Commission Implementing Regulation (EU) 2025/1878 of 16 September 2025 granting a Union authorisation for the biocidal product family BPF Propanol in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Image omitted; see official source	Official Journal of the European Union	EN L series
---	---	---
	2025/1878	17.9.2025

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products [^ntr1-L_202501878EN.000101-E0001], and in particular Article 44(5), first subparagraph, thereof,

Whereas:

• (1) On 29 March 2019, Bode Chemie GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘BPF Propanol’ of product-types 1, 2 and 4 as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-NE050445-47 in the Register for Biocidal Products.

• (2) ‘BPF Propanol’ contains propan-1-ol and propan-2-ol as the active substances, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 1, 2 and 4.

• (3) On 14 August 2024, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

• (4) On 21 March 2025, the Agency submitted to the Commission its opinion [^ntr2-L_202501878EN.000101-E0002], the draft summary of the biocidal product characteristics (‘SPC’) of ‘BPF Propanol’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

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

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

• (7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘BPF Propanol’.

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

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0034602-0000 is hereby granted to Bode Chemie GmbH for the making available on the market and use of the biocidal product family ‘BPF Propanol’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 7 October 2025 until 30 September 2035.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 16 September 2025.

For the Commission

The President

Ursula VON DER LEYEN

[^ntr1-L_202501878EN.000101-E0001]: OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

[^ntr2-L_202501878EN.000101-E0002]: ECHA opinion of 27 February 2025 on the Union authorisation of ‘BPF Propanol’ (ECHA/BPC/462/2025), https://echa.europa.eu/opinions-on-union-authorisation.

ANNEX

Summary of product characteristics for a biocidal product family

BPF Propanol

Product type(s)

PT01: Human hygiene

PT04: Food and feed area

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

Authorisation number EU-0034602-0000

R4BP asset number EU-0034602-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	BPF Propanol

1.2.   Product type(s)

Product type(s)	PT01: Human hygiene PT04: Food and feed area PT02: Disinfectants and algaecides not intended for direct application to humans or animals

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	BODE Chemie GmbH
Name and address of the authorisation holder	Address	Melanchthonstr. 27 22525 Hamburg DE
Authorisation number		EU-0034602-0000
R4BP asset number		EU-0034602-0000
Date of the authorisation		7 October 2025
Expiry date of the authorisation		30 September 2035

1.4.   Manufacturer(s) of the product

Name of manufacturer	Bode Chemie GmbH
Address of manufacturer	Melanchthonstrasse 27 22525 Hamburg Germany
Location of manufacturing sites	BODE Chemie GmbH site 1 Melanchthonstraße 27 22525 Hamburg Germany

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

Active substance	Propan-1-ol
Name of manufacturer	BASF SE
Address of manufacturer	Carl-Bosch-Str. 38 67056 Ludwigshafen Germany
Location of manufacturing sites	BASF SE site 1 Carl-Bosch-Str. 38 67056 Ludwigshafen Germany
---	---
Active substance	Propan-2-ol
Name of manufacturer	INEOS Solvents Germany GmbH
Address of manufacturer	Römerstr. 733 47443 Moers Germany
Location of manufacturing sites	INEOS Solvents Germany GmbH site 1 Römerstr. 733 47443 Moers Germany

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	71-23-8	200-746-9	30 - 45 % (w/w)
Propan-2-ol		Active substance	67-63-0	200-661-7	25 - 45 % (w/w)
1-Tetradecanol	-	Non-active substance	112-72-1	204-000-3	0 - 1 % (w/w)

2.2.   Type(s) of formulation

Formulation type(s)	AL Any other liquid XX Impregnated wipes

PART II

SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier	Meta SPC: meta SPC 1

1.2.   Suffix to the authorisation number

Number	1-1

1.3.   Product type(s)

Product type(s)	PT01: Human hygiene

2. META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	71-23-8	200-746-9	30 - 30 % (w/w)
Propan-2-ol		Active substance	67-63-0	200-661-7	45 - 45 % (w/w)
1-Tetradecanol	-	Non-active substance	112-72-1	204-000-3	0,25 - 1 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 1

