Commission Implementing Regulation (EU) 2023/2701of 4 December 2023granting 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(Text with EEA relevance)

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 (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 products OJ L 167, 27.6.2012, p. 1. , and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) On 29 March 2018, European Lime Association aisbl submitted to the European Chemicals Agency (the Agency) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a single biocidal product named EuLA hydra-lime 23 of product-types 2 and 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-JR038510-32 in the Register for Biocidal Products. (2) EuLA hydra-lime 23 contains calcium dihydroxide (hydrated 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 13 December 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. (4) On 5 July 2022, the Agency submitted to the Commission its opinion ECHA opinion of 14 June 2022 on the Union authorisation of EULA HYDRA-LIME 23 (ECHA/BPC/341/2022) (https://echa.europa.eu/it/opinions-on-union-authorisation). , the draft summary of the biocidal product characteristics (SPC) of EuLA hydra-lime 23 and the final assessment report on the single biocidal product, in accordance with Article 44(3) of Regulation (EU) No 528/2012. (5) The opinion concludes that EuLA hydra-lime 23 is a biocidal product within the meaning of Article 3(1), point (a), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation. (6) On 18 July 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. (7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for 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-0028954-0000 is hereby granted to European Lime Association aisbl for the making available on the market and use of the single biocidal product EuLA hydra-lime 23 in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 25 December 2023 to 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, 4 December 2023. For the Commission The President Ursula von der Leyen

Annex

ANNEX Summary of product characteristics for a biocidal product EuLA hydra-lime 23 Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Product type 3 – Veterinary hygiene (Disinfectants) Authorisation number: EU-0028954-0000 R4BP asset number: EU-0028954-0000

1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s)EuLA hydra-lime 23 1.2. Authorisation holder Name and address of the authorisation holderNameEuropean Lime Association aisblAddressc/o IMA-Europe aisbl, Rue des Deux Églises 26, box 2, 1000 Brussels, BelgiumAuthorisation numberEU-0028954-0000R4BP asset numberEU-0028954-0000Date of the authorisation25 December 2023Expiry date of the authorisation30 November 2033 1.3. Manufacturer(s) of the product Name of manufacturerCal Industrial SLAddress of manufacturerPedro I, 19-21, 31007 Pamplona, SpainLocation of manufacturing sitesPedro I, 19-21, 31 007 Pamplona, SpainName of manufacturerCalera de Alzo, S. L.Address of manufacturerPostal number: 20.268, Egileor auzoa, 101, Altzo (Guipúzcoa), SpainLocation of manufacturing sitesEgileor auzoa, 101, Altzo (Guipúzcoa), SpainName of manufacturerCaleras de San Cucao, S.A.Address of manufacturerAgüera s/n, 33425 San Cucao de Llanera, SpainLocation of manufacturing sitesAgüera s/n, 33425 San Cucao de Llanera, Spain Name of manufacturerCales Pascual S.L.Address of manufacturerC/Cura Bau, 15, 46112 Valencia, SpainLocation of manufacturing sitesCtra. Valencia-Ademuz, KM 9.3. Paterna, Valencia, SpainName of manufacturerCalGovAddress of manufacturerCarretera Fuente, Apartado 2, 41560 Estepa, SpainLocation of manufacturing sitesCarretera Fuente, Apartado 2, 41560 Estepa, SpainName of manufacturerCarmeuse ChauxAddress of manufacturer215 route d’Arras, 62320 Bois Bernard, FranceLocation of manufacturing sites215 route d’Arras, 62320 Bois Bernard, FranceName of manufacturerCarmeuse Czech Republic s.r.o.Address of manufacturerMokrá 359, 664 04 Mokrá, CzechiaLocation of manufacturing siteszávod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá , CzechiaName of manufacturerCarmeuse Holding SrlAddress of manufacturerStr. Carierei nr. 127A, 500047 Brașov, RomaniaLocation of manufacturing sitesStr. Principală 1, 337457 Com. Șoimuș, Romania. Valea Mare Pravăț, 117805 Câmpulung, RomaniaName of manufacturerCarmeuse Hungaria kftAddress of manufacturerHRSZ 064/1, 7827 Beremend, HungaryLocation of manufacturing sitesHRSZ 064/1, 7827 Beremend, HungaryName of manufacturerCarmeuse Nederland BVAddress of manufacturerNijverheidsstraat 32, 2802 AL Gouda, NetherlandsLocation of manufacturing sitesNijverheidsstraat 32, 2802 AL Gouda, NetherlandsName of manufacturerCarmeuse SAAddress of manufacturerRue du Château 13a, 5300 Seilles, BelgiumLocation of manufacturing sites

