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
Date: 2024-09-05
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, animal welfare, biocide, chemical product, decontamination, food safety, market approval, oxide, pharmaceutical product








L_202402209EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2209


11.9.2024







            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’
         
(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 with authorisation 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’.












(2)


Commission Implementing Regulation (EU) No 354/2013 (3) lays down the procedural rules for the different categories of changes referred to in Article 50(3) of Regulation (EU) No 528/2012. On 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 28 September 2022, Ecolab Deutschland GmbH submitted a notification to the Agency, in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013, regarding administrative changes to the Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’, as referred to in Title 1 of the Annex to that Regulation. Ecolab Deutschland GmbH proposed the addition of trade names for five biocidal products of the family, the addition of four product manufacturers and a change in the administrative details of two of the product manufacturers. The notification was recorded under the case number BC-RU080137-08 in the Register for Biocidal Products (‘the Register’).












(4)


On 13 October 2022, Ecolab Deutschland GmbH submitted an application to the Agency, in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, for a minor change 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 extension of the shelf-life from 6 months to 18 months for the products in meta summary of biocidal product characteristics (SPC) 8. The application was recorded in the Register under case number BC-SX080682-96.












(5)


On 5 December 2022, Ecolab Deutschland GmbH submitted a further application to the Agency, in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, for a minor change to the Union authorisation for the biocidal product family ‘Hydrogen Peroxide Family 1’. In that application Ecolab Deutschland GmbH asked for the addition of several packaging materials and pack sizes for the products in meta SPC 1, 5 and 11, addition of new wipe material for the products in meta SPC 1 and the removal of one packaging material for the products in meta SPC 1. The application was recorded in the Register under case number BC-SR082474-07.












(6)


On 4 November 2022, the Agency submitted an opinion (4) on the notified administrative changes to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder fall under Article 3(1), point (aa), of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 of that Regulation are still met.












(7)


On 11 October 2023, the Agency submitted the opinions of the Biocidal Products Committee (5) on the two applications for minor changes to the Commission, 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. Both opinions conclude that after the implementation of the changes the conditions of Article 19 of Regulation (EU) No 528/2012 are still met.












(8)


On 10 November 2023, 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 all administrative and minor changes notified and applied for, in accordance with Article 11(6) and Article 12(6) of Implementing Regulation (EU) No 354/2013.












(9)


The Commission concurs with the opinions 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 administrative and minor changes requested by Ecolab Deutschland GmbH.












(10)


Except for the amendments regarding the administrative and 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.












(11)


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.












(12)


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 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, 5 September 2024.


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) 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).

(4)  ECHA Opinion of 4 November 2022 on the administrative change of the Union authorisation of the biocidal product family Hydrogen Peroxide Family 1, Opinion N° UAD-C-1622642-38-00/F, https://echa.europa.eu/documents/10162/3443008/opinion_for_ua-admin_changes_bc-ru080137-08_en.pdf/469baca4-81c1-8874-38b5-9c2527e91b22?t=1686113940831.

(5)  Opinion of the Biocidal Products Committee of 10 October 2023 on the minor change to the Union authorisation of the biocidal product family ‘Hydrogen Peroxide Family 1’, ECHA/BPC/398/2023, https://echa.europa.eu/documents/10162/79839763/hydrogen_peroxide_fam1_ua_mic_bc_SX080682_96_final_bpc_opinion_en.pdf/cd4031f2-7320-012f-abf1-f2a3cde1b836?t=1714715369299, and Opinion of the Biocidal Products Committee of 10 October 2023 on the minor change to the Union authorisation of the biocidal product family ‘Hydrogen Peroxide Family 1’, ECHA/BPC/399/2023, https://echa.europa.eu/documents/10162/3443008/hydrogen_peroxide_fam1_ua_mic_bc_SR082474_07_final_bpc_opinion_en.pdf/f2800274-60a5-ec70-011b-57a6ab561b7e?t=1714716331548.




ANNEX

Summary of product characteristics for a biocidal product family


Hydrogen Peroxide Family 1

Product type 1 - Human hygiene (Disinfectants)
Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 3 - Veterinary hygiene (Disinfectants)
Product type 4 - Food and feed area (Disinfectants)
Authorisation number: EU-0024303-0000
R4BP asset number: EU-0024303-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Hydrogen Peroxide Family 1




1.2.   Product type(s)







Product type(s)


