Commission Implementing Regulation (EU) 2025/839 of 5 May 2025 granting a Union authorisation for the biocidal product family Oxivir Excel BPF in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2025-05-05
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval








L_202500839EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/839


6.5.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/839
of 5 May 2025
         
granting a Union authorisation for the biocidal product family ‘Oxivir Excel BPF’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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


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

Whereas:







(1)


On 16 December 2016, Diversey Europe Operations B.V. submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Oxivir Excel BPF’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-DL028504-45 in the Register for Biocidal Products.












(2)


‘Oxivir Excel BPF’ contains hydrogen peroxide as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.












(3)


On 25 September 2023, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 20 March 2024, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Oxivir Excel BPF’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


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












(6)


On 15 April 2024, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘Oxivir Excel BPF’.












(8)


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





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0032483-0000 is hereby granted to Diversey Europe Operations B.V. for the making available on the market and use of the biocidal product family ‘Oxivir Excel BPF’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 26 May 2025 until 30 April 2035.


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 May 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  ECHA opinion of 29 February 2024 on the Union authorisation of ‘Oxivir Excel BPF’ (ECHA/BPC/417/2024), https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
Oxivir Excel BPF

Product type(s)

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

Authorisation number EU-0032483-0000

R4BP asset number EU-0032483-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Oxivir Excel BPF




1.2.   Product type(s)







Product type(s)


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




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Diversey Europe Operations B.V.




Address


De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL




Authorisation number


 


EU-0032483-0000





R4BP asset number



 


EU-0032483-0000




Date of the authorisation


26 May 2025




Expiry date of the authorisation


30 April 2035




1.4.   Manufacturer(s) of the product







Name of manufacturer


Diversey Europe Operations B.V.




Address of manufacturer


De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL




Location of manufacturing sites


 













Name of manufacturer


Multifill BV




Address of manufacturer


Constructieweg 25a 3640 AJ Mijdrecht Netherlands (the)




Location of manufacturing sites







Multifill BV site 1




Constructieweg 25a 3640 AJ Mijdrecht Netherlands (the)

















Name of manufacturer


Pluswipes LTD




Address of manufacturer


Pywell Rd, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites







Pluswipes LTD site 1




Pywell Rd, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)

















Name of manufacturer


Flexible Medical Packaging Ltd




Address of manufacturer


Unit 8, Hightown - White Cross Industrial Estate LA1 4XS Lancanster, Lancashire United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Flexible Medical Packaging Ltd site 1
Unit 8, Hightown - White Cross Industrial Estate LA1 4XS Lancanter, Lancashire United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Entegris Cleaning Process (ECP) S.A.S




Address of manufacturer


395 rue Louis Lépine 34000 Montpellier France




Location of manufacturing sites







Entegris Cleaning Process (ECP) S.A.S site 1




395 rue Louis Lépine 34000 Montpellier France

















Name of manufacturer


Cheport spol s.r.o.




Address of manufacturer


Lhotsko 93 76312 Vizovice Czechia




Location of manufacturing sites







Cheport spol s.r.o. site 1




Lhotsko 93 76312 Vizovice Czechia

















Name of manufacturer


Helichem




Address of manufacturer


Kozakkenberg 5 5951 DL Belfeld Netherlands (the)




Location of manufacturing sites







Helichem site 1




Kozakkenberg 5 5951 DL Belfeld Netherlands (the)

















Name of manufacturer


LARA KOZMETİK HİJYENİK ÜRÜNLERİ SAN. VE DIŞ TİC. A.Ş.




Address of manufacturer


Türkgücü Organize San. Bölgesi 123.Sokak No 4/1 59580 Çorlu, Tekirdağ Türkiye




Location of manufacturing sites







LARA KOZMETİK HİJYENİK ÜRÜNLERİ SAN. VE DIŞ TİC. A.Ş. site 1




Türkgücü Organize San. Bölgesi 123.Sokak No:4/1 59580 Çorlu, Tekirdağ Türkiye

















Name of manufacturer


SAPRO Temizlik Ürünleri Sanayi ve Ticaret A.Ş.




Address of manufacturer


Ortaköy Mah. İlter Bulvarı No: 27 34592 Silivri, Istanbul Türkiye




Location of manufacturing sites







SAPRO Temizlik Ürünleri Sanayi ve Ticaret A.Ş. site 1




Ortaköy Mah. İlter Bulvarı No: 27 34592 Silivri, Istanbul Türkiye

















Name of manufacturer


ITW Contamination Control BV




Address of manufacturer


Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the)




Location of manufacturing sites







ITW Contamination Control BV site 1




Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the)

















Name of manufacturer


Arkema




Address of manufacturer


Tankhoofd 10 Haven 3255 3196 KE Rotterdam Netherlands (the)




Location of manufacturing sites







Arkema site 1




Morschheimer Strasse 19 D-67292 Kirchheimbolanden Germany








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







Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Operations GmbH




Address of manufacturer


Evonik Resource Efficiency GmbH, Rellinghauser Strasse 1-11 D-45128 Essen Germany




Location of manufacturing sites







Evonik Resource Efficiency GmbH site 1




Untere Kanalstr. 3 79618 Rheinfelden Germany

















Active substance


Hydrogen peroxide




Name of manufacturer


Solvay Chemicals International SA




Address of manufacturer


Solvay Chemicals International SA, Rue Ransbeek 310 1120 Brussels Belgium




Location of manufacturing sites







Solvay Chemicals International site 1




Via Piave 6 57013 Rosignano Solvay Italy




Solvay Chemicals International site 2




Köthensche Strasse 1-3 06406 Bernburg Germany




Solvay Chemicals International site 3




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




Solvay Chemicals International site 4




Yrjonojantie 2 45911 Voikkaa Finland




Solvay Chemicals International site 5




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

















Active substance


Hydrogen peroxide




Name of manufacturer


Kemira Oyj




Address of manufacturer


Kemira Oyj, Porkkalankatu 3, PL 330 00101 Helsinki Finland




Location of manufacturing sites







Kemira Oyj site 1




Moezelweg 151 3198 LS Rotterdam Netherlands (the)




Kemira Oyj site 2




Typpitie PL 171 90101 Oulu Finland




Kemira Oyj site 3




Industrigatan 83 25109 Helsingborg Sweden

















Active substance


Hydrogen peroxide




Name of manufacturer


Arkema France




Address of manufacturer


420, rue dÉstienne dÓrves F-92705 Colombes Cedex France




Location of manufacturing sites







Arkema b.v. site 1




Route National 85 38560 Jarrie France




Arkema b.v. site 2




Am Haupttor, Bau 2410 06237 Leuna Germany

















Active substance


Hydrogen peroxide




Name of manufacturer


Arkema GmbH




Address of manufacturer


Tersteegenstr. 28 D-40474 Düsseldorf Germany




Location of manufacturing sites







Arkema b.v site 1




Route National 85 3856 Jarrie France




Arkema b.v. site 2




Am Haupttor, Bau 2410 0623 Leuna Germany

















Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Antwerpen NV




Address of manufacturer


Tijsmanstunnel West 2040 Antwerpen Belgium




Location of manufacturing sites







Evonik Antwerpen site 1




Tijsmanstunnel West 2040 Antwerpen Belgium

















Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxid GmbH




Address of manufacturer


Industriestraße 1 9721 Weißenstein Austria




Location of manufacturing sites







Evonik Peroxid GmbH site 1




Industriestrasse 1 9721 Weissenstein Austria

















Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxide Netherlands BV




Address of manufacturer


Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the)




Location of manufacturing sites







Evonik Peroxide Netherlands BV site 1




Oosterhorn 14 9936 HD Farmsum Netherlands (the)

















Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Peroxide Spain, S.L.U.




