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
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) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal productsOJ L 167, 27.6.2012, p. 1., 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 opinionECHA 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 1A 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 2This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 4 December 2023.For the CommissionThe PresidentUrsula von der LeyenANNEXSummary of product characteristics for a biocidal productEuLA hydra-lime 23Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)Product type 3 – Veterinary hygiene (Disinfectants)Authorisation number: EU-0028954-0000R4BP asset number: EU-0028954-00001.ADMINISTRATIVE INFORMATION1.1.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 aisbl
Addressc/o IMA-Europe aisbl, Rue des Deux Églises 26, box 2, 1000 Brussels, Belgium
Authorisation numberEU-0028954-0000
R4BP asset numberEU-0028954-0000
Date of the authorisation25 December 2023
Expiry date of the authorisation30 November 2033
1.3.Manufacturer(s) of the product
Name of manufacturerCal Industrial SL
Address of manufacturerPedro I, 19-21, 31007 Pamplona, Spain
Location of manufacturing sitesPedro I, 19-21, 31 007 Pamplona, Spain
Name of manufacturerCalera de Alzo, S. L.
Address of manufacturerPostal number: 20.268, Egileor auzoa, 101, Altzo (Guipúzcoa), Spain
Location of manufacturing sitesEgileor auzoa, 101, Altzo (Guipúzcoa), Spain
Name of manufacturerCaleras de San Cucao, S.A.
Address of manufacturerAgüera s/n, 33425 San Cucao de Llanera, Spain
Location 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, Spain
Location of manufacturing sitesCtra. Valencia-Ademuz, KM 9.3. Paterna, Valencia, Spain
Name of manufacturerCalGov
Address of manufacturerCarretera Fuente, Apartado 2, 41560 Estepa, Spain
Location of manufacturing sitesCarretera Fuente, Apartado 2, 41560 Estepa, Spain
Name of manufacturerCarmeuse Chaux
Address of manufacturer215 route d’Arras, 62320 Bois Bernard, France
Location of manufacturing sites215 route d’Arras, 62320 Bois Bernard, France
Name of manufacturerCarmeuse Czech Republic s.r.o.
Address of manufacturerMokrá 359, 664 04 Mokrá, Czechia
Location of manufacturing siteszávod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá , Czechia
Name of manufacturerCarmeuse Holding Srl
Address of manufacturerStr. Carierei nr. 127A, 500047 Brașov, Romania
Location of manufacturing sitesStr. Principală 1, 337457 Com. Șoimuș, Romania. Valea Mare Pravăț, 117805 Câmpulung, Romania
Name of manufacturerCarmeuse Hungaria kft
Address of manufacturerHRSZ 064/1, 7827 Beremend, Hungary
Location of manufacturing sitesHRSZ 064/1, 7827 Beremend, Hungary
Name of manufacturerCarmeuse Nederland BV
Address of manufacturerNijverheidsstraat 32, 2802 AL Gouda, Netherlands
Location of manufacturing sitesNijverheidsstraat 32, 2802 AL Gouda, Netherlands
Name of manufacturerCarmeuse SA
Address of manufacturerRue du Château 13a, 5300 Seilles, Belgium
Location of manufacturing sitesRue du Val Notre Dame 300, 4520 Moha, BelgiumRue du Château 13a, 5300 Seilles, Belgium
Name of manufacturerCarmeuse Slovakia s.r.o.
Address of manufacturerSlavec, 049 11 Slavec, Slovakia
Location of manufacturing siteszávod Vápenka Slavec, Slavec 179, 049 11 Slavec, Slovakia
Name of manufacturerCarrières et Chaux Balthazard et Cotte
Address of manufacturerRue du Pra Paris, 38360 Sassenage, France
Location of manufacturing sitesRue du Pra Paris, 38360 Sassenage, France
Name of manufacturerCarrières et fours à chaux de Dugny
Address of manufacturerBP 1, 55100 Dugny-sur-Meuse, France
Location of manufacturing sitesBP 1, 55100 Dugny-sur-Meuse, France
Name of manufacturerCementos Tudela Veguín, S.A.U.
