard box: 3 kg 10 kg, re-closable LDPE lined carton Use-specific instructions for use -Baits must be securely deposited in a way so as to minimise the risk of consumption by animals or children. Where possible secure baits so that they cannot be dragged away. -.- Replace eaten bait only after 3 days and then at maximum 7 day intervals. Collect any spilled bait and dead rodents. - Remove the remaining product at the end of treatment period. - [When available] Follow the specific instructions for pulsed baiting provided by the applicable code 9 / 223

10 NL STORM Secure PT 14 of good practice at national level. -The frequency of visits to the treated area should be at the discretion of the operator, in the light of the survey conducted at the outset of the treatment. That frequency should be consistent with the recommendations provided by the relevant code of best practice Use-specific risk mitigation measures - Where possible, prior to the treatment inform any possible bystanders (e.g. users of the treated area and their surroundings) about the rodent control campaign. - Consider preventive control measures (plug holes, remove potential food and drinking as far as possible) to improve product intake and reduce the likelihood of reinvasion. - To reduce risk of secondary poisoning, search for and remove dead rodents during treatment at frequent intervals, in line with the recommendations provided by the relevant code of best practice. - Do not use the product as permanent baits for the prevention of rodent infestation or monitoring of rodent activities. - Do not wash the bait stations or utensils used in covered and protected bait points with water between applications. - The product information (i.e. label and/or leaflet) shall clearly show that the product shall only be supplied to trained professional users holding certification demonstrating compliance with the applicable training requirements (e.g. "for trained professionals only". - Do not use in areas where resistance to the active substance can be suspected. - Do not rotate the use of different anticoagulants with comparable or weaker potency for resistance management purposes. For rotational use, consider using a non-anticoagulant rodenticide, if available, or a more potent anticoagulant. -The baits must be securely deposited in a way so as to minimise the risk of consumption by other animals or children. Where possible secure baits so that they cannot be dragged away. 10 / 223

11 NL STORM Secure PT Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment When placing bait points close to water drainage systems, ensure that bait contact with water is avoided Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use Use 2 appropriate for further authorisation House mice and rats- trained professionals- outdoor around buildings Product Type(s) 14 Where relevant, an exact description of the use Target organism(s) (including development stage) Adult and juvenile: Rattus norvegicus (Norway rat / brown rat), Rattus rattus (roof rat/black rat), Field(s) of use Application method(s) Mus musculus (house mouse) Outdoor around buildings Pulsed baiting Bait formulations: - Ready-to-use bait to be used in tamper-resistant bait stations Application rate(s) and frequency - Covered and protected baiting points (as long as they provide the same level of protection for non-target species and humans as tamper-resistant bait stations). - Direct application of ready-to-use bait into the burrow Bait products: 11 / 223

12 NL STORM Secure PT 14 Mice: 1 block (20 g) per bait station. Rats: 2-3 blocks (40 g 60 g) per bait station. Pulsed baiting technique: Replace eaten bait only after 3 days and then at maximum 7 day intervals. Move any untouched bait to active areas. At each visit, replace eaten bait. Place bait throughout the infested area, in tamper-resistant bait boxes or at covered and protected bait points. If control is not achieved, survey site again to establish reasons and consider re-siting or increasing the number of bait points. Category(ies) of users Pack sizes and packaging material Trained professionals Bait products: Mice: 1 block (20 g) per bait station or burrow. Rats: 2-3 blocks (40 g 60 g) per bait station or burrow. Pulsed baiting technique: Replace eaten bait only after 3 days and then at maximum 7 day intervals. Move any untouched bait to active areas. At each visit, replace eaten bait. Place bait throughout the infested area, in tamperresistant bait boxes or at covered and protected bait points. If control is not achieved, survey site again to establish reasons and consider re-siting or increasing the number of bait points. Bait products: Rats: 40 g - 60 g of bait per burrow Use-specific instructions for use - Protect the bait from the atmospheric conditions. Place the baiting points in areas not liable to flooding. - Replace any bait in baiting points in which baits has been damaged by water or contaminated by dirt. - Remove the remaining product at the end of treatment period. - Baits must be placed to minimise the exposure to non-target species and children. - [When available] Follow the specific instructions for pulsed baiting provided by the applicable code 12 / 223

13 NL STORM Secure PT 14 of good practice at national level. - Replace eaten bait only after 3 days and then at maximum 7 day intervals. Collect any spilled bait and dead rodents. - Cover or block the entrances of baited burrows to reduce the risks of bait being rejected and spilled. - For outdoor use, baiting points must be covered and placed in strategic sites to minimise the exposure to non-target species -The frequency of visits to the treated area should be at the discretion of the operator, in the light of the survey conducted at the outset of the treatment. That frequency should be consistent with the recommendations provided by the relevant code of best practice Use-specific risk mitigation measures - Where possible, prior to the treatment inform any possible bystanders (e.g. users of the treated area and their surroundings) about the rodent control campaign [in accordance with the applicable code of good practice, if any]. - Consider preventive control measures (plug holes, remove potential food and drinking as far as possible) to improve product intake and reduce the likelihood of reinvasion. - To reduce risk of secondary poisoning, search for and remove dead rodents during treatment at frequent intervals, in line with the recommendations provided by the relevant code of best practice. - Do not use the product as permanent baits for the prevention of rodent infestation or monitoring of rodent activities. - Do not wash the bait stations or utensils used in covered and protected bait points with water between applications. - The product information (i.e. label and/or leaflet) shall clearly show that the product shall only be supplied to trained professional users holding certification demonstrating compliance with the applicable training requirements (e.g. "for trained professionals only". - Do not use in areas where resistance to the active substance can be suspected. - Do not rotate the use of different anticoagulants with comparable or weaker potency for resistance management purposes. For rotational use, consider using a non-anticoagulant rodenticide, if available, or a more potent anticoagulant. 13 / 223

14 NL STORM Secure PT Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment When placing bait points close to surface waters (e.g. rivers, ponds, water channels, dykes, irrigation ditches) or water drainage systems, ensure that bait contact with water is avoided Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use Use 3 appropriate for further authorisation Brown rats- trained professionals - in sewers Product Type(s) 14 Where relevant, an exact description of the use Target organism(s) (including development stage) Adult and juvenile: Rattus norvegicus (Norway rat / brown rat), Field(s) of use Application method(s) Application rate(s) and frequency In sewers Bait formulations: - Ready-to-use bait to be anchored or applied in bait stations preventing the bait from getting into contact with waste water. - Covered and protected baiting points grams per bait point (manhole), depending on the size of the infestation. Category(ies) of users Pack sizes and packaging material Trained professionals Either loose bait blocks (20 gram each) or PE/PP/PET/HDP laminated 14 / 223

15 NL STORM Secure PT 14 sachets containing 60 g bait, further packaged in: Plastic container: 3 kg 10 kg, PP or HDPE or PET; closure: lid of PP or PE Lined reclosable cardboard box: 3 kg 10 kg,, re-closable LDPE lined carton Use-specific instructions for use - Place the bait points in the sewer system, for example at manholes. Secure the bait blocks, e.g. by using wire, to protect from flooding or displacement. Check the uptake of bait periodically and replenish as necessary. - Baits must be applied in away so that they do not come into contact with water and are not washed away. - [When available] Follow any additional instructions provided by the relevant code of best practice Use-specific risk mitigation measures - Do not use this product in pulsed baiting treatments. - [if national policy requires it] Place baits only in sewer systems which are connected to the sewage treatment plant Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 15 / 223

16 NL STORM Secure PT Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use Use 4 appropriate for further authorisation House mice - professionals - indoor Product Type(s) 14 Where relevant, an exact description of the use Target organism(s) (including development stage) Field(s) of use Application method(s) Application rate(s) and frequency Adult and juvenile: Mus musculus (house mouse) Indoor Ready-to-use bait to be used in tamper-resistant bait stations. Place bait throughout the infested area, in tamper-resistant bait boxes. Mice: 1 block (20 g) per bait station. If more than one bait station is needed, the distance between bait stations should be1-2 meters. Rats: 2-3 blocks (40 g 60 g) per bait station. If more than one bait station is needed, the distance between bait stations should be 5-10 meters. Category(ies) of users Pack sizes and packaging material Professionals Either loose bait blocks (20 gram each) or PE/PP/PET/HDP laminated sachets containing 60 g bait, further packaged in: Plastic container:3 kg 10 kg, PP or HDPE or PET, closure: lid of PP or PE Reclosable bag: 3 kg 10 kg, paper laminate, re-closable flexible bags 16 / 223

17 NL STORM Secure PT 14 Lined reclosable cardboard box: 3 kg 10 kg,, re-closable LDPE lined carton Use-specific instructions for use - The bait stations should be visited at least every 2 to 3 days at the beginning of the treatment and at least weekly afterwards, in order to check whether the bait is accepted, the bait stations are intact and to remove rodent bodies. Re-fill bait when necessary. - [When available] Follow any additional instructions provided by the relevant code of best practice. - Consider preventive control measures (e.g. plug holes, remove potential food and drinking as far as possible) to improve product intake and reduce the likelihood of reinvasion. - Remove the remaining bait or the bait stations at the end of the treatment period Use-specific risk mitigation measures - See general directions for use Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment - When placing bait stations close to water drainage systems, ensure that bait contact with water is avoided Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 17 / 223

18 NL STORM Secure PT Use 5 appropriate for further authorisation Rats- professionals - indoor Product Type(s) 14 Where relevant, an exact description of the use Target organism(s) (including development stage) Adult and juvenile: Rattus norvegicus (Norway rat / brown rat), Rattus rattus (roof rat/black rat), Field(s) of use Application method(s) Application rate(s) and frequency Indoor Ready-to-use bait to be used in tamper-resistant bait stations. Place bait throughout the infested area, in tamper-resistant bait boxes. Rats: 2-3 blocks (40 g 60 g) per bait station. If more than one bait station is needed, the distance between bait stations should be 5-10 meters. Category(ies) of users Pack sizes and packaging material Professionals Either loose bait blocks (20 gram each) or PE/PP/PET/HDP laminated sachets containing 60 g bait, further packaged in: Plastic container:3 kg 10 kg, PP or HDPE or PET, closure: lid of PP or PE Reclosable bag: 3 kg 10 kg, paper laminate, re-closable flexible bags Lined reclosable cardboard box: 3 kg 10 kg,, re-closable LDPE lined carton Use-specific instructions for use - The bait stations should be visited only 5 to 7 days after the beginning of the treatment and at least weekly afterwards, in order to check whether the bait is accepted, the bait stations are intact and to remove rodent bodies. Re-fill bait when necessary. 18 / 223

19 NL STORM Secure PT 14 - [When available] Follow any additional instructions provided by the relevant code of best practice. - Consider preventive control measures (e.g. plug holes, remove potential food and drinking as far as possible) to improve product intake and reduce the likelihood of reinvasion. - Remove the remaining bait or the bait stations at the end of the treatment period Use-specific risk mitigation measures - See general directions for use Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment When placing bait stations close to water drainage systems, ensure that bait contact with water is avoided Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use Use 6 appropriate for further authorisation House mice and rats- professionals - outdoor around buildings Product Type(s) 14 Where relevant, an exact description of the use Target organism(s) (including development stage) Adult and juvenile: 19 / 223

20 NL STORM Secure PT 14 Rattus norvegicus (Norway rat / brown rat), Rattus rattus (roof rat/black rat), Field(s) of use Application method(s) Application rate(s) and frequency Mus musculus (house mouse) Outdoor around buildings Ready-to-use bait to be used in tamper-resistant bait stations. Place bait throughout the infested area, in tamper-resistant bait boxes. Mice: 1 block (20 g) per bait station. If more than one bait station is needed, the distance between bait stations should be1-2 meters. Rats: 2-3 blocks (40 g 60 g) per bait station. If more than one bait station is needed, the distance between bait stations should be 5-10 meters. Category(ies) of users Pack sizes and packaging material Professionals Either loose bait blocks (20 gram each) or PE/PP/PET/HDP laminated sachets containing 60 g bait, further packaged in: Plastic container:3 kg 10 kg, PP or HDPE or PET, closure: lid of PP or PE Reclosable bag: 3 kg 10 kg, paper laminate, re-closable flexible bags Lined reclosable cardboard box: 3 kg 10 kg,, re-closable LDPE lined carton Use-specific instructions for use - Protect bait from the atmospheric conditions (e.g. rain, snow, etc.). Place the bait stations in areas not liable to flooding. - The bait stations should be visited [for mice - at least every 2 to 3 days at] [for rats - only 5 to 7 days after] the beginning of the treatment and at least weekly afterwards, in order to check whether the bait is accepted, the bait stations are intact and to remove rodent bodies. Re-fill bait when 20 / 223

21 NL STORM Secure PT 14 necessary. - Replace any bait in a bait station in which bait has been damaged by water or contaminated by dirt. - [When available] Follow any additional instructions provided by the relevant code of best practice Use-specific risk mitigation measures - Do not apply this product directly in the burrows. - Do not wash the bait stations with water between applications. - The product information (i.e. label and/or leaflet) shall clearly show that: The product shall not be supplied to the general public (e.g. "for professionals only"). The product shall be used in adequate tamper resistant bait stations (e.g. "use in tamper resistant bait stations only"). Users shall properly label bait stations with the information referred to in section 5.3 of the SPC (e.g. label bait stations according to the product recommendations") -Using this product should eliminate rodents within 35 days. The product information (i.e. label and/or leaflet) shall clearly recommend that in case of suspected lack of efficacy by the end of the treatment (i.e. rodent activity is still observed), the user should seek advice from the product supplier or call a pest control service. - The baits must be securely deposited in a way so as to minimise the risk of consumption by other animals or children. Where possible secure baits so that they cannot be dragged away Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment - When placing bait stations close to surface waters (e.g. rivers, ponds, water channels, dykes, irrigation ditches) or water drainage systems, ensure that bait contact with water is avoided 21 / 223

22 NL STORM Secure PT Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 2.5 General directions for use Instructions for use - Read and follow the product information as well as any information accompanying the product or provided at the point of sale before using it. - Carry out a pre-baiting survey of the infested area and an on-site assessment in order to identify the rodent species, their places of activity and determine the likely cause and the extent of the infestation. - Remove food which is readily attainable for rodents (e.g. spilled grain or food waste). Apart from this, do not clean up the infested area just before the treatment, as this only disturbs the rodent population and makes bait acceptance more difficult to achieve. - The product should only be used as part of an integrated pest management (IPM) system, including, amongst others, hygiene measures and, where possible, physical methods of control. - Consider preventive control measures (e.g. plug holes, remove potential food and drinking as far as possible) to improve product intake and reduce the likelihood of reinvasion. - The product should be placed in the immediate vicinity of places where rodent activity has been previously observed (e.g. travel paths, nesting sites, feedlots, holes, burrows etc.). - Where possible, bait stations must be fixed to the ground or other structures. - Bait stations must be clearly labelled to show they contain rodenticides and that they must not be 22 / 223

23 NL STORM Secure PT 14 moved or opened (see section 5.3 for the information to be shown on the label). - [If national policy or legislation require it] When the product is being used in public areas, the areas treated should be marked during the treatment period and a notice explaining the risk of primary or secondary poisoning by the anticoagulant as well as indicating the first measures to be taken in case of poisoning must be made available alongside the baits. - Bait should be secured so that it cannot be dragged away from the bait station. - Place the product out of the reach of children, birds, pets and farm animals and other nontarget animals. - Place the product away from food, drink and animal feeding stuffs, as well as from utensils or surfaces that have contact with these. - Wear protective chemical resistant gloves during product handling phase - When using the product do not eat, drink or smoke. Wash hands and directly exposed skin after using the product. - If bait uptake is low relative to the apparent size of the infestation, consider the replacement of bait stations to further places and the possibility to change to another bait formulation. - If after a treatment period of 35 days baits are continued to be consumed and no decline in rodent activity can be observed, the likely cause has to be determined. Where other elements have been excluded, it is likely that there are resistant rodents so consider the use of a non-anticoagulant rodenticide, where available, or a more potent anticoagulant rodenticide. Also consider the use of traps as an alternative control measure Risk mitigation measures - Where possible, prior to the treatment inform any possible bystanders (e.g. users of the treated area and their surroundings) about the rodent control campaign". - To reduce the risk of secondary poisoning, search for and remove dead rodents at frequent intervals during treatment in line with the recommendations provided by the relevant code of best 23 / 223

24 NL STORM Secure PT 14 practice. - Products shall not be used beyond 35 days without an evaluation of the state of the infestation and of the efficacy of the treatment. - Do not use baits containing anticoagulants active substances as permanent baits or for the prevention of rodent infestation or monitoring of rodent activities. - Dispose dead rodents in accordance with local requirements. [The method of disposal shall be described specifically in the national SPC and be reflected on the product label]. -The baits must be securely deposited in a way so as to minimise the risk of consumption by other animals or children. Where possible secure baits so that they cannot be dragged away. - The product information (i.e. label and/or leaflet) shall clearly show that: the product shall not be supplied to the general public (e.g. "for professionals only"). - The product shall be used in adequate tamper resistant bait stations (e.g. "use in tamper resistant bait stations only").users shall properly label bait stations with the information referred to in section 5.3 of the SPC (e.g. label bait stations according to the product recommendations"). - Using this product should eliminate rodents within 35 days. The product information (i.e. label and/or leaflet) shall clearly recommend that in case of suspected lack of efficacy by the end of the treatment (i.e. rodent activity is still observed), the user should seek advice from the product supplier or call a pest control service - Do not wash the bait stations with water between applications Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment - This product contains an anticoagulant substance. If ingested, symptoms, which may be delayed, may include nosebleed and bleeding gums. In severe cases, there may be bruising and blood present in the faeces or urine. - Antidote: Vitamin K1 administered by medical/veterinary personnel only. 24 / 223

25 NL STORM Secure PT 14 - In case of: Dermal exposure, wash skin with water and then with water and soap. Eye exposure, rinse eyes with eyes-rinse liquid or water, keep eyes lids open at least 10 minutes. Oral exposure, rinse mouth carefully with water. Never give anything by mouth to unconscious person. Do not provoke vomiting. If swallowed, seek medical advice immediately and show the product's container or label. Contact a veterinary surgeon in case of ingestion by a pet. - Bait stations must be labelled with the following information: "do not move or open"; "contains a rodenticide"; "product name or authorisation number"; "active substance(s)" and "in case of incident, call a poison centre [insert national phone number]" - Hazardous to wildlife Instructions for safe disposal of the product and its packaging - At the end of the treatment, dispose the uneaten bait and the packaging in accordance with local requirements - Do not reuse the container for any other purpose Conditions of storage and shelf-life of the product under normal conditions of storage - Store in a dry, cool and well ventilated place. Keep the container closed and away from direct sunlight - Store in places prevented from the access of children, birds, pets and farm animals. - Shelf life: The shelf-life of the product is 3 years. Product is not to be stored at temperatures >30 C. 25 / 223

26 NL STORM Secure PT Other information - Because of their delayed mode of action, anticoagulant rodenticides may take from 4 to 10 days to be effective after effective consumption of the bait. - Rodents can be disease carriers. Do not touch dead rodents with bare hands, use gloves or use tools such as tongs when disposing them. - This product contains a bittering agent and a dye. 2.6 Packaging of the biocidal product Type of packaging Size/volume of the packaging Material of the packaging Type and material of closure(s) Intended user (e.g. professional, non-professional) Compatibility of the product with the proposed packaging materials (Yes/No) Plastic container (bucket, bottle, 3 kg to 10 kg PP or HDPE or PET Lid: PP or PE professional and trained professional users Yes bag or similar) with resealable lid containing either loose blocks or sachets* containing up to 60 g bait Recloseable Bag, containing either loose blocks or 3 kg to 10 kg paper laminated with PE / PP / PET / HDPE re-closable flexible bags professional and trained professional users Yes sachets* containing up to 60 g baits Lined reclosable 3 kg to 10 kg LDPE lined cardboard re-closable carton professional and trained Yes 26 / 223

27 NL STORM Secure PT 14 cardboard box, containing either loose blocks or sachets* containing up to 60 g baits professional users * Sachet material is PE / PP / PET / HDPE 27 / 223

28 NL STORM Secure PT 14 3 Assessment of the product 3.1 Use(s) considered appropriate for authorisation after former assessment (uses currently under authorisation) Use(s) considered appropriate for authorisation after former assessment (uses currently under authorisation) 1 Rats and house mice (in and around buildings professionals and nonprofessionals) 2 Brown rats (Rattus norvegicus) (sewer, professionals) Use(s) appropriate for further authorisation 1 Rats and house mice (in and around buildings, trained professionals) 2 Rats and house mice (in and around buildings, professionals) 3 Brown rats (Rattus norvegicus) (sewer, trained professionals) 28 / 223

29 3.2 Physical, chemical and technical properties Neither new data was provided nor new guidance had to be taken into account for re-assessment. Accordingly, the conclusion from the former assessment regarding physical, chemical and technical properties remains valid. 3.3 Physical hazards and respective characteristics Neither new data was provided nor new guidance had to be taken into account for re-assessment. Accordingly, the conclusion from the former assessment regarding physical hazards and respective characteristics remains valid. 3.4 Methods for detection and identification Analytical methods for the analysis of the product as such including the active substance, impurities and residues Analyte Analytica Fortification Lineari Specifi- Recovery rate (%) Limit of Reference (type of analyte e.g. active substanc l method range / Number of measureme nts -ty city Range Mea n RSD (precisio n) quantificati on (LOQ) or other limits e) Flocoumaf HPLC-UV 50% level y = yes ± 3.15 not required Weatherhea en 308 nm (0.025 g/kg) (n = 6) x (no interfere nces 107- (50%) (n=6) for a.s. d, P. (2012) 2012/ % level (0.05 g/kg) (n = 5) 150% level r > (1.000) >3%) (100%) (150%) 88 88% Weatherhea d, P. (2012) 2012/ (0.075 g/kg) (n = 5) Preservati ve Please refer to the confidential annex of the PAR.

30 The available method for flocoumafen determination in baits was already evaluated and accepted by authorities based on the method validation for the bait BAS I. With this additional study validation is presented for BAS I which deviates only by minor degree from BAS I (see confidential annex). Furthermore, this analytical method using acid digestion represents a very harsh method which is considered to work for a wide range of bait matrices. Conclusion on the methods for detection and identification of the product The analytical method for flocoumafen in the bait product was successfully validated regarding linearity, precision, specificity and accuracy for the formulation BAS I (Wax Blocks). 3.5 Efficacy against target organisms Neither new data was provided nor new guidance had to be taken into account for reassessment. Accordingly, the conclusion from the former assessment regarding efficacy against target organisms remains valid Occurrence of resistance For a status report on the resistance situation for anticoagulants in Europe please refer to the following document: RRAC guidelines on Anticoagulant Rodenticide Resistance Management (October 2016). This document provides guidance to advisors, national authorities, professionals, practitioners and others on the nature of anticoagulant resistance in rodents, the identification of anticoagulant resistance, strategies for rodenticide application that will avoid the development of resistance and the management of resistance where it occurs. To download the latest version visit: For Flocoumafen it is confirmed that there is no known resistance. Flocoumafen was shown to be effective against strains of rats and house mice resistant to other anticoagulants. 3.6 Risk assessment for human health Assessment of effects of the active substance on human health Neither new data was provided nor new guidance had to be taken into account for re-assessment. Accordingly, the conclusion from the former assessment regarding effects of the active substance on human health remains valid.

31 3.6.2 Assessment of effects of the product on human health The following new guidance had to be taken into account for the reassessment: EFSA Guidance on dermal absorption (2012) Reassessment of the relevant data: Taking the new guidance on dermal absorption into account the data previously submitted was reassessed: Re-Assessment of available dermal absorption data Dermal absorption of flocoumafen has been tested in vitro using STORM Secure (Roper C.S., 2008). In this chapter, the available in vitro dermal absorption data reported in the study are critically reviewed, based on the criteria laid down in the EFSA Guidance on dermal Absorption (2012) considering (1) residues in the stratum corneum, (2) recovery, (3) variability within the results and (4) rounding of values. (1) Residues in the stratum corneum For establishment of dermal absorption values exclusion of residues in stratum corneum is adequate, if absorption is essentially complete at the end of the study. In the EFSA Guidance Document it is stated, that absorption is completed when over 75% of the absorption occurs within half of the study duration (i.e. 12 hours). Based on the study results, the absorption of flocoumafen from the relevant 0.005% preparation was assessed accordingly. Table 3: t0.5 estimation of the 0.005% flocoumafen preparation Derivation of T0.5 values Rf t12 (ng equiv/cm2) Rf t24 (ng equiv/cm2) Based on the calculated t0.5 value of 77% the permeation in receptor fluid occurred in the first half of the study is considered to be essentially complete and all tape stripped material can be excluded from the calculation of the absorbable dose. (2) Recovery Since the mean recovery over all replicates is >95%, there is no need to consider whether further material is absorbed. (3) Variability within the results and (4) Rounding of values If there is significant variation between replicates (i.e. the standard deviation is equal to or larger than

32 25% of the mean of the absorption) consideration should be given to using a value other than the mean or rejecting the study entirely. The preferred approach would be the addition of a standard deviation to the mean value. Therefore, the variability between results in the study is assessed and the dermal absorption values were adapted. For details please refer to the table below. Table 5: Re-assessment of dermal absorption data considering variability within the results and mean sd receptor fluid receptor compartment skin (inc. exposed and u dermal absorption: 0.95 rounding of values Conclusion Taking into account that >75% of the absorption of flocoumafen occurred in the first half of the study period (i.e. 12 hours) and the absorption is considered essentially completed, the exclusion of stratum corneum for establishment of dermal absorption values of flocoumafen is considered reliable according to the scientific opinion of EFSA Guidance on Dermal Absorption (2012). For establishment of dermal absorption values, the addition of standard deviation to the mean value is considered adequate. Overall, a proposed rounded dermal absorption value of 0.95% in human skin for the 0.005% test preparations, is considered appropriate for use in risk assessment. (In contrast to 1.17% dermal absorption value which was used during product authorisation in the last evaluation.) Further new data was not provided nor had new guidance to be taken into account for re-assessment. Accordingly, the conclusion from the former assessment regarding effects of the product on human health remains valid Exposure assessment The biocidal product STORM Secure contains the active substance flocoumafen (50 ppm). STORM Secure is a ready-to-use block bait used for the control of rats and mice in and around buildings, and the control of rats in sewers, with the purpose of protecting human food and animal feedstuffs, and for general human hygiene. STORM Secure is supplied as a 20 g block with a hole for the use in sewers and in and around buildings. The product is intended for both professional users and trained professional users (in and around buildings) and for trained professionals in sewers. Identification of main paths of human exposure towards active substance(s) and substances of concern from its use in biocidal product Summary table: relevant paths of human exposure Exposure Primary (direct) exposure Secondary (indirect) exposure

33 path Industrial use Professional use Nonprofessional use Industrial use Profession al use General public Via food Inhalation n.a. No No n.a. No No No Dermal n.a. Yes No n.a. No No No Oral n.a. No No n.a. No Yes No n.a. = not applicable

34 List of scenarios Summary table: scenarios Scenario Scenario Primary or secondary exposure Exposed group number (e.g. mixing/ Description of scenario (e.g. professionals, non- loading) professionals, bystanders) STORM Secure 1.1 in and Application, (incl. Primary: Loading of the bait stations with the Trained professional users around clean-up) ready to use bait including cleaning of bait buildings stations. 1.2 in and Application, (incl. Primary: Loading of the bait stations with the Professional users around clean-up) ready to use bait including cleaning of bait buildings stations. 2. in sewer Application Primary: Loading of the bait points in the sewage Trained professional users systems system, for example at manholes, with the readyto-use block bait. Scenario [1.1 Application in and around buildings] Description of Scenario [1.1 Application in and around buildings] Biological activity: Type of formulation: Size: Anticoagulant rodenticide block bait, ready for use (RB) 20 g A.S. content: Flocoumafen: 50 mg/kg (0.005% w/w) Recommended application rate: 60 g of bait per bait station, (equivalent to a maximum of 3 of 20 g baits) Number of loadings of bait boxes: professionals: 60 Number of cleanings of bait boxes: professional users: 15 Placing baits: Indicative value (75th percentile, HEEG Opinion 12): 5.56 mg/bait block Cleaning bait boxes: Indicative value (75th percentile, HEEG Opinion 12): 5.70 mg/bait box Parameters Value Tier 1 Dermal absorption value: 0.95% Body weight 60 kg No PPE - Tier 2 Dermal absorption value: 0.95% Reduction by PPE (chemical resistant gloves) 95% Calculations for Scenario [1.1 Application in and around buildings]

35 Exposure scenario Summary table: estimated exposure from professional uses Tier/PPE Estimated inhalation uptake Estimated dermal uptake Estimated oral uptake Estimated total uptake Scenario [1.1] 1/no PPE None mg/kg bw/d None mg/kg bw/d Scenario [1.1] 2/gloves None mg/kg bw/d None mg/kg bw/d Further information and considerations on scenario [1.1 Application in and around buildings] Post-application exposure is already included in the scenario above. Apart from that no further information and considerations are relevant. Scenario [1.2 Application in and around buildings] Description of Scenario [1.2 Application in and around buildings] Biological activity: Type of formulation: Size: Anticoagulant rodenticide block bait, ready for use (RB) 20 g A.S. content: Flocoumafen: 50 mg/kg (0.005% w/w) Recommended application rate: 60 g of bait per bait station, (equivalent to a maximum of 3 of 20 g baits) Number of loadings of bait boxes: professionals: 60 Number of cleanings of bait boxes: professional users: 15 Placing baits: Indicative value (75th percentile, HEEG Opinion 12): 5.56 mg/bait block Cleaning bait boxes: Indicative value (75th percentile, HEEG Opinion 12): 5.70 mg/bait box Parameters Value Tier 1 Dermal absorption value: 0.95% Body weight 60 kg No PPE - Tier 2 Dermal absorption value: 0.95% Reduction by PPE (chemical resistant gloves) 95% Calculations for Scenario [1.2 Application in and around buildings] Summary table: estimated exposure from professional uses

36 Exposure scenario Tier/PPE Estimated inhalation uptake Estimated dermal uptake Estimated oral uptake Estimated total uptake Scenario [1.1] 1/no PPE None mg/kg bw/d None mg/kg bw/d Scenario [1.1] 2/gloves None mg/kg bw/d None mg/kg bw/d Further information and considerations on scenario [1.2 Application in and around buildings] Post-application exposure is already included in the scenario above. Apart from that no further information and considerations are relevant. Scenario [2. Application in sewers] Description of Scenario [2. Application in sewers] Biological activity: Type of formulation: Size: Anticoagulant rodenticide block bait, ready for use (RB) 20 g A.S. content: Flocoumafen: 50 mg/kg (0.005% w/w) Recommended application rate: 200 g of bait per bait station, (equivalent to a maximum of 10 of 20 g baits) Number of loadings of bait boxes: professionals: 60 Number of cleanings of bait boxes: No cleaning is expected to be performed in sewers. Placing baits: Indicative value (75th percentile, HEEG Opinion 12): 5.56 mg/bait block Parameters Value Tier 1 Dermal absorption value: 0.95% No PPE - Body weight 60 kg Tier 2 Dermal absorption value: 0.95% Reduction by PPE (chemical resistant gloves) 95% Calculations for Scenario [2 Application in sewers] Exposure scenario Summary table: estimated exposure from professional uses Tier/PPE Estimated inhalation uptake Estimated dermal uptake Estimated oral uptake Estimated total uptake Scenario [2] 1/no PPE None mg/kg bw/d None mg/kg bw/d

37 Scenario [2] 2/gloves None mg/kg bw/d None mg/kg bw/d Further information and considerations on scenario [2 Application in sewers] Post-application exposure is already included in the scenario above. Apart from that no further information and considerations are relevant. Combined scenarios Combining scenarios for mixing/loading and application is not relevant for STORM Secure as it is a ready-for-use bait product where mixing is not required. Summary of exposure assessment Scenarios and values to be used in risk assessment Scenario number Exposed group (e.g. professionals, nonprofessionals, bystanders) Tier/PPE Estimated total uptake 1.1 Trained professional users 1/none mg/kg bw/d 1.1 Trained professional users 2/gloves mg/kg bw/d 1.2 Professional users 1/none mg/kg bw/d 1.2 Professional users 2/gloves mg/kg bw/d 2 Trained professional users 1/none mg/kg bw/d 2 Trained professional users 2/gloves mg/kg bw/d Risk characterisation for human health Reference values to be used in Risk Characterisation Reference Study NOAEL (LOAEL) AF 1 Correction for oral absorption AELshort-term Teratogenicity study, rabbits NOAEL mg/kg bw/d AELmedium-term 28-days, rats NOAEL mg/kg bw/d AELlong-term 90-days, rats NOAEL mg/kg bw/d ARfD ADI Not applicable. Not allocated, not necessary. Value *10-6 mg/kg bw/d *10-6 mg/kg bw/d *10-6 mg/kg bw/d

38 1 The European Commission has decided that an assessment factor of 300 shall be applied to this NOAEL for establishing safe exposure levels (10 for intra-species variation 10 for inter-species variation 3 for severity of effects (teratogenicity by readacross from Warfarin). Although the existing developmental toxicity studies on Flocoumafen do not indicate a potential of this substance for teratogenicity or developmental toxicity, developmental toxicity studies on Flocoumafen do not indicate a potential of this substance for teratogenicity or developmental toxicity, RAC has decided to classify flocoumafen with Repro. 1B, H360D based on the same mode of action as Warfarin and a weight of evidence approach (for more details please see RAC opinion: Risk for trained professional users Systemic effects Task/ Scenario Tier Systemic NOAEL mg/kg bw/d AEL mg/kg bw/d Estimated uptake mg/kg bw/d Estimated uptake/ AEL (%) Acceptable (yes/no) Application/ mg/kg bw/d Application/ mg/kg bw/d 8.3*10-6 mg/kg bw/d 8.3*10-6 mg/kg bw/d 8.6*10-6 mg/kg bw/d 4.3*10-7 mg/kg bw/d 104 no 5.2 yes Application/ mg/kg bw/d Application/ mg/kg bw/d 8.3*10-6 mg/kg bw/d 8.3*10-6 mg/kg bw/d 2.71*10-5 mg/kg bw/d 1.35*10-6 mg/kg bw/d 326 no 16.3 yes Combined scenarios Combining scenarios for mixing/loading and application is not relevant for STORM Secure as it is a ready-for-use bait product where mixing is not required. Local effects There is no need to consider local effects separately. Conclusion Based on the risk assessment of STORM Secure, an undue risk for trained professional users wearing gloves resulting from the intended uses is unlikely. Regarding occupational safety, there are no objections against the intended uses Risk for professional users Systemic effects Task/ Scenario Tier Systemic NOAEL mg/kg bw/d AEL mg/kg bw/d Estimated uptake mg/kg bw/d Estimated uptake/ AEL (%) Acceptable (yes/no) Application/ mg/kg bw/d Application/ mg/kg bw/d 8.3*10-6 mg/kg bw/d 8.3*10-6 mg/kg bw/d 8.6*10-6 mg/kg bw/d 4.3*10-7 mg/kg bw/d 104 no 5.2 Yes Combined scenarios

39 Combining scenarios for mixing/loading and application is not relevant for STORM Secure as it is a ready-for-use bait product where mixing is not required. Local effects There is no need to consider local effects separately. Conclusion Based on the risk assessment of STORM Secure, an undue risk for professional users wearing gloves resulting from the intended uses is unlikely. Regarding occupational safety, there are no objections against the intended uses Risk for the general public The currently authorised uses for non-professionals are not included in this application for renewal as this use will not be permitted after application of 9th ATP on March 01, 2018 and thus classification of STORM Secure with Repr. 1B. Neither new data was provided nor had new guidance to be taken into account for re-assessment. Accordingly, the conclusion from the former assessment regarding risks for the general public via indirect contact remain valid. Based on the former assessment the following risk mitigations are included: - The baits must be securely deposited in a way so as to minimise the risk of consumption by other animals or children. Bait should be secured so that it cannot be dragged away from the bait station. - Place the product out of the reach of children, birds, pets and farm animals and other non-target animals. - Where possible, prior to the treatment inform any possible bystanders (e.g. users of the treated area and their surroundings) about the rodent control campaign. - Store in places prevented from the access of children, birds, pets and farm animals. Furthermore, it should be stated here that the product contains an bittering agent in order to prevent accidental intake by infants Risk for consumers via residues in food Neither new data was provided nor had new guidance to be taken into account for re-assessment. Accordingly, the conclusion from the former assessment regarding risks for consumers via residues in food remain valid. Based on the former assessment the following risk mitigations are included:

40 - Place the product away from food, drink and animal feeding stuffs, as well as from utensils or surfaces that have contact with these. - When using the product do not eat, drink or smoke. Wash hands and directly exposed skin after using the product Risk characterisation from combined exposure to several active substances or substances of concern within a biocidal product Not considered to be relevant for STORM Secure since the product is a ready-touse bait. The product contains citric acid (CAS: ) which is an active substance for PT02 and should therefore be considered as a substance of concern. However, exposure to citric acid in a low concentration (see confidential Annex) will not pose any risks when compared to the high reference value (100 mg/kg bw/day MRTD (Maximum Recommended Therapeutic Dose) of FDA list (US Food and Drugs Admnistration, Assessment Report BPR)). Summary of risk characterisation In conclusion, no risk was identified during the renewal and the reassessment of STORM Secure, when the appropriate PPE(gloves) and RMMs were taken into account. 3.7 Risk assessment for animal health Neither new data was provided nor had new guidance to be taken into account for re-assessment. Accordingly, the conclusion from the former assessment regarding animal health remains valid. 3.8 Risk assessment for the environment Neither new data was provided for the renewal of the product nor new guidance had to be taken into account for re-assessment. Accordingly, the conclusion from the former assessment regarding the environment remains valid and is displayed below Please note, that in the previous PAR for STORM Secure it was concluded: Due to very low soil concentrations, the restricted use pattern, the low water solubility (0.114 mg/l at ph 7) and the strong adsorption of the active substance (Koc = 101,684 L/kg) to soil, flocoumafen is not considered to leach to groundwater and hence no PECgroundwater was calculated.

