Commission Implementing Regulation (EU) 2024/1707 of 19 June 2024 granting a Union authorisation for the biocidal product family STERI-PEROX in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

ANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
STERI-PEROX®
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Authorisation number EU-0031643-0000
R4BP asset number EU-0031643-0000
PART I
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
STERI-PEROX®
1.2.    Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
Veltek Associates Inc. Europe
Address
Rozengaard 1940 8212DT Lelystad NL
Authorisation number
EU-0031643-0000
R4BP asset number
EU-0031643-0000
Date of the authorisation
10 July 2024
Expiry date of the authorisation
30 June 2034
1.4.    Manufacturer(s) of the product
Name of manufacturer
Veltek Associates, Inc.
Address of manufacturer
15 Lee Blvd. PA19355 Malvern United States (the)
Location of manufacturing sites
15 Lee Blvd. PA19355 Malvern United States (the)
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Hydrogen peroxide
Name of manufacturer
Evonik Operations GmbH (Acting for Evonik Active Oxygens, LLC (US))
Address of manufacturer
One Commerce Square 2005 Market Street Suite 3200 PA 19103 Philadelphia United States (the)
Location of manufacturing sites
Evonik Operations GmbH (Acting for Evonik Active Oxygens, LLC (US)) site 1 PeroxyChem Bayport Plant, 12000 Bay Area Blvd TX 77507 Passadena United States (the)
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
6,4 - 6,4 % (w/w)
2.2.    Type(s) of formulation
Formulation type(s)
AL Any other liquid
XX diverse: Ready to Use Wipe
PART II.
SECOND INFORMATION LEVEL - META SPC(S)
1.    META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
Meta SPC 1 - Wipes
1.2.    Suffix to the authorisation number
Number
1-1
1.3.    Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
2.    META SPC 1 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Hydrogen peroxide
active substance
7722-84-1
231-765-0
6,4 - 6,4 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 1
Formulation type(s)
XX Diverse: Ready to Use Wipe
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
H319: Causes serious eye irritation.
Precautionary statements
P264: Wash face and hands thoroughly after handling.
P280: Wear eye protection/face protection.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1.
1.1 – Industrial use – Wipe - Indoors - Meta SPC 1
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
Field(s) of use
indoor use
Disinfectant of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs. Not for use in medical areas. Disinfectant for use in manufacturing facilities including the clean room areas found in the pharmaceutical,biopharmaceutical, medical device and diagnostic product manufacturing facilities.
Application method(s)
Method: Wiping
Detailed description: -
Application rate(s) and frequency
Application rate: 30,5 cm x 30,5 cm wipe – 32,5 ml per wipe. 7,5 ml is freely available per wipe. 1 wipe = 7,5 ml per m 2
Dilution (%): The product is ready to use.
Number and timing of application:
Frequency: 3 applications per day.
Contact time: 10 minutes
Use temperature: room temperature
Category(ies) of users
industrial
Pack sizes and packaging material
Wipe is composed of 100% continuous filament polyester fibre.
Pack sizes are detailed below:
Sterile (gamma irradiated) or non-sterile
Wipes:
12 x 12 inches (30,5 cm x 30,5 cm). 20 wipes per pack. 10 packs per case. Reclosable (peel and seal) low density polyethylene (opaque) bags.
12 x 12 inches (30,5 cm x 30,5 cm). Individual wipe. 100 packs per case. Low density polyethylene (opaque) bags.
4.1.1.    Use-specific instructions
See general directions for use
4.1.2.    Use-specific risk mitigation measures
See general directions for use
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
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use
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
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1.    Instructions for use
Apply away from eyes and face. Pre-clean surface before application.
Only use wet wipes. Remove one or two wipes at a time. Wipe article thoroughly to ensure it is visibly wet. Allow surface to remain wet for 10 minutes (bactericidal and yeasticidal uses). Discard wipe after use. Close the package after opening.
5.2.    Risk mitigation measures
During application only the user of the product can be present in the room.
During application and for re-entry, the airborne hydrogen peroxide levels may not exceed the AEC inhalation limit of 1,25 mg/m 3  (or a lower relevant national reference value). A calibrated sensor shall be used to establish that the airborne hydrogen peroxide levels are not exceeded.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.
Prevent entry to sewers and public waters. Notify authorities if product enters sewers or public waters.
5.4.    Instructions for safe disposal of the product and its packaging
Waste disposal recommendation: Dispose in a safe manner in accordance with local/national regulations. Ecology - waste materials: Avoid release to the environment.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Keep in a cool, well-ventilated place. Reseal package between uses to retain moisture.
Store in original container. Protect from frost. Do not store at temperatures high than 40°C.
Shelf-life = 2 years
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)
STERI-PEROX® 6% WIPE
Market area: EU
Authorisation number
EU-0031643-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Hydrogen peroxide
active substance
7722-84-1
231-765-0
6,4
1.    META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
Meta SPC2 - Liquid
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
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
6,4 - 6,4 % (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
H319: Causes serious eye irritation.
Precautionary statements
P264: Wash face and hands thoroughly after handling.
P280: Wear eye protection/face protection.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1.
2.1 - Industrial use – Liquid spraying - Indoors - Meta SPC 2
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: Fungi
Development stage: no data
Field(s) of use
indoor use
Disinfectant of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs. Not for use in medical areas. Disinfectant for use in manufacturing facilities including the clean room areas found in the pharmaceutical, biopharmaceutical, medical device and diagnostic industries.
