COMMISSION IMPLEMENTING REGULATION (EU) 2022/1423

of 22 July 2022

granting a Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:

(1) On 19 January 2017, Ecolab Deutschland GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Hydrogen Peroxide Family 1’ of product-types 1, 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Latvia had agreed to evaluate the application. The application was recorded under case number BC-DY029028-18 in the Register for Biocidal Products.

(2) ‘Hydrogen Peroxide Family 1’ contains hydrogen peroxide as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 in product-types 1, 2, 3 and 4.

(3) On 5 October 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency ('the Agency').

(4) On 2 July 2020, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics ('SPC') of ‘Hydrogen Peroxide Family 1’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘Hydrogen Peroxide Family 1’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(6) On 15 July 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Hydrogen Peroxide Family 1’.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

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

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

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 July 2022.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 167, 27.6.2012, p. 1

(2) ECHA opinion of 18 June 2020 on the Union authorisation of the biocidal product family ‘Hydrogen Peroxide Family 1’ (ECHA/BPC/264/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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)

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:

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.

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/m

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)

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 m

) must not be larger than 1/10 of the room volume (in m

) e.g. in a room of 120 m

volume, the maximum surface to be disinfected is 12 m

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

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/m

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)

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.

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

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.

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 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

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/m

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 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

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/m

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)

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 m

) must not be larger than 1/10 of the room volume (in m

) e.g. in a room of 120 m

volume, the maximum surface to be disinfected is 12 m

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

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 m

) must not be larger than 1/10 of the room volume (in m

) e.g. in a room of 120 m

volume, the maximum surface to be disinfected is 12 m

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

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

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).

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 m

) must not be larger than 1/10 of the room volume (in m

) e.g. in a room of 120 m

volume, the maximum surface to be disinfected is 12 m

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

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

5.2. Risk mitigation measures

— 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

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/m

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

META SPC 6

1.2. Suffix to the authorisation number

Number

1-6

1.3. 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 6 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 6

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	2,0	2,3
N-propanol	Propan-1-ol	Non-active substance	71-23-8	200-746-9	17,5	17,5

2.2. Type(s) of formulation of the meta SPC 6

Formulation(s)

AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements

Flammable liquid and vapour.

Causes serious eye damage.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical equipment.

Use explosion-proof ventilating equipment.

Use explosion-proof lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Wear eye protection.

Wear face protection.

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a doctor.

Immediately call a POISON CENTER.

In case of fire: Use water to extinguish.

Store in a well-ventilated place. Keep cool.

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 6

4.1. Use description

Table 23

Use # 1 – Disinfection of small surfaces in industry (e.g. dining areas, bathrooms) by spraying using trigger sprayer

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:

Field(s) of use

Indoor

Application method(s)

Method: Spraying using trigger sprayer and dry wipe

Detailed description:

Disinfection of small surfaces in industry (e.g. dining areas, bathrooms).

Contact time for spraying at 10 °C and 20 °C in dirty conditions:

—	5 min for bacteria and yeasts.

Contact time for spraying at 10 °C in clean conditions:

—	1 min for bacteria and yeasts.

Application rate(s) and frequency

Application Rate: Application rate: 10 ml/m2

Dilution (%): RTU product

Number and timing of application:

Application frequency: up to 3 times per day

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 Spray bottle, up to 1 l

4.1.1. Use-specific instructions for use

See general directions of use of meta SPC 6.

4.1.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 6.

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 6.

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 6.

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 6.

4.2. Use description

Table 24

Use # 2 – Disinfection of food contact surfaces in food and beverage industry by spraying using trigger 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: Spraying using trigger sprayer and dry wipe

Detailed description:

Disinfection of small surfaces in food processing plants.

Contact time for spraying at 10 °C and 20 °C in dirty conditions:

—	5 min for bacteria and yeasts.

Contact time for spraying at 10 °C in clean conditions:

—	1 min for bacteria and yeasts.

Application rate(s) and frequency

Application Rate: Application rate: 10 ml/m2

Dilution (%): RTU product

Number and timing of application:

Application frequency: up to 4 times per day

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 Spray bottle, up to 1 l

4.2.1. Use-specific instructions for use

See general directions for use of meta SPC 6.

4.2.2. 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.

4.2.3. 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 6.

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 6.

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 6.

5. GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6

5.1. Instructions for use

Always read the label or leaflet before use and follow all the instructions. When used under clean conditions: clean surface before applying the product. The product should be applied to a dry surface. For optimum results, hold the bottle upright and spray from a distance of 10 cm to 20 cm. Spray the product onto the surface, wipe the surface with a clean, dry wipe or let air dry. Always close the nozzle after use. 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. Used wipes must be disposed of in a closed container.

5.2. Risk mitigation measures

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

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 skin contact: Rinse with plenty of water.

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

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. Keep away from heat and sources of ignition. Keep in a cool, well ventilated place. Keep away from oxidizing agents.

Storage temperature: 0-30 °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/m

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 6

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

Trade name(s)	OxyDes Rapid		Market area: EU
Authorisation number	EU-0024303-0007 1-6
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance		7722-84-1	231-765-0	2,0
N-propanol	Propan-1-ol	Non-active substance		71-23-8	200-746-9	17,5

META SPC 7

1. META SPC 7 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 7 identifier

Identifier

META SPC 7

1.2. Suffix to the authorisation number

Number

1-7

1.3. 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 7 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 7

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	4,95	5,45
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		2,15	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		0,62	0,62

2.2. Type(s) of formulation of the meta SPC 7

Formulation(s)

SL - Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

Hazard statements

Causes severe skin burns and eye damage.

Precautionary statements

Do not breathe spray.

