Commission Implementing Regulation (EU) 2022/1423 of 22 July 2022 granting a Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’ (Text with EEA relevance)

Article 1

A Union authorisation with authorisation number EU-0024303-0000 is granted to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘Hydrogen Peroxide Family 1’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 15 September 2022 until 31 August 2032.

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.

ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

Hydrogen Peroxide Family 1

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

PT04: Food and feed area

PT03: Veterinary hygiene

PT01: Human hygiene

Authorisation number EU-0024303-0000

R4BP asset number EU-0024303-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	Hydrogen Peroxide Family 1

1.2.   Product type(s)

Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area PT03: Veterinary hygiene PT01: Human hygiene

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	Ecolab Deutschland GmbH
Name and address of the authorisation holder	Address	Ecolab Allee 1 40789 Monheim am Rhein DE
Authorisation number		EU-0024303-0000
R4BP asset number		EU-0024303-0000
Date of the authorisation	15 September 2022	15 September 2022
Expiry date of the authorisation	31 October 2032	31 October 2032

1.4.   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 A.F.P. GmbH Otto-Brenner-Straße 16 21337 Lüneburg Germany Ecolab Europe GmbH site 2 ACIDEKA S.A. Edificio Feria. Capuchinos de Basurto 6, 4a planta 48013 Bilbao. Bizkaia Spain Ecolab Europe GmbH site 3 ADIEGO HNOS CTRA DE VALENCIA, KM 5,900 50410 CUARTE DE HUERVA (ZARAGOZA) 50410 Zaragoza Spain Ecolab Europe GmbH site 4 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 5 Arkema GmbH Morschheimer Srtrasse 19 D-67292 Krichheimbolanden Germany Ecolab Europe GmbH site 6 AZELIS DENMARK Lundtoftegårdsvej 95 2800 Kgs. 2800 Kgs Lyngby Denmark Ecolab Europe GmbH site 7 Belinka Zasavska Cesta 95 1001 Ljubljana Slovenia Ecolab Europe GmbH site 8 BENTUS LABORATORIES LTD. RUSSIA, 105005, MOSCOW, RADIO STREET, 24 BLD.1 105005 Moscow Russian Federation (the) Ecolab Europe GmbH site 9 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 10 BIOXAL SA Route des Varennes - Secteur A – BP 30072 71103 Chalon sur Saône Cedex France Ecolab Europe GmbH site 11 Bores Srl Via Pioppa, 179 44020 Pontegradella Italy Ecolab Europe GmbH site 12 BRENNTAG ARDENNES Route de Tournes CD n 2 FR-08090 FR-08090 Cliron France Ecolab Europe GmbH site 13 BRENNTAG CEE - GUNTRAMSDORF Brenntag CEE GmbH Mixing / Blending Bahnstr. 13 A-2353 Guntramsdorf Austria Ecolab Europe GmbH site 14 BRENNTAG Duisburg/Glauchau/Hamburg/Heilbronn Brenntag GmbH Humboldtring 15 45472 Muehlheim Germany Ecolab Europe GmbH site 15 BRENNTAG Kaiserslautern Brenntag Merkurstr. 47 67663 Kaiserslautern Germany Ecolab Europe GmbH site 16 BRENNTAG Kleinkarlbach/Lohfelden Brenntag GmbH Humboldtring 15 45472 Muehlheim Germany Ecolab Europe GmbH site 17 BRENNTAG Nordic - HASLEV Høsten Teglværksvej 47 4690 Haslev Denmark Ecolab Europe GmbH site 18 Brenntag Nordic, Strandgade 35 7100 Vejle Denmark Ecolab Europe GmbH site 19 BRENNTAG Normandy Brenntag Normandie 12 Sente des Jumelles - BP 11 76710 76710 Montville France Ecolab Europe GmbH site 20 BRENNTAG PL -Zgierz ul. Kwasowa 5 95-100 Zgierz Poland Ecolab Europe GmbH site 21 Brenntag Quimica S.A. - Madrid. Calle Gutemberg no 22,.Poligono Industrial El Lomo 28906 Madrid Spain Ecolab Europe GmbH site 22 BRENNTAG Schweizerhall Brenntag Schweizerhall AG Elsaesserstr. 