Commission Implementing Regulation (EU) 2024/2419 of 13 September 2024 granting a Union authorisation for the single biocidal product Soft Care Med H5 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

ANNEXSummary of product characteristics for a biocidal product
ANNEX
Summary of product characteristics for a biocidal product
Soft Care Med H5
Product type(s)
PT01: Human hygiene
Authorisation number: EU-0032018-0000
R4BP asset number: EU-0032018-0000
1.    ADMINISTRATIVE INFORMATION
1.1.    Trade name(s) of the product
Trade name(s)
Soft Care Med H5
Soft Care Med
DivoCare Alco P VR203
DivoCare Alco P
Soft Care Alcoplus
Soft Care Impact Med
PrimeSource MED
Soft Care Alcogel
PrimeSource Alcoplus
PrimeSource Alcogel
PrimeSource Hand Sanitizer
STAPLES Med
STAPLES Alcogel
STAPLES Alcoplus
STAPLES Hand Sanitizer
Optimax Hand Sanitizer
Optimax Med
Optimax Alcogel
Optimax Alcoplus
Trust MED
1.2.    Authorisation holder
Name and address of the authorisation holder
Name
Diversey Europe Operations B.V.
Address
Regulatory team Maarssenbroeksedijk 2 3542 DN Utrecht NL
Authorisation number
EU-0032018-0000
R4BP asset number
EU-0032018-0000
Date of the authorisation
6 October 2024
Expiry date of the authorisation
30 September 2034
1.3.    Manufacturer(s) of the product
Name of manufacturer
Diversey Europe Operations B.V.
Address of manufacturer
Maarssenbroeksedijk 2 3542 DN Utrecht, Netherlands (the)
Location of manufacturing sites
Diversey Europe Operations B.V. site 1 Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy
Diversey Europe Operations B.V. site 2 Rembrandtlaan 414 7545 ZW Enschede, Netherlands (the)
Diversey Europe Operations B.V. site 3 Cotes Park Industrial Estate DE55 4PA Somercotes, Alfreton, United Kingdom of Great Britain and Northern Ireland (the)
Diversey Europe Operations B.V. site 4 Avenida Conde Duque 5, 7 y 9, Poligono Industrial La Postura 28343 Valdemoro, Madrid, Spain
Diversey Europe Operations B.V. site 5 Morschheimer Strasse 12 67292 Kirchheimbolanden, Germany
Name of manufacturer
Multifill B.V.
Address of manufacturer
Constructieweg 25a, P.O. Box 367 3640 Mijdrecht, Netherlands (the)
Location of manufacturing sites
Multifill B.V. site 1 Constructieweg 25a, P.O. Box 367 3640 AJ Mijdrecht, Netherlands (the)
1.4.    Manufacturer(s) of the active substance(s)
Active substance
Propan-1-ol
Name of manufacturer
BASF SE
Address of manufacturer
Carl-Bosch-Str. 38 67056 Ludwigshafen, Germany
Location of manufacturing sites
BASF SE site 1 Carl-Bosch-Str. 38 67056 Ludwigshafen, Germany
Active substance
Propan-1-ol
Name of manufacturer
OXEA Corporation
Address of manufacturer
2001 FM 3057 TX 77414 Bay City United States (the)
Location of manufacturing sites
OXEA Corporation site 1 2001 FM 3057 TX 77414 Bay City United States (the)
Active substance
Propan-2-ol
Name of manufacturer
SASOL Solvents Germany, GmbH
Address of manufacturer
Anckelmannsplatz D-20537 Hamburg, Germany
Location of manufacturing sites
SASOL Solvents Germany GmbH site 1 Shamrockstrasse 88 D-44623 Herne, Germany
SASOL Solvents Germany GmbH site 2 Römerstr. 733 D-47443 Moers, Germany
Active substance
Propan-2-ol
Name of manufacturer
Shell Chemicals Europe B.V.