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




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Ecolab Deutschland GmbH




Address


Ecolab Allee 1, 40789 Monheim am Rhein Germany




Authorisation number


EU-0024303-0000





R4BP asset number



EU-0024303-0000




Date of the authorisation


15 September 2022




Expiry date of the authorisation


31 August 2032




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


Ecolab Europe GmbH




Address of manufacturer


Richtistrasse 7, 8304 Walliselen Switzerland




Location of manufacturing sites


A.F.P. GmbH Otto-Brenner-Straße 16, 21337 Lüneburg Germany
ACIDEKA S.A. Edificio Feria. Capuchinos de Basurto 6, 4a planta, 48013 Bilbao. Bizkaia Spain
ADIEGO HNOS CTRA DE VALENCIA, KM 5,900 50410 CUARTE DE HUERVA (ZARAGOZA), 50410 Zaragoza Spain
ALLIED PRODUCTS Allied Hygiene Unit 11, Belvedere Industrial Estate Fishers Way, DA17 6BS Belvedere, Kent United Kingdom
Arkema GmbH Morschheimer Srtrasse 19, D-67292 Krichheimbolanden Germany
AZELIS DENMARK Lundtoftegårdsvej 95 2800 Kgs., 2800 Kgs Lyngby Denmark
Belinka Zasavska cesta 95, 1001 Ljubljana Slovenia
BENTUS LABORATORIES LTD. RUSSIA, 105005, MOSCOW, RADIO STREET, 24 BLD.1, 105005 Moscow Russian Federation
BIO PRODUCTIONS 72 VICTORIA ROAD, VICTORIA INDUSTRIAL ESTATE, BURGESS HILL, WEST SUSSEX, RH159LH Burgess Hill United Kingdom
BIOXAL SA Route des Varennes - Secteur A – BP 30072, 71103 Chalon sur Saône Cedex France
Bores Srl Via Pioppa, 179, 44020 Pontegradella Italy
BRENNTAG ARDENNES Route de Tournes CD n 2 FR-08090, FR-08090 Cliron France
BRENNTAG CEE - GUNTRAMSDORF Brenntag CEE GmbH Mixing / Blending Bahnstr. 13, A-2353 Guntramsdorf Austria
BRENNTAG Duisburg/Glauchau/Hamburg/Heilbronn Brenntag GmbH Humboldtring 15, 45472 Muehlheim Germany
BRENNTAG Kaiserslautern Brenntag Merkurstr. 47, 67663 Kaiserslautern Germany
BRENNTAG Kleinkarlbach/Lohfelden Brenntag GmbH Humboldtring 15, 45472 Muehlheim Germany
BRENNTAG Nordic - HASLEV Høsten Teglværksvej 47, 4690 Haslev Denmark
Brenntag Nordic, Strandgade 35, 7100 Vejle Denmark
BRENNTAG Normandy Brenntag Normandie 12 Sente des Jumelles - BP 11 76710, 76710 Montville France
BRENNTAG PL -Zgierz ul. Kwasowa 5, 95-100 Zgierz Poland
Brenntag Quimica S.A. - Madrid. Calle Gutemberg no 22,.Poligono Industrial El Lomo, 28906 Madrid Spain
BRENNTAG Schweizerhall Brenntag Schweizerhall AG Elsaesserstr. 231, CH-4056 Basel Switzerland
Budich International GmbH Dieselstrasse 10, 32120 Hiddenhause Germany
Caldic Deutschland Chemie B.V Caldic Deutschland GmbH & Co.Kg Am Karlshof 10 D, 40231 Duesseldorf Germany
Carbon Chemicals Group Ltd, Ringaskiddy, P43 R772 County Cork Ireland
COLEP BAD SCHMIEDEBERG ColepCCL Bad Schmiedeberg GmbH Kemberger Str. 3, 06905 Bad Schmiedeberg Germany
COMERCIAL FARMACEUTICA CASTEL: LANA, S.A. “COFARCAS” Condado de Treviño, 46 P.I. Villalonquejar 09080 – BURGOS, 09080 Burgos Spain
COMERCIAL GODO França, 13 08700 – IGUALADA (BARCELONA), 08700 BARCELONA Spain
COURTOIS SARL ZA SOUS LE BEER Route de Pacy, 27730 BUEIL France
DAN MOR (DR WIPE) DAN-MOR Natural Products and Chemicals Ltd. Or Akiva Industrial Zone, 30600 Akiva Industrial Zone Israel
Denteck BV Heliumstraat 8, 2718 SL ZOETERMEER Netherlands
DETERGENTS BURGUERA DETERGENTS BURGUERA, S.L. Joan Ballester, 50 07630 CAMPOS (ILLES BALEARES) Spain
ECL Biebesheim NLC Biebesheim Justus-von-Liebig-Straße 11, 64584 Biebesheim am Rhein Germany
ECL Celra NALCO - Celra C/ Tramuntana s/n Poligona Industrial Celra, 17460 Girona Spain
ECL Châlons AVENUE DU GENERAL PATTON, 51000 CHALONS EN CHAMPAGNE France
ECL Cisterna Nalco Italiana Manufacturing Srl.Via Ninfina II, 04012 Cisterna di Latina Italy
ECL Fawley NLC Fawley Cadland Road, Hythe,, SO45 3NP Southampton, Hampshire United Kingdom
ECL Leeds ECOLAB Lotherton Way Garforth Leeds LS25 2JY, LS25 2JY Leeds United Kingdom
ECL Mandra 25TH KM OLD NATIONAL ROAD OF ATHENS TO THIVA, GR 19600, GR 19600 ATHENS Greece
ECL Maribor Vajngerlova 4, SI-2001 Maribor, SI-2001 Maribor Slovenia
ECL MICROTEK BV MICROTEK MEDICAL B.V. GESINKKAMPSTRAAT 19, 7051 HR, VARSSEVELD, 7051 HR VARSSEVELD Netherlands
ECL MICROTEK MOSTA SORBONNE CENTRE, F20 MOSTA TECHNOPARK, MOSTA, MST 3000 MOSTA Malta
ECL Nieuwegein BRUGWAL 11 A, 3432 NZ NIEUWEGEIN, 3432 NZ NIEUWEGEIN Netherlands
ECL Rovigo Esoform Esoform S.p.A. Laboratorio Chimico Farmaceutico Viale del Lavoro 10, 45100 Rovigo Italy
ECL Rozzano Via A. Grandi, 20089 Rozzano MI, 20089 Rozzano Italy
ECL Tesjoki NLC Tesjoki Kivikummuntie 1, Tesjoki, 07955 Tesjoki Finland
ECL Tessenderlo INDUSTRIEZONE RAVENSHOUT 4, 3980 Tessenderlo Belgium
Ecolab Ltd Baglan/Swindon, Plot 7a Baglan Energy Park, Baglan, Port Talbot, SA11 2HZ Port Talbot United Kingdom
EXTRUPLAST ZI Fief du Passage 56 rue Robert Geffré, 17000 La Rochelle France
Ferdinand Eimermacher GmbH & Co. KG Westring 24, 48356 Nordwalde Germany
F.E.L.T. BP 64 10 rue du Vertuquet, 59531 NEUVILLE EN FERRAIN France
Gallows Green Services Ltd. Cod Beck Mill Industrial Estate Dalton Lane, YO7 3HR Thirsk North Yorkshire United Kingdom
GERDISA GERMAN RGUEZ DROGAS IND Gerdisa Polígono Industrial Miralcampo parc.37, 19200 Azuqueca de Henares Guadalajara Spain
GIRASOL NATURAL PRODUCTS BV De Veldoven 12-14 3342 GR Hendrik-Ido-Ambacht, 3342 GR Hendrik-Ido-Ambacht Netherlands
HENKEL ENGELS Henkel Engels 413116 Engels Prospekt StroiTel ei Russia, 413116 Engels Russian Federation
Imeco GmbH & Co. KG Boschstraße 5, D-63768 Hösbach Germany
INTERFILL LLC-TOSNO INTERFILL LLC 187000, Moskovskoye shosse 1, 187000 Tosno - Leningradskaya Russian Federation
JODEL - PRODUCTOS QUIMICOS Jodel Zona Industrial 2050 Aveiras de Cima, 2050 Aveiras de Cima Portugal
Kleinmann GmbH Am Trieb 13, 72820 Sonnenbühl Germany
Kompak Nederland B.V. Ambachtsweg 4,, 4854 MK, Bavel Netherlands
La Antigua Lavandera SL LA ANTIGUA LAVANDERA, S.L. Ctra. Antigua Sevilla-Alcalá Km.1,5 (SE-410) Apartado de Correos, 58, 41500 Sevilla Spain
LABORATOIRES ANIOS Pavé du moulin, 59260 Lille-Hellemmes France
LABORATOIRES ANIOS 3330 Rue de Lille, 59262 Sainghin-en-Mélantois France
LICHTENHELDT GmbH Lichtenheldt Industriestrasse 7-9, 23812 Wahlstedt Germany
Lonza GmbH Morianstr.32, 42103 Wuppertal Germany
McBride SA Polígon Industrial L’Illa C / Ramon Esteve, 20- 22, 08650 Sallent Spain
Multifill BV Constructieweg 25-A 3641 SB Mijdrecht, 3641 Mijdrecht Netherlands
NOPA NORDISK PARFUMERIVARE Nordisk Parfumerivarefabrik A/S Hvedevej 2-22, DK-8900 Randers Denmark
PAL INTERNATIONAL LTD Pal International Ltd. Sandhurst Street, Oadby, Leicester Leicester United Kingdom
Planol GmbH Maybachstr. 17, 63456 Hanau Germany
Plum A/S Frederik Plums Vej 2, DK 5610 Assens Denmark
PRODUCTOS LC LA CORBERANA, S.L. Crta. Corbera – Polinyá, 46612 Valencia Spain
THE PROTON GROUP LTD Ripley Drive, Normanton Industrial Estate, WF6 1QT Wakefield United Kingdom
QUIMICAS MORALES, S.L. Misiones, 11 - Urb. El Sebadal, 05005 LAS PALMAS DE GRAN CANARIA Spain
RNM PRODUCTOS QUIMICOS RNM - Produtos Quimicos, Lda Rua da Fabrica, 123, 4765-080 Segade Portugal
ROQUETTE & BARENTZ Roquette Freres Route De La Gorgue, F-62136 Lestrem France
RUTPEN LTD MEMBURY AIRFIELD, RG16 7TJ LAMBOURN United Kingdom
SOLIMIX Solimix Montseny 17-19 Pol. Ind. Sant Pere Molanta, 08799 Barcelona Spain
Staub & Co. – Silbermann GmbH , Industriestraße 3, D-86456 Gablingen Germany
Stockmeier Chemie Eilenburg GmbH & Co. KG Gustav-Adolf-Ring 5, 04838 Eilenburg Germany
SYNERLOGIC BV ( - IN2FOOD) Synerlogic BV afd. L.J. Costerstraat 5, 6827 ARNHEM Netherlands
Univar Ltd, Argyle House, Epsom Avenue, SK9 3RN Wilmslow United Kingdom
Univar SPA Via Caldera 21, 20-153 Milano Milano Italy
van Dam Bodegraven B.V Postbus 48, NL 2410 AA Bodegraven Netherlands
Laboratoires Prodene Klint Rue Denis Papin, 2 Z.I. Mitry Compans F-77290 Mitry Mory, F-77290 Mitry Mory France
Simagec Z.I. de Rousset / Peynier, 54 Avenue de la Plaine, 13790 Rousset France
INNOVATE GmbH, Innovate GmbH Am Hohen Stein 11, 06618 Naumburg Germany
Sima Pharma, 54 Avenue de la Plaine, ZI, 13106 Rousset Cedex France
Techtex (Technical Textile Services Ltd) Units 7 & 8, Rhodes Business Park, Silburn Way, Middleton,, M24 4NE Manchester United Kingdom
Helico B.V. Hoogschaijksestraat 31, 5374 EC Schaijk Netherlands
INCARE BV Keizersveld 99, 5803 AP Venray Netherlands
ECL Mullingar Ecolab Ltd (IE). Forrest Park Zone C Mullingar Industrial Estate Mullingar Co., Westmeath Ireland
ECL Mullingar. Ecolab Manufacturing IE Ltd (IE) Forest Park, Zone C Mullingar Ind. Estate N91 Mullingar, Co., Westmeath Ireland
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
ECL Weavergate, Ecolab Ltd (UK) Winnington Avenue, CW8 3AA Northwich, Cheshire, United Kingdom
ECL Weavergate, Ecolab Manufacturing UK Ltd (UK) Winnington Avenue, CW8 3AA Northwich, Cheshire United Kingdom




