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Commission Implementing Regulation (EU) 2024/1302 of 14 May 2024 granting a Union authorisation for the single biocidal product CaO PT03 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Commission Implementing Regulation (EU) 2024/1302of 14 May 2024granting a Union authorisation for the single biocidal product CaO PT03 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 "CaO PT03", of product-type 3, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-JG038697-30 in the Register for Biocidal Products. The application also indicated the case number of the related reference single biocidal product "EuLA oxi-lime 23" later authorised by Commission Implementing Regulation (EU) 2023/2703Commission Implementing Regulation (EU) 2023/2703 of 4 December 2023 granting a Union authorisation for the single biocidal product "EuLA oxi-lime 23" in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2023/2703, 5.12.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj)., recorded in that register under case number BC-VJ038509-19.(2)The single biocidal product "CaO PT03" contains calcium oxide/lime/burnt lime/quicklime 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 3.(3)On 20 September 2022, the Agency submitted to the Commission its opinionEuropean Chemicals Agency opinion of 20 September 2022 on the Union authorisation of the same single biocidal product "CaO PT3", https://echa.europa.eu/opinions-on-union-authorisation. and the draft summary of the biocidal product characteristics ("SPC") of "CaO PT03" 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 "CaO PT03" and the related reference single biocidal product "EuLA oxi-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 oxi-lime 23" and subject to compliance with the draft SPC, the same single biocidal product "CaO PT03" meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.(5)On 26 January 2024, the Agency transmitted to the Commission the revised draft SPCs of "CaO PT03" 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 "CaO PT03".(7)The expiry date of this authorisation is aligned to the expiry date of the authorisation of the related reference single biocidal product "EuLA oxi-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-0029492-0000 is hereby granted to Lhoist for the making available on the market and use of the same single biocidal product "CaO PT03" in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 4 June 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, 14 May 2024.For the CommissionThe PresidentUrsula von der LeyenANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCTCaO PT03Product type(s)PT03: Veterinary hygieneAuthorisation number: EU-0029492-0000R4BP asset number: EU-0029492-00001.ADMINISTRATIVE INFORMATION1.1.Trade name(s) of the product

Trade name(s)

Saniblanc® DSaniblanc® Q2Saniblanc® Q2/10Saniblanc® VS

1.2.Authorisation holder

Name and address of the authorisation holder	Name	Lhoist
Name and address of the authorisation holder	Address	Rue Charles Dubois, 28 1342 Ottignies-Louvain-La-Neuve Belgium
Authorisation number		EU-0029492-0000
R4BP asset number		EU-0029492-0000
Date of the authorisation		4 June 2024
Expiry date of the authorisation		30 November 2033

1.3.Manufacturer(s) of the product

Name of manufacturer	Cal Industrial SL
Address of manufacturer	Pedro I 19-21 31 007 Pamplona Spain
Location of manufacturing sites	Cal Industrial SL site 1Pedro I 19-21 31 007 Pamplona Spain

Name of manufacturer	CalGov
Address of manufacturer	Carretera Fuente, Apartado 2 41 560 Estepa Spain
Location of manufacturing sites	CalGov site 1Carretera Fuente, Apartado 2 41 560 Estepa Spain

Name of manufacturer	Carrières et Chaux Balthazard et Cotte
Address of manufacturer	Rue du Pra Paris 38360 Sassenage France
Location of manufacturing sites	Carrières et Chaux Balthazard et Cotte site 1Rue du Pra Paris 38 360 Sassenage France

Name of manufacturer	Carrières et fours à chaux de Dugny
Address of manufacturer	B.P.1 55 100 Dugny-sur-Meuse France
Location of manufacturing sites	Carrières et fours à chaux de Dugny site 1B.P.1 55 100 Dugny-sur-Meuse France

Name of manufacturer	Chaux de Boran
Address of manufacturer	Route de Boran 60 640 Précy-Sur-Oise France
Location of manufacturing sites	Chaux de Boran site 1Route de Boran 60 640 Précy-Sur-Oise France

Name of manufacturer	Chaux de Provence
Address of manufacturer	Ancien Chemin de Martigues 13 160 Châteauneuf Les Martigues France
Location of manufacturing sites	Chaux de Provence site 1Ancien Chemin de Martigues 13 160 Châteauneuf Les Martigues France

Name of manufacturer	Chaux et Dolomies du Boulonnais
Address of manufacturer	Rue Jules Guesde 62 720 Réty France
Location of manufacturing sites	Chaux et Dolomies du Boulonnais site 1Rue Jules Guesde 62 720 Réty France

