Home Europe European Commission Commission Implementing Regulation (EU) 2023/2703 of 4 Decem...
Date: 2023-12-05 Category: Not Applicable State: Union Government Country: Europe

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

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

Executive Summary: Commission Implementing Regulation (EU) 2023/2703 grants Union authorisation EU00289630000 to European Lime Association aisbl for the biocidal product EuLA oxilime 23, containing calcium oxide, for product types 2 and 3. The authorisation is valid from December 25, 2023, to November 30, 2033. The regulation details the authorized uses, manufacturers, composition, hazard statements, and risk mitigation measures. Key Points / Main Content: * **Authorisation Details:** * A Union authorisation (EU00289630000) is granted to European Lime Association aisbl for EuLA oxilime 23. * The authorisation is valid from December 25, 2023, to November 30, 2033. * EuLA oxilime 23 is authorised for product types 2 (Disinfectants and algaecides not intended for direct application to humans or animals) and 3 (Veterinary hygiene disinfectants). * **Product Information:** * The active substance is Calcium oxide/lime/burnt lime/quicklime (CAS number 1305-78-8, EC number 215-138-9), comprising 100% of the product. * The formulation type is DP (Dustable powder). * **Hazard and Precautionary Statements:** * Hazard statements include: Causes skin irritation, causes serious eye damage, may cause respiratory irritation, and reacts violently with water. * Precautionary measures include: avoiding breathing dust, washing hands, using outdoors or in ventilated areas, wearing protective gear, and specific first aid measures. * **Authorised Uses:** * Use 1: Disinfection of sewage sludge (PT02). * Application rate: 0.15-1.5 kg product/kg dry weight of substance, maintaining a pH of 12 and a temperature of 50°C for 24 hours. * Loading and application must be fully automated. * Specific RPE required. * Use 2: Disinfection of manure (PT03). * Application rate: Sufficient to maintain a pH of 12 and a temperature of 60°C for 24 hours; do not apply more than 100 kg product/m3 of manure. * Loading and application must be fully automated. * Specific RPE required. * Use 3: Disinfection of indoor floor surfaces of animal accommodations and transportation (PT03). * Application rate: 800 g product/m2; contact time of 48 hours. * Manual or automated application techniques. * Specific RPE required. * Use 4: Disinfection of floors of outdoor animal enclosures (PT03). * Application rate: 600-800 g product/m2; contact time of 48 hours; maximum two applications per year. * Manual or automated application techniques. * Specific RPE required. * **General Directions for Use:** * Comply with the instructions for use and conditions of use. * Do not let bystanders enter the treatment area. * Use only in a well-ventilated area. * Specific first aid instructions are provided. * Dispose of unused product and packaging according to local regulations. * Store below 30°C and protect from humidity; shelf life is 15 months. Impact Analysis: European Lime Association aisbl * Impact: Granted authorisation to market and use EuLA oxilime 23 within the EU under specific conditions. * Action Required: Ensure compliance with the summary of biocidal product characteristics, including proper manufacturing, labeling, risk mitigation measures, and reporting requirements. Professional Users (Disinfection of sewage sludge, manure, indoor floor surfaces of animal accommodations and transportation, floors of outdoor animal enclosures) * Impact: Governed by specific application methods, rates, and risk mitigation measures when using EuLA oxilime 23. * Action Required: Adhere to the prescribed application methods, wear required PPE, and follow disposal instructions to ensure safe and effective use of the product. Manufacturers of the product and active substances: * Impact: Listed manufacturers must ensure their production processes and product composition align with the authorized specifications. * Action Required: Maintain quality control, ensure compliance with regulatory requirements, and provide necessary information for safe handling and use of the product.

Key Entities Referenced

European Lime Association aisbl: Applicant for the Union authorisation of the biocidal product EuLA oxilime 23 and holder of the authorization. EuLA oxilime 23: Single biocidal product authorized for use within the Union. Regulation EU No 528/2012: Regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products. European Chemicals Agency: The agency that received the application for Union authorization and submitted an opinion to the Commission. Ursula VON DER LEYEN: The President of the European Commission. Brussels, Belgium: Location where the regulation was done. Calcium oxide: Active substance contained in EuLA oxilime 23. France: Country whose competent authority agreed to evaluate the application for Union authorisation of the biocidal product.
