Date: 2022-07-22 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2022/1282 of 8 July 2022 granting a Union authorisation for the biocidal product family ‘Knieler & Team Propanol Family’ (Text with EEA relevance)

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

                    Executive Summary:
Commission Implementing Regulation (EU) 2022/1282 of 8 July 2022 grants Union authorisation to Knieler Team GmbH for the biocidal product family "Knieler Team Propanol Family," concerning product types 1, 2, and 4. The authorisation, numbered EU0027467-0000, is valid from August 11, 2022, to July 31, 2032. The regulation details the product's characteristics, composition, authorised uses, and safety measures.

Key Points / Main Content:

*   **Authorisation Details:**
    *   Union authorisation EU0027467-0000 is granted to Knieler Team GmbH for the biocidal product family Knieler Team Propanol Family.
    *   The authorisation is valid from August 11, 2022, to July 31, 2032.

*   **Product Composition:**
    *   Active substances: Propan-1-ol and Propan-2-ol.
    *   Product types covered: PT01 (Human hygiene disinfectants), PT02 (Disinfectants and algaecides not for direct human/animal use), and PT04 (Food and feed area disinfectants).
    *   Formulation type: AL (Any other liquid).

*   **Meta SPCs (Summary of Product Characteristics):**
    *   The authorisation covers seven Meta SPCs, each with specific compositions, hazard statements, precautionary statements, and authorised uses.
    *   Meta SPCs 1, 2, 3, 4, and 5 are for PT01, while Meta SPCs 6 and 7 cover PT02 and PT04.
    *   Detailed information on target organisms, fields of use, application methods, rates, user categories, and pack sizes are provided for each Meta SPC.

*   **Authorised Uses & Instructions:**
    *   Includes uses for hygienic and surgical hand rubs (Meta SPCs 1-5) and hard surface disinfection (Meta SPCs 6 & 7).
    *   Specific instructions for use, risk mitigation measures, first aid, disposal, storage, and shelf life are outlined for each Meta SPC.
    *   Professional use only is specified for all Meta SPCs.

*   **Hazard & Precautionary Statements:**
    *   Common hazards include flammable liquid and vapour, serious eye damage, drowsiness or dizziness, and skin dryness/cracking.
    *   Precautionary measures involve keeping away from heat/sparks/open flames, avoiding breathing vapours, using in ventilated areas, and wearing eye protection (where specified).

Impact Analysis:

*   Knieler Team GmbH:
    *   Impact: Granted authorisation to market and use the Knieler Team Propanol Family biocidal products within the Union, subject to compliance with the SPC.
    *   Action Required: Ensure products are manufactured, labelled, and placed on the market in accordance with the regulation and the SPC.

*   Professional Users (healthcare facilities, food industry, etc.):
    *   Impact: Authorised to use the biocidal products for specific applications (hand disinfection, surface disinfection) following detailed instructions.
    *   Action Required: Follow instructions for use, risk mitigation measures, and disposal as outlined in the relevant Meta SPC.

*   Manufacturers of active substances (OQ Chemicals, BASF SE, SASOL Chemie GmbH Co. KG, Stockmeier Chemie GmbH Co. KG, Brenntag GmbH, INEOS Solvent Germany GmbH):
    *   Impact: Their substances are approved for use in the biocidal product family.
    *   Action Required: Ensure the continued quality and compliance of the active substances.

*   Regulatory Authorities:
    *   Impact: Responsible for monitoring and enforcing compliance with the regulation.
    *   Action Required: Ensure that Knieler Team GmbH and users of the product comply with the terms of the authorisation.
                

Key Entities Referenced

European Union: A political and economic union of member states located primarily in Europe. European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU. Regulation EU No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products. Knieler Team GmbH: The company that submitted the application for authorisation of the biocidal product family. Knieler Team Propanol Family: The name of the biocidal product family for which Union authorisation is granted. Switzerland: The country whose competent authority agreed to evaluate the application for the biocidal product. European Chemicals Agency: An agency of the European Union which prepares opinions on biocidal product characteristics and assessment reports. Hamburg, Germany: City in Germany where Knieler Team GmbH is located.

