Commission Implementing Regulation (EU) 2025/534 of 21 March 2025 amending Implementing Regulation (EU) 2022/1226 as regards administrative changes to the Union authorisation for the single biocidal product Bioquell HPV-AQ

ANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT
ANNEX
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 1
153 Quai de Rancy, Bonneuil-sur-Marne 94380 Paris France
Ecolab Europe GmbH site 2
53 Royce Close SP10 3TS Andover United Kingdom of Great Britain and Northern Ireland (the)
Ecolab Europe GmbH site 3
Unit E4, Eastway Business Park, Ballysimon Road V94 K267 Limerick Ireland
Ecolab Europe GmbH site 4
A.F.P. GmbH Otto-Brenner-Straße 16 21337 Lüneburg Germany
Ecolab Europe GmbH site 5
ACIDEKA S.A. Edificio Feria. Capuchinos de Basurto 6, 4a planta 48013 Bilbao. Bizkaia Spain
Ecolab Europe GmbH site 6
ADIEGO HNOS CTRA DE VALENCIA, KM 5,900 50410 CUARTE DE HUERVA (ZARAGOZA) 50410 Zaragoza Spain
Ecolab Europe GmbH site 7
ALLIED 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 8
Arkema GmbH Morschheimer Srtrasse 19 D-67292 Krichheimbolanden Germany
Ecolab Europe GmbH site 9
AZELIS DENMARK Lundtoftegårdsvej 95 2800 Kgs. 2800 Kgs Lyngby Denmark
Ecolab Europe GmbH site 10
Belinka Zasavska Cesta 95 1001 Ljubljana Slovenia
Ecolab Europe GmbH site 11
BENTUS LABORATORIES LTD. RUSSIA, 105005, MOSCOW, RADIO STREET, 24 BLD.1 105005 Moscow Russian Federation (the)
Ecolab Europe GmbH site 12
BIO 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 13
BIOXAL SA Route des Varennes - Secteur A – BP 30072 71103 Chalon sur Saône Cedex France
Ecolab Europe GmbH site 14
Bores Srl Via Pioppa, 179 44020 Pontegradella Italy
Ecolab Europe GmbH site 15
BRENNTAG ARDENNES Route de Tournes CD n 2 FR-08090 FR-08090 Cliron France
Ecolab Europe GmbH site 16
BRENNTAG CEE - GUNTRAMSDORF Brenntag CEE GmbH Mixing / Blending Bahnstr. 13 A-2353 Guntramsdorf Austria
Ecolab Europe GmbH site 17
BRENNTAG Duisburg/Glauchau/Hamburg/Heilbronn Brenntag GmbH Humboldtring 15 45472 Muehlheim Germany
Ecolab Europe GmbH site 18
BRENNTAG Kaiserslautern Brenntag Merkurstr. 47 67663 Kaiserslautern Germany
Ecolab Europe GmbH site 19
BRENNTAG Kleinkarlbach/Lohfelden Brenntag GmbH Humboldtring 15 45472 Muehlheim Germany
Ecolab Europe GmbH site 20
BRENNTAG Nordic - HASLEV Høsten Teglværksvej 47 4690 Haslev Denmark
Ecolab Europe GmbH site 21
Brenntag Nordic, Strandgade 35 7100 Vejle Denmark
Ecolab Europe GmbH site 22
BRENNTAG Normandy Brenntag Normandie 12 Sente des Jumelles - BP 11 76710 76710 Montville France
Ecolab Europe GmbH site 23
BRENNTAG PL -Zgierz ul. Kwasowa 5 95-100 Zgierz Poland
Ecolab Europe GmbH site 24
Brenntag Quimica S.A. - Madrid. Calle Gutemberg n o  22,.Poligono Industrial El Lomo 28906 Madrid Spain
Ecolab Europe GmbH site 25
BRENNTAG Schweizerhall Brenntag Schweizerhall AG Elsaesserstr. 231 CH-4056 Basel Switzerland
Ecolab Europe GmbH site 26
Budich International GmbH Dieselstrasse 10 32120 Hiddenhause Germany
Ecolab Europe GmbH site 27
Caldic Deutschland Chemie B.V Caldic Deutschland GmbH & Co.Kg Am Karlshof 10 D 40231 Duesseldorf Germany
Ecolab Europe GmbH site 28
Carbon Chemicals Group Ltd, Ringaskiddy P43 R772 County Cork Ireland
Ecolab Europe GmbH site 29
COLEP BAD SCHMIEDEBERG ColepCCL Bad Schmiedeberg GmbH Kemberger Str. 3 06905 Bad Schmiedeberg Germany
Ecolab Europe GmbH site 30
COMERCIAL FARMACEUTICA CASTEL: LANA, S.A. “COFARCAS” Condado de Treviño, 46 P.I. Villalonquejar 09080 – BURGOS 09080 Burgos Spain
Ecolab Europe GmbH site 31
COMERCIAL GODO França, 13 08700 – IGUALADA (BARCELONA) 08700 BARCELONA Spain
Ecolab Europe GmbH site 32