Address of manufacturer


C/ Afueras s/h. 50784 La Zaida Spain




Location of manufacturing sites







Evonik Peroxide Spain, S.L.U. site 1




Calle Afueras s/n 50784 La Zaida Spain








2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


0,36  - 7,2  % (w/w)




(C9-C11) Alkyl alcohol ethoxylate


(C9-C11) Alkyl alcohol ethoxylate


Non-Active substance


68439-46-3


 


0,09  - 1,8  % (w/w)




alkyl benzene sulphonic acid


2-Dodecylbenzenesulfonic acid


Non-Active substance


85536-14-7


287-494-3


0,97  - 19,4  % (w/w)




methane sulphonic acid


 


Non-Active substance


75-75-2


200-898-6


0,12  - 2,4  % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AL Any other liquid
SL Soluble concentrate
AL (Any other liquid) - RTU wipe




PART II

SECOND INFORMATION LEVEL - META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


Meta SPC: Meta-SPC 1: Concentrate




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
PT04: Food and feed area




2.   META SPC 1 COMPOSITION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


7,2  - 7,2  % (w/w)




alkyl benzene sulphonic acid


2-Dodecylbenzenesulfonic acid


Non-Active substance


85536-14-7


287-494-3


19,4  - 19,4  % (w/w)




(C9-C11) Alkyl alcohol ethoxylate


(C9-C11) Alkyl alcohol ethoxylate


Non-Active substance


68439-46-3


 


1,8  - 1,8  % (w/w)




methane sulphonic acid


 


Non-Active substance


75-75-2


200-898-6


2,4  - 2,4  % (w/w)




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







Formulation type(s)


SL Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


H314: Causes severe skin burns and eye damage.
H412: Harmful to aquatic life with long lasting effects.
H290: May be corrosive to metals.




Precautionary statements


P234: Keep only in original packaging.
P273: Avoid release to the environment.
P280: Wear protective gloves, protective clothing and eye or face protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P310: Immediately call a POISON CENTRE, doctor or physician.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTRE, doctor or physician.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P310: Immediately call a POISON CENTRE, doctor or physician.
P363: Wash contaminated clothing before reuse.
P390: Absorb spillage to prevent material damage.
P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1.


Use # 1.1 – Cleaning and disinfection by mopping for healthcare areas.







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces for healthcare areas.




Application method(s)


Method: Mopping
Detailed description:
Mopping with a soaked mop.




Application rate(s) and frequency


Application rate: 11 to 40 ml/m2 Dilute the product with water to reach 4,5 % product
Number and timing of application:
Frequency of use: 7 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE intermediate bulk container (IBC): 100-1 000  litres




4.1.1.   Use-specific instructions

Product dilution:
bactericidal, yeasticidal and virucidal 4,5% product.
For packs with manual dilution system:
To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the dilution of 4,5%. Carefully fill up with the rest of the water.
Add the concentrated product to the water to avoid splashes of concentrated product.
Dip the mop into the container. Squeeze the surplus solution. Clean and disinfect the floor with the wet mop.
Make sure to wet the surface completely.
Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection.
For packs with (semi-)automatic dilution system with 2 settings:
Select the right setting on the dosing equipment. Fill a container with the diluted product (4,5%). Dip the mop into the container. Squeeze the surplus solution. Clean and disinfect the floor with the wet mop. Make sure to wet the surface completely. Allow to act for 5 minutes.
Let it air dry. No rinsing needed after disinfection.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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 # 1.2– Cleaning and disinfection with a cloth or sponge for healthcare areas.







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces for healthcare areas




Application method(s)


Method: spreading
Detailed description:
Spreading with a soaked cloth or sponge.




Application rate(s) and frequency


Application rate: 11 to 40 ml/m2 Dilute the product with water to reach 4,5% product
Number and timing of application:
Frequency of use: 7 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2.5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.2.1.   Use-specific instructions

Product dilutions:
Bactericidal, yeasticidal & virucidal 4,5%
For packs with manual dilution system
To prevent foaming, fill a container three quarters full of water. Add the correct amount of product to reach the dilution of 4,5%. Carefully fill up with the rest of the water.
Soak the cloth or sponge in the solution. Distribute the liquid on the surface. Make sure to wet the surface completely.
Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
For packs with (semi-)automatic dilution system
Select the right setting on the dosing equipment. Fill a container with the diluted product (4,5%). Soak the cloth or sponge in the solution. Distribute the liquid on the surface.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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 # 1.3 – Cleaning and disinfection of small objects by soaking or dipping for healthcare areas.







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for small objects (e.g. scissors and brushes) for healthcare areas.
The biocidal use excludes disinfection of medical devices.




Application method(s)


Method: Soaking or dipping
Detailed description:
Soaking or dipping in the solution.




Application rate(s) and frequency


Application rate: up to 3 litres Dilute the product with water to reach 4,5% product
Number and timing of application:
Frequency of use: 1 time a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.3.1.   Use-specific instructions

Product dilutions:
bactericidal, yeasticidal & virucidal 4,5%
For packs with manual dilution system:
To prevent foaming, fill a container three quarters with water. Add the correct amount of product to reach the dilution of 4,5%. Carefully fill up with the rest of the water.
Add the product to the water to avoid splashes of concentrated product.
Cover dipping bath with a lid after placing the objects in the disinfection solution.
Ensure that items to be disinfected are fully submerged in the solution for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
For packs with (semi-)automatic dilution system:
Select the right setting on the dosing equipment. Fill a container with the diluted product (4,5%).
Cover dipping bath with a lid after placing the objects in the disinfection solution.
Ensure that items to be disinfected are fully submerged in the solution for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
The solutions for soaking or dipping can be used only once.
4.3.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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 # 1.4 – Cleaning and disinfection by foaming for healthcare areas.







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces for healthcare areas.




Application method(s)


Method: spraying
Detailed description:
Spraying using a trigger foam. Optionally wipe to spread the solution.




Application rate(s) and frequency


Application rate: 11 ml/m2 Dilute the product with water to reach 4,5% product
Number and timing of application:
Frequency of use:
For use in toilets and bathrooms: 4 times a day
For use in hospitals and medical practices: 8 times a day
For use in laboratories: 10 times a day
For use in cleanrooms: 10 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.4.1.   Use-specific instructions

Product dilutions:
bactericidal, yeasticidal & virucidal 4,5%
For packs with manual dilution system:
To prevent foaming, fill a foaming spray bottle three quarters full of water. Add the correct amount of concentrated product. to reach the dilution of 4,5%. Carefully fill up with the rest of the water.
Apply the diluted product. Optionally wipe to spread the solution.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
Only for small surface disinfection.
For packs with (semi-)automatic dilution system:
Select the right setting on the dosing equipment. Fill a foaming spray bottle with the diluted product. Apply the diluted product. Optionally wipe to spread the solution.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
Only for small surface disinfection.
4.4.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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
4.5.   Use description


Table 5.


