Commission Implementing Regulation (EU) 2025/2074 of 16 October 2025 granting a Union authorisation for the biocidal product family B. Braun Medical Propanol Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2025-10-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_202502074EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/2074


20.10.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/2074
of 16 October 2025
         
granting a Union authorisation for the biocidal product family ‘B. Braun Medical Propanol Family’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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


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

Whereas:







(1)


On 12 April 2019, B. Braun Medical AG 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 ‘B. Braun Medical 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 the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-CP050930-37 in the Register for Biocidal Products.












(2)


‘B. Braun Medical Propanol Family’ 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 7 June 2024, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 13 December 2024, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘B. Braun Medical 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 ‘B. Braun Medical 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(6) of that Regulation.












(6)


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












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘B. Braun Medical Propanol Family’.












(8)


In its opinion, the Agency recommends that the authorisation holder conducts a long-term storage stability test as a condition in the authorisation to confirm the storage stability. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on existing data.












(9)


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-0033840-0000 is granted to B. Braun Medical AG for the making available on the market and use of the biocidal product family ‘B. Braun Medical Propanol Family’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.
The Union authorisation is valid from 9 November 2025 until 31 October 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 October 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  ECHA opinion of 28 November 2024 on the Union authorisation of the biocidal product family ‘B. Braun Medical Propanol Family’ (ECHA/BPC/453/2024), https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX I

Terms and conditions (EU-0033840-0000)

The authorisation holder shall conduct a long-term storage stability test of products representative for all meta-SPCs within the biocidal product family ‘B. Braun Medical Propanol Family’. The tests shall be performed at ambient temperature in commercial packaging in which the products in the family will be made available on the market. All relevant properties should be determined prior and after storage.
By 9 September 2026 the authorisation holder shall submit the results of the test to the Agency.





ANNEX

Summary of product characteristics for a biocidal product family

B. Braun Medical Propanol Family

Product type(s)

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

Authorisation number EU-0033840-0000

R4BP asset number EU-0033840-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


B. Braun Medical Propanol Family




1.2.   Product type(s)







Product type(s)


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




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


B. Braun Medical AG




Address


Seesatz 17 6204 Sempach CH




Authorisation number


 


EU-0033840-0000





R4BP asset number



 


EU-0033840-0000




Date of the authorisation


9 November 2025




Expiry date of the authorisation


31 October 2035




1.4.   Manufacturer(s) of the product







Name of manufacturer


B. Braun Medical AG




Address of manufacturer


Seesatz 17 6204 Sempach Switzerland




Location of manufacturing sites


B. Braun Medical AG site 1 B. Braun Medical AG, Seesatz 17 6204 Sempach Switzerland




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







Active substance


Propan-1-ol




Name of manufacturer


BASF SE




Address of manufacturer


Carl-Bosch Strasse 38 67056 Ludwigshafen Germany




Location of manufacturing sites


BASF SE site 1 BASF SE, Carl-Bosch Strasse 38 67056 Ludwigshafen Germany













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 GmbH (formerly Oxea GmbH) site 1 OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX 77414 Bay City United States (the)













Active substance


Propan-1-ol




Name of manufacturer


Oxea GmbH




Address of manufacturer


Rheinpromenade 4a 40789 Monheim am Rhein Germany




Location of manufacturing sites


Oxea GmbH site 1 Oxea Corporation, 2001 FM 3057 TX 77414 Bay City United States (the)













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 INEOS Solvents Germany GmbH, Römerstr. 733 47443 Moers Germany
INEOS Solvents Germany GmbH site 2 INEOS Solvents Germany GmbH, Shamrockstrasse 88 44623 Herne Germany













Active substance


Propan-2-ol




Name of manufacturer


Shell Chemicals Europe B.V.