Do not breathe vapours.

Wash hands thoroughly after handling.

Wear eye protection.

Wear face protection.

Wear protective gloves.

Wear protective clothing.

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

Immediately call a POISON CENTER.

Immediately call a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

Specific treatment (see first aid instruction on this label).

Wash contaminated clothing before reuse.

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 7

4.1. Use description

Table 25

Use # 1 – Disinfection of non-food contact surfaces in healthcare applications 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:

Field(s) of use

Indoor

Application method(s)

Method: Mopping using flat mop and bucket

Detailed description:

Routine and non-routine disinfection of floors in hospital rooms and medical practices that are frequently touched by people and that are not frequently touched by people.

Contact times for mopping at 20 °C in clean conditions:

—	5 min for bacteria and yeasts (10 % dilution);

—	15 min for bacteria (7,5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate: 20 ml/m2

Dilution (%): Dilution (%): 7,5-10

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, 0,5-5 l

Light precluding HDPE Canister, 1-100 l

Light precluding HDPE Pouch, 0,01-1 l

Light precluding HDPE Jug, 0,5-5 l

4.1.1. 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. Clean surface before applying the product. Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with clean, dry floor mop and let air dry. Do not rinse after use.

4.1.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 7.

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 7.

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 7.

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 7.

4.2. Use description

Table 26

Use # 2 – Disinfection of small and/or large non-food contact surfaces in institutional/commercial buildings 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:

Field(s) of use

Indoor

Application method(s)

Method: Spraying using trigger sprayer and dry wipe

Detailed description:

Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms).

Contact times for spraying at 20 °C in clean conditions:

—	5 min for bacteria and yeasts (10 % dilution);

—	15 min for bacteria (7,5 % dilution).

Contact times for spraying at 20 °C in dirty conditions:

—	5 min for bacteria (10 % dilution);

—	5 min for yeasts (15 % dilution);

—	15 min for bacteria (7,5 % dilution).

Method: Mopping using flat mop and bucket

Detailed description:

Routine disinfection of large surfaces in small non-food areas (e.g. bathrooms).

Contact times for mopping at 20 °C in clean conditions:

—	5 min for bacteria and yeasts (10 % dilution);

—	15 min for bacteria (7,5 % dilution).

Method: Spraying using trigger sprayer and dry wipe and mopping using flat mop and bucket

Detailed description:

Routine disinfection of small and large surfaces in small non-food areas (e.g. bathrooms).

Contact times for spraying and mopping at 20 °C in clean conditions:

—	5 min for bacteria and yeasts (10 % dilution);

—	15 min for bacteria (7,5 % dilution).

Contact times for spraying at 20 °C in dirty conditions:

—	5 min for bacteria (10 % dilution);

—	5 min for yeasts (15 % dilution);

—	15 min for bacteria (7,5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate for spraying: 10 ml/m2

Dilution (%): Dilution (%): 7,5-15

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 (%): Dilution (%): 7,5-10

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 (%): Dilution (%): 7,5-15

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 Bottle, 0,5-5 l

Light precluding HDPE Canister, 1-100 l

Light precluding HDPE Pouch, 0,01-1 l

Light precluding HDPE jug, 0,5-5 l

4.2.1. Use-specific instructions for use

Do not rinse after use.

Spraying: 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 diluted 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: The product is intended for one-step cleaning and disinfection. Clean surface before applying the product. Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with clean, dry mop and let air dry.

4.2.2. Use-specific risk mitigation measures

Do not breathe vapours/spray.

For spraying: The area of the surfaces to be disinfected (in m

) must not be larger than 1/10 of the room volume (in m

) e.g. in a room of 120 m

volume, the maximum surface to be disinfected is 12 m

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 7.

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 7.

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 7.

4.3. Use description

Table 27

Use # 3 – Disinfection of large non-food contact surfaces in institutional/commercial buildings 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:

Field(s) of use

Indoor

Application method(s)

Method: Mopping using flat mop and bucket

Detailed description:

Routine disinfection of large surfaces in large non-food areas.

Contact time for mopping at 20 °C in clean conditions:

—	5 min for bacteria and yeasts (10 % dilution);

—	15 min for bacteria (7,5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate: 20 ml/m2

Dilution (%): Dilution (%): 7,5-10

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, 0,5-5 l

Light precluding HDPE Canister, 1-100 l

Light precluding HDPE Pouch, 0,01-1 l

Light precluding HDPE Jug, 0,5-5 l

4.3.1. Use-specific instructions for use

The product is intended for one-step cleaning and disinfection. Clean surface before applying the product. Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with a clean, dry floor mop and let air dry. Do not rinse after use.

4.3.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 7.

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 7.

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 7.

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 7.

4.4. Use description

Table 28

Use # 4 – Disinfection of large non-food contact surfaces in institutional/commercial buildings by spraying using wall- mounted device

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:

Field(s) of use

Indoor

Application method(s)

Method: Spraying with a wall-mounted device

Detailed description:

Routine disinfection of large surfaces in large non-food and food areas.

Contact times for spraying at 20 °C in clean conditions:

—	5 min for bacteria and yeasts (10 % dilution);

—	15 min for bacteria (7,5 % dilution).

Contact times for spraying at 20 °C in dirty conditions:

—	5 min for bacteria (10 % dilution);

—	5 min for yeasts (15 % dilution);

—	15 min for bacteria (7,5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate: 180 ml/m2

Dilution (%): Dilution (%): 7,5-15

Number and timing of application:

Application frequency: once per day per room

Category(ies) of users

Professional

Pack sizes and packaging material

Light precluding HDPE Bottle, 0,5-5 l

Light precluding HDPE Canister, 1-100 l

Light precluding HDPE Pouch, 0,01-1 l

Light precluding HDPE Jug, 0,5-5 l

4.4.1. Use-specific instructions for use

Apply product via wall-mounted device. When used under clean conditions: clean surface before applying the product. Rinse after application.

