Commission Implementing Regulation (EU) 2023/2703of 4 December 2023granting a Union authorisation for the single biocidal product EuLA oxi-lime 23 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council(Text with EEA relevance)

Commission Implementing Regulation (EU) 2023/2703 of 4 December 2023 granting a Union authorisation for the single biocidal product EuLA oxi-lime 23 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (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 oxi-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-VJ038509-19 in the Register for Biocidal Products. (2) EuLA oxi-lime 23 contains calcium oxide (burnt 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 OXI-LIME 23 (ECHA/BPC/342/2022), https://echa.europa.eu/it/opinions-on-union-authorisation , the draft summary of the biocidal product characteristics (SPC) of EuLA oxi-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 oxi-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 oxi-lime 23. (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0028963-0000 is hereby granted to European Lime Association aisbl for the making available on the market and use of the biocidal product EuLA oxi-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 oxi-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-0028963-0000 R4BP asset number: EU-0028963-0000

1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s)EuLA oxi-lime 23 1.2. Authorisation holder Name and address of the authorisation holderNameEuropean Lime Association aisblAddressc/o IMA-Europe aisbl, Rue des Deux Eglises 26 box 2 , B-1000 Brussels BelgiumAuthorisation numberEU-0028963-0000R4BP asset numberEU-0028963-0000Date 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 31 007 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), 20.268 Altzo (Guipúzcoa) SpainLocation of manufacturing sitesEgileor auzoa, 101. Altzo, 20.268 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, KM 9.3 Valencia SpainName of manufacturerCalGovAddress of manufacturerCarretera Fuente, Apartado 2, 41 560 Estepa SpainLocation of manufacturing sitesCarretera Fuente, Apartado 2, 41 560 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, Mokrá, 664 04 Mokrá, Czech RepublicLocation of manufacturing siteszávod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá, Czech RepublicName of manufacturerCarmeuse Holding SrlAddress of manufacturerStr.Carierei Nr.127A, 500047 Brasov RomaniaLocation of manufacturing sites Str Garii 2, 135100 Fieni Romania Str Principala 1, 337457 Com. Soimus Romania Valea Mare Privat, 117805 Campulung Romania Name of manufacturerCarmeuse Hungaria kftAddress of manufacturerHRSZ 064/1, 7827 Beremend HungaryLocation of manufacturing sitesHRSZ 064/1, 7827 Beremend HungaryName of manufacturerCarmeuse SAAddress of manufacturerRue du Château 13a, 5300 Seilles BelgiumLocation of manufacturing sites

Rue de Boudjesse 1, 5070 Aisemont Belgium 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 manufacturer-, 04911 Slavec SlovakiaLocation of manufacturing sites závod Vápenka Košice, Vstupný areál U.S. Steel, 04454 Košice Slovakia závod Vápenka Slavec, Slavec 179, 049 11 Slavec Slovakia Name of manufacturerCarrières et Chaux Balthazard et CotteAddress of manufacturerRue du Pra Paris, 38360 Sassenage FranceLocation of manufacturing sitesRue du Pra Paris, 38 360 Sassenage FranceName of manufacturerCarrières et fours à chaux de DugnyAddress of manufacturerB.P.1, 55 100 Dugny-sur-Meuse FranceLocation of manufacturing sitesB.P.1, 55 100 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, 60 640 Précy-Sur-Oise FranceLocation of manufacturing sitesRoute de Boran, 60 640 Précy-Sur-Oise FranceName of manufacturerChaux de BretagneAddress of manufacturer-, 53600 Evron FranceLocation of manufacturing sites-, 53600 Evron FranceName of manufacturerChaux de ProvenceAddress of manufacturerAncien Chemin de Martigues, 13 160 Châteauneuf Les Martigues FranceLocation of manufacturing sitesAncien Chemin de Martigues, 13 160 Châteauneuf Les Martigues FranceName of manufacturerChaux et Dolomies du BoulonnaisAddress of manufacturerRue Jules Guesde, 62 720 Réty FranceLocation of manufacturing sitesRue Jules Guesde, 62 720 Réty France Name of manufacturerChaux de la TourAddress of manufacturer1 chemin des Chaux de la Tour, 13 820 Ensues La Redonne FranceLocation of manufacturing sites1 chemin des Chaux de la Tour, 13 820 Ensues La Redonne FranceName of manufacturerClogrennane Lime LTDAddress of manufacturerClogrennane Lime LTD, Clogrennane, R93 EV26 Carlow IrelandLocation of manufacturing sitesClogrennane, R93 EV26, Ireland Carlow IrelandName of manufacturerDumont-WautierAddress of manufacturerRue la Mallieue, 95, B-4470 Saint-Georges-sur-Meuse BelgiumLocation of manufacturing sitesRue la Mallieue, 95, B-4470 Saint-Georges-sur-Meuse BelgiumName 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 Bukowa Sp. z o.o.Address of manufacturerBukowa, ul. Osiedlowa 10, 29-105 Krasocin PolandLocation of manufacturing sitesBukowa, ul. Osiedlowa 10, 29-105 Krasocin PolandName of manufacturerLhoist Central Europe / Lhoist Česká republika a Slovensko Vápenka Čertovy schody a.sAddress of manufacturerTmaň 200, 267 21 Tmaň Czech RepublicLocation of manufacturing sitesTmaň 200, 267 21 Tmaň Czech Republic