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







Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Degussa Antwerpen NV




Address of manufacturer


Tijsmanstunnel West, 2040 Antwerpen Belgium




Location of manufacturing sites


Tijsmanstunnel West, 2040 Antwerpen Belgium













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Degussa GmbH




Address of manufacturer


Untere Kanalstr. 3, 79618 Rheinfelden Germany




Location of manufacturing sites


Untere Kanalstr. 3, 79618 Rheinfelden Germany













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxid GmbH




Address of manufacturer


Industriestraβe 1, 9721 Weiβenstein Austria




Location of manufacturing sites


Industriestraβe 1, 9721 Weiβenstein Austria













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxide Netherlands BV




Address of manufacturer


Oosterhorn 14, 9936 HD Farmsum Netherlands




Location of manufacturing sites


Oosterhorn 14, 9936 HD Farmsum Netherlands













Active substance


Hydrogen peroxide




Name of manufacturer


Belinka Perkemija D.O.O




Address of manufacturer


Zasavska cesta 95, 1231 Ljubljana-Črnuče Slovenia




Location of manufacturing sites


Zasavska cesta 95, 1231 Ljubljana-Črnuče Slovenia













Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Chemie SA




Address of manufacturer


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




Location of manufacturing sites


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













Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Chimica Italia S.p.A




Address of manufacturer


Via Piave 6, I-57013 Rosignano Solvay LI Italy




Location of manufacturing sites


Via Piave 6, I-57013 Rosignano Solvay LI Italy













Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Chemicals GmbH




Address of manufacturer


Köthensche Strasse 1-3, D-06406 Bernburg Germany




Location of manufacturing sites


Köthensche Strasse 1-3, D-06406 Bernburg Germany













Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Interox Limited




Address of manufacturer


Baronet Road, WA4 6HB Warrington Cheshire United Kingdom




Location of manufacturing sites


Baronet Road, WA4 6HB Warrington Cheshire United Kingdom













Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Chemicals Finland OY




Address of manufacturer


Yrjonojantie 2, 45910 Voikkaa Finland




Location of manufacturing sites


Yrjonojantie 2, 45910 Voikkaa Finland













Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Interox Produtos Peroxidados SA




Address of manufacturer


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




Location of manufacturing sites


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













Active substance


Hydrogen peroxide




Name of manufacturer


Kemira Rotterdam BV




Address of manufacturer


Moezelweg 151, 3198 LS Europoort Rotterdam Netherlands




Location of manufacturing sites


Moezelweg 151, 3198 LS Europoort Rotterdam Netherlands













Active substance


Hydrogen peroxide




Name of manufacturer


Kemira Chemical Oy




Address of manufacturer


Typpitie PL 171, 90101 Oulu Finland




Location of manufacturing sites


Typpitie PL 171, 90101 Oulu Finland













Active substance


Hydrogen peroxide




Name of manufacturer


Kemira Kemi AB




Address of manufacturer


Industrigatan 83, 25109 Helsingborg Sweden




Location of manufacturing sites


Industrigatan 83, 25109 Helsingborg Sweden













Active substance


Hydrogen peroxide




Name of manufacturer


ARKEMA France – USINE DE JARRIE




Address of manufacturer


Route National 85, BP 1, 38560 JARRIE France




Location of manufacturing sites


Route National 85, BP 1, 38560 JARRIE France













Active substance


Hydrogen peroxide




Name of manufacturer


ARKEMA GMBH – NIEDERLASSUNG LEUNA




Address of manufacturer


Am Haupttor, Bau 2410, 06237 LEUNA Germany




Location of manufacturing sites


Am Haupttor, Bau 2410, 06237 LEUNA Germany













Active substance


Hydrogen peroxide




Name of manufacturer


Ecolab Europe GmbH




Address of manufacturer


Ecolab-Allee 1, 40789 Monheim am Rhein Germany




Location of manufacturing sites


Ecolab-Allee 1, 40789 Monheim am Rhein Germany




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


1,0 


36,75 




N-propanol


Propan-1-ol


Non-active substance


71-23-8


200-746-9


0,0 


17,5 




Citric acid monohydrate


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


Non-active substance


5949-29-1


201-069-1


0,0 


0,9 




Phenoxyethanol


2-Phenoxyethanol


Non-active substance


122-99-6


204-589-7


0,0 


0,9 




Sodium lauryl Sulphate


Sodium dodecyl sulphate


Non-active substance


151-21-3


205-788-1


0,0 


3,88 




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


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


Non-active substance


68187-32-6


269-087-2


0,0 


2,0 




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


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


Non-active substance


90583-11-2


292-209-0


0,0 


1,12 




Phosphoric acid


Orthophosphoric acid


Non-active substance


7664-38-2


231-633-2


0,0 


1,5 




Nitric acid


Nitric acid


Non-active substance


7697-37-2


231-714-2


0,0 


3,71 




Alcohol EO phosphate ester


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


Non-active substance


68130-47-2


 


0,0 


14,625 




Alkylpolyglycoside C8-C10


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


Non-active substance


68515-73-1


500-220-1


0,0 


6,35 




Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)


Alcohols, C10-C16 ethoxylated propoxylated


Non-active substance


69227-22-1


 


0,0 


3,0 




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


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


Non-active substance


53563-70-5


 


0,0 


2,15 




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


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


Non-active substance


105391-15-9


 


0,0 


0,62 




2.2.   Type(s) of formulation







Formulation(s)


AL - Any other liquid
GW - Water soluble gel
SL - Soluble concentrate




PART II

SECOND INFORMATION LEVEL - META SPC(S)


META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


META SPC 1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




2.   META SPC 1 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


6,0 


6,6 




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







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


Causes serious eye irritation.




Precautionary statements


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




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

4.1.   Use description


Table 1


Use # 1 – Disinfection of life sciences cleanrooms by spraying using trigger sprayer and dry wipe







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of small surfaces, materials and equipment in life sciences cleanrooms, classified as grades A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments.
Contact times for spraying at 200C 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 200C in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


60 minutes for viruses and bacterial spores.








Application rate(s) and frequency


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 use

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

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

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

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

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


Table 2


Use # 2 – Disinfection of life sciences cleanrooms by mopping using flat mop and bucket







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using a flat mop and bucket
Detailed description:
Disinfection of floors in life sciences cleanrooms, classified as grades A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments.
Contact times for mopping at 200C in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


60 minutes for viruses and bacterial spores.








Application rate(s) and frequency


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 for use

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

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

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

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

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


Table 3


Use # 3 – Disinfection of life sciences cleanrooms by wiping using impregnated RTU wipes







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of small surfaces, materials and equipment in life sciences cleanrooms, classified as grades A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments.
Contact times for wiping at 200C in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


60 minutes for viruses and bacterial spores.