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Official Journal EN of the European Union L series 2023/2703 5.12.2023 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 2012concerning the making available on the market and use of biocidal products(1), and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) On 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(2), 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, (1) OJ L 167, 27.6.2012, p. 1. (2) 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 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 1/26EN OJ L, 5.12.2023 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 2023to 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 2/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 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 Name European Lime Association aisbl holder Address c/o IMA-Europe aisbl, Rue des Deux Eglises 26 box 2 , B-1000 Brussels Belgium Authorisation number EU-0028963-0000 R4BP asset number EU-0028963-0000 Date of the authorisation 25 December 2023 Expiry date of the authorisation 30 November 2033 1.3. Manufacturer(s) of the product Name of manufacturer Cal Industrial SL Address of manufacturer Pedro I, 19-21 31 007 Pamplona Spain Location of manufacturing sites Pedro I, 19-21 31 007 Pamplona Spain Name of manufacturer Calera de Alzo, S. L. Address of manufacturer Postal number: 20.268, Egileor auzoa, 101. Altzo (Guipúzcoa), 20.268 Altzo (Guipúzcoa) Spain Location of manufacturing sites Egileor auzoa, 101. Altzo, 20.268 Altzo (Guipúzcoa) Spain Name of manufacturer Caleras de San Cucao, S.A. Address of manufacturer Agüera s/n 33425, - San Cucao de Llanera Spain Location of manufacturing sites Agüera s/n 33425, - San Cucao de Llanera Spain ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 3/26EN OJ L, 5.12.2023 Name of manufacturer Cales Pascual S.L. Address of manufacturer C/ Cura Bau, 15, 46112 Valencia Spain Location of manufacturing sites Ctra. Valencia-Ademuz, KM 9.3. Paterna, KM 9.3 Valencia Spain Name of manufacturer CalGov Address of manufacturer Carretera Fuente, Apartado 2, 41 560 Estepa Spain Location of manufacturing sites Carretera Fuente, Apartado 2, 41 560 Estepa Spain Name of manufacturer Carmeuse Chaux Address of manufacturer 215 route d’Arras, 62320 Bois Bernard France Location of manufacturing sites 215 route d’Arras, 62320 Bois Bernard France Name of manufacturer Carmeuse Czech Republic s.r.o. Address of manufacturer Mokrá 359, Mokrá, 664 04 Mokrá, Czech Republic Location of manufacturing sites závod Vápenka Mokrá, Mokrá 359, 664 04 Mokrá, Czech Republic Name of manufacturer Carmeuse Holding Srl Address of manufacturer Str.Carierei Nr.127A, 500047 Brasov Romania Location of manufacturing sites Str Garii 2, 135100 Fieni Romania Str Principala 1, 337457 Com. Soimus Romania Valea Mare Privat, 117805 Campulung Romania Name of manufacturer Carmeuse Hungaria kft Address of manufacturer HRSZ 064/1, 7827 Beremend Hungary Location of manufacturing sites HRSZ 064/1, 7827 Beremend Hungary Name of manufacturer Carmeuse SA Address of manufacturer Rue du Château 13a, 5300 Seilles Belgium Location 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 4/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 Name of manufacturer Carmeuse Slovakia s.r.o. Address of manufacturer -, 04911 Slavec Slovakia Location 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 manufacturer Carrières et Chaux Balthazard et Cotte Address of manufacturer Rue du Pra Paris, 38360 Sassenage France Location of manufacturing sites Rue du Pra Paris, 38 360 Sassenage France Name of manufacturer Carrières et fours à chaux de Dugny Address of manufacturer B.P.1, 55 100 Dugny-sur-Meuse France Location of manufacturing sites B.P.1, 55 100 Dugny-sur-Meuse France Name of manufacturer Cementos Tudela Veguín, S.A.U. Address of manufacturer CL Argüelles 25, 33003 Oviedo Asturias Spain Location of manufacturing sites CL Tino Casal, s/n., 33910 Tudela Veguín, Asturias Spain Name of manufacturer Chaux de Boran Address of manufacturer Route de Boran, 60 640 Précy-Sur-Oise France Location of manufacturing sites Route de Boran, 60 640 Précy-Sur-Oise France Name of manufacturer Chaux de Bretagne Address of manufacturer -, 53600 Evron France Location of manufacturing sites -, 53600 Evron France Name of manufacturer Chaux de Provence Address of manufacturer Ancien Chemin de Martigues, 13 160 Châteauneuf Les Martigues France