COMMISSION IMPLEMENTING REGULATION (EU) 2020/1425
of 8 October 2020
granting a Union authorisation for the biocidal product family ‘PeridoxRTU Product Family’
(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 |
PeridoxRTU 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, 56 000 Vannes, France |
|
Authorisation number |
EU-0023658-0000 |
|
R4BP asset number |
EU-0023658-0000 |
|
Date of the authorisation |
29 October 2020 |
|
Expiry date of the authorisation |
30 September 2030 |
1.4.
Manufacturer(s) of the biocidal products
Name of manufacturer |
Enviro Tech Chemical Services, Inc. |
Address of manufacturer |
500 Winmoore Way, CA 95 358 Modesto United States |
Location of manufacturing sites |
500 Winmoore Way, CA 95 358 Modesto United States 724 Phillips Rd 411, AR 72 342 Helena United States |
1.5.
Manufacturer(s) of the active substance(s)
Active substance |
Peracetic acid |
Name of manufacturer |
Evonik Peroxid GmbH |
Address of manufacturer |
Industriestraße 1, 9721 Weißenstein Austria |
Location of manufacturing sites |
Industriestraße 1, 9721 Weißenstein Austria |
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 |
|||||
Peracetic acid |
|
Active Substance |
79-21-0 |
201-186-8 |
0,23 |
0,23 |
Hydrogen Peroxide |
Hydrogen Peroxide |
Non-active Substance |
7722-84-1 |
231-765-0 |
4,4 |
4,4 |
Acetic Acid |
Acetic Acid |
Non-active Substance |
64-19-7 |
200-580-7 |
5,0 |
5,0 |
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 |
Contec PeridoxRTU |
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 |
|||||
Peracetic acid |
|
Active Substance |
79-21-0 |
201-186-8 |
0,23 |
0,23 |
Hydrogen Peroxide |
Hydrogen Peroxide |
Non-active Substance |
7722-84-1 |
231-765-0 |
4,4 |
4,4 |
Acetic Acid |
Acetic Acid |
Non-active Substance |
64-19-7 |
200-580-7 |
5,0 |
5,0 |
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 severe skin burns and eye damage. May be corrosive to metals. Harmful to aquatic life with long lasting effects. |
Precautionary statements |
Do not breathe vapours. Do not breathe spray. Keep only in original packaging. Wash hands thoroughly after handling. Avoid release to the environment. Wear protective gloves. Wear protective clothing. Wear eye protection. Wear face protection. IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. IF INHALED: Remove person to fresh air and keep comfortable for breathing. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTRE or doctor/physician. Specific treatment (see information on this label). Wash contaminated clothing before reuse. Absorb spillage to prevent material damage. Store locked up. Dispose of contents to in accordance with local/regional/national/international regulations (to be specified). Dispose of container to in accordance with local/regional/national/international regulations (to be specified). |
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) |
Bacteria Fungi Yeast Bacterial spores |
Field(s) of use |
Indoor Surface disinfection of clean, hard non-porous surfaces in cleanrooms not associated with food or feed areas, by spraying onto a suitable cleanroom wipe and using the wipe to distribute the liquid on the surface. |
Application method(s) |
Spraying Spray onto a suitable cleanroom wipe and use the wipe to distribute the liquid on the surface. Uniform distribution of the biocidal product should be ensured. |
Application rate(s) and frequency |
50,0 mL/m2 – Ready-to-use product Ensure the surface is uniformly covered with the product and leave for the required contact time. Contact time for bacteria – 2-minutes. Contact time for fungi, yeasts and bacterial spores – 3-minutes. |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
900 ml High density polyethylene (HDPE) bottle, delivered with a poly propylene screw cap which is replaced with the poly propylene trigger. |
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) |
Bacteria Fungi Yeast Bacterial spores |
Field(s) of use |
Indoor Surface disinfection of clean, hard non-porous surfaces in cleanrooms not associated with food or feed areas, by pouring into a container and then applying the liquid on the surface with a suitable cleanroom mop/wipe. |
Application method(s) |
Pouring Pour into a container and then apply with a suitable cleanroom mop/wipe. |
Application rate(s) and frequency |
50,0 mL/m2 – Ready-to-use product Ensure the surface is uniformly covered with the product and leave for the required contact time. Contact time for bacteria – 2-minutes. Contact time for fungi, yeasts and bacterial spores – 3-minutes. |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
3 750 ml HDPE bottle with a poly propylene screw cap 900 ml HDPE bottle, delivered with a poly propylene screw cap which is replaced with the poly propylene push/pull cap |
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
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
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 Sterile PeridoxRTU |
|
|||
Authorisation number |
EU-0023658-0001 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Peracetic acid |
|
Active Substance |
79-21-0 |
201-186-8 |
0,23 |
Hydrogen Peroxide |
Hydrogen Peroxide |
Non-active Substance |
7722-84-1 |
231-765-0 |
4,4 |
Acetic Acid |
Acetic Acid |
Non-active Substance |
64-19-7 |
200-580-7 |
5,0 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
Contec PeridoxRTU |
|
|||
Authorisation number |
EU-0023658-0002 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Peracetic acid |
|
Active Substance |
79-21-0 |
201-186-8 |
0,23 |
Hydrogen Peroxide |
Hydrogen Peroxide |
Non-active Substance |
7722-84-1 |
231-765-0 |
4,4 |
Acetic Acid |
Acetic Acid |
Non-active Substance |
64-19-7 |
200-580-7 |
5,0 |