Commission Implementing Regulation (EU) 2022/1185 of 8 July 2022 granting a Union authorisation for the biocidal product family ‘Contec Hydrogen Peroxide Biocidal Product Family’ (Text with EEA relevance)

ANNEXSummary of product characteristics for a biocidal product family
ANNEX
Summary of product characteristics for a biocidal product family
Contec Hydrogen Peroxide Biocidal Product Family
Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Authorisation number: EU-0027735-0000
R4BP asset number: EU-0027735-0000
PART I
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
Contec Hydrogen Peroxide Biocidal Product Family
1.2.    Product type(s)
Product type(s)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
Contec Europe
Address
Zl Du Prat Avenue Paul Duplaix, 56000 Vannes France
Authorisation number
EU-0027735-0000
R4BP asset number
EU-0027735-0000
Date of the authorisation
31 July 2022
Expiry date of the authorisation
30 June 2032
1.4.    Manufacturer(s) of the biocidal products
Name of manufacturer
Contec Inc.,
Address of manufacturer
525 Locust Grove,, 29303 Spartanburg, United States
Location of manufacturing sites
Unit 6A, Wansbeck Business Park, Rotary Parkway,, NE63 8QW Ashington, United Kingdom
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Hydrogen peroxide
Name of manufacturer
Solvay Chemicals International
Address of manufacturer
Rue Ransbeek 310,, 1120 Brussels, Belgium
Location of manufacturing sites
Rue Solvay 39,, B-5190 Jemeppe-sur-Sambre, Belgium
Via Piave 6, Rosignano Solvay,, I-57013 Livorno, Italy
Köthensche Strasse 1-3,, D06406 Bernburg, Germany
Baronet Road,, WA4 6HA Warrington, United Kingdom
Yrjönojantie 2,, 45910 Voikkaa, Finland
Rua Eng. Clement Dumoulin,, P-2625-106 Povoa de Santa Iria, Portugal
2.    PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1.    Qualitative and quantitative information on the composition of the family
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Hydrogen peroxide
Active Substance
7722-84-1
231-765-0
6,67
6,67
2.2.    Type(s) of formulation
Formulation(s)
AL - Any other liquid
PART II
SECOND INFORMATION LEVEL - META SPC(S)
META SPC 1
1.    META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
meta SPC 1
1.2.    Suffix to the authorisation number
Number
1-1
1.3.    Product type(s)
Product type(s)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
2.    META SPC 1 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Hydrogen peroxide
Active Substance
7722-84-1
231-765-0
6,67
6,67
2.2.    Type(s) of formulation of the meta SPC 1
Formulation(s)
AL - Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
Causes serious eye irritation.
Precautionary statements
Wash hands thoroughly after handling.
Wear eye protection/face protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists:Get medical attention.
If eye irritation persists:Get medical advice.
4.    AUTHORISED USE(S) OF THE META SPC 1
4.1.    Use description
Table 1. Use # 1 – Use #1 - Application by trigger spray onto a suitable cleanroom wipe to distribute onto the inner surface of isolators and Restricted Access Barrier Systems ('RABS')
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
/
Target organism(s) (including development stage)
Scientific name: /
Common name: Bacteria
Development stage: /
Scientific name: /
Common name: Yeasts
Development stage: /
Scientific name: /
Common name: Fungi
Development stage: /
Field(s) of use
Indoor
In isolators and RABS positioned in cleanrooms: disinfection of hard/non-porous surfaces. Not for use in healthcare.
Application method(s)
Method: Spraying the product onto a suitable cleanroom wipe used to distribute the product on the surface.
Detailed description:
/
Application rate(s) and frequency
Application Rate: /
Dilution (%): No dilution - product is ready to use ('RTU')
Number and timing of application:
Ready-to-use product active against bacteria in 15 min and against yeasts and fungi in 30 min contact time at room temperature (~ 20 °C).
Application frequency is specific to the user’s site and requirements.
Category(ies) of users
Professional
Pack sizes and packaging material
1L adjustable trigger spray high density polyethylene ('HDPE') bottle sealed with a polyethylene outer bag.
