Commission Implementing Regulation (EU) 2024/2430 of 16 September 2024 granting a Union authorisation for the single biocidal product EuLA Ca(OH)2 template in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2024/2430of 16 September 2024granting a Union authorisation for the single biocidal product EuLA Ca(OH)2 template 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, ELI: http://data.europa.eu/eli/reg/2012/528/oj., and in particular Article 44(5), first subparagraph, thereof,Whereas:(1)On 12 April 2018, Lhoist submitted an application to the European Chemicals Agency ("the Agency") in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj). for Union authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named "EuLA Ca(OH)2 template", of product-types 2 and 3, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-ER038692-23 in the Register for Biocidal Products. The application also indicated the case number of the related reference single biocidal product "EuLA hydra-lime 23" later authorised by Commission Implementing Regulation (EU) 2023/2701Commission Implementing Regulation (EU) 2023/2701 of 4 December 2023 granting a Union authorisation for the single biocidal product EuLA hydra-lime 23 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2023/2701, 5.12.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2701/oj)., recorded in that register under case number BC-JR038510-32.(2)The single biocidal product "EuLA Ca(OH)2 template" contains calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime 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-types 2 and 3.(3)On 22 September 2022, the Agency submitted to the Commission its opinionEuropean Chemicals Agency opinion of 22 September 2022 on the Union authorisation of the same single biocidal product "EuLA Ca(OH)2 template" (https://echa.europa.eu/opinions-on-union-authorisation). and the draft summary of the biocidal product characteristics ("SPC") of "EuLA Ca(OH)2 template" in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.(4)In its opinion, the Agency concludes that the proposed differences between the single biocidal product "EuLA Ca(OH)2 template" and the related reference single biocidal product "EuLA hydra-lime 23" are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj)., and that, based on the assessment of the related reference single biocidal product "EuLA hydra-lime 23" and subject to compliance with the draft SPC, the same single biocidal product "EuLA Ca(OH)2 template" meets the conditions laid down in Article 19(1)of Regulation (EU) No 528/2012.(5)On 26 February 2024, the Agency transmitted to the Commission the revised SPC of "EuLA Ca(OH)2 template" in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.(6)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product "EuLA Ca(OH)2 template".(7)The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference single biocidal product "EuLA hydra-lime 23".(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-0029505-0000 is granted to Lhoist for the making available on the market and use of the same single biocidal product "EuLA Ca(OH)2 template" in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 7 October 2024 until 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, 16 September 2024.For the CommissionThe PresidentUrsula von der LeyenANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCTEuLA Ca(OH)2 templateProduct type(s)PT02: Disinfectants and algaecides not intended for direct application to humans or animalsPT03: Veterinary hygieneAuthorisation number: EU-0029505-0000R4BP asset number: EU-0029505-00001.ADMINISTRATIVE INFORMATION1.1.Trade name(s) of the product
Trade name(s)Neutralac® HNeutralac® H SQSaniblanc® H
1.2.Authorisation holder
Name and address of the authorisation holderNameLhoist
AddressRue Charles Dubois 28, 1342 Ottignies-Louvain-La-Neuve, Belgium
Authorisation numberEU-0029505-0000
R4BP asset numberEU-0029505-0000
Date of the authorisation7 October 2024
Expiry date of the authorisation30 November 2033
1.3.Manufacturer(s) of the product
Name of manufacturerCal Industrial SL
Address of manufacturerPedro I, 19-21, 31007 Pamplona, Spain
Location of manufacturing sitesCal Industrial SL site 1, Pedro I, 19-21, 31007 Pamplona, Spain
Name of manufacturerCalGov
Address of manufacturerCarretera Fuente, Apartado 2, 41560 Estepa, Spain
Location of manufacturing sitesCalGov site 1, Carretera Fuente, Apartado 2, 41560 Estepa, Spain
Name of manufacturerCarrières et Chaux Balthazard et Cotte
Address of manufacturerRue du Pra Paris, 38360 Sassenage, France
Location of manufacturing sitesCarrières et Chaux Balthazard et Cotte site 1, Rue du Pra Paris, 38 360 Sassenage, France
Name of manufacturerCarrières et fours à chaux de Dugny
Address of manufacturerBP 1, 55100 Dugny-sur-Meuse, France
Location of manufacturing sitesCarrières et fours à chaux de Dugny site 1, BP 1, 55100 Dugny-sur-Meuse, France
Name of manufacturerChaux de Boran
Address of manufacturerRoute de Boran, 60640 Précy-Sur-Oise, France
Location of manufacturing sitesChaux de Boran site 1, Route de Boran, 60640 Précy-Sur-Oise, France
