Commission Implementing Regulation (EU) 2021/1044 of 22 June 2021 granting a Union authorisation for the single biocidal product ‘Pesguard® Gel’ (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) 2022/2405of 7 December 2022correcting Implementing Regulation (EU) 2021/1044 as regards the period of validity of the Union authorisation for the single biocidal product Pesguard® Gel(Text with EEA relevance), 32022R2405, December 9, 2022
Commission Implementing Regulation (EU) 2021/1044of 22 June 2021granting a Union authorisation for the single biocidal product Pesguard® Gel(Text with EEA relevance)
Article 1A Union authorisation with authorisation number EU-0024951-0000 is granted to Sumitomo Chemical Agro Europe SAS for the making available on the market and use of the single biocidal product "Pesguard® Gel" in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 15 July 2021 until 30 June 2026.
Article 2This 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.ANNEXSummary of product characteristics for a biocidal productPesguard® GelProduct type 18 – Insecticides, acaricides and products to control other arthropods (Pest control)Authorisation number: EU-0024951-0000R4BP asset number: EU-0024951-00001.ADMINISTRATIVE INFORMATION1.1.Trade name(s) of the product
Trade name(s)Pesguard® Gel
1.2.Authorisation holder
Name and address of the authorisation holderNameSumitomo Chemical Agro Europe SAS
AddressParc d’Affaires de Crécy 10A, rue de la Voie Lactée, 69370 Saint Didier au Mont d’Or, France
Authorisation numberEU-0024951-0000
R4BP asset numberEU-0024951-0000
Date of the authorisation15 July 2021
Expiry date of the authorisation30 June 2026
1.3.Manufacturer(s) of the product
Name of manufacturerMcLaughlin Gormley King Company (MGK)
Address of manufacturer8810 10th Avenue North, MN 55427 Minneapolis United States
Location of manufacturing sitesMcLaughlin Gormley King Company, 4001 Peavey Road, MN 55318 Chaska United States
1.4.Manufacturer(s) of the active substance(s)
Active substance(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine (Clothianidin)
Name of manufacturerSumitomo Chemical Co. Ltd
Address of manufacturer27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan
Location of manufacturing sitesSumitomo Chemical Company LTD, Oita Works, 2200, Tsurusaki, Oita City„ 870-0106 Oita Japan
Active substancepyriproxyfen
Name of manufacturerSumitomo Chemical Co. Ltd
Address of manufacturer27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan
Location of manufacturing sitesSumitomo Chemical Company LTD, Misawa Works, Aza-Sabishirotaira, Oaza-Misawa, Misawa„ 033-0022 Aomori Japan
2.PRODUCT COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the product
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Clothianidin(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidineActive Substance210880-92-5433-460-10,526
pyriproxyfen4-phenoxyphenyl (RS)-2-(2- pyridyloxy)propyl etherActive Substance95737-68-1429-800-10,515
Acetic acidEthanoic acidNon-active substance64-19-7200-580-70,3
Potassium sorbatepotassium (E,E)-hexa-2,4-dienoateNon-active substance24634-61-5246-376-10,5
2.2.Type of formulationRB – Bait (ready for use)3.HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statementsMay cause an allergic skin reaction.Very toxic to aquatic life with long lasting effects.
Precautionary statementsIF ON SKIN:Wash with plenty of water.If skin irritation or rash occurs: Get medical advice.Wear protective gloves.Avoid release to the environment.Dispose of container in accordance with local regulations.Collect spillage.
4.AUTHORISED USE(S)4.1.Use description
Table 1. Use # 1 – Professional Use – RTU Bait
Product typePT18 – Insecticides, acaricides and products to control other arthropods (Pest control)
Where relevant, an exact description of the authorised useInsecticide
Target organism(s) (including development stage)Scientific name: Blattella germanicaCommon name: German cockroachDevelopment stage: NymphsScientific name: Blattella germanicaCommon name: German cockroachDevelopment stage: AdultsScientific name: Supella longipalpaCommon name: Brown-banded cockroachDevelopment stage: NymphsScientific name: Supella longipalpaCommon name: Brown-banded cockroachDevelopment stage: AdultsScientific name: Blatta orientalisCommon name: Oriental CockroachDevelopment stage: NymphsScientific name: Blatta orientalisCommon name: Oriental CockroachDevelopment stage: AdultsScientific name: Periplaneta americanaCommon name: American CockroachDevelopment stage: NymphsScientific name: Periplaneta americanaCommon name: American CockroachDevelopment stage: Adults
Field(s) of useIndoorIn cracks and crevices, or in concealed locations inaccessible to humans or domestic animals: behind refrigerators cupboards and shelves, under kitchen appliances, in electrical control boxes, voids and ducting and under bathroom fixtures etc.