Location of manufacturing sites Ancien Chemin de Martigues, 13 160 Châteauneuf Les Martigues France Name of manufacturer Chaux et Dolomies du Boulonnais Address of manufacturer Rue Jules Guesde, 62 720 Réty France Location of manufacturing sites Rue Jules Guesde, 62 720 Réty France ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 5/26EN OJ L, 5.12.2023 Name of manufacturer Chaux de la Tour Address of manufacturer 1 chemin des Chaux de la Tour, 13 820 Ensues La Redonne France Location of manufacturing sites 1 chemin des Chaux de la Tour, 13 820 Ensues La Redonne France Name of manufacturer Clogrennane Lime LTD Address of manufacturer Clogrennane Lime LTD, Clogrennane, R93 EV26 Carlow Ireland Location of manufacturing sites Clogrennane, R93 EV26, Ireland Carlow Ireland Name of manufacturer Dumont-Wautier Address of manufacturer Rue la Mallieue, 95, B-4470 Saint-Georges-sur-Meuse Belgium Location of manufacturing sites Rue la Mallieue, 95, B-4470 Saint-Georges-sur-Meuse Belgium Name of manufacturer Etablissement Leon Lhoist Address of manufacturer Usine de On-Jemelle, 6900 Marche-en-Famenne Belgium Location of manufacturing sites Usine de On-Jemelle, 6900 Marche-en-Famenne Belgium Name of manufacturer Européenne des Chaux et Liants Address of manufacturer 2745 route du Bugey, CS22015, 38307 Bourgoin-Jallieu France Location of manufacturing sites Usine de Duin, 38460 TREPT France Name of manufacturer Lhoist Bukowa Sp. z o.o. Address of manufacturer Bukowa, ul. Osiedlowa 10, 29-105 Krasocin Poland Location of manufacturing sites Bukowa, ul. Osiedlowa 10, 29-105 Krasocin Poland Name of manufacturer Lhoist Central Europe / Lhoist Česká republika a Slovensko Vápenka Čertovy schody a.s Address of manufacturer Tmaň 200, 267 21 Tmaň Czech Republic Location of manufacturing sites Tmaň 200, 267 21 Tmaň Czech Republic 6/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 Name of manufacturer Lhoist Faxe Kalk A/S Address of manufacturer Hovedgaden 13, 4654 Faxe Ladeplads Denmark Location of manufacturing sites Nordkajen 17, 7100 Vejle Denmark Gl. Strandvej 14, 4640 Faxe Denmark Name of manufacturer Lhoist France Ouest Address of manufacturer 15 rue Henri Dagallier, 38 100 Grenoble France Location of manufacturing sites 15 rue Henri Dagallier, 38 100 Grenoble France Name of manufacturer Lhoist UK Ltd Address of manufacturer Hindlow, Buxton, SK17 OEL Derbyshire United Kingdom Location of manufacturing sites Hindlow, Buxton, Derbyshire, SK17 OEL Derbyshire United Kingdom Name of manufacturer Lusical Address of manufacturer Valverde, 2025-201 Alcanede Portugal Location of manufacturing sites Valverde, 2025-201 Alcanede Portugal Name of manufacturer Nordkalk AB Address of manufacturer Box 901, SE-731 29 Köping Sweden Location 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 manufacturer Nordkalk AS Address of manufacturer Faehlmanni tee 11A, Rakke, 46 301 Lääne-Virumaa Estonia Location of manufacturing sites Faehlmanni tee 11A, Rakke, 46 301 Lääne-Virumaa Estonia Name of manufacturer Nordkalk Oy Ab Address of manufacturer Skräbbölevägen 18, 21600 Pargas Finland Location of manufacturing sites Nordkalk Oy Ab, Louhi, Louhi, Fi-57100 Savonlinna Finland Nordkalk Oy Ab, Tytyri, Tytyrinkatu 7, Fi-08100 Lohja Finland Nordkalk Oy Ab, Pargas, Kalkhamnsvägen 5, 21600 Pargas Finland ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 7/26EN OJ L, 5.12.2023 Name of manufacturer Pigeon Chaux SAS Address of manufacturer 29 Rue des Ruettes, 53410 Saint-Pierre-la-Cour France Location of manufacturing sites La Hunaudiere, 53480 Vaiges France Name of manufacturer See Bruyeres & Fils Address of manufacturer Le Bourg, 47500 Saint Front sur Lémance France Location of manufacturing sites Le Bourg, 47500 Saint Front sur Lémance France Name of manufacturer Singleton Birch Address of manufacturer Melton Ross Quarries, Barnetby, DN38 6AE N Lincolnshire United Kingdom Location of manufacturing sites Melton Ross Quarries, Barnetby, DN38 6AE N Lincolnshire United Kingdom Name of manufacturer SMA Mineral AB Address of manufacturer Box 329, SE-682 27 Filipstad Sweden Location 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 manufacturer SMA Mineral Burgas Var LTD Address of manufacturer dis. Pobeda, Chataldzha str. No52, 8002 Burgas Bulgaria Location of manufacturing sites dis. Pobeda, Chataldzha str. No52, 8002 Burgas Bulgaria Name of manufacturer SMA Mineral Oy Address of manufacturer Selleenkatu 281, 95450 Torino Finland