4.4.2. Use-specific risk mitigation measures

Do not breathe vapours/spray.

Ensure technical ventilation with at least 15 air exchanges/hour.

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 7.

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 7.

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 7.

4.5. Use description

Table 29

Use # 5 – Disinfection of large food contact surfaces in institutional/commercial buildings by spraying using trigger 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: Spraying using trigger sprayer and dry wipe

Detailed description:

Routine disinfection of large surfaces in large food areas (e.g. kitchens).

Contact time for spraying at 20 °C in clean conditions:

—	5 min for bacteria and yeasts (10 % dilution);

—	15 min for bacteria (7,5 % dilution).

Contact times for spraying at 20 °C in dirty conditions:

—	5 min for bacteria (10 % dilution);

—	5 min for yeasts (15 % dilution);

—	15 min for bacteria (7,5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate: 10 ml/m2

Dilution (%): Dilution (%): 7,5-15

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, 0,5-5 l

Light precluding HDPE Canister, 1-100 l

Light precluding HDPE Pouch, 0,01-1 l

Light precluding HDPE Jug, 0,5-5 l

4.5.1. 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 diluted product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Do not rinse after use. Used wipes must be disposed of in a closed container.

4.5.2. Use-specific risk mitigation measures

Do not breathe vapours/spray.

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

The area of the surfaces to be disinfected (in m

) must not be larger than 1/10 of the room volume (in m

) e.g. in a room of 120 m

volume, the maximum surface to be disinfected is 12 m

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 7.

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 7.

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 7.

5. GENERAL DIRECTIONS FOR USE (7) OF THE META SPC 7

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 use on surfaces sensitive to oxidative agents such as marble, copper or brass.

Dilution instruction (7,5 %): to produce 1 l of diluted surface disinfectant, add 75 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 l with distilled water or water of equal quality.

Dilution instruction (10 %): to produce 1 l of diluted surface disinfectant, add 100 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 l with distilled water or water of equal quality.

Dilution instruction (15 %): to produce 1 l of diluted surface disinfectant, add 150 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 l with distilled water or water of equal quality.

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.

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 skin contact: Wash off immediately with plenty of water for at least 15 minutes. Use a mild soap if available. Wash clothing before reuse. Thoroughly clean shoes before reuse. Seek medical attention immediately.

If swallowed: Rinse mouth with water. Do NOT induce vomiting. Never give anything by mouth to an unconscious person. Seek medical attention immediately.

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

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. 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/m

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 7

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

Trade name(s)	Incidin OxyConcentrate		Market area: EU
	UltraSan Floor		Market area: EU
Authorisation number	EU-0024303-0008 1-7
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance		7722-84-1	231-765-0	4,95
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		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		0,62

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

Trade name(s)	KitchenPro Oxy Des Super Concentrate		Market area: EU
	Incidin OxyConcentrate FF		Market area: EU
	CidalSan Large Area		Market area: EU
Authorisation number	EU-0024303-0009 1-7
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance		7722-84-1	231-765-0	4,95
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		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		0,62

META SPC 8

1. META SPC 8 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 8 identifier

Identifier

META SPC 8

1.2. Suffix to the authorisation number

Number

1-8

1.3. 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 8 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 8

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 8

Formulation(s)

AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

Hazard statements
Precautionary statements

4. AUTHORISED USE(S) OF THE META SPC 8

4.1. Use description

Table 30

Use # 1 – Disinfection of surfaces in industry (e.g. dining areas, bathrooms) 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: Mycobacteria

Common name: Mycobacteria

Development stage:

Field(s) of use

Indoor

Application method(s)

Method: Wiping using impregnated RTU wipes

Detailed description:

Disinfection of surfaces in industry (e.g. dining areas, bathrooms).

Contact time for wiping at 10 °C in dirty conditions:

—	5 min for bacteria and yeasts.

Contact times for wiping at 20 °C in dirty conditions:

—	2 min for bacteria;

—	5 min for yeasts;

—	15 min for fungi;

—	60 min for mycobacteria.

Application rate(s) and frequency

Application Rate: Application rate: 1 wipe per m2 (corresponding to 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 PP Bucket with 10-5 000 impregnated 60 % polyester / 40 % lyocell blend or non-woven 100 % polypropylene wipes (wipe size: 200 × 250 mm or 200 × 200 mm).

Light precluding PP Pouch with 10-5 000 impregnated 60 % polyester / 40 % lyocell blend or non-woven 100 % polypropylene wipes (wipe size: 200 × 250 mm or 200 × 200 mm).

4.1.1. Use-specific instructions for use

See general directions for use of meta SPC 8.

4.1.2. Use-specific risk mitigation measures

— 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 8.

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 8.

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 8.

4.2. Use description

Table 31

Use # 2 – Disinfection of small food contact surfaces in food and beverage industry by wiping using impregnated RTU wipes

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: Wiping using impregnated RTU wipes

Detailed description:

Disinfection of small surfaces in food processing plant.

Contact time for wiping at 10 °C in dirty conditions:

—	5 min for bacteria and yeasts.

Contact times for wiping at 20 °C in dirty conditions:

—	2 min for bacteria;

—	5 min for yeasts;

—	15 min for fungi;

—	60 min for mycobacteria.