Name of manufacturerChaux de Bretagne
Address of manufacturer53600 Evron, France
Location of manufacturing sitesChaux de Bretagne site 1. 53600 Evron, France
Name of manufacturerChaux de la Tour
Address of manufacturer1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France
Location of manufacturing sitesChaux de la Tour site 1, 1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France
Name of manufacturerCarrières et Fours à Chaux Dumont Wautier
Address of manufacturerRue la Mallieue 95, 4470 Saint-Georges-sur-Meuse, Belgium
Location of manufacturing sitesCarrières et Fours à Chaux Dumont Wautier site 1, Rue la Mallieue 95, 4470 Saint-Georges-sur-Meuse, Belgium
Name of manufacturerEtablissement Leon Lhoist
Address of manufacturerUsine de On-Jemelle, 6900 Marche-en-Famenne, Belgium
Location of manufacturing sitesEtablissement Leon Lhoist site 1, Usine de On-Jemelle, 6900 Marche-en-Famenne, Belgium
Name of manufacturerVápenka Čertovy schody a.s
Address of manufacturerTmaň 200, 267 21 Tmaň, Czechia
Location of manufacturing sitesVápenka Čertovy schody a.s site 1, Tmaň 200, 267 21 Tmaň, Czechia
Name of manufacturerFaxe Kalk
Address of manufacturerHovedgaden 13, 4654 Faxe Ladeplads, Denmark
Location of manufacturing sitesFaxe Kalk site 1, Gl. Strandvej 14, 4640 Faxe, Denmark
Name of manufacturerLhoist France Ouest
Address of manufacturer15 rue Henri Dagallier, 38100 Grenoble, France
Location of manufacturing sitesLhoist France Ouest site 1, 15 rue Henri Dagallier, 38100 Grenoble, France
Name of manufacturerLusical
Address of manufacturerValverde, 2025-201 Alcanede, Portugal
Location of manufacturing sitesLusical site 1, Valverde, 2025-201 Alcanede, Portugal
Name of manufacturerZakłady Wapiennicze Lhoist S.A.
Address of manufacturerul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland
Location of manufacturing sitesZakłady Wapiennicze Lhoist S.A. site 1, ul. Fabryczna 22, 47-316 Górażdże, PolandZakłady Wapiennicze Lhoist S.A. site 2, ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów, PolandZakłady Wapiennicze Lhoist S.A. site 3, ul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland
Name of manufacturerLhoist Bukowa Sp. z.o.o
Address of manufacturerul. Osiedlowa 10, 29-105 Krasocin, Poland
Location of manufacturing sitesLhoist Bukowa Sp. z o.o. site 1, ul. Osiedlowa 10, 29-105 Krasocin, Poland
1.4.Manufacturer(s) of the active substance(s)
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCal Industrial SL
Address of manufacturerPedro I, 19-21, 31007 Pamplona, Spain
Location of manufacturing sitesCal Industrial SL site 1, Pedro, I 19-21, 31007 Pamplona, Spain
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCalGov
Address of manufacturerCarretera Fuente, Apartado 2, 41560 Estepa, Spain
Location of manufacturing sitesCalGov site 1, Carretera Fuente, Apartado 2, 41560 Estepa, Spain
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarrières et Chaux Balthazard et Cotte
Address of manufacturerRue du Pra Paris, 38360 Sassenage, France
Location of manufacturing sitesCarrières et Chaux Balthazard et Cotte site 1, Rue du Pra Paris, 38360 Sassenage, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarrières et fours à chaux de Dugny
Address of manufacturerBP 1, 55100 Dugny-sur-Meuse, France
Location of manufacturing sitesCarrières et fours à chaux de Dugny site 1, BP 1, 55100 Dugny-sur-Meuse France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerChaux de Boran
Address of manufacturerRoute de Boran, 60640 Précy-Sur-Oise, France
Location of manufacturing sitesChaux de Boran site 1, Route de Boran, 60640 Précy-Sur-Oise, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerChaux de Bretagne
Address of manufacturer53600 Evron, France
Location of manufacturing sitesChaux de Bretagne site 1. 53600 Evron, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerChaux de la Tour
Address of manufacturer1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France
Location of manufacturing sitesChaux de la Tour site 1, 1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarrières et Fours à Chaux Dumont Wautier
Address of manufacturerRue la Mallieue 95, 4470 Saint-Georges-sur-Meuse, Belgium
Location of manufacturing sitesCarrières et Fours à Chaux Dumont Wautier site 1, Rue la Mallieue 95, 4470 Saint-Georges-sur-Meuse, Belgium
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerEtablissement Leon Lhoist
Address of manufacturerUsine de On-Jemelle, 6900 Marche-en-Famenne, Belgium
Location of manufacturing sitesEtablissement Leon Lhoist site 1, Usine de On-Jemelle, 6900 Marche-en-Famenne, Belgium
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerLhoist France Ouest
Address of manufacturer15 rue Henri Dagallier, 38100 Grenoble, France
Location of manufacturing sitesLhoist France Ouest site 1, 15 rue Henri Dagallier, 38100 Grenoble, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerLusical
Address of manufacturerValverde, 2025-201 Alcanede, Portugal
Location of manufacturing sitesLusical site 1, Valverde, 2025-201 Alcanede, Portugal
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerZakłady Wapiennicze Lhoist S.A.