Use # 1.5 –Cleaning and disinfection using moist wipes (incl. healthcare areas)







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces.




Application method(s)


Method: Wiping
Detailed description:
Wiping with prepared moist wipes.




Application rate(s) and frequency


Application rate: 1,5 m2 per wipe Dilute the product with water to reach 5% product.
Number and timing of application:
Frequency of use: 8 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material



Liquid: High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres

Dry Wipes are packed in a HDPE bucket with 125 wipes (polypropylene (PP) sold separately).




4.5.1.   Use-specific instructions

Prepare 1,5 litres dilution by adding 75 ml Oxivir Excel to 1,425 litres water.
Apply 1,5 litres diluted product to the Dry Wipes bucket. Distribute the liquid evenly. Close the bucket.
Open the lid. Take a single wipe. Close the lid after taking a wipe. Only use wet wipes. Wipe the surface and make sure to wet the surface completely.
Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection.
4.5.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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 1
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 1
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 1
4.6.   Use description


Table 6.


Use # 1.6 – Cleaning and disinfection of food contact surfaces using a mop







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces that get into contact with food




Application method(s)


Method: Mopping
Detailed description:
Mopping with a soaked mop.




Application rate(s) and frequency


Application rate: 11 to 40 ml/m2 Dilute the product with water to reach 3,75% product
Number and timing of application:
Frequency of use: 7 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.6.1.   Use-specific instructions

Product dilution: bactericidal, yeasticidal & virucidal 3,75%
For packs with manual dilution system:
To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the dilution of 3,75%. Carefully fill up with the rest of the water.
Add the concentrated product to the water to avoid splashes of the concentrated product.
Dip the mop into the container. Squeeze the surplus solution. Clean and disinfect the floor with the wet mop.
Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection.
For packs with (semi-) automatic dilution system:
Select the right setting on the dosing equipment. Fill a container with the diluted product (3,75%). Soak the mop in the solution. Distribute the liquid.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
4.6.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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 1
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 1
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 1
4.7.   Use description


Table 7.


Use # 1.7 – Cleaning and disinfection of food contact surfaces using a cloth or sponge.







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces that get into contact with food.




Application method(s)


Method: spreading
Detailed description:
Spreading with a soaked cloth or sponge.




Application rate(s) and frequency


Application rate: 11 to 40 ml/m2 Dilute the product with water to reach 3,75% product
Number and timing of application:
Frequency of use: 7 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.7.1.   Use-specific instructions

Product dilution: bactericidal, yeasticidal & virucidal 3,75%
For packs with manual dilution system:
To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the dilution of 3,75%. Carefully fill up with the rest of the water.
Add the concentrated product to the water to avoid splashes of concentrated product.
Soak the cloth or sponge in the solution. Distribute the liquid.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
For packs with (semi-) automatic dilution system:
Select the right setting on the dosing equipment. Fill a container with the diluted product (3,75%). Soak the cloth or sponge in the solution. Distribute the liquid.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
4.7.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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 1
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 1
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 1
4.8.   Use description


Table 8.


Use #1.8 – Cleaning and disinfection of food contact small objects by soaking or dipping.







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for small objects (e.g. kitchen utensils) that get into contact with food.




Application method(s)


Method: Soaking or dipping
Detailed description:
Soaking or dipping in the solution.




Application rate(s) and frequency


Application rate: up to 3 litres Dilute the product with water to reach 3,75% product
Number and timing of application:
Use at room temperature
Frequency of use: 1 time a day




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.8.1.   Use-specific instructions

Product dilution: bactericidal, yeasticidal & virucidal 3,75%
For packs with manual dilution system:
To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product. to reach the dilution of 3,75%. Carefully fill up with the rest of the water.
Cover dipping bath with a lid after placing the objects in the disinfection solution.
Ensure that items to be disinfected are fully submerged in the solution for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
For packs with(semi-) automatic dilution system:
Select the right setting on the dosing equipment. Fill a container with diluted product (3,75%). Cover dipping bath with a lid after placing the objects in the disinfection solution.
Ensure that items to be disinfected are fully submerged in the solution for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
The solutions for soaking or dipping can be used only once.
4.8.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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 1
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 1
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 1
4.9.   Use description


Table 9.


Use # 1.9 – Cleaning and disinfection of food contact surfaces by foaming.







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces that get into contact with food.




Application method(s)


Method: spraying
Detailed description:
Spraying using a trigger foam. Optionally wipe to spread the solution.




Application rate(s) and frequency


Application rate: 11 ml/m2 Dilute the product with water to reach 3,75% product
Number and timing of application:
Use at room temperature
Frequency of use:
For use in kitchens and canteen: 4 times a day
For use in food processing industries: 4 times a day
For use on a counter in a shop/supermarket: 8 times a day




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.9.1.   Use-specific instructions

Product dilution: 3,75%
For packs with manual dilution system:
To prevent foaming, fill a foaming spray bottle three quarters withfull of water. Add the correct amount of the concentrated product. to reach a dilution of 3,75%. Carefully fill up with the rest of the water.
Apply the diluted product. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
Only for small surface disinfection.
For packs with full (semi-) automatic dilution system:
Select the right setting on the dosing equipment. Fill a foaming spray bottle with the diluted product (3,75%). Apply the diluted product. Optionally wipe to spread the solution.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
Only for small surface disinfection.
4.9.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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 1
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 1
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 1
4.10.   Use description


Table 10.


Use # 1.10 –Cleaning and disinfection of food contact surfaces with moist wipes







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces that get in contact with food.




Application method(s)


Method: Wiping
Detailed description:
Wiping with prepared moist wipes.




Application rate(s) and frequency


Application rate: 1,5 m2 per wipe Dilute the product with water to reach 5% product.
Number and timing of application:
Frequency of use: 8 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material



Oxivir Excel:
High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres

Dry Wipes are packed in a HDPE bucket with 125 wipes (PP). (sold separately)




4.10.1.   Use-specific instructions

Product dilution 5%
Prepare 1,5 litres dilution by adding 75 ml of the concentrated product to 1,425 litres of water. To prevent foaming , fill a container three quarters full of water.
Apply 1,5 litres of the diluted product to the Dry Wipes bucket. Distribute the liquid evenly. Close the bucket.
Open the lid, take a single wipe, close the lid after taking a wipe. Only use wet wipes. Wipe the surface.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Let it air dry. No rinsing needed after disinfection.
4.10.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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 1
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 1
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 1
4.11.   Use description


Table 11.


Use # 1.11 – Cleaning and disinfection of hard surfaces by mopping in non-health care areas.







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces.




Application method(s)


Method: Mopping
Detailed description:
Mopping with a soaked mop.