Address of manufacturerCL Argüelles 25, 33003 Oviedo, Asturias, Spain
Location of manufacturing sitesCL Tino Casal, s/n., 33910 Tudela Veguín, Asturias, Spain
Name of manufacturerChaux de Boran
Address of manufacturerRoute de Boran, 60640 Précy-Sur-Oise, France
Location of manufacturing sitesRoute de Boran, 60640 Précy-Sur-Oise, France
Name of manufacturerChaux de Bretagne
Address of manufacturer—, 53600 Evron, France
Location of manufacturing sites—, 53600 Evron, France
Name of manufacturerChaux de la Tour
Address of manufacturer1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France
Location of manufacturing sites1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France
Name of manufacturerClogrennane Lime LTD
Address of manufacturerClogrennane, R93 EV26 Carlow, Ireland
Location of manufacturing sitesClogrennane, R93 EV26 Carlow, Ireland
Name of manufacturerDumont-Wautier
Address of manufacturerRue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, Belgium
Location of manufacturing sitesRue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, Belgium
Name of manufacturerEtablissement Leon Lhoist
Address of manufacturerUsine de On-Jemelle, 6900 Marche-en-Famenne, Belgium
Location of manufacturing sitesUsine de On-Jemelle, 6900 Marche-en-Famenne, Belgium
Name of manufacturerEuropéenne des Chaux et Liants
Address of manufacturer2745 route du Bugey, CS22015, 38307 Bourgoin-Jallieu, France
Location of manufacturing sitesUsine de Duin, 38460 Trept, France
Name of manufacturerLhoist Central Europe/Lhoist Česká republika a Slovensko Vápenka Čertovy schody a.s
Address of manufacturerTmaň 200, 267 21 Tmaň, Czechia
Location of manufacturing sitesTmaň 200, 267 21 Tmaň, Czechia
Name of manufacturerLhoist Faxe Kalk A/S
Address of manufacturerHovedgaden 13, 4654 Faxe Ladeplads, Denmark
Location of manufacturing sitesGl. Strandvej 14, 4640 Faxe, Denmark
Name of manufacturerLhoist France Ouest
Address of manufacturer15 rue Henri Dagallier, 38100 Grenoble, France
Location of manufacturing sites15 rue Henri Dagallier, 38100 Grenoble, France
Name of manufacturerLusical
Address of manufacturerValverde, 2025-201 Alcanede, Portugal
Location of manufacturing sitesValverde, 2025-201 Alcanede, Portugal
Name of manufacturerNordkalk AB
Address of manufacturerBox 901, SE-731 29 Köping, Sweden
Location of manufacturing sitesNordkalk AB, Köping, Kungsängsvägen 22, SE-731 36 Köping, SwedenNordkalk AB, Landskrona, Verkstadsgatan, SE-261 35 Landskrona, SwedenNordkalk AB, Luleå, Viktoriavägen 5, SE-974 37 Luleå, Sweden
Name of manufacturerNordkalk Oy Ab
Address of manufacturerSkräbbölevägen 18, FI-21600 Pargas, Finland
Location of manufacturing sitesNordkalk Oy Ab, Louhi, Louhi, FI-57100 Savonlinna, FinlandNordkalk Oy Ab, Tytyri, Tytyrinkatu 7, FI-08100 Lohja, Finland
Name of manufacturerSingleton Birch
Address of manufacturerMelton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire. United Kingdom
Location of manufacturing sitesMelton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire. United Kingdom
Name of manufacturerSMA Mineral AB
Address of manufacturer—, SE-682 27 Filipstad, Sweden
Location of manufacturing sitesLuleå Lime Plant, C/O SSAB Europe, SE-971 88 Luleå, SwedenBoda Lime Plant, Kärvsåsen Kalkverksvägen 15, SE-795 96 Boda kyrkby, SwedenRättivik lime plant, Kalkvagen 7, SE-795 32 Rättvik, SwedenSSAB Industriområde, Kalkverket, SE-613 80 Oxelösund, SwedenMo Industripark, Verkstedsøypa, NO-8626 Mo i Rana, Norway