41 This is in line with the current Emission Scenario Document for rodenticides (Danish EPA, J. Larsen, Supplement to the methodology for risk evaluation of biocides - Emission scenario document for biocides used as rodenticides, May 2003) which states the following: A detailed groundwater scenario is not considered necessary due to the limited quantities of active substances, the limited frequency and the limited contaminated area. However, in the BPC Opinions for SGARs (i.e. Flocoumafen ECHA/BPC/115/2016 dated June 16, 2016), it states: A general discussion will take place on data requirements for renewal at the BPC APCP and Environment Working Groups. It may be possible that a Working Group requests additional data to be submitted for the following renewal of the active substance approval. Further, Document CG AP 14.5c WG update on AVKs questions states the following: Groundwater assessment for rodenticides As required by Article 31(3) of the BPR and Article 2(1)(f) of Regulation 492/2014, when carrying out their assessment of whether the conclusions of the first authorisation regarding Article 19(1)(iv) remain valid, applicants will have to address the groundwater assessment. Since no new guidance was agreed in the past that could become applicable at the time of the completion of the applications for renewal by 28/02/2017, the guidance of reference are the existing methods that are applied since years as standard tools for the assessment of active substances: - Tier I according to Vol. IV Part B (the former TGD), - Tier II using the FOCUS models PEARL or PELMO. Given that this is a new requirement (i.e. it replaces the guidance in the PT14 ESD) and following the general principles on the applicability of new guidance (BPC ). The requirements for a ground water assessment of rodenticides should only apply two years from the date of the WG decision and an assessment should not be necessary in the current product authorisation renewal process. Nevertheless, with regard to Tier I as a worst case, the local concentration in pore water (PEClocal, agr.soil,porew) would have to be considered. However, the applicant has indicated that the number of refillings in pulse baitings is now 6 times instead of 3/4 times, and the Cporewater for use in and around buildings and in burrows has been calculated according to the higher PECsoils. In around buildings (worst-case): Cporewater = µg/l Burrow baiting: Cporewater = 0.07 µg/l Sewer systems: Cporewater = 7.0E-06 until 1.8E-05 µg/l

42 Conclusion: The values obtained for the concentration of flocoumafen in porewater are far below the trigger for drinking water of 0.1 µg/l. therefore, it can be concluded that already based on the Tier I of worst case estimation no risk for groundwater is expected from the uses of flocoumafen in STORM Secure. The table below summarises the risks for the other receiving environmental compartments that have been identified as potentially exposed during the use of the product for the different intended uses of the product. Risks for the foreseeable routes of entry into the environment on the basis of the intended uses, calculated in original authorisation. Risk for environmental compartments exposed Intended use STP 1 Freshwater 2 Soil Air Primary and secondary poisoning of birds and mammals In and around buildings n.r. n.r. No No Yes Sewer systems No No No No No 1 Sewage Treatment Plant, 2 Including sediment, 3 Including groundwater; n.r. = not relevant Exposure to the STP and subsequently surface water after cleaning operations at the end of a campaign for the scenario in and around buildings is considered negligible (according to ESD). No risks were calculated for soil and air. The PEC/PNEC ratio for primary and secondary poisoning for birds and mammals resulting from the use in and around buildings exceeds 1, showing the need for implementation of use restrictions and RMMs to minimise the risk. In NL this means a restriction to the use by (trained) professionals as part of Integrated Pest Management (IPM) principles. The use of STORM Secure in sewer systems does not result in a risk for the environmental compartments exposed. For further measures to protect animals and the environment we refer to the SPC which shall be duly taken into consideration for a clear labelling of STORM Secure. Overall conclusion on the risk assessment for the environment of the product As there are no new data or information available since the previous evaluation for authorisation, there is no change regarding the conclusion: STORM Secure has been evaluated as a rodenticide intended to be used for the control of commensal rodents (brown and black rats, house mice) in and around buildings by (trained) professionals and of brown rats in the sewer system by trained professionals. This includes the use of the product in animal

43 burrows burrow baiting by trained professionals only. The assessment presented in the effects and exposure assessment from the applicant for the product has shown that STORM Secure may be reauthorised for use as a rodenticide (Product Type 14). 3.9 Assessment of a combination of biocidal products A use with other biocidal products is not intended Comparative assessment The NL CA for biocides has processed an application for renewal for the biocidal product STORM Secure which contains the active substance flocoumafen. The active substance flocoumafen meets the criteria for exclusion according to Article 5(1) BPR as well as for substitution according to Article 10 BPR (for details see chapter 2.2.3). Therefore, in line with Article 23 (1) BPR a comparative assessment for the product STORM Secure has to be conducted. At the 60th meeting of representatives of Members States Competent Authorities for the implementation of BPR held on 20 and 21 May 2015, all Member States submitted to the Commission a number of questions to be addressed at Union level in the context of the comparative assessment to be carried out at the renewal of anticoagulant rodenticide biocidal products ('anticoagulant rodenticides'). The questions submitted were the following: (a) Is the chemical diversity of the active substances in authorised rodenticides in the Union adequate to minimise the occurrence of resistance in the target harmful organisms?; (b) For the different uses specified in the applications for renewal, are alternative authorised biocidal products or non-chemical means of control and prevention methods available?; (c) Do these alternatives present a significantly lower overall risk for human health, animal health and the environment?; d) Are these alternatives sufficiently effective?; (e) Do these alternatives present no other significant economic or practical disadvantages? The information addressing these questions is provided in the Annex of the Commission Implementing Decision (EU) 2017/1532 According to Article 1 of Commission Implementing Decision (EU) 2017/1532 the NL CA considered the information in the Annex during the comparative assessment of anticoagulant rodenticide biocidal products. Conclusion

44 Based on the information provided in the Annex of the Commission Implementing Decision (EU) 2017/1532 the NL CA came to the conclusion that in the absence of anticoagulant rodenticides, the use of rodenticides containing other active substances would lead to an inadequate chemical diversity to minimize the occurrence of resistance in the target harmful organisms. These products also showed some significant practical or economical disadvantages for the relevant uses. The opinion also considered a number of non-chemical control or prevention methods ("non-chemical alternatives"), which may provide sufficient efficacy in certain circumstances on their own or in a combination of them. However, there is insufficient scientific evidence to prove that those non-chemical alternatives are sufficiently effective according to the criteria established in agreed Union guidance (1) with a view to prohibit or restrict the authorised uses of anticoagulant rodenticides. In summary it can be concluded that the criteria according Article 23(3) a), b) BPR are not fulfilled. Therefore, the authorisation of the product STORM Secure will be renewed for 5 years. 4 Confidential annex (Access level: Restricted to applicant and authority) 4.1 Methods for detection and identification Please refer to confidential annex. 4.2 Full composition of the product Please refer to confidential annex.

45 APPENDIX: Product Assessment Report for first authorisation STORM Secure / STORM 4g / STORM BB 5 th of July 2013 Internal registration/file no: Authorisation/Registration no: Granting date/entry into force of authorisation/ registration: Expiry date of authorisation/ registration: Active ingredient: Product type: THB 13337N 5 th of July th of September 2016 flocoumafen PT14 Biocidal product assessment report related to product authorisation under Directive 98/8/EC

46

47 Contents 1 General information about the product application Applicant PERSON AUTHORISED FOR COMMUNICATION ON BEHALF OF THE APPLICANT Current authorisation holder Proposed authorisation holder Information about the product application Information about the biocidal product GENERAL INFORMATION 2 STORM SECURE (20G BLOCK WITH HOLE) INFORMATION ON THE INTENDED USE(S) INFORMATION ON ACTIVE SUBSTANCE(S) INFORMATION ON THE SUBSTANCE(S) OF CONCERN Documentation DATA SUBMITTED IN RELATION TO PRODUCT APPLICATION ACCESS TO DOCUMENTATION 6 2 Summary of the product assessment Identity related issues Classification, labelling and packaging HARMONISED CLASSIFICATION AND LABELLING OF THE BIOCIDAL PRODUCT 7 NON-PROFESSIONAL USERS: PACKAGING OF THE BIOCIDAL PRODUCT Physico/chemical properties and analytical methods PHYSICO-CHEMICAL PROPERTIES ANALYTICAL METHODS Risk assessment for Physico-chemical properties Effectiveness against target organisms Exposure assessment DESCRIPTION OF THE INTENDED USE(S) ASSESSMENT OF EXPOSURE TO HUMANS AND THE ENVIRONMENT Risk assessment for human health HAZARD POTENTIAL EXPOSURE RISK CHARACTERISATION Risk assessment for the environment EFFECTS ASSESSMENT EXPOSURE ASSESSMENT RISK ASSESSMENT Measures to protect man, animals and the environment 79 3 Proposal for decision National paragraph 80

48 1 General information about the product application 1.1 Applicant Company Name: BASF Agro B.V. Arnhem (NL) Wädenswil Branch Address: Moosacherstrasse 2 City: Au Postal Code: 8804 Country: Telephone: Fax: Switzerland n/a n/a address: Person authorised for communication on behalf of the applicant Name: Function: Address: City: Postal Code: Country: Telephone: Fax: address: 1.2 Current authorisation holder Company Name: BASF Nederland B.V. Address: Groningensingel 1 City: Postal Code: Country: Telephone: Fax: address: Letter of appointment for the applicant to Arnhem 6835 EA The Netherlands n/a n/a n/a n/a

49 represent the authorisation holder provided (yes/no): 1.3 Proposed authorisation holder Company Name: BASF Nederland B.V. Address: Groningensingel 1 City: Postal Code: Country: Telephone: Fax: address: Letter of appointment for the applicant to represent the authorisation holder provided (yes/no): Arnhem 6835 EA The Netherlands n/a n/a n/a n/a 1.4 Information about the product application Application received: 2 nd of November 2011 Application reported complete: Type of application: Further information: 30 th of July 2012 Reregistration of an existing authorisation n/a 1.5 Information about the biocidal product General information Trade name: Manufacturer s development code number(s), if appropriate: Product type: Composition of the product (identity and content of active substance(s) and substances of concern; full composition see confidential annex): Formulation type: STORM Secure BAS I PT % w/w flocoumafen RB (ready for use bait)

50 Ready to use product (yes/no): Is the product the very same (identity and content) to another product already authorised under the regime of directive 98/8/EC (yes/no); If yes: authorisation/registration no. and product name: or Has the product the same identity and composition like the product evaluated in connection with the approval for listing of active substance(s) on to Annex I to directive 98/8/EC (yes/no): Yes No Throughout this PAR reference is being made to three sizes of the product STORM Secure, these will be marketed under the following names: STORM Secure (20g block with hole) STORM BB (16g block) STORM 4g (4g block) Information on the intended use(s) Overall use pattern (manner and area of use): Target organisms: Use in and around buildings Farm buildings e.g. barns, animal housings, warehouses, domestic premises, industry buildings Use in the sewer system Rattus norvegicus (Norway rat / brown rat) Rattus rattus (roof rat/black rat) Mus musculus (house mouse) Effective against rodents resistant to firstgeneration anticoagulants as warfarin, and the second-generation anticoagulants difenacoum and bromadiolone. Category of users: Professionals: -Use in and around buildings -Use in the sewer system Non-professionals: -Use in and around buildings Directions for use including minimum and maximum application rates, General use: Ready-for-use product, wax bait blocks with

51 application rates per time unit (e.g. number of treatments per day), typical size of application area: % w/w flocoumafen and with nominal weights of either 4, 16 or 20 grams. Application: Pre-baiting (non-poisonous) to estimate the infestation (population) size. Appropriate amount of bait to be deployed in infested areas; Pulse baiting technique with three baiting pulses, spaced at 7-day intervals (optional additional pulse on day 4). Post-baiting (non-poisonous) for evaluation of treatment success. Use in and around buildings: The blocks are safely covered by suitable material found at the site; where necessary, additional material for fixing the bait, e.g. wire is used; otherwise temper resistant bait boxes are used. Dose: Against mice:16-32g bait per bait point; Bait points 1-2 m apart. Against rats: 32-60g bait per bait point; Bait points 5 10 m apart. Treatment period no longer than 28 days Use in the sewer system (only for Rattus norvegicus): Use the 20 gram hexagonal blocks with a central hole (STORM Secure). The blocks are fixed safely with for example wire Dose: g bait blocks per bait point (manhole) Treatment period no longer than 5 weeks. Potential for release into the environment (yes/no): Yes

52 Potential for contamination of food/feedingstuff (yes/no) No Proposed Label: Translation of the Dutch labels, see annex 9. Use Restrictions: Bait should not be laid out open and unprotected. No long-term-baiting Information on active substance(s) Active substance chemical name: IUPAC: 4-hydroxy-3-[(1RS,3RS;1RS,3RS)-1,2,3,4- tetrahydro-3- [4-(4-trifluoromethylbenzyloxy)phenyl]-1- naphthyl]coumarin CAS No: EC No: Purity (minimum, g/kg or g/l): Inclusion directive: (ELINCS) Minimum purity 95.5% w/w (50% to 80% cisand 20% to 50% trans- isomers) 2009/150/EC Date of inclusion: 27 November 2009 Is the active substance equivalent to the active substance listed in Annex I to 98/8/EC (yes/no): Manufacturer of active substance(s) used in the biocidal product: Yes (same source as evaluated for inclusion in annex I of Directive 98/8/EC) Please refer to annex I to this report Information on the substance(s) of concern Not applicable. The product STORM Secure does not contain Substances of Concern. 1.6 Documentation Data submitted in relation to product application New studies concerning the product STORM Secure have been submitted with respect to physicalchemical properties of the product, analytical methods, toxicity and efficacy. The studies are listed in Annex 2. Four additional studies related to the active substance have been submitted for the environmental section (bioconcentration in fish, toxicity to soil microorganisms, acute toxicity to earthworms and acute toxicity to plants) to assess the risk for burrow baiting. Also a study on foreseeable routes of entry in the environment on the basis of the use envisaged is submitted. The studies are listed in Annex 2A List of studies reviewed. Study summaries (including evaluation) from the four environmental studies are included in Annex 2B.

53 1.6.2 Access to documentation The applicant BASF Nederland B.V. has provided a letter of access for the dossier on the active substance flocoumafen placed on Annex I of the Biocides Directive 98/8/EC.

54 2 Summary of the product assessment 2.1 Identity related issues Trade name STORM Secure Active ingredient Purity (%w/w) CAS No. EC No. Content (%w/w) Flocoumafen > 95.5% w/w (pure active) The source of flocoumafen is the same as evaluated for inclusion of flocoumafen in Annex I of Directive 98/8/EC. The source has a minimum purity of 95.5%w/w, and an isomeric ratio of 50-80% cis and 20%-50% trans-isomers. STORM Secure does not contain Substances of Concern and is comparable to the formulation included in the evaluation of flocoumafen. Differences in the composition are specified in the confidential annex of this report. 2.2 Classification, labelling and packaging Harmonised classification and labelling of the biocidal product Proposal for the classification and labelling of the formulation concerning physical chemical properties Proposed classification based on Directive 1999/45/EC: Professional and non-professional users: Classification and labeling of the formulation concerning physical chemical properties is not required. Proposed classification based on Regulation EC 1272/2008 Professional and non-professional users: Classification and labeling of the formulation concerning physical chemical properties is not required. Supported shelf life of the formulation: at least 3 years Proposal for the classification and labelling of the formulation concerning human toxicology properties Proposed classification based on Directive 1999/45/EC: Professional users: Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

55 - Symbol: - Indication of danger: - R phrases - - S phrases S2 Keep out of the reach of children S37 Wear suitable gloves Special provisions: DPD-phrases - - Child-resistant fastening obligatory? Not applicable Tactile warning of danger obligatory? Not applicable Explanation: Hazard symbol: - Risk phrases: - Safety phrases: S13 is not indicated for professional users. S20/21 is not indicated, as no R-phrases are assigned. S37 is indicated based on the risk assessment. Other: - Non-professional users: Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances): - Symbol: - Indication of danger: - R phrases - - S phrases S2 Keep out of the reach of children S13 Keep away from food, drink and animal feedingstuffs Special provisions: DPD-phrases - - Child-resistant fastening obligatory? No Tactile warning of danger obligatory? No Explanation: Hazard symbol: - Risk phrases: - Safety phrases: S20/21 is not indicated, as no R-phrases are assigned. Other: - Proposed classification based on Regulation EC 1272/2008 Professional users:

56 Signal word: - Pictogram: - Hazard statements: Precautionary statements: Hazard classand-category Code Hazard statement P102 Keep out of reach of children P280 Wear protective gloves Explanation: Pictogram: - H-statements: - P-statements: P102 is compulsory based on Annex I placing of flocoumafen. P280 is indicated based on the risk assessment for professional users. Non-professional users: Signal word: - Pictogram: - Hazard statements: Precautionary statements: Hazard classand-category Code Hazard statement P102 Keep out of reach of children Explanation: Pictogram: - H-statements: - P-statements: P102 is compulsory based on Annex I placing of flocoumafen Proposal for the classification and labelling of the formulation concerning environmental properties Proposed classification based on Directive 1999/45/EC Professional and non-professional users: Classification and labeling of the formulation concerning environmental properties is not required. Proposed classification based on Regulation EC 1272/2008 Professional and non-professional users: Classification and labeling of the formulation concerning environmental properties is not required.

57 2.2.2 Packaging of the biocidal product A shelf-life of 3 years is supported by shelf-life studies in 2kg polypropylene (PP) containers and 1kg paper/ldpe laminated bags. Professional use Packaging types applied for Packaging types considered acceptable Packaging types applied for and authorised in the Netherlands* Up to 25 kg in plastic (e.g. PP/HDPE/PET) container (bucket, bottle, bag or similar) Up to 25 kg in plastic (e.g. PP/HDPE/PET) container (bucket, bottle, bag or similar) 20g blocks: kg in plastic (PET, PP or HDPE) container. closed by plastic (e.g. PP/PE) lid or by welding containing either loose baits or sachets containing up to 60 g bait closed by plastic (e.g. PP/PE) lid or by welding containing either loose baits or sachets containing up to 60 g bait Up to 25 kg in paper-laminate, poly-weave or similar bag, containing either loose baits or Up to 25 kg in paper-laminate, poly-weave or similar bag, containing either loose baits or 16g blocks: kg in plastic (PET, PP or HDPE) container. sachets containing up to 60 g baits sachets containing up to 60 g baits Up to 10 kg in LDPE lined cardboard carton, containing either loose baits or sachets containing up to 60 g baits Up to 10 kg in LDPE lined cardboard carton, containing either loose baits or sachets containing up to 60 g baits *Member state specific regulations in the Netherlands only allow pack sizes of up to 200 g. for nonprofessional use and from 800 g. for professional use. Non-professional use Packaging types applied for Packaging types considered acceptable Packaging types applied for and authorised in the Netherlands* Same packagings as for professional use, but with pack size limited to 3 kg Same packagings as for professional use, but with pack size limited to 3 kg 20g blocks: 0.2 kg in plastic (PET, PP or HDPE) container. Up to 3 kg in polypropylene/hdpe or similar (plastic) container, paperlaminate or cardboard carton containing pre-filled bait boxes containing up to 60 g of baits Up to 3 kg in polypropylene/hdpe or similar (plastic) container, paperlaminate or cardboard carton containing pre-filled bait boxes containing up to 60 g of baits 16g blocks: 0.15kg or 0.2kg in plastic (PET, PP or HDPE) container. *Member state specific regulations in the Netherlands only allow pack sizes of up to 200 g. for nonprofessional use and from 800 g. for professional use.

58 2.3 Physico/chemical properties and analytical methods Physico-chemical properties Data presented on the active substance (table 1) is the same as included in doc IIA of the competent authority report, established during the evaluation of flocoumafen (final CAR, May 2009). The applicant is main notifier of the active substance. Table 1: Physico-chemical properties of the active substance: Method/ Guideline Result Reference Melting point/ OECD 102 (1995) range capillary/liquid bath method Kofler melting point apparatus / DTA C (purified active Daum A, 2001 ingredient, 99.4%) C (cis-isomer, >99%) Weaver RC, C (trans-isomer, Camilleri P, ~95%) 1985 Boiling point/ range DSC according to OECD 103 No boiling point exists at Daum, A, 2001 atmospheric pressure Relative density OECD 109 Gay-Lussac pycnometer D4 20 = 1.40 (purified active ingredient, 99.4%) Werle H, 2001 Vapour pressure EC A.4; OECD 104 Vapour pressure balance (effusion method) p (20 C) < Pa p (25 C) < Pa p (50 C) < Pa (purified active ingredient, 99.4%) Franke J, 2001 Henry s Law Constant (1) Calculation based on vapour pressure and water solubility H < Pa m 3 /mol Ohnsorge U, 2002 Henry s Law QSAR model calculation by H = Pa m 3 /mol Sendor T, 2003 Constant (2) bond contributions Physical state Visual examination Substance is a fine crystalline Daum, A, 2001 solid (purified active ingredient, and Daum, A, 99.4%) 2002 Colour Visual examination White (purified active ingredient, 99.4%) Daum, A, 2001 and Daum, A, 2002 Odour Organoleptic Odourless (purified active ingredient, 99.4%) Daum, A, 2001 and Daum, A, 2002 Absorption spectra OECD 101 UV absorption maximum at 309 nm, ε = L.mol - 1.cm -1 depending on ph and Daum A, 2003 solvent.

59 Method/ Guideline Result Reference Solubility in water EC A.6; OECD 105 Column elution method Dissociation Calculation based on constant 1) water solubility 2) molecular structure Solubility (20 C) (mg/l ± SD) ph ± ph ± ph ± 0.39 (purified active ingredient, 99.4%) Solubility in deionised water = 0.14 ± mg/l 1) pka = 4.5 ± 0.4 2) pka = 4.5 ± 1.0 Daum A, ) Daum A, ) Daum A, 2002 Solubility in organic Adopted from OECD 105 Solvent Solubility (g/l) Daum A, 2002 solvents Shake flask method Methanol 14.1 (20 C) Toluene 31.3 (20 C) n-octanol 17.4 (20 C) (TGAI, 98.6%) Partition coefficient EC A.8; OECD 107 log P ow (ph 4) > 6.12 log P ow (ph 7) = 6.12 log P ow (ph 9) = 5.11 (purified active ingredient, 99.4%) Daum A, 2002 Thermal stability OECD 113 / DSC Stable up to 250 o C under air Daum, A, 2001 and nitrogen. Flammability EC A10 Not highly flammable Daum, A, 2001 Flashpoint Not relevant (substance is not a liquid) Surface tension - Not considered to be required - due to low solubility (< 1 mg/l) Viscosity - Not relevant for solid - substances. Explosive properties CHETAH 7.2 model calculation / EC A14 Based on the structure of flocoumafen no explosive Battersby RV, 2004 properties are expected. Oxidising properties CHETAH 7.2 model calculation / EC A17 Based on the structure of flocoumafen no oxidising properties are expected. Battersby RV, 2004

60 Method/ Guideline Result Reference Reactivity towards container material Lupolen is used as packaging material. Corrosiveness towards packaging material, containers or apparatus has not been observed. Kaltz, 2001 Most studies included in table 2 were performed on the product with code BAS I, which is the representative product included in the CA-Report. This is acceptable as the new formulation (specification code BAS I) is considered highly similar to BAS I. A detailed comparison of the two products can be found in the confidential part in the summary of product characteristics (annex I). Table 2: Physico-chemical properties of the biocidal product: Method Purity/Specification Results Reference Physical state and nature Visual GLP BAS I Solid hexagonal blocks with Kröhl, T, 2004 and 2005 central hole Colour Visual GLP BAS I Blue Kröhl, T, 2004 and 2005 Odour Organoleptic BAS I Odourless Kaestel, R, 2003 GLP Organoleptic GLP BAS I Grassy Kröhl, T, 2004 and 2005 Explosive properties EC A14, waiver BAS I Not explosive Kröhl, T, 2004 and 2005 GLP Oxidizing properties EC A17, waiver BAS I Not oxidising Kröhl, T, 2004 and 2005 GLP Flash point Not applicable. The product is a solid. Autoflammability EC A16 GLP DF 06826* 0.005% flocoumafen 267 C Schuurman, P., 1989 EC A16 GLP BAS I 267 C Kröhl, T, 2004 and 2005 Other indications of EC A10 DF 06826* Not highly Schuurman, P., flammability GLP 0.005% flocoumafen flammable 1989 EC A10 BAS I Not highly Kröhl, T, 2004

61 Method Purity/Specification Results Reference GLP flammable and 2005 UN Class 4, BAS I Not a self-heating Kröhl, T, 2004 Div 4.2 GLP substance of Division 4.2. and 2005 Acidity / Alkalinity Not applicable CIPAC BAS I 1% in pure water: Kröhl, T, 2004 MT75.2 GLP 4.8 and 2005 Relative density / bulk OECD 109 / density EC A3. GLP CIPAC MT159 GLP Storage stability GLP stability and shelf life GLP Not to GLP Effects of temperature GLP BAS I Density: g/cm 3 at 20 C D4 20 : Kaestel, R, 2003 BAS I Bulk density: Kröhl, T, 2004 Pour: 0.56 g/ml and 2005 Tap: 0.65 g/ml BAS I Stored at 54 C In 2kg PP packs for two weeks, 12 In 1kg paper/pe bags weeks at 37 C, 52 weeks at 28 C, 156 weeks at 20 C. See table 2.1 below BAS I Stored at 54 C In 1kg paper/pe bags for two weeks, 12 weeks at 37 C, 52 weeks at 28 C, 156 weeks at 20 C. See table 2.2 below BAS I Stored for 8 (BAS I) years. Aged sample within FAO range (+/- 25%). 6 samples, mean 41ppm. BAS I Stored at 54 C In 2kg PP packs for two weeks, 12 In 1kg paper/pe bags weeks at 37 C, 52 weeks at 28 C See table 2.1 Kröhl, T, 2004 and 2005 Randt, C, 2006 Wolf, H, 2009 Kröhl, T, 2004 and 2005

62 Effects of light Reactivity towards container material Technical characteristics in dependence of the formulation type Attrition resistance Compatibility with other products Method Purity/Specification Results Reference below GLP BAS I Stored at 54 C Randt, C, 2006 In 1kg paper/pe bags for two weeks, 12 weeks at 37 C, 52 weeks at 28 C. See table 2.2 below Not applicable as the product is stored in nontransparant containers and/or are not expected to be exposed to light. GLP BAS I Stored at 54 C Kröhl, T, 2004 In 2kg PP packs for two weeks, 12 and 2005 In 1kg paper/pe bags weeks at 37 C, 52 weeks at 28 C, 156 weeks at 20 C. See table 2.1 below GLP BAS I Stored at 54 C Randt, C, 2006 In 1kg paper/pe bags for two weeks, 12 weeks at 37 C, 52 weeks at 28 C, 156 weeks at 20 C. See table 2.2 below CIPAC MT178 BAS I <0.1% ** Kröhl, T, 2004 GLP and 2005 Not applicable. Not intended to be mixed with

63 Method Purity/Specification Results Reference other products. Surface tension Not applicable Viscosity Not applicable Particle size distribution Not applicable (not a powder or granule) * The specification of formulation DF is included in the CA-Report. Considering the product does not contain components that are highly flammable or self-igniting, the study is considered acceptable. In addition, there are more recent studies available covering these endpoints. Therefore, the specification is not included in this report. ** The results are not reported as required by the CIPAC method. Attrition is expected to be acceptable for this product type, however, as the report shows the inhalable dust fraction is negligible. Table 2.1 results shelf-life (Kröhl T, 2004) Property Initial 2 wks 12 wks 52 wks 52 wks 104 wks 156 wks 54 C 37 C 28 C 20 C 20 C 20 C Flocoumafe , PP PP PP PP PP PP n content , * (%w/w) , * , paper/pe paper/pe paper/pe paper/pe (0.0051*, paper/pe , *) * paper/pe * (0.0052*, *) Bioassay Rats Rats: Rats: Rats: Rats: Rats: Rats: (mean days M: 5.1 M: 4.9 M: 5.8 M: 5.1 M: 5.9 M: 6.1 M: 5.5 until death) F: 5.4 F: n.d. F: n.d. F: n.d. F: n.d. F: n.d. F: n.d. n.d. = not Mice Mice: Mice: Mice: Mice: Mice: Mice: determined M: 4.7 M: n.d. M: n.d. M: n.d. M: n.d. M: n.d. M: n.d. F: 5.6 F: n.d. F: n.d. F: n.d. F: n.d. F: n.d. F: n.d. Palatibility Rats: Rats: Rats: Rats: Rats: Rats: Rats: (ratio) M: 0.79 M: 0.67 M: 0.60 M: 0.97 M: 0.93 M: 0.96 M: 0.81 n.d. = not F: 1.31 F: n.d. F: n.d. F: n.d. F: n.d. F: n.d. F: n.d. determined Mice: Mice: Mice: Mice: Mice: Mice: Mice: M: 0.54 M: n.d. M: n.d. M: n.d. M: n.d. M: n.d. M: n.d. F: 0.44 F: n.d. F: n.d. F: n.d. F: n.d. F: n.d. F: n.d. Appearance Blue free- PP: PP: PP: PP: PP: PP: flowing no no no no no no solid change change change change change change hexagonal Paper/PE Paper/PE Paper/PE Paper/PE Paper/PE Paper/PE

64 blocks with : no : no : no : no : no : no central change change change change change change hole Odour Not PP: PP: PP: PP: PP: PP: determined Grassy Paper/PE : Grassy Grassy Paper/PE : Grassy Grassy Paper/PE : Grassy Grassy Paper/PE : Grassy Grassy Paper/PE : Grassy Grassy Paper/PE : Grassy ph (1% slurry) Attrition (% dust content) Packaging appearance Packaging weight change (%) 4.8 PP: 4.9 Paper/PE : 4.9 PP: 4.7 Paper/PE : 4.7 PP: 4.1 Paper/PE : 4.6 PP: 4.1 Paper/PE : 4.0 PP: 4.8 Paper/PE : 4.8 <0.1% PP: PP: PP: PP: PP: <0.1% <0.1% <0.1% <0.1% <0.1% Paper/PE Paper/PE Paper/PE Paper/PE Paper/PE : : : : : <0.1% <0.1% <0.1% <0.1% <0.1% Clean, PP: PP: PP: PP: satisfactory no no no no in appearanc e change Paper/PE : no change change Paper/PE : no change change Paper/PE : no change change Paper/PE : no change N/A PP: PP: PP: PP: -0.1% -0.1% -0.1% -0.1% Paper/PE Paper/PE Paper/PE Paper/PE : : : : -1.7% ** -1.5% ** -1.8% ** -0.7% PP: no change Paper/PE : no change PP: -0.1% Paper/PE : -0.7% PP: 5.1 Paper/PE : 5.1 PP: <0.1% Paper/PE : <0.1% PP: no change Paper/PE : no change PP: -0.1% Paper/PE : -0.5% *(re-)analysed using an improved analytical method (RLA 12671) ** RMS considers the weight change likely to be caused by evaporation of water from the paper layer of the packaging rather than from the product itself, caused by the elevated temperatures at which the product is stored. Table 2.2 results shelf-life in paper/pe using improved analytical method (Randt, C, 2006) Property Initial 2 wks 54 C 12 wks 37 C 52 wks 30 C 104wks 30 C 52 wks 20 C 104 wks 20 C 156 wks 20 C Flocoumafen , , , , , , , , content (%w/w)

65 Summary and evaluation The ready to use bait STORM Secure is not explosive, not oxidising, is not highly flammable and does not self-ignite. Based on the data provided, no classification or labelling is required based on physical and chemical properties of the product. The product is sufficiently stable for three years stored in paper/polyethylene (LDPE) bags and polypropylene (PP) containers. Additional data was provided after eight year storage of the product. However, only active substance content was investigated. Palatability and other physical parameters were not investigated. In addition, the active substance content was % after storage, which deviates more than 10% from the specification. No t = 0 value is reported for the batches stored. The flocoumafen content of a freshly produced batch was compared to the aged sample, which is not considered acceptable. A three year shelf-life of the product in PP, paper/ldpe or comparable packs is considered fully supported Analytical methods Technical active substance as manufactured: Impurities in technical active substance: active substance in the formulation: Principle of method Dissolution in hexane/dichloromethane/acetic acid 70/30/0.5 (v/v/v). Normal-phase HPLC-UV (235 nm). Dissolution in acetonitrile/dioxane/0.1% phosphoric acid. C18-reversed-phase HPLC-UV (215 nm). HPLC-UV at 308nm, LC-MS/MS confirmation (RLA V) In addition to the reports available in the competent authority report on flocoumafen, validation of the improved HPLC-UV method RLA V for determination of flocoumafen in flocoumafen (0.005%) baits was provided (Class, T., 2010). The method is able to distinguish flocoumafen s cis and trans isomers, has an improved extraction procedure and was successfully validated regarding linearity, precision, specificity and accuracy. Residue analytical methods for monitoring purposes A new residue analytical method for animal tissues (Hartwig, L, 2010), not included in the CA-Report of flocoumafen is submitted. However, for extraction chloroform is used. The use of chloroform is not allowed for methods intended for routine analysis and therefore, the method cannot be accepted. The flocoumafen dossier already included residue analytical methods for blood, urine, liver and meat. This is considered sufficient (see annex 3 to this report). 2.4 Risk assessment for Physico-chemical properties No new data was provided on physical and chemical properties of the active substance flocoumafen. The data as included in the CA-Report is considered sufficient.

