Commission Implementing Regulation (EU) 2025/455 of 7 March 2025 granting a Union authorisation for the single biocidal product SatPax® 70/30 IPA in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

ANNEX
ANNEX
Summary of product characteristics for a biocidal product
SatPax® 70/30 IPA
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Authorisation number: EU-0032869-0000
R4BP asset number: EU-0032869-0000
1.    ADMINISTRATIVE INFORMATION
1.1.    Trade name(s) of the product
Trade name(s)
SatPax® 70/30 IPA
SatPax® Choice® 500
Sterile SatPax® Choice® 500
SatPax® 550
Sterile SatPax® 550
SatPax® 550 Low Endotoxin
Sterile SatPax® 550 Low Endotoxin
SatPax® Choice® 600
Sterile SatPax® Choice® 600
SatPax® 670
Sterile SatPax® 670
SatPax® 670A
Sterile SatPax® 670A
SatPax® 670-R
Sterile SatPax® 670-R
SatPax® 3000
Sterile SatPax® 3000
SatPax® Choice® 700
Sterile SatPax® Choice® 700
SatPax® Choice® 900
Sterile SatPax® Choice® 900
SatPax® 1000
Sterile SatPax® 1000
SatPax® S1200
Sterile SatPax® S1200
SatPax® Choice® SuperSorb
Sterile SatPax® Choice® SuperSorb
SatPax® MicroSeal SuperSorb®
Sterile SatPax® MicroSeal SuperSorb®
SatPax® Microseal®-VP
Sterile SatPax® Microseal®-VP
SatPax® Microseal®-VP Low Endotoxin
Sterile SatPax® MicroSeal®-VP Low Endotoxin
SatPax® ValuSeal-HA®
Sterile SatPax® ValuSeal-HA®
SatPax® SPSE
Sterile SatPax® SPSE
SatPax® SPLWSE
Sterile SatPax® SPLWSE
SatPax® SPSWSE
Sterile SatPax® SPSWSE
SatPax® ValuSeal® IonX®
Sterile SatPax® ValuSeal® IonX®
1.2.    Authorisation holder
Name and address of the authorisation holder
Name
CSI-Ireland
Address
Block C Ardilaun Court 112-114 St. Stephen’s Green D02 TD28 Dublin IE
Authorisation number
EU-0032869-0000
R4BP asset number
EU-0032869-0000
Date of the authorisation
30 March 2025
Expiry date of the authorisation
28 February 2035
1.3.    Manufacturer(s) of the product
Name of manufacturer
Berkshire International Ltd
Address of manufacturer
Unit A, The Apex, Farrier Close NR18 0WF Wymondham United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites
Berkshire International Ltd site 1 Techtex, Units 7 & 8, Rhodes Business Park M24 4NE Middleton United Kingdom of Great Britain and Northern Ireland (the)
Berkshire International Ltd site 2 Berkshire Corporation, 6509 Franz Warner Parkway NC 27377 Whitsett United States (the)
Berkshire International Ltd site 3 Berkshire International Ltd. Unit A , The Apex, Farrier Close NR18 0WF Wymondham United Kingdom of Great Britain and Northern Ireland (the)
1.4.    Manufacturer(s) of the active substance(s)
Active substance
Propan-2-ol
Name of manufacturer
Ineos Solvents Germany GmbH
Address of manufacturer
Römerstraße 733 47443 Moers Germany
Location of manufacturing sites
Ineos Solvents Germany GmbH site 1 Römerstraße 733 47443 Moers Germany
Active substance
Propan-2-ol
Name of manufacturer
Exxon Mobil Chemical Europe
Address of manufacturer
Hermeslaan 2 1831 Machelen Belgium
Location of manufacturing sites
Exxon Mobil Chemical Europe site 1 Exxon Mobil Chemical Plant, 4999 Scenic Highway Louisiana 70897 Baton Rouge United States (the)
2.    PRODUCT COMPOSITION AND FORMULATION
2.1.    Qualitative and quantitative information on the composition of the product
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
active substance
67-63-0
200-661-7
64,7 % (w/w)
2.2.    Type(s) of formulation
RTU wipe pre-saturated with a liquid formulation (AL)
3.    HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements
H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye protection/face protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
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.
P312: Call a doctor if you feel unwell.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents in accordance with all local, national and international regulations.
4.    AUTHORISED USE(S)
4.1.    Use description
Table 1
Disinfection of smaller hard surface areas by wiping in cleanrooms and in similar controlled areas within manufacturing and industrial settings (e.g.: work benches in a cleanroom)
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: all
Scientific name: no data
Common name: Yeasts
Development stage: all
Field(s) of use
indoor use
Disinfection of smaller hard surface areas by wiping in cleanrooms and in similar controlled areas within manufacturing and industrial settings (e.g.: work benches in a cleanroom)
Application method(s)
Method: wiping
Detailed description: Wiping. Direct application onto surfaces with a pre-saturated wipe.
Application rate(s) and frequency
Application rate: 30 - 130 ml/m 2
Dilution (%): Not required.