Rue du Val Notre Dame 300, 4520 Moha, Belgium Rue du Château 13a, 5300 Seilles, Belgium Name of manufacturerCarmeuse Slovakia s.r.o.Address of manufacturerSlavec, 049 11 Slavec, SlovakiaLocation of manufacturing siteszávod Vápenka Slavec, Slavec 179, 049 11 Slavec, SlovakiaName of manufacturerCarrières et Chaux Balthazard et CotteAddress of manufacturerRue du Pra Paris, 38360 Sassenage, FranceLocation of manufacturing sitesRue du Pra Paris, 38360 Sassenage, FranceName of manufacturerCarrières et fours à chaux de DugnyAddress of manufacturerBP 1, 55100 Dugny-sur-Meuse, FranceLocation of manufacturing sitesBP 1, 55100 Dugny-sur-Meuse, FranceName of manufacturerCementos Tudela Veguín, S.A.U.Address of manufacturerCL Argüelles 25, 33003 Oviedo, Asturias, SpainLocation of manufacturing sitesCL Tino Casal, s/n., 33910 Tudela Veguín, Asturias, SpainName of manufacturerChaux de BoranAddress of manufacturerRoute de Boran, 60640 Précy-Sur-Oise, FranceLocation of manufacturing sitesRoute de Boran, 60640 Précy-Sur-Oise, FranceName of manufacturerChaux de BretagneAddress of manufacturer—, 53600 Evron, FranceLocation of manufacturing sites—, 53600 Evron, FranceName of manufacturerChaux de la TourAddress of manufacturer1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, FranceLocation of manufacturing sites1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, FranceName of manufacturerClogrennane Lime LTDAddress of manufacturerClogrennane, R93 EV26 Carlow, IrelandLocation of manufacturing sitesClogrennane, R93 EV26 Carlow, IrelandName of manufacturerDumont-WautierAddress of manufacturerRue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, BelgiumLocation of manufacturing sitesRue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, Belgium Name of manufacturerEtablissement Leon LhoistAddress of manufacturerUsine de On-Jemelle, 6900 Marche-en-Famenne, BelgiumLocation of manufacturing sitesUsine de On-Jemelle, 6900 Marche-en-Famenne, BelgiumName of manufacturerEuropéenne des Chaux et LiantsAddress of manufacturer2745 route du Bugey, CS22015, 38307 Bourgoin-Jallieu, FranceLocation of manufacturing sitesUsine de Duin, 38460 Trept, FranceName of manufacturerLhoist Central Europe/Lhoist Česká republika a Slovensko Vápenka Čertovy schody a.sAddress of manufacturerTmaň 200, 267 21 Tmaň, CzechiaLocation of manufacturing sitesTmaň 200, 267 21 Tmaň, CzechiaName of manufacturerLhoist Faxe Kalk A/SAddress of manufacturerHovedgaden 13, 4654 Faxe Ladeplads, DenmarkLocation of manufacturing sitesGl. Strandvej 14, 4640 Faxe, DenmarkName of manufacturerLhoist France OuestAddress of manufacturer15 rue Henri Dagallier, 38100 Grenoble, FranceLocation of manufacturing sites15 rue Henri Dagallier, 38100 Grenoble, FranceName of manufacturerLusicalAddress of manufacturerValverde, 2025-201 Alcanede, PortugalLocation of manufacturing sitesValverde, 2025-201 Alcanede, PortugalName of manufacturerNordkalk ABAddress of manufacturerBox 901, SE-731 29 Köping, SwedenLocation of manufacturing sites