Location of manufacturing sites Röyttä Lime Plant Selleenkatu 281, 95450 Torino Finland Name of manufacturer Société des fours à chaux de Sorcy Address of manufacturer Route de Sorcy, B.P.16, 55 190 Void France Location of manufacturing sites Route de Sorcy, B.P.16, 55 190 Void France 8/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 Name of manufacturer Spenner GmbH & Co. KG Address of manufacturer Bahnhofstraße 20, D-59597 Erwitte Germany Location of manufacturing sites Hüchtchenweg 2, D-59597 Erwitte Germany Name of manufacturer Tarmac, Lime and Powders Address of manufacturer Tunstead House, Wormhill, Buxton, SK17 8TG Derbyshire United Kingdom Location of manufacturing sites Tunstead Quarry, Wormhill, Buxton, SK17 8TG Derbyshire United Kingdom Hindlow Works, Sterndale Moor, Buxton, SK17 9QD Derbyshire United Kingdom Name of manufacturer Trzuskawica S.A. Address of manufacturer Sitkówka 24, 26-052 Nowiny Poland Location of manufacturing sites Trzuskawica S.A., Sitkówka 24, 26-052 Nowiny Poland Name of manufacturer Unicalce S.p.A Address of manufacturer Via Tonio da Belledo, 30, l-23900 Lecco (LC), Italy Location 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 manufacturer Vápenka Vitošov s.r.o Address of manufacturer č.p. 54, 78901 Hrabová Czech Republic Location of manufacturing sites č.p. 54, 78901 Hrabová Czech Republic Name of manufacturer Wietersdorfer & Peggauer Zementwerke GmbH Address of manufacturer Wietersdorf 1, 9373 Klein St. Paul Austria Location of manufacturing sites Alois-Kern-Straße 1, 8120 Peggau Austria ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 9/26EN OJ L, 5.12.2023 Name of manufacturer Zakłady Wapiennicze Lhoist S.A. Address of manufacturer ul. Wapiennicza 7, 46-050 Tarnów Opolski Poland Location of manufacturing sites ul. Fabryczna 22, 47-316 Górażdże Poland ul. 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 manufacturer Zement- und Kalkwerke Otterbein GmbH & Co. KG Address of manufacturer Hauptstrasse 50, 36137 Grossenlueder-Mues Germany Location of manufacturing sites Georg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues Germany Name of manufacturer SMA Mineral AS Address of manufacturer Postbox 500, NO-8601 Mo I Rana Norway Location of manufacturing sites Mo Industripark, Verkstedsøypa, NO-8626 Mo I Rana Norway 1.4. Manufacturer(s) of the active substance(s) Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Cal Industrial SL Address of manufacturer Pedro I, 19-21, 31 007 Pamplona, Spain Location of manufacturing sites Pedro I, 19-21, 31 007 Pamplona Spain Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Calera de Alzo, S. L. Address of manufacturer Egileor auzoa, 101, 20.268 Altzo (Guipúzcoa) Spain Location of manufacturing sites Egileor auzoa, 101, 20.268 Altzo (Guipúzcoa) Spain Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Caleras de San Cucao, S.A. Address of manufacturer Agüera s/n, 33425 San Cucao de Llanera, Spain Location of manufacturing sites Agüera s/n, 33425 San Cucao de Llanera, Spain Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer CalGov Address of manufacturer Carretera Fuente, Apartado 2, 41 560, Estepa Spain Location of manufacturing sites Carretera Fuente, Apartado 2, 41 560, Estepa, Spain 10/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Carmeuse Chaux Address of manufacturer 215 route d’Arras, 62320 Bois Bernard France Location of manufacturing sites 215 route d’Arras, 62320 Bois Bernard France Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Carmeuse Czech Republic s.r.o. Address of manufacturer závod Vápenka Mokrá, Mokrá 359,, 664 04 Mokrá Czech Republic Location of manufacturing sites závod Vápenka Mokrá, Mokrá 359,, 664 04 Mokrá Czech Republic Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Carmeuse Holding Srl Address of manufacturer Str.Carierei Nr.127A,, 500047 Brasov Romania Location of manufacturing sites Str Garii 2,, 135100 Fieni Romania Str Principala 1,, 337457 Com. Soimus Romania Valea Mare Pravat,, 117805 Campulung Romania Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Carmeuse Hungaria kft Address of manufacturer HRSZ 064/1,, 7827 Beremend Hungary Location of manufacturing sites HRSZ 064/1,, 7827 Beremend Hungary Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Carmeuse SA Address of manufacturer Rue du Château 13a,, 5300 Seilles Belgium Location 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 substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Carmeuse