4.1.1.    Use-specific instructions for use
Spray the product onto a cleanroom wipe inside the isolator or RABS and use to apply the product to the surface to be disinfected. Ensure the entire surface is visibly wet for the contact time: 15 minutes for bacteria and 30 minutes for yeasts and fungi. Do not use more than 50 ml product/m 2 . Uniform distribution of the biocidal product should be ensured. For visibly soiled surfaces, cleaning prior to the disinfection is required.
4.1.2.    Use-specific risk mitigation measures
Avoid hand to eye contact.
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 section General directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 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 section General directions for use.
4.2.    Use description
Table 2. Use # 2 – Use #2 - Application by pouring into a container and using a suitable cleanroom wipe or mop to distribute onto the inner surface of isolators and RABS
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
/
Target organism(s) (including development stage)
Scientific name: /
Common name: Bacteria
Development stage: /
Scientific name: /
Common name: Yeasts
Development stage: /
Scientific name: /
Common name: Fungi
Development stage: /
Field(s) of use
Indoor
In isolators and RABS positioned in cleanrooms: disinfection of hard/non-porous surfaces.
Not for use in healthcare.
Application method(s)
Method: Pouring the product into a suitable container and then distributing it on the surface with a suitable cleanroom wipe or mop.
Detailed description:
/
Application rate(s) and frequency
Application Rate: /
Dilution (%): No dilution - product is RTU.
Number and timing of application:
Ready-to-use product active against bacteria in 15 min and against yeasts and fungi in 30 min contact time at room temperature (~ 20 °C). Application frequency is specific to the user’s site and requirements.
Category(ies) of users
Professional
Pack sizes and packaging material
0.5L, 1 L and 5L tamper evident cap HDPE bottle sealed with a polyethylene outer bag.
4.2.1.    Use-specific instructions for use
Pour the product into a suitable container inside the isolator or RABS and use a cleanroom wipe or mop to apply the product to the surface to be disinfected. Ensure the entire surface is visibly wet for the contact time: 15 minutes for bacteria and 30 minutes for yeasts and fungi. Do not use more than 50 ml product/m 2 . Uniform distribution of the biocidal product should be ensured. For visibly soiled surfaces, cleaning prior to the disinfection is required.
4.2.2.    Use-specific risk mitigation measures
Avoid hand to eye contact.
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 section General directions for use.
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 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 section General directions for use.
4.3.    Use description
Table 3. Use # 3 – Use #3 - Application by trigger spray onto a suitable cleanroom wipe to distribute onto the surface of cleanrooms
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
/
Target organism(s) (including development stage)
Scientific name: /
Common name: Bacteria
Development stage: /
Scientific name: /
Common name: Yeasts
Development stage: /
Scientific name: /
Common name: Fungi
Development stage: /
Field(s) of use
Indoor
Disinfection of hard, non-porous surfaces in cleanrooms.
Not for use in healthcare.
Application method(s)
Method: Spray the product onto a suitable cleanroom wipe used to distribute the product on the surface.
Detailed description:
/
Application rate(s) and frequency
Application Rate: /
Dilution (%): No dilution - product is RTU.
Number and timing of application:
Ready-to-use product active against bacteria in 15 min and against yeasts and fungi in 30 min contact time at room temperature (~ 20 °C). Application frequency is specific to the user’s site and requirements.
Category(ies) of users
Professional
Pack sizes and packaging material
1L adjustable trigger spray HDPE bottle sealed with a polyethylene outer bag.
4.3.1.    Use-specific instructions for use
Spray the product onto a cleanroom wipe and use to apply the product to the surface to be disinfected in the cleanroom. Ensure the entire surface is visibly wet for the contact time: 15 minutes for bacteria and 30 minutes for yeasts and fungi. Do not use more than 50 ml product/m 2 . Uniform distribution of the biocidal product should be ensured. For visibly soiled surfaces, cleaning prior to the disinfection is required.
4.3.2.    Use-specific risk mitigation measures
The product must only be applied for disinfection of small surfaces.
The use of eye protection during handling of the product is mandatory.
For use in cleanrooms, adequate technical/engineering controls to remove airborne residues is mandatory (e.g. room ventilation or Local Exhaust Ventilation ('LEV')). A minimum ventilation rate of 360/hr is mandatory for cleanrooms where the product is applied.
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 section General directions for use.
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See section General directions for use.
4.3.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See section General directions for use.