Nordkalk AB, Köping, Kungsängsvägen 22, SE-731 36 Köping, Sweden Nordkalk AB, Landskrona, Verkstadsgatan, SE-261 35 Landskrona, Sweden Nordkalk AB, Luleå, Viktoriavägen 5, SE-974 37 Luleå, Sweden Name of manufacturerNordkalk Oy AbAddress of manufacturerSkräbbölevägen 18, FI-21600 Pargas, FinlandLocation of manufacturing sites Nordkalk Oy Ab, Louhi, Louhi, FI-57100 Savonlinna, Finland Nordkalk Oy Ab, Tytyri, Tytyrinkatu 7, FI-08100 Lohja, Finland Name of manufacturerSingleton BirchAddress of manufacturerMelton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire. United KingdomLocation of manufacturing sitesMelton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire. United KingdomName of manufacturerSMA Mineral ABAddress of manufacturer—, SE-682 27 Filipstad, SwedenLocation of manufacturing sites Luleå Lime Plant, C/O SSAB Europe, SE-971 88 Luleå, Sweden Boda Lime Plant, Kärvsåsen Kalkverksvägen 15, SE-795 96 Boda kyrkby, Sweden Rättivik lime plant, Kalkvagen 7, SE-795 32 Rättvik, Sweden SSAB Industriområde, Kalkverket, SE-613 80 Oxelösund, Sweden Mo Industripark, Verkstedsøypa, NO-8626 Mo i Rana, Norway Name of manufacturerSMA Mineral Burgas Var LTDAddress of manufacturerdis. Pobeda, Chataldzha str. No 52, 8002 Burgas, BulgariaLocation of manufacturing sitesdis. Pobeda, Chataldzha str. No 52, 8002 Burgas, BulgariaName of manufacturerSMA Mineral OyAddress of manufacturer—, FI-95450 Tornio, FinlandLocation of manufacturing sitesSMA Mineral Oy, Röyttä Lime Plant, Selleenkatu 281, FI-95450 Tornio, FinlandName of manufacturerTarmac, Lime and PowdersAddress of manufacturerTunstead House, Wormhill, Buxton, SK17 8TG Derbyshire, United KingdomLocation of manufacturing sitesTunstead House, Wormhill, Buxton, SK17 8TG Derbyshire, United KingdomName of manufacturerUnicalce S.p.AAddress of manufacturerVia Tonio da Belledo, 30, 23900 Lecco LC, Italy Location of manufacturing sites Via Ponti, 18, 24012 Val Brembilla BG, Italy Via Lisso, 12, 24010 Sedrina BG, Italy Strada Amerina Località S.Pellegrino, 05035 Narni TR, Italy Via Di S.Vincenzo 21, 57021 Campiglia Marittima LI, Italy S.S.Appia km 134, 04020 Itri LT, Italy Contrada Lupini – C.P.33, 74019 Palagiano TA, Italy Name of manufacturerWietersdorfer & Peggauer Zementwerke GmbHAddress of manufacturerWietersdorf 1, 9373 Klein St. Paul, AustriaLocation of manufacturing sitesAlois-Kern-Straße 1, 8120 Peggau, AustriaName of manufacturerZakłady Wapiennicze Lhoist S.A.Address of manufacturerul. Wapiennicza 7, 46-050 Tarnów Opolski, PolandLocation of manufacturing sites ul. Fabryczna 22, 47-316 Górażdże, Poland ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów, Poland Name of manufacturerZement- und Kalkwerke Otterbein GmbH & Co. KGAddress of manufacturerHauptstrasse 50, 36137 Grossenlueder-Mues, GermanyLocation of manufacturing sitesGeorg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues, GermanyName of manufacturerSMA Mineral ASAddress of manufacturerPostbox 500, NO-8601 Mo i Rana, NorwayLocation of manufacturing sitesMo Industripark, Verkstedsøypa, NO-8626 Mo i Rana, Norway