Slovakia s.r.o Address of manufacturer závod Vápenka Slavec 179,, 04911 Slavec Slovakia Location of manufacturing sites závod Vápenka Slavec 179,, 04911 Slavec Slovakia závod Vápenka Košice, Vstupný areál U.S. Steel, 0455 Košice Slovakia ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 11/26EN OJ L, 5.12.2023 Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Carrières et Chaux Balthazard et Cotte Address of manufacturer Rue du Pra Paris, 38360 Sassenage, France Location of manufacturing sites Rue du Pra Paris, 38360 Sassenage France Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Carrières et fours à chaux de Dugny Address of manufacturer B.P.1,, 55 100 Dugny-sur-Meuse France Location of manufacturing sites B.P.1,, 55 100 Dugny-sur-Meuse France Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Cementos Tudela Veguín, S.A.U. Address of manufacturer CL Argüelles 25., 33003 Oviedo, Asturias Spain Location of manufacturing sites CL Tino Casal, s/n., 33910, Tudela Veguín, Asturias, Spain Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Chaux de Boran Address of manufacturer Route de Boran, 60640 Précy-Sur-Oise France Location of manufacturing sites Route de Boran, 60640 Précy-Sur-Oise France Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Chaux de Provence Address of manufacturer Ancien Chemin de Martigues, 13160 Châteauneuf Les Martigues France Location of manufacturing sites Ancien Chemin de Martigues, 13160 Châteauneuf Les Martigues France Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Chaux et Dolomies du Boulonnais Address of manufacturer Rue Jules Guesde,, 62 720 Réty France Location of manufacturing sites Rue Jules Guesde,, 62 720 Réty France 12/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Chaux de la Tour Address of manufacturer 1 chemin des Chaux de la Tour,, 13 820 Ensues La Redonne France Location of manufacturing sites 1 chemin des Chaux de la Tour,, 13 820 Ensues La Redonne France Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Clogrennane Lime LTD Address of manufacturer Clogrennane, R93 EV26 Carlow, Ireland Location of manufacturing sites Clogrennane, R93 EV26 Carlow, Ireland Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Dumont-Wautier Address of manufacturer Rue la Mallieue, 95, B-4470 Saint-Georges-sur-Meuse, Belgium Location of manufacturing sites Rue la Mallieue, 95,, B-4470 Saint-Georges-sur-Meuse, Belgium Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Etablissement Leon Lhoist Address of manufacturer Usine de On-Jemelle, 6900 Marche-en-Famenne Belgium Location of manufacturing sites Usine de On-Jemelle, 6900 Marche-en-Famenne Belgium Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Européenne des Chaux et Liants Address of manufacturer 2745 route du Bugey, CS22015, 38307 Bourgoin-Jallieu France Location of manufacturing sites Usine de Duin,, 38460 TREPT France Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Lhoist Bukowa Sp. z o.o Address of manufacturer Bukowa, ul. Osiedlowa 10,, 29-105 Krasocin Poland Location of manufacturing sites Bukowa, ul. Osiedlowa 10,, 29-105 Krasocin Poland ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 13/26EN OJ L, 5.12.2023 Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Lhoist France Ouest Address of manufacturer 15 rue Henri Dagallier,, 38 100 Grenoble France Location of manufacturing sites 15 rue Henri Dagallier,, 38 100 Grenoble France Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Lusical Address of manufacturer Valverde, 2025-201 Alcanede Portugal Location of manufacturing sites Valverde, 2025-201 Alcanede Portugal Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Nordkalk AB Address of manufacturer Box 901, SE-731 29 Köping Sweden Location of manufacturing sites Kungsängsvägen 22, SE-731 36 Köping Sweden Lärbro Storugns 2741, SE-624 53, Lärbro Sweden Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Nordkalk AS Address of manufacturer Faehlmanni tee 11A, Rakke, 46 301, Lääne-Virumaa Estonia Location of manufacturing sites Faehlmanni tee 11A, Rakke, 46 301, Lääne-Virumaa Estonia Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Nordkalk Oy Ab Address of manufacturer Skräbbölevägen 18, 21600 Pargas Finland Location 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 substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Pigeon Chaux SAS Address of manufacturer 29 Rue des Ruettes, 53410 Saint-Pierre-la-Cour France Location of manufacturing sites