66 For an overview of the physical and chemical properties of the product, please refer to chapter Effectiveness against target organisms Function STORM Secure is a rodenticide (PT14) based on 0,005% w/w flocoumafen. The product is a readyfor-use wax bait block, with nominal weights of 4, 16 and 20 gram. The product is for both professional and non-professional use Organisms to be controlled and products, organisms or objects to be protected STORM Secure is used to control: - Rattus norvegicus (Norway rat / brown rat) - Rattus rattus (roof rat/black rat) - Mus musculus (house mouse) The product is suitable for the control of rodents resistant to first-generation anticoagulants as warfarin, and the second-generation anticoagulants difenacoum and bromadiolone. STORM Secure is used for the control of rats and mice in and around buildings (farm buildings, e.g. barns, animal housings, warehouses, domestic premises, industry buildings) and for control of brown rats in sewers. Professional and non-professional use: the control of rats and mice in and around buildings Professional use only: the control of brown rats in sewers The purpose of STORM Secure is the protection of public health, including: - Prevention of transmission of disease - Prevention of the contamination of food and feeding stuffs and other materials, with urine, faeces and rodent hairs, at all stages of their production, storage and use - Protection of buildings and structures including pipes, cables and overall integrity - Protection of livestock, wild and domestic - Legal requirement Effects on target organisms Flocoumafen is a second-generation anticoagulant. Ingestion of a lethal dose leads to death of the target rodents due to internal haemorrhaging usually within 3 8 days. The efficacy studies were done with the following three formulations: - a hexagonal block with a central hole, with a nominal weight of 20 g (STORM Secure) - a compact block with a nominal weight of 16 g (STORM BB) - a small compact block with a nominal weight of 4 g. (STORM 4 g) These three formulations are all based on the same bait base BAS I. The composition of all these products is identical and only the physical form differs (shape and weight), which does not affect the efficacy of the products. The product evaluated in the CAR of flocoumafen is STORM BB. Several new laboratory and field studies have been conducted with mice and rats using STORM Secure, STORM BB and STORM 4 g BB. Additionally efficacy tests have also been done with STORM BB and STORM 4 g BB based on a different bait base with code number BAS I. The bait base BAS I is identical to BAS I, but excluding a preservative insecticide (0.0002% content), which was removed during product development. The Competent Authority concluded this is to be considered as a minor change of the formulation which does not affect the efficacy or palatability of the product.

67 The results are summarised in tables up to and are discussed per label claim. Claim 1: Efficacy against Rattus norvegicus (Norway rat / brown rat) A. In and around buildings Tests with STORM wax block baits Nineteen studies (5 non-choice tests, 10 choice tests and 4 field tests) were provided for the three different forms of STORM wax block baits (STORM Secure, STORM 4 g and STORM BB wax block 15 g). These are summarized in table Table : Efficacy tests done with STORM wax block baits for Rattus norvegicus (Norway rat / brown rat) Test substance / Test system / Test conditions Test results: effects, mode of Reference Test organism(s) concentrations action, resistance applied / exposure time No-choice tests STORM 4g BB BAS I Rattus norvegicus Wistar strain (anticoagulant susceptible) No-choice feeding of bait for 24 h. Amount of bait in excess of the animals daily food requirement. Observation of deaths and poisoning symptoms Singly-caged, 10 male and 10 female rats, no control. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Cages: cm (l w h) Up to 14 d posttreatment observation 100 % mortality in the male and female rats The mean time to death: 5.3 (range 4-7) days for males (ingestion of 13.9 g =mean amount) 5.9 (range 4-7) days for females (ingestion of 11.0 g =mean amount) IIIB B5.10.2/24 STORM 4g BB BAS I Rattus norvegicus Hampshire strain (Difenacoum and Bromadiolone tolerant strain) No-choice feeding of bait for 24 h. Amount of bait in excess of the animals daily food requirement. Observation of deaths and poisoning symptoms Singly-caged, 10 male and 10 female rats, no control. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Cages: cm (l w h) Up to 14 d posttreatment observation 100 % mortality in the male and female rats The mean time to death: 3.8 (range 3-4) days for males (ingestion of 18.6 g =mean amount) 4.2 (range 3-5) days for females (ingestion of 18.4 g =mean amount) IIIB B5.10.2/25

68 Test substance / Test system / Test conditions Test results: effects, mode of Reference Test organism(s) concentrations applied / exposure action, resistance time STORM 4g BB BAS I Rattus norvegicus Berkshire strain (Difenacoum and Bromadiolone resistant) No-choice feeding of bait for 72 h. Amount of bait in excess of the animals daily food requirement. Observation of deaths and poisoning symptoms Singly-caged, 10 male and 10 female rats, no control. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Cages: cm (l w h) Up to 14 d posttreatment observation 100 % mortality in the male and female rats The mean time to death: 4.5 (range 3-5) days for males (ingestion of 55.1 g =mean amount) 4.2 (range 3-5) days for females (ingestion of 52.5 g =mean amount) IIIB B5.10.2/26 STORM BB wax block BAS I Rattus norvegicus, Wistar strain (anticoagulant susceptible) STORM BB wax block BAS I Rattus norvegicus, Wistar strain (anticoagulant susceptible) No choice feeding of bait for 24 h. Restricted amounts of bait (0.6, 0.8, 1.0, 1.2, 1.6, and 2.0 % of body weight). Comparison of prothrombin times after no-choice bait feeding with those for pure Flocoumafen. Singly-caged, 5male rats. No choice feeding of bait for 24 h. Restricted amounts of bait (0.8, 1.0, 1.2, 1.4, and 1.6 % of an individual s body weight). Determination of bait takes Singly-caged, 5 male and 5 female rats, no control. Not reported Temperature: 20 ± 2 C Relative humidity: 55 ± 10 % Up to 13 d posttreatment observation Median effective doses for the wax block ranged between 9.4 and 14.6 g/kg for two different batches of bait. The mean effective dose for the formulated product was determined at 12.0 g/kg b.w. in males and 11.4 g/kg in females. The lethal dose was delivered with a single feed (within 24 h). LD50 (males) = 0.60 mg/kg (a.i./b.w.) LD50 (females) = 0.57 mg/kg (a.i./b.w.) 100 % mortality was effected by an amount of bait equivalent to 1.4 % of an individual s body weight. Since it is known that rats consume about 10 % of their body weight of food per day, a lethal dose is delivered by an amount of bait corresponding to approximately one seventh of the daily food requirements. IIIB B5.10.2/08 IIIB B5.10.2/09 Choice tests

69 Test substance / Test system / Test conditions Test results: effects, mode of Reference Test organism(s) concentrations applied / exposure action, resistance time STORM 4g BB BAS I Rattus norvegicus Wistar strain (anticoagulant susceptible) STORM Secure wax block BAS I Rattus norvegicus Wistar strain (anticoagulant susceptible) simulating sewer use STORM Secure wax block BAS I Rattus norvegicus, Berkshire strain (Difenacoum and Bromadiolone tolerant) 4-day choice feeding (palatability) test, commercial bait (fresh bait), vs. standard laboratory diet; Amount of bait and laboratory diet in excess of the animals daily food requirement. Singly-caged, 10 male and 10 female rats. 4-day choice feeding simulating sewer use (palatability) test, commercial bait (fresh bait or post 5 day storage at 21 ± 2 C and high relative humidity conditions (80 90 % RH, simulating sewer use), vs. standard laboratory diet; Amount of bait and laboratory diet in excess of the animals daily food requirement. Singly-caged, 5male and 5 female rats. 4-day choice feeding (palatability) test, commercial bait (fresh bait), vs. standard laboratory diet; Amount of bait and laboratory diet in excess of the animals daily food requirement. Singly-caged, 10 male and 10 female rats. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Cages: cm (l w h) Pseudo-random placement of test substance*; Up to 10 d posttreatment observation Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Cages: cm (l w h) Pseudo-random placement of test substance*; Up to 10 d posttreatment observation Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Cages: cm (l w h) Up to 14 d posttreatment observation Fresh bait: Males 100 % mortality Palatability ratio, T/C** = 0.42 (range ) Mean time to death = 5.7 (range 4 8) days Females: 100 % mortality Palatability ratio, T/C = 0.82 (range ) Mean time to death = 5.8 (range 4 8) days The bait was significantly more palatable in the female Wistar rats (analysis of covariance = ANCOVA, p=0.001) Fresh bait: Males and females Mortality = 100 % Palatability ratio, T/C = 1.28 (range ) Mean time to death = 5.8 (range: 4-7) days Stored bait: Males and females Mortality = 100 % Palatability ratio, T/C = 0.70 (range ) days Mean time to death = 5.7 (range: 3 8) days There was a significant difference in the palatability of the initial bait and the bait post storage (storage at 21 ± 2 C and high relative humidity) in male and female Wistar rats. (fresh bait was more palatable, analysis of covariance =ANCOVA, p=0.04). However, 100 % mortality showed that baits were palatable and highly efficacious prior to and after storage. 90 % mortality Male rats: Palatability ratio, T/C = 0.53 (range ) Mean time to death = 4.9 (range 3-10) daus Female rats: Palatability ratio, T/C = 0.94 (range ) Mean time to death = 4.7 (range 3-6) days There was no significant difference between the palatability of the bait in male and female Berkshire rats (analysis of covariance = ANCOVA, p=0.21). IIIB B5.10.2/27 IIIB B5.10.2/01 B5.10.2/02

70 Test substance / Test system / Test conditions Test results: effects, mode of Reference Test organism(s) concentrations applied / exposure action, resistance time STORM BB wax block BAS I Rattus norvegicus, Wistar strain (anticoagulant susceptible) 4-day choice feeding (palatability) test, commercial bait (fresh bait), vs. standard laboratory diet; Amount of bait and laboratory diet in excess of the animals daily food requirement. Singly-caged, 10 male and 10 female rats. Temperature: 20 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Cages: cm (l w h) Pseudo-random placement of test substance Up to 10 d posttreatment observation Males: Mortality = 90 % Palatability ratio, T/C = 0.33 (range ) Mean time to death = 5.9 (range: 4 8 ) days Females: Mortality = 100 % Palatability ratio, T/C = 0.71 (range ) Mean time to death = 7.9 (range: 6 12) days Equally palatable to and efficacious against male Rattus norvegicus. IIIB B5.10.2/10 STORM BB wax block BAS I Rattus norvegicus, Wistar strain (anticoagulant susceptible) STORM BB wax block BAS I 15 g Rattus norvegicus, Wistar strain (anticoagulant susceptible) 4-day choice feeding (palatability) test, commercial bait vs. standard laboratory diet; Singly-caged male and female rats 4-day choice feeding (palatability) test, commercial bait, stored for 52 weeks at 28 C vs. standard laboratory diet; Singly-caged male rats T = 20 ± 2 C; 12-h photoperiod; pseudo-random placement of test substance; 10 d posttreatment observation; test on palatability and efficacy. T = 20 ± 2 C; 12-h photoperiod; pseudo-random placement of test substance; 10 d posttreatment observation; test on fresh bait and post 52 weeks storage at 28 C. Male rats: Palatability ratio, T/C = 0.79 (range ) Mortality = 100 % Mean time to death = 5.1 d (range: 3 7 d) Female rats: Palatability ratio, T/C = 1.31 (range ) Mortality = 100 % Mean time to death = 5.4 d (range: 4 7 d) Equally palatable to and efficacious against male and female Rattus norvegicus. Fresh bait: Palatability ratio, T/C = 0.79 (range ) Mortality = 100 % Mean time to death = 5.1 d (range: 3 7 d) Stored bait: Palatability ratio, T/C = 0.97 (range ) Mortality = 100 % Mean time to death = 5.1 d (range: 3 7 d) Statistical analysis of covariance: p = 0.79, thus equally palatable to and efficacious against male Rattus norvegicus. B5.10.2/11 B5.10.2/12

71 Test substance / Test system / Test conditions Test results: effects, mode of Reference Test organism(s) concentrations applied / exposure action, resistance time STORM BB wax block BAS I Rattus norvegicus, Wistar strain (anticoagulant susceptible) STORM BB wax block BAS I Rattus norvegicus, Wistar strain (anticoagulant susceptible) STORM BB wax block BAS I Rattus norvegicus, Wistar strain (anticoagulant susceptible) 4-day choice feeding (palatability) test, commercial bait, stored for 104 weeks at 20 C vs. standard laboratory diet; Singly-caged male rats 4-day choice feeding (palatability) test, commercial bait, stored for 156 weeks at 20 C vs. standard laboratory diet; Singly-caged male rats 4-day choice feeding (palatability) test, commercial bait, stored for 208 weeks at 20 C vs. standard laboratory diet; Singly-caged male rats T = 20 ± 2 C; 12-h photoperiod; pseudo-random placement of test substance; 10 d posttreatment observation; test on fresh bait and post 104 weeks storage at 20 C. T = 20 ± 2 C; 12-h photoperiod; pseudo-random placement of test substance; 10 d posttreatment observation; test on fresh bait and post 156 weeks storage at 20 C. T = 20 ± 2 C; 12-h photoperiod; pseudo-random placement of test substance; 10 d posttreatment observation; Test on fresh bait and post 208 weeks storage at 20 C Fresh bait: Palatability ratio, T/C = 0.79 (range ) Mortality = 100 % Mean time to death = 5.1 d (range: 3 7 d) Stored bait: Palatability ratio, T/C = 0.96 (range ) Mortality = 100 % Mean time to death = 6.1 d (range 5 7 d) Thus, fresh and stored bait were equally palatable to and efficacious against male Rattus norvegicus (p = 0.79, ANCOVA) Fresh bait: Palatability ratio, T/C = 0.79 (range ) Mortality = 100 % Mean time to death = 5.1 d (range: 3 7 d) Stored bait: Palatability ratio, T/C = 0.81 (range ) Mortality = 100 % Mean time to death = 5.5 d (range 4 6 d) Thus, fresh and stored bait were equally palatable to and efficacious against male Rattus norvegicus (p = 0.50, ANCOVA) Fresh bait: Palatability ratio, T/C = 0.79 (range ) Mortality = 100 % Mean time to death = 5.1 d (range: 3 7 d) Stored bait: Palatability ratio, T/C = 0.63 (range ) Mortality = 100 % Mean time to death = 5.8 d (range 4 7 d) The fresh bait was significantly more palatable than the stored bait (p = , ANCOVA), but both fresh and stored bait were fully efficacious (100 % mortality). B5.10.2/13 B5.10.2/14 B5.10.2/15

72 Test substance / Test system / Test conditions Test results: effects, mode of Reference Test organism(s) concentrations applied / exposure action, resistance time STORM BB wax block BAS I Rattus norvegicus, Wistar strain (anticoagulant susceptible) 4-day choice feeding (palatability) test, commercial bait, stored for 260 weeks at 20 C vs. standard laboratory diet; Singly-caged male rats T = 20 ± 2 C; 12-h photoperiod; pseudo-random placement of test substance; 10 d posttreatment observation; Test on fresh bait and post 260 weeks storage at 20 C Fresh bait: Palatability ratio, T/C = 0.79 (range ) Mortality = 100 % Mean time to death = 5.1 d (range: 3 7 d) Stored bait: Palatability ratio, T/C = 0.60 (range ) Mortality = 100 % Mean time to death = 5.2 d (range 4 6 d) Thus, fresh and stored bait were equally palatable to and efficacious against male Rattus norvegicus (p = 0.268, ANCOVA) B5.10.2/16 Field tests STORM 4g BB BAS I Rattus norvegicus wild free-living population 2 months prior to efficacy 11 rats were trapped in trial site for genetic characterisation: 2 rates (18%) = wildtype 4 rats (36%) = heterozygous Y139C 5 rats (45%) = homozygous Y139C Warfarinresistance is characterised by the Y139C variant of the VKORC1 gene Field test, rural infestation in and around buildings cattle and milk cows) in Germany. 33 bait containers (black plastic bait stations with 2 entrances) or plastic bait trays, the top of which was closed or covered, were installed throughout the infested area. 50 g of bait was placed on each bait point. Baiting period: Bait was replenished with 50 g bait on day 5, 10 and 16 (pulse baiting). Total duration of the baiting period: 24 d Post treatment: 3 days lag period followed by a posttreatment census of 4 days (identical to pre-trial census). June July 2011: Pre-trial census: 4 days Pre-treatment lag period: 10 days Treatment period: the baiting regime was that of pulse baiting (24 days). Post treatment: 3 days lag period followed by a post-treatment census of 4 days. Pre-baiting census: consumption of g wheat. 100% control indicated by both index values of census feed and tracking census. After 24 days of baiting, the infestation was eradicated (100% control success) 100% (4/4) of the rats found dead possessed the genotype Y139C, heterozygous. Flocoumafen is fully effective against this westphalian Y139C strain. IIIB B5.10.2/28

73 Test substance / Test system / Test conditions Test results: effects, mode of Reference Test organism(s) concentrations applied / exposure action, resistance time STORM BB wax block BAS I Rattus norvegicus, Wild free-living population STORM BB wax block BAS I Rattus norvegicus, Wild free-living population Field trial on two farms with rat infestations. Duration: 21 days; pulse baiting technique with three baiting pulses, spaced at 7-day intervals. Bait deployed in infested areas as appropriate, 2 blocks (=30 gram) per bait point or 2 blocks per active hole; bait stations 5 10 m apart. Field trial on six farms with rat infestations. Duration: 29 days; pulse baiting technique with five baiting pulses, spaced at 7-day intervals, with an additional bait replenishment after 3 days. Bait deployed in infested areas as appropriate, 3 blocks (=45 gram) per bait point, 1 block (15 gram) per active burrow hole; bait stations 5 10 m apart. Field conditions, as typical for the study period (April June). Pre- and posttreatment population densities assessed based on consumption of control bait and tracking board indices; monitoring of activity during the trials based on rodenticide consumption, bait station visits, and tracking board scores. Field conditions, as typical for the trial period (spring). Pre- and posttreatment population densities assessed based on consumption of control bait and tracking board indices; monitoring of rat activity during the trials based on rodenticide consumption, bait station visits, and tracking board scores. Rat activity decreased markedly during the treatment. On one farm, the population was completely eradicated, irrespective of the census method. On the other farm a control level of %, depending on the census method, was achieved. In the latter case, only a part of the infested area was covered due to public access to parts of the farm. Rat activity decreased markedly during the treatment. Overall reduction of the populations varied among the six trial sites and was % (based on control bait consumption), % ( active bait stations), (tracking board scores), and % (number of active tracking boards). On average, population densities were reduced by 99.2 %. Efficacy was limited on one farm as a small area was inaccessible to baiting. The applied baiting regime was still premature. Suggestions for improvements of the baiting technique were made. B5.10.2/17 B5.10.2/18

74 Test substance / Test system / Test conditions Test results: effects, mode of Reference Test organism(s) concentrations applied / exposure action, resistance time STORM BB wax block BAS I Rattus norvegicus, Wild free-living population Field trial on six farms with rat infestations. Duration: 21 days; pulse baiting technique with three baiting pulses, spaced at 7-day intervals. Bait deployed in infested areas as appropriate, 2 blocks (=30 gram) per bait point and per active burrow hole; bait stations c. 10 m apart. Field conditions; trials conducted in March/ April; temporarily, cold weather with heavy snowfall occurred. Pre- and posttreatment population densities assessed based on consumption of control bait and tracking board indices; monitoring of activity during the trials based on rodenticide consumption, bait station visits, and tracking board scores. Rat activity decreased markedly during the treatment. Overall reduction of the populations was 100 % on four farms, irrespective of the method employed. On the two other farms, reduction rates varied between 67 and 98 %, depending on site and scoring method. On average, population densities were reduced by 96 %. The difficult weather conditions were supposed to have interfered with baiting success during the first week. * = Pseudo-random placement of test substance: The bait and the control diet are placed in identical B5.10.2/19 feeding dishes, symmetrically placed and replaced daily with fresh material. The position of each dish is alternated daily to eliminate preferred feeding positions. ** = Palatability ratio (T/C) is the amount of the bait consumed (=bait take) divided by the amount of control diet consumed (= control diet take) The efficacy tests demonstrate efficacy of STORM Secure bait against Rattus norvegicus : In laboratory non-choice tests, as the pass criterion of 90% mortality within normally 20 days has been met in the 5 non-choice tests; In laboratory choice tests, as the pass criterion of percentage of ingested bait containing the product 20% (which is equivalent to a palatability ratio (T/C) of 0,25) has been met in all 10 non-choice tests. Moreover in 8 tests mortality was 100% and in 2 tests 90%; In the field tests in most trials % control is indicated by various index values (census feed and tracking). The dosing of the bait applied in the field test ranged from grams per bait station. Bait stations were put 5 10 m apart, pulse baiting technique with three baiting pulses, spaced at 7-day intervals (optional additional pulse on day 4) was used. The baiting periods in the 4 field trials lasted 21, 21, 24 and 29 days, respectively. This does not comply with the instructions of use on the label and in paragraph that state: treatment period no longer than 21 days. The Competent Authority NL concludes that based on the data presented a treatment period no longer than 28 days (following the 7 day interval of the pulse baiting procedure) for brown rats is more appropriate. The Competent Authority NL concludes that STORM Secure is effective in controlling Rattus norvegicus (Norway rat / brown rat) in and around buildings, at a use dosage of grams (2-3 blocks of 20g, 2-3 blocks of 16g, 8-15 blocks of 4 g) of bait per bait point and with bait points spaced 5-10 meter apart, using pulse baiting with a treatment period no longer than 28 days. Efficacy against resistant populations

75 For Rattus norvegicus the field test has been done in a region where warfarin resistance is present in the wild rat populations. Warfarin resistance has been demonstrated by genetical characterisation before the test of trapped rats and in dead rats during the field test. Moreover two strains of Rattus norvegicus with known tolerance/resistance to difenacoum and bromadiolone (Hampshire strain and Berkshire strain) have been tested in no-choice tests, in which efficacy has been demonstrated The Competent Authority NL concludes that the label claim: The product is suitable for the control of rodents resistant to first generation anticoagulants as warfarin and to second-generation anticoagulants difenacoum and bromadiolone can be sustained for Rattus norvegicus. B. In sewer systems: A palatability study (B5.10.2/01) with fresh bait (STORM Secure 20 gram bait blocks) and bait stored during 5 days at 21 ± 2 C and high relative humidity conditions (80 90 % RH, simulating sewer use) has been done for Rattus norvegicus. There was a significant difference in the palatability of the fresh bait and the bait post storage (storage at 21 ± 2 C and high relative humidity) in male and female Wistar rats. However, also the stored bait meets the criteria for efficacy as a mortality of 100 % and a palatability ratio of 0.70 have been demonstrated (see table ref IIIB B5.10.2/01). Use the 20 gram hexagonal STORM Secure blocks with a central hole, as they can be easily fixed by wire. The Competent Authority NL concludes that STORM Secure bait remains palatable and effective against Rattus norvegicus under sewer conditions with a high relative humidity. The proposed dose usage of grams (5-10 blocks of 20 g) of bait per bait station (manholes), using pulse baiting with a treatment period no longer than 35 days for control of brown rats in sewers are realistic and acceptable. C. Use of bait stations The applicant states that placing the product in bait boxes has a strong negative effect on bait consumption. This was concluded based on a field test with plain wheat bait placed in three different commonly used tamper-resistant bait box types and in protected wooden bait trays against a natural population of Norway rats. The results show that 8 times more bait was consumed from the wooden bait trays covered with local material available at the test site (see table ). Therefore, the mandatory use of tamper-resistant bait boxes is not advised by the applicant where other means of securing bait and preventing access by non-targets are available. However, during the field tests of the product, the bait blocks were placed in different types of bait stations and sufficient efficacy was shown in all tests. Table : Field trials to evaluate the consumption of plain wheat bait from bait boxes and trays for Rattus norvegicus (Norway rat / brown rat) Test Test system / Test conditions Test results: effects, mode of Reference organism(s) concentrations applied action, resistance / exposure time

76 Test Test system / Test conditions Test results: effects, mode of Reference organism(s) concentrations applied action, resistance / exposure time Rattus norvegicus wild free-living population Field test, agricultural infestation (in and around buildings) in England. Three trial sites, applications were replicated three times at each site. Four bait placement types: A: Secure wooden bait tray B: Bait box (upright design) C: Bait box (narrow tunnel design) D:Bait box (partitioned atrium design) Test design, based on three balanced Latin Squares. Baits were offered for a period of 4 nights in each replicated treatment. Total trial duration: 12 days. Total bait take during entire test period: Wooden bait trays A: 36,85 kg Bait box type B: 4,40 kg Bait box type C: 4,28 kg Bait box type D: 4,27 kg The consumption of bait from the four different types of bait placement differed significantly and accounted for more than 76% of the total variation (ANOVA, p< 0,001). IIIB B5.10.2/37 Study report and B5.10.2/38 Publication of the same study report Bait boxes and trays were filled with whole dry wheat bait The Competent Authority NL is of the opinion that the product should in principle be placed in tamper-resistant bait boxes or well covered secure ( wooden) trays to prevent acces by children, pets and other non-target organisms and protect the product from wheather conditions. Only in case the product is placed in places to which children, pets and other non-target organisms have no access, such as in sewers and on suspended ceilings, other means of securing are permitted. Claim 2: Efficacy against Rattus rattus (roof rat / black rat) Two efficacy studies have been provided for the two different forms of STORM wax block baits (STORM BB bait and STORM 4 g BB) that are summarized in table These are semi-field pen trials with a colony of wild-derived rats of Rattus rattus. In the TNsG on product evaluation for PT14 (February 2009) is stated that as an alternative or addition to field trials, evidence of the efficacy of a rodenticide product may be obtained from trials against colonies of wild rodents housed within a semi-natural environment ( semi-field trial). Therefore the provided pen trials are acceptable. These efficacy studies demonstrate efficacy of STORM Secure bait against Rattus rattus in semifield pen-trials as % mortality is achieved within less than 20 days. Next to these semi-field trials no other laboratory studies have been provided. In the TNsG on product evaluation for PT14 (February 2009) it is stated under point 4.2 Assessment, that if field data are available, that show that the product is effective against wild rodents, the Competent Authority might consider field trials overweigh laboratory trials.

77 Table : Efficacy tests done with STORM wax block baits against Rattus rattus (roof rat / black rat) Test organism(s) Test system / Test conditions Test results: effects, mode of Reference concentrations action, resistance applied / exposure time STORM BB bait BAS I Rattus rattus colony of wildderived rats (no known resistance status) Pen trial study, with 50 rats. The rats were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Per bait point 8 blocks (120g) attached together by wire and Secured to a wooden tray were placed. Total weight bait per pen: 480 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: 2,5 x 1,1 x 2,1 m (l w h) Acclimatisation period 2 months, 3d pre-test census Pulse baiting, bait was not replenished until day 8. Up to 10 d posttreatment observation If there were any survivors. The colony consisted of 50 rats (32 male, 18 female) 100 % mortality by day 12 of the bait treatment period Mean time to death: 6.2 days (range 3 12 days). Palatability ratio: 0.79 No evidence of carriage of the block bait by the rats was observed. IIIB B5.10.2/20 STORM 4 g BB bait BAS I Rattus rattus colony of wildderived rats (no known resistance status) Pen trial study, with 24 rats. The rats were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Per bait point approximately 50 g of block bait was placed in an aluminium pot which was then placed on an aluminium tray. Total weight bait per pen: 200 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: 2,5 x 1,1 x 2,1 m (l w h) Acclimatisation period 1 month, 3d pre-test census. Test period 16 days. Pulse baiting, bait was not replenished until day 4 and 8. Up to 10 d posttreatment observation If there were any survivors. The colony consisted of 24 rats (14 male, 10 female) 96 % mortality by day 12 of the bait (one single surviving rat) Mean time to death: 6.6 days (range 3 12 days) IIIB B5.10.2/29 Taking into account that the results of laboratory and field tests for both the brown rat (Rattus norvegicus) and the house mouse (Mus musculus) clearly demonstrate high levels of efficacy, the Competent Authority NL considers the pen trials to be sufficient for the efficacy evaluation of STORM Secure and concludes that STORM Secure is effective in controlling Rattus rattus (roof rat /

78 black rat ) in and around buildings, at a use dosage of grams (2-3 blocks of 20g, 2-3 blocks of 16g, 8-15 blocks of 4 g) of bait block per bait point and with bait points spaced 5-10 meter apart, using pulse baiting with a treatment period no longer than 28 days. Efficacy against resistant populations For Rattus rattus no new studies with strains resistance to first-generation anticoagulants and second generation anticoagulants difenacoum and bromadiolone have been provided. However, in the CAR (A5.3/05, Doc IIA) it is sufficiently demonstrated that flocoumafen is effective against roof rats resistant to warfarin. Studies against the second-generation anticoagulants difenacoum and bromadiolone were not provided. The Competent Authority NL concludes therefore that the label claim The product is suitable for the control of rodents resistant to first-generation anticoagulants as warfarin, and the second-generation anticoagulants difenacoum and bromadiolone. can only be sustained for first-generation anticoagulants as warfarin for this species.. Claim 3: Efficacy against Mus musculus (house mouse) Tests with STORM wax block baits (BAS I) Eleven efficacy studies (1 choice test, 9 pen trials and 1 field test) have been provided for the three different forms of STORM wax block baits (STORM Secure, STORM BB and STORM 4 g BB) that are summarized in table The test organism of all studies is Mus musculus domesticus. According to the TNsG on Product Evaluation Chapter 7, PT14 (2009) efficacy data generated using either Mus (musculus) musculus or Mus (musculus) domesticus is acceptable for a label claim against house mice. Table : Efficacy of STORM Secure bait (0.005 % w/w flocoumafen) with Mus musculus domesticus Test Test system / Test conditions Test results: effects, mode of Reference organism(s) concentrations action, resistance applied / exposure time Choice feeding tests

79 Test Test system / Test conditions Test results: effects, mode of Reference organism(s) concentrations action, resistance applied / exposure time STORM 4g BB BAS I Mus musculus domesticus CD1 strain 4-day choice feeding (palatability) test, commercial bait (fresh bait), vs. standard laboratory diet; Amount of bait and laboratory diet in excess of the animals daily food requirement. Singly-caged 10 male mice, no control. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Cages: cm (l w h) Pseudo-random placement of test substance*; Up to 10 d posttreatment observation Fresh bait: Mortality = 90 % Palatability ratio, T/C = 0.23 (range ) Mean time to death = 6.0 (range: 4 8) days A single mouse did not ingest the amount of bait required to deliver a fatal outcome. IIIB B5.10.2/30 STORM 4g BB BAS I Mus musculus domesticus, C57BL/10 strain 4-day choice feeding (palatability) test, commercial bait (fresh bait and bait stored 6 months at ambient conditions), vs. standard laboratory diet; Amount of bait and laboratory diet in excess of the animals daily food requirement. Singly-caged, 10 male mice. Temperature: 20 ± 2 C 12 h light, 12 h dark cycle Cages: cm (l w h) Pseudo-random placement of test substance*; Up to 10 d posttreatment observation Fresh bait: Mortality = 100 % Palatability ratio, T/C = 0.22 ( ) Mean time to death = 4.7 (range: 4 6) days Stored bait: Mortality = 100 % Palatability ratio, T/C (95 % CI) = 2.13 ( ) Mean time to death = 4.8 (range: 4 6) days IIIB B5.10.2/31 STORM 4g BB BAS I Mus musculus domesticus, C57BL/10 strain 4-day choice feeding (palatability) test, commercial bait (fresh bait and bait stored 24 months at ambient conditions), vs. standard laboratory diet; Amount of bait and laboratory diet in excess of the animals daily food requirement. Temperature: 20 ± 2 C 12 h light, 12 h dark cycle Cages: cm (l w h) Pseudo-random placement of test substance*; Up to 10 d posttreatment observation Fresh bait: Mortality = 100 % Palatability ratio, T/C = 0.22 ( ) Mean time to death = 4.7 (range: 4 6) days Stored bait: Mortality = 90 % Palatability ratio, T/C = 0.19 ( ) Mean time to death = 6.3 (range: 5 9) days IIIB B5.10.2/32 Singly-caged, 10 male mice. Pen trial tests