1.4. Manufacturer(s) of the active substance(s) Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCal Industrial SLAddress of manufacturerPedro I, 19-21, 31007 Pamplona, SpainLocation of manufacturing sitesPedro I, 19-21, 31007 Pamplona, SpainActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCalera de Alzo, S. L.Address of manufacturer20.268, Egileor auzoa, 101 Altzo (Guipúzcoa), SpainLocation of manufacturing sitesEgileor auzoa, 101 Altzo (Guipúzcoa), Spain Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCaleras de San Cucao, S.A.Address of manufacturerAgüera s/n, 33425 San Cucao de Llanera, SpainLocation of manufacturing sitesAgüera s/n, 33425 San Cucao de Llanera, SpainActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCales Pascual S.L.Address of manufacturerC/Cura Bau, 15, 46112 Valencia, SpainLocation of manufacturing sitesCtra. Valencia-Ademuz, KM 9.3., Paterna, SpainActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCalGovAddress of manufacturerCarretera Fuente, Apartado 2, 41560 Estepa, SpainLocation of manufacturing sitesCarretera Fuente, Apartado 2, 41560 Estepa, SpainActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCarmeuse ChauxAddress of manufacturer215 route d’Arras, 62320 Bois Bernard, FranceLocation of manufacturing sites215 route d’Arras, 62320 Bois Bernard, FranceActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCarmeuse Czech Republic s.r.o.Address of manufacturerMokrá 359, 664 04 Mokrá, CzechiaLocation of manufacturing siteszávod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá, CzechiaActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCarmeuse Holding SrlAddress of manufacturerStr. Carierei nr. 127A, 500047 Brașov, RomaniaLocation of manufacturing sites Str. Principală 1, 337457 Com. Șoimuș, Romania. Valea Mare Pravăț, 117805 Câmpulung, Romania Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCarmeuse Hungaria kftAddress of manufacturerHRSZ 064/1, 7827 Beremend, HungaryLocation of manufacturing sitesHRSZ 064/1, 7827 Beremend, HungaryActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCarmeuse Nederland BVAddress of manufacturerNijverheidsstraat 32, 2802 AL Gouda, NetherlandsLocation of manufacturing sitesNijverheidsstraat 32, 2802 AL Gouda, NetherlandsActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCarmeuse SAAddress of manufacturerRue du Château 13a, 5300 Seilles, BelgiumLocation of manufacturing sites