Address of manufacturerul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland
Location of manufacturing sitesZakłady Wapiennicze Lhoist S.A. site 1, ul. Fabryczna 22, 47-316 Górażdże, PolandZakłady Wapiennicze Lhoist S.A. site 2, ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów, Poland
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerVápenka Čertovy schody a.s
Address of manufacturerTmaň 200, 267 21 Tmaň, Czechia
Location of manufacturing sitesVápenka Čertovy schody a.s site 1, Tmaň 200, 267 21 Tmaň, Czechia
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerLhoist Bukowa Sp. z.o.o
Address of manufacturerul. Osiedlowa 10, 29-105 Krasocin, Poland
Location of manufacturing sitesLhoist Bukowa Sp. z o.o. site 1, ul. Osiedlowa 10, 29-105 Krasocin, Poland
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerFaxe Kalk
Address of manufacturerHovedgaden 13, 4654 Faxe Ladeplads, Denmark
Location of manufacturing sitesFaxe Kalk site 1, Gl. Strandvej 14, 4640 Faxe, Denmark
2.PRODUCT COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the product
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeactive substance1305-62-0215-137-3100 % (w/w)
2.2.Type(s) of formulationDP – Dustable powder WP – Wettable powder (only for use for disinfection of animal accommodations; limewashing of walls)
3.HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statementsH315: Causes skin irritation.H318: Causes serious eye damage.H335: May cause respiratory irritation.
Precautionary statementsP261: Avoid breathing dust.P264: Wash hands thoroughly after handling.P271: Use only outdoors or in a well-ventilated area.P280: Wear protective gloves, protective clothing, eye protection and face protection.P302 + P352: IF ON SKIN: Wash with plenty of water.P321: Specific treatment (see instructions on this label).P332 + P313: If skin irritation occurs: Get medical advice.P362 + P364: Take off contaminated clothing and wash it before reuse.P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.P310: Immediately call a POISON CENTER/doctor/physician.P304 + P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.P312: Call a POISON CENTER/doctor if you feel unwell.P403 + P233: Store in a well-ventilated place. Keep container tightly closed.P405: Store locked up.P501: Dispose of container to accordance with local regulations.
4.AUTHORISED USE(S)4.1.Use description
Table 1Disinfection of sewage sludge
Product typePT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: BacteriaDevelopment stage: –Scientific name: EndoparasitesCommon name: Helminth eggsDevelopment stage: –
Field(s) of useindoor use
Application method(s)Method: Automatic direct applicationDetailed description: The product is dosed into the sewage sludge and mixed by means of a blender. The dry product is mixed with the sewage sludge in an open mixer. The product shall be loaded by fully automated processes.
Application rate(s) and frequencyApplication rate: 0,2-2 kg product/kg dry weight of substrate; typical dry solids content – 12-25 % in sewage sludge. The application rate must be sufficient to maintain a pH > 12 during the contact time.Dilution (%): – Ready-to-use (RTU) productNumber and timing of application:Contact time: 24 hours to 90 days for endoparasites (helminth eggs) – the specific contact time depends on several parameters (e.g. temperature, content of dry matter, etc.). Preliminary laboratory tests must be performed to guarantee efficacy.