231 CH-4056 Basel Switzerland Ecolab Europe GmbH site 23 Budich International GmbH Dieselstrasse 10 32120 Hiddenhause Germany Ecolab Europe GmbH site 24 Caldic Deutschland Chemie B.V Caldic Deutschland GmbH & Co.Kg Am Karlshof 10 D 40231 Duesseldorf Germany Ecolab Europe GmbH site 25 Carbon Chemicals Group Ltd, Ringaskiddy P43 R772 County Cork Ireland Ecolab Europe GmbH site 26 COLEP BAD SCHMIEDEBERG ColepCCL Bad Schmiedeberg GmbH Kemberger Str. 3 06905 Bad Schmiedeberg Germany Ecolab Europe GmbH site 27 COMERCIAL FARMACEUTICA CASTEL: LANA, S.A. ‘COFARCAS’ Condado de Treviño, 46 P.I. Villalonquejar 09080 – BURGOS 09080 Burgos Spain Ecolab Europe GmbH site 28 COMERCIAL GODO França, 13 08700 – IGUALADA (BARCELONA) 08700 BARCELONA Spain Ecolab Europe GmbH site 29 COURTOIS SARL ZA SOUS LE BEER Route de Pacy 27730 BUEIL France Ecolab Europe GmbH site 30 DAN MOR (DR WIPE) DAN-MOR Natural Products and Chemicals Ltd. Or Akiva Industrial Zone 30600 Akiva Industrial Zone Israel Ecolab Europe GmbH site 31 Denteck BV Heliumstraat 8 2718 SL ZOETERMEER Netherlands (the) Ecolab Europe GmbH site 32 DETERGENTS BURGUERA DETERGENTS BURGUERA, S.L. Joan Ballester 50 07630 CAMPOS (ILLES BALEARES) Spain Ecolab Europe GmbH site 33 ECL Biebesheim NLC Biebesheim Justus-von-Liebig-Straße 11 64584 Biebesheim am Rhein Germany Ecolab Europe GmbH site 34 ECL Celra NALCO - Celra C/ Tramuntana s/n Poligona Industrial Celra 17460 Girona Spain Ecolab Europe GmbH site 35 ECL Châlons AVENUE DU GENERAL PATTON 51000 CHALONS EN CHAMPAGNE France Ecolab Europe GmbH site 36 ECL Cisterna Nalco Italiana Manufacturing Srl.Via Ninfina II 04012 Cisterna di Latina Italy Ecolab Europe GmbH site 37 ECL Fawley NLC Fawley Cadland Road, Hythe, SO45 3NP Southampton, Hampshire United Kingdom of Great Britain and Northern Ireland (the) Ecolab Europe GmbH site 38 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 39 ECL Mandra 25TH KM OLD NATIONAL ROAD OF ATHENS TO THIVA, GR 19600 GR 19600 ATHENS Greece Ecolab Europe GmbH site 40 ECL Maribor Vajngerlova 4, SI-2001 Maribor SI-2001 Maribor Slovenia Ecolab Europe GmbH site 41 ECL MICROTEK BV MICROTEK MEDICAL B.V. GESINKKAMPSTRAAT 19, 7051 HR, VARSSEVELD 7051 HR VARSSEVELD Netherlands (the) Ecolab Europe GmbH site 42 ECL MICROTEK MOSTA SORBONNE CENTRE, F20 MOSTA TECHNOPARK, MOSTA MST 3000 MOSTA Malta Ecolab Europe GmbH site 43 ECL Nieuwegein BRUGWAL 11 A, 3432 NZ NIEUWEGEIN 3432 NZ NIEUWEGEIN Netherlands (the) Ecolab Europe GmbH site 44 ECL Rovigo Esoform Esoform S.p.A. Laboratorio Chimico Farmaceutico Viale del Lavoro 10 45100 Rovigo Italy Ecolab Europe GmbH site 45 ECL Rozzano Via A. Grandi, 20089 Rozzano MI 20089 Rozzano Italy Ecolab Europe GmbH site 46 ECL Tesjoki NLC Tesjoki Kivikummuntie 1, Tesjoki 07955 Tesjoki Finland Ecolab Europe GmbH site 47 ECL Tessenderlo INDUSTRIEZONE RAVENSHOUT 4 3980 Tessenderlo Belgium Ecolab Europe GmbH site 48 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 49 EXTRUPLAST ZI Fief du Passage 56 rue Robert Geffré 17000 La Rochelle France Ecolab Europe GmbH site 50 Ferdinand Eimermacher GmbH & Co. KG Westring 24 48356 Nordwalde Germany Ecolab Europe GmbH site 51 F.E.L.T. BP 64 10 rue du Vertuquet 59531 NEUVILLE EN FERRAIN France Ecolab Europe GmbH site 52 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 53 GERDISA GERMAN RGUEZ DROGAS IND Gerdisa Polígono Industrial Miralcampo parc.37 19200 Azuqueca de Henares Guadalajara Spain Ecolab Europe GmbH site 54 GIRASOL NATURAL PRODUCTS BV De Veldoven 12-14 3342 GR Hendrik-Ido-Ambacht 3342 GR Hendrik-Ido-Ambacht Netherlands (the) Ecolab Europe GmbH site 55 HENKEL ENGELS Henkel Engels 413116 Engels Prospekt StroiTel ei Russia 413116 Engels Russian Federation (the) Ecolab Europe GmbH site 56 Imeco GmbH & Co. KG Boschstraße 5 D-63768 Hösbach Germany Ecolab Europe GmbH site 57 INTERFILL LLC-TOSNO INTERFILL LLC 187000, Moskovskoye shosse 1 187000 Tosno - Leningradskaya Russian Federation (the) Ecolab Europe GmbH site 58 JODEL - PRODUCTOS QUIMICOS Jodel Zona Industrial 2050 Aveiras de Cima 2050 Aveiras de Cima Portugal Ecolab Europe GmbH site 59 Kleinmann GmbH Am Trieb 13 72820 Sonnenbühl Germany Ecolab Europe GmbH site 60 Kompak Nederland B.V. Ambachtsweg 4, 4854 MK, Bavel Netherlands (the) Ecolab Europe GmbH site 61 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 62 LABORATOIRES ANIOS Pavé du moulin 59260 Lille-Hellemmes France Ecolab Europe GmbH site 63 LABORATOIRES ANIOS 3330 Rue de Lille 59262 Sainghin-en-Mélantois France Ecolab Europe GmbH site 64 LICHTENHELDT GmbH Lichtenheldt Industriestrasse 7-9 23812 Wahlstedt Germany Ecolab Europe GmbH site 65 Lonza GmbH Morianstr.32 42103 Wuppertal Germany Ecolab Europe GmbH site 66 McBride SA Polígon Industrial L’Illa C / Ramon Esteve, 20- 22 08650 Sallent Spain Ecolab Europe GmbH site 67 Multifill BV Constructieweg 25-A 3641 SB Mijdrecht 3641 Mijdrecht Netherlands (the) Ecolab Europe GmbH site 68 NOPA NORDISK PARFUMERIVARE Nordisk Parfumerivarefabrik A/S Hvedevej 2-22 DK-8900 Randers Denmark Ecolab Europe GmbH site 69 PAL INTERNATIONAL LTD Pal International Ltd. Sandhurst Street, Oadby Leicester Leicester United Kingdom of Great Britain and Northern Ireland (the) Ecolab Europe GmbH site 70 Planol GmbH Maybachstr. 17 63456 Hanau Germany Ecolab Europe GmbH site 71 Plum A/S Frederik Plums Vej 2 DK 5610 Assens Denmark Ecolab Europe GmbH site 72 PRODUCTOS LC LA CORBERANA, S.L. Crta. Corbera – Polinyá 46612 Valencia Spain Ecolab Europe GmbH site 73 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 74 QUIMICAS MORALES, S.L. Misiones, 11 - Urb. El Sebadal 05005 LAS PALMAS DE GRAN CANARIA Spain Ecolab Europe GmbH site 75 RNM PRODUCTOS QUIMICOS RNM - Produtos Quimicos, Lda Rua da Fabrica, 123 4765-080 Segade Portugal Ecolab Europe GmbH site 76 ROQUETTE & BARENTZ Roquette Freres Route De La Gorgue F-62136 Lestrem France Ecolab Europe GmbH site 77 RUTPEN LTD MEMBURY AIRFIELD RG16 7TJ LAMBOURN United Kingdom of Great Britain and Northern Ireland (the) Ecolab Europe GmbH site 78 SOLIMIX Solimix Montseny 17-19 Pol. Ind. Sant Pere Molanta 08799 Barcelona Spain Ecolab Europe GmbH site 79 Staub & Co. – Silbermann GmbH , Industriestraße 3 D-86456 Gablingen Germany Ecolab Europe GmbH site 80 Stockmeier Chemie Eilenburg GmbH & Co. KG Gustav-Adolf-Ring 5 04838 Eilenburg Germany Ecolab Europe GmbH site 81 SYNERLOGIC BV ( - IN2FOOD) Synerlogic BV afd. L.J. Costerstraat 5 6827 ARNHEM Netherlands (the) Ecolab Europe GmbH site 82 Univar Ltd, Argyle House, Epsom Avenue SK9 3RN Wilmslow United Kingdom of Great Britain and Northern Ireland (the) Ecolab Europe GmbH site 83 Univar SPA Via Caldera 21 20-153 Milano Milano Italy Ecolab Europe GmbH site 84 van Dam Bodegraven B.V Postbus 48 NL 2410 AA Bodegraven Netherlands (the) Ecolab Europe GmbH site 85 Laboratoires Prodene Klint Rue Denis Papin, 2 Z.I. Mitry Compans F-77290 Mitry Mory F-77290 Mitry Mory France Ecolab Europe GmbH site 86 Simagec Z.I. de Rousset / Peynier, 54 Avenue de la Plaine 13790 Rousset France Ecolab Europe GmbH site 87 INNOVATE GmbH, Innovate GmbH Am Hohen Stein 11 06618 Naumburg Germany Ecolab Europe GmbH site 88 Sima Pharma, 54 Avenue de la Plaine, ZI 13106 Rousset Cedex France Ecolab Europe GmbH site 89 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 90 Helico B.V. Hoogschaijksestraat 31 5374 EC Schaijk Netherlands (the) Ecolab Europe GmbH site 91 INCARE BV Keizersveld 99 5803 AP Venray Netherlands (the) Ecolab Europe GmbH site 92 ECL Mullingar Ecolab Ltd (IE). Forrest Park Zone C Mullingar Industrial Estate Mullingar Co. Westmeath Westmeath Ireland Ecolab Europe GmbH site 93 ECL Mullingar. Ecolab Manufacturing IE Ltd (IE) Forest Park, Zone C Mullingar Ind. Estate N91 Mullingar, Co. Westmeath Westmeath Ireland Ecolab Europe GmbH site 94 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 Ecolab Europe GmbH site 95 ECL Weavergate, Ecolab Ltd (UK) Winnington Avenue CW8 3AA Northwich, Cheshire United Kingdom of Great Britain and Northern Ireland Ecolab Europe GmbH site 96 ECL Weavergate, Ecolab Manufacturing UK Ltd (UK) Winnington Avenue CW8 3AA Northwich, Cheshire United Kingdom of Great Britain and Northern Ireland

