Commission Implementing Regulation (EU) 2025/223 of 6 February 2025 amending Implementing Regulation (EU) 2022/1423 as regards minor changes to the Union authorisation for the biocidal product family Hydrogen Peroxide Family 1
Date: 2025-02-06
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, animal welfare, biocide, chemical product, decontamination, food safety, hygiene product, market approval, oxide, pharmaceutical product








L_202500223EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/223


12.2.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/223
of 6 February 2025
         
amending Implementing Regulation (EU) 2022/1423 as regards minor changes to the 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 50(2) thereof,

Whereas:







(1)


On 22 July 2022, Commission Implementing Regulation (EU) 2022/1423 (2) granted a Union authorisation, under number EU-0024303-0000, to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘Hydrogen Peroxide Family 1’. That Regulation was later amended by Commission Implementing Regulation (EU) 2024/2209 (3), which introduced administrative and minor changes to the authorisation.












(2)


Commission Implementing Regulation (EU) No 354/2013 (4) lays down the procedural rules for the different categories of changes referred to in Article 50(3) of Regulation (EU) No 528/2012. Upon receipt of an opinion from the European Chemicals Agency (‘the Agency’) on an application from an authorisation holder of a Union authorisation seeking to change any of the information submitted for the initial application for authorisation, the Commission is to decide whether the conditions of Article 19 or, where relevant, Article 25 of Regulation (EU) No 528/2012, are still met and whether the terms and conditions of the authorisation need to be amended.












(3)


On 24 April 2024, Ecolab Deutschland GmbH submitted an application to the Agency, in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, for minor changes to the Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’, as referred to in Title 2 of the Annex to that Regulation. Ecolab Deutschland GmbH applied for the following changes, concerning five uses of the products in meta summary of biocidal product characteristics 5: (i) amending the contact time from 30 minutes to 60 minutes for bacterial spores in clean conditions; (ii) amending the contact time from 5 min to 60 min for Clostridium difficile spores in clean conditions; and (iii) removing the claim of 60 minutes for bacterial spores in dirty conditions. The application was recorded in the register for biocidal products under case number BC-AJ094453-41.












(4)


On 20 September 2024, the Agency submitted to the Commission an opinion of the Biocidal Products Committee (5) on the application for minor changes, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics and a revised assessment report. In the opinion, the Agency concludes that after the implementation of the changes sought by the authorisation holder, the conditions of Article 19 of Regulation (EU) No 528/2012 are still met.












(5)


On 11 October 2024, the Agency transmitted to the Commission the revised summary of biocidal product characteristics of the Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’ in all official languages of the Union covering the minor changes applied for, in accordance with Article 12(6) of Implementing Regulation (EU) No 354/2013.












(6)


The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’ to introduce the minor changes requested by Ecolab Deutschland GmbH.












(7)


Except for the amendments regarding the minor changes, all other information included in the summary of the biocidal product characteristics of ‘Hydrogen Peroxide Family 1’ as set out in the Annex to Implementing Regulation (EU) 2022/1423 remains unchanged.












(8)


In order to enhance clarity and to ease the access of users and interested parties to the final consolidated version of the summary of biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2022/1423 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the register for biocidal products in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes.












(9)


Implementing Regulation (EU) 2022/1423 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
The Annex to Implementing Regulation (EU) 2022/1423 is replaced by the text set out in the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 February 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1; ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Commission Implementing Regulation (EU) 2022/1423 of 22 July 2022 granting a Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’ (OJ L 222, 26.8.2022, p. 1; ELI: http://data.europa.eu/eli/reg_impl/2022/1423/oj).

(3)  Commission Implementing Regulation (EU) 2024/2209 of 5 September 2024 amending Implementing Regulation (EU) 2022/1423 as regards administrative and minor changes to the Union authorisation for the biocidal product family Hydrogen Peroxide Family 1 (OJ L, 2024/2209, 11.9.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2209/oj).

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p.4; ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).

(5)  Opinion of the Biocidal Products Committee (BPC) of 19 September 2024 on the minor change of the Union authorisation of the biocidal product family Hydrogen Peroxide Family 1, ECHA/BPC/445/2024, https://echa.europa.eu/documents/10162/79839763/hydrogen_peroxide_fam_1_ua-mic_bc-AJ094453-41_final_bpc_opinion_en.pdf/e7a69440-c1e0-bcc4-0ca8-88138895fef0?t=1726819953228.




ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
Hydrogen Peroxide Family 1

Product type(s)

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

Authorisation number EU-0024303-0000

R4BP asset number EU-0024303-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Hydrogen Peroxide Family 1




1.2.   Product type(s)







Product type(s)


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




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Ecolab Deutschland GmbH




Address


Ecolab Allee 1 40789 Monheim am Rhein DE




Authorisation number


 


EU-0024303-0000





R4BP asset number



 


EU-0024303-0000




Date of the authorisation


15 September 2022




Expiry date of the authorisation


31 October 2032




1.4.   Manufacturer(s) of the product







Name of manufacturer


Ecolab Europe GmbH




Address of manufacturer


Richtistrasse 7 8304 Walliselen Switzerland




Location of manufacturing sites







Ecolab Europe GmbH site 1




A.F.P. GmbH Otto-Brenner-Straße 16 21337 Lüneburg Germany




Ecolab Europe GmbH site 2




ACIDEKA S.A. Edificio Feria. Capuchinos de Basurto 6, 4a planta 48013 Bilbao. Bizkaia Spain




Ecolab Europe GmbH site 3




ADIEGO HNOS CTRA DE VALENCIA, KM 5,900 50410 CUARTE DE HUERVA (ZARAGOZA) 50410 Zaragoza Spain




Ecolab Europe GmbH site 4




ALLIED PRODUCTS Allied Hygiene Unit 11, Belvedere Industrial Estate Fishers Way DA17 6BS Belvedere, Kent United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 5




Arkema GmbH Morschheimer Srtrasse 19 D-67292 Krichheimbolanden Germany




Ecolab Europe GmbH site 6




AZELIS DENMARK Lundtoftegårdsvej 95 2800 Kgs. 2800 Kgs Lyngby Denmark




Ecolab Europe GmbH site 7




Belinka Zasavska Cesta 95 1001 Ljubljana Slovenia




Ecolab Europe GmbH site 8




BENTUS LABORATORIES LTD. RUSSIA, 105005, MOSCOW, RADIO STREET, 24 BLD.1 105005 Moscow Russian Federation (the)




Ecolab Europe GmbH site 9




BIO PRODUCTIONS 72 VICTORIA ROAD, VICTORIA INDUSTRIAL ESTATE, BURGESS HILL, WEST SUSSEX RH159LH Burgess Hill United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 10




BIOXAL SA Route des Varennes - Secteur A – BP 30072 71103 Chalon sur Saône Cedex France




Ecolab Europe GmbH site 11




Bores Srl Via Pioppa, 179 44020 Pontegradella Italy




Ecolab Europe GmbH site 12




BRENNTAG ARDENNES Route de Tournes CD n 2 FR-08090 FR-08090 Cliron France




Ecolab Europe GmbH site 13




BRENNTAG CEE - GUNTRAMSDORF Brenntag CEE GmbH Mixing / Blending Bahnstr. 13 A-2353 Guntramsdorf Austria




Ecolab Europe GmbH site 14




BRENNTAG Duisburg/Glauchau/Hamburg/Heilbronn Brenntag GmbH Humboldtring 15 45472 Muehlheim Germany




Ecolab Europe GmbH site 15




BRENNTAG Kaiserslautern Brenntag Merkurstr. 47 67663 Kaiserslautern Germany




Ecolab Europe GmbH site 16




BRENNTAG Kleinkarlbach/Lohfelden Brenntag GmbH Humboldtring 15 45472 Muehlheim Germany




Ecolab Europe GmbH site 17




BRENNTAG Nordic - HASLEV Høsten Teglværksvej 47 4690 Haslev Denmark




Ecolab Europe GmbH site 18




Brenntag Nordic, Strandgade 35 7100 Vejle Denmark




Ecolab Europe GmbH site 19




BRENNTAG Normandy Brenntag Normandie 12 Sente des Jumelles - BP 11 76710 76710 Montville France




Ecolab Europe GmbH site 20




BRENNTAG PL -Zgierz ul. Kwasowa 5 95-100 Zgierz Poland




Ecolab Europe GmbH site 21




Brenntag Quimica S.A. - Madrid. Calle Gutemberg no 22,.Poligono Industrial El Lomo 28906 Madrid Spain




Ecolab Europe GmbH site 22




BRENNTAG Schweizerhall Brenntag Schweizerhall AG Elsaesserstr. 231 CH-4056 Basel Switzerland




Ecolab Europe GmbH site 23




Budich International GmbH Dieselstrasse 10 32120 Hiddenhause Germany




Ecolab Europe GmbH site 24




Caldic Deutschland Chemie B.V Caldic Deutschland GmbH & Co.Kg Am Karlshof 10 D 40231 Duesseldorf Germany




Ecolab Europe GmbH site 25




Carbon Chemicals Group Ltd, Ringaskiddy P43 R772 County Cork Ireland




Ecolab Europe GmbH site 26




COLEP BAD SCHMIEDEBERG ColepCCL Bad Schmiedeberg GmbH Kemberger Str. 3 06905 Bad Schmiedeberg Germany




Ecolab Europe GmbH site 27




COMERCIAL FARMACEUTICA CASTEL: LANA, S.A. “COFARCAS” Condado de Treviño, 46 P.I. Villalonquejar 09080 – BURGOS 09080 Burgos Spain