Category(ies) of usersprofessional
Pack sizes and packaging materialBulk powderBig bags or sacks (with Polypropylene (PP) or polyethylene (PE) inner layer): 500-1000 kg
4.1.1.Use-specific instructionsThe dose must be sufficient to maintain a pH > 12 during the contact time.Application rate: 0,2-2 kg product/kg dry weight of substrate; typical dry solids content – 12-25 % in sewage sludge.The ratios may vary between applications and treatment plant designs. The user should ensure that the treatment is effective through preliminary laboratory tests that guarantee efficacy according to the legislation applicable to each case.4.1.2.Use-specific risk mitigation measuresThe loading of the product into the treatment unit and the application must be done fully automatically. The loading into the treatment unit and the disposal of empty bags and sacs must be performed using a telehandler (including a closed cabin).During the loading of the product and the disposal of empty bags, wear:respiratory protective equipment (RPE) of at least assigned protection factor (APF) 40 (airtight face piece covering eyes, nose, mouth and chin according to European Standard (EN) 149 with a P3 filter or equivalent);chemical resistant gloves classified under EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).During the treatment of sewage sludge, the wearing of air-fed or canister RPE specific for ammonia gas in accordance with EN 14387 or equivalent, is recommended in the absence of collective management measures to estimate and prevent an exposure greater than the EU occupational exposure limit value (OEL) of 14 mg/m3 for that gas.During the manual handling of treated sewage sludge wear protective gloves in accordance with EN 374 or equivalent and protective coverall in accordance with EN 14126 or equivalent protecting against the intrinsic properties of the sewage sludge.The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.See section 6 for the full titles of the EN standards and legislationThe cleaning of the unit treatment must be avoided or performed with an automated process with no exposure of the professional.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 environment4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packaging4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.Use description
Table 2Disinfection of manure
Product typePT03: Veterinary hygiene
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: BacteriaDevelopment stage:Scientific name: VirusesCommon name: VirusesDevelopment stage:Scientific name: EndoparasitesCommon name: Helminth eggsDevelopment stage:
Field(s) of useindoor use
Application method(s)Method: Automatic direct applicationDetailed description: The product is mixed with the manure. The product is dosed into the manure and mixed by means of a blender. The product should be loaded by fully automated processes.
Application rate(s) and frequencyApplication rate: –Dilution (%): – RTU productNumber and timing of application:The application rate must be sufficient to maintain a pH > 12 during the contact time.Contact time: 72 hours to 90 days for endoparasites (helminth eggs) – the specific contact time depends on several parameters (e.g. temperature, content of dry matter, etc.). Preliminary laboratory tests must be performed to guarantee efficacy.
Category(ies) of usersprofessional
Pack sizes and packaging materialBulk powderBig bags or sacks (with PP or PE inner layer): 500-1000 kg
4.2.1.Use-specific instructionsThe dose must be sufficient to maintain a pH > 12 during the contact time.Do not apply more than 100 kg product/m3 of manureAfter the necessary contact time, remove the treated manure from the animal house. Use of the treated manure according to local legislation.4.2.2.Use-specific risk mitigation measuresThe loading of the product into the treatment unit and the application must be done fully automatically.The loading into the treatment unit and the disposal of empty bags and sacs must be performed using a telehandler (including a closed cabin).During the loading of the product and the disposal of empty bags, wear:chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);a protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information);RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent).During the treatment of manure, the wearing of air-fed or canister RPE specific for ammonia gas in accordance with EN 14387 or equivalent, is recommended in the absence of collective management measures to estimate and prevent an exposure greater than the EU occupational exposure limit value (OEL) of 14 mg/m3 for that gas.During the manual handling of treated manure wear protective gloves in accordance with EN 374 or equivalent and protection coverall in accordance with EN 14126 or equivalent protecting against the intrinsic properties of the manure.The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.See section 6 for the full titles of the EN standards and legislation.The cleaning of the unit treatment must be avoided or performed with an automated process with no exposure of the professional.Do not apply the product if releases from animal housings or manure/slurry storage areas can be directed to a sewage treatment plant or directly to surface water.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 environment4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packaging4.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.Use description
Table 3Disinfection of indoor floor surfaces of animal accomodations and transportation
Product typePT03: Veterinary hygiene
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: BacteriaDevelopment stage: –Scientific name: YeastCommon name: YeastsDevelopment stage: –Scientific name: FungiCommon name: FungiDevelopment stage: –Scientific name: VirusesCommon name: VirusesDevelopment stage: –
Field(s) of useindoor use
Application method(s)Method: Direct applicationDetailed description: The product is spread directly onto the floors of animal accommodations using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.
