Contents
- THE EUROPEAN COMMISSION, Having regard to the Treaty on th…
- 1 The Annex to Implementing Regulation (EU) 2022/1226 is rep…
- 2 This Regulation shall enter into force on the twentieth da…
- Summary of product characteristics for a biocidal product
- 1. Administrative information
- 2. Product composition and formulation
- 3. Hazard and precautionary statements
- 4. Authorised use(s)
- 5. GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
- 6. Other information
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 productsnote, and in particular Article 50(2) thereof,Whereas:
(1)On 14 July 2022, Commission Implementing Regulation (EU) 2022/1226note granted a Union authorisation, under number EU-0027469-0000, to Ecolab Deutschland GmbH for the making available on the market and use of the single biocidal product ‘Bioquell HPV-AQ’. The Annex to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for that single biocidal product.
(2)On 24 January 2023 and 24 April 2024, Ecolab Deutschland GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013note, notifications of administrative changes to the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’, recorded in the register for biocidal products under case numbers BC-EE084020-66 and BC-VW094451-98. The notified proposed changes concern the addition of active substance manufacturers and formulators of biocidal products, a change of the manufacturer name from ‘Ecolab SNC’ to ‘Ecolab Europe GmbH’ to align with other Ecolab biocidal product authorisations and the addition of one packaging size within the packaging range assessed during the evaluation.
(3)On 10 March 2023 and 20 May 2024note, the Agency submitted to the Commission in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions on the notified administrative changes to the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’. In the opinions, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.
(4)On 29 April 2024, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics of the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’ in all official languages of the Union, covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.
(5)The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the single biocidal product ‘Bioquell HPV-AQ’ to introduce the administrative changes requested by Ecolab Deutschland GmbH.
(6)Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘Bioquell HPV-AQ’ as set out in the Annex to Implementing Regulation (EU) 2022/1226 remains unchanged.
(7)In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2022/1226 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the register for biocidal products in 2024, the summary of biocidal product characteristics in that Annex, should also include some minor editorial and layout changes.
(8)Implementing Regulation (EU) 2022/1226 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1#
The Annex to Implementing Regulation (EU) 2022/1226 is replaced by the text set out in the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Summary of product characteristics for a biocidal product
Bioquell HPV-AQ
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT03: Veterinary hygiene
PT04: Food and feed area
Authorisation number: EU-0027469-0000
R4BP asset number: EU-0027469-0000
1. Administrative information
1.1. Trade name(s) of the product
| Trade name(s) | Bioquell HPV-AQ |
