Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2024/2422 16.9.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/2422 of 13 September 2024 granting a Union authorisation for the single biocidal product ‘Ca(OH)2 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...
Official Journal EN of the European Union L series 2024/2422 16.9.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/2422 of 13 September 2024 granting a Union authorisation for the single biocidal product ‘Ca(OH)2 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 2012concerning the making available on the market and use of biocidal products(1), 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 414/2013(2) for Union authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘Ca(OH)2 PT03’, of product-type 3, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-PN038694-16 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) 2023/2701(3), recorded in that register under case number BC-JR038510-32.
(2) The single biocidal product ‘Ca(OH)2 PT03’ 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-type 3.
(3) On 22 September 2022, the Agency submitted to the Commission its opinion(4) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Ca(OH)2 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 ‘Ca(OH)2 PT03’ 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 354/2013(5), 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 ‘Ca(OH)2 PT03’ meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission 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).
(3) Commission 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).
(4) European Chemicals Agency opinion of 22 September 2022 on the Union authorisation of the same single biocidal product ‘Ca(OH)2 PT03’, https://echa.europa.eu/opinions-on-union-authorisation.
(5) Commission 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).
ELI: http://data.europa.eu/eli/reg_impl/2024/2422/oj 1/19EN OJ L, 16.9.2024
(5) On 26 February 2024, the Agency transmitted to the Commission the revised SPC of ‘Ca(OH)2 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 ‘Ca(OH)2 PT03’.
(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 1 A Union authorisation with authorisation number EU-0029520-0000 is granted to Lhoist for the making available on the market and use of the same single biocidal product ‘Ca(OH)2 PT03’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 6 October 2024until 30 November 2033.
Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 September 2024.
For the Commission The President Ursula VON DER LEYEN 2/19 ELI: http://data.europa.eu/eli/reg_impl/2024/2422/ojEN OJ L, 16.9.2024 ANNEX Summary of product characteristics for a biocidal product Ca(OH)2 PT03 Product type(s) PT03: Veterinary hygiene
Authorisation number: EU-0029520-0000 R4BP asset number: EU-0029520-0000
1. ADMINISTRATIVE INFORMATION
1.1. Trade name(s) of the product Trade name(s) Saniblanc® H90 Saniblanc® Liz
1.2. Authorisation holder Name Lhoist Name and address of the authorisation holder Address Rue Charles Dubois, 28 1342 Ottignies-Louvain- La-Neuve BE Authorisation number EU-0029520-0000 R4BP asset number EU-0029520-0000 Date of the authorisation 6 October 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 1 Pedro 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 1 Carretera Fuente, Apartado 2 41 560 Estepa, Spain 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 1 Rue du Pra Paris 38 360 Sassenage, France
ELI: http://data.europa.eu/eli/reg_impl/2024/2422/oj 3/19EN OJ L, 16.9.2024 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 1 B.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 1 Route de Boran 60 640 Précy-Sur- Oise, France Name of manufacturer Chaux de Bretagne Address of manufacturer - 53600 Evron, France Location of manufacturing sites Chaux de Bretagne site 1 - 53600 Evron, 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 1 1 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 1 Rue 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 1 Usine de On-Jemelle 6900 Marche-en-Famenne, Belgium 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 1 Tmaň 200 267 21 Tmaň, Czechia 4/19 ELI: http://data.europa.eu/eli/reg_impl/2024/2422/ojEN OJ L, 16.9.2024 Name of manufacturer Faxe Kalk Address of manufacturer Hovedgaden 13 4654 Faxe Ladeplads, Denmark Location of manufacturing sites Faxe Kalk site 1 Gl. 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 1 15 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 1 Valverde 2025-201 Alcanede, Portugal 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 1 ul. Fabryczna 22 47-316 Górażdże, Poland Zakłady Wapiennicze Lhoist S.A. site 2 ul. Bolesława Chrobrego 77B 59-550 Wojcieszów, Poland Zakłady Wapiennicze Lhoist S.A. site 3 ul. Wapiennicza 7 46-050 Tarnów Opolski, Poland Name of manufacturer Lhoist Bukowa Sp. z.o.o Address of manufacturer ul. Osiedlowa 10 29-105 Krasocin, Poland Location of manufacturing sites Lhoist Bukowa Sp. z o.o. site 1 ul. Osiedlowa 10 29-105 Krasocin, Poland
1.4. Manufacturer(s) of the active substance(s) Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime 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 1 Pedro I 19-21 31 007 Pamplona, Spain