Formulation type(s)	AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements	H226: Flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H412: Harmful to aquatic life with long lasting effects. EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements	P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear eye protection. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a doctor if you feel unwell. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local/ regional/national/international regulations. P501: Dispose of container in accordance with local/ regional/national/international regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Hygienic handrub, PT1, professional and industrial user - meta SPC 1

Product type	PT01: Human hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hygienic handrub for use in industrial, institutional, health care and domestic areas.
Application method(s)	Method: Hygienic handrub Detailed description:
Application rate(s) and frequency	Application Rate: 3 ml per application Number and timing of application: Product is used as required which may be multiple times per day (frequency: 25 per day) Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 30 seconds Limited spectrum virucidal activity – 60 seconds
Category(ies) of users	industrial professional
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml HDPE container 5 l

4.1.1.   Use-specific instructions for use

Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time.

4.1.2.   Use-specific risk mitigation measures

The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied:

The use of eye protection during refilling of the application bottles is mandatory.

Eye protection according to the European Standard EN ISO 16321 or equivalent.

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 section

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

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 section

4.2.   Use description

Table 2

Hygienic handrub, PT1, general public - meta SPC 1

Product type	PT01: Human hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hygienic handrub for use in institutional, health care and domestic areas.
Application method(s)	Method: Hygienic handrub Detailed description:
Application rate(s) and frequency	Application Rate: 3 ml (the amount of liquid should resemble the size of a large-sized coin) Number and timing of application: Product is used as required, for adults and children older than 2 years up to 10 times per day, for toddlers up to 8 times per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 30 seconds Limited spectrum virucidal activity – 60 seconds
Category(ies) of users	general public (non-professional)
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml

4.2.1.   Use-specific instructions for use

Comply with the instructions for use.

Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time.

4.2.2.   Use-specific risk mitigation measures

Do not use more than the specified number of applications per day

The authorisation holder shall specify the application rate in a simple, easily understandable form on the label.

Use for children only under supervision of an adult. Apply the amount for the child/toddler on your own hand first and rub the product on child’s/toddler’s hand. Make sure that the child/toddler does not touch eyes or mouth before the product has dried.

Avoid contact with eyes.

Avoid unnecessary contact to skin.

In case of skin dryness, use appropriate skin care lotion.

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

If medical advice is needed, have product container or label at hand.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

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 section

4.3.   Use description

Table 3

Surgical hand disinfection / residential bacterial skin flora, PT1, professional user - meta SPC 1

Product type	PT01: Human hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity)
Field(s) of use	indoor use Surgical hand disinfection / resident bacterial skin flora. The product is a ready-to-use alcoholic disinfectant for use in health care areas / hospital sector.
Application method(s)	Method: Surgical handrub Detailed description:
Application rate(s) and frequency	Application Rate: 2 times 3 ml per application Number and timing of application: Product is used as required which may be multiple times per day (frequency: 4 times per day). Contact time: 90 seconds
Category(ies) of users	professional
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml HDPE container 5 l

4.3.1.   Use-specific instructions for use

Rub 2 times 3 ml into dry and visibly clean hands and forearms for 1,5 minutes, keeping the skin moist during the application time.

Any decanting or refilling may only be carried out under aseptic conditions.

4.3.2.   Use-specific risk mitigation measures

The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied:

The use of eye protection during refilling of the application bottles is mandatory. Eye protection according to the European Standard EN ISO16321-1 or equivalent.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

see general section

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general section

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

see use-specific instructions

5.2.   Risk mitigation measures

Keep out of reach of children and pets or non-target animals.

Ensure adequate ventilation during the application.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTER or a doctor.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTER or a doctor.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

5.4.   Instructions for safe disposal of the product and its packaging

Avoid release to the environment.

Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months.

Store at temperatures not exceeding 40 °C.

Protect from direct light.

6. OTHER INFORMATION

Please be aware of the European reference values of 129,28 mg/m³ for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product.

The full title of the EN standard referenced in the Risk mitigation measures are:

the European Standard EN ISO 16321 - Eye and face protection for occupational use.