La Hunaudiere -, 53480 Vaiges France 14/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer See Bruyeres & Fils Address of manufacturer Le Bourg -, 47500 Saint Front sur Lémance, France Location of manufacturing sites Le Bourg -, 47500 Saint Front sur Lémance, France Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Singleton Birch Address of manufacturer Melton Ross Quarries, DN38 6AE Barnetby, , N Lincolnshire United Kingdom Location of manufacturing sites Melton Ross Quarries, DN38 6AE Barnetby, N Lincolnshire United Kingdom Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer SMA Mineral AB Address of manufacturer Box 329,, SE-682 27 Filipstad Sweden Location 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 substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer SMA Mineral Burgas Var LTD Address of manufacturer Chataldzha str. No52, 8002, Burgas, dis. Pobeda Bulgaria Location of manufacturing sites Chataldzha str. No52, 8002, Burgas, dis. Pobeda Bulgaria Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer SMA Mineral Oy Address of manufacturer Selleenkatu 281, 95450 Torino Finland Location of manufacturing sites Röyattä lime plant, Selleenkatu 281, 95450 Torino Finland Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Société des fours à chaux de Sorcy Address of manufacturer Route de Sorcy B.P.16, 55 190 Void France Location of manufacturing sites Route de Sorcy B.P.16, 55 190 Void France ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 15/26EN OJ L, 5.12.2023 Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Spenner GmbH & Co. KG Address of manufacturer Bahnhofstraße 20, D-59597 Erwitte Germany Location of manufacturing sites Hüchtchenweg 2, D-59597 Erwitte Germany Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Trzuskawica S.A. Address of manufacturer Trzuskawica S.A., Sitkówka 24,, 26-052 Nowiny, Poland Location of manufacturing sites Trzuskawica S.A., Sitkówka 24,, 26-052 Nowiny, Poland Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Unicalce S.p.A Address of manufacturer Via Tonio da Belledo, 30, l-23900 Lecco (LC), Italy Location 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 substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Vápenka Vitošov s.r.o. Address of manufacturer č.p. 54, 78901 Hrabová, Czech Republic Location of manufacturing sites č.p. 54, 78901 Hrabová, Czech Republic Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Wietersdorfer & Peggauer Zementwerke GmbH Address of manufacturer Wietersdorf 1, 9373 Klein St. Paul, Austria Location of manufacturing sites Alois-Kern-Straße 1, 8120 Peggau Austria Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Zakłady Wapiennicze Lhoist S.A. Address of manufacturer ul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland Location of manufacturing sites ul. Fabryczna 22, 47-316 Górażdże Poland ul. Wapiennicza 7, 46-050 Tarnów Opolski, Poland ul. Bolesława Chrobrego 77B, 59-550 Wojcieszów Poland 16/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Zement- und Kalkwerke Otterbein GmbH & Co. KG Address of manufacturer Hauptstrasse 50, 36137 Grossenlueder-Mues Germany Location of manufacturing sites Georg-Otterbein-Strasse 123, 36137 Grossenlueder-Mues Germany Active substance Calcium oxide/lime/burnt lime/quicklime Name of manufacturer Lhoist UK Ltd Address of manufacturer Hindlow, Buxton, SK17 OEL Derbyshire United Kingdom Location of manufacturing sites Hindlow, Buxton, SK17 OEL Derbyshire United Kingdom 2. PRODUCT COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the product Common name IUPAC name Function CAS number EC number Content (%) Calcium Active 1305-78-8 215-138-9 100,0 oxide/lime/burnt Substance lime/quicklime 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. ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 17/26EN OJ L, 5.12.2023 4. AUTHORISED USE(S) 4.1. Use description Table 1. Use # 1 – Disinfection of sewage sludge Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of - the authorised use Target organism(s) (including Scientific name: Bacteria development stage) Common name: Bacteria Development stage: - Scientific name: Endoparasites Common name: Helminth eggs Development stage: - Field(s) of use Indoor Application method(s) Method: automatic direct application Detailed description: The product is dosed into the sewage sludge and mixed by means of a blender. The dry product is mixed 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 users Professional Pack sizes and packaging material Bulk powder Big bags or sacks (with Polypropylene (PP) or Polyethylene (PE) inner layer): 500 - 1 200kg 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. 