Commission Implementing Regulation (EU) 2023/2649 of 28 November 2023 granting a Union authorisation for the single biocidal product Hokoex in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2023/2649of 28 November 2023granting a Union authorisation for the single biocidal product Hokoex 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 productsOJ L 167, 27.6.2012, p. 1., and in particular Article 44(5), first subparagraph, thereof,Whereas:(1)On 12 December 2017, Hokochemie GmbH submitted to the European Chemicals Agency ("the Agency") an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a single biocidal product named "Hokoex" of product-type 18, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Switzerland had agreed to evaluate the application. The application was recorded under case number BC-TH035808-24 in the Register for Biocidal Products.(2)"Hokoex" contains cyromazine 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 18.(3)On 25 March 2021, 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 4 November 2021, the Agency submitted its opinionECHA opinion of 14 October 2021 on the Union authorisation of the biocidal product "Hokoex" (ECHA/BPC/297/2021), https://echa.europa.eu/it/opinions-on-union-authorisation., the draft summary of the biocidal product characteristics ("SPC") of "Hokoex" and the final assessment report on the single biocidal product, to the Commission in accordance with Article 44(3) of Regulation (EU) No 528/2012.(5)The opinion concludes that "Hokoex" is a single biocidal product within the meaning of Article 3(1), point (r), 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 summary of the biocidal product characteristics (SPC), it meets the conditions laid down in Article 19(1) of that Regulation.(6)On 2 December 2021, 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 "Hokoex".(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 1A Union authorisation with authorisation number EU-0027471-0000 is granted to Hokochemie GmbH for the making available on the market and use of the single biocidal product "Hokoex" in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 19 December 2023 to 30 November 2033.
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.Done at Brussels, 28 November 2023.For the CommissionThe PresidentUrsula von der LeyenANNEXSummary of product characteristics for a biocidal productHokoexProduct type 18 – Insecticides, acaricides and products to control other arthropods (Pest control)Authorisation number: EU-0027471-0000R4BP asset number: EU-0027471-00001.ADMINISTRATIVE INFORMATION1.1.Trade name(s) of the product
Trade name(s)HOKOEXZeroCatchElmadexCyracid 2.0HO.K.O.Meijerin Toukkatuho Cyracid 2.0DiptosolBut-exFly tomb 2.0Neo-Larventox CBEG Madenstop UltraLarvo-MixBEG Larva C2 Ultra
1.2.Authorisation holder
Name and address of the authorisation holderNameHokochemie GmbH
AddressPannerhofstrasse 7, 6353 Weggis Switzerland
Authorisation numberEU-0027471-0000
R4BP asset numberEU-0027471-0000
Date of the authorisation19 December 2023
Expiry date of the authorisation30 November 2033
1.3.Manufacturer(s) of the product
Name of manufacturerSchirm GmbH
Address of manufacturerGeschwister-Scholl-Strasse 127, 39218 Schönebeck Germany
Location of manufacturing sitesDieselstrasse 8, 85107 Baar-Ebenhausen Germany
1.4.Manufacturer(s) of the active substance(s)
Active substanceN-cyclopropyl-1,3,5-triazine-2,4,6-triamine (Cyromazine)
Name of manufacturerJiangsu Flag Chemical Industry Co., Ltd
Address of manufacturerSuyan Road, 210042 Nanjing China
Location of manufacturing sitesHuangyu Industrial Zone, – Shangtang, Zhejiang China
2.PRODUCT COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the product
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
N-cyclopropyl-1,3,5-triazine-2,4,6-triamine (Cyromazine)Active Substance66215-27-8266-257-82,0
2.2.Type of formulationSG – Water soluble granule3.HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statementsHarmful to aquatic life with long lasting effects.
Precautionary statementsAvoid release to the environment.Dispose of contents to (according to local regulation).
4.AUTHORISED USE(S)4.1.Use description
Table 1Use # 1 – Control of nuisance and biting flies in professional livestock in professional farming – professional users
Product typePT18 – Insecticides, acaricides and products to control other arthropods (Pest control)
Where relevant, an exact description of the authorised useLarvicide to control nuisance and biting flies in professional livestock:Indoors for use in animal housings of the following types of animals in places where manure and/or other excrements are not compressed: dairy cows, beef cattle, veal calves, sows in individual pens, sows in groups, fattening pigs, laying hens in free range, laying hens in enriched battery cages, broilers, turkeys, ducks, geese, rabbits, horses, goats, sheep, and minks.
