Product Assessment Report - ECHA

Product Assessment Report Biocidal product assessment report related to product

authorisation under Regulation UE 528/2012

AFOURMI F

Scotts France SAS

Updated March 2016

Internal registration/file no: PB-13-00408/ BC-AF010825-60

Authorisation/Registration no:

Granting date/entry into force of authorisation/ registration:

Expiry date of authorisation/ registration:

Active ingredient: Fipronil (CAS: 120068-37-3)

Product type: 18 Competent Authority in charge of delivering the pro duct authorisation: French Ministry of Ecology Department for Nuisance Prevention and Quality of the Environment Chemical Substances and Preparation Unit Tour Séquoia 92 055 La Défense cedex-FRANCE [email protected] Authority in charge of the efficacy and risk assess ment: Anses – French agency for food, environmental and occupational health and safety Regulated Products Directorate 14 rue Pierre et Marie Curie 94 701 Maisons-Alfort Cedex - FRANCE [email protected]

Product Assessment Report – AFOURMI F - Fipronil

Contents 1 General information about the product application . ................................................... 1 1.1 Applicant ............................................................................................................................ 1

1.1.1 Person authorised for communication on behalf of the applicant ........................ 1 1.2 Current authorisation holder .............................................................................................. 1 1.3 Proposed authorisation holder .......................................................................................... 2 1.4 Information about the product application ......................................................................... 2 1.5 Information about the biocidal product .............................................................................. 2

1.5.1 General information .............................................................................................. 2 1.5.2 Information on the intended use(s)....................................................................... 3 1.5.3 Information on active substance ........................................................................... 3 1.5.4 Information on the substance(s) of concern ......................................................... 4

1.6 Documentation .................................................................................................................. 4 1.6.1 Data submitted in relation to product application ................................................. 4 1.6.2 Access to documentation ..................................................................................... 5

2 Summary of the product assessment ................. .......................................................... 5 2.1 Identity related issues ........................................................................................................ 5 2.2 Classification, labelling and packaging ............................................................................. 5

2.2.1 Harmonised classification of the active substance ............................................... 5 2.2.2 Classification of the biocidal product .................................................................... 6 2.2.3 Labelling of the biocidal product ........................................................................... 7 2.2.4 Packaging of the biocidal product ........................................................................ 8

2.3 Physico/chemical properties and analytical methods ....................................................... 8 2.3.1 Active ingredient ................................................................................................... 8 2.3.2 Biocidal product .................................................................................................... 8

2.4 Risk assessment for Physico-chemical properties .......................................................... 17 2.5 Effectiveness against target organisms .......................................................................... 17

2.5.1 Function .............................................................................................................. 17 2.5.2 Organisms to be controlled and products, organisms or objects to be protected18 2.5.3 Effect on target organisms and efficacy ............................................................. 19 2.5.4 Mode of action including time delay ................................................................... 23 2.5.5 Occurrence of resistance - resistance management / Unacceptable Effect ...... 23 2.5.6 Evaluation of the label claim ............................................................................... 24 2.5.7 Summary of efficacy assessment ....................................................................... 24

2.6 Description of the intended use(s) .................................................................................. 24 2.7 Risk assessment for human health ................................................................................. 25

2.7.1 Hazard potential ................................................................................................. 25 2.7.2 Human exposure assessment ............................................................................ 29 2.7.3 Risk assessment for human health .................................................................... 31

2.8 Risk assessment for the environment ............................................................................. 32 2.8.1 Fate and distribution in the environment of the active substance fipronil .......... 32 2.8.2 Effects on environmental organisms for active substance fipronil ..................... 35 2.8.3 Effects on environmental organisms for biocidal product AFOURMI F .............. 42 2.8.4 Environmental exposure assessment ................................................................ 43 2.8.5 Risk characterisation for the environment .......................................................... 50 2.8.6 Conclusions ........................................................................................................ 52

2.9 Measures to protect man, animals and the environment ................................................ 53 3 Proposal for decision ............................. ....................................................................... 54 4 Appendices ........................................ ............................................................................ 57 Annex 0a: Practical use claimed by the applicant .. ............................................................. 57 Annex 0b: Proposed uses for authorisation ......... ................................................................ 59 Annex 1: Summary of product characteristics ....... .............................................................. 60 Annex 2: List of studies reviewed ................. ........................................................................ 61 Annex 3: Analytical methods residues – active subst ance .............................................. .. 75 Annex 4: Toxicology and metabolism –active substanc e ................................................... 82 Annex 5: Toxicology – biocidal product ............ ................................................................... 83 Annex 6: Safety for professional operators ........ .................................................................. 84 Annex 7: Safety for non-professional operators and the general public .......................... 85 Annex 8: Residue behaviour ........................ .......................................................................... 86 Annex 9: Efficacy of the active substance from its use in the biocidal product .............. 87


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1 General information about the product application

1.1 Applicant

Company Name: Scotts Poland Sp. z.o.o.

Address: ul. Ostrobramska 101A

City: Warszawa

Postal Code: 04 - 041

Country: Poland

Telephone: 0048 22 465 61 96

Fax: 0048 22 465 61 91

E-mail address: [email protected]

1.1.1 Person authorised for communication on behalf of th e applicant

Name: Mr Andrzej Zielinski

Function: Regulatory Affairs Officer

Address: ul. Ostrobramska 101A

City: Warszawa

Postal Code: 04 - 041

Country: Poland

Telephone: 0048 22465 61 96

Fax: 0048 22 465 61 91


1.2 Current authorisation holder 1

Company Name: Scotts France SAS

Address: 21, chemin de la Sauvegarde

City: Ecully

Postal Code: 69134

Country: France

Telephone: +33 (0) 472 86 67 68

Fax:


Letter of appointment for the applicant to represent the authorisation holder provided (yes/no):

No, since the applicant and authorisation holder are both member of the same group

1 Applies only to existing authorisations


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1.3 Proposed authorisation holder

Company Name: Scotts France SAS

Address: 21, chemin de la Sauvegarde

City: Ecully

Postal Code: 69134

Country: France

Telephone: +33 (0) 472866768

Fax:


Letter of appointment for the applicant to represent the authorisation holder provided (yes/no):

No, since the applicant and authorisation holder are both member of the same group

1.4 Information about the product application

Application received: 29/08/2013

Application reported complete:

12/09/2013

Type of application: First authorisation

Further information: -

1.5 Information about the biocidal product

1.5.1 General information

Trade name: AFOURMI F

Manufacturer’s development code number(s), if appropriate:

EXP 61210 N

Product type: 18 - insecticide

Composition of the product (identity and content of active substance(s) and substances of concern; full composition see confidential annex):

Active substance: - Fipronil, pure active substance: 0.05 % (w/w) - Fipronil technical (limits at minimum purity): 0.04-0.06% (w/w) - Fipronil technical (at minimum purity of 95.0%): 0.526 % (w/w) For all other information please refer to Document III-B_confidential.

Formulation type: RB

Ready to use product (yes/no): yes

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

No


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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):

No

1.5.2 Information on the intended use(s)

Overall use pattern (manner and area of use):

Bait box to control ants in and around buildings (in and around houses on hard surfaces e.g. terraces and patios).

Target organisms / stages: Common garden ants (e.g. Lasius niger, Tetramorium caespitum, Tapinoma erraticum), Argentine ants (Linepithema humile), Lasius Flavus and Lasius emarginatus.

Category of users: Non-professional users.

Directions for use including minimum and maximum application rates, application rates per time unit (e.g. number of treatments per day), typical size of application area:

In buildings: 2 bait stations for 15 m2. Around buildings: 1 bait station to control 1 nest. 10 g product per bait station. 1 application is intended.

Potential for release into the environment (yes/no):

Release to environment (soil) is theoretically possible when used outdoors.

Potential for contamination of food/feedingstuff (yes/no)

no

Proposed Label: Please refer to label of existing product

Use Restrictions: -- For full details of the intended uses claimed by the applicant, please see annex 0a.

1.5.3 Information on active substance

Active substance chemical name: Fipronil

CAS No: 120068-37-3

EC No: 424-610-5

Purity (minimum, g/kg or g/l): 95 % w/w

Inclusion directive: 2011/79/EU of 20 September 2011

Date of inclusion: 01 October 2013

Is the active substance equivalent to the active substance listed in Annex I to Directive 98/8/EC (yes/no):

yes

Manufacturer of active substance(s) used in the biocidal product:

Company Name: BASF Agro B.V. Arnhem (NL) Zürich Branch

BASF AGRI Production SAS

Address: Im Tiergarten 7 32, rue de Verdun

City: Zürich St.-Aubin-les-Elbeuf

Postal Code: 8055 76410

Country: Switzerland France


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Contact: Marie-Josèphe Alix Damien Fages

Telephone: + 33 (0) 4 72 32 53 14 + 33 (0) 4 72 32 48 54

Fax: + 33 (0) 4 72 32 53 41 + 33 (0) 4 78 34 28 86

E-mail address; [email protected]

[email protected]

1.5.4 Information on the substance(s) of concern

_

1.6 Documentation

1.6.1 Data submitted in relation to product application

Identity, physico-chemical and analytical method da ta

Physico-chemical properties studies and analytical methods on the biocidal product AFOURMI F were provided by Scotts. The biocidal product is not the same as the one assessed for the inclusion of the active substance to Annex I of Directive 98/8/EC.

Efficacy data

Regarding Lasius niger

- 11 Arena studies according to CEB N°1962 method conducted with the product AFOURMI F, old and new formulation, gel bait in bait box (0.05% w/w fipronil), as fresh and aged bait, with and without food competition.

- 9 vivarium studies according to CEB N°196 method conducted with the product AFOURMI F, old and new formulation, gel bait in bait box (0.05% w/w fipronil), as fresh and aged bait., with and without food competition.

- 6 field trials conducted with the product AFOURMI F, old and new formulation, gel bait in bai t box (0.05 % w/w fipronil), as fresh and aged bait.

Regarding Lasius flavus:

- 1 vivarium study according to CEB N°196 method conducted with the product AFOURMI F, old formulation (CRLD 951145), gel bait in bait box (0.05% w/w fipronil), as fresh bait, with food competition.

Regarding Lasius emarginatus

- 3 arena studies according to CEB N°196 method conducted with the product AFOURMI F, old and new formulation, gel bait in bait box (0.05% w/w fipronil), as fresh and aged bait, with food competition.

Regarding Tetramorium caespitum

- 4 arena studies according to CEB N°196 method conducted with the product AFOURMI F, old and new formulation, gel bait in bait box (0.05% w/w fipronil), as fresh and aged bait, with or without food competition.

2 CEB n° 196 method : ”efficacy trials method for bait insecticide products intended to control ants”.


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Regarding Tapinoma erraticum

- 3 arena studies according to CEB N°196 method conducted with the product AFOURMI F, old and new formulation, gel bait in bait box (0.05% w/w fipronil), as fresh and aged bait, with or without food competition.

Regarding Linepithema humile

- 1 field trial conducted with the product FOURMIDOR, gel bait in tube (0.05% w/w fipronil), as fresh bait.

Toxicology data

The applicant submitted toxicological data on the formulation AFOURMI F.

Residue data

No specific residue data were submitted in the context of this dossier. The product AFOURMI F is intended to be used by non-professional users in and around their houses on hard surfaces and therefore does not leave residues in commodities for human or animal consumption.

Ecotoxicology data

No new studies were conducted with AFOURMI F.

1.6.2 Access to documentation

BASF FRANCE SAS has provided a letter of access to SCOTTS FRANCE SAS to some study reports presented in the active substance dossier for Annex I inclusion, in order to grant registration to SCOTTS FRANCE SAS Biocidal Product AFOURMI F.

BASF France SAS Arnhem (NL) Zürich Branch, 8036 Zürich-Wiedikon, Switzerland or its affiliates has provided a letter of access to some study reports, in order to grant registration to SCOTTS FRANCE SAS Biocidal Product AFOURMI F.

Please refer to Annex 2 for the complete list of studies for which access has been granted.

2 Summary of the product assessment

2.1 Identity related issues

The source of the active substance used in the biocidal product AFOURMI F is the same as the one evaluated for the inclusion of Fipronnil in Annex I of Directive 98/8/EC. The biocidal product is not the representative biocidal product assessed for the inclusion of the active substance in Annex I of Directive 98/8/EC.

2.2 Classification, labelling and packaging

2.2.1 Harmonised classification of the active substance

Classification - Regulation (EC) 1272/2008


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Class of danger Acute Tox 3

Acute Tox 3

Acute Tox 3

STOT RE 1

Aquatic acute cat. 1

Aquatic chronic cat. 1

Hazard statement H331: toxic if inhaled.

H311: toxic in contact with skin.

H301: toxic if swallowed.

H372: causes damage to organs through prolonged or repeated exposure.

H400: very toxic to aquatic life (M-factor = 10).

H410: very toxic to aquatic life with long lasting effects.

According to the RAC opinion adopted the 5 June 2015, the following classification can be proposed:


Class of danger Acute Tox 3

Acute Tox 3

Acute Tox 3

STOT RE 1

Aquatic acute cat. 1


Hazard statements H331: toxic if inhaled.

H311: toxic in contact with skin.

H301: toxic if swallowed.

H372: causes damage to organs through prolonged or repeated exposure.

H400: very toxic to aquatic life (M-factor = 1000).

H410: very toxic to aquatic life with long lasting effects (M-factor = 10000).

2.2.2 Classification of the biocidal product

According to the current classification of fipronil, the classification of the biocidal product is as follow:


Hazard statements Aquatic chronic cat. 3

H412: Harmful to aquatic life with long lasting effects.

Precautionary statements P273: Avoid release to the environment.

P501: Dispose of contents/container to …


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According to the RAC opinion adopted the 5 June 2015, the following classification can be proposed:


Hazard statements Aquatic acute cat. 1

H400 : Very toxic to aquatic life


H410: Very toxic to aquatic life with long lasting effects

Precautionary statements P273: Avoid release to the environment.

P391: Collect spillage.


There is a sensitizing substance in the composition of the formulation for which a specific labelling is needed: 1,2-benzisothiazolin-3-one.

Substance chemical name 1,2-benzisothiazolin-3-one

CAS No: 2634-33-5

Relevant toxicological/ecotoxicological information:

May cause sensitisation by skin contact

2.2.3 Labelling of the biocidal product

Pictograms: None

Signal words: None

Hazard statements: Aquatic chronic cat. 3

H412: Harmful to aquatic life with long lasting effects.

Contains 1,2-benzisothiazolin-3-one. May produce an allergic reaction.

Precautionary statements: P273: Avoid release to the environment.


According to the RAC opinion adopted the 5 June 2015, the following classification can be proposed

Pictograms:

Signal words: Warning

Hazard statements: Aquatic acute cat. 1

H400 : Very toxic to aquatic life


H410: Very toxic to aquatic life with long lasting effects

Contains 1,2-benzisothiazolin-3-one. May produce an allergic


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reaction.

Precautionary statements: P273: Avoid release to the environment.

P391: Collect spillage.


2.2.4 Packaging of the biocidal product

Type: Ready-to-use bait box with 4 predefined openings Size: round, Ø 77.6 mm Colour green Material bait box: PS 2 or 4 bait stations are sold in one cardboard box Content per bait box: 10 g.

2.3 Physico/chemical properties and analytical meth ods

2.3.1 Active ingredient

2.3.1.1 Identity, origin of active ingredient

The source of the active substance used in AFOURMI F is the same as the source used for Annex I inclusion to Directive 98/8/EC. A letter of Access from BASF for the active substance is provided in the dossier.

2.3.1.2 Physico-chemical properties and Analytical method for determination of active ingredient and impurities in the technical active i ngredient

Physical and chemical properties of the active substance have already been evaluated at EU level and are presented in the CAR of the active substance fipronil (January 2011). The applicant Scott has a letter of access to these data.

2.3.2 Biocidal product

2.3.2.1 Identity, composition of the biocidal produ ct, packaging

The biocidal product is not the same as the one assessed for the inclusion of the active substance in Annex I of Directive 98/8/EC. The composition of the product is confidential and is presented in a confidential annex. There is a sensitizer substance in the composition of the formulation for which a specific labelling is needed: 1,2-benzisothiazolin-3-one. The primary packaging of the biocidal product as claimed by the applicant is: Type: Ready-to-use bait box with 4 predefined openings Size: round, Ø 77.6 mm Colour green Material bait box: PS 2 or 4 bait stations are sold in one cardboard box Content per bait box: 10 g.


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AFOURMI F is a ready to use product (gel formulation presented in ready-to use bait). 10 g of the formulation is enclosed in a bait station. The ants are attracted by the product in the ant bait station. They can enter through predefined holes. They ingest the liquid with the active substance and die.

AFOURMI F is intended to be used by non-professional users in and around their house on hard surfaces.

2.3.2.2 Physico-chemical properties

The composition of the formulation AFOURMI F (EXP 61210N) and the formulation FORMICIDE TUBE F (EXP 61210N) is identical.

The composition of the preparation EXP 61210N (AFOURMIF) is similar to EXP 61210A except for some co-formulant which are not impact on physico-chemical properties.

The 2 year shelf life study has been performed on the preparation EXP 61210A.

The composition of the formulation EXP 61210A is detailed in the confidential annex.

The preparation does not contain hydrocarbon. The preparation is not classed H304 cat 1 (viscosity > 20.5mm2/s).


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Table 1: Physico-chemical properties of the biocida l product

Method Purity/Specification Results Reference Acceptable Yes/no

Physical state and nature Visual and organoleptical inspection

EXP 61210 A 505/SR1958 0.05% w/w Fipronil

Viscous bright blue liquid Odourless

Ballard, K.M. (2004)

Acceptable

Colour

Odour

Explosive properties Expert statement: EXP 61210 N does not have any oxidizing or explosive properties.

Ott, C. (2012) Acceptable

Oxidizing properties

Flash point

Flash point A9

EXP 61210N 0.05% w/w Fipronil Batch: 14-13

No flash point was detected up t o 400 °C.

Meinerling, M. Herrmann, S. (2013)

Acceptable

Autoflammability EECA15 Batch 044/14 405°C Hernandes .C, 2014 Acceptable

Flammability EEC A10 EXP 61210N 0.05% w/w Fipronil Batch: 14-13

No flammability Meinerling, M. Herrmann, S. (2013)

Acceptable But not required for liquid formulation

Other indications of flammability

None / / / /

pH 1% aqueous suspension

pH of a 1% aqueous solution FAM 290 similar to CIPAC MT 75.2 (20°C)

EXP 61210 A 505/SR1958 0.05% Fipronil

Mean values Initial = 5.73 6 months = 5.83 24 months = 5.60


Acceptable

pH CIPAC MT 75,3 1% suspension (20°C)


Before storage: pH 6,6 After storage (14 d, 54°C): pH 6,4


Relative density A 3 / OECD No. 109


1,229 Meinerling, M. Herrmann, S. (2013)

Acceptable


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Storage stability – stability and shelf life Effects of temperature

CIPAC 46.3 14 d, 54°C accelerated storage


A.I. content (IBACON Project 85081204-validated) Before storage: 0,461 g/kg After storage (14 d, 54°C): 0,412 g/kg After storage, there were a loss of 10.62%. Moreover, the appearance of the preparation after the accelerated storage is inhomogeneous liquid – blue solids at the bottom- Consequently, a study at lower temperature was required.


Not Acceptable

CIPAC 46.3 35°C for 12w CIPAC MT 75.3 Determlination of active substance: HPLC-DAD (test facility ID131120SV/CGB15799 - validated)

EXP 61210N Batch 337 13

Appearance of test item Before storage: cotton pad soaked with viscous liquid; white with light to dark turquoise spots; weak lemony After storage: viscous liquid; colourless; weak lemony AI content Before storage: 0.0420%w/w After storage: 0.0422%w/w pH(1%): squeezed out from the Cotton Pad Before storage: 5.98 After storage: 5.92 (room temperature) pH(1%): (whole content of test container diluted in 1L flask) Before storage: 6.33 After storage: 6.21 (room temperature)

Vinh An Thieu-Simchen 2014

Acceptable The PPP is stable for 12W at 35°C.