80 Test Test system / Test conditions Test results: effects, mode of Reference organism(s) concentrations action, resistance applied / exposure time STORM Secure wax block BAS I Mus musculus domesticus (wild derived, no known resistance status) Pen trial study with 42 mice. The mice were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Per bait point one block of bait (approximately 20 g) Secured onto an aluminium tray. Total weight bait per pen: 80 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: m (l w h) Acclimatisation period 1 month, 3d pre-test census Pulse baiting, bait was not replenished until day 4 and 8. Up to 10 d posttreatment observation if there are any survivors The colony consisted of 42 mice (28 male, 14 female) 100 % mortality by day 6 of the bait treatment period Mean time to death: 3.4 days (range 2-6 days) IIIB B5.10.2/04 STORM Secure wax block BAS I Mus musculus domesticus (wild derived, no known resistance status) Pen trial study with 93 mice. The mice were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Per bait point one block of bait (approximately 20 g) Secured by wire onto a wooden tray, which was then placed on an aluminium tray. Total weight bait per pen: 80 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: m (l w h) Acclimatisation period 1 month, 3d pre-test census Pulse baiting, bait was not replenished until day 4 and 8. Up to 10 d posttreatment observation if there are any survivors The colony consisted of 93 mice (50 male, 43 female) 100 % mortality by day 10 of the bait treatment period Mean time to death: 4.1 days (range 2-10 days) IIIB B5.10.2/05 STORM Secure wax block BAS I Mus musculus domesticus (wild derived Bromadiolone resistant strain) Pen trial study with 42 mice. The mice were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Per bait point approximately 25 g of block bait secured by wire onto a wooden tray, which was then placed on an aluminium tray. Total weight bait per pen: 100 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: m (l w h) Acclimatisation period 1 month, 3d pre-test census Pulse baiting, bait was not replenished until day 4 and 8. Up to 10 d posttreatment observation if there are any survivors The colony consisted of 42 mice (50 male, 43 female) 100 % mortality by day 12 of the bait treatment period Mean time to death: 6.9 days (range 2-12 days) IIIB B5.10.2/06

81 Test Test system / Test conditions Test results: effects, mode of Reference organism(s) concentrations action, resistance applied / exposure time STORM Secure wax block BAS I 20 g Mus musculus domesticus (wild derived Bromadiolone resistant strain) Pen trial study with 70 mice. The mice were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Per bait point 1 block (approximately 20 g) of bait were placed in an aluminium pot on an aluminium tray. Total weight bait per pen: 80 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: m (l w h) Acclimatisation period 1 month, 3d pre-test census Pulse baiting, bait was not replenished until day 4 and 8. Up to 10 d posttreatment observation if there are any survivors The colony consisted of 70 mice (42 male, 28 female) 100 % mortality by day 11 of the bait treatment period Mean time to death: 6.6 days (range 3-11 days) Palatability ratio on day 1: 0.79 IIIB B5.10.2/07 STORM BB bait BAS I Mus musculus domesticus (wild derived, no known resistance status) Pen trial study with 105 mice. The mice were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Each bait point consisted of an open metal pot placed on an aluminium tray. The pot contained approximately 6 STORM blocks (90 g bait) held together with metal wire. Total weight bait per pen: 360 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: m (l w h) Acclimatisation period 1 month, 3d pre-test census Up to 10 d posttreatment observation if there are any survivors The colony consisted of 105 mice (48 male, 57 female) 100 % mortality by day 7 of the bait treatment period Mean time to death: 4.2 days (range 2-7 days) Palatability ratio (days 1 3): 2.9 ( ) IIIB B5.10.2/21 STORM 4g BB BAS I Mus musculus domesticus (wild derived, no known resistance status) Pen trial study with 29 mice. The mice were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Per bait point 8 blocks bait (approximately 25 g) were placed in an aluminium pot on an aluminium tray. Total weight bait per pen: 100 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: m (l w h) Acclimatisation period 1 month, 3d pre-test census Pulse baiting, bait was not replenished until day 4 and 7. Up to 10 d posttreatment observation if there are any survivors The colony consisted of 29 mice (9 male, 20 female) 100 % mortality by day 9 of the bait treatment period Mean time to death: 4.1 days (range 2 9 days) IIIB B5.10.2/33

82 Test Test system / Test conditions Test results: effects, mode of Reference organism(s) concentrations action, resistance applied / exposure time STORM 4g BB BAS I Mus musculus domesticus (wild derived, no known resistance status) Pen trial study with 45 mice. The mice were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Per bait point 8 blocks bait (approximately 25 g) were placed in an aluminium pot on an aluminium tray. Total weight bait per pen: 100 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: m (l w h) Acclimatisation period 1 month, 3d pre-test census Pulse baiting, bait was not replenished until day 4 and 8. Up to 10 d posttreatment observation if there are any survivors The colony consisted of 45 mice (28 male, 17 female) 100 % mortality by day 8 of the bait treatment period Mean time to death: 3.9 days (range 2 8 days) IIIB B5.10.2/34 STORM 4g BB BAS I Mus musculus domesticus (wild derived, Bromadiolone resistant) Pen trial study with 50 mice. The mice were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Per bait point 8 blocks bait (approximately 25 g) were placed in an aluminium pot on an aluminium tray. Total weight bait per pen: 100 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: m (l w h) Acclimatisation period 1 month, 3d pre-test census Pulse baiting, bait was not replenished until day 4 and 7. Up to 10 d posttreatment observation if there are any survivors The colony consisted of 50 mice (24 male, 26 female) 100 % mortality by day 12 of the bait treatment period Mean time to death: 6.2 days (range 2 12 days) IIIB B5.10.2/35 STORM BB wax block BAS I Mus musculus domesticus (wild derived, warfarin resistant PBI mice) Pen trial study with 105 mice. Four family groups housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen.. Single bait blocks (15 g bait) offered at each bait point within the pens Total weight bait per pen: 60 g. Four family groups housed in pens measuring m (l w h), with a separate nesting area of m. 7 days conditioning Test duration: 21 days The colony consisted of 84 mice (38 male, 46 female) 100 % mortality by day 16 of the bait treatment period Mean time to death: 7.2 days (range 3-16 days) Palatability ratio (days 1 3): 2.9 ( ) IIIB B5.10.2/22

83 Test Test system / Test conditions Test results: effects, mode of Reference organism(s) concentrations action, resistance applied / exposure time STORM BB bait BAS I Mus musculus domesticus (wild derived, Bromadiolone resistant strain) Pen trial study with 41 mice. The mice were housed in a test pen = semi-natural environment. Control diet and 4 bait points per test pen. Each bait point consisted of an open metal pot placed on an aluminium tray. The pot contained approximately 200 g bait. Total weight bait per pen: 800 g. Temperature: 21 ± 2 C Relative humidity: 55 ± 10 % 12 h light, 12 h dark cycle Test pens: m (l w h) Acclimatisation period 1 month, 3d pre-test census Pulse baiting, bait was not replenished until day 4 and 8. Up to 10 d posttreatment observation if there are any survivors The colony consisted of 94 mice (21 male, 20 female) 100 % mortality by day 6 of the bait treatment period Mean time to death: 3.4 days (range 3-6 days) Palatability ratio (days 1 2): 2.0 ( ) IIIB B5.10.2/23 Field tests STORM 4g BB BAS I Mus musculus domesticus Free living population (no known resistance status) Field test, rural infestation (three storage units and an office) in England. 37 bait trays were installed in protected positions sited strategically ca. 1-2 m apart throughout the infested area. 15 g of bait was placed on each tray. Baiting period: Bait was replenished on day 4 (pulse baiting). April May 2011: Pre-trial census: 4 days Pre-treatment lag period: 10 days Treatment period: 7 days. The baiting regime was that of pulse baiting. Post treatment: 3 days lag period followed by a posttreatment census of 4 days. Pre-baiting census: consumption indicated ca. 6mice (mean pretreatment census) to ca.37 mice (maximum pre-treatment census) assuming a census diet takes of 2,5 g per mouse per day % control after 7 days is indicated by various indices of treatment success (based on bait census and tracking data) The post treatment census indicated a low level of post treatment activity with no control diet take. It was not possible to determine if this was a residual population or immigration. IIIB B5.10.2/36 * = Pseudo-random placement of test substance: The bait and the control diet are placed in identical feeding dishes, symmetrically placed and replaced daily with fresh material. The position of each dish is alternated daily to eliminate preferred feeding positions. ** = Palatability ratio (T/C) is the amount of the bait consumed (=bait take) divided by the amount of control diet consumed (= control diet take) The efficacy tests demonstrate efficacy of STORM Secure against Mus musculus: In three laboratory choice tests. Although the palatability ratio (T/C), which is ,23 in this test, is slightly lower than the pass criterion of percentage of ingested bait containing the product 20%, which is equivalent to a palatability ratio (T/C) of 0,25, these results are acceptable, as the test results in a mortality of %. In semi-field pen-trials as in all ten studies 100% mortality is achieved within 6-16 days with use dosages of grams (most tests:15-30 grams) per bait point and 4 bait points per pen (4.5m 2 ).

84 In one field test as % control is indicated by various indices of treatment success (based on bait census and tracking data) after 7 days. Per bait point 15 grams of bait was used and the bait points were spaced 1-2 meter apart. This differs from the label claim that states that for control of mice 1 bait point with1-3 bait blocks of 20g should be used per 10-15m 2. In the pen trials and in the field trials 100% mortality is achieved after 6-16 days, therefore a treatment period no longer than 21 days, as proposed by the applicant is acceptable for mice. Therefore the Competent Authority NL concludes that STORM Secure is effective in controlling house mice (Mus musculus) when used at a dosage of grams (1 block of 16g or 20g) per bait station with bait stations spaced 1-2 meter apart, using pulse baiting and a treatment period no longer than 21 days. Efficacy against resistant populations For Mus musculus one strain resistant to first-generation anticoagulants (family colonies of wild derived warfarin-resistant PBI strain) has been tested in a pen trial, that demonstrated efficacy. Moreover, family colonies of wild-derived mice of Mus musculus domesticus with known resistance to bromadiolone have been tested in four pen-trials, in which efficacy has been demonstrated. Therefore the Competent Authority concludes that the label claim The product is suitable for the control of rodents resistant to first-generation anticoagulants as warfarin and to second-generation anticoagulants bromadiolone and difenacoum. can only be sustained for warfarin and bromadiolone for this species. Claim 4: Shelf-life. Only for Rattus norvegicus and Mus musculus palatability tests (4-day choice feeding) have been done with fresh bait and bait (STORM BB wax block, BAS I) that had been stored for various periods under various conditions (see tables and ). Both types of bait, fresh and stored, were tested versus standard laboratory diet. No significant difference in the palatability of the initial bait and the bait post storage were found in male and female Rattus norvegicus for the following storage conditions: - 52 weeks storage at 28 C weeks storage at 20 C weeks storage at 20 C weeks storage at 20 C weeks storage at 20 C These efficacy results sustain a shelf- life time of 4 years under normal conditions of storage for rats, as claimed by the applicant. Moreover efficacy has been shown for stored bait in male Mus musculus for the following storage conditions:

85 - 6 months at ambient temperatures - 24 months at ambient temperatures. Although the palatability ratio (T/C) for bait stored during 24 months at ambient temperatures is only 0.19 in the test, and thus lower than the pass criterion of percentage of ingested bait containing the product 20%, which is equivalent to a palatability ratio (T/C) of 0.25, these results are acceptable, as the test results in a mortality of 90%. The shelf life period tested of 24 months is, however, much shorter that the claim of the applicant for a shelf life of four years. The Competent Authority NL concludes that the overall efficacy results do not sustain a shelf- life time of 4 years under normal conditions of storage, as claimed by the applicant, but only a shelf-life of at least 3 years under normal storage conditions. Additional information: A number of studies was provided that may contain additional information on the efficacy of wax block baits with a flocoumafen content of % w/w. Since sufficient information is presented above, these studies are only listed in the Annex 2 list under references B5.10.2/39 - B5.10.2/52 as supportive data. General conclusions on efficacy STORM Secure bait is palatable to Rattus norvegicus, Rattus rattus and Mus musculus and causes mortality as required for satisfactory control of rodent infestations. The efficacy data support the following label claims of STORM Secure baits: Effective against Rattus norvegicus, Rattus rattus and Mus musculus when used according to the use instructions summarized in Table ; For professional and non-professional use to control of Rattus norvegicus, Rattus rattus and Mus musculus in and around buildings;; For professional use to control Rattus norvegicus in sewers; Palatable and effective after 3 years of storage under normal storage conditions. Effective against Rattus norvegicus resistant to first-generation anticoagulants as warfarin and the second-generation anticoagulants difenacoum and bromadiolone. Effective against Rattus rattus resistant to first-generation anticoagulants as warfarin. Effective against Mus musculus resistant to first-generation anticoagulants as warfarin and the second-generation anticoagulant bromadiolone Dose Table : Summary of use pattern for STORM Secure for professional and non-professional users Species Recommended Application rate for Frequency of controls Checking / Replenishing Time of treatment and

86 one bait point/baiting place of point intervals application Mice Rats: Brown & Black Brown rats grams of bait per bait station/bait point. 20g : 1 block 16g: 1 block 4g: 2-3 blocks Place bait stations 1-2 m apart grams of bait per bait station. 20g : 2-3 blocks 16g: 2-3 blocks 4g: blocks Place bait stations 5 10 m apart grams of bait per bait point (manhole). Check the uptake of bait after 4 and 7 days and thereupon on a regular basis based on bait uptake every 7 days. Treatment period no longer than 21 days. Check the uptake of bait after 4 and 7 days and thereupon on a regular basis based on bait uptake every 7 days Treatment period no longer than 28 days. Check the uptake of bait after 4 and 7 days and thereupon on a regular basis based on bait uptake every 7 days. At each control, re-apply the bait. At each control, re-apply the bait. At each control, re-apply the bait. All year In & around buildings All year In & around buildings All year in sewers 20g: 5-10 blocks Treatment period no longer than 35 days Mode of action Flocoumafen, just like other coumarin derivatives, acts as a vitamin K antagonist. Vitamin K in its reduced form (KH2) is essential in the synthesis of blood coagulation factors, taking place in the vertebrate liver. KH2 is recycled in a two-step process by reductases. Flocoumafen blocks these reductases, resulting in the depletion of Vitamin K stores. Consequently, the synthesis of blood coagulation factors is disrupted, which leads to loss of blood clotting ability Limitations The bait should not be laid out open and unprotected. Long-term-baiting should not be applied. For the authorisation of rodenticides for controlling rats, the Competent Authority NL, is of the opinion that the general public is not able to use rodenticides against rats in a correct way. Incorrect use can cause resistance in rats which will increase problems of controlling rats in the future. Furthermore, in the Netherlands the control of rats and use of rodenticides against rats is restricted to licensed professional users and rodenticides against rats have never been used by the general public. Therefore the authorisation of rodenticides for controlling rats in the Netherlands is restricted to licensed professional users, only due to national policy Resistance Resistance to flocoumafen has not become known to date. The long pharmacokinetic half-life of flocoumafen and its fluorinated side chain which prevents biotransformation may be seen as a reason why resistance to flocoumafen has not yet been reported. Rodenticide products containing flocoumafen like STORM Secure are eligible for controlling rat and mouse infestations where resistance to first-generation anticoagulants as warfarin and also

87 resistance to difenacoum and bromadiolone has evolved. Indeed, the resistance breaking potential of STORM products is recognised at International levels in guidelines issued, for example, by the Rodenticide Resistance Action Group and the Rodenticide Resistance Action Committee of CropLife International. Nonetheless the Competent Authority NL is of the opinion, because of the history of resistance development in rodents against anti-coagulants, that there is a potential for resistance development also against flocoumafen. Therefore a management strategy to minimise the likelihood of resistance to the active substance developing in the target species is proposed Resistance management strategy To avoid the development of resistance in rodent populations the following points should be adopted for all control programmes: Ensure that all baiting points are inspected weekly and old bait is replaced where necessary. Undertake treatment according to the label until the infestation is completely cleared. On completion of the treatment remove all unused baits. Do not use anticoagulant rodenticides as permanent baits routinely. Monitoring of rodent activity should be undertaken using visual survey, through the use of non-toxic placebo monitors or by other effective means. Record details of the treatment. Where rodent activity persists due to problems other than resistance, use alternate baits or baiting strategy or apply alternate control techniques to eliminate the residual infestation (acute or sub-acute rodenticides, gassing or trapping). Ensure that complete elimination of the infestation is achieved. As appropriate during the rodenticide treatment apply effective Integrated Pest Management measures (remove alternate food sources, remove water sources, remove harbourage and proof susceptible areas against rodent access). When resistance to anticoagulants is suspected or identified, the following should be conducted: Where rodent infestations containing resistant individuals are identified, immediately use an alternate anticoagulant of the same potency. If in doubt, seek expert advice on the local circumstances. Alternatively use an acute or sub-acute but non-anticoagulant rodenticide. In both cases it is essential that complete elimination of the rodent population is achieved. Gassing or fumigation may be useful in specific situations. Apply thorough Integrated Pest Management procedures (environmental hygiene, proofing and exclusion). Do not use anticoagulant rodenticides as permanent baits as routine. Record details of the treatment. In NL rat control is only allowed by professionals and these professionals always need to be certificated as a pest controller. They are educated in resistance management strategies. On the label for professional use the following sentence is added: For the active substance in this product, flocoumafen, there is a risk of development of resistance. Therefore, this product should not be used in cases where resistance against flocoumafen is presumed, for instance in cases where the last treatment with flocoumafen containing products did not results in a reduction of the population. In most cases, treatment with this product should have achieved control within 21 days for mice and 28 days for rats in and around buildings and 35 days for brown rats in sewers. Should activity of house mice, brown or black rats continue beyond this time, the likely cause should be determined and measures should be taken It cannot be expected that non-professionals have any knowledge on resistance. Therefore, it is

88 stated on the Dutch label for non-professionals that a professional pest controller should be consulted when the control of mice is not sufficient after 21 days Humaneness The use of flocoumafen as a rodenticide could cause suffering of vertebrate target organisms but it is considered that this is not in conflict with the requirements of Art. 5.1 of the BPD to avoid unnecessary pain and suffering of vertebrates, as long as effective, but comparable less painful alternative biocidal substances or biocidal products or even non-biocidal alternatives are not available. The use of anti-coagulant rodenticides is necessary as there are at present no other valuable measures available to control rodent populations in the European Union. Rodent control is needed to prevent disease transmission, contamination of food and feeding stuffs and structural damage Evaluation of the label claim The applicant has provided a Dutch WG/GA. This has been adapted to our standards. For the convenience of the competent authorities authorising this product through mutual recognition, the Dutch labels, translated in English, are added to the PAR in annex 9. Field of use Efficacy is claimed for indoor and outdoor use and use in sewers. However, authorisation for this product in NL is only allowed for indoor use and use in sewers. For environmental reasons outdoor use is not authorized (see 2.8). Target species The organisms claimed to be controlled by non-professionals are brown rats, black rats and mice. However, the authorisation to use rodenticides for controlling rats in the Netherlands is restricted to licensed professional users only due to national policy. The Dutch label claims (WG/GA) have been adapted accordingly. The claim: Effective against rodents resistant to first-generation anticoagulants as warfarin, and the second-generation anticoagulants difenacoum and bromadiolone has been changed into: The product is suitable for the control of rats and mice resistant to first-generation anticoagulants as warfarin, and to brown rats resistant to the second-generation anticoagulants difenacoum and bromadiolone and mice resistant to resistant to the second-generation anticoagulant bromadiolone. Use instructions The use dosages, spacing of bait stations for mice and the treatment periods have been adapted. They are summarized in Table Resistance management In the PAR a resistance management strategy is outlined. A short remark on resistance is added to the Dutch label (WG/GA), this differs for professional and non-professional use since nonprofessionals are not expected to have knowledge on resistance. For professional use:

89 For the active substance in this product, flocoumafen, there is a risk of development of resistance. Therefore, this product should not be used in cases where resistance against flocoumafen is presumed, for instance in cases where the last treatment with flocoumafen containing products did not results in a reduction of the population. In most cases, treatment with this product should have achieved control within 21 days for mice and 28 days for rats and 35 days for brown rats in sewers. Should activity of house mice, brown or black rats continue beyond this time, the likely cause should be determined and measures should be taken. For non-professional use (mice only in NL): If 21 days after the start of the treatment the control of mice is not sufficient, a professional in pest control should be consulted. 2.6 Exposure assessment Description of the intended use(s) STORM Secure is a ready-for-use rodenticide block bait based on 0,005% w/w flocoumafen for the control of brown and black rats and house mice in and around buildings. The product is for both professional and non-professional use. Baits should be placed in temper resistant bait boxes or safely covered by suitable material found at the site; where necessary, additional material for fixing the bait, e.g. wire is used; For control of rats in and around buildings 32-60g bait should be placed per bait station, which should be positioned at 5 to10 meter distance of each other. For control of mice in and around buildings 15-30g bait should be placed per bait station, which should be used at a rate of 1 bait point per 1-2 meter. For control of brown rats in sewers gram bait per bait point (manhole) is used. The product is suitable for the control of rats and mice resistant to first-generation anticoagulants as warfarin, and of brown rats resistant to the second-generation anticoagulants difenacoum and bromadiolone and of mice resistant to the second-generation anticoagulant bromadiolone Assessment of exposure to humans and the environment STORM Secure is intended to be used for the control of commensal rodents (brown and black rats, house mice) in and around buildings and of rats in the sewerage. This includes the use of the product in animal burrows burrow baiting. The product is for both professional and non-professional use. The product is placed on the market in the form of solid wax blocks with a nominal weight of 20 g for the use in sewers; as a 16 g block, and as a 4 g block. The environmental exposure and risk assessment of the biocidal product STORM Secure containing 50 mg/kg flocoumafen from the applicant was examined appropriately according to standard requirements. The product was not a reference product in the EU-review program for inclusion of the active substance in Annex I of Directive 98/8/EC. The applicant has submitted an exposure and risk

90 assessment for STORM Secure. The RMS NL has updated this exposure and risk assessment for the environmental aspect to be in line with the Assessment Report of flocoumafen. For authorisation purposes the risk assessment of STORM Secure is included in this Product Authorisation Report. Environmental exposure to soil occurs when STORM Secure is deployed outdoors. When the product is used in sewerage exposure of surface water and sediment via the STP can take place. Non-target vertebrates may be exposed to STORM Secure either directly by ingestion of parts of blocks (primary poisoning) or indirectly by ingestion of the carcasses of target rodents that contain flocoumafen residues (secondary poisoning). See for more detail section 2.8 below. 2.7 Risk assessment for human health STORM Secure is a ready-to-use block bait used for the control of rats and mice. STORM Secure is one of the marketed forms of STORM Wax Block Baits formulation, which have identical composition and differ only in nominal weight of the bait. In the CAR of flocoumafen another marketed form of the same formulation, STORM BB, was evaluated as a reference product. The composition of STORM Secure, STORM BB and STORM 4g (code: BAS I) arethus virtually identical to that of the reference product STORM BB (code: BAS I), with one exception: a preservative (insecticide) was removed during product development for global registration (minor change of the formulation). The applicant submitted a justification that this change of formulation has no effects on the human toxicological properties of the formulation. This justification is considered acceptable by the RMS The Netherlands. The applicant has submitted GLP-compliant studies with the product STORM BB to address acute oral and dermal toxicity, skin and eye irritation and skin sensitization of STORM Secure (see for results). These studies have already been evaluated in the CAR of flocoumafen. For acute inhalation toxicity, a waiver has been submitted by the applicant. As the formulation is a solid wax block and the active substance is not volatile (vapour pressure < 1 x 10-3 Pa at 20 ºC), the inhalation is considered to be negligible and the non-submittance of the acute inhalation toxicity study is considered acceptable by the RMS. In addition a GLP-compliant dermal penetration study with two dummy products (blank wax bait suspensions in artificial sweat containing 0.066% and 0.005% active substance in the wax matrix) has been submitted. This study has not been evaluated in the CAR of flocoumafen. The results are reported in Section Hazard potential Toxicology of the active substance The toxicology of the active substance was examined extensively according to standard requirements. The results of this toxicological assessment can be found in the CAR. The threshold limits and labelling regarding human health risks listed in Annex 4 Toxicology and metabolism must be taken into consideration.

91 Toxicology of the substance(s) of concern The biocidal product does not contain any substances of concern Toxicology of the biocidal product GLP-compliant studies with the product STORM BB have been submitted by the applicant to address acute oral and dermal toxicity, skin and eye irritation and skin sensitization of STORM Secure. Based on the composition of two formulations the submitted studies are considered to be representative for STORM Secure by the RMS. The submitted studies have already been evaluated in the CAR of flocoumafen. Based on the results of the studies, STORM Secure does not need to be classified for acute oral and acute dermal toxicity, skin and eye irritation and sensitization. In addition a GLP-compliant in vitro dermal absorption study using split-thickness human skin with two dummy products (wax bait suspensions in artificial sweat containing 0.066% and 0.005% flocoumafen) has been submitted by the applicant. Following 6 hours exposure a potentially absorbable dose after 24 hours, corresponding to the sum of the absorbed dose in the receptor fluid, exposed skin and stratum corneum (the first two tape strips being excluded) was 0.97% for the highdose and 1.17% for the low-dose formulation. These dermal absorption percentages are used instead of the default values used in the CAR (10% and 4% proposed based on comparable molecular mass and log Pow of the other similar second generation anticoagulants). The basis for the health assessment of the biocidal product is laid out in Annex 5 Toxicology biocidal product Exposure The biocidal product STORM Secure contains the active substance flocoumafen (pure: g/kg). STORM Secure is a ready-to-use wax block bait used for the control of rats and mice in and around buildings, and the control of rats in sewers, with the purpose of protecting human food and animal feedstuffs, and for general human hygiene. STORM Secure is supplied in three different forms: as a hexagonal block with a central hole, with a nominal weight of 20 g, for the use in sewers; as a 16 g block, and as a 4 g block. The product is intended for both professional and non-professional use. It should be noted, however, that non-professional use against rats is not permitted in the Netherlands by national specific policy, but as it is allowed by other Member States, it will be assessed in this risk assessment. The potential for exposure to flocoumafen is summarized in the table below.

92 Exposure path Industrial use Professional use General public Via the environment Inhalation Not relevant Not relevant Not relevant Negligible Dermal Not relevant Potentially significant Potentially significant Negligible Oral Not relevant Negligible Negligible Negligible Inhalation exposure Flocoumafen is not volatile and STORM Secure is a non-dusty wax bait formulation. Therefore, the risk of inhalation exposure to flocoumafen for professional or amateur users during use is not considered a relevant exposure path. Similarly, for non-users, the risk of inhalation exposure to residues during or after application via the environment is considered to be negligible. Dermal exposure STORM Secure is supplied in the form of a ready-to-use wax block which will be placed in position by hand. Dermal exposure to the product is therefore possible during application and clean-up operations. Dermal exposure is considered to be limited to the hands, while the exposure to other parts of the body is expected to be negligible. Children could potentially be the group most at risk as they may play inside or around buildings were baits have been placed. However, product labels and good practice advise users to prevent access to bait by children. Oral exposure STORM Secure bait is not likely to reach the mouth of professional or amateur users. Therefore, the risk during use is considered to negligible. To prevent dermal-oral uptake, the following sentence is included in the WG/GA (instruction of use) Wash hands after use. For for non-users, risk of oral exposure to residues during or after application is considered to be negligible if the instruction of use is followed. Children or infants may play close to the floor where baits have been placed indoors. However, product labels and good practice advise users to prevent access to bait by children. STORM Secure bait also contains a bittering agent to prevent infants ingesting bait Exposure of professional users In Annex 6 Safety for professional operators, the results of the exposure calculations for the active substance and the substance of concern for the professional user are laid out Exposure of non-professional users and the general public In Annex 7 Safety for non-professional operators and the general public, the results of the exposure calculations for the active substance and the substance of concern for the non-professional user and the general public are laid out Exposure to residues in food In Annex 8 Residue behaviour, the results of the residue assessment are laid out.

93 2.7.3 Risk Characterisation With proper use in accordance with regulations harmful effects on the health of users and third parties are not expected. The estimated exposures for the intended use are compared to the respective systemic AEL Risk for Professional Users Based on the risk assessment of the active substance, a risk for professional users resulting from the intended use is unlikely. Regarding occupational safety, there are no objections against the intended use Risk for non-professional users and the general public The direct exposure, exposure via the environment or to other residues resulting from the intended use is unlikely to cause any unacceptable acute or chronic risk to consumers (non-professionals, bystanders and residents). Regarding consumer health protection, there are no objections against the intended uses Risk for consumers via residues The acute or chronic exposure to residues in food resulting from the intended uses is unlikely to cause a risk to consumers. Regarding consumer health protection, there are no objections against the intended uses. 2.8 Risk assessment for the environment The risk characterisation for the environment is based on proprietary product information, on the EUBEES 2 Emission scenario document for biocides used as rodenticides (Larsen, 2003, CA- Jun03-Doc.8.2-PT14), hereafter referred to as EUBEES, and on the Technical Guidance Document (TGD; ECB 2003). The risk characterisation and the underlying assumptions presented here are also confirmed in the Assessment Report for flocoumafen (Product Type 14). Application of STORM Secure containing 50 mg/kg flocoumafen is confined to commensal rodents (brown and black rats, house mice) in and around buildings and of rats in the sewerage. The product is for both professional and non-professional use Effects Assessment New Data Four studies for the active substance flocoumafen that were not evaluated during the Annex I active review stage were submitted with the new product authorisation application. The new studies are as follows: Wenzel A. (2011): Fish, bioconcentration of Flocoumafen according to the OECD-Guideline 305 and EU method C.13 Simon, M. (2007): Soil microorganisms: Effects of Flocoumafen on nitrogen and carbon transformation. Simon, M. (2007): Earthworm acute toxicity test: acute toxicity of Flocoumafen on Eisenia fetida.

94 Simon, M. (2007): Terrestrial plants, growth test: Effect of Flocoumafen on the seedling emergence and growth of Avena sativa, Lactuca sativa, Phaseolus aureus, Raphanus sativus, Sinapis alba, and Triticum aestivum. As these were new data, the RMS NL briefly reviewed the environmental summaries produced by the applicant, and compared those with the conclusions of the study reports. A brief summary is given as follows: Soil microorganisms: EC mg/kg dry soil or 10.7 mg/kg wet soil (nitrogen mineralization) EC50 > 1000 mg/kg dry soil or mg/kg wet soil (nitrogen mineralization) NOEC > 1000 mg/kg dry soil or mg/kg wet soil (carbon mineralization) EC50 > 1000 mg/kg dry soil or mg/kg wet soil (carbon mineralization) Earthworms: EC50 > 1000 mg/kg dry soil or mg/kg wet soil Plants: EC mg/kg dry soil or mg/kg wet soil NOEC = 179 mg/kg dry soil or mg/kg wet soil Considering that the soil microorganism test provides the lowest endpoint, the plant test can be considered as a chronic test, thus two long etrm tests of two trophic levels are available. An assessment factor of 50 on the lowest EC10 of 12.1 mg/kg dwt (10.7 mg/kg wwt) can be applied, this results in a predicted no-effect concentration of 0.21 mg/kg wwt. The resulting bioconcentration factor (kinetic) of the bioaccumulation study in fish is given as BCFfish = 24,300 L/kg wwt. Detailed data on the fate and distribution of flocoumafen in the environment and the effect of the active substance on environmental organisms can be consulted in Doc IIA of the Assessment Report of BASF (May 2009) for flocoumafen (PT14) and in Annex 2B to this product assessment report. The PNEC derivation is also described in detail in the Assessment Report for flocoumafen (Product Type 14), section and a summary is included in the table below. Summary of the PNECs derived for flocoumafen in the different compartments Compartment Organism Endpoint AF PNEC Aquatic Fish (Oncorhynchus Mykiss) LC50 = 0.07 mg/l µg/l Sediment Equilibrium partitioning mg/kg wwt STP Microorganisms from an NOEC = 4 mg/l mg/l activated sludge Soil Soil micro organisms EC10 (10.7 mg/kg wwt) mg/kg

95 Compartment Organism Endpoint AF PNEC wwt Terrestrial Birds (Coturnix japonica) NOEC > mg/kg food NOEL > mg/kg bw/d (read across from study with difenacoum) Terrestrial Mammals (rat) NOEC = 0.05 mg/kg food or mg/kg bw/d mg/kg food mg/kg bw/d mg/kg food mg/kg bw/d Exposure Assessment The environmental exposure to flocoumafen is assessed for the use of the active substance as a rodenticide (product type 14) in and around buildings and in sewerage. The local environmental concentrations of flocoumafen were estimated based on the respective EUBEES emission scenario document (ESD). EUBEES emission scenarios have been implemented in Excel. The PEC in soil following burrow baiting was calculated according to the respective section of the open area emission scenario. It must be highlighted that, although an open area scenario was adopted, the corresponding PEC applies only to a particular case of the use pattern in and around buildings, i.e. burrow baiting close to outer walls of rodent infested premises. Regional and continental environmental concentrations of flocoumafen due to the production and formulation are generally regarded to be insignificant: flocoumafen containing products are formulated in small batches in closed systems and appropriate control measures are taken to exclude release of the active substance to the environment during formulation. In view of the small production volume and the applied control measurements taken, regional and continental PECs therefore need not be considered in the exposure assessment. The environmental exposure assessment covers the application of three blocks corresponding to 60 g in and around buildings, and up to 10 blocks corresponding to 200 g in the sewerage. Other use patterns are not foreseen for this product. Bait is replenished once per week on days 0, 7, 14 and 21 (additionally on day 4 if required) after the first application, i.e. pulse baiting. As a worst-case a total of five times refillling was assumed in the risk assessment. Consequently, the following worst-case scenarios are considered: In around buildings, use of STORM Secure In the sewerage, use of STORM Secure Fate and distribution in the environment The formulation is considered not to alter any of the physicochemical properties of the active substance since it is based on paraffin wax and cereals as main components. Based on Level 1 Mackay modelling, flocoumafen may be considered to partition predominantly to soil (> 97 %) and to a much lesser extent to sediment (2%), with negligible amounts anticipated to be distributed to surface water and the atmosphere (<< 1 % in both cases). These figures represent fugacity

96 estimates, outlining the general tendency of flocoumafen to distribute into the respective compartments. Since flocoumafen is virtually non-volatile (< Pa at 25 C), partitioning of the active substance to the atmosphere to any relevant extent cannot be anticipated. However, any potentially volatilised material may be expected to be rapidly eliminated via photo-oxidative reactions. Flocoumafen is poorly soluble in water in neutral conditions (0.114 mg/l at 20 C, ph 7). In water, although flocoumafen is hydrolytically stable, however it is sensitive to photo-transformation (DT50 = 1.67 d at average light conditions in Central Europe considered as the normal case in April), which is only relevant if the product is not covered. Based on its octanol/water partition coefficient (log Pow = 6.12, HPLC method) and the soil adsorption coefficient (KOC = 101,684 L/kg, mean value for cis- and trans-isomer), the active substance is expected to adsorb strongly to soil, sediment and sewage sludge. A recently conducted bioaccumulation study in fish resulted in a bioconcentration factor BCFfish of 24,300 L/kg wwt. The terrestrial bioaccumulation factor in earthworms is tentatively still based on theoretical derivation from the log Pow, resulting in BCFearthworm = 15,820 L/kg wwt PEC in surface water, sediment, STP and groundwater In and around buildings Direct exposure of surface water and sediment or indirect exposure of these compartments via the STP arising from the use of bait blocks in and around buildings is not expected to be significant or widespread. Therefore, estimates of flocoumafen concentrations in surface water or sediment have not been calculated for this scenario. Negligible exposure of surface water under these circumstances is also stated in the EUBEES 2 emission scenario document. In the Netherlands, however, it is well known that rats live near surface waters and that therefore also rodenticide campaigns may occur near these surface waters. Agreed scenarios to calculate the exposure in surface water from leaching of rodenticides are lacking, therefore risk mitigation measures derived from CLP characteristics of the active substance are set in place. Furthermore, due to the likely low soil concentrations, the restricted use pattern and the strong adsorption of the active substance (Koc = 101,684 L/kg) to soil, flocoumafen is not considered to move to groundwater in significant quantities and hence no PECgroundwater was calculated. Sewer systems STORM Secure is a ready-for-use product, to be applied directly in suitable places for rodent control. If unused product, urine or excreta from target rodents or dead rodents enter the sewage system, flocoumafen may reach surface waters via the final effluent discharged from a sewage treatment plant (STP). Estimates of flocoumafen concentrations in surface water that arise from this application are calculated below.