Application rate(s) and frequency


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 Aluminium/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 Aluminium/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 Aluminium/PE Pouch or PE Pouch with 10-100 impregnated 100% polyester wipes (wipe size: 300x300 mm)




4.3.1.   Use-specific instructions for use

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

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

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

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

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


Table 4


Use # 4 – Disinfection of life sciences cleanrooms by mopping using impregnated RTU mop wipes







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using impregnated RTU mop wipes
Detailed description:
Disinfection of floors in life sciences cleanrooms, classified as grades A to D according to Good Manufacturing Practice (GMP) EU classification, and supporting environments.
Contact times for mopping at 200C in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


60 minutes for viruses and bacterial spores.








Application rate(s) and frequency


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 Aluminium/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 Aluminium/PE Pouch or PE Pouch with 10-100 impregnated 100% polyester wipes (wipe size: 300x300 mm).




4.4.1.   Use-specific instructions for use

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

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

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

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

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

5.1.   Instructions for use

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

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

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

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

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

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

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












Trade name(s)


Klercide Sporicidal Low Residue Peroxide


Market area: EU




 


Klerwipe Sporicidal Low Residue Peroxide


Market area: EU




ANIOS H2O2 6% IP STERILE


Market area: EU




Authorisation number


EU-0024303-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


6,0





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


META SPC 2




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 2 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


1,0 


1,0 




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







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


 




Precautionary statements


 




4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description


Table 5.


Use # 1 – Disinfection of small and/or large surfaces in industry (e.g. dining areas, bathrooms) by spraying using trigger sprayer and dry wipe and/or by mopping using flat mop and bucket







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of small surfaces in industry.
Contact times for spraying at 200C 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 200C 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 200C in dirty conditions:






—


5 minutes for bacteria and yeasts;










—


15 minutes for fungi;










—


60 minutes for mycobacteria.








Application rate(s) and frequency


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 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 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 Intermediate bulk container (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 for use

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

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

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

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

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


Table 6


Use # 2 – Disinfection of small surfaces (floors) in industry [(e.g. dining areas, bathrooms)] by mopping using flat mop and bucket







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using flat mop and bucket
Detailed description:
Disinfection of small surfaces (floors) in industry plants
Contact times for mopping at 200C in dirty conditions:






—


5 minutes for bacteria and yeasts;










—


15 minutes for fungi;










—


60 minutes for mycobacteria.








Application rate(s) and frequency


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 for use

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

None
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

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


Table 7


Use # 3 – Disinfection of small food contact surfaces in food and beverage industry by spraying using trigger sprayer and dry wipe







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of small surfaces in food processing plants.
Contact time for spraying at 200C in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact times for spraying and wiping at 200C in dirty conditions:






—


5 minutes for bacteria and yeasts;










—


15 minutes for fungi;










—


60 minutes for mycobacteria.








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 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 use

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

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

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

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

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


Table 8


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







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Fixed installed spraying
Detailed description:
Automated disinfection application in industrial process equipment.
Contact time for spraying at 200C in dirty conditions:






—


5 minutes for bacteria and yeasts.








Application rate(s) and frequency


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 for use

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

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

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

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

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

5.1.   Instructions for use

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

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

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

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

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

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

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












Trade name(s)


DrySan Oxy


Market area: EU




Authorisation number


EU-0024303-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


1,0





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


META SPC 3




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)




2.   META SPC 3 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0 


36,75 




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







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


May intensify fire; oxidiser.
Harmful if swallowed.
Causes skin irritation.
Causes serious eye damage.
May cause respiratory irritation.
Harmful to aquatic life with long lasting effects.




Precautionary statements


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




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

4.1.   Use description


Table 9


Use # 1 – Disinfection of food contact surfaces in food and beverage industry by automated dipping or spraying in closed system







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Automated dipping or spraying in closed system
Detailed description:
Disinfection of packaging (aseptic filling) by fully automated dipping and spraying (closed process).
Packaging disinfection in food, beverage and feed manufacturing (dip and spray application).
Contact time for dipping and spraying at 600C in clean conditions:






—


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








Application rate(s) and frequency


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 for use

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






—


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










—


Continuous use of the product










—


Application temperature: 60°C










—


Application takes place in a closed and vented system.




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

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






1.


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










2.


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










3.


In case of maintenance of the aseptic packaging plant (e.g. manual cleaning, technical incidents or repair) appropriate PPE (including respiratory protective equipment, chemical protective gloves, chemical protective coverall, eye protection) is required. The type of RPE, the filter type (code letter, colour) and glove material are to be specified by the 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 10.


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







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: CIP
Detailed description:
Disinfection in food and beverage industry (food contact).
Contact times for closed systems at 600C in clean conditions:






—


5 minutes for bacteria and yeasts;










—


15 minutes for fungi.








Application rate(s) and frequency


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 for use

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

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

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

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

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

5.1.   Instructions for use

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

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

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

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

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

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

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












Trade name(s)


Oxypak D


Market area: EU




 


Oxypak S


Market area: EU




Oxypak S10


Market area: EU




Authorisation number


EU-0024303-0003 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


35,0





META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier







Identifier


META SPC 4




1.2.   Suffix to the authorisation number







Number


1-4




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (Disinfectants)




2.   META SPC 4 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


1,4 


1,61 




Citric acid monohydrate


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


Non-active substance


5949-29-1


201-069-1


0,9 


0,9 




Phenoxyethanol


2-Phenoxyethanol


Non-active substance


122-99-6


204-589-7


0,9 


0,9 




Sodium lauryl Sulphate


Sodium dodecyl sulphate


Non-active substance


151-21-3


205-788-1


3,88 


3,88 




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


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


Non-active substance


68187-32-6


269-087-2


2,0 


2,0 




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


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


Non-active substance


90583-11-2


292-209-0


1,12 


1,12 




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







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4







Hazard statements


May be corrosive to metals.
Causes serious eye irritation.




Precautionary statements


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




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

4.1.   Use description


Table 11


Use # 1 – Teat dips for pre-milking disinfection







Product type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Manual dipping using a dip/foam cup (pre-milking disinfection)
Detailed description:
Pre-milking teat disinfection by manual dipping using a dip/foam cup.
Contact time for dipping at 300C in clean conditions:






—


60 seconds for bacteria and yeasts.








Application rate(s) and frequency


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 for use

See general directions for use of meta SPC 4.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 4.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 4.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 4.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 4.
5.   GENERAL DIRECTIONS FOR USE (4)
OF THE META SPC 4

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions. The product should be applied pre-milking by use of a dipping 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


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


1,4




Citric acid monohydrate


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


Non-active substance


5949-29-1


201-069-1


0,9




Phenoxyethanol


2-Phenoxyethanol


Non-active substance


122-99-6


204-589-7


0,9




Sodium lauryl Sulphate


Sodium dodecyl sulphate


Non-active substance


151-21-3


205-788-1


3,88




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


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


Non-active substance


68187-32-6


269-087-2


2,0




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


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


Non-active substance


90583-11-2


292-209-0


1,12





META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier







Identifier


META SPC 5




1.2.   Suffix to the authorisation number







Number


1-5




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 5 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active substance


7722-84-1


231-765-0


1,5 


1,5 




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







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5







Hazard statements


 




Precautionary statements


 




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

4.1.   Use description


Table 12


Use # 1 – Disinfection of life sciences cleanrooms by spraying using trigger sprayer and dry wipe







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of surfaces, materials and equipment in life sciences cleanrooms A - D and supporting environments (e.g. pharmaceutical industry). Transfer disinfection or disinfection of small surfaces.
Contact times for spraying and wiping at 200C 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 200C in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.




Contact times for spraying at 200C 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 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 for use

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

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

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

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

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


Table 13


Use # 2 – Disinfection of life sciences cleanrooms by mopping using flat mop and bucket







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using a flat mop and bucket
Detailed description:
Disinfection of floors in life sciences cleanrooms and supporting environments (e.g. pharmaceutical industry).
Contact times for mopping at 200C 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 200C in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.