Name of manufacturerLhoist Faxe Kalk A/SAddress of manufacturerHovedgaden 13, 4654 Faxe Ladeplads DenmarkLocation of manufacturing sites Nordkajen 17, 7100 Vejle Denmark Gl. Strandvej 14, 4640 Faxe Denmark Name of manufacturerLhoist France OuestAddress of manufacturer15 rue Henri Dagallier, 38 100 Grenoble FranceLocation of manufacturing sites15 rue Henri Dagallier, 38 100 Grenoble FranceName of manufacturerLhoist UK LtdAddress of manufacturerHindlow, Buxton, SK17 OEL Derbyshire United KingdomLocation of manufacturing sitesHindlow, Buxton, Derbyshire, SK17 OEL Derbyshire United KingdomName 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, KPAB Storugns Lärbro, Lärbro Storugns 2741, SE-624 53 Lärbro Sweden Name of manufacturerNordkalk ASAddress of manufacturerFaehlmanni tee 11A, Rakke, 46 301 Lääne-Virumaa EstoniaLocation of manufacturing sitesFaehlmanni tee 11A, Rakke, 46 301 Lääne-Virumaa EstoniaName of manufacturerNordkalk Oy AbAddress of manufacturerSkräbbölevägen 18, 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 Nordkalk Oy Ab, Pargas, Kalkhamnsvägen 5, 21600 Pargas Finland Name of manufacturerPigeon Chaux SASAddress of manufacturer29 Rue des Ruettes, 53410 Saint-Pierre-la-Cour FranceLocation of manufacturing sitesLa Hunaudiere, 53480 Vaiges FranceName of manufacturerSee Bruyeres & FilsAddress of manufacturerLe Bourg, 47500 Saint Front sur Lémance FranceLocation of manufacturing sitesLe Bourg, 47500 Saint Front sur Lémance FranceName 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 manufacturerBox 329, SE-682 27 Filipstad SwedenLocation of manufacturing sites Luleå lime plant, C/O SSAB Europe, SE-971 88 Luleå Sweden Boda lime plant, Kärvsåsen Kalkveerksvägen 15, SE-795 96 Boda kyrkby Sweden Rättivik lime plant, Kalkvägen 7, SE-795 32 RÄTTVIK Sweden SSAB Industriområde, Kalkverket, SE-613 80 Oxelösund Sweden Name of manufacturerSMA Mineral Burgas Var LTDAddress of manufacturerdis. Pobeda, Chataldzha str. No52, 8002 Burgas BulgariaLocation of manufacturing sitesdis. Pobeda, Chataldzha str. No52, 8002 Burgas BulgariaName of manufacturerSMA Mineral OyAddress of manufacturerSelleenkatu 281, 95450 Torino FinlandLocation of manufacturing sitesRöyttä Lime Plant Selleenkatu 281, 95450 Torino FinlandName of manufacturerSociété des fours à chaux de SorcyAddress of manufacturerRoute de Sorcy, B.P.16, 55 190 Void FranceLocation of manufacturing sitesRoute de Sorcy, B.P.16, 55 190 Void France

