ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

INSECTICIDES FOR HOME USE

Product type(s)

PT18: Insecticides, acaricides and products to control other arthropods

Authorisation number EU-0021035-0000

R4BP asset number EU-0021035-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

Name	INSECTICIDES FOR HOME USE

1.2. Product type(s)

Product type(s)

PT18: Insecticides, acaricides and products to control other arthropods

1.3. Authorisation holder

Name and address of the authorisation holder	Name	Agrobiothers Laboratoire
Name and address of the authorisation holder	Address	ZI Route des Platières 71290 CUISERY FR
Authorisation number		EU-0021035-0000
R4BP asset number		EU-0021035-0000
Date of the authorisation		16.06.2020
Expiry date of the authorisation		31.05.2030

1.4. Manufacturer(s) of the product

Name of manufacturer

AGROBIOTHERS LABORATOIRE

Address of manufacturer

ZI Les Platières 71290 Cuisery France

Location of manufacturing sites

AF3

16 Rue de l oberwald 68360 Soultz France

1.5. Manufacturer(s) of the active substance(s)

Active substance

Permethrin

Name of manufacturer

Tagros Chemicals india Ltd. (Art.95 List: LIMARU NV (Acting for Tagros Chemicals India Private Limited)

Address of manufacturer

Jhaver Centre, Rajah Annamalai Bldg., IV floor 72 Marshal s road Egmore 600008 Chennai India

Location of manufacturing sites

Tagros Chemicals india Ltd. (Art.95 List: LIMARU NV (Acting for Tagros Chemicals India Private Limited)

A-4/1&2, Sipcot Industrial Complex, Pachayankuppam Cuddalore 607 005 Tamilnadu India

Active substance

S-Methoprene

Name of manufacturer

Babolna bio Ltd.

Address of manufacturer

Szallas u.6 H- 1107 Budapest Hungary

Location of manufacturing sites

Babolna bio Ltd.

Szallas u.6 H- 1107 Budapest Hungary

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1. Qualitative and quantitative information on the composition of the family

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Permethrin	3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate	active substance	52645-53-1	258-067-9	0,177 - 0,177 % (w/w)
S-Methoprene	Isopropyl-(2E,4E,7S)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate	active substance	65733-16-6		0,00225 - 0,00225 % (w/w)
2-Propanol	Propan-2-ol	Non-Active substance	67-63-0	200-661-7	3,33475 - 3,33475 % (w/w)
Butane	n-butane	Non-Active substance	106-97-8	203-448-7	63,458 - 63,458 % (w/w)
Propane	propane	Non-Active substance	74-98-6	200-827-9	16,271 - 16,271 % (w/w)
isobutane	Isobutane	Non-Active substance	75-28-5	200-857-2	4,068 - 4,068 % (w/w)

2.2. Type(s) of formulation

Formulation type(s)

AE Aerosol dispenser

PART II

SECOND INFORMATION LEVEL - META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

Identifier

INSECTICIDE HOUSEHOLD SPRAY

1.2. Suffix to the authorisation number

Number

1-1

1.3. Product type(s)

Product type(s)

PT18: Insecticides, acaricides and products to control other arthropods

2. META SPC 1 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 1

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Permethrin	3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate	active substance	52645-53-1	258-067-9	0,177 - 0,177 % (w/w)
S-Methoprene	Isopropyl-(2E,4E,7S)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate	active substance	65733-16-6		0,00225 - 0,00225 % (w/w)
2-Propanol	Propan-2-ol	Non-Active substance	67-63-0	200-661-7	3,33475 - 3,33475 % (w/w)
Butane	n-butane	Non-Active substance	106-97-8	203-448-7	63,458 - 63,458 % (w/w)
Propane	propane	Non-Active substance	74-98-6	200-827-9	16,271 - 16,271 % (w/w)
isobutane	Isobutane	Non-Active substance	75-28-5	200-857-2	4,068 - 4,068 % (w/w)

2.2. Type(s) of formulation of the meta SPC 1

Formulation type(s)

AE Aerosol dispenser

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

H222 : Extremely flammable aerosol, H229 : Pressurised container: May burst if heated

H229: Pressurised container: May burst if heated

H304: May be fatal if swallowed and enters airways.