Application method(s)Bait applicationA ready to use (RTU) insecticidal gel bait for the control of cockroaches in public hygiene
Application rate(s) and frequencyPesguard® Gel should be applied as a number of spots of approximately 4 mm diameter (each spot comprising approximately 0,032 g of bait).In cases of severe infestation, where larger cockroach species are present (B. orientalis or P. americana), in areas that are particularly dirty or cluttered or where alternative sources of food cannot be entirely eliminated the higher application rate (e.g. 2 instead of 1 spot per m2 in case of a light infestation) should be used.Light infestation 1 – 2 (0,032 – 0,064 g) spots per m2Medium infestation 3 – 6 (0,096 – 0,192 g) spots per m2Heavy infestation 6 – 10 (0,192 – 0,320 g) spots per m2The maximum number of annual applications is 11.
Category(ies) of usersProfessional
Pack sizes and packaging material30 g Polypropylene (PP) syringeScrew top cap High Density Poly Ethylene (HDPE)
4.1.1.Use-specific instructions for useSee the general directions for use.4.1.2.Use-specific risk mitigation measuresSee the general directions for use.4.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee the general directions for use.4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee the general directions for use.4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee the general directions for use.5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.5.1.Instructions for useAlways read the label or leaflet before use and respect/follow all the instructions provided.Do not expose bait drops to sunlight or heat (e.g. radiator).The pre-filled plastic reservoir containing Pesguard® Gel is intended for use with the plunger provided or a specific bait application device common to the pest control industry. Refer to the manufacturer’s instructions for directions on the use of the applicator.Inject the bait into cracks and crevices, void spaces, or in concealed locations inaccessible to humans or domestic animals where insects may live, feed and breed. Such areas are generally warm/damp and dark (behind refrigerators, cupboards and shelves, under kitchen appliances, in electrical control boxes, voids and ducting and under bathroom fixtures etc.). Inspection or trapping to confirm infestation is recommended prior to treatment. Ensure that any alternative food sources are removed and concentrate the bait placements as individual spots at cockroach activity sites. The product should not be applied to areas accessible to children and pets.Do not apply Pesguard® Gel where it will come into contact with water or in areas that are routinely cleaned. Typically cockroaches will die a few hours after a single feed on Pesguard® Gel. In infested premises, dead cockroaches will normally be seen within 24 hours of treatment.Remove the cap from the nozzle, touch the top to the surface to be treated, and push down on the plunger. Replace the cap on the dispenser after treatment is completed.The bait will adhere to non-greasy or non-dusty surfaces and will remain pliable and palatable to cockroaches as long as it is visibly present.Treated area’s should be visually inspected after 1-2 weeks. Where initial infestation was heavy a second Pesguard® Gel application may be required if the first treatment has been consumed and live cockroaches are still present.A second visual inspection of bait placements is recommended 2-4 weeks after the initial treatment. Reapply when bait is no longer visibly present, according to the level of infestation (light, medium or heavy). Replace bait before it is completely consumed to keep cockroaches from returning.Inform the registration holder if the treatment is ineffective.Spills and residues containing the product need to be removed as chemical waste.Care should be taken to avoid depositing gel onto exposed surfaces. If gel contacts an exposed surface, remove gel with a paper towel and clean the area with disposable wet wipes.During follow-up visits, inspect bait placements and re-apply when necessary.Do not place bait in locations that are routinely washed, as bait will be removed by washing. Do not use this product in or on electrical equipment where a possibility of shock hazard exists. Avoid contact with textiles and clothing, as bait may stain.5.2.Risk mitigation measuresWear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).Do not apply bait in areas where repellent insecticides have been used without thoroughly cleaning the surface with disposable wet tissue. Do not apply repellent insecticides after application of the bait.Do not apply directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food, feed, drinks and animals.Spills and residues containing the product must be removed as chemical waste.Avoid placing gel on fabrics or carpets since it may stain some absorbent materials. To prevent staining, exposed bait should be cleaned up immediately with disposable wet wipes.Cleaning materials must be disposed of as to solid waste.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentThis biocidal product contains clothianidin, which is dangerous to bees.Description of first aid measuresSkin contact: Remove contaminated clothing immediately and wash skin with soap and water. Get medical attention if irritation persists after washing.Eye contact: If symptoms occur, rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.Ingestion: If swallowed: If symptons occur call a POISON CENTRE or a doctor.If inhaled: not applicable.Most important symptoms and effects, both acute and delayedEyes: May cause temporary eye irritation.Emergency measures to protect the environmentAvoid release of the product to the environment.5.4.Instructions for safe disposal of the product and its packagingOnly pass on empty containers/packaging for recycling.Disposal of this packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageProtect from frost. Store away from direct sunlight.Shelf life: 2 years.6.OTHER INFORMATION
Article 1A Union authorisation with authorisation number EU-0024951-0000 is granted to Sumitomo Chemical Agro Europe SAS for the making available on the market and use of the single biocidal product "Pesguard® Gel" in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 15 July 2021 until 30 June 2026.