Official Source Record View Original Source →

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                L 195/34 EN Official Journal of the European Union 22.7.2022
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1282
of 8 July 2022
granting a Union authorisation for the biocidal product family ‘Knieler & Team Propanol Family’
(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 2012concerning
the making available on the market and use of biocidal products(1), and in particular Article 44(5), first subparagraph,
thereof,
Whereas:
(1) On 17 April 2019, Knieler & Team GmbH submitted an application in accordance with Article 43(1) of Regulation
(EU) No 528/2012 for authorisation of a biocidal product family named ‘Knieler & Team Propanol Family’ of
product-types 1, 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the
competent authority of Switzerland had agreed to evaluate the application. The application was recorded under case
number BC-AQ050985-22 in the Register for Biocidal Products.
(2) ‘Knieler & Team Propanol Family’ contains propan-1-ol and propan-2-ol, as the active substances, which are
included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012
for product-types 1, 2 and 4.
(3) On 29 March 2021, 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 European Chemicals Agency
(‘the Agency’).
(4) On 4 November 2021, the Agency submitted to the Commission an opinion(2), including the draft summary of the
biocidal product characteristics (‘SPC’) of ‘Knieler & Team Propanol Family’ 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 ‘Knieler & Team Propanol Family’ 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(1) and (6) of that Regulation.
(6) On 22 November 2021, 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 ‘Knieler & Team Propanol Family’.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
biocidal products,
(1) OJ L 167, 27.6.2012, p. 1.
(2) ECHA opinion of 7 October 2021 on the Union authorisation of ‘Knieler & Team Propanol Family’ (ECHA/BPC/292/2021), https://
echa.europa.eu/bpc-opinions-on-union-authorisation.22.7.2022 EN Official Journal of the European Union L 195/35
HAS ADOPTED THIS REGULATION:
Article 1
A Union authorisation with authorisation number EU-0027467-0000 is granted to Knieler & team GmbH for the making
available on the market and use of the biocidal product family ‘Knieler & Team Propanol Family’ in accordance with the
summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 11 August 2022to 31 July 2032.
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, 8 July 2022.
For the Commission
The President
Ursula VON DER LEYENL 195/36 EN Official Journal of the European Union 22.7.2022
ANNEX
Summary of product characteristics for a biocidal product family
Knieler & Team Propanol Family
Product type 1 - Human hygiene (Disinfectants)
Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 - Food and feed area (Disinfectants)
Authorisation number: EU-0027467-0000
R4BP asset number: EU-0027467-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
Name Knieler & Team Propanol Family
1.2. Product type(s)
Product type(s) PT01 - Human hygiene (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to
humans or animals (Disinfectants)
PT04 - Food and feed area (Disinfectants)
1.3. Authorisation holder
Name and address of the authorisation holder Name Knieler & Team GmbH
Address Kattrepelsbrücke 1, 20095 Hamburg Germany
Authorisation number EU-0027467-0000
R4BP asset number EU-0027467-0000
Date of the authorisation 11 August 2022
Expiry date of the authorisation 31 July 2032
1.4. Manufacturer(s) of the biocidal products
Name of manufacturer Knieler & Team GmbH
Address of manufacturer Kattrepelsbrücke 1, 20095 Hamburg Germany
Location of manufacturing sites Knieler & Team GmbH, Kattrepelsbrücke 1, 20095 Hamburg Germany22.7.2022 EN Official Journal of the European Union L 195/37
A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH, Otto-
Brenner-Straße 16-18, 21337 Lüneburg Germany
1.5. Manufacturer(s) of the active substance(s)
Active substance Propan-1-ol
Name of manufacturer OQ Chemicals GmbH (formerly Oxea GmbH)
Address of manufacturer Rheinpromenade 4a, 40789 Monheim am Rhein Germany
Location of manufacturing sites OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX,
77414 Bay City United States
Active substance Propan-1-ol
Name of manufacturer BASF SE
Address of manufacturer Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany
Location of manufacturing sites BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany
Active substance Propan-1-ol
Name of manufacturer SASOL Chemie GmbH & Co. KG
Address of manufacturer Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090
Sandton South Africa
Location of manufacturing sites Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South
Africa
Active substance Propan-2-ol
Name of manufacturer Stockmeier Chemie GmbH & Co. KG
Address of manufacturer Am Stadtholz 37, 33609 Bielefeld Germany
Location of manufacturing sites INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany
Active substance Propan-2-ol
Name of manufacturer Brenntag GmbH
Address of manufacturer Stinnes-Platz 1, 45472 Mülheim an der Ruhr Germany
Location of manufacturing sites Shell Nederland Raffinaderij B.V., 3196 KK Rotterdam-Pernis Netherlands
Exxon Mobil, LA 70805 Baton Rouge United States
Active substance Propan-2-ol
Name of manufacturer INEOS Solvent Germany GmbHL 195/38 EN Official Journal of the European Union 22.7.2022
Address of manufacturer Römerstrasse 733, 47443 Moers Germany
Location of manufacturing sites INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany
INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne
Germany
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
Content (%)
IUPAC
Common name Function CAS number EC number
name
Min Max
Propan-1-ol Active Substance 71-23-8 200-746-9 12,229 35,0
Propan-2-ol Active Substance 67-63-0 200-661-7 30,0 63,14
2.2. Type(s) of formulation
Formulation(s) AL - Any other liquid
PART II
SECOND INFORMATION LEVEL - META SPC(S)
META SPC 1
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 (Disinfectants)22.7.2022 EN Official Journal of the European Union L 195/39
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
Content (%)
IUPAC
Common name Function CAS number EC number
name
Min Max
Propan-1-ol Active Substance 71-23-8 200-746-9 30,0 32,5
Propan-2-ol Active Substance 67-63-0 200-661-7 45,0 45,0
2.2. Type(s) of formulation of the meta SPC 1
Formulation(s) AL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements Flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition
sources. - No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Use only outdoors or in a well-ventilated area.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact
lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of container to an authorised waste collection point.
4. AUTHORISED USE(S) OF THE META SPC 1
4.1. Use description
Table 1
Use # 1 – hygienic handrub, liquid
Product type PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised useL 195/40 EN Official Journal of the European Union 22.7.2022
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Mycobacteria
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: Enveloped viruses
Development stage:
Field(s) of use Indoor
— hospitals and other health care institutions, ambulances, surgeries, nur­
sing homes (including home-care of patients)
— hospital canteens, large kitchens, pharmaceutical industries, production
sites, laboratories: hygienic handrub onto visibly clean and dry hands
— for professional use only
Application method(s) Method: Manual application
Detailed description:
Rubbing
Application rate(s) and frequency Application Rate: Dosage: At least 3 ml (use dispensers: for example set to
1,5 ml per stroke, 2 strokes per 3 ml) Contact time: 30 s
Dilution (%): Ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety
intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users Industrial
Professional
Pack sizes and packaging material 100, 125, 500, 1 000ml in transparent/white high-density polyethylene
(HDPE) bottles with polypropylene (PP) flip top caps;
5 000ml transparent/white HDPE canister with HDPE screwed cap.
In addition, exclusively for E-HDL (product 1.2):
500 and 1 000ml in transparent HDPE lightweight bottle with integrated PP
pump.
4.1.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
Do not refill.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 122.7.2022 EN Official Journal of the European Union L 195/41
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 # 2 – surgical handrub, liquid
Product type PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Mycobacteria
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: enveloped viruses
Development stage:
Field(s) of use Indoor
Hospitals and other health care institutions: surgical handrub onto visibly
clean and dry hands and forearms.
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Rubbing
