Commission Implementing Regulation (EU) 2024/1752 of 24 June 2024 amending Implementing Regulation (EU) 2021/552 as regards administrative and minor changes to the Union authorisation for the biocidal product family DEC-AHOL® Product Family

ANNEX
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
DEC-AHOL® Product Family
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Authorisation number EU-0024324-0000
R4BP asset number EU-0024324-0000
PART I.
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
DEC-AHOL® Product Family
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-0024324-0000
R4BP asset number
EU-0024324-0000
Date of the authorisation
20 April 2021
Expiry date of the authorisation
31 March 2031
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
Propan-2-ol
Name of manufacturer
Exxon Mobil Chemical Company
Address of manufacturer
4045 Scenic Hwy, Baton Rouge, LA 70805 Louisiana United States (the)
Location of manufacturing sites
Exxon Mobil Chemical Company site 1
4045 Scenic Hwy, Baton Rouge, LA 70805 Louisiana United States (the)
Active substance
Propan-2-ol
Name of manufacturer
Monument Chemical Houston, LTD
Address of manufacturer
16717 Jacintoport Boulevard 77015 Houston United States (the)
Location of manufacturing sites
Monument Chemical Houston, LTD site 1
16717 Jacintoport Boulevard 77015 Houston United States (the)
Active substance
Propan-2-ol
Name of manufacturer
Shell Chemicals
Address of manufacturer
150 St Claire Parkway ON N0N 1G0 Corunna Canada
Location of manufacturing sites
Shell Chemicals site 1
150 St Claire Parkway ON N0N 1G0 Corunna Canada
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 (%)
Propan-2-ol
active substance
67-63-0
200-661-7
64,8 - 65,4 % (w/w)
2.2.    Type(s) of formulation
Formulation type(s)
AE Aerosol dispenser
AL Any other liquid
XX others - RTU wipe
PART II.
SECOND INFORMATION LEVEL - META SPC(S)
1.    META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
Meta SPC: 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
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 (%)
Propan-2-ol
active substance
67-63-0
200-661-7
65,4 - 65,4 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 1
Formulation type(s)
XX other - RTU wipe
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
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.
P280: Wear protective gloves.
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.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents to in accordance with local/national regulations.
P280: Wear eye protection.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1.
1.1 Disinfection of hard non-porous surfaces; Wipes (individual wipes and multi-pack wipes)
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: -
Scientific name: no data
Common name: yeast
Development stage: -
Field(s) of use
indoor use
Disinfectant wipe for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.
Application method(s)
Method: Wiping of surfaces
Detailed description: -
Application rate(s) and frequency
Application rate: -
Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required.
Contact time: 2 min
Individual wipes:
15.2 cm x 15.2 cm wipe - 4 wipes per m 2
30.5 cm x 30.5 cm wipe - 1 wipe per m 2
45.7 cm x 45.7 cm wipe - 1 wipe per m 2
Multi pack wipes:
23 cm x 23 cm - 2 wipes per m 2
30.5 cm x 30.5 cm - 1 wipe per m 2
Category(ies) of users
industrial
Pack sizes and packaging material
Pre-saturated 65.4% w/w propan-2-ol and water for injection (WFI) wipes.
Individual wipes
A wipe is composed of 100% continuous filament polyester fibre. The wipes are packaged in individual heat-sealed plastic bags made of low density polyethylene.
Pack sizes:
15.2 cm x 15.2 cm wipe - 100/case, non- sterile
15.2 cm x 15.2 cm wipe - 100/case, sterile
30.5 cm x 30.5 cm wipe - 100/case, sterile
45.7 cm x 45.7 cm wipe - 100/case, sterile
Multi pack wipes
A wipe is composed of 100% continuous filament knitted polyester fibre; 20 wipes per pack; folded together in a re-closable bag package.
Pack sizes:
100% polyester 30.5 cm x 30.5 cm wipe - 200/case, non-sterile
100% polyester 30.5 cm x 30.5 cm wipe - 200/case, sterile
100% polyester 23 cm x 23 cm wipe - 200/case, sterile
4.1.1.    Use-specific instructions
Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to Good Manufacturing Practice (GMP) EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Only use wet wipes. Remove one or two wipes at a time for individual wipes and one wipe at a time for multipack wipes. Make sure to wet surfaces completely. Allow to take effect for at least 2 minutes. Discard wipe after use in a closed container and for multipack wipes close the package after opening.
Individual wipes:
15.2 cm x 15.2 cm wipe - 4 wipes per m 2
30.5 cm x 30.5 cm wipe - 1 wipe per m 2
45.7 cm x 45.7 cm wipe - 1 wipe per m 2
Multi pack wipes:
30.5 cm x 30.5 cm - 1 wipe per m 2
23 cm x 23 cm wipe - 2 wipes per m 2
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
See use-specific instructions for use.