ELI: http://data.europa.eu/eli/reg_impl/2024/2422/oj 5/19EN OJ L, 16.9.2024 Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime Name of manufacturer CalGov Address of manufacturer Carretera Fuente, Apartado 2 41 560 Estepa, Spain Location of manufacturing sites CalGov site 1 Carretera Fuente, Apartado 2 41 560 Estepa, Spain Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime 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 1 Rue du Pra Paris 38 360 Sassenage, France Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime 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 1 B.P.1 55 100 Dugny-sur-Meuse, France Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime 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 1 Route de Boran 60 640 Précy-Sur- Oise, France Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime Name of manufacturer Chaux de Bretagne Address of manufacturer - 53 600 Evron, France Location of manufacturing sites Chaux de Bretagne site 1 - 53 600 Evron, France Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime 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 1 1 chemin des Chaux de la Tour 13 820 Ensues La Redonne, France 6/19 ELI: http://data.europa.eu/eli/reg_impl/2024/2422/ojEN OJ L, 16.9.2024 Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime 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 1 Rue la Mallieue, 95 B-4470 Saint-Georges-sur-Meuse, Belgium Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime 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 1 Usine de On-Jemelle 6900 Marche-en-Famenne, Belgium Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime 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 1 15 rue Henri Dagallier 38 100 Grenoble, France Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime Name of manufacturer Lusical Address of manufacturer Valverde 2025-201 Alcanede, Portugal Location of manufacturing sites Lusical site 1 Valverde 2025-201 Alcanede, Portugal Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime 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 1 ul. Fabryczna 22 47-316 Górażdże, Poland Zakłady Wapiennicze Lhoist S.A. site 2 ul. Bolesława Chrobrego 77B 59-550 Wojcieszów, Poland
ELI: http://data.europa.eu/eli/reg_impl/2024/2422/oj 7/19EN OJ L, 16.9.2024 Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime 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 1 Tmaň 200 267 21 Tmaň, Czechia Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime Name of manufacturer Lhoist Bukowa Sp. z.o.o Address of manufacturer ul. Osiedlowa 10 29-105 Krasocin, Poland Location of manufacturing sites Lhoist Bukowa Sp. z o.o. site 1 ul. Osiedlowa 10 29-105 Krasocin, Poland Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/ hydrated lime/slaked lime Name of manufacturer Faxe Kalk Address of manufacturer Hovedgaden 13 4654 Faxe Ladeplads, Denmark Location of manufacturing sites Faxe Kalk site 1 Gl. Strandvej 14 4640 Faxe, Denmark
2. PRODUCT COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the product Common name IUPAC name Function CAS number EC number Content (%) Calcium dihydr active substance 1305-62-0 215-137-3 100 % (w/w) oxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
2.2. Type(s) of formulation DP - Dustable powder WP - Wettable powder (only for use for disinfection of animal accommodations; limewashing of walls) 8/19 ELI: http://data.europa.eu/eli/reg_impl/2024/2422/ojEN OJ L, 16.9.2024
3. HAZARD AND PRECAUTIONARY STATEMENTS Hazard statements H315: Causes skin irritation.
H318: Causes serious eye damage.
H335: May cause respiratory irritation.
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 pre sent and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor/phy sician.
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 con tainer tightly closed.
P405: Store locked up.
P501: Dispose of container to accordance with local reg ulations.
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 Scientific name: Bacteria stage) Common name: Bacteria
Development stage: no data
Scientific name: Viruses
Common name: Viruses
ELI: http://data.europa.eu/eli/reg_impl/2024/2422/oj 9/19EN OJ L, 16.9.2024
Development stage: no data
Scientific name: Endoparasites
Common name: Helminth eggs
Development stage: no data Field(s) of use indoor use Application method(s) Method: Automatic direct application
Detailed 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 frequency Application rate: - Dilution (%): - RTU product
Number 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. tem perature, content of dry matter, etc.). Preliminary laboratory tests must be performed to guarantee efficacy.
Category(ies) of users professional Pack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500-1 000 kg
4.1.1. Use-specific instructions — The dose must be sufficient to maintain a pH > 12 during the contact time. — Do not apply more than 100 kg product/ m3 of manure — 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 measures — The 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).