Target organism(s) (including development stage)Scientific name: Muscidae:Common name: FliesDevelopment stage: All larval stages
Field(s) of useIndoorIndoors in animal housings
Application method(s)Method: SprayingDetailed description:Low pressure spraying – Add water to product up to approximately half of the final water volume, stir thoroughly, top up to the final volume and stir briefly before use. Spray the same day.In case of dry organic matter, only apply by spraying or pouring.Method: PouringDetailed description:Pouring with watering can – Add water to product up to approximately half of the final water volume, stir thoroughly, top up to the final volume and stir briefly before use. Use the same day.Method: SpreadingDetailed description:Dry scattering by hand – Apply directly to places where fly maggots develop. Do not spread onto dry manure or manure with dried surface. In case of dry organic matter, only apply by spraying or pouring.
Application rate(s) and frequencyApplication Rate: Low pressure spraying: 25 g/m2 (undiluted product (granules))Dilution (%): For a surface of 10 m2 add 250 g product in water, fill up to a total volume of 1 – 4 L depending on the humidity of the substrate to be treated.Number and timing of application:Initial application:Ideally shortly after stable clean-outs or directly prior to fly season. Can also be applied when fly season has commenced.Due to the mode of action of cyromazine, effective larval control starts delayed. The biocidal product efficiently controls fly populations from two weeks up to 10 weeks after larvicidal treatment.Re-applicationIf necessary, applications may be repeated once fly larvae reappear. For the number of maximum applications, see section use-specific instructions for use below.Application Rate: Pouring with watering can: 25 g/m2 (undiluted product (granules))Dilution (%): For a surface of 10 m2 add 250 g product in water, fill up to a total volume of 4 – 10 L depending on the humidity of the substrate to be treated.Number and timing of application:Initial application:Ideally shortly after stable clean-outs or directly prior to fly season. Can also be applied when fly season has commenced.Due to the mode of action of cyromazine, effective larval control starts delayed. The biocidal product efficiently controls fly populations from two weeks up to 10 weeks after larvicidal treatment.Re-applicationIf necessary, applications may be repeated once fly larvae reappear. For the number of maximum applications, see section use-specific instructions for use below.Application Rate: Dry scattering by hand: 25 g/m2Dilution (%): Direct application of granulesNumber and timing of application:Initial application:Ideally shortly after stable clean-outs or directly prior to fly season. Can also be applied when fly season has commenced.Due to the mode of action of cyromazine, effective larval control starts delayed. The biocidal product efficiently controls fly populations from two weeks up to 10 weeks after larvicidal treatment.Re-applicationIf necessary, applications may be repeated once fly larvae reappear. For the number of maximum applications, see section use-specific instructions for use below.
Category(ies) of usersProfessional
Pack sizes and packaging materialSizes:1, 5, 7, 10, 12,5, 20, 25, 50 kg.Packaging materials:PP or PE container (non-flexible) with screw on tab (max. 1 kg)PP or PE bucket with handle (non- flexible) (max. 10 kg)Kraft paper sack with inner PP or PE lining (flexible) (max. 50 kg)PP or PE pouches (max. 25 kg), grouped into cartonsPP or PE sack in carton box (max. 25 kg)Aluminium pouches with inner PP or PE lining grouped into cartons (max. 5 kg)
4.1.1.Use-specific instructions for useSpray application only by low pressure downwards spraying using a knapsack sprayer.Wear sturdy footwear/boots during the application of the product.The product may be applied by spraying, pouring or dry scattering. Only one of those specific application methods with its maximum number of biocidal product applications is allowed within one year.Cattle in feedlots or rearing pens (dairy cows, beef cattle, veal calves):Apply in a 50 cm band along the walls, under and next to machinery installations. The first application is best carried out 1-3 days after dung removal, once dung starts to accumulate again.Spraying or pouring:Maximum 5 applications per year for dairy cowsMaximum 4 applications per year for beef cattle and veal calvesDry scattering:Maximum 4 applications per year for dairy cowsMaximum 2 applications per year for beef cattle and veal calvesCattle on mesh floor (dairy cows, beef cattle, veal calves):Apply in a 50 cm band along the walls, under and next to machinery installations. When treating liquid manure, the granules can be dispersed directly. The first application