24 months shelf life Analysis of Fipronil content (RP method F-909-04-97-validated)

EXP 61210 A 505/SR1958 0.05% Fipronil Packaging material PS

Packaging : PS (Polystyrene) AI content (mean values) Initial = 0.0434% 6 months = 0.0423% 24 months = 0.0416%


Acceptable The product is stable after 2 year at ambient temperature


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After storage 24 months, there is a loss of 4.15%

A 5 years ambient storage test with EXP 61210 N is ongoing. The formulation was stored in two different packaging materials: PS and HDPE.

Effect of light / / No study to demonstrate the stability of the biocidal product has been submitted. The active substance fipronil is sensitive to light (DT50=3.6h), however, claimed packagings are barrier light. No study is required.

/ /

Storage stability at 0°C

CIPAC MT 39.3

EXP 61210N Batch 042/14

After storage for 7 days at 0°C, the formulation showed only a very small amount separated material (<<0.05mL).

Vinh An Thieu-Simchen 2014

Acceptable

Technical characteristics in dependence of the formulation type

Not relevant, other formulation type

-

Compatibility with other products

Not relevant, EXP 61210 N will not be used together with other products.

-

Surface tension Not relevant, ready-to-use product, formulation enclosed in bait box

Viscosity OECD 114


Before storage: The viscosity of EXP 61210N varied with different shear rates. The viscosity of EXP 61210N ranged between 87.06mm2/s and 159mm2/s at 20 °C ± 0.2 °C and between 46.4mm2/s and 70mm2/s at 40 °C ± 0.2 °C After storage: The viscosity of EXP 61210N varied with different shear rates. The viscosity of EXP 61210N ranged between 86.2mm2/s and 130mm2/s at 20 °C ± 0.2 °C and between 45.6mm2/s and 70.78 mm2/s at 40 °C ± 0.2 °C

M. Herrmann, S. (2013)

Acceptable The test item EXP 61210N was considered to be a non-Newtonian fluid


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Particle size distribution Not relevant, ready-to-use product, formulation enclosed in bait box

Conclusion: FR recommends to store the product at a temperature below 35°C.


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2.3.2.3 Analytical method for determining the activ e substance and relevant component in the biocidal product

Determination of the Accelerated Storage Stability of EXP 61210N, IBACON Project 85081204, Meinerling. M, 2013

Principle: The active substance is extracted from the formulation using water/acetonitrile (50%/50%) then analysed by HPLC-UV (220nm). Specificity Chromatograms of standard solution, of blank formulation, and of fortified sample are provided. No interference is observed at the retention time of fipronil. Linearity Data concerning the linearity are reported below: -Equation: Y=ax+b (R2>0.999) -n=6 -Range: 0.489mg/l to 7.340mg/l Repeatability Data concerning the repeatability are reported below: Substance repeatability (Peak Area)) Mean (peak

area) RSD%

Fipronil 11677894/1176687/1164893/1191853/1186547 1177574.8 1.0 Accuracy Accuracy of the method is reported below: Substance Accuracy (%) Mean% RSD% Fipronil 110/103/95/101/109 104 6

102/102/101/102/100 101 4.2 Conclusion The method is validated for the determination of active substance in the preparation according to SANCO 3030/99 rev 4.

Content determination of Fipronil in EXP 61210N, Meinerling. M, 2013

IBACON 56743103 (HLPC-method)

GLP: Yes

Principle: About 500 mg of the test item were weighed into a 50 mL volumetric flask containing 25 mL pure water and ultrasonicated for 10 minutes. It was made up to the mark using acetonitrile and ultrasonicated for 10 minutes. The analyte in the test item solutions was analysed by HPLC-UV (220nm). Specificity Chromatograms of standards solution, of fortified samples, of test item samples, of blank formulation have provided in the dossier. No interference is observed at the retention time of fipronil. The specificity of the method is acceptable. Linearity Data concerning the linearity are reported below: -Equation: Y=ax+b (R2=0.999) -n=5


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-Range: 1mg/l to 10mg/l Repeatability Data concerning the repeatability are reported below: Substance repeatability (Peak Area)) Mean (peak

area) RSD%

Fipronil 1186197/1163606/1170012/1176730/1172360 1173781 0.7 Accuracy Accuracy of the method is reported below: Substance Accuracy (%) Mean% RSD% Fipronil 91/95/93/88/94 94 3.0

97/98/99/98/96 98 1.2 Conclusion The method is validated for the determination of active substance in the preparation according to SANCO 3030/99 rev 4.

Ant bait station Fipronil and Tube VR AF fipronil 0.05% (EXP 61210N), Method validation and content determination, Study N°CGB15799, Goller S, 2014 test facility ID131120SV/CGB15799

Only data concerning Ant bait station fipronil is reported. Principle The active substance is extracted from the formulation using water/acetonitrile (50/50v/v), then analysed by reversed phase liquid chromatography and UV detection (280mm). Specificity Chromatograms of solution standard, of fortified sample and of the formulation are provided in the dossier. No interference is observed at the retention time of active substance. The specificity of the method is acceptable. Linearity Data concerning the linearity are reported below: -Equation: Y=ax+b (R2=0.999) -n=7 -Range: 0.3mg/l to 6.4mg/l Accuracy Data concerning accuracy is reported below: Substance

Theoretical samples mg/L

Fortified samples mg/L Accuracy% Mean%

RSD%

Fipronil 7.80 7.905/7.847/7.730/7.983/8.042 101/101/99/102/103 101 1.4 15.60 16.027/15.774/15.686/15.813/15.7

35 103/101/101/101/101

101 0.8

Conclusion The method is validated for the determination of active substance in the preparation according to SANCO 3030/99 rev.


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Determination of content of active substance in 2 years ambient shelf life study, Ballard, K.M. (2004), Method F-909-04-97

GLP: Yes

Principle: The active substance is extracted from the formulation using water/acetonitrile (50/50v/v), then analysed by reversed phase liquid chromatography and UV detection (254nm). Specificity Chromatograms of blank formulation, of solution standard and the formulation are provided in the dossier. No interference is observed at the retention time of active substance. The specificity of the method is acceptable. Linearity Data concerning the linearity are reported below: -Equation: Y=ax+b (R2=0.999) -n=5 -Range: 0.0250g/l to 0.505g/l Repeatability Data concerning the repeatability are reported below: Substance Repeatability (g/kg) Mean (g/kg) RSD% Fipronil 0.457/0.460/0.466/0.472/0.476/0.480 0.47 2.0 Accuracy Accuracy of the method is reported below: Substance Accuracy (%) Mean% RSD% Fipronil 95.96/97.22/97.43/97.76/98.29/98.41 97.5 0.9 Conclusion The method is validated for the determination of active substance in the preparation according to SANCO 3030/99 rev 4.

CELAFLOR UNGEZIEFERKODER and Tube VR AF Fipronil 0.05% and composite box (containing Denatonium Benzoate as Bittern) –Method validation, Olivier Buttler, 2014

Only validation data of Tube VR AF Fipronil 0.05% (i.e AFOURMI F) are reported. Principle: Denatonium Benzoate is extracted from the formulation using water/acetonitrile (25/75v/v), then analysed by reversed phase liquid chromatography and UV detection (220nm). Specifity Chromatograms of blank formulation, of fortified sample and formulation are provided. No interference is observed at the retention time of denatonium benzoate. Linearity Data concerning linearity is reported below: -Y=ax+b R2=0.99 -range=0.2 to 6.4mg/L


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Accuracy Data concerning accuracy is reported below: Substance Theoretical

samples mg/L

Fortified samples mg/L Accuracy% Mean% RSD%

Denatonium benzoate

1.00 0.967/0.971/0.957/0.947/0.968 97/98/96/95/97 97 1.1 2.00 1.954/1.953/1.972/1.972/1.972 98/98/99/99/99 99 0.5

LOQ The LOQ of the method is 1mg/L. Conclusion The analytical method is validated for the determination of denatonium benzoate with an LOQ of 1mg/L.

2.3.2.4 Analytical methods for determining relevant components and/or residues in different matrices

The analytical methods for determination of residues of active substance in different matrices (soil, drinking and surface water, body fluids and tissues, in food and feedstuff) provided in the CAR of the active substance are presented in Annex 1 of this document. No contamination of food is expected. Therefore, no method is required.

No analytical method for the determination of fipronil residue in air has been provided in the CAR. However, considering the application mode of biocidal product, an analytical for the determination of fipronil in air is not necessary.

2.4 Risk assessment for Physico-chemical properties

AFOURMI F is a ready-to-use bait fipronil (0.05% (w/w)). It is under the form of gel presented in ready-to use bait. It is not highly flammable, auto-flammable at ambient temperature, not explosive and does not have oxidizing properties. The product is stable for 12 weeks at 35°C and 2 years at ambient temperature. The product AFOURMI F is compatible with PS package. Risk mitigation measures linked to risk assessment for physico-chemical

- Do not store at a temperature above 35°C. Disposal considerations None.

2.5 Effectiveness against target organisms

2.5.1 Function

Main Group 03: Pest Control


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Product Type 18: Insecticides, acaricides and products to control other arthropods. AFOURMI F is presented as a ready-for-use gel, in a bait station. The formulation contains 0.05 % w/w of the insecticidal active substance, fipronil. The biocidal product AFOURMI F is an insecticidal bait preparation (product type 18) used to reduce ants infestation including nest population in and around buildings on hard surfaces e.g. terraces and patios. It is intended for the use of non-professional users in their household/private areas. The bait stations are used for curative purpose.

2.5.2 Organisms to be controlled and products, organisms or objects to be protected

According to the uses claimed by the applicant, AFOURMI F is intended to be used to control ants. The target organisms to be controlled are ants (Lasius niger, Tetramorium caespitum, Tapinoma erraticum, Lasius emarginatus, Lasius flavus, and Linepithema humile). Relevant application aims are: food protection and material protection. A third aim is the quality of life, since it is not pleasant to stay or to play on an area infested with ants. Especially inside the house ants are regarded as vermin Application rates recommended by the applicant are the following: Bait box: The product is placed on the ground and is activated by twisting the box so that slits open allowing ants to feed on the bait formulation. Bait box contains 10 g of the formulation AFOURMI F (coded EXP61210 N). The claimed application dose is up to 2 bait boxes per 15 m² (indoors) or one bait box per nest (around buildings) without reapplication.


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2.5.3 Effect on target organisms and efficacy

The applicant submitted 32 new studies.

These studies were performed with different formulations of AFOURMI F, the formulation for which an authorisation is sought (EXP61210N), and an old formulation without bittering agent and with another in-can preservative (EXP61210A or EXP61210 = CRLD951145).

The applicant submitted new studies set up in 2014 which compared directly the efficacy of the old (EXP61210A) and new (EXP61210N) formulation in order to consolidate bridging data from old and new formulations applied in bait station:

- vivarium trial carried out on Lasius niger, n°1760-FRIN14LC3/0414,showing that the formulations EXP61210A and EXP61210N offer a total reduction of surface and depth activity after 7 days and 100 % of mortality at the end of the trial after 28 days;

- arena trial carried out on Lasius emarginatus, Tapinoma erraticum and Tetramorium caespitum, n°1760-FRIN14LC5/0414, showing that the formulations EXP61210A and EXP61210N offer 100 % of efficacy after 4 days on the 3 species.

- arena trial carried out on Lasius emarginatus, Tetramorium caespitum and Tapinoma erraticum, n°14/196:

o on Lasius emarginatus, the formulations EXP61210A and EXP61210N offer 100 % of efficacy after respectively 3 days and 1 day.

o on Tetramorium caespitum, after 4 days, the formulations EXP61210A and EXP61210N offer respectively 98,1 % and 99,2 % of efficacy. Complete efficacy for both formulations is obtained after 14 days.

o on Tapinoma erraticum, after 7 days, the formulations EXP61210A and EXP61210N offer respectively 95,7 % and 90,4 % of efficacy. Efficacy close to 100 % for both formulations is obtained after 28 days (respectively 99,5 % and 99,8 %).

All these studies demonstrated the equivalence between the old formulation (EXP61210A = CRLD951145) and the new formulation (EXP61210N), so it was considered that results of the old formulation are also applicable to the new formulation.

In order to support efficacy on the different claimed species, the applicant has submitted the following studies:

2.5.3.1 Lasius niger

2.5.3.1.1 Arena studies

The applicant submitted 11 arena studies conducted with the product AFOURMI F, old and new formulation, gel bait in bait box (0.05 % w/w fipronil), as fresh and 1 year aged bait, just opened and opened for 2 months, with and without food competition (sugar and honey). One of these studies was considered as not acceptable since the mortality of the untreated control reaches about 30 % in 9 days. In these arena trials, the product was applied at the dose of 1 bait box containing 10 g per arena (i.e. 660 to 900 cm²) containing a mean of 100 to 343 ants in each plate. The mortality of the ants was recorded regularly for up to 28 days. The test product was compared with an untreated control. Three to four replicates were made for each test condition. The product AFOURMI F (old and new formulation) showed a complete lethal efficacy against Lasius niger, within 5 to 14 days of treatment.


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Some of these trials (B_5.10-15, B_5.10-21 and B_5.10-24) performed with an alternative competition food (sugar or honey) seem to show a slower efficacy compared to the product tested without competition food. Then the measure proposed by the applicant on the product label to discard any food sources during the treatment seems to be justified. One of these trials (B_5.10-24) was performed with a product (CRLD951145) opened 2 months before the test and compared with a product that has just been opened. The product opened for 2 months reaches 100% efficacy within 13 days as the freshly opened one but it seems to show a slower efficacy. Indeed, the results are the following: 61.7 % and 81.3 % against 90 % and 98.7 % in respectively 7 and 9 days. Two of these trials (B_5.10-10 and B_5.10-19) were also performed with a 1 year aged product (EXP61210N and CRLD951145). The 1 year aged product AFOURMI F showed a complete lethal efficacy against Lasius niger, within 7 to 14 days of treatment. So, we can consider that 1 year aged and fresh products have the same effectiveness. One of these trials (B_5.10-22) was also performed with an aged (2 weeks at 40°C) product (CRLD951145). Compared to the fresh product, effectiveness was equivalent with 100 % in 9 days for the fresh product and 100 % in 10 days for the aged product.

2.5.3.1.2 Vivarium studies (semi-field)

The applicant submitted 9 vivarium studies conducted with the product AFOURMI F, old and new formulation, gel bait in bait box (0.05 % w/w fipronil), as fresh, 7 month and 1 year aged bait, with and without food competition (honey or sugar). Two of these studies were considered as not acceptable since the mortality of the untreated control reaches about 50 %. In these vivarium trials, the product was applied at the dose of 1 bait box containing 10 g per vivarium containing an acclimatized nest with all the development instars except the queen (approx. 500 to 6500 ants in each vivarium, depending on the study). The frequency of ants on surface and inside the nest was recorded weekly. After 2 to 7 weeks, the nest was opened and the number of remaining alive ants was counted. The test product was compared with an untreated control. Three replicates were made for each test condition. In all but one studies, the product AFOURMI F (new and old formulation, fresh and 1 year aged) showed a complete lethal efficacy against Lasius niger within 2 to 7 weeks. Two tests (IIIB_5.10-32 and IIIB_5.10-33) showed no ants in surface and inside the nest after one week. One study (IIIB_5.10-25) performed with honey as competition food resulted in 88.2% efficacy after 32 days, which is insufficient. But other studies although with honey gave complete mortality. Anyway, the applicant proposes on the product label to discard any food sources during the treatment.

2.5.3.1.3 Field trials

The applicant submitted 6 field trials conducted in different locations representative of the use, with the product AFOURMI F, old and new formulation, gel bait in bai t box (0.05 % w/w fipronil), as fresh and 2 year aged bait. Two of these studies (B_5-10.18 and B_5.10-23), performed with the old formulation, were considered not acceptable for methodological reasons. In the other studies the product was mostly applied at the dose of 1 bait box (containing 10 g of product) per nest. Two studies were performed with a dose of 1 to 2 bait boxes per nest (1 bait box per nest entry).


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The ground surface activity was assessed before treatment, 1 and 3 days after and then every week after treatment. At the end of the trials, 1 to 3 months after treatment, the nests were opened and the remaining alive ants were counted. The test product was compared with an untreated control. Four replicates were made for each test condition. For all tested formulations (new, old, fresh or 2 year aged), the reduction of the activity was total after 1 to 3 months and there was no remaining activity in the nest and no ants alive.

2.5.3.2 Lasius flavus

The applicant submitted 1 vivarium study conducted with the product AFOURMI F, old formulation (CRLD 951145), gel bait in bait box (0.05 % w/w fipronil), as fresh bait, with food competition. But, in this vivarium trial, there was no real population counting at the beginning of the test (the test reports mentions a quarter of a nest). Furthermore, surface activity and mortality of the untreated control was not reported but solely the number of alive ants at the end of the test. So, the lack of monitoring of the untreated control makes this test not acceptable. So, effectiveness on Lasius flavus has not been proved.

2.5.3.3 Lasius emarginatus

The applicant submitted 3 arena studies conducted with the product AFOURMI F, old and new formulation, gel bait in bait box (0.05 % w/w fipronil), as fresh and aged bait, with food competition. In these arena trials, the product was applied at the dose of 1 bait box containing 10 g per arena (i.e. 660 to 900 cm²) containing a mean of 100 to 322 ants in each plate. All of these trials (B_5.10-28, B_5.10-30 and B_5.10-31) were performed with an alternative competition food (sugar).The mortality of the ants was recorded regularly for 9, 21 or 28 days. The test product was compared with an untreated control. Three to four replicates were made for each test condition. The product AFOURMI F (old and new formulation) showed a complete lethal efficacy against Lasius emarginatus, within 1 to 9 days of treatment. Two of these trials (B_5.10-30 and B_5.10-31) were also performed with a 2 year aged product (EXP61210N) and compared with the fresh one. The 2 year aged product AFOURMI F showed a complete lethal efficacy against Lasius emarginatus, within 2 to 4 days of treatment. So, we can consider that aged and fresh products have the same effectiveness. It has to be noted that these studies are only laboratory studies, no semi-field and no field studies have been performed on this species. So, efficacy data are insufficient to conclude on Lasius emarginatus.

2.5.3.4 Tetramorium caespitum

The applicant submitted 4 arena studies conducted with the product AFOURMI F, old and new formulation, gel bait in bait box (0.05 % w/w fipronil), as fresh and aged bait, with or without food competition. In these arena trials, the product was applied at the dose of 1 bait box containing 10 g per arena (i.e. 600 to 900 cm²) containing a mean of 100 to 318 ants in each plate. Three of these trials (B_5.10-20, B_5.10-30 and B_5.10-31) were performed with an alternative competition food (sugar).The mortality of the ants was recorded regularly for 7, 21, 25 or 28 days. The test product was compared with an untreated control. Three to four replicates were made for each test condition. The product AFOURMI F


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(old and new formulation) showed a complete lethal efficacy against Tetramorium caespitum, within 4 to 15 days of treatment. Two of these trials (B_5.10-30 and B_5.10-31) were also performed with a 2 year aged product (EXP61210N) and compared with the fresh one. The 2 year aged product AFOURMI F showed complete lethal efficacy against Tetramorium caespitum, within 4 to 7 days of treatment. So, we can consider that aged and fresh products have the same effectiveness. It has to be noted that these studies are only laboratory studies, no semi-field and no field studies have been performed on this specie. So, efficacy data are insufficient to conclude on Tetramorium caespitum.