Application rate(s) and frequency Application Rate: Dosage: Rub sufficient amount in portions of 3 ml (use
dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Contact
time: 90 s
Dilution (%): Ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety
intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users ProfessionalL 195/42 EN Official Journal of the European Union 22.7.2022
Pack sizes and packaging material 100, 125, 500, 1 000ml in transparent/white high-density polyethylene
(HDPE) bottles with polypropylene (PP) flip top caps;
5 000ml transparent/white HDPE canister with HDPE screwed cap.
In addition, exclusively for E-HDL (product 1.2):
500 and 1 000ml in transparent HDPE lightweight bottle with integrated PP
pump.
4.2.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
Do not refill.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 1
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
5. GENERAL DIRECTIONS FOR USE(1)OF THE META SPC 1
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the
environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention
if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a
doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within
the meta SPC 1.22.7.2022 EN Official Journal of the European Union L 195/43
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11),
amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT
induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames.
No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous
earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local
regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic
waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior
to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
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) A-HDL Market area: EU
Authorisation number EU-0027467-0001 1-1
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 32,5
Substance
Propan-2-ol Active 67-63-0 200-661-7 45,0
SubstanceL 195/44 EN Official Journal of the European Union 22.7.2022
7.2. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) E-HDL Market area: EU
Authorisation number EU-0027467-0002 1-1
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 30,0
Substance
Propan-2-ol Active 67-63-0 200-661-7 45,0
Substance
7.3. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) H-HDL Market area: EU
Authorisation number EU-0027467-0003 1-1
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 30,0
Substance
Propan-2-ol Active 67-63-0 200-661-7 45,0
Substance
META SPC 2
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 (Disinfectants)22.7.2022 EN Official Journal of the European Union L 195/45
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
Content (%)
Common name IUPAC name Function CAS number EC number
Min Max
Propan-1-ol Active Substance 71-23-8 200-746-9 20,0 20,0
Propan-2-ol Active Substance 67-63-0 200-661-7 60,0 60,0
2.2. Type(s) of formulation of the meta SPC 2
Formulation(s) AL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements Highly flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition
sources. - No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Use only outdoors or in a well-ventilated area.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact
lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of container to an authorised waste collection point.
4. AUTHORISED USE(S) OF THE META SPC 2
4.1. Use description
Table 3
Use # 1 – hygienic handrub, liquid
Product type PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:L 195/46 EN Official Journal of the European Union 22.7.2022
Scientific name: other
Common name: Tuberculosis bacilli
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: Enveloped viruses
Development stage:
Field(s) of use Indoor
— hospitals and other health care institutions, ambulances, surgeries, nur­
sing homes (including home-care of patients)
— hospital canteens, large kitchens, pharmaceutical industries, production
sites, laboratories: hygienic handrub onto visibly clean and dry hands
— for professional use only.
Application method(s) Method: Manual application
Detailed description:
Rubbing
Application rate(s) and frequency Application Rate: Dosage: At least 3 ml (use dispensers: for example set to 1,5
ml per stroke, 2 strokes per 3 ml). Contact time: 30 s
Dilution (%): Ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety
intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users Industrial
Professional
Pack sizes and packaging material 150, 500, 1 000ml in transparent/white high-density polyethylene (HDPE)
bottles with polypropylene (PP) flip top caps;
5 000ml HDPE canister with transparent/white HDPE screwed cap;
700 and 1 000ml vacuum bag in white PE composite foil with integrated PP
pump/valve and PE cap.
4.1.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
Do not refill.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 222.7.2022 EN Official Journal of the European Union L 195/47
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 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 4
Use # 2 – surgical handrub, liquid
Product type PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Tuberculosis bacilli
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: enveloped viruses
Development stage:
Field(s) of use Indoor
Hospitals and other health care institutions: surgical handrub onto visibly
clean and dry hands and forearms.
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Rubbing
Application rate(s) and frequency Application Rate: Dosage: Rub sufficient amount in portions of 3 ml (use
dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml Contact
time: 90 s
Dilution (%): Ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety
intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users Professional
Pack sizes and packaging material 150, 500, 1 000ml in transparent/white high-density polyethylene (HDPE)
bottles with polypropylene (PP) flip top caps;L 195/48 EN Official Journal of the European Union 22.7.2022
5 000ml HDPE canister with transparent/white HDPE screwed cap;
700 and 1 000ml vacuum bag in white PE composite foil with integrated PP
pump/valve and PE cap.
4.2.1. Use-specific instructions for use
The product can be applied directly or the product can be used in a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
Do not refill.
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 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 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 2
5. GENERAL DIRECTIONS FOR USE(2)OF THE META SPC 2
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the
environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention
if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a
doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
(2) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within
the meta SPC 2.22.7.2022 EN Official Journal of the European Union L 195/49
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11),
amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT
induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames.
No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous
earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local
regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic
waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior
to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feeding stuff. Keep away from combustible material.
6. OTHER INFORMATION
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-HDL Market area: EU
Authorisation number EU-0027467-0004 1-2
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 20,0
Substance
Propan-2-ol Active 67-63-0 200-661-7 60,0
SubstanceL 195/50 EN Official Journal of the European Union 22.7.2022
META SPC 3
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
Identifier meta SPC 3
1.2. Suffix to the authorisation number
Number 1-3
1.3. Product type(s)
Product type(s) PT01 - Human hygiene (Disinfectants)
2. META SPC 3 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 3
Content (%)
Common name IUPAC name Function CAS number EC number
Min Max
Propan-1-ol Active Substance 71-23-8 200-746-9 12,229 14,3
Propan-2-ol Active Substance 67-63-0 200-661-7 62,751 63,14
2.2. Type(s) of formulation of the meta SPC 3
Formulation(s) AL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements Highly flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition
sources. - No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Use only outdoors or in a well-ventilated area.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact
lenses, if present and easy to do. Continue rinsing.22.7.2022 EN Official Journal of the European Union L 195/51
Immediately call a POISON CENTER/doctor.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of container to an authorised waste collection point.
4. AUTHORISED USE(S) OF THE META SPC 3
4.1. Use description
Table 5
Use # 1 – hygienic handrub, liquid
Product type PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Tuberculosis bacilli