1.2. Authorisation holder
| Name and address of the authorisation holder | Name | Ecolab Deutschland GmbH |
| Address | Ecolab Allee 1 40789 Monheim am Rhein DE | |
| Authorisation number | EU-0027469-0000 | |
| R4BP asset number | EU-0027469-0000 | |
| Date of the authorisation | 7 August 2022 | |
| Expiry date of the authorisation | 31 July 2032 |
1.3. Manufacturer(s) of the product
| Name of manufacturer | Ecolab Europe GmbH |
| Address of manufacturer | Richtistrasse 7 8304 Walliselen Switzerland |
| Location of manufacturing sites | Ecolab Europe GmbH site 1153 Quai de Rancy, Bonneuil-sur-Marne 94380 Paris FranceEcolab Europe GmbH site 253 Royce Close SP10 3TS Andover United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 3Unit E4, Eastway Business Park, Ballysimon Road V94 K267 Limerick IrelandEcolab Europe GmbH site 4A.F.P. GmbH Otto-Brenner-Straße 16 21337 Lüneburg GermanyEcolab Europe GmbH site 5ACIDEKA S.A. Edificio Feria. Capuchinos de Basurto 6, 4a planta 48013 Bilbao. Bizkaia SpainEcolab Europe GmbH site 6ADIEGO HNOS CTRA DE VALENCIA, KM 5,900 50410 CUARTE DE HUERVA (ZARAGOZA) 50410 Zaragoza SpainEcolab Europe GmbH site 7ALLIED PRODUCTS Allied Hygiene Unit 11, Belvedere Industrial Estate Fishers Way DA17 6BS Belvedere, Kent United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 8Arkema GmbH Morschheimer Srtrasse 19 D-67292 Krichheimbolanden GermanyEcolab Europe GmbH site 9AZELIS DENMARK Lundtoftegårdsvej 95 2800 Kgs. 2800 Kgs Lyngby DenmarkEcolab Europe GmbH site 10Belinka Zasavska Cesta 95 1001 Ljubljana SloveniaEcolab Europe GmbH site 11BENTUS LABORATORIES LTD. RUSSIA, 105005, MOSCOW, RADIO STREET, 24 BLD.1 105005 Moscow Russian Federation (the)Ecolab Europe GmbH site 12BIO PRODUCTIONS 72 VICTORIA ROAD, VICTORIA INDUSTRIAL ESTATE, BURGESS HILL, WEST SUSSEX RH159LH Burgess Hill United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 13BIOXAL SA Route des Varennes - Secteur A – BP 30072 71103 Chalon sur Saône Cedex FranceEcolab Europe GmbH site 14Bores Srl Via Pioppa, 179 44020 Pontegradella ItalyEcolab Europe GmbH site 15BRENNTAG ARDENNES Route de Tournes CD n 2 FR-08090 FR-08090 Cliron FranceEcolab Europe GmbH site 16BRENNTAG CEE - GUNTRAMSDORF Brenntag CEE GmbH Mixing / Blending Bahnstr. 13 A-2353 Guntramsdorf AustriaEcolab Europe GmbH site 17BRENNTAG Duisburg/Glauchau/Hamburg/Heilbronn Brenntag GmbH Humboldtring 15 45472 Muehlheim GermanyEcolab Europe GmbH site 18BRENNTAG Kaiserslautern Brenntag Merkurstr. 47 67663 Kaiserslautern GermanyEcolab Europe GmbH site 19BRENNTAG Kleinkarlbach/Lohfelden Brenntag GmbH Humboldtring 15 45472 Muehlheim GermanyEcolab Europe GmbH site 20BRENNTAG Nordic - HASLEV Høsten Teglværksvej 47 4690 Haslev DenmarkEcolab Europe GmbH site 21Brenntag Nordic, Strandgade 35 7100 Vejle DenmarkEcolab Europe GmbH site 22BRENNTAG Normandy Brenntag Normandie 12 Sente des Jumelles - BP 11 76710 76710 Montville FranceEcolab Europe GmbH site 23BRENNTAG PL -Zgierz ul. Kwasowa 5 95-100 Zgierz PolandEcolab Europe GmbH site 24Brenntag Quimica S.A. - Madrid. Calle Gutemberg no 22,.Poligono Industrial El Lomo 28906 Madrid SpainEcolab Europe GmbH site 25BRENNTAG Schweizerhall Brenntag Schweizerhall AG Elsaesserstr. 