Commission Implementing Regulation (EU) 2025/1203 of 19 June 2025 granting a Union authorisation for the biocidal product family REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2025-06-19
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, domestic animal, market approval, pest








L_202501203EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1203


20.6.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/1203
of 19 June 2025
         
granting a Union authorisation for the biocidal product family ‘REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(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 44(5), first subparagraph, thereof,

Whereas:







(1)


On 27 March 2019, Agrobiothers Laboratoire submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES’ of product-type 19, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-TV050221-21 in the Register for Biocidal Products.












(2)


‘REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES’ contains margosa extract from cold-pressed oil of kernels of Azadirachta indica extracted with super-critical carbon dioxide as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 19.












(3)


On 1 December 2023, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 25 June 2024, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(6) of that Regulation.












(6)


On 10 July 2024, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES’.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0032868-0000 is hereby granted to Agrobiothers Laboratoire for the making available on the market and use of the biocidal product family ‘REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 10 July 2025 until 30 June 2035.


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, 19 June 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)  ECHA opinion of 30 May 2024 on the Union authorisation of ‘ANTIPARASITE FOR PETS USE’ (ECHA/BPC/434/2024) (https://echa.europa.eu/opinions-on-union-authorisation).




ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES

Product type(s)

PT19: Repellents and attractants

Authorisation number: EU-0032868-0000

R4BP asset number: EU-0032868-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES




1.2.   Product type(s)







Product type(s)


PT19: Repellents and attractants




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Agrobiothers Laboratoire




Address


ZI route des Platières, 71290 Cuisery, France




Authorisation number


 


EU-0032868-0000





R4BP asset number



 


EU-0032868-0000




Date of the authorisation


 


10 July 2025




Expiry date of the authorisation


 


30 June 2035




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


Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide




Name of manufacturer


Flavex Naturextrakte GmbH




Address of manufacturer


Nordstraße 7, 66780 Rehlingen, Germany




Location of manufacturing sites


Flavex Naturextrakte GmbH, Nordstraße 7, 66780, Rehlingen, Germany




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 (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


0,4 -20  % (w/w)




2-fenoxietanol


—


Non-active substance


122-99-6


204-589-7


0 -0,42  % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AE Aerosol dispenser
AL Any other liquid
SA Spot-on




PART II

SECOND INFORMATION LEVEL META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


REPELLENT SPRAY




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT19: Repellents and attractants




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 (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


0,5 -0,5  % (w/w)




2-fenoxietanol


—


Non-active substance


122-99-6


204-589-7


0,4 -0,4  % (w/w)




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







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


 




Precautionary statements


 




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Repellent lotion for cats and dogs







Product type


PT19: Repellents and attractants




Where relevant, an exact description of the authorised use


REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES




Target organism(s) (including development stage)


Scientific name: Ctenocephalides sp.
Common name: fleas
Development stage: adults
Scientific name: Rhipicephalus sanguineus, Ixodes ricinus
Common name: ticks
Development stage: adults
Scientific name: Aedes sp., Culex sp
Common name: mosquitoes
Development stage: adults




Field(s) of use


Repellent lotion for cats and dogs




Application method(s)


Method: spraying
Detailed description:
—




Application rate(s) and frequency


Application Rate:
1,6 g/kg bodyweight
Number and timing of application:
6 sprays for 3 kg cat (250 ml) and 10 sprays for a 10 kg dog (500 ml) per application
Protection time up to 12 days
Maximum 30 applications per year




Category(ies) of users


general public (non-professional)




Pack sizes and packaging material








—


250 ml bottle in PET (polyethylene terephthalate)










—


500 ml bottle in HDPE (high density polyethylene)








4.1.1.   Use-specific instructions for use

—
4.1.2.   Use-specific risk mitigation measures

—
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

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

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

—
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use







—


Comply with the instructions for use.










—


The application rate of the product is 1,6 g/kg bodyweight, e.g. 6 sprays for 3 kg cat (250 ml) and 10 sprays for a 10 kg dog (500 ml) per application










—


90 % repellent efficacy lasts up to 12 days against fleas, ticks, and mosquitoes in areas with low parasite pressure (e.g. urban or semi-urban areas with low exposure to target organisms, animals living indoors).