COURTOIS SARL ZA SOUS LE BEER Route de Pacy 27730 BUEIL France
Ecolab Europe GmbH site 33
DAN MOR (DR WIPE) DAN-MOR Natural Products and Chemicals Ltd. Or Akiva Industrial Zone 30600 Akiva Industrial Zone Israel
Ecolab Europe GmbH site 34
Denteck BV Heliumstraat 8 2718 SL ZOETERMEER Netherlands (the)
Ecolab Europe GmbH site 35
DETERGENTS BURGUERA DETERGENTS BURGUERA, S.L. Joan Ballester 50 07630 CAMPOS (ILLES BALEARES) Spain
Ecolab Europe GmbH site 36
ECL Biebesheim NLC Biebesheim Justus-von-Liebig-Straße 11 64584 Biebesheim am Rhein Germany
Ecolab Europe GmbH site 37
ECL Celra NALCO - Celra C/ Tramuntana s/n Poligona Industrial Celra 17460 Girona Spain
Ecolab Europe GmbH site 38
ECL Châlons AVENUE DU GENERAL PATTON 51000 CHALONS EN CHAMPAGNE France
Ecolab Europe GmbH site 39
ECL Cisterna Nalco Italiana Manufacturing Srl.Via Ninfina II 04012 Cisterna di Latina Italy
Ecolab Europe GmbH site 40
ECL Fawley NLC Fawley Cadland Road, Hythe, SO45 3NP Southampton, Hampshire United Kingdom of Great Britain and Northern Ireland (the)
Ecolab Europe GmbH site 41
ECL Leeds ECOLAB Lotherton Way Garforth Leeds LS25 2JY LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)
Ecolab Europe GmbH site 42
ECL Mandra 25TH KM OLD NATIONAL ROAD OF ATHENS TO THIVA, GR 19600 GR 19600 ATHENS Greece
Ecolab Europe GmbH site 43
ECL Maribor Vajngerlova 4, SI-2001 Maribor SI-2001 Maribor Slovenia
Ecolab Europe GmbH site 44
ECL MICROTEK BV MICROTEK MEDICAL B.V. GESINKKAMPSTRAAT 19, 7051 HR, VARSSEVELD 7051 HR VARSSEVELD Netherlands (the)
Ecolab Europe GmbH site 45
ECL MICROTEK MOSTA SORBONNE CENTRE, F20 MOSTA TECHNOPARK, MOSTA MST 3000 MOSTA Malta
Ecolab Europe GmbH site 46
ECL Nieuwegein BRUGWAL 11 A, 3432 NZ NIEUWEGEIN 3432 NZ NIEUWEGEIN Netherlands (the)
Ecolab Europe GmbH site 47
ECL Rovigo Esoform Esoform S.p.A. Laboratorio Chimico Farmaceutico Viale del Lavoro 10 45100 Rovigo Italy
Ecolab Europe GmbH site 48
ECL Rozzano Via A. Grandi, 20089 Rozzano MI 20089 Rozzano Italy
Ecolab Europe GmbH site 49
ECL Tesjoki NLC Tesjoki Kivikummuntie 1, Tesjoki 07955 Tesjoki Finland
Ecolab Europe GmbH site 50
ECL Tessenderlo INDUSTRIEZONE RAVENSHOUT 4 3980 Tessenderlo Belgium
Ecolab Europe GmbH site 51
ECL Weavergate NLC Weavergate Northwich, Cheshire West and Chester CW8 4EE Northwich United Kingdom of Great Britain and Northern Ireland (the)
Ecolab Europe GmbH site 52
Ecolab 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 53
EXTRUPLAST ZI Fief du Passage 56 rue Robert Geffré 17000 La Rochelle France
Ecolab Europe GmbH site 54
Ferdinand Eimermacher GmbH & Co. KG Westring 24 48356 Nordwalde Germany
Ecolab Europe GmbH site 55
F.E.L.T. BP 64 10 rue du Vertuquet 59531 NEUVILLE EN FERRAIN France
Ecolab Europe GmbH site 56
Gallows 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 57
GERDISA GERMAN RGUEZ DROGAS IND Gerdisa Polígono Industrial Miralcampo parc.37 19200 Azuqueca de Henares Guadalajara Spain
Ecolab Europe GmbH site 58
GIRASOL NATURAL PRODUCTS BV De Veldoven 12-14 3342 GR Hendrik-Ido-Ambacht 3342 GR Hendrik-Ido-Ambacht Netherlands (the)
Ecolab Europe GmbH site 59
HENKEL ENGELS Henkel Engels 413116 Engels Prospekt StroiTel ei Russia 413116 Engels Russian Federation (the)
Ecolab Europe GmbH site 60
Imeco GmbH & Co. KG Boschstraße 5 D-63768 Hösbach Germany
Ecolab Europe GmbH site 61
INTERFILL LLC-TOSNO INTERFILL LLC 187000, Moskovskoye shosse 1 187000 Tosno - Leningradskaya Russian Federation (the)
Ecolab Europe GmbH site 62
JODEL - PRODUCTOS QUIMICOS Jodel Zona Industrial 2050 Aveiras de Cima 2050 Aveiras de Cima Portugal
Ecolab Europe GmbH site 63
