Commission Implementing Regulation (EU) 2025/265 of 7 February 2025 amending Implementing Regulation (EU) 2020/704 as regards administrative changes to the Union authorisation of the biocidal product family INSECTICIDES FOR HOME USE
Date: 2025-02-07
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, insecticide, market approval








L_202500265EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/265


10.2.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/265
of 7 February 2025
         
amending Implementing Regulation (EU) 2020/704 as regards administrative changes to the Union authorisation of the biocidal product family ‘INSECTICIDES FOR HOME USE’
         
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 50(2) thereof,

Whereas:







(1)


On 26 May 2020, Commission Implementing Regulation (EU) 2020/704 (2) granted a Union authorisation, under number EU-0021035-0000, to Agrobiothers Laboratoire for the making available on the market and use of the biocidal product family ‘INSECTICIDES FOR HOME USE’. Annex II to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for that biocidal product family.












(2)


On 30 November 2021, Commission Implementing Regulation (EU) 2021/2109 (3) amended Implementing Regulation (EU) 2020/704 to make administrative changes to the Union authorisation of the biocidal product family ‘INSECTICIDES FOR HOME USE’, in accordance with Article 50(2) and Article 50(3), point (a), of Regulation (EU) No 528/2012.












(3)


On 24 August 2022, 5 January 2023, 15 February 2023 and 26 September 2023 Agrobiothers Laboratoire submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013 (4), further notifications of administrative changes, recorded in the register for biocidal products under case numbers BC-RR079365-04, BC-TJ083601-30, BC-GR084556-13 and BC-FT088928-97 to the Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’. The notified proposed changes concern the addition of 4 trade names, changes to 2 trade names and the removal of 2 trade names.












(4)


On 3 October 2022 (5), 2 February 2023 (6), 9 March 2023 (7) and 19 October 2023 (8) the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions on the notified administrative changes to the Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’, together with a revised summary of the biocidal product characteristics. In the opinions, ECHA concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.












(5)


On 19 October 2023, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’ in all official languages of the Union, covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.












(6)


The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’ to introduce the administrative changes requested by Agrobiothers Laboratoire.












(7)


Except for the amendments regarding the administrative changes, other substantive information included in the summary of the biocidal product characteristics of ‘INSECTICIDES FOR HOME USE’ as set out in Annex II to Implementing Regulation (EU) 2020/704 remains unchanged.












(8)


In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, Annex II to Implementing Regulation (EU) 2020/704 should be replaced in its entirety. Due to a change in the format for the generation of the summary of biocidal product characteristics in the register for biocidal products in 2024, the summary of the biocidal product characteristics in that Annex should also include some minor editorial and layout changes.












(9)


Implementing Regulation (EU) 2020/704 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
Annex II to Implementing Regulation (EU) 2020/704 is replaced by the text set out in the Annex to this Regulation.


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.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 February 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Commission Implementing Regulation (EU) 2020/704 of 26 May 2020 granting a Union authorisation for the biocidal product family ‘INSECTICIDES FOR HOME USE’ (OJ L 164, 27.5.2020, p. 19, ELI: http://data.europa.eu/eli/reg_impl/2020/704/oj).

(3)  Commission Implementing Regulation (EU) 2021/2109 of 30 November 2021 amending Implementing Regulation (EU) 2020/704 to make administrative changes to the Union authorisation of the biocidal product family ‘INSECTICIDES FOR HOME USE (OJ L 429, 1.12.2021, p. 99, ELI: http://data.europa.eu/eli/reg_impl/2021/2109/oj).

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).

(5)  ECHA Opinion N° UAD-C-1614316-40-00/F of 3 October 2022 on the administrative change of the Union authorisation of the biocidal product family: INSECTICIDES FOR HOME USE, https://echa.europa.eu/opinions-on-union-authorisation.

(6)  ECHA Opinion N° UAD-C-1642252-38-00/F of 2 February 2023 on the administrative change of the Union authorisation of the biocidal product family: INSECTICIDES FOR HOME USE, https://echa.europa.eu/opinions-on-union-authorisation.

(7)  ECHA Opinion N° UAD-C-1648354-23-00/F of 9 March 2023 on the administrative change of the Union authorisation of the biocidal product family: INSECTICIDES FOR HOME USE, https://echa.europa.eu/opinions-on-union-authorisation.

(8)  ECHA opinion N° UAD-C-1689543-18-00/F of 19 October 2023 on the administrative change of the Union authorisation of the biocidal product family: INSECTICIDES FOR HOME USE, https://echa.europa.eu/opinions-on-union-authorisation.




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




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)







ELI: http://data.europa.eu/eli/reg_impl/2025/265/oj
ISSN 1977-0677 (electronic edition)