ANNEX

Summary of product characteristics for a biocidal product family

Hydrogen Peroxide Family 1

Product type 1 - Human hygiene (Disinfectants)

Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 3 - Veterinary hygiene (Disinfectants)

Product type 4 - Food and feed area (Disinfectants)

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

1.3. Authorisation holder

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

1.4. Manufacturer(s) of the biocidal products

Name of manufacturer Ecolab Europe GmbH Address of manufacturer Richtistrasse 7, 8304 Walliselen Switzerland Location of manufacturing sites A.F.P. GmbH Otto-Brenner-Straße 16, 21337 Lüneburg Germany ACIDEKA S.A. Edificio Feria. Capuchinos de Basurto 6, 4a planta, 48013 Bilbao. Bizkaia Spain ADIEGO HNOS CTRA DE VALENCIA, KM 5,900 50410 CUARTE DE HUERVA (ZARAGOZA), 50410 Zaragoza Spain ALLIED PRODUCTS Allied Hygiene Unit 11, Belvedere Industrial Estate Fishers Way, DA17 6BS Belvedere, Kent United Kingdom Arkema GmbH Morschheimer Srtrasse 19, D-67292 Krichheimbolanden Germany AZELIS DENMARK Lundtoftegårdsvej 95 2800 Kgs., 2800 Kgs Lyngby Denmark Belinka Zasavska Cesta 95, 1001 Ljubljana Slovenia BENTUS LABORATORIES LTD. RUSSIA, 105005, MOSCOW, RADIO STREET, 24 BLD.1, 105005 Moscow Russian Federation BIO PRODUCTIONS 72 VICTORIA ROAD, VICTORIA INDUSTRIAL ESTATE, BURGESS HILL, WEST SUSSEX, RH159LH Burgess Hill United Kingdom BIOXAL SA Route des Varennes - Secteur A – BP 30072, 71103 Chalon sur Saône Cedex France Bores Srl Via Pioppa, 179, 44020 Pontegradella Italy BRENNTAG ARDENNES Route de Tournes CD n 2 FR-08090, FR-08090 Cliron France BRENNTAG CEE - GUNTRAMSDORF Brenntag CEE GmbH Mixing / Blending Bahnstr. 13, A-2353 Guntramsdorf Austria BRENNTAG Duisburg/Glauchau/Hamburg/Heilbronn Brenntag GmbH Humboldtring 15, 45472 Muehlheim Germany BRENNTAG Kaiserslautern Brenntag Merkurstr. 47, 67663 Kaiserslautern Germany BRENNTAG Kleinkarlbach/Lohfelden Brenntag GmbH Humboldtring 15, 45472 Muehlheim Germany BRENNTAG Nordic - HASLEV Høsten Teglværksvej 47, 4690 Haslev Denmark Brenntag Nordic, Strandgade 35, 7100 Vejle Denmark BRENNTAG Normandy Brenntag Normandie 12 Sente des Jumelles - BP 11 76710, 76710 Montville France BRENNTAG PL -Zgierz ul. Kwasowa 5, 95-100 Zgierz Poland Brenntag Quimica S.A. - Madrid. Calle Gutemberg no 22,.Poligono Industrial El Lomo, 28906 Madrid Spain BRENNTAG Schweizerhall Brenntag Schweizerhall AG Elsaesserstr. 231, CH-4056 Basel Switzerland Budich International GmbH Dieselstrasse 10, 32120 Hiddenhause Germany Caldic Deutschland Chemie B.V Caldic Deutschland GmbH & Co.Kg Am Karlshof 10 D, 40231 Duesseldorf Germany Carbon Chemicals Group Ltd, Ringaskiddy, P43 R772 County Cork Ireland COLEP BAD SCHMIEDEBERG ColepCCL Bad Schmiedeberg GmbH Kemberger Str. 3, 06905 Bad Schmiedeberg Germany COMERCIAL FARMACEUTICA CASTEL: LANA, S.A. ‘COFARCAS’ Condado de Treviño, 46 P.I. Villalonquejar 09080 – BURGOS, 09080 Burgos Spain COMERCIAL GODO França, 13 08700 – IGUALADA (BARCELONA), 08700 BARCELONA Spain COURTOIS SARL ZA SOUS LE BEER Route de Pacy, 27730 BUEIL France DAN MOR (DR WIPE) DAN-MOR Natural Products and Chemicals Ltd. Or Akiva Industrial Zone, 30600 Akiva Industrial Zone Israel Denteck BV Heliumstraat 8, 2718 SL ZOETERMEER Netherlands DETERGENTS BURGUERA DETERGENTS BURGUERA, S.L. Joan Ballester, 50 07630 CAMPOS (ILLES BALEARES) Spain ECL Biebesheim NLC Biebesheim Justus-von-Liebig-Straße 11, 64584 Biebesheim am Rhein Germany ECL Celra NALCO - Celra C/ Tramuntana s/n Poligona Industrial Celra, 17460 Girona Spain ECL Châlons AVENUE DU GENERAL PATTON, 51000 CHALONS EN CHAMPAGNE France ECL Cisterna Nalco Italiana Manufacturing Srl.Via Ninfina II, 04012 Cisterna di Latina Italy ECL Fawley NLC Fawley Cadland Road, Hythe, SO45 3NP Southampton, Hampshire United Kingdom ECL Leeds ECOLAB Lotherton Way Garforth Leeds LS25 2JY, LS25 2JY Leeds United Kingdom ECL Mandra 25TH KM OLD NATIONAL ROAD OF ATHENS TO THIVA, GR 19600, GR 19600 ATHENS Greece ECL Maribor Vajngerlova 4, SI-2001 Maribor, SI-2001 Maribor Slovenia ECL MICROTEK