Commission Implementing Regulation (EU) 2025/427 of 4 March 2025 granting a Union authorisation for the biocidal product family Orochemie hand disinfectants in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

ANNEXSummary of product characteristics for a biocidal product family
ANNEX
Summary of product characteristics for a biocidal product family
orochemie hand disinfectants
Product type(s)
PT01: Human hygiene
Authorisation number EU-0032838-0000
R4BP asset number EU-0032838-0000
PART I.
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
orochemie hand disinfectants
1.2.    Product type(s)
Product type(s)
PT01: Human hygiene
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
orochemie GmbH + Co. KG
Address
Max-Planck-Str. 27 70806 Kornwestheim DE
Authorisation number
EU-0032838-0000
R4BP asset number
EU-0032838-0000
Date of the authorisation
26 March 2025
Expiry date of the authorisation
28 February 2035
1.4.    Manufacturer(s) of the product
Name of manufacturer
orochemie GmbH & Co.KG
Address of manufacturer
Max-Planck-Str. 27 70806 Kornwestheim Germany
Location of manufacturing sites
orochemie GmbH & Co.KG site 1
Max-Planck-Str. 27 70806 Kornwestheim Germany
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Propan-1-ol
Name of manufacturer
BASF SE
Address of manufacturer
not relevant 67056 Ludwigshafen Germany
Location of manufacturing sites
BASF SE site 1
Carl-Bosch-Strasse 38 67056 Ludwigshafen Germany
Active substance
Propan-1-ol
Name of manufacturer
Sasol Chemie GmbH & Co. KG
Address of manufacturer
Anckelmannsplatz 1 20537 Hamburg Germany
Location of manufacturing sites
Sasol Chemie GmbH & Co. KG site 1
PDP Kruger Street 2302 Secunda South Africa
Active substance
Propan-2-ol
Name of manufacturer
AUG.Hedinger GmbH & co. KG (supplied by Shell Nederland Chemie B.V.)
Address of manufacturer
Vondelingenweg 601 3196 KK Hoogvliet – Rotterdam Netherlands (the)
Location of manufacturing sites
AUG.Hedinger GmbH & co. KG (supplied by Shell Nederland Chemie B.V.) site 1
Vondelingenweg 601 3196 KK Hoogvliet – Rotterdam Netherlands (the)
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
Stockmeier Holding GmbH
Address of manufacturer
Am Stadtholz 37 33609 Bielefeld Germany
Location of manufacturing sites
Stockmeier Holding GmbH site 1
Römerstraße 733 47443 Moers Germany
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-1-ol
active substance
71-23-8
200-746-9
26 – 26  % (w/w)
Propan-2-ol
active substance
67-63-0
200-661-7
47 – 47  % (w/w)
2.2.    Type(s) of formulation
Formulation type(s)
AL Any other liquid
PART II.
SECOND INFORMATION LEVEL – META SPC(S)
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)
PT01: Human hygiene
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-1-ol
active substance
71-23-8
200-746-9
26 – 26  % (w/w)
Propan-2-ol
active substance
67-63-0
200-661-7
47 – 47  % (w/w)
2.2.    Type(s) of formulation of the meta SPC 1
Formulation type(s)
AL Any other liquid
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
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye 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.
P312: Call a POISON CENTER if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: In case of fire: Use water spray jet to extinguish.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to hazardous or special waste collection point, in accordance with local regulation.
P501: Dispose of container to hazardous or special waste collection point, in accordance with local regulation.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1.
hygienic hand rub – non-professional user
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)
Common name: Yeast
Common name: Bacteria
Common name: Mycobacteria
Common name: Viruses (limited spectrum virucidal activity)
Common name: Enveloped viruses
Field(s) of use
indoor use
Use in health care and health care facilities, domestic, institutional, veterinary, local authorities, nail and cosmetics studios, beauty and wellness salons, tattoo studios, hotels, funeral parlour.
Application method(s)
Method: Rubbing
Detailed description: -
Application rate(s) and frequency
Application rate: Application amount of the formulated product according to product information:
—
per hygienic hand rub: 3 ml (the amount of liquid should resemble the size of a large-sized coin) equal to 2 pumps with the dosing system
Contact time:
—
Bacteria and yeast: 30 s
—
Mycobactericidal/tuberculocidal activity: 30 s
—
Limited spectrum virucidal activity: 2 min (1,5 min on visibly clean hands)
—
Activity against enveloped viruses: 30 s.