Name of manufacturer	Chaux de la Tour
Address of manufacturer	1 chemin des Chaux de la Tour 13 820 Ensues La Redonne France
Location of manufacturing sites	Chaux de la Tour site 11 chemin des Chaux de la Tour 13 820 Ensues La Redonne France

Name of manufacturer	Carrières et Fours à Chaux Dumont Wautier
Address of manufacturer	Rue la Mallieue, 95 B-4470 Saint-Georges-sur-Meuse Belgium
Location of manufacturing sites	Carrières et Fours à Chaux Dumont Wautier site 1Rue la Mallieue, 95 B-4470 Saint-Georges-sur-Meuse Belgium

Name of manufacturer	Etablissement Leon Lhoist
Address of manufacturer	Usine de On-Jemelle 6900 Marche-en-Famenne Belgium
Location of manufacturing sites	Etablissement Leon Lhoist site 1Usine de On-Jemelle 6900 Marche-en-Famenne Belgium

Name of manufacturer	Lhoist Bukowa Sp. z o.o.
Address of manufacturer	Bukowa, ul. Osiedlowa 10 29-105 Krasocin Poland
Location of manufacturing sites	Lhoist Bukowa Sp. z o.o. site 1Bukowa, ul. Osiedlowa 10 29-105 Krasocin Poland

Name of manufacturer	Vápenka Čertovy schody a.s
Address of manufacturer	Tmaň 200 267 21 Tmaň Czechia
Location of manufacturing sites	Vápenka Čertovy schody a.s site 1Tmaň 200 267 21 Tmaň Czechia

Name of manufacturer	Faxe Kalk
Address of manufacturer	Hovedgaden 13 4654 Faxe Ladeplads Denmark
Location of manufacturing sites	Faxe Kalk site 1Nordkajen 17 7100 Vejle DenmarkFaxe Kalk site 2Gl. Strandvej 14 4640 Faxe Denmark

Name of manufacturer	Lhoist France Ouest
Address of manufacturer	15 rue Henri Dagallier 38 100 Grenoble France
Location of manufacturing sites	Lhoist France Ouest site 115 rue Henri Dagallier 38 100 Grenoble France

Name of manufacturer	Lusical
Address of manufacturer	Valverde 2025-201 Alcanede Portugal
Location of manufacturing sites	Lusical site 1Valverde 2025-201 Alcanede Portugal

Name of manufacturer	Société des fours à chaux de Sorcy
Address of manufacturer	Route de Sorcy, B.P.16 55 190 Void France
Location of manufacturing sites	Société des fours à chaux de Sorcy site 1Route de Sorcy, B.P.16 55 190 Void France

Name of manufacturer	Zakłady Wapiennicze Lhoist S.A.
Address of manufacturer	ul. Wapiennicza 7 46-050 Tarnów Opolski Poland
Location of manufacturing sites	Zakłady Wapiennicze Lhoist S.A. site 1ul. Fabryczna 22 47-316 Górażdże PolandZakłady Wapiennicze Lhoist S.A. site 3ul. Wapiennicza 7 46-050 Tarnów Opolski PolandZakłady Wapiennicze Lhoist S.A. site 2ul. Bolesława Chrobrego 77B 59-550 Wojcieszów Poland

1.4.Manufacturer(s) of the active substance(s)

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Cal Industrial SL
Address of manufacturer	Pedro I 19-21 31 007 Pamplona Spain
Location of manufacturing sites	Cal Industrial SL site 1Pedro I, 19-21 31 007 Pamplona Spain

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	CalGov
Address of manufacturer	Carretera Fuente, Apartado 2 41 560 Estepa Spain
Location of manufacturing sites	CalGov site 1Carretera Fuente, Apartado 2 41 560, Estepa, Spain

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Carrières et Chaux Balthazard et Cotte
Address of manufacturer	Rue du Pra Paris 38 360 Sassenage France
Location of manufacturing sites	Carrières et Chaux Balthazard et Cotte site 1Rue du Pra Paris 38360 Sassenage France

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Carrières et fours à chaux de Dugny
Address of manufacturer	B.P.1 55 100 Dugny-sur-Meuse France
Location of manufacturing sites	Carrières et fours à chaux de Dugny site 1B.P.1, 55 100 Dugny-sur-Meuse France

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Chaux de Boran
Address of manufacturer	Route de Boran 60 640 Précy-Sur-Oise France
Location of manufacturing sites	Chaux de Boran site 1Route de Boran 60640 Précy-Sur-Oise France

