Commission Implementing Regulation (EU) 2025/1885 of 11 September 2025 granting a Union authorisation for the biocidal product family BPF Propan-2-ol Dr Deppe in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2025-09-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval, pharmaceutical product








L_202501885EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1885


19.9.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/1885
of 11 September 2025
         
granting a Union authorisation for the biocidal product family ‘BPF Propan-2-ol Dr Deppe’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 29 June 2016, Laboratorium Dr. Deppe GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘BPF Propan-2-ol Dr Deppe’ of product-type 1, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-GH025503-55 in the Register for Biocidal Products.












(2)


‘BPF Propan-2-ol Dr Deppe’ contains propan-2-ol as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1.












(3)


On 27 May 2024, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 13 December 2024, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘BPF Propan-2-ol Dr Deppe’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘BPF Propan-2-ol Dr Deppe’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(6) of that Regulation.












(6)


On 8 January 2025, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘BPF Propan-2-ol Dr Deppe’.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0033834-0000 is hereby granted to Laboratorium Dr. Deppe GmbH for the making available on the market and use of the biocidal product family ‘BPF Propan-2-ol Dr Deppe’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 9 October 2025 until 30 September 2035.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 September 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Opinion of 28 November 2024 on the Union authorisation of the biocidal product family ‘BPF Propan-2-ol Dr Deppe’ (ECHA/BPC/454/2024), https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY
BPF Propan-2-ol Dr Deppe

Product type(s)

PT01: Human hygiene

Authorisation number: EU-0033834-0000

R4BP asset number: EU-0033834-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION
1.1.   Family name







Name


BPF Propan-2-ol Dr Deppe




1.2.   Product type(s)







Product type(s)


PT01: Human hygiene




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Laboratorium Dr. Deppe GmbH




Address


Hooghe Weg 35 47906 Kempen DE




Authorisation number


 


EU-0033834-0000





R4BP asset number



 


EU-0033834-0000




Date of the authorisation


 


9 October 2025




Expiry date of the authorisation


 


30 September 2035




1.4.   Manufacturer(s) of the product







Name of manufacturer


Laboratorium Dr. Deppe GmbH




Address of manufacturer


Hooghe Weg 35 47906 Kempen Germany




Location of manufacturing sites


Laboratorium Dr. Deppe GmbH site 1
Laboratorium Dr. Deppe GmbH, Hooghe Weg 35 47906 Kempen Germany
Laboratorium Dr. Deppe GmbH site 2
Laboratorium Dr. Deppe GmbH, Am Selder 35 47906 Kempen Germany




1.5.   Manufacturer(s) of the active substance(s)







Active substance


Propan-2-ol




Name of manufacturer


Brenntag GmbH




Address of manufacturer


Stinnes-Platz 1 45472 Muelheim an der Ruhr Germany




Location of manufacturing sites


Brenntag GmbH site 1
Shell Nederland Raffinaderij B.V., Vondelingenweg 601, Vondelingenplaat 3196KK Rotterdam Netherlands (the)
Brenntag GmbH site 2
Exxon Mobil Chemical Plant, 4999 Scenic Highway LA 70805 Baton Rouge United States (the)




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


63,14 -64  % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AL Any other liquid
XX: wipes impregnated with liquid, ready-to-use




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)


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-2-ol


 


Active substance


67-63-0


200-661-7


63,14 -64  % (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, ventilating, lighting equipment.
P243: Take actions to prevent static discharges.
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.
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 / doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: In case of fire: Use CO2, dry chemical, or foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to conform with local / regional / national / international regulations.




4.   AUTHORISED USE(S) OF THE META SPC
4.1.   Use description


Table 1


Use # 1.1 – Hygienic Handrub, General – BP01







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


n/a




Target organism(s) (including development stage)


Common name: Bacteria
Common name: Tuberculosis bacteria
Common name: Yeasts
Common name: Enveloped viruses




Field(s) of use


Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:






—


Domestic use










—


Recreational areas








Application method(s)


Method: Handrub (hygienic), liquid dispensing onto hands
Detailed description:
The product is ready to use (RTU).