Application rate(s) and frequency


Application rate: 11 to 40 ml/m2 Dilute the product with water to reach the following concentration of the product Bactericidal – 1,5% product Yeasticidal – 3,75% product Virucidal – 2% product
Number and timing of application:
Frequency of use: 7 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.11.1.   Use-specific instructions

Product dilutions:
Bactericidal – 1,5% product
Yeasticidal – 3,75% product
Virucidal – 2% product
For packs with manual dilution system:
To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the appropriate dilution of the product. Carefully fill up with the rest of the water.
Add the concentrated product to the water to avoid splashes of the concentrated product. Dip the mop into the container. Squeeze the surplus solution. Clean and disinfect the floor with the wet mop. Make sure to wet the surface completely. Allow to act for 5 minutes.
Let it air dry. No rinsing needed after disinfection.
For packs with (semi-) automatic dilution system:
Select the right setting on the dosing equipment. Fill a container with the diluted product. Dip the mop into the container. Squeeze the surplus solution. Clean and disinfect the floor with the wet mop. Make sure to wet the surface completely. Allow to act for 5 minutes.
Let it air dry. No rinsing needed after disinfection.
4.11.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
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 1
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 1
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 1
4.12.   Use description


Table 12.


Use # 1.12 – Cleaning and disinfection of hard surfaces with a cloth or sponge in non-health care areas.







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces




Application method(s)


Method: spreading
Detailed description:
Spreading with a soaked cloth or sponge.




Application rate(s) and frequency


Application rate: 11 to 40 ml/m2 Dilute the product with water to reach the following concentration of the product bactericidal – 1,5% product yeasticidal – 3,75% product virucidal – 2% product
Number and timing of application:
Use at room temperature
Frequency of use: 7 times a day




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.12.1.   Use-specific instructions

Product dilutions:
bactericidal 1,5%; yeasticidal 3,75%; virucidal 2%
For packs with manual dilution system:
To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the appropriate dilution of the product. Carefully fill up with the rest of the water.
Soak the cloth or sponge in the solution. Distribute the liquid. Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
For packs with(semi-) automatic dilution system:
Select the right setting on the dosing equipment. Fill a container with the diluted product. Soak the cloth or sponge in the solution. Distribute the liquid.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
4.12.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
4.12.3.   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
4.12.4.   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
4.12.5.   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
4.13.   Use description


Table 13.


Use # 1.13 – Cleaning and disinfection of small objects by soaking or dipping in non-health care areas







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for small objects (e.g. scissors and brushes).




Application method(s)


Method: Soaking or dipping
Detailed description:
Soaking or dipping in the solution.




Application rate(s) and frequency


Application rate: up to 3 litres Dilute the product with water to reach the following concentration of the product Bactericidal – 1,5% product. Yeasticidal – 3,75% product. Virucidal – 2% product
Number and timing of application:
Frequency of use: 1 time a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE)canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.13.1.   Use-specific instructions

Product dilution:
Bactericidal – 1,5% product.
Yeasticidal – 3,75% product.
Virucidal – 2% product
For packs with manual dilution system:
To prevent foaming, fill a container three quarters full of water. Add the correct amount of the concentrated product to reach the appropriate dilution of the product. Carefully fill up with the rest of the water. Cover dipping bath with a lid after placing the objects in the disinfection solution.
Ensure that items to be disinfected are fully submerged in the solution for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
For packs with (semi-) automatic dilution system:
Select the right setting on the dosing equipment. Fill a container with the diluted product.
Cover dipping bath with a lid after placing the objects in the disinfection solution.
Ensure that items to be disinfected are fully submerged in the solution for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
The solutions for soaking or dipping can be used only once.
4.13.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
4.13.3.   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
4.13.4.   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
4.13.5.   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
4.14.   Use description


Table 14.


Use # 1.14 – Cleaning and disinfection of surfaces by foaming in non-health care areas.







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces.




Application method(s)


Method: spraying
Detailed description:
Spraying using a trigger foam. Optionally wipe to spread out the solution.




Application rate(s) and frequency


Application rate: 11 ml/m2 Dilute the product with water to reach the following concentration of the product Bactericidal - 1,5% product, Yeasticidal - 3,75% product, Virucidal - 2% product
Number and timing of application:
Use at room temperature
Frequency of use:
If product is intended for use in toilets and bathrooms: 4 times a day
If product is intended for use in cosmetic/pharmaceutical manufacturing facilities: 8 times a day
If product is intended for use in laboratories: 10 times a day
If product is intended for use in cleanrooms: 10 times a day




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.14.1.   Use-specific instructions

Product dilutions:
bactericidal 1.5%; yeasticidal 3.75%; virucidal 2%
For packs with manual dilution system:
To prevent foaming, fill a foaming spray bottle three quarters full of water. Add the correct amount of the concentrated product to reach the appropriate dilution of the product. Carefully fill up with the rest of the water.
Apply the diluted product. Optionally wipe to spread the solution.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
Only for small surfaces disinfection.
For packs with (semi) automatic dilution system:
Select the right setting on the dosing equipment. Fill a foaming spray bottle with the diluted product. Apply the diluted product. Optionally wipe to spread the solution.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
Only for small surfaces disinfection.
4.14.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
4.14.3.   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
4.14.4.   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
4.14.5.   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
4.15.   Use description


Table 15.


Use # 1.15 – Disinfection of pre-cleaned hard surfaces.







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Disinfection product for pre-cleaned hard surfaces (incl. healthcare areas, pharmaceutical industry, cosmetic industry, laboratories and cleanrooms)




Application method(s)


Method: Spreading, dipping and foam spraying
Detailed description:
Spreading using a soaked mop.Spreading using a soaked cloth or sponge.Dipping in a solution.Foam spraying, optionally wipe to spread the solution




Application rate(s) and frequency


Application rate: Application using a soaked mop: 11 to 40 ml/m2, application using a soaked cloth or sponge: 11 to 40 ml/m2, dipping in a solution: 3 litres, foam spraying: 11 ml/m2. Dilute the product with water to reach 2,5%
Number and timing of application:
Frequency of use:
Application using a soaked mop: 7 times a day
Application using a soaked cloth/sponge: 7 times a day
Dipping: 1 time a day
Foam spraying: bathrooms & toilets 4 times a day
healthcare 8 times a day
laboratories & cleanrooms 10 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.15.1.   Use-specific instructions

Product dilutions:
Bactericidal, yeasticidal & virucidal 2,5%
For packs with manual dilution system:
To prevent foaming, fill a container three quaters full of water. Add the correct amount of concentrated product to reach the dilution of 2,5%. Carefully fill up with the rest of the water.
For packs with (semi-)automatic dilution system:
Select the right setting on the dosing equipment. Fill a container eith the diluted product (2,5%).
Application using a soaked mop: Dip the mop into the container. Squeeze the surplus solution. Apply onto floor.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Application using a soaked cloth/sponge: Soak the cloth or sponge in the solution. Distribute the liquid on the surface.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Dipping: Cover dipping bath with a lid after placing the objects in the disinfection solution.
Ensure that items to be disinfected are fully submerged in the solution for 5 minutes. The solutions for soaking or dipping can be used only once.
Foam spraying: Fill a spray bottle with foam head. Apply the diluted product. Optionally wipe to spread the solution. Make sure to wet the surface completely. Allow to act for 5 minutes. Only for small surfaces disinfection.
Wipe dry or let air dry. No rinsing needed after disinfection
4.15.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 1
4.15.3.   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
4.15.4.   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
4.15.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