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Chaux de Provence
Address of manufacturer	Ancien Chemin de Martigues 13160 Châteauneuf Les Martigues France
Location of manufacturing sites	Chaux de Provence site 1Ancien Chemin de Martigues 13160 Châteauneuf Les Martigues France

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Chaux et Dolomies du Boulonnais
Address of manufacturer	Rue Jules Guesde, 62 720 Réty France
Location of manufacturing sites	Chaux et Dolomies du Boulonnais site 1Rue Jules Guesde, 62 720 Réty France

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Chaux de la Tour
Address of manufacturer	1 chemin des Chaux de la Tour 13 820 Ensues La Redonne France
Location of manufacturing sites	Chaux de la Tour site 11 chemin des Chaux de la Tour, 13 820 Ensues La Redonne France

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Carrières et Fours à Chaux Dumont Wautier
Address of manufacturer	Rue la Mallieue, 95 B-4470 Saint-Georges-sur-Meuse Belgium
Location of manufacturing sites	Carrières et Fours à Chaux Dumont Wautier site 1Rue la Mallieue, 95, B-4470 Saint-Georges-sur-Meuse, Belgium

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Etablissement Leon Lhoist
Address of manufacturer	Usine de On-Jemelle 6900 Marche-en-Famenne Belgium
Location of manufacturing sites	Etablissement Leon Lhoist site 1Usine de On-Jemelle 6900 Marche-en-Famenne Belgium

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Lhoist Bukowa Sp. z o.o
Address of manufacturer	Bukowa, ul. Osiedlowa 10, 29-105 Krasocin Poland
Location of manufacturing sites	Lhoist Bukowa Sp. z o.o site 1Bukowa, ul. Osiedlowa 10, 29-105 Krasocin Poland

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Lhoist France Ouest
Address of manufacturer	15 rue Henri Dagallier, 38 100 Grenoble France
Location of manufacturing sites	Lhoist France Ouest site 115 rue Henri Dagallier, 38 100 Grenoble France

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Lusical
Address of manufacturer	Valverde 2025-201 Alcanede Portugal
Location of manufacturing sites	Lusical site 1Valverde 2025-201 Alcanede Portugal

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Société des fours à chaux de Sorcy
Address of manufacturer	Route de Sorcy B.P.16 55 190 Void France
Location of manufacturing sites	Société des fours à chaux de Sorcy site 1Route de Sorcy B.P.16 55 190 Void France

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Zakłady Wapiennicze Lhoist S.A.
Address of manufacturer	ul. Wapiennicza 7 46-050 Tarnów Opolski, Poland
Location of manufacturing sites	Zakłady Wapiennicze Lhoist S.A. site 1ul. Fabryczna 22 47-316 Górażdże PolandZakłady Wapiennicze Lhoist S.A. site 2ul. Wapiennicza 7 46-050 Tarnów Opolski, PolandZakłady Wapiennicze Lhoist S.A. site 3ul. Bolesława Chrobrego 77B 59-550 Wojcieszów Poland

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Faxe Kalk
Address of manufacturer	Hovedgaden 13 4654 Faxe Ladeplads Denmark
Location of manufacturing sites	Faxe Kalk site 1Nordkajen 17 7100 Vejle DenmarkFaxe Kalk site 2Gl. Strandvej 14 4640 Faxe Denmark

Active substance	Calcium oxide/lime/burnt lime/quicklime
Name of manufacturer	Vápenka Čertovy schody a.s
Address of manufacturer	Tmaň 200 267 21 Tmaň Czechia
Location of manufacturing sites	Vápenka Čertovy schody a.s site 1Tmaň 200 267 21 Tmaň Czechia

2.PRODUCT COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Calcium oxide/lime/burnt lime/quicklime		active substance	1305-78-8	215-138-9	100

2.2.Type(s) of formulationDP Dustable powder3.HAZARD AND PRECAUTIONARY STATEMENTS

Hazard statements

H315: Causes skin irritation.H318: Causes serious eye damage.H335: May cause respiratory irritation.EUH014: Reacts violently with water.

Precautionary statements

P261: 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 CENTRE or 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.P501: Dispose of container to accordance with local regulations.P405: Store locked up.