97 EUBEES 2 describes two regimes for the deployment of rodenticide blocks in sewers. In normal, routine use to prevent rat populations exceeding acceptable levels, blocks are placed at strategic points in a selected target area of the sewerage network, with a frequency normally not exceeding one application per year. Alternatively, a realistic worst case, when uncontrolled rat infestations demand more urgent action, blocks are applied by pulse-baiting during campaigns that typically last 21 days. Under this more intensive regime, bait points are revisited 7 and 14 days after the first baiting and fresh blocks deployed to replace any consumed since the previous visit. Realistic worst case scenario. EUBEES 2 considers a typical scenario that involves a sewerage network serving a population equivalent (PE) of 10,000 and fitted with 300 access manholes. A maximum of 300 g block bait is initially deployed beneath each manhole, giving a total of 90 kg formulated product distributed throughout the sewer network. For the current emission estimation the EUSES-scenario was adapted according to the use instructions for STORM Secure, using 200 g (10 blocks of 20 g per manhole) as input value instead of 300 g. With 100 manholes to be baited, this results in a total amount of 60 kg product applied. Maximum input of rodenticide into sewage occurs during the first week of pulse baiting campaigns and EUBEES 2 cites a figure of one third of the total deployment (i.e. 20 kg formulated product) in the first seven days. Under these conditions, the worst-case total daily emission (mg a.s/day) of a rodenticide into sewage is calculated by the formula: Mean local emission of active substance to waste water during episode: E local water = Q prod x Fc product Temission x F released F released = 0.3+ (0.6 - F metab) where T emission is the number of days (7) of the initial worst-case phase of a pulsebaiting operation and Freleased is the a.s. fraction entering sewage. Freleased comprises two components: the portion (30%) contained in block fragments that fall directly into sewage and the remainder that enters sewage after consumption by the target organisms, corrected, if appropriate, to take any metabolism into account (Freleased = (0.6 - Fmetab). For use in sewers, flocoumafen is incorporated at a concentration of 50 mg a.s/kg product into bait blocks of uniform 20 g weight and it is assumed that ten of such blocks are positioned at each baiting point to make up the 200 g weight. The fraction of flocoumafen metabolized (F metab) in the target organisms is taken into account for the assessment of the concentration in the local water. On the basis of mammalian ADME studies, F metab has been

98 agreed to amount to 20 %. The same reduction is used in the scenario Control around buildings, bait boxes. 20 kg product 50 mg a.s./kg product E localwater = 0.7 = mg a.s/d 7days For the input it is assumed that the number of replaced bait blocks equals the number of blocks released to the sewer. This implies that 100% of a lost block, including the fraction eaten by the rodent, enters the sewer. In accordance with the sewer scenario specified in the ESD, the maximum number of blocks replaced is 100. This occurs on day 7 of the 21-day campaign. The average sewage volume that flows through a sewer system serving a population of 10,000 PE is assumed to be 2,000,000 l/day. The concentration in the sewage water can be estimated by dividing the Elocalwater by 2,000,000 l/day, which is the daily amount of sewage water to a local STP (kg/l) in a city with 10,000 PE. Elocalwater mg a.s/d [a.s]sewage water = = = 50 ng a.s./l 200 l/pe 10,000 PE 2x10 6 L/d The total daily emissions for flocoumafen, and the resulting concentrations in sewage, calculated according to worst-case default assumptions are presented below. Table Predicted realistic worst-case concentration of flocoumafen during the first week of a pulse-baiting sewer campaign flocoumafen weight (mg a.s) per 20 kg of bait blocks 1 Qprod x Fcproduct Total daily emission (kg flocoumafen /day) 2 Elocal water Total flocoumafen concentration in sewage (mg a.s/l) 3 Elocal water/ L/d based on consumption of one third of 60 kg bait block deployment in 7 days and 50 mg flocoumafen/kg; 2 (flocoumafen weight per 20 kg bait blocks 7) 0.7; 3 based on a daily sewage volume of L The pulse-baiting scenario outlined in EUBEES 2 suggests bait consumption is subsequently reduced to 10 kg bait blocks between days 7 and 14 and, on this basis, the average concentrations of flocoumafen in sewage during the second week of the campaign will fall to half the worst-case levels that occur during the first week. Normal scenario. With regard to the routine deployment of bait blocks in sewers, EUBEES 2 cites an average annual consumption of approximately 50 kg formulated product/10,000 PE in Denmark and a similar consumption (60 kg bait/10,000 PE) for a city in Germany. Based on the higher value (equivalent to 2, g bait blocks), the estimated mean normal concentration of flocoumafen in sewage is indicated below.

99 Mean local emission of active substance to waste water during episode: E local water = Qprod Fcproduct Temission x Freleased Freleased = 0.3+ (0.6 - Fmetab) = ( )= kgproduct 50 mg a.s/kg product E localwater = 0.70 = 5.8 mg a.s./d 365 days Concentration in the sewage water considering 2,000,000 l/day as the daily amount of sewage water to a local STP in a city with 10,000 PE: Total flocoumafen = concentration in sewage water Elocalwater 5.8 mg a.s/d 200 L/PE 10,000 PE L/d = 2.9 ng a.s./l Table Predicted concentration of flocoumafen arising from long-term, routine baiting in sewers (normal scenario) flocoumafen weight (mg a.s) per 60 kg of bait blocks 1 Total daily emission (kg flocoumafen /day) 2 Total flocoumafen concentration in sewage (mg a.s/l) 3 Qprod Fcproduct Elocal water based on consumption of 60 kg formulated product in 365 days and 50 mg flocoumafen/kg; 2 (flocoumafen weight per 60 kg bait blocks 365) 0.7; 3 based on a daily sewage volume of L The daily default volume of 2,000,000 liters sewage, containing rodenticide in bait block fragments, in rat urine and faeces and in the body tissues of poisoned rats, flows to a STP. As it arrives there, the sewage passes through a mechanical screen (a large sieve) that removes untreatable solids, including dead rats (pers. comm.: D. Fearnside, Yorkshire Water plc, Bradford, UK) and the larger pieces of bait blocks. Solids retained by the screen are removed, collected and transported for landfilling at licensed disposal sites. The screened sewage then collects in a primary settling basin where the majority of the solids that passed through the screen are deposited before the settled supernatant is channelled toward aerobic secondary (biological) treatment. In the primary settler, the relative density of the bait block matrix determines whether the smaller block fragments that passed through the screen float or sink. If the former, they will tend to be trapped by scum/baffle boards, and will be collected and disposed of in the same way as the dead rats. If they sink, they will be deposited into the primary sewage

100 sludge that funnels into the base of the primary settler, and which is typically channelled toward mesophilic anaerobic digestion. The remaining contribution to the rodenticide load entering the primary settler is that which entered the sewer by the indirect route via rat urine and faeces. The manner in which the load partitions between the supernatant settled sewage and the deposited primary sludge, and ultimately the relative split between aerobic and anaerobic biological treatment processes, is determined by the physico-chemical properties of the rodenticide and, in particular, its aqueous solubility and octanol:water partition coefficient (Kow). In addition, consideration of the Henry s Law constant provides insight into the role of volatilisation as a removal mechanism during waste-water treatment. The SimpleTreat predictions show that the minority (14%) of the flocoumafen that passes through the mechanical screening stage and enters a STP will be associated with the aqueous phase and remain in the treated effluent. The residual 86% is estimated to be bound up with sludge solids. For assessing the risk of a substance to microorganisms in the STP it is assumed that only the dissolved concentration is bioavailable and that homogeneous mixing in the aeration tank (STP) occurs. This implies that the dissolved concentration of a substance is equal to the effluent concentration: PECSTP = Clocaleff = Clocal influent x FSTP water Table Predicted concentrations of flocoumafen in surface waters arising from routine and pulse-baiting in sewers Baiting Influent Effluent PECsurface water (mg PECsediment (mg regime concentration (mg concentration (mg a.s/l) a.s/kg wwt) a.s/l) a.s/l) 1 PECSTP Routine Pulse week week Based on the expectation that 86% of the influent load will remain in the final STP effluent Due to the likely low soil concentrations (see Section ), the restricted usage patterns and the reasonably strong adsorption of the active substance to soil (Koc of 101,684 L/kg), it is considered that flocoumafen will not move to groundwater in significant quantities PEC in air In view of the type of use in wax blocks and limited volatility of flocoumafen, emissions to air are regarded to be insignificant. Thus, the PEC of flocoumafen in air is considered to be negligible PEC in soil (I) Standard scenario according to the EUBEES ESD - In and around buildings

101 Environmental concentrations were calculated using the in and around buildings scenario for bait boxes. According to this scenario only direct and indirect releases to soil are considered relevant during the application and use phase. To estimate the concentration of flocoumafen in soil arising from heterogeneous release, it is assumed that most of the activity of the target rodents is confined to a strip of ground running along a baited wall with a length of 55 m (10 bait stations, 5 m apart) and extending to 10 m in front of it. The strip accounts for an area of 550 m 2 (55 m 2 per bait station) with an assumed depth of 0,1 m. Based on the soil density value, the mass of soil in the strip exposed to indirect releases is 93,500 kg (wwt). EUBEES considers a realistic worst-case, campaign that lasts 21 days, where secured bait stations are initially filled on day 1 and refilled on days 3, 7, 14 and 21. It is assumed that they are repeatedly and completely emptied by the target rodents. A typical scenario (normal use) may also be considered, in which the bait consumption progressively declines as the campaign proceeds, such that the replenishments made on days 3, 7, 14 and 21 represent 100%, 25-50%, 10% and 0%, respectively, of the quantity initially deployed on day 1. It should be noted that the typical scenario is considered the more representative consumption pattern for a potent anticoagulant rodenticide such as flocoumafen, as demonstrated by the field studies summarised in Doc IIIB, section of final CAR of flocoumafen). Direct and indirect release estimations to soil during use of the product were based on the Emission scenario document for biocides used as rodenticides (EUBEES Doc CA-Jun03-Doc.8.2-PT14). The number of (re)filling times was set at 5 (based on worst case baiting scheme, start on day 0, replenishment on day 3, 7, 14 and 21). The fraction metabolised was set at 0.2 (worst case scenario based on Doc IIIA, section 6.2/06 of final CAR of flocoumafen: up to 74% (faeces) and 88% (liver) of the residue was unchanged flocoumafen, and the major part of the total residue was found in faeces and liver). All other parameters were EUBEES defaults. Input values and output for the in and around buildings scenario for bait boxes are presented in Table Table : Estimation of concentrations of flocoumafen in soil following direct and indirect release (via rat urine and faeces) according to the in and around buildings scenario for bait blocks. Variable/parameter (unit) Symbol Unit Value S/D/O/P Input: Amount of product used at each refilling in the control operation for each bait box Qprod g 60 S Fraction of active substance in product Fcprod S Number of application sites Nsites 10 D Number of refilling times (realistic worst case)* Nrefil 5 D Number of refilling times (typical case) Nrefil 1.5 S Fraction released indirectly to soil ** Frelease-ID, 0.7 S soil Fraction released directly to soil Frelease D

102 Variable/parameter (unit) Symbol Unit Value S/D/O/P D,soil Fraction of active ingredient metabolised Fmetabolised 0.2 S Output: Realistic worst case Local concentration in soil due to direct release after a Clocal,soil-D mg kg 1 wwt O campaign (around bait station, 0.09 m 2 ) Concentration in soil due to indirect (heterogeneous) release Clocal,soil-ID mg kg 1 wwt O after a campaign (55 m 2 per bait station) Total concentration in soil (around bait station, 0.09 m 2 ) Clocal,soil mg kg 1 wwt O Typical case Local concentration in soil due to direct release after a Clocal,soil-D mg kg 1 wwt O campaign (around bait station, 0.09 m 2 ) Concentration in soil due to indirect (heterogeneous) release Clocal,soil-ID mg kg 1 wwt O after a campaign (55 m2 per bait station) Total concentration in soil (around bait station, 0.09 m 2 ) Clocal,soil mg kg 1 wwt O **) Frelease-ID, soil = 0.3+ (0.6 Fmetab) with Fmetab = 0.2 (see Doc III-B 7.1/02 of final CAR of flocoumafen) S: User-specified; D = Default; O = Output; P = Selected from a pick-list Max. concentration in soil: Clocal, direct + Clocal, indirect = mg/kg (worst case) and mg/kg (typical case). (II) Burrow baiting For supporting burrow baiting for rodent control, a dedicated exposure assessment reflecting this case was requested in the Assessment Report upon which the Annex I entry of flocoumafen is based. It is highlighted here that burrow baiting typically comprises application of wax blocks in rat holes in a man-made environment, i.e. holes that rats have dug into walls, foundations etc. in and around buildings. Nevertheless, in some cases it may be required to place bait in rat burrows in natural soil in close vicinity to buildings. For this instance, the assumptions and calculations from the EUBEES open area scenario are adopted, however stressing that this has to be considered within the in and around buildings scenario, since open area use is explicitly not supported. Table : Estimation of concentrations of flocoumafen in soil following burrow baiting (open area scenario adopted, applicable to in and around building use only). Variable/parameter (unit) Symbol Unit Value S/D/O/P Input: Amount of product used at each refilling in the control operation Qprod g 60 S Fraction of active substance in product Fcprod S Number of applica tion sites Nsites 1 D Number of refilling times Nrefil 2 D Fraction of product released to soil during application Frelease, soil, appl 0.05 D Fraction of product released to soil during use Frelease,soil, use 0.2 D Output: Local emission of active substance to soil during a Elocalsoil- g O

103 campaign campaign Release to soil is calculated using the following formula: Elocal = Q Fc N N + soil campaign prod prod sites refil ( Frelease, soil, appl Frelease, soil, use The exposed soil area is assumed to be the lower half of the burrow wall surrounding an 8- cm diameter tunnel, with the mixing soil depth of 10 cm and up to 30 cm from the entrance ( R r ) π l hole. Thus the total soil volume is: Vsoilexposed = = m³ 2 Table : Soil parameters used to estimate the concentrations of flocoumafen in soil following burrow baiting (open area scenario adopted, applicable to in and around building use only). Variable/parameter (unit) Symbol Unit Value S/D/O/P Input: Local emission to soil from the episode Elocalsoil-campaign g O (Table ) Soil volume exposed to rodenticide Vsoilexposed m³ D Density of wet exposed soil RHOsoil kg m ³ 1700 D Output: Local concentration in soil after a campaign Clocalsoil-campaign mg kg O Clocal soil Elocal = Vsoil soil campaign exposed 10 RHO soil 3 The environmental concentration in soil in direct vicinity of individual bait points (rat burrows in natural soil) is calculated as: C local,soil = mg/kg wwt (baiting of rat burrows in natural soil in and around buildings) 2 2 ) Sewer systems Contamination of soil following the use of wax blocks in sewers is highly unlikely during application and use. However, soil may contain low concentrations of flocoumafen from the spreading of sludge on land derived from waste water treatment works receiving water after the baiting of sewer systems. The sewer deployment scenario and the concentrations of flocoumafen arising from it have been described above. The SimpleTreat model predictions suggest that the minority (14%) of the flocoumafen entering an STP will remain in the aqueous phase. The residual 86% is estimated to be bound up with the sludge solids. Air-stripping is not expected to occur and subsequent aerial transport and air-to-ground deposition are therefore not relevant for flocoumafen. The concentration in dry sludge (Csludge) corresponding to routine baiting and each of the two weekly phases of a pulse-baiting campaign may be calculated, as indicated in the TGD supporting Commission Directive 93/67/EEC for new notified substances, Commission Regulation (EC) No 1488/94 for existing substances and Directive 98/8/EC for biocidal products, by the formulas: C sludge = FSTP sludge Elocal sewage SLUDGE RATE 10 6

104 SLUDGE RATE =2/3 x (SUSPCONCinf x EFFLUENTstp)+ (SURPLUSsludge x CAPACITYstp) where: Csludge: concentration of flocoumafen in dry sewage sludge (mg/kg); FSTPsludge: the fraction of the influent flocoumafen that is bound to sludge solids (86%); Elocalsewage: the emission rate of flocoumafen to sewage (kg/day); SLUDGE the sludge production rate (kg/day). RATE: The rate appropriate to the EUBEES 2 scenario of a sewer system serving 10,000 PE is 2/3 [(0.45 kg/m m 3 ) + (0.011 kg/day/pe 10,000)] = 673 kg/day. (according to equation 37 in the TGD, chapter 3 section ) According to the sewer-baiting scenarios described above, the usual concentration of flocoumafen that arises from routine baiting has been calculated to be 2.9 ng/l. Higher concentrations are predicted for pulse-baiting campaigns which typically last no more than three weeks. The peak concentration occurs in the first week and concentrations are halved during the second week of the campaign and no further bait consumption occurs during the third. The PEC values for weeks 1 and 2 of the pulse-baiting campaign are thus 50 and 25 ng/l. The corresponding Csludge value for each of these weekly phases is presented below. Table : Concentrations of flocoumafen in sludge arising from routine and pulse-baiting activity in sewers Baiting regime PECsewage Elocalsewage Csludge (ng a.s./l) (kg a.s./day) 1 (mg a.s./kg) Routine Pulse week week based on a daily sewage flow of L Sewage sludge is not generally applied directly to land in its raw state, but is instead typically first treated by anaerobic digestion. Although some operate cold with long retention, digesters serving 10,000 PE are most likely to operate in the mesophilic temperature range (approximately 35 C) and, according to Mosey ( ), will have a sludge retention time of between 20 and 40 days necessary to ensure reliable removal of fats and greases. For the purposes of this assessment, it is assumed that a retention time of 30 days (4 weeks) applies. Moreover, it is assumed that: - digested sludge passes out of the digester at the same rate as raw sewage sludge enters; - the contents of the digester are completely mixed; - flocoumafen is not degraded anaerobically, and - the worst-case concentration of flocoumafen in sludge coincides with a single annual pulsebaiting campaign that lasts for three weeks. The concentration arising from routine baiting applies for the remaining 49 weeks of the year. 2 Mosey, F.E. (1983) Anaerobic Processes. In: Used-Water Treatment, Vol. 2, Chapter 5. (Curds C.R. and Hawkes H.A.: Eds.) Academic Press, London.

105 The baseline concentration of flocoumafen in the digester during the week prior to the start of a pulse-baiting campaign is thus mg/kg dry sludge. During the first week of intensive baiting, the incoming sludge contains mg flocoumafen/kg dry weight, but as the digester operates with a four week retention time and its contents are completely mixed, the incoming flocoumafen is diluted to ( ) = mg/kg. On this basis, the concentration of flocoumafen reaches a peak of mg/kg dry sludge on the second week of the campaign (for the first week of a pulse baiting campaign the concentration in sewage sludge is = mg/kg; for the second week of such campaign the concentration in sewage sludge is (0.75 x ) + (0.25 x ) = mg/kg). The worst-case concentration of flocoumafen in digested sludge applied to soil is therefore mg/kg. Although higher estimates could be calculated by assuming shorter retention times, the four-week assessment is considered to be sufficiently conservative by virtue of the fact that PECsewage has not been lowered to take account of the mechanical removal from the system of rodenticide in the body tissues of poisoned rats. Assuming the digested and de-watered sludge is applied to soil without prior dilution and/or composting with other sludge, and a single annual sludge application, the immediate worst-case concentration of flocoumafen in soil (Csludgesoil(0)) arising after the first year s application and from the peak concentration in dry sludge is calculated according to the formula: Csludge soil (0) = C sludge DEPTH APPL soil sludge RHO soil where: Csludge: APPLsludge: DEPTHsoil: peak concentration of flocoumafen in dry sewage sludge ( mg/kg); dry sludge application rate (kg/m 2 /year); mixing depth of soil (m); RHOsoil: bulk density of soil (1700 kg/m 3 ). Values of APPLsludge and DEPTHsoil both vary according to the use of the soil to which the sludge is applied, with the consequent variation in Csludgesoil(0) indicated in the table below: Table : Estimated worst-case concentrations of flocoumafen in sludge-amended soils following the first annual application to soils with no previous exposure to flocoumafen Soil use APPLsludge DEPTHsoil Csludgesoil(0) (kg dw/m 2 /year) (m) (mg a.s./kg wwt) general purpose agricultural soil (cultivation of crops for human consumption) grassland (cattle grazing) The Risk Assessment TGD supporting Commission Directive 93/67/EEC for new notified substances, Commission Regulation (EC) No 1488/94 for existing substances and Directive 98/8/EC

106 for biocidal products considers the consequences of successive annual sludge applications over a period of 10 years. Worst-case predictions of 10-year accumulation in each of the three soil categories considered above may be made by assuming that no degradation occurs and that flocoumafen does not migrate beyond the initial soil mixing depth between applications: they range from mg/kg for grassland to mg/kg for general purpose and agricultural soils. These accumulated estimates are unrealistically high. Firstly, flocoumafen degrades in soil, with measured aerobic DT50 values ranging from 4 to 53 days. Secondly, the values presented assume that the same area of soil is treated on 10 consecutive occasions with sludge containing a peak concentration of flocoumafen that occurs only once each year for a window lasting only one week. The likelihood of this occurring in reality is very small. Finally, flocoumafen is highly photo-unstable (predicted DT50 in pond water: 29.4 minutes under natural sunlight). Flocoumafen exposed to sunlight in sludge spread over the soil or grassland surface will therefore break down rapidly, as will flocoumafen residues brought to the soil surface by tillage in an agricultural setting Non compartment specific exposure relevant to the food chain (secondary poisoning) Non-target mammals and birds are unlikely to enter sewers and feed on bait blocks in sewage systems. Therefore, there will be no significant exposure following the use of bait blocks in sewers. Rats that live underground in sewers are also unlikely to take bait and deposit significant quantities in accessible places above ground, thus preventing exposure to non-target animals living above sewers. The exposure of flocoumafen directly to non-target birds and mammals and indirectly via target rodent carcasses (secondary poisoning) from use in and around buildings is quantified in section These exposure routes to non-target vertebrates are not considered to have consequences for widespread contamination of environmental compartments. Estimation of exposure due to secondary poisoning via the aquatic food chain Release to surface water, and hence exposure due to secondary poisoning via the aquatic food chain occurs when effluent of an STP is discharged to surface water. Biomagnification may occur via the aquatic food chain. The food-chain surface water fish fisheating birds or mammals is assessed according to the TGD, based on steady state bioaccumulation in fish and a calculated PECwater. The PECoral, predator is equal to the Cfish. Cfish was calculated as follows, in agreement with the guidance in the TGD, part II, section : C fish = PEC surface water * BCF fish * BMF, where BCFfish = 24,300 L/kg wwt BMF = 1 (default) For the assessment of Cfish, the PECsurface water values are reduced to 50% according to the TGD (EC, 2003). In the TGD, a scenario where 50% of the diet comes from a local area and 50% of the diet comes from a regional area is considered. Table : Estimation of concentrations in fish after exposure of surface water to flocoumafen in the use phase for application in sewer systems. Baiting regime PECsurface water (mg a.s/l) Cfish (mg/kg wwt)

107 Routine x 10-4 Pulse week x 10-3 week x 10-3 Estimation of exposure due to secondary poisoning via the terrestrial food chain Release to surface water, and hence exposure due to secondary poisoning via the aquatic food chain, can be assumed to be negligible. Biomagnification may occur via the terrestrial food chain. The food-chain soil earthworm wormeating birds or mammals is assessed according to the TGD, based on steady state bioaccumulation in earthworm and a calculated Csoil. The PECoral, predator is equal to the Cearthworm. Cearthworm was calculated as follows, in agreement with the guidance in the TGD, part II, section : C earthworm = BCF earthworm * C porewater + C soil * F gut * CONV soil /(1 + F gut * CONV soil), where BCF earthworm = * Kow = L/kg wwt (based on Kow = 10^6.12 = 1,318,256 L/kg wwt) F gut = 0.1 CONV soil = 1.13 C porewater = C soil * RHO soil /(K soil-water * 1000) (K soil-water = 3050 m 3 /m 3 ) In and around buildings The worst case and typical case soil concentrations derived from heterogeneous release related to the surface of 550 m 2 for application in and around buildings were used for the calculations, because earthworms at locations further away from the bait boxes are the major food source for mammals and birds. Additionally, in line with some other assessments of rodenticides 50 % of the maximum PECsoil (combined direct and indirect release) is used as input. The table below summarises the input values for Csoil and Cporewater and gives the results for Cearthworm. Table : Estimation of concentrations in earthworms after exposure of soil to flocoumafen in the use phase for application in and around buildings. Cearthworm Scenario Csoil (mg/kg wwt) Cporewater (mg/l) (mg/kg wwt) use (indirect heterogeneous release) Realistic worst case E Typical case E use (combined direct and indirect release) 50 % of maximum PECsoil E Sewer systems The table below summarises the input values for C soil and C porewater and gives the results for C earthworm.

108 Table : Estimation of concentrations in earthworms after exposure of soil to flocoumafen in the use phase for application in sewer systems. Soil use Csludgesoil(0) Cporewater (mg/l) Cearthworm (mg/kg (mg a.s./kg wwt) 1 wwt) general purpose agricultural soil (cultivation of crops for human consumption) grassland (cattle grazing) For the assessment of Cearthworm, the Csoil values are reduced to 50% according to the TGD (EC, 2003). In the TGD, a scenario where 50% of the diet comes from a local area and 50% of the diet comes from a regional area is considered. It should be emphasised that the notifier also included in the intended use application of bait to active rat and mouse holes. These application methods will cause an increased emission to soil, but are not part of the Emission Scenario in and around buildings and therefore secodary poisoning via the consumption of earthworms is not assessed for burrow baiting Risk Assessment The risk characterisation and the underlying assumptions presented here are also confirmed in the Assessment Report for flocoumafen (Product Type 14). Risk to the environment is characterized by comparing a Predicted Environmental Concentration (PEC) with a Predicted No-Effect Concentration (PNEC) in different environmental compartments and scenarios Aquatic compartment (incl. sediment and STP) In and around buildings There are no direct and indirect releases of flocoumafen to surface water for the intended use (bait blocks, in and around buildings). Negligible exposure of surface water under these circumstances is also stated in the EUBEES 2 emission scenario document. In the Netherlands, however, it is well known that rats live near surface waters and that therefore also rodenticide campaigns may occur near these surface waters. Agreed scenarios to calculate the exposure in surface water from leaching of rodenticides are lacking, therefore risk mitigation measures derived from CLP characteristics of the active substance are set in place. In view of the envisaged use pattern, that includes cleaning operations at the end of a campaign to remove carcasses and residual bait, exposure to the STP is considered negligible (ESD, in and around buildings ). Sewer systems The predicted environmental concentrations of flocoumafen in surface water and sediment were calculated in section , and are presented in the tables below. PEC/PNEC ratios for both

109 compartments are identical as both the PECsediment and PNECsediment is based on equilibrium partitioning with respectively the PECsurface water and PNECsurface water. Table PEC/PNEC ratios for contamination of surface water and sediment resulting from routine and pulse-baiting in sewers Baiting regime Maximum PECsurface water PNECsurface water (mg PEC/PNEC* (mg a.s./l) a.s./l) Routine Pulse week week * In line with the TGD (2003), the PEC/PNECsurface water ratio is increased by a factor of 10 for compounds with a log Kow > 5 which is valid for flocoumafen. Table PEC/PNEC ratios for contamination of sediment resulting from routine and pulse-baiting in sewers Baiting regime Maximum PECsediment (mg PNECsediment (mg a.s./kg PEC/PNEC* a.s./kg wwt) wwt) Routine Pulse week week * In line with the TGD (2003), the PEC/PNECsediment ratio is increased by a factor of 10 for compounds with a log Kow > 5 which is valid for flocoumafen. The PEC/PNEC ratio is <1 for the aquatic compartment and the risk should therefore be acceptable for use in sewage systems Assessment of drinking water criterion In addition to the risk assessment based on the PEC/PNEC comparison, Annex VI to the Directive states that an active substance shall not be included into Annex I if the foreseeable concentration of the active substance or of relevant metabolites, breakdown or reaction products to be expected in surface water or its sediments after use of the biocidal product under the proposed conditions of use: exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, the values fixed by Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the member states, Directive 98/83/EC or has an impact deemed unacceptable on non-target species unless it is scientifically demonstrated that under relevant field conditions this concentration is not exceeded. According to the TNsG on Annex I inclusion, the Water Framework Directive 2000/60/EC may also be relevant for limit concentrations in surface water. The drinking water criterion for flocoumafen is mg/l. The envisaged use of flocoumafen in and around buildings is expected to cause no significant emission to groundwater due to the high adsorption characteristics. Therefore, flocoumafen does comply with the drinking water criteria Atmosphere

110 Due to the low vapour pressure ( 10 3 Pa at 50 C) and Henry s law constant ( Pa m 3 /mol), flocoumafen is not expected to partition to the atmosphere to any relevant extent. In addition, the degradation rate of photochemical reactions of flocoumafen with hydroxyl and ozone radicals was estimated to be 1.5 and 2.0 h, respectively, hence any volatilised flocoumafen may be expected to be quickly degraded by photo-oxidation. In conclusion, the physico-chemical properties (resulting in limited exposure) and the potential atmospheric degradation rates do not indicate a risk of flocoumafen to the atmosphere Terrestrial compartment In and around buildings Exposure to the STP after cleaning operations at the end of a campaign for the scenario in and around buildings is considered negligible (according to ESD). It should be emphasised that the notifier also included in the intended use application of bait to active rat and mouse holes. These application methods will cause an increased emission to soil, but are not part of the Emission Scenario in and around buildings and therefore not assessed. In the application and use phase soil may be directly and indirectly exposed. The PEC/PNEC ratios are shown in the table below. Table : PEC/PNEC ratios for direct and indirect contamination of soil resulting from the use phase of flocoumafen as a rodenticide in and around buildings. PECsoil PNECsoil PEC/PNEC* scenario mg/kg wwt mg/kg wwt Typical case Realistic worst case * In line with the TGD (2003), the PECsoil/PNECsoil ratio is increased by a factor of 10 for compounds with a log Kow > 5 which is valid for flocoumafen. The PEC/PNEC ratio is <1 for the terrestrial compartment and the risk should therefore be acceptable for use which employs placement of bait in bait boxes. Sewer systems Contamination of soil following the use of bait blocks in sewers is highly unlikely during application and use. However, soil may contain low concentrations of flocoumafen from the spreading of sludge on land derived from waste water treatment works receiving water after the baiting of sewer systems.

111 Table : PEC/PNEC ratios for direct and indirect contamination of soil resulting from the use phase of flocoumafen as a rodenticide in sewer systems. Soil use PECsoil PNECsoil PEC/PNEC* mg/kg wwt mg/kg wwt general purpose agricultural soil (cultivation of crops for human consumption) grassland (cattle grazing) * In line with the TGD (2003), the PECsoil/PNECsoil ratio is increased by a factor of 10 for compounds with a log Kow > 5 which is valid for flocoumafen. The PEC/PNEC ratios for all three soil uses are < 1, indicating that the exposure to flocoumafen that arises from STP sludge disposal following the use of bait blocks in sewers presents no unacceptable risks to soil-dwelling invertebrates Primary poisoning and secondary poisoning (non compartment specific effects relevant to the food chain) Non-target vertebrates (mammals and birds) may be exposed to bait blocks containing flocoumafen either directly by ingestion of products containing flocoumafen (primary poisoning) or indirectly by ingestion of the carcasses of target rodents that contain flocoumafen residues (secondary poisoning). Flocoumafen is very toxic to birds and non-target mammals. The following quantification of the risk to birds and non-target mammals considers long-term situations where non-target vertebrates gain access to bait blocks directly (primary poisoning) or to rodents that have consumed flocoumafen containing products (secondary poisoning). The primary and secondary poisoning assessment has further on been conducted in accordance with the newly developed guidance document on the PNECoral derivation for the primary and secondary poisoning assessment of anticoagulant rodenticides, which has been adopted by the Competent Authorities (March 2006) and published on ECB s biocides website. It describes a quantitative risk assessment for the long-term exposure situation regarding primary and secondary poisoning with anticoagulant rodenticides and what PNECoral to be used for this assessment. It is proposed to introduce tiered approaches for assessing the risks through both primary and secondary poisoning and to derive different PECs for each step. Table : Exposure scenarios for primary and secondary poisoning according to EUBEES 2 Primary poisoning Secondary poisoning Tier 1 Risk is quantified as the ratio between the concentration in the food for the non-target organism (PECoral) and the predicted noeffect-concentration for oral intake for the non-target organism (PNECoral) Risk is quantified as the ratio between the concentration in the rodent immediately after a last meal on day 5 (EC5) and the predicted no-effect-concentration for oral intake for the non-target organism (PNECoral)

112 Tier 2 Risk is quantified as the ratio between the estimated daily intake of a compound (ETE) and the predicted no-effect-concentration for oral intake for the non-target organism (PNECoral). For the long-term exposure the estimated concentration of the active substance in the animal can be calculated and compared with the NOAEL. Risk is quantified as the ratio between the estimated concentration in predatory mammals or birds and the no-observedadverse-effect levels (NOAEL) for the organism. The primary and secondary poisoning assessment has further on been conducted in accordance with the guidance document on the PNECoral derivation for the primary and secondary poisoning assessment of anticoagulant rodenticides, which has been adopted by the Competent Authorities and published on JRC IHCP s biocides website. It describes a quantitative risk assessment for the long-term exposure situation regarding primary and secondary poisoning with anticoagulant rodenticides and what PNECoral to be used for this assessment. As at the moment no guidance is available on how to derive a PNECoral for an acute exposure situation, only a qualitative risk assessment for the acute primary and secondary poisoning situations is carried out. Object of a quantitative risk assessment is: Primary poisoning, Tier 1 (concentration in bait versus PNEC in food) Primary poisoning, Tier 2 for 5 day exposure Secondary poisoning; Tier 1 for long-term exposure Secondary poisoning; Tier 2 for long-term exposure Object of a qualitative risk assessment will be: Primary poisoning, Tier 2 for 1 day exposure Secondary poisoning; Tier 1 for acute exposure Regarding the qualitative assessment only a description of the toxicity of the substance compared to the possible single uptake is presented instead of carrying out a quantitative risk assessment. It is important to stress that this qualitative assessment is a simple comparison of the acute exposure situation with single dose LD50 values. It is not intended to be used for risk characterisation; no PNECoral shall be derived and hence no PEC/PNEC ratio can be established. This comparison gives only a first indication of the acute toxicity of the substance. Regarding the long-term exposure situation a quantitative risk assessment of the primary and secondary poisoning situation is carried out. However, it is not possible to quantify primary or secondary exposure accurately, given highly variable factors such as the specific locality of a rodent control campaign, whether there are nontarget scavengers or predators present, whether predators will catch many rodents and whether such rodents will contain high levels of flocoumafen. Because of many uncertainties the following assessments of risk should be considered as a worst case. Primary and secondary poisoning of birds and mammals is included in this assessment is based on use of bait blocks in the scenario in and around buildings using default parameters from EUBEES for calculations. Primary poisoning of non-target organisms

113 Regarding the qualitative assessment only a description of the toxicity of the substance compared to the possible single uptake is presented instead of carrying out a quantitative risk assessment. It is important to stress that this qualitative assessment is a simple comparison of the acute exposure situation with single dose LD50 values. It is not intended to be used for risk characterisation; no PNECoral shall be derived and hence no PEC/PNEC ratio can be established. This comparison gives only a first indication of the acute toxicity of the substance. Tier 1 short-term risk assessment, qualitative assessment Quantities of STORM Secure are placed at secured bait points in and around buildings. Based on the maximum amount of bait at one bait point the following table indicates various amounts of flocoumafen that may be taken from a secured bait point. Table : Quantities of flocoumafen potentially accessible to non-target vertebrates at one bait point Maximum amount of bait at one bait point Maximum weight of flocoumcafen per bait point [mg] Proportion of bait point contents accessible [%] Flocoumafen potentially ingested by non-target vertebrates [mg] PECoral 60 g for wax blocks As an absolute worst case the risk at this tier is quantified as the ratio between the concentration of flocoumafen in food and the PNECoral. It is assumed that non-target animals have direct access to an unlimited amount of formulated product. Bait blocks contain 50 mg/kg flocoumafen and hence the PECoral is 50 mg/kg food. The PNECoral for birds is 2.1 μg/kg food, the PNECoral (mammal) is 0.56 μg/kg food. The PEC/PNEC values are rounded values. There are many uncertainties related to the calculation of PEC/PNEC values. Moreover, the PEC/PNEC values are very high. Birds: PEC/PNEC 24,000 Mammals: PEC/PNEC 89,000 This conservative approach clearly highlights a high risk to birds and non-target mammals if flocoumafen containing products are freely consumed. This risk characterisation has been carried out with the PNECoral values representative for a long-term exposure situation. Tier 2 short-term risk assessment, qualitative assessment At Tier 2 a refinement of the Tier 1 is made by assessing the amount of food ingested by non target animals. The step 1 worst case exposure estimates were based on an avoidance factor (AV) of 1 (no avoidance), and a fraction of diet obtained in the treated area (PT) of 1 and no elimination (EL). The Tier 2 worst exposure estimates were based on AV=0.9 instead of 1, PT=0.8 instead of 1 and EL=0.7 or 0.3 instead of 1.