5.1.   Instructions for use

For professional use:
Keep away from food, drink and animal feeding stuffs.
Wash hands after handling.
Keep only in original container.
Do not mix with other products.
5.2.   Risk mitigation measures

The following personal protective equipment (PPE) is stipulated without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.
The use of eye protection (consistent with the European Standard EN 166)16 321 or equivalent during handling of the concentrated product is mandatory.
Wear protective chemical resistant gloves (classified under the European Standard EN ISO 374) or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
Wear chemical-resistant clothing (consistent with the European Standard EN 14605) or equivalent and wear suitable protective footwear (consistent with the European Standards EN 13832) or equivalent when handling concentrated products.
See section 6 for the full titles of the EN standards.
Keep pets away from treated surfaces until dried.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

Environmental precautions:

Do not allow to enter drainage system, surface or groundwater. Do not allow to enter the ground/soil. Dilute with plenty of water. Inform responsible authorities in case undiluted product reaches drainage system, surface or ground water or the ground/soil.
5.4.   Instructions for safe disposal of the product and its packaging

Dispose of contents/container to a hazardous waste disposal service in accordance with the statutory regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

2 year shelf life.
Store in the dark. Do not store at temperatures above 30°C.
6.   OTHER INFORMATION

The products of this meta-SPC may also be intended for the disinfecting of Medical Device surfaces in medical and clinical areas. In such a case, their placing on the market or putting into service must comply with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 05/05/2017, p. 1) and they are medical devices classified as class IIa. Those uses are out of the scope of this biocidal registration.product family authorisation and are not covered by it.
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full titles of the EN standards referenced in section 5.2 “Risk mitigation measures” are:
EN 13832 - Footwear protecting against chemicals
EN ISO 374 - Protective gloves against dangerous chemicals and micro-organisms
EN ISO 16321 - Eye and face protection for occupational use
EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]).
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
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)


Oxivir Excel


Market area: EU




Oxivir Excel H+


Market area: EU




Oxivir Excel J-flex


Market area: EU




Oxivir Excel SmartDose


Market area: EU




Oxivir Excel SD


Market area: EU




Oxivir Excel Conc


Market area: EU




Oxivir Excel Concentrate


Market area: EU




Oxivir Excel IBC


Market area: EU




Oxivir Excel Acti


Market area: EU




Oxivir Excel Des


Market area: EU




Oxivir Excel Duo


Market area: EU




Clinell H2O2 concentrate


Market area: EU




Antibac Oxivir concentrate


Market area: EU




Divosan AHP VS70


Market area: EU




TASKI Sani AHP-Des


Market area: EU




TASKI Sprint AHP-Des


Market area: EU




Suma AHP D10.7


Market area: EU




Suma AHP


Market area: EU




Suma San AHP D10.7


Market area: EU




Suma San AHP


Market area: EU




ClearKlens AHP Conc


Market area: EU




ClearKlens Excel Conc


Market area: EU




DOMESTOS Expert Conc


Market area: EU




GLORIX Expert Conc


Market area: EU




KLINEX Expert Conc


Market area: EU




LYSOFORM Expert Conc


Market area: EU




SAVO Expert Conc


Market area: EU




CIF Expert Conc


Market area: EU




VISS Expert Conc


Market area: EU




JIF Expert Conc


Market area: EU




FLORASZEPT Expert Conc


Market area: EU




ANDY Expert Conc


Market area: EU




SUPERANDY Expert Conc


Market area: EU




LIFEBUOY Expert Conc


Market area: EU




ANDYSAN Expert Conc


Market area: EU




Authorisation number


 


EU-0032483-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


7,2 % (w/w)




alkyl benzene sulphonic acid


2-Dodecylbenzenesulfonic acid


Non-Active substance


85536-14-7


287-494-3


19,4 % (w/w)




(C9-C11) Alkyl alcohol ethoxylate


(C9-C11) Alkyl alcohol ethoxylate


Non-Active substance


68439-46-3


 


1,8 % (w/w)




methane sulphonic acid


 


Non-Active substance


75-75-2


200-898-6


2,4 % (w/w)




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC: Meta-SPC 2: RTU




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 2 COMPOSITION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


0,36  - 0,36  % (w/w)




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







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


H290: May be corrosive to metals.




Precautionary statements


P102: Keep out of reach of children.
P234: Keep only in original packaging.
P390: Absorb spillage to prevent material damage.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1.


Use # 2.1 – Cleaning and disinfection by mopping (incl. healthcare areas).







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces (incl. healthcare areas)




Application method(s)


Method: Mopping
Detailed description:
Mopping with a soaked mop.




Application rate(s) and frequency


Application rate: 11 to 40 ml/m2 Ready to use product
Number and timing of application:
Use at room temperature
Frequency of use: 7 times a day




Category(ies) of users


professional ; general public (non-professional)




Pack sizes and packaging material


Professional and non-professional users:
High Density Polyethene (HDPE)Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres
Professional users:
HDPE canister 20 litres – 50 litres – 100 litres – 200 litres
HDPE IBC 100 - 1 000  litres




4.1.1.   Use-specific instructions

Fill a container with the product. Dip the mop into the container. Squeeze the surplus of the product. Mop the floor with the wet mop.
Make sure to wet the surface completely. Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 2
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

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


Table 2.


Use # 2.2 – Cleaning and disinfection with a cloth or sponge (incl. healthcare areas)







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for hard surfaces (incl. healthcare areas).




Application method(s)


Method: spreading
Detailed description:
Spreading with a soaked cloth or sponge.




Application rate(s) and frequency


Application rate: 11 to 40 ml/m2 Ready to use product
Number and timing of application:
Use at room temperature
Frequency of use: 1 time a day




Category(ies) of users


professional ; general public (non-professional)




Pack sizes and packaging material


Professional and non-professional users:
High Density Polyethene (HDPE) Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres
Professional users:
HDPE canister 20 litres – 50 litres – 100 litres – 200 litres
HDPE IBC 100 - 1 000  litres




4.2.1.   Use-specific instructions

Soak the cloth or sponge in the product by dipping. Distribute the liquid on the surface.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 2
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

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


Table 3.


Use # 2.3 – Cleaning and disinfection of small objects by soaking or dipping (incl. healthcare areas)







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Cleaning and disinfection product for small objects (e.g. scissors, brushes. ) incl. objects for healthcare areas.
The biocidal use excludes disinfection of medical devices.




Application method(s)


Method: Soaking or dipping
Detailed description:
Soaking or dipping in the solution.




Application rate(s) and frequency


Application rate: up to 3 litres Ready to use product
Number and timing of application:
Use at room temperature
Frequency of use: 1 time a day




Category(ies) of users


professional ; general public (non-professional)




Pack sizes and packaging material


Professional and non-professional users:
High Density Polyethene (HDPE)Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres
Professional users:
HDPE canister 20 litres – 50 litres – 100 litres – 200 litres
HDPE IBC 100 - 1 000  litres




4.3.1.   Use-specific instructions

Ensure that items to be disinfected are fully submerged in the solution for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
The solutions for soaking or dipping can be used only once.
4.3.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 2
4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

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


Table 4.