Ecolab Europe GmbH site 28




COMERCIAL GODO França, 13 08700 – IGUALADA (BARCELONA) 08700 BARCELONA Spain




Ecolab Europe GmbH site 29




COURTOIS SARL ZA SOUS LE BEER Route de Pacy 27730 BUEIL France




Ecolab Europe GmbH site 30




DAN MOR (DR WIPE) DAN-MOR Natural Products and Chemicals Ltd. Or Akiva Industrial Zone 30600 Akiva Industrial Zone Israel




Ecolab Europe GmbH site 31




Denteck BV Heliumstraat 8 2718 SL ZOETERMEER Netherlands (the)




Ecolab Europe GmbH site 32




DETERGENTS BURGUERA DETERGENTS BURGUERA, S.L. Joan Ballester 50 07630 CAMPOS (ILLES BALEARES) Spain




Ecolab Europe GmbH site 33




ECL Biebesheim NLC Biebesheim Justus-von-Liebig-Straße 11 64584 Biebesheim am Rhein Germany




Ecolab Europe GmbH site 34




ECL Celra NALCO - Celra C/ Tramuntana s/n Poligona Industrial Celra 17460 Girona Spain




Ecolab Europe GmbH site 35




ECL Châlons AVENUE DU GENERAL PATTON 51000 CHALONS EN CHAMPAGNE France




Ecolab Europe GmbH site 36




ECL Cisterna Nalco Italiana Manufacturing Srl.Via Ninfina II 04012 Cisterna di Latina Italy




Ecolab Europe GmbH site 37




ECL Fawley NLC Fawley Cadland Road, Hythe, SO45 3NP Southampton, Hampshire United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 38




ECL Leeds ECOLAB Lotherton Way Garforth Leeds LS25 2JY LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 39




ECL Mandra 25TH KM OLD NATIONAL ROAD OF ATHENS TO THIVA, GR 19600 GR 19600 ATHENS Greece




Ecolab Europe GmbH site 40




ECL Maribor Vajngerlova 4, SI-2001 Maribor SI-2001 Maribor Slovenia




Ecolab Europe GmbH site 41




ECL MICROTEK BV MICROTEK MEDICAL B.V. GESINKKAMPSTRAAT 19, 7051 HR, VARSSEVELD 7051 HR VARSSEVELD Netherlands (the)




Ecolab Europe GmbH site 42




ECL MICROTEK MOSTA SORBONNE CENTRE, F20 MOSTA TECHNOPARK, MOSTA MST 3000 MOSTA Malta




Ecolab Europe GmbH site 43




ECL Nieuwegein BRUGWAL 11 A, 3432 NZ NIEUWEGEIN 3432 NZ NIEUWEGEIN Netherlands (the)




Ecolab Europe GmbH site 44




ECL Rovigo Esoform Esoform S.p.A. Laboratorio Chimico Farmaceutico Viale del Lavoro 10 45100 Rovigo Italy




Ecolab Europe GmbH site 45




ECL Rozzano Via A. Grandi, 20089 Rozzano MI 20089 Rozzano Italy




Ecolab Europe GmbH site 46




ECL Tesjoki NLC Tesjoki Kivikummuntie 1, Tesjoki 07955 Tesjoki Finland




Ecolab Europe GmbH site 47




ECL Tessenderlo INDUSTRIEZONE RAVENSHOUT 4 3980 Tessenderlo Belgium




Ecolab Europe GmbH site 48




Ecolab Ltd Baglan/Swindon, Plot 7a Baglan Energy Park, Baglan, Port Talbot SA11 2HZ Port Talbot United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 49




EXTRUPLAST ZI Fief du Passage 56 rue Robert Geffré 17000 La Rochelle France




Ecolab Europe GmbH site 50




Ferdinand Eimermacher GmbH & Co. KG Westring 24 48356 Nordwalde Germany




Ecolab Europe GmbH site 51




F.E.L.T. BP 64 10 rue du Vertuquet 59531 NEUVILLE EN FERRAIN France




Ecolab Europe GmbH site 52




Gallows Green Services Ltd. Cod Beck Mill Industrial Estate Dalton Lane YO7 3HR Thirsk North Yorkshire United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 53




GERDISA GERMAN RGUEZ DROGAS IND Gerdisa Polígono Industrial Miralcampo parc.37 19200 Azuqueca de Henares Guadalajara Spain




Ecolab Europe GmbH site 54




GIRASOL NATURAL PRODUCTS BV De Veldoven 12-14 3342 GR Hendrik-Ido-Ambacht 3342 GR Hendrik-Ido-Ambacht Netherlands (the)




Ecolab Europe GmbH site 55




HENKEL ENGELS Henkel Engels 413116 Engels Prospekt StroiTel ei Russia 413116 Engels Russian Federation (the)




Ecolab Europe GmbH site 56




Imeco GmbH & Co. KG Boschstraße 5 D-63768 Hösbach Germany




Ecolab Europe GmbH site 57




INTERFILL LLC-TOSNO INTERFILL LLC 187000, Moskovskoye shosse 1 187000 Tosno - Leningradskaya Russian Federation (the)




Ecolab Europe GmbH site 58




JODEL - PRODUCTOS QUIMICOS Jodel Zona Industrial 2050 Aveiras de Cima 2050 Aveiras de Cima Portugal




Ecolab Europe GmbH site 59




Kleinmann GmbH Am Trieb 13 72820 Sonnenbühl Germany




Ecolab Europe GmbH site 60




Kompak Nederland B.V. Ambachtsweg 4, 4854 MK, Bavel Netherlands (the)




Ecolab Europe GmbH site 61




La Antigua Lavandera SL LA ANTIGUA LAVANDERA, S.L. Ctra. Antigua Sevilla-Alcalá Km.1,5 (SE-410) Apartado de Correos, 58 41500 Sevilla Spain




Ecolab Europe GmbH site 62




LABORATOIRES ANIOS Pavé du moulin 59260 Lille-Hellemmes France




Ecolab Europe GmbH site 63




LABORATOIRES ANIOS 3330 Rue de Lille 59262 Sainghin-en-Mélantois France




Ecolab Europe GmbH site 64




LICHTENHELDT GmbH Lichtenheldt Industriestrasse 7-9 23812 Wahlstedt Germany




Ecolab Europe GmbH site 65




Lonza GmbH Morianstr.32 42103 Wuppertal Germany




Ecolab Europe GmbH site 66




McBride SA Polígon Industrial L’Illa C / Ramon Esteve, 20- 22 08650 Sallent Spain




Ecolab Europe GmbH site 67




Multifill BV Constructieweg 25-A 3641 SB Mijdrecht 3641 Mijdrecht Netherlands (the)




Ecolab Europe GmbH site 68




NOPA NORDISK PARFUMERIVARE Nordisk Parfumerivarefabrik A/S Hvedevej 2-22 DK-8900 Randers Denmark




Ecolab Europe GmbH site 69




PAL INTERNATIONAL LTD Pal International Ltd. Sandhurst Street, Oadby Leicester Leicester United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 70




Planol GmbH Maybachstr. 17 63456 Hanau Germany




Ecolab Europe GmbH site 71




Plum A/S Frederik Plums Vej 2 DK 5610 Assens Denmark




Ecolab Europe GmbH site 72




PRODUCTOS LC LA CORBERANA, S.L. Crta. Corbera – Polinyá 46612 Valencia Spain




Ecolab Europe GmbH site 73




THE PROTON GROUP LTD Ripley Drive, Normanton Industrial Estate WF6 1QT Wakefield United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 74




QUIMICAS MORALES, S.L. Misiones, 11 - Urb. El Sebadal 05005 LAS PALMAS DE GRAN CANARIA Spain




Ecolab Europe GmbH site 75




RNM PRODUCTOS QUIMICOS RNM - Produtos Quimicos, Lda Rua da Fabrica, 123 4765-080 Segade Portugal




Ecolab Europe GmbH site 76




ROQUETTE & BARENTZ Roquette Freres Route De La Gorgue F-62136 Lestrem France




Ecolab Europe GmbH site 77




RUTPEN LTD MEMBURY AIRFIELD RG16 7TJ LAMBOURN United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 78




SOLIMIX Solimix Montseny 17-19 Pol. Ind. Sant Pere Molanta 08799 Barcelona Spain




Ecolab Europe GmbH site 79




Staub & Co. – Silbermann GmbH , Industriestraße 3 D-86456 Gablingen Germany




Ecolab Europe GmbH site 80




Stockmeier Chemie Eilenburg GmbH & Co. KG Gustav-Adolf-Ring 5 04838 Eilenburg Germany




Ecolab Europe GmbH site 81




SYNERLOGIC BV ( - IN2FOOD) Synerlogic BV afd. L.J. Costerstraat 5 6827 ARNHEM Netherlands (the)




Ecolab Europe GmbH site 82




Univar Ltd, Argyle House, Epsom Avenue SK9 3RN Wilmslow United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 83




Univar SPA Via Caldera 21 20-153 Milano Milano Italy




Ecolab Europe GmbH site 84




van Dam Bodegraven B.V Postbus 48 NL 2410 AA Bodegraven Netherlands (the)




Ecolab Europe GmbH site 85




Laboratoires Prodene Klint Rue Denis Papin, 2 Z.I. Mitry Compans F-77290 Mitry Mory F-77290 Mitry Mory France




