Commission Implementing Regulation (EU) 2024/2423 of 13 September 2024 granting a Union authorisation for the single biocidal product Ca(OH)2 PT02 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Article 1

A Union authorisation with authorisation number EU-0029527-0000 is granted to Lhoist for the making available on the market and use of the same single biocidal product ‘Ca(OH)2 PT02’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 6 October 2024 until 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 .

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT

ANNEXSupplementary provisions

ANNEX SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT Ca(OH)2 PT02 Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Authorisation number: EU-0029527-0000 R4BP asset number: EU-0029527-0000 1.    ADMINISTRATIVE INFORMATION 1.1.    Trade name(s) of the product Trade name(s) Neutralac® H UP Neutralac® CEC Neutralac® H LP Neutralac® H100 Neutralac® H200 Neutralac® H90 Neutralac® RH Eurolime Olimpic 1.2.    Authorisation holder Name and address of the authorisation holder Name Lhoist Address Rue Charles Dubois, 28, 1342 Ottignies-Louvain-La-Neuve, Belgium Authorisation number EU-0029527-0000 R4BP asset number EU-0029527-0000 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 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 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 Rue 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 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 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 -, 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 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 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 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, Czech Republic Location of manufacturing sites Tmaň 200, 267 21 Tmaň, Czech Republic Name of manufacturer Faxe Kalk Address of manufacturer Hovedgaden 13, 4654 Faxe Ladeplads, Denmark Location of manufacturing sites 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 15 rue Henri Dagallier, 38 100 Grenoble, France Name of manufacturer Lusical Address of manufacturer Valverde, 2025-201 Alcanede, Portugal Location of manufacturing sites 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 ul. Fabryczna 22, 47-316 Górażdże, Poland ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów, Poland ul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland Name of manufacturer Lhoist Bukowa Sp. z o.o. Address of manufacturer Bukowa, ul. Osiedlowa 10, 29-105 Krasocin, Poland Location of manufacturing sites Bukowa, 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 Pedro I 19-21, 31 007 Pamplona, Spain 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 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 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 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 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 -, 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 1 chemin des Chaux de la Tour, 13 820 Ensues La Redonne, France 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 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 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 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 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 ul. Fabryczna 22, 47-316 Górażdże, Poland ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów, 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 Gl. Strandvej 14, 4640 Faxe, Denmark Active substance Calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime Name of manufacturer Lhoist Bukowa Sp. z o.o. Address of manufacturer Bukowa, ul. Osiedlowa 10, 29-105 Krasocin, Poland Location of manufacturing sites Bukowa, ul. Osiedlowa 10, 29-105 Krasocin, Poland 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, Czech Republic Location of manufacturing sites Tmaň 200, 267 21 Tmaň, Czech Republic 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 dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime   Active Substance 1305-62-0 215-137-3 100,0 2.2.    Type of formulation DP - Dustable powder WP - Wettable powder (only for use for disinfection of animal accommodations; limewashing of walls) 3.    HAZARD AND PRECAUTIONARY STATEMENTS Hazard statements Causes skin irritation. Causes serious eye damage. May cause respiratory irritation. Precautionary statements Avoid breathing dust. Wash hands thoroughly after handling. Use only outdoors or in a well-ventilated area. Wear protective gloves, protective clothing, eye protection and face protection. IF ON SKIN:Wash with plenty of water. Specific treatment (see instructions on this label). If skin irritation occurs:Get medical advice. Take off contaminated clothing.And wash it before reuse. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor/physician. IF INHALED:Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER/doctor if you feel unwell. Store in a well-ventilated place.Keep container tightly closed. Store locked up. Dispose of container to accordance with local regulations. 4.    AUTHORISED USE(S) 4.1.    Use description Table Use # 1 – Disinfection of sewage sludge Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use - Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: - Scientific name: Endoparasites Common name: Helminth eggs Development stage: - Field(s) of use Indoor Application method(s) Method: Automatic direct application Detailed 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 frequency Application 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) product Number 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 users Professional Pack sizes and packaging material Bulk powder Big bags or sacks (with Polypropylene (PP) or polyethylene (PE) inner layer): 500-1 000 kg 4.1.1.    Use-specific instructions for use — The 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 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: — 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/m 3 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 legislation — The 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 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 - 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. 6.    OTHER INFORMATION Full titles of EN standards and legislation referred to in section 4.1.2: 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 .) ( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.