Use # 2.4 – Cleaning and disinfection by foaming (incl. healthcare areas)







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Ready to use cleaning and disinfection product for hard surfaces (incl. healthcare areas).




Application method(s)


Method: spraying
Detailed description:
Spraying using a trigger foam. Optionally wipe to spread the solution.




Application rate(s) and frequency


Application rate: 11 ml/m2 Ready to use product
Number and timing of application:
Use at room temperature
Frequency of use:
For use in toilets and bathrooms: 4 times a day
For use for cosmetic/pharmaceutical manufacturing facilities: 8 times a day
For use in laboratories: 10 times a day
For use in cleanrooms: 10 times a day
For use on a counter in a shop/supermarket: 8 times a day
For use in hospitals and medical practices: 8 times a day




Category(ies) of users


professional ; general public (non-professional)




Pack sizes and packaging material


Professional and non-professional users:
750 ml High Density Polyethene (HDPE) trigger spray with foam head
HDPE Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres
Professional users:
HDPE canister 20 litres – 50 litres – 100 litres – 200 litres
HDPE IBC 100 - 1 000  litres




4.4.1.   Use-specific instructions

Apply the product on the surface. Optionally wipe to spread the solution.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
Only for small surface disinfection.
4.4.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 2
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
4.5.   Use description


Table 5.


Use # 2.5 – Cleaning and disinfection using moist wipes (incl. healthcare areas).







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Ready to use cleaning and disinfection product for hard surfaces (incl. healthcare areas).




Application method(s)


Method: Wiping
Detailed description:
Wiping with prepared moist wipes.




Application rate(s) and frequency


Application rate: 1,5 m2 per wipe Ready to use product
Number and timing of application:
Frequency of use: 8 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


HDPE Canister 1L - 1,5 L – 2 L - 2,5 L – 3 L – 5 L – 10 L - 20 L – 50 L – 100 L – 200 L
HDPE IBC 100 - 1 000  Liter
Dry Wipes are packed in a HDPE bucket with 125 wipes (PP) sold separately.




4.5.1.   Use-specific instructions

Apply 1,5 litres product to the Dry Wipes bucket. Distribute the liquid evenly. Close the bucket.
Open the lid. Take a single wipe. Close the lid after taking a wipe. Only use wet wipes. Wipe the surface and make sure to wet the surface completely.
Allow to act for 5 minutes. Let it air dry. No rinsing needed after disinfection.
4.5.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 2
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 2
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 2
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 2
4.6.   Use description


Table 6.


Use # 2.6 – Cleaning and disinfection by mopping (incl. food contact surfaces)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Ready to use cleaning and disinfection product (incl. food contact surfaces)




Application method(s)


Method: Mopping
Detailed description:
Mopping with a soaked mop.




Application rate(s) and frequency


Application rate: 11 to 40 ml/m2 Ready to use product
Number and timing of application:
Use at room temperature
Frequency of use: 1 time a day




Category(ies) of users


professional ; general public (non-professional)




Pack sizes and packaging material


Professional and non-professional users:
High Density Polyethene (HDPE) canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres
Professional users:
HDPE canister 20 litres – 50 litres – 100 litres – 200 litres
HDPE IBC 100 - 1 000  litres




4.6.1.   Use-specific instructions

Fill a container with the product. Dip the mop into the container. Squeeze the surplus solution. Mop the floor with the wet mop.
Make sure to wet the surface completely. Allow to act for 5 minutes and let it air dry. No rinsing needed after disinfection.
4.6.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 2
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 2
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 2
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 2
4.7.   Use description


Table 7.


Use # 2.7 – Cleaning and disinfection with a cloth or sponge (incl. food contact surfaces)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Ready to use cleaning and disinfection product for hard surfaces (incl. food contact surfaces).




Application method(s)


Method: spreading
Detailed description:
Spreading with a soaked cloth or sponge.




Application rate(s) and frequency


Application rate: 11 to 40 ml/m2 Ready to use product
Number and timing of application:
Use at room temperature
Frequency of use: 1 time a day




Category(ies) of users


professional ; general public (non-professional)




Pack sizes and packaging material


Professional and non-professional users:
High Density Polyethene (HDPE) canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres
Professional users:
HDPE canister 20 litres – 50 litres – 100 litres – 200 litres
HDPE IBC 100 - 1 000  litres




4.7.1.   Use-specific instructions

Soak the cloth or sponge in the product by dipping. Distribute the liquid on the surface.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
4.7.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 2
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 2
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 2
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 2
4.8.   Use description


Table 8.


Use # 2.8 – Cleaning and disinfection by soaking or dipping of small objects (incl. food contact surfaces)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Ready to use cleaning and disinfection product for small objects (e.g. kitchen utensils) incl. food contact surfaces).




Application method(s)


Method: Soaking or dipping
Detailed description:
Soaking or dipping in the product.




Application rate(s) and frequency


Application rate: up to 3 litres Ready to use product
Number and timing of application:
Use at room temperature
Frequency of use: 1 time a day




Category(ies) of users


professional ; general public (non-professional)




Pack sizes and packaging material


Professional and non-professional users:
High Density Polyethene (HDPE) canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres
Professional users:
HDPE canister 20 litres – 50 litres – 100 litres – 200 litres
HDPE IBC 100 - 1 000  litres




4.8.1.   Use-specific instructions

Ensure that items to be disinfected are fully submerged in the solution for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection. The solutions for soaking or dipping can be used only once.
4.8.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 2
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 2
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 2
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 2
4.9.   Use description


Table 9.


Use # 2.9 – Cleaning and disinfection by foaming (incl. food contact surfaces)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Ready to use cleaning and disinfection product for hard surfaces (incl. food contact surfaces).




Application method(s)


Method: spraying
Detailed description:
Spraying using a trigger foam. Optionally wipe to spread out the solution.




Application rate(s) and frequency


Application rate: 11 ml/m2 Ready to use product
Number and timing of application:
Use at room temperature
Frequency of use for:
For use in kitchens and canteen: 4 times a day
For use in food processing industries: 4 times a day
For use on a counter in a shop/supermarket: 8 times a day




Category(ies) of users


professional ; general public (non-professional)




Pack sizes and packaging material


Professional and non-professional users:
750 ml High Density Polyethene (HDPE) trigger foam HDPE Canister
1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres
Professional users:
HDPE canister 20 litres – 50 litres – 100 litres – 200 litres
HDPE IBC 100 - 1 000  litres




4.9.1.   Use-specific instructions

Apply the product on the surface. Optionally wipe to spread the solution.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Wipe dry or let it air dry. No rinsing needed after disinfection.
Only for small surface disinfection.
4.9.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 2
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 2
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 2
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 2
4.10.   Use description


Table 10.


Use # 2.10 – Cleaning and disinfection with moist wipes (incl. food contact surfaces)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Ready to use cleaning and disinfection product for hard surfaces (incl. food contact surfaces).




Application method(s)


Method: Wiping
Detailed description:
Wiping with prepared moist wipes.