is best carried out 1-3 days after dung removal, once dung starts to accumulate again. In cow sheds with slatted floor apply uniformly to the entire surface.Spraying or pouring:Maximum 5 applications per year for dairy cowsMaximum 4 applications per year for beef cattle and veal calvesDry scattering:Maximum 4 applications per year for dairy cowsMaximum 2 applications per year for beef cattle and veal calvesPigs (sows in individual pens, sows in groups and fattening pigs):Apply in a 50 cm band along the walls, under and next to machinery installations.Spraying or pouring: Maximum 2 applications per year.Dry scattering: Maximum 1 application per year.Poultry (Chicken and broilers – battery cages and free range):Broilers in free range with litter or grating floor, parent broilers in free range or rearing with grating floor (indoor rearing), laying hens in enriched battery cages or in free range with litter floor: Apply to the entire surface. Commence treatment approximately 1 week after removal of excrements but before a depth of 10 cm has accumulated.Laying hens in free range with grating floor: Apply to the area under nesting places and feed troughs.Application only by spraying or pouring: Maximum 1 application per year.Poultry (Turkeys, ducks, and geese):Apply to the entire surface. Commence treatment approximately 1 week after removal of excrements but before a depth of 10 cm has accumulated.Spraying, pouring or dry scattering: Maximum 5 applications per year.Rabbits:Treat entire surface of pits under cages about 3 days after arrival of the animals.Spraying, pouring or dry scattering: Maximum 5 applications per year.Horses:Apply in a 50 cm band along the walls, under and next to machinery installations by dry scattering, pouring or spraying.First application is best carried out 1-3 days after dung removal, once dung starts to accumulate again. For best results use on non-compacted bedding areas.Spraying or pouring: Maximum 4 applications per year.Dry scattering: Maximum 2 applications per year.Goat and sheep sheds:Treat the entire litter surface, respectively the entire floor surface in case of slatted floors.Spraying or pouring: Maximum 5 applications per year.Dry scattering: Maximum 4 applications per year.Minks:Treat area directly under cages where excrements will drop during the rearing cycle.Maximum 1 treatment per year.After use, the application equipment is emptied of any residual product and rinsed with water.4.1.2.Use-specific risk mitigation measuresDuring the handling of the pure product (manual dry scattering, mixing and loading): wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).During the application of the diluted product by spraying or with a watering-can and during the cleaning of the spray equipment or watering-can: wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and coated coveralls. The area treated by spraying must be limited to 600 m2 per day per user.Adapt the nozzle and the pressure of the spray equipment to ensure a minimum application rate of 1 liter/min.Use disposable protective coveralls (at least type 6, EN 13034).For use only in areas that are inaccessible to children.Do not apply directly on animals.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 livestock.Do not store near food, drink and animal feedingstuff.Do not use in breeding stations or other breeding areas for chicksDo not use the biocidal product in animal housings where exposure to a sewage treatment plant or direct emission to surface water cannot be prevented.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 general directions for use.4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee 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 general directions for use.4.2.Use description
Table 2Use # 2 – Control of nuisance and biting flies in animal husbandry – non professional users
Product typePT18 – Insecticides, acaricides and products to control other arthropods (Pest control)
Where relevant, an exact description of the authorised useLarvicide to control nuisance and biting flies in animal husbandry:Indoors in housings of animals (horses, sheep, goats, rabbits, ferrets).
Target organism(s) (including development stage)Scientific name: Muscidae:Common name: FliesDevelopment stage: All larval stages
Field(s) of useIndoorIndoors in animal housings.
Application method(s)Method: SprayingDetailed description:Low pressure spraying: – Add water to product up to approximately half of the final water volume, stir thoroughly, top up to the final volume and stir briefly before use. Spray the same day.Method: SpreadingDetailed description:Dry scattering – Apply product directly to places where fly maggots develop. Do not spread onto dry manure or manure with dried surface.In case of dry organic matter only apply by spraying.
