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

Official Journal EN of the European Union 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, (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). ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 1/22EN OJ L, 20.6.2025 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 2/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/ojEN OJ L, 20.6.2025 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 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 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 3/22EN OJ L, 20.6.2025 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, Not applicable Active 84696-25-3 283-644-7 0,4-20 % (w/w) cold-pressed oil substance of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide 2-fenoxietanol — Non-active 122-99-6 204-589-7 0-0,42 % (w/w) substance 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 4/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/ojEN OJ L, 20.6.2025 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, Not applicable Active 84696-25-3 283-644-7 0,5-0,5 % (w/w) cold-pressed oil substance of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide 2-fenoxietanol — Non-active 122-99-6 204-589-7 0,4-0,4 % (w/w) substance 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 REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES authorised use Target organism(s) (including development Scientific name: Ctenocephalides sp. stage) 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 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 5/22EN OJ L, 20.6.2025 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. 6/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/ojEN OJ L, 20.6.2025 — 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 — ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 7/22EN OJ L, 20.6.2025 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 Market area: EU 0,5 % M REPELLENT DOGS SPRAY PROTECA­ Market area: EU NIS 0,5 % M REPELLENT DOGS SPRAY REPULSIS Market area: EU 0,5 % M REPELLENT DOGS SPRAY EFFECTIS Market area: EU 0,5 % M REPELLENT DOGS SPRAY PREVEN­ Market area: EU CID 0,5 % M REPELLENT DOGS SPRAY Authorisation number EU-0032868-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Margosa extract, Not applicable Active substance 84696-25-3 283-644-7 0,5 % (w/w) cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide 2-fenoxietanol — Non-active 122-99-6 204-589-7 0,4 % (w/w) substance 8/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/ojEN OJ L, 20.6.2025 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) PREVENTIS Market area: EU 0,5 % M REPELLENT CATS SPRAY PROTECA­ Market area: EU NIS 0,5 % M REPELLENT CATS SPRAY REPULSIS Market area: EU 0,5 % M REPELLENT CATS SPRAY EFFECTIS Market area: EU 0,5 % M REPELLENT CATS SPRAY PREVENCID Market area: EU 0,5 % M REPELLENT CATS SPRAY Authorisation number EU-0032868-0002 1-1 Common name IUPAC name Function CAS number EC number Content (%) Margosa extract, Not applicable Active substance 84696-25-3 283-644-7 0,5 % (w/w) cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide 2-fenoxietanol — Non-active 122-99-6 204-589-7 0,4 % (w/w) substance 1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier Identifier REPELLENT FOAM ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 9/22EN OJ L, 20.6.2025 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, Not applicable Active 84696-25-3 283-644-7 0,4-0,4 % (w/w) cold-pressed oil substance of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide 2-fenoxietanol — Non-active 122-99-6 204-589-7 0,42-0,42 % (w/w) substance 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. 10/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/ojEN OJ L, 20.6.2025 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 REPELLENT AGAINST FLEAS, TICKS, AND MOSQUITOES authorised use Target organism(s) (including development Scientific name: Ctenocephalides sp. stage) 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 — ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 11/22EN OJ L, 20.6.2025 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. 12/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/ojEN OJ L, 20.6.2025 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 Market area: EU 0,4 % M REPELLENT CATS FOAM PROTECA­ Market area: EU NIS 0,4 % M REPELLENT CATS FOAM REPULSIS Market area: EU 0,4 % M REPELLENT CATS FOAM EFFECTIS Market area: EU 0,4 % M REPELLENT CATS FOAM PREVEN­ Market area: EU CID 0,4 % M REPELLENT CATS FOAM Authorisation number EU-0032868-0003 1-2 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 13/22EN OJ L, 20.6.2025 Common name IUPAC name Function CAS number EC number Content (%) Margosa extract, Not applicable Active substance 84696-25-3 283-644-7 0,4 % (w/w) cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide 2-fenoxietanol — Non-active 122-99-6 204-589-7 0,42 % (w/w) substance 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, Not applicable Active 84696-25-3 283-644-7 10-20 % (w/w) cold-pressed oil substance of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide 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 14/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/ojEN OJ L, 20.6.2025 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 Repellent against fleas, ticks and mosquitoes authorised use Target organism(s) (including development Scientific name: Aedes sp. stage) 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 — ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 15/22EN OJ L, 20.6.2025 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. 16/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/ojEN OJ L, 20.6.2025 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 Market area: EU 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS PROTECA­ Market area: EU NIS 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 17/22EN OJ L, 20.6.2025 REPULSIS Market area: EU 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS EFFECTIS Market area: EU 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS PREVEN­ Market area: EU CID 20 % M REPELLENT SPOT-ON SOLUTION FOR SMALL DOGS Authorisation number EU-0032868-0004 1-3 Common name IUPAC name Function CAS number EC number Content (%) Margosa extract, Not applicable Active substance 84696-25-3 283-644-7 20 % (w/w) cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) PREVENTIS Market area: EU 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM- SIZED DOGS 18/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/ojEN OJ L, 20.6.2025 PROTECA­ Market area: EU NIS 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM- SIZED DOGS REPULSIS Market area: EU 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM- SIZED DOGS EFFECTIS Market area: EU 20 % M REPELLENT SPOT-ON SOLUTION FOR MEDIUM- SIZED DOGS PREVEN­ Market area: EU CID 20 % REPELLENT SPOT-ON SOLUTION FOR MEDIUM- SIZED DOGS Authorisation number EU-0032868-0005 1-3 Common name IUPAC name Function CAS number EC number Content (%) Margosa extract, Not applicable Active substance 84696-25-3 283-644-7 20 % (w/w) cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 19/22EN OJ L, 20.6.2025 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) PREVENTIS Market area: EU 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS PROTECA­ Market area: EU NIS 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS REPULSIS Market area: EU 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS EFFECTIS Market area: EU 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS PREVEN­ Market area: EU CID 20 % M REPELLENT SPOT-ON SOLUTION FOR LARGE DOGS Authorisation number EU-0032868-0006 1-3 Common name IUPAC name Function CAS number EC number Content (%) Margosa extract, Not applicable Active substance 84696-25-3 283-644-7 20 % (w/w) cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide 20/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/ojEN OJ L, 20.6.2025 7.4. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) PREVENTIS Market area: EU 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS PROTECA­ Market area: EU NIS 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS REPULSIS Market area: EU 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS EFFECTIS Market area: EU 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS PREVEN­ Market area: EU CID 10 % M REPELLENT SPOT-ON SOLUTION FOR CATS Authorisation number EU-0032868-0007 1-3 Common name IUPAC name Function CAS number EC number Content (%) Margosa extract, Not applicable Active substance 84696-25-3 283-644-7 10 % (w/w) cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj 21/22EN OJ L, 20.6.2025 7.5. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) PREVENTIS Market area: EU 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS PROTECA­ Market area: EU NIS 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS REPULSIS Market area: EU 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS EFFECTIS Market area: EU 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS PREVEN­ Market area: EU CID 10 % M REPELLENT SPOT-ON SOLUTION FOR KITTENS Authorisation number EU-0032868-0008 1-3 Common name IUPAC name Function CAS number EC number Content (%) Margosa extract, Not applicable Active substance 84696-25-3 283-644-7 10 % (w/w) cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide 22/22 ELI: http://data.europa.eu/eli/reg_impl/2025/1203/oj