Article 2This 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.ANNEXSummary of product characteristics for a biocidal productPesguard® GelProduct type 18 – Insecticides, acaricides and products to control other arthropods (Pest control)Authorisation number: EU-0024951-0000R4BP asset number: EU-0024951-00001.ADMINISTRATIVE INFORMATION1.1.Trade name(s) of the product
Trade name(s)Pesguard® Gel
1.2.Authorisation holder
Name and address of the authorisation holderNameSumitomo Chemical Agro Europe SAS
AddressParc d’Affaires de Crécy 10A, rue de la Voie Lactée, 69370 Saint Didier au Mont d’Or, France
Authorisation numberEU-0024951-0000
R4BP asset numberEU-0024951-0000
Date of the authorisation15 July 2021
Expiry date of the authorisation30 June 2026
1.3.Manufacturer(s) of the product
Name of manufacturerMcLaughlin Gormley King Company (MGK)
Address of manufacturer8810 10th Avenue North, MN 55427 Minneapolis United States
Location of manufacturing sitesMcLaughlin Gormley King Company, 4001 Peavey Road, MN 55318 Chaska United States
1.4.Manufacturer(s) of the active substance(s)
Active substance(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine (Clothianidin)
Name of manufacturerSumitomo Chemical Co. Ltd
Address of manufacturer27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan
Location of manufacturing sitesSumitomo Chemical Company LTD, Oita Works, 2200, Tsurusaki, Oita City„ 870-0106 Oita Japan
Active substancepyriproxyfen
Name of manufacturerSumitomo Chemical Co. Ltd
Address of manufacturer27-1, Shinkawa 2-chome, Chuo-ku, 104-8260 Tokyo Japan
Location of manufacturing sitesSumitomo Chemical Company LTD, Misawa Works, Aza-Sabishirotaira, Oaza-Misawa, Misawa„ 033-0022 Aomori Japan
2.PRODUCT COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the product
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Clothianidin(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidineActive Substance210880-92-5433-460-10,526
pyriproxyfen4-phenoxyphenyl (RS)-2-(2- pyridyloxy)propyl etherActive Substance95737-68-1429-800-10,515
Acetic acidEthanoic acidNon-active substance64-19-7200-580-70,3
Potassium sorbatepotassium (E,E)-hexa-2,4-dienoateNon-active substance24634-61-5246-376-10,5
2.2.Type of formulationRB – Bait (ready for use)3.HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statementsMay cause an allergic skin reaction.Very toxic to aquatic life with long lasting effects.
Precautionary statementsIF ON SKIN:Wash with plenty of water.If skin irritation or rash occurs: Get medical advice.Wear protective gloves.Avoid release to the environment.Dispose of container in accordance with local regulations.Collect spillage.
4.AUTHORISED USE(S)4.1.Use description
Table 1. Use # 1 – Professional Use – RTU Bait
Product typePT18 – Insecticides, acaricides and products to control other arthropods (Pest control)
Where relevant, an exact description of the authorised useInsecticide
Target organism(s) (including development stage)Scientific name: Blattella germanicaCommon name: German cockroachDevelopment stage: NymphsScientific name: Blattella germanicaCommon name: German cockroachDevelopment stage: AdultsScientific name: Supella longipalpaCommon name: Brown-banded cockroachDevelopment stage: NymphsScientific name: Supella longipalpaCommon name: Brown-banded cockroachDevelopment stage: AdultsScientific name: Blatta orientalisCommon name: Oriental CockroachDevelopment stage: NymphsScientific name: Blatta orientalisCommon name: Oriental CockroachDevelopment stage: AdultsScientific name: Periplaneta americanaCommon name: American CockroachDevelopment stage: NymphsScientific name: Periplaneta americanaCommon name: American CockroachDevelopment stage: Adults
Field(s) of useIndoorIn cracks and crevices, or in concealed locations inaccessible to humans or domestic animals: behind refrigerators cupboards and shelves, under kitchen appliances, in electrical control boxes, voids and ducting and under bathroom fixtures etc.