4.AUTHORISED USE(S)4.1.Use description

Table 1. Disinfection of manure

Product type	PT03: 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 use	indoor 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 shall be loaded by fully automated processes.
Application rate(s) and frequency	Application Rate: -Dilution (%): - RTU productNumber and timing of application:The application rate must be sufficient to maintain a pH of > 12 and a temperature > 60°C during the contact time.Contact time: 24 hours
Category(ies) of users	professional
Pack sizes and packaging material	Bulk powderBig bags or sacks (with PP or PE inner layer): 500 - 1200 kg

4.1.1.Use-specific instructions for useThe application rate must be sufficient to maintain a pH of > 12 and a temperature > 60°C during the 24 hours contact time.Do not apply more than 100 kg product /m3 of manure.The mixture should be moistened and any self-ignition that might occur should be extinguished with water.After the necessary contact time, remove the treated manure from the animal house. Use of the treated manure according to local legislation.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 pr sacks must be performed using a telehandler (including a closed cabin).During the loading of the product and the disposal of empty bags or sacks, 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).During the treatment of the manure, the wearing of air-fed or canister RPE specific for ammonia gas in accordance with EN 374 or equivalent, is recommended in the absence of collective management measures to estimate and prevent an exposure greater than the EU 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 legislations.The cleaning of the treatment unit 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.4.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment-4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packaging-4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage-4.2.Use description

Table 2. Disinfection of indoor floor surfaces of animal accommodations and transportation

Product type	PT03: 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 use	indoor use
Application method(s)	Method: Direct applicationDetailed description: The product is spread directly onto the floors of animal accomodations using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.
Application rate(s) and frequency	Application 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 users	professional
Pack sizes and packaging material	Bulk powderBig bags or sacks (with PP or PE inner layer): 500 - 1200 kgPaper sacks (with PP or PE inner layer): 25 kg

4.2.1.Use-specific instructions for useThe product is spread 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 long-handled shovel must be used for the manual spreading application.A.On concrete floors:1.Wash the surface with running water;2.Sprinkle approximatively 800 g of product / m2 to cover the damp ground and add 0,9 litre/m2 of water;3.Leave to act for at least 48 hours.B.On beaten-earth floor:1.Brush and wet the surface;2.Sprinkle approx. 800 g of product / m2 on the damp ground and add 0,9 litre/m2 of water;3.Leave to act for at least 48 hours.4.2.2.Use-specific risk mitigation measuresDuring the loading, the application of the product and the disposal of empty bags or sacks, 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);a 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 or sacks (500-1200 kg), the loading of the product and the disposal of empty bags or sacks must be performed fully automatically using a telehandler (including a closed cabin).During the loading of small sacks (25 kg), thoroughly empty out the sacks in order to minimise the remaining powder.Fold carefully the small bag in order to avoid any spills.During the disposal of any residues 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 must not be present during the entire treatment duration.Remove residues of the product on the ground by 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.4.2.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment-4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingAfter treatment, remove the product by brushing. Collect the resulting dry waste and recycle it as agricultural liming material or dispose of the dry waste according to local requirements.For animal transportation use only: after brushing, rinse and clean the vehicle.4.2.5.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 3. Disinfection of floors of outdoor animal enclosures

Product type	PT03: 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: VirusCommon name: VirusDevelopment stage: -
Field(s) of use	outdoor 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 frequency	Application Rate: 600 - 800 g product/m2Dilution (%): - RTU productNumber and timing of application:Contact time 48 hoursFrequency: maximum two applications per year.
Category(ies) of users	professional
Pack sizes and packaging material	Bulk powderBig bags or sacks (with PP or PE inner layer): 500 - 1200 kgPaper sacks (with PP or PE inner layer): 25 kg

4.3.1.Use-specific instructions for useBefore the introduction of new animals:Brush and wet the floor.spread 600 - 800 g product/m2 onto the ground then add 0,9 litre/m2 of water.leave to act for at least 48 hours.Do not apply in the case of wind or rain.4.3.2.Use-specific risk mitigation measuresDuring the loading, the application of the product on the floor and the disposal of empty bags, 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);a 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 or sacks (500-1200 kg), the loading of the product and the disposal of empty bags or sacks must be performed fully automatically using a telehandler (including a closed cabin).During the loading of small sacks (25 kg), thoroughly empty out the sacks to minimise the remaining powder.Fold carefully the small bag 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 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.Do not exceed two applications per year.Animals must not be present during the entire treatment duration.Remove the residues of the product on the ground by thorough sweeping before allowing re-entry of animals.Feed and drinking water must be carefully covered or removed during the application of the product.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 environment-4.3.4.Where specific to the use, the instructions for safe disposal of the product and its packagingAfter treatment, remove the product by brushing. Collect the resulting dry waste and recycle it as agricultural liming material or dispose of the dry waste according to local requirements.4.3.5.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 uses, do not apply in the case of rain or wind5.2.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 or sacks, the required 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 easy 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 chemicals (pH > 11), amines and acids like acetic 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. sink, 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 - 4.4.2: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.