Number and timing of application:
Ready to use product. Use sufficient wipes in order to maintain a wet surface for a contact time of 1 min. Each wipe contains 3,0 – 56,3 ml of IPA : water 64,7:35,3 w/w% solution (1,6 to 30,9 g active substance). The application rate is depending on the wipe type (see below).
1. 55 % cellulose / 45 % polyester
ml of formulated liquid/wipe: 9 - 18
wipes to keep 0,5 m 2 wet: 2
ml of formulated liquid/wipe: 6 - 9
wipes to keep 0,5 m 2 wet: 3
ml of formulated liquid/wipe: 4,5 - 6
wipes to keep 0,5 m 2 wet: 4
ml of formulated liquid/wipe: 4 – 4,5
wipes to keep 0,5 m 2 wet: 5
ml of formulated liquid/wipe: 3 - 4
wipes to keep 0,5 m 2 wet: 6
2. 60 % cellulose / 40 % polyester
ml of formulated liquid/wipe: 9 - 15
wipes to keep 0,5 m 2 wet: 2
ml of formulated liquid/wipe: 5,75 - 9
wipes to keep 0,5 m 2 wet: 3
ml of formulated liquid/wipe: 4,5 – 5,75
wipes to keep 0,5 m 2 wet: 4
ml of formulated liquid/wipe: 3,75 – 4,5
wipes to keep 0,5 m 2 wet: 5
ml of formulated liquid/wipe: 3 – 3,75
wipes to keep 0,5 m 2 wet: 6
ml of formulated liquid/wipe: 2 - 3
wipes to keep 0,5 m 2 wet: 7
3. 100 % polypropylene
ml of formulated liquid/wipe: 7,5 - 15
wipes to keep 0,5 m 2 wet: 2
ml of formulated liquid/wipe: 5 – 7,5
wipes to keep 0,5 m 2 wet: 3
ml of formulated liquid/wipe: 3,5 - 5
wipes to keep 0,5 m 2 wet: 4
4. 100 % polyester
ml of formulated liquid/wipe: 16 - 56
wipes to keep 0,5 m 2 wet: 1
ml of formulated liquid/wipe: 8 - 16
wipes to keep 0,5 m 2 wet: 2
ml of formulated liquid/wipe: 7 - 8
wipes to keep 0,5 m 2 wet: 3
Typical number of applications per day: 10
Category(ies) of users
professional
Pack sizes and packaging material
Pre-saturated Wipes – 55% cellulose / 45% polyester
Canister/refill pouches
60, 75, 100, 125 wipes
Wipe size (cm): 13 × 20, 15 × 23, 30 × 30
Tub material: HDPE (high density polyethylene)
Lid material: PP (polypropylene)
Pouch
25, 30, 50, 75 or 100 wipes
Wipe size (cm): 15 × 23, 18 × 20, 23 × 23, 23 × 28, 30 × 30
Outer layer material: PET (polyethylene terephthalate)
Inner Layer material: PE or LLDPE (polyethylene or linear low density polyethylene)
Pre-saturated Wipes – 60% cellulose / 40% polyester
Canister/refill pouch
75, 100, 125 or 150 wipes
Wipe size (cm): 13 × 20, 15 × 23, 30 × 30
Tub material: HDPE
Lid material: PP
Pouch
30, 75, 90 or 100 wipes
Wipe size (cm): 15 × 20, 18 × 20, 23 × 23, 23 × 28, 30 × 30
Outer layer material: PET
Inner Layer material: PE or LLDPE
Pre-saturated Wipes – 100% polypropylene
Canister/refill pouch
50, 75, 100, 125 or 150 wipes
Wipe size (cm): 15 × 23, 23 × 30
Tub material: HDPE
Lid material: PP
Pouch
50, 75, 100 or 125 wipes
Wipe size (cm): 18 × 28, 23 × 28, 28 × 36
Outer layer material: PET
Inner Layer material: PE or LLDPE
Pre-saturated Wipes – 100% polyester
Pouch
20, 25, 30, 50, 75, 100 wipes
Wipe size (cm): 15 × 23, 18 × 20, 23 × 23, 30 × 30
Outer layer material: PET
Inner Layer material: PE or LLDPE
4.1.1.    Use-specific instructions
Use at room temperature.
Only use on clean surfaces.
Remove one wipe from pack. Close pack.
Quarter fold the wiper and refold as needed to use each surface of the wiper.
Apply pre-saturated wipe directly to the surface to be disinfected.
Ensure complete wetting of the surface.
No additional wiping necessary.
Allow contact time of 1 min for bacteria and yeast.
Use wipe once.
Dispose of the wipe immediately after use in a closed container.
Do not mix with other products.