2.5.3.5 Tapinoma erraticum

The applicant submitted 3 arena studies conducted with the product AFOURMI F, old and new formulation, gel bait in bait box (0.05 % w/w fipronil), as fresh and aged bait, with or without food competition. In these arena trials, the product was applied at the dose of 1 bait box containing 10 g per arena (i.e. 600 to 900 cm²) containing a mean of 100 to 152 ants in each plate. Two of these trials (B_5.10-30 and B_5.10-31) were performed with an alternative competition food (sugar).The mortality of the ants was recorded regularly for 7, 21 or 28 days. The test product was compared with an untreated control. Three to four replicates were made for each test condition. The product AFOURMI F (old and new formulation) showed almost complete lethal efficacy (>95 % to 100 %) against Tapinoma erraticum, within 4 to 28 days of treatment. Two of these trials (B_5.10-30 and B_5.10-31) were also performed with a 2 year aged product (EXP61210N) and compared with the fresh one. The 2 year aged product AFOURMI F showed a complete lethal efficacy against Tapinoma erraticum, within 4 to 21 days of treatment. So, we can consider that aged and fresh products have the same effectiveness. It has to be noted that these studies are only laboratory studies, no semi-field and no field studies have been performed on this specie. So, efficacy data are insufficient to conclude on Tapinoma erraticum.

2.5.3.6 Linepithema humile

A field trial (trial 13/041 (2013/1283217 BASF) (Doc. IIIB_5.10-14)) has been conducted with the product FOURMIDOR (EXP 61210 N), gel bait in tube (0.05 % w/w fipronil), as fresh bait. In this trial the applied rate was between 2,88 g and 7,56 g product per nest (according to the nest size), and the method of application was to put 3 drops (30 mg each) every 90 cm of ants runs and allocated in a wide surface around the nest. But, AFOURMI F contains 10 g of gel EXP61210N included in a bait box and the recommended rate is 1 bait box per nest. So, as application methods are different and as mentioned by the applicant “the gel in AFOURMI F is relatively less reachable by the ants than drops of gel (only one bait box placed around the nest, while gel drops are allocated in a wider surface and on an optimized way around the nest and on ants runs)”; this study cannot be acceptable because it is not representative of the product’s final use. Effectiveness on Linepithema humile has not been proved.


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2.5.3.7 Conclusion

All efficacy studies are presented in Annex 9. Based on these efficacy data, the product AFOURMI F (0.05 % w/w fipronil), formulated as gel bait in a bait box, at a rate of 1 bait box (10 g of product) per nest (around buildings) or 1 up to 2 bait boxes per 15 m² (indoor) showed a complete lethal efficacy against Lasius niger within 1 to 3 months. In laboratory tests, the biocidal effect began 1 day after application. Aged products of 2 years have shown the same effectiveness as the fresh product on all species (except Lasius flavus and Linepithema humile).

2.5.4 Mode of action including time delay

Fipronil is an insecticide acting both by contact and ingestion on the nervous system, blocking the GABA regulated chloride channel at very low doses. Its use causes uncontrolled nervous system activity and death of the exposed arthropods. It leads to reduction of ants infestation through the death of insects consuming the bait (as a result uncontrolled nervous system activity) and the contamination of the nest by trophallaxy. The ants are attracted by the sugary gel. They ingest the gel with the active substance and take it back to the nest to feed their brood. The ants will begin to die in the nest a few hours after feeding on an application. The effect begins around 1 day after ingestion of the product in the laboratory trials submitted by the applicant.

2.5.5 Occurrence of resistance - resistance management / Unacceptable Effect

Concerning ants, there has not been resistance or lack of efficacy situations related to fipronil for the target species. Their eusocial lifestyles as supraorganismic arthropods preclude any developmental resistance.

However, the risk of developing resistance to fipronil cannot be excluded. So, the authorization holder should report any observed resistance incidents to the Competent Authorities (CA) or other appointed bodies involved in resistance management.

As with any insecticide a sound resistance monitoring and management plan is necessary to ensure fipronil remains effective. To avoid the development of resistance in susceptible insect populations, the following recommendations have to be implemented:

Always read the label or leaflet before use and respect all the instructions provided.

Inform the authorisation holder if the treatment is ineffective.


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2.5.6 Evaluation of the label claim

According to the TNsG for product evaluation PT18, for bait products, the label can only claim efficacy against species that have been tested under field conditions. So the claims must be “control of garden ants (Lasius niger)”. As no field test has been submitted for the other ant species claimed, the species Linepithema humile, Tapinoma erraticum, Tetramorium caespitum, Lasius flavus and Lasius emarginacus have to be deleted

Tests on persistence of action and effectiveness after maximal storage period have been performed and show that the product is still effective after a 2 year storage period. Then, the shelf life of 2 years claimed is acceptable from an efficacy point of view.

French competent authorities (FR CA) assessed that :

- the product AFOURMI F (0.05 % w/w fipronil), as bait station (10 g of product), at a dose of 1 up to 2 bait stations for 15 m2 (0.67 à 1.33 g/m2) or one bait box per nest has shown a sufficient efficacy for the control of garden ants (Lasius niger) within 1 to 3 months.

The following claims have to be withdrawn:

“Safe bait stations: only ants can reach the product”.

“Appropriate for permanent use in inhabitated areas”.

2.5.7 Summary of efficacy assessment

The efficacy level of the product AFOURMI F (0.05% w/w fipronil) is acceptable for the uses proposed in the Table 2 below. Conditions of use linked to efficacy assessment

- Always read the label or leaflet before use and respect all the instructions provided. - Inform the authorisation holder if the treatment is ineffective. - Do not apply the product on absorbing surfaces. - Apply only in areas that are not liable to submersion or becoming wet, i.e. protected from rain,

floods and cleaning water. - Apply the product away from direct sunlight or heat sources (eg. do not place it under a

radiator). - To optimise the treatment efficacy, respect good hygiene practices: remove or prevent

access to all source of food. The bait must be the main source of food available for ants. - Check the bait boxes once a week. - At the end of the treatment campaign, collect all bait boxes for disposal. - If the infestation persists despite following the instructions of the label, contact a pest control

professional. - Avoid continuous use of products.

Required information linked to efficacy assessment

None.

2.6 Description of the intended use(s)

AFOURMI F is an insecticidal bait preparation which contains 0.05 % w/w of the insecticidal active substance, fipronil (product type 18).


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The biocidal product is efficacious against garden ants (Lasius niger). This biocidal product is a bait gel in a bait box. This product will be used by non-professional users (general public).

Table 2: Summary of intended uses

MG/PT Field of uses envisaged Likely concentrations at which product will be used

Main Group 03; Pest Control PT18: insecticides, acaricides and products to control other arthropods

Non-professional uses

Insecticide for use by non-professionals against garden ants (Lasius niger) infestation. In and around buildings.

AFOURMI F (0.05 % w/w fipronil)

Indoor: 0.67 à 1.33 g/m2 i.e.1 up to 2 bait boxes of 10 g of product for 15 m2 (depending on the infestation).

Outdoor: 1 bait box per nest.

Method of application The product is a bait box containing 10 g of the formulation AFOURMI F. Depending on the location and the infestation, several bait boxes need to be placed along the ants' paths and/or in the near of the nest(s). At least one up to 2 bait boxes per 15 m² indoor or one bait box per nest around buildings for at least 1 to 3 months are recommended. Since the product is formulated as a ready-for-use product, no dilution or other preparation is necessary.

2.7 Risk assessment for human health

2.7.1 Hazard potential

2.7.1.1 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. The following corresponds to the summary of the effect assessment available in the assessment report of Fipronil. Toxicokinetics

• Absorption

Fipronil is rapidly and extensively absorbed after oral intake. An oral absorption estimate of approximately 90% was actually estimated from radiolabelled recoveries in urine, bile and tissues within 72 hours following oral gavage treatment with 4 mg/kg bw radiolabelled fipronil. Thus, a default factor of 100% for oral absorption has been retained because the real value has not been determined. For dermal exposure assessment, a factor of 11% was used, based on information available on fipronil formulations. This dermal absorption value is a conservative estimate based on an in vitro study carried out with a 100-fold dilution of a suspension concentrate (initially at 50 g/L) over 24h. The tested concentration was therefore 0.05% (m/m) which corresponds to the fipronil concentration in the representative product (Goliath Gel). Although not fully adapted for extrapolating the dermal absorption of a gel for which a skin contact duration will be much shorter, this value was nevertheless considered as the most relevant for a conservative approach in the absence of any better data.

• Distribution


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Fipronil is widely distributed with a preference for fatty tissues.

• Metabolisation

Fipronil is extensively metabolised.

• Elimination

Fipronil is slowly eliminated via both bile (metabolites) and faeces and urine (parent residue). The slow elimination appears to be partly due to the distribution of fipronil into fatty compartments and to the extent of gastrointestinal reabsorption of biliary excreted fipronil metabolites. Acute toxicity

Fipronil is toxic by oral route (LD50 = 92 mg/kg bw in male rats), by dermal route (LD50 = 354 mg/kg bw in female rabbits) and by inhalation (LC50 = 0.36 mg/L in male rats exposed to air-milled fipronil for 4h). Accordingly, fipronil is classified as T, R25/24/23. Local toxicity

Fipronil is neither a skin nor an eye irritant. No study is available for respiratory irritation, but based on the different available data, fipronil is not expected to have a respiratory irritant potential. Fipronil is not a skin sensitiser (negative results in a Magnusson and Kligman test and in a Buehler test). No study is available for respiratory sensitisation, but based on the available data, fipronil is not expected to have a respiratory sensitising potential. Repeated dose toxicity

When orally administered to Sprague-Dawley rats for 28 days, fipronil induced hepatic effects. From 100 ppm (corresponding to 12.6 and 12.9 mg/kg bw/d in males and females respectively), a follicular hypertrophy was observed in thyroid. These target organs were confirmed in a 90-day study in the same strain since a tendency towards higher liver and thyroid weights were observed from 30 ppm (corresponding to 1.9 and 2.3 mg/kg bw/d in males and females respectively). At the next higher dose of 300 ppm (corresponding to 20 and 24 mg/kg bw/d in males and females respectively) a fat deposition in male liver was observed together with a thyroid follicular hypertrophy and follicular cell hyperplasia. On the basis of these observed effects, a NOAEL was set at 0.35 mg/kg bw/d, which is the average of values corresponding to 5 ppm in males and females (i.e. 0.33 and 0.37 mg/kg bw/d respectively). Oral studies in Beagle dogs are also available. In a 90-day study, a reduction of food consumption and body weight in females exposed to 2 mg/kg bw/d was considered as a critical effect. Overt toxicity was reported at the next higher dose of 10 mg/kg/ bw/d. This consisted in inappetence, underactivity, hunched posture, emaciation and neurotoxicity (tremors and/or convulsions, head nodding, facial twitching, ataxia, exaggerated blink and gag reflexes). Based on these observed effects, the NOAEL was set at 0.5 mg/kg bw/d. Two 1-year studies were performed showing significant toxicity including mortality, neurological effects characterised by convulsions, twitching or tremors, changes in behaviour (nervousness or aggression) and activity patterns and gait abnormalities, at dose levels of 1 to 5 mg/kg bw/d. Other signs were exaggerated rigidity or stiffness of limbs, ataxia, vocalisation, head nodding and resistance to dosing. There were no histopathological changes.


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A NOAEL of 0.35 mg/kg bw/d was retained for derivin g a medium-term AEL, based on the 1-year dog studies and the 90-day in rat study. In a combined chronic/carcinogenicity study in rat, convulsive episodes were observed in a dose dependent manner at 1.5 ppm (corresponding to 0.059 and 0.078 mg/kg bw/d in males and females respectively) and above. Neurological signs were seen at 300 ppm and to lesser degree at 1.5 and 30 ppm. Moreover, functional and morphological changes were found in the liver, thyroid and kidney particularly at 30 and 300 ppm. The NOAEL of 0.5 ppm (corresponding to 0.019 mg/kg bw/day) was chosen for deriving a long-term AEL. Another combined chronic/carcinogenicity study was conducted in mouse. Convulsions were recorded at 60 ppm and significantly low body weight gains were seen at 30 ppm. Liver was identified as the target organ characterised by an increase in organ weight correlated with histopathological changes in both sexes. The NOAEL was 0.5 ppm, corresponding to 0.055 mg/kg bw/d of fipronil in males and to 0.063 mg/kg bw/d in females. Finally, one dermal 21-day study in rabbit was submitted. At 10 mg/kg bw/d, some animals showed one episode of extreme hyperactivity and bodyweight gain in both sexes and food consumption were reduced. The NOAEL was 5 mg/kg bw/d. Genotoxicity

� In vitro tests Fipronil gave negative results in Ames tests until cytotoxic doses, in a gene mutation assay in Chinese hamster cells (V79) and in a cytogenicity study in human lymphocytes. However, evidence of clastogenicity at cytotoxic concentrations with and without S9 mix following 6-h exposure was mentioned in Chinese hamster lung cells. No evidence was reported at lower concentrations or in cultures treated for 24- or 48-hours.

� In vivo tests Three in vivo tests were conducted. Fipronil did not induce a clastogenic response in two micronucleus tests in mouse exposed to a single oral application of 1, 5 or 25 mg/kg bw or of 12.5, 25 and 50 mg/kg bw. Moreover, it did not possess a genotoxic potential in an UDS assay in primary hepatocytes from treated rats.

Fipronil does not seem to be mutagenic with in vitro and in vivo tests. Carcinogenicity

Fipronil is not carcinogenic in mice. In rats, exposure to fipronil for 89/91 weeks, has led to increased incidences of thyroid tumors at 300 ppm (corresponding to 12.68 and 16.75 mg/kg bw/d in males and females). It is known that rats are especially sensitive to generate this tumor type. Additional mechanistic studies have suggested that the rat thyroid tumors are induced by a mechanism which is not relevant for humans (thyroid follicular cell tumours due to a rat specific non-genotoxic mechanism), therefore it was concluded that fipronil is not a likely human carcinogen, Toxicity on the reproduction and teratogenicity

� Developmental toxicity In two oral teratogenicity studies in rat and rabbit, fipronil did not induce adverse effects in foetus. The only effect observed in dams was reduced bodyweight gain. The NOAEL for maternal toxicity were 4 and 0.2 mg/kg bw/d for rat and rabbit, respectively the NOAEL and for developmental effects, were 20 and 1 mg/kg bw/d for rat and rabbit, respectively.

� Fertility


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An oral two-generation reproduction study was conducted in rat. Toxicity on the liver and on the thyroid at 30 ppm (corresponding to 2.54 mg/kg bw/d for males or 2.74 mg/kg bw/d for females) and above, a decreased body weight gain and food consumption and a neurotoxicity with mortality at 300 ppm (approx. 25 mg/kg bw/d for males or 27 mg/kg bw/d for females) were reported. A slightly reduced mating performance and fertility index of F1 parents were reduced at toxic dose of 300 ppm. A reduced viability, a neurotoxicity and a delayed development were observed in offspring, in the presence of parental toxicity at 300 ppm. The NOAEL for systemic toxicity was 3 ppm (equivalent to 0.25 mg/kg bw/d for males or 0.27 mg/kg bw/d for females). The NOAEL for reproductive and developmental toxicity was 30 ppm (equivalent to 2.54 mg/kg bw/d for males or 2.74 mg/kg bw/d for females).

Fipronil is not a reproduction toxicant and is not regarded as a teratogenic substance. Neurotoxicity

Fipronil has shown to be neurotoxic in all species tested in single and/or repeated-dose toxicity studies. The observed clinical symptoms are consistent with fipronil's mode of action at the GABA-gated chloride channel in the central and peripheral nervous system. Specific neurotoxicity studies have shown that the neurotoxicity of fipronil is of a pharmacological nature and repeated exposure does not lead to histopathological changes in the brain or other parts of the nervous system. The NOAEL of 2.5 mg/kg bw from an acute neurotoxici ty study was chosen for deriving a acute-term AEL. It is based on reduction of hind-leg splay at the higher doses of 5 and 7.5 mg/kg bw at 7 hours post dosing. Human data

Several effects such as headache, nausea, vomiting, dizziness and weakness were mentioned after ingestion. Some cases of toxicity on central nervous system were also reported after ingestion of fipronil. After inhalation or eye contact, irritation was observed. Therapy is based on barbiturates and benzodiazepines.

2.7.1.2 Toxicology of the substance(s) of concern

2.7.1.3 Toxicology of the biocidal product

The toxicology of the biocidal product was examined appropriately according to standard requirements. The toxicological studies have been carried out with a similar formulation than AFOURMI F. The basis for the health assessment of the biocidal product is laid out in Annex 5 ”Toxicology – biocidal product”.

2.7.1.3.1 Percutaneous absorption

Dermal absorption value of 11% for product with an active substance concentration ≥ 0.05% has been considered in the CAR of Fipronil.

2.7.1.3.2 Acute toxicity

Acute oral and acute dermal toxicity of the product was tested: In the acute oral toxicity study (OECD 401), rats were exposed to a single dose of 2002 mg/kg bw. No mortality was observed during the test. There were no abnormal clinical signs in any of the treated animals during the observation period. The oral LD50 of the test article was higher than 2002 mg/kg bw in rats.


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In the dermal acute toxicity study (OECD 402), rats were exposed to a single dose of 2002 mg/kg bw. One of the female rats died during the observation period of 14 days. However, this dead was not related to the treatment. No abnormal clinical signs were observed. No cutaneous lesion (erythema or oedema) was noted. The dermal LD50 of the test article was higher than 2002 mg/kg bw in rats. Based on the results, no classification is required for AFOURMI F. No acute inhalation toxicity study was generated for AFOURMI F. The product AFOURMI F does not contain ingredient classified for health effects resulting from an acute exposure by inhalation. Therefore, according to the classification rules in the CLP regulation, no classification regarding acute inhalation toxicity is warranted for the product AFOURMI F.

2.7.1.3.3 Irritation and corrosivity

No dermal reactions were observed in the skin irritation study (OECD 404) in rabbits (3 animals). Therefore, no classification is required for AFOURMI F regarding skin irritation. No ocular reactions were observed in the eye irritation study (OECD 405) in rabbits (3 animals). Therefore, no classification is required for AFOURMI F regarding eye irritation.

2.7.1.3.4 Sensitisation

A modified Buehler Test (9 induction applications - OECD 406) in guinea pigs was submitted. No skin reactions were observed under the experimental conditions. Therefore, AFOURMI F is not classified as skin sensitiser. Nevertheless, AFOURMI F contains one sensitizer substance for which a specific labelling is needed: 1,2-benzisothiazolin-3-one. A non-radiactive LLNA test has been carried out with the formulation AFOURMI F. However, the non-radioactive LLNA using cell counting method is not currently validated. Furthermore, according to Basketter et al3, the proposed non-RI LLNA uses cell number as a correlate of cell proliferation, but, as other modifications to the standard LLNA were also made, the method constitutes a major change.” Therefore, this test was considered as unacceptable by FR.

2.7.2 Human exposure assessment

AFOURMI F is an insecticidal bait preparation which contains 0.0526% of technical fipronil (product type 18). The product is meant for the control of ants by non professional users (general public). It is sold in ready to use bait stations containing 10 g of product (corresponding to 5 mg of active substance).

3 An evaluation of performance standards and non-radioactive endpoints for the LLNA – The report and recommendations of ECVAM Workshop 65 (2008)


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2.7.2.1 Identification of main paths of human expos ure towards active substance from its use in biocidal product

The product is contained in a sealed bait station, therefore no exposure (dermal and inhlalation) to the formulation is expected. The box cannot be opened, so that small children cannot ingest the contents of the bait box.

Exposure path Industrial use Professional use Gener al public via the environment Inhalation Not relevant Not relevant No No Dermal Not relevant Not relevant Negligible No Oral Not relevant Not relevant Negligible No

2.7.2.2 Direct exposure as a result of use of the a ctive substance in biocidal product

2.7.2.2.1 Exposure of professional users

Not relevant, the product is for non professionnal users only.

2.7.2.2.2 Exposure of non-professional users

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. The product is contained in a sealed bait station, therefore exposure is considered as negligible when the station is positioned.

2.7.2.3 Indirect exposure as a result of use of the active substance in biocidal product

The product is contained in a sealed bait station, therefore secondary exposure is considered as negligible. However, a reverse scenario was performed in order to assess the amount of product needed to reach the short-term AEL for an adult, a child and an infant The following parameters were taken into account in the calculations:

- Concentration of fipronil in AFOURMI F: 0.0526%; - Dermal absorption value: 11% - Oral absorption value: 100%; - Body weight of an adult: 60 kg; - Body weight of a child: 23.9 kg; - Body weight of an infant: 8 kg; - AEL short-term: 0.025 mg/kg bw/day.