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: Enveloped viruses
Development stage:
Field(s) of use Indoor
— hospitals and other health care institutions, ambulances, surgeries, nur­
sing homes (including home-care of patients)
— hospital canteens, large kitchens, pharmaceutical industries, production
sites, laboratories: hygienic handrub onto visibly clean and dry hands
— For professional use only.
Application method(s) Method: Manual application
Detailed description:
Rubbing
Application rate(s) and frequency Application Rate: Dosage: At least 3 ml (use dispensers: for example set to 1,5
ml per stroke, 2 strokes per 3 ml). Contact time: 30 s
Dilution (%): Ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety
intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users Industrial
ProfessionalL 195/52 EN Official Journal of the European Union 22.7.2022
Pack sizes and packaging material 100, 125, 150, 500, 1 000ml in transparent/white high-density
polyethylene (HDPE) bottles with polyethylene (PP) flip top caps;
5 000ml transparent/white HDPE canister with HDPE screwed cap.
In addition, exclusively for D-HDL (product 3.1): 100, 125, 150, 500, 1 000
ml in white HDPE bottles with PP flip top caps; 5 000ml white HDPE canister
with HDPE screwed cap.
In addition, exclusively for B-HDL (product 3.3): 700 ml Pouch of transparent
PE composite foil with integrated PP pump; 75 ml transparent/white HDPE
bottle with PP flip top cap.
4.1.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
Do not refill.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 3
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 6
Use # 2 – surgical handrub, liquid
Product type PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description Not relevant.
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Tuberculosis bacilli
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: enveloped viruses
Development stage:22.7.2022 EN Official Journal of the European Union L 195/53
Field(s) of use Indoor
Hospitals and other health care institutions: surgical handrub onto visibly
clean and dry hands and forearms.
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Rubbing
Application rate(s) and frequency Application Rate: Dosage: Rub sufficient amount in portions of 3 ml (use
dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Contact
time: 90 s
Dilution (%): Ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety
intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users Professional
Pack sizes and packaging material 100, 125, 150, 500, 1 000ml in transparent/white high-density
polyethylene (HDPE) bottles with polyethylene (PP) flip top caps;
5 000ml transparent/white HDPE canister with HDPE screwed cap.
In addition, exclusively for D-HDL (product 3.1): 100, 125, 150, 500, 1 000
ml in white HDPE bottles with PP flip top caps; 5 000ml white HDPE canister
with HDPE screwed cap.
In addition, exclusively for B-HDL (product 3.3): 700 ml Pouch of transparent
PE composite foil with integrated PP pump; 75 ml transparent/white HDPE
bottle with PP flip top cap.
4.2.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
Do not refill.
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 3L 195/54 EN Official Journal of the European Union 22.7.2022
5. GENERAL DIRECTIONS FOR USE(3)OF THE META SPC 3
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the
environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention
if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a
doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11),
amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT
induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames.
No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous
earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local
regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic
waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior
to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
(3) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within
the meta SPC 3.22.7.2022 EN Official Journal of the European Union L 195/55
6. OTHER INFORMATION
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) D-HDL Market area: EU
Authorisation number EU-0027467-0005 1-3
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 12,229
Substance
Propan-2-ol Active 67-63-0 200-661-7 62,751
Substance
7.2. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) G-HDL Market area: EU
Authorisation number EU-0027467-0006 1-3
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 14,3
Substance
Propan-2-ol Active 67-63-0 200-661-7 63,14
Substance
7.3. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) B-HDL Market area: EU
Authorisation number EU-0027467-0007 1-3
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 14,3
Substance
Propan-2-ol Active 67-63-0 200-661-7 63,14
SubstanceL 195/56 EN Official Journal of the European Union 22.7.2022
META SPC 4
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
Identifier meta SPC 4
1.2. Suffix to the authorisation number
Number 1-4
1.3. Product type(s)
Product type(s) PT01 - Human hygiene (Disinfectants)
2. META SPC 4 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 4
Content (%)
Common name IUPAC name Function CAS number EC number
Min Max
Propan-1-ol Active Substance 71-23-8 200-746-9 30,0 32,5
Propan-2-ol Active Substance 67-63-0 200-661-7 45,0 45,0
2.2. Type(s) of formulation of the meta SPC 4
Formulation(s) AL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
Hazard statements Highly flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition
sources. - No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Use only outdoors or in a well-ventilated area.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact
lenses, if present and easy to do. Continue rinsing.22.7.2022 EN Official Journal of the European Union L 195/57
Immediately call a POISON CENTER/doctor.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of container to an authorised waste collection point.
4. AUTHORISED USE(S) OF THE META SPC 4
4.1. Use description
Table 7
Use # 1 – hygienic handrub, gel
Product type PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Mycobacteria
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: Enveloped viruses
Development stage:
Field(s) of use Indoor
— hospitals and other health care institutions, ambulances, surgeries, nur­
sing homes (including home-care of patients)
— hospital canteens, large kitchens, pharmaceutical industries, production
sites, laboratories: hygienic handrub onto visibly clean and dry hands.
— For professional use only.
Application method(s) Method: Manual application
Detailed description:
Rubbing
Application rate(s) and frequency Application Rate: Dosage: At least 3 ml (use dispensers: for example set to 1,5
ml per stroke, 2 strokes per 3 ml). Contact time: 30 s
Dilution (%): Ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety
intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users Industrial
ProfessionalL 195/58 EN Official Journal of the European Union 22.7.2022
Pack sizes and packaging material 100, 125, 500, 1 000ml in transparent/white high-density polyethylene
(HDPE) bottles with polypropylene (PP) flip top caps;
5 000ml transparent/white HDPE canister with HDPE screwed cap.
In addition, exclusively for E-HDG (product 4.2): 500 and 1 000ml in
transparent HDPE lightweight bottle with integrated PP pump.
4.1.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
Do not refill.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 4
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 4
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 4
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 4
4.2. Use description
Table 8
Use # 2 – surgical handrub, gel
Product type PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Mycobacteria
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: enveloped viruses
Development stage:22.7.2022 EN Official Journal of the European Union L 195/59
Field(s) of use Indoor
Hospitals and other health care institutions: surgical handrub onto visibly
clean and dry hands and forearms.
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Rubbing
Application rate(s) and frequency Application Rate: Dosage: Rub sufficient amount in portions of 3 ml (use
dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Contact
time: 90 s
Dilution (%): Ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety
intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users Professional
Pack sizes and packaging material 100, 125, 500, 1 000ml in transparent/white high-density polyethylene
(HDPE) bottles with polypropylene (PP) flip top caps;
5 000ml transparent/white HDPE canister with HDPE screwed cap.
In addition, exclusively for E-HDG (product 4.2): 500 and 1 000ml in
transparent HDPE lightweight bottle with integrated PP pump.
4.2.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
Do not refill.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 4
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 4