Dry hands should be completely moistened with the undiluted product. ready-to-use product
Number and timing of application:
Non-professional use: Do not exceed 10 applications per day.
Category(ies) of users
general public (non-professional)
Pack sizes and packaging material
50 ml, oval, bottle white + white coloured lid (flip-top lid)
75 ml, oval, bottle white + white coloured lid (flip-top lid)
100 ml, oval, bottle white + white coloured lid (flip-top lid)
125 ml, oval, bottle white + white coloured lid (flip-top lid)
500 ml square bottle opaque + white coloured lid or pink coloured lid (flip-top lid)
500 ml square bottle white + white coloured lid or pink coloured lid (flip-top lid)
Ophard 500 ml KX bottle, opaque + Ophard NUX S spray pump (shower head)
Ophard 500 ml hygiene packaging, opaque + Ophard pump
500 ml round bottle opaque + white coloured lid (screw cap)
800 ml square bottle opaque + white coloured or pink coloured lid (flip-top lid)
1 litre square bottle opaque + white coloured lid or pink coloured lid (flip-top lid)
1 litre square bottle opaque + white coloured lid (screw cap)
1 litre square bottle white + white coloured lid or pink coloured lid (flip-top lid)
1 litre square bottle white + white coloured lid (screw cap)
Ophard 1 litre KX bottle, opaque + Ophard NUX S spray pump (shower head)
Ophard 1 litre hygiene packaging, opaque + Ophard pump
All bottles: polyethylene (PE)
Lids: PE or polypropylene (PP)
4.1.1.    Use-specific instructions
Comply with the instructions for use.
The biocidal product is always applied undiluted. For hygienic hand rub, completely moisten dry hands with 3 ml and keep moist for 30 seconds to 2 minutes. When used in food preparation and handling (restaurants and large-scale/canteen kitchens, grocery shops, butcher, etc.) only use on visibly clean hands. For use in medical area against viruses, only use on visibly clean hands.
4.1.2.    Use-specific risk mitigation measures
Use for children only under supervision of an adult. Apply the amount on your own hand first and rub the product on child’s/toddler’s hand. Make sure that the child/toddler does not touch eyes or mouth before the product has dried.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
Avoid unnecessary contact to skin.
In case of skin dryness, use appropriate skin care lotion.
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
If medical advice is needed, have product container or label at hand.
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
Keep out of reach of children and non-target animals / pets.
4.2.    Use description
Table 2.
hygienic and surgical hand rub – professional user
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Hygienic hand disinfection by hand rubbing without rinsing.
Surgical hand disinfection by hand rubbing without rinsing in health care (including ambulance) and veterinary health care.
Target organism(s) (including development stage)
Common name: Yeast
Common name: Bacteria
Common name: Mycobacteria
Common name: Viruses (limited spectrum virucidal activity)
Common name: Enveloped viruses
Field(s) of use
indoor use
Use in health care and health care facilities (including ambulance), domestic, institutional, veterinary, industry, food preparation and handling (restaurants and large-scale/canteen kitchens, grocery shops, butcher, etc.), local authorities, building cleaning services, nail and cosmetics studios, beauty and wellness salons, tattoo studios, hotels, funeral parlour
Surgical hand disinfection by hand rubbing without rinsing in health care (including ambulance) and veterinary health care.
Application method(s)
Method: Rubbing
Detailed description: -
Application rate(s) and frequency
Application rate: Application amount of the formulated product according to product information:
—
per hygienic hand rub: 3 ml
—
per surgical hand rub: 10 ml (100 %).
Contact time:
Hygienic hand rub:
—
Bacteria and yeasts: 30 s
—
Mycobactericidal/tuberculocidal activity: 30 s
—
Limited spectrum virucidal activity: 2 min (1,5 min on visibly clean hands)
—
Activity against enveloped viruses: 30 s Surgical hand rub: 1,5 min.