231 CH-4056 Basel SwitzerlandEcolab Europe GmbH site 26Budich International GmbH Dieselstrasse 10 32120 Hiddenhause GermanyEcolab Europe GmbH site 27Caldic Deutschland Chemie B.V Caldic Deutschland GmbH & Co.Kg Am Karlshof 10 D 40231 Duesseldorf GermanyEcolab Europe GmbH site 28Carbon Chemicals Group Ltd, Ringaskiddy P43 R772 County Cork IrelandEcolab Europe GmbH site 29COLEP BAD SCHMIEDEBERG ColepCCL Bad Schmiedeberg GmbH Kemberger Str. 3 06905 Bad Schmiedeberg GermanyEcolab Europe GmbH site 30COMERCIAL FARMACEUTICA CASTEL: LANA, S.A. “COFARCAS” Condado de Treviño, 46 P.I. Villalonquejar 09080 – BURGOS 09080 Burgos SpainEcolab Europe GmbH site 31COMERCIAL GODO França, 13 08700 – IGUALADA (BARCELONA) 08700 BARCELONA SpainEcolab Europe GmbH site 32COURTOIS SARL ZA SOUS LE BEER Route de Pacy 27730 BUEIL FranceEcolab Europe GmbH site 33DAN MOR (DR WIPE) DAN-MOR Natural Products and Chemicals Ltd. Or Akiva Industrial Zone 30600 Akiva Industrial Zone IsraelEcolab Europe GmbH site 34Denteck BV Heliumstraat 8 2718 SL ZOETERMEER Netherlands (the)Ecolab Europe GmbH site 35DETERGENTS BURGUERA DETERGENTS BURGUERA, S.L. Joan Ballester 50 07630 CAMPOS (ILLES BALEARES) SpainEcolab Europe GmbH site 36ECL Biebesheim NLC Biebesheim Justus-von-Liebig-Straße 11 64584 Biebesheim am Rhein GermanyEcolab Europe GmbH site 37ECL Celra NALCO - Celra C/ Tramuntana s/n Poligona Industrial Celra 17460 Girona SpainEcolab Europe GmbH site 38ECL Châlons AVENUE DU GENERAL PATTON 51000 CHALONS EN CHAMPAGNE FranceEcolab Europe GmbH site 39ECL Cisterna Nalco Italiana Manufacturing Srl.Via Ninfina II 04012 Cisterna di Latina ItalyEcolab Europe GmbH site 40ECL Fawley NLC Fawley Cadland Road, Hythe, SO45 3NP Southampton, Hampshire United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 41ECL Leeds ECOLAB Lotherton Way Garforth Leeds LS25 2JY LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 42ECL Mandra 25TH KM OLD NATIONAL ROAD OF ATHENS TO THIVA, GR 19600 GR 19600 ATHENS GreeceEcolab Europe GmbH site 43ECL Maribor Vajngerlova 4, SI-2001 Maribor SI-2001 Maribor SloveniaEcolab Europe GmbH site 44ECL MICROTEK BV MICROTEK MEDICAL B.V. GESINKKAMPSTRAAT 19, 7051 HR, VARSSEVELD 7051 HR VARSSEVELD Netherlands (the)Ecolab Europe GmbH site 45ECL MICROTEK MOSTA SORBONNE CENTRE, F20 MOSTA TECHNOPARK, MOSTA MST 3000 MOSTA MaltaEcolab Europe GmbH site 46ECL Nieuwegein BRUGWAL 11 A, 3432 NZ NIEUWEGEIN 3432 NZ NIEUWEGEIN Netherlands (the)Ecolab Europe GmbH site 47ECL Rovigo Esoform Esoform S.p.A. Laboratorio Chimico Farmaceutico Viale del Lavoro 10 45100 Rovigo ItalyEcolab Europe GmbH site 48ECL Rozzano Via A. Grandi, 20089 Rozzano MI 20089 Rozzano ItalyEcolab Europe GmbH site 49ECL Tesjoki NLC Tesjoki Kivikummuntie 1, Tesjoki 07955 Tesjoki FinlandEcolab Europe GmbH site 50ECL Tessenderlo INDUSTRIEZONE RAVENSHOUT 4 3980 Tessenderlo BelgiumEcolab Europe GmbH site 51ECL Weavergate NLC Weavergate Northwich, Cheshire West and Chester CW8 4EE Northwich United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 52Ecolab Ltd Baglan/Swindon, Plot 7a Baglan Energy Park, Baglan, Port Talbot SA11 2HZ Port Talbot United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 53EXTRUPLAST ZI Fief du Passage 56 rue Robert Geffré 17000 La Rochelle FranceEcolab Europe GmbH site 54Ferdinand Eimermacher GmbH & Co. KG Westring 24 48356 Nordwalde GermanyEcolab Europe GmbH site 55F.E.L.T. BP 64 10 rue du Vertuquet 59531 NEUVILLE EN FERRAIN FranceEcolab Europe GmbH site 56Gallows Green Services Ltd. Cod Beck Mill Industrial Estate Dalton Lane YO7 3HR Thirsk North Yorkshire United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 