Ecolab Europe GmbH site 86




Simagec Z.I. de Rousset / Peynier, 54 Avenue de la Plaine 13790 Rousset France




Ecolab Europe GmbH site 87




INNOVATE GmbH, Innovate GmbH Am Hohen Stein 11 06618 Naumburg Germany




Ecolab Europe GmbH site 88




Sima Pharma, 54 Avenue de la Plaine, ZI 13106 Rousset Cedex France




Ecolab Europe GmbH site 89




Techtex (Technical Textile Services Ltd) Units 7 & 8, Rhodes Business Park, Silburn Way, Middleton, M24 4NE Manchester United Kingdom of Great Britain and Northern Ireland (the)




Ecolab Europe GmbH site 90




Helico B.V. Hoogschaijksestraat 31 5374 EC Schaijk Netherlands (the)




Ecolab Europe GmbH site 91




INCARE BV Keizersveld 99 5803 AP Venray Netherlands (the)




Ecolab Europe GmbH site 92




ECL Mullingar Ecolab Ltd (IE). Forrest Park Zone C Mullingar Industrial Estate Mullingar Co. Westmeath Westmeath Ireland




Ecolab Europe GmbH site 93




ECL Mullingar. Ecolab Manufacturing IE Ltd (IE) Forest Park, Zone C Mullingar Ind. Estate N91 Mullingar, Co. Westmeath Westmeath Ireland




Ecolab Europe GmbH site 94




ECL Weavergate Site: Nalco Manufacturing Limited, Winnington Avenue, CW8 3AA Northwich, Cheshire (Postal Address: PO Box 11, Winnington Avenue, Northwich, Cheshire CW8 4DX) United Kingdom of Great Britain and Northern Ireland




Ecolab Europe GmbH site 95




ECL Weavergate, Ecolab Ltd (UK) Winnington Avenue CW8 3AA Northwich, Cheshire United Kingdom of Great Britain and Northern Ireland




Ecolab Europe GmbH site 96




ECL Weavergate, Ecolab Manufacturing UK Ltd (UK) Winnington Avenue CW8 3AA Northwich, Cheshire United Kingdom of Great Britain and Northern Ireland








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







Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Degussa Antwerpen NV




Address of manufacturer


Tijsmanstunnel West 2040 Antwerpen Belgium




Location of manufacturing sites







Evonik Degussa Antwerpen NV site 1




Tijsmanstunnel West 2040 Antwerpen Belgium

















Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Degussa GmbH




Address of manufacturer


Untere Kanalstr. 3 79618 Rheinfelden Germany




Location of manufacturing sites







Evonik Degussa GmbH site 1




Untere Kanalstr. 3 79618 Rheinfelden Germany

















Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxid GmbH




Address of manufacturer


Industriestraβe 1 9721 Weiβenstein Austria




Location of manufacturing sites







Evonik Peroxid GmbH site 1




Industriestraβe 1 9721 Weiβenstein Austria

















Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxide Netherlands BV




Address of manufacturer


Oosterhorn 14 9936 HD Farmsum Netherlands (the)




Location of manufacturing sites







Evonik Peroxide Netherlands BV site 1




Oosterhorn 14 9936 HD Farmsum Netherlands (the)

















Active substance


Hydrogen peroxide




Name of manufacturer


Belinka Perkemija D.O.O




Address of manufacturer


Zasavska cesta 95 1231 Ljubljana-Črnuče Slovenia




Location of manufacturing sites







Belinka Perkemija D.O.O site 1




Zasavska cesta 95 1231 Ljubljana-Črnuče Slovenia

















Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Chemie SA




Address of manufacturer


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




Location of manufacturing sites







Solvay Chemie SA site 1




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

















Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Chimica Italia S.p.A




Address of manufacturer


Via Piave 6 I-57013 Rosignano Solvay LI Italy




Location of manufacturing sites







Solvay Chimica Italia S.p.A site 1




Via Piave 6 I-57013 Rosignano Solvay LI Italy

















Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Chemicals GmbH




Address of manufacturer


Köthensche Strasse 1-3 D-06406 Bernburg Germany




Location of manufacturing sites







Solvay Chemicals GmbH site 1




Köthensche Strasse 1-3 D-06406 Bernburg Germany

















Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Interox Limited




Address of manufacturer


Baronet Road WA4 6HB Warrington Cheshire United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







Solvay Interox Limited site 1




Baronet Road WA4 6HB Warrington Cheshire United Kingdom of Great Britain and Northern Ireland (the)

















Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Chemicals Finland OY




Address of manufacturer


Yrjonojantie 2 45910 Voikkaa Finland




Location of manufacturing sites







Solvay Chemicals Finland OY site 1




Yrjonojantie 2 45910 Voikkaa Finland

















Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Interox Produtos Peroxidados SA




Address of manufacturer


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




Location of manufacturing sites







Solvay Interox Produtos Peroxidados SA site 1




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

















Active substance


Hydrogen peroxide




Name of manufacturer


Kemira Rotterdam BV




Address of manufacturer


Moezelweg 151 3198 LS Europoort Rotterdam Netherlands (the)




Location of manufacturing sites







Kemira Rotterdam BV site 1




Moezelweg 151 3198 LS Europoort Rotterdam Netherlands (the)

















Active substance


Hydrogen peroxide




Name of manufacturer


Kemira Chemical Oy




Address of manufacturer


Typpitie PL 171 90101 Oulu Finland




Location of manufacturing sites







Kemira Chemical Oy site 1




Typpitie PL 171 90101 Oulu Finland

















Active substance


Hydrogen peroxide




Name of manufacturer


Kemira Kemi AB




Address of manufacturer


Industrigatan 83 25109 Helsingborg Sweden




Location of manufacturing sites







Kemira Kemi AB site 1




Industrigatan 83 25109 Helsingborg Sweden

















Active substance


Hydrogen peroxide




Name of manufacturer


ARKEMA France – USINE DE JARRIE




Address of manufacturer


Route National 85, BP 1 38560 JARRIE France




Location of manufacturing sites







ARKEMA France – USINE DE JARRIE site 1




Route National 85, BP 1 38560 JARRIE France

















Active substance


Hydrogen peroxide




Name of manufacturer


ARKEMA GMBH – NIEDERLASSUNG LEUNA




Address of manufacturer


Am Haupttor, Bau 2410 06237 LEUNA Germany




Location of manufacturing sites







ARKEMA GMBH – NIEDERLASSUNG LEUNA site 1




Am Haupttor, Bau 2410 06237 LEUNA Germany

















Active substance


Hydrogen peroxide




Name of manufacturer


Ecolab Europe GmbH




Address of manufacturer


Ecolab-Allee 1 40789 Monheim am Rhein Germany




Location of manufacturing sites







Ecolab Europe GmbH site 1




Ecolab-Allee 1 40789 Monheim am Rhein Germany








2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


1  - 36,75  % (w/w)




N-propanol


Propan-1-ol


Non-Active substance


71-23-8


200-746-9


0  - 17,5  % (w/w)




Citric acid monohydrate


2-hydroxypropane -1,2,3-tricarboxylic acid


Non-Active substance


5949-29-1


201-069-1


0  - 0,9  % (w/w)




Phenoxyethanol


2-Phenoxyethanol


Non-Active substance


122-99-6


204-589-7


0  - 0,9  % (w/w)




Sodium lauryl Sulphate


Sodium dodecyl sulphate


Non-Active substance


151-21-3


205-788-1


0  - 3,88  % (w/w)




L-Glutamic acid, N-coco acyl derivs., monosodium salts


Sodium;(4S)-4-amino-5-hydroxy-5-oxopentanoate


Non-Active substance


68187-32-6


269-087-2


0  - 2  % (w/w)




Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts (Texapon ALS)


Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts


Non-Active substance


90583-11-2


292-209-0


0  - 1,12  % (w/w)




Phosphoric acid


Orthophosphoric acid


Non-Active substance


7664-38-2


231-633-2


0  - 1,5  % (w/w)




Nitric acid


Nitric acid


Non-Active substance


7697-37-2


231-714-2


0  - 3,71  % (w/w)




Alcohol EO phosphate ester


Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, mono-C8-10-alkyl ethers, phosphates


Non-Active substance


68130-47-2


 


0  - 14,625  % (w/w)




Alkylpolyglycoside C8-C10


(3R,4S,5S,6R)-2-decoxy-6-(hydroxymethyl)oxane-3,4,5-triol


Non-Active substance


68515-73-1


500-220-1


0  - 6,35  % (w/w)




Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)


Alcohols, C10-C16 ethoxylated propoxylated


Non-Active substance


69227-22-1


 


0  - 3  % (w/w)




Capryleth-9 Carboxylic acid (mixture of alkyl ether carboxylic acid)


Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(octyloxy)- (4-11 EO)


Non-Active substance


53563-70-5


 


0  - 2,15  % (w/w)




Hexeth-4 Carboxylic Acid (mixture of alkyl ether carboxylic acid)


Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(hexyloxy)- (3 EO)


Non-Active substance


105391-15-9


 


0  - 0,62  % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AL Any other liquid
GW Water soluble gel
SL Soluble concentrate




PART II.

SECOND INFORMATION LEVEL - META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


Meta SPC: META SPC 1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 1 COMPOSITION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


6  - 6,6  % (w/w)




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







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


H319: Causes serious eye irritation.




Precautionary statements


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




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


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







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: No data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of small surfaces, materials and equipment in life sciences cleanrooms, classified as grade A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments. Contact times for spraying at 20oC in clean conditions:






—


15 minutes for bacteria and fungi;










—


5 minutes for yeasts;










—


60 minutes for viruses and bacterial spores.




Contact times for spraying and wiping at 20oC in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


60 minutes for viruses and bacterial spores.