Name of manufacturerSMA Mineral Burgas Var LTD
Address of manufacturerdis. Pobeda, Chataldzha str. No 52, 8002 Burgas, Bulgaria
Location of manufacturing sitesdis. Pobeda, Chataldzha str. No 52, 8002 Burgas, Bulgaria
Name of manufacturerSMA Mineral Oy
Address of manufacturer—, FI-95450 Tornio, Finland
Location of manufacturing sitesSMA Mineral Oy, Röyttä Lime Plant, Selleenkatu 281, FI-95450 Tornio, Finland
Name of manufacturerTarmac, Lime and Powders
Address of manufacturerTunstead House, Wormhill, Buxton, SK17 8TG Derbyshire, United Kingdom
Location of manufacturing sitesTunstead House, Wormhill, Buxton, SK17 8TG Derbyshire, United Kingdom
Name of manufacturerUnicalce S.p.A
Address of manufacturerVia Tonio da Belledo, 30, 23900 Lecco LC, Italy
Location of manufacturing sitesVia Ponti, 18, 24012 Val Brembilla BG, ItalyVia Lisso, 12, 24010 Sedrina BG, ItalyStrada Amerina Località S.Pellegrino, 05035 Narni TR, ItalyVia Di S.Vincenzo 21, 57021 Campiglia Marittima LI, ItalyS.S.Appia km 134, 04020 Itri LT, ItalyContrada Lupini – C.P.33, 74019 Palagiano TA, Italy
Name of manufacturerWietersdorfer & Peggauer Zementwerke GmbH
Address of manufacturerWietersdorf 1, 9373 Klein St. Paul, Austria
Location 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, Poland
Location of manufacturing sitesul. Fabryczna 22, 47-316 Górażdże, Polandul. Bolesława Chrobrego 77B, 59-550 Wojcieszów, Poland
Name of manufacturerZement- und Kalkwerke Otterbein GmbH & Co. KG
Address of manufacturerHauptstrasse 50, 36137 Grossenlueder-Mues, Germany
Location of manufacturing sitesGeorg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues, Germany
Name of manufacturerSMA Mineral AS
Address of manufacturerPostbox 500, NO-8601 Mo i Rana, Norway
Location 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 lime
Name of manufacturerCal Industrial SL
Address of manufacturerPedro I, 19-21, 31007 Pamplona, Spain
Location of manufacturing sitesPedro I, 19-21, 31007 Pamplona, Spain
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCalera de Alzo, S. L.
Address of manufacturer20.268, Egileor auzoa, 101 Altzo (Guipúzcoa), Spain
Location of manufacturing sitesEgileor auzoa, 101 Altzo (Guipúzcoa), Spain
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCaleras de San Cucao, S.A.
Address of manufacturerAgüera s/n, 33425 San Cucao de Llanera, Spain
Location of manufacturing sitesAgüera s/n, 33425 San Cucao de Llanera, Spain
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCales Pascual S.L.
Address of manufacturerC/Cura Bau, 15, 46112 Valencia, Spain
Location of manufacturing sitesCtra. Valencia-Ademuz, KM 9.3., Paterna, Spain
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCalGov
Address of manufacturerCarretera Fuente, Apartado 2, 41560 Estepa, Spain
Location of manufacturing sitesCarretera Fuente, Apartado 2, 41560 Estepa, Spain
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarmeuse Chaux
Address of manufacturer215 route d’Arras, 62320 Bois Bernard, France
Location of manufacturing sites215 route d’Arras, 62320 Bois Bernard, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarmeuse Czech Republic s.r.o.