Kleinmann GmbH Am Trieb 13 72820 Sonnenbühl Germany
Ecolab Europe GmbH site 64
Kompak Nederland B.V. Ambachtsweg 4, 4854 MK, Bavel Netherlands (the)
Ecolab Europe GmbH site 65
La Antigua Lavandera SL LA ANTIGUA LAVANDERA, S.L. Ctra. Antigua Sevilla-Alcalá Km.1,5 (SE-410) Apartado de Correos, 58 41500 Sevilla Spain
Ecolab Europe GmbH site 66
LABORATOIRES ANIOS Pavé du moulin 59260 Lille-Hellemmes France
Ecolab Europe GmbH site 67
LABORATOIRES ANIOS 3330 Rue de Lille 59262 Sainghin-en-Mélantois France
Ecolab Europe GmbH site 68
LICHTENHELDT GmbH Lichtenheldt Industriestrasse 7-9 23812 Wahlstedt Germany
Ecolab Europe GmbH site 69
Lonza GmbH Morianstr.32 42103 Wuppertal Germany
Ecolab Europe GmbH site 70
McBride SA Polígon Industrial L’Illa C / Ramon Esteve, 20- 22 08650 Sallent Spain
Ecolab Europe GmbH site 71
Multifill BV Constructieweg 25-A 3641 SB Mijdrecht 3641 Mijdrecht Netherlands (the)
Ecolab Europe GmbH site 72
NOPA NORDISK PARFUMERIVARE Nordisk Parfumerivarefabrik A/S Hvedevej 2-22 DK-8900 Randers Denmark
Ecolab Europe GmbH site 73
PAL INTERNATIONAL LTD Pal International Ltd. Sandhurst Street, Oadby Leicester Leicester United Kingdom of Great Britain and Northern Ireland (the)
Ecolab Europe GmbH site 74
Planol GmbH Maybachstr. 17 63456 Hanau Germany
Ecolab Europe GmbH site 75
Plum A/S Frederik Plums Vej 2 DK 5610 Assens Denmark
Ecolab Europe GmbH site 76
PRODUCTOS LC LA CORBERANA, S.L. Crta. Corbera – Polinyá 46612 Valencia Spain
Ecolab Europe GmbH site 77
THE PROTON GROUP LTD Ripley Drive, Normanton Industrial Estate WF6 1QT Wakefield United Kingdom of Great Britain and Northern Ireland (the)
Ecolab Europe GmbH site 78
QUIMICAS MORALES, S.L. Misiones, 11 - Urb. El Sebadal 05005 LAS PALMAS DE GRAN CANARIA Spain
Ecolab Europe GmbH site 79
RNM PRODUCTOS QUIMICOS RNM - Produtos Quimicos, Lda Rua da Fabrica, 123, 4765-080 Segade Portugal
Ecolab Europe GmbH site 80
ROQUETTE & BARENTZ Roquette Freres Route De La Gorgue F-62136 Lestrem France
Ecolab Europe GmbH site 81
RUTPEN LTD MEMBURY AIRFIELD RG16 7TJ LAMBOURN United Kingdom of Great Britain and Northern Ireland (the)
Ecolab Europe GmbH site 82
SOLIMIX Solimix Montseny 17-19 Pol. Ind. Sant Pere Molanta 08799 Barcelona Spain
Ecolab Europe GmbH site 83
Staub & Co. – Silbermann GmbH , Industriestraße 3 D-86456 Gablingen Germany
Ecolab Europe GmbH site 84
Stockmeier Chemie Eilenburg GmbH & Co. KG Gustav-Adolf-Ring 5 04838 Eilenburg Germany
Ecolab Europe GmbH site 85
SYNERLOGIC BV ( - IN2FOOD) Synerlogic BV afd. L.J. Costerstraat 5 6827 ARNHEM Netherlands (the)
Ecolab Europe GmbH site 86
Univar Ltd, Argyle House, Epsom Avenue SK9 3RN Wilmslow United Kingdom of Great Britain and Northern Ireland (the)
Ecolab Europe GmbH site 87
Univar SPA Via Caldera 21 20-153 Milano Milano Italy
Ecolab Europe GmbH site 88
van Dam Bodegraven B.V Postbus 48 NL 2410 AA Bodegraven Netherlands (the)
Ecolab Europe GmbH site 89
Laboratoires Prodene Klint Rue Denis Papin, 2 Z.I. Mitry Compans F-77290 Mitry Mory F-77290 Mitry Mory France
Ecolab Europe GmbH site 90
Simagec Z.I. de Rousset / Peynier, 54 Avenue de la Plaine 13790 Rousset France
Ecolab Europe GmbH site 91
INNOVATE GmbH, Innovate GmbH Am Hohen Stein 11 06618 Naumburg Germany
Ecolab Europe GmbH site 92
Sima Pharma, 54 Avenue de la Plaine, ZI 13106 Rousset Cedex France
Ecolab Europe GmbH site 93
Techtex (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 94
Helico B.V. Hoogschaijksestraat 31 5374 EC Schaijk Netherlands (the)
Ecolab Europe GmbH site 95
INCARE BV Keizersveld 99 5803 AP Venray Netherlands (the)
Ecolab Europe GmbH site 96