Application rate(s) and frequency


Application rate:
Application rate: 10 ml/m2

Dilution (%):
Ready to use (RTU) product
Number and timing of application:
Application frequency: up to twice per day per room




Category(ies) of users


professional




Pack sizes and packaging material


Light precluding High Density Poly Ethylene (HDPE) or Poly Ethylene (PE) Bottle, 1-5 L
Light precluding Polypropylene and Polyethylene (PP+PE) spray bottle, 0.5 -5 L




4.1.1.   Use-specific instructions

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

The use of eye protection while handling the product is mandatory.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 1.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1.
4.2.   Use description


Table 2


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







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Mopping using a flat mop and bucket
Detailed description:
Disinfection of floors in life sciences cleanrooms, classified as grade A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments. Contact times for mopping at 20oC in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


60 minutes for viruses and bacterial spores.








Application rate(s) and frequency


Application rate:
Application rate: 20 ml/m2

Dilution (%):
RTU product
Number and timing of application:
Application frequency: up to twice per day per room




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE or PE Bottle, 0.5 -5 L




4.2.1.   Use-specific instructions

Apply to surfaces by mopping and let air dry.
4.2.2.   Use-specific risk mitigation measures

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

See general directions for use of meta SPC 1.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1.
4.3.   Use description


Table 3


Disinfection of life sciences cleanrooms by wiping using impregnated RTU wipes







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of small surfaces, materials and equipment in life sciences cleanrooms, classified as grade A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments. Contact times for wiping at 20oC in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


60 minutes for viruses and bacterial spores.








Application rate(s) and frequency


Application rate:
Application rate: 1 wipe per m2 (corresponds to 10 ml/m2)
Dilution (%):
RTU product
Number and timing of application:
Application frequency: up to twice per day per room




Category(ies) of users


professional




Pack sizes and packaging material


Light precluding PP or PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 45% polyester / 55% cellulose blend wipes (wipe size: 200x200 mm)
Light precluding PP or PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 100% polyester wipes (wipe size: 200x200 mm).
Light precluding PP or PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 100% polyester wipes (wipe size: 300x300 mm)




4.3.1.   Use-specific instructions

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

Avoid hand to eye transfer.
4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 1.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1.
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1.
4.4.   Use description


Table 4


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







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Mopping using impregnated RTU mop wipes
Detailed description:
Disinfection of floors in life sciences cleanrooms, classified as grade A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments. Contact times for mopping at 20oC in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


60 minutes for viruses and bacterial spores.








Application rate(s) and frequency


Application rate:
Application rate: 1 wipe per m2 (corresponds to 10 ml/m2)
Dilution (%):
RTU product
Number and timing of application:
Application frequency: up to twice per day per room




Category(ies) of users


professional




Pack sizes and packaging material


Light precluding PP or PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 45% polyester / 55% cellulose blend wipes (wipe size: 420x250 mm).
Light precluding PP or PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 100% polyester wipes (wipe size: 300x300 mm).




4.4.1.   Use-specific instructions

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

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

See general directions for use of meta SPC 1.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1.
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

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

See use-specific risk mitigation measures of meta SPC 1.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

FIRST AID MEASURES
In case of eye contact: Rinse immediately with plenty of water, including under the eyelids, for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Seek medical attention.
In case of skin contact: Rinse with plenty of water.
If swallowed: Rinse mouth. Seek medical attention if symptoms occur.
If inhaled: Seek medical attention if symptoms occur.
ENVIRONMENTAL EMERGENCY MEASURES
Do not allow contact with soil, surface or ground water.
Consider the provision of containment around storage vessels.
5.4.   Instructions for safe disposal of the product and its packaging

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature: 0-35°C
Shelf life: 24 months
6.   OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

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













Trade name(s)


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 % (w/w)




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC: META SPC 2




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




2.   META SPC 2 COMPOSITION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


1  - 1  % (w/w)




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







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


 




Precautionary statements


 




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


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







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of small surfaces in industry.
Contact times for spraying at 20oC in dirty conditions:






—


5 minutes for bacteria and yeasts;










—


15 minutes for fungi;










—


60 minutes for mycobacteria.




Method: Mopping using flat mop and bucket
Detailed description:
Disinfection of large surfaces in industry. Contact times for mopping at 20oC in dirty conditions:






—


5 minutes for bacteria and yeasts;










—


15 minutes for fungi;










—


60 minutes for mycobacteria.




Method: Spraying using trigger sprayer and dry wipe and mopping using flat mop and bucket.
Detailed description:
Disinfection of small and large surfaces in industry.
Contact times for spraying and mopping at 20oC in dirty conditions:






—


5 minutes for bacteria and yeasts;










—


15 minutes for fungi;










—


60 minutes for mycobacteria.








Application rate(s) and frequency


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

Dilution (%):
RTU product
Number and timing of application:
Application frequency for trigger spraying: up to 10 times per day per room
Application rate:
Application rate for mopping: 20 ml/m2

Dilution (%):
RTU product
Number and timing of application:
Application frequency for mopping: up to twice per day per room
Application rate:
Application rate for spraying: 10 ml/m2; Application rate for mopping: 20 ml/m2

Dilution (%):
RTU product
Number and timing of application:
Application frequency for combined trigger spraying and mopping: once per day per room.




Category(ies) of users


professional




Pack sizes and packaging material


Light precluding HDPE Container, 1-100L
Light precluding HDPE Jerry can, 1-100L
Light precluding HDPE IBC, 600-1000L
Light precluding HDPE Drum, 60-220L
Light precluding HDPE Bottle, 0,1-5L
Light precluding HDPE; PE Spray bottle, 0,5-1L




4.1.1.   Use-specific instructions

Spraying: For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto the surface, wait for 5 minutes and then wipe the surface with a clean, dry wipe or let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
Mopping: Remove excess water using a dry floor mop. Fill the bucket with ready-to use product and distribute across floor using flat mop. Wait 5 minutes, then wipe the surface with a clean, dry mop or let air dry.
4.1.2.   Use-specific risk mitigation measures

For spraying of large surface areas the following applies: The area of the surface to be disinfected (in m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
For spraying of small surface areas the above specific risk mitigation measure does not apply.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 2.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2.
4.2.   Use description


Table 2


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







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Mopping using flat mop and bucket
Detailed description:
Disinfection of small surfaces (floors) in industry plants Contact times for mopping at 20oC in dirty conditions:






—


5 minutes for bacteria and yeasts;










—


15 minutes for fungi;










—


60 minutes for mycobacteria.








Application rate(s) and frequency


Application rate:
Application rate: 20 ml/m2

Dilution (%):
RTU product
Number and timing of application:
Application frequency: up to twice per day per room




Category(ies) of users


professional




Pack sizes and packaging material


Light precluding HDPE Container, 1-100 L
Light precluding HDPE Jerry can, 1-100 L
Light precluding HDPE IBC, 600-1000 L
Light precluding HDPE Drum, 60-220 L
Light precluding HDPE Bottle, 0,1-5 L




4.2.1.   Use-specific instructions

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

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

See general directions for use of meta SPC 2.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2
4.3.   Use description


Table 3


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







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of small surfaces in food processing plants. Contact time for spraying at 20oC in dirty conditions:






—


5 minutes for bacteria and yeasts.




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






—


5 minutes for bacteria and yeasts;










—


15 minutes for fungi;










—


60 minutes for mycobacteria.








Application rate(s) and frequency


Application rate:
Application rate: 10 ml/m2

Dilution (%):
RTU product
Number and timing of application:
Application frequency: up to 10 times per day per room




Category(ies) of users


professional




Pack sizes and packaging material


Light precluding HDPE Container, 1-100 L
Light precluding HDPE Jerry can, 1-100 L
Light precluding HDPE IBC, 600-1000 L
Light precluding HDPE Drum, 60-220 L
Light precluding HDPE Bottle, 0,1-5 L
Light precluding HDPE; PE Spray bottle, 0,5-1 L




4.3.1.   Use-specific instructions

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

Keep food, feed or beverages away from treated surfaces until dried. Do not use directly on or near food, feed or drinks.
4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 2.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2.
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2.
4.4.   Use description


Table 4


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







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Fixed installed spraying
Detailed description:
Automated disinfection application in industrial process equipment. Contact time for spraying at 20oC in dirty conditions:






—


5 minutes for bacteria and yeasts.