Application rate(s) and frequency

Application Rate: Application rate: 1 wipe per m2 (corresponding to 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 PP Bucket with 10-5 000 impregnated 60 % polyester / 40 % lyocell blend or non-woven 100 % polypropylene wipes (wipe size: 200 × 250 mm or 200 × 200 mm).

Light precluding PP Pouch with 10-5 000 impregnated 60 % polyester / 40 % lyocell blend or non-woven 100 % polypropylene wipes (wipe size: 200 × 250 mm or 200 × 200 mm).

4.2.1. Use-specific instructions for use

See general directions for use of meta SPC 8.

4.2.2. 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.

4.2.3. 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 8.

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 8.

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 8.

4.3. Use description

Table 32

Use # 3 – Disinfection of small non-food contact surfaces in healthcare applications 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: Mycobacteria

Common name: Mycobacteria

Development stage:

Field(s) of use

Indoor

Application method(s)

Method: Wiping using impregnated RTU wipes

Detailed description:

Routine disinfection of smaller surfaces in hospital rooms and medical practices that are not frequently touched by people.

Contact time for wiping at 10 °C in dirty conditions:

—	5 min for bacteria and yeasts.

Contact times for wiping at 20 °C in dirty conditions:

—	15 min for bacteria, yeasts and fungi;

—	60 min for mycobacteria.

Application rate(s) and frequency

Application Rate: Application rate: 1 wipe per m2 (corresponding to 10 ml/m2)

Dilution (%): RTU product

Number and timing of application:

Application frequency: up to twice per day per room

Category(ies) of users

Professional

Pack sizes and packaging material

Light precluding PP Bucket with 10-5 000 impregnated 60 % polyester / 40 % lyocell blend or non-woven 100 % polypropylene wipes (wipe size: 200 × 250 mm or 200 × 200 mm).

Light precluding PP Pouch with 10-5 000 impregnated 60 % polyester / 40 % lyocell blend or non-woven 100 % polypropylene wipes (wipe size: 200 × 250 mm or 200 × 200 mm).

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.

4.3.2. Use-specific risk mitigation measures

— 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 8.

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 8.

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 8.

5. GENERAL DIRECTIONS FOR USE (8) OF THE META SPC 8

5.1. Instructions for use

The product is intended for one-step cleaning and disinfection. 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. Allow surface to air dry after using the product. Do not rinse after use. Close container when not in use. Do not use wipes which have become dehydrated. Dispose of the container when empty. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass. Used wipes must be disposed of in closed container.

5.2. Risk mitigation measures

— 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

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: 6 months

6. OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m

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 8

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

Trade name(s)	DrySan Oxy Wipes		Market area: EU
	IncidinOxyWipe		Market area: EU
Authorisation number	EU-0024303-0010 1-8
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance		7722-84-1	231-765-0	1,0

META SPC 9

1. META SPC 9 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 9 identifier

Identifier

META SPC 9

1.2. Suffix to the authorisation number

Number

1-9

1.3. 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 9 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 9

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	7,0	7,7
Phosphoric acid	Orthophosphoric acid	Non-active substance	7664-38-2	231-633-2	1,5	1,5
Nitric acid	Nitric acid	Non-active substance	7697-37-2	231-714-2	3,71	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		14,625	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	6,35	6,35
Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)	Alcohols, C10-C16 ethoxylated propoxylated	Non-active substance	69227-22-1		3,0	3,0

2.2. Type(s) of formulation of the meta SPC 9

Formulation(s)

SL - Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

Hazard statements

May be corrosive to metals.

Causes severe skin burns and eye damage.

Precautionary statements

Keep only in original packaging.

Wash hands thoroughly after handling.

Do not breathe vapours.

Do not breathe spray.

Wear face protection.

Wear protective gloves.

Wear eye protection.

Wear protective clothing.

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

Immediately call a doctor.

Immediately call a POISON CENTER.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

Specific treatment (see first aid instruction on this label).

Wash contaminated clothing before reuse.

Absorb spillage to prevent material damage.

Store in a corrosion-resistant container with a resistant inner liner.

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 9

4.1. Use description

Table 33

Use # 1 – Disinfection of small 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: 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 smaller surfaces in hospital rooms and medical practices that are frequently touched by people and that are not frequently touched by people.

Contact times for wiping at 20 °C in dirty conditions:

—	5 min for bacteria (5 % dilution);

—	5 min for yeasts (3 % dilution);

—	5 min for fungi (4 % dilution);

—	50 min for viruses (5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate: 10 ml/m2

Dilution (%): Dilution (%): 3-5

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, 0,5-5 l

Light precluding HDPE Jug, 0,5-5 l

Light precluding HDPE Pouch, 0,01-1 l

4.1.1. 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 diluted product into a clean bucket and distribute across surface using a single-use cloth/wipe, wipe the surface with a clean cloth/wipe and let air dry. Do not rinse after use. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass. 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 9.

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 9.

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 9.

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 9.

4.2. Use description

Table 34

Use # 2 – Disinfection of large non-food contact surfaces in healthcare applications 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:

Field(s) of use

Indoor

Application method(s)

Method: Mopping using flat mop and bucket

Detailed description:

Routine and non-routine disinfection of larger surfaces in hospital rooms and medical practices that are frequently touched by people and that are not frequently touched by people.

Contact times for mopping at 20 °C in dirty conditions:

—	5 min for bacteria (5 % dilution);

—	5 min for yeasts (3 % dilution);

—	5 min for fungi (4 % dilution);

—	50 min for viruses (5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate: 20 ml/m2

Dilution (%): Dilution (%): 3-5

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, 0,5-5 l

Light precluding HDPE Jug, 0,5-5 l

Light precluding HDPE Pouch, 0,01-1 l

4.2.1. 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. Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with a clean, dry mop and let air dry. Do not rinse after use.