Address of manufacturerMokrá 359, 664 04 Mokrá, Czechia
Location of manufacturing siteszávod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá, Czechia
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarmeuse Holding Srl
Address of manufacturerStr. Carierei nr. 127A, 500047 Brașov, Romania
Location of manufacturing sitesStr. Principală 1, 337457 Com. Șoimuș, Romania.Valea Mare Pravăț, 117805 Câmpulung, Romania
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarmeuse Hungaria kft
Address of manufacturerHRSZ 064/1, 7827 Beremend, Hungary
Location of manufacturing sitesHRSZ 064/1, 7827 Beremend, Hungary
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarmeuse Nederland BV
Address of manufacturerNijverheidsstraat 32, 2802 AL Gouda, Netherlands
Location of manufacturing sitesNijverheidsstraat 32, 2802 AL Gouda, Netherlands
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarmeuse SA
Address of manufacturerRue du Château 13a, 5300 Seilles, Belgium
Location of manufacturing sitesRue du Val Notre Dame 300, 4520 Moha, BelgiumRue du Château 13a, 5300 Seilles, Belgium
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarmeuse Slovakia s.r.o
Address of manufacturerSlavec, 049 11 Slavec, Slovakia
Location of manufacturing siteszávod Vápenka Slavec 179, 04911 Slavec, Slovakia
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarrières et Chaux Balthazard et Cotte
Address of manufacturerRue du Pra Paris, 38360 Sassenage, France
Location of manufacturing sitesRue du Pra Paris, 38360 Sassenage, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCarrières et fours à chaux de Dugny
Address of manufacturerBP 1, 55100 Dugny-sur-Meuse, France
Location of manufacturing sitesBP 1, 55100 Dugny-sur-Meuse, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerCementos Tudela Veguín, S.A.U.
Address of manufacturerCL Argüelles 25, 33003 Oviedo, Asturias, Spain
Location of manufacturing sitesCL Tino Casal, s/n., 33910 Tudela Veguín, Asturias, Spain
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerChaux de Boran
Address of manufacturerRoute de Boran, 60640 Précy-Sur-Oise, France
Location of manufacturing sitesRoute de Boran, 60640 Précy-Sur-Oise, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerChaux de Bretagne
Address of manufacturer—, 53600 Evron, France
Location of manufacturing sites—, 53600 Evron, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerChaux de la Tour
Address of manufacturer1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France
Location of manufacturing sites1 chemin des Chaux de la Tour, 13820 Ensues La Redonne, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerClogrennane Lime LTD
Address of manufacturerClogrennane, R93 EV26 Carlow, Ireland
Location of manufacturing sitesClogrennane, R93 EV26 Carlow, Ireland
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerDumont-Wautier
Address of manufacturerRue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, Belgium
Location of manufacturing sitesRue la Mallieue, 95, 4470 Saint-Georges-sur-Meuse, Belgium
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerEtablissement Leon Lhoist
Address of manufacturerUsine de On-Jemelle, 6900 Marche-en-Famenne, Belgium
Location of manufacturing sitesUsine de On-Jemelle, 6900 Marche-en-Famenne, Belgium
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerEuropéenne des Chaux et Liants
Address of manufacturer2745 route du Bugey, CS22015, 38307 Bourgoin-Jallieu, France
Location of manufacturing sitesUsine de Duin, 38460 Trept, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerLhoist France Ouest
Address of manufacturer15 rue Henri Dagallier, 38100 Grenoble, France
Location of manufacturing sites15 rue Henri Dagallier, 38100 Grenoble, France
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerLusical
Address of manufacturerValverde, 2025-201 Alcanede, Portugal
Location of manufacturing sitesValverde, 2025-201 Alcanede, Portugal
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerNordkalk AB
Address of manufacturerBox 901, SE-731 29 Köping, Sweden
Location of manufacturing sitesNordkalk AB, Köping, Kungsängsvägen 22, SE-731 36 Köping, SwedenNordkalk AB, Landskrona, Verkstadsgatan, SE-261 35 Landskrona, SwedenNordkalk AB, Luleå, Viktoriavägen 5, SE-974 37 Luleå, Sweden
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerNordkalk Oy Ab
Address of manufacturerSkräbbölevägen 18, FI-21600 Pargas, Finland
Location of manufacturing sitesNordkalk Oy Ab, Louhi, Louhi, FI-57100 Savonlinna, FinlandNordkalk Oy Ab, Tytyri, Tytyrinkatu 7, FI-08100 Lohja, Finland
