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)
Article 1
Article 2
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
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
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 (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
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 (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
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 (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
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
5.
GENERAL DIRECTIONS FOR USE
(1)
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
DIRECT/INDIRECT EFFECTS
FIRST AID INSTRUCTIONS
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) |
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 |