18/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 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 - 1 200 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 type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of - the authorised use Target organism(s) (including Scientific name: Bacteria development stage) Common name: Bacteria Development stage: - Scientific name: Viruses Common name: Viruses Development stage: - ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 19/26EN OJ L, 5.12.2023 Scientific name: Endoparasites Common name: Helminth eggs Development stage: - Field(s) of use Indoor Application method(s) Method: Automatic direct application Detailed description: The product is 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 users Professional Pack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500 - 1 200kg 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. 20/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 — 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 type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of - the authorised use Target organism(s) (including Scientific name: Bacteria development stage) Common name: Bacteria Development stage: - Scientific name: Yeast Common name: Yeasts Development stage: - Scientific name: Fungi Common name: Fungi Development stage: - Scientific name: viruses Common name: Viruses Development stage: - Field(s) of use Indoor Application 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. ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 21/26EN OJ L, 5.12.2023 Application rate(s) and frequency Application Rate: 800 g product / m2 Dilution (%): - RTU product Number and timing of application: Frequency in animal housing: before each production cycle. Frequency in animal transportation: after each animal transport. Contact time: 48 hours Category(ies) of users Professional Pack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500 - 1 200kg 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: 1. Brush and wet the surface; 2. Sprinkle approx. 800 g of product / m2 on the damp ground and add 0,9 litre/m2 of water; 3. 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 (500-1 200kg), 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. 22/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 — 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 type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of - the authorised use Target organism(s) (including Scientific name: Bacteria development stage) Common name: Bacteria Development stage: - Scientific name: Yeast Common name: Yeasts Development stage: - Scientific name: other fungi Common name: Fungi Development stage: - ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 23/26EN OJ L, 5.12.2023 Scientific name: Virus Common name: Virus Development stage: - Field(s) of use Outdoor Application method(s) Method: Direct application Detailed description: The product is spread directly onto the surfaces (floors) of animal enclosures using manual or automated techniques. Manual spreading using a shovel or semi-automated using a low-impact spreader. Application rate(s) and frequency Application Rate: 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 users Professional Pack sizes and packaging material Bulk powder Big bags or sacks (with PP or PE inner layer): 500 - 1 200kg 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 (500-1 200kg), 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: 24/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/ojEN OJ L, 5.12.2023 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 - 5. GENERAL DIRECTIONS FOR USE(1) 5.1. Instructions for use — Comply with the instructions for use. — Respect the conditions of use of the product. — Refer to hygiene plan in place in order to ensure that necessary efficacy level is achieved. — For outdoor 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. (1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses. ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj 25/26EN OJ L, 5.12.2023 — 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. 26/26 ELI: http://data.europa.eu/eli/reg_impl/2023/2703/oj

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