LegalizeCommission 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
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| Image omitted; see official source | Official Journal of the European Union | EN L series |
| --- | --- | --- |
| 2025/427 | 6.3.2025 |
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
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 |
| Name and address of the authorisation holder | 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) | Trade name(s) | Trade name(s) | C 14 | C 14 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | oro® med | oro® med | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 410 plus | HD 410 plus | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 413 plus | HD 413 plus | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 400 plus | HD 400 plus | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 420 plus | HD 420 plus | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032838-0001 1-1 | EU-0032838-0001 1-1 | EU-0032838-0001 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | active substance | active substance | 71-23-8 | 71-23-8 | 200-746-9 | 26 % (w/w) | |
| Propan-2-ol | active substance | active substance | 67-63-0 | 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) | Trade name(s) | Trade name(s) | C 10 | C 10 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 410 | HD 410 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 413 | HD 413 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Dürr System-Hygiene HD 410 hand disinfection | Dürr System-Hygiene HD 410 hand disinfection | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 400 | HD 400 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 420 | HD 420 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | C 10 hand disinfection | C 10 hand disinfection | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 410 hand disinfection | HD 410 hand disinfection | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032838-0002 1-1 | EU-0032838-0002 1-1 | EU-0032838-0002 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | active substance | active substance | 71-23-8 | 71-23-8 | 200-746-9 | 26 % (w/w) | |
| Propan-2-ol | active substance | active substance | 67-63-0 | 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) | Trade name(s) | Trade name(s) | C 12 | C 12 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | oro® pure | oro® pure | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | oro® care | oro® care | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | oro® Händedesinfektion | oro® Händedesinfektion | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 410 essential | HD 410 essential | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 413 essential | HD 413 essential | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 400 essential | HD 400 essential | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 420 essential | HD 420 essential | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0032838-0003 1-2 | EU-0032838-0003 1-2 | EU-0032838-0003 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-1-ol | active substance | active substance | 71-23-8 | 71-23-8 | 200-746-9 | 26 % (w/w) | |
| Propan-2-ol | active substance | active substance | 67-63-0 | 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)
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.