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerSingleton Birch
Address of manufacturerMelton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire, United Kingdom
Location of manufacturing sitesMelton Ross Quarries, Barnetby, DN38 6AE N. Lincolnshire, United Kingdom
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerSMA Mineral AB
Address of manufacturer—, SE-682 27 Filipstad, Sweden
Location of manufacturing sitesLuleå Lime Plant, C/O SSAB Europe, SE-971 88 Luleå, SwedenBoda Lime Plant, Kärvsåsen Kalkverksvägen 15, SE-795 96 Boda kyrkby, SwedenRättivik lime plant, Kalkvagen 7, SE-795 32 Rättvik, SwedenSSAB Industriområde, Kalkverket, SE-613 80 Oxelösund, SwedenMo Industripark, Verkstedsøypa, NO-8626 Mo i Rana, Norway
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerSMA Mineral Burgas Var LTD
Address of manufacturerChataldzha str. No 52, 8002 Burgas, dis. Pobeda Bulgaria
Location of manufacturing sitesChataldzha str. No 52, 8002 Burgas, dis. Pobeda Bulgaria
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerSMA Mineral Oy
Address of manufacturer—, FI-95450 Tornio, Finland
Location of manufacturing sitesSMA Mineral Oy, Röyttä Lime Plant, Selleenkatu 281, FI-95450 Tornio, Finland
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerUnicalce S.p.A
Address of manufacturerVia Tonio da Belledo, 30, 23900 Lecco LC, Italy
Location of manufacturing sitesVia Ponti, 18, 24012 Val Brembilla BG, ItalyVia Lisso, 12, 24010 Sedrina BG, ItalyStrada Amerina Località S.Pellegrino, 05035 Narni TR, ItalyVia Di S.Vincenzo 21, 57021 Campiglia Marittima LI, ItalyS.S.Appia km 134, 04020 Itri LT, ItalyContrada Lupini – C.P.33, 74019 Palagiano TA, Italy
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerWietersdorfer & Peggauer Zementwerke GmbH
Address of manufacturerWietersdorf 1, 9373 Klein St. Paul, Austria
Location of manufacturing sitesAlois-Kern-Straße 1, 8120 Peggau, Austria
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerZakłady Wapiennicze Lhoist S.A.
Address of manufacturerul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland
Location of manufacturing sitesul. Fabryczna 22, 47-316 Górażdże, Polandul. Bolesława Chrobrego 77B, 59-550 Wojcieszów, Poland
Active substanceCalcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked lime
Name of manufacturerZement- und Kalkwerke Otterbein GmbH & Co. KG
Address of manufacturerHauptstrasse 50, 36137 Grossenlueder-Mues, Germany
Location of manufacturing sitesGeorg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues, Germany
2.PRODUCT COMPOSITION AND FORMULATION2.1.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 formulationDP – Dustable powder WP – Wettable powder (only for use for disinfection of animal accommodations; limewashing of walls)3.HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statementsCauses skin irritation.Causes serious eye damage.May cause respiratory irritation.
Precautionary statementsAvoid 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 1Use # 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: BacteriaCommon name: BacteriaDevelopment stage: —Scientific name: EndoparasitesCommon name: Helminth eggsDevelopment stage: —
Field(s) of useIndoor
Application method(s)Method: Automatic direct applicationDetailed 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 frequencyApplication 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) productNumber 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 usersProfessional
Pack sizes and packaging materialBulk powderBig bags or sacks (with Polypropylene (PP) or polyethylene (PE) inner layer): 500–1000 kg
4.1.1.Use-specific instructions for useThe 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 measuresThe loading of the product into the treatment unit and the application must be done fully automatically. The loading into the treatment unit and the disposal of empty bags 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 2Use # 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: BacteriaCommon name: BacteriaDevelopment stage:Scientific name: VirusesCommon name: VirusesDevelopment stage:Scientific name: EndoparasitesCommon name: Helminth eggsDevelopment stage:
Field(s) of useIndoor
Application method(s)Method: Automatic direct applicationDetailed description:The product is mixed with the manure. The product is dosed into the manure and mixed by means of a blender. The product should be loaded by fully automated processes.