H319: Causes serious eye irritation.

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

EUH208: Contains PERMETHRIN. May produce an allergic reaction.

Precautionary statements

P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P211: Do not spray on an open flame or other ignition source.

P251: Do not pierce or burn, even after use.

P264: Wash hands thoroughly after handling.

P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P337+P313: If eye irritation persists: Get medical advice.

P410+P412: Protect from sunlight. Do no expose to temperatures exceeding 50 °C/122 °F.

P411: Store at temperatures not exceeding 40 °C/104 °F.

P273: Avoid release to the environment.

P391: Collect spillage.

P501: Dispose of contents to in accordance with local regulation.

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description

Table 1

Insecticide household spray

Product type	PT18: Insecticides, acaricides and products to control other arthropods
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Ctenocephalides felis Common name: fleas Development stage: larvae Scientific name: Ctenocephalides felis Common name: fleas Development stage: adults Scientific name: Ixodes ricinus Common name: ticks Development stage: - Scientific name: Rhipicephalus sanguineus Common name: ticks Development stage: -
Field(s) of use	indoor use Targeted treatment of non-washable furniture and home textile such as carpets, mats, arm chairs.
Application method(s)	Method: spraying Detailed description: After vacuuming the surface to be treated, the product is sprayed at a distance of 30 cm.
Application rate(s) and frequency	Application rate: 1,3 second spray treat for approximately 1 m2 (2,1 g/m2) Number and timing of application: The minimum time interval between two treatments is 6 months.
Category(ies) of users	general public (non-professional)
Pack sizes and packaging material	Tin plate aerosol can with internal coating made of epoxy phenolic protective lacquer (250 mL or 500 mL) Tin plate aerosol can without internal coating (300 mL)

4.1.1. Use-specific instructions

See general directions for use

4.1.2. Use-specific risk mitigation measures

See general directions for use

4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1. Instructions for use

—	The product is to be used for targeted treatment of non-washable furniture and home textile as carpets, mats, arm chairs.

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

—	Respect the recommended application doses.

—	Residual efficacy until up to 6 months that can be lowered in case of normal cleaning (e.g. vacuum on carpets) or extensive use of the surfaces (e.g., walking, friction).

—	In case of continuous infestation, use alternate products containing active substances with a different mode of action in order to avoid the occurance of resistance. This is to remove the resistant individuals from the population.

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

—	Do not use on cats and other animals or pet baskets for cats.

—	Inform the authorization holder if the treatment is ineffective.

5.2. Risk mitigation measures

—	Do not use on wet washable surfaces and textile.

—	Do not wash furniture with wet wiping clothes and do not wet clean carpets or mats to avoid discharges into the sewer system.

—	Remove all food, feed and drinks prior treatment.

—	Do not use on surfaces and facilities in the vicinity or likely to be in contact with food, feed and drinks.

—	Avoid contact with eyes.

—	After spraying, leave the room and let act for one hour before airing.

—	Remove or cover terrariums, aquariums and animal cages before application.

—	Turn off aquarium air-filter while spraying.

—	Keep cats away from treated surfaces. Due to their particular sensitivity to permethrin, the product can cause severe adverse reactions in cats.

—	Keep children and pets away during treatment.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

—	Inhalation: Remove victim to fresh air and keep at rest in a half-sitting position. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.

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

—	Skin contact: Remove contaminated clothing and shoes. Wash contaminated skin with water. Contact poison treatment specialist if symptoms occur.

—	Mouth contact: Wash out mouth with water. Contact poison treatment specialist immediately if symptoms occur and/or in case of mouth contact with large quantities.

—	Do not give fluids or induce vomiting in case of impaired consciousness; place in recovery position and seek medical advice immediately.

—	Keep the container or label available.

—	Permethrin may be dangerous for cats. If signs of poisoning occur, seek veterinary advice immediately and show the package to a veterinarian.