57GERDISA GERMAN RGUEZ DROGAS IND Gerdisa Polígono Industrial Miralcampo parc.37 19200 Azuqueca de Henares Guadalajara SpainEcolab Europe GmbH site 58GIRASOL NATURAL PRODUCTS BV De Veldoven 12-14 3342 GR Hendrik-Ido-Ambacht 3342 GR Hendrik-Ido-Ambacht Netherlands (the)Ecolab Europe GmbH site 59HENKEL ENGELS Henkel Engels 413116 Engels Prospekt StroiTel ei Russia 413116 Engels Russian Federation (the)Ecolab Europe GmbH site 60Imeco GmbH & Co. KG Boschstraße 5 D-63768 Hösbach GermanyEcolab Europe GmbH site 61INTERFILL LLC-TOSNO INTERFILL LLC 187000, Moskovskoye shosse 1 187000 Tosno - Leningradskaya Russian Federation (the)Ecolab Europe GmbH site 62JODEL - PRODUCTOS QUIMICOS Jodel Zona Industrial 2050 Aveiras de Cima 2050 Aveiras de Cima PortugalEcolab Europe GmbH site 63Kleinmann GmbH Am Trieb 13 72820 Sonnenbühl GermanyEcolab Europe GmbH site 64Kompak Nederland B.V. Ambachtsweg 4, 4854 MK, Bavel Netherlands (the)Ecolab Europe GmbH site 65La Antigua Lavandera SL LA ANTIGUA LAVANDERA, S.L. Ctra. Antigua Sevilla-Alcalá Km.1,5 (SE-410) Apartado de Correos, 58 41500 Sevilla SpainEcolab Europe GmbH site 66LABORATOIRES ANIOS Pavé du moulin 59260 Lille-Hellemmes FranceEcolab Europe GmbH site 67LABORATOIRES ANIOS 3330 Rue de Lille 59262 Sainghin-en-Mélantois FranceEcolab Europe GmbH site 68LICHTENHELDT GmbH Lichtenheldt Industriestrasse 7-9 23812 Wahlstedt GermanyEcolab Europe GmbH site 69Lonza GmbH Morianstr.32 42103 Wuppertal GermanyEcolab Europe GmbH site 70McBride SA Polígon Industrial L’Illa C / Ramon Esteve, 20- 22 08650 Sallent SpainEcolab Europe GmbH site 71Multifill BV Constructieweg 25-A 3641 SB Mijdrecht 3641 Mijdrecht Netherlands (the)Ecolab Europe GmbH site 72NOPA NORDISK PARFUMERIVARE Nordisk Parfumerivarefabrik A/S Hvedevej 2-22 DK-8900 Randers DenmarkEcolab Europe GmbH site 73PAL INTERNATIONAL LTD Pal International Ltd. Sandhurst Street, Oadby Leicester Leicester United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 74Planol GmbH Maybachstr. 17 63456 Hanau GermanyEcolab Europe GmbH site 75Plum A/S Frederik Plums Vej 2 DK 5610 Assens DenmarkEcolab Europe GmbH site 76PRODUCTOS LC LA CORBERANA, S.L. Crta. Corbera – Polinyá 46612 Valencia SpainEcolab Europe GmbH site 77THE PROTON GROUP LTD Ripley Drive, Normanton Industrial Estate WF6 1QT Wakefield United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 78QUIMICAS MORALES, S.L. Misiones, 11 - Urb. El Sebadal 05005 LAS PALMAS DE GRAN CANARIA SpainEcolab Europe GmbH site 79RNM PRODUCTOS QUIMICOS RNM - Produtos Quimicos, Lda Rua da Fabrica, 123, 4765-080 Segade PortugalEcolab Europe GmbH site 80ROQUETTE & BARENTZ Roquette Freres Route De La Gorgue F-62136 Lestrem FranceEcolab Europe GmbH site 81RUTPEN LTD MEMBURY AIRFIELD RG16 7TJ LAMBOURN United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 82SOLIMIX Solimix Montseny 17-19 Pol. Ind. Sant Pere Molanta 08799 Barcelona SpainEcolab Europe GmbH site 83Staub & Co. – Silbermann GmbH , Industriestraße 3 D-86456 Gablingen GermanyEcolab Europe GmbH site 84Stockmeier Chemie Eilenburg GmbH & Co. KG Gustav-Adolf-Ring 5 04838 Eilenburg GermanyEcolab Europe GmbH site 85SYNERLOGIC BV ( - IN2FOOD) Synerlogic BV afd. L.J. Costerstraat 5 6827 ARNHEM Netherlands (the)Ecolab Europe GmbH site 86Univar Ltd, Argyle House, Epsom Avenue SK9 3RN Wilmslow United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 87Univar SPA Via Caldera 21 20-153 