1.5.   Manufacturer(s) of the active substance(s)

Active substance	Hydrogen peroxide
Name of manufacturer	Evonik Degussa Antwerpen NV
Address of manufacturer	Tijsmanstunnel West 2040 Antwerpen Belgium
Location of manufacturing sites	Evonik Degussa Antwerpen NV site 1 Tijsmanstunnel West 2040 Antwerpen Belgium
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Active substance	Hydrogen peroxide
Name of manufacturer	Evonik Degussa GmbH
Address of manufacturer	Untere Kanalstr. 3 79618 Rheinfelden Germany
Location of manufacturing sites	Evonik Degussa GmbH site 1 Untere Kanalstr. 3 79618 Rheinfelden Germany
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Active substance	Hydrogen peroxide
Name of manufacturer	Evonik Peroxid GmbH
Address of manufacturer	Industriestraβe 1 9721 Weiβenstein Austria
Location of manufacturing sites	Evonik Peroxid GmbH site 1 Industriestraβe 1 9721 Weiβenstein Austria
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Active substance	Hydrogen peroxide
Name of manufacturer	Evonik Peroxide Netherlands BV
Address of manufacturer	Oosterhorn 14 9936 HD Farmsum Netherlands (the)
Location of manufacturing sites	Evonik Peroxide Netherlands BV site 1 Oosterhorn 14 9936 HD Farmsum Netherlands (the)
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Active substance	Hydrogen peroxide
Name of manufacturer	Belinka Perkemija D.O.O
Address of manufacturer	Zasavska cesta 95 1231 Ljubljana-Črnuče Slovenia
Location of manufacturing sites	Belinka Perkemija D.O.O site 1 Zasavska cesta 95 1231 Ljubljana-Črnuče Slovenia
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Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Chemie SA
Address of manufacturer	Rue Solvay 39 B-5190 Jemeppe-sur-Sambre Belgium
Location of manufacturing sites	Solvay Chemie SA site 1 Rue Solvay 39 B-5190 Jemeppe-sur-Sambre Belgium
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Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Chimica Italia S.p.A
Address of manufacturer	Via Piave 6 I-57013 Rosignano Solvay LI Italy
Location of manufacturing sites	Solvay Chimica Italia S.p.A site 1 Via Piave 6 I-57013 Rosignano Solvay LI Italy
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Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Chemicals GmbH
Address of manufacturer	Köthensche Strasse 1-3 D-06406 Bernburg Germany
Location of manufacturing sites	Solvay Chemicals GmbH site 1 Köthensche Strasse 1-3 D-06406 Bernburg Germany
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Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Interox Limited
Address of manufacturer	Baronet Road WA4 6HB Warrington Cheshire United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites	Solvay Interox Limited site 1 Baronet Road WA4 6HB Warrington Cheshire United Kingdom of Great Britain and Northern Ireland (the)
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Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Chemicals Finland OY
Address of manufacturer	Yrjonojantie 2 45910 Voikkaa Finland
Location of manufacturing sites	Solvay Chemicals Finland OY site 1 Yrjonojantie 2 45910 Voikkaa Finland
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Active substance	Hydrogen peroxide
Name of manufacturer	Solvay Interox Produtos Peroxidados SA
Address of manufacturer	Rua Eng. Clement Dumoulin P-2625-106 Povoa de Santa Iria Portugal
Location of manufacturing sites	Solvay Interox Produtos Peroxidados SA site 1 Rua Eng. Clement Dumoulin P-2625-106 Povoa de Santa Iria Portugal
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Active substance	Hydrogen peroxide
Name of manufacturer	Kemira Rotterdam BV
Address of manufacturer	Moezelweg 151 3198 LS Europoort Rotterdam Netherlands (the)
Location of manufacturing sites	Kemira Rotterdam BV site 1 Moezelweg 151 3198 LS Europoort Rotterdam Netherlands (the)
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Active substance	Hydrogen peroxide
Name of manufacturer	Kemira Chemical Oy
Address of manufacturer	Typpitie PL 171 90101 Oulu Finland
Location of manufacturing sites	Kemira Chemical Oy site 1 Typpitie PL 171 90101 Oulu Finland
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Active substance	Hydrogen peroxide
Name of manufacturer	Kemira Kemi AB
Address of manufacturer	Industrigatan 83 25109 Helsingborg Sweden
Location of manufacturing sites	Kemira Kemi AB site 1 Industrigatan 83 25109 Helsingborg Sweden
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Active substance	Hydrogen peroxide
Name of manufacturer	ARKEMA France – USINE DE JARRIE
Address of manufacturer	Route National 85, BP 1 38560 JARRIE France
Location of manufacturing sites	ARKEMA France – USINE DE JARRIE site 1 Route National 85, BP 1 38560 JARRIE France
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Active substance	Hydrogen peroxide
Name of manufacturer	ARKEMA GMBH – NIEDERLASSUNG LEUNA
Address of manufacturer	Am Haupttor, Bau 2410 06237 LEUNA Germany
Location of manufacturing sites	ARKEMA GMBH – NIEDERLASSUNG LEUNA site 1 Am Haupttor, Bau 2410 06237 LEUNA Germany
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Active substance	Hydrogen peroxide
Name of manufacturer	Ecolab Europe GmbH
Address of manufacturer	Ecolab-Allee 1 40789 Monheim am Rhein Germany
Location of manufacturing sites	Ecolab Europe GmbH site 1 Ecolab-Allee 1 40789 Monheim am Rhein Germany

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		active substance	7722-84-1	231-765-0	1 - 36,75  % (w/w)
N-propanol	Propan-1-ol	Non-Active substance	71-23-8	200-746-9	0 - 17,5  % (w/w)
Citric acid monohydrate	2-hydroxypropane -1,2,3-tricarboxylic acid	Non-Active substance	5949-29-1	201-069-1	0 - 0,9  % (w/w)
Phenoxyethanol	2-Phenoxyethanol	Non-Active substance	122-99-6	204-589-7	0 - 0,9  % (w/w)
Sodium lauryl Sulphate	Sodium dodecyl sulphate	Non-Active substance	151-21-3	205-788-1	0 - 3,88  % (w/w)
L-Glutamic acid, N-coco acyl derivs., monosodium salts	Sodium;(4S)-4-amino-5-hydroxy-5-oxopentanoate	Non-Active substance	68187-32-6	269-087-2	0 - 2  % (w/w)
Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts (Texapon ALS)	Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts	Non-Active substance	90583-11-2	292-209-0	0 - 1,12  % (w/w)
Phosphoric acid	Orthophosphoric acid	Non-Active substance	7664-38-2	231-633-2	0 - 1,5  % (w/w)
Nitric acid	Nitric acid	Non-Active substance	7697-37-2	231-714-2	0 - 3,71  % (w/w)
Alcohol EO phosphate ester	Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, mono-C8-10-alkyl ethers, phosphates	Non-Active substance	68130-47-2		0 - 14,625  % (w/w)
Alkylpolyglycoside C8-C10	(3R,4S,5S,6R)-2-decoxy-6-(hydroxymethyl)oxane-3,4,5-triol	Non-Active substance	68515-73-1	500-220-1	0 - 6,35  % (w/w)
Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)	Alcohols, C10-C16 ethoxylated propoxylated	Non-Active substance	69227-22-1		0 - 3  % (w/w)
Capryleth-9 Carboxylic acid (mixture of alkyl ether carboxylic acid)	Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(octyloxy)- (4-11 EO)	Non-Active substance	53563-70-5		0 - 2,15  % (w/w)
Hexeth-4 Carboxylic Acid (mixture of alkyl ether carboxylic acid)	Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(hexyloxy)- (3 EO)	Non-Active substance	105391-15-9		0 - 0,62  % (w/w)

2.2.   Type(s) of formulation

Formulation type(s)	AL Any other liquid GW Water soluble gel SL Soluble concentrate

PART II.