BV MICROTEK MEDICAL B.V. GESINKKAMPSTRAAT 19, 7051 HR, VARSSEVELD, 7051 HR VARSSEVELD Netherlands ECL MICROTEK MOSTA SORBONNE CENTRE, F20 MOSTA TECHNOPARK, MOSTA, MST 3000 MOSTA Malta ECL Mullingar Ecolab Ltd. Forrest Park Zone C Mullingar Industrial Estate Mullingar Co., Westmeath Westmeath Ireland ECL Nieuwegein BRUGWAL 11 A, 3432 NZ NIEUWEGEIN, 3432 NZ NIEUWEGEIN Netherlands ECL Rovigo Esoform Esoform S.p.A. Laboratorio Chimico Farmaceutico Viale del Lavoro 10, 45100 Rovigo Italy ECL Rozzano Via A. Grandi, 20089 Rozzano MI, 20089 Rozzano Italy ECL Tesjoki NLC Tesjoki Kivikummuntie 1, Tesjoki, 07955 Tesjoki Finland ECL Tessenderlo INDUSTRIEZONE RAVENSHOUT 4, 3980 Tessenderlo Belgium ECL Weavergate NLC Weavergate Northwich, Cheshire West and Chester, CW8 4EE Northwich United Kingdom Ecolab Ltd Baglan/Swindon, Plot 7a Baglan Energy Park, Baglan, Port Talbot, SA11 2HZ Port Talbot United Kingdom EXTRUPLAST ZI Fief du Passage 56 rue Robert Geffré, 17000 La Rochelle France Ferdinand Eimermacher GmbH & Co. KG Westring 24, 48356 Nordwalde Germany F.E.L.T. BP 64 10 rue du Vertuquet, 59531 NEUVILLE EN FERRAIN France Gallows Green Services Ltd. Cod Beck Mill Industrial Estate Dalton Lane, YO7 3HR Thirsk North Yorkshire United Kingdom GERDISA GERMAN RGUEZ DROGAS IND Gerdisa Polígono Industrial Miralcampo parc.37, 19200 Azuqueca de Henares Guadalajara Spain GIRASOL NATURAL PRODUCTS BV De Veldoven 12-14 3342 GR Hendrik-Ido-Ambacht, 3342 GR Hendrik-Ido-Ambacht Netherlands HENKEL ENGELS Henkel Engels 413116 Engels Prospekt StroiTel ei Russia, 413116 Engels Russian Federation Imeco GmbH & Co. KG Boschstraße 5, D-63768 Hösbach Germany INTERFILL LLC-TOSNO INTERFILL LLC 187000, Moskovskoye shosse 1, 187000 Tosno - Leningradskaya Russian Federation JODEL - PRODUCTOS QUIMICOS Jodel Zona Industrial 2050 Aveiras de Cima, 2050 Aveiras de Cima Portugal Kleinmann GmbH Am Trieb 13, 72820 Sonnenbühl Germany Kompak Nederland B.V. Ambachtsweg 4, 4854 MK, Bavel Netherlands 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 LABORATOIRES ANIOS Pavé du moulin, 59260 Lille-Hellemmes France LABORATOIRES ANIOS 3330 Rue de Lille, 59262 Sainghin-en-Mélantois France LICHTENHELDT GmbH Lichtenheldt Industriestrasse 7-9, 23812 Wahlstedt Germany Lonza GmbH Morianstr.32, 42103 Wuppertal Germany McBride SA Polígon Industrial L’Illa C / Ramon Esteve, 20- 22, 08650 Sallent Spain Multifill BV Constructieweg 25-A 3641 SB Mijdrecht, 3641 Mijdrecht Netherlands NOPA NORDISK PARFUMERIVARE Nordisk Parfumerivarefabrik A/S Hvedevej 2-22, DK-8900 Randers Denmark PAL INTERNATIONAL LTD Pal International Ltd. Sandhurst Street, Oadby, Leicester Leicester United Kingdom Planol GmbH Maybachstr. 17, 63456 Hanau Germany Plum A/S Frederik Plums Vej 2, DK 5610 Assens Denmark PRODUCTOS LC LA CORBERANA, S.L. Crta. Corbera – Polinyá, 46612 Valencia Spain THE PROTON GROUP LTD Ripley Drive, Normanton Industrial Estate, WF6 1QT Wakefield United Kingdom QUIMICAS MORALES, S.L. Misiones, 11 - Urb. El Sebadal, 05005 LAS PALMAS DE GRAN CANARIA Spain RNM PRODUCTOS QUIMICOS RNM - Produtos Quimicos, Lda Rua da Fabrica, 123, 4765-080 Segade Portugal ROQUETTE & BARENTZ Roquette Freres Route De La Gorgue, F-62136 Lestrem France RUTPEN LTD MEMBURY AIRFIELD, RG16 7TJ LAMBOURN United Kingdom SOLIMIX Solimix Montseny 17-19 Pol. Ind. Sant Pere Molanta, 08799 Barcelona Spain Staub & Co. – Silbermann GmbH, Industriestraße 3, D-86456 Gablingen Germany Stockmeier Chemie Eilenburg GmbH & Co. KG Gustav-Adolf-Ring 5, 04838 Eilenburg Germany SYNERLOGIC BV ( - IN2FOOD) Synerlogic BV afd. L.J. Costerstraat 5, 6827 ARNHEM Netherlands Univar Ltd, Argyle House, Epsom Avenue, SK9 3RN Wilmslow United Kingdom Univar SPA Via Caldera 21, 20-153 Milano Milano Italy van Dam Bodegraven B.V Postbus 48, NL 2410 AA Bodegraven Netherlands Laboratoires Prodene Klint Rue Denis Papin, 2 Z.I. Mitry Compans F-77290 Mitry Mory, F-77290 Mitry Mory France Simagec Z.I. de Rousset / Peynier, 54 Avenue de la Plaine, 13790 Rousset France INNOVATE GmbH, Innovate GmbH Am Hohen Stein 11, 06618 Naumburg Germany