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

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

Trade name(s)	Trade name(s)	Trade name(s)	Sterillium pure	Sterillium pure	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0034602-0001 1-1	EU-0034602-0001 1-1	EU-0034602-0001 1-1
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	Active substance	71-23-8	71-23-8	200-746-9	30 % (w/w)
Propan-2-ol		Active substance	Active substance	67-63-0	67-63-0	200-661-7	45 % (w/w)
1-Tetradecanol	-	Non-active substance	Non-active substance	112-72-1	112-72-1	204-000-3	0,95 % (w/w)

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

Trade name(s)	Trade name(s)	Trade name(s)	Sterillium classic blue	Sterillium classic blue	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0034602-0002 1-1	EU-0034602-0002 1-1	EU-0034602-0002 1-1
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	Active substance	71-23-8	71-23-8	200-746-9	30 % (w/w)
Propan-2-ol		Active substance	Active substance	67-63-0	67-63-0	200-661-7	45 % (w/w)
1-Tetradecanol	-	Non-active substance	Non-active substance	112-72-1	112-72-1	204-000-3	0,95 % (w/w)

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier	Meta SPC: meta SPC 2

1.2.   Suffix to the authorisation number

Number	1-2

1.3.   Product type(s)

Product type(s)	PT01: Human hygiene

2. META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	71-23-8	200-746-9	30 - 30 % (w/w)
Propan-2-ol		Active substance	67-63-0	200-661-7	45 - 45 % (w/w)

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

Formulation type(s)	AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements	H226: Flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements	P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a doctor if you feel unwell. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local/ regional/national/international regulations. P501: Dispose of container in accordance with local/ regional/national/international regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Hygienic handrub, PT1, professional and industrial user - meta SPC 2

Product type	PT01: Human hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hygienic handrub for use in industrial, institutional, health care and domestic areas.
Application method(s)	Method: Hygienic handrub Detailed description:
Application rate(s) and frequency	Application Rate: 3 ml per application Number and timing of application: Product is used as required which may be multiple times per day (frequency: 25 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 30 seconds Limited spectrum virucidal activity – 60 seconds
Category(ies) of users	industrial professional
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml HDPE container 5 l

4.1.1.   Use-specific instructions for use

Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time.

4.1.2.   Use-specific risk mitigation measures

The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied:

The use of eye protection during refilling of the application bottles is mandatory.

Eye protection according to the European Standard EN ISO 16321 or equivalent.

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 section

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

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 section

4.2.   Use description

Table 2

Hygienic handrub, PT1, general public - meta SPC 2

Product type	PT01: Human hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hygienic handrub for use in institutional, health care and domestic areas.
Application method(s)	Method: Hygienic handrub Detailed description:
Application rate(s) and frequency	Application Rate: 3 ml (the amount of liquid should resemble the size of a large-sized coin) Number and timing of application: Product is used as required, for adults and children older than 2 years up to 10 times per day, for toddlers up to 8 times per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 30 seconds Limited spectrum virucidal activity – 60 seconds
Category(ies) of users	general public (non-professional)
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml

4.2.1.   Use-specific instructions for use

Comply with the instructions for use.

Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time.

4.2.2.   Use-specific risk mitigation measures

Do not use more than the specified number of applications per day.

The authorisation holder shall specify the application rate in a simple, easily understandable form on the label.

Use for children only under supervision of an adult. Apply the amount for the child/toddler on your own hand first and rub the product on child’s/toddler’s hand. Make sure that the child/toddler does not touch eyes or mouth before the product has dried.

Avoid contact with eyes.

Avoid unnecessary contact to skin.

In case of skin dryness, use appropriate skin care lotion.

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

If medical advice is needed, have product container or label at hand.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

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 section

4.3.   Use description

Table 3

Surgical hand disinfection / residential bacterial skin flora, PT1, professional user

Product type	PT01: Human hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity)
Field(s) of use	indoor use Surgical hand disinfection / resident bacterial skin flora. The product is a ready-to-use alcoholic disinfectant for use in health care areas / hospital sector.
Application method(s)	Method: surgical handrub Detailed description:
Application rate(s) and frequency	Application Rate: 2 times 3 ml per application Number and timing of application: Product is used as required which may be multiple times per a day (frequency: 4 per day). Contact time: 90 seconds
Category(ies) of users	professional
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml HDPE container 5 l

4.3.1.   Use-specific instructions for use

Rub 2 times 3 ml into dry and visibly clean hands and forearms for 1.5 minutes, keeping the skin moist during the application time.