ECL Mullingar Ecolab Ltd (IE). Forrest Park Zone C Mullingar Industrial Estate Mullingar Co. Westmeath Westmeath Ireland
Ecolab Europe GmbH site 97
ECL Mullingar. Ecolab Manufacturing IE Ltd (IE) Forest Park, Zone C Mullingar Ind. Estate N91 Mullingar, Co. Westmeath Westmeath Ireland
Ecolab Europe GmbH site 98
ECL 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 99
ECL Weavergate, Ecolab Ltd (UK) Winnington Avenue CW8 3AA Northwich, Cheshire United Kingdom of Great Britain and Northern Ireland (the)
Ecolab Europe GmbH site 100
ECL 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 1
C/ 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 1
12000 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 GmbH
Industriestrasse 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 1
Untere 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
Table 1
Surface disinfection in small (0,25 m 3 - 4 m 3 ) enclosures
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT03: Veterinary hygiene
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: bacteria spores
Development stage: no data
Scientific name: no data
Common name: Mycobacteria
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: Viruses
Development stage: no data
Scientific name: no data
Common name: bacteriophage
Development stage: no data
Field(s) of use
indoor use
Hard, non-porous surfaces in small (0,25 m 3 to 4 m 3 ) 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 facilities
PT4 – clean conditions in, for example, aseptic filling lines, storage containers.
Application method(s)
Method: vapourisation
Detailed 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/m 3 of undiluted product, contact time of 35 minutes (after diffusion). 0
Number 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, 1 000  ml, 2 000  ml, 5 000  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
Table 2
Surface disinfection within large (> 4 m 3 ) enclosures
Product type
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT03: Veterinary hygiene
PT04: Food and feed area
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Mycobacteria
Development stage: no data
Scientific name: no data
Common name: Bacteria spores
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: Viruses
Development stage: no data
Scientific name: no data
Common name: bacteriophages
Development stage: no data
Field(s) of use
indoor use
Hard, non-porous surfaces in large (> 4 m 3 ) 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 institutions
PT3 – 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: vapourisation
Detailed 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/m 3 of undiluted product, contact time of 35 minutes (after diffusion) 0
Number 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, 1 000  ml, 2 000  ml, 5 000  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 USE   ( 1 )
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/m 3 (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/m 3 ).
The professional user may only enter the room in emergency situations when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m 3 ) 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/m 3 ) 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.
( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
Commission Implementing Regulation (EU) 2025/534 of 21 March 2025 amending Implementing Regulation (EU) 2022/1226 as regards administrative changes to the Union authorisation for the single biocidal product Bioquell HPV-AQ

Schedules & Appendices

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