Address of manufacturer


Postbus 2334 3000 CH Rotterdam Netherlands (the)




Location of manufacturing sites


Shell Chemicals Europe B.V. site 1 Shell Nederland Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


20 - 30 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


10 - 45 % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AL Any other liquid
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)




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







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


H225: Highly flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH208: Contains (2R)-6-methyl-2-[(1R)-4-methyl-1-cyclohex-3-enyl]hept-5-en-2-ol. May produce an allergic reaction.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye protection.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor.
P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Hygienic handrub







Product type


PT01: Human hygiene




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: yeasts
Common name: bacteria
Common name: Mycobacteria
Common name: enveloped viruses
Common name: viruses (limited spectrum virucidal activity)




Field(s) of use


indoor use
The product can be applied for hygienic handrub in all situations necessary, e.g.






—


hospitals and other health care institutions such as in ambulances, surgeries and nursing homes (incl. home-care of patients)










—


hospital canteens, large kitchens, pharmaceutical industries, production sites and laboratories.








Application method(s)


Method: Handrub
Detailed description:
It is a ready-to-use product which shall be rubbed undiluted into visibly clean and dry hands only.




Application rate(s) and frequency


Undiluted; ready-to-use product
Number and timing of application:
Application rate: 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strikes per 3 ml).
Frequency:
Professional user: Up to 25 applications per day
General public (home-dialysis): Once per day
General public (entering/leaving hospitals):
Adults: Up to 11 applications per day
Children: Up to 3 applications per day




Category(ies) of users


professional




Pack sizes and packaging material


pigmented high-density polyethylene (HDPE) bottles with screwed flip top caps of pigmented polypropylene (PP).
Sizes: 100/500/1 000  ml
pigmented HDPE folding bottle with integrated Pump.
Sizes: 500/1 000  ml
pigmented HDPE canister with screwed caps of pigmented HDPE.
Size: 5 000  ml




4.1.1.   Use-specific instructions for use

The ready-to-use product shall be rubbed undiluted into visibly clean and dry hands only.
Rub sufficient amount (at least 3 ml) into hands and keep moist during the indicated minimum exposure time:






—


for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 30 seconds










—


limited spectrum virucidal activity: 2 minutes




The product can be applied directly, or the product can be used in a dispenser or with a pump (use integrated pump: 2 strokes for 3 ml; use dispensers: e.g. set to 1,5 ml per stroke, 2 strokes for 3 ml).
4.1.2.   Use-specific risk mitigation measures

In case of skin dryness, use appropriate skin care lotion.
Use by children only under adult supervision when visiting hospitals.
Avoid contact with eyes.
Avoid unnecessary contact to skin.
Keep out of reach of children and pets.
The following personal protective equipment (PPE) is stipulated 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:
During refilling: The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
The product information (i.e. label and/or leaflet) shall clearly state that: for the following specific uses the product can be exceptionally used by the general public:






—


Hygienic hand rub during home dialysis.










—


Hygienic hand rub when entering/leaving hospitals.




Application by a non-professional is always carried out after professional instruction or under professional supervision.
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

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
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.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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


Surgical handrub







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




Field(s) of use


indoor use
The products can be applied for surgical handrub in hospitals and other health care institutions.




Application method(s)


Method: Handrub
Detailed description:
It is a ready-to-use product which shall be rubbed undiluted in portions into the visibly clean hands and forearms only.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: 2 or 3 portions of 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strikes per 3 ml).
Frequency professional user: Typically up to 25 applications per day




Category(ies) of users


professional




Pack sizes and packaging material


pigmented HDPE bottles with screwed flip top caps of pigmented PP.
Sizes: 100/500/1 000  ml
pigmented HDPE folding bottle with integrated PP pump.
Sizes: 500/1 000  ml
pigmented HDPE canister with screwed caps of pigmented HDPE.
Size: 5 000  ml




4.2.1.   Use-specific instructions for use

The ready-to-use product shall be rubbed undiluted in portions into the visibly clean and dry hands and forearms only.
Rub sufficient amount in portions of 3 ml (2 or 3 times) into hands and forearms and keep moist during the indicated minimum contact time:






—


for the control of bacteria, mycobacteria and yeasts: 90 seconds




The product can be applied directly, or the product can be used in a dispenser or with a pump (use integrated pump: 2 strokes for 3 ml; use dispensers: e.g. set to 1,5 ml per stroke, 2 strokes for 3 ml).
Refilling/decanting of the product should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: The authorisation number; The trade name of the biocidal product; The identity and content of each active ingredient; The instructions for use, including the incorporation time required for the biocidal action. The information according to CLP.
4.2.2.   Use-specific risk mitigation measures