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 4
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 4L 195/60 EN Official Journal of the European Union 22.7.2022
5. GENERAL DIRECTIONS FOR USE(4)OF THE META SPC 4
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the
environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention
if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a
doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11),
amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT
induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures: Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static
electric charges. No open flames. No smoking.Prevent entry to sewers and public waters. Wipe up with absorbent
material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible.
Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic
waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior
to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
(4) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within
the meta SPC 4.22.7.2022 EN Official Journal of the European Union L 195/61
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) A-HDG Market area: EU
Authorisation number EU-0027467-0008 1-4
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 32,5
Substance
Propan-2-ol Active 67-63-0 200-661-7 45,0
Substance
7.2. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) E-HDG Market area: EU
Authorisation number EU-0027467-0009 1-4
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 30,0
Substance
Propan-2-ol Active 67-63-0 200-661-7 45,0
Substance
META SPC 5
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 5 identifier
Identifier meta SPC 5
1.2. Suffix to the authorisation number
Number 1-5
1.3. Product type(s)
Product type(s) PT01 - Human hygiene (Disinfectants)L 195/62 EN Official Journal of the European Union 22.7.2022
2. META SPC 5 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 5
Content (%)
Common name IUPAC name Function CAS number EC number
Min Max
Propan-1-ol Active Substance 71-23-8 200-746-9 14,3 15,5
Propan-2-ol Active Substance 67-63-0 200-661-7 60,0 63,14
2.2. Type(s) of formulation of the meta SPC 5
Formulation(s) AL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
Hazard statements Highly flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition
sources. - No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Use only outdoors or in a well-ventilated area.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
IF IN EYES: Rinse cautiously with water for several minutes.Remove contact
lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Store in a well-ventilated place. Keep cool.
Store locked up.
Dispose of container to an authorised waste collection point.
4. AUTHORISED USE(S) OF THE META SPC 5
4.1. Use description
Table 9
Use # 1 – hygienic handrub, gel
Product type PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:22.7.2022 EN Official Journal of the European Union L 195/63
Scientific name: other
Common name: Tuberculosis bacilli
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: Enveloped viruses
Development stage:
Field(s) of use Indoor
— hospitals and other health care institutions, ambulances, surgeries, nur­
sing homes (including home-care of patients)
— hospital canteens, large kitchens, pharmaceutical industries, production
sites, laboratories: hygienic handrub onto visibly clean and dry hands.
— For professional use only.
Application method(s) Method: Manual application
Detailed description:
Rubbing
Application rate(s) and frequency Application Rate: Dosage: At least 3 ml (use dispensers: for example set to 1,5
ml per stroke, 2 strokes per 3 ml). Contact time: 30 s
Dilution (%): Ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety
intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users Industrial
Professional
Pack sizes and packaging material 125, 150, 500, 1 000ml in transparent/white high-density polypropylene
(HDPE) bottles with polypropylene (PP) flip top caps;
5 000ml transparent/white HDPE canister with HDPE screwed cap.
In addition, exclusively for C-HDG (product 5.1): 700 and 1 000ml vacuum
bag in white PE composite foil with integrated PP pump/valve and PE cap.
In addition, exclusively for B-HDG (product 5.2): 700 ml pouch of
transparent PE composite foil with integrated PP pump; 75 ml transparent
HDPE bottle with PP flip top cap.
4.1.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
Do not refill.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 5L 195/64 EN Official Journal of the European Union 22.7.2022
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 5
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 5
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 5
4.2. Use description
Table 10
Use # 2 – surgical handrub, gel
Product type PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Tuberculosis bacilli
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: enveloped viruses
Development stage:
Field(s) of use Indoor
Hospitals and other health care institutions: surgical handrub onto visibly
clean and dry hands and forearms.
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Rubbing
Application rate(s) and frequency Application Rate: Dosage: Rub sufficient amount in portions of 3 ml (use
dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Contact
time: 90 s
Dilution (%): Ready-to-use product
Number and timing of application:
There is no restriction in the number and timing of applications. No safety
intervals need to be considered between the application phases.
The product may be used at any time and as often as required.
Category(ies) of users Professional22.7.2022 EN Official Journal of the European Union L 195/65
Pack sizes and packaging material 125, 150, 500, 1 000ml in transparent/white high-density polypropylene
(HDPE) bottles with polypropylene (PP) flip top caps;
5 000ml transparent/white HDPE canister with HDPE screwed cap.
In addition, exclusively for C-HDG (product 5.1): 700 and 1 000ml vacuum
bag in white PE composite foil with integrated PP pump/valve and PE cap.
In addition, exclusively for B-HDG (product 5.2): 700 ml pouch of
transparent PE composite foil with integrated PP pump; 75 ml transparent
HDPE bottle with PP flip top cap.
4.2.1. Use-specific instructions for use
The products can be applied directly or the products can be used in a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
Do not refill.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 5
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 5
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 5
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 5
5. GENERAL DIRECTIONS FOR USE(5)OF THE META SPC 5
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the
environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention
if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a
doctor.
(5) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within
the meta SPC 5.L 195/66 EN Official Journal of the European Union 22.7.2022
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11),
amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT
induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames.
No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous
earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local
regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic
waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior
to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) C-HDG Market area: EU
Authorisation number EU-0027467-0010 1-5
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 15,5
Substance
Propan-2-ol Active 67-63-0 200-661-7 60,0
Substance22.7.2022 EN Official Journal of the European Union L 195/67
7.2. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) B-HDG Market area: EU
Authorisation number EU-0027467-0011 1-5
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 14,3
Substance
Propan-2-ol Active 67-63-0 200-661-7 63,14
Substance
META SPC 6
1. META SPC 6 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 6 identifier
Identifier meta SPC 6
1.2. Suffix to the authorisation number
Number 1-6
1.3. Product type(s)
Product type(s) PT02 - Disinfectants and algaecides not intended for direct application to
humans or animals (Disinfectants)
PT04 - Food and feed area (Disinfectants)
2. META SPC 6 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 6
Content (%)
Common name IUPAC name Function CAS number EC number
Min Max
Propan-1-ol Active Substance 71-23-8 200-746-9 25,0 35,0
Propan-2-ol Active Substance 67-63-0 200-661-7 30,0 40,0L 195/68 EN Official Journal of the European Union 22.7.2022
2.2. Type(s) of formulation of the meta SPC 6
Formulation(s) AL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
Hazard statements Flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition
sources. - No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Use only outdoors or in a well-ventilated area.
Wear eye protection..
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact
lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of container to an authorised waste collection point.
4. AUTHORISED USE(S) OF THE META SPC 6
4.1. Use description
Table 11
Use # 1 – hard non-porous small surface disinfection RTU liquid
Product type PT02 - Disinfectants and algaecides not intended for direct application to
humans or animals (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: viruses (limited spectrum virucidal activity)
Development stage:
Field(s) of use Indoor
Health care facilities and pharmaceutical and cosmetic industry, for example
patient-near surrounding, working areas/desks, general equipment (excluding
food contact surfaces):
disinfection of small hard/non-porous surfaces.
For professional use only.22.7.2022 EN Official Journal of the European Union L 195/69
Application method(s) Method: Manual application
Detailed description:
Ready-to-use surface disinfectant at room temperature (20±2 °C).
The entire surface to be disinfected is wetted by pouring or spraying from a
short distance and subsequently thoroughly wiped with a cloth. The amount
of product should be sufficient (max. 50 ml/m2 to keep the surface wet during
the contact time.
Application rate(s) and frequency Application Rate: Minimum exposure time: • for the control of bacteria,
yeasts and enveloped viruses: 60 sec • for the control of viruses (limited
spectrum virucidal activity): 5 min
Dilution (%): Ready-to-use product
Number and timing of application:
A reasonable frequency of disinfection in a patient’s room is 1-2 per day.
Maximum number of applications is 6 per day. No safety intervals need to
be considered between the application phases.
Category(ies) of users Industrial
Professional
Pack sizes and packaging material 100, 500, 750 and 1 000ml transparent/white high-density polyethylene
(HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw
closure with spray head);
5 000ml transparent/white HDPE canister with HDPE screwed cap.
4.1.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 6
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 6
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 6
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 6L 195/70 EN Official Journal of the European Union 22.7.2022
4.2. Use description
Table 12
Use # 2 – hard non-porous small surface disinfection RTU liquid
Product type PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Field(s) of use Indoor
Health care facilities and in food industry, for example food preparation and
handling in kitchens/restaurants: disinfection of small hard/non-porous
surfaces.
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Ready-to-use surface disinfectant at room temperature (20±2 °C).
The entire surface to be disinfected is wetted by pouring or spraying from a
short distance and subsequently thoroughly wiped with a cloth. The amount
of product should be sufficient (max. 50 ml/m2) to keep the surface wet
during the contact time.
Application rate(s) and frequency Application Rate: Minimum exposure time: for the control of bacteria and
yeasts at 20°C: 60 sec
Dilution (%): Ready-to-use product
Number and timing of application:
The products can be used as often as necessary. A reasonable frequency in
kitchens is 1-2 per day. No safety intervals need to be considered between the
application phases.
Category(ies) of users Industrial
Professional
Pack sizes and packaging material 100, 500, 750 and 1 000ml transparent/white high-density polyethylene
(HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw
closure with spray head);
5 000ml transparent/white HDPE canister with HDPE screwed cap.
4.2.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 622.7.2022 EN Official Journal of the European Union L 195/71
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 6
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 6
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 6
5. GENERAL DIRECTIONS FOR USE(6)OF THE META SPC 6
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
The use of eye protection during handling of the product is mandatory.
Keep out of reach of children
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the
environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention
if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a
doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11),
amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT
induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures: Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static
electric charges. No open flames. No smoking. Prevent entry to sewers and public waters. Wipe up with absorbent
material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible.
Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic
waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior
to disposal. When totally empty, containers are recyclable like any other packing.
(6) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within
the meta SPC 6.L 195/72 EN Official Journal of the European Union 22.7.2022
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) F-FDL Market area: EU
Authorisation number EU-0027467-0012 1-6
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 25,0
Substance
Propan-2-ol Active 67-63-0 200-661-7 30,0
Substance
7.2. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) A-FDL Market area: EU
Authorisation number EU-0027467-0013 1-6
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 35,0
Substance
Propan-2-ol Active 67-63-0 200-661-7 35,0
Substance
7.3. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) C-FDL Market area: EU
Authorisation number EU-0027467-0014 1-6
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 30,0
Substance
Propan-2-ol Active 67-63-0 200-661-7 40,0
Substance22.7.2022 EN Official Journal of the European Union L 195/73
7.4. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) E-FDL Market area: EU
Authorisation number EU-0027467-0015 1-6
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 25,0
Substance
Propan-2-ol Active 67-63-0 200-661-7 40,0
Substance
META SPC 7
1. META SPC 7 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 7 identifier
Identifier meta SPC 7
1.2. Suffix to the authorisation number
Number 1-7
1.3. Product type(s)
Product type(s) PT02 - Disinfectants and algaecides not intended for direct application to
humans or animals (Disinfectants)
PT04 - Food and feed area (Disinfectants)
2. META SPC 7 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 7
Content (%)
Common name IUPAC name Function CAS number EC number
Min Max
Propan-1-ol Active Substance 71-23-8 200-746-9 14,3 14,925
Propan-2-ol Active Substance 67-63-0 200-661-7 44,73 63,14
2.2. Type(s) of formulation of the meta SPC 7
Formulation(s) AL - Any other liquidL 195/74 EN Official Journal of the European Union 22.7.2022
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
Hazard statements Highly flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition
sources. - No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
Immediately call a POISON CENTER/doctor.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact
lenses, if present and easy to do. Continue rinsing.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of container to an authorised waste collection point.
4. AUTHORISED USE(S) OF THE META SPC 7
4.1. Use description
Table 13
Use # 1 – hard non-porous small surface disinfection RTU liquid
Product type PT02 - Disinfectants and algaecides not intended for direct application to
humans or animals (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: Enveloped viruses
Development stage:
Field(s) of use Indoor
Health care facilities and pharmaceutical and cosmetic industry, for example
in patient-near surrounding, working areas/desks, general equipment
(excluding food contact surfaces): disinfection of small hard/non-porous
surfaces.
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Ready-to-use surface disinfectant at room temperature (20±2 °C).22.7.2022 EN Official Journal of the European Union L 195/75
The entire surface to be disinfected is wetted by pouring or spraying from
short distance and subsequently thoroughly wiped with a cloth. The amount
of product should be sufficient (max. 50 ml/m2) to keep the surface wet
during the contact time.
Application rate(s) and frequency Application Rate: Minimum exposure time: • for the control of bacteria,
yeasts and enveloped viruses: 60 sec
Dilution (%): Ready-to-use product
Number and timing of application:
A reasonable frequency of disinfection in a patient’s room is 1-2 per day.
Maximum number of applications is 6 per day. No safety intervals need to be
considered between the application phases.
Category(ies) of users Industrial
Professional
Pack sizes and packaging material 125, 150, 500, 1 000ml transparent/white high-density polyethylene
(HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw
closure with spray head);
5 000ml transparent/white HDPE canister with HDPE screwed cap.
4.1.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 7