Application method(s)Bait applicationA ready to use (RTU) insecticidal gel bait for the control of cockroaches in public hygiene
Application rate(s) and frequencyPesguard® Gel should be applied as a number of spots of approximately 4 mm diameter (each spot comprising approximately 0,032 g of bait).In cases of severe infestation, where larger cockroach species are present (B. orientalis or P. americana), in areas that are particularly dirty or cluttered or where alternative sources of food cannot be entirely eliminated the higher application rate (e.g. 2 instead of 1 spot per m2 in case of a light infestation) should be used.Light infestation 1 – 2 (0,032 – 0,064 g) spots per m2Medium infestation 3 – 6 (0,096 – 0,192 g) spots per m2Heavy infestation 6 – 10 (0,192 – 0,320 g) spots per m2The maximum number of annual applications is 11.
Category(ies) of usersProfessional
Pack sizes and packaging material30 g Polypropylene (PP) syringeScrew top cap High Density Poly Ethylene (HDPE)
4.1.1.Use-specific instructions for useSee the general directions for use.4.1.2.Use-specific risk mitigation measuresSee the general directions for use.4.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee the general directions for use.4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee the general directions for use.4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee the general directions for use.5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.5.1.Instructions for useAlways read the label or leaflet before use and respect/follow all the instructions provided.Do not expose bait drops to sunlight or heat (e.g. radiator).The pre-filled plastic reservoir containing Pesguard® Gel is intended for use with the plunger provided or a specific bait application device common to the pest control industry. Refer to the manufacturer’s instructions for directions on the use of the applicator.Inject the bait into cracks and crevices, void spaces, or in concealed locations inaccessible to humans or domestic animals where insects may live, feed and breed. Such areas are generally warm/damp and dark (behind refrigerators, cupboards and shelves, under kitchen appliances, in electrical control boxes, voids and ducting and under bathroom fixtures etc.). Inspection or trapping to confirm infestation is recommended prior to treatment. Ensure that any alternative food sources are removed and concentrate the bait placements as individual spots at cockroach activity sites. The product should not be applied to areas accessible to children and pets.Do not apply Pesguard® Gel where it will come into contact with water or in areas that are routinely cleaned. Typically cockroaches will die a few hours after a single feed on Pesguard® Gel. In infested premises, dead cockroaches will normally be seen within 24 hours of treatment.Remove the cap from the nozzle, touch the top to the surface to be treated, and push down on the plunger. Replace the cap on the dispenser after treatment is completed.The bait will adhere to non-greasy or non-dusty surfaces and will remain pliable and palatable to cockroaches as long as it is visibly present.Treated area’s should be visually inspected after 1-2 weeks. Where initial infestation was heavy a second Pesguard® Gel application may be required if the first treatment has been consumed and live cockroaches are still present.A second visual inspection of bait placements is recommended 2-4 weeks after the initial treatment. Reapply when bait is no longer visibly present, according to the level of infestation (light, medium or heavy). Replace bait before it is completely consumed to keep cockroaches from returning.Inform the registration holder if the treatment is ineffective.Spills and residues containing the product need to be removed as chemical waste.Care should be taken to avoid depositing gel onto exposed surfaces. If gel contacts an exposed surface, remove gel with a paper towel and clean the area with disposable wet wipes.During follow-up visits, inspect bait placements and re-apply when necessary.Do not place bait in locations that are routinely washed, as bait will be removed by washing. Do not use this product in or on electrical equipment where a possibility of shock hazard exists. Avoid contact with textiles and clothing, as bait may stain.5.2.Risk mitigation measuresWear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).Do not apply bait in areas where repellent insecticides have been used without thoroughly cleaning the surface with disposable wet tissue. Do not apply repellent insecticides after application of the bait.Do not apply directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food, feed, drinks and animals.Spills and residues containing the product must be removed as chemical waste.Avoid placing gel on fabrics or carpets since it may stain some absorbent materials. To prevent staining, exposed bait should be cleaned up immediately with disposable wet wipes.Cleaning materials must be disposed of as to solid waste.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentThis biocidal product contains clothianidin, which is dangerous to bees.Description of first aid measuresSkin contact: Remove contaminated clothing immediately and wash skin with soap and water. Get medical attention if irritation persists after washing.Eye contact: If symptoms occur, rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.Ingestion: If swallowed: If symptons occur call a POISON CENTRE or a doctor.If inhaled: not applicable.Most important symptoms and effects, both acute and delayedEyes: May cause temporary eye irritation.Emergency measures to protect the environmentAvoid release of the product to the environment.5.4.Instructions for safe disposal of the product and its packagingOnly pass on empty containers/packaging for recycling.Disposal of this packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageProtect from frost. Store away from direct sunlight.Shelf life: 2 years.6.OTHER INFORMATION