Application rate(s) and frequencyApplication Rate: —Dilution (%): – RTU productNumber 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 usersProfessional
Pack sizes and packaging materialBulk powderBig bags or sacks (with PP or PE inner layer): 500–1000 kg
4.2.1.Use-specific instructions for useThe 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 measuresThe loading of the product into the treatment unit and the application must be done fully automatically.The loading into the treatment unit and the disposal of empty bags 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 3Use # 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: BacteriaCommon name: BacteriaDevelopment stage: —Scientific name: YeastsCommon name: YeastsDevelopment stage: —Scientific name: FungiCommon name: FungiDevelopment stage: —Scientific name: virusesCommon name: VirusesDevelopment stage: —
Field(s) of useIndoor
Application method(s)Method: Direct applicationDetailed 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 frequencyApplication Rate: 800 g product/m2Dilution (%): – RTU productNumber and timing of application:Frequency in animal housing: before each production cycle.Frequency in animal transportation: after each animal transport.Contact time: 48 hours
Category(ies) of usersProfessional
Pack sizes and packaging materialBulk powderBig bags or sacks (with PP or PE inner layer): 500–1000 kgPaper sacks (with PP or PE inner layer): 25 kg
4.3.1.Use-specific instructions for useThe product is spread directly onto the floors of animal accommodations and transportation, using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.A.On concrete floors:1.Wash the surface with running water;2.Sprinkle 800 g of product per m2 to cover the damp ground and add 0,9 litre/m2 of water;3.Leave to act for at least 48 hours;4.After treatment, remove the lime by brushing.B.On beaten-earth floors:1.Brush and wet the surface;2.Sprinkle 800 g of product per m2 on the damp ground and add 0,9 litre/m2 of water;3.Leave to act for at least 48 hours.4.After treatment, remove the lime by brushing.4.3.2.Use-specific risk mitigation measuresDuring 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 packagingAfter 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 4Use # 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: BacteriaCommon name: BacteriaDevelopment stage: —Scientific name: YeastsCommon name: YeastsDevelopment stage: —Scientific name: FungiCommon name: FungiDevelopment stage: —Scientific name: VirusesCommon name: VirusesDevelopment stage: —
Field(s) of useIndoor
Application method(s)Method: Direct application with a brushDetailed description:—
Application rate(s) and frequencyApplication Rate: 800 g product/m2Dilution (%): —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 hoursFrequency: before each production cycle
Category(ies) of usersProfessional
Pack sizes and packaging materialBulk powderBig bags or sacks (with PP or PE inner layer): 500–1000 kg
4.4.1.Use-specific instructions for useFor 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 measuresDuring 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 5Use # 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: BacteriaCommon name: BacteriaDevelopment stage: —Scientific name: YeastsCommon name: YeastsDevelopment stage: —Scientific name: FungiCommon name: FungiDevelopment stage: —Scientific name: VirusesCommon name: VirusesDevelopment stage: —
Field(s) of useOutdoor
Application method(s)Method: Direct applicationDetailed description:The product is spread directly onto the surfaces (floors) of animal enclosures using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader.
Application rate(s) and frequencyApplication Rate: 800 g product/m2Dilution (%): – RTU productNumber and timing of application:Contact time 48 hoursFrequency: maximum two applications per year.
Category(ies) of usersProfessional
Pack sizes and packaging materialBulk powderBig bags or sacks (with PP or PE inner layer): 500–1000 kgPaper sacks (with PP or PE inner layer): 25 kg
4.5.1.Use-specific instructions for useBrush 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 measuresDuring 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 packagingAfter 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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.5.1.Instructions for useComply with the instructions for use.Respect the conditions of use of the product.Refer to hygiene plan in place in order to ensure that necessary efficacy level is achieved.For outdoor use of the product, do not apply in the case of wind or rain.5.2.Risk mitigation measuresDo not let bystanders (including co-workers and children) and pets enter the treatment area during the entire treatment duration (including the loading, the application of the product, the disposal of empty bags 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 environmentIF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON 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 packagingDo 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 storageDo not store at a temperature above 30 °C.Protect from humidity.Shelf-life: 15 months.6.OTHER INFORMATIONFull titles of EN standards and legislation referred to in Sections 4.1.2–4.5.2: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).