Address of manufacturer
Postbus 2334 3000 CH Rotterdam, Netherlands (the)
Location of manufacturing sites
Shell Chemicals Europe B.V. site 1 Shell Nederland Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis, Netherlands (the)
Active substance
Propan-2-ol
Name of manufacturer
Exxon Mobil Chemicals
Address of manufacturer
Hermeslaan 2 1831 Machelen, Belgium
Location of manufacturing sites
Exxon Mobil Chemicals site 1 ExxonMobil’s Baton Rouge Refinery and Chemical Plant, 4045 Scenic Hwy LA 70805 Baton Rouge, United States (the)
Exxon Mobil Chemicals site 2 Esso Refinery Fawley SO45 1TX Southampton, United Kingdom of Great Britain and Northern Ireland (the)
Active substance
Propan-2-ol
Name of manufacturer
Novapex
Address of manufacturer
21 Chemin de la Sauvegarde - 21 Ecully Parc - CS 33167 69134 Écully Cedex, France
Location of manufacturing sites
Novapex site 1 Novapex SAS Usine de Rousillon, Rue Gaston Monmousseau 38556 Saint Maurice l’Exil, France
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-1-ol
active substance
71-23-8
200-746-9
2,96 % (w/w)
Propan-2-ol
active substance
67-63-0
200-661-7
70 % (w/w)
2.2.    Type(s) of formulation
AL Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements
H225: Highly flammable liquid and vapour.
H336: May cause drowsiness or dizziness.
H319: Causes serious eye irritation.
Precautionary statements
P101: If medical advice is needed, have product container or label at hand.
P102: Keep out of reach of children.
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.
P271: Use only outdoors or in a well-ventilated area.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER if you feel unwell.
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.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P370+P378: In case of fire: Use water to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to chemical waste.
P103: Read carefully and follow all instructions.
4.    AUTHORISED USE(S)
4.1.    Use description
Table 1
PT01 - Hygienic hand rub
Product type
PT01: Human hygiene
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: Yeasts
Development stage: no data
Scientific name: no data
Common name: Enveloped viruses
Development stage: no data
Scientific name: no data
Common name: limited spectrum viruses
Development stage: no data
Scientific name: no data
Common name: Tuberculosis bacilli
Development stage: no data
Field(s) of use
indoor use
outdoor use
Ready to use disinfectant hand rub for hands for use in hospitals and other medical areas, institutional and industrial areas, restaurants and large-scale canteen kitchens and recreational areas. Not for domestic use.
Application method(s)
Method: Dispense
Detailed description: For pump or pouch with pump:Dispense ready to use disinfectant by applying the product onto the hands. Rub to completely cover clean hands. For flip top or cap bottle:Pour the ready to use liquid into the palm of one cupped hand. Rub to completely cover clean hands.
Application rate(s) and frequency
Application rate: Adult: 3 ml (the amount of liquid should resemble the size of a large-sized coin) equal to 3 pumps with the dosing system Child under 12 years: 2 ml equal to 2 pumps with the dosing system Child under 6 years: 1 ml equal to 1 pump with the dosing system
Dilution (%): Ready to use
Number and timing of application:
Professional user: Up to 25 applications per day
Non-professional user:
—
Adults: Up to 11 applications per day
—
Children: Up to 3 applications per day
Category(ies) of users
industrial ; professional ; general public (non-professional)
Pack sizes and packaging material
Professional and industrial:
Rigid container (flip top) high-density polyethylene (HDPE): 100, 150, 200, 500 ml
Rigid container (pump or cap) (HDPE): 0,5, 0,6, 0,7, 0,75, 0,8, 0,9, 1, 1,3, 1,5, 2, 3, 5, 10, 20, 50, 100, 200, 900, 950, 1000 litres
Flexible container (pouch with pump or cap) low-density polyethylene (LDPE): 0,8, 1,3, 2,5 litres
Non-professional:
Rigid container (flip top) (HDPE): 100, 150, 200, 500 ml
Rigid container (pump or cap) (HDPE): 0,5, 0,6, 0,7, 0,75, 0,8, 0,9, 1, 1,3, 1,5, 2, 3, 5 litres
Flexible container (pouch with pump or cap) (LDPE): 0,8, 1,3, 2,5 litres
4.1.1.    Use-specific instructions
Comply with the instructions for use.
The product needs to be used on visibly clean hands.
Step 1: Apply the following amount of disinfectant:
—
Adult: 3 ml equal to 3 pumps with the dosing system
—
Child under 12 years: 2 ml equal to 2 pumps with the dosing system
—
Child under 6 years: 1 ml equal to 1 pump with the dosing system
Rub into palm of hand. Rub palm to palm to spread disinfectant over entire hands and fingers.
Step 2: Rub the back of your left hand with the palm of the right hand. Reverse and repeat action.
Step 3: Open fingers and rub the finger webs. Reverse and repeat action.
Step 4: Rub palm to palm with fingers interlocked (5 times).