Application rate(s) and frequency


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 for use

When used under clean conditions: clean surface before applying the product. Apply to surfaces by mopping.
4.2.2.   Use-specific risk mitigation measures

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

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

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

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


Table 14


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger spray and dry wipe
Detailed description:
Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices.
Contact times for spraying at 200C in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi;










—


15 minutes for mycobacteria.








Application rate(s) and frequency


Application Rate: 10 ml/m2

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




Category(ies) of users


Professional




Pack sizes and packaging material


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




4.3.1.   Use-specific instructions for use

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

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

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

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

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


Table 15


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger spray and dry wipe
Detailed description:
Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices.
Contact times for spraying and wiping at 200C 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 200C in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.




Contact times for spraying at 200C 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 twice per day per room




Category(ies) of users


Professional




Pack sizes and packaging material


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




4.4.1.   Use-specific instructions for use

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

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

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

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

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


Table 16


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using cloth/wipe and bucket
Detailed description:
Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices.
Contact times for wiping at 200C in dirty conditions:






—


1 minute for bacteria and yeasts;










—


5 minutes for fungi;










—


15 minutes for mycobacteria.








Application rate(s) and frequency


Application Rate: 10 ml/m2

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




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE Jerry can, 1-5 L




4.5.1.   Use-specific instructions for use

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

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

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

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

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


Table 17


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using cloth/wipe and bucket
Detailed description:
Routine and non-routine disinfection of small and large surfaces in hospital rooms and medical practices.
Contact times for wiping at 200C 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 wiping at 200C in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.








Application rate(s) and frequency


Application Rate: 10 ml/m2

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




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE Bottle, 1-5 L
Light precluding HDPE Jerry can, 1-5 L




4.6.1.   Use-specific instructions for use

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

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

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

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

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


Table 18


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using mop and bucket
Detailed description:
Non-routine disinfection of larger surfaces in hospital room .
Contact times for mopping at 200C 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 200C in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.








Application rate(s) and frequency


Application Rate: 20 ml/m2

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




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE Bottle, 1-5 L
Light precluding HDPE Jerry can, 1-5 L




4.7.1.   Use-specific instructions for use

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

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

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

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

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


Table 19


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using mop and bucket
Detailed description:
Non-routine disinfection of larger surfaces in medical practices.
Contact times for mopping at 200C 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 200C in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.








Application rate(s) and frequency


Application Rate: 20 ml/m2

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




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE Bottle, 1-5 L
Light precluding HDPE Jerry can, 1-5 L




4.8.1.   Use-specific instructions for use

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

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

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

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

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


Table 20


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger sprayer and dry wipe and mopping using mop and bucket
Detailed description:
Non-routine disinfection of smaller and larger surfaces in hospital rooms and medical practices.
Contact times for spraying and wiping, mopping at 200C 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, mopping at 200C in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.




Contact times for spraying at 200C in clean conditions:






—


5 minutes for bacteria, yeasts and fungi;










—


30 minutes for viruses and bacterial spores.




Method: Wiping using cloth/wipe and bucket and mopping using mop and bucket
Detailed description:
Non-routine disinfection of smaller and larger surfaces in hospital rooms and medical practices.
Contact times for wiping and mopping at 200C 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 wiping and mopping at 200C in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.








Application rate(s) and frequency


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

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




Category(ies) of users


Professional




Pack sizes and packaging material


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




4.9.1.   Use-specific instructions for use

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

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

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

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

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


Table 21


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger spray and dry wipe
Detailed description:
Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms).
Contact times for spraying and wiping at 200C 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 200C in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.




Contact times for spraying at 200C 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 for use

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

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

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

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

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


Table 22


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







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger spray and dry wipe
Detailed description:
Routine disinfection of small surfaces in small food areas (e.g. kitchens).
Contact times for spraying and wiping at 200C 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 200C in clean conditions:






—


5 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores.




Contact times spraying at 200C 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




4.11.1.   Use-specific instructions for use

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

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

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

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

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

5.1.   Instructions for use

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

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

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

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

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

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

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












Trade name(s)


Incidin OxyFoam


Market area: EU




Authorisation number


EU-0024303-0005 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active substance


7722-84-1


231-765-0


1,5




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












Trade name(s)


Incidin OxyFoam S


Market area: EU




 


Klercide Sporicidal Enhanced Peroxide


Market area: EU




KitchenPro Oxy Foam S


Market area: EU




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





META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier







Identifier


META SPC 6




1.2.   Suffix to the authorisation number







Number


1-6




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 6 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


2,0 


2,3 




N-propanol


Propan-1-ol


Non-active substance


71-23-8


200-746-9


17,5 


17,5 




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







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6







Hazard statements


Flammable liquid and vapour.
Causes serious eye damage.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical equipment.
Use explosion-proof ventilating equipment.
Use explosion-proof lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Wear eye protection.
Wear face protection.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a doctor.
Immediately call a POISON CENTER.
In case of fire: Use water to extinguish.
Store in a well-ventilated place. Keep cool.
Dispose of contents to in accordance with national regulations.
Dispose of container to in accordance with national regulations.




4.   AUTHORISED USE(S) OF THE META SPC 6

4.1.   Use description


Table 23


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of small surfaces in industry (e.g. dining areas, bathrooms).
Contact time for spraying at 100C and 200C in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact time for spraying at 100C in clean conditions:






—


1 minute for bacteria and yeasts.








Application rate(s) and frequency


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 for use

See general directions of use of meta SPC 6.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 6.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 6.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 6.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 6.
4.2.   Use description


Table 24


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







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Disinfection of small surfaces in food processing plants.
Contact time for spraying at 100C and 200C in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact time for spraying at 100C in clean conditions:






—


1 minute for bacteria and yeasts.








Application rate(s) and frequency


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 for use

See general directions for use of meta SPC 6.
4.2.2.   Use-specific risk mitigation measures

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

See general directions for use of meta SPC 6.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 6.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 6.
5.   GENERAL DIRECTIONS FOR USE (6)
OF THE META SPC 6

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions. When used under clean conditions: clean surface before applying the product. The product should be applied to a dry surface. For optimum results, hold the bottle upright and spray from a distance of 10 cm to 20 cm. Spray the product onto the surface, wipe the surface with a clean, dry wipe or let air dry. Always close the nozzle after use. Wet surface completely using the product. Do not rinse after use. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass. Used wipes must be disposed of in a closed container.
5.2.   Risk mitigation measures

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

FIRST AID MEASURES
In case of 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


2,0




N-propanol


Propan-1-ol


Non-active substance


71-23-8


200-746-9


17,5





META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier







Identifier


META SPC 7




1.2.   Suffix to the authorisation number







Number


1-7




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 7 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


4,95 


5,45 




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


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


Non-active substance


53563-70-5


 


2,15 


2,15 




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


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


Non-active substance


105391-15-9


 


0,62 


0,62 




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







Formulation(s)


SL - Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7







Hazard statements


Causes severe skin burns and eye damage.




Precautionary statements


Do not breathe spray.
Do not breathe vapours.
Wash hands thoroughly after handling.
Wear eye protection.
Wear face protection.
Wear protective gloves.
Wear protective clothing.
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing. Rinse skin with water.
Immediately call a POISON CENTER.
Immediately call a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
Specific treatment (see first aid instruction on this label).
Wash contaminated clothing before reuse.
Store locked up.
Dispose of contents to in accordance with national regulations.
Dispose of container to in accordance with national regulations.