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 Tijsmanstunnel West, 2040 Antwerpen Belgium





Active substance Hydrogen peroxide Name of manufacturer Evonik Degussa GmbH Address of manufacturer Untere Kanalstr. 3, 79618 Rheinfelden Germany Location of manufacturing sites Untere Kanalstr. 3, 79618 Rheinfelden Germany





Active substance Hydrogen peroxide Name of manufacturer Evonik Peroxid GmbH Address of manufacturer Industriestraβe 1, 9721 Weiβenstein Austria Location of manufacturing sites Industriestraβe 1, 9721 Weiβenstein Austria





Active substance Hydrogen peroxide Name of manufacturer Evonik Peroxide Netherlands BV Address of manufacturer Oosterhorn 14, 9936 HD Farmsum Netherlands Location of manufacturing sites Oosterhorn 14, 9936 HD Farmsum Netherlands





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 Zasavska cesta 95, 1231 Ljubljana-Črnuče Slovenia





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 Rue Solvay 39, B-5190 Jemeppe-sur-Sambre Belgium





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 Via Piave 6, I-57013 Rosignano Solvay LI Italy





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 Köthensche Strasse 1-3, D-06406 Bernburg Germany





Active substance Hydrogen peroxide Name of manufacturer Solvay Interox Limited Address of manufacturer Baronet Road, WA4 6HB Warrington Cheshire United Kingdom Location of manufacturing sites Baronet Road, WA4 6HB Warrington Cheshire United Kingdom





Active substance Hydrogen peroxide Name of manufacturer Solvay Chemicals Finland OY Address of manufacturer Yrjonojantie 2, 45910 Voikkaa Finland Location of manufacturing sites Yrjonojantie 2, 45910 Voikkaa Finland





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 Rua Eng. Clement Dumoulin, P-2625-106 Povoa de Santa Iria Portugal





Active substance Hydrogen peroxide Name of manufacturer Kemira Rotterdam BV Address of manufacturer Moezelweg 151, 3198 LS Europoort Rotterdam Netherlands Location of manufacturing sites Moezelweg 151, 3198 LS Europoort Rotterdam Netherlands





Active substance Hydrogen peroxide Name of manufacturer Kemira Chemical Oy Address of manufacturer Typpitie PL 171, 90101 Oulu Finland Location of manufacturing sites Typpitie PL 171, 90101 Oulu Finland





Active substance Hydrogen peroxide Name of manufacturer Kemira Kemi AB Address of manufacturer Industrigatan 83, 25109 Helsingborg Sweden Location of manufacturing sites Industrigatan 83, 25109 Helsingborg Sweden





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 Route National 85, BP 1, 38560 JARRIE France





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 Am Haupttor, Bau 2410, 06237 LEUNA Germany





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-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 (%) Min Max Hydrogen peroxide Active Substance 7722-84-1 231-765-0 1,0 36,75 N-propanol Propan-1-ol Non-active substance 71-23-8 200-746-9 0,0 17,5 Citric acid monohydrate 2-hydroxypropane -1,2,3-tricarboxylic acid Non-active substance 5949-29-1 201-069-1 0,0 0,9 Phenoxyethanol 2-Phenoxyethanol Non-active substance 122-99-6 204-589-7 0,0 0,9 Sodium lauryl Sulphate Sodium dodecyl sulphate Non-active substance 151-21-3 205-788-1 0,0 3,88 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 0,0 2,0 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 0,0 1,12 Phosphoric acid Orthophosphoric acid Non-active substance 7664-38-2 231-633-2 0,0 1,5 Nitric acid Nitric acid Non-active substance 7697-37-2 231-714-2 0,0 3,71 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 0,0 14,625 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 0,0 6,35 Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980) Alcohols, C10-C16 ethoxylated propoxylated Non-active substance 69227-22-1 0,0 3,0 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 0,0 2,15 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 0,62