4.1.2.    Use-specific risk mitigation measures
See section 5.2
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 5.3
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 5.4
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 5.5
4.2.    Use description
Table 2
Disinfection of larger hard surface areas using wipes and a mop in cleanrooms and in similar controlled areas within manufacturing and industrial settings (e.g.: floors in a cleanroom)
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: all
Scientific name: no data
Common name: Yeasts
Development stage: all
Field(s) of use
indoor use
Disinfection of larger hard surface areas using wipes and a mop in cleanrooms and in similar controlled areas within manufacturing and industrial settings (e.g.: floors in a cleanroom)
Application method(s)
Method: mopping
Detailed description: Mopping. Attach the pre-saturated wipe to a floor mop for application onto surfaces
Application rate(s) and frequency
Application rate: 17 mL/m 2
Dilution (%): Not required.
Number and timing of application:
Ready to use product. Use sufficient wipes in order to maintain a wet surface for a contact time of 1 min. Each floor wipe contains 22,0 to 24,7 ml of IPA:water 64,7:35,3w/w % solution (12,4 to 13,9 g active substance).
ml of formulated liquid/per wipe: 25
wipes to keep 25 m 2 wet:17
ml of formulated liquid/wipe: 22
wipes to keep 25 m 2 wet: 19
Typical number of applications per day: 1
Category(ies) of users
professional
Pack sizes and packaging material
Pre-saturated Wipes – 55% cellulose / 45% polyester
Pouch
25, 30, 50, 75 wipes
Wipe size (cm): 23 × 58
Product saturation: 60 %
Outer layer material: PET (polyethylene terephtalate)
Inner Layer material: PE or LLDPE (polyethylene or linear low density polyethylene)
4.2.1.    Use-specific instructions
Use at room temperature.
Only use on clean surfaces.
Remove wipe(s) from pack. Close pack.
Attach 4 layers on the mop head and refold or rotate wipers as needed to maintain a wet surface for a contact time of 1 minute.
Apply wipe directly to the surface to be disinfected.
Use sufficient wipes in order to maintain a wet surface for a contact time of 1 min.
No additional wiping necessary.
Allow contact time of 1 min for bacteria and yeast.
Use wipe once.
Dispose of the wipe immediately after use in a closed container.
Do not mix with other products.
4.2.2.    Use-specific risk mitigation measures
See section 5.2
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 5.3
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 5.4
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 5.5
5.    GENERAL DIRECTIONS FOR USE   ( 1 )
5.1.    Instructions for use
See section 4.1.1 and 4.2.1
5.2.    Risk mitigation measures
Avoid contact with eyes.
Ensure that application is carried out in areas with a minimum ventilation rate of 20 air changes/hour.
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.
See Section 6 for information on the EN standard and the Council Directive.
Keep in the original container, kept tightly closed when not in use. Empty containers retain product residue and can be hazardous. Do not reuse container.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid instructions
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 INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Take off all contaminated clothing and wash it before reuse.Wash skin with water. If skin irritation occurs: Get medical advice.
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.
Emergency measures
Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air).
Small spill:
Vacuum or sweep up material and place in a designated, labelled waste container. Dispose of via a licensed waste disposal contractor
Large spill:
Stop leak if without risk. Move containers from spill area. Use spark-proof tools and explosion-proof equipment. Approach the release from upwind. Prevent entry into sewers, soil, water courses, basements or confined areas. Contain and collect spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in container for disposal according to local regulations. Dispose of via a licensed waste disposal contractor. Contaminated absorbent material may pose the same hazard as the spilt product.
5.4.    Instructions for safe disposal of the product and its packaging
The generation of waste should be avoided or minimised wherever possible. Disposal of this product should comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Dispose of surplus and non-recyclable products via a licensed waste disposal contractor. Waste should not be disposed to the sewer. Do not flush wipes down the toilet. Do not macerate.
Disposal of packaging:
The generation of waste should be avoided or minimised wherever possible. Waste packaging should be recycled. Incineration or landfill should only be considered when recycling is not feasible. This material and its container must be disposed of in a safe way. Empty containers or liners may retain some product residues. Residual alcohol should be emptied prior to disposal of container.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store in a cool, dry, well-ventilated place in original container.
Keep container tightly closed.
Store at temperatures not exceeding 40 °C. Protect from frost.
Store protected from direct sunlight.
Shelf-life: 2 years
6.    OTHER INFORMATION
The product contains wipes of four types of material impregnated with IPA:water (64,7:35,3 % w/w) solution. The materials are cellulose/polyester (55%/45%), cellulose/polyester (60%/40%), polypropylene (100%) and polyester (100%). The sizes of the wipes range from 13 × 20 cm to 23 × 58 cm. More detailed information on the sizes of the wipes is included under the title “Pack sizes and packaging material” in Sections 4.1 and 4.2.
Please be aware of the European reference value of 129,28 mg/m 3 for the active substance propan-2-ol (CAS No: 67-63-0) which was used for the risk assessment for this product.
Full titles of EN standards and legislation mentioned in section 5.2:
EN 374 – Protective gloves against dangerous chemicals and micro-organisms.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC).
With respect to the “Category(ies) of users” note: Professionals (including industrial users) means trained professionals if this is required by national legislation.
( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
Commission Implementing Regulation (EU) 2025/455 of 7 March 2025 granting a Union authorisation for the single biocidal product SatPax® 70/30 IPA in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

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