Dry hands should be completely moistened with the undiluted product. ready-to-use product
Number and timing of application:
Professional use: Use up to 25 times per 8-hour shift
Category(ies) of users
professional
Pack sizes and packaging material
50 ml, oval, bottle white + white coloured lid (flip-top lid)
75 ml, oval, bottle white + white coloured lid (flip-top lid)
100 ml, oval, bottle white + white coloured lid (flip-top lid)
125 ml, oval, bottle white + white coloured lid (flip-top lid)
500 ml square bottle opaque + white coloured lid or pink coloured lid (flip-top lid)
500 ml square bottle white + white coloured lid or pink coloured lid (flip-top lid)
Ophard 500 ml KX bottle, opaque + Ophard NUX S spray pump (shower head)
Ophard 500 ml hygiene packaging, opaque + Ophard pump
500 ml round bottle opaque + white coloured lid (screw cap)
800 ml square bottle opaque + white coloured or pink coloured lid (flip-top lid)
1 litre square bottle opaque + white coloured lid or pink coloured lid (flip-top lid)
1 litre square bottle opaque + white coloured lid (screw cap)
1 litre square bottle white + white coloured lid or pink coloured lid (flip-top lid)
1 litre square bottle white + white coloured lid (screw cap)
Ophard 1 litre KX bottle, opaque + Ophard NUX S spray pump (shower head)
Ophard 1 litre hygiene packaging, opaque + Ophard pump
only for hygienic hand rub:
2,5 litre bottle white + pink coloured lid (screw cap)
5 litre canister white + white coloured lid (screw cap)
10 litre canister white + white coloured lid (screw cap)
220 litre barrel
1000 litre IBC container
All bottles: PE
Lids: PE or PP
4.2.1.    Use-specific instructions
The biocidal product is always applied undiluted. For surgical hand rub, completely moisten previously cleaned and dried hands and forearms with biocidal product and continue to apply it for 1,5 minutes to keep the skin moist (at least 10 ml total).
For hygienic hand rub completely moisten the hands with biocidal product and keep moist for 30 seconds to 2 minutes. When used for hygienic hand rub in food preparation and handling (restaurants and large-scale/canteen kitchens, grocery shops, butcher, etc.) only use on visibly clean hands. For use in medical area against viruses, only use on visibly clean hands.
Do not refill or decant products used as surgical hand rub.
For refilling, a funnel must be applied.
4.2.2.    Use-specific risk mitigation measures
The use of eye protection during refilling of the application bottles is mandatory.
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
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1.    Instructions for use
-
5.2.    Risk mitigation measures
Ensure adequate ventilation during the application.
Avoid contact with eyes.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
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 ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
5.4.    Instructions for safe disposal of the product and its packaging
Do not allow to enter into surface water or drains. Do not allow to enter into soil or subsoil. To cleaning up: absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents). Collect in closed and suitable containers for disposal.
Dispose of contents/container to an approved waste disposal plant. Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 48 months
Protect from direct sunlight.
Keep container tightly closed.
Store in a well ventilated place. Keep cool.
6.    OTHER INFORMATION
Please be aware of the European reference values 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 the biocidal product family.
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)
C 14
Market area: EU
oro® med
Market area: EU
HD 410 plus
Market area: EU
HD 413 plus
Market area: EU
HD 400 plus
Market area: EU
HD 420 plus
Market area: EU
Authorisation number
EU-0032838-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-1-ol
active substance
71-23-8
200-746-9
26 % (w/w)
Propan-2-ol
active substance
67-63-0
200-661-7
47 % (w/w)
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
C 10
Market area: EU
HD 410
Market area: EU
HD 413
Market area: EU
Dürr System-Hygiene HD 410 hand disinfection
Market area: EU
HD 400
Market area: EU
HD 420
Market area: EU
C 10 hand disinfection
Market area: EU
HD 410 hand disinfection
Market area: EU
Authorisation number
EU-0032838-0002 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-1-ol
active substance
71-23-8
200-746-9
26 % (w/w)
Propan-2-ol
active substance
67-63-0
200-661-7
47 % (w/w)
1.    META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
meta SPC 2
1.2.    Suffix to the authorisation number
Number
1-2
1.3.    Product type(s)
Product type(s)
PT01: Human hygiene
2.    META SPC 2 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-1-ol
active substance
71-23-8
200-746-9
26 – 26  % (w/w)
Propan-2-ol
active substance
67-63-0
200-661-7
47 – 47  % (w/w)
2.2.    Type(s) of formulation of the meta SPC 2
Formulation type(s)
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
H226: 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
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
P103: Read carefully and follow all instructions.
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye 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.