Application rate(s) and frequency


Application Rate:
Adults and children of 12 years and above: 3 ml. The amount of liquid shall resemble the size of a large-sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).
Children under 12 years: 1,5 ml (The number of pumps with the dosing system equivalent to 1,5 ml of the product to be specified by the authorisation holder within the product information).
RTU
Number and timing of application:
Frequency:
Adults and children of 12 years and above: Up to 10 × per day
Children under 12 years: Up to 3 × per day




Category(ies) of users


General public (non-professional)




Pack sizes and packaging material








—


1 000  ml bottle – high density polyethylene (HDPE) + polypropylene (PP) screw cap (with and without low density polyethylene (LDPE) nozzle)










—


500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)










—


250 ml bottle – HDPE + PP screw flip top cap










—


150 ml bottle – HDPE + PP screw flip top cap










—


100 ml bottle – HDPE + PP screw flip top cap




Abbreviations:
HDPE: high density polyethylene
LDPE: low density polyethylene
PP: polypropylene




4.1.1.   Use-specific instructions for use

The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
The product is ready-to-use. The product shall be either applied directly or used in a dispenser or with a pump.
Step 1: Apply the following amount of disinfectant:






—


Adults and children of 12 years and above: 3 ml










—


Children under 12 years: 1,5 ml




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 seconds against bacteria, yeast, tuberculosis bacteria and enveloped viruses.
Do not rinse.
Repeat if renewed hand disinfection is required.
Adults and children of 12 years and above: up to 10 × per day
Children under 12 years: up to 3 × per day
4.1.2.   Use-specific risk mitigation measures

Use for children (age > 1 year) only under supervision of an adult.
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 of Meta SPC 1.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of Meta SPC 1.
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 of Meta SPC 1
4.2.   Use description


Table 2


Use #1.2 – Hygienic Handrub, Professional – BP01







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


n/a




Target organism(s) (including development stage)


Common name: Bacteria
Common name: Tuberculosis bacteria
Common name: Yeasts
Common name: Enveloped viruses




Field(s) of use


Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:






—


Domestic use (home care etc.);










—


Institutional use (research etc.);










—


Industrial applications, e.g. food, cosmetic, pharmaceutical industry etc.;










—


Restaurants and large-scale/canteen kitchens;










—


Recreational areas.








Application method(s)


Method: Handrub (hygienic), liquid dispensing onto hands
Detailed description:
The product is ready to use (RTU).




Application rate(s) and frequency


Application Rate:
Adult: 3 ml. The amount of liquid shall resemble the size of a large-sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).
RTU
Number and timing of application:
Frequency: Adult: Up to 25 × per day




Category(ies) of users


Professional




Pack sizes and packaging material








—


5 000  ml canister - HDPE + HDPE screw cap










—


1 000  ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)










—


500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)










—


250 ml bottle – HDPE + PP screw flip top cap










—


150 ml bottle – HDPE + PP screw flip top cap










—


100 ml bottle – HDPE + PP screw flip top cap








4.2.1.   Use-specific instructions for use

The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
The product is ready-to-use. The product shall be either applied directly or used in a dispenser or with a pump.
Step 1: Apply the following amount of disinfectant:






—


Adult: 3 ml




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 seconds against bacteria, yeast, tuberculosis bacteria and enveloped viruses.
Do not rinse.
Repeat if renewed hand disinfection is required (Adult: Up to 25 × per day).
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.
Transferring the content of larger packages to e.g. dispenser vessels is possible as far as hygienic requirements for the ambient conditions and for the materials used are met and contamination of the product can be safely excluded.
The canister must be equipped with canister pump dispenser or canister valve. The smaller vessel shall be fitted with a funnel.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number










—


The trade name of the biocidal product










—


The identity and content of each active ingredient










—


The instructions for use, including the incorporation time required for the biocidal action










—


The information according to CLP




4.2.2.   Use-specific risk mitigation measures

See general directions for use of Meta SPC1.
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 of Meta SPC 1.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of Meta SPC 1.
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 of Meta SPC 1.
4.3.   Use description


Table 3


Use #1.3 – Surgical Handrub – BP01







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


n/a




Target organism(s) (including development stage)


Common name: Bacteria
Common name: Tuberculosis bacteria
Common name: Yeasts
Common name: Enveloped viruses




Field(s) of use


Indoor use
Surgical handrub




Application method(s)


Method: Handrub (surgical), liquid dispensing onto hands and lower arms
Detailed description:
The product is ready to use (RTU).




Application rate(s) and frequency


Application Rate:
6-12 ml for 90 seconds contact time
RTU
Number and timing of application:
Frequency: Up to 4 × per day.