Application rate(s) and frequency


Application rate:
Application rate: 300 L maximum per application
Dilution (%):
RTU product
Number and timing of application:
Application frequency: once per week




Category(ies) of users


professional




Pack sizes and packaging material


Light precluding HDPE Container, 1-100 L
Light precluding HDPE Jerry can, 1-100 L
Light precluding HDPE IBC, 600-1000 L
Light precluding HDPE Drum, 60-220 L
Light precluding HDPE Bottle, 0,1-5 L




4.4.1.   Use-specific instructions

Use outside food production time, once per week.
4.4.2.   Use-specific risk mitigation measures

Application only after the working shift/overnight application.
During spraying application, no person shall be present.
To determine the appropriate re-entry time after application of the product, workplace release measurements using suitable measurement equipment shall be performed upon implementation of the fixed installed spraying, and at regular intervals thereafter (annual intervals recommended), and after any change in relevant boundary conditions. The national regulations for workplace measurements shall be followed. In case of unscheduled maintenance tasks during spraying application, use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory.
4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 2.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2.
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

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

See use-specific risk mitigation measures of meta SPC 2.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

FIRST AID MEASURES
In case of eye contact: Rinse with plenty of water.
In case of skin contact: Rinse with plenty of water.
If swallowed: Rinse mouth. Seek medical attention if symptoms occur.
If inhaled: Seek medical attention if symptoms occur.
ENVIRONMENTAL EMERGENCY MEASURES
Do not allow contact with soil, surface or ground water.
Consider the provision of containment around storage vessels.
5.4.   Instructions for safe disposal of the product and its packaging

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature:0-35 °C
Shelf life: 24 months
6.   OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

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













Trade name(s)


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 % (w/w)




1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


Meta SPC: META SPC 3




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT04: Food and feed area




2.   META SPC 3 COMPOSITION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


35  - 36,75  % (w/w)




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







Formulation type(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


H272: May intensify fire; oxidiser.
H302: Harmful if swallowed.
H315: Causes skin irritation.
H318: Causes serious eye damage.
H335: May cause respiratory irritation.
H412: Harmful to aquatic life with long lasting effects.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P220: Keep away from clothing or other combustible materials.
P261: Avoid breathing vapours.
P261: Avoid breathing spray.
P264: Wash hands thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P280: Wear eye protection.
P280: Wear face protection.
P280: Wear protective gloves.
P301+P312: IF SWALLOWED: Call a POISON CENTER if you feel unwell.
P330: Rinse mouth.
P302+P352: IF ON SKIN: Wash with plenty of water.
P332+P313: If skin irritation occurs: Get medical advice.
P332+P313: If skin irritation occurs: Get medical attention.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER.
P310: Immediately call a doctor.
P321: Specific treatment (see first aid instruction on this label).
P362+P364: Take off contaminated clothing and wash it before reuse.
P370+P378: In case of fire: Use water to extinguish.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents to in accordance with national regulations.
P501: Dispose of container to in accordance with national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


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







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Automated dipping or spraying in closed system
Detailed description:
Disinfection of packaging (aseptic filling) by fully automated dipping and spraying (closed process). Packaging disinfection in food, beverage and feed manufacturing (dip and spray application). Contact time for dipping and spraying at 60oC in clean conditions:






—


1 minute for bacteria, yeasts, fungi and bacterial spores.








Application rate(s) and frequency


Application rate:
Application rate: constant automated dosing
Dilution (%): RTU product
Number and timing of application:
Application frequency: constant automated dosing




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE Bulk delivery container, > 1 L - bulk
Light precluding HDPE Jerry can, 1-100 L
Light precluding HDPE IBC, 600-1000 L
Light precluding HDPE Drum, 60-220 L
Light precluding HDPE Bottle, 0,1-5 L




4.1.1.   Use-specific instructions

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






—


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










—


Continuous use of the product










—


Application temperature: 60°C










—


Application takes place in a closed and vented system.




Do not rinse after use. After sterilisation, blow-dry the packaging with hot sterile air.
4.1.2.   Use-specific risk mitigation measures

Do not breathe vapours/spray.
During operation, ensure adequate ventilation along the machines Local exhaust ventilation (LEV) and in the industrial halls (technical ventilation).
During manual maintenance tasks, ensure adequate ventilation inside the machine (LEV) before opening the doors of the aseptic area.






1.


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










2.


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










3.


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




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

See general directions for use of meta SPC 3.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3.
4.2.   Use description


Table 2


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







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data




Field(s) of use


Indoor use




Application method(s)


Method: CIP
Detailed description:
Disinfection in food and beverage industry (food contact).Contact times for closed systems at 60oC in clean conditions:






—


5 minutes for bacteria and yeasts;










—


15 minutes for fungi.








Application rate(s) and frequency


Application rate:
Application rate: automated dosing
Dilution (%):
RTU product
Number and timing of application:
Application frequency: once per day




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE Bulk delivery container, > 1 L - bulk
Light precluding HDPE Jerry can, 1-100 L
Light precluding HDPE IBC, 600-1000 L
Light precluding HDPE Drum, 60-220 L
Light precluding HDPE Bottle, 0,1-5 L




4.2.1.   Use-specific instructions

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

Keep food, feed or beverages away from treated surface until rinsed off with water.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 3.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1.   Instructions for use

See use-specific instruction for use of meta SPC 3.
5.2.   Risk mitigation measures

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information).
The use of eye protection while handling the product is mandatory.
The process of dilution shall be carried out using an automatic dosing system.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

FIRST AID MEASURES
In case of eye contact: Rinse immediately with plenty of water, including under the eyelids, for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Seek medical attention immediately.
In case of skin contact: Wash off immediately with plenty of water for at least 15 minutes. Use a mild soap if available. Seek medical attention if irritation develops and persists.
If swallowed: Rinse mouth. Seek medical attention if symptoms occur.
If inhaled: Remove person to fresh air. Treat symptomatically. Seek medical attention if symptoms occur.
ENVIRONMENTAL EMERGENCY MEASURES
Do not allow contact with soil, surface or ground water.
Consider the provision of containment around storage vessels.
5.4.   Instructions for safe disposal of the product and its packaging

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature: 0 - 35 °C
Shelf life: 24 months
6.   OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

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













Trade name(s)


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 % (w/w)




1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier







Identifier


Meta SPC: META SPC 4




1.2.   Suffix to the authorisation number







Number


1-4




1.3.   Product type(s)







Product type(s)


PT03: Veterinary hygiene




2.   META SPC 4 COMPOSITION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


1,4  - 1,61  % (w/w)




Citric acid monohydrate


2-hydroxypropane -1,2,3-tricarboxylic acid


Non-Active substance


5949-29-1


201-069-1


0,9  - 0,9  % (w/w)




Phenoxyethanol


2-Phenoxyethanol


Non-Active substance


122-99-6


204-589-7


0,9  - 0,9  % (w/w)




Sodium lauryl Sulphate


Sodium dodecyl sulphate


Non-Active substance


151-21-3


205-788-1


3,88  - 3,88  % (w/w)




L-Glutamic acid, N-coco acyl derivs., monosodium salts


Sodium;(4S)-4-amino-5-hydroxy-5-oxopentanoate


Non-Active substance


68187-32-6


269-087-2


2  - 2  % (w/w)




Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts (Texapon ALS)


Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts


Non-Active substance


90583-11-2


292-209-0


1,12  - 1,12  % (w/w)




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







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4







Hazard statements


H290: May be corrosive to metals.
H319: Causes serious eye irritation.




Precautionary statements


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




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Teat dips for pre-milking disinfection







Product type


PT03: Veterinary hygiene




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


Indoor use




Application method(s)


Method: 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 30oC 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, 600-1000 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

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 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 or foam cup. The product must be brought to room temperature before use.
Clean teat with a dry wipe, fill foam cup with product and press foam cup until foam is generated. Dip teat into the cup. Apply foam for 60 seconds on the teat. Wipe the product away with a clean towel. Do not rinse after use.
5.2.   Risk mitigation measures

Avoid splashes and spills.
Avoid hand to eye transfer.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

FIRST AID MEASURES
In case of eye contact: Rinse immediately with plenty of water, including under the eyelids, for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Seek medical attention.
In case of skin contact: Rinse with plenty of water.
If swallowed: Rinse mouth. Seek medical attention if symptoms occur.
If inhaled: Seek medical attention if symptoms occur.
ENVIRONMENTAL EMERGENCY MEASURES
Do not allow contact with soil, surface or ground water.
Consider the provision of containment around storage vessels.
5.4.   Instructions for safe disposal of the product and its packaging

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature: 0-25°C
Shelf life: 18 months
6.   OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

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













Trade name(s)


OxyFoamPlus


Market area: EU




MEPA Foampro D


Market area: EU




Predip PLUS


Market area: EU




Authorisation number


 


EU-0024303-0004 1-4




Common name


UPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


1,4 % (w/w)




Citric acid monohydrate


2-hydroxypropane -1,2,3-tricarboxylic acid


Non-Active substance


5949-29-1


201-069-1


0,9 % (w/w)




Phenoxyethanol


2-Phenoxyethanol


Non-Active substance


122-99-6


204-589-7


0,9 % (w/w)




Sodium lauryl Sulphate


Sodium dodecyl sulphate


Non-Active substance


151-21-3


205-788-1


3,88 % (w/w)




L-Glutamic acid, N-coco acyl derivs., monosodium salts


Sodium;(4S)-4-amino-5-hydroxy-5-oxopentanoate


Non-Active substance


68187-32-6


269-087-2


2 % (w/w)




Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts (Texapon ALS)


Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts


Non-Active substance


90583-11-2


292-209-0


1,12 % (w/w)




1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier







Identifier


Meta SPC: META SPC 5




1.2.   Suffix to the authorisation number







Number


1-5




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




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 (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


1,5  - 1,5  % (w/w)




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







Formulation type(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

4.1.   Use description


Table 1


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







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


Indoor use




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of 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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi and mycobacteria;










—


60 minutes for bacterial spores;










—


30 minutes for viruses.




Contact times for spraying and wiping at 20oC in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.




Contact times for spraying at 20oC in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


30 minutes 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 Polypropylene and Polyethylene (PP+PE) Spray bottle, 0.25-1 L
Light precluding High Density Poly Ethylene (HDPE) or Poly Ethylene (PE) Bottle, 1-5 L




4.1.1.   Use-specific instructions

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 2


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







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi and mycobacteria;










—


60 minutes for bacterial spores;










—


30 minutes for viruses.




Contact times for mopping at 20oC in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes 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 or PE Bottle, 1-5 L




4.2.1.   Use-specific instructions

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Spraying using trigger 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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi;










—


15 minutes for mycobacteria.