Application rate(s) and frequencyApplication rate: 800 g product/m2Dilution (%): – RTU productNumber and timing of application:Frequency in animal housing: before each production cycle.Frequency in animal transportation: after each animal transport.Contact time: 48 hours
Category(ies) of usersprofessional
Pack sizes and packaging materialBulk powderBig bags or sacks (with PP or PE inner layer): 500-1000 kgPaper sacks (with PP or PE inner layer): 25 kg
4.3.1.Use-specific instructionsThe product is spread directly onto the floors of animal accommodations and transportation, using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.A.On concrete floors:1.Wash the surface with running water;2.Sprinkle 800 g of product per m2 to cover the damp ground and add 0,9 litre/m2 of water;3.Leave to act for at least 48 hours;4.After treatment, remove the lime by brushing.B.On beaten-earth floors:1.Brush and wet the surface;2.Sprinkle 800 g of product per m2 on the damp ground and add 0,9 litre/m2 of water;3.Leave to act for at least 48 hours.4.After treatment, remove the lime by brushing.4.3.2.Use-specific risk mitigation measuresDuring the loading, the application of the product and the disposal of empty bags and sacs, wear:RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent);chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).For the use of big bags (500-1000 kg), the loading of the product and the disposal of empty bags must be performed fully automatically using a telehandler (including a closed cabin).During the loading of small bags (25 kg), thoroughly empty out the bag in order to minimise the remaining powder.For the disposal of small empty bags, moisten the bag and fold it carefully in order to avoid any spills.During the disposal of the product after the application, wear:RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent);chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information).The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.See section 6 for the full titles of the EN standards and legislation.Animals shall not be present during all the treatment duration.Remove residues of the product on the ground by thorough sweeping before re-entry of animals.Feed and drinking water must be carefully covered or removed during the application of the product.Do not apply the product if releases from animal housings, manure/slurry storage areas, or animal transportation disinfection areas can be directed to a sewage treatment plant or directly to surface water.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 environment4.3.4.Where specific to the use, the instructions for safe disposal of the product and its packagingAfter treatment, remove the lime by brushing. Collect the resulting dry waste and recycle them as agricultural liming material or dispose the dry waste according to local requirements.For animal transportation use only: after brushing and the required contact time, rinse and clean the vehicle.4.3.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.Use description
Table 4Disinfection of animal accommodations; limewashing of walls
Product typePT03: Veterinary hygiene
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: BacteriaDevelopment stage: –Scientific name: YeastCommon name: YeastsDevelopment stage: –Scientific name: FungiCommon name: FungiDevelopment stage: –Scientific name: VirusesCommon name: VirusesDevelopment stage: –
Field(s) of useindoor use
Application method(s)Method: Direct application with a brushDetailed description: –
Application rate(s) and frequencyApplication rate: 800 g product/m2Dilution (%): –Number and timing of application:The product is suspended in water (50 % w/v) prior to its application by brushing on the walls.Contact time: 48 hoursFrequency: before each production cycle
Category(ies) of usersprofessional
Pack sizes and packaging materialBulk powderBig bags or sacks (with PP or PE inner layer): 500-1000 kg
4.4.1.Use-specific instructionsFor one layer:Application method for 150 to 200 m2 of wall (depending on the porosity of the wall):1.Clean the surface with running water before the application of the product.2.Introduce 25 kg of product into 50 litres of water;3.Let the mixture rest for 12 hours;4.Mix the resulting mixture and brush onto the wall;5.Leave to act for at least 48 hoursThe application rate is 125-167 g product/m2 for a single layer. A final application rate of 800 g product/m2 is required, therefore 5-7 coats should be applied, depending on the porosity of the wall.Stir before and during application.The product must be first fully automatically transferred to a medium lower volume tank. Then, the product is manually loaded from the medium tank to a bucket.4.4.2.Use-specific risk mitigation measuresDuring the loading of the product and the disposal of empty bags and sacs, wear:chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);protective coverall in accordance with EN 13982 (coverall material to be specified by the authorisation holder within the product information);RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent).During the application of the product on the walls, wear:chemical resistant gloves in accordance with EN 374 (glove material to be specified by the authorisation holder within the product information);protective coverall in accordance with EN 13034 (coverall material to be specified by the authorisation holder within the product information);RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P1 filter or equivalent).The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.See section 6 for the full titles of the EN standards and legislation.The loading of the product and the disposal of empty bags and sacs must be performed fully automatically using a telehandler (including a closed cabin).Minimise splashes and spills during application.Do not let bystanders (including co-workers and children) touch treated surfaces until completely dry.Do not apply the product if releases from animal housings or manure/slurry storage areas can be directed to a sewage treatment plant or directly to surface water.Animals shall not be present during all the treatment duration.Do not let animal re-enter the accommodations before complete drying of surfaces.Feed and drinking water must be carefully covered or removed during the application of the product.4.4.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment4.4.4.Where specific to the use, the instructions for safe disposal of the product and its packaging4.4.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.5.Use description
Table 5Disinfection of floors of outdoor animal enclosures
Product typePT03: Veterinary hygiene
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: BacteriaDevelopment stage: –Scientific name: YeastCommon name: YeastsDevelopment stage: –Scientific name: FungiCommon name: FungiDevelopment stage: –Scientific name: VirusesCommon name: VirusesDevelopment stage: –
Field(s) of useoutdoor use
Application method(s)Method: Direct applicationDetailed description: The product is spread directly onto the surfaces (floors) of animal enclosures using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.