Application rate(s) and frequency


Application rate: 1,5 m2 per wipe Ready to use product
Number and timing of application:
Use at room temperature
Frequency of use: 8 times a day




Category(ies) of users


professional




Pack sizes and packaging material



RTU liquid:

High Density Polyethene (HDPE) Canister 1 litres - 1,5 litres – 2 litres - 2,5 litres – 3 litres – 5 litres – 10 litres - 20 litres – 50 litres – 100 litres – 200 litres
HDPE IBC 100 - 1 000  litres

Dry Wipes are packed in a HDPE bucket with 125 wipes (PP). (sold separately)




4.10.1.   Use-specific instructions

Apply 1,5 litres product to the Dry Wipes bucket. Distribute the liquid evenly. Close the bucket.
Open the lid, take a single wipe, close the lid after taking a wipe. Only use wet wipes. Wipe the surface.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Let it air dry. No rinsing needed after disinfection.
4.10.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 2
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 2
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 2
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 2
4.11.   Use description


Table 11.


Use # 2.11 – Disinfection of pre-cleaned hard surfaces







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Disinfection product for pre-cleaned hard surfaces (incl. healthcare areas, pharmaceutical industry, cosmetic industry, laboratories and cleanrooms)




Application method(s)


Method: Spreading, dipping and foam spraying
Detailed description:
Spreading with a soaked mop.Spreading with a soaked cloth or sponge.Dipping in a solution.Foam spraying, optionally wipe to spread the solution.




Application rate(s) and frequency


Application rate: Application using a soaked mop: 11 to 40 ml/m2, application using a soaked cloth/sponge: 11 to 40 ml/m2, dipping: 3 litres, foam spraying: 11 ml/m2 ready to use product
Number and timing of application:
Frequency of use:
Application using a soaked mop: 7 times a day
Application using a soaked cloth/sponge: 7 times a day
Dipping: 1 time a day
Foam spraying: bathrooms & toilets 4 times a day
healthcare 8 times a day
laboratories & cleanrooms 10 times a day
Use at room temperature




Category(ies) of users


professional




Pack sizes and packaging material


High Density Polyethene (HDPE) canister: 1 litres - 1,5 litres – 2 litres – 2,5 litres – 3 litres – 5 litres – 10 litres – 20 litres – 50 litres – 100 litres – 200 litres
HDPE bottle (J-Flex): 1,5 litres
HDPE Bottle (Smart Dose): 1,4 litres – 1,5 litres
HDPE IBC: 100-1 000  litres




4.11.1.   Use-specific instructions

Contact time: 5 minutes
Mopping: Dip the mop into the container. Squeeze the surplus solution. Apply onto floor.
Make sure to wet the surface completely. Allow to act for the required contact time.
Cloth/sponge application: Soak the cloth or sponge in the solution. Distribute the liquid on the surface.
Make sure to wet the surface completely. Allow to act for the required contact time.
Dipping:
Cover dipping bath with a lid after placing the objects in the disinfection solution.
Ensure that items to be disinfected are fully submerged in the solution for 5 minutes.
The solutions for soaking or dipping can be used only once.
Foam spraying: Apply the product. Optionally wipe to spread the solution.
Make sure to wet the surface completely. Allow to act for the required contact time.
Only for small surfaces disinfection.
Wipe dry or let air dry. No rinsing needed after disinfection.
4.11.2.   Use-specific risk mitigation measures

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

5.1.   Instructions for use

For professional use:
Keep away from food, drink and animal feeding stuffs.
Wash hands after handling.
Keep only in original container.
Do not mix with other products.
See use-specific instructions for use.
For non-professional use:
Comply with the instructions for use.
Keep away from food, drink and animal feeding stuffs.
Wash hands after handling.
Keep only in original container.
Do not mix with other products.
See use-specific instructions for use.
5.2.   Risk mitigation measures

Keep pets away from treated surfaces until dried.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor..
If medical advice is needed, have product container or label at hand.
5.4.   Instructions for safe disposal of the product and its packaging

Dispose of contents/container to a hazardous waste disposal service in accordance with the statutory regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

2 years shelf life.
Store in the dark. Do not store at temperatures above 50°C.
Keep out of reach of children and non-target animals/pets.
6.   OTHER INFORMATION

The products of this meta-SPC may also be intended for the disinfection of medical devices’ surfaces in medical and clinical areas. In such a case, their placing on the market or putting into service must comply with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 05/05/2017, p. 1) and they are medical devices classified as class IIa. Those uses are out of the scope of this biocidal product family authorisation and are not covered by it.
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
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)


Oxivir Excel Foam


Market area: EU




Oxivir Excel Foam H+


Market area: EU




Oxivir Excel Spray


Market area: EU




Oxivir Excel Spray H+


Market area: EU




Oxivir Excel RTU


Market area: EU




Oxivir Excel RTU H+


Market area: EU




Oxivir Excel RTU IBC


Market area: EU




Oxivir Excel Foam Acti


Market area: EU




Oxivir Excel Foam Des


Market area: EU




Oxivir Excel Foam Duo


Market area: EU




Clinell H2O2 RTU


Market area: EU




Antibac Oxivir RTU


Market area: EU




Divosan AHP Foam RTU VS71


Market area: EU




TASKI Sani AHP-Des Spray


Market area: EU




TASKI Sprint AHP-Des Spray


Market area: EU




Suma AHP RTU D10.7


Market area: EU




Suma AHP Spray D10.7


Market area: EU




Suma AHP RTU


Market area: EU




Suma AHP Spray


Market area: EU




ClearKlens AHP RTU


Market area: EU




ClearKlens Excel RTU


Market area: EU




DOMESTOS Expert


Market area: EU




GLORIX Expert


Market area: EU




KLINEX Expert


Market area: EU




LYSOFORM Expert


Market area: EU




SAVO Expert


Market area: EU




CIF Expert


Market area: EU




VISS Expert


Market area: EU




JIF Expert


Market area: EU




FLORASZEPT Expert


Market area: EU




ANDY Expert


Market area: EU




SUPERANDY Expert


Market area: EU




LIFEBUOY Expert


Market area: EU




ANDYSAN Expert


Market area: EU




Authorisation number


 


EU-0032483-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


0,36 % (w/w)




1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


Meta SPC: Meta-SPC 3: Wipes




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 3 COMPOSITION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


0,36  - 0,36  % (w/w)




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







Formulation type(s)


AL (Any other liquid) - RTU wipe




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


H290: May be corrosive to metals.




Precautionary statements


P102: Keep out of reach of children.
P234: Keep only in original packaging.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1.


Use # 3.1 – Cleaning and disinfection using moist wipes on hard surfaces incl. healthcare areas







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Wipe for cleaning-disinfecting for hard surfaces incl. healthcare areas.




Application method(s)


Method: Wiping
Detailed description:
Wiping with ready to use moist wipes.




Application rate(s) and frequency


Application rate: 1,5 m2 per wipe Ready to use wipe.
Number and timing of application:
Frequency of use: 8 times a day
Use at room temperature




Category(ies) of users


professional ; general public (non-professional)




Pack sizes and packaging material


High Density Polyethene (HDPE) bucket or tub with 100 PP wipes
Polyethylene terephthalate (PET)/low-density polyethylene (LDPE) flow-pack with 100 polypropylene (PP) wipes
PET/LDPE standing bag with 100 PP wipes
All packages are both for professional and non-professional use




4.1.1.   Use-specific instructions

Open the lid. Take a single wipe. Close the lid after taking a wipe. Only use wet wipes. Wipe the surface.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Let it air dry. No rinsing needed after disinfection.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 3
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

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


Table 2.