Amounts of 27 g, 10.2 g and 3.4 g of AFOURMI F should be present to reach an exposure equal to the short-term AEL, for an adult, a child and an infant, respectively. For a child and an infant, 1.12 g and 377 mg of product, respectively, should be ingested to achieve the short term AEL.


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2.7.2.4 Indirect exposure via residues in food

No specific residue data were submitted in the context of this dossier. The product AFOURMI F is intended to be used by non-professional users in and around their houses on hard surfaces and therefore does not leave residues in commodities for human or animal consumption. In this purpose, the following precautionary statement should be indicated on the labels:

- the product should not be applied or disposed in the vicinity of food or feed. In Annex 8 “Residue behaviour”, the results of the residue assessment should be laid out. However, AFOURMI F will not get in contact with food, residues in food are not expected.

2.7.3 Risk assessment for human health

2.7.3.1 Risk for direct exposure

No exposure has been identified during use of AFOURMI F; therefore no risk assessment is required.

2.7.3.2 Risk for indirect exposure

Amounts of 27 g, 10.2 g and 3.4 g of AFOURMI F should be present to reach an exposure equal to the short-term AEL, for an adult, a child and an infant, respectively. This amount was considered as not relevant, the product is not sufficiently available in the bait station. For a child and an infant, 1.12 g and 377 mg of product, respectively, should be ingested to achieve the short term AEL. The product is contained in a sealed bait station with only 4 predefined openings; therefore it is not relevant to consider 11.2% and 3.8% of the product as available for ingestion by a child and an infant.

2.7.3.3 Risk for consumers via residues

Based on the intended use and the proposed restriction, the acute or chronic exposure to residues resulting from the intended use is unlikely to cause a dietary risk to consumers. The product should not be used in the vicinity of food or feed as stated in the precautionary statement on the labels. Regarding consumer health protection, there are no objections against the intended uses.

2.7.3.4 Summary of risks characterisation of the pr oduct for human health

No exposure (direct or indirect) is expected during use of AFOURMI F; therefore no risk has been identified. Risk mitigation measures linked to risk assessment for human health

- Do not use in areas accessible to infants, children, pets or other non-target animals in order to minimise the risk of poisoning as much as possible.

- At the end of the treatment campaign, collect all bait boxes for disposal. - Apply strict hygiene measures: do not eat, drink or smoke while handling the product and

wash hands after use. - Do not force open the bait boxes and do not damage them, even when empty.

Risk mitigation measures linked to risk assessment for consumers

- Do not use directly on or near food, feed or drinks, nor on surfaces or ustensils likely to be in direct contact with food, feed or drinks.

Required information linked to risk assessment for human health and consumers None


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Disposal considerations

- At the end of the treatment campaign, collect all bait boxes for disposal. Emergency

- Eye contact: Immediately flush with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Continue to rinse for at least 10 minutes. Get medical attention if irritation occurs.

- Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical attention if symptoms occur, show this container or label.

- Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur. Wash clothing before reuse. Clean shoes thoroughly before reuse.

- Ingestion: Wash out mouth with water. Get medical attention if symptoms occur, show this container or label.

Note to physician: Treat symptomatically. Contact poison treatment specialist immediately if large quantities have been ingested or inhaled.

2.8 Risk assessment for the environment

The summary of information about the active substance fipronil is carried out with the data from the CAR of fipronil supplied by the applicant BASF Agro B.V. (Assessment Report According to Directive 98/8/EC, Active substance in Biocidal Products, Fipronil CAS 120068-37-3, Product Type 18 (Insecticides, acaricides and products to control other arthropods), RMS France, May 2011.

2.8.1 Fate and distribution in the environment of the act ive substance fipronil

2.8.1.1 Degradation

2.8.1.1.1 Abiotic degradation

2.8.1.1.1.1 Hydrolysis in function of pH

At pHs 5 and 7, fipronil was hydrolytically stable. At pH 9, fipronil is unstable with only RPA 200766 as breakdown product. At this pH, the rate of conversion is best modelled by pseudo-first order kinetics with at 25°C a half-life of 28 days and a rate constant k = 0.0243 day-1, and at 12°C a half-life of 76.2 days and a rate constant k = 0.009 day-1.

2.8.1.1.1.2 Photolysis in water

Two major degradation products were formed during photolysis in water. The major organic extract photo-product was MB 46513 (43.4 % of the applied radioactivity) and a minor component (HPLC RT = 2 min) accounting for 4.0% of applied radioactivity. The aqueous extract photo-products RPA 104615 and a minor component (HPLC RT = 3.3 min) accounted for 8.2 and 5.6% of applied radioactivity, respectively. The kinetics of photolytic degradation were first order with a half-life of 3.63 hours under the xenon lamp corresponding to 0.33 days of summer sunlight in Florida and a rate constant k = 0.0176 days-1. Photolysis can be considered as a significant route of fipronil degradation when it reaches the aqueous environment.


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2.8.1.1.1.3 Photolysis in soil

No study on the photolysis of the active substance in soil has been submitted in the CAR of fipronil.

2.8.1.1.1.4 Photodegradation in air

The photo-oxidative degradation of fipronil in air was estimated by a structural activity relationship (QSAR) method using the Atmospheric Oxidation Program v1.92 (AOPWIN). Fipronil is rapidly degraded in the troposphere with a half-life of 0.167 days (4 hours) assuming 24 hours of sunlight. Fipronil has a vapour pressure lower than 2E-06 Pa and a Henry’s law constant lower than 2.31E-04 Pa·m3·mol-1. Thus, an extensive accumulation of fipronil in air and long range transport is unlikely.

2.8.1.1.2 Biotic degradation

2.8.1.1.2.1 Aquatic compartment

• Ready biodegradation / inherent biodegradation Fipronil is not readily biodegradable under OECD 301B Test (degradation 47% after 28 days).

• Degradation in water/sediment system

A [14C]-fipronil degradation in two water/sediment systems showed that in an aerobic aquatic environment, fipronil partitions steadily into the underlying sediment where it degrades partly by reduction to MB 45950. MB 45950 is further degraded by hydrolysis to MB 46126. Fipronil is also hydrolysed to RPA 200766 and, to a much lesser extent oxidised to MB 46136. There is evidence than RPA 200766 and MB 46136 are further transformed to RPA 105320 via oxidation or hydrolysis respectively. MB 46126 reaches a max. 6.33% in water and max. 6.48% in sediment. Amongst all those metabolites identified, RPA 200766 is a major metabolite in water (max. 20%) and MB 45950 is a major metabolite in sediment (max. 54.69% at 163 days). Two others water/sediment degradation studies were provided from the PPP dossier. The results of one study showed that the majority of the test substance, [14C]-fipronil, was rapidly transferred/adsorbed to the sediment within 7 days of incubation with less than 4% in the water phase after 7 days. The half-life of [14C]-fipronil under aerobic aquatic conditions was 14.5 days at 25°C. MB 45950 was found as the major metabolite in the sediment and accounted for <1% in the water phase. The results of the other study showed that fipronil was readily degraded in aerobic water with anaerobic sediment systems with DT50 values in the water of less than 14 days and in the total system less than 35 days. Fipronil was the only major component found in the water. It rapidly transferred to the sediment (up to 20 to 40% of applied) and was reduced to MB 45950 which was the major metabolite in the sediment, which undergoes further degradation. The geometric mean degradation half-lives were calculated based on these values for water and total system compartments as follows: DT50 water = 18.6 days and DT50 total system = 44.2 days at 12°C .

2.8.1.1.2.2 Degradation in STP

No study on the degradation of the active substance in STP has been submitted in the CAR of fipronil.

2.8.1.1.2.3 Terrestrial compartment

• Aerobic degradation


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In studies of [14C]-fipronil degradation in six soils (at 20°C) and two soils (at 10°C), fipronil was degraded under aerobic conditions by hydrolysis to RPA 200766 (38.44%) and by oxidation to MB 46136 (34.34%); these two compounds were considered as major metabolites in soil. The reduced metabolite MB 45950 was found in minor quantities (<10%), except in one soil (16.99%). The rate of degradation was temperature dependent with more rapid degradation at 20°C than 10°C. The rate of degradation was also related to the soil microbial biomass activity. For risk assessment purposes for soil, the geometric mean value from all the submitted studies (with converted half-lives at 12°C) was calculated. This DT50 value of 334 days was used for risk assessment purposes.

• Anaerobic degradation

No study on the anaerobic degradation of fipronil in soil has been submitted in the CAR.

2.8.1.2 Distribution

The soil adsorption/desorption properties of [14C]-fipronil were investigated using five European soil types using the slurry technique. The adsorption constants (K) obtained ranged from 4.19 in a UK sandy loam to 20.69 in a UK loam. The value of K increased with increasing organic carbon content of the soil suggesting that more fipronil was adsorbed. The KOC values obtained ranged from 427 to 1248 with a mean of 727. The Freundlich desorption constants increased with the increasing desorption cycles, the results suggest that the adsorption was reversible with similar processes involved in desorption as in adsorption. The results of this test indicated that fipronil is unlikely to demonstrate significant mobility in soil due to its relatively high sorption to soil. According to McCall’s designation, fipronil would be expected to show medium to low mobility. This was confirmed by a column leaching study on five European soils where fipronil and its metabolites were shown to have a low mobility in soil.

2.8.1.3 Accumulation

The bioconcentration factor and bioaccumulation potential of [14C]-labelled fipronil were measured in a fish species (bluegill, Lepomis macrochirus). The bioconcentration factor (BCF) estimated in whole fish was 321 . Uptake residues were rapidly and nearly completely (>99%) eliminated from whole fish within the 14-day depuration phase. Using samples of fractions, muscle and viscera obtained in this fish bioaccumulation study, analyses were carried out to identify and quantify metabolites. Results indicate that MB 45950 and MB 46136 were the major metabolites detected in fish tissues after uptake of fipronil and that all metabolites were rapidly eliminated. No experimental data are available for terrestrial bioconcentration. Therefore, the terrestrial BCF have been estimated using a linear Quantitative Structure Activity Relationship (QSAR) model and the log Kow of 4.0:

BCFearthworm = 121 L.kg -1 (according to TGDII Equation 82d)

It should be concluded that fipronil has low bioaccumulation potential in aquatic and terrestrial organisms.

2.8.1.4 Behaviour in air

Fipronil has a vapour pressure lower than 2E-06 Pa and a Henry’s law constant lower than 2.31E-04 Pa·m3·mol-1. In addition, Fipronil is expected to be quickly degraded by photo-oxidation, the atmospheric photochemical half-life was 0.167 days (see 2.8.1.1.1.4). Based on these data, fipronil is not expected to volatilize and to persist in air.


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2.8.2 Effects on environmental organisms for active subst ance fipronil

The summary of information about the active substance fipronil and its relevant environmental metabolites is carried out with the data from the CAR of fipronil supplied by the applicant BASF Agro B.V. (Competent Authority Report According to Directive 98/8/EC, Active substance in Biocidal Products, Fipronil CAS 120068-37-3, Product Type 18 (Insecticides, acaricides and products to control other arthropods), RMS France, January 2011. No new ecotoxicological information on the active substance fipronil has been submitted in the product dossier.

2.8.2.1 Aquatic compartment (including water, sedim ent and STP)

2.8.2.1.1 Aquatic organisms

The table 3 summarises all the data available for the active substance fipronil and its relevant metabolites. Table 3: Toxicity to aquatic organisms

Test item Species Guideline Endpoints Toxicity (µg /L)

Reference

Fish Fipronil Lepomis

macrochirus US EPA FIFRA 72-1

LC50 – 96h Flow-through conditions

85.21 A.7.4.1.1/01 R010444 / R1

Fipronil Oncorhynchus mykiss

US EPA FIFRA 72-4

NOECELS - Flow-through conditions

151 A.7.4.3.2/01 R010466/ R1

RPA 200766 Oncorhynchus mykiss

OECD 203 LC50 – 96h Semi-static conditions

>170001 C015729/ R0*

MB45950 Oncorhynchus mykiss

OECD 203


29.51 R010521/ R0*

MB 46136 Lepomis macrochirus

US EPA FIFRA 72-1


251 R010487/ R0*

MB46513 Lepomis macrochirus

US EPA FIFRA 72-1

LC50 – 96h Semi-static conditions

201 R010491/ R0*

Invertebrates Fipronil Daphnia magna US EPA FIFRA

72-2 LC50 – 48h-96h Flow-through conditions

12.91 R010451/ R0*

Fipronil Hexagenia sp. ASTM Guideline E-729

LC50 – 96h Semi-static conditions

0.441 A.7.4.1.2/02 2003/5000542 / R1

Fipronil Chironomus riparius

OECD Draft guideline 219

NOEC - 28d/spiked water Static conditions

0.122 A.7.4.3.4/02 2004/1004394/R2


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RPA200766 Chironomus riparius

OECD 202 LC50 – 48h Static conditions

2501 2004/1004396/ R0*

Chironomus riparius

OECD Draft guideline 219

NOEC – 28d spiked water Static conditions

3.582 2004/1027278 2005/1006535/ R0*

MB45950 Daphnia magna US EPA 72-2 EC50 – 48h Flow-through conditions

1001 R010485/ R0*

Daphnia magna OECD 202 NOEC – 21d Flow-through conditions

131 R010469/ R0*

Mysidopsis bahia USEPA (=EPA) FIFRA 72-3

LC50 – 96h Static conditions

0.0771 B002875/ R0*


NOEC – 28d Flow-through conditions

0.00461 B003049/ R0*

MB 46136 Daphnia magna US EPA EC50 – 48h Flow-through conditions

291 R010486/ R0*

Daphnia magna OECD 202 NOEC – 21d Flow-through conditions

0.631 R010496/ R3*

Chironomus riparius(water)

OECD 219 (draft 2001)

NOEC – 28d spiked water Static conditions

0.0692 2004/1004395/ R0*



0.0561 B002876/ R0*


NOEC – 28d Flow-through conditions

0.00511 B003055/ R0*

MB 46513 Daphnia magna US EPA 72-4 NOEC – 21d Semi-static conditions

411 R010492/ R0*



1.51 B002794/ R0*

Algae - Plants Fipronil Scenedesmus

subspicatus

OECD 201 – EEC Commission Directive 87/302

EbC50 – 96h Static conditions

683 A.7.4.1.3/01 R010456 / R2

Fipronil Lemna gibba US EPA FIFRA 122-2 and 123-2 (1982)

EC10 – 14days Static conditions

814 A.7.4.3.5.2/01 R010498 / R2


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RPA 200766 Scenedesmus subspicatus

OECD 201 EbC50 and ErC50 – 72h Static conditions

> 7 5002 C015726/ R0*

MB 45950 Scenedesmus subspicatus

OECD 201 EbC50 – 72h ErC50 – 72h Static conditions

4501

R010553/ R0*


OECD 201 EbC50 – 72h ErC50 – 72h Static conditions

>5102 R016259/ R0*


EPA 122-2 & 122-3

EC50 – 120h Static conditions

>651 R010503/ R0*

1 mean measured concentrations 2 initial measured concentrations 3 nominal concentrations with analytical verification 4 NOEC based on frond number and corresponds to a significant effect of 7.7 %. Only one concentration was tested (see Document III-A section 7.4.3.5.2/01 for full details). * Studies not submitted in Document III-A, and consequently not evaluated. Data are from the pesticide risk assessment document of fipronil. Additional endpoints: Not relevant Justification of PNEC water According to the TGD for Risk Assessment (2003), if long term toxicity data from at least three species representing three trophic levels are available, an assessment factor of 10 will be applied on the lowest NOEC values (0.12 µg.L-1) for chironomus riparius. Therefore,

PNECsurface water = 0.012 µg.L -1

No PNECsurface water was derived for metabolites since toxicity results show that the parent compound is more toxic than these metabolites. Therefore the risk assessment of metabolites is covered by the active substance.

2.8.2.1.2 Sediment dwelling organisms

The table 4 summarises the data available for the active substance fipronil. Table 4: Toxicity to sediment dwelling organisms

Test item Species Guideline Endpoints Toxicity (µg/kg

dw) Reference

Fipronil Chironomus

riparius

OECD Guideline

218

NOECemergence – 28d/ Spiked sediment Static conditions

1.391 A7.4.3.5.1/02 2009/1122509/R1

1 mean measured concentrations Additional endpoints: not relevant Justification of PNEC sediment According to the TGD for Risk Assessment (2003), if long term toxicity data from three species representing three trophic levels are available, an assessment factor of 10 will be applied to the NOEC (1.39 µg/kg dw corresponding to 0.302 µg/kg ww). Therefore,


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PNECsediment = 3.02 x 10 -2

µg.kg -1 ww

2.8.2.1.3 STP micro-organisms

The table 5 summarises the data available for the active substance fipronil. Table 5: Toxicity to STP micro-organisms

Test item Guideline/Test

method

Species / inoculums

Endpoint / type of test

Exposure design

duration

Result [µg a.s./L]

reference

EXP60720A: a water dispersible granule formulation of fipronil at 788 g a.s./kg

OECD 209

Activated sludge, micro-organisms from a domestic waste water treatment plant

Inhibition of respiration

NOEC - 3h

>1000000 A.7.4.1.4/01 C016004 / R1

Additional endpoints: not relevant Justification of PNEC micororganisms

According to the TGD for Risk Assessment (2003), and taking into account that fipronil had no significant effect at the highest tested concentration (NOEC ≥ 1000 mg/L), an assessment factor of 10 can be applied. Thus, the PNECmicroorganisms of 100 mg.L-1 is derived. However, as the calculated PNEC is higher than the limit of solubility for fipronil = 3.35 mg.L-1, PNECmicroorganisms was set to this limit of solubility. Then,

PNECSTP microorganisms = 3.35 mg.L -1

2.8.2.2 Atmosphere

Significant exposure of the environment via air is not expected. Fipronil has a vapour pressure lower than 2E-06 Pa and a Henry’s law constant lower than 2.31E-04 Pa·m3·mol-1. In addition, fipronil is expected to be quickly degraded by photo-oxidation, the atmospheric photochemical half-life was 0.167 days (see 2.8.1.1.1.4).