—	Pyrethroids may cause paresthesia (burning and prickling of the skin without irritation). If symptoms persist: Get medical advice.

5.4. Instructions for safe disposal of the product and its packaging

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

—	Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

—	Shelf life: 24 months.

—	Do not store at a temperature higher than 40 °C.

—	Do not expose to direct sunlight.

—	Protect from frost.

6. OTHER INFORMATION

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1. Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)		FRONTLINE PET CARE SPRAY INSECTICIDE ET ACARICIDE POUR L’HABITAT			Market area: EU
		SPRAY ANTIPARASITAIRE POUR L’HABITAT 300 ML FRISKIES			Market area: EU
		INSECTICIDE HABITAT/ HOME VETOCANIS			Market area: EU
		FRONTLINE HOMEGARD SPRAY INSECTICIDE ET ACARICIDE POUR L’HABITAT			Market area: EU
		INSECTICIDE HABITAT/ HOME VITALVETO			Market area: EU
		SPRAY INSECTICIDE POUR L’HABITAT VITALVETO / INSECTICIDE HOUSEHOLD SPRAY VITALVETO			Market area: EU
		SPRAY INSECTICIDE POUR L’HABITAT VETOCANIS / INSECTICIDE HOUSEHOLD SPRAY VETOCANIS			Market area: EU
		BEAPHAR SPRAY POUR L’HABITAT INSECTICIDE			Market area: EU
		BEAPHAR OMGEVINGSSPRAY BINNEN INSECTICIDE			Market area: EU
		BEAPHAR UMGEBUNGSSPRAY INNEN INSECTICIDE			Market area: EU
		FRONTLINE HOMEGARD Husholdningsspray med insekticid og acaricid			Market area: EU
		FRONTLINE HOMEGARD Insecticide and acaricide household spray			Market area: EU
		FRONTLINE HOMEGARD Hyönteisten ja punkkien torjuntasuihke kotitalouksille			Market area: EU
		FRONTLINE HOMEGARD insektizides und akarizides Haushaltsspray			Market area: EU
		FRONTLINE HOMEGARD Spray Εντομοκτόνο και ακαρεοκτόνο σπρέι οικιακής χρήσης			Market area: EU
		FRONTLINE HOMEGARD Spray insetticida e acaricida per l’ambiente domestico			Market area: EU
		FRONTLINE HOMEGARD Insecticide en acaricidespray voor huishoudelijk gebruik			Market area: EU
		FRONTLINE HOMEGARD Husholdningsspray med insekticid og acaricid			Market area: EU
		FRONTLINE HOMEGARD INSETICIDA E ACARICIDA EM SPRAY PARA USO DOMÉSTICO			Market area: EU
		FRONTLINE HOMEGARD Hushållspray med insekticid och akaricid			Market area: EU
		PECUSANOL CASA Spray Inseticida para uso doméstico			Market area: EU
		FLEA FREE omgevingsspray combo binnen insecticide			Market area: EU
		INSECTICIDE HABITAT CLÉMENT THÉKAN SPRAY ENVIRONNEMENT			Market area: EU
		BOGAPROTECT INSEKTIZIDES UMGEBUNGSSPRAY			Market area: EU
Authorisation number					EU-0021035-0001 1-1
Common name	IUPAC name		Function	CAS number		EC number	Content (%)
Permethrin	3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate		active substance	52645-53-1		258-067-9	0,177 % (w/w)
S-Methoprene	Isopropyl-(2E,4E,7S)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate		active substance	65733-16-6			0,00225 % (w/w)
2-Propanol	Propan-2-ol		Non-Active substance	67-63-0		200-661-7	3,33475 % (w/w)
Butane	n-butane		Non-Active substance	106-97-8		203-448-7	63,458 % (w/w)
Propane	propane		Non-Active substance	74-98-6		200-827-9	16,271 % (w/w)
isobutane	Isobutane		Non-Active substance	75-28-5		200-857-2	4,068 % (w/w)