4.   AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description


Table 25


Use # 1 – Disinfection of non-food contact surfaces in healthcare applications by mopping using flat mop and bucket







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using flat mop and bucket
Detailed description:
Routine and non-routine disinfection of floors in hospital rooms and medical practices that are frequently touched by people and that are not frequently touched by people.
Contact times for mopping at 200C 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: 20 ml/m2

Dilution (%): 7,5-10
Number and timing of application:
Application frequency: up to 10 times per day per room




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE Bottle, 0,5-5 L
Light precluding HDPE Canister, 1-100 L
Light precluding HDPE Pouch, 0,01-1 L
Light precluding HDPE Jug, 0,5-5 L




4.1.1.   Use-specific instructions for use

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 26


Use # 2 – Disinfection of small and/or large non-food contact surfaces in institutional/commercial buildings by spraying using trigger sprayer and dry wipe and/or by mopping using flat mop and bucket







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms).
Contact times for spraying at 200C in clean conditions:






—


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










—


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




Contact times for spraying at 200C 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 200C 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 200C in clean conditions:






—


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










—


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




Contact times for spraying at 200C 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 for spraying: 10 ml/m2

Dilution (%): 7,5-15
Number and timing of application:
Application frequency for trigger spraying: up to 10 times per day per room
Application rate for mopping: 20 ml/m2

Dilution (%): 7,5-10
Number and timing of application:
Application frequency for mopping: up to twice per day per room
Application rate for spraying: 10 ml/m2; Application rate for mopping: 20 ml/m2

Dilution (%): 7,5-15
Number and timing of application:
Application frequency for combined trigger spraying and mopping: once per day per room.




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE Bottle, 0,5-5 L
Light precluding HDPE Canister, 1-100 L
Light precluding HDPE Pouch, 0,01-1 L
Light precluding HDPE jug, 0,5-5 L




4.2.1.   Use-specific instructions for use

Do not rinse after use.
Spraying: When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 10 cm to 20 cm. Spray the diluted product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
Mopping: The product is intended for one-step cleaning and disinfection. Clean surface before applying the product. Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with clean, dry mop and let air dry.
4.2.2.   Use-specific risk mitigation measures

Do not breathe vapours/spray.
For spraying: The area of the surfaces to be disinfected (in 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 27


Use # 3 – Disinfection of large non-food contact surfaces in institutional/commercial buildings by mopping using flat mop and bucket







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using flat mop and bucket
Detailed description:
Routine disinfection of large surfaces in large non-food areas.
Contact time for mopping at 200C 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: 20 ml/m2

Dilution (%): 7,5-10
Number and timing of application:
Application frequency: up to 10 times per day per room




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE Bottle, 0,5-5 L
Light precluding HDPE Canister, 1-100 L
Light precluding HDPE Pouch, 0,01-1 L
Light precluding HDPE Jug, 0,5-5 L




4.3.1.   Use-specific instructions for use

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

See general directions for use of meta SPC 7.
4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 7.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 7.
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 7.
4.4.   Use description


Table 28


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying with a wall-mounted device
Detailed description:
Routine disinfection of large surfaces in large non-food and food areas.
Contact times for spraying at 200C in clean conditions:






—


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










—


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




Contact times for spraying at 200C 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: 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 for use

Apply product via wall-mounted device. When used under clean conditions: clean surface before applying the product. Rinse after application.
4.4.2.   Use-specific risk mitigation measures

Do not breathe vapours/spray.
Ensure technical ventilation with at least 15 air exchanges/hour.
4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 7.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 7.
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 7.
4.5.   Use description


Table 29


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







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Routine disinfection of large surfaces in large food areas (e.g. kitchens).
Contact time for spraying at 200C in clean conditions:






—


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










—


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




Contact times for spraying at 200C 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: 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 for use

When used under clean conditions: clean surface before applying the product. For optimum results, hold the bottle upright and spray from a distance of 10 cm to 20 cm. Spray the diluted product onto the surface, wipe the surface with a clean, dry wipe and let air dry. Always close the nozzle after use. Do not rinse after use. Used wipes must be disposed of in a closed container.
4.5.2.   Use-specific risk mitigation measures

Do not breathe vapours/spray.
Keep food, feed or beverages away from treated surfaces until dried. Do not use directly on or near food, feed or drinks.
The area of the surfaces to be disinfected (in 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 (7)
OF THE META SPC 7

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions. The product should be applied to a dry surface. Wet surface completely using the product. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass.
Dilution instruction (7,5%): to produce 1 L of diluted surface disinfectant, add 75 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
Dilution instruction (10%): to produce 1 L of diluted surface disinfectant, add 100 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
Dilution instruction (15%): to produce 1 L of diluted surface disinfectant, add 150 ml of the concentrated product to approximately 500 ml of distilled water or water of equal quality (e.g. demineralised), mix and fill up to 1 L with distilled water or water of equal quality.
5.2.   Risk mitigation measures

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

FIRST AID MEASURES
In case of 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




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


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


Non-active substance


53563-70-5


 


2,15




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


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


Non-active substance


105391-15-9


 


0,62




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












Trade name(s)


KitchenPro Oxy Des Super Concentrate


Market area: EU




 


Incidin OxyConcentrate FF


Market area: EU




CidalSan Large Area


Market area: EU




Authorisation number


EU-0024303-0009 1-7




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


4,95




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


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


Non-active substance


53563-70-5


 


2,15




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


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


Non-active substance


105391-15-9


 


0,62





META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier






Identifier


META SPC 8




1.2.   Suffix to the authorisation number







Number


1-8




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 8 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


1,0 


1,0 




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







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8







Hazard statements


 




Precautionary statements


 




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

4.1.   Use description


Table 30


Use # 1 – Disinfection of surfaces in industry (e.g. dining areas, bathrooms) by wiping using impregnated RTU wipes







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of surfaces in industry (e.g. dining areas, bathrooms).
Contact time for wiping at 100C in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact times for wiping at 200C 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: 1 wipe per m2 (corresponding to 10 ml/m2)
Dilution (%): RTU product
Number and timing of application:
Application frequency: up to 10 times per day per room




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding PP Bucket with 10-5 000  impregnated 60% polyester / 40% lyocell blend or non-woven 100% polypropylene wipes (wipe size: 200x250 mm or 200x200 mm).
Light precluding PP Pouch with 10-5 000  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 for use

See general directions for use of meta SPC 8.
4.1.2.   Use-specific risk mitigation measures

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

See general directions for use of meta SPC 8.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 8.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 8.
4.2.   Use description


Table 31


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







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of small surfaces in food processing plant.
Contact time for wiping at 100C in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact times for wiping at 200C 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: 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 for use

See general directions for use of meta SPC 8.
4.2.2.   Use-specific risk mitigation measures

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

See general directions for use of meta SPC 8.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 8.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 8.
4.3.   Use description


Table 32


Use # 3 – Disinfection of small non-food contact surfaces in healthcare applications by wiping using impregnated RTU wipes







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Routine disinfection of smaller surfaces in hospital rooms and medical practices that are not frequently touched by people.
Contact time for wiping at 100C in dirty conditions:






—


5 minutes for bacteria and yeasts.




Contact times for wiping at 200C in dirty conditions:






—


15 minutes for bacteria, yeasts and fungi;










—


60 minutes for mycobacteria.








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 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 for use

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

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

See general directions for use of meta SPC 8.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 8.
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 8.
5.   GENERAL DIRECTIONS FOR USE (8)
OF THE META SPC 8

5.1.   Instructions for use

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

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

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

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


1,0





META SPC 9

1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier







Identifier


META SPC 9




1.2.   Suffix to the authorisation number







Number


1-9




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 9 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


7,0 


7,7 




Phosphoric acid


Orthophosphoric acid


Non-active substance


7664-38-2


231-633-2


1,5 


1,5 




Nitric acid


Nitric acid


Non-active substance


7697-37-2


231-714-2


3,71 


3,71 




Alcohol EO phosphate ester


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


Non-active substance


68130-47-2


 


14,625 


14,625 




Alkylpolyglycoside C8-C10


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


Non-active substance


68515-73-1


500-220-1


6,35 


6,35 




Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)


Alcohols, C10-C16 ethoxylated propoxylated


Non-active substance


69227-22-1


 


3,0 


3,0 




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







Formulation(s)


SL - Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9







Hazard statements


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




Precautionary statements


Keep only in original packaging.
Wash hands thoroughly after handling.
Do not breathe vapours.
Do not breathe spray.
Wear face protection.
Wear protective gloves.
Wear eye protection.
Wear protective clothing.
IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
Immediately call a doctor.
Immediately call a POISON CENTER.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
Specific treatment (see first aid instructions on this label).
Wash contaminated clothing before reuse.
Absorb spillage to prevent material damage.
Store in a corrosion-resistant container with a resistant inner liner.
Store locked up.
Dispose of contents to in accordance with national regulations.
Dispose of container to in accordance with national regulations.