4.4.    Use description
Table 4. Use # 4 – Use #4 - Application by pouring into a container and using a suitable cleanroom wipe or mop to distribute onto the surface of cleanrooms
Product type
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
/
Target organism(s) (including development stage)
Scientific name: /
Common name: Bacteria
Development stage: /
Scientific name: /
Common name: Yeasts
Development stage: /
Scientific name: /
Common name: Fungi
Development stage: /
Field(s) of use
Indoor
Disinfection of hard, non-porous surfaces in cleanrooms.
Not for use in healthcare.
Application method(s)
Method: Pouring the product into a suitable container and then distributing it on the surface with a suitable cleanroom wipe or mop
Detailed description:
/
Application rate(s) and frequency
Application Rate: /
Dilution (%): No dilution - product is RTU.
Number and timing of application:
Ready-to-use product active against bacteria in 15 min and against yeasts and fungi in 30 min contact time at room temperature (~ 20 °C). Application frequency is specific to the user’s site and requirements.
Category(ies) of users
Professional
Pack sizes and packaging material
0.5L, 1L and 5L tamper evident cap HDPE bottle sealed with a polyethylene outer bag.
4.4.1.    Use-specific instructions for use
Pour the product into a suitable container and use a cleanroom wipe or mop to apply the product to the surface to be disinfected in the cleanroom. Ensure the entire surface is visibly wet for the contact time: 15 minutes for bacteria and 30 minutes for yeasts and fungi. Do not use more than 50 ml product/m 2 . Uniform distribution of the biocidal product should be ensured. For visibly soiled surfaces, cleaning prior to the disinfection is required.
4.4.2.    Use-specific risk mitigation measures
Pouring of product shall be done in ventilated rooms only (with min. 3 air change/h).
The use of eye protection during handling of the product is mandatory.
For use in cleanrooms, adequate technical/engineering controls to remove airborne residues is mandatory (e.g. room ventilation or LEV. A minimum ventilation rate of 360/hr is mandatory for cleanrooms where the product is applied.
If the product is applied by wiping, the disinfection must be limited to small area.
When using the product with a mop to disinfect floors or other large surfaces in cleanrooms, additional risk mitigation measures must be considered:
—
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory for the professional user and all other personnel within the room. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a half/full mask with combination filter gas/P2 is required (filter type (code letter, colour) to be specified by the authorisation holder within the product information).
—
All personnel must leave the room after mopping.
—
Technical or engineering controls to remove airborne residues is mandatory (e.g. ventilation or LEV) before professionals are permitted to enter into treated areas after large surface disinfection. Monitor the air concentration and ensure that the limit value (1.25 mg/m 3 ) is not exceeded when professionals re-enter the area.
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 section General directions for use.
4.4.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See section General directions for use.
4.4.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See section General directions for use.
5.    GENERAL DIRECTIONS FOR USE   ( 1 )
OF THE META SPC 1
5.1.    Instructions for use
See Use-specific instructions for use.
5.2.    Risk mitigation measures
Used wipes must be disposed in a closed container.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
DIRECT/INDIRECT EFFECTS
Causes serious eye irritation. No other health injuries are known or expected under normal use.
FIRST AID INSTRUCTIONS
IF INHALED: If symptoms occur, 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 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.
EMERGENCY MEASURES TO PROTECT THE ENVIRONMENT
Avoid release to the environment.
5.4.    Instructions for safe disposal of the product and its packaging
Disposal of this packaging should at all times comply with the waste disposal legislation and any regional local authority requirements.
Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store in a dry well ventilated area and protect from damage and direct sunlight.
Store in properly designed bulk storage tanks or in original vented container.
Keep container tightly closed.
Do not freeze.
Do not store at temperature above 30°C.
The shelf-life: 24 months.
6.    OTHER INFORMATION
Not relevant.
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)
Contec HydroPure
Market area: EU
Contec Sterile HydroPure
Market area: EU
Authorisation number
EU-0027735-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Hydrogen peroxide
Active Substance
7722-84-1
231-765-0
6,67
( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.
Commission Implementing Regulation (EU) 2022/1185 of 8 July 2022 granting a Union authorisation for the biocidal product family ‘Contec Hydrogen Peroxide Biocidal Product Family’ (Text with EEA relevance)

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