2.8.2.3 Terrestrial compartment

The table 6 summarises all the data available for the active substance fipronil and their relevant metabolites. Table 6: Toxicity to soil organisms

Test item Species Guideline Endpoints Toxicity

(mg as/kg)

Reference

Soil microorganisms Fipronil - OCDE 216 and

217 28d – inhibition microbiological activity

no effects up to 0.667 mg a.i./kg dw

A.7.5.1.1/01 C019589 R1


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soil1

MB 45950 MB 46136 RPA 200766

-

Not specified 28d – inhibition microbiological activity

0.133 0.60 0.267

C019592/R0* C019591/R0* C019591/R0*

Earthworms Fipronil Eisenia fetida OECD 207 LC50 – 14d

>10001 A7.5.1.2/01

R010457 R2

Fipronil Eisenia fetida Guideline ISO 11268 part II (draft) / Eartnworm, ReproductionToxicity Test

NOEC – 56d >10001 A7.5.2.1/01 R016269 R2

MB 45950 MB 46136 RPA 200766

Eisenia fetida Not specified LC50 – 14d

>10001 R016267/R0* R016261/R0* R010552/R0*

MB 46136

Eisenia fetida Not specified NOEC – 56d >10001 C015762/R0*

Plants Fipronil Allium cepa,

Daucus carota, Pisum sativum Zea mays

Guideline OEDC 208 / Terrestrial Plants, Growth Test

NOEC-21d Seedling emergence, plant fresh weight and phytotoxicity

>21 A.7.5.1.3/01 2004/1027260 and 2005/1006512 / R2 Avena sativa,

Brassica napu 0.51,2

Beneficial arthropods

Fipronil Rove beetle (Aleochara bilineata)

Grimm et al., 20003

NOEC – 28d Reproduction

0.243 A7.5.4.1/02 1020069 R2

Fipronil Collembola (Folsomia candida)

Guideline ISO 11267 Collembola, Reproduction toxicity test (1999)

NOEC – 28d Reproduction

0.479 1018453 R0

*Studies not submitted in Document IIIA and consequently not evaluated. Data are from the pesticide risk assessment document of fipronil. 1nominal concentrations without analytical verification. 2NOEC based on the slight reduction of plant fresh weight observed in two species, B. napus and A. Sativa. 3Grimm et al., 2000 is a test for evaluating the chronic effects of plant protection products on the rove beetle Aleochara bilineata Gyll. (Coleoptera: Staphylinidae) under laboratory and extended laboratory conditions. Additional endpoints: not relevant Justification of PNEC soil : For the terrestrial compartment, five NOEC values from long-term toxicity tests (terrestrial plants, soil microorganisms, earthworms, collembolan and soil-dwelling beetles) were identified. As there is no agreed approach for the use of non-target arthropod (NTA) studies coming from PPP-dossiers within the biocides framework, the TMIV09 decided not to include additional taxonomic groups such as NTA


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for the derivation of the PNECsoil value for fipronil. Then, according to the TGD for Risk Assessment (2003) and as agreed in TMIV09, the NOEC value from the most sensitive species in three taxonomic groups (i.e., the terrestrial plants) is considered to determine the PNECsoil. The results are converted to standard soil which is defined as a soil with an organic matter content of 3.4% using the following equation: NOECstandard = NOECexp x Fom, soil standard / Fom, soil exp (TGD, part II, Eq. 71) With NOECexp = 0.5 mg.kg-1 dry soil

Fom, soil standard = 3.4 % Fom, soil exp = 1.2 %

Then, NOECstandard = 1.4 mg.kg-1 dry soil An assessment factor of 10 can be applied. Thus, the following PNECsoil is derived:

PNECsoil = 0.14 mg.kg -1 dry soil (0.123 mg.kg -1 wet soil) It could be noted that the lowest effect concentration was observed on Aleochara bilineata with a LOEC of 0.241 mg/kg dry soil. As suggested during the discussion at TMIV09, this LOEC could be divided by 2 to obtain a NOEC and to derive a PNECsoil of 0.0106 mg.kg-1 wet soil. The risk for the terrestrial compartment using this lower PNECsoil remains acceptable. No PNECsoil was derived for metabolites since toxicity results show that the parent compound is more toxic than these metabolites. Therefore the risk assessment of metabolites is covered by the active substance.

2.8.2.4 Effects on honeybees

The table 7 summarises the data available for the active substance fipronil:

Table 7: Toxicity to honeybees

Test item

Guideline /

Test method

Species Endpoint Exposure

design duration

Results (µg/bee)

reference

ACUTE Fipronil

USEPA l, 141-1 Apis

mellifera

LD50 48h - oral 0.00417 A.7.5.4.1/01 R010458 / R2

LD50 48h - contact

0.00593

MB 46163 Not specified

LD50 96h - oral 0.0064 1027274/R0*

* Since fipronil used as biocidal product Goliath Gel leads to negligible exposure in the environment, the studies with metabolites have not been submitted in Document III-A and consequently not evaluated. Data are from the pesticide risk assessment document of fipronil.

2.8.2.5 Non compartment specific effect relevant to the food chain

The table 8 summarises the data available for the active substance fipronil:

Table 8: Toxicity to birds and mammals


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Test item Guideline/Te

st method Species Endpoint

Exposure design

duration Results reference

Birds

ACUTE Fipronil US EPA FIFRA E 71-1 / OPPTS 850.2100

Bobwhite quail (Colinus

virginianus)

LD50 21 d Oral gavage

11.3 mg/kg bw A7.5.3.1.1/01 R010437/R1

MB46136 OPPTS 850.2100

LD50 Oral gavage 41 mg/kg bw C017030/R0*

MB46513

OPPTS 850.2100

LD50 Oral gavage 5.4 mg/kg bw R010518/R0*

SHORT TERM

Fipronil US EPA FIFRA E 71-2 / OECD 205

LC50 22 d Oral diet

48 mg/kg diet A.7.5.3.1.2/01 R010442 /R2

MB46136 OECD 205 LC50 Oral diet 84 mg/kg diet R010549/R0*

MB45950 OECD 205 LC50 Oral diet 114 mg/kg diet R010550/R0*

MB46513 OECD 205 LC50 Oral diet 110-120 mg/kg diet

R010551/R0*

CHRONIC Fipronil US EPA FIFRA E 71-4 / OECD 206

NOECrepro

duction 142 d 10 mg/kg diet A7.5.3.1.3

/01 R010462/ R2

Mammals

CHRONIC Fipronil USEPA 83-4 (1984)

rat NOEC

Two-generation

reproduction

Oral diet 30 mg/kg diet A6.8.2/01/ A6.8.2/02

* The studies with metabolites have not been submitted in Document III-A and consequently not evaluated. Data are from the pesticide risk assessment document of fipronil. Justification of PNECoral,bird and PNECoral,mammal for secondary poisoning The PNECbird and the PNECmammals calculations are therefore based on a long-term toxicity / reproduction study with bird and on a reproduction test on rat. According to the TGD for Risk Assessment (2003), and taking into account the duration of the test (2-generation), an assessment factor of 30 for bird and mammal can be applied. Thus, the following PNECoral are derived:

PNECoral,bird = 0.33 mg.kg -1 diet PNECoral,mammal = 1 mg.kg -1 diet

2.8.2.6 Summary of PNECs of the active substance fi pronil

Table 9: Summary of PNECs of fipronil

Compartment Species Endpoint Safety factor

PNEC

Surface water Chironomus riparius

NOECEmergence and development rates = 0.12 µg.L-1

10 0.012 µg.L-1


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Sediment Chironomus riparius

NOECEmergence rate = 1.39 µg.kg-1

dw 10 3.02 x 10-2

µg.kg-1 ww

Microorganisms (STP)

Activated sludge NOEC > 1000 mg.L-1 - 3.35 mg.L-1

(Limit of solubility) Soil Terrestrial plants NOECplant fresh weight = 1.4 mg.kg-1

dw 10 0.123 mg.kg-1 ww

Bird Colinus virginianus NOEC = 10 mg/kg diet 30 0.33 mg.kg-1 diet Mammal Rat NOEC = 30 mg/kg diet 30 1 mg.kg-1 diet

2.8.2.7 PBT and ED Assessment

According to the PBT assessment in TGD, criteria for substance to be persistent are fulfilled when: - T 1/2 in freshwater > 40 days or, - T 1/2 in freshwater sediment > 120 days.

Results of biodegradation studies show that fipronil will degrade in an aerobic aquatic environment: the half-life of biodegradation of fipronil is 18.61 days. Taking into account the studies submitted in the biocide dossier, fipronil will also persist in the soil compartment with a DT50 at 12°C which can reach 334 days. Considering these results, fipronil fulfills the P criterion . According to the PBT assessment in TGD, a substance is considered to fulfill the B criterion when the bioconcentration factor (BCF) exceeds a value of 2 000 L/kg. In a BCF study done with Lepomis macrochirus, the steady-state BCF for uptake of fipronil estimated in whole fish was 321 L/kg. Considering this result, fipronil is not selected according to the B criteri on . According to the PBT assessment in TGD, the toxicity criterion is fulfilled when the chronic NOEC for aquatic organism is less than 0.01 mg/L or when the substance is toxic to mammals and classified as Very Toxic or Toxic after oral dosing. Based on ecotoxicity freshwater data on Chironomus riparius, NOEC (28 d) = 0.121 µg/L, and on ecotoxicity marine data on Mysidopsis bahia, NOEC (28 d) = 0.0077 µg/L, T criterion is fulfilled . As the B criterion is not fulfilled, fipronil is no t classified according the PBT assessment . It should be noted that fipronil was listed in the document of the EU Commission on endocrine disrupting chemicals (Communication from the Commission to the council and the European parliament on the implementation of the Community Strategy for Endocrine Disrupters - a range of substances suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706) in Table 4 (Substances with insufficient data). Nevertheless, in 2007, the progress report of the European Commission on the Community Strategy for Endocrine Disrupters does not include fipronil in the range of substances suspected of interfering with hormone systems of humans and wildlife.

2.8.3 Effects on environmental organisms for biocidal pro duct AFOURMI F

The applicant did not provide ecotoxicological data about the biocidal product AFOURMI F. The risk assessment is based on the data obtained from the active substance fipronil (Competent Authority Report According to Directive 98/8/EC, Active substance in Biocidal Products, Fipronil CAS 120068-37-3, Product Type 18 (Insecticides, acaricides and products to control other arthropods), RMS France, May 2011. In spite of the presence of three classified compounds in the biocidal product, they do not contribute to increase the classification of the biocidal product. Therefore, FR CA considered that the effects of fipronil outweigh those of the non-active components of the product and that the effects assessment


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for the product AFOURMI F can be extrapolated from the effects assessment of the active substance fipronil.

2.8.3.1 Aquatic compartment (including water, sedim ent and STP)

2.8.3.1.1 Aquatic organisms

Refer to section 2.8.2.1.1

2.8.3.1.2 Sediment dwelling organisms


2.8.3.1.3 STP micro-organisms


2.8.3.2 Atmosphere

Refer to section 2.8.2.2

2.8.3.3 Terrestrial compartment


2.8.3.4 Effects on honeybees


2.8.3.5 Non compartment specific effect relevant to the food chain


2.8.3.6 Summary of PNECs


2.8.4 Environmental exposure assessment

2.8.4.1 Assessment of exposure to the environment

The product AFOURMI F is an insecticidal bait preparation which contains 0.0526 % w/w of technical fipronil. It is sold as a ready-to-use bait box used by non-professionals only for ants' nests destruction. It is applied in and around the private houses along the ant runs on hard and non-absorbing infested surfaces. The intended uses lead to direct emissions to the terrestrial compartment and to indirect emissions via the sewage treatment plant (STP).


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Indeed, for outdoor applications, the soil surrounding the treated houses in rural areas can be directly exposed following wash-off of the treated areas by rainfall. This route of direct entry in the terrestrial compartment (soil and groundwater) has been assessed. The intended outdoor applications can also lead to emissions in STP in urban area, when the treated non-absorbing surface is washed off by rainfall. The risk for the aquatic compartment (STP, surface water and sediment) and for the terrestrial compartment indirectly exposed via contaminated STP sludge, have also been assessed. For indoor applications, no risk has been assessed since environmental emissions are considered negligible when the product is placed in boxes (see below 2.8.4.2). In the following sections, emission values are derived by using the Emission Scenario Document (ESD) for PT18 (Insecticides for household and professional uses)4, equations from the TGD Part II and updated data from MOTA5. The exposure assessment has been carried out only for the active substance fipronil. As presented in the CAR (2011), the comparison between the relative quantities of metabolites (major or minor) in the environment and the toxicity ratio fipronil/metabolites showed that a risk assessment carried out for fipronil covers the risk for all its metabolites. Therefore risk characterization was presented only for the parent compound fipronil.

2.8.4.2 Release estimations from INDOOR application s

According to the ESD for PT18, emissions to the environment during the indoor treatments are possible only when the box is eliminated to solid waste. Cleaning efficiency for gel in bait boxes is FCE = 0, no environmental emission is expected following indoor application of AFOURMI F bait boxes.

2.8.4.3 Releases estimations from OUTDOOR applicati ons

It has been considered that bait boxes can be used to treat infested zones on non-absorbing surfaces of private houses (“Terrace” scenario). The recommended application rate for outdoor use is one bait station of 10 g of product AFOURMI F to kill one whole nest. In urban areas, the main receiving compartment is the STP directly exposed to the applied product transferred to the rainwater/sewage water system during the rain event. Risk assessments have also been proposed for the secondarily exposed aquatic (surface water and sediment) and terrestrial (soil and groundwater) compartments. In rural areas, the only relevant receiving compartment is the soil surrounding the treated buildings. According to the ESD for PT18, emissions can occur during the steps described below. The following assumptions are considered:

1- Mixing and loading step: the product is a ready-to-use box product, therefore no mixing and loading is necessary and emission is considered not relevant (Eprep,applicator and Eprep,floor = 0 kg/d).

4 OECD Series on Emission Scenario Documents, Number 18, Emission Scenario Document for insecticides, acaricides and products to control other arthropods for household and professional uses, 17 July 2008 5 Manual of Technical Agreements of the Biocides Technical Meeting (MOTA), Version 5. (2013)


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2- Application step and wash-off by rainfall: emissions to air, to the applicator, to floor and to treated surfaces are considered.

Emission to air, applicator and floor: Due to the mode of application (bait boxes) and the characteristic of the active substance (non-volatile), no emission to air, applicator and is expected (Eapplication,air, Eapplication,applicator and Eapplication,floor = 0 kg/d).

Emission to treated surfaces: Emissions from the treated surfaces are calculated considering as a realistic worst-case scenario, four infestation sites treated with 10 g of product each on a 30 m2 terrace of a private house. The release fraction to the environment following wash-off by rainfall is set to 0.2 according to the ESD PT18 for bait box. The equation for local releases following application of AFOURMI F in bait boxes on a terrace is: Ebox, outdoor = Qprod * FAI * Nsites * Fbox where: Ebox, outdoor : Emission rate of active substance from outdoor application (g) Qprod : Amount of product used per application site (specific value for AFOURMI F = 10 g) FAI : Fraction of active substance in product (specific value for AFOURMI F = 0.000526) Nsites : Number of application sites (specific value for AFOURMI F = 4 on a terrace of 30 m2) Fbox : Fraction released to the environment following wash-off by rainfall (default value ESD

PT18 for bait box = 20%) Ebox, outdoor, terrace = 4.21E-03 g Direct release to soil (rural areas, surfaces not c onnected to STP): Emissions to soil in rural areas are directly defined from the above values: Ebox, outdoor, terrace = 4.21E-03 g Indirect releases via the STP (urban areas): Simultaneous treatments in different houses have to be taken into account for releases to the STP. Then, following the ESD, it is assumed that 2500 houses are connected to one STP for outdoor uses. The default value of the simultaneity factor for outdoor applications (0.03) has been applied. Ebox , ww = Ebox, outdoor, terrace * Nhouse * Fsimultaneity *10E-03 With Ebox, ww : Total emission rate to wastewater from outdoor application (kg.d-1) Ebox, outdoor, terrace: Emission rate of active substance from outdoor application for one house (see above

4.21E-03 g) Nhouse: Number of houses connected to STP (default value ESD PT18 = 2500) Fsimultaneity: Simultaneity factor for outdoor use (default value ESD PT18 = 0.03) Ebox, ww = 3.16E-04 kg.d -1

2.8.4.4 PEC calculations

In the following sections, environmental concentrations values are derived by using the emission rates calculated above and the equations from the TGD Part II.

2.8.4.4.1 Aquatic compartment (surface water, sediment, STP)


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Considering the intended uses of the product, only indirect releases to the aquatic compartment via the STP are foreseen.

According to the Simple Treat model integrated in EUSES, the fractions to surface water and sludge in the STP considering the physico-chemical properties of fipronil are presented in the table below:

Table 10: Fractions of emission by the STP

Symbol Parameter Value Unit

INPUTS Characterisation of

biodegradability Not readily biodegradable

[-]

VP Vapour pressure 2E-06 (at 25°C) [Pa] Sol Solubility in water 3.35 [mg.L-1] Koc Partition coefficient

organic carbon-water 727 [L.kg-1]

HENRY Henry’s law constant 2.31E-04 (at 25°C) [Pa.m3.mol-1] OUTPUTS FSTP air Fraction of emission to

air by STP 1.88E-04 [%]

FSTP water Fraction of emission to effluent by STP

91.7 [%]

FSTP sludge Fraction of emission to sludge by STP

8.28 [%]

Fipronil concentrations in the STP effluent and in surface water are calculated according to the TGD equations considering the emissions to waste water (Eww) calculated above from outdoor applications of AFOURMI F and the different parameters presented in the following table:

Table 11: Input and output values for the calculati on of fipronil concentrations in STP and surface water and sediment

Local emission of active substance to waste water during episode: Value Unit Reference

INPUTS

Elocalwater Emission rate to wastewater 3.16E-04 [kg.d-1] See section 2.8.4.3

Clocalinf Concentration in sewage water to default STP 1.58E-04 [mg.L-1] TGD Eq. 32

Fstp water Fraction emitted to water by STP 91.7 [%] Table 10

Koc Partition coefficient organic carbon-water 727 [L.kg-1] -

Kpsusp Solids-water partitioning coefficient 72.7 [L.kg-1] TGD Eq. 23

Ksusp-water Suspended matter-water partitioning coefficient

19.1 [m3.m-3] TGD Eq.24

OUTPUTS

PECSTP Concentration in STP 1.45E-04 [mg.L-1] TGD Eq. 33

PEClocal,water Concentration in surface water 1.45E-05 [mg.L-1] TGD Eq. 45

PEClocalsed Concentration in sediment 2.40E-04 [mg.kg-1wwt] TGD Eq. 50


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2.8.4.4.2 Atmospheric compartment

Significant exposure of the environment via air is not expected. Fipronil has a vapour pressure lower than 2E-06 Pa and a Henry’s law constant lower than 2.31E-04 Pa·m3·mol-1. In addition, fipronil is expected to be quickly degraded by photo-oxidation, the atmospheric photochemical half-life was 0.167 days (see 2.8.1.1.1.4). Based on these data, fipronil is not expected to volatilize and to persist in air.

2.8.4.4.3 Terrestrial compartment (soil and groundwater)

2.8.4.4.3.1 INDIRECT releases

The concentrations in agricultural soil, following the spreading of contaminated STP sludge, are calculated according to the TGD equations considering the emission rates to wastewater (Eww) and the different parameters presented in the table 12 below. Degradation of fipronil in soil is based on DT50 of 334 days; dissipation by leaching and volatilisation is also taken into account based on the TGD equations. Table 12: Input values and output values for the ca lculation of fipronil concentrations for the terrestrial compartment

Indirect releases to the terrestrial compartment via the STP Value Unit Reference

INPUTS

Elocalwater Emission rate to wastewater 3.16E-04 [kg.d-1] See section

2.8.4.3

Fstp sludge Fraction emitted to sludge by STP 8.28 [%] Table 2.8.4.4-1

ksoil Rate constant for removal in soil based on biodegradation and dissipation

2.19E-03 [-] TGD Eq. 56

Koc Partition coefficient organic carbon-water

727 [L.kg-1] CAR (2011)

SLUDGERATE Rate of sewage sludge production 710 [kg.d-1] TGD Eq. 37

Ksoil water Soil-water partitioning coefficient 22 [m3.m-3] TGD Eq. 24

OUTPUTS

Csludge,soil Initial concentration in soil 5.41E-05 [mg.kg-1dwt] TGD Eq. 60

PEClocal soil Concentration in soil after 10 years of application - Twa over 30 d

9.53E-05 [mg.kg-1wwt] TGD Eq. 55

PEClocal soil

porewater

Concentration in porewater (based on PEC local soil after 10 years – Twa over 180 d

6.29E-06 [mg.L-1] TGD Eq. 67

2.8.4.4.3.2 DIRECT releases

Outdoor applications of AFOURMI F can lead to the contamination of the surrounding garden soil following wash-off by rainfall in rural environment. Then, direct exposure of the soil compartment was assessed. Considering the low degradation rate of fipronil (DT50 = 334 days) and as a worst case, no degradation in soil was considered.


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The values were calculated considering a release of 20% of the applied product as defined in the ESD for PT18. Furthermore, the soil area was calculated in accordance with scenarios where houses are treated by spray applications i.e., a 0.5 m soil strip adjacent to the terrace is defined as the receiving compartment. It is assumed that the 30 m2 terrace of a private house is quadratic and that one side of the terrace is adjacent to one side of the house (5.48 m). The surface of the two soil corners of 0.5 m side length is added. Hence, the soil area exposed around a terrace is: AREAexposed = [3*(5.48*0.5)] + [2*(0.5*0.5)] = 8.72 m2.