Category(ies) of users


Professional




Pack sizes and packaging material








—


5 000  ml canister – HDPE + HDPE screw cap










—


1 000  ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)










—


500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)










—


250 ml bottle – HDPE + PP screw flip top cap










—


150 ml bottle – HDPE + PP screw flip top cap










—


100 ml bottle – HDPE + PP screw flip top cap








4.3.1.   Use-specific instructions for use

The product shall be used on visibly clean hands and lower arms. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
Rub undiluted solution on skin to keep hands and lower arms moist for 90 seconds.
Use sufficient product to ensure complete coverage during contact time. This may vary with hand size and skin condition.
Approximately 6-12 ml are needed for 90 seconds contact time.
Refilling/decanting of the product shall only be done under aseptic conditions.
The canister must be equipped with canister pump dispenser or canister valve.
The smaller vessel shall be fitted with a funnel.
All materials must be fully compatible with the product.
The dispenser or container, which is refilled, must have the following minimum labelling information:






—


The authorisation number










—


The trade name of the biocidal product










—


The identity and content of each active ingredient










—


The instructions for use, including the incorporation time required for the biocidal action










—


The information according to CLP




4.3.2.   Use-specific risk mitigation measures

See general directions for use of Meta SPC 1.
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 of Meta SPC 1.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of Meta SPC 1.
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 of Meta SPC 1.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1.   Instructions for use

See use-specific instructions for each use.
Comply with the instructions for use.
5.2.   Risk mitigation measures

All handling shall only take place in well-ventilated areas.
In case of skin dryness, use appropriate skin care lotion.
Avoid contact with eyes.
5.3.   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.
In case of fire: Use CO2, dry chemical, or foam to extinguish.
Dispose of contents/container according to local / regional / national / international regulations.
First aid:
IF INHALED: If symptoms occur 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. 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.
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.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
Waste disposal code: 070604
5.5.   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.
Store in the dark. Keep cool. Do not store at temperatures exceeding 35 °C.
Shelf life: 3 years
6.   OTHER INFORMATION
Please be aware of the European reference value of 129,2 mg/m3 for the active substance propan-2-ol (CAS No: 67-63-0) which was used for the risk assessment of the biocidal product family.
Professionals (including industrial, professionals) mean trained professional if this is required by national legislation.
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)


OP Sept Color


Market area: EU




Op Sept Blau


Market area: EU




Teva Sept Skin poly-alkoholos bőrfertőtlenítő (színezett)


Market area: EU




Authorisation number


EU-0033834-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,14  % (w/w)




7.2.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


OP Sept residue-free


Market area: EU




Curacid HD-sept


Market area: EU




Manorapid pure


Market area: EU




Op Sept pur


Market area: EU




Op Sept pure


Market area: EU




Authorisation number


EU-0033834-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,14  % (w/w)




7.3.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


OP Sept Classic


Market area: EU




Camed HD-Plus


Market area: EU




Curacid Poly


Market area: EU




Dezodent HW


Market area: EU




Dr. Desi Händedesinfektion


Market area: EU




Kühn Händedesinfektion


Market area: EU




Kühn Händedesinfektion


Market area: EU




Maimed Clean


Market area: EU




Manorapid Basic


Market area: EU




Manorapid r.f.u.


Market area: EU




Op Derm


Market area: EU




Op Derm Medical


Market area: EU




Op Sept


Market area: EU




OPSept


Market area: EU




OP-Sept


Market area: EU




Septomed


Market area: EU




Teva Sept Hand


Market area: EU




Teva Sept Hand


Market area: EU




Teva Sept Skin poly-alkoholos bőrfertőtlenítő és sebészi bemosakodó (színezetlen)


Market area: EU




Alcoman


Market area: EU




Alcoman +


Market area: EU




Alcoman Optima


Market area: EU




Alcoman Plus


Market area: EU




Hand Antiseptic


Market area: EU




Hand Disinfection


Market area: EU




Hände Antiseptikum


Market area: EU




Händedesinfektion


Market area: EU




MyClean IP-Sept


Market area: EU




MyClean OP-Sept


Market area: EU




Sicu Sept


Market area: EU




Actoderm


Market area: EU




OP Sept perfume-free


Market area: EU




OpSeptClassic - parfumfrei


Market area: EU




Authorisation number


EU-0033834-0003 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,14  % (w/w)




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)


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-2-ol


 


Active substance


67-63-0


200-661-7


63,14 -64  % (w/w)




2.2.   Type(s) of formulation of the meta SPC 2







Formulation type(s)


XX: wipes impregnated with liquid, ready-to-use




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2






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, ventilating, lighting equipment.
P243: Take actions to prevent static discharges.
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.
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 / doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: In case of fire: Use CO2, dry chemical, or foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to conform with local / regional / national / international regulations.