10/19 ELI: http://data.europa.eu/eli/reg_impl/2024/2422/ojEN OJ L, 16.9.2024 — 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.
4.1.3. 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 accomodations and transportation Product type PT03: Veterinary hygiene Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: Bacteria
Development stage: -
Scientific name: Yeast
Common name: Yeasts
Development stage: -
Scientific name: Fungi
Common name: fungi
Development stage: -
Scientific name: viruses
Common name: Viruses
Development stage: - Field(s) of use indoor use
ELI: http://data.europa.eu/eli/reg_impl/2024/2422/oj 11/19EN OJ L, 16.9.2024 Application method(s) Method: Direct application
Detailed 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 frequency Application rate: 800 g product/m2 Dilution (%): - RTU product
Number 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 powder Big bags or sacks (with PP or PE inner layer): 500-1 000 kg Paper sacks (with PP or PE inner layer): 25 kg
4.2.1. Use-specific instructions The 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.
4.2.2. Use-specific risk mitigation measures — During 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).
12/19 ELI: http://data.europa.eu/eli/reg_impl/2024/2422/ojEN OJ L, 16.9.2024 — For the use of big bags (500-1 000 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.
4.2.3. 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 packaging After 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.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage —
ELI: http://data.europa.eu/eli/reg_impl/2024/2422/oj 13/19EN OJ L, 16.9.2024
4.3. Use description Table 3 Disinfection of animal accommodations; limewashing of walls Product type PT03: Veterinary hygiene Where relevant, an exact description of the - authorised use Target organism(s) (including development Scientific name: Bacteria stage) Common name: Bacteria
Development stage: -
Scientific name: Yeast
Common name: Yeasts
Development stage: -
Scientific name: Fungi
Common name: fungi
Development stage: -
Scientific name: Viruses
Common name: Viruses
Development stage: - Field(s) of use indoor use Application method(s) Method: Direct application with a brush
Detailed description: - Application rate(s) and frequency Application rate: 800 g product / m2 Dilution (%): -
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 hours
Frequency: before each production cycle Category(ies) of users professional Pack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500-1 000 kg
4.3.1. Use-specific instructions
For 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 hours The 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.
14/19 ELI: http://data.europa.eu/eli/reg_impl/2024/2422/ojEN OJ L, 16.9.2024 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.
4.3.2. Use-specific risk mitigation measures — During 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.
4.3.3. 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 packaging —
4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage —
ELI: http://data.europa.eu/eli/reg_impl/2024/2422/oj 15/19EN OJ L, 16.9.2024
4.4. Use description Table 4 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 Scientific name: Bacteria stage) Common name: Bacteria
Development stage: -
Scientific name: Yeast
Common name: Yeasts
Development stage: -
Scientific name: Fungi
Common name: fungi
Development stage: -
Scientific name: Viruses
Common name: Viruses
Development stage: - Field(s) of use outdoor use Application method(s) Method: Direct application
Detailed 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: 800 g product/m2 Dilution (%): - RTU product
Number and timing of application:
Contact time 48 hours
Frequency: maximum two applications per year.
Category(ies) of users professional Pack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500-1 000 kg Paper sacks (with PP or PE inner layer): 25 kg
4.4.1. Use-specific instructions — Brush 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.
16/19 ELI: http://data.europa.eu/eli/reg_impl/2024/2422/ojEN OJ L, 16.9.2024
4.4.2. Use-specific risk mitigation measures — During 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 (500-1 000 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.
4.4.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment —
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging — After 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.
ELI: http://data.europa.eu/eli/reg_impl/2024/2422/oj 17/19EN OJ L, 16.9.2024
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage —
5. GENERAL DIRECTIONS FOR USE(1)
5.1. Instructions for use — Comply 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 measures — Do 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 environment — IF 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 packaging — Do 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 storage — Do not store at a temperature above 30 °C. — Protect from humidity. — Shelf-life: 15 months.
(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
18/19 ELI: http://data.europa.eu/eli/reg_impl/2024/2422/ojEN OJ L, 16.9.2024
6. OTHER INFORMATION Full 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).
ELI: http://data.europa.eu/eli/reg_impl/2024/2422/oj 19/19