Application rate(s) and frequency


Application rate:
Application rate: 10 ml/m2

Dilution (%):
RTU product
Number and timing of application:
Application frequency: up to 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

Routine disinfection: Disinfection of surfaces, which might be contaminated with pathogens during medical or nursing processes, on a regular basis to reduce the risk of transmission of such organisms via surfaces.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto the surface, then wipe surface with a clean, dry wipe and leave to dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
4.3.2.   Use-specific risk mitigation measures

The area of the surfaces to be disinfected (in m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5.
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5.
4.4.   Use description


Table 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi and mycobacteria;










—


30 minutes for viruses.




Contact times for spraying and wiping at 20oC in clean conditions:






—


60 minutes for Clostridium difficile spores;










—


60 minutes for bacterial spores.




Contact times for spraying at 20oC in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


30 minutes for viruses;










—


60 minutes 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 PET Spray bottle, 0,25-1 L
Light precluding HDPE Jerry can, 1-5 L




4.4.1.   Use-specific instructions

Routine disinfection: Disinfection of surfaces, which might be contaminated with pathogens during medical or nursing processes, on a regular basis to reduce the risk of transmission of such organisms via surfaces.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray product onto the surface, then wipe surface with a clean, dry wipe and leave to dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
4.4.2.   Use-specific risk mitigation measures

The area of the surface to be disinfected (in m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5
4.5.   Use description


Table 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data




Field(s) of use


Indoor




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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi;










—


15 minutes for mycobacteria.








Application rate(s) and frequency


Application rate:
Application rate: 10 ml/m2

Dilution (%):
RTU product
Number and timing of application:
Application frequency: up to 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

Routine disinfection: Disinfection of surfaces, which might be contaminated with pathogens during medical or nursing processes, on a regular basis to reduce the risk of transmission of such organisms via surfaces.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. Pour product into a clean bucket and distribute across surface using single-use cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.
4.5.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 5.
4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5.
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5.
4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5.
4.6.   Use description


Table 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi and mycobacteria ;










—


30 minutes for viruses.




Contact times for wiping at 20oC in clean conditions:






—


60 minutes for Clostridium difficile spores;










—


60 minutes 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

Routine disinfection: Disinfection of surfaces, which might be contaminated with pathogens during medical or nursing processes, on a regular basis to reduce the risk of transmission of such organisms via surfaces.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. Pour product into a clean bucket and distribute across surface using single-use cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.
4.6.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 5.
4.6.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5
4.6.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5.
4.6.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5
4.7.   Use description


Table 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi and mycobacteria;










—


30 minutes for viruses.




Contact times for mopping at 20oC in clean conditions:






—


60 minutes for Clostridium difficile spores;










—


60 minutes 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

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi and mycobacteria;










—


30 minutes for viruses.




Contact times for mopping at 20oC in clean conditions:






—


60 minutes for Clostridium difficile spores;










—


60 minutes 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

Non routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product. Fill the bucket with ready to use product and distribute across floor using mop, wipe the surface with a clean, dry mop and let air dry.
4.8.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 5.
4.8.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5.
4.8.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5
4.8.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5
4.9.   Use description


Table 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi and mycobacteria;










—


30 minutes for viruses.




Contact times for spraying and wiping, mopping at 20oC in clean conditions:






—


60 minutes for Clostridium difficile spores;










—


60 minutes for bacterial spores.




Contact times for spraying at 20oC in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


30 minutes for viruses;










—


60 minutes for 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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi and mycobacteria;










—


30 minutes for viruses.




Contact times for wiping and mopping at 20oC in clean conditions:






—


60 minutes for Clostridium difficile spores;










—


60 minutes 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

The product is intended for one-step cleaning and disinfection. When used under clean conditions: clean surface before applying the product.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
Spraying using trigger sprayer and wiping using a dry wipe: For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray the product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
Mopping using mop and bucket: Fill the bucket with ready to use product and distribute across floor using mop, wipe the surface with a clean, dry mop and let air dry.
Wiping using cloth/wipe and bucket: Pour product into a clean bucket and distribute across surface using single-use cloth/wipe, wipe the surface with clean cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.
4.9.2.   Use-specific risk mitigation measures

For spraying: The area of the surfaces to be disinfected (in m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
4.9.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5
4.9.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5.
4.9.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5
4.10.   Use description


Table 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi and mycobacteria;










—


60 minutes for bacterial spores;










—


30 minutes for viruses.




Contact times for spraying and wiping at 20oC in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.




Contact times for spraying at 20oC in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


30 minutes for viruses and bacterial spores.








Application rate(s) and frequency


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

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi and mycobacteria;










—


60 minutes for bacterial spores;










—


30 minutes for viruses.




Contact times for spraying and wiping at 20oC in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.




Contact times spraying at 20oC in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


30 minutes 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

When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray the product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
4.11.2.   Use-specific risk mitigation measures

Keep food, feed or beverages away from treated surface until dried. Do not use directly on or near food, feed or drinks.
4.11.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5.
4.11.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5.
4.11.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 5

5.1.   Instructions for use

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

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

FIRST AID MEASURES
In case of eye contact: Rinse with plenty of water.
In case of skin contact: Rinse with plenty of water.
If swallowed: Rinse mouth. Seek medical attention if symptoms occur.
If inhaled: Seek medical attention if symptoms occur.
ENVIRONMENTAL EMERGENCY MEASURES
Do not allow contact with soil, surface or ground water.
Consider the provision of containment around storage vessels.
5.4.   Instructions for safe disposal of the product and its packaging

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature:0-35 °C. Protect from frost.
Shelf life: 18 months
6.   OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

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













Trade name(s)


Incidin OxyFoam


Market area: EU




Authorisation number


 


EU-0024303-0005 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


1,5 % (w/w)




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




Anios Low Peroxide IP sterile


Market area: EU




Sirafan Oxy


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 % (w/w)




1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier







Identifier


Meta SPC: META SPC 6




1.2.   Suffix to the authorisation number







Number


1-6




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




2.   META SPC 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 (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


2  - 2,3  % (w/w)




N-propanol


Propan-1-ol


Non-Active substance


71-23-8


200-746-9


17,5  - 17,5  % (w/w)




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







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6







Hazard statements


H226: Flammable liquid and vapour.
H318: Causes serious eye damage.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P241: Use explosion-proof ventilating equipment.
P241: Use explosion-proof lighting equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P280: Wear eye protection.
P280: Wear face protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a doctor.
P310: Immediately call a POISON CENTER.
P370+P378: In case of fire: Use water to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P501: Dispose of contents to in accordance with national regulations.
P501: Dispose of container to in accordance with national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Disinfection of 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: 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 10oC and 20oC in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact time for spraying at 10oC in clean conditions:






—


1 minute 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, 600-1000 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

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 2


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







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of small surfaces in food processing plants.
Contact time for spraying at 10oC and 20oC in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact time for spraying at 10oC in clean conditions:






—


1 minute 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, 600-1000 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

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

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. 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/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 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 % (w/w)




N-propanol


Propan-1-ol


Non-Active substance


71-23-8


200-746-9


17,5 % (w/w)




1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier







Identifier


Meta SPC: META SPC 7




1.2.   Suffix to the authorisation number







Number


1-7




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




2.   META SPC 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 (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


4,95 - 5,45 % (w/w)




Capryleth-9 Carboxylic acid (mixture of alkyl ether carboxylic acid)


Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(octyloxy)- (4-11 EO)


Non-Active substance


53563-70-5


 


2,15 - 2,15 % (w/w)




Hexeth-4 Carboxylic Acid (mixture of alkyl ether carboxylic acid)


Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(hexyloxy)- (3 EO)


Non-Active substance


105391-15-9


 


0,62 - 0,62 % (w/w)




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







Formulation type(s)


SL Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7







Hazard statements


H314: Causes severe skin burns and eye damage.




Precautionary statements


P260: Do not breathe spray.
P260: Do not breathe vapours.
P264: Wash hands thoroughly after handling.
P280: Wear eye protection.
P280: Wear face protection.
P280: Wear protective gloves.
P280: Wear protective clothing.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P310: Immediately call a POISON CENTER.
P310: Immediately call a doctor.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P321: Specific treatment (see first aid instruction on this label).
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents to in accordance with national regulations.
P501: Dispose of container to in accordance with national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Disinfection of 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: 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 20oC in clean conditions:






—


5 minutes for bacteria and yeasts (10 % dilution);










—


15 minutes 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

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. 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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: 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 20oC in clean conditions:






—


5 minutes for bacteria and yeasts (10 % dilution);










—


15 minutes for bacteria (7,5 % dilution).




Contact times for spraying at 20oC in dirty conditions:






—


5 minutes for bacteria (10 % dilution);










—


5 minutes for yeasts (15 % dilution);










—


15 minutes 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 20oC in clean conditions:






—


5 minutes for bacteria and yeasts (10 % dilution);










—


15 minutes 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 20oC in clean conditions:






—


5 minutes for bacteria and yeasts (10 % dilution);










—


15 minutes for bacteria (7,5 % dilution).Contact times for spraying at 20oC in dirty conditions:










—


5 minutes for bacteria (10 % dilution);










—


5 minutes for yeasts (15 % dilution);










—


15 minutes 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

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 m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
4.2.3.   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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Mopping using flat mop and bucket
Detailed description:
Routine disinfection of large surfaces in large non-food areas.
Contact time for mopping at 20oC in clean conditions:






—


5 minutes for bacteria and yeasts (10 % dilution);










—


15 minutes 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

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: 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 20oC in clean conditions:






—


5 minutes for bacteria and yeasts (10 % dilution);










—


15 minutes for bacteria (7,5 % dilution).