4.   AUTHORISED USE(S) OF THE META SPC
4.1.   Use description


Table 1


Use #2.1 – Hygienic Handrub, General – BP02







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


n/a




Target organism(s) (including development stage)


Common name: Bacteria
Common name: Tuberculosis bacteria
Common name: Yeasts
Common name: Enveloped viruses




Field(s) of use


Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:






—


Domestic use (home care etc.);










—


Recreational areas.








Application method(s)


Method: Handrub (hygienic), Wiping
Detailed description:
Ready to use (RTU) wipes.




Application rate(s) and frequency


Application Rate:
Use one wipe to disinfect hands.
RTU wipes
Number and timing of application:
Frequency: Up to 9 wipes per day.




Category(ies) of users


General public (non-professional)




Pack sizes and packaging material


Small wipes:
Pack sizes: 6 / 12 / 15 / 30 / 48 / 60 / 72 / or 84 wipes per package
Total volume of biocide in package: 51,38 / 102,75 / 128,44 / 256,88 / 411,01 / 513,76 / 616,51 / or 719,26 ml
Package material: Polyethylene terephthalate/aluminium/low density polyethylene (PET/Alu/LDPE) laminated foil
Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100 % wood cellulose)
Wipe size: 20 × 15 cm
Wipe weight: 1,5 g (per wipe)
Impregnation liquid weight: 7,5 g (per wipe)
Large wipes:
Pack sizes: 30 / 42 / 60 / 80 or 84 wipes per package
Total volume of biocide in package: 513,76 / 719,26 / 1 027,51  / 1 370,02  or 1 438,52  ml
Package material: PET/Alu/LDPE laminated foil
Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100 % wood cellulose)
Wipe size: 20 × 30 cm
Wipe weight: 3 g (per wipe)
Impregnation liquid weight: 15 g (per wipe)




4.1.1.   Use-specific instructions for use

See general directions for use of Meta SPC 2.
4.1.2.   Use-specific risk mitigation measures

Use for children (age > 1 year) only under supervision of an adult.
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 direction for use of Meta SPC 2.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of Meta SPC 2.
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 of Meta SPC 2.
4.2.   Use description


Table 2


Use #2.2 – Hygienic Handrub, Professional – BP02







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


n/a




Target organism(s) (including development stage)


Common name: Bacteria
Common name: Tuberculosis bacteria
Common name: Yeasts
Common name: Enveloped viruses




Field(s) of use


Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:






—


Domestic use (home care etc.);










—


Institutional use (research etc.);










—


Industrial applications, e.g. food, cosmetic, pharmaceutical industry etc.;










—


Restaurants and large-scale/canteen kitchens;










—


Recreational areas.








Application method(s)


Method: Handrub (hygienic), Wiping
Detailed description:
Ready to use (RTU) wipes.




Application rate(s) and frequency


Application Rate:
Use one wipe to disinfect hands.
RTU wipes
Number and timing of application:
Frequency: Typically 25 applications per day




Category(ies) of users


Professional




Pack sizes and packaging material


Small wipes:
Pack sizes: 6 / 12 / 15 / 30 / 48 / 60 / 72 / or 84 wipes per package
Total volume of biocide in package: 51,38 / 102,75 / 128,44 / 256,88 / 411,01 / 513,76 / 616,51 / or 719,26 ml
Package material: PET/Alu/LDPE laminated foil
Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100 % wood cellulose)
Wipe size: 20 × 15 cm
Wipe weight: 1,5 g (per wipe)
Impregnation liquid weight: 7,5 g (per wipe)
Large wipes:
Pack sizes: 30 / 42 / 60 / 80 / or 84 wipes per package
Total volume of biocide in package: 513,76 / 719,26 / 1 027,51  / 1 370,02  / or 1 438,52  ml
Package material: Polyethylene terephthalate (PET)/Alu/LDPE laminated foil
Wipe material: 100 % Lyocell (white fabric, a fiber regenerated from 100% wood cellulose)
Wipe size: 20 × 30 cm
Wipe weight: 3 g (per wipe)
Impregnation liquid weight: 15 g (per wipe)




