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)
Article 1
Article 2
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
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 |
|
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 |
|
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 |
|
Name of manufacturer |
Cheport spol s.r.o. |
||
Address of manufacturer |
Lhotsko 93 76312 Vizovice Czechia |
||
Location of manufacturing sites |
|
Name of manufacturer |
Helichem |
||
Address of manufacturer |
Kozakkenberg 5 5951 DL Belfeld Netherlands (the) |
||
Location of manufacturing sites |
|
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 |
|
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 |
|
Name of manufacturer |
ITW Contamination Control BV |
||
Address of manufacturer |
Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the) |
||
Location of manufacturing sites |
|
Name of manufacturer |
Arkema |
||
Address of manufacturer |
Tankhoofd 10 Haven 3255 3196 KE Rotterdam Netherlands (the) |
||
Location of manufacturing sites |
|
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 |
|
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 |
|
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 |
|
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 |
|
Active substance |
Hydrogen peroxide |
||||
Name of manufacturer |
Arkema GmbH |
||||
Address of manufacturer |
Tersteegenstr. 28 D-40474 Düsseldorf Germany |
||||
Location of manufacturing sites |
|
Active substance |
Hydrogen peroxide |
||
Name of manufacturer |
Evonik Antwerpen NV |
||
Address of manufacturer |
Tijsmanstunnel West 2040 Antwerpen Belgium |
||
Location of manufacturing sites |
|
Active substance |
Hydrogen peroxide |
||
Name of manufacturer |
Evonik Peroxid GmbH |
||
Address of manufacturer |
Industriestraße 1 9721 Weißenstein Austria |
||
Location of manufacturing sites |
|
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 |
|
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 |
|
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
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
4.1.2.
Use-specific risk mitigation measures
4.1.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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
4.2.2.
Use-specific risk mitigation measures
4.2.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.
Use description
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
4.3.2.
Use-specific risk mitigation measures
4.3.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
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
4.4.2.
Use-specific risk mitigation measures
4.4.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.4.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.5.
Use description
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
4.5.2.
Use-specific risk mitigation measures
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
4.5.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.5.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.6.
Use description
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
4.6.2.
Use-specific risk mitigation measures
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
4.6.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.6.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.7.
Use description
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
4.7.2.
Use-specific risk mitigation measures
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
4.7.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.7.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.8.
Use description
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
4.8.2.
Use-specific risk mitigation measures
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
4.8.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.8.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.9.
Use description
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
4.9.2.
Use-specific risk mitigation measures
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
4.9.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.9.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.10.
Use description
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
4.10.2.
Use-specific risk mitigation measures
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
4.10.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.10.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.11.
Use description
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
4.11.2.
Use-specific risk mitigation measures
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
4.11.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.11.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.12.
Use description
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
4.12.2.
Use-specific risk mitigation measures
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
4.12.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.12.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.13.
Use description
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
4.13.2.
Use-specific risk mitigation measures
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
4.13.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.13.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.14.
Use description
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
4.14.2.
Use-specific risk mitigation measures
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
4.14.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.14.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.15.
Use description
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
4.15.2.
Use-specific risk mitigation measures
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
4.15.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.15.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5.
GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6.
OTHER INFORMATION
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
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
4.1.2.
Use-specific risk mitigation measures
4.1.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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
4.2.2.
Use-specific risk mitigation measures
4.2.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.
Use description
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
4.3.2.
Use-specific risk mitigation measures
4.3.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.4.
Use description
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
4.4.2.
Use-specific risk mitigation measures
4.4.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.4.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.4.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.5.
Use description
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
4.5.2.
Use-specific risk mitigation measures
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
4.5.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.5.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.6.
Use description
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
4.6.2.
Use-specific risk mitigation measures
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
4.6.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.6.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.7.
Use description
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
4.7.2.
Use-specific risk mitigation measures
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
4.7.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.7.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.8.
Use description
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
4.8.2.
Use-specific risk mitigation measures
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
4.8.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.8.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.9.
Use description
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
4.9.2.
Use-specific risk mitigation measures
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
4.9.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.9.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.10.
Use description
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
4.10.2.
Use-specific risk mitigation measures
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
4.10.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.10.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.11.
Use description
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
4.11.2.
Use-specific risk mitigation measures
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
4.11.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.11.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5.
GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6.
OTHER INFORMATION
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
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
4.1.2.
Use-specific risk mitigation measures
4.1.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.2.
Use description
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
4.2.2.
Use-specific risk mitigation measures
4.2.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
4.3.
Use description
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
4.3.2.
Use-specific risk mitigation measures
4.3.3.
Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
4.3.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.3.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5.
GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6.
OTHER INFORMATION
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) |