4.2.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 9.

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 9.

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 9.

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 9.

4.3. Use description

Table 35

Use # 3 – Disinfection of small and/or large non-food contact surfaces in institutional/commercial buildings by spraying using trigger sprayer and dry wipe or by wiping using single-use cloth and bucket, and/or floors 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:

Field(s) of use

Indoor

Application method(s)

Method: Spraying using trigger sprayer 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:

—	5 min for bacteria (5 % dilution);

—	5 min for yeasts (3 % dilution);

—	5 min for fungi (4 % dilution);

—	50 min for viruses (5 % dilution).

Method: Wiping using single-use cloth/wipe and bucket

Detailed description:

Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms).

Contact times for wiping at 20 °C in dirty conditions:

—	5 min for bacteria (5 % dilution);

—	5 min for yeasts (3 % dilution);

—	5 min for fungi (4 % dilution);

—	50 min for viruses (5 % dilution).

Method: Mopping using flat mop and bucket

Detailed description:

Routine disinfection of large surfaces in small non-food areas (e.g. bathrooms).

Contact times for mopping at 20 °C in dirty conditions:

—	5 min for bacteria (5 % dilution);

—	5 min for yeasts (3 % dilution);

—	5 min for fungi (4 % dilution);

—	50 min for viruses (5 % dilution).

Method: Spraying using trigger sprayer and dry wipe and mopping using flat mop and bucket

Detailed description:

Routine disinfection of small and large surfaces in small non-food areas (e.g. bathrooms).

Contact times for spraying and wiping, mopping at 20 °C in dirty conditions:

—	5 min for bacteria (5 % dilution);

—	5 min for yeasts (3 % dilution);

—	5 min for fungi (4 % dilution);

—	50 min for viruses (5 % dilution).

Method: Wiping using cloth/wipe and bucket and mopping using flat mop and bucket

Detailed description:

Routine disinfection of small and large surfaces in small non-food areas (e.g. bathrooms).

Contact times for wiping and mopping at 20 °C in dirty conditions:

—	5 min for bacteria (5 % dilution);

—	5 min for yeasts (3 % dilution);

—	5 min for fungi (4 % dilution);

—	50 min for viruses (5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate for spraying: 10 ml/m2

Dilution (%): Dilution (%): 3-5

Number and timing of application:

Application frequency for trigger spraying: up to 10 times per day per room

Application Rate: Application rate for wiping: 10 ml/m2

Dilution (%): Dilution (%): 3-5

Number and timing of application:

Application frequency for wiping: up to 10 times per day per room

Application Rate: Application rate for mopping: 20 ml/m2

Dilution (%): Dilution (%): 3-5

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 (%): Dilution (%): 3-5

Number and timing of application:

Application frequency for combined trigger spraying and mopping: once per day per room.

Application Rate: Application rate for wiping: 10 ml/m2; Application rate for mopping: 20 ml/m2

Dilution (%): Dilution (%): 3-5

Number and timing of application:

Application frequency for combined wiping and mopping: once per day per room

Category(ies) of users

Professional

Pack sizes and packaging material

Light precluding HDPE Bottle, 0,5-5 l

Light precluding HDPE Jug, 0,5-5 l

Light precluding HDPE Pouch, 0,01-1 l

4.3.1. Use-specific instructions for use

Do not rinse after use.

Spraying: For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the diluted product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray the diluted product onto the surface, 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.

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

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

4.3.2. Use-specific risk mitigation measures

Do not breathe vapours/spray.

For spraying: The area of the surface to be disinfected (in m

) must not be larger than 1/10 of the room volume (in m

) e.g. in a room of 120 m

volume, the maximum surface to be disinfected is 12 m

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 9.

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 9.

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 9.

4.4. Use description

Table 36

Use # 4 – Disinfection of large non-food contact surfaces in institutional/commercial buildings 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:

Field(s) of use

Indoor

Application method(s)

Method: Mopping using flat mop and bucket

Detailed description:

Routine disinfection of large surfaces in large non-food areas.

Contact times for mopping at 20 °C in dirty conditions:

—	5 min for bacteria (5 % dilution);

—	5 min for yeasts (3 % dilution);

—	5 min for fungi (4 % dilution);

—	50 min for viruses (5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate: 20 ml/m2

Dilution (%): Dilution (%): 3-5

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, 0,5-5 l

Light precluding HDPE Jug, 0,5-5 l

Light precluding HDPE Pouch, 0,01-1 l

4.4.1. Use-specific instructions for use

Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with a clean, dry mop and let air dry. Do not rinse after use.

4.4.2. Use-specific risk mitigation measures

Ensure technical ventilation with at least 15 air exchanges/hour.

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 9.

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 9.

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 9.

4.5. Use description

Table 37

Use # 5 – Disinfection of large non-food contact surfaces in institutional/commercial buildings by spraying using wall- mounted device

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:

Field(s) of use

Indoor

Application method(s)

Method: Spraying with a wall- mounted device

Detailed description:

Routine disinfection of large surfaces in large non-food and food areas.

Contact time for spraying at 20 °C in dirty conditions:

—	5 min for bacteria and yeasts (3 % dilution).

Contact times for spraying at 20 °C in clean conditions:

—	5 min for bacteria (1,5 % dilution);

—	15 min for yeasts (2 % dilution).

Application rate(s) and frequency

Application Rate: Application rate: 180 ml/m2

Dilution (%): Dilution (%): 1,5-3

Number and timing of application:

Application frequency: once per day per room

Category(ies) of users

Professional

Pack sizes and packaging material

Light precluding HDPE Bottle, 0,5-5 l

Light precluding HDPE Jug, 0,5-5 l

Light precluding HDPE Pouch, 0,01-1 l

4.5.1. Use-specific instructions for use

When used under clean conditions: clean surface before applying the product. Apply product via wall-mounted device. Rinse after application.