SECOND INFORMATION LEVEL - META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier	Meta SPC: META SPC 1

1.2.   Suffix to the authorisation number

Number	1-1

1.3.   Product type(s)

Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals

2. META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		active substance	7722-84-1	231-765-0	6 - 6,6  % (w/w)

2.2.   Type(s) of formulation of the meta SPC 1

Formulation type(s)	AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements	H319: Causes serious eye irritation.
Precautionary statements	P264: Wash hands thoroughly after handling. P280: Wear eye protection. P280: Wear face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313: If eye irritation persists: Get medical advice. P337+P313: If eye irritation persists: Get medical attention.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Disinfection of life sciences cleanrooms by spraying using trigger sprayer and dry wipe

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: No data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data Scientific name: Bacterial spores Common name: Bacterial spores Development stage: no data
Field(s) of use	indoor use
Application method(s)	Method: Spraying using trigger sprayer and dry wipe Detailed description: Disinfection of small surfaces, materials and equipment in life sciences cleanrooms, classified as grade A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments. Contact times for spraying at 20oC in clean conditions: — 15 minutes for bacteria and fungi; — 5 minutes for yeasts; — 60 minutes for viruses and bacterial spores. Contact times for spraying and wiping at 20oC in clean conditions: — 5 minutes for bacteria, yeasts and fungi; — 60 minutes for viruses and bacterial spores.
Application rate(s) and frequency	Application rate: Application rate: 10 ml/m2 Dilution (%): Ready to use (RTU) product Number and timing of application: Application frequency: up to twice per day per room
Category(ies) of users	professional
Pack sizes and packaging material	Light precluding High Density Poly Ethylene (HDPE) or Poly Ethylene (PE) Bottle, 1-5 L Light precluding Polypropylene and Polyethylene (PP+PE) spray bottle, 0.5 -5 L

4.1.1.   Use-specific instructions

For optimum results, hold the bottle upright and spray from a distance of 10 cm to 20 cm. Spray the product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray the product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.

4.1.2.   Use-specific risk mitigation measures

The use of eye protection while handling the product is mandatory.

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 of meta SPC 1.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1.

4.2.   Use description

Table 2

Disinfection of life sciences cleanrooms by mopping using flat mop and bucket

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data Scientific name: Bacterial spores Common name: Bacterial spores Development stage: no data
Field(s) of use	indoor use
Application method(s)	Method: Mopping using a flat mop and bucket Detailed description: Disinfection of floors in life sciences cleanrooms, classified as grade A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments. Contact times for mopping at 20oC in clean conditions: — 5 minutes for bacteria, yeasts and fungi; — 60 minutes for viruses and bacterial spores.
Application rate(s) and frequency	Application rate: Application rate: 20 ml/m2 Dilution (%): RTU product Number and timing of application: Application frequency: up to twice per day per room
Category(ies) of users	Professional
Pack sizes and packaging material	Light precluding HDPE or PE Bottle, 0.5 -5 L

4.2.1.   Use-specific instructions

Apply to surfaces by mopping and let air dry.

4.2.2.   Use-specific risk mitigation measures

The use of eye protection while handling the product is mandatory.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory for professionals applying the product and for other professionals present in the treated area. An air purifying respirator with helmet/hood/mask (TH1/TM1), or a half/full mask with combination filter gas/P2 is at least required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). For repeated application or re-entry into the room, the professional needs to follow the same risk mitigation measures as for the first application in the room.

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 of meta SPC 1.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1.

4.3.   Use description

Table 3

Disinfection of life sciences cleanrooms by wiping using impregnated RTU wipes

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data Scientific name: Bacterial spores Common name: Bacterial spores Development stage: no data
Field(s) of use	indoor use
Application method(s)	Method: Wiping using impregnated RTU wipes Detailed description: Disinfection of small surfaces, materials and equipment in life sciences cleanrooms, classified as grade A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments. Contact times for wiping at 20oC in clean conditions: — 5 minutes for bacteria, yeasts and fungi; — 60 minutes for viruses and bacterial spores.
Application rate(s) and frequency	Application rate: Application rate: 1 wipe per m2 (corresponds to 10 ml/m2) Dilution (%): RTU product Number and timing of application: Application frequency: up to twice per day per room
Category(ies) of users	professional
Pack sizes and packaging material	Light precluding PP or PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 45% polyester / 55% cellulose blend wipes (wipe size: 200x200 mm) Light precluding PP or PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 100% polyester wipes (wipe size: 200x200 mm). Light precluding PP or PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 100% polyester wipes (wipe size: 300x300 mm)

4.3.1.   Use-specific instructions

Allow surface to air dry after using the product. Close container when not in use. Do not use wipes which have become dehydrated. Used wipes must be disposed of in a closed container.

4.3.2.   Use-specific risk mitigation measures

Avoid hand to eye transfer.

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

See general directions for use of meta SPC 1.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1.

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1.

4.4.   Use description

Table 4

Disinfection of life sciences cleanrooms by mopping using impregnated RTU mop wipes

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Viruses Common name: Viruses Development stage: no data Scientific name: Bacterial spores Common name: Bacterial spores Development stage: no data
Field(s) of use	indoor use
Application method(s)	Method: Mopping using impregnated RTU mop wipes Detailed description: Disinfection of floors in life sciences cleanrooms, classified as grade A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments. Contact times for mopping at 20oC in clean conditions: — 5 minutes for bacteria, yeasts and fungi; — 60 minutes for viruses and bacterial spores.
Application rate(s) and frequency	Application rate: Application rate: 1 wipe per m2 (corresponds to 10 ml/m2) Dilution (%): RTU product Number and timing of application: Application frequency: up to twice per day per room
Category(ies) of users	professional
Pack sizes and packaging material	Light precluding PP or PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 45% polyester / 55% cellulose blend wipes (wipe size: 420x250 mm). Light precluding PP or PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 100% polyester wipes (wipe size: 300x300 mm).

4.4.1.   Use-specific instructions

Allow surface to air dry after using the product. Close container when not in use. Do not use wipes which have become dehydrated. Used wipes must be disposed of in a closed container.

4.4.2.   Use-specific risk mitigation measures

Avoid hand to eye transfer.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory for professionals applying the product and for other professionals present in the treated area. An air purifying respirator with helmet/hood/mask (TH1/TM1), or a half/full mask with combination filter gas/P2 is at least required (filter type (code letter, colour) to be specified by the authorisation holder within the product information). For repeated application or re-entry into the room, the professional needs to follow the same risk mitigation measures as for the first application in the room.

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

See general directions for use of meta SPC 1.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1.

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1.