Step 5: Rub thumb of each hand using a rotating movement.
Step 6: Rub the tips of the fingers against the opposite palm using circular movement. Rub wrist with both hands. Allow hands to dry completely.
Keep wet for 30 sec against bacteria, yeast, tuberculosis bacilli and enveloped viruses or 2 minutes against limited spectrum viruses.
Do not rinse.
Repeat if renewed hand disinfection is required.
Children and toddler shall only perform hand disinfection under adult supervision: apply the amount for children/toddler at your own hand first and rub the product at child’s/toddler’s hand until both hands are totally dried (see 6-Step instructions). Make sure that the child/toddler does not touch eyes or mouth before the product has dried.
4.1.2.    Use-specific risk mitigation measures
See general directions for use
Use by children only under supervision of an adult.
Do not use for children under 1 year.
Make sure that the user applies the product in an area where people will not be present for a longer period.
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
Keep out of reach of children and non-target animals/pets
4.2.    Use description
Table 2
PT01 - Surgical hand rub
Product type
PT01: Human hygiene
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: Yeasts
Development stage: no data
Scientific name: no data
Common name: Limited spectrum viruses
Development stage: no data
Scientific name: no data
Common name: Tuberculosis bacilli
Development stage: no data
Field(s) of use
indoor use
Ready to use surgical disinfectant for hands and forearms for use in hospitals and other medical areas.
Application method(s)
Method: Dispense
Detailed description: Dispense ready to use disinfectant by pumping at least 3 times (1 ml per pump) onto the hands (pump or pouch with pump) and rub to completely cover clean hands and arms.
OR
Pour the ready to use liquid into the palm of one cupped hand (flip top or cap bottle) applying sufficiently to completely cover clean hands and arms.
Application rate(s) and frequency
Application rate: Portions of 3 ml up to 12 ml in total
Dilution (%): Ready to use
Number and timing of application:
Up to 4 applications per day
Category(ies) of users
professional
Pack sizes and packaging material
Rigid container (flip top) high-density polyethylene (HDPE): 100, 150, 200, 500 ml
Rigid container (pump or cap) (HDPE): 0,5, 0,6, 0,7, 0,75, 0,8, 0,9, 1, 1,3, 1,5, 2, 3, 5, 10, 20, 50, 100, 200 litres
Flexible container (pouch with pump or cap) low-density polyethylene (LDPE): 0,8, 1,3, 2,5 litres
4.2.1.    Use-specific instructions
The product shall be used on visibly clean hands and arms.
Do not refill or decant products used as surgical hand rub.
For pump or pouch with pump:
Dispense by pumping at least 3 times (1 ml per pump) onto the hands and rub to completely cover clean hands and arms up to the elbow. Repeat the procedure and use multiple portions of 3 ml to keep hands and arms wet for 2 minutes.
Keep wet for 2 minutes against bacteria, yeast, tuberculosis bacteria and limited spectrum viruses.
Do not rinse.
Repeat if renewed hand disinfection is required. (Up to 4 applications per day).
For flip top or cap bottle:
Pour the liquid into the palm of one cupped hand, applying sufficiently to completely cover clean hands and arms up to the elbow. Repeat the procedure and use multiple portions of 3 ml to keep hands and arms wet for 2 minutes.
Keep wet for 2 minutes against bacteria, yeast, tuberculosis bacteria and limited spectrum viruses.
Do not rinse.
Repeat if renewed hand disinfection is required. (Up to 4 applications per day).
4.2.2.    Use-specific risk mitigation measures
See general directions for use
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   ( 1 )
5.1.    Instructions for use
See use specific instructions for the individual uses.
5.2.    Risk mitigation measures
Avoid contact with eyes.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
Inhalation: May cause drowsiness or dizziness.
Skin contact: No known effects or symptoms in normal use.
Eye contact: Causes severe irritation.
Ingestion: Ingestion might lead to nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children).
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. If symptoms: Call 112/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 ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
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.
Environmental precautions:
Avoid (direct) release (of undiluted product) to the environment/sewage system.
Dilute spills with water and mop up.
5.4.    Instructions for safe disposal of the product and its packaging
Dispose according to national or local regulations.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
2 years shelf life
Store below 30°C
Store away from heat and direct sunlight.
6.    OTHER INFORMATION
( 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) 2024/2419 of 13 September 2024 granting a Union authorisation for the single biocidal product Soft Care Med H5 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Schedules & Appendices

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