Any decanting or refilling may only be carried out under aseptic conditions.

4.3.2.   Use-specific risk mitigation measures

The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied:

The use of eye protection during refilling of the application bottles is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

see general section

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general section

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

see use-specific instructions for use

5.2.   Risk mitigation measures

Keep out of reach of children and pets or non-target animals.

Ensure adequate ventilation during the application.

Make sure that the applied product is completely dried before entering a room or area where people will stay for a longer period of time.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

5.4.   Instructions for safe disposal of the product and its packaging

Avoid release to the environment.

Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months

Store at temperatures not exceeding 40 °C.

Protect from direct light.

6. OTHER INFORMATION

Please be aware of the European reference values of 129,28 mg/m³ for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product.

The full title of the EN standard referenced in the Risk mitigation measures are:

the European Standard EN ISO 16321 - Eye and face protection for occupational use.

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

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

Trade name(s)	Trade name(s)	Trade name(s)	Sterillium pure IPM	Sterillium pure IPM	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0034602-0003 1-2	EU-0034602-0003 1-2	EU-0034602-0003 1-2
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	Active substance	71-23-8	71-23-8	200-746-9	30 % (w/w)
Propan-2-ol		Active substance	Active substance	67-63-0	67-63-0	200-661-7	45 % (w/w)

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier	Meta SPC: meta SPC 3

1.2.   Suffix to the authorisation number

Number	1-3

1.3.   Product type(s)

Product type(s)	PT01: Human hygiene

2. META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	71-23-8	200-746-9	30 - 30 % (w/w)
Propan-2-ol		Active substance	67-63-0	200-661-7	45 - 45 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 3

Formulation type(s)	AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements	H226: Flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements	P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P312: Call a doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of container in accordance with local/ regional/national/international regulations. P501: Dispose of contents in accordance with local/ regional/national/international regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Hygienic handrub, PT1, professional and industrial user

Product type	PT01: Human hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hygienic handrub for use in industrial, institutional, health care and domestic areas.
Application method(s)	Method: Hygienic handrub Detailed description:
Application rate(s) and frequency	Application Rate: 3 ml per application Number and timing of application: Product is used as required which may be multiple times per day (frequency: 25 per day). Contact time: 30 seconds
Category(ies) of users	industrial professional
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml HDPE bottle 35 - 100 ml HDPE container 5 l

4.1.1.   Use-specific instructions for use

Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time.

4.1.2.   Use-specific risk mitigation measures

The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied:

The use of eye protection during refilling of the application bottles is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent.

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 section

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

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 section

4.2.   Use description

Table 2

Hygienic handrub, PT1, general public

Product type	PT01: Human hygiene
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hygienic handrub for use in institutional, health care and domestic areas.
Application method(s)	Method: Hygienic handrub Detailed description:
Application rate(s) and frequency	Application Rate: 3 ml (the amount of liquid should resemble the size of a large-sized coin) Number and timing of application: Product is used as required, for adults and children older than 2 years up to 10 times per day, for toddlers up to 8 times per day. Contact time: 30 seconds
Category(ies) of users	general public (non-professional)
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml HDPE bottle 35 - 100 ml

4.2.1.   Use-specific instructions for use

Comply with the instructions for use.

Rub 3 ml into the dry and visibly clean hands and keep moist for the required contact time.

4.2.2.   Use-specific risk mitigation measures

Do not use more than the specified number of applications per day.

The authorisation holder shall specify the application rate in a simple, easily understandable form on the label.

Use for children only under supervision of an adult. Apply the amount for the child/toddler on your own hand first and rub the product on child’s/toddler’s hand. Make sure that the child/toddler does not touch eyes or mouth before the product has dried.

Avoid contact with eyes.

Avoid unnecessary contact to skin.