Use # 3.2 – Cleaning and disinfection using moist wipes on hard surfaces incl. food contact surfaces







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Wipe for cleaning-disinfecting hard surfaces (incl. food contact surfaces)




Application method(s)


Method: Wiping
Detailed description:
Wiping with ready to use moist wipes.




Application rate(s) and frequency


Application rate: 1,5 m2 per wipe Ready to use wipe.
Number and timing of application:
Use at room temperature
Frequency of use: 8 times a day




Category(ies) of users


professional ; general public (non-professional)




Pack sizes and packaging material


High Density Polyethene (HDPE) bucket or tub with 100 PP wipes
PET or LDPE flow-pack with 100 PP wipes
PET or LDPE standing bag with 100 PP wipes
All packages are both for professional and non-professional use




4.2.1.   Use-specific instructions

Open the lid. Take a single wipe. Close the lid after taking a wipe. Only use wet wipes. Wipe the surface.
Make sure to wet the surface completely. Allow to act for 5 minutes.
Let it air dry. No rinsing needed after disinfection.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of Meta-SPC 3
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
4.3.   Use description


Table 3.


Use # 3.3 – Wipe for disinfecting pre-cleaned hard surfaces







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


indoor use
Disinfection wipe for pre-cleaned hard surfaces (incl. healthcare areas, pharmaceutical industry, cosmetic industry, laboratories and cleanrooms)




Application method(s)


Method: Wiping
Detailed description:
Wiping with ready to use moist wipes.




Application rate(s) and frequency


Application rate: 1,5 m2 per wipe Ready to use
Number and timing of application:
Use at room temperature
Frequency of use: 8 times a day




Category(ies) of users


professional




Pack sizes and packaging material


HDPE bucket/tub with 100 PP wipes
PET/LDPE flow-pack with 100 PP wipes
PET/LDPE standing bag with 100 PP wipes




4.3.1.   Use-specific instructions

Contact time: 5 minutes
Open the lid. Take a single wipe. Close the lid after taking a wipe. Only use wet wipes. Wipe the surface.
Make sure to wet the surface completely. Allow to act for the required contact time.
Let it air dry. No rinsing needed after disinfection.
4.3.2.   Use-specific risk mitigation measures

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

5.1.   Instructions for use

For professional use:
Keep away from food, drink and animal feeding stuffs.
Wash hands after handling.
Keep only in original container.
Do not mix with other products.
See use-specific instructions for use.
For non-professional use:
Comply with the instructions for use.
Wash hands after handling.
Keep only in original container.
Do not mix with other products.
See use-specific instructions for use.
5.2.   Risk mitigation measures

Keep pets away from treated surfaces until dried.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.
If medical advice is needed, have product container or label at hand.
5.4.   Instructions for safe disposal of the product and its packaging

Dispose of contents/container to a hazardous waste disposal service in accordance with the statutory regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

2 years shelf life.
Store in the dark. Do not store at temperatures above 50°C.
Keep out of reach of children and non-target animals/pets.
6.   OTHER INFORMATION

The products of this meta-SPC may also be intended for the disinfection of medical devices’ surfaces in medical and clinical areas. In such a case, their placing on the market or putting into service must comply with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 05/05/2017, p. 1) and they are medical devices classified as class IIa. Those uses are out of the scope of this biocidal product family authorisation and are not covered by it.
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The following types of wipes are included:
Wipe with size 15 x 25 cm; weight is 1,52 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%)
Wipe with size 15,2 x 17,7 cm; weight is 1,51 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%)
Wipe with size 15,2 x 20,3 cm; weight is 1,51 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%)
Wipe with size 17,7 x 20,3 cm; weight is 1,50 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%)
Wipe with size 19 x 25,4 cm; weight is 1,49 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%)
Wipe with size 20 x 26,7 cm; weight is 1,49 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%)
Wipe with size 20 x 30 cm; weight is 1,50 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%)
Wipe with size 25 x 25 cm; weight is 1,51 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%)
Wipe with size 25,4 x 25,4 cm; weight is 1,51 gr; 3,75 ml liquid per wipe (wipe liquid load is 250%)
Wipe with size 15 x 25 cm; weight is 1,52 gr; 6 ml liquid per wipe (wipe liquid load is 400%)
Wipe with size 15,2 x 17,7 cm; weight is 1,51 gr; 6 ml liquid per wipe (wipe liquid load is 400%)
Wipe with size 15,2 x 20,3 cm; weight is 1,51 gr; 6 ml liquid per wipe (wipe liquid load is 400%)
Wipe with size 17,7 x 20,3 cm; weight is 1,50 gr; 6 ml liquid per wipe (wipe liquid load is 400%)
Wipe with size 19 x 25,4 cm; weight is 1,49 gr; 6 ml liquid per wipe (wipe liquid load is 400%)
Wipe with size 20 x 26,7 cm; weight is 1,49 gr; 6 ml liquid per wipe (wipe liquid load is 400%)
Wipe with size 20 x 30 cm; weight is 1,50 gr; 6 ml liquid per wipe (wipe liquid load is 400%)
Wipe with size 25 x 25 cm; weight is 1,51 gr; 6 ml liquid per wipe (wipe liquid load is 400%)
Wipe with size 25,4 x 25,4 cm; weight is 1,51 gr; 6 ml liquid per wipe (wipe liquid load is 400%)
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)


Oxivir Excel Wipe


Market area: EU




Oxivir Excel Wipe H+


Market area: EU




Oxivir Excel Wipe Acti


Market area: EU




Oxivir Excel Wipe Des


Market area: EU




Oxivir Excel Wipe Duo


Market area: EU




Clinell H2O2 wipes


Market area: EU




Antibac Oxivir wipes


Market area: EU




Divosan AHP Wipes VS72


Market area: EU




Suma AHP Wipes


Market area: EU




Suma San AHP Wipes


Market area: EU




ClearKlens AHP Wipes


Market area: EU




ClearKlens Excel Wipes


Market area: EU




DOMESTOS Expert Wipes


Market area: EU




GLORIX Expert Wipes


Market area: EU




KLINEX Expert Wipes


Market area: EU




LYSOFORM Expert Wipes


Market area: EU




SAVO Expert Wipes


Market area: EU




CIF Expert Wipes


Market area: EU




VISS Expert Wipes


Market area: EU




JIF Expert Wipes


Market area: EU




FLORASZEPT Expert Wipes


Market area: EU




ANDY Expert Wipes


Market area: EU




SUPERANDY Expert Wipes


Market area: EU




LIFEBUOY Expert Wipes


Market area: EU




ANDYSAN Expert Wipes


Market area: EU




Authorisation number


 


EU-0032483-0003 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hydrogen peroxide


 


active substance


7722-84-1


231-765-0


0,36 % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2025/839/oj
ISSN 1977-0677 (electronic edition)