—


The product shall not be applied on wet animals.










—


Only to be used by adults.










—


Do not wash or bathe the animal after application and during all the protection time. Reapply the product if the animal has been unintentionally wetted after the application (e.g. rain), without exceeding the maximum number of applications per year.










—


The protection time is only indicative. Environmental factors (e.g. high temperature, wind velocity) or trimming the hairs can modify it.










—


This product is not intended to be applied on already infested pets.










—


Do not apply on injured skin.










—


Do not use on a sick or convalescent animal nor on animals under 3 months old.










—


The use of the product with other repellent products is not recommended.










—


Efficacy in tropical conditions has not been verified.










—


Spray at about 10-20 cm over the entire body of your animal while brushing against the grain and avoiding the eyes and the mucous membranes. Brush to help spread the lotion until the fur is completely dry.










—


Protection against biting has not been demonstrated.




5.2.   Risk mitigation measures

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







—


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










—


IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.










—


IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.










—


IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.










—


IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.




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







—


Keep out of reach of children and non-target animals/pets.










—


Protect from frost.










—


Store at a temperature below 40 °C.










—


Shelf life: 2 years.




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)


PREVENTIS 0,5 % M REPELLENT DOGS SPRAY


Market area: EU




PROTECANIS 0,5 % M REPELLENT DOGS SPRAY


Market area: EU




REPULSIS 0,5 % M REPELLENT DOGS SPRAY


Market area: EU




EFFECTIS 0,5 % M REPELLENT DOGS SPRAY


Market area: EU




PREVENCID 0,5 % M REPELLENT DOGS SPRAY


Market area: EU




Authorisation number


 


EU-0032868-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


0,5 % (w/w)




2-fenoxietanol


—


Non-active substance


122-99-6


204-589-7


0,4 % (w/w)




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













Trade name(s)


PREVENTIS 0,5 % M REPELLENT CATS SPRAY


Market area: EU




PROTECANIS 0,5 % M REPELLENT CATS SPRAY


Market area: EU




REPULSIS 0,5 % M REPELLENT CATS SPRAY


Market area: EU




EFFECTIS 0,5 % M REPELLENT CATS SPRAY


Market area: EU




PREVENCID 0,5 % M REPELLENT CATS SPRAY


Market area: EU




Authorisation number


 


EU-0032868-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


0,5 % (w/w)




2-fenoxietanol


—


Non-active substance


122-99-6


204-589-7


0,4 % (w/w)




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


REPELLENT FOAM




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT19: Repellents and attractants




2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


0,4 -0,4  % (w/w)




2-fenoxietanol


—


Non-active substance


122-99-6


204-589-7


0,42 -0,42  % (w/w)




2.2.   Type(s) of formulation of the meta SPC 2







Formulation type(s)


AE Aerosol dispenser




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


H222: Extremely flammable aerosol
H229: Pressurised container: May burst if heated
EUH208: Contains benzyl alcohol. 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.
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.
P410 + P412: Protect from sunlight. Do no expose to temperatures exceeding 50 °C/ 122 °F.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Repellent foam for cats







Product type


PT19: Repellents and attractants




Where relevant, an exact description of the authorised use


REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES




Target organism(s) (including development stage)


Scientific name: Ctenocephalides sp.
Common name: fleas
Development stage: adults
Scientific name: Rhipicephalus sanguineus
Common name: ticks
Development stage: adults
Scientific name: Ixodes ricinus
Common name: ticks
Development stage: adults
Scientific name: Aedes sp.
Common name: mosquitoes
Development stage: adults
Scientific name: Culex sp.
Common name: mosquitoes
Development stage: adults




Field(s) of use


Repellent foam for cats




Application method(s)


Method: foam application
Detailed description:
—




Application rate(s) and frequency


Application Rate:
4 g/kg bodyweight
Number and timing of application:
Protection time up to 4 days (ticks) and up to 7 days (fleas and mosquitoes)
Maximum 91 applications per year




Category(ies) of users


general public (non-professional)




Pack sizes and packaging material


150 ml aerosol can in varnished aluminium




4.1.1.   Use-specific instructions for use

—
4.1.2.   Use-specific risk mitigation measures

—
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

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

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

—
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use







—


Comply with instructions for use.