2.2. Type(s) of formulation

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

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

Identifier 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 (Disinfectants)

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 (%) Min Max Hydrogen peroxide Active Substance 7722-84-1 231-765-0 6,0 6,6

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

Formulation(s) AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

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

4. AUTHORISED USE(S) OF THE META SPC 1

4.1. Use description

Table 1

Use # 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 (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Viruses Common name: Viruses Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Field(s) of use Indoor 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 20 °C in clean conditions: — 15 min for bacteria and fungi; — 5 min for yeasts; — 60 min for viruses and bacterial spores. Contact times for spraying and wiping at 20 °C in clean conditions: — 5 min for bacteria, yeasts and fungi; — 60 min 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) Bottle, 1-5 l Light precluding Polypropylene and Polyethylene (PP+PE) spray bottle, 1-5 l

4.1.1. Use-specific instructions for use

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

Use # 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 (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Viruses Common name: Viruses Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Field(s) of use Indoor 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 20 °C in clean conditions: — 5 min for bacteria, yeasts and fungi; — 60 min 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 Bottle, 1-5 l

4.2.1. Use-specific instructions for use

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

Use # 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 (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Viruses Common name: Viruses Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Field(s) of use Indoor 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 20 °C in clean conditions: — 5 min for bacteria, yeasts and fungi; — 60 min 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 HDPE Bucket with 100 impregnated 45 % polyester / 55 % cellulose blend wipes (wipe size: 200 × 200 mm). Light precluding PP Pouch with 10-100 impregnated 45 % polyester / 55 % cellulose blend wipes (wipe size: 200 × 200 mm).

4.3.1. Use-specific instructions for use

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

Use # 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 (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Viruses Common name: Viruses Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Field(s) of use Indoor 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 20 °C in clean conditions: — 5 min for bacteria, yeasts and fungi; — 60 min 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 HDPE Bucket with 100 impregnated 45 % polyester / 55 % cellulose blend wipes (wipe size: 420 × 250 mm). Light precluding PP Pouch with 10-100 impregnated 45 % polyester / 55 % cellulose blend wipes (wipe size: 420 × 250 mm).

4.4.1. Use-specific instructions for use

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

META SPC 2

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier

Identifier 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 (Disinfectants) PT04 - Food and feed area (Disinfectants)

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 (%) Min Max Hydrogen peroxide Active Substance 7722-84-1 231-765-0 1,0 1,0

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

Formulation(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 2

4.1. Use description

Table 5

Use # 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 (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Field(s) of use Indoor Application method(s) Method: Spraying using trigger sprayer and dry wipe Detailed description: Disinfection of small surfaces in industry. Contact times for spraying at 20 °C in dirty conditions: — 5 min for bacteria and yeasts; — 15 min for fungi; — 60 min for mycobacteria. Method: Mopping using flat mop and bucket Detailed description: Disinfection of large surfaces in industry. Contact times for mopping at 20 °C in dirty conditions: — 5 min for bacteria and yeasts; — 15 min for fungi; — 60 min 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 20 °C in dirty conditions: — 5 min for bacteria and yeasts; — 15 min for fungi; — 60 min 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, 1-100 l Light precluding HDPE Jerry can, 1-100 l Light precluding HDPE Intermediate bulk container (IBC), 600-1 000 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

4.1.1. Use-specific instructions for use

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 6

Use # 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 (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Field(s) of use Indoor 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 20 °C in dirty conditions: — 5 min for bacteria and yeasts; — 15 min for fungi; — 60 min 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, 600-1 000 l Light precluding HDPE Drum, 60-220 l Light precluding HDPE Bottle, 0,1-5 l

4.2.1. Use-specific instructions for use

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 measures

None

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 7

Use # 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 (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Field(s) of use Indoor 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 20 °C in dirty conditions: — 5 min for bacteria and yeasts. Contact times for spraying and wiping at 20 °C in dirty conditions: — 5 min for bacteria and yeasts; — 15 min for fungi; — 60 min 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, 600-1 000 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 use

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 8

Use # 4 – Disinfection of food contact surfaces in food and beverage industry by spraying using fixed installed sprayer

Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Field(s) of use Indoor Application method(s) Method: Fixed installed spraying Detailed description: Automated disinfection application in industrial process equipment. Contact time for spraying at 20 °C in dirty conditions: — 5 min 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, 600-1 000 l Light precluding HDPE Drum, 60-220 l Light precluding HDPE Bottle, 0,1-5 l

4.4.1. Use-specific instructions for use

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 (2) 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) DrySan Oxy Market area: EU Authorisation number EU-0024303-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Hydrogen peroxide Active Substance 7722-84-1 231-765-0 1,0

META SPC 3

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 3 identifier

Identifier 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 (Disinfectants)