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions. Clean surface before applying the product. Product should be applied to a clean dry surface. Wet surface completely using the product. Do not rinse after use. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures of meta SPC 1.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

FIRST AID MEASURES

In case of eye contact: Rinse immediately with plenty of water, including under the eyelids, for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Seek medical attention.

In case of skin contact: Rinse with plenty of water.

If swallowed: Rinse mouth. Seek medical attention if symptoms occur.

If inhaled: Seek medical attention if symptoms occur.

ENVIRONMENTAL EMERGENCY MEASURES

Do not allow contact with soil, surface or ground water.

Consider the provision of containment around storage vessels.

5.4.   Instructions for safe disposal of the product and its packaging

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.

Contaminated packaging: Dispose of container in accordance with national regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.

Storage temperature: 0-35°C

Shelf life: 24 months

6. OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m³ for the professional user was agreed and used for the risk assessment of the product.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	Trade name(s)	Trade name(s)	Klercide Sporicidal Low Residue Peroxide	Klercide Sporicidal Low Residue Peroxide	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Klerwipe Sporicidal Low Residue Peroxide	Klerwipe Sporicidal Low Residue Peroxide	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	ANIOS H2O2 6% IP STERILE	ANIOS H2O2 6% IP STERILE	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0024303-0001 1-1	EU-0024303-0001 1-1	EU-0024303-0001 1-1
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Hydrogen peroxide		active substance	active substance	7722-84-1	7722-84-1	231-765-0	6 % (w/w)

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier	Meta SPC: META SPC 2

1.2.   Suffix to the authorisation number

Number	1-2

1.3.   Product type(s)

Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area

2. META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		active substance	7722-84-1	231-765-0	1 - 1  % (w/w)

2.2.   Type(s) of formulation of the meta SPC 2

Formulation type(s)	AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements
Precautionary statements

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Disinfection of small and/or large surfaces in industry (e.g. dining areas, bathrooms) by spraying using trigger sprayer and dry wipe and/or by mopping using flat mop and bucket

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Mycobacteria Common name: Mycobacteria Development stage: no data
Field(s) of use	indoor use
Application method(s)	Method: Spraying using trigger sprayer and dry wipe Detailed description: Disinfection of small surfaces in industry. Contact times for spraying at 20oC in dirty conditions: — 5 minutes for bacteria and yeasts; — 15 minutes for fungi; — 60 minutes for mycobacteria. Method: Mopping using flat mop and bucket Detailed description: Disinfection of large surfaces in industry. Contact times for mopping at 20oC in dirty conditions: — 5 minutes for bacteria and yeasts; — 15 minutes for fungi; — 60 minutes for mycobacteria. Method: Spraying using trigger sprayer and dry wipe and mopping using flat mop and bucket. Detailed description: Disinfection of small and large surfaces in industry. Contact times for spraying and mopping at 20oC in dirty conditions: — 5 minutes for bacteria and yeasts; — 15 minutes for fungi; — 60 minutes for mycobacteria.
Application rate(s) and frequency	Application rate: Application rate for spraying: 10 ml/m2 Dilution (%): RTU product Number and timing of application: Application frequency for trigger spraying: up to 10 times per day per room Application rate: Application rate for mopping: 20 ml/m2 Dilution (%): RTU product Number and timing of application: Application frequency for mopping: up to twice per day per room Application rate: Application rate for spraying: 10 ml/m2; Application rate for mopping: 20 ml/m2 Dilution (%): RTU product Number and timing of application: Application frequency for combined trigger spraying and mopping: once per day per room.
Category(ies) of users	professional
Pack sizes and packaging material	Light precluding HDPE Container, 1-100L Light precluding HDPE Jerry can, 1-100L Light precluding HDPE IBC, 600-1000L Light precluding HDPE Drum, 60-220L Light precluding HDPE Bottle, 0,1-5L Light precluding HDPE; PE Spray bottle, 0,5-1L

4.1.1.   Use-specific instructions

Spraying: For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto the surface, wait for 5 minutes and then wipe the surface with a clean, dry wipe or let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.

Mopping: Remove excess water using a dry floor mop. Fill the bucket with ready-to use product and distribute across floor using flat mop. Wait 5 minutes, then wipe the surface with a clean, dry mop or let air dry.

4.1.2.   Use-specific risk mitigation measures

For spraying of large surface areas the following applies: The area of the surface to be disinfected (in m²) must not be larger than 1/10 of the room volume (in m³) e.g. in a room of 120 m³ volume, the maximum surface to be disinfected is 12 m².

For spraying of small surface areas the above specific risk mitigation measure does not apply.

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 of meta SPC 2.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2.

4.2.   Use description

Table 2

Disinfection of small surfaces (floors) in industry [(e.g. dining areas, bathrooms)] by mopping using flat mop and bucket

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Mycobacteria Common name: Mycobacteria Development stage: no data
Field(s) of use	indoor use
Application method(s)	Method: Mopping using flat mop and bucket Detailed description: Disinfection of small surfaces (floors) in industry plants Contact times for mopping at 20oC in dirty conditions: — 5 minutes for bacteria and yeasts; — 15 minutes for fungi; — 60 minutes for mycobacteria.
Application rate(s) and frequency	Application rate: Application rate: 20 ml/m2 Dilution (%): RTU product Number and timing of application: Application frequency: up to twice per day per room
Category(ies) of users	professional
Pack sizes and packaging material	Light precluding HDPE Container, 1-100 L Light precluding HDPE Jerry can, 1-100 L Light precluding HDPE IBC, 600-1000 L Light precluding HDPE Drum, 60-220 L Light precluding HDPE Bottle, 0,1-5 L

4.2.1.   Use-specific instructions

Fill the bucket with ready-to-use product and distribute across floor using flat mop, afterwards wipe the surface with a clean, dry mop or let air dry.