—


90 % repellent efficacy lasts up to 4 days against ticks and up to 7 days against fleas and mosquitoes, in areas with low parasite pressure (e.g. urban or semi-urban areas with low exposure to target organisms, animals living indoors).










—


The product shall not be applied on wet animals.










—


Only to be used by adults.










—


Do not wash or bathe the animal after application and during all the protection time.










—


Reapply the product if the animal has been unintentionally wetted after the application (e.g. rain), without exceeding the maximum number of applications per year.










—


The protection time is only indicative. Environmental factors (e.g. high temperature, wind velocity) or trimming the hairs can modify it.










—


This product is not intended to be applied on already infested pets.










—


Do not apply on injured skin.










—


Do not use on a sick or convalescent animal nor on animals under 3 months old.










—


The use of the product with other repellent products is not recommended.










—


Efficacy in tropical conditions has not been verified.










—


Shake before use. Place a quantity equivalent to the size of a lemon in the palm of your hand. For a cat of 3 kg, this is equivalent to a pressure on the spray of 3 seconds. Apply the foam to the entire body of the animal (avoiding the eyes and the mucous membranes) and massage until the fur is completely dry.










—


Protection against biting has not been demonstrated.




5.2.   Risk mitigation measures

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







—


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










—


IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If irritation or rash occur: get medical advice.










—


IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.










—


IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.










—


IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.




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







—


Keep out of reach of children and non-target animals/pets.










—


Protect from frost.










—


Store at a temperature below 40 °C.










—


Shelf life: 8 weeks.




6.   OTHER INFORMATION

—
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

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













Trade name(s)


PREVENTIS 0,4 % M REPELLENT CATS FOAM


Market area: EU




PROTECANIS 0,4 % M REPELLENT CATS FOAM


Market area: EU




REPULSIS 0,4 % M REPELLENT CATS FOAM


Market area: EU




EFFECTIS 0,4 % M REPELLENT CATS FOAM


Market area: EU




PREVENCID 0,4 % M REPELLENT CATS FOAM


Market area: EU




Authorisation number


 


EU-0032868-0003 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


0,4 % (w/w)




2-fenoxietanol


—


Non-active substance


122-99-6


204-589-7


0,42 % (w/w)




1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


Repellent spot-on




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT19: Repellents and attractants




2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


10 -20  % (w/w)




2.2.   Type(s) of formulation of the meta SPC 3







Formulation type(s)


SA Spot-on




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


 




Precautionary statements


 




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Spot-on Repellent for cats and dogs







Product type


PT19: Repellents and attractants




Where relevant, an exact description of the authorised use


Repellent against fleas, ticks and mosquitoes




Target organism(s) (including development stage)


Scientific name: Aedes sp.
Common name: mosquitoes
Development stage: adults
Scientific name: Culex sp.
Common name: mosquitoes
Development stage: adults
Scientific name: Ctenocephalides sp.
Common name: fleas
Development stage: adults
Scientific name: Rhipicephalus sanguineus
Common name: ticks
Development stage: adults
Scientific name: Ixodes ricinus
Common name: ticks
Development stage: adults




Field(s) of use


Spot-on Repellent for cats and dogs




Application method(s)


Method: Spot-on
Detailed description:
—




Application rate(s) and frequency


Application Rate:






 


0,368 g/kg bodyweight (10 % Margosa)










 


0,184 g/kg bodyweight (20 % Margosa)




Number and timing of application:






 


0,368 g/kg bodyweight (10 % Margosa), i.e. 0,6 ml of product for cats until 1,5 kg bodyweight and 1,2 ml for cats until 3 kg bodyweight.