In case of skin dryness, use appropriate skin care lotion.

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

If medical advice is needed, have product container or label at hand.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

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 section

4.3.   Use description

Table 3

Surgical hand disinfection / residential bacterial skin flora, PT1, professional user

Product type	PT01: Human hygiene
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Mycobacteria Common name: Enveloped viruses
Field(s) of use	indoor use Surgical hand disinfection / resident bacterial skin flora. The product is a ready-to-use alcoholic disinfectant for use in health care areas / hospital sector.
Application method(s)	Method: surgical handrub Detailed description:
Application rate(s) and frequency	Application Rate: At least 3 ml per application Number and timing of application: Product is used as required which may be multiple times per day (frequency: 4 per day). Contact time: 90 seconds
Category(ies) of users	professional
Pack sizes and packaging material	HDPE bottle 35 - 100 ml HDPE bottle 50 - 1000 ml HDPE container 5 l

4.3.1.   Use-specific instructions for use

Rub at least 3 ml into dry and visibly clean hands and forearms for 1,5 minutes, keeping the skin moist during the application time.

Any decanting or refilling may only be carried out under aseptic conditions.

4.3.2.   Use-specific risk mitigation measures

The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied:

The use of eye protection during refilling of the application bottles is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

see general section

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general section

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1.   Instructions for use

see use-specific instructions for use

5.2.   Risk mitigation measures

Keep out of reach of children and pets or non-target animals.

Ensure adequate ventilation during the application.

Make sure that product is applied and completely dried before entering the room or area where people will stay for a longer period.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

5.4.   Instructions for safe disposal of the product and its packaging

Avoid release to the environment.

Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months.

Store at temperatures not exceeding 40 °C.

6. OTHER INFORMATION

Please be aware of the European reference values of 129,28 mg/m³ for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product.

The full title of the EN standard referenced in the Risk mitigation measures are:

the European Standard EN ISO 16321 - Eye and face protection for occupational use.

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

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

Trade name(s)	Trade name(s)	Trade name(s)	Sterillium Gel PRO	Sterillium Gel PRO	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0034602-0004 1-3	EU-0034602-0004 1-3	EU-0034602-0004 1-3
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	Active substance	71-23-8	71-23-8	200-746-9	30 % (w/w)
Propan-2-ol		Active substance	Active substance	67-63-0	67-63-0	200-661-7	45 % (w/w)

1. META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier	Meta SPC: meta SPC 4

1.2.   Suffix to the authorisation number

Number	1-4

1.3.   Product type(s)

Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area

2. META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	71-23-8	200-746-9	30 - 30 % (w/w)
Propan-2-ol		Active substance	67-63-0	200-661-7	45 - 45 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 4

Formulation type(s)	AL Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements	H226: Flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements	P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a doctor if you feel unwell. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of container in accordance with local/ regional/national/international regulations. P501: Dispose of contents in accordance with local/ regional/national/international regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Small surface disinfection, PT2, professional and industrial user - meta SPC 4

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Fungi Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in industrial, institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area.
Application method(s)	Method: Spraying or pouring followed by wiping Detailed description:
Application rate(s) and frequency	Application Rate: Institutional, health care and domestic area: 18 ml/m2; Industrial area: 18 - 50 ml/m2. Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes
Category(ies) of users	industrial professional
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml HDPE container 5 l

4.1.1.   Use-specific instructions for use

For institutional, health care and domestic area:

Pouring: Invert the bottle and pour (8 sec/m²) on the surface.

Spraying (500 – 1000ml bottle): 15 pump strokes per m².

Spraying (50ml bottle): 12 pump strokes per 0,1m².

For industrial area:

Pouring: Invert the bottle and pour (8 - 22 sec/m²) on the surface.

Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m².

Spraying (50ml bottle): at least 12 pump strokes per 0,1m².

4.1.2.   Use-specific risk mitigation measures

The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied:

The use of eye protection during refilling of the application bottles of the product is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent.