Milano Milano ItalyEcolab Europe GmbH site 88van Dam Bodegraven B.V Postbus 48 NL 2410 AA Bodegraven Netherlands (the)Ecolab Europe GmbH site 89Laboratoires Prodene Klint Rue Denis Papin, 2 Z.I. Mitry Compans F-77290 Mitry Mory F-77290 Mitry Mory FranceEcolab Europe GmbH site 90Simagec Z.I. de Rousset / Peynier, 54 Avenue de la Plaine 13790 Rousset FranceEcolab Europe GmbH site 91INNOVATE GmbH, Innovate GmbH Am Hohen Stein 11 06618 Naumburg GermanyEcolab Europe GmbH site 92Sima Pharma, 54 Avenue de la Plaine, ZI 13106 Rousset Cedex FranceEcolab Europe GmbH site 93Techtex (Technical Textile Services Ltd) Units 7 & 8, Rhodes Business Park, Silburn Way, Middleton, M24 4NE Manchester United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 94Helico B.V. Hoogschaijksestraat 31 5374 EC Schaijk Netherlands (the)Ecolab Europe GmbH site 95INCARE BV Keizersveld 99 5803 AP Venray Netherlands (the)Ecolab Europe GmbH site 96ECL Mullingar Ecolab Ltd (IE). Forrest Park Zone C Mullingar Industrial Estate Mullingar Co. Westmeath Westmeath IrelandEcolab Europe GmbH site 97ECL Mullingar. Ecolab Manufacturing IE Ltd (IE) Forest Park, Zone C Mullingar Ind. Estate N91 Mullingar, Co. Westmeath Westmeath IrelandEcolab Europe GmbH site 98ECL Weavergate Site: Nalco Manufacturing Limited, Winnington Avenue, CW8 3AA Northwich, Cheshire (Postal Address: PO Box 11, Winnington Avenue, Northwich, Cheshire CW8 4DX) United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 99ECL Weavergate, Ecolab Ltd (UK) Winnington Avenue CW8 3AA Northwich, Cheshire United Kingdom of Great Britain and Northern Ireland (the)Ecolab Europe GmbH site 100ECL Weavergate, Ecolab Manufacturing UK Ltd (UK) Winnington Avenue CW8 3AA Northwich, Cheshire United Kingdom of Great Britain and Northern Ireland (the) |
1.4. Manufacturer(s) of the active substance(s)
| Active substance | Hydrogen peroxide |
| Name of manufacturer | Evonik Peroxide Spain |
| Address of manufacturer | Beethoven 15, Sobreatico 08021 Barcelona Spain |
| Location of manufacturing sites | Evonik Peroxide Spain site 1C/ Afueras s/n La Zaida 50784 Zaragoza Spain |
| Active substance | Hydrogen peroxide |
| Name of manufacturer | Evonik Operations GmbH (Acting for Evonik Active Oxygens, LLC (US)) |
| Address of manufacturer | Creavis, Rellinghauser Straße 1-11 45128 Essen Germany |
| Location of manufacturing sites | Evonik Operations GmbH (Acting for Evonik Active Oxygens, LLC (US)) site 112000 Bay Area Blvd 77507 Pasadena, TX United States (the) |
| Active substance | Hydrogen peroxide |
| Name of manufacturer | Evonik Peroxid GmbH |
| Address of manufacturer | Industriestrasse 1 A-9721 Weissenstein Austria |
| Location of manufacturing sites | Evonik Peroxid GmbHIndustriestrasse 1 A-9721 Weissenstein Austria |
| Active substance | Hydrogen peroxide |
| Name of manufacturer | Evonik Operations GmbH |
| Address of manufacturer | Creavis, Rellinghauser Straße 1-11 45128 Essen Germany |
| Location of manufacturing sites | Evonik Operations GmbH site 1Untere Kanatstrabe 3 79618 Rheinfelden Germany |
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 (%) |
|---|---|---|---|---|---|
| Hydrogen peroxide | active substance | 7722-84-1 | 231-765-0 | 35 % (w/w) |
2.2. Type(s) of formulation
HN Hot fogging concentrate
3. Hazard and precautionary statements