Application method(s)
Method: spraying
Detailed description: -
Application rate(s) and frequency
Application rate: 60 ml product per m 2
Dilution (%): The product is ready to use.
Number and timing of application:
Frequency: 3 applications per day.
Contact time: 10 minutes for bacteria and yeasts, 20 minutes for fungi
Use temperature: room temperature
Category(ies) of users
industrial
Pack sizes and packaging material
473 ml bottle (sterile only).
946 ml bottle (sterile only).
Trigger spray attachment is supplied separately.
Packaging materials:
Bottles
Bottles are made of high density polyethylene (opaque). A separate hand sprayer has polypropylene dip tube. The bottle cap is polypropylene, the induction seal is polypropylene. Bottles are provided with a polyethylene sprayer separately within bags, the sprayers are not connected to the bottles and are supplied separately. The sterile versions are individually double-bagged and bags are heat-sealed shut. Optional quadruple bagging is available. Distributors distribute sealed cases, not individual customers.
4.1.1.    Use-specific instructions
Pre-clean surface before application. Unwrap and apply trigger to bottle. Pre-clean surface before application. Direct the spray onto the surface from a distance of 15-20 cm away. Thoroughly wet surface with product and allow to take effect for a minimum of 10 minutes (bactericidal, yeasticidal uses) and 20 minutes (for fungicidal uses). Allow surface to air dry, or after the required contact time has been achieved, wipe dry with sterilised cloth or wipe, if necessary.
4.1.2.    Use-specific risk mitigation measures
See general directions for use
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
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use
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
4.2.    Use description
Table 2.
2.2 - Industrial use – Liquid Soaking – Indoors – Meta SPC 2
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: Fungi
Development stage: no data
Scientific name: no data
Common name: Bacterial spores
Development stage: no data
Field(s) of use
indoor use
Disinfectant of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs. Not for use in medical areas. Disinfectant for use in manufacturing facilities including the clean room areas found in the pharmaceutical, biopharmaceutical, medical device and diagnostic industries.
Application method(s)
Method: Soaking
Detailed description: -
Application rate(s) and frequency
Application rate: -
Dilution (%): The product is ready to use.
Number and timing of application:
Frequency: 3 applications per day
Contact time: 10 minutes (bactericidal, yeasticidal), 20 minutes (fungicidal), 60 minutes (sporicidal)
Use temperature: room temperature
Category(ies) of users
industrial
Pack sizes and packaging material
Bottles:
473 ml bottle (sterile only)
946 ml bottle (sterile only).
Bottles are made of high density polyethylene (opaque). The bottle cap is polypropylene, the induction seal is polypropylene. The sterile versions are individually double-bagged and bags are heat-sealed shut. Optional quadruple bagging is available.
3,79 litres (sterile and non-sterile)
Containers made of high density polyethylene (opaque) with a moulded carrying handle and small screw-capped pouring spout moulded towards the top edge. Polypropylene screw cap with liner covers the pouring opening, the induction seal is polypropylene. All bottle caps are screw caps and able to be re-applied onto the bottle.
Distributors distribute sealed cases, not individual containers. The sterile versions are individually double-bagged and bags are heat-sealed shut. Optional quadruple bagging is available.
Drum:
200 litres (sterile only)
High Density polyethylene (opaque). Blow moulded, closed head. Molded integral top ring. Double bagged and shrink wrapped to secure it.
For secure dispensing after opening, the 200 litres drum has a 5 centimeter top-mounted polypropylene screw cap having a one-way directional dip tube attached to a length of 0,95 cm Santoprene® 73A FDA rubber tubing to connect to a peristaltic non-product contact dispensing pump of the customer’s choice – not supplied. The pump and tubing remain attached and ready for dispensing during the entire use period. There are no fittings for adding material back into the drum.
4.2.1.    Use-specific instructions
Pre-clean surface before application. immerse item in a basin with product and allow to remain in the basin for a minimum of 10 minutes (bactericidal, yeasticidal uses), 20 minutes (fungicidal uses) or 60 minutes (sporicidal use). After the required contact time has been achieved, allow surface to air dry, or wipe dry with sterilised cloth or wipe, if necessary. Only use dipping bath once.
4.2.2.    Use-specific risk mitigation measures
See general directions for use
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
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use
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
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1.    Instructions for use
Use with adequate ventilation and apply away from eyes and face.
5.2.    Risk mitigation measures
During application only the user of the product can be present in the room.
During application and for re-entry, the airborne hydrogen peroxide levels may not exceed the AEC inhalation limit of 1,25 mg/m 3  (or a lower relevant national reference value). A calibrated sensor shall be used to establish that the airborne hydrogen peroxide levels are not exceeded.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.
Prevent entry to sewers and public waters. Notify authorities if product enters sewers or public waters.
5.4.    Instructions for safe disposal of the product and its packaging
Waste disposal recommendations: Dispose in a safe manner in accordance with local or national regulations. Ecology – waste materials: Avoid release to the environment
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep container tightly closed. Keep in a cool, well-ventilated place. Reseal package between uses to retain moisture. For the liquid discard 60 days after opening
Store in original container. Protect from frost. Do not store at temperatures higher than 40°C.
Shelf-life = 2 years
6.    OTHER INFORMATION
Trade name: STERI-PEROX ®  6%
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)
STERI-PEROX 6%
Market area: EU
Authorisation number
EU-0031643-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Hydrogen peroxide
active substance
7722-84-1
231-765-0
6,4
Commission Implementing Regulation (EU) 2024/1707 of 19 June 2024 granting a Union authorisation for the biocidal product family STERI-PEROX in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

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