4.2.2.   Use-specific risk mitigation measuresNone

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 of meta SPC 2.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2

4.3.   Use description

Table 3

Disinfection of small food contact surfaces in food and beverage industry by spraying using trigger sprayer and dry wipe

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Mycobacteria Common name: Mycobacteria Development stage: no data
Field(s) of use	indoor use
Application method(s)	Method: Spraying using trigger sprayer and dry wipe Detailed description: Disinfection of small surfaces in food processing plants. Contact time for spraying at 20oC in dirty conditions: — 5 minutes for bacteria and yeasts. Contact times for spraying and wiping at 20oC in dirty conditions: — 5 minutes for bacteria and yeasts; — 15 minutes for fungi; — 60 minutes for mycobacteria.
Application rate(s) and frequency	Application rate: Application rate: 10 ml/m2 Dilution (%): RTU product Number and timing of application: Application frequency: up to 10 times per day per room
Category(ies) of users	professional
Pack sizes and packaging material	Light precluding HDPE Container, 1-100 L Light precluding HDPE Jerry can, 1-100 L Light precluding HDPE IBC, 600-1000 L Light precluding HDPE Drum, 60-220 L Light precluding HDPE Bottle, 0,1-5 L Light precluding HDPE; PE Spray bottle, 0,5-1 L

4.3.1.   Use-specific instructions

For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto the surface, leave for the required contact time and then either remove excess liquid with dry wipe or let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.

4.3.2.   Use-specific risk mitigation measures

Keep food, feed or beverages away from treated surfaces until dried. Do not use directly on or near food, feed or drinks.

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

See general directions for use of meta SPC 2.

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2.

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2.

4.4.   Use description

Table 4

Disinfection of food contact surfaces in food and beverage industry by spraying using fixed installed sprayer

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data
Field(s) of use	indoor use
Application method(s)	Method: Fixed installed spraying Detailed description: Automated disinfection application in industrial process equipment. Contact time for spraying at 20oC in dirty conditions: — 5 minutes for bacteria and yeasts.
Application rate(s) and frequency	Application rate: Application rate: 300 L maximum per application Dilution (%): RTU product Number and timing of application: Application frequency: once per week
Category(ies) of users	professional
Pack sizes and packaging material	Light precluding HDPE Container, 1-100 L Light precluding HDPE Jerry can, 1-100 L Light precluding HDPE IBC, 600-1000 L Light precluding HDPE Drum, 60-220 L Light precluding HDPE Bottle, 0,1-5 L

4.4.1.   Use-specific instructions

Use outside food production time, once per week.

4.4.2.   Use-specific risk mitigation measures

Application only after the working shift/overnight application.

During spraying application, no person shall be present.

To determine the appropriate re-entry time after application of the product, workplace release measurements using suitable measurement equipment shall be performed upon implementation of the fixed installed spraying, and at regular intervals thereafter (annual intervals recommended), and after any change in relevant boundary conditions. The national regulations for workplace measurements shall be followed. In case of unscheduled maintenance tasks during spraying application, use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory.

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

See general directions for use of meta SPC 2.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2.

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2.

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions. The product should be applied to a dry surface. Wet surface completely using the product. Do not rinse after use. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures of meta SPC 2.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

FIRST AID MEASURES

In case of eye contact: Rinse with plenty of water.

In case of skin contact: Rinse with plenty of water.

If swallowed: Rinse mouth. Seek medical attention if symptoms occur.

If inhaled: Seek medical attention if symptoms occur.

ENVIRONMENTAL EMERGENCY MEASURES

Do not allow contact with soil, surface or ground water.

Consider the provision of containment around storage vessels.

5.4.   Instructions for safe disposal of the product and its packaging

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.

Contaminated packaging: Dispose of container in accordance with national regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.

Storage temperature:0-35 °C

Shelf life: 24 months

6. OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m³ for the professional user was agreed and used for the risk assessment of the product.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	Trade name(s)	Trade name(s)	DrySan Oxy	DrySan Oxy	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0024303-0002 1-2	EU-0024303-0002 1-2	EU-0024303-0002 1-2
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Hydrogen peroxide		active substance	active substance	7722-84-1	7722-84-1	231-765-0	1 % (w/w)

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier	Meta SPC: META SPC 3

1.2.   Suffix to the authorisation number

Number	1-3

1.3.   Product type(s)

Product type(s)	PT04: Food and feed area

2. META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		active substance	7722-84-1	231-765-0	35 - 36,75  % (w/w)

2.2.   Type(s) of formulation of the meta SPC 3

Formulation type(s)	AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

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	P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P261: Avoid breathing vapours. P261: Avoid breathing spray. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear eye protection. P280: Wear face protection. P280: Wear protective gloves. P301+P312: IF SWALLOWED: Call a POISON CENTER 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 advice. P332+P313: If skin irritation occurs: Get medical attention. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312: Call a POISON CENTER if you feel unwell. 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. P310: Immediately call a doctor. P321: Specific treatment (see first aid instruction on this label). P362+P364: Take off contaminated clothing and wash it before reuse. 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 in accordance with national regulations. P501: Dispose of container to in accordance with national regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Disinfection of food contact surfaces in food and beverage industry by automated dipping or spraying in closed system

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Fungi Common name: fungi Development stage: no data Scientific name: Bacterial spores Common name: Bacterial spores Development stage: no data
Field(s) of use	indoor use
Application method(s)	Method: Automated dipping or spraying in closed system Detailed description: Disinfection of packaging (aseptic filling) by fully automated dipping and spraying (closed process). Packaging disinfection in food, beverage and feed manufacturing (dip and spray application). Contact time for dipping and spraying at 60oC in clean conditions: — 1 minute for bacteria, yeasts, fungi and bacterial spores.
Application rate(s) and frequency	Application rate: Application rate: constant automated dosing Dilution (%): RTU product Number and timing of application: Application frequency: constant automated dosing
Category(ies) of users	Professional
Pack sizes and packaging material	Light precluding HDPE Bulk delivery container, > 1 L - bulk Light precluding HDPE Jerry can, 1-100 L Light precluding HDPE IBC, 600-1000 L Light precluding HDPE Drum, 60-220 L Light precluding HDPE Bottle, 0,1-5 L

4.1.1.   Use-specific instructions

Packaging disinfection in food, beverage and feed manufacturing (spraying or dipping application):

• — Dosing of product directly into the packaging to disinfect or applied into additional steam

• — Continuous use of the product

• — Application temperature: 60°C

• — Application takes place in a closed and vented system.