 


0,184 g/kg bodyweight (20 % Margosa), i.e. approximately 2 ml of product for dogs until 10 kg bodyweight and 3 ml for dogs until 15 kg bodyweight.




Protection time up to 30 days
Maximum 4 applications per year




Category(ies) of users


general public (non-professional)




Pack sizes and packaging material


3 mL tubes in LDPE/HDPE (filled from 0,6 ml to 3 ml according to pet category)




4.1.1.   Use-specific instructions for use

—
4.1.2.   Use-specific risk mitigation measures

—
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

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

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

—
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1.   Instructions for use







—


Comply with the instructions for use.










—


The application rate of the product is:










—


0,368 g/kg bodyweight (10 % Margosa), i.e. 0,6 ml of product for cats until 1,5 kg bodyweight and 1,2 ml for cats until 3 kg bodyweight.










—


0,184 g/kg bodyweight (20 % Margosa), i.e. approximately 2 ml of product for dogs until 10 kg and 3 ml for dogs until 15 kg bodyweight.










—


90 % repellent efficacy lasts up to 30 days against fleas, ticks and mosquitoes, in areas with low parasite pressure (e.g. urban or semi-urban areas with low exposure to target organisms, animals living indoors).










—


The product shall not be applied on wet animals.










—


Only to be used by adults.










—


Do not wash or bathe the animal after application and during all the protection time










—


Reapply the product if the animal has been unintentionally wetted after the application (e.g. rain), without exceeding the maximum number of applications per year.










—


The protection time is only indicative. Environmental factors (e.g. high temperature, wind velocity) can modify it.










—


This product is not intended to be applied on already infested pets.










—


Do not apply on injured skin.










—


Do not use on a sick or convalescent animal.










—


The use of the product with other repellent products is not recommended.










—


Efficacy in tropical conditions has not been verified.










—


Spread the hairs at the base of the neck until the skin is visible. Place the tip of the pipette on the skin and gently press down to empty the pipette. Avoid applying the pipette on the coat and do not rub the skin.










—


Protection against biting has not been demonstrated.










—


The frequency of use of the product is limited to maximum 4 applications per year.




5.2.   Risk mitigation measures







—


Do not use on animals under 3 months old nor on dogs under 2 kg.




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







—


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










—


IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.










—


IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.










—


IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.










—


IF INHALED: not applicable.




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







—


Keep out of reach of children and non-target animals pets.










—


Protect from frost.










—


Store at a temperature below 40 °C.










—


Shelf life: 1 year




6.   OTHER INFORMATION

—
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

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













Trade name(s)


PREVENTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS


Market area: EU




PROTECANIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS


Market area: EU




REPULSIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS


Market area: EU




EFFECTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS


Market area: EU




PREVENCID 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS


Market area: EU




Authorisation number


 


EU-0032868-0004 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


20 % (w/w)




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













Trade name(s)


PREVENTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS


Market area: EU




PROTECANIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS


Market area: EU




REPULSIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS


Market area: EU




EFFECTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS


Market area: EU




PREVENCID 20 % REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS


Market area: EU




Authorisation number


 


EU-0032868-0005 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


20 % (w/w)




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













Trade name(s)


PREVENTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS


Market area: EU




PROTECANIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS


Market area: EU




REPULSIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS


Market area: EU




EFFECTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS


Market area: EU




PREVENCID 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS


Market area: EU




Authorisation number


 


EU-0032868-0006 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


20 % (w/w)




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













Trade name(s)


PREVENTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS


Market area: EU




PROTECANIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS


Market area: EU




REPULSIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS


Market area: EU




EFFECTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS


Market area: EU




PREVENCID 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS


Market area: EU




Authorisation number


 


EU-0032868-0007 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


10 % (w/w)




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













Trade name(s)


PREVENTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS


Market area: EU




PROTECANIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS


Market area: EU




REPULSIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS


Market area: EU




EFFECTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS


Market area: EU




PREVENCID 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS


Market area: EU




Authorisation number


 


EU-0032868-0008 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide


Not applicable


Active substance


84696-25-3


283-644-7


10 % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj
ISSN 1977-0677 (electronic edition)