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 section

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

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 section

4.2.   Use description

Table 2

Small surface disinfection, PT2, general public - meta SPC 4

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Fungi Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area.
Application method(s)	Method: Spraying or pouring followed by wiping Detailed description:
Application rate(s) and frequency	Application Rate: 18 ml/m2. Number and timing of application: maximum 5 applications per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes
Category(ies) of users	general public (non-professional)
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml

4.2.1.   Use-specific instructions for use

Comply with the instructions for use.

Pouring: Invert the bottle and pour (8 sec/m²) on the surface.

Spraying (500 – 1000ml bottle): 15 pump strokes per m².

Spraying (50ml bottle): 12 pump strokes per 0,1m².

4.2.2.   Use-specific risk mitigation measures

The authorisation holder shall specify the application rate in a simple, easily understandable form on the label.

Avoid contact with eyes.

Avoid unnecessary contact to skin.

In case of skin dryness, use appropriate skin care lotion.

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

If medical advice is needed, have product container or label at hand.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

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 section

4.3.   Use description

Table 3

Small surface disinfection, PT4, professional and industrial user - meta SPC 4

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Fungi Common name: Mycobacteria Common name: Viruses Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in industrial, institutional, health care and domestic area.
Application method(s)	Method: Spraying or pouring followed by wiping Detailed description:
Application rate(s) and frequency	Application Rate: Institutional, health care and domestic area: 18ml/m2; Industrial area: 18 - 50 ml/m2. Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes
Category(ies) of users	industrial professional
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml HDPE container 5 l

4.3.1.   Use-specific instructions for use

For institutional, health care and domestic area:

Pouring: Invert the bottle and pour (8 sec/m²) on the surface.

Spraying (500 – 1000ml bottle): 15 pump strokes per m².

Spraying (50ml bottle): 12 pump strokes per 0,1m².

For industrial area:

Pouring: Invert the bottle and pour (8 - 22 sec/m²) on the surface.

Spraying (500 – 1000ml bottle): 15 - 41 pump strokes per m².

Spraying (50ml bottle): at least 12 pump strokes per 0,1m².

4.3.2.   Use-specific risk mitigation measures

The following risk mitigation measures without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work shall be applied:

The use of eye protection during refilling of the application bottles of the product is mandatory. Eye protection according to the European Standard EN ISO 16321 or equivalent.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

see general section

4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general section

4.4.   Use description

Table 4

Small surface disinfection, PT4, general public - meta SPC 4

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Fungi Common name: Mycobacteria Common name: Viruses Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hard non-porous surface disinfectant for use in institutional, health care and domestic area.
Application method(s)	Method: Spraying or pouring followed by wiping Detailed description:
Application rate(s) and frequency	Application Rate: 18 ml/m2 Number and timing of application: maximum 1 application per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and viruses – 5 minutes
Category(ies) of users	general public (non-professional)
Pack sizes and packaging material	HDPE bottle 50 - 1000 ml

4.4.1.   Use-specific instructions for use

Comply with the instructions for use.

Pouring: Invert the bottle and pour (8 sec/m²) on the surface.

Spraying (500 – 1000ml bottle): 15 pump strokes per m².

Spraying (50ml bottle): 12 pump strokes per 0,1m².

4.4.2.   Use-specific risk mitigation measures

The authorisation holder shall specify the application rate in a simple, easily understandable form on the label.

Avoid contact with eyes.

Avoid unnecessary contact to skin.

In case of skin dryness, use appropriate skin care lotion.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

If medical advice is needed, have product container or label at hand.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

see general section

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4

5.1.   Instructions for use

Spray or pour a sufficient amount of the product on the surface to be disinfected, if needed wipe to ensure complete coverage and allow to act for the required contact time.

For use at room temperature.

5.2.   Risk mitigation measures

Ensure adequate ventilation (e. g. by opening windows or by mechanical ventilation) during application. In small rooms avoid presence of toddlers and pets for 15 min before re-entry.

Keep out of reach of children and non-target animals or pets.

Used wipes must be disposed in a closed container.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel or doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTER or a doctor.

5.4.   Instructions for safe disposal of the product and its packaging

Avoid release to the environment.

Dispose of contents and container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months.

Store at temperatures not exceeding 40 °C.

6. OTHER INFORMATION

Please be aware of the European reference values of 129,28 mg/m³ for the active substance Propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the biocidal product.