5.2.    Risk mitigation measures
Use adequate ventilation with an air change rate of 8 per hour or more.
Apply away from eyes and face.
Hand protection: Wear chemically resistant protective gloves.
Eye protection: Wear eye protection.
Avoid contact with eyes.
Do not breathe vapours.
Do not eat, drink or smoke when using the product.
Wash hands thoroughly after handling.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Symptoms/injuries after inhalation : May cause drowsiness or dizziness
Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
Symptoms/injuries after eye contact: Causes serious eye irritation
Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Rinse skin with water/ or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
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 conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
Empty containers must be discharged as normal waste or recycled where possible.
Additional information: Handle empty containers with care because residual vapours are flammable.
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. Keep away from open flames, hot surfaces and sources of ignition. Store at temperatures below 30°C.
Shelf-life: 3 years
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
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)
ALCOH-WIPE®
Market area: EU
PROCESS2WIPE® IPA70
Market area: EU
Authorisation number
EU-0024324-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
active substance
67-63-0
200-661-7
65,4
1.    META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
Meta SPC: Meta SPC 2
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
UPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
active substance
67-63-0
200-661-7
64,8 - 64,8 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 2
Formulation type(s)
AE Aerosol dispenser
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
H222 : Extremely flammable aerosol, H229 : Pressurised container: May burst if heated
H229: Pressurised container: May burst if heated
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.
P211: Do not spray on an open flame or other ignition source.
P251: Do not pierce or burn, even after use.
P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves.
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.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P410+P412: Protect from sunlight. Do no expose to temperatures exceeding 50°C/ 122°F.
P501: Dispose of contents to in accordance with local/national regulations.
P280: Wear eye protection.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1.
2.1 Disinfection of hard non-porous surfaces in cleanrooms; Aerosols (propellant)
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: -
Scientific name: no data
Common name: yeast
Development stage: -
Field(s) of use
indoor use
Disinfectant for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.
Application method(s)
Method: Aerosol spraying on surfaces
Detailed description: -
Application rate(s) and frequency
Application rate: Maximal application 35 ml/m 2
Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required.
Apply product by spraying from 15-20 cm distance for 20 seconds/m 2 .
Contact time: 1 minute
Category(ies) of users
industrial
Pack sizes and packaging material
325 ml (11 oz) - aerosol can (aluminium coated on the inside with epoxy phenolic resin)
4.1.1.    Use-specific instructions
Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Spray the surface to be disinfected from a distance of 15-20 cm. Thoroughly wet surface with product for 20 seconds/m 2 , make sure to wet surfaces completely. Allow to take effect for at least 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe. Clothes or wipes treated with the product must be discarded in a closed container.
4.1.2.    Use-specific risk mitigation measures
Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
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 2
5.1.    Instructions for use
See use-specific instructions for use.
5.2.    Risk mitigation measures
Use adequate ventilation with an air change rate of 8 per hour or more.
Apply away from eyes and face.
Hand protection: Wear chemically resistant protective gloves.
Eye protection: Wear eye protection.
Avoid contact with eyes.
Do not breathe vapours.
Do not eat, drink or smoke when using the product.
Wash hands thoroughly after handling.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Symptoms/injuries after inhalation : May cause drowsiness or dizziness
Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
Symptoms/injuries after eye contact: Causes serious eye irritation
Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Rinse skin with water/or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
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 conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
Empty containers must be discharged as normal waste or recycled where possible.
Additional information: Handle empty containers with care because residual vapours are flammable.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep away from open flames, hot surfaces and sources of ignition.
Keep container tightly closed. Keep in a cool, well-ventilated place. Store at temperatures below 40°C. Protect from frost.
Shelf-life: 3 years
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129.28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
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)
DEC-AHOL® AEROSOL WFI Formula
Market area: EU
Authorisation number
EU-0024324-0002 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
active substance
67-63-0
200-661-7
64,8
1.    META SPC 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
Meta SPC: Meta SPC 3
1.2.    Suffix to the authorisation number
Number
1-3
1.3.    Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
2.    META SPC 3 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
active substance
67-63-0
200-661-7
65,4 - 65,4 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 3
Formulation type(s)
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
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.
P233: Keep container tightly closed.
P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves.
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.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to in accordance with local/national regulations.
P261: Avoid breathing spray.
P280: Wear eye protection.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1
3.1 Disinfection of hard non-porous surfaces in cleanrooms; Trigger Spray, Liquid
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: yeast
Development stage: -
Field(s) of use
indoor use
Disinfectant for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.