Do not rinse after use. After sterilisation, blow-dry the packaging with hot sterile air.

4.1.2.   Use-specific risk mitigation measures

Do not breathe vapours/spray.

During operation, ensure adequate ventilation along the machines Local exhaust ventilation (LEV) and in the industrial halls (technical ventilation).

During manual maintenance tasks, ensure adequate ventilation inside the machine (LEV) before opening the doors of the aseptic area.

• 1. The product shall only be transferred in closed pipes after mixing and loading. Open product and waste water flows are not allowed.

• 1. Workplace release measurements using suitable measurement equipment shall be performed upon implementation of the aseptic packaging plant, and at regular intervals thereafter (annual intervals recommended), and after any change in relevant boundary conditions. The national regulations for workplace measurements shall be followed.

• 1. In case of maintenance of the aseptic packaging plant (e.g. manual cleaning, technical incidents or repair) appropriate PPE (including respiratory protective equipment, chemical protective gloves, chemical protective coverall, eye protection) is required. The type of RPE, the filter type (code letter, colour) and glove material are to be specified by the authorisation holder within the product information.

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 of meta SPC 3.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3.

4.2.   Use description

Table 2

Disinfection of food contact surfaces in food and beverage industry by Clean-in-place (CIP)

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: no data Scientific name: Yeasts Common name: Yeasts Development stage: no data Scientific name: Fungi Common name: fungi Development stage: no data
Field(s) of use	Indoor use
Application method(s)	Method: CIP Detailed description: Disinfection in food and beverage industry (food contact).Contact times for closed systems at 60oC in clean conditions: — 5 minutes for bacteria and yeasts; — 15 minutes for fungi.
Application rate(s) and frequency	Application rate: Application rate: automated dosing Dilution (%): RTU product Number and timing of application: Application frequency: once per day
Category(ies) of users	Professional
Pack sizes and packaging material	Light precluding HDPE Bulk delivery container, > 1 L - bulk Light precluding HDPE Jerry can, 1-100 L Light precluding HDPE IBC, 600-1000 L Light precluding HDPE Drum, 60-220 L Light precluding HDPE Bottle, 0,1-5 L

4.2.1.   Use-specific instructions

Before disinfection, system should be washed. Disinfection of CIP tanks, CIP pumps, pipe work and internal system of the processing equipment for food, beverage and feed, including milking machine hygiene (MMH) (closed systems). Rinse with water after treatment.

4.2.2.   Use-specific risk mitigation measures

Keep food, feed or beverages away from treated surface until rinsed off with 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

See general directions for use of meta SPC 3.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3.

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1.   Instructions for use

See use-specific instruction for use of meta SPC 3.

5.2.   Risk mitigation measures

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).

The use of eye protection while handling the product is mandatory.

The process of dilution shall be carried out using an automatic dosing system.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

FIRST AID MEASURES

In case of eye contact: Rinse immediately with plenty of water, including under the eyelids, for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Seek medical attention immediately.

In case of skin contact: Wash off immediately with plenty of water for at least 15 minutes. Use a mild soap if available. Seek medical attention if irritation develops and persists.

If swallowed: Rinse mouth. Seek medical attention if symptoms occur.

If inhaled: Remove person to fresh air. Treat symptomatically. Seek medical attention if symptoms occur.

ENVIRONMENTAL EMERGENCY MEASURES

Do not allow contact with soil, surface or ground water.

Consider the provision of containment around storage vessels.

5.4.   Instructions for safe disposal of the product and its packaging

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.

Contaminated packaging: Dispose of container in accordance with national regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.

Storage temperature: 0 - 35 °C

Shelf life: 24 months

6. OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m³ for the professional user was agreed and used for the risk assessment of the product.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

7.1.   Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	Trade name(s)	Trade name(s)	Oxypak D	Oxypak D	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Oxypak S	Oxypak S	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Oxypak S10	Oxypak S10	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0024303-0003 1-3	EU-0024303-0003 1-3	EU-0024303-0003 1-3
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Hydrogen peroxide		active substance	active substance	7722-84-1	7722-84-1	231-765-0	35 % (w/w)

1. META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier	Meta SPC: META SPC 4

1.2.   Suffix to the authorisation number

Number	1-4

1.3.   Product type(s)

Product type(s)	PT03: Veterinary hygiene

2. META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Hydrogen peroxide		active substance	7722-84-1	231-765-0	1,4 - 1,61  % (w/w)
Citric acid monohydrate	2-hydroxypropane -1,2,3-tricarboxylic acid	Non-Active substance	5949-29-1	201-069-1	0,9 - 0,9  % (w/w)
Phenoxyethanol	2-Phenoxyethanol	Non-Active substance	122-99-6	204-589-7	0,9 - 0,9  % (w/w)
Sodium lauryl Sulphate	Sodium dodecyl sulphate	Non-Active substance	151-21-3	205-788-1	3,88 - 3,88  % (w/w)
L-Glutamic acid, N-coco acyl derivs., monosodium salts	Sodium;(4S)-4-amino-5-hydroxy-5-oxopentanoate	Non-Active substance	68187-32-6	269-087-2	2 - 2  % (w/w)
Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts (Texapon ALS)	Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts	Non-Active substance	90583-11-2	292-209-0	1,12 - 1,12  % (w/w)

2.2.   Type(s) of formulation of the meta SPC 4

Formulation type(s)	AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements	H290: May be corrosive to metals. H319: Causes serious eye irritation.
Precautionary statements	P234: Keep only in original packaging. P264: Wash hands thoroughly after handling. P280: Wear eye protection. P280: Wear face protection. P390: Absorb spillage to prevent material damage. P406: Store in a a corrosion-resistant container with a resistant inner liner. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313: If eye irritation persists: Get medical attention. P337+P313: If eye irritation persists: Get medical advice.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Teat dips for pre-milking disinfection