| Hazard statements | H272: May intensify fire; oxidiser.H302: Harmful if swallowed.H315: Causes skin irritation.H318: Causes serious eye damage.H335: May cause respiratory irritation.H412: Harmful to aquatic life with long lasting effects. |
| Precautionary statements | P220: Keep away from clothing or other combustible materials.P261: Avoid breathing vapours.P270: Do not eat, drink or smoke when using this product.P273: Avoid release to the environment.P280: Wear protective gloves/protective clothing/eye protection.P301+P312: IF SWALLOWED: Call a Poison Center or doctor/physician if you feel unwell.P330: Rinse mouth.P302+P352: IF ON SKIN: Wash with plenty of water.P332+P313: If skin irritation occurs: Get medical attention.P362+P364: Take off contaminated clothing and wash it before reuse.P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.P310: Immediately call a POISON CENTER or doctor/physician..P312: Call a POISON CENTER/doctor if you feel unwell.P370+P378: In case of fire: Use water to extinguish.P403+P233: Store in a well-ventilated place. Keep container tightly closed.P405: Store locked up.P501: Dispose of contents to waste in accordance with applicable local, national and international regulations. |
4. Authorised use(s)
4.1. Use description
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animalsPT03: Veterinary hygienePT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: no dataCommon name: BacteriaDevelopment stage: no dataScientific name: no dataCommon name: bacteria sporesDevelopment stage: no dataScientific name: no dataCommon name: MycobacteriaDevelopment stage: no dataScientific name: no dataCommon name: fungiDevelopment stage: no dataScientific name: no dataCommon name: YeastsDevelopment stage: no dataScientific name: no dataCommon name: VirusesDevelopment stage: no dataScientific name: no dataCommon name: bacteriophageDevelopment stage: no data |
| Field(s) of use | indoor useHard, non-porous surfaces in small (0,25 m3 to 4 m3) sealed enclosures by vapourisation, with prior cleaning.PT2 – clean conditions in, for example, isolators, pass-through chambers, cabinets, material airlocks, cupboards, filling lines, emergency vehicles.PT3 – pre-cleaned animal cages/racks within biomedical and animal laboratory facilitiesPT4 – clean conditions in, for example, aseptic filling lines, storage containers. |
| Application method(s) | Method: vapourisationDetailed description:Vapourisation with Bioquell Hydrogen Peroxide Vapour system followed by microcondensation – to deliver the disinfectant to surfaces in closed systems.Temperature range: room temperatureHumidity range: 10 % - 80 % |
| Application rate(s) and frequency | Application rate: 100 g/m3 of undiluted product, contact time of 35 minutes (after diffusion). 0Number and timing of application:Users should carry out decontaminations in line with their requirements and operating procedures |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 75 ml, 150 ml, 500 ml, 950 ml, 1000 ml, 2000 ml, 5000 ml, 20 L, and 25 L. Bottles are constructed of HDPE |
4.1.1. Use-specific instructions
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
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
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Only recycle completely emptied packaging. Dispose of any residual product in accordance with EWC 160903
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost. Do not store at temperatures above 35 °C
Shelf life 18 months.