Application method(s)
Method: Trigger Spraying on surfaces
Detailed description: -
Application rate(s) and frequency
Application rate: Maximal application 35 ml/m 2
Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required.
Apply product by spraying from 15-20 cm distance. Use 40 squeezes/m 2
Contact time: 1 minute
Category(ies) of users
industrial
Pack sizes and packaging material
Trigger:
473 ml (16 oz) - trigger spray - 12/case, sterile
946 ml (32 oz) - trigger spray - 12/case, sterile
473 ml (16 oz) - trigger spray - 12/case, non-sterile
946 ml (32 oz) - trigger spray - 12/case, non-sterile
Bottles are made of high density polyethylene, the dip tube is polypropylene. The bottle cap is polypropylene, the induction seal is polypropylene. Bottles are provided with a polyethylene sprayer already on the bottle or provided separately for customer to put on themselves. If triggers are not installed, a polyethylene screw cap is supplied on the bottles. Bottles are individually triple bagged in cardboard boxes. The product is only supplied to the users in sealed cases.
Bag in bottle- Trigger:
500 ml (16 oz)– Bag in bottle trigger spray - 12/case, sterile
1000 ml (32 oz) - Bag in bottle trigger spray - 12/case, sterile
Bottles are made of high density polyethylene, they are provided with a polyethylene sprayer already on the bottle, the dip tube is polypropylene. The bag inside the bottle is Surlyn® (thermoplastic resins). Bottles are individually triple bagged in cardboard boxes. The product is only supplied to the users in sealed cases.
4.1.1.    Use-specific instructions
Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Direct the spray onto the surface from a distance of 15-20 cm. Make sure to wet the surface completely (40 squeezes/m 2 ). Allow to take effect for at least 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe, if necessary. Only small surfaces may be disinfected. Cloths or wipes treated with the product must be discarded in a closed container.
4.1.2.    Use-specific risk mitigation measures
Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
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.
3.2 Disinfection of hard non-porous surfaces (including floors) in cleanrooms; Wiping
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: -
Scientific name: no data
Common name: yeast
Development stage: -
Field(s) of use
indoor use
Disinfectant for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.
Application method(s)
Method: Wetting of sterile wipe/cloth prior to wiping of surface
Detailed description: -
Application rate(s) and frequency
Application rate: Maximal application 35 ml/m 2
Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required.
Contact time: 1 minute.
Category(ies) of users
industrial
Pack sizes and packaging material
Squeeze bottle:
473 ml (16 oz) – squeeze individually bagged- 12/case, sterile
473 ml (16 oz) – squeeze, bulk group in one large bag – 12/case, sterile. Bulk pack bottles are not individually bagged.
Bottle is made of low density polyethylene
Drum or bottle:
18.9 litre (5 gallon drum) - container double bagged- 1/case, sterile
3.79 litre (1 gallon bottle) – each container double bagged- 4/case, sterile
3.79 litre (1 gallon bottle) – each container double bagged- 4/case, non-sterile
4.2.1.    Use-specific instructions
Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Thoroughly wet a sterile wipe/cloth with the product, make sure to wet the surfaces completely. Allow to take effect for at least 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe, if necessary. Only small surfaces may be disinfected. Cloths or wipes treated with the product must be discarded in a closed container.
4.2.2.    Use-specific risk mitigation measures
Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
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.
4.3.    Use description
Table 3.
3.3 Disinfection of cleanroom gloves
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: -
Scientific name: no data
Common name: yeast
Development stage: -
Field(s) of use
indoor use
Disinfectant for use on gloved hands in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities.
Application method(s)
Method: Dispensing of liquid droplets on gloves
Detailed description: -
Application rate(s) and frequency
Application rate: 1.5 ml per glove
Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required.
Contact time: 1 minute.
Category(ies) of users
industrial
Pack sizes and packaging material
946 ml (32 oz) bottle - 12/case, sterile
946 ml (32 oz) bottle - 12/case, non-sterile
The bottle is low density polyethylene
4.3.1.    Use-specific instructions
Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
Hold gloved hands under spout sensor to catch liquid. Thoroughly rub to distribute liquid evenly and wet clean glove surfaces with product. Do not wipe off and allow to remain wet for a minimum of 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe, if necessary. Cloths or wipes treated with the product must be discarded in a closed container.
Do not use on bare hands.
4.3.2.    Use-specific risk mitigation measures
Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
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 general directions for use.
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See 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 general directions for use.
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1.    Instructions for use
See use-specific instructions for use.
5.2.    Risk mitigation measures
Use adequate ventilation with an air change rate of 8 per hour or more.