The full title of the EN standard referenced in the Risk mitigation measures are:

the European Standard EN ISO 16321 - Eye and face protection for occupational use.

With respect to the “Category (ies) of users” note: “Professionals (including industrial users)” means trained professionals if this is required by national legislation.

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)	Trade name(s)	Trade name(s)	Bacillol pure	Bacillol pure	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0034602-0005 1-4	EU-0034602-0005 1-4	EU-0034602-0005 1-4
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	Active substance	71-23-8	71-23-8	200-746-9	30 % (w/w)
Propan-2-ol		Active substance	Active substance	67-63-0	67-63-0	200-661-7	45 % (w/w)

1. META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

Identifier	Meta SPC: meta SPC 5

1.2.   Suffix to the authorisation number

Number	1-5

1.3.   Product type(s)

Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area

2. META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-1-ol		Active substance	71-23-8	200-746-9	30 - 30 % (w/w)
Propan-2-ol		Active substance	67-63-0	200-661-7	45 - 45 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 5

Formulation type(s)	XX Impregnated wipes

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements	H226: Flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking.
Precautionary statements	P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P103: Read carefully and follow all instructions. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground and bond container and receiving equipment. P241: Use explosion-proof electrical equipment. P241: Use explosion-proof lighting equipment. P242: Use non-sparking tools. P243: Take actions to prevent static discharges. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a doctor if you feel unwell. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use water mist, foam, carbon dioxide or powder extinguishing agent to extinguish. P403+P233: Store in a well-ventilated place. Keep container tightly closed. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local/ regional/national/international regulations. P501: Dispose of container in accordance with local/ regional/national/international regulations.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Small surface disinfection, PT2, professional and industrial user - meta SPC 5

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Fungi Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in industrial, institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area.
Application method(s)	Method: Wiping Detailed description:
Application rate(s) and frequency	Application Rate: 0,2 - 0,5 m2/wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: Product is used as required which may be multiple times per day (frequency: 8 per day). Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes
Category(ies) of users	industrial professional
Pack sizes and packaging material	PET tissues/wipes in a PET/PE flowpack or PET/PE sachet.

4.1.1.   Use-specific instructions for use

Wipe the surface with a tissue/wipe ensuring the complete coverage with the product.

Use 2 - 3 wipes per m².

4.1.2.   Use-specific risk mitigation measures

see general section

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 section

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

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 section

4.2.   Use description

Table 2

Small surface disinfection, PT2, general public - meta SPC 5

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Common name: Bacteria Common name: Yeasts Common name: Fungi Common name: Mycobacteria Common name: Viruses (limited spectrum virucidal activity) Common name: Enveloped viruses
Field(s) of use	indoor use The product is a ready-to-use hard non-porous surface disinfectant tissue/wipe for use in institutional (e.g. hotels), health care (e.g. hospitals, medical practices) and domestic area.
Application method(s)	Method: Wiping Detailed description:
Application rate(s) and frequency	Application Rate: 0,2 - 0,5 m2/wipe. The wipe should be replaced as frequently as needed to ensure complete wetting of the surface. Number and timing of application: maximum 5 applications per day. Contact times: Bacteria, yeasts, mycobacteria and enveloped viruses – 1 minute Fungi and limited spectrum virucidal activity – 5 minutes
Category(ies) of users	general public (non-professional)
Pack sizes and packaging material	PET tissues/wipes in a PET/PE flowpack or PET/PE sachet.

4.2.1.   Use-specific instructions for use

Comply with the instructions for use.

Wipe the surface with a tissue/wipe ensuring the complete coverage with the product.

Use 2 - 3 wipes per m².

4.2.2.   Use-specific risk mitigation measures

The authorisation holder shall specify the application rate in a simple, easily understandable form on the label.

Provide adequate ventilation (e.g. by opening windows or by mechanical ventilation) for 15 min before re-entry.

Avoid contact with eyes.

Avoid unnecessary contact to skin.

In case of skin dryness, use appropriate skin care lotion.

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

If medical advice is needed, have product container or label at hand.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

see general section

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 section

4.3.   Use description

Table 3