Name of manufacturerSpenner GmbH & Co. KGAddress of manufacturerBahnhofstraße 20, D-59597 Erwitte GermanyLocation of manufacturing sitesHüchtchenweg 2, D-59597 Erwitte GermanyName of manufacturerTarmac, Lime and PowdersAddress of manufacturerTunstead House, Wormhill, Buxton, SK17 8TG Derbyshire United KingdomLocation of manufacturing sites Tunstead Quarry, Wormhill, Buxton, SK17 8TG Derbyshire United Kingdom Hindlow Works, Sterndale Moor, Buxton, SK17 9QD Derbyshire United Kingdom Name of manufacturerTrzuskawica S.A.Address of manufacturerSitkówka 24, 26-052 Nowiny PolandLocation of manufacturing sitesTrzuskawica S.A., Sitkówka 24, 26-052 Nowiny PolandName of manufacturerUnicalce S.p.AAddress of manufacturerVia Tonio da Belledo, 30, l-23900 Lecco (LC), ItalyLocation of manufacturing sites Via Ponti, 18, 1-24012 Val Brembilla (BG) Italy Via Lisso 12, I-24010 Sedrina (BG) Italy Strada Amerina Località S.Pellegrino, l-05035 Narni (TR) Italy Via Di S.Vincenzo 21, I-57021 Campiglia Marittima (LI) Italy S.S.Appia km 134, l-04020 Itri (LT) Italy S.S.Appia km 134, l-04020 Itri (LT) Italy Contrada Lupini – C.P.33, l-74019 Palagiano (TA) Italy Name of manufacturerVápenka Vitošov s.r.oAddress of manufacturerč.p. 54, 78901 Hrabová Czech RepublicLocation of manufacturing sitesč.p. 54, 78901 Hrabová Czech RepublicName of manufacturerWietersdorfer & Peggauer Zementwerke GmbHAddress of manufacturerWietersdorf 1, 9373 Klein St. Paul AustriaLocation of manufacturing sitesAlois-Kern-Straße 1, 8120 Peggau Austria Name 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. Wapiennicza 7, 46-050 Tarnów Opolski Poland ul. Wapiennicza 7, 46-050 Tarnów Opolski 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 oxide/lime/burnt lime/quicklimeName of manufacturerCal Industrial SLAddress of manufacturerPedro I, 19-21, 31 007 Pamplona, SpainLocation of manufacturing sitesPedro I, 19-21, 31 007 Pamplona SpainActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerCalera de Alzo, S. L.Address of manufacturerEgileor auzoa, 101, 20.268 Altzo (Guipúzcoa) SpainLocation of manufacturing sitesEgileor auzoa, 101, 20.268 Altzo (Guipúzcoa) SpainActive substanceCalcium oxide/lime/burnt lime/quicklimeName 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 oxide/lime/burnt lime/quicklimeName of manufacturerCalGovAddress of manufacturerCarretera Fuente, Apartado 2, 41 560, Estepa SpainLocation of manufacturing sitesCarretera Fuente, Apartado 2, 41 560, Estepa, Spain

Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerCarmeuse ChauxAddress of manufacturer215 route d’Arras, 62320 Bois Bernard FranceLocation of manufacturing sites215 route d’Arras, 62320 Bois Bernard FranceActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerCarmeuse Czech Republic s.r.o.Address of manufacturerzávod Vápenka Mokrá, Mokrá 359,, 664 04 Mokrá Czech RepublicLocation of manufacturing siteszávod Vápenka Mokrá, Mokrá 359,, 664 04 Mokrá Czech RepublicActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerCarmeuse Holding SrlAddress of manufacturerStr.Carierei Nr.127A,, 500047 Brasov RomaniaLocation of manufacturing sites Str Garii 2,, 135100 Fieni Romania Str Principala 1,, 337457 Com. Soimus Romania Valea Mare Pravat,, 117805 Campulung Romania Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerCarmeuse Hungaria kftAddress of manufacturerHRSZ 064/1,, 7827 Beremend HungaryLocation of manufacturing sitesHRSZ 064/1,, 7827 Beremend HungaryActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerCarmeuse SAAddress of manufacturerRue du Château 13a,, 5300 Seilles BelgiumLocation of manufacturing sites Rue de Boudjesse 1,, 5070 Aisemont Belgium Rue du Val Notre Dame 300,, 4520 Moha Belgium Rue du Château 13a,, 5300 Seilles, Belgium Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerCarmeuse Slovakia s.r.oAddress of manufacturerzávod Vápenka Slavec 179,, 04911 Slavec SlovakiaLocation of manufacturing sites závod Vápenka Slavec 179,, 04911 Slavec Slovakia závod Vápenka Košice, Vstupný areál U.S. Steel, 0455 Košice Slovakia Active substanceCalcium oxide/lime/burnt lime/quicklimeName 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 oxide/lime/burnt lime/quicklimeName of manufacturerCarrières et fours à chaux de DugnyAddress of manufacturerB.P.1,, 55 100 Dugny-sur-Meuse FranceLocation of manufacturing sitesB.P.1,, 55 100 Dugny-sur-Meuse FranceActive substanceCalcium oxide/lime/burnt lime/quicklimeName 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 oxide/lime/burnt lime/quicklimeName of manufacturerChaux de BoranAddress of manufacturerRoute de Boran, 60640 Précy-Sur-Oise FranceLocation of manufacturing sitesRoute de Boran, 60640 Précy-Sur-Oise FranceActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerChaux de ProvenceAddress of manufacturerAncien Chemin de Martigues, 13160 Châteauneuf Les Martigues FranceLocation of manufacturing sitesAncien Chemin de Martigues, 13160 Châteauneuf Les Martigues FranceActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerChaux et Dolomies du BoulonnaisAddress of manufacturerRue Jules Guesde,, 62 720 Réty FranceLocation of manufacturing sitesRue Jules Guesde,, 62 720 Réty France

Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerChaux de la TourAddress of manufacturer1 chemin des Chaux de la Tour,, 13 820 Ensues La Redonne FranceLocation of manufacturing sites1 chemin des Chaux de la Tour,, 13 820 Ensues La Redonne FranceActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerClogrennane Lime LTDAddress of manufacturerClogrennane, R93 EV26 Carlow, IrelandLocation of manufacturing sitesClogrennane, R93 EV26 Carlow, IrelandActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerDumont-WautierAddress of manufacturerRue la Mallieue, 95, B-4470 Saint-Georges-sur-Meuse, BelgiumLocation of manufacturing sitesRue la Mallieue, 95,, B-4470 Saint-Georges-sur-Meuse, BelgiumActive substanceCalcium oxide/lime/burnt lime/quicklimeName 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 oxide/lime/burnt lime/quicklimeName 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 oxide/lime/burnt lime/quicklimeName of manufacturerLhoist Bukowa Sp. z o.oAddress of manufacturerBukowa, ul. Osiedlowa 10,, 29-105 Krasocin PolandLocation of manufacturing sitesBukowa, ul. Osiedlowa 10,, 29-105 Krasocin Poland Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerLhoist France OuestAddress of manufacturer15 rue Henri Dagallier,, 38 100 Grenoble FranceLocation of manufacturing sites15 rue Henri Dagallier,, 38 100 Grenoble FranceActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerLusicalAddress of manufacturerValverde, 2025-201 Alcanede PortugalLocation of manufacturing sitesValverde, 2025-201 Alcanede PortugalActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerNordkalk ABAddress of manufacturerBox 901, SE-731 29 Köping SwedenLocation of manufacturing sites Kungsängsvägen 22, SE-731 36 Köping Sweden Lärbro Storugns 2741, SE-624 53, Lärbro Sweden Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerNordkalk ASAddress of manufacturerFaehlmanni tee 11A, Rakke, 46 301, Lääne-Virumaa EstoniaLocation of manufacturing sitesFaehlmanni tee 11A, Rakke, 46 301, Lääne-Virumaa EstoniaActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerNordkalk Oy AbAddress of manufacturerSkräbbölevägen 18, 21600 Pargas FinlandLocation of manufacturing sites Nordkalk Oy Ab, Tytyri, Tytyrinkatu 7, Fi-08100, Lohja Finland Nordkalk Oy Ab, Pargas, Kalkhamnsvägen 5, Fi-21600, Pargas Finland Nordkalk Oy Ab, Louhi, Louhi, Fi-57100 Savonlinna Finland Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerPigeon Chaux SASAddress of manufacturer29 Rue des Ruettes, 53410 Saint-Pierre-la-Cour FranceLocation of manufacturing sitesLa Hunaudiere -, 53480 Vaiges France

Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerSee Bruyeres & FilsAddress of manufacturerLe Bourg -, 47500 Saint Front sur Lémance, FranceLocation of manufacturing sitesLe Bourg -, 47500 Saint Front sur Lémance, FranceActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerSingleton BirchAddress of manufacturerMelton Ross Quarries, DN38 6AE Barnetby, , N Lincolnshire United KingdomLocation of manufacturing sitesMelton Ross Quarries, DN38 6AE Barnetby, N Lincolnshire United KingdomActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerSMA Mineral ABAddress of manufacturerBox 329,, SE-682 27 Filipstad SwedenLocation of manufacturing sites Luleå lime plant, C/O SSAB Europe, SE-971 88 Luleå Sweden Boda lime plant, Kärvsåsen Kalkveerksvägen 15, SE-795 96 Boda kyrkby Sweden Rättivik lime plant, Kalkvägen 7, SE-795 32 RÄTTVIK Sweden SSAB Industriområde, Kalkverket,, SE-613 80 Oxelösund, Sweden Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerSMA Mineral Burgas Var LTDAddress of manufacturerChataldzha str. No52, 8002, Burgas, dis. Pobeda BulgariaLocation of manufacturing sitesChataldzha str. No52, 8002, Burgas, dis. Pobeda BulgariaActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerSMA Mineral OyAddress of manufacturerSelleenkatu 281, 95450 Torino FinlandLocation of manufacturing sitesRöyattä lime plant, Selleenkatu 281, 95450 Torino FinlandActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerSociété des fours à chaux de SorcyAddress of manufacturerRoute de Sorcy B.P.16, 55 190 Void FranceLocation of manufacturing sitesRoute de Sorcy B.P.16, 55 190 Void France Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerSpenner GmbH & Co. KGAddress of manufacturerBahnhofstraße 20, D-59597 Erwitte GermanyLocation of manufacturing sitesHüchtchenweg 2, D-59597 Erwitte GermanyActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerTrzuskawica S.A.Address of manufacturerTrzuskawica S.A., Sitkówka 24,, 26-052 Nowiny, PolandLocation of manufacturing sitesTrzuskawica S.A., Sitkówka 24,, 26-052 Nowiny, PolandActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerUnicalce S.p.AAddress of manufacturerVia Tonio da Belledo, 30, l-23900 Lecco (LC), ItalyLocation of manufacturing sites Via Ponti, 18, 1-24012 Val Brembilla (BG), Italy Via Lisso, 12, l-24010 Sedrina (BG) Italy Strada Amerina Località S.Pellegrino, l-05035 Narni (TR) Italy Via Di S.Vincenzo 21, I-57021 Campiglia Marittima (LI) Italy S.S.Appia km 134, l-04020 Itri (LT) Italy Contrada Lupini – C.P.33, l-74019 Palagiano (TA) Italy Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerVápenka Vitošov s.r.o.Address of manufacturerč.p. 54, 78901 Hrabová, Czech RepublicLocation of manufacturing sitesč.p. 54, 78901 Hrabová, Czech RepublicActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerWietersdorfer & Peggauer Zementwerke GmbHAddress of manufacturerWietersdorf 1, 9373 Klein St. Paul, AustriaLocation of manufacturing sitesAlois-Kern-Straße 1, 8120 Peggau AustriaActive substanceCalcium oxide/lime/burnt lime/quicklimeName 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. Wapiennicza 7, 46-050 Tarnów Opolski, Poland ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów Poland Active substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerZement- und Kalkwerke Otterbein GmbH & Co. KGAddress of manufacturerHauptstrasse 50, 36137 Grossenlueder-Mues GermanyLocation of manufacturing sitesGeorg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues GermanyActive substanceCalcium oxide/lime/burnt lime/quicklimeName of manufacturerLhoist UK LtdAddress of manufacturerHindlow, Buxton, SK17 OEL Derbyshire United KingdomLocation of manufacturing sitesHindlow, Buxton, SK17 OEL Derbyshire United Kingdom 2. PRODUCT COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the product Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Calcium oxide/lime/burnt lime/quicklimeActive Substance1305-78-8215-138-9100,0 2.2. Type of formulation DP - Dustable powder 3. HAZARD AND PRECAUTIONARY STATEMENTS Hazard statements Causes skin irritation. Causes serious eye damage. May cause respiratory irritation. Reacts violently with water. 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 or 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. Dispose of container in accordance with local regulations. Store locked up. 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 by means of a blender. The dry product is mixed with the sewage sludge in an open mixer. The product should be loaded by fully automated processes. Application rate(s) and frequency Application Rate: 0,15 - 1,5 kg product / kg dry weight of substance; typical dry solid content - 12-25 % in sewage sludge Dilution (%): - Ready to use (RTU) product