114 Table : qualitative comparison of acute exposure (1 meal) of non target mammals and birds to primary poisoning with single dose LD50 values. Exposure scenario (Species) Uptake of flocoumafen after a single meal (one day) [mg/kg bw/day] (ETE) LD50 mammals/birds [mg/kg bw] Worst case Realistic Worst case Normal use Step 1 Step 2 Dog (rat) Cat (rat) General non-target (rat) mammal 1 Pig (rat) Pig, young (rat) Tree sparrow (Anas platyrhynchos) Chaffinch (Anas platyrhynchos) Wood pigeon (Anas platyrhynchos) Pheasant (Anas platyrhynchos) Step 1: AV= 1, PT = 1, PD = 1 and EL = 0; Step 2: AV= 0.9, PT = 0.8, PD = 1 and EL = 0 1 Body weight of a fox was chosen Table : qualitative comparison of acute exposure (1 meal and 24 hours elimination) of non target mammals and birds to primary poisoning with single dose LD50 values. Exposure scenario (Species) Uptake of flocoumafen after a single meal (one day) [mg/kg bw/day] (ETE) LD50 mammals/birds [mg/kg bw] Worst case Realistic Worst case Normal use Step 1 Step 2 Dog (rat) Cat (rat) General non-target (rat) mammal 1 Pig (rat) Pig, young (rat) Tree sparrow (Anas platyrhynchos) Chaffinch (Anas platyrhynchos) Wood pigeon (Anas platyrhynchos) Pheasant (Anas platyrhynchos) Step 1: AV= 1, PT = 1, PD = 1 and EL = 0.3 (mammals) and 0.7 (birds); Step 2: AV= 0.9, PT = 0.8, PD = 1 and EL = 0.3 (mammals) and 0.7 (birds) 1 Body weight of a fox was chosen As no acute PNECoral could be derived the exposure concentrations are only compared in a qualitative way with acute LD50 values. It is clear from Table and that for mammals values for ETE already after one meal exceed the lowest LD50 for rats. This is even the case when lowering AV and PT and considering elimination through excretion. From this calculation

115 it becomes clear that the mammals die if consuming 100% of their daily food uptake on rodenticide bait, even without applying an assessment factor to a single dose LD50 value. For birds ETE is below the single dose LD50 values. However, this qualitative assessment is a simple comparison of the acute exposure situation with single dose LD50 values and the conclusion should not be that the substance is not acutely toxic or "unproblematic" with regard to the acute primary poisoning situation of birds. A comparison has been made with a single dose LD50 without applying an assessment factor. This comparison is not intended to be used for risk characterisation as no PNECoral has been derived and hence no PEC/PNEC ratio can be established. Tier 2 long-term risk assessment At Tier 2 long-term a refinement of the acute exposure is made by assessing the amount of food (as bait blocks from one bait point ingested by non target animals after 5 meals. The step 1 worst case exposure estimates were based on an avoidance factor (AV) of 1 (no avoidance), and a fraction of diet obtained in the treated area (PT) of 1 and no elimination (EL). The Tier 2 worst case exposure estimates were based on AV=0.9 instead of 1, PT=0.8 instead of 1 and EL=0.7 or 0.3 instead of 1. From table can be seen that PEC/PNEC ratios are very high. Table : Long term PEC/PNECoral for non-target mammals and birds Exposure scenario Uptake of flocoumafen after a 5 meals [mg/kg bw/day] (EC5) PEC/PNEC Step l 1 PEC/PNEC Step 2 2 (Species) Step 1 Step 2 PNEC Dog ~ 297,000 ~ 214,000 Cat ~ 281,000 ~ 202,000 General non-target ~ 226,000 ~ 163,000 mammal 1 Pig ~ 37,000 ~ 26,800 Pig, young ~ 119,000 ~ 85,700 Tree sparrow ~ 98,000 ~ 71,000 Chaffinch ~ 86,000 ~ 62,000 Wood pigeon ~ 31,000 ~ 22,000 Pheasant ~ 31,000 ~ 22,000 Step 1: AV= 1, PT = 1, PD = 1 and EL = 0.3 (mammals) and 0.7 (birds); Step 2: AV= 0.9, PT = 0.8, PD = 1 and EL = 0.3 (mammals) and 0.7 (birds) Conclusion When comparing the concentration of flocoumafen in food with the PNECoral a high risk can be identified. Regarding the short-term exposure at Tier 2, ETE values after 1 meal for non-target mammals exceed the lowest LD50 values for mammals both without and with excretion. ETE values after 5 days intake of flocoumafen (long-term exposure) are higher than those after a single day of exposure. Even though excretion from the non-target animal is anticipated accumulation of flocoumafen in the non-target animals outweigh loss of flocoumafen in non-target animals due to excretion. For the long-term assessment all PEC/PNECoral ratios are far above one. In general small animals have a higher risk than large ones.

116 The worst-case PEC/PNEC ratio for birds at step 1 is about 98,000 (sparrow) and about 297,000 for mammals (dog). The worst-case PEC/PNEC ratio for birds at step 2 is about 71,000 (sparrow) and about 214,000 for mammals (dog). Worst case assumptions have been made. It was assumed that the non-target animals have fed entirely, respectively mostly, on flocoumafen containing products (PT was 1 and 0.8, respectively) and that no avoidance (AV = 1) respectively little avoidance (AV = 0.9) occurred due to bait blocks. Consumption of these quantities of flocoumafen containing products is clearly a worst case and the risk in reality might probably not be as high as presented in these scenarios. Based on the maximum recommended baiting regime that entails deployment of for example 60 g bait per secured bait point, the daily food intakes of 600 g for both dogs and pigs correspond to the contents of 10 bait points, respectively. However, as the PEC/PNEC ratio for dogs is above 100,000 the PEC/PNECoral value below 1 for dogs would only be achieved if the daily intake of bait blocks/pellets by dogs was less than 0.01 % of its daily food requirement (3 mg bait per day for dogs). As the EC5 is higher than the EC1 (ETE after 1 day) these values would be lower for the long-term assessment. The values for birds are in the same range. Based on the recommended baiting regime that entails deployment of a maximum of 60 g bait blocks per secured bait point, the daily food intakes of 7.6, 6.42, 53.1 and g for P. montanus (Tree sparrow), F. coelebs (Chaffinch), C. palumbus (Wood pigeon) and P. colchicus (Pheasant) (values from EUBEES) correspond to the contents of at least 8, 9, 1 and 0.6 full bait boxes, respectively. It is unlikely that such amounts of bait would be available to the larger birds whereas smaller species may be able to reach bait inside the bait boxes by entering through the access hole, simply on the basis of their size. However, PEC/PNEC ratios for bigger and smaller birds are above 10,000. Values below 1 for the different bird species would only be achieved if the daily intake of bait blocks by birds were below 0.1 % of their daily food requirement. Possible measures to reduce the risk of primary poisoning to non-target animals As indicated by the PEC/PNEC ratios presented in the above tables, there is a clear primary poisoning hazard for non-target animals if the assumption is made that their diet exclusively or largely consists of rodenticide bait. This is the case regardless of whether moderate corrections for avoidance and food ratio are made. This necessitates the stringent use of careful baiting practice to avoid negative impact on non-target species. This is also acknowledged by the EUBEES-ESD, which states that normal use (adherence to good baiting practice) is expected to minimise primary poisoning hazards. In that case, exposure levels and PEC/PNEC ratios for normal use are estimated to be close to zero. The claim of negligible primary hazard is accepted provided that the submitted directions for use are made sufficiently strict to ensure negligible primary exposure of non-target animals. The adaptation must include that bait is placed in specially designed baiting boxes inaccessible to

117 children and non-target animals. In case any other bait covers are used, it should be explicitly stated that these other covers should be tamper proof and heavy enough to avoid displacement by nontarget organisms. Conclusion: Calculated risks of primary poisoning are high. It is recognised, however, and confirmed in field trials with flocoumafen, that the risk of flocoumafen-poisoning of livestock and household animals as well as of wild seed-eating birds can be reduced to a minimum when the rodenticide is handled with diligence and care (adherence to good baiting practice). Primary poisoning risks may be considered to be acceptable when the product is used as recommended, is accepted provided that the directions for use are made sufficiently strict to ensure acceptable primary exposure of nontarget animals. The mitigation measures presented in section 2.9 must be included in the directions for use Non compartment specific effects relevant to the food chain (secondary poisoning), quantitative assessment Secondary poisoning as a result of consumption of contaminated rodents The calculation of predators body burdens (PECoral, predator) according to EUBEES based on various standard assumptions have been performed using the recommended spreadsheet model. These values will be compared with the predicted no-effect concentration PNECoral calculated according to the TGD. This procedure is in agreement with the guidance laid down in the EUBEES ESD document. Tier 1 risk assessment for short-term secondary poisoning, qualitative assessment The worst case tier 1 risk assessment assumes that predators consume poisoned rodents that have met 100 % of their daily food requirements with bait (PD = 1). The concentration in the rodent is calculated after 5 days of successive feeding exclusively on rodenticide bait (immediately after the last meal on day 5) and Frodent is 1 (non-target animals consume 100% of their daily intake on poisoned rodents). As the rat represents the food for the predator in this assessment, the unit of the PECoral, predator equals mg/kg food in the secondary poisoning risk assessment. The maximum residue level in target rodents that arise on day 5 after the last meal is mg/kg food. For this short-term situation no quantitative risk assessment is carried out. This values in Table are qualitatively compared to the lowest LC50 value for birds and mammals. Table : Residues of flocoumafen in target rodent after 1 to 5 days of exposure Time Residues of flocoumafen in target rodent [mg/kg bw 100% bait consumption 50% bait consumption 20% bait consumption Day 1, after first meal Day 2 before new meal Day 3 before new meal Day 4 before new meal Day 5 before new meal Day 5 after last meal For mammals no such qualitative comparison has been carried out because no short-term LC50 values are available. The lowest LC50 for birds is 4.1 mg/kg food (mallard duck). This LC50 for birds

118 is lower than the 5 days residue values in target rodents for bait consumptions (50 and 100 %). Even after one single meal the residue values for 50 and 100 % bait consumption are clearly above the LC50 value for birds. This highlights the high acute toxicity of flocoumafen to birds. This is a worst case scenario that assumes that rodents containing flocoumafen residues are wholly ingested by predatory or scavenging birds which feed exclusively on target rodents (PD and Frodent = 1). No account has been taken to the daily food intakes of different predatory birds. It is also assumed that target rodents are taken only on one day when they contain peak flocoumafen residue levels. At consumption rate of about 30% of their daily intake on poisoned food the LC50 for birds is approximately the same as the residue value in the target rodents after a single meal. Tier 1 risk assessment for long-term secondary poisoning For a more long-term exposure it is assumed that the rodents have fed entirely on rodenticide (PD = 1) and that the non-target animals consume 50 % of their daily intake on poisoned rats (Frodent = 0.5). As refinement also PD=0.5 and 0.2 are included in the assessment and compared with the PNECoral. The results are shown in the Table below. Table : Tier 1 risk characterisation of secondary poisoning. Concentration in target rodents is compared to the PNECoral related to concentration in food. Rodents are assumed to consume entirely bait (PD = 1) with the refinement that rodents consume 50 and 20% of the diet. 50% of the predator's diet is poisoned rodents (Frodent = 0.5). Species PEC [mg/kg rodent] PEC/PNEC (PNECoral, predator) Worst case Intermediate case Normal case Worst case Intermediate case Normal case Birds (PNEC = mg/kg diet) Mammals (PNEC = mg/kg diet) ~ 300 ~ 1,700 ~ ~ 12,500 ~ 6,200 ~2,500 pray: AV= 1, PT = 1 and EL = 0.3 Based on the above PEC/PNEC values, the risk of secondary poisoning is high for birds and mammals. Tier 2 risk assessment for long-term secondary poisoning In a manner similar to the second tier primary poisoning calculations the concentrations in the relevant predatory mammals and birds can be calculated. In the following table the expected values for uptake of flocoumafen by a mammal predator or a bird of prey are presented after a single day of exposure and the expected concentration in the non-target animals are presented. It is assumed that rodents fed 100 % on rodenticide (PD = 1) and that predators fed 50 % on poisoned rodents (Frodent = 0.5). The residue of flocoumafen at day 5 after the last meal is mg/kg food. As Frodent in this scenario is 0.5 instead of 1 the residue of flocoumafen at day 5 after the last meal is

119 6.93 mg/kg food. The bodyweights and food intake data of raptorial species are drawn from EUBEES. Table : Comparison expected concentrations of flocoumafen in non-target predators due to Species Barn owl (Tyto alba) Kestrel (Falco tinnunculus Little owl (Athene noctua) Tawny owl (Strix aluco) Fox (Vulpes vulpes) Polecat (Mustela putorius) Stoat (Mustela erminea) Weasel (Mustela nivalis) Dog (Canis domesticus) secondary poisoning with PNECoral Rodents caught on day Rodents caught on 5 before their last meal day 5 after their last Concentration in the non-target animal [mg/kg bw predator] meal Concentration in the non-target animal [mg/kg bw predator] PNEC [mg/kg bw] PEC/PNEC PEC/PNEC ~ 4,400 ~ 6,900 ~ 6,700 ~ 10,000 ~ 5,000 ~ 7,800 ~ 4,000 ~ 6, ~ 14,000 ~ 23, ~ 30,000 ~ 47, ~ 43,000 ~ 67, ~ 62,000 ~ 97, ~ 7,100 ~ 11,000 It has to be stated that the values in Table represent only a single day of exposure. Poisoned rodents are likely to be available for at least several days during a rodenticide treatment and a predator could therefore be exposed over several days. In principle, exposure should be estimated over several days because of the chronic mode of action of anticoagulant rodenticides (a low dose over several days may be more toxic than a higher dose on one day). Therefore the PEC/PNEC ratios in Table do not necessarily represent a realistic worst case situation. Even though this scenario does not represent a realistic worst case all PEC/PNECoral ratios are clearly above one. Birds and mammals have approximately the same risk of secondary poisoning and small animals have a greater risk than large animals. Tier 3: Exposure based on residues measured in field trials and monitoring data Refinement may be based on actual measured residues in rodents during field trails. In the table below an overview is presented of flocoumafen residue levels in dead and alive rodents during rat control campaigns. Table : Overview flocoumafen residues in rodents (From field studies Doc IIIB, section

120 /05 and B /07 of final CAR of flocoumafen) Sample type Residue concentration [mg/kg] Restricted baiting (B /07) Saturation baiting (B /05) Species (B /07) n Mean (range) Species (B /05) n Mean (range) Rats found dead ( ) Rat surface ( ) Rat sub-surface ( ) Rats, trapped (< ) Small rodents found dead ( ) House mouse ( ) Wood mouse 7 (2) 1.6 ( ) Voles ( ) Small rodents, trapped (< ) n: number of samples ( ): below detection limit In the study using saturation baiting (Doc IIIB, section /05 of final CAR of flocoumafen) flocoumafen residues in rat carcasses were found comparable with the normal case scenario (fraction treated bait in rodent s diet = 20%) (see table ). For non-target rodents average flocoumafen residues were even higher, comparable with the intermediate case (fraction treated bait in rodent s diet = 50%). In the study using restricted baiting (Doc IIIB, section /07 of final CAR of flocoumafen) average flocoumafen residues in rat and mice carcasses were ca. a factor 2 lower than the normal case concentrations. It should be noticed that all the residues flocoumafen in both alive and dead rodents exceed the PNECs ( and mg/kg diet) for birds and mammals, respectively. Further data available from field trials and monitoring data concerning poisoning of non-target animals are summarised in Table A secondary hazard was identified in field trials in UK at 10 farms which employed an exaggerated baiting scheme (saturation baiting): flocoumafen residues were detected in one barn owl, one cat and one stoat found dead. Also slight primary hazards was found to birds as there were 4 observations of birds entering bait boxes and one observation of a bird pecking at the bait. However, no blue dyed bird faeces were found. A clear primary hazard was identified in non-target rodents (house mouse, wood mouse and vole) with 60 carcasses containing flocoumafen residues. Trials at 6 other farms in UK using the proposed minimal baiting scheme (3 pulses of 2 blocks per baiting point) however produced no evidence of a secondary hazard. A primary hazard was found for nontarget rodents (house mouse, wood mouse and vole) with 12 carcasses. No primary hazard to nonrodents and birds was not identified at any farm. Only 2 of 89 barn owl pellets collected in an area, where 22% of the interviewed farmers used flocoumafen, contained low flocoumafen residues ( mg/kg). Analysis of regurgitated pellets is a well-established method for exposure monitoring of owls. The barn owl is the predatory bird most frequently hunting in close proximity to farm buildings, thus at comparatively higher risk of secondary poisoning than other species. It should be emphasised, however, that a low concentration of flocoumafen residues in barn owl pellets is not sufficient to conclude that the exposure is low, as the highest concentration of flocoumafen is expected in the liver of the prey (rats) and this is not part of the owl pellets. It is therefore questionable to whether pellets of birds of prey provide relevant monitoring information. In 1998 and 1999 monitoring programmes of suspected poisoning incidents, on a total of 76 cases involving coumarin-based rodenticides, only two cases of flocoumafen intoxication were reported

121 (one tawny owl and one dog), but in both cases the source of the compound could not be established. In a UK monitoring programme during , flocoumafen was detected in 5 out of 363 submitted owls, but these birds were not identified as likely rodenticide victims. In another UK monitoring study during , flocoumafen was not detected in any of the 29 polecat carcases that were analysed. It should be noted that flocoumafen may not have appeared significantly in the data because the use of products containing this active substance is not significant compared to other actives. Therefore, any conclusion made on these data may not be sufficiently robust. The RMS considers that the available field studies can be used as supporting evidence, recognizing that the information on effects to non-target animals is limited. Table Overview of field trials and monitoring data concerning primary and secondary poisoning due to flocoumafen. Study type Results primary and/or secondary poisoning Reference (s) HPLC screening of barn owl pellets in areas with variable levels of flocoumafen use (Ireland); 22% of interviewed farmers used flocoumafen wax block bait. Field trial, saturation baiting at 3 farms (five blocks (105 g) per tray, bait replenished every 2-3 days, duration 3-4 weeks) Field trial, saturation baiting (five blocks (105 g) per tray, bait replenished every 2-3 days), duration 2-4 weeks at 5 farms and 6-9 weeks at 2 farms) Field trial, pulse baiting at 6 farms (three pulses of 2 blocks per baiting point separated by one week interval, removal of remaining bait after 21 days) 1998 UK monitoring of suspected pesticide poisoning incidents; residue No owl carcasses were found. No evidence of a primary hazard of non-rodents and birds. Evidence of primary hazard for non-target rodents. 20 carcasses of non-target rodents (wood mouse and voles) were found. No evidence of a secondary hazard (based on carcass search only). Limited evidence of a primary hazard for nonrodents. One barn owl carcass, one cat carcass and one stoat carcass were found, all containing flocoumafen residues. Birds were frequently observed in close proximity to the bait points. Four incidents were documented of observed entering a bait station, and one record of a bird pecking at the bait. However, no blue-dyed bird faeces were found. Evidence of primary hazard for non-target rodents. 40 carcasses of non-target rodents (house mouse, wood mouse and vole) were found containing flocoumafen residues. No evidence of a primary and secondary hazard of non-rodents and birds. Evidence of primary hazard for non-target rodents. 12 carcasses of non-target rodents (house mouse, wood mouse and vole) were found. On a total of 42 cases of intoxication involving coumarin-based rodenticides, one case of B /01, /02, /03 B /04 B /05 B /06 B /18

122 analysis 1999 UK monitoring of suspected pesticide poisoning incidents; residue analysis Monitoring (HPLC screening for rodenticides) of wildlife fatalities from UK, mainly from the years HPLC screening of polecat carcases from the years , UK flocoumafen intoxication was reported (tawny owl), but the source of the compound could not be established. On a total of 34 cases of intoxication involving coumarin-based rodenticides, one case of flocoumafen intoxication was reported (a dog). The source of the compound could not be established, and the outcome of the incident was not reported. Flocoumafen was detected in 5 out of 363 submitted owls (range mg/kg, mean mg/kg). These birds were not identified as likely rodenticide victims. 29 polecat carcases were analysed; flocoumafen was not detected B /19 B /20 & /21 B / 22 Conclusion for primary and secondary poisoning (consumption of contaminated rodents): The aim of a rodenticide is to control rodent pests, which inevitably entails a risk of secondary poisoning of predators and scavengers. Primary exposure of non-target animals may also occur. An assessment based on theoretical assumptions indicates a risk of primary and secondary poisoning by flocoumafen. The risk to non-target mammals and birds may be overestimated because they do not take behavioural factors into account, such as specific feeding behaviour (only feeding on the less contaminated sections of a carcass, several species are generally gregarious and may consequently pick at the same carcass thus lowering the individual exposure). Data from monitoring studies of wildlife mortalities show only a few isolated incidents of poisoning by flocoumafen of non-target non-rodent mammals and birds. Identified cases in 3 studies were one barn owl, one cat, one stoat, one rabbit and one hedgehog. On the other hand the same studies show that non-target rodents such as house mouse, wood mouse and vole have a high risk for primary poisoning. Furthermore the PEC/PNEC ratios do not include the possibility of recurrent exposure. Many predatory birds are territorial and may therefore actively hunt in areas where they have experienced good success, even feeding young birds with contaminated prey. The latter exposure route to young birds was not part the emission scenarios. In one study however it was stated that a total of 15 bird nests were recorded. Apart from one pheasant nest that was deserted early in the baiting period, all other birds reproduced successfully. Whether this analysis is complete and representative for other campaigns is not known. To conclude, flocoumafen causes a high risk for secondary poisoning in field studies a clear primary poisoning risk was identified for non-target rodents. As non-target and target rodents have a similar feeding behaviour, it will be impossible to reduce the risks for non-target rodents. The true primary and secondary poisoning risks posed to non-target non-rodent mammals and birds by flocoumafen containing products might be lower than those indicated in the quantitative assessment of risk as a result of mitigating factors. The most significant reductions in exposure and risk are achieved by restricting its use to treatment campaigns of limited duration, limiting access of non-target animals to the bait and removing unused bait and dead and moribund rodents during a baiting campaign to

123 minimise the opportunity of primary secondary exposure of non-target animals. However, it has to be stated that only professionals are expected to follow these instructions Secondary poisoning as a result of consumption of contaminated fish Release to surface water, and hence exposure due to secondary poisoning via the aquatic food chain occurs when effluent of an STP is discharged to surface water. The table below shows the PECoral, predator values and the PEC/PNEC ratios for birds and mammals. Table : PEC/PNEC ratios for birds and mammals due to secondary poisoning as a result of consumption of contaminated earthworms (use phase). PECoral, bird mammal Soil use predator PNEC PNEC (mg/kg wwt) (mg/kg diet) PEC/PNEC (mg/kg diet) PEC/PNEC Routine 4.28 x Pulse week x week x The risk is considered to be high (PEC/PNEC >1) for mammals and birds for pulse baiting. For routine bainting the risk is acceptable (PEC/PNEC <1) for mammals and birds Secondary poisoning as a result of consumption of contaminated earthworms In and around buildings The worst case and typical case soil concentrations derived from heterogeneous release (see section ) related to the surface of 550 m 2 were used for the calculations, because earthworms at locations further away from the bait boxes are the major food source for mammals and birds. Additionally, in line with some other assessments of rodenticides 50% of the maximum PECsoil (combined direct and indirect release) is used as input. The table below shows the PECoral, predator values and the PEC/PNEC ratios for birds and mammals. Table : PEC/PNEC ratios for birds and mammals due to secondary poisoning as a result of consumption of contaminated earthworms (use phase). PECoral, bird mammal Scenario use (combined direct and indirect release) predator PNEC (mg/kg wwt) (mg/kg diet) PEC/PNEC PNEC (mg/kg diet) PEC/PNEC 50 % of maximum PECsoil use (indirect heterogeneous release) Realistic worst case

124 Typical case The risk is considered to be high (PEC/PNEC >1) for mammals and birds. Sewer systems The table below shows the PECoral, predator values and the PEC/PNEC ratios for birds and mammals. Table : PEC/PNEC ratios for birds and mammals due to secondary poisoning as a result of consumption of contaminated earthworms (use phase) for application in sewer systems. PECoral, bird mammal Soil use PNEC PNEC predator (mg/kg PEC/PNE (mg/kg PEC/PNE (mg/kg wwt) diet) C diet) C general purpose agricultural soil (cultivation of crops for human consumption) grassland (cattle grazing) The risk is considered to be low (PEC/PNEC <1) for mammals and birds. Additional thoughts: Concerning the risk assessment for secondary poisoning of earthworm eating mammals and birds the following remarks can be made: The scenarios assume release of flocoumafen through urine and faeces of the target species. This is not the case as excretion of flocoumafen is restricted to release via faeces, causing an even more heterogeneous exposure of earthworms to flocoumafen. The scenarios assume a steady state bioaccumulation in earthworms. This is not the case as there is only a temporary and spatially limited exposure of worms to flocoumafen in faeces. Additionally the BCF earthworm is based on a QSAR. It is well known that substances with a high logkow (>6) often have a lower measured BCF in worm bioaccumulation studies than the QSAR BCF. To substantiate this, however, a bioaccumulation study is required. The secondary poisoning scenarios assume that the diet of birds and mammals consists of 100% contaminated worms. The expected flocoumafen intake is probably lower due to the very heterogeneous contamination of earthworms. This leads to the conclusion that the scenarios are not realistic and most likely overestimate the exposure. On basis of the uncertainties mentioned, it is not possible to take into consideration the secondary poisoning due to the consumption of contaminated earthworms by mammals and birds. To improve the scenario further development and validation is needed. Additionally it is to be expected that rat faeces are mainly eaten by snails. A possible food chain scenario for such a prey species is not developed yet PBT assessment According to the TNsG on Annex I inclusion substances that fulfil the following PBT or vpvb criteria shall not be included in Annex I unless releases to the environment can be effectively prevented:

125 Since December 2010 it is agreed that the PBT assessment is carried out on basis of REACH guidance. This means that the following criteria apply: Substances which fulfil the PBT or vpvb criteria or POPs criteria will not be included in Annex I unless releases to the environment can be effectively prevented. P-criterion: The following information on degradation / transformation in water is available: Flocoumafen has been shown to be hydrolytically stable under environmentally relevant conditions (DT50 > 1 year). Flocoumafen is not readily biodegradable and does not degrade under anaerobic conditions. Flocoumafen was found to be susceptible to photo-transformation in water (DT50 = 1.67 d). Transformation products could be identified partially as 4-hydroxy-3-[3-(4-hydroxyphenyl)- 1,2,3,4-tetrahydro-1-naphthyl]coumarin and 4-(Trifluoromethyl)-benzoic acid. Information on degradation rates in water and sediments (freshwater and marine) is lacking. However, based on the low biodegradation potential in soil (DT50 = 213 days) and the high hydrolytical stability flocoumafen is considered to be very persistent in water and sediment. B-criterion: In a bioconcentration study in fish a BCF of 24,300 L/kg based on whole body wet weight is determined. From the BCF value of flocoumafen it can be concluded that the active substance is very bioaccumulative. T-criterion:

126 Long-term exposure of the aquatic environment to flocoumafen is not expected. A prolonged toxicity study in fish is not considered to be required. A chronic NOEC of flocoumafen for marine or freshwater organisms is not available. Lowest acute toxicity was observed with a fish species (Oncorhynchus mykiss). LC50(4d) = 0.07 mg/l. Extrapolation to a chronic NOEC would result in mg/l (extrapolation factor 0.1). Conclusion chronic toxicity <0.01 mg/l (T criterion). There is no information on eventual endocrine disrupting effects of flocoumafen. Based on CMR data, flocoumafen is considered to be non-genotoxic (see Doc IIA, chapter 3.6). Therefore, and since there is a risk that animals bleed to death during labour the performance of a two-generation reproduction study might cause unnecessary harm to laboratory animals, it is concluded that a carcinogenicity study with flocoumafen is not considered necessary (see Doc IIA, chapter 3.7 of final CAR of flocoumafen). Teratogenity: based on read-across from warfarin the Commission Working Group of Specialised Experts on Reproductive Toxicity (in the meeting of 19 and 20 September 2006) and subsequently the Classification&Labelling group for biocides and pesticides (in the meeting dated 14 and 15 November 2006) made a provisional decision for all anticoagulants rodenticides to classify them with R61 without a decision on Cat. 1 or Cat 2 (see Doc IIA, chapter of final CAR of flocoumafen). Fertility: based on the fact that the fertility effects are possibly non-specific accompaniments to severe generalised toxicity and on read-across from warfarin as discussed at 14 and 15 November 2006 the Classification&Labelling group for biocides and pesticides made a provisional decision not to classify all anticoagulant rodenticides and especially flocoumafen with R62 (see Doc IIA, chapter of final CAR of flocoumafen). It is concluded that flocoumafen should be considered a PBT and vpvb substance. The chemical characteristics of flocoumafen comply with the criteria for Persistence, Bioaccumulation and Toxicity. As is decided at the CA meeting of March 2007 (ENV B.3/PC D(2007) - 21/03/2007) the following restriction must be included in the directions for use: In view of the fact that the active substance is a PBT/vPvB substance appropriate risk mitigation measures must be taken to protect the environment (see chapter 2.9). 2.9 Measures to protect man, animals and the environment For the measures to protect animals and the environment we refer to the elements to be taken into account by Member States when authorising products from the Assessment Report and inclusion directive 2009/150/EC for flocoumafen which shall be duly taken into consideration for a clear labelling of STORM Secure. The instructions for use must contain the following indications: Bait must be placed using specially designed bait boxes, inaccessible to children and nontarget animals, or in case any other bait covers are used, it must be explicitly stated that these other covers must be tamper proof and heavy enough to avoid displacement by nontarget organisms. Blocks containing bait must be secured in such a way that they cannot be dragged away. The duration of the control operation must be as short as possible, and, depending on the reduction of the population, observations on activity of rats and mice during the control operation are necessary.

127 During the control operation pets are not allowed free movement at or around the places where the pest control takes place. During the control operation, at and around the campaign location, active searches must be made at frequent intervals, at least as often as when baits are checked and/or replenished, for missing bait, spilled bait, dead rat and mice and other dead animals. Dispose of dead rodents in accordance with local requirements. An accurate record must be kept of the number of bait blocks applied and disappeared from the bait points. During the control operation, at and around the campaign location all inactive rodent holes should be closed, after removal of spilled bait, dead rat and mice and other dead animals. At the end of the control operation all bait must be removed and an active search must be made for missing bait, spilled bait, dead rat and mice and other dead animals not only on the soil surface, but also in rat and mouse holes and in places that are difficult to access. The restriction of products to trained professionals only, should be considered. 3 Proposal for decision STORM Secure has been evaluated as a rodenticide intended to be used for the control of commensal rodents (brown and black rats, house mice) in and around buildings and of rats in the sewerage. This includes the use of the product in animal burrows burrow baiting. The product is for both professional and non-professional use. The assessment presented in the effects and exposure assessment from the applicant for the product has shown that STORM Secure may be authorised for use as a rodenticide (product type 14). The Dutch CA considers that sufficient data have been provided to verify the outcome and conclusions, and permits the authorisation of STORM Secure. 3.1 National paragraph In the Netherlands the use of rodenticides against rats is restricted to licensed professional users. The Dutch CA is of the opinion that the general public might use rodenticides against rats in an incorrect way, which can cause resistance in rats and increased risk for the environment. Resistance development will increase problems of controlling rats in the future. For this reason, it is the Dutch CA s national policy to restrict the authorisation of rodenticides for controlling rats to licensed professional users only. The intended use concerns use of the product in and around buildings and in sewer systems. The Dutch CA is of the opinion considering the risk of primary and secondary poising determined in the PAR, the use needs to be restricted to closed buildings and in sewer systems only for authorization in the Netherlands. Further restrictions are necessary to prevent access of non-target animals to the product, see section 2.9.