Table 13: Input and output values for the calculati on of concentrations of fipronil following direct releases to terrestrial compartment

Direct emission of fipronil to the soil compartment

Value Unit Reference

INPUTS

Esoil Direct emission rate of

spinosad to soil 4.21E-03 [g]

See section 2.8.4.3

AREA exposed Area of soil directly

exposed to insecticide 8.72 [m2] -

Koc Solids-water partitioning

coefficient in soil 727 [L.kg-1]

CAR (2011)

Ksoil water Soil-water partitioning

coefficient 22 [m3.m-3] TGD Eq.24

RHOsoil Density of exposed soil 1700 [kg.m-3] TGD Eq.18 DEPTHsoil Depth of exposed soil 0.5 [m] ESD PT18

OUTPUTS

Csoil Initial concentration in

soil due to direct release

5.68E-04 [mg.kg-

1wwt]

ESD PT18 Eq.60

PECsoil porewater Concentration in

porewater (based on initial PEC soil)

4.39E-05 [mg.L-1] TGD Eq.

67

2.8.4.4.4 PEC biota

The AFOURMI F product is intended for outdoor use as gel in bait boxes. Then, the potential for direct (primary poisoning) and indirect (secondary poisoning) exposure of non-target organisms should be considered.

2.8.4.4.4.1 Primary poisoning

- Birds and mammals Considering the ESD for PT18, it is not believed that gels or any other sort of insecticides are in a form that could be sufficiently appetent to bird or mammals so they would be at risk. Furthermore, the gel is placed inside a plastic box with small hole for entrance of ants. Then, the risk of primary poisoning birds and mammals from the outdoor use of AFOURMI F can be considered negligible.

- Effects on honeybees (and non-target arthropods) Fipronil was shown to be highly toxic to bees both by oral and contact exposure with LD50 of 0.0042 µg per bee and 0.0059 µg per bee respectively. Considering the concentration of fipronil in FORMICIDE TUBE F (0.0526% w/w) and its density (d=1.705), volumes of product necessary to reach LD50 oral and the LD50 contact are respectively 0.046 µL and 0.007 µL per bee. Therefore, exposure of a honeybee at and above the LD50 is very likely.


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The product is attractive to honeybees because of its sugar-based composition (43%). Regarding the high toxicity of fipronil, the mortality of honeybees which would consume the biocidal product can not be excluded. However, since gel is placed inside a plastic box, it can be considered that AFOURMI F gel is not accessible for bees. Consequently, non-target arthropods exposure to the gel can be considered as negligible for outdoor applications.

2.8.4.4.4.2 Secondary poisoning

During the use of AFOURMI F, birds and mammals may be poisoned secondarily by the consumption of fish and earthworms from contaminated surface water and soils and from the consumption of insects. According to the TGD, 50% of the diet comes from the local area. Then, the worst-case PEC in earthworms and in fish are: Table 14: Calculation of the predicted environmental concentr ation in earthworms and in fish

Parameter Parameter Symbol Value

INPUTS

Cspot, soil Local concentration in soil due to direct release [mg/kgwwt]

5.68E-04 See Table 13

PEClocalsoil,porewater Predicted environmental concentration in porewater** [mg/L]

4.39E-05 See Table 13

PEClocalwater Concentration in surface water 1.45E-05 See Table 11

Kow Octanol/water partition coefficient [-] 10000 -

BCFearthworm Bioconcentration factor for earthworm

[L/kgwet earthworm] 121 TGD Eq.82d

BCFfish Bioconcentration factor for fish [L/kgwet

fish] 321

See section 2.8.1.3

BMF Biomagnification factor in fish 1 TGD Table 21

Fgut Fraction of gut loasing in worm [kgdwt/kgwwt]

0.1 -

CONVsoil Conversion factor for soil concentration wet-dry weight soil [kgwwt/kgdwt]

1.13 TGD Eq.82b

OUTPUT

PECearthworm Predicted Environmental Concentration in earthworms [mg/kg wet earthworm ]

2.41E-03 TGD Eq.82c

PECfish Predicted Environmental Concentration in fish [mg/kg wet fish ]

2.32E-03 TGD Eq.76

For the assessment of the secondary poisoning via the consumption of contaminated insects, the registrant used the ‘Estimated Theoretical Exposure’ (ETE) approach adapted from the EU guidance document (SANCO/4145/2002) as proposed in the ESD PT18. However, this scenario has been primarily developed for spray applications and takes into account the Residue values per Unit Dose


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(RUD) estimated from specific data for spray formulations. This RUD parameter cannot be extrapolated to gel formulations in bait boxes. As stated in the ESD PT18, this ETE approach has to be adapted for other applications such as spot application. This topic is currently under discussions at EU level.

2.8.5 Risk characterisation for the environment

Risk characterization for the environment is done quantitatively by comparing predicted environmental concentrations (PEC) and the concentrations below which effects on organisms will not occur (PNEC) according to the Technical Guidance Document (TGD, 2003) and 'Emission scenario document for PT18 (Insecticides for household and professional uses). As presented in the CAR (2011), the comparison between the relative quantities of metabolites (major or minor) in the environment and the toxicity ratio fipronil/metabolites showed that a risk assessment carried out for fipronil covers the risk for all its metabolites. Therefore environmental risk characterization was presented only for the parent compound fipronil.

2.8.5.1 Aquatic (including water and STP) and terre strial (including soil and groundwater) compartments

2.8.5.1.1 INDOOR applications

No environmental emission is expected following indoor application of AFOURMI F bait boxes (see 2.8.4.2). Then, environmental risk assessment has not been conducted for indoor uses and the risks have been considered acceptable for all the environmental compartments.

2.8.5.1.2 OUTDOOR applications

The table 15 summarizes the PEC/PNEC ratios for aquatic and terrestrial compartments receiving indirect (via the STP) and direct (soil only) releases following outdoor uses of AFOURMI F in bait boxes.

Table 15: Risk characterization in aquatic and terr estrial compartments for indirect emissions (via the STP) and direct emissions to soil following ou tdoor application of AFOURMI F in boxes

PEC PEC/PNEC Risks

Bait boxes

« Terrace » scenario in urban zone (indirect emissions via the STP)

Aquatic compartment

STP

[mg/L]

PNECSTP microorganisms = 3.35

1.45E-04 4.32E-05 Acceptable

Surface water

[mg/L]

PNECsurface water = 1.20E-05

1.45E-05 1.20 Unacceptable

Sediment

[mg/kg ]

PNECsediment = 3.02E-05


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2.40E-04 7.94 Unacceptable

Terrestrial compartment

Soil [mg/kg ww] PNECsoil = 0.123


Groundwater

[µg/L]

Threshold value = 0.1 µg/L

6.28E-02 Acceptable

Bait boxes

« Terrace » scenario in rural area (direct emissions to soil only)


Soil [mg/kg wwt] PNECsoil = 0.123


Groundwater

[µg/L]

Threshold value = 0.1 µg/L

4.39E-01 Acceptable

In urban area , for outdoor application of AFOURMI F in bait boxes on non-absorbing surfaces of private house (Terrace scenario), risks are acceptable for STP. Risks are unacceptable for surface water and sediment (PEC/PNEC>1). For terrestrial compartment, risks are acceptable for the soil and groundwater. In rural area , for outdoor application of AFOURMI F in bait boxes on non-absorbing surfaces of private house (Terrace scenario), risks are acceptable for the soil and groundwater. It could be noted that the risk for the terrestrial compartment using the lowest PNECsoil of 0.0106 mg.kg-1 wet soil remains acceptable in urban and in rural area (see section 2.8.2.3). Conclusion: In order to make the risk for outdoor uses (around buildings) acceptable, the product AFOURMI F has to be applied only on places which are not connected with a rainwater/sewer collection system or, if the treated zones are connected with rainwater/sewer collection systems, ensure that the bait boxes are protected from water (rain, flooding, cleaning water....)

2.8.5.2 Atmospheric compartment

According to the characteristics of fipronil, the risk to the atmospheric compartment is considered negligible.

2.8.5.3 Honeybees

The risks to honeybees are considered negligible as the product is enclosed in a bait station (see section -).


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2.8.5.4 Non-compartmental specific effects relevant to the food chain (secondary poisoning)

The risk assessment for secondary poisoning is presented in the table 16 and covers the risks assessment for mammals.

Table 16: Risk characterization for bird predators following outdoor applications of AFOURMI F

Value PEC/PNEC RISKS

Aquatic compartment

PECoral,aquatic

predator 2.32E-03 mg.kgfood

-1 7.03E-03

Acceptable

PNECoral bird 0.33 mg.kg diet-1


PECoral,terrestrial

predator 2.41E-03 mg.kgfood

-

1 7.31E-04 Acceptable

PNECoral bird 0.33 mg.kg diet-1

The PEC/PNEC ratios for are below 1 for aquatic and terrestrial food chain. This result indicates that the risk, following the use of AFOURMI F as an outdoor insecticide, of secondary poisoning to fish and worms-eating birds and mammals can be considered acceptable.

2.8.6 Conclusions

For indoor application (in buildings) of AFOURMI F product in bait boxes, risks to the environment are acceptables for the aquatic compartment (STP, surface water and sediment) and terrestrial compartment (soil and groundwater), taking into account the intended application rate and with respect to the use recommendations presented below.

For outdoor application (around buildings) of AFOURMI F product in bait boxes, risks to the environment are acceptable for all the compartments only when water which can wash-off the product is not directed to the STP or if the bait boxes are protected from water (rain, flooding, cleaning water....), taking into account the intended application rate and with respect to the use recommendations presented below. The risk of secondary poisoning via ingestion of potentially contaminated fish and earthworms by birds and mammals is acceptable. Therefore, it can be concluded on acceptable environmental risks for the biocidal product AFOURMI F for indoor uses and outdoor uses. Risk mitigation measures linked to risk assessment for environment

- When used around buildings, do not apply near drains. If the treated zone is connected to rainwater collection or sewer, use only in areas that are not liable to submersion or becoming wet, i.e. protected from rain, floods and cleaning water.

- When used around buildings, do not use where insectivorous can feed on treated ants. Disposal considerations

- At the end of the treatment campaign, collect all bait boxes for disposal. - Do not clean bait boxes with water between treatments. - Dispose of unused product, its packaging and all other waste (i.e. dead insects) in

accordance with local regulations.


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- Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.

2.9 Measures to protect man, animals and the enviro nment

See Summary of Product Characteristics (SPC)


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3 Proposal for decision

This section is a proposal from the authority in charge of the risk assessment (Anses) for the decision to be adopted by the competent authority in charge of the decision (French Ministry of Ecology). In case of inconsistency between the risk assessment and the decision, only the original and signed decision has a legal value. The decision specifies the terms and conditions to the making available on the market and use of the biocidal product.

Conclusions of efficacy and risk assessment Risk assessment for Physico-chemical properties

AFOURMI F is a ready-to-use product containing fipronil (0.05% (w/w) pure fipronil). It is a gel formulation presented in ready-to use bait boxes. It is not highly flammable, auto-flammable at ambient temperature, not explosive and does not have oxidizing properties. The product is stable for 12 weeks at 35°C and 2 years at ambient temperature. The product AFOURMI F is compatible with PS package. Summary of efficacy assessment

The efficacy level of the product A FOURMI F is acceptable for the uses proposed in the annex 0b. Summary of risks characterisation of the product for human health

No exposure (direct or indirect) is expected during use of AFOURMI F; therefore no risk has been identified. Summary of risks characterisation of the product for consumer Based on the intended use and the proposed restriction, the acute or chronic exposure to residues resulting from the intended use is unlikely to cause a dietary risk to consumers. The product should not be used in the vicinity of food or feed as stated in the precautionary statement on the labels. Regarding consumer health protection, there are no objections against the intended uses. Summary of risks characterisation of the product for the environment

For indoor application of AFOURMI F product in bait boxes, risks to the environment are acceptables for the aquatic compartment (STP, surface water and sediment) and terrestrial compartment (soil and groundwater), taking into account the intended application rate and with respect to the use recommendations presented below.

For outdoor application of AFOURMI F product in bait boxes, risks to the environment are acceptable for all the compartments only when water which can wash-off the product is not directed to the STP or if the bait boxes are protected from water (rain, flooding, cleaning water....), taking into account the intended application rate and with respect to the use recommendations presented below. The risk of secondary poisoning via ingestion of potentially contaminated fish and earthworms by birds and mammals is acceptable. Therefore, it can be concluded on acceptable environmental risks for the biocidal product AFOURMI F for indoor uses and outdoor uses. Risk mitigation measures and conditions of use Conditions of use linked to efficacy assessment

- Always read the label or leaflet before use and respect all the instructions provided.


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- Inform the authorisation holder if the treatment is ineffective.

- Do not apply the product on absorbing surfaces.

- Apply only in areas that are not liable to submersion or becoming wet, i.e. protected from rain, floods and cleaning water.

- Apply the product away from direct sunlight or heat sources (eg. do not place it under a radiator).

- To optimise the treatment efficacy, respect good hygiene practices: remove or prevent access to all source of food. The bait must be the main source of food available for ants.

- Check the bait boxes once a week.

- At the end of the treatment campaign, collect all bait boxes for disposal.

- If the infestation persists despite following the instructions of the label, contact a pest control professional.

- Avoid continuous use of products.

Risk mitigation measures

- Do not store at a temperature above 35°C.

- Do not use in areas accessible to infants, children, pets or other non-target animals in order to minimise the risk of poisoning as much as possible.

- At the end of the treatment campaign, collect all bait boxes for disposal.

- Apply strict hygiene measures: do not eat, drink or smoke while handling the product and wash hands after use.

- Do not force open the bait boxes and do not damage them, even when empty.

- Do not use directly on or near food, feed or drinks, nor on surfaces or ustensils likely to be in direct contact with food, feed or drinks.

- When used around buildings, do not apply near drains. If the treated zone is connected to rainwater collection or sewer, use only in areas that are not liable to submersion or becoming wet, i.e. protected from rain, floods and cleaning water.

- When used around buildings, do not use where insectivorous can feed on treated ants.

Emergency (information provided in the product Safety Data Sheet)

- Eye contact: Immediately flush with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Continue to rinse for at least 10 minutes. Get medical attention if irritation occurs.

- Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical attention if symptoms occur, show this container or label.

- Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur. Wash clothing before reuse. Clean shoes thoroughly before reuse.

- Ingestion: Wash out mouth with water. Get medical attention if symptoms occur, show this container or label.

Note to physician: Treat symptomatically. Contact poison treatment specialist immediately if large quantities have been ingested or inhaled.

Disposal - At the end of the treatment campaign, collect all bait boxes for disposal.

- Do not clean bait boxes with water between treatments.

- Dispose of unused product, its packaging and all other (i.e. dead insects) waste in accordance with local regulations.


Page 56/96

- Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.


Page 57/96

-

4 Appendices

Annex 0a: Practical use claimed by the applicant

Table 17: Practical use claimed by the applicant

Name of the product and

type of formulation (gel, paste, spray, dust,

powder, fumigation…)

Tar

get o

rgan

ism

s (

com

mon

spe

cies

an

d ge

nus)

and

dev

elop

men

t sta

ges

(egg

s, la

rvae

, nym

ph, a

dults

…)

*

Use

r ca

tego

ry (

prof

essi

onal

/non

pr

ofes

sion

al)

*

App

licat

ion

aim

Are

a of

use

(in

door

, out

door

, and

fie

ld o

f use

)

Met

hod

of a

pplic

atio

n

App

licat

ion

rate

(ex

pres

sed

in g

/m3 ,

g/m

2 , ml/m

2 …)

M

axim

um a

nd m

inim

um d

osag

e (

if ap

prop

riate

)

Mod

e of

act

ion

incl

udin

g tim

e de

lay

(kill

, kno

ckdo

wn.

..)

Tim

e d

elay

of r

esid

ual e

ffica

cy if

in

dire

ct o

r su

rfac

e tr

eatm

ent (

ho

urs,

day

s, w

eeks

and

mon

ths)

Tim

e de

lay

for

hum

an ,

food

and

an

imal

s re

entr

ance

afte

r tr

eatm

ent (

if ap

prop

riate

)

Fre

quen

cy a

nd d

urat

ion

of

appl

icat

ion

Dos

age

and

appl

icat

ions

re

quire

men

ts (

expo

sure

tim

e,

vent

ilatio

n, te

mpe

ratu

re,)

Pac

kage

det

ails

: In

divi

dual

pac

kagi

ng (

yes/

no)*

*

Prim

ary

pack

agin

g **

* : t

ype

: bul

k,

indi

vidu

al w

rapp

ing…

/ nat

ure:

bu

cket

, bot

tle, s

ache

t…/ m

ater

ial:

pape

r, p

olye

thyl

ene…

/ siz

es

Sec

onda

ry p

acka

ging

Acc

epte

d an

d au

thor

ized

by

the

RM

S

(yes

/no)

AF

OU

RM

I F

For

mul

atio

n:

gel

Lasius spec,

especially Lasius niger

non professional

Control of ants

in and around building

s: in and

around houses on hard surfaces e.g.

terraces and

Viscous liqui

d formulation

presented in a

read

2 bait boxes per 15 m²

(indoors) or one bait box

per nest (outdoors)

Fipronil is acting on the

nervous system, blocking

the GABA

regulated chloride channel. Fipronil

In the efficacy trials, no

evidence of resistance could be

observed.

Not Applicable

One application

is intend

ed.

One bait station

contains 10 g

product which

corresponds to

0.005 g Fipronil

Yes Ready-to-use bait box

with 4 predefined

openings

2 or 4 bait stations are sold in one cardboard

box

Material bait box: PS, Content per bait box: 10 g

Tetramorium

ceaspitum

Tapinoma erraticum

Linepithema humile


Page 58/96

Lasius emarginat

us

patios. y-to use bait station

is active by both contact

exposure and

ingestion within a

few days.

Lasius flavus


Page 59/96

Annex 0b: Proposed uses for authorisation This table reflects the results of the risk assessment. In case of differences between the uses suggested by Anses to be authorised and the uses contained in the decision taken by the French ministry, only the original and signed decision has a legal value. Table 18: Proposed uses for authorisation

Name of the product and type of formulation (gel, paste, spray, dust, powder, fumigation…)

Target organism Dosage validated User category A rea of use Methods of application

Primary packaging: type: bulk, individual wrapping…

Authori-sation

AFOURMI F Formulation: gel

Ants (Lasius niger)

AFOURMI F (0.05 % w/w fipronil)

Indoor: 0.67 à 1.33 g/m2

i.e.1 up to 2 bait boxes of 10 g of product for 15 m2 (depending on the infestation)

Outdoor: 1 bait box per nest.

Non-professional users.

In and around buildings on hard surfaces e.g. terraces, patios.

Gel formulation presented in a ready to use bait. Bait stations are placed along the ants’ paths and/or in the near of the nest(s).

2 or 4 bait stations are sold in one cardboard box.

Yes


Page 60/96

Annex 1: Summary of product characteristics

See separated file.


Page 61/96

Annex 2: List of studies reviewed

Table 19: 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

Essential studies for evaluation

Yes No Yes No Yes No

IIIB 2 B2 Anonymous 2013 Safety Data Sheet AFOURMI F, product code EXP 61210 N Scotts France SAS, Ecully, France Date of issue/date of revision: 09.08.2013 Version 2.0 Non GLP, published

-

B2.2/01 Anonymous 2013 Safety Data Sheet Fipronil Technical ID no. 30210633/SDS_CPA_EU/EN BASF SE, Ludwigshafen, Germany Print and revision date: 18.04.2013 Non-GLP, published

-

B2.2/02 Anonymous 2012 Confidential Please refer to confidential data

-


-

B2.2/04 Anonymous 2009 Confid ential Please refer to confidential data

-

B2.2/05 Anonymous 2012 Confiden tial Please refer to confidential data

-


-


-


Page 62/96

Section No


of data

Letter of access

Data protection

claimed



B2.2/08 Anonymous 2013 Confidential

Please refer to confidential data -

IIIB 3 B3.1/01 Ballard, K.M. 2004 EXP 61210 A, Fourmis Boite Appat - 24 month ambient storage stability & pack compatibility study on the product stored in polystyrene packs. The Scotts Company (UK) Limited, UK Report No. C04PSP004 GLP, unpublished

Scotts

B3.1/02 Meinerling, M. Herrmann, S.