Number and timing of application: The application rate must be sufficient to maintain a pH of > 12 and a temperature >50°C during the contact time. Contact time: 24 hours Category(ies) of usersProfessionalPack sizes and packaging material Bulk powder Big bags or sacks (with Polypropylene (PP) or Polyethylene (PE) inner layer): 500 - 1200 kg 4.1.1. Use-specific instructions for use The dose must be sufficient to maintain a pH of > 12 and a temperature >50°C during the 24 hour contact time. Application rate : 0,15 – 1,5 kg product / kg dry weight of substrate; typical dry solids content - 12-25% in sewage sludge. The ratio may vary between application and treatment plant designs. The user must ensure that the treatment is effective through preliminary laboratory test 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 big bags or sacks (500 - 1200 kg) must be performed using a telehandler (including a closed cabin). During the loading of the product and the disposal of empty bags or sacks, wear: a respiratory protective equipment (RPE) 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 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 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 protection 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 treatment unit 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 shall 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 of > 12 and a temperature > 60°C during the contact time. Contact time: 24 hours Category(ies) of usersProfessionalPack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500 - 1200 kg 4.2.1. Use-specific instructions for use The application rate must be sufficient to maintain a pH of > 12 and a temperature > 60°C during the 24 hour contact time. Do not apply more than 100 kg product /m3 of manure. The mixture should be moistened and any self-ignition that might occur should be extinguished with water. After the necessary contact time, remove the treated manure from the animal house. Use of the treated manure according to local legislation. 4.2.2. 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 or sacks must be performed using a telehandler (including a closed cabin). During the loading of the product and the disposal of empty bags or sacks, wear: RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalant); 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 equivalant (coverall material to be specified by the authorisation holder within the product information). During the treatment of the manure, the wearing of air-fed or canister RPE specific for ammonia gas in accordance with EN 14387 or equivalent, is recommended in the absence of collective management measures to estimate and prevent an exposure greater than the EU OEL of 14 mg/m3 for that gas. During the manual handling of treated manure wear protective gloves in accordance with EN 374 or equivalent and protection coverall in accordance with EN 14126 or equivalent protecting against the intrinsic properties of the manure. The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

See section 6 for the full titles of the EN standards and legislations. The cleaning of the treatment unit must be avoided or performed with an automated process with no exposure of the professional. Do not apply the product if releases from animal housings or manure/slurry storage areas can be directed to a sewage treatment plant or directly to surface water. 4.2.3. 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 accommodations 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: 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 useIndoorApplication method(s) Method: Direct application Detailed description: The product is spread directly onto the floors of animal accomodations using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader. Application rate(s) and frequency Application Rate: 800 g product / 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 - 1200 kg Paper sacks (with PP or PE inner layer): 25 kg 4.3.1. Use-specific instructions for use The product is spread onto the floors of animal accommodations and transportation using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader. A long-handled shovel must be used for the manual spreading application. A. On concrete floors:

1. Wash the surface with running water;
2. Sprinkle approximatively 800 g of product / m2 to cover the damp ground and add 0,9 litre/m2 of water;
3. Leave to act for at least 48 hours. B. On beaten-earth floor:
4. Brush and wet the surface;
5. Sprinkle approx. 800 g of product / m2 on the damp ground and add 0,9 litre/m2 of water;
6. Leave to act for at least 48 hours. 4.3.2. Use-specific risk mitigation measures During the loading, the application of the product and the disposal of empty bags or sacks, wear: RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent);

chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information); a protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information). For the use of big bags or sacks (500-1200 kg), the loading of the product and the disposal of empty bags or sacks must be performed fully automatically using a telehandler (including a closed cabin). During the loading of small sacks (25 kg), thoroughly empty out the sacks in order to minimise the remaining powder. Fold carefully the small bag in order to avoid any spills. During the disposal of any residues of the product after the application, wear: RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent); chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information); protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information). The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full titles of the EN standards and legislation. Animals must not be present during the entire treatment duration. Remove residues of the product on the ground by sweeping before re-entry of animals. Feed and drinking water must be carefully covered or removed during the application of the product. Do not apply the product if releases from animal housings, manure/slurry storage areas or animal transportation disinfection areas can be directed to a sewage treatment plant or directly to surface water. 4.3.3. 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 product by brushing. Collect the resulting dry waste and recycle it as agricultural liming material or dispose of the dry waste according to local requirements. For animal transportation use only: after brushing, rinse and clean the vehicle. 4.3.5. 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 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: Yeast Common name: Yeasts Development stage: - Scientific name: other fungi

Common name: Fungi Development stage: - Scientific name: Virus Common name: Virus 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: 600 - 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 - 1200 kg Paper sacks (with PP or PE inner layer): 25 kg 4.4.1. Use-specific instructions for use Before the introduction of new animals: Brush and wet the floor. spread 600 - 800 g product/m2 onto the ground then add 0,9 litre/m2 of water. leave to act for at least 48 hours. Do not apply in the case of wind or rain. 4.4.2. Use-specific risk mitigation measures During the loading, the application of the product on the floor and the disposal of empty bags, wear: RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to EN 149 with a P3 filter or equivalent); chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information); a protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information). For the use of big bags or sacks (500-1200 kg), the loading of the product and the disposal of empty bags or sacks must be performed fully automatically using a telehandler (including a closed cabin). During the loading of small sacks (25 kg), thoroughly empty out the sacks to minimise the remaining powder. Fold carefully the small bag in order to avoid any spills. During the disposal of the product after the application, wear: RPE of at least APF 40 (airtight face piece covering eyes, nose, mouth and chin according to NF EN 149 with a P3 filter or equivalent); chemical resistant gloves in accordance with EN 374 or equivalent (glove material to be specified by the authorisation holder within the product information); protective coverall in accordance with EN 13982 or equivalent (coverall material to be specified by the authorisation holder within the product information). The provisions on personal protective equipment are without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full titles of the EN standards and legislation. Do not exceed two applications per year. Animals must not be present during the entire treatment duration. Remove the residues of the product on the ground by thorough sweeping before allowing re-entry of animals.

Feed and drinking water must be carefully covered or removed during the application of the product. 4.4.3. 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 product by brushing. Collect the resulting dry waste and recycle it as agricultural liming material or dispose of the dry waste according to local requirements. 4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

1. 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 uses, do not apply in the case of rain or wind 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 or sacks, the required contact time and the subsequent removal of the product and its residues from the ground). Use only in a well-ventilated area. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the 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 easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.Information to Healthcare personnel/doctor: The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid or propionic acid. 5.4. Instructions for safe disposal of the product and its packaging Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) or down the drains. Dispose of unused product, its packaging and all other waste, in accordance with local regulations. 5.5. Conditions of storage and shelf-life of the product under normal conditions of 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 - 4.4.2: EN 149 - Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking; EN 374 - EN ISO 374-1: 2018: Protective gloves against dangerous chemicals and micro-organisms. Part 1: terminology and performance requirements for chemical risks; EN 13982 - Protective clothing for use against solid particulates - Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulates; EN 14387 - EN 14387:2021: Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking; EN 14126 - BS EN 14126: 2003 - Protective clothing. Performance requirements and tests methods for protective clothing against infective agent; Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11.