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 7
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 7
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 7
4.2. Use description
Table 14
Use # 2 – hard non-porous small surface disinfection RTU liquid
Product type PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:L 195/76 EN Official Journal of the European Union 22.7.2022
Scientific name: other
Common name: Yeasts
Development stage:
Field(s) of use Indoor
Health care facilities and in food industry, for example food preparation and
handling in kitchens/restaurants): disinfection of small hard/non-porous
surfaces.
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Ready-to-use surface disinfectant at room temperature (20±2 °C).
The entire surface to be disinfected is wetted by pouring or spraying from
short distance and subsequently thoroughly wiped with a cloth. The amount
of product should be sufficient (max. 50 ml/m2) to keep the surface wet
during the contact time.
Application rate(s) and frequency Application Rate: Minimum exposure time: for the control of bacteria and
yeasts at 20°C: 60 sec
Dilution (%): Ready-to-use product
Number and timing of application:
The products can be used as often as necessary. A reasonable frequency in
kitchens is 1-2 per day. No safety intervals need to be considered between the
application phases.
Category(ies) of users Industrial
Professional
Pack sizes and packaging material 125, 150, 500, 1 000ml transparent/white high-density polyethylene
(HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw
closure with spray head);
5 000ml transparent/white HDPE canister with HDPE screwed cap.
4.2.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 7
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 7
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 7
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 722.7.2022 EN Official Journal of the European Union L 195/77
5. GENERAL DIRECTIONS FOR USE(7)OF THE META SPC 7
5.1. Instructions for use
For professional use only.
5.2. Risk mitigation measures
The use of eye protection during handling of the product is mandatory.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the
environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention
if you feel unwell. If possible show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a
doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11),
amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT
induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static
electric charges. No open flames. No smoking.Prevent entry to sewers and public waters.Wipe up with absorbent
material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible.
Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic
waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior
to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
(7) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within
the meta SPC 7.L 195/78 EN Official Journal of the European Union 22.7.2022
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) D-FDL Market area: EU
Authorisation number EU-0027467-0016 1-7
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 14,925
Substance
Propan-2-ol Active 67-63-0 200-661-7 44,73
Substance
7.2. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) B-FDL Market area: EU
Authorisation number EU-0027467-0017 1-7
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 14,3
Substance
Propan-2-ol Active 67-63-0 200-661-7 63,14
Substance
META SPC 8
1. META SPC 8 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 8 identifier
Identifier meta SPC 8
1.2. Suffix to the authorisation number
Number 1-8
1.3. Product type(s)
Product type(s) PT02 - Disinfectants and algaecides not intended for direct application to
humans or animals (Disinfectants)
PT04 - Food and feed area (Disinfectants)22.7.2022 EN Official Journal of the European Union L 195/79
2. META SPC 8 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 8
Content (%)
Common name IUPAC name Function CAS number EC number
Min Max
Propan-1-ol Active Substance 71-23-8 200-746-9 25,0 30,0
Propan-2-ol Active Substance 67-63-0 200-661-7 30,0 40,0
2.2. Type(s) of formulation of the meta SPC 8
Formulation(s) AL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
Hazard statements Flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition
sources. - No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Use only outdoors or in a well-ventilated area.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
IF IN EYES:Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER or doctor/physician.
Store in a well-ventilated place. Keep cool.
Store locked up.
Dispose of container to an authorised waste collection point.
4. AUTHORISED USE(S) OF THE META SPC 8
4.1. Use description
Table 15
Use # 1 – hard non-porous small surface disinfection RTU wipes
Product type PT02 - Disinfectants and algaecides not intended for direct application to
humans or animals (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:L 195/80 EN Official Journal of the European Union 22.7.2022
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: viruses (limited spectrum virucidal activity)
Development stage:
Field(s) of use Indoor
Health care facilities and pharmaceutical and cosmetic industry, for example
patient-near surrounding, working areas/desks, general equipment (excluding
food contact surfaces): disinfection of small hard/non-porous surfaces.
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Ready-to-use disinfectant wipes at room temperature (20±2 °C).
The surface to be disinfected is wiped and wetted with a sufficient amount of
the product, ensuring complete coverage.
Application rate(s) and frequency Application Rate: Minimum exposure time: • for the control of bacteria,
yeasts and enveloped viruses: 60 sec • for the control of viruses (limited
spectrum virucidal activity): 5 min; Make the surface completely wet.
Dilution (%): Ready-to-use product
Number and timing of application:
A reasonable frequency of disinfection in a patient’s room is 1-2 per day.
Maximum number of applications is 6 per day. No safety intervals need to be
considered between the application phases.
Category(ies) of users Industrial
Professional
Pack sizes and packaging material Flow-pack of white polyethylene (PE)-composite foil with polypropylene (PP)
Flap cover, containing 40 30% Viscose and 70% Polyethylene Terephtalate
(VIS/PET) wipes.
Exclusively for C-FDT (product 8.2):
Transparent high-density polyethylene (HDPE) Canister with PP screwed cap,
containing 30 PET wipes;
Dispenser bag of white PE composite foil, containing 30 or 90 PET wipes used
with dispenser box.
4.1.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 8.
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 8.22.7.2022 EN Official Journal of the European Union L 195/81
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 8
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 8
4.2. Use description
Table 16
Use # 2 – hard non-porous small surface disinfection RTU wipes
Product type PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Field(s) of use Indoor
Health care facilities and food industry, for example food preparation and
handling in kitchens/restaurants): disinfection of small hard/non-porous
surfaces.
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Ready-to-use disinfectant wipes at room temperature (20±2 °C).
The surface to be disinfected is wiped and wetted with a sufficient amount of
the product by wiping, ensuring complete coverage.
Application rate(s) and frequency Application Rate: Minimum exposure time: • for the control of bacteria and
yeasts at 20°C: 60 sec; Make the surface completely wet
Dilution (%): Ready-to-use product
Number and timing of application:
The product can be used as often as necessary. A reasonable frequency of
disinfection in kitchens is 1-2 per day. No safety intervals need to be
considered between the application phases.
Category(ies) of users Industrial
Professional
Pack sizes and packaging material Flow-pack of white polyethylene (PE)-composite foil with polypropylene (PP)
Flap cover, containing 40 30% viscose and 70% polyethylene terephtalate
(VIS/PET) wipes.
Exclusively for C-FDT (product 8.2):
Transparent high-density polyethylene (HDPE) Canister with PP screwed cap,
containing 30 PET wipes;
Dispenser bag of white PE composite foil, containing 30 or 90 PET wipes used
with dispenser box.L 195/82 EN Official Journal of the European Union 22.7.2022
4.2.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 8
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 8
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 8
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 8
5. GENERAL DIRECTIONS FOR USE(8)OF THE META SPC 8
5.1. Instructions for use
For professional use only.
For wipes reseal the package after opening.
5.2. Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the
environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention
if you feel unwell. If possible show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a
doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11),
amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT
induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames.
No smoking.
Prevent entry to sewers and public waters.
(8) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within
the meta SPC 8.22.7.2022 EN Official Journal of the European Union L 195/83
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous
earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local
regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic
waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior
to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) F-FDT Market area: EU
Authorisation number EU-0027467-0018 1-8
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 25,0
Substance
Propan-2-ol Active 67-63-0 200-661-7 30,0
Substance
7.2. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) C-FDT Market area: EU
Authorisation number EU-0027467-0019 1-8
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 30,0
Substance
Propan-2-ol Active 67-63-0 200-661-7 40,0
SubstanceL 195/84 EN Official Journal of the European Union 22.7.2022
META SPC 9
1. META SPC 9 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 9 identifier
Identifier meta SPC 9
1.2. Suffix to the authorisation number
Number 1-9
1.3. Product type(s)
Product type(s) PT02 - Disinfectants and algaecides not intended for direct application to
humans or animals (Disinfectants)
PT04 - Food and feed area (Disinfectants)
2. META SPC 9 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 9
Content (%)
Common name IUPAC name Function CAS number EC number
Min Max
Propan-1-ol Active Substance 71-23-8 200-746-9 14,3 14,925
Propan-2-ol Active Substance 67-63-0 200-661-7 44,73 63,14
2.2. Type(s) of formulation of the meta SPC 9
Formulation(s) AL - Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
Hazard statements Highly flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition
sources. - No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Use only outdoors or in a well-ventilated area.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.22.7.2022 EN Official Journal of the European Union L 195/85
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact
lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to an authorised waste collection point.
4. AUTHORISED USE(S) OF THE META SPC 9
4.1. Use description
Table 17
Use # 1 – hard non-porous small surface disinfection RTU wipes
Product type PT02 - Disinfectants and algaecides not intended for direct application to
humans or animals (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Scientific name: other
Common name: Enveloped viruses
Development stage:
Field(s) of use Indoor
Health care facilities and pharmaceutical and cosmetic industry, for example
patient-near surrounding, working areas/desks, general equipment (excluding
food contact surfaces): disinfection of small hard/non-porous surfaces
For professional use only.
Application method(s) Method: Manual application
Detailed description:
Ready-to-use disinfectant wipes at room temperature (20±2 °C).
The surface to be disinfected is wiped and wetted with a sufficient amount of
the product, ensuring complete Coverage.
Application rate(s) and frequency Application Rate: Minimum exposure time: for the control of bacteria, yeasts
and enveloped viruses: 60 sec; Make the surface completely wet.
Dilution (%): Ready-to-use product
Number and timing of application:
A reasonable frequency of disinfection in a patient’s room is 1-2 per day.
Maximum number of applications is 6 per day. No safety intervals need to be
considered between the application phases.L 195/86 EN Official Journal of the European Union 22.7.2022
Category(ies) of users Industrial
Professional
Pack sizes and packaging material Flow-pack of polyethylene (PE) composite foil with high-density polyethylene
(HDPE) Flap cover, containing 80 Cellulose wipes;
Dispenser bag of PE composite foil, containing 70 Cellulose wipes used with
dispenser box
Exclusively for B-FDT (product 9.2):
Dispenser of PE composite foil with screwed-in PE cap, containing 100 PP/PE
wipes.
4.1.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 9
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 9
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 9
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 9
4.2. Use description
Table 18
Use # 2 – hard non-porous small surface disinfection RTU wipes
Product type PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description Not relevant
of the authorised use
Target organism(s) (including Scientific name: other
development stage) Common name: Bacteria
Development stage:
Scientific name: other
Common name: Yeasts
Development stage:
Field(s) of use Indoor
Health care facilities and food industry, for example patient-near
surrounding, food preparation and handling in kitchens/restaurants):
disinfection of small hard/non-porous surfaces.
For professional use only.22.7.2022 EN Official Journal of the European Union L 195/87
Application method(s) Method: Manual application
Detailed description:
Ready-to-use disinfectant wipes at room temperature (20±2 °C).
The surface to be disinfected is wetted with a sufficient amount of the product
by wiping, ensuring complete coverage.
Application rate(s) and frequency Application Rate: Minimum exposure time: for the control of bacteria and
yeasts at 20°C: 60 sec; Make the surface completely wet.
Dilution (%): Ready-to-use product
Number and timing of application:
The product can be used as often as necessary. A reasonable frequency
of disinfection in kitchens is 1-2 per day. No safety intervals need to be
considered between the application phases.
Category(ies) of users Industrial
Professional
Pack sizes and packaging material Flow-pack of polyethylene (PE) composite foil with high-density polyethylene
(HDPE) Flap cover, containing 80 Cellulose wipes;
Dispenser bag of PE composite foil, containing 70 Cellulose wipes used with
dispenser box
Exclusively for B-FDT (product 9.2):
Dispenser of PE composite foil with screwed-in PE cap, containing 100 PP/PE
wipes.
4.2.1. Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection.
4.2.2. Use-specific risk mitigation measures
See general directions for use of meta SPC 9
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 9
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 9
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
ee general directions for use of meta SPC 9
5. GENERAL DIRECTIONS FOR USE(9)OF THE META SPC 9
5.1. Instructions for use
For professional use only.
For wipes reseal the package after opening.
(9) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within
the meta SPC 9.L 195/88 EN Official Journal of the European Union 22.7.2022
5.2. Risk mitigation measures
Avoid contact with eyes.
Keep out of reach of children
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the
environment
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention
if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a
doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it
before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11),
amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT
induce vomiting. Call 112/ambulance for medical assistance.
Accidental release measures:Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static
electric charges. No open flames. No smoking.Prevent entry to sewers and public waters.Wipe up with absorbent
material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible.
Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4. Instructions for safe disposal of the product and its packaging
Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic
waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior
to disposal. When totally empty, containers are recyclable like any other packing.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feeding stuff. Keep away from combustible material.
6. OTHER INFORMATION22.7.2022 EN Official Journal of the European Union L 195/89
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9
7.1. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) D-FDT Market area: EU
Authorisation number EU-0027467-0020 1-9
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 14,925
Substance
Propan-2-ol Active 67-63-0 200-661-7 44,73
Substance
7.2. Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) B-FDT Market area: EU
Authorisation number EU-0027467-0021 1-9
Common name IUPAC name Function CAS number EC number Content (%)
Propan-1-ol Active 71-23-8 200-746-9 14,3
Substance
Propan-2-ol Active 67-63-0 200-661-7 63,14
Substance
            

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Commission Implementing Regulation (EU) 2022/1282 of 8 July 2022 granting a Union authorisation for the biocidal product family ‘Knieler & Team Propanol Family’ (Text with EEA relevance)

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