4.2. Use description
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animalsPT03: Veterinary hygienePT04: Food and feed area |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: no dataCommon name: BacteriaDevelopment stage: no dataScientific name: no dataCommon name: MycobacteriaDevelopment stage: no dataScientific name: no dataCommon name: Bacteria sporesDevelopment stage: no dataScientific name: no dataCommon name: fungiDevelopment stage: no dataScientific name: no dataCommon name: YeastsDevelopment stage: no dataScientific name: no dataCommon name: VirusesDevelopment stage: no dataScientific name: no dataCommon name: bacteriophagesDevelopment stage: no data |
| Field(s) of use | indoor useHard, non-porous surfaces in large (> 4 m3) sealed enclosures by vapourisation, with prior cleaning.PT2 – clean conditions in, for example hospitals, clean rooms, aseptic processing facilities, laboratories, nursing homes, research facilities, schools, cruise ships, emergency vehicles, veterinary hospitals (excluding animal housing), laboratories in veterinary institutionsPT3 – pre-cleaned animal cages/racks within biomedical and animal laboratory facilities.PT4 – clean conditions in, for example, aseptic filling lines, food production facilities, storage containers |
| Application method(s) | Method: vapourisationDetailed description:Vapourisation with Bioquell Hydrogen Peroxide Vapour system followed by micro condensation – to deliver the disinfectant to surfaces in closed systems.Temperature range: Room temperatureHumidity range:10 % - 80 % |
| Application rate(s) and frequency | Application rate: 10g/m3 of undiluted product, contact time of 35 minutes (after diffusion) 0Number and timing of application:Users should carry out decontaminations in line with their requirements and operating procedures. |
| Category(ies) of users | professional |
| Pack sizes and packaging material | 75 ml, 150 ml, 500 ml, 950 ml, 1000 ml, 2000 ml, 5000 ml, 20 L, and 25 L. Bottles are constructed of HDPE. |
4.2.1. Use-specific instructions
See general directions for use
4.2.2. Use-specific risk mitigation measures
See general directions for use
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
See general directions for use
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
Only recycle completely emptied packaging. Dispose of any residual product in accordance with EWC 160903
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Protect from frost. Do not store at temperatures above 35 °C. Shelf life 18 months.
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 use
Surfaces must be pre-cleaned and dry before disinfection and cupboard doors and drawers should be opened for the process to be effective.
Users should carry out decontaminations in line with their requirements and operating procedures.
For disinfection of pre-cleaned animal cages/racks within biomedical and animal laboratory facilities, disinfection can only take place on thoroughly cleaned non-porous surfaces (PT3), when possible use automated washing machines.
Do not mix with detergents or other chemicals. Undiluted.
Bioquell HPV-AQ is to be used with a Bioquell vaporisation module as a disinfectant for surfaces and other inanimate objects in enclosures.
Seal the enclosure (e.g. with tape) to ensure no leakage of the vapourised active substance outside the enclosure prior to initiating a cycle.
Refer to the Bioquell HPV-AQ Labelling insert prior to running a cycle.
At the end of the dwell period, the aeration phase is activated which removes the hydrogen peroxide. The aeration phase is deactivated by the user when the enclosure has been confirmed to be less than or equal to 1,25 mg/m3 (0,9 ppm) using an independent calibrated low-level hydrogen peroxide sensor.
Biological validation should be performed for enclosures to be disinfected. Where environmental conditions within an enclosure are well controlled, a protocol for disinfection of the enclosure should be made and used thereafter. Validated quantitative chemical indicators can be used in place of biological indicators for routine disinfection.
Biological or chemical indicators shall be placed in the enclosure to validate the cycle.
Users should not carry out manual cleaning operations (for example sweeping) immediately post-decontamination.
5.2. Risk mitigation measures
No person or animals are allowed to be present in a room during treatment.
Treated areas may not be entered until the concentration of hydrogen peroxide is ≤ 0,9 ppm (1,25mg/m3).
The professional user may only enter the room in emergency situations when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m3 ) considering RPE with APF 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective equipment (gloves, eye protection, coverall) must be worn.
Use a calibrated sensor to confirm the enclosure is ≤ 0,9 ppm (1,25 mg/m3) prior to re-entry.
When opening the container and preparing contents wear suitable personal protective equipment (gloves, eye protection, coverall).
Wash hands after use.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Possible exposure effects:
Skin – chemical burn – transient, non-permanent whitening of the skin
Eyes – potential for permanent damage
Inhalation - irritation of the throat and nose
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.
Information to Healthcare personnel/doctor:
Initiate life support measures if needed, thereafter call a POISON CENTRE.
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: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
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.
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 (sink, toilets ...) nor 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
Protect from Frost. Do not store at temperatures above 35 °C.
Shelf life 18 months.
6. Other information
Bioquell HPV-AQ is not intended for use as a terminal sterilant / disinfectant for medical devices.
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.