2013 Determination of the accelerated storage stability of EXP 61210 N IBACON GmbH, Rossdorf, Germany Project 85081204 GLP, unpublished

Scotts

B3.1/03 Same report as B3.7/03

Thieu -Simchen, V.A.

2014 Ant bait station Fipronil, Formulation code EXP 61210 N. Accelerated storage procedure at 35°C for 12 weeks Dr. U. Noack Laboratorien, Sarstedt, Germany Study no. CPL15799 GLP, unpublished

Scot ts

B3.2 Ott, C. 2012 Confidential Please refer to confidential data

Scotts

B3.3 Same report as B3.2

Ott, C. 2012 Confidential Please refer to confidential data

Scotts


Meinerling, M. Herrmann, S.


Scotts

B3.4/02 Hernandez, C. 2014 Determination of physico-chemical properties. Auto-Ignition Temperature

Scotts


Page 63/96

Section No


of data

Letter of access

Data protection

claimed



(liquids and gases) (EC A.15) consilab, Frankfurt, Germany Study no. CSL-14-0499.01 GEP, unpublished


Ballard, K.M. 2004 EXP 61210 A, Fourmis Boite Appat - 24 month ambient storage stability & pack compatibility study on the product stored in polystyrene packs The Scotts Company (UK) Limited, UK Report No. C04PSP004 GLP, unpublished

Scotts




Scotts


Thieu -Simchen, V.A.


Scotts

B3.6 Same report as B3.1/02



Scotts




Scotts

B3.7/02 Ballard, K.M. 2004 EXP 61210 A, Fourmis Boite Appat - 24 Scotts


Page 64/96

Section No


of data

Letter of access

Data protection

claimed



Same report as B3.1/01

month ambient storage stability & pack compatibility study on the product stored in polystyrene packs The Scotts Company (UK) Limited, UK Report No. C04PSP004 GLP, unpublished

B3.7/03 Thieu -Simchen, V.A.


Scotts

B3.7/04 Thieu -Simchen, V.A.

2014 Formicide Tube F Formulation code EXP61210 N. Low temperature stability of liquid formulations Dr. U. Noack Laboratorien, Sarstedt, Germany Study no. CLN15907 GLP, unpublished

Scotts / BASF

IIIB 4 B4.1/01 Meinerling, M. Herrmann, S.

2013 Content Determination of Fipronil in EXP 61210 N IBACON GmbH, Rossdorf, Germany Project 56743103 GLP, unpublished

Scotts

B4.1/02 Goller, S. 2014 Ant bait station Fipronil & Tube VR AF Fipronil 0.05% (gel formulations containing Fipronil as active ingredient) Method validation & cntent determination Dr. U. Noack Laboratorien, Sarstedt, Germany Study no. CGB15799 GLP, unpublished

Scotts


Page 65/96

Section No


of data

Letter of access

Data protection

claimed



B4.1/03 Buttler, O. 2014 Celaflor Ungezieferköder & Tube VR AF Fipronil 0.05% & Composite box (containing denatonium benzoate as bittern) Method validation Dr. U. Noack Laboratorien, Sarstedt, Germany Study no. CMV15905 GLP, unpublished

Scotts

IIIB 5 B5.10/01 Zangiacomi, L. 1999 Dosier biologique AFOURMI F, AFOURMI FM 1ère partie: synthese generale Scotts France S.A.S, Ecully, France Ref. LZ 82.99 Date 07 July 1999 Non-GEP, unpublished

Scotts

B5.10/02 Zangiacomi, L. 1999 AFOURMI F, AFOURMI FM - dossier biologique, 2ème partie: resultats detailles des essais Scotts France S.A.S, France Ref. LZ 82.99 Non-GEP, unpublished

Scotts

B5.10/03 Desbois, L. Zangiacomi, L.

2008 Trial report 2008 - Ant Bait Kwizda: Acetamiprid and Bifenthrin Efficacy trial against Lasius niger in arena Scotts France S.A.S., France Report No. official: FRHO088432 Report No. Scotts intern: FRIN0803L1 GEP, unpublished

Scotts

B5.10/04 Serrano, B. 2005 Laboratory trials (C.E.B. Method 196 - arena trial) on an ant gel bait intended to control garden ants Laboratoire T.E.C., France Report No. 1010/0405R

Scotts


Page 66/96

Section No


of data

Letter of access

Data protection

claimed



GEP, unpublished

B5.10/05 Zangiacomi, L. Desigaux, E.

2009 Trial Report 2009 - Efficacy trial in arena against Lasius niger Scotts France S.A.S., France Report No. official: FRHO097835 Report No. Scotts intern: FRIN0923W1 GEP, unpublished

Scotts


2009 Trial Report 2009 - Efficacy trial in arena against Lasius niger Scotts France S.A.S., France Report No. Scotts intern: FRIN0918W1 Report No. official: FRHO095001 GEP, unpublished

Scotts

B5.10/07 Zangiacomi, L. Martin, L.

2012 Trial report 2012 - Efficacy trial against black ant Lasius niger in vivarium Scotts France S.A.S., France Report No. official: FRHO128431 Report No. Scotts intern: FRIN1216M1 GEP, unpublished

Scotts

B5.10/08 Serrano, B. 2010 Field assessment of the efficacy of a bait station against garden ants T.E.C. Laboratory, France Report no. 1390b-0710R Report no. Scotts intern: FRIN10Z9 GEP, unpublished

Scot ts

B5.10/09 Serrano, B. 2010 Field assessment of the efficacy of a bait station against garden ants T.E.C. Laboratory, France Report no. 1390c-0710RReport no. Scotts intern: FRBIOZ1 GEP, unpublished

Scotts


Page 67/96

Section No


of data

Letter of access

Data protection

claimed



B5.10/10 Heaven, H. 2012 Laboratory bioassay to determine the efficacy of bait formulations against black ants, Lasius niger (E12PAE093) i2L Research Ltd, UK Report no. 12/135 GLP, unpublished

Scotts


2010 Trial report 2010 - Efficacy trial in vivarium against Lasius niger Scotts France SAS, France Report no. official: FRHO105965 Report no. Scotts intern: FRIN1014W1 GEP, unpublished

Scotts

B5.10/12 Radecki, C. 2009 Biological Test report - Efficacy of various products against colonies of black ants BioGenius GmbH, Germany Report no. BIO33a-12 GLP, unpublished

Scotts

B5.10/13 Serrano, B. 2012 Field assessment of the efficacy of a gel bait and bait station against garden ants T.E.C. Laboratory, France Report no. Scotts intern: FRIN12Z15 Report no. 1515/0612R GEP, unpublished CoA with batch number was attached

Scotts

B5.10/14 Heaven, H. 2013 Field study to determine the efficacy of a gel bait against Argentine ants, Linepithema humile. BASF Pest Control Solutions Europe, BASF Española S.L., Barcelona, Spain Report No. 13/041 GEP, unpublished

BASF


Page 68/96

Section No


of data

Letter of access

Data protection

claimed



B5.10/15 Peter, R., Chazalet, L.

1996 Compte-Rendu 1995, Efficacité, Fourmis Lasius niger [Test report 1995, Efficacy, ants Lasius niger] Scotts France SAS, France Trial number JA195I15 France official trial number FRHO 954545 GEP, unpublished

Scotts

B5.10/16 Peter, R., Chazalet, L.


Scotts

B5.10/17 Pallud, D., Chazalet, L.

1996 Compte-Rendu 1995, Efficacité, Fourmis Lasius flavus [Test report 1995, Efficacy, ants Lasius flavus] Scotts France SAS, France Trial number JA195I17 France official trial number FRHO 954481 GEP, unpublished

Scotts

B5.10/18 Pallud, D., Chazalet, L.


Scotts


Page 69/96

Section No


of data

Letter of access

Data protection

claimed



B5.10/19 Pilato, C. 1998 Compte-Rendu 1998, Efficacité, Fourmis Lasius niger [Test report 1998, Efficacy, ants Lasius niger] Scotts France SAS, France Trial number JB198I28 France official trial number FRHO 986330 GEP, unpublished

Scotts

B5.10/20 Pilato, C. 1998 Compte-Rendu 1998, Efficacité, Fourmis Tetramorium caespitum [Test report 1998, Efficacy, ants Tetramorium caespitum] Scotts France SAS, France Trial number JB198I29 France official trial number FRHO 986356 GEP, unpublished

Scotts

B5.10/21 Chion, B. 1996 Compte-Rendu 1996, Efficacité, Fourmis Lasius niger [Test report 1996, Efficacy, ants Lasius niger] Scotts France SAS, France Trial number JC196I27 France official trial number FRHO 965011 GEP, unpublished

Scotts

B5.10/22 Chion, B. 1996 Compte-Rendu 1996, Efficacité, Fourmis Lasius niger [Test report 1996, Efficacy, ants Lasius niger] Scotts France SAS, France Trial number JC196I28 France official trial number FRHO 963209 GEP, unpublished

Scotts


Page 70/96

Section No


of data

Letter of access

Data protection

claimed



B5.10/23 Chion, B. 1996 Compte-Rendu 1996, Efficacité, Lasius niger [Test report 1996, Efficacy, Lasius niger] Scotts France SAS, France Trial number JC196I29 France official trial number FRHO 964261 GEP, unpublished

Scotts

B5.10/24 Chion, B. 1996 Compte-Rendu 1996, Efficacité, Lasius niger [Test report 1996, Efficacy, Lasius niger] Scotts France SAS, France Trial number JC196I32 France official trial number FRHO 965158 GEP, unpublished

Scotts

B5.10/25 Chion , B. 1996 Compte-Rendu 1996, Efficacité, Lasius niger, Vivariums [Test report 1996, Efficacy, Lasius niger, Vivarium] Scotts France SAS, France Trial number JC196I43 France official trial number FRHO 966296 GEP, unpublished

Scotts

B5.10/26 Chion, B. 1997 Compte-Rendu 1997, Efficacité, Lasius niger, Vivarium [Test report 1996, Efficacy, Lasius niger, Vivarium] Scotts France SAS, France Trial number JD197I18 France official trial number FRHO 976593 GEP, unpublished

Scotts


Page 71/96

Section No


of data

Letter of access

Data protection

claimed



B5.10/27 Chion, B. 1997 Compte-Rendu 1997, Efficacité, Lasius niger L., Vivarium [Test report 1996, Efficacy, Lasius niger L., Vivarium] Scotts France SAS, France Trial number JD197I24 France official trial number FRHO 972462 GEP, unpublished

Scotts

B5.10/28 Chion, B. 1997 Compte-Rendu 1997, Efficacité, Lasius emarginatus [Test report 1996, Efficacy, Lasius emarginatus] Scotts France SAS, France Trial number JD197I25 France official trial number FRHO 972483 GEP, unpublished

Scotts

B5.10/29 Chion, B. 1997 Compte-Rendu 1997, Efficacité, Lasius niger, Vivarium [Test report 1996, Efficacy, Lasius niger, Vivarium] Scotts France SAS, France Trial number JD197I27 France official trial number FRHO 974434 GEP, unpublished

Scotts

B5.10/30 Kinsey, R. 2014 Laboratory bioassay to determine the efficacy of bait formulations against ants, Lasius emarginatus, Tetramorium caespitum, and Tapinoma erraticum (FRIN14LC5)) i2L Research Ltd, UK Report no. 14/196 GEP, unpublished

Scotts

B5.10/31 Serrano, B 2014 Laboratory assessment of the efficacy of insecticidal ant baits against three

Scotts


Page 72/96

Section No


of data

Letter of access

Data protection

claimed



species of ants - Arena trial Laboratoire T.E.C. Anglet, France Report no. 1760-FRIN14LC5/0414 GEP, unpublished

B5.10/32 Serrano, B. 2014 Laboratory assessment of the efficacy of insecticidal ant baits - Vivarium trial Laboratoire T.E.C. Anglet, France Report no. 1760-FRIN14LC3/0414 GEP, unpublished

Scotts

B5.10/33 Zangiacomi, L., Desigaux, E.

2014 Trial report 2014. Efficacy trial in vivarium against Lasius niger Scotts France S.A.S., Testing facility Morancé, France Report no. FRIN1415W1 GEP, unpublished

Scotts

B5.10/34 Serrano, B. 2014 Field assessment of the efficacy of insecticidal baits against garden ants. Laboratoire T.E.C., Anglet, France Report no. 1760-FRIN14LC4/0414 GEP, unpublished

Scotts

IIIB-6 B6.1.1 Mercier, O. 1996 EXP 61210 A – Single dose toxicity study by the oral route in the rat (limit test) Pharmakon Europe, France Report No 603306 GLP, unpublished

Scotts

B6.1.2 Mercier, O. 1996 EXP 61210 A – Single dose toxicity study by the cutaneous route in the rat (limit test) Pharmakon Europe, France Report No 603307 GLP, unpublished

Scotts

B6.2.1 Mercier, O. 1996 EXP 61210A – Primary cutaneous irritation and corrosivity test in the rabbit

Scotts


Page 73/96

Section No


of data

Letter of access

Data protection

claimed



(P.C.I.C.) – 3 rabbits Pharmakon Europe, France Report No 603308 GLP, unpublished

B6.2.2 Mercier, O. 1996 EXP 61210 A – Ocular irritation and reversibility test in the rabbit (O.I.R.) – 3 rabbits Pharmakon Europe, France Report No 603309 GLP, unpublished

Scotts

B6.3/01 Mercier, O. 1996 EXP 61210A – Sensitizing potential in the guinea pig – modified Buehler Test (9 induction applications) Pharmakon Europe, France Report No 603310 GLP, unpublished

Scotts

B6.3/02 Colas, S. 2013 EXP 61210 N - Assessment of the skin sensentisation potential in the mouse using the local lymph node assay (LLNA) Phycher Bio Développement, Martillac, France Study No LLNA-PH-13/0064 GLP, unpublished

Scotts

IIIB-7 B7/01 Ott, C. 2013 Exposure and risk assessment EXP 61210 N bait station DHD-Consulting GmbH, Hildesheim, Germany Report no. SCO-2013-01 Report date: 06 August 2013 Non GLP, unpublished

Scotts

B7/02 Arnich, N. Cervantés, P. Gallotti, S.

2005 Evaluation des risques pour la santé humaine liés á une exposition au fipronil. AFSSA, AFFSE, France

-


Page 74/96

Section No


of data

Letter of access

Data protection

claimed



Loulergue, M -H. Solal, C.

Non-GLP, published

IIIB-8 B8 Anonymous 2013 Safety Data Sheet AFOURMI F, product code EXP 61210 N Scotts France SAS, Ecully, France Date of issue/date of revision: 09.08.2013 Version 2.0 Non GLP, published

-

IIIB-9 B9/01 Leroux, B. 2008 Packaging component specifications Ant Bait Station Lid Scotts Supplier: Intermoveplast 16. Dec 2008 Non-GLP, unpublished

Scotts

B9/02 Leroux, B. 2008 Packaging component specifications Ant Bait Station Box Scotts Supplier: Intermoveplast 16. Dec 2008 Non-GLP, unpublished

Scotts

/96

Annex 3: Analytical methods residues – active subst ance

Fipronil

Date: 07/10/2014 Table 20: Methods suitable for the determination of residues (monitoring methods)

Sample Test substance

Analytical method

Fortification range / Number of measurements

Linearity Specificity Recovery rate (%)

Limit of determination Reference

Range Mean St. Dev.

Technical material

Active substance

HPLC with UV detection

n.a/ 14

r2=0.994 No interfering substances1

100.3 – 102.1

101.2 0.4 Not applicable A.4.1-1

Technical material

Impurities Appendix 1 – Business confidential data

Table 21: Analytical methods for the determination of fipronil residue


Analytical method

Fortificatio n range /

Number of measureme

nts

Linearity Specificity

Recovery rate (%) Limit of determinatio

n Reference

Range Mean St. Dev.

Soil (3 types)

Fipronil and metabolites MB45950 MB46136 MB46513

GC –EC/MS

0.002 and 0.02 mg/kg 3 to 9 for each fortification

fipronil r2>0.9973 MB45950 r2>0.9991 MB46136 r2>0.9993 MB46513 r2>0.9988

No interfering substances

For each compound, soil type, and at each fortification level, the mean of recoveries was between 76 and 103 % (general mean = 89%) For each compound, soil type and at each fortification level, the mean RSD was lower than 18% (mean = 14%)

LOQ=0.002 mg/kg (for each product – active substance and metabolites).

A4.2.1/01

Soil Fipronil and LC-MS/MS 0.002-0.2 fipronil No For each compound, soil type and LOQ=0.002

/96


Analytical method


Number of measureme

nts



n Reference

Range Mean St. Dev.

(2 types) metabolites MB45950 MB46136 MB46513 RPA200766

mg/kg 5 per fortification (3 levels)

r2>0.9998 MB45950 r2>0.9992 MB46136 r2>0.9994 MB46513 2>0.9994 RPA200766 r2>0.9986

interfering substances

at each fortification level, the mean of recoveries was between 98% and 112% (general mean = 102%) For each compound, soil type and at each fortification level, the mean RSD was lower than 9% (general mean = 3%)

mg/kg (for each product – active substance and metabolites).

A4.2.1/02

Drinking water (mineral and tap)


GC-MS (only confirmatory method for the GC-EC method)

0.05 µg/l 5 per fortification



For each compound and at each fortification level, the mean of recoveries was between 94% and 110% For each compound and at each fortification level, the mean RSD was lower than 5%

LOQ=0.05 µg/l for each analyte

A4.2.3.1/01

Drinking water (mineral and tap)


GC-EC 0.1-1 µg/l 5 per fortification



For each compound and at each fortification level, the mean of recoveries was between 84% and 105% (general mean : 94%) For each compound and at each fortification level, the mean RSD lower than 10% (general mean = 4%)


A4.2.3.1/02

Surface water (7 types)

Fipronil and metabolites : MB45950 MB46136

LC-MS/MS 10-2000 ng/l >=10

fipronil r2>0.9991 MB45950 r2>0.9985 MB46136


For each compound and at each fortification level, the mean of recoveries was between 71% and 91% (general mean = 85%)


A4.2.3.2/01

/96


Analytical method


Number of measureme

nts



n Reference

Range Mean St. Dev.

MB46513 r2>0.9992 MB46513 r2>0.9969

For each compound and at each fortification level, the mean RSD was lower than 20% (except for MB46136 at 10 ng/l RSD=22.5%) (general mean = 13%)

Surface water (3 types)


GC-EC 0.2-2 µg/l 5 per fortification



For each compound and at each fortification level, the mean of recoveries was between 85% and 102% (general mean = 94%) For each compound and at each fortification level, the mean RSD was lower than 12% (general mean = 7%)

LOQ=0.2 µg/l for each compound.

A4.2.3.2/02

Surface water (1 type)(1)

Fipronil and metabolites MB45950 MB46136 MB46513 RPA200766

GC-EC 1-10 µg/l 5 per fortification

fipronil r2>0.9966 MB45950 r2>0.9991 MB46136 r2>0.9952 MB46513 r2>0.9691 RPA200766 r2>0.9894



LOQ=1 µg/l for each compound.

A4.2.3.2/03

(1): This method was not validated for ground water and rice paddy water. Prefer the other methods.