Contact times for spraying at 20oC in dirty conditions:






—


5 minutes for bacteria (10 % dilution);










—


5 minutes for yeasts (15 % dilution);










—


15 minutes for bacteria (7,5 % dilution).








Application rate(s) and frequency


Application rate:
Application rate: 180 ml/m2

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

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 5


Disinfection of large food contact surfaces in institutional/commercial buildings by spraying using trigger sprayer







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: 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 20oC in clean conditions:






—


5 minutes for bacteria and yeasts (10 % dilution);w










—


15 minutes for bacteria (7,5 % dilution).




Contact times for spraying at 20oC in dirty conditions:






—


5 minutes for bacteria (10 % dilution);










—


5 minutes for yeasts (15 % dilution);










—


15 minutes for bacteria (7,5 % dilution).








Application rate(s) and frequency


Application rate:
Application rate: 10 ml/m2

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

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 m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
4.5.3.   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 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 eye contact: Rinse immediately with plenty of water, including under the eyelids, for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Seek medical attention immediately.
In case of skin contact: Wash off immediately with plenty of water for at least 15 minutes. Use a mild soap if available. 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

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature: 0-25 °C. Protect from frost.
Shelf life: 18 months
6.   OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 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 % (w/w)




Capryleth-9 Carboxylic acid (mixture of alkyl ether carboxylic acid)


Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(octyloxy)- (4-11 EO)


Non-Active substance


53563-70-5


 


2,15 % (w/w)




Hexeth-4 Carboxylic Acid (mixture of alkyl ether carboxylic acid)


Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(hexyloxy)- (3 EO)


Non-Active substance


105391-15-9


 


0,62 % (w/w)




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 % (w/w)




Capryleth-9 Carboxylic acid (mixture of alkyl ether carboxylic acid)


Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(octyloxy)- (4-11 EO)


Non-Active substance


53563-70-5


 


2,15 % (w/w)




Hexeth-4 Carboxylic Acid (mixture of alkyl ether carboxylic acid)


Poly(oxy-1,2-ethanediyl), .alpha.-(carboxymethyl)-.omega.-(hexyloxy)- (3 EO)


Non-Active substance


105391-15-9


 


0,62 % (w/w)




1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier







Identifier


Meta SPC: META SPC 8




1.2.   Suffix to the authorisation number







Number


1-8




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




2.   META SPC 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 (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


1 - 1 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 8







Formulation type(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

4.1.   Use description


Table 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of surfaces in industry (e.g. dining areas, bathrooms).
Contact time for wiping at 10oC in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact times for wiping at 20oC in dirty conditions:






—


2 minutes for bacteria;










—


5 minutes for yeasts;










—


15 minutes for fungi;










—


60 minutes 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 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm).
Light precluding PP Pouch with 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm).




4.1.1.   Use-specific instructions

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data




Field(s) of use


Indoor use




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of small surfaces in food processing plant.
Contact time for wiping at 10oC in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact times for wiping at 20oC in dirty conditions:






—


2 minutes for bacteria;










—


5 minutes for yeasts;










—


15 minutes for fungi;










—


60 minutes 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 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm).
Light precluding PP Pouch with 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm).




4.2.1.   Use-specific instructions

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: 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 10oC in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact times for wiping at 20oC in dirty conditions:






—


15 minutes for bacteria, yeasts and fungi;










—


60 minutes 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 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm).
Light precluding PP Pouch with 10-5000 impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm).




4.3.1.   Use-specific instructions

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 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

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature: 0-35 °C. Protect from frost.
Shelf life: 18 months
6.   OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 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 % (w/w)




1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier







Identifier


Meta SPC: META SPC 9




1.2.   Suffix to the authorisation number







Number


1-9




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




2.   META SPC 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 (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


7 - 7,7 % (w/w)




Phosphoric acid


Orthophosphoric acid


Non-Active substance


7664-38-2


231-633-2


1,5 - 1,5 % (w/w)




Nitric acid


Nitric acid


Non-Active substance


7697-37-2


231-714-2


3,71 - 3,71 % (w/w)




Alcohol EO phosphate ester


Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, mono-C8-10-alkyl ethers, phosphates


Non-Active substance


68130-47-2


 


14,625 - 14,625 % (w/w)




Alkylpolyglycoside C8-C10


(3R,4S,5S,6R)-2-decoxy-6-(hydroxymethyl)oxane-3,4,5-triol


Non-Active substance


68515-73-1


500-220-1


6,35 - 6,35 % (w/w)




Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)


Alcohols, C10-C16 ethoxylated propoxylated


Non-Active substance


69227-22-1


 


3 - 3 % (w/w)




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







Formulation type(s)


SL Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9







Hazard statements


H290: May be corrosive to metals.
H314: Causes severe skin burns and eye damage.




Precautionary statements


P234: Keep only in original packaging.
P264: Wash hands thoroughly after handling.
P260: Do not breathe vapours.
P260: Do not breathe spray.
P280: Wear face protection.
P280: Wear protective gloves.
P280: Wear eye protection.
P280: Wear protective clothing.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P310: Immediately call a doctor.
P310: Immediately call a POISON CENTER.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P321: Specific treatment (see first aid instruction on this label).
P363: Wash contaminated clothing before reuse.
P390: Absorb spillage to prevent material damage.
P406: Store in a a corrosion-resistant container with a resistant inner liner.
P405: Store locked up.
P501: Dispose of contents to in accordance with national regulations.
P501: Dispose of container to in accordance with national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Disinfection of 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


5 minutes for bacteria (5 % dilution);










—


5 minutes for yeasts (3 % dilution);










—


5 minutes for fungi (4 % dilution);










—


50 minutes for viruses (5 % dilution).








Application rate(s) and frequency


Application rate:
Application rate: 10 ml/m2

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

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


5 minutes for bacteria (5 % dilution);










—


5 minutes for yeasts (3 % dilution);










—


5 minutes for fungi (4 % dilution);










—


50 minutes 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

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


5 minutes for bacteria (5% dilution);










—


5 minutes for yeasts (3% dilution);










—


5 minutes for fungi (4% dilution);










—


50 minutes 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 20oC in dirty conditions:






—


5 minutes for bacteria (5% dilution);










—


5 minutes for yeasts (3% dilution);










—


5 minutes for fungi (4% dilution);










—


50 minutes 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 20oC in dirty conditions:






—


5 minutes for bacteria (5% dilution);










—


5 minutes for yeasts (3% dilution);










—


5 minutes for fungi (4% dilution);










—


50 minutes 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 20oC in dirty conditions:






—


5 minutes for bacteria (5% dilution);










—


5 minutes for yeasts (3% dilution);










—


5 minutes for fungi (4% dilution);










—


50 minutes 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 20oC in dirty conditions:






—


5 minutes for bacteria (5% dilution);










—


5 minutes for yeasts (3% dilution);










—


5 minutes for fungi (4% dilution);










—


50 minutes 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 (%): 3-5
Number and timing of application:
Application frequency for wiping: up to 10 times per day per room
Application rate for mopping: 20 ml/m2

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 (%): 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 (%): 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

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 m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


5 minutes for bacteria (5% dilution);










—


5 minutes for yeasts (3% dilution);










—


5 minutes for fungi (4% dilution);










—


50 minutes for viruses (5% dilution).








Application rate(s) and frequency


Application rate:
Application rate: 20 ml/m2

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

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: 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 20oC in dirty conditions:






—


5 minutes for bacteria and yeasts (3% dilution).




Contact times for spraying at 20oC in clean conditions:






—


5 minutes for bacteria (1,5 % dilution);










—


15 minutes 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

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


5 minutes for bacteria (5% dilution);










—


5 minutes for yeasts (3% dilution);










—


5 minutes for fungi (4% dilution);










—


50 minutes 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 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 m2) must not be larger than 1/10 of the room volume (in m3) e.g. in a room of 120 m3 volume, the maximum surface to be disinfected is 12 m2.
4.6.3.   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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in dirty conditions:






—


5 minutes for bacteria (5% dilution);










—


5 minutes for yeasts (3% dilution);










—


5 minutes for fungi (4% dilution);










—


50 minutes for viruses (5% dilution).