P312: Call a POISON CENTER if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: In case of fire: Use water spray jet to extinguish.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
4.    AUTHORISED USE(S) OF THE META SPC
4.1.    Use description
Table 1.
hygienic hand rub – non-professional user
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)
Common name: Yeast
Common name: Bacteria
Common name: Mycobacteria
Common name: Viruses (limited spectrum virucidal activity)
Common name: Enveloped viruses
Field(s) of use
indoor use
Use in health care and health care facilities, domestic, institutional, veterinary, local authorities, nail and cosmetics studios, beauty and wellness salons, tattoo studios, hotels, funeral parlour.
Application method(s)
Method: Rubbing
Detailed description: -
Application rate(s) and frequency
Application rate: Application amount of the formulated product according to product information:
—
per hygienic hand rub: 3 ml (the amount of liquid should resemble the size of a large-sized coin) equal to 2 pumps with the dosing system
Contact time:
—
Bacteria and yeast: 30 s
—
Mycobactericidal/tuberculocidal activity: 30 s
—
Limited spectrum virucidal activity: 2 min (1,5 min on visibly clean hands)
—
Activity against enveloped viruses: 30 s Dry hands should be completely moistened with the undiluted product. ready-to-use product
Number and timing of application:
Non-professional use: Do not exceed 10 applications per day.
Category(ies) of users
general public (non-professional)
Pack sizes and packaging material
50 ml, oval, bottle white + white coloured lid (flip-top lid)
75 ml, oval, bottle white + white coloured lid (flip-top lid)
100 ml, oval, bottle white + white coloured lid (flip-top lid)
125 ml, oval, bottle white + white coloured lid (flip-top lid)
500 ml square bottle opaque + white coloured lid or pink coloured lid (flip-top lid)
500 ml square bottle white + white coloured lid or pink coloured lid (flip-top lid)
Ophard 500 ml KX bottle, opaque + Ophard NUX S spray pump (shower head)
Ophard 500 ml hygiene packaging, opaque + Ophard pump
500 ml round bottle opaque + white coloured lid (screw cap)
800 ml square bottle opaque + white coloured or pink coloured lid (flip-top lid)
1 litre square bottle opaque + white coloured lid or pink coloured lid (flip-top lid)
1 litre square bottle opaque + white coloured lid (screw cap)
1 litre square bottle white + white coloured lid or pink coloured lid (flip-top lid)
1 litre square bottle white + white coloured lid (screw cap)
Ophard 1 litre KX bottle, opaque + Ophard NUX S spray pump (shower head)
Ophard 1 litre hygiene packaging, opaque + Ophard pump
All bottles: PE
Lids: PE or PP
4.1.1.    Use-specific instructions
Comply with the instructions for use.
The biocidal product is always applied undiluted. For hygienic hand rub, completely moisten dry hands with 3 ml and keep moist for 30 seconds to 2 minutes. When used in food preparation and handling (restaurants and large-scale/canteen kitchens, grocery shops, butcher, etc.) only use on visibly clean hands. For use in medical area against viruses, only use on visibly clean hands.
4.1.2.    Use-specific risk mitigation measures
Use for children only under supervision of an adult. Apply the amount on your own hand first and rub the product on child’s/toddler’s hand. Make sure that the child/toddler does not touch eyes or mouth before the product has dried.
Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.
Avoid unnecessary contact to skin.
In case of skin dryness, use appropriate skin care lotion.
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
If medical advice is needed, have product container or label at hand.
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
Keep out of reach of children and non-target animals / pets.
4.2.    Use description
Table 2.
hygienic and surgical hand rub – professional user
Product type
PT01: Human hygiene
Where relevant, an exact description of the authorised use
Hygienic hand disinfection by hand rubbing without rinsing.
Surgical hand disinfection by hand rubbing without rinsing in health care (including ambulance) and veterinary health care.
Target organism(s) (including development stage)
Common name: Yeast
Common name: Bacteria
Common name: Mycobacteria
Common name: Viruses (limited spectrum virucidal activity)
Common name: Enveloped viruses
Field(s) of use
indoor use
Use in health care and health care facilities (including ambulance), domestic, institutional, veterinary, industry, food preparation and handling (restaurants and large-scale/canteen kitchens, grocery shops, butcher, etc.), local authorities, building cleaning services, nail and cosmetics studios, beauty and wellness salons, tattoo studios, hotels, funeral parlour
Surgical hand disinfection by hand rubbing without rinsing in health care (including ambulance) and veterinary health care.