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 (%) Min Max Hydrogen peroxide Active Substance 7722-84-1 231-765-0 35,0 36,75

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

Formulation(s) AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements May intensify fire; oxidiser Harmful if swallowed. Causes skin irritation. Causes serious eye damage. May cause respiratory irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep away from clothing and other combustible materials. Avoid breathing vapours. Avoid breathing spray. Wash hands thoroughly after handling. Do no eat, drink or smoke when using this product. Use only outdoors or in a well-ventilated area. Avoid release to the environment. Wear eye protection. Wear face protection. Wear protective gloves. IF SWALLOWED: Call a POISON CENTER if you feel unwell. Rinse mouth. IF ON SKIN: Wash with plenty of water. If skin irritation occurs: Get medical advice. If skin irritation occurs: Get medical attention. IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER if you feel unwell. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER. Immediately call a doctor. Specific treatment (see first aid instruction on this label). Take off contaminated clothing. And wash it before reuse. In case of fire: Use water to extinguish. Store in a well-ventilated place. Keep container tightly closed. Store locked up. Dispose of contents to in accordance with national regulations. Dispose of container to in accordance with national regulations.

4. AUTHORISED USE(S) OF THE META SPC 3

4.1. Use description

Table 9

Use # 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 (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Field(s) of use Indoor 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 60 °C in clean conditions: — 1 min 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, 600-1 000 l Light precluding HDPE Drum, 60-220 l Light precluding HDPE Bottle, 0,1-5 l.

4.1.1. Use-specific instructions for use

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.

2. 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.

3. 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 authorsation 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 10

Use # 2 – Disinfection of food contact surfaces in food and beverage industry by Clean-in-place (CIP)

Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Field(s) of use Indoor Application method(s) Method: CIP Detailed description: Disinfection in food and beverage industry (food contact). Contact times for closed systems at 60 °C in clean conditions: — 5 min for bacteria and yeasts; — 15 min 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, 600-1 000 l Light precluding HDPE Drum, 60-220 l Light precluding HDPE Bottle, 0,1-5 l.

4.2.1. Use-specific instructions for use

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 (3) 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) Oxypak D Market area: EU Oxypak S Market area: EU Oxypak S10 Market area: EU Authorisation number EU-0024303-0003 1-3 Common name IUPAC name Function CAS number EC number Content (%) Hydrogen peroxide Active Substance 7722-84-1 231-765-0 35,0

META SPC 4

1. META SPC 4 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 4 identifier

Identifier META SPC 4

1.2. Suffix to the authorisation number

Number 1-4

1.3. Product type(s)

Product type(s) PT03 - Veterinary hygiene (Disinfectants)

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 (%) Min Max Hydrogen peroxide Active Substance 7722-84-1 231-765-0 1,4 1,61 Citric acid monohydrate 2-hydroxypropane -1,2,3-tricarboxylic acid Non-active substance 5949-29-1 201-069-1 0,9 0,9 Phenoxyethanol 2-Phenoxyethanol Non-active substance 122-99-6 204-589-7 0,9 0,9 Sodium lauryl Sulphate Sodium dodecyl sulphate Non-active substance 151-21-3 205-788-1 3,88 3,88 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 2,0 2,0 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

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

Formulation(s) AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

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

4. AUTHORISED USE(S) OF THE META SPC 4

4.1. Use description

Table 11

Use # 1 – Teat dips for pre-milking disinfection

Product type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Field(s) of use Indoor Application method(s) Method: Manual dipping using a dip/foam cup (pre-milking disinfection) Detailed description: Pre-milking teat disinfection by manual dipping using a dip/foam cup. Contact time for dipping at 30 °C in clean conditions: — 60 seconds for bacteria and yeasts. Application rate(s) and frequency Application Rate: Application rate: 4 ml of product per application (i.e. 1 ml per teat therefore 4 ml product for animals with four teats) Dilution (%): RTU product Number and timing of application: Application frequency: up to twice per day Category(ies) of users Professional Pack sizes and packaging material Light precluding HDPE Jugs, 1-100 l Light precluding HDPE Jerry can, 1-100 l Light precluding HDPE IBC, 600-1 000 l Light precluding HDPE Drum, 60-220 l Light precluding HDPE Bottle, 0,1-5 l Light precluding HDPE; PE Pouch, 0,5-100 l

4.1.1. Use-specific instructions for use

See general directions for use of meta SPC 4.

4.1.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 4.

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 4.

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 4.

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 4.

5. GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4

5.1. Instructions for use

Always read the label or leaflet before use and follow all the instructions. The product should be applied pre-milking by use of a dipping/foam cup. The product must be brought to room temperature before use.

Clean teat with a dry wipe, fill foam cup with product and press foam cup until foam is generated. Dip teat into the cup. Apply foam for 60 seconds on the teat. Wipe the product away with a clean towel. Do not rinse after use.

5.2. Risk mitigation measures

Avoid splashes and spills.

Avoid hand to eye transfer.