For professional use only.
In case of skin dryness, use appropriate skin care lotion
Avoid contact with eyes.
Avoid unnecessary contact to skin.
Keep out of reach of children and pets.
The following personal protective equipment (PPE) is stipulated 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:
During refilling: The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
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.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 OF THE META SPC 1

5.1.   Instructions for use

See use-specific instructions for use.
5.2.   Risk mitigation measures

See use-specific risk mitigation measures.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See use-specific instructions and measures.
5.4.   Instructions for safe disposal of the product and its packaging

See use-specific instructions.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months).
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store at temperatures not exceeding 40°C.
6.   OTHER INFORMATION

Please be aware of the European reference value 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.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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)


Softalind Pro


Market area: EU




Softa-Man


Market area: EU




Authorisation number


 


EU-0033840-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


30 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


45 % (w/w)




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













Trade name(s)


Softalind Pro pure


Market area: EU




Authorisation number


 


EU-0033840-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


30 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


45 % (w/w)




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













Trade name(s)


Softalind Pro acute


Market area: EU




Authorisation number


 


EU-0033840-0003 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


30 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


45 % (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


H225: Highly flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH208: Contains (2R)-6-methyl-2-[(1R)-4-methyl-1-cyclohex-3-enyl]hept-5-en-2-ol. May produce an allergic reaction.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye/face protection.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor.
P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Hygienic handrub







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 can be applied for hygienic handrub in all situations necessary, e.g.






—


hospitals and other health care institutions such as in ambulances, surgeries and nursing homes (incl. home-care of patients)










—


hospital canteens, large kitchens, pharmaceutical industries, production sites and laboratories.








Application method(s)


Method: Handrub
Detailed description:
It is a ready-to-use product which shall be rubbed undiluted into visibly clean and dry hands only.




Application rate(s) and frequency


Undiluted; ready-to-use product
Number and timing of application:
Application rate: 3 ml.
Frequency:
Professional user: Typically up to 25 applications per day
General public (home-dialysis): Once per day
General public (entering/leaving hospitals):
Adults: Typically up to 11 applications per day
Children: Typically up to 3 applications per day




Category(ies) of users


professional




Pack sizes and packaging material


pigmented HDPE bottles with screwed flip top caps of pigmented PP.
Sizes: 100/500/1 000  ml
pigmented HDPE canister with screwed caps of pigmented HDPE.
Size: 5 000  ml




4.1.1.   Use-specific instructions for use

The ready-to-use product shall be rubbed undiluted into visibly clean and dry hands only.
Rub sufficient amount (at least 3 ml) into hands and keep moist during the indicated minimum exposure time:






—


for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 30 seconds




The product can be applied directly, or the product can be used in a dispenser or with a pump (use dispensers: e.g. set to 1,5 ml per stroke, 2 strokes for 3 ml).
4.1.2.   Use-specific risk mitigation measures

In case of skin dryness, use appropriate skin care lotion
Use by children only under adult supervision when visiting hospitals.
Avoid contact with eyes.
Avoid unnecessary contact to skin.
Keep out of reach of children and pets.
The following personal protective equipment (PPE) is stipulated 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
During refilling: The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
The product information (i.e. label and/or leaflet) shall clearly state that: for the following specific uses the product can be exceptionally used by the general public:






—


Hygienic hand rub during home dialysis.










—


Hygienic hand rub when entering/leaving hospitals.




Application by a non-professional is always carried out after professional instruction or under professional supervision..
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

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
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.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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


Table 2


Surgical handrub







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




Field(s) of use


indoor use
The product can be applied for surgical handrub in hospitals and other health care institutions.




Application method(s)


Method: Handrub
Detailed description:
It is a ready-to-use product which shall be rubbed undiluted in portions into the visibly clean hands and forearms only.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: 2 or 3 portions of 3 ml.
Frequency professional user: Typically up to 25 applications per day.




Category(ies) of users


professional




Pack sizes and packaