Commission Implementing Regulation (EU) 2020/704 of 26 May 2020 granting a Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’ (Text with EEA relevance)

Article 1

A Union authorisation with authorisation number EU-0021035-0000 is granted to Agrobiothers Laboratoire for the making available on the market and use of the biocidal product family ‘INSECTICIDES FOR HOME USE’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II. The Union authorisation is valid from 16 June 2020 until 31 May 2030.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEX ISupplementary provisions

ANNEX I Terms and conditions (EU-0021035-0000) The authorisation holder shall conduct a shelf life study of INSECTICIDE HOUSEHOLD SPRAY in packagings in which the product will be made available on the market. The study shall determine the active substance contents, the cis/trans ratio of permethrin, the spray pattern, the functioning of the trigger device, the discharge rate and the mass median aerodynamic diameter, before and after storage. By 16 December 2022 the authorisation holder shall submit the results of the study to the Agency.

Summary of product characteristics for a biocidal product family

ANNEX IISupplementary provisions

ANNEX II 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 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 m 2 (2,1 g/m 2 ) 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)