128 Annex: 1. Summary of product characteristics 2. List of studies reviewed 3. Analytical methods residues active substance 4. Toxicology and metabolism active substance 5. Toxicology biocidal product 6. Safety for professional operators 7. Safety for non-professional operators and the general public 8. Residue behaviour 9. Translation of Dutch labels

129 Annex 1: Summary of product characteristics (a) Product trade name: STORM Secure (BAS I) (b) (i) Qualitative and quantitative information on the composition of the biocidal product NB: This information is confidential and should not be disclosed to third parties. 82

130 Annex 2: List of studies reviewed List of new data submitted in support of the evaluation of the active substance Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed Yes No Yes No A /01 A /01 Wenzel, 2011 Fish, bioconcentration of Flocoumafen according to the OECD- BASF No yes A. Guideline 305 and EU method C.13 Fraunhofer Institute for Molecular Biology and Applied Ecology, Schmallenberg, Germany, Report no. EBR-003/4-10 BASF ID: 2010/ GLP / unpublished A /01 A /01 Simon, M Soil microorganisms: Effects of Flocoumafen on nitrogen and carbon transformation Fraunhofer Institute for Molecular Biology and Applied Ecology, Schmallenberg, Germany, Report no. EBR-003/3-35 BASF ID: 2007/ GLP / unpublished BASF No yes 83

131 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed A /01 A /01 Simon, 2007 Earthworm acute toxicity test: acute toxicity of Flocoumafen on Eisenia BASF No yes M. fetida Fraunhofer Institute for Molecular Biology and Applied Ecology, Schmallenberg, Germany, Report no. EBR-003/3-08 BASF ID: 2007/ GLP / unpublished A /01 A /01 Simon, M Terrestrial plants, growth test: Effect of Flocoumafen on the seedling emergence and growth of Avena sativa, Lactuca sativa, Phaseolus aureus, Raphanus sativus, Sinapis alba, and Triticum aestivum Fraunhofer Institute for Molecular Biology and Applied Ecology, Schmallenberg, Germany, Report no. EBR-003/4-40 BASF ID: 2007/ GLP / unpublished BASF No yes List of new data submitted in support of the evaluation of the biocidal product Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed Yes No Yes No 84

132 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed B Randt, C Flocoumafen 0.005% wlw BB: BASF X X chemical stability of formula reference BAS when stored in Paper/PE block bottom bags week final report BASF Agricultural Center, Limburgerhof, Germany, Report No.: APDFU 021 BASF-ID: 2006/ , GLP, Not Published 85

133 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed B Kröhl, T Flocoumafen 0.005% w/w BB: BASF X X bioassay and chemical and physical stability of formula reference BAS I when stored in candidate commercial packaging week final report BASF AG, Ecology and Environmental Analytics, Limburgerhof, Germany, Report No.: 96034/E BASF-ID: 2005/ , Not GLP, Not Published B Wolf, H Shelf Life study of STORM products containing Flocoumafen BASF Crop Protection, Ludwigshafen, Germany Not GLP, Not Published BASF X X 86

134 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed B Sharples, R Suitability and comparability of BASF X X packaging materials for STORM rodenticide bait BASF plc, Widnes, UK GLP, Not Published B Moyle, J Method validation of RLA BASF X X 12671, an HPLC method for the determination of Flocoumafen in rodenticide baits using acid digestion BASF Agro Research, Gosport, UK, Report No.: RLG 4892 BASF-ID: 2002/ , GLP, Not Published B Class, T Validation of method RLA V for the HPLC/UV determination of Flocoumafen in rodenticide bait PTRL Europe, Ulm, Germany, Report No.: P/B 1473 G BASF-ID: 2010/ , GLP, Not Published BASF X X 87

135 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed Yes No Yes No 5 B5.10.2/01 Hughes, C.S Choice feeding (palatability) tests on STORM Secure block bait (BAS I), fresh and post 5 days stored at high relative humidity conditions, against male and female Wistar rats. BASF plc, Report No.: LR033/11 BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 5 B5.10.2/02 Hughes, C.S Choice feeding tests on STORM Secure block bait against male and female Rattus norvegicus, Berkshire (Difenacoum and Bromadiolone resistant) strain BASF plc, Report No.: LR060/09 BASF-ID: 2009/ , Not GLP, Not Published BASF No Yes 88

136 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/03 Klemann, N Field trial to determine the efficacy of the rodenticide block formulation "STORM Secure" (BAS I), containing 50 ppm flocoumafen, in controlling Norway rats (Rattus norvegicus), in and around buildings, animal housing (barns), open Dr. Nicole Klemann, Warendorf, Germany, Report No.: KLN/BASF/ BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 89

137 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/04 Hughes, C.S Pen trial study on STORM Secure bait (BAS I), using pulse baiting method, against a colony of wild derived Mus domesticus (experiment 6156) BASF plc, Report No.: LR048/11 BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 5 B5.10.2/05 Hughes, C.S Pen trial study on STORM Secure bait (BAS I), using pulse baiting method, against a colony of wild derived Mus domesticus BASF plc, Report No.: LR047/10 BASF-ID: 2010/ , Not GLP, Not Published BASF No Yes 90

138 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/06 Hughes, C.S Pen trial study on STORM BASF No Yes Secure bait (BAS I), using pulse baiting method, against a colony of wild derived Mus domesticus, bromadiolone resistant strain. BASF plc, Report No.: LR011/11 BASF-ID: 2011/ , Not GLP, Not Published 5 B5.10.2/07 Hughes, C.S Pen trial study on STORM Secure bait (BAS I), using pulse baiting method, against a colony of wild derived Mus domesticus, Bromadiolone resistant strain (experiment 6130) BASF plc, Report No.: LR041/11 BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 91

139 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/08 Sharples, R An experimental note on the BASF No Yes median effective dose of 50ppm Flocoumafen wax blocks against Wistar rats Sorex Ltd., Agricultural Research Departement, BASF-ID: FL Not GLP, Not Published 5 B5.10.2/09 Sharples, R A bait LD50 feeding test of STORM rodenticide bait blocks against Rattus norvegicus, Wistar strain Sorex Ltd., Agricultural Research Departement, BASF-ID: FL Not GLP, Not Published BASF No Yes 92

140 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/10 Sharples, R., 1987 A choice feeding test of BASF No Yes Chorley, C. STORM rodenticide bait blocks against Rattus norvegicus, Wistar strain Sorex Ltd., Agricultural Research Departement, BASF-ID: FL Not GLP, Not Published 5 B5.10.2/11 Hughes, C.S Choice feeding (palatability) tests ob Flocoumafen 0.005% BB (initial) bait against male and female Rattus norvegicus, Wistar strain Sorex Limited Product, Development Laboratory, Report No.: LR038/01 BASF-ID: 2001/ , Not GLP, Not Published BASF No Yes 93

141 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/12 Hughes, C.S Choice feeding (palatability) BASF No Yes tests on Flocoumafen % BB Bait, initial and post 52 weeks storage at 28 C, against male Rattus norvegicus, Wistar strain Sorex Limited, UK, Report No.: LR021/02 BASF-ID: 2002/ , Not GLP, Not Published 5 B5.10.2/13 Hughes, C.S Choice feeding (palatability) tests on Flocoumafen % BB Bait, initial and post 104 weeks storage at 20 C, against male Rattus norvegicus, Wistar strain Sorex Limited, UK, Report No.: LR030/03 BASF-ID: 2003/ , Not GLP, Not Published BASF No Yes 94

142 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/14 Hughes, C.S Choice feeding (palatability) BASF No Yes tests on Flocoumafen % BB Bait, initial and post 156 weeks storage at 20 C, against male Rattus norvegicus, Wistar strain Sorex Limited, UK, Report No.: LR033/04 BASF-ID: 2004/ , Not GLP, Not Published 5 B5.10.2/15 Hughes, C.S Choice feeding (palatability) tests on Flocoumafen % BB Bait, initial and post 208 weeks storage at 20 C, against male Rattus norvegicus, Wistar strain Sorex Limited, UK, Report No.: LR036/05 BASF-ID: 2005/ , Not GLP, Not Published BASF No Yes 95

143 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/16 Hughes, C.S Choice feeding (palatability) BASF No Yes tests on Flocoumafen % BB Bait, initial and post 260 weeks storage at 20 C, against male Rattus norvegicus, Wistar strain Sorex Limited, UK, Report No.: LR024/06 BASF-ID: 2006/ , Not GLP, Not Published 5 B5.10.2/17 Lazarus, A.B A determination of the efficacy of 'STORM' against rat (Rattus norvegicus, Berk.) infestations and an evaluation of the risks of toxicity to non- target vertebrate species MAFF, Tolworth Laboratory, Tolworth, UK, Report No.: C90/0079 BASF-ID: FL Not GLP, Not Published BASF No Yes 96

144 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/18 Greaves, J.H., 1986 Six field trials of 'STORM' BASF No Yes Lazarus, A.B. Flocoumafen bait blocks for the control of Rattus norvegicus on farms MAFF, Tolworth Laboratory, Tolworth, UK, BASF-ID: FL Not GLP, Not Published 5 B5.10.2/19 Lazarus, A.B Restricted application of 'STORM' Flocoumafen bait blocks on six farms for the control of Rattus norvegicus MAFF, Tolworth Laboratory, Tolworth, UK, Report No.: SSD 289/86 BASF-ID: FL Not GLP, Not Published BASF No Yes 97

145 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/20 Hughes, C.S Pen trial study on STORM block bait against a colony of wild derived Rattus rattus BASF plc, Report No.: LR046/09 BASF-ID: 2009/ , Not GLP, Not Published BASF No Yes 5 B5.10.2/21 Hughes, C.S Pen trial study on STORM BASF No Yes block bait against a colony of wild derived Mus domesticus BASF plc, Report No.: LR041/09 BASF-ID: 2009/ , Not GLP, Not Published 5 B5.10.2/22 Anonymous 1986 Pen trials to assess the toxicity of STORM wax blocks to wild Warfarin-resistant mice (Mus domesticus) MAFF, ADAS Slough Laboratory, UK, BASF-ID: 1986/ , Not GLP, Not Published BASF No Yes 98

146 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/23 Hughes, C.S Pen trial study on STORM BASF No Yes block bait against a colony of wild derived Mus domesticus, bromadiolone resistant strain BASF plc, Report No.: LR038/09 BASF-ID: 2009/ , Not GLP, Not Published 5 B5.10.2/24 Hughes, C.S Twenty four hour no-choice feeding tests on STORM 4g block bait (BAS I) against male and female Rattus norvegicus, Wistar Strain. BASF plc, Report No.: LR050/11 BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 99

147 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/25 Hughes, C.S Twenty four hour no-choice BASF No Yes feeding tests on STORM 4g block bait (BAS I) against male and female Rattus norvegicus, Hampshire (Difenacoum and Bromadiolone tolerant) strain BASF plc, Report No.: LR038/10 BASF-ID: 2010/ , Not GLP, Not Published 5 B5.10.2/26 Hughes, C.S Three day no-choice feeding tests on STORM 4g Block Bait (BAS I) against male and female Rattus norvegicus, Berkshire (Difenacoum and Bromadiolone resistant) strain BASF plc, Report No.: LR055/11 BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 100

148 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/27 Hughes, C.S Choice feeding tests on STORM 4g block bait (BAS I), against male and female Rattus norvegicus, Wistar strain BASF plc, Report No.: LR053/11 BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 101

149 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/28 Klemann, N Field trial to determine the efficacy of the rodenticide block formulation "STORM 4g block (BAS I)" containing 50 ppm flocoumafen, in controlling Norway rats (Rattus norvegicus), in and around buildings, animal housing (barns), open areas and... Dr. Nicole Klemann, Warendorf, Germany, Report No.: KLN/BASF/ BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 102

150 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/29 Hughes, C.S Pen trial study on STORM 4g BASF No Yes block bait (BAS I), using pulse baiting method, against a colony of wild derived Rattus rattus BASF plc, Report No.: LR047/11 BASF-ID: 2011/ , Not GLP, Not Published 5 B5.10.2/30 Hughes, C.S Choice feeding test on STORM 4g block bait (BAS I) against female Mus domesticus, CD1 strain BASF plc, Report No.: LR054/11 BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 103

151 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/31 Redpath, C.S Choice feeding (palatability) BASF No Yes test on STORM 4g rodenticide bait block, fresh and post 6 month storage at ambient conditions, against male C57BL/10 mice Sorex Ltd., Agricultural Research Departement, Report No.: LR007/91 BASF-ID: FL Not GLP, Not Published 5 B5.10.2/32 Redpath, C.S Choice feeding (palatability) test on STORM 4g block bait, fresh and post 6 month storage at ambient conditions, against male C57BL/10 mice Sorex Ltd., Agricultural Research Departement, Report No.: LR069/92 BASF-ID: 1992/ , Not GLP, Not Published BASF No Yes 104

152 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/33 Hughes, C.S Pen trial study on STORM 4g BASF No Yes Block bait (BAS I), using pulse baiting method, against a colony of wild derived Mus domesticus BASF plc, Report No.: LR021/11 BASF-ID: 2011/ , Not GLP, Not Published 5 B5.10.2/34 Hughes, C.S Pen trial study on STORM 4g block bait (BAS I), using pulse baiting method, against a colony of wild derived Mus domesticus (Experiment Number 6221) BASF plc, Report No.: LR056/11 BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 105

153 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/36 Hughes, C.S Field trial study on STORM 4g block rodenticide bait (BAS I) for the control of the house mouse, Mus domesticus, at the storage units at New Crickett Farm, Ellesmere, Shropshire, England. BASF plc, Report No.: LR044/11 BASF-ID: 2011/ , Not GLP, Not Published BASF No Yes 106

154 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/37 Buckle, A.P., Prescott, C.V Field trial to evaluate the consumption of plain wheat bait from three different tamper-resistant bait stations, and from protected wooden bait trays, by Norway rats, Rattus norvegicus (Berkenhout, 1769), infesting agricultural holdings University of Reading, Vertebrate Pest Unit, School of Biological Sciences, Reading, United Kingdom, Report No.: VPU/08/009 BASF-ID: 2008/ , Not GLP, Not Published BASF No No 107

155 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/38 Buckle, A.P., 2011 Effects of tamper-resistant bait BASF No No Prescott, C.V. boxes on bait uptake by Norway rats (Rattus norvegicus Berk.) Int. J. Pest Managem. 57, 77-83, BASF-ID: 2010/ , Not GLP, Published 5 B5.10.2/39 Redpath, C.S Choice feeding (palatability) tests on STORM II block bait, fresh and post 6 month stored at ambient conditions against male Wistar rats Sorex Ltd., Agricultural Research Departement, Report No.: LR026/95 BASF-ID: FL Not GLP, Not Published BASF No Yes 108

156 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/40 Latteur, G Efficacité du STORM formulé BASF No Yes en blocks de 3,6 g. contre le rat brun (Rattus norvegicus L.) Centre de Recherches Agronomiques Gembloux, Report No.: 895 BASF-ID: FL Not GLP, Not Published 5 B5.10.2/41 Latteur, G Efficacité du STORM formulé BASF No Yes en blocks de 16 g. contre le rat brun (Rattus norvegicus L.) Centre de Recherches Agronomiques Gembloux, Report No.: 896 BASF-ID: FL Not GLP, Not Published 5 B5.10.2/42 Sharples, R The palatability of baits containing cis- or- trans- WL Sorex Ltd., Agricultural Research Departement, BASF-ID: FL Not GLP, Not Published BASF No Yes 109

157 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/43 Sharples, R The palatability of Bepex wax BASF No Yes blocks containing 50ppm Flocoumafen Sorex Ltd., Agricultural Research Departement, BASF-ID: FL Not GLP, Not Published 5 B5.10.2/44 Sharples, R A WL wax block field trial at the Pit, Linner Farm, Halebank, Cheshire Shell Agriculture Regulatory Affairs, BASF-ID: FL Not GLP, Not Published BASF No Yes 110

158 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/45 Townsend, M.G Post-treatment censusing on six farms, six and twelve months after controlling the Rattus norvegicus infestations with "STORM"(Flocoumafen) bait blocks MAFF, Tolworth Laboratory, Tolworth, UK, Report No.: SSD 308/86 BASF-ID: FL Not GLP, Not Published BASF No Yes 5 B5.10.2/46 Johnson, R.A Performance studies with the new anticoagulant rodenticide, Flocoumafen, against Mus domesticus and Rattus norvegicus Bull. OEPP/EPPO Bull. 18, , BASF-ID: FL Not GLP, Published BASF No No 111

159 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/47 Anonymous 1987 Rodent palatability studies on BASF No Yes STORM wax blocks containing 10ppm Bitrex (denatonium benzoate) as a deterrent to ingestion by humans Sorex Ltd., Agricultural Research Departement, BASF-ID: FL Not GLP, Not Published 5 B5.10.2/48 Sharples, R., Chorley, C A choice feeding test of STORM rodenticide bait blocks against Mus domesticus C57BL/10 strain Sorex Ltd., Agricultural Research Departement, Report No.: C/S/C57 BASF-ID: FL Not GLP, Not Published BASF No Yes 112

160 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/49 Redpath, C.S Choice feeding (palatability) BASF No Yes tests on STORM II block bait, fresh and post 6 month stored at ambient conditions against male BKW mice Sorex Ltd., Agricultural Research Departement, Report No.: LR027/95 BASF-ID: FL Not GLP, Not Published 5 B5.10.2/50 Latteur, G Evaluation de la perte d'efficacité au cours du viellissement du bloc STORM de 3,6 g, rodenticide à base de 0,005% de Flocoumafene pour lutter contre la souris grise Centre de Recherches Agronomiques Gembloux, Report No.: 938 BASF-ID: FL Not GLP, Not Published BASF No Yes 113

161 Section No Reference No Author Year Title Owner of data Letter of Access Data protection claimed 5 B5.10.2/51 Latteur, G Efficacité des blocs STORM BASF No Yes de 3,6 g a base de 0,005 % de flocoumafene contre la souris grise (Mus musculus L.) en presence de froment concasse ou de farine d'avoine Centre de Recherches Agronomiques Gembloux, Report No.: 911 BASF-ID: FL Not GLP, Not Published 5 B5.10.2/52 Garforth, B., Johnson, R.A Performance and safety of the new anticoagulant rodenticide Flocoumafen Brighton Crop Protect. Conf. (1987), , BASF-ID: FL Not GLP, Published BASF No No 114

162 Annex 2B: Study summaries Study Summary A /01 Section A Bioconcentration in an appropriate species of fish Annex Point IIA Reference A /01: 1.2 Data protection Yes 1.3 Data owner BASF SE 1.4 Companies with letter of access 1.5 Criteria for data protection 1 Reference Official Wenzel, A. (2011): Fish, bioconcentration of Flocoumafen according to the OECD-Guideline 305 and EU method C.13. Fraunhofer Institute for Molecular Biology and Applied Ecology, Schmallenberg, Germany, Report no. EBR-003/4-10, April 14, 2011 (unpublished). (BASF DocID: 2010/ ) No 2.1 Guideline study Yes 2.2 GLP Yes 2.3 Deviations Yes Data on existing a.s. to maintain or vary a.s. Annex I entry 2 Guidelines and Quality Assurance OECD guideline 305 (1996) EU method C.13 (Council Regulation (EC) No. 440/2008) Certified laboratory See 3 Materials and Methods 3.1 Test material As given in Section A Lot/Batch number L Specification As given in Section A Purity 98.4 % w/w use only 115

163 Section A Bioconcentration in an appropriate species of fish Annex Point IIA Further relevant Flocoumafen is susceptible to phototransformation in water. properties Thus, light intensity during the test was maintained at the minimum permitted by the test guideline. Furthermore, the test substance is hydrolytically stable (at ph 4, 7, and 9 at 50 C over 5 days, OECD 111), the vapour pressure is < 10 5 Pa, the water solubility is ± mg/l at ph 7, 20 C (see section A3). These properties are not considered to affect the test performance Radiolabelling No 116

164 analysis. Section A Bioconcentration in an appropriate species of fish Annex Point IIA Method of analysis Separation method (for both water and fish): LC-MS/MS, reversed phase column, C18, 5 µm, mm, guard column with identical solid phase, 4 3 mm Gradient with mobile phase A (2 mmol ammonium acetate in methanol) and B (2 mmol ammonium acetate in purified water/methanol 90/10) Internal standard (IS): Brodifacoum (CAS No ) Detection: MRM of 2 mass pairs/channels Flocoumafen: [m/z] Brodifacoum (IS): Calibration range µg/l, 9 concentrations in duplicate; detector response followed a quadratic function, r² = Sample preparation and clean-up (water): Water samples (60 ml) were spiked with IS and acidified with HCl; addition of 12 ml tert-butyl methyl ether (BME), agitation of the sample for 15 min, phases separated (centrifugation); BME phases were concentrated to ca. 0.2 ml by a nitrogen stream, then to near dryness on a Fraunhofer concentration workstation; precipitates were re-dissolved in 200 µl methanol, and a 50 µl aliquot injected into the HPLC device. Specificity: Highly specific (MS/MS). No matrix effects observed. Accuracy was determined by fortifying water samples to give Flocoumafen concentrations of 0.25 and 2.5 ng/l (n=5, respectively). Mean recovery 95.5 %, RSD 4.5%; accuracy was therefore acceptable. Precision/repeatability: Recovery and variability at the fortification levels were 93.4 and 97.5 % (RSD = 4.5 and 3.9 %), respectively; the method is thus sufficiently precise. LOQ, as validated: 0.25 ng/l Sample preparation and clean-up (fish): Fish samples (ca. 1 g) were homogenised with ca. 20 ml water and IS, then acidified with HCl; addition of 35 ml pentane, agitation for 30 min, phases separated (centrifugation); pentane phases were concentrated to near dryness on a TurboVap concentration workstation; the residue was re-dissolved in 1 ml elution agent B (dichloromethane/ n-hexane (30/70)); further clean-up on a deactivated silica gel column, removal of fat with 8 ml elution agent B, elution of the analyte fraction with 20 ml elution agent A (dichloromethane, % formic acid); the eluate was concentrated to near dryness, the residue re-dissolved in a defined volume of methanol, and aliquots submitted to HPLC

165 Section A Bioconcentration in an appropriate species of fish Annex Point IIA Reference substance None Method of analysis Not applicable for reference substance 3.3 Testing/estimation (Non-entry field) procedure Test system/ Flow-through test using zebra fish (Danio rerio). performance The test organism is described in Table A Details on the test system are given in Table A The test conditions are specified in Table A Test substance concentration (nominal): 1.0 ng/l A second concentration was deliberately not employed, in view of the high toxicity of Flocoumafen, and also due to its high theoretically predicted bioconcentration potential. In a non-glp 28-day toxicity experiment, the LC10 was approximately 10 ng/l. To ensure a sufficiently large safety margin, it was decided to run the BCF study at a tenfold lower maximum concentration. Further lowering of test substance levels for obtaining a low test concentration would not have been feasible from a technical/analytical perspective. Duration of uptake phase: 28 days Duration of depuration phase: 56 days Sampling of fish and test water: At 0, 7, 14, 21, 25, and 28 days of the uptake phase At 1, 2, 4, 8, 16, 28, and 56 days of the depuration phase For concentration measurements, 4 3 fish were removed at each sampling date. Concentration in fish was measured in quadruplicate, with 3 fish per sub-sample. Temperature, ph and dissolved oxygen were measured daily. Fish lipid content was determined on the pooled control fish sampled at day 0 (3 3 fish) and day 56 of the depuration phase (3 3 fish) according to the method originally described by Smedes (1999, Analyst 124, ). 3.4 Estimation of A theoretical estimation of the BCF was provided in section bioconcentration A Results 118

166 Section A Bioconcentration in an appropriate species of fish Annex Point IIA Experimental data Mortality/ behaviour No mortality was reported Lipid content Day 0: 4.1 % Depuration phase day 56: 9.8 % Mean: 6.93 % Concentrations of See Table A and Table A test material during test On day 7, the test substance concentration in water dropped to 0.49 ng/l, i.e. half of nominal which had apparently delayed test substance uptake by the fish. However, after re-adjustment of the test concentration to 1 ng/l, a steady-state in fish was reached after 28 days at the latest Bioconcentration BCFsteady-state = 8993 factor (BCF) BCFk = (expressed in relation to the whole body) Uptake and Uptake: k 1 = (SE = 46.75) depuration rate constants Depuration: k 2 = (SE = ) k 2 was estimated using log-linear regression of Flocoumafen concentrations in fish over time. k 1 was estimated by fitting the Cf/Cw ratios from the the uptake phase over time conditional on the depuration rate (k 2) above Depuration time DT95 was estimated at days Metabolites None identified Other Observations A second concentration was deliberately not employed, in view of the high toxicity of Flocoumafen, and also due to its high theoretically predicted bioconcentration potential. In a non-glp 28-day toxicity experiment, the LC10 was approximately 10 ng/l. To ensure a sufficiently large safety margin, it was decided to run the BCF study at a tenfold lower maximum concentration. Further lowering of test substance levels for obtaining a low test concentration would not have been feasible from a technical/analytical perspective Estimation of Not appropriate. bioconcentration Estimates of bioconcentration based on physicochemical properties are presented elsewhere (e.g. section A7.4.2 of the dossier). 119

167 Section A Bioconcentration in an appropriate species of fish Annex Point IIA Applicant s Summary and conclusion 5.1 Materials and methods The bioaccumulation of Flocoumafen in fish was investigated according to OECD guideline 305 (1996) and EU method C.13 using technical grade active substance (non-radiolabelled). The study was performed without employing radiolabelled test material since a sufficiently high specific activity for reliable radiodetection at the required test concentration could not be achieved. Instead, an LC-MS/MS method enabling specific quantification of Flocoumafen at an LOQ of 0.25 ng/l could be developed. The test was performed at a concentration of 1.0 ng/l in water. A second concentration (as required by the test guideline) was not employed in view of the expected BCF and the high toxicity of Flocoumafen: The second concentration would need to be as low as ng/l, which is clearly below any technically feasible LOQ. The uptake phase lasted 28 days; fish samples were drawn on days 0, 7, 14, 21, 25, and 28 (4 3 fish per date) and analysed for Flocoumafen content; water samples were drawn concurrently and the test substance concentration determined. On day 28, the remaining fish were transferred to untreated test water and samples of 4 3 fish removed for analysis on days 1, 2, 4, 8, 16, 28, and 56 of the depuration phase (except days 28 and 56, where the number of remaining fish required reducing the samples to 3 3. Depuration rate constant and uptake rate constant were estimated using log-linear and non-linear regression, and the steady-state and kinetic BCF calculated, as appropriate. 5.2 Results and BCFsteady-state = 8993 discussion BCFk = Uptake rate constant: k 1 = (SE = 46.75) Depuration rate constant: k 2 = (SE = ) DT95 = d 120

168 Section A Bioconcentration in an appropriate species of fish Annex Point IIA Conclusion The validity criteria according to OECD guideline 305 (1996) are fulfilled: Temperature variation < ± 2 C: fulfilled O2 concentration > 60% saturation: fulfilled TS concentration ± 20%: fulfilled (average) Mortality < 10%: fulfilled Absence of other adverse effects: fulfilled Therefore, the test can be considered fully valid. The methodological deviations from the test guideline discussed in chapter 5.1 above were necessary due to substance-specific properties and are therefore not considered to compromise the quality of the study. The test results confirm that Flocoumafen has a high potential to accumulate in organisms Reliability Deficiencies No The deviations from the test guideline chapter 5.1 above were technically necessary, do not affect the validity of the study, and should therefore not be regarded as deficiencies. Date 7 March 2013 Evaluation by Competent Authorities Use separate evaluation boxes to provide transparency as to the comments and views submitted EVALUATION BY RAPPORTEUR MEMBER STATE (*) Materials and methods Results and discussion Conclusion - The test results confirm that flocoumafen has a high potential to accumulate in organisms. The BCF based on whole body wet weight is 24,300 L/kg Reliability 1 121

169 Acceptability The reliability of the study is 1, since the test was conducted according to the standard test guideline OECD 305. Remarks - Date Materials and methods Results and discussion Conclusion Reliability Acceptability Remarks COMMENTS FROM... Table A : Test organisms. Criteria Details Species/strain Danio rerio Source Test laboratory Original source of the breed: West Aquarium GmbH, Bad Lauterberg, Germany Wild caught No Age/size Body length: 3.1 ± 0.2 cm Lipid content Day 0: 4.1 % Depuration phase day 56: 9.8 % Mean: 6.93 % Kind of food TetraMin Hauptfutter (Tetra Werke, Melle, Germany) Amount of food Ad libitum Feeding frequency Once daily Pre-treatment Holding water was identical to test dilution water Feeding of animals during test Yes Table A : Test system. Criteria Details Test type Flow-through Renewal of test solution Flow rate = 8 L/h 122

170 Volume of test vessels 60 L glass aquaria, filled with 50 L test solution/water Volume/animal 0.36 L/individual Number of animals/vessel 140 Number of 1 vessels/concentration Solubilising agents/co-solvents None (acetone was used during preparation of stock solutions, but was completely evaporated, thus present neither in aqueous stock solutions nor in the test solution) Table A : Test conditions. Criteria Details Test temperature 22 C (range of measurements: C) Dissolved oxygen mg/l (= % saturation) ph Adjustment of ph No Aeration of dilution water Yes Continuous Intensity of irradiation Not reported Photoperiod 12:12 h (L:D) Table A : Measured concentrations of Flocoumafen in the test water (n=2) and fish (n=4) in the uptake phase. Day Flocoumafen concentration In water [ng/l] In fish [µg/kg] < LOQ Mean SD SE C.V. (%) Max.dev (%) BCFsteady-state (± SE) 8993 (± 532) 123

171 Table A : Measured concentrations of Flocoumafen in fish in the depuration phase. Day Flocoumafen concentration in fish [µg/kg]

172 Study Summary A /01 Section A Inhibition of microbial activity (terrestrial) Annex Point IIA Reference Official use only 1.1 Reference A /01: Simon, M. (2007): Soil microorganisms: Effects of Flocoumafen on nitrogen and carbon transformation. Fraunhofer-Institute for Molecular Biology and Applied Ecology (IME), Schmallenberg, Germany, Report no. EBR-003/3-35, April 23, 2007 (unpublished). (BASF DocID: 2007/ ) 1.2 Data protection Yes Data owner BASF SE Companies with No letter of access Criteria for data Data on existing a.s. to maintain or vary a.s. Annex I entry protection 2 Guidelines and Quality Assurance 2.1 Guideline study Yes OECD guidelines 216 and 217 (2000) EU Test Method C.21 and C.22 (2004/73/EC) 2.2 GLP Yes 2.3 Deviations No 3 Materials and Methods 3.1 Test material Flocoumafen, as given in Section A Lot/Batch number L Specification As given in Section A Purity 98.4% Composition of Not applicable product Further relevant The test substance is hydrolytically stabile (at ph 4, 7, and 9 at properties 50 C over 5 days, OECD 111), the vapour pressure is < 10 5 Pa, the water solubility is ± mg/l at ph 7, 20 C (see section A3). 125

173 Section A Inhibition of microbial activity (terrestrial) Annex Point IIA Method of analysis Not required 3.2 Reference substance No Not required according to OECD 216 and Method of analysis Not applicable for reference substance 3.3 Testing procedure Soil sample/ Agricultural soil (loamy sand soil) was used for the study. Please inoculum refer to Table A Test system See Table A Application of TS Refer to Table A Test conditions Please see Table A Test parameter Inhibition of microbial activity by Flocoumafen, as assessed by nitrogen transformation and carbon transformation: Oxygen consumption Analytical Nitrate concentration: measured photometrically (Spectroquant parameter NOVA 400) following extraction from soil with 0.1 M KCl solution at a ratio of 5 ml of KCl solution per gram dry weight Oxygen consumption (measurement of glucose-induced respiration rates using a Sapromat Voith Inc.) Duration of the test 28 days Two additional days were appended for the determination of basal respiration Sampling On day 0 and after 28 days Monitoring of TS No concentration Controls Test soil and 10 g quartz sand /kg dry mass soil without test substance. The controls were prepared in four replicates. 126

174 Section A Inhibition of microbial activity (terrestrial) Annex Point IIA Statistics The respiration rates found in each treated samples after 28 days was compared to those found in the controls. The percent inhibition value for each test concentration was calculated. The percent inhibition of nitrate content and respiration rate were calculated in comparison to the control. The NOEC was determined by comparing mean values using Williams test. The concentration-effect relationship was calculated applying probit-analysis assuming log-normal distribution of the values. All calculations were conducted using the computer software ToxRat Professional version 2.09 by ToxRat Solutions GmbH. 4 Results 4.1 Range finding test Not performed Concentration effect data 4.2 Results test substance Initial The nominal test item concentrations in the test containers were concentrations of test 62.5, 125, 250, 500 and 1000 mg Flocoumafen / kg dry soil. substance Actual Nominal concentrations of test substance Growth curves Not appropriate Cell concentration Not appropriate data Concentration/ Please refer to Figure A and Figure A response curve Effect data Nitrogen transformation: The results of the nitrate measurement are presented as mean values in Table A Carbon transformation: The results of the short-term respiration measurement are presented as mean values in Table A Effect concentrations: In Table A the NOECs and ECX values of Flocoumafen for nitrogen and carbon transformation are presented. 127

175 Section A Inhibition of microbial activity (terrestrial) Annex Point IIA Other observed Carbon transformation was not inhibited, but a significant increase effects in short-term respiration was determined at the two highest test concentrations (see Table A ) 4.3 Results of controls The results of control are given in the tables below (Table A , Table A and Table A ) 4.4 Test with reference Not performed substance Concentrations Results 5 Applicant s Summary and conclusion 5.1 Materials and The effect of Flocoumafen on nitrogen and carbon transformation methods by soil microorganisms was investigated according to the OECD guidelines 216 and 217 and EU Test Method C.21 and C.22, respectively. For this, the nitrate content and the short-term respiration were measured. 5.2 Results and The nitrogen transformation capacity of the tested loamy sand field discussion soil was only moderately inhibited by Flocoumafen (NOEC < 62.5 mg /kg dry soil (lowest concentration tested)). Although a concentration-response relationship could be observed, an EC50 could not be computed since inhibition was lower than 50% at all concentrations up to the limit test concentration. No inhibitory effect of Flocoumafen was observed with respect to short-term respiration. Therefore, a hypothetical EC50 for carbon transformation would be >1000 mg Flocoumafen /kg dry soil NOEC Nitrogen transformation: NOEC < 62.5 mg /kg dry soil Carbon transformation: NOEC >1000 mg /kg dry soil EC EC50 Nitrogen transformation: EC50 >1000 mg/kg dry soil Carbon transformation: EC50 >1000 mg /kg dry soil 5.3 Conclusion The validity criteria of the test guidelines (nitrogen and carbon transformation test, OECD 2176 and 217) were fulfilled. The variation between replicate control samples was less than ± 15% at day Reliability Deficiencies No 128