Rue du Val Notre Dame 300, 4520 Moha, Belgium Rue du Château 13a, 5300 Seilles, Belgium Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCarmeuse Slovakia s.r.oAddress of manufacturerSlavec, 049 11 Slavec, SlovakiaLocation of manufacturing siteszávod Vápenka Slavec 179, 04911 Slavec, SlovakiaActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCarrières et Chaux Balthazard et CotteAddress of manufacturerRue du Pra Paris, 38360 Sassenage, FranceLocation of manufacturing sitesRue du Pra Paris, 38360 Sassenage, FranceActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCarrières et fours à chaux de DugnyAddress of manufacturerBP 1, 55100 Dugny-sur-Meuse, FranceLocation of manufacturing sitesBP 1, 55100 Dugny-sur-Meuse, France Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerCementos Tudela Veguín, S.A.U.Address of manufacturerCL Argüelles 25, 33003 Oviedo, Asturias, SpainLocation of manufacturing sitesCL Tino Casal, s/n., 33910 Tudela Veguín, Asturias, SpainActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerChaux de BoranAddress of manufacturerRoute de Boran, 60640 Précy-Sur-Oise, FranceLocation of manufacturing sitesRoute de Boran, 60640 Précy-Sur-Oise, FranceActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerChaux de BretagneAddress of manufacturer—, 53600 Evron, FranceLocation of manufacturing sites—, 53600 Evron, FranceActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerChaux de la TourAddress of manufacturer1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, FranceLocation of manufacturing sites1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, FranceActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerClogrennane Lime LTDAddress of manufacturerClogrennane, R93 EV26 Carlow, IrelandLocation of manufacturing sitesClogrennane, R93 EV26 Carlow, IrelandActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerDumont-WautierAddress of manufacturerRue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, BelgiumLocation of manufacturing sitesRue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, Belgium Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerEtablissement Leon LhoistAddress of manufacturerUsine de On-Jemelle, 6900 Marche-en-Famenne, BelgiumLocation of manufacturing sitesUsine de On-Jemelle, 6900 Marche-en-Famenne, BelgiumActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerEuropéenne des Chaux et LiantsAddress of manufacturer2745 route du Bugey, CS22015, 38307 Bourgoin-Jallieu, FranceLocation of manufacturing sitesUsine de Duin, 38460 Trept, FranceActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerLhoist France OuestAddress of manufacturer15 rue Henri Dagallier, 38100 Grenoble, FranceLocation of manufacturing sites15 rue Henri Dagallier, 38100 Grenoble, FranceActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerLusicalAddress of manufacturerValverde, 2025-201 Alcanede, PortugalLocation of manufacturing sitesValverde, 2025-201 Alcanede, PortugalActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerNordkalk ABAddress of manufacturerBox 901, SE-731 29 Köping, SwedenLocation of manufacturing sites

Nordkalk AB, Köping, Kungsängsvägen 22, SE-731 36 Köping, Sweden Nordkalk AB, Landskrona, Verkstadsgatan, SE-261 35 Landskrona, Sweden Nordkalk AB, Luleå, Viktoriavägen 5, SE-974 37 Luleå, Sweden Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerNordkalk Oy AbAddress of manufacturerSkräbbölevägen 18, FI-21600 Pargas, Finland Location of manufacturing sites Nordkalk Oy Ab, Louhi, Louhi, FI-57100 Savonlinna, Finland Nordkalk Oy Ab, Tytyri, Tytyrinkatu 7, FI-08100 Lohja, Finland Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerSingleton BirchAddress of manufacturerMelton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire, United KingdomLocation of manufacturing sitesMelton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire, United KingdomActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerSMA Mineral ABAddress of manufacturer—, SE-682 27 Filipstad, SwedenLocation of manufacturing sites Luleå Lime Plant, C/O SSAB Europe, SE-971 88 Luleå, Sweden Boda Lime Plant, Kärvsåsen Kalkverksvägen 15, SE-795 96 Boda kyrkby, Sweden Rättivik lime plant, Kalkvagen 7, SE-795 32 Rättvik, Sweden SSAB Industriområde, Kalkverket, SE-613 80 Oxelösund, Sweden Mo Industripark, Verkstedsøypa, NO-8626 Mo i Rana, Norway Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerSMA Mineral Burgas Var LTDAddress of manufacturerChataldzha str. No 52, 8002 Burgas, dis. Pobeda BulgariaLocation of manufacturing sitesChataldzha str. No 52, 8002 Burgas, dis. Pobeda BulgariaActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerSMA Mineral OyAddress of manufacturer—, FI-95450 Tornio, FinlandLocation of manufacturing sitesSMA Mineral Oy, Röyttä Lime Plant, Selleenkatu 281, FI-95450 Tornio, FinlandActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerUnicalce S.p.AAddress of manufacturerVia Tonio da Belledo, 30, 23900 Lecco LC, Italy Location of manufacturing sites Via Ponti, 18, 24012 Val Brembilla BG, Italy Via Lisso, 12, 24010 Sedrina BG, Italy Strada Amerina Località S.Pellegrino, 05035 Narni TR, Italy Via Di S.Vincenzo 21, 57021 Campiglia Marittima LI, Italy S.S.Appia km 134, 04020 Itri LT, Italy Contrada Lupini – C.P.33, 74019 Palagiano TA, Italy Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerWietersdorfer & Peggauer Zementwerke GmbHAddress of manufacturerWietersdorf 1, 9373 Klein St. Paul, AustriaLocation of manufacturing sitesAlois-Kern-Straße 1, 8120 Peggau, AustriaActive substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerZakłady Wapiennicze Lhoist S.A.Address of manufacturerul. Wapiennicza 7, 46-050 Tarnów Opolski, PolandLocation of manufacturing sites