4.   AUTHORISED USE(S) OF THE META SPC 9

4.1.   Use description


Table 33


Use # 1 – Disinfection of small non-food contact surfaces in healthcare applications by wiping using clean single-use cloth/wipe and bucket







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using cloth/wipe and bucket
Detailed description:
Routine and non-routine disinfection of smaller surfaces in hospital rooms and medical practices that are frequently touched by people and that are not frequently touched by people.
Contact times for wiping at 200C 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




4.1.1.   Use-specific instructions for use

Routine disinfection: Disinfection of surfaces which might be contaminated with pathogens during medical or nursing processes, on a regular basis, to reduce the risk of transmission of such organisms via surfaces.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. Pour diluted product into a clean bucket and distribute across surface using a single-use cloth/wipe, wipe the surface with a clean cloth/wipe and let air dry. Do not rinse after use. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass. Used wipes must be disposed of in a closed container.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 9.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 9.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 9.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 9.
4.2.   Use description


Table 34


Use # 2 – Disinfection of large non-food contact surfaces in healthcare applications by mopping using flat mop and bucket







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using flat mop and bucket
Detailed description:
Routine and non-routine disinfection of larger surfaces in hospital rooms and medical practices that are frequently touched by people and that are not frequently touched by people.
Contact times for mopping at 200C 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: 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




4.2.1.   Use-specific instructions for use

Routine disinfection: Disinfection of surfaces which might be contaminated with pathogens during medical or nursing processes, on a regular basis to reduce the risk of transmission of such organisms via surfaces.
Non-routine disinfection: Disinfection in specific risk situations (unless differently regulated by national public health authorities).
The product is intended for one-step cleaning and disinfection. Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with a clean, dry mop and let air dry. Do not rinse after use.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 9.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 9.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 9.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 9.
4.3.   Use description


Table 35


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger sprayer and dry wipe
Detailed description:
Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms).
Contact times for spraying and wiping at 200C 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 200C 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 200C 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 200C 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 200C 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 for spraying: 10 ml/m2

Dilution (%): 3-5
Number and timing of application:
Application frequency for trigger spraying: up to 10 times per day per room
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 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 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 for use

Do not rinse after use.
Spraying: For optimum results, hold the bottle upright and spray from a distance of 30 cm. Spray the diluted product onto a dry wipe and wipe small surfaces such as worktops and equipment, or spray the diluted product onto the surface, wipe the surface with a clean, dry wipe or let air dry. Always close the nozzle after use. Used wipes must be disposed of in a closed container.
Wiping: Pour diluted product into a clean bucket and distribute across surface using single-use cloth/wipe, wipe the surface with a clean cloth/wipe and let air dry. Used wipes must be disposed of in a closed container.
Mopping: Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with a clean, dry mop and let air dry.
4.3.2.   Use-specific risk mitigation measures

Do not breathe vapours/spray.
For spraying: The area of the surface to be disinfected (in 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 36


Use # 4 – Disinfection of large non-food contact surfaces in institutional/commercial buildings by mopping using flat mop and bucket







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using flat mop and bucket
Detailed description:
Routine disinfection of large surfaces in large non-food areas.
Contact times for mopping at 200C 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: 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 for use

Fill the bucket with diluted product and distribute across floor using flat mop, wipe the surface with a clean, dry mop and let air dry. Do not rinse after use.
4.4.2.   Use-specific risk mitigation measures

Ensure technical ventilation with at least 15 air exchanges/hour.
4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 9.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 9.
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 9.
4.5.   Use description


Table 37


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







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying with a wall- mounted device
Detailed description:
Routine disinfection of large surfaces in large non-food and food areas.
Contact time for spraying at 200C in dirty conditions:






—


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




Contact times for spraying at 200C in clean conditions:






—


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










—


15 minutes for yeasts (2% dilution).








Application rate(s) and frequency


Application rate: 180 ml/m2

Dilution (%): 1,5-3
Number and timing of application:
Application frequency: once per day per room




Category(ies) of users


Professional




Pack sizes and packaging material


Light precluding HDPE Bottle, 0,5-5 L
Light precluding HDPE Jug, 0,5-5 L
Light precluding HDPE Pouch, 0,01-1 L




4.5.1.   Use-specific instructions for use

When used under clean conditions: clean surface before applying the product. Apply product via wall-mounted device. Rinse after application.
4.5.2.   Use-specific risk mitigation measures

Do not breathe vapours/spray.
Ensure technical ventilation with at least 15 air exchanges/hour.
4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 9.
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 9.
4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 9.
4.6.   Use description


Table 38


Use # 6 – Disinfection of large food contact surfaces in institutional/commercial buildings by spraying using trigger sprayer and dry wipe







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Spraying using trigger spray and dry wipe
Detailed description:
Routine disinfection of large surfaces in large food areas (e.g. kitchens).
Contact times for spraying and wiping at 200C 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




4.6.1.   Use-specific instructions for use

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

Do not breathe vapours/spray.
Keep food, feed or beverages away from treated surface until dried. Do not use directly on or near food, feed or drinks.
The area of the surface to be disinfected (in 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 39


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







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using single-use cloth/wipe and bucket
Detailed description:
Routine disinfection of large surfaces in large food areas (e.g. kitchens).
Contact times for wiping at 200C 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 for use

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

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

See general directions for use of meta SPC 9.
4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 9.
4.7.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 9.
5.   GENERAL DIRECTIONS FOR USE (9)
OF THE META SPC 9

5.1.   Instructions for use

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


7,0




Phosphoric acid


Orthophosphoric acid


Non-active substance


7664-38-2


231-633-2


1,5




Nitric acid


Nitric acid


Non-active substance


7697-37-2


231-714-2


3,71




Alcohol EO phosphate ester


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


Non-active substance


68130-47-2


 


14,625




Alkylpolyglycoside C8-C10


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


Non-active substance


68515-73-1


500-220-1


6,35




Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)


Alcohols, C10-C16 ethoxylated propoxylated


Non-active substance


69227-22-1


 


3,0




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












Trade name(s)


Oasis Pro Oxy Des


Market area: EU




 


Maxx Oxy Des 2


Market area: EU




Authorisation number


EU-0024303-0012 1-9




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


7,0




Phosphoric acid


Orthophosphoric acid


Non-active substance


7664-38-2


231-633-2


1,5




Nitric acid


Nitric acid


Non-active substance


7697-37-2


231-714-2


3,71




Alcohol EO phosphate ester


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


Non-active substance


68130-47-2


 


14,625




Alkylpolyglycoside C8-C10


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


Non-active substance


68515-73-1


500-220-1


6,35




Alcohols, C10-C16 ethoxylated propoxylated (Dehydol 980)


Alcohols, C10-C16 ethoxylated propoxylated


Non-active substance


69227-22-1


 


3,0





META SPC 10

1.   META SPC 10 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 10 identifier







Identifier


META SPC 10




1.2.   Suffix to the authorisation number







Number


1-10




1.3.   Product type(s)







Product type(s)


PT01 - Human hygiene (Disinfectants)




2.   META SPC 10 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active Substance


7722-84-1


231-765-0


1,4 


1,61 




Citric acid monohydrate


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


Non-active substance


5949-29-1


201-069-1


0,9 


0,9 




Phenoxyethanol


2-Phenoxyethanol


Non-active substance


122-99-6


204-589-7


0,9 


0,9 




Sodium lauryl Sulphate


Sodium dodecyl sulphate


Non-active substance


151-21-3


205-788-1


3,88 


3,88 




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


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


Non-active substance


68187-32-6


269-087-2


2,0 


2,0 




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


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


Non-active substance


90583-11-2


292-209-0


1,12 


1,12 




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







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10







Hazard statements


May be corrosive to metals.
Causes serious eye irritation.