176 Evaluation by Competent Authorities Use separate evaluation boxes to provide transparency as to the comments and views submitted EVALUATION BY RAPPORTEUR MEMBER STATE (*) Date 7 March 2013 Materials and Methods OECD guidelines 216 and 217 state that at least on day 0, 7 and 14, 28 days samples should be taken. However, the frequency of sampling on day 0 and 28 is accepted as no inhibitory effect of flocoumafen was observed with respect to short-term respiration during the test period of 28 days. Results and discussion Nitrogen transformation: NOEC < 62.5 mg/kg dry soil (55.1 mg/kg wet soil) EC mg/kg dry soil (10.7 mg/kg wet soil) Carbon transformation: NOEC >1000 mg /kg dry soil (> mg/kg wet soil) EC10 >1000 mg/kg dry soil soil (> mg/kg wet soil) Nitrogen transformation: EC50 >1000 mg/kg dry soil soil (> mg/kg wet soil) Carbon transformation: EC50 >1000 mg /kg dry soil soil (> mg/kg wet soil) Conclusion The variation between replicate control samples was less than ± 15% at day 28. Reliability 1 Acceptability The reliability of the study is 1, since the test was largely conducted according to the standard test guidelines OECD 216 and 217 (2000) and EU Test Method C.21 and C.22 (2004/73/EC). Remarks - Date Materials and Methods Results and discussion Conclusion Reliability Acceptability COMMENTS FROM

177 Remarks Table A : Inoculum. Criteria Details Nature Soil sample (RefeSol 01-A, Batch No. IME-01) Sampling site Reference soil, loamy sand soil Geographical reference on the sampling See site Data on the history of the site For at least one year prior to soil sampling at the field, no plant protection products had been applied to the sampling site. No organic or mineral fertilizer had been applied to the soil for six or three months prior to soil sampling, respectively. Use pattern Agricultural soil Depth of sampling [cm] Not stated Sand / Silt / Clay content [% dry weight] 71% sand, 24% slit, 5% clay ph 5.7 Organic carbon content [% dry weight] 0.93 % total org. C Nitrogen content [% dry weight] 0.09% total nitrogen, 58.8% NO3 (mg/kg dry weight) Cation exchange capacity [mmol/kg] CECeff = 37.9 mmol/kg Initial microbial biomass Microbial biomass: 109 mg C/kg dry mass soil, calculated from respiration activity Reference of methods ISO (1997): Soil quality Determination of soil microbial biomass Part 1: Substrate-induced respiration method ISO (2002): Soil quality Determination of abundance and activity of the soil microflora using respiration curves. Collection / storage of samples Samples of each treated and control replicate were analysed for nitrate (powdered plant amended samples) and glucose-induced respiration (samples without powdered plant amendment) at the beginning of the exposure period (day 0) and after 28 days. Additionally, the basal respiration (samples without powdered plant amendment) was measured after 30 days. Preparation of inoculum for exposure Sieving to a particle size of 2 mm Pre-treatment Indoor storage at 4 C in the dark for 13 days 130

178 Table A : Test system. Criteria Details Culturing apparatus Incubation containers of stainless steel (given in the study plan) Number of vessels/concentration 3 Control: 4 Aeration device None Measuring equipment Photometer (Spectroquant NOVA400) Apparatus for continuous measurement of respiration rates (Sapromat Voith Inc.) Test performed in closed vessels No Table A : Application of test substance. Criteria Details Application procedure The quantity of the test item required to obtain the desired concentrations was applied as an acetonic stock solution to a quantity of quartz sand resulting in a ratio of approx. 10 g sand/kg dry soil. After evaporation of the solvent, the mixture was added to the test substrate (adjusted to % water holding capacity) and mixed thoroughly. Carrier Organic solvent: acetone, carrier: quartz sand Concentration of liquid carrier [% v/v] Not stated; however, since acetone was completely evaporated, its concentration in the test medium can be considered as negligible Liquid carrier control The control consisted of test soil and 10 g quartz sand /kg dry soil. In view of the complete evaporation of the acetone, a solvent control is not required Other procedures None Table A : Test conditions. Criteria Details 131

179 Organic substrate Incubation temperature Soil moisture Method of soil incubation Aeration Nitrogen transformation: sieved and spiked soil was amended by the addition of powdered plant material (lucerne-grass-green meal) at a plant-soil ratio of 5 g plant per kilogram of soil (dry mass). Three incubation containers per concentration were filled up with 500 g of control and spiked soil, resp. Carbon transformation: The soil samples (100 mg dry mass) were mixed with 4000 mg glucose per kg dry weight (concentration based on a range finding test) using a glucose/talcum mixture to optimise a homogeneous distribution in the soil. The glucose amended soil samples were incubated in an apparatus for continuous measurement of respiration rates. The oxygen consumed was measured for 12 consecutive hours. The incubation temperature was measured continuously, being C. The permitted range of 20 ± 2 C was maintained. Further the permitted ranges of 20 ± 2 C for respiration measurement (OECD 217) and 22 ± 1 C for biomass determination based on SIR according to ISO were maintained. The moisture content of the soil was maintained during the test at 50 % of the WHCmax with a range of 5 %. The masses of the test vessels were measured weekly. Deionised water was added as needed. Individual subsamples No Table A : Mean nitrate content [mg/kg] and deviation from control [%]. TI = Test item; * Significant deviation from control (Williams test, one-sided). Control 62.5 mg TI per kg DM 125 mg TI per kg DM 250 mg TI per kg DM 500 mg TI per kg DM 1000 mg TI per kg DM Test start Nitrate [mg/kg] Day 28 Nitrate [mg/kg]

180 Deviation [%] 21.1 * 23.1 * 32.3 * 42.3 * 44.3 * Table A : Mean short-term respiration rate ([mg O2/(100 g*h)] and deviation from control [%]. TI = Test item; SIR = Substrate induced respiration; * Significant deviation from control (Williams test, onesided). Control 62.5 mg TI per kg DM 125 mg TI per kg DM 250 mg TI per kg DM 500 mg TI per kg DM 1000 mg TI per kg DM Test start SIR [mg O2/(kg*h)] Day 28 SIR [mg O2/(kg*h)] Deviation [%] Table A : NOECs and ECX values [mg/kg TM] for nitrogen and carbon transformation. NOEC = No observed effect concentration; EC = Effect concentration where x % inhibition occurred against control; CL = Confidence level; n.d. = not determined due to mathematical reasons. Nitrogen transformation Carbon transformation NOEC < EC10 (95% CL) [mg/kg] 12.1 ( ) 1000 EC20 (95% CL) [mg/kg] 62.4 ( ) 1000 EC50 (95% CL) [mg/kg] > 1000 (n.d.) > 1000 (n.d.) Table A : Mean short-term respiration rate and basal respiration at test end [mg O2/(100 g*h)], deviation from control [%] and Respiratory Activation Quotient (QR).TI = Test item; SIR = Substrate induced respiration; * Significant deviation from control (Williams test, two-sided). Control 62.5 mg TI per kg DM 125 mg TI per kg DM 250 mg TI per kg DM 500 mg TI per kg DM 1000 mg TI per kg DM SIR [mg O2/(kg*h)] Deviation [%] * 65.7 * Basal respiration [mg O2/(kg*h)] Deviation [%] * 25.9 * QR

181 Figure A : Nitrogen transformation: Effect related to control at test end, response curve. Figure A : Carbon transformation: Effect related to control at test end, effect on substrate induced respiration (SIR), no calculation of response curve possible. 134

182 Study Summary A /01 Section A Annex Point IIIA Acute toxicity test to earthworms or other soil non-target organisms 1 Reference Official use only 1.1 Reference A /01: Simon, M. (2007): Earthworm acute toxicity test: acute toxicity of Flocoumafen on Eisenia fetida. Fraunhofer-Institute for Molecular Biology and Applied Ecology (IME), Schmallenberg, Germany, Report no. EBR-003/3-08, May 21, 2007 (unpublished). (BASF DocID: 2007/ ) 1.2 Data protection Yes Data owner BASF AG Companies with letter of access No Criteria for data protection Data on existing a.s. to maintain or vary a.s. Annex I entry 2 Guidelines and Quality Assurance 2.1 Guideline study Yes OECD guideline 207 (1984) and EU method C GLP Yes 2.3 Deviations No 3 Materials and Methods 3.1 Test material Flocoumafen, as given in Section A Lot number L Specification As given in Section A Purity 98.4 % Composition of product Not applicable Further relevant properties The test substance is hydrolytically stabile (at ph 4, 7, and 9 at 50 C over 5 days, OECD 111), the vapour pressure is < 10 5 Pa, the water solubility is ± mg/l at ph 7, 20 C (see section A3) 135

183 Section A Annex Point IIIA Acute toxicity test to earthworms or other soil non-target organisms Method of analysis Not required according to the test guidelines. 3.2 Reference substance Yes: 2-Chloroacetamide A test with the reference substance is regularly performed at the test facility once a year, thus fulfilling guideline recommendations Method of analysis for reference Not required according to the test guidelines. substance 3.3 Testing procedure Preparation of the test substance Table A Application of the test substance The quantity of test item required to obtain the desired concentrations was dissolved in 10 ml acetone and applied to 54 g of quartz sand. After evaporation of the solvent, the mixture was added to the test substrate and mixed thoroughly. The amount of quartz sand used for application was considered for the ratio of ingredients of the test substrate Test organisms Table A Test system Table A Test conditions Table A Test duration 14 days Test parameter Mortality, body weight Examination At the beginning and at the end of the test Monitoring of TS concentration No Not required according to the test guidelines. 136

184 Section A Annex Point IIIA Acute toxicity test to earthworms or other soil non-target organisms Statistics The percent weight change of the worms was calculated as an absolute value and in comparison to the control. Potential effects of the solvent were evaluated by comparison of blank and solvent control using Student s t-test; the NOEC regarding weight change was determined using Williams test, and the LC50 was estimated by probit analysis of log-normal distributed data using the computer software ToxRat Professional version 2.09 (release ) by ToxRat Solutions GmbH. 4 Results 4.1 Filter paper test Not performed Concentration Not applicable Number/ percentage of animals Not applicable showing adverse effects Nature of adverse effects Not applicable 4.2 Soil test Initial concentrations of test 12.3, 37.0, 111.1, 333.3, 1000 mg/kg artificial soil substance (dry mass) (nominal concentrations) Effect data (Mortality) Please refer to Table A , Table A and Table A Concentration / effect curve No mortality Other effects Body weights after 14 days were slightly depressed at and 1000 mg/kg compared to the (solvent) control (see Figure A ). The NOEC for body weight change was therefore determined at mg/kg. Apart from this, neither any physical or pathological symptoms nor changes in behaviour were observed. All individuals gave the impression of healthy condition (please refer to Table A ). 4.3 Results of controls Please refer to Table A Mortality None (see Table A ). 137

185 Section A Annex Point IIIA Acute toxicity test to earthworms or other soil non-target organisms Number/ percentage of None (see Table A ). earthworms showing adverse effects Nature of adverse effects None. 4.4 Test with reference substance Performed Concentrations 80 mg/kg Results Weight change: Control: 3% 80 mg chloroacetamide/kg: not determinable (all specimens dead) Mortality: Control: 0 % 80 mg chloroacetamide/kg: 100 % EC50 values: Weight change: mg/kg Mortality: mg/kg 5 Applicant s Summary and conclusion 5.1 Materials and methods The influence of Flocoumafen on mortality of adult earthworms of the species Eisenia fetida was investigated according to OECD guideline 207 and EU method C.8. For this, the worms were placed in a defined artificial soil substrate containing the test item at different concentrations. The test item was incorporated into the test soil at the beginning of the experiment, and the effects on biomass and mortality were determined after 14 days. 138

186 Section A Annex Point IIIA Acute toxicity test to earthworms or other soil non-target organisms 5.2 Results and discussion There was no mortality, neither in the controls nor at any test concentration up to the limit test concentration of 1000 mg Flocoumafen per kg dry soil. The NOEC for the tested species was found to be 1000 mg Flocoumafen per kg soil. A slight but statistically significant influence of Flocoumafen on body weight change was detected. The NOEC for the tested species was found to be mg Flocoumafen per kg soil. However, since body weight reduction was below 10 % at all concentrations up to 1000 mg Flocoumafen per kg dry soil (highest concentration in the test), an EC50 could not be derived by statistical analysis LC mg/kg dry soil LC50 > 1000 mg/kg dry soil (n.d.) LC100 (n.d.) 5.3 Conclusion Flocoumafen is not acutely toxic to Eisenia fetida under the given test conditions. NOEC and EC50 are > 1000 mg per kg dry soil, respectively Reliability Deficiencies No Evaluation by Competent Authorities Use separate evaluation boxes to provide transparency as to the comments and views submitted EVALUATION BY RAPPORTEUR MEMBER STATE (*) Date 7 March 2013 Materials and Methods - Results and discussion NOEC and EC50 > 1000 mg/kg dry soil (> mg/kg wet soil) Conclusion Flocoumafen is not acutely toxic to Eisenia fetida under the given test conditions. NOEC and EC50 are > 1000 mg/kg dry soil (> mg/kg wet soil), respectively. Reliability 1 139

187 Acceptability The reliability of the study is 1, since the test was conducted according to the standard test guidelines OECD 207 (1984) and EU method C.8 Remarks - COMMENTS FROM... Date Materials and Methods Results and discussion Conclusion Reliability Acceptability Remarks Table A : Preparation of TS solution. Criteria Details Type and source of dilution water Not applicable Alkalinity / Salinity Not applicable Hardness Not applicable ph Not applicable Oxygen content Not applicable Conductance Not applicable Holding water different from dilution Not applicable water Organic solvent No Dispersion No Vehicle Yes: Acetone for the purpose of mixing with quartz sand The quantity of test item required to obtain the desired concentrations was dissolved in 10 ml acetone and applied to an amount of quartz sand of 54 g. After evaporation of the solvent, the mixture was added to 761 g test substrate (adjusted to 60 % water holding capacity) and mixed thoroughly. The amount of quartz sand used for application was considered for the ratio of ingredients of the test substrate. Concentration of vehicle Not applicable; acetone was completely evaporated 140

188 Vehicle control performed Other procedures Yes Quartz sand mixed with acetone and subsequently completely evaporated (conducted in quadruplicate) No Table A : Test organisms. Criteria Details Species Eisenia fetida andrei (Annelida, Oligochaeta) Source of the initial stock Regenwurmfarm Tacke, Klosterdiek 61, Borken. Specimens used in the test were bred in the laboratory of the Fraunhofer IME. Culturing techniques The breeding conditions followed SOP V3-255/02. Worms were bred in 1:1 mixtures of cow manure and Sphagnum peat (dry mass basis) at 20 C ± 2 C. Age/weight 2 3 months old, with a clitellum, and a wet mass between 300 mg and 600 mg. Pre-treatment The worms were conditioned in the artificial soil for 6 days before start of the test. Table A : Test system. Criteria Details 141

189 Artificial soil test substrate Artificial soil components Sphagnum peat, air-dried, finely ground 10 % Kaolinite, air-dried 20 % Industrial quartz sand, air-dried 70 % Moisture of the test substrate was adjusted to 51.9% (w/w) of the maximum water holding capacity (WHC) with deionised water. This is in full compliance with the range of 40 60% WHC specified by OECD guideline 222 (2004, earthworm reproduction test). The procedure for adjusting moisture content was adopted from the more recent OECD guideline 222, in order to adequately cope with the properties of the artificial soil substrate used. This is fully covered by the test guideline OECD 207, stating that with some peats a moisture content of over 35 per cent may be suitable. The ph of the substrate was measured and found to be 6.4 at test start, thus in full compliance with the permitted range of 6.0 ± 0.5 (1 mol/l KCl). Test mixture See Table A Size, volume and material of test container Round glass containers with a diameter of 9.5 cm and a height of 20 cm; the containers were covered with glass caps to prevent evaporation; however, to permit gas exchange between the medium and the atmosphere, the caps were not closed air tight. Amount of artificial soil (kg)/ container 500 g dry mass/container Nominal levels of test concentrations 12.3, 37.0, 111.1, 333.3, 1000 mg/kg artificial soil (dry mass) Number of replicates/concentration 4 Number of earthworms/test concentration 40 Number of earthworms/container 10 Light source Continuous light with an intensity of about 550 lx Test performed in closed vessels due to No significant volatility of test substrate Table A : Test conditions. Criteria Details 142

190 Test temperature The incubation temperature was measured continuously with a thermograph. With C the permitted range of 20 ± 2 C was maintained. Moisture content See Table A ph See Table A Adjustment of ph No Light intensity / photoperiod Continuous light with an intensity of about 550 lx Relevant degradation In view of the hydrolytical stability, the slow biological degradation of products Flocoumafen in soil and the relatively short test period, relevant degradation products are not expected. Table A : Soil moisture as % WHC at test start and test end; single values of the parallel test pots (TI = test item, DM = dry mass). Control Solvent control 12.3 mg TI/kg DM 37.0 mg TI/kg DM mg TI/ kg DM mg TI/kg DM 1000 mg TI/kg DM Test start Test end Table A : The ph of the artificial soil (DM = dry mass) at test start was 6.4. At test end, ph of the artificial soil was , slightly varying across the test item (TI) concentrations. Control Solvent control 12.3 mg TI/kg DM 37.0 mg TI/kg DM mg TI/kg DM mg TI/kg DM 1000 mg TI/kg DM Test start Test end Table A : Mortality data. Test substance Mortality concentration Number of living worms Percentage (nominal) [mg/kg 7 d 14 d 7 d 14 d artificial soil] Control Solvent Control

191 ph Measurements of ph and moisture content are given in Table A Moisture content Table A : Weight change at test end. Weight change compared to the start value [%] and compared to the control [%], TI = Test item. DM = dry mass; *: significant when compared with solvent control. Control Solvent Control 12.3 mg TI/kg DM 37.0 mg TI/kg DM mg TI/kg DM mg TI/kg DM 1000 mg TI/kg DM compared to start value [%] compared to solvent control [%] * 9.8 * Table A : Effect data. NOECs and EC50 values for weight change and mortality at test end [mg/kg dry mass]. NOEC = No observed effect concentration; EC = Effect concentration; CL = Confidence limits; n.d. = not determined due to mathematical reasons. Weight change Mortality NOEC LC/EC50 (95% CL) > 1000 (n.d.) > 1000 (n.d.) Table A : Validity criteria for acute earthworm test according to OECD 207. Fulfilled The control individuals did not exhibit pathological symptoms or abnormal X behaviour Mortality of control animals < 10% X Not fulfilled 144

192 Figure A : Dose response curve for the effect of test item concentration on body weight development (% reduction relative to the solvent control). 145

193 Study Summary A /01 Section Acute toxicity to plants Annex Point IIIA XIII Reference Official use only 1.1 Reference A /01: Simon, M. (2007): Terrestrial plants, growth test: Effect of Flocoumafen on the seedling emergence and growth of Avena sativa, Lactuca sativa, Phaseolus aureus, Raphanus sativus, Sinapis alba, and Triticum aestivum. Fraunhofer-Institute for Molecular Biology and Applied Ecology (IME), Schmallenberg, Germany, Report no. EBR-003/4-40, June 01, 2007 (unpublished). (BASF DocID: 2007/ ) 1.2 Data protection Yes Data owner BASF AG Companies with letter of access No Criteria for data protection Data on existing a.s. to maintain or vary a.s. Annex I entry 2 Guidelines and Quality Assurance 2.1 Guideline study Yes OECD guideline 208 (2006) 2.2 GLP Yes 2.3 Deviations No 3 Method 3.1 Test material Flocoumafen, as given in Section A Lot number L Specification As given in Section A Purity 98.4 % Composition of Product Not applicable Further relevant properties The test substance is hydrolytically stabile (at ph 4, 7, and 9 at 50 C over 5 days, OECD 111), the vapour pressure is < 10 5 Pa, the water solubility is ± mg/l at ph 7, 20 C (see section A3) 146

194 Section Acute toxicity to plants Annex Point IIIA XIII Method of analysis The concentration of the test item in soil was determined analytically in 5 parallel samples of the highest test concentration (1000 mg/kg, nominal), thus fulfilling the guideline requirements of OECD 208 (2006). Extraction with Acetonitrile, threefold. Separation: Reversed-phase HPLC (Inertsil ODS-3, acetontrile/0.01 M acetic acid, ph 7, isocratic. Mean recovery: 94.8% Also see reference A7.2.1/ Preparation of TS solution for Yes, see Table A poorly soluble or volatile test For verification of item concentration and substances homogeneity of distribution, five samples of the highest test concentration were taken from the soil matrix directly after incorporation of the spiked quartz sand. 3.3 Reference substance Yes: Trichloroacetic acid A test with the reference substance is regularly performed at the test facility once a year, thus fulfilling guideline recommendations Method of analysis for reference Not required according to the test guidelines. substance 3.4 Testing procedure Dilution water Not applicable, please refer to Table A Test plants Please refer to Table A Test system Please refer to Table A Test conditions Please refer to Table A Test duration 14 days after emergence of 50 % of the control seedlings Test parameter Fresh shoot biomass Pathological symptoms Seedling emergence 147

195 Section Acute toxicity to plants Annex Point IIIA XIII Sampling At growth day 14, all seedlings were counted and the aboveground biomass was measured. For this, the wet mass of the plants was measured immediately after harvesting. See Table A for details Method of analysis of the plant Not applicable, analytical determination of the test material substance in plant material not required Quality control Yes Statistics The percent inhibition of seedling emergence for each plant species was calculated as an absolute value and in comparison to the control. Survival of emerged seedlings was calculated as an absolute value. The percent inhibition of fresh weight was calculated in comparison to the control. All statistical analyses (Mann-Whitney U-test, Fisher s exact binomial test, or Welch s t-test for comparison of controls; the Chi² 2 2 table test with Bonferroni correction, Williams test, or Welch s t-test for the NOEC calculation; EC50 estimation, as appropriate) were performed with the computer software ToxRat Professional by ToxRat Solutions GmbH. For the EC50 calculation probit-analysis assuming lognormal distribution of the data was applied. 4 Results 4.1 Results test substance 148

196 Section Acute toxicity to plants Annex Point IIIA XIII Applied initial concentration The nominal concentrations in the test containers were 62.5, 125, 250, 500 and 1000 mg Flocoumafen/kg dry soil. Analytical verification of the highest nominal test concentration (1000 mg/kg) resulted in a mean recovery of 714 ± 22 mg/kg. The low standard deviation (five parallels) indicates that the test item was homogeneously distributed in the soil matrix. Due to the high deviation of the measured concentration from the nominal concentration, effect concentrations were determined based on recalculated test concentrations, applying a correction factor of to take account for the apparent loss during test substance application Phytotoxicity rating Emergence was not affected in any species Plant height Not determined Plant dry weights Not determined but the fresh weights, please refer to Table A Root dry weights Not applicable Root length Not applicable Number of dead plants Please refer to Table A Effect data The results of seedling emergence and growth inhibition are presented as mean values in Table A , Table A , Table A , and Table A Concentration / response curve Please refer to Figure A Other effects None 4.2 Results of controls Number/ percentage of plants showing adverse effects Nature of adverse effects Emergence was not affected in any species: Neither the solvent control nor Flocoumafen at any test concentration did elicit any inhibition of the germination rate. In the solvent control, plant growth was not inhibited. 149

197 Section Acute toxicity to plants Annex Point IIIA XIII Test with reference substance Performed Concentrations Employed concentrations of trichloroacetic acid are not explicitly reported. However, these are fully documented in report no. IME 002/4-40/2, which is available from the test facility on request Results Seedling emergence: Avena sativa: Control 97.5 % 100 mg TCA/kg 85.0 % Lactuca sativa: Control 85.0 % 100 mg TCA/kg 62.5 % Phaseoulus aureus: Control 92.5 % 100 mg TCA/kg 77.5 % Raphanus sativus: Control 97.5 % 100 mg TCA/kg 95.0 % Sinapis alba: Control 90.0 % 100 mg TCA/kg 80.0 % Triticum aestivum: Control 95.0 % 100 mg TCA/kg 90.0 % EC50 values could not be computed. EC50 for growth (fresh mass per plant): Avena sativa: 6 mg/kg Lactuca sativa: 55 mg/kg Phaseoulus aureus: 21 mg/kg Raphanus sativus: 175 mg/kg Sinapis alba: 46 mg/kg Triticum aestivum: 1 mg/kg 5 Applicant s Summary and conclusion 150

198 Section Acute toxicity to plants Annex Point IIIA XIII Materials and methods The effect of Flocoumafen on the emergence and growth of terrestrial plant seedlings was investigated according to the OECD guideline 208. The following test species were used: Avena sativa (oat), Lactuca sativa (lettuce), Phaseolus aureus (mung bean), Raphanus sativus (radish), Sinapis alba (mustard), and Triticum aestivum (wheat). The seeds were placed in a natural sandy soil containing the test item at nominal concentrations of 62.5, 125, 250, 500 and 1000 mg Flocoumafen /kg dry soil. The test item was incorporated into the test soil at the beginning of the experiment, and the effects on seedling emergence and growth were determined 14 days after emergence of 50 % of the control seedlings. Four replicates were prepared for the control and per concentration. Due to a mean recovery of 71.4 % at analytical verification of the highest test concentration, nominal concentrations were corrected using a factor of

199 Section Acute toxicity to plants Annex Point IIIA XIII Results and discussion Emergence was not affected in any species: Neither the solvent control nor Flocoumafen at any test concentration did elicit any inhibition of the germination rate. The NOEC (no observed effect concentration) for the tested species Avena sativa (oat), Lactuca sativa (lettuce), Phaseolus aureus (mung bean), Raphanus sativus (radish), Sinapis alba (mustard), and Triticum aestivum (wheat) was thus found to be 714 mg Flocoumafen (measured) per kg soil (dry mass). The EC50 and the NOEC for Avena sativa, Lactuca sativa, and Sinapis alba were found to be 714 mg/kg (measured). The EC50 for Phaseolus aureus and Raphanus sativus was 714 mg/kg (measured). The NOEC was found to be 179 mg/kg (recalculated) for both species. The EC50 for Triticum aestivum was 714 mg/kg (measured). The NOEC was found to be 357 mg/kg (recalculated) EC EC mg/kg TM EC Conclusion The validity criteria of OECD 208 (2006) were fulfilled (see Table A ) Reliability Deficiencies No Evaluation by Competent Authorities Use separate evaluation boxes to provide transparency as to the comments and views submitted EVALUATION BY RAPPORTEUR MEMBER STATE (*) Date 7 March 2013 Materials and Methods - 152

200 Results and discussion EC mg/kg dw ( 630 mg/kg ww) Lowest NOEC = 179 mg/kg dw or mg/kg ww (recalculated) Conclusion Emergence was not affected in any species: Neither the solvent control nor Flocoumafen at any test concentration did elicit any inhibition of the germination rate Reliability 1 Acceptability The reliability of the study is 1, since the test was conducted according to the standard test guideline OECD 208 (2006) Remarks - COMMENTS FROM... Date Materials and Methods Results and discussion Conclusion Reliability Acceptability Remarks Table A : Preparation of TS solution for poorly soluble or volatile test substances. Criteria Details Dispersion No Vehicle Yes: Flocoumafen was dissolved in acetone at an adequate concentration, mixed with 10 g quartz sand, the acetone evaporated, and this mixture incorporated into the soil matrix (adjusted to % water holding capacity) Concentration of vehicle Not appropriate, the solvent was completely evaporated Vehicle control performed Yes Soil mixed with quartz sand treated with blank acetone Other procedures Not required Table A : Dilution water. Criteria Details Source Not stated 153

201 Alkalinity / Salinity Hardness ph Oxygen content Conductance Holding water different from dilution water Not stated Not stated Not stated Not stated Not stated After sowing, the test substrate was moistened to 60 % water holding capacity. Twenty-four hours after test start, the glass fibre wicks, passing through the bottom of the container, were connected with a reservoir of deionised water to ensure constant soil moisture. Table A : Test plants. Family Species Common Source (seed) name Dicotyledonae Asteraceae Lactuca sativa Lettuce Raiffeisen Naturkraft Kiepenkerl Fabaceae Phaseolus aureus Mung bean Carl Sperling & Co. Lüneburg Brassicaceae Raphanus sativus Radish Raiffeisen Naturkraft Kiepenkerl Brassicaceae Sinapis alba White mustard Landesinstitut für Landwirtschaftliche Qualitätskontrolle Monocotyledonae Poaceae Triticum aestivum Wheat Saatgutveredelung Nueckel, Schmallenberg-Winkhausen Poaceae Avena sativa Oat Raiffeisen Genossenschaft Nordwest eg Table A : Test system. Criteria Details Test type Growth chamber test Container type Round containers of nonporous plastic with a diameter of mm, filled up with ca. 280 g moist soil Seed germination potential Identification of the plant species See Table A above. Number of replicates 4 Numbers of plants per replicate per 5 dose 154

202 Date of planting Within 24 h after incorporation of the test item Plant density Not stated Date of test substance application 24 h prior to sowing. Height of plants at application Not applicable Date of phytotoxicity rating or harvest 14 days after 50 % of the seedlings in the control group had emerged Dates of analysis Not applicable Table A : Test conditions. Criteria Details Test type Growth chamber test. Method of application Incorporation of the test substance into soil after applying to quartz sand using acetone, which was completely evaporated Single application Application levels Not applicable (not a plant protection product) Dose rates 62.5, 125, 250, 500 and 1000 mg /kg dry soil The concentration of 1000 mg/l corresponds to the limit test concentration recommended by OECD guideline 208. Substrate characteristics A natural sandy soil (Certified RefeSol 01-A; batch IME-01, loamy sand [DIN], Org C: 0.93 %, ph 5.7, clay: 5 %), sieved to 5 mm, not sterilized. The soil had been stored outdoor in high grade stainless steel basins with drainage and ground contact at the test facility. Watering of the plants Continuous bottom watering of the test container via glass fibre wicks. The water was amended with fertilizer (COMBO Grünpflanzendünger) Temperature C, thus maintaining the permitted range of 20 ± 2 C Thermoperiod Not appropriate Light regime 16 hours per day with a light intensity of > 7000 lx (light colour 25, universal white). The light intensity was measured using an illuminance meter (MINOLTA) with a photometric sensor in Lux. With lx, the guideline requirement of > 7000 lx was fulfilled Relative humidity % Wind volatility Not applicable Observation periods and duration of 14 days after emergence of 50 % of the control seedlings test 155

203 Pest control Any other treatments and procedures None Not appropriate Table A : Pathological symptoms [% plants, TI = Test item, - = no visual symptom, a = discolouration, b = deformation, c = necrosis, d = dead plant Test species Control Solvent 62.5 mg/kg 125 mg/kg 250 mg/kg 500 mg/kg 1000 control DM DM DM DM mg/kg DM Avena sativa Lactuca sativa Phaseolus 5 % d aureus 6 % d Raphanus sativus Sinapis alba 5 % d Triticum aestivum Table A : Emergence rate at test end [%]. TI = Test item. Test species Control Solvent 62.5 mg/kg 125 mg/kg 250 mg/kg 500 mg/kg 1000 control DM DM DM DM mg/kg DM Avena sativa Lactuca sativa Phaseolus aureus Raphanus sativus Sinapis alba Triticum aestivum Table A : Emergence related to solvent control at test end [%]. TI = Test item; *: significant when compared with control. Test species 62.5 mg/kg DM 125 mg/kg DM 250 mg/kg DM 500 mg/kg DM 1000 mg/kg DM Avena sativa Lactuca sativa

204 Phaseolus aureus Raphanus sativus Sinapis alba Triticum aestivum Table A : Fresh weight of the shoots. Mean values ± SD [g] TI = Test item. Test species Control Solvent control 62.5 mg/kg DM 125 mg/kg DM 250 mg/kg DM 500 mg/kg DM 1000 mg/kg DM Avena sativa Lactuca sativa Phaseolus aureus Raphanus sativus Sinapis alba Triticum aestivum Table A : Growth inhibition related to solvent control at test end. [% FM]. TI = Test item; negative value = growth stimulation; *: significant when compared with control. Test species 62.5 mg/kg DM 125 mg/kg DM 250 mg/kg DM 500 mg/kg DM 1000 mg/kg DM Avena sativa Lactuca sativa Phaseolus aureus Raphanus sativus Sinapis alba Triticum aestivum Table A : NOECs and EC50 values of Flocoumafen for emergence [mg/kg TM]. NOEC = No observed effect concentration; EC = Effect concentration; CL = Confidence level; n.d. = not determined 157

205 due to mathematical reasons; nominal concentrations were multiplied with the factor to take application loss into account. Test species Avena sativa Lactuca sativa Phaseolus aureus Raphanus sativus Sinapis alba Triticum aestivum NOEC EC50 (95% CL) 714 (n.d.) 714 (n.d.) 714 (n.d.) 714 (n.d.) 714 (n.d.) 714 (n.d.) Table A : NOEC and EC50 values for growth inhibition on the basis of fresh mass [mg/kg TM]. NOEC = No observed effect concentration; EC = Effect concentration; CL = Confidence level; n.d. = not determined due to mathematical reasons; Nominal concentrations were multiplied with the factor to take application loss into account. Test species Avena sativa Lactuca sativa Phaseolus aureus Raphanus sativus Sinapis alba Triticum aestivum NOEC EC50 (95% CL) 714 (n.d.) 714 (n.d.) 714 (n.d.) 714 (n.d.) 714 (n.d.) 714 (n.d.) A B C D 158

206 E F Figure A : Growth inhibition related to control at test end [% FM]. For computation nominal concentrations were applied. A: Avena sativa, B: Lactuca sativa; C: Phaseolus aureus; D: Raphanus sativus; E: Sinapis alba; F: Triticum aestivum; A, C, D, F: response curve; B, E: no calculation of response curve possible. Table A : Validity criteria for terrestrial plant toxicity according to OECD 208 (2006). Criterion Fulfilled Not fulfilled The seedling emergence in the controls exceeded 70 % at the end of X the test as recommended in the guideline adopted on July 19, 2006 The control seedlings did not exhibit phytotoxic effects X The mean survival of emerged control seedlings was at least 90 % for X the duration of the study Environmental conditions for a particular species were identical and growing media contained the same amount of soil matrix, support media, or substrate from the same source X 159