4.5.2. Use-specific risk mitigation measures

Do not breathe vapours/spray.

Ensure technical ventilation with at least 15 air exchanges/hour.

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 9.

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 9.

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 9.

4.6. Use description

Table 38

Use # 6 – Disinfection of large 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: Yeasts

Common name: Yeasts

Development stage:

Scientific name: Fungi

Common name: Fungi

Development stage:

Scientific name: Viruses

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Application method(s)

Method: Spraying using trigger spray and dry wipe

Detailed description:

Routine disinfection of large surfaces in large food areas (e.g. kitchens).

Contact times for spraying and wiping at 20 °C in dirty conditions:

—	5 min for bacteria (5 % dilution);

—	5 min for yeasts (3 % dilution);

—	5 min for fungi (4 % dilution);

—	50 min for viruses (5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate: 10 ml/m2

Dilution (%): Dilution (%): 3-5

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, 0,5-5 l

Light precluding HDPE Jug, 0,5-5 l

Light precluding HDPE Pouch, 0,01-1 l

4.6.1. Use-specific instructions for use

For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the diluted product onto a dry wipe and wipe small surfaces such as worktops and equipment or spray the diluted product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Do not rinse after use. Used wipes must be disposed of in a closed container.

4.6.2. Use-specific risk mitigation measures

Do not breathe vapours/spray.

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

The area of the surface to be disinfected (in m

) must not be larger than 1/10 of the room volume (in m

) e.g. in a room of 120 m

volume, the maximum surface to be disinfected is 12 m

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 9.

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 9.

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 9.

4.7. Use description

Table 39

Use # 7 – Disinfection of large food contact surfaces in institutional/commercial buildings by wiping using single-use cloth and bucket

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: Viruses

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Application method(s)

Method: Wiping using single-use cloth/wipe and bucket

Detailed description:

Routine disinfection of large surfaces in large food areas (e.g. kitchens).

Contact times for wiping at 20 °C in dirty conditions:

—	5 min for bacteria (5 % dilution);

—	5 min for yeasts (3 % dilution);

—	5 min for fungi (4 % dilution);

—	50 min for viruses (5 % dilution).

Application rate(s) and frequency

Application Rate: Application rate: 10 ml/m2

Dilution (%): Dilution (%): 3-5

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, 0,5-5 l

Light precluding HDPE Jug, 0,5-5 l

Light precluding HDPE Pouch, 0,01-1 l

4.7.1. Use-specific instructions for use

Pour diluted product into a clean bucket and distribute across surface using single-use cloth/wipe, wipe the surface with a clean cloth/wipe and let air dry. Do not rinse after use. Used wipes must be disposed of in a closed container.

4.7.2. 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.

4.7.3. 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 9.

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 9.

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 9.

5. GENERAL DIRECTIONS FOR USE (9) OF THE META SPC 9

5.1. Instructions for use

Dilution instruction (1,5 %): to produce 1 l of diluted surface disinfectant, add 15 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 l with distilled water or water of equal quality.

Dilution instruction (2 %): to produce 1 l of diluted surface disinfectant, add 20 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 l with distilled water or water of equal quality.

Dilution instruction (3 %): to produce 1 l of diluted surface disinfectant, add 30 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 l with distilled water or water of equal quality.

Dilution instruction (4 %): to produce 1 l of diluted surface disinfectant, add 40 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 l with distilled water or water of equal quality.

Dilution instruction (5 %): to produce 1 l of diluted surface disinfectant, add 50 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 l with distilled water or water of equal quality.

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.

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 skin contact: Wash off immediately with plenty of water for at least 15 minutes. Use a mild soap if available. Wash contaminated clothing before reuse. Thoroughly clean shoes before reuse. Seek medical attention immediately.

If swallowed: Rinse mouth with water. Do NOT induce vomiting. Never give anything by mouth to an unconscious person. Seek medical attention immediately.

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

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. 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/m

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 9

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

Trade name(s)	KitchenPro Oxy Des Concentrate		Market area: EU
Trade name(s)	Incidin OxyPro		Market area: EU
Authorisation number	EU-0024303-0011 1-9
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance		7722-84-1	231-765-0	7,0
Phosphoric acid	Orthophosphoric acid	Non-active substance		7664-38-2	231-633-2	1,5
Nitric acid	Nitric acid	Non-active substance		7697-37-2	231-714-2	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		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	6,35
Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)	Alcohols, C10-C16 ethoxylated propoxylated	Non-active substance		69227-22-1		3,0

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

Trade name(s)	Oasis Pro Oxy Des		Market area: EU
Trade name(s)	Maxx Oxy Des 2		Market area: EU
Authorisation number	EU-0024303-0012 1-9
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance		7722-84-1	231-765-0	7,0
Phosphoric acid	Orthophosphoric acid	Non-active substance		7664-38-2	231-633-2	1,5
Nitric acid	Nitric acid	Non-active substance		7697-37-2	231-714-2	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		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	6,35
Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)	Alcohols, C10-C16 ethoxylated propoxylated	Non-active substance		69227-22-1		3,0

META SPC 10

1. META SPC 10 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 10 identifier

Identifier

META SPC 10

1.2. Suffix to the authorisation number

Number

1-10

1.3. Product type(s)

PT01 - Human hygiene (Disinfectants)

2. META SPC 10 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 10

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 10

Formulation(s)

AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10

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 10

4.1. Use description

Table 40

Use # 1 – Hygienic hand wash

Product type

PT01 - Human 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: Direct application onto skin

Detailed description:

Antimicrobial hand soap, intended only as hygienic hand wash for food and beverage industry.