4.2.1.   Use-specific instructions for use

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.
See the general use instructions of Meta SPC 2.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of Meta SPC 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 general directions for use of Meta SPC 2.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of Meta SPC 2.
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 of Meta SPC 2.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1.   Instructions for use

Comply with the instructions for use.
The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
The wipes are ready-to-use. Only wet wipes are efficacious, dried wipes are to be discarded. Rub hands evenly with one wipe to keep hands moist for 30 seconds.
Please ensure that also all spaces between the fingers, the fingernail angles and skin folds are moistened completely and over the entire exposure time.
5.2.   Risk mitigation measures

All handling shall only take place in well-ventilated areas.
Used wipes must be disposed in a closed container.
In case of skin dryness, use appropriate skin care lotion.
Avoid contact with eyes.
5.3.   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.
In case of fire: Use CO2, dry chemical, or foam to extinguish.
Dispose of contents/container according to local / regional / national / international regulations.
Keep out of reach of children and non-target animals/pets.
First aid:
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.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements
Waste disposal code: 070604
5.5.   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.
Store in the dark. Keep cool. Do not store at temperatures exceeding 40 °C.
Shelf life: 1 year
6.   OTHER INFORMATION
Please be aware of the European reference value of 129,2 mg/m3 for the active substance propan-2-ol (CAS No: 67-63-0) which was used for the risk assessment of the biocidal product family.
Professionals (including industrial, professionals) mean trained professional if this is required by national legislation.
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)


OPSept Medical


Market area: EU




Alcohol Wipes


Market area: EU




Alcoman Tücher


Market area: EU




Alcoman Wipes


Market area: EU




Chucky Wipes


Market area: EU




Deppe Wipes


Market area: EU




Desi Wipes


Market area: EU




IP-Wipes


Market area: EU




Op Sept Medical


Market area: EU




Op Sept Wipes


Market area: EU




OPSept medical perfume-free


Market area: EU




Authorisation number


EU-0033834-0004 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,14  % (w/w)




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)


PT01: Human hygiene




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


64 -64  % (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


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, ventilating, lighting equipment.
P243: Take actions to pevent static discharges.
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.
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 / doctor if you feel unwell.
P337+P313: If eye irritation persists: Get medical POISON CENTER / doctor.
P370+P378: In case of fire: Use CO2, dry chemical, or foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to conform with local / regional / national / international regulations.




4.   AUTHORISED USE(S) OF THE META SPC
4.1.   Use description


Table 1


Use #3.1 – Hygienic Handrub, General – BP03







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


n/a




Target organism(s) (including development stage)


Common name: Bacteria
Common name: Yeasts
Common name: Enveloped viruses




Field(s) of use


Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:






—


Domestic use (home care etc.);










—


Recreational areas.








Application method(s)


Method: Handrub (hygienic), gel dispensing onto hands
Detailed description:
The product is ready to use (RTU).




Application rate(s) and frequency


Application Rate:
Adults and children of 12 years and above: 3 ml. The amount of gel shall resemble the size of a large-sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).
Children under 12 years: 1,5 ml (The number of pumps with the dosing system equivalent to 1,5 ml of the product to be specified by the authorisation holder within the product information).
RTU
Number and timing of application:
Frequency:
Adults and children of 12 years and above: Up to 10 × per day
Children under 12 years: Up to 3 × per day




Category(ies) of users


General public (non-professional)




Pack sizes and packaging material








—


1 000  ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)










—


1 000  ml bottle – HDPE + PP/PE dosing cap










—


500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)










—


150 ml bottle – HDPE + PP screw flip top cap










—


100 ml bottle – HDPE+ PP screw flip top cap








4.1.1.   Use-specific instructions for use

The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
The product is ready-to-use.
Step 1: Apply the following amount of disinfectant:






—


Adult and children of 12 years and above: 3 ml










—


Child under 12 years: 1,5 ml




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 and enveloped viruses.
Do not rinse.
Repeat if renewed hand disinfection is required.
Adults and children of 12 years and above: up to 10 × per day
Children under 12 years: up to 3 × per day
4.1.2.   Use-specific risk mitigation measures

Use for children (age > 1 year) only under supervision of an adult.
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 of Meta SPC 3.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of Meta SPC 3.
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 of Meta SPC 3.
4.2.   Use description


Table 2


Use #3.2 – Hygienic Handrub, Professional – BP03







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


n/a




Target organism(s) (including development stage)


Common name: Bacteria
Common name: Yeasts
Common name: Enveloped viruses




Field(s) of use


Indoor use
In hospitals and other areas, if a high level of hand hygiene is necessary, e.g.:






—


Domestic use (home care etc.);










—


Institutional use (research etc.);










—


Industrial applications, e.g. food, cosmetic, pharmaceutical industry etc.;










—


Restaurants and large-scale/canteen kitchens;










—


Recreational areas.








