LegalizeCommission 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
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| Image omitted; see official source | Official Journal of the European Union | EN L series |
| --- | --- | --- |
| 2025/1203 | 20.6.2025 |
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
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 |
| Name and address of the authorisation holder | 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) | Trade name(s) | Trade name(s) | PREVENTIS 0,5 % M REPELLENT DOGS SPRAY | PREVENTIS 0,5 % M REPELLENT DOGS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PROTECANIS 0,5 % M REPELLENT DOGS SPRAY | PROTECANIS 0,5 % M REPELLENT DOGS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | REPULSIS 0,5 % M REPELLENT DOGS SPRAY | REPULSIS 0,5 % M REPELLENT DOGS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | EFFECTIS 0,5 % M REPELLENT DOGS SPRAY | EFFECTIS 0,5 % M REPELLENT DOGS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PREVENCID 0,5 % M REPELLENT DOGS SPRAY | PREVENCID 0,5 % M REPELLENT DOGS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032868-0001 1-1 | EU-0032868-0001 1-1 | EU-0032868-0001 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | 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 | Active substance | 84696-25-3 | 84696-25-3 | 283-644-7 | 0,5 % (w/w) |
| 2-fenoxietanol | — | Non-active substance | Non-active substance | 122-99-6 | 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) | Trade name(s) | Trade name(s) | PREVENTIS 0,5 % M REPELLENT CATS SPRAY | PREVENTIS 0,5 % M REPELLENT CATS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PROTECANIS 0,5 % M REPELLENT CATS SPRAY | PROTECANIS 0,5 % M REPELLENT CATS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | REPULSIS 0,5 % M REPELLENT CATS SPRAY | REPULSIS 0,5 % M REPELLENT CATS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | EFFECTIS 0,5 % M REPELLENT CATS SPRAY | EFFECTIS 0,5 % M REPELLENT CATS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PREVENCID 0,5 % M REPELLENT CATS SPRAY | PREVENCID 0,5 % M REPELLENT CATS SPRAY | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032868-0002 1-1 | EU-0032868-0002 1-1 | EU-0032868-0002 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | 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 | Active substance | 84696-25-3 | 84696-25-3 | 283-644-7 | 0,5 % (w/w) |
| 2-fenoxietanol | — | Non-active substance | Non-active substance | 122-99-6 | 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) | Trade name(s) | Trade name(s) | PREVENTIS 0,4 % M REPELLENT CATS FOAM | PREVENTIS 0,4 % M REPELLENT CATS FOAM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PROTECANIS 0,4 % M REPELLENT CATS FOAM | PROTECANIS 0,4 % M REPELLENT CATS FOAM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | REPULSIS 0,4 % M REPELLENT CATS FOAM | REPULSIS 0,4 % M REPELLENT CATS FOAM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | EFFECTIS 0,4 % M REPELLENT CATS FOAM | EFFECTIS 0,4 % M REPELLENT CATS FOAM | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PREVENCID 0,4 % M REPELLENT CATS FOAM | PREVENCID 0,4 % M REPELLENT CATS FOAM | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032868-0003 1-2 | EU-0032868-0003 1-2 | EU-0032868-0003 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | 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 | Active substance | 84696-25-3 | 84696-25-3 | 283-644-7 | 0,4 % (w/w) |
| 2-fenoxietanol | — | Non-active substance | Non-active substance | 122-99-6 | 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) | Trade name(s) | Trade name(s) | PREVENTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS | PREVENTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PROTECANIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS | PROTECANIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | REPULSIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS | REPULSIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | EFFECTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS | EFFECTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PREVENCID 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS | PREVENCID 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032868-0004 1-3 | EU-0032868-0004 1-3 | EU-0032868-0004 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | 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 | Active substance | 84696-25-3 | 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) | Trade name(s) | Trade name(s) | PREVENTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS | PREVENTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PROTECANIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS | PROTECANIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | REPULSIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS | REPULSIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | EFFECTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS | EFFECTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PREVENCID 20 % REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS | PREVENCID 20 % REPELLENT SPOT-ON SOLUTION FOR MEDIUM-SIZED DOGS | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032868-0005 1-3 | EU-0032868-0005 1-3 | EU-0032868-0005 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | 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 | Active substance | 84696-25-3 | 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) | Trade name(s) | Trade name(s) | PREVENTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS | PREVENTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PROTECANIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS | PROTECANIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | REPULSIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS | REPULSIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | EFFECTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS | EFFECTIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PREVENCID 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS | PREVENCID 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032868-0006 1-3 | EU-0032868-0006 1-3 | EU-0032868-0006 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | 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 | Active substance | 84696-25-3 | 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) | Trade name(s) | Trade name(s) | PREVENTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS | PREVENTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PROTECANIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS | PROTECANIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | REPULSIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS | REPULSIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | EFFECTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS | EFFECTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PREVENCID 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS | PREVENCID 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032868-0007 1-3 | EU-0032868-0007 1-3 | EU-0032868-0007 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | 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 | Active substance | 84696-25-3 | 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) | Trade name(s) | Trade name(s) | PREVENTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS | PREVENTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PROTECANIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS | PROTECANIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | REPULSIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS | REPULSIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | EFFECTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS | EFFECTIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | PREVENCID 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS | PREVENCID 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032868-0008 1-3 | EU-0032868-0008 1-3 | EU-0032868-0008 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | 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 | Active substance | 84696-25-3 | 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)
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