Contact time at 20 °C in dirty conditions:

—	60 seconds for bacteria and yeasts.

Application rate(s) and frequency

Application Rate: Application rate: 3 ml of product per application

Dilution (%): RTU product

Number and timing of application:

Application frequency: 1-10 times/day

Category(ies) of users

Professional

Pack sizes and packaging material

Light precluding HDPE Jug, 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 Pouch, 0,5-100 l

4.1.1. Use-specific instructions for use

See general directions for use of meta SPC 10.

4.1.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 10.

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 10.

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 10.

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 10.

5. GENERAL DIRECTIONS FOR USE (10) OF THE META SPC 10

5.1. Instructions for use

Apply approximately 3 ml of product to wet hands and rub for 60 seconds. Rinse thoroughly with running tap water for about 30 seconds.

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 with water.

In case of skin contact: Rinse with 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

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/m

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 10

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

Trade name(s)	Manosan Oxy		Market area: EU
Authorisation number	EU-0024303-0013 1-10
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 11

1. META SPC 11 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 11 identifier

Identifier

META SPC 11

1.2. Suffix to the authorisation number

Number

1-11

1.3. 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 11 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 11

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 11

Formulation(s)

AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11

Hazard statements
Precautionary statements

4. AUTHORISED USE(S) OF THE META SPC 11

4.1. Use description

Table 41

Use # 1 – 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:

Scientific name: Clostridium difficile

Common name: Bacterial spores

Development stage:

Scientific name: Mycobacteria

Common name: Mycobacteria

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 and supporting environments (e.g. pharmaceutical industry) and transfer disinfection.

Contact times for wiping at 20 °C in dirty conditions:

—	5 min for bacteria, yeasts, fungi and mycobacteria;

—	30 min for viruses;

—	60 min for bacterial spores.

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: 1 wipe per m2 (corresponding 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 PET Bucket with 10-5 000 impregnated 45 % polyester / 55 % cellulose blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

4.1.1. Use-specific instructions for use

See general directions for use of meta SPC 11.

4.1.2. Use-specific risk mitigation measures

— 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 11.

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 11.

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 11.

4.2. Use description

Table 42

Use # 2 – 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:

Scientific name: Clostridium difficile

Common name: Bacterial spores

Development stage:

Scientific name: Mycobacteria

Common name: Mycobacteria

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 and supporting environments (e.g. pharmaceutical industry).

Contact times for wiping at 20 °C in dirty conditions:

—	5 min for bacteria, yeasts, fungi and mycobacteria;

—	30 min for viruses;

—	60 min for bacterial spores.

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: 1 wipe per m2 (corresponding 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 PET Bucket with 10-5 000 impregnated 45 % polyester / 55 % cellulose blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

4.2.1. Use-specific instructions for use

See general directions for use of meta SPC 11.

4.2.2. Use-specific risk mitigation measures

— 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 11.

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 11.

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 11.

4.3. Use description

Table 43

Use # 3 – Disinfection of small non-food contact surfaces in health care applications 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: Mycobacteria

Common name: Mycobacteria

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 impregnated RTU wipes

Detailed description:

Routine disinfection of smaller surfaces in hospital rooms and medical practices that are not frequently touched by people.

Contact times for wiping at 20 °C in clean conditions:

—	15 min for Clostridium difficile;

—	30 min for bacterial spores, mycobacteria and viruses.

Contact times for wiping at 20 °C in dirty conditions:

—	15 min for bacteria and yeasts;

—	30 min for fungi, mycobacteria and viruses.

Application rate(s) and frequency

Application Rate: Application rate: 1 wipe per m2 (corresponding 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 pre-printed pouch with 10-100 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

Light precluding PET canister with 10-1 000 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

Light precluding PET bucket with 10-1 000 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

Light precluding PET pouch with 10-1 000 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

4.3.1. Use-specific instructions for use

4.3.2. Use-specific risk mitigation measures

— 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 11.

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 11.

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 11.

4.4. Use description

Table 44

Use # 4 – Disinfection of small non-food contact surfaces in institutional/commercial buildings 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: Mycobacteria

Common name: Mycobacteria

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 impregnated RTU wipes

Detailed description:

Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms).

Contact times for wiping at 20 °C in clean conditions:

—	15 min for Clostridium difficile spores;

—	30 min for bacterial spores, mycobacteria and viruses.

Contact times for wiping at 20 °C in dirty conditions:

—	2 min for bacteria;

—	15 min for yeasts;

—	30 min for fungi, mycobacteria and viruses.

Application rate(s) and frequency

Application Rate: Application rate: 1 wipe per m2 (corresponding to 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 pre-printed pouch with 10-100 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

Light precluding PET canister with 10-1 000 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

Light precluding PET bucket with 10-1 000 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

Light precluding PET pouch with 10-1 000 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

4.4.1. Use-specific instructions for use

See general directions for use of meta SPC 11.

4.4.2. Use-specific risk mitigation measures

— 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 11.

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 11.

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 11.

4.5. Use description

Table 45

Use # 5 – Disinfection of small food contact surfaces in institutional/commercial buildings by wiping using impregnated RTU wipes

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:

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 impregnated RTU wipes

Detailed description:

Routine disinfection of small surfaces in small food areas (e.g. kitchens).

Contact times for wiping at 20 °C in clean conditions:

—	15 min for Clostridium difficile spores;

—	30 min for bacterial spores, mycobacteria and viruses.