Application method(s)


Method: Handrub (hygienic), gel dispensing onto hands
Detailed description:
The product is ready to use (RTU).




Application rate(s) and frequency


Application Rate:
Adult: 3 ml. The amount of gel shall resemble the size of a large-sized coin (The number of pumps with the dosing system equivalent to 3 ml of the product to be specified by the authorisation holder within the product information).
RTU
Number and timing of application:
Frequency:
Adult: Typically 25 applications per day.




Category(ies) of users


Professional




Pack sizes and packaging material








—


1 000  ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)










—


1 000  ml bottle – HDPE + PP/PE dosing cap










—


500 ml bottle – HDPE + PP screw cap (with and without LDPE nozzle)










—


150 ml bottle – HDPE + PP screw flip top cap










—


100 ml bottle – HDPE + PP screw flip top








4.2.1.   Use-specific instructions for use

The product shall be used on visibly clean hands. If hands are dirty, wash with soap and water, rinse and dry before applying the product.
The product is ready-to-use. The product shall be either applied directly or used in a dispenser or with a pump.
Step 1: Apply the following amount of disinfectant:






—


Adult: 3 ml




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 and enveloped viruses.
Do not rinse.
Repeat if renewed hand disinfection is required.
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.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of Meta SPC 3.
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 of Meta SPC 3.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of Meta SPC 3.
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 of Meta SPC 3.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1.   Instructions for use

See use-specific instructions for each use.
Comply with the instructions for use.
5.2.   Risk mitigation measures

All handling shall only take place in well-ventilated areas.
In case of skin dryness, use appropriate skin care lotion.
Avoid contact with eyes.
5.3.   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.
In case of fire: Use CO2, dry chemical, or foam to extinguish.
Dispose of contents/container according to local / regional / national / international regulations.
First aid:
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.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements
Waste disposal code: 070604
5.5.   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.
Store in the dark. Keep cool. Do not store at temperatures exceeding 35 °C.
Shelf life: 3 years
6.   OTHER INFORMATION
Please be aware of the European reference value of 129,2 mg/m3 for the active substance propan-2-ol (CAS No: 67-63-0) which was used for the risk assessment of the biocidal product family.
Professionals (including industrial, professionals) mean trained professional if this is required by national legislation.
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)


Lotio Sept Gel


Market area: EU




Alco Gel


Market area: EU




Care Sept Gel


Market area: EU




Lotio-Sept-Gel


Market area: EU




Manorapid gel


Market area: EU




Op Sept Gel


Market area: EU




SeptoMed Gel


Market area: EU




Sicu Gel


Market area: EU




Sicu Sept Gel


Market area: EU




Teva Lotio Sept Gel


Market area: EU




Tork Alcohol Gel


Market area: EU




Alcohol Gel


Market area: EU




Alcoman-Gel


Market area: EU




Alkohol Gel


Market area: EU




antiseptic gel


Market area: EU




Deppe Gel


Market area: EU




Desinfektionsgel


Market area: EU




desinfizierendes Handgel


Market area: EU




Händedesinfektionsgel


Market area: EU




Handgel


Market area: EU




Hygienegel


Market area: EU




Hygienic Hand Gel


Market area: EU




Actoderm Gel


Market area: EU




Lotio Sept Gel perfume-free


Market area: EU




Lotio Sept Gel pur


Market area: EU




Lotio Sept Gel pure


Market area: EU




Manorapid gel pure


Market area: EU




Authorisation number


EU-0033834-0005 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


64  % (w/w)




7.2.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


Lotio Sept Gel Color


Market area: EU




Lotio Sept Gel blau


Market area: EU




Lotio Sept Gel blue


Market area: EU




OP Sept Gel Color


Market area: EU




Authorisation number


EU-0033834-0006 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


64  % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2025/1885/oj
ISSN 1977-0677 (electronic edition)