ul. Fabryczna 22, 47-316 Górażdże, Poland ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów, Poland Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limeName of manufacturerZement- und Kalkwerke Otterbein GmbH & Co. KGAddress of manufacturerHauptstrasse 50, 36137 Grossenlueder-Mues, GermanyLocation of manufacturing sitesGeorg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues, Germany 2. PRODUCT COMPOSITION AND FORMULATION 2.1. 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 Substance1305-62-0215-137-3100,0 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 CENTRE/doctor/physician. IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTRE/doctor if you feel unwell. Store in a well-ventilated place. Keep container tightly closed. Store locked up. Dispose of container in accordance with local regulations. 4. AUTHORISED USE(S) 4.1. Use description Table 1 Use # 1 – Disinfection of sewage sludge Product typePT02 – 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 useIndoorApplication 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 usersProfessionalPack sizes and packaging material Bulk powder Big bags or sacks (with Polypropylene (PP) or polyethylene (PE) inner layer): 500–1000 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/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 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 — 4.2. Use description Table 2 Use # 2 – Disinfection of manure Product typePT03 – Veterinary hygiene (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: Viruses Common name: Viruses Development stage: Scientific name: Endoparasites Common name: Helminth eggs Development stage: Field(s) of useIndoorApplication 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. temperature, content of dry matter, etc.). Preliminary laboratory tests must be performed to guarantee efficacy. Category(ies) of usersProfessionalPack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500–1000 kg 4.2.1. Use-specific instructions for use 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. 4.2.2. 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). 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 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 environment — 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging — 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 Use # 3 – Disinfection of indoor floor surfaces of animal accomodations and transportation Product typePT03 – Veterinary hygiene (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: Yeasts Common name: Yeasts Development stage: — Scientific name: Fungi Common name: Fungi Development stage: — Scientific name: viruses Common name: Viruses Development stage: — Field(s) of useIndoorApplication 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 usersProfessionalPack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500–1000 kg Paper sacks (with PP or PE inner layer): 25 kg 4.3.1. Use-specific instructions for use 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:
5. Brush and wet the surface;
6. Sprinkle 800 g of product per m2 on the damp ground and add 0,9 litre/m2 of water;
7. Leave to act for at least 48 hours.
8. After treatment, remove the lime by brushing. 4.3.2. 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). 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 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 environment — 4.3.4. 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. 4.3.5. 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 4 Use # 4 – Disinfection of animal accommodations; limewashing of walls Product typePT03 – Veterinary hygiene (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: Yeasts Common name: Yeasts Development stage: — Scientific name: Fungi Common name: Fungi Development stage: — Scientific name: Viruses Common name: Viruses Development stage: —

Field(s) of useIndoorApplication 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 usersProfessionalPack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500–1000 kg 4.4.1. Use-specific instructions for use 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. 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 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 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 animals 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 environment — 4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging — 4.4.5. 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 5 Use # 5 – Disinfection of floors of outdoor animal enclosures Product typePT03 – Veterinary hygiene (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: Yeasts Common name: Yeasts Development stage: — Scientific name: Fungi Common name: Fungi Development stage: — Scientific name: Viruses Common name: Viruses Development stage: — Field(s) of useOutdoorApplication 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 usersProfessionalPack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500–1000 kg Paper sacks (with PP or PE inner layer): 25 kg 4.5.1. Use-specific instructions for use 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. 4.5.2. 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 (500–1000 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 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 environment — 4.5.4. 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. 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 USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses. 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 CENTRE 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 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).