Application rate(s) and frequency


Application rate: 10 ml/m2

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

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 OF THE META SPC 9

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 (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 eye contact: Rinse immediately with plenty of water, including under the eyelids, for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Seek medical attention immediately.
In case of skin contact: Wash off immediately with plenty of water for at least 15 minutes. Use a mild soap if available. 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

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature: 0-25 °C. Protect from frost.
Shelf life: 18 months
6.   OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 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




Incidin OxyPro


Market area: EU




Sirafan Oxy Conc


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 % (w/w)




Phosphoric acid


Orthophosphoric acid


Non-Active substance


7664-38-2


231-633-2


1,5 % (w/w)




Nitric acid


Nitric acid


Non-Active substance


7697-37-2


231-714-2


3,71 % (w/w)




Alcohol EO phosphate ester


Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, mono-C8-10-alkyl ethers, phosphates


Non-Active substance


68130-47-2


 


14,625 % (w/w)




Alkylpolyglycoside C8-C10


(3R,4S,5S,6R)-2-decoxy-6-(hydroxymethyl)oxane-3,4,5-triol


Non-Active substance


68515-73-1


500-220-1


6,35 % (w/w)




Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)


Alcohols, C10-C16 ethoxylated propoxylated


Non-Active substance


69227-22-1


 


3 % (w/w)




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













Trade name(s)


Oasis Pro Oxy Des


Market area: EU




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 % (w/w)




Phosphoric acid


Orthophosphoric acid


Non-Active substance


7664-38-2


231-633-2


1,5 % (w/w)




Nitric acid


Nitric acid


Non-Active substance


7697-37-2


231-714-2


3,71 % (w/w)




Alcohol EO phosphate ester


Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-, mono-C8-10-alkyl ethers, phosphates


Non-Active substance


68130-47-2


 


14,625 % (w/w)




Alkylpolyglycoside C8-C10


(3R,4S,5S,6R)-2-decoxy-6-(hydroxymethyl)oxane-3,4,5-triol


Non-Active substance


68515-73-1


500-220-1


6,35 % (w/w)




Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)


Alcohols, C10-C16 ethoxylated propoxylated


Non-Active substance


69227-22-1


 


3 % (w/w)




1.   META SPC 10 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 10 identifier







Identifier


Meta SPC: META SPC 10




1.2.   Suffix to the authorisation number







Number


1-10




1.3.   Product type(s)







Product type(s)


PT01: Human hygiene




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 (%)




Hydrogen peroxide


 


Active substance


7722-84-1


231-765-0


1,4  - 1,61  % (w/w)




Citric acid monohydrate


2-hydroxypropane -1,2,3-tricarboxylic acid


Non-Active substance


5949-29-1


201-069-1


0,9  - 0,9  % (w/w)




Phenoxyethanol


2-Phenoxyethanol


Non-Active substance


122-99-6


204-589-7


0,9  - 0,9  % (w/w)




Sodium lauryl Sulphate


Sodium dodecyl sulphate


Non-Active substance


151-21-3


205-788-1


3,88  - 3,88  % (w/w)




L-Glutamic acid, N-coco acyl derivs., monosodium salts


Sodium;(4S)-4-amino-5-hydroxy-5-oxopentanoate


Non-Active substance


68187-32-6


269-087-2


2  - 2  % (w/w)




Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts (Texapon ALS)


Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts


Non-Active substance


90583-11-2


292-209-0


1,12  - 1,12  % (w/w)




2.2.   Type(s) of formulation of the meta SPC 10







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10







Hazard statements


H290: May be corrosive to metals.
H319: Causes serious eye irritation.




Precautionary statements


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




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Hygienic hand wash







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Direct application onto skin
Detailed description:
Antimicrobial hand soap, intended only as hygienic hand wash for food and beverage industry.
Contact time at 20oC 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, 600-1000 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

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 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

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature: 0-25°C
Shelf life: 18 months
6.   OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 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 % (w/w)




Citric acid monohydrate


2-hydroxypropane -1,2,3-tricarboxylic acid


Non-Active substance


5949-29-1


201-069-1


0,9 % (w/w)




Phenoxyethanol


2-Phenoxyethanol


Non-Active substance


122-99-6


204-589-7


0,9 % (w/w)




Sodium lauryl Sulphate


Sodium dodecyl sulphate


Non-Active substance


151-21-3


205-788-1


3,88 % (w/w)




L-Glutamic acid, N-coco acyl derivs., monosodium salts


Sodium;(4S)-4-amino-5-hydroxy-5-oxopentanoate


Non-Active substance


68187-32-6


269-087-2


2 % (w/w)




Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts (Texapon ALS)


Sulfuric acid, mono-C12-14-alkyl esters, ammonium salts


Non-Active substance


90583-11-2


292-209-0


1,12 % (w/w)




1.   META SPC 11 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 11 identifier







Identifier


Meta SPC: META SPC 11




1.2.   Suffix to the authorisation number







Number


1-11




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




2.   META SPC 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 (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


1,5 - 1,5 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 11







Formulation type(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

4.1.   Use description


Table 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of small surfaces, materials and equipment in life sciences cleanrooms and supporting environments (e.g. pharmaceutical industry) and transfer disinfection.
Contact times for wiping at 20oC in dirty conditions:






—


5 minutes for bacteria, yeasts, fungi and mycobacteria;










—


30 minutes for viruses;










—


60 minutes for bacterial spores.




Contact times for wiping at 20oC in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes 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 or PE Bucket with 10-5000 impregnated 45% polyester / 55% cellulose blend wipes (wipe size: 420x250 mm or 200x200 mm).
Light precluding PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 45% polyester / 55% cellulose blend wipes (wipe size: 420x250 mm or 200x200 mm)




4.1.1.   Use-specific instructions

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Mopping using 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 20oC in dirty conditions:






—


5 minutes for bacteria, yeasts, fungi and mycobacteria;










—


30 minutes for viruses;










—


60 minutes for bacterial spores.




Contact times for wiping at 20oC in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.








Application rate(s) and frequency


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 or PE Bucket with 10-5000 impregnated 45% polyester / 55% cellulose blend wipes (wipe size: 420x250 mm or 200x200 mm)
Light precluding PET/PE or EVA/PP or Aluminum/PE Pouch or PE Pouch with 10-100 impregnated 45% polyester / 55% cellulose blend wipes (wipe size: 420x250 mm or 200x200 mm)




4.2.1.   Use-specific instructions

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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: No data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in clean conditions:






—


15 minutes for Clostridium difficile;










—


30 minutes for bacterial spores, mycobacteria and viruses.




Contact times for wiping at 20oC in dirty conditions:






—


15 minutes for bacteria and yeasts;










—


30 minutes for fungi, mycobacteria and viruses.








Application rate(s) and frequency


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: 420x250 mm or 200x200 mm).
Light precluding PET canister with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm).
Light precluding PET bucket with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm).
Light precluding PET pouch with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm).




4.3.1.   Use-specific instructions

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 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 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: No data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in clean conditions:






—


15 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores, mycobacteria and viruses.




Contact times for wiping at 20oC in dirty conditions:






—


2 minutes for bacteria;










—


15 minutes for yeasts;










—


30 minutes 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: 420x250 mm or 200x200 mm).
Light precluding PET canister with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm).
Light precluding PET bucket with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm).
Light precluding PET pouch with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm).




4.4.1.   Use-specific instructions

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 5


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







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: No data
Scientific name: Fungi
Common name: fungi
Development stage: no data
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage: no data
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage: no data
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage: no data
Scientific name: Viruses
Common name: Viruses
Development stage: no data




Field(s) of use


indoor use




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 20oC in clean conditions:






—


15 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores, mycobacteria and viruses.




Contact time for wiping at 20oC in dirty conditions:






—


2 minutes for bacteria;










—


15 minutes for yeasts;










—


30 minutes 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: 420x250 mm or 200x200 mm).
Light precluding PET canister with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm).
Light precluding PET bucket with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm).
Light precluding PET pouch with 10-1000 impregnated 60% polyester / 40% lyocell blend wipes (wipe size: 420x250 mm or 200x200 mm).




4.5.1.   Use-specific instructions

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 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

Product: Where possible, recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with national regulations. Dispose of waste in an approved waste disposal facility.
Contaminated packaging: Dispose of container in accordance with national regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Keep out of reach of children. Keep container tightly closed. Store in suitable, labelled containers.
Storage temperature: 0-35 °C. Protect from frost.
Shelf life: 18 months
6.   OTHER INFORMATION

The product contains hydrogen peroxide (CAS No.: 7722-84-1), for which a European reference value of 1,25 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 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




Anios Low Peroxide IP sterile wipes


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 % (w/w)




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




Sirafan Oxy Wipes


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 % (w/w)




1.   META SPC 12 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 12 identifier







Identifier


Meta SPC: META SPC 12




1.2.   Suffix to the authorisation number







Number


1-12




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area




2.   META SPC 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 (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


2 - 2,3 % (w/w)




N-propanol


Propan-1-ol


Non-Active substance


71-23-8


200-746-9


17,5 - 17,5 % (w/w)




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







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12







Hazard statements


H226: Flammable liquid and vapour.
H318: Causes serious eye damage.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P241: Use explosion-proof ventilating equipment.
P241: Use explosion-proof lighting equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P280: Wear eye protection.
P280: Wear face protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER.
P310: Immediately call a doctor.
P370+P378: In case of fire: Use water to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P501: Dispose of contents to in accordance with national regulations.
P501: Dispose of container to in accordance with national regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Disinfection of 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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of surfaces in industry (e.g. dining areas, bathrooms).
Contact time for wiping at 10oC and 20oC in dirty conditions:






—


5 minutes 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 10-5000 impregnated non-woven, 100% polypropylene wipes (wipe size: 200x250 mm).
Light precluding PE Pouch with 10-5000 impregnated non-woven, 100% polypropylene wipes (wipe size: 200x250 mm).




4.1.1.   Use-specific instructions

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 2


Disinfection of food contact surfaces in food and beverage industry by wiping using impregnated RTU wipes







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeasts
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of small surfaces in food processing plants.
Contact time for wiping at 10oC and 20oC in dirty conditions:






—


5 minutes 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 10-5000 impregnated non-woven, 100% polypropylene wipes (wipe size: 200x250 mm).
Light precluding PE Pouch with 10-5000 impregnated non-woven, 100% polypropylene wipes (wipe size: 200x250 mm).




4.2.1.   Use-specific instructions

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

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. 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: 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/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 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 % (w/w)




N-propanol


Propan-1-ol


Non-Active substance


71-23-8


200-746-9


17,5 % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2025/223/oj
ISSN 1977-0677 (electronic edition)