Application rate(s) and frequencyApplication Rate: Low pressure spraying: 25 g/m2 (undiluted product (granules))Dilution (%): For a surface of 10 m2 add 250 g product in water, fill up to a total volume of 1 – 4 L depending on the humidity of the substrate to be treated. —Dilution 250g in 1 L: 100 mL needed per 1 m2; 5L needed per 50 m2 — —Dilution 250g in 2 L: 200 mL needed per 1 m2; 10L needed per 50 m2 — —Dilution 250g in 3 L: 300 mL needed per 1 m2; 15L needed per 50 m2 — —Dilution 250g in 4 L: 400 mL needed per 1 m2; 20L needed per 50 m2 —Number and timing of application:Due to the mode of action of cyromazine, effective larval control starts delayed. The biocidal product efficiently controls fly populations from two weeks up to 10 weeks after larvicidal treatment.If necessary, applications may be repeated once fly larvae reappear. For the number of maximum applications, see section use-specific instructions for use below.Application Rate: Dry scattering: 25 g/m2Dilution (%): Direct application of granulesNumber and timing of application:Due to the mode of action of cyromazine, effective larval control starts delayed. The biocidal product efficiently controls fly populations from two weeks up to 10 weeks after larvicidal treatment.If necessary, applications may be repeated once fly larvae reappear. For the number of maximum applications, see section use-specific instructions for use below.
Category(ies) of usersGeneral public (non-professional)
Pack sizes and packaging materialSizes:1, 5 kg.Packaging materials:PP or PE container (non-flexible) with screw on tab (max. 1 kg)PP or PE bucket with handle (non-flexible) (max. 5 kg)PP or PE pouches (max. 5 kg), grouped into cartons.PP or PE sack in carton box (max. 5 kg)Aluminium pouches with inner PP or PE lining (max. 5 kg)Packagings for private users need to be supplied with a measuring device.
4.2.1.Use-specific instructions for useWear sturdy footwear/boots during the application of the product.Prepare the spray solution by adding the appropriate volume of the biocidal product to the required volume of clean water and agitate.The appropriate volume of the biocidal product is measured using the dosing device provided in the packaging in accordance with the table for application rate(s) and frequency.For spraying: Only apply this product with a handheld manually operated low pressure (3 bar or below) device preferably in combination with a spraying shield.For scattering: Only apply this product using the device provided in the product pack.The product may be applied by spraying or dry scattering. Only one of these specific application methods with its maximum number of biocidal product applications is allowed within one year.Horses:Apply in a 50 cm band along the walls.First application is best carried out 1-3 days after dung removal, once dung starts to accumulate again. For best results use on non-compacted bedding areas.Spraying: Maximum 4 applications per yearDry scattering: Maximum 2 applications per yearGoat and sheep sheds:Treat the entire litter surface, respectively the entire floor surface in case of slatted floors.Spraying: Maximum 5 applications per year.Dry scattering: Maximum 4 applications per year.Rabbits:Treat area directly under cages where excrements will drop during the rearing cycle. First treatment about 3 days after arrival of the animals.Spraying or dry scattering: Maximum 5 applications per year.Ferrets:Treat the litter box under cages or the litter area.Spraying or dry scattering: Maximum 1 application per year.Do not spread granules onto dry manure or manure with dried surface, apply by spraying.4.2.2.Use-specific risk mitigation measuresFor use only in areas that are inaccessible to children.Do not apply directly on animals.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 livestock.4.2.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.4.3.Use description
Table 3Use # 3 – Control of nuisance fly larvae in waste management facilities – professional users
Product typePT18 – Insecticides, acaricides and products to control other arthropods (Pest control)
Where relevant, an exact description of the authorised useLarvicide to control nuisance and biting flies in the following waste treatment facilities:MBT (mechanical biological treatment) facilities and composting sites.
Target organism(s) (including development stage)Scientific name: Muscidae:Common name: FliesDevelopment stage: All larval stages
Field(s) of useIndoorIndoor at MBT (mechanical biological treatment) facilitiesIndoor at composting sites
Application method(s)Method: SprayingDetailed description:Low pressure spraying – Add water to product up to approximately half of the final water volume, stir thoroughly, top up to the final volume and stir briefly before use. Spray the same day.