Precautionary statements


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




4.   AUTHORISED USE(S) OF THE META SPC 10

4.1.   Use description


Table 40


Use # 1 – Hygienic hand wash







Product type


PT01 - Human hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Direct application onto skin
Detailed description:
Antimicrobial hand soap, intended only as hygienic hand wash for food and beverage industry.
Contact time at 200C in dirty conditions:






—


60 seconds for bacteria and yeasts.








Application rate(s) and frequency


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 for use

See general directions for use of meta SPC 10.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 10.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 10.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 10.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 10.
5.   GENERAL DIRECTIONS FOR USE (10)
OF THE META SPC 10

5.1.   Instructions for use

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

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

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

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




Citric acid monohydrate


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


Non-active substance


5949-29-1


201-069-1


0,9




Phenoxyethanol


2-Phenoxyethanol


Non-active substance


122-99-6


204-589-7


0,9




Sodium lauryl Sulphate


Sodium dodecyl sulphate


Non-active substance


151-21-3


205-788-1


3,88




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


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


Non-active substance


68187-32-6


269-087-2


2,0




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


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


Non-active substance


90583-11-2


292-209-0


1,12





META SPC 11

1.   META SPC 11 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 11 identifier







Identifier


META SPC 11




1.2.   Suffix to the authorisation number







Number


1-11




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 11 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active substance


7722-84-1


231-765-0


1,5 


1,5 




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







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11







Hazard statements


 




Precautionary statements


 




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

4.1.   Use description


Table 41


Use # 1 – Disinfection of life sciences cleanrooms by wiping using impregnated RTU wipes







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of small surfaces, materials and equipment in life sciences cleanrooms and supporting environments (e.g. pharmaceutical industry) and transfer disinfection.
Contact times for wiping at 200C 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 200C 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 Aluminium/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 for use

See general directions for use of meta SPC 11.
4.1.2.   Use-specific risk mitigation measures

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

See general directions for use of meta SPC 11.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 11.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 11.
4.2.   Use description


Table 42


Use # 2 – Disinfection of life sciences cleanrooms by mopping using impregnated RTU mop wipes







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Mopping using impregnated RTU mop wipes
Detailed description:
Disinfection of floors in life sciences cleanrooms and supporting environments (e.g. pharmaceutical industry).
Contact times for wiping at 200C 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 200C 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 Aluminium/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 for use

See general directions for use of meta SPC 11.
4.2.2.   Use-specific risk mitigation measures

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

See general directions for use of meta SPC 11.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 11.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 11.
4.3.   Use description


Table 43


Use # 3 – Disinfection of small non-food contact surfaces in health care applications by wiping using impregnated RTU wipes







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Routine disinfection of smaller surfaces in hospital rooms and medical practices that are not frequently touched by people.
Contact times for wiping at 200C in clean conditions:






—


15 minutes for Clostridium difficile;










—


30 minutes for bacterial spores, mycobacteria and viruses.




Contact times for wiping at 200C 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 for use

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

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

See general directions for use of meta SPC 11.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 11.
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 11.
4.4.   Use description


Table 44


Use # 4 – Disinfection of small non-food contact surfaces in institutional/commercial buildings by wiping using impregnated RTU wipes







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Routine disinfection of small surfaces in small non-food areas (e.g. bathrooms).
Contact times for wiping at 200C in clean conditions:






—


15 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores, mycobacteria and viruses.




Contact times for wiping at 200C 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: 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 for use

See general directions for use of meta SPC 11.
4.4.2.   Use-specific risk mitigation measures

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

See general directions for use of meta SPC 11.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 11.
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 11.
4.5.   Use description


Table 45


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







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:
Scientific name: Fungi
Common name: Fungi
Development stage:
Scientific name: Mycobacteria
Common name: Mycobacteria
Development stage:
Scientific name: Bacterial spores
Common name: Bacterial spores
Development stage:
Scientific name: Clostridium difficile
Common name: Bacterial spores
Development stage:
Scientific name: Viruses
Common name: Viruses
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Routine disinfection of small surfaces in small food areas (e.g. kitchens).
Contact times for wiping at 200C in clean conditions:






—


15 minutes for Clostridium difficile spores;










—


30 minutes for bacterial spores, mycobacteria and viruses.




Contact time for wiping at 200C 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: 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 for use

See general directions for use of meta SPC 11.
4.5.2.   Use-specific risk mitigation measures

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

See general directions for use of meta SPC 11.
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 11.
4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 11.
5.   GENERAL DIRECTIONS FOR USE (11)
OF THE META SPC 11

5.1.   Instructions for use

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

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

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

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




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





META SPC 12

1.   META SPC 12 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 12 identifier







Identifier


META SPC 12




1.2.   Suffix to the authorisation number







Number


1-12




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 12 COMPOSITION

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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Hydrogen peroxide


 


Active substance


7722-84-1


231-765-0


2,0 


2,3 




N-propanol


Propan-1-ol


Non-active substance


71-23-8


200-746-9


17,5 


17,5 




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







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12







Hazard statements


Flammable liquid and vapour.
Causes serious eye damage.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical equipment.
Use explosion-proof ventilating equipment.
Use explosion-proof lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Wear eye protection.
Wear face protection.
IF ON SKIN (or hair):Take off immediately all contaminated clothing. Rinse skin with water.
IF IN EYES :Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER.
Immediately call a doctor.
In case of fire: Use water to extinguish.
Store in a well-ventilated place. Keep cool.
Dispose of contents to in accordance with national regulations.
Dispose of container to in accordance with national regulations.




4.   AUTHORISED USE(S) OF THE META SPC 12

4.1.   Use description


Table 46


Use # 1 – Disinfection of surfaces in industry (e.g. dining areas, bathrooms) by wiping using impregnated RTU wipes







Product type


PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of surfaces in industry (e.g. dining areas, bathrooms).
Contact time for wiping at 100C and 200C in dirty conditions:






—


5 minutes for bacteria and yeasts.








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 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 for use

See general directions for use of meta SPC 12.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 12.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 12.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 12.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 12.
4.2.   Use description


Table 47


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







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage:
Scientific name: Yeasts
Common name: Yeasts
Development stage:




Field(s) of use


Indoor




Application method(s)


Method: Wiping using impregnated RTU wipes
Detailed description:
Disinfection of small surfaces in food processing plants.
Contact time for wiping at 100C and 200C in dirty conditions:






—


5 minutes for bacteria and yeasts.








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 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 for use

See general directions for use of meta SPC 12.
4.2.2.   Use-specific risk mitigation measures

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

See general directions for use of meta SPC 12.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 12.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 12.
5.   GENERAL DIRECTIONS FOR USE (12)
OF THE META SPC 12

5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions. The product should be applied to a dry surface. Wet surface completely using the product. Allow surface to air dry after using the product. Do not rinse after use. Close container when not in use. Do not use wipes which have become dehydrated. Dispose of the container when empty. Do not use on surfaces sensitive to oxidative agents such as marble, copper or brass. Used wipes must be disposed of in closed container.
5.2.   Risk mitigation measures

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

FIRST AID MEASURES
In case of 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


2,0




N-propanol


Propan-1-ol


Non-active substance


71-23-8


200-746-9


17,5






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

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

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

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

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

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

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

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

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

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

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

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



ELI: http://data.europa.eu/eli/reg_impl/2024/2209/oj
ISSN 1977-0677 (electronic edition)