Apply away from eyes and face.
Hand protection: Wear chemically resistant protective gloves.
Eye protection: Wear eye protection.
Avoid contact with eyes.
Do not breathe vapours.
Do not eat, drink or smoke when using the product.
Wash hands thoroughly after handling.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Symptoms/injuries after inhalation : May cause drowsiness or dizziness
Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
Symptoms/injuries after eye contact: Causes serious eye irritation
Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
IF ON SKIN: Rinse skin with water/or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
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 conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
Empty containers must be discharged as normal waste or recycled where possible.
Additional information: Handle empty containers with care because residual vapours are flammable.
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. Keep away from open flames, hot surfaces and sources of ignition. Store at temperatures below 40°C.
Protect from frost.
Shelf-life : 3 years
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129.28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
DEC-AHOL® WFI Formula
Market area: EU
DEC-AHOL® ASEPTI-CLEANSE
Market area: EU
Authorisation number
EU-0024324-0003 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
active substance
67-63-0
200-661-7
65,4
1.    META SPC 4 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 4 identifier
Identifier
Meta SPC: Meta SPC 4
1.2.    Suffix to the authorisation number
Number
1-4
1.3.    Product type(s)
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
2.    META SPC 4 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
active substance
67-63-0
200-661-7
65,4 - 65,4 % (w/w)
2.2.    Type(s) of formulation of the meta SPC 4
Formulation type(s)
AE Aerosol dispenser
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements
H222 : Extremely flammable aerosol, H229 : Pressurised container: May burst if heated
H229: Pressurised container: May burst if heated
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.
P211: Do not spray on an open flame or other ignition source.
P251: Do not pierce or burn, even after use.
P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
P280: Wear protective gloves.
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.
P312: Call a doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P410+P412: Protect from sunlight. Do no expose to temperatures exceeding 50°C/ 122°F.
P501: Dispose of contents to in accordance with local/national regulations.
P280: Wear eye protection.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1.
4.1 Disinfection of hard non-porous surfaces in cleanrooms; Aerosols
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: -
Scientific name: no data
Common name: yeast
Development stage: -
Field(s) of use
indoor use
Disinfectant for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.
Application method(s)
Method: Aerosol spraying on surfaces
Detailed description: -
Application rate(s) and frequency
Application rate: Maximal application 35 ml/m 2
Dilution (%): RTU
Number and timing of application:
Product may be used multiple times a day, if required. Apply product by spraying from 15-20 cm distance for 20 seconds/m 2 .
Contact time: 1 minute
Category(ies) of users
industrial
Pack sizes and packaging material
325 ml (11 oz) – Inverta-Spray® mist spray
Aluminium coated inside with epoxy phenolic resin fitted with low density polyethylene bag liner (bag-on-valve), compressed air propellant.
4.1.1.    Use-specific instructions
Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
Clean and dry surfaces prior to disinfection. Spray the surface to be disinfected from a distance of 15-20 cm. Thoroughly wet surface with product for 20 seconds/m 2 , make sure to wet surfaces completely. Allow to take effect for at least 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe. Cloths or wipes treated with the product must be discarded in a closed container.
4.1.2.    Use-specific risk mitigation measures
Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
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 4
5.1.    Instructions for use
See use-specific instructions for use.
5.2.    Risk mitigation measures
Use adequate ventilation with an air change rate of 8 per hour or more.
Apply away from eyes and face.
Hand protection: Wear chemically resistant protective gloves.
Eye protection: Wear eye protection.
Avoid contact with eyes.
Do not breathe vapours.
Do not eat, drink or smoke when using the product.
Wash hands thoroughly after handling.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Symptoms/injuries after inhalation : May cause drowsiness or dizziness
Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
Symptoms/injuries after eye contact: Causes serious eye irritation
Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
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: Rinse skin with water or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
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 conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
Empty containers must be discharged as normal waste or recycled where possible.
Additional information: Handle empty containers with care because residual vapours are flammable.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Keep away from open flames, hot surfaces and sources of ignition.
Keep container tightly closed. Keep in a cool, well-ventilated place. Store at temperatures below 40°C. Protect from frost.
Shelf-life: 3 years
6.    OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129.28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
7.    THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
DEC-AHOL® AEROSOL WFI Formula Invertaspray
Market area: EU
Authorisation number
EU-0024324-0004 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
active substance
67-63-0
200-661-7
65,4
Commission Implementing Regulation (EU) 2024/1752 of 24 June 2024 amending Implementing Regulation (EU) 2021/552 as regards administrative and minor changes to the Union authorisation for the biocidal product family DEC-AHOL® Product Family

Schedules & Appendices

Cite this act