Contact time for wiping at 20 °C in dirty conditions:

—	2 min for bacteria;

—	15 min for yeasts;

—	30 min for fungi, mycobacteria and viruses.

Application rate(s) and frequency

Application Rate: Application rate: 1 wipe per m2 (corresponding to 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 pre-printed pouch with 10-100 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

Light precluding PET canister with 10-1 000 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

Light precluding PET bucket with 10-1 000 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

Light precluding PET pouch with 10-1 000 impregnated 60 % polyester / 40 % lyocell blend wipes (wipe size: 420 × 250 mm or 200 × 200 mm).

4.5.1. Use-specific instructions for use

See general directions for use of meta SPC 11.

4.5.2. 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.

4.5.3. 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 11.

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 11.

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 11.

5. GENERAL DIRECTIONS FOR USE (11) OF THE META SPC 11

5.1. Instructions for use

The product is intended for one-step cleaning and disinfection. Always read the label or leaflet before use and follow all the instructions. When used under clean conditions: clean surface before applying the product. Apply product to a dry surface. Wet surface completely using the product. Allow surface to air dry. Do not rinse after use. Close container when not in use. Do not use wipes which have become dehydrated. Dispose of the container when empty. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass. Used wipes must be disposed of in a closed container.

5.2. Risk mitigation measures

— 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

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/m

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 11

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

Trade name(s)	Klerwipe Sporicidal Enhanced Peroxide		Market area: EU
Authorisation number	EU-0024303-0014 1-11
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 OxyWipe S		Market area: EU
	KitchenPro Oxy Wipes S		Market area: EU
Authorisation number	EU-0024303-0015 1-11
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance		7722-84-1	231-765-0	1,5

META SPC 12

1. META SPC 12 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 12 identifier

Identifier

META SPC 12

1.2. Suffix to the authorisation number

Number

1-12

1.3. 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 12 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 12

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Hydrogen peroxide		Active Substance	7722-84-1	231-765-0	2,0	2,3
N-propanol	Propan-1-ol	Non-active substance	71-23-8	200-746-9	17,5	17,5

2.2. Type(s) of formulation of the meta SPC 12

Formulation(s)

AL - Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12

Hazard statements

Flammable liquid and vapour.

Causes serious eye damage.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical equipment.

Use explosion-proof ventilating equipment.

Use explosion-proof lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Wear eye protection.

Wear face protection.

IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.

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.

In case of fire: Use water to extinguish.

Store in a well-ventilated place. Keep cool.

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 12

4.1. Use description

Table 46

Use # 1 – Disinfection of surfaces in industry (e.g. dining areas, bathrooms) 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:

Field(s) of use

Indoor

Application method(s)

Method: Wiping using impregnated RTU wipes

Detailed description:

Disinfection of surfaces in industry (e.g. dining areas, bathrooms).

Contact time for wiping at 10 °C and 20 °C in dirty conditions:

—	5 min for bacteria and yeasts.

Application rate(s) and frequency

Application Rate: Application rate: 1 wipe per m2 (corresponding to 10 ml/m2)

Dilution (%): RTU product

Number and timing of application:

Application frequency: up to 3 times per day

Category(ies) of users

Professional

Pack sizes and packaging material

Light precluding PP Bucket with 10-5 000 impregnated non-woven, 100 % polypropylene wipes (wipe size: 200 × 250 mm).

Light precluding PE Pouch with 10-5 000 impregnated non-woven, 100 % polypropylene wipes (wipe size: 200 × 250 mm).

4.1.1. Use-specific instructions for use

See general directions for use of meta SPC 12.

4.1.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 12.

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 12.

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 12.

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 12.

4.2. Use description

Table 47

Use # 2 – Disinfection of food contact surfaces in food and beverage industry by wiping using impregnated RTU wipes

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: Wiping using impregnated RTU wipes

Detailed description:

Disinfection of small surfaces in food processing plants.

Contact time for wiping at 10 °C and 20 °C in dirty conditions:

—	5 min for bacteria and yeasts.

Application rate(s) and frequency

Application Rate: Application rate: 1 wipe per m2 (corresponding to 10 ml/m2)

Dilution (%): RTU product

Number and timing of application:

Application frequency: up to 4 times per day

Category(ies) of users

Professional

Pack sizes and packaging material

Light precluding PP Bucket with 10-5 000 impregnated non-woven, 100 % polypropylene wipes (wipe size: 200 × 250 mm).

Light precluding PE Pouch with 10-5 000 impregnated non-woven, 100 % polypropylene wipes (wipe size: 200 × 250 mm).

4.2.1. Use-specific instructions for use

See general directions for use of meta SPC 12.

4.2.2. 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.

4.2.3. 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 12.

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 12.

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 12.

5. GENERAL DIRECTIONS FOR USE (12) OF THE META SPC 12

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. Allow surface to air dry after using the product. Do not rinse after use. Close container when not in use. Do not use wipes which have become dehydrated. Dispose of the container when empty. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass. Used wipes must be disposed of in closed container.

5.2. Risk mitigation measures

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 skin contact: Rinse with plenty of water.

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

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

Storage temperature: 0-30 °C.

Shelf life: 12 months

6. OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m

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 12

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

Trade name(s)	OxyDes Maxi Wipes		Market area: EU
Authorisation number	EU-0024303-0016 1-12
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Hydrogen peroxide		Active Substance		7722-84-1	231-765-0	2,0
N-propanol	Propan-1-ol	Non-active substance		71-23-8	200-746-9	17,5

(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

(4) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.

(5) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.

(6) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.

(7) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.

(8) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.

(9) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.

(10) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 10.

(11) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 11.

(12) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 12.