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
Date: 2025-03-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, cosmetic product, market approval, pharmaceutical product








L_202500427EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/427


6.3.2025







            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
(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 20 December 2018, Orochemie GmbH + Co. KG, 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 ‘Orochemie hand disinfectants’ of product-type 1, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-KA047310-68 in the Register for Biocidal Products.












(2)


‘Orochemie hand disinfectants’ contains propan-1-ol and propan-2-ol, as active substances, 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 22 November 2023, 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 26 June 2024, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Orochemie hand disinfectants’ 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 ‘Orochemie hand disinfectants’ 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 15 July 2024, 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 ‘Orochemie hand disinfectants’.












(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-0032838-0000 is granted to Orochemie GmbH + Co. KG for the making available on the market and use of the biocidal product family ‘Orochemie hand disinfectants’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 26 March 2025 until 28 February 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, 4 March 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)  ECHA opinion of 30 May 2024 on the Union authorisation of ‘Orochemie hand disinfectants’ (ECHA/BPC/433/2024), https://echa.europa.eu/opinions-on-union-authorisation.




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/m3 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

-
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/m3 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)







ELI: http://data.europa.eu/eli/reg_impl/2025/427/oj
ISSN 1977-0677 (electronic edition)