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: 0-25 °C

Shelf life: 18 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 4

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

Trade name(s) OxyFoamPlus Market area: EU MEPA Foampro D Market area: EU Predip PLUS Market area: EU Authorisation number EU-0024303-0004 1-4 Common name IUPAC name Function CAS number EC number Content (%) Hydrogen peroxide Active Substance 7722-84-1 231-765-0 1,4 Citric acid monohydrate 2-hydroxypropane -1,2,3-tricarboxylic acid Non-active substance 5949-29-1 201-069-1 0,9 Phenoxyethanol 2-Phenoxyethanol Non-active substance 122-99-6 204-589-7 0,9 Sodium lauryl Sulphate Sodium dodecyl sulphate Non-active substance 151-21-3 205-788-1 3,88 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 2,0 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

META SPC 5

1. META SPC 5 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 5 identifier

Identifier META SPC 5

1.2. Suffix to the authorisation number

Number 1-5

1.3. Product type(s)

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

2. META SPC 5 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 5

Common name IUPAC name Function CAS number EC number Content (%) Min Max Hydrogen peroxide Active Substance 7722-84-1 231-765-0 1,5 1,5

2.2. Type(s) of formulation of the meta SPC 5

Formulation(s) AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements Precautionary statements

4. AUTHORISED USE(S) OF THE META SPC 5

4.1. Use description

Table 12

Use # 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 (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: Scientific name: Viruses Common name: Viruses Development stage: Field(s) of use Indoor Application method(s) Method: Spraying using trigger sprayer and dry wipe Detailed description: Disinfection of surfaces, materials and equipment in life sciences cleanrooms A - D and supporting environments (e.g. pharmaceutical industry). Transfer disinfection or disinfection of small surfaces. Contact times for spraying and wiping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi and mycobacteria; — 60 min for bacterial spores; — 30 min for viruses. Contact times for spraying and wiping at 20 °C in clean conditions: — 5 min for Clostridium difficile spores; — 30 min for bacterial spores. Contact times for spraying at 20 °C in clean conditions: — 5 min for bacteria, yeasts and fungi; — 30 min for viruses and bacterial spores. Application rate(s) and frequency Application Rate: Application rate: 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 Polyethylene terephthalate (PET) Spray bottle, 0,25-1 l Light precluding HDPE Bottle, 1-5 l

4.1.1. Use-specific instructions for use

When used under clean conditions: clean surface before applying the product. 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

See general directions for use of meta SPC 5.

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 5

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 5.

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 5

4.2. Use description

Table 13

Use # 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 (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: Scientific name: Viruses Common name: Viruses Development stage: Field(s) of use Indoor Application method(s) Method: Mopping using a flat mop and bucket Detailed description: Disinfection of floors in life sciences cleanrooms and supporting environments (e.g. pharmaceutical industry). Contact times for mopping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi and mycobacteria; — 60 min for bacterial spores; — 30 min for viruses. Contact times for mopping at 20 °C in clean conditions: — 5 min for Clostridium difficile spores; — 30 min for 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 Bottle, 1-5 l

4.2.1. Use-specific instructions for use

When used under clean conditions: clean surface before applying the product. Apply to surfaces by mopping.

4.2.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 5.

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 5

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 5

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 5

4.3. Use description

Table 14

Use # 3 – Disinfection of small and/or large non-food contact surfaces in healthcare applications by spraying using trigger sprayer and dry wipe

Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Field(s) of use Indoor Application method(s) Method: Spraying using trigger spray and dry wipe Detailed description: Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices. Contact times for spraying at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi; — 15 min 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 twice per day per room Category(ies) of users Professional Pack sizes and packaging material Light precluding PET Spray bottle, 0,25-1 l Light precluding HDPE Jerry can, 1-5 l

4.3.1. Use-specific instructions for use

Routine disinfection: Disinfection of surfaces, which might be contaminated with pathogens during medical or nursing processes, on a regular basis to reduce the risk of transmission of such organisms via surfaces.

Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).

The product is intended for one-step cleaning and disinfection. For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto the surface, then wipe surface with a clean, dry wipe and leave to 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

The area of the surfaces 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.

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 5.

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 5.

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 5.

4.4. Use description

Table 15

Use # 4 – Disinfection of small and/or large non-food contact surfaces in healthcare applications by spraying using trigger sprayer and dry wipe

Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: Scientific name: Viruses Common name: Viruses Development stage: Field(s) of use Indoor Application method(s) Method: Spraying using trigger spray and dry wipe Detailed description: Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices. Contact times for spraying and wiping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi and mycobacteria; — 60 min for bacterial spores; — 30 min for viruses. Contact times for spraying and wiping at 20 °C in clean conditions: — 5 min for Clostridium difficile spores; — 30 min for bacterial spores. Contact times for spraying at 20 °C in clean conditions: — 5 min for bacteria, yeasts and fungi; — 30 min for viruses and bacterial spores. Application rate(s) and frequency Application Rate: Application rate: 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 HDPE Bottle, 1-5 l Light precluding PET Spray bottle, 0,25-1 l Light precluding HDPE Jerry can, 1-5 l

4.4.1. Use-specific instructions for use

Routine disinfection: Disinfection of surfaces, which might be contaminated with pathogens during medical or nursing processes, on a regular basis to reduce the risk of transmission of such organisms via surfaces.

Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).

The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray product onto the surface, then wipe surface with a clean, dry wipe and leave to dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.

4.4.2. Use-specific risk mitigation measures

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.

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 5

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 5

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 5

4.5. Use description

Table 16

Use # 5 – Disinfection of small and/or large non-food contact surfaces in healthcare applications by wiping using clean single-use cloth/wipe and bucket

Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Field(s) of use Indoor Application method(s) Method: Wiping using cloth/wipe and bucket Detailed description: Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices. Contact times for wiping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi; — 15 min 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 twice per day per room Category(ies) of users Professional Pack sizes and packaging material Light precluding HDPE Jerry can, 1-5 l

4.5.1. Use-specific instructions for use

Routine disinfection: Disinfection of surfaces, which might be contaminated with pathogens during medical or nursing processes, on a regular basis to reduce the risk of transmission of such organisms via surfaces.

Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).

The product is intended for one-step cleaning and disinfection. Pour product into a clean bucket and distribute across surface using single-use cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.

4.5.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 5.

4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5.

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

See general directions for use of meta SPC 5.

4.5.5. 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 5.

4.6. Use description

Table 17

Use # 6 – Disinfection of small and/or large non-food contact surfaces in healthcare applications by wiping using clean single-use cloth/wipe and bucket

Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: Scientific name: Viruses Common name: Viruses Development stage: Field(s) of use Indoor Application method(s) Method: Wiping using cloth/wipe and bucket Detailed description: Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices. Contact times for wiping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi and mycobacteria; — 60 min for bacterial spores; — 30 min for viruses. Contact times for wiping at 20 °C in clean conditions: — 5 min for Clostridium difficile spores; — 30 min for bacterial spores. Application rate(s) and frequency Application Rate: Application rate: 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 HDPE Bottle, 1-5 l Light precluding HDPE Jerry can, 1-5 l

4.6.1. Use-specific instructions for use

Routine disinfection: Disinfection of surfaces, which might be contaminated with pathogens during medical or nursing processes, on a regular basis to reduce the risk of transmission of such organisms via surfaces.

Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).

The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. Pour product into a clean bucket and distribute across surface using single-use cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.

4.6.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 5.

4.6.3. 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 5

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

See general directions for use of meta SPC 5.

4.6.5. 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 5

4.7. Use description

Table 18

Use # 7 – Disinfection of large non-food contact surfaces in healthcare applications by mopping using mop and bucket

Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: Scientific name: Viruses Common name: Viruses Development stage: Field(s) of use Indoor Application method(s) Method: Mopping using mop and bucket Detailed description: Non-routine disinfection of larger surfaces in hospital room. Contact times for mopping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi and mycobacteria; — 60 min for bacterial spores; — 30 min for viruses. Contact times for mopping at 20 °C in clean conditions: — 5 min for Clostridium difficile spores; — 30 min for 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 Bottle, 1-5 l Light precluding HDPE Jerry can, 1-5 l

4.7.1. Use-specific instructions for use

Non routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).

The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. Fill the bucket with ready to use product and distribute across floor using mop and let air dry.

4.7.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 5.

4.7.3. 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 5

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

See general directions for use of meta SPC 5

4.7.5. 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 5

4.8. Use description

Table 19

Use # 8 – Disinfection of large non-food contact surfaces in healthcare applications by mopping using mop and bucket

Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: Scientific name: Viruses Common name: Viruses Development stage: Field(s) of use Indoor Application method(s) Method: Mopping using mop and bucket Detailed description: Non-routine disinfection of larger surfaces in medical practices. Contact times for mopping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi and mycobacteria; — 60 min for bacterial spores; — 30 min for viruses. Contact times for mopping at 20 °C in clean conditions: — 5 min for Clostridium difficile spores; — 30 min for 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 Bottle, 1-5 l Light precluding HDPE Jerry can, 1-5 l

4.8.1. Use-specific instructions for use

Non routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).

The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. Fill the bucket with ready to use product and distribute across floor using mop, wipe the surface with a clean, dry mop and let air dry.

4.8.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 5.

4.8.3. 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 5.

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

See general directions for use of meta SPC 5

4.8.5. 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 5

4.9. Use description

Table 20

Use # 9 – Disinfection of small and/or large non-food contact surfaces in healthcare applications by spraying the surface and then wiping with a clean cloth/wipe or spraying liquid onto a wipe and then wiping the surface, or by having the disinfectant in a bucket and wiping with a single-use clean cloth/wipe, and non-routine disinfection of larger surfaces by mopping using mop and bucket

Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: Scientific name: Viruses Common name: Viruses Development stage: Field(s) of use Indoor Application method(s) Method: Spraying using trigger sprayer and dry wipe and mopping using mop and bucket Detailed description: Non-routine disinfection of smaller and larger surfaces in hospital rooms and medical practices. Contact times for spraying and wiping, mopping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi and mycobacteria; — 60 min for bacterial spores; — 30 min for viruses. Contact times for spraying and wiping, mopping at 20 °C in clean conditions: — 5 min for Clostridium difficile spores; — 30 min for bacterial spores. Contact times for spraying at 20 °C in clean conditions: — 5 min for bacteria, yeasts and fungi; — 30 min for viruses and bacterial spores. Method: Wiping using cloth/wipe and bucket and mopping using mop and bucket Detailed description: Non-routine disinfection of smaller and larger surfaces in hospital rooms and medical practices. Contact times for wiping and mopping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi and mycobacteria; — 60 min for bacterial spores; — 30 min for viruses. Contact times for wiping and mopping at 20 °C in clean conditions: — 5 min for Clostridium difficile spores; — 30 min for bacterial spores. Application rate(s) and frequency 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: up to twice per day per room Application Rate: Application rate for wiping: 10 ml/m2; Application rate for mopping: 20 ml/m2 Dilution (%): RTU product Number and timing of application: Application frequency for combined wiping and mopping: up to twice per day per room Category(ies) of users Professional Pack sizes and packaging material Light precluding HDPE Bottle, 1-5 l Light precluding PET Spray bottle, 0,25-1 l Light precluding HDPE Jerry can, 1-5 l

4.9.1. Use-specific instructions for use

The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product.

Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).

Spraying using trigger sprayer and wiping using a dry wipe: For optimum results, hold the bottle upright and spray from a distance of 30 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.

Mopping using mop and bucket: Fill the bucket with ready to use product and distribute across floor using mop, wipe the surface with a clean, dry mop and let air dry.

Wiping using cloth/wipe and bucket: Pour product into a clean bucket and distribute across surface using single-use cloth/wipe, wipe the surface with clean cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.

4.9.2. Use-specific risk mitigation measures

For spraying: The area of the surfaces 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.

4.9.3. 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 5

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

See general directions for use of meta SPC 5.

4.9.5. 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 5

4.10. Use description

Table 21

Use # 10 – Disinfection of small non-food contact surfaces in institutional/commercial buildings by spraying using trigger sprayer and dry wipe

Product type PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: Scientific name: Viruses Common name: Viruses Development stage: Field(s) of use Indoor Application method(s) Method: Spraying using trigger spray and dry wipe Detailed description: Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms). Contact times for spraying and wiping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi and mycobacteria; — 60 min for bacterial spores; — 30 min for viruses. Contact times for spraying and wiping at 20 °C in clean conditions: — 5 min for Clostridium difficile spores; — 30 min for bacterial spores. Contact times for spraying at 20 °C in clean conditions: — 5 min for bacteria, yeasts and fungi; — 30 min for viruses and bacterial spores. 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 Bottle, 1-5 l Light precluding PET Spray bottle, 0,25-1 l

4.10.1. Use-specific instructions for use

When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 30 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.

4.10.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 5.

4.10.3. 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 5

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

See general directions for use of meta SPC 5.

4.10.5. 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 5

4.11. Use description

Table 22

Use # 11 – Disinfection of small food contact surfaces in institutional/commercial buildings by spraying using trigger sprayer and dry wipe

Product type PT04 - Food and feed area (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Mycobacteria Common name: Mycobacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Fungi Common name: Fungi Development stage: Scientific name: Bacterial spores Common name: Bacterial spores Development stage: Scientific name: Clostridium difficile Common name: Bacterial spores Development stage: Scientific name: Viruses Common name: Viruses Development stage: Field(s) of use Indoor Application method(s) Method: Spraying using trigger spray and dry wipe Detailed description: Routine disinfection of small surfaces in small food areas (e.g. kitchens). Contact times for spraying and wiping at 20 °C in dirty conditions: — 1 min for bacteria and yeasts; — 5 min for fungi and mycobacteria; — 60 min for bacterial spores; — 30 min for viruses. Contact times for spraying and wiping at 20 °C in clean conditions: — 5 min for Clostridium difficile spores; — 30 min for bacterial spores. Contact times spraying at 20 °C in clean conditions: — 5 min for bacteria, yeasts and fungi; — 30 min for viruses and bacterial spores. 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 Bottle, 1-5 l Light precluding PET Spray bottle, 0,25-1 l

4.11.1. Use-specific instructions for use

When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 30 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.

4.11.2. Use-specific risk mitigation measures

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

4.11.3. 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 5.

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

See general directions for use of meta SPC 5.

4.11.5. 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 5.

5. GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5

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

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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. Protect from frost.

Shelf life: 18 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 5

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

Trade name(s) Incidin OxyFoam Market area: EU Authorisation number EU-0024303-0005 1-5 Common name IUPAC name Function CAS number EC number Content (%) Hydrogen peroxide Active Substance 7722-84-1 231-765-0 1,5

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

Trade name(s) Incidin OxyFoam S Market area: EU Klercide Sporicidal Enhanced Peroxide Market area: EU KitchenPro Oxy Foam S Market area: EU Authorisation number EU-0024303-0006 1-5 Common name IUPAC name Function CAS number EC number Content (%) Hydrogen peroxide Active Substance 7722-84-1 231-765-0 1,5

META SPC 6

1. META SPC 6 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 6 identifier

Identifier