Application rate(s) and frequencyApplication rate: 800 g product/m2Dilution (%): – RTU productNumber and timing of application:Contact time 48 hoursFrequency: maximum two applications per year.
Category(ies) of usersprofessional
Pack sizes and packaging materialBulk powderBig bags or sacks (with PP or PE inner layer): 500-1000 kgPaper sacks (with PP or PE inner layer): 25 kg
4.5.1.Use-specific instructionsBrush and wet the floor before the application of the product.At the beginning of a production cycle, spread 800 g product /m2 of the product onto the ground and then add 0,9 litre/m2 of water.Leave to act for at least 48 hours before bringing animals in the treated area.For outdoor uses of the product, do not apply in the case of wind or rain.4.5.2.Use-specific risk mitigation measuresDuring the loading, the application of the product and the disposal of empty bags and sacs, wear:RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to NF EN 149 with a P3 filter or equivalent);chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);protective coverall in accordance with EN 13982 (coverall material to be specified by the authorisation holder within the product information).For the use of big bags (500-1000 kg), the loading of the product and the disposal of empty bags must be performed fully automatically using a telehandler (including a closed cabin).During the loading of small bags (25 kg), thoroughly empty out the bags in order to minimise the remaining powder.For the disposal of small empty bags, moisten the bag and fold it carefully in order to avoid any spills.During the disposal of the product after the application, wear:RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to NF EN 149 with a P3 filter or equivalent);chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information);protective coverall in accordance with EN 13982 (coverall material to be specified by the authorisation holder within the product information).The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.See section 6 for the full titles of the EN standards and legislation.Do not exceed two applications per year.Animals shall not be present during all the treatment duration.Remove residues of the product on the ground by thorough brushing before re-entry of animals.Feed and drinking water must be carefully covered or removed during the application of the product.4.5.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment4.5.4.Where specific to the use, the instructions for safe disposal of the product and its packagingAfter treatment, remove the lime by brushing. Collect the resulting dry waste and recycle them as agriculture liming material or dispose the dry waste according to local requirements.4.5.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.5.1.Instructions for useComply with the instructions for use.Respect the conditions of use of the product.Refer to hygiene plan in place in order to ensure that necessary efficacy level is achieved.For outdoor use of the product, do not apply in the case of wind or rain.5.2.Risk mitigation measuresDo not let bystanders (including co-workers and children) and pets enter the treatment area during the entire treatment duration (including the loading, the application of the product, the disposal of empty bags and sacs, the agreed contact time and the subsequent removal of the product and its residues from the ground).Use only in a well-ventilated area.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentIF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTER or a doctor.IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and ease to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance. Information to healthcare personnel/doctor: the eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemical (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.5.4.Instructions for safe disposal of the product and its packagingDo not discharge unused product on the ground, into water courses, into pipes (e.g. of sinks, toilets) or 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 storageDo not store at a temperature above 30 °C.Protect from humidity.Shelf-life: 15 months.6.OTHER INFORMATIONFull titles of EN standards and legislation referred to in sections 4.1.2-4.5.2:EN 149 – Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking;EN 374 – EN ISO 374-1: 2018: Protective gloves against dangerous chemicals and micro-organisms – Part 1: terminology and performance requirements for chemical risks;EN 13982 – Protective clothing for use against solid particulates – Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates;EN 14387 – EN 14387:2021: Respiratory protective devices – Gas filter(s) and combined filter(s) – Requirements, testing, marking;EN 14126 – BS EN 14126: 2003 – Protective clothing. Performance requirements and tests methods for protective clothing against infective agent;Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).