Application rate(s) and frequencyApplication Rate: 25 g/m2 (undiluted product (granules))Dilution (%): For a surface of 10 m2 add 250 g product in water, fill up to a total volume of 1 – 4 L depending on the humidity of the substrate to be treated.Number and timing of application:Initial application:Initial treatment: Apply preferably early spring prior to fly season.Due to the mode of action of cyromazine, effective larval control starts delayed. The biocidal product efficiently controls fly populations from two weeks up to 10 weeks after larvicidal treatment.Re-application:Re-application for MBT sites:Re-treat when maggots are observed again or when treated area is covered up by new material containing organic components by more than 10 cm.
Category(ies) of usersProfessional
Pack sizes and packaging materialSizes:1, 5, 7, 10, 12.5, 20, 25, 50 kg.Packaging materials:PP or PE container (non-flexible) with screw on tab (max. 1 kg)PP or PE bucket with handle (non- flexible) (max. 10 kg)Kraft paper sack with inner PP or PE lining (flexible) (max. 50 kg)PP or PE pouches (max. 25 kg), grouped into cartonsPP or PE sack in carton box (max. 25 kg)Aluminium pouches with inner PP and PE lining grouped into cartons (max. 5 kg).
4.3.1.Use-specific instructions for useSpray application only by low pressure downwards spraying using a knapsack sprayer.MBT sites:Spray onto top layer in reception pits that are located indoors.Only treat waste that is stored in contained storage places, such as storage pits or containers.Waste storage places must not be wet cleaned.Only apply the product on waste that will be incinerated.Composting sites:Apply by spraying to the lower third of the height of the compost heaps.After use, the application equipment is emptied of any residual product and rinsed with water.4.3.2.Use-specific risk mitigation measuresDuring the handling of the pure product (manual dry scattering, mixing and loading): wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).During the application of the diluted product by spraying or with a watering-can and during the cleaning of the spray equipment or watering-can: wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and coated coveralls.The area treated by spraying must be limited to 600 m2 per day per user.Adapt the nozzle and the pressure of the spray equipment to ensure a minimum application rate of 1 liter/min.Use disposable protective coveralls (at least type 6, EN 13034).Any losses of the product into water collected in the reception pit must be disposed as hazardous waste.Treat waste only indoors at MBT sites.Waste treated indoors must not be stored outdoors.4.3.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use.4.3.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use.4.3.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee 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 useThe general resistance management measures need to be followed:The use of this product must be alternated with the use of products based on other active substances with different mode of action to avoid development of resistance.Use only at the recommended dose (0,5 g active substance/m2) to get good control (90 % or more). Systematic (covering entire populations), uninterrupted and excessive (inappropriately high concentrations) selection pressure on fly populations needs to be avoided.Fly infestation in the animal house can be estimated by monitoring methods (e.g. monitoring of (re)-appearance of larvae in the manure or adult fly population with glue strips) prior to chemical treatment.The use of biocidal products can be combined with other sanitation measures (e.g. frequent removal of manure) or non-chemical means of control (for example biological including the use of parasitoids, where this is commercially viable) within an integrated fly control program.The control of fly populations resistant to cyromazine is possible through an integrated management scheme that includes cultural and biological strategies and chemicals (larvicides and adulticides) in a rational manner.In the case of reduced or presumed reduced efficacy, contact a professional.Inform the authorisation holder if the treatment is ineffective.5.2.Risk mitigation measuresSee use -pecific risk mitigation measures.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentFirst aid measuresAntidote: No specific antidote is known. Treat symptomatically.IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.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.Measures to protect the environmentBrush up any spillage of granules and transfer into a sealable container. Either use up granules in compliance with directions for use in case they are not contaminated by any liquid or dispose in accordance with the instructions for safe disposal.Absorb spills of liquid by any absorbent and dispose off in accordance with national regulations.Do not discharge any washing water from treatment equipment to drains.Do not discharge the biocidal product or the diluted solution of the biocidal product into the sewage system or into the environment.5.4.Instructions for safe disposal of the product and its packagingDispose the product, its residues and packaging according to national regulations.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageStore in places prevented from the access of children, pets and livestock animals.Do not store near food, drink and animal feedingstuff.Store in the original and closed container in a dry place, at a maximum of 35 °C, protected from direct sunlight and from humidity.Shelf-life: 5 years6.OTHER INFORMATIONAdditional label element: The biocidal product contains amorphous silicon dioxide (nano).