Drinking and surface water (1

Fipronil and metabolites MB45950 MB46136

LC-MS/MS 4-40 ng/l 5 per fortification

fipronil r2 = 0.9984 MB45950 r2 = 0.9994

No interfering substanc

For each compound and at each fortification level, the mean of recoveries was between 87% and 110%

LOQ=0.004 µg/kg for each analyte

A4.2.3.2/04

/96


Analytical method


Number of measureme

nts



n Reference

Range Mean St. Dev.

type of each)

MB46513 MB46136 r2 = 0.9992 MB46513 r2 = 0.9996

es For each compound and at each fortification level, the mean RSD was lower than 20%

Drinking and surface water (1 type of each)

Fipronil and metabolites MB45950 MB46136 MB46513 RPA200766

LC-MS/MS 0.01-1 µg/l 5 per fortification

fipronil r2 = 0.9999 MB45950 r2 = 0.9997 MB46136 r2 = 0.9998 MB46513 r2 = 0.9997 RPA200766 r2 = 0.9998



LOQ=0.01 µg/kg for each analyte

A4.2.3.2/05

Blood plasma

Fiproles (fipronil, MB45950, MB46136)

GC-EC 50 µg/l 6

fipronil r2>1.000 MB45950 r2>0.999 MB46136 r2>1.000


fipronil : 87-98%, Mean 91%, RSD 4.3% MB45950 : 76 – 99%, Mean 89%, RSD 9.7% MB46136 : 88 – 100%, Mean 95% RSD 4.6%

LOQ=50 µg/l for each compound

A4.2.4/01

Human plasma


GC-EC

50-400 µg/l for fipronil MB45950 and MB46136 2-8 µg/l for MB46513 6 at 3 levels

fipronil r2=0.9957 MB45950 r2=0.9954 MB46136 r2=0.9930 MB46513 r2=0.9928


Recovery rates at three levels: fipronil 94 – 99% MB45950 93 – 108% MB46136 91 – 102% MB46513 96 – 103% RSD: fipronil 4.5 – 7.6% MB45950 3.7 – 8.6%

LOQ=50 µg/L for fipronil, MB46136, MB45950 and LOQ=2 µg/L for MB46513

A4.2.4/02

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Analytical method


Number of measureme

nts



n Reference

Range Mean St. Dev.

MB46136 4.5 – 6.8% MB46513 4.0 – 12%

Human plasma

Fipronil and metabolites MB 46136, MB 46513

GC-EC confirmatory method Not acceptable

1.5, 5.0 and 10 ng/mL 9

Fipronil r2=0.9964 MB46136 r2=0.9936 MB46513 r2=0.9968

In some cases chromatographic interferences; then a second GC analysis was performed using a DB210 column to measure specifically the Fipronil level

Recovery rate at three levels: fipronil 73 - 93 % MB46136 77 - 94 % MB46513 76 - 113 % RSD: fipronil 2.3 - 4.6 % MB46136 5.4 - 6.9 % MB46513 3.7 - 11 %

LOQ=1.5 ng/mL, for Fipronil, MB46136 and MB46513

A4.2.4/03

Micro-pigs plasma

Fipronil and metabolites MB 46136, MB 45950

GC-EC confirmatory method Acceptable

1, 5, 10 and 100 ng/mL 4 or 5

For the low calibration range: Fipronil r2=0.9997 MB46136 r2=0.9929 MB45950 r2=0.9985

Negligible matrix interference

Recovery rate at four levels: Fipronil 82 - 110 % MB46136 98-120 % MB45950 64-130 % Mean RSD (calculated): fipronil 2.0 – 14.4 % MB46136 2.0-25 % MB45950 2.1-15 %

LOQ=1ng/mL, Fipronil LOQ=5ng/mL, MB45950 LOQ=10ng/mL, MB46136

A4.2.4/04

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Analytical method


Number of measureme

nts



n Reference

Range Mean St. Dev.

For the high calibration range: Fipronil r2=0.9996 MB46136 r2=0.9979 MB45950 r2=0.9999

Plants (beans, potatoes, maize corn, sunflower seeds)

fipronil and metabolites MB 46136 MB46513

GC-EC/MS

0.002-0.02 mg/kg 5 for each compund, level and plant

Mean r2>0.991


Depending on plants : fipronil : 70-101%, RSD 2.6-13.8% MB46513 : 80-102%, RSD 2.4-7.7% MB46136 : 74-106%, RSD 1.1-14.7% obtained with ECD except in maize corn and sunflower seeds at 0.002mg/kg (MSD)

LOQ=0.002 mg/kg for each compound

A.3.1/01

Foodstuffs of animal origin (bovine muscle, milk and chichen egg) not validated for

fipronil and metabolites MB45950, MB46136, MB46513

GC-EC

0.002-0.02 mg/kg 5 per level (2), matrix and substance

Mean r2>0.987



LOQ=0.002 mg/kg for each compound

A.3.2/01

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Analytical method


Number of measureme

nts



n Reference

Range Mean St. Dev.

bovine fat

Foodstuffs of animal origin: liver, fat, muscle, milk, kidney, egg.

fipronil and metabolites MB45950, MB46136, MB46513, RPA200766

HPLC-MS/MS

0.0005 – 0.005 mg/kg

r²>0.999 for each substance


For each type of compound at each fortification level the mean recovery was between 70 % and 110 %

LOQ=0.0005 mg/kg

A.3.2/02

Animal fat

fipronil and MB46136,

HPLC-MS/MS

0.0005 – 0.01 mg/kg

r>0.998


For each type of compound at each fortification level the mean recovery was between 70 % and 110 %

LOQ=0.0005 mg/kg for each product

A4.3.2/03

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Annex 4: Toxicology and metabolism –active substanc e

Fipronil

Threshold Limits and other Values for Human Health Risk Assessment

Date: 12/11/2013

Summary Value Study SF AEL long-term 0.0002 mg/kg bw/d Combined

chronic/carcinogenicity in rats 100

AEL medium-term 0.0035 mg/kg bw/d 90d oral in rat and 1-year studies in dog

100

AEL acute

ADI

ARfD Not relevant

0.025 mg/kg bw/d Acute oral neurotoxicity studies in rats

100

Inhalative absorption 100%

Oral absorption 100%

Dermal absorption 11%

Classification with regard to toxicological data (according to the criteria in Reg. 1272/2008)

Acute Tox 3 H331

Acute Tox 3 H311

Acute Tox 3 H301

STOT RE 1 H372

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Annex 5: Toxicology – biocidal product

AFOURMI F

Date: 12/11/2013 General information Formulation Type RTU bait station

Active substance(s) (incl. content) 0.0526% fipronil

Category

Acute toxicity, irritancy and skin sensitisation of the preparation (Annex IIIB, point 6.1, 6.2, 6.3) Rat LD50 oral (OECD 401) > 2002 mg/kg bw Rat LD50 dermal (OECD 402) > 2002 mg/kg bw Skin irritation (OECD 404) Not irritant Eye irritation (OECD 405) Not irritant Skin sensitisation (OECD 406; Buehler modified)

Not skin sensitizer

Additional toxicological information (e.g. Annex II IB, point 6.5, 6.7) Short-term toxicity studies None Toxicological data on active substance(s) (not tested with the preparation)

None

Toxicological data on non-active substance(s) (not tested with the preparation)

None

Further toxicological information None

Classification and labelling proposed for the prepa ration with regard to toxicological properties (Annex IIIB, point 9) Directive 1999/45/EC

No classification Contains 1,2-benzisothiazolin-3-one. May produce an allergic reaction.

Regulation 1272/2008/EC

No classification Contains 1,2-benzisothiazolin-3-one. May produce an allergic reaction.

/96

Annex 6: Safety for professional operators

AFOURMI F

Date: 12/11/2013

Exposure assessment Not relevant, the product is for non professional users only.

/96

Annex 7: Safety for non-professional operators and the general public

AFOURMI F

Date:12/11/2013 The product is contained in a sealed bait station, therefore no exposure (dermal and inhlalation) to the formulation is expected. No secondary exposure is expected. However, a reverse scenario was realized in order to assess the amount of product needed to achieve the short-term AEL for and adult, a child and an infant The following parameters were taken into account in the calculations:

- Concentration fipronil in AFOURMI F: 0.0526%; - Dermal absorption value: 11%; - Body weight of an adult: 60 kg; - Body weight of a child:23.9 kg; - Body weight of an infant: 8 kg; - AEL short-term: 0.025 mg/kg bw/day.

Amounts of 27g, 10.2g and 3.4g of AFOURMI F should be present to reach an exposure equal to the short-term AEL, for an adult, a child and an infant, respectively. This amount was considered as not relevant, the product is not sufficiently available in the bait station. For a child and an infant, 1.12g and 377mg of product, respectively, should be ingested to achieve the short term AEL. The product is contained in a sealed bait station with only 4 predefined openings; therefore it is not relevant to consider 11.2% and 3.8% of the product as available for ingestion by a child and an infant.

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Annex 8: Residue behaviour

Fipronil

Date: 22/11/2013 Intended Use (critical application): control of ants by non professionals Active substance(s): fipronil Formulation of biocidal product: reaydy to use bait station Place of treatment: in and around buildings (in and around houses on hard surfaces). Target organismes: ants 2 bait boxes with 10 g product each per 15 m², Waiting periods after treatment: - days/hours The intended use descriptions of the fipronil-containing biocidal products for which authorisation is sought indicate that these uses are not relevant in terms of residues in food and feed. The product is enclosed in a bait station, used for the control of ants. It does not come in direct contact with food and feedstuff.

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Annex 9: Efficacy of the active substance from its use in the biocidal product Table 22: Efficacy of the active susbstance from it s use in the biocidal product

Test substance Test

organisms Test system / Concentrations

applied / exposure time Test conditions

Test results: effects, mode of action, resistance

Reference RI

AFOURMI F (EXP 61210 A) + control

Lasius niger 33 x 33 x 3 cm plastic tray 100 ants per arena 1 bait station per arena 11 days exposure

Laboratory Ambient temperature Ambient humidity Alternative food source is provided

AFOURMI F kills ants to 100 % within 7 days Mode of action: ingestion Resistance: n.a. 26% mortality in the control.

B5.10/03 Zangiacomi, L., Desbois, i. (2008)

3

AFOURMI F

(EXP 61210 A) + control

Lasius niger Tetramorium caespitum Tapinoma erraticum

Not reported

100 ants per arena

1 bait station per arena

7 and 15 days exposure

Laboratory

25 ± 1 °C

65 ± 4 % rel. humidity

Alternative food source is

provided

100 % kill effect in 5 days for Lasius niger and Tapinoma erraticum, after 10 days against Tetramorium caespitum Mode of action: by ingestion

Resistance: none reported

B5.10/04 Serrano, B.

(2005) 2

AFOURMI F bait box

(EXP 61210 A)

+ control

Lasius niger 33 x 33 x 3 cm plastic tray

100 ants per arena 1 bait station per arena 20 days

Laboratory Ambient temperature Ambient humidity

Alternative food source is provided

AFOURMI F kills ants to 100 % within 7 days Mode of action: by ingestion Resistance: none reported

B5.10/05

Zangiacomi, L., Desigaux E. (2009)

2

AFOURMI F (EXP 61210 A)

+ control

Lasius niger 33 x 33 x 3 cm plastic tray

100 ants per arena 1 bait station per arena 29 days

Laboratory Ambient temperature Ambient humidity

Alternative food source provided

AFOURMI F: 100 % efficacy in 14 days Mode of action: by ingestion Resistance: none reported

B5.10/06

Zangiacomi, L., Desigaux E. (2009

2

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Test substance Test




Reference RI

AFOURMI F (EXP 61210 N) Former formulation EXP 61210 A + control

Lasius niger Transparent vivarium 33 x 21 x 25 cm 1 entire ant hill per vivarium, approx. 3965 ants 1 bait station per vessel 41 days

Laboratory Ambient temperature Room light during days of work With alternative food source

AFOURMI F (EXP 61210 N) and EXP 61210 A full destruction of ant hill after 49 days. No difference between old and new formulation Mode of action: by ingestion Resistance: none reported 52% mortality in the control.

B5.10/07 Zangiacomi, Z, Laurianne, M. (2012)

3

AFOURMI F (EXP 61210 A) 2 years old samples + control

Lasius niger Field Whole nest 1 bait box per nest entry (i.e. 1 to 2 bait boxes / nest), placed on hard surface 28 days

Field Ambient temperature Ambient humidity

No extra feeding

100 % efficacy on ant activity on surface, 100 % nest kill within 4 weeks. Mode of action: by ingestion Resistance: none reported

B5.10/08 Serrano, B. (2010)

2

AFOURMI F (EXP 61210 A) 2 years old samples + control

Lasius niger

Field Whole nest 1 bait box per nest entry (i.e. 1 bait box / nest), placed on hard surface 90 days

Field Ambient temperature Ambient humidity

No extra feeding

100 % efficacy on ant activity on surface after 21 days, 100 % nest kill after 3 months Mode of action: by ingestion Resistance: none reported

B5.10/09 Serrano, B. (2010)

2

AFOURMI F

(EXP 61210 N)

+ control

Lasius niger Plastic tank 33 x 20 x 21 cm

One nest per arena

1 bait box per arena

17 days

Laboratory

19.0 – 27.4 °C

20 % rel. humidity

daylight

Alternative food source is

provided

100 % efficacy after 7 days Mode of action: by ingestion


B5.10/10 Heaven, H. (2012)

1

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Test substance Test




Reference RI

AFOURMI F (EXP 61210 N)

+ control

Lasius niger

Transparent vivarium 33 x 21 x 25 cm One entire ant hill, approx. 5100 ants 1 bait box per vivarium

32 days

Laboratory Ambient temperature ca. 20-30 °C 45-85 % rel. humidity Alternative food source is provided

Complete stop of ant activity within 8 days Nest kill: 86 % brood, 100 % ants within 32 days Mode of action: by ingestion Resistance: none reported 51% mortality in the control.

B5.10/11 Zangiacomi, L., Desigaux, E. (2010) 3

AFOURMI F (EXP 61210 N) + control

Lasius niger Cardboard arena 60 x 40 x 15 cm, One complete colony 1 bait station per vivarium 6 weeks

Laboratory 25-26 °C 60 – 62 % rel. humidity With alternative food source

Total nest kill within 2 weeks Mode of action: by ingestion Resistance: none reported

B5.10/12 Radecki, C. (2012)

1

AFOURMI F (EXP 61210 N) + control

Lasius niger Field Whole nest 1 bait box per nest entry (i.e. 1 to bait boxes / nest) 28 days

Field Ambient conditions No extra feeding

100 % efficacy on ant activity and total nest kill within 28 days. Mode of action: by ingestion Resistance: none reported

B5.10/13 Serrano, B. (2012) 2

Fourmidor® (Exp 61210 N) gel in tube + control

Linepithema humile

5 sites, patios and lawn Natural infestation 3 drops = 0.03 g every 90 cm on the ant runs In total 2.88 g at side 1, 7.56 g at site 2 and 3.6 g at site 3 15 days


Mortality 100 % mortality was achieved on all sides after 5-6 days after application Mode of action: by ingestion Resistance: none reported

B5.10/14 Heaven, H. (2013)

3

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Test substance Test




Reference RI

AFOURMI F (CRLD951145) + control

Lasius niger 30x30x3 cm plastic tray 100 ants/arena


16 days exposure

Laboratory 20°C 70 % With or without alternative food source (sugar, honey)

100 % mortality within 7 days without alternative food 100 % mortality within 12 days with alternative food (sugar) 68.3 % mortality within 16 days with alternative food (honey) Mode of action: ingestion


B5.10/15 Peter, R.; Chazalet, L. (1996)

2

AFOURMI F (CRLD951145) Bait box with impregnated cotton Bait box without cotton + control



8 days exposure

Laboratory 24°C 70 % With or without cotton wool)

99.8 % mortality within 5-8 days with cotton wool 100 % mortality within 5 days without cotton wool Mode of action: ingestion


B5.10/16 Peter, R.; Chazalet, L. (1996) 2


Lasius flavus 33x21x20 cm vivarium

A quarter of a nest in one vivarium

1 bait box per vivarium

21 days exposure

Laboratory 24-28 °C 70 % Alternative food source is provided

Complete stop of ant activity within 7 days Nest kill: 92.8 % ants mortality within 21 days Mode of action: ingestion


B5.10/17

Pallud, D.; Chazalet, L. (1996)

3


Lasius niger Field Whole nest 1 bait box per nest 21 days


Incomplete stop of ant activity within 21 days (92.5 %) No nest kill: 77.5 % ants within 21 days Mode of action: ingestion


B5.10/18

Pallud, D; Chazalet, L. (1996) 3

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Test substance Test




Reference RI

AFOURMI F (CRLD951145) fresh and 1 year aged + control



24 days exposure

Laboratory 23 °C 65 % Alternative food source is provided

100 % mortality within 14 days for fresh and one year aged product Mode of action: ingestion


B5.10/19 Pilato, C. (1998)

2


Tetramorium caespitum

30x30x3 cm plastic tray 100 ants/arena


25 days exposure


100 % mortality within 15 days Mode of action: ingestion


B5.10/20

Pilato, C. (1998) 2




13 days exposure

Laboratory 20 °C 70 % With or without alternative food source (honey)

100 % mortality within 13 days with or without honey Mode of action: ingestion


B5.10/21 Chion, B. (1996)

2

AFOURMI F (CRLD951145) fresh, 2 weeks-40 °C aged + control



10 days exposure


100 % mortality within 9 days for fresh product and within 10 days for 2 weeks-40 °C aged product.

B5.10/22

Chion, B. (1996) 2




Nest kill: 93 % ants within 35 days Mode of action: ingestion

Resistance: none reported Building of new nests near the treated area + rainy weather.

B5.10/23 Chion, B. (1996)

3

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Test substance Test




Reference RI

AFOURMI F (CRLD951145) fresh and 2 month aged (opened box) + control



13 days exposure

Laboratory 20 °C 67 % With or without alternative food source (sugar)

100 % mortality within 13 days for fresh product with and without sugar and for 2 month opened product

B5.10/24 Chion, B. (1996)

2


Lasius niger 33x21x20 cm vivarium

A nest in one vivarium


32 days exposure

Laboratory 19°C 65 % Alternative food source is provided

Low residual ant activity within 27 days Insufficient nest kill : 88.2 % ant mortality within 32 days Mode of action: ingestion


B5.10/25 Chion, B. (1996)

2

AFOURMI F (CRLD951145) fresh and 7 month aged + control




22 days exposure

Laboratory 22°C 65 % Alternative food source is provided (honey)

Complete stop of ant activity within 20 days with fresh and 7 months aged product Nest kill: 99 and 98 % ants with fresh and 7 months aged product within 22 days Mode of action: ingestion


B5.10/26 Chion, B. (1996)

2





27 days exposure


Complete stop of ant activity within 27 days Nest kill: 100 % ants within 27 days Mode of action: ingestion


B5.10/27 Chion, B. (1997)

2

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Test substance Test




Reference RI


Lasius emarginatus

30x30x3 cm plastic tray 100 ants/arena


9 days exposure

Laboratory 21°C 61 % Alternative food source is provided (sugar)



B5.10/28 Chion, B. (1997)

2





47 days exposure


Complete stop of ant activity within 47 days Nest kill: 100 % ants Mode of action: ingestion


B5.10/29 Chion, B. (1997)

2

AFOURMI F (EXP61210N) fresh and 2 years aged product + Former formulation (EXP 61210 A) + control

Lasius emarginatus Tetramorium caespitum Tapinoma erraticum

33 x 20 x 21 cm plastic tanks

Per arena:

Lasius 298-339 adults

Tapinoma 94-236 adults

Tetramorium 195-395 adults


28 days exposure

Laboratory 18.2-25.9 °C 34.5-84.5 % Alternative food source is provided (sugar)

100 % mortality within 1-3 days for L. emarginatus, 7-14 days for T. caespitum, and 99.5 -100% within 21-28 days for T .erraticum Mode of action: ingestion


B5.10/30

Kinsey, R. (2014)

1


Lasius emarginatus Tetramorium caespitum Tapinoma erraticum

30 x 30 x 15 cm plastic tanks 100 ants/arena


21 days exposure

Laboratory 25 °C 65 % Alternative food source is provided (sugar)



B5.10/31

Serrano, B. (2014)

1

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Test substance Test




Reference RI





28 days exposure

Laboratory 27 °C 53 % Alternative food source is provided (sugar)



B5.10/32 Serrano, B. (2014)

1

AFOURMI F (EXP61210N) fresh and 2 years aged + control




21 days exposure

Laboratory 25 °C 65 % Alternative food source is provided (honey)



B5.10/33

Zangiacomi, L., Desigaux, E. (2014) 1

AFOURMI F (EXP61210N) + control



Nest kill: 100 % ants within 28 days Mode of action: ingestion


B5.10/34 Serrano, B. (2014) 1

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