Application method(s)
Method: Rubbing
Detailed description: -
Application rate(s) and frequency
Application rate: Application amount of the formulated product according to product information:
—
per hygienic hand rub: 3 ml
—
per surgical hand rub: 10 ml (100 %)
Contact time: Hygienic hand rub:
—
Bacteria and yeasts: 30 s
—
Mycobactericidal/tuberculocidal activity: 30 s
—
Limited spectrum virucidal activity: 2 min (1,5 min on visibly clean hands)
—
Activity against enveloped viruses: 30 s Surgical hand rub: 1,5 min
Dry hands should be completely moistened with the undiluted product. ready-to-use product
Number and timing of application:
Professional use: Use up to 25 times per 8-hour shift
Category(ies) of users
professional
Pack sizes and packaging material
50 ml, oval, bottle white + white coloured lid (flip-top lid)
75 ml, oval, bottle white + white coloured lid (flip-top lid)
100 ml, oval, bottle white + white coloured lid (flip-top lid)
125 ml, oval, bottle white + white coloured lid (flip-top lid)
500 ml square bottle opaque + white coloured lid or pink coloured lid (flip-top lid)
500 ml square bottle white + white coloured lid or pink coloured lid (flip-top lid)
Ophard 500 ml KX bottle, opaque + Ophard NUX S spray pump (shower head)
Ophard 500 ml hygiene packaging, opaque + Ophard pump
500 ml round bottle opaque + white coloured lid (screw cap)
800 ml square bottle opaque + white coloured or pink coloured lid (flip-top lid)
1 litre square bottle opaque + white coloured lid or pink coloured lid (flip-top lid)
1 litre square bottle opaque + white coloured lid (screw cap)
1 litre square bottle white + white coloured lid or pink coloured lid (flip-top lid)
1 litre square bottle white + white coloured lid (screw cap)
Ophard 1 litre KX bottle, opaque + Ophard NUX S spray pump (shower head)
Ophard 1 litre hygiene packaging, opaque + Ophard pump
only for hygienic hand rub:
2,5 litre bottle white + pink coloured lid (screw cap)
5 litre canister white + white coloured lid (screw cap)
10 litre canister white + white coloured lid (screw cap)
220 litre barrel
1000 litre IBC container
All bottles: PE
Lids: PE or PP
4.2.1.    Use-specific instructions
The biocidal product is always applied undiluted. For surgical hand rub, completely moisten previously cleaned and dried hands and forearms with biocidal product and continue to apply it for 1,5 minutes to keep the skin moist (at least 10 ml total).
For hygienic hand rub completely moisten the hands with biocidal product and keep moist for 30 seconds to 2 minutes. When used for hygienic hand rub in food preparation and handling (restaurants and large-scale/canteen kitchens, grocery shops, butcher, etc.) only use on visibly clean hands. For use in medical area against viruses, only use on visibly clean hands.
Do not refill or decant products used as surgical hand rub.
For refilling, a funnel must be applied.
4.2.2.    Use-specific risk mitigation measures
The use of eye protection during refilling of the application bottles is mandatory.
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
5.    GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1.    Instructions for use
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5.2.    Risk mitigation measures
Ensure adequate ventilation during the application.
Avoid contact with eyes.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. 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. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
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 ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
5.4.    Instructions for safe disposal of the product and its packaging
Do not allow to enter into surface water or drains. Do not allow to enter into soil or subsoil. To cleaning up: absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents). Collect in closed and suitable containers for disposal.
Dispose of contents/container to an approved waste disposal plant. Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 48 months
Protect from direct sunlight.
Keep container tightly closed.
Store in a well ventilated place. Keep cool.
6.    OTHER INFORMATION
Please be aware of the European reference values 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 the biocidal product family.
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)
C 12
Market area: EU
oro® pure
Market area: EU
oro® care
Market area: EU
oro® Händedesinfektion
Market area: EU
HD 410 essential
Market area: EU
HD 413 essential
Market area: EU
HD 400 essential
Market area: EU
HD 420 essential
Market area: EU
Authorisation number
EU-0032838-0003 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-1-ol
active substance
71-23-8
200-746-9
26 % (w/w)
Propan-2-ol
active substance
67-63-0
200-661-7
47 % (w/w)
Commission Implementing Regulation (EU) 2025/427 of 4 March 2025 granting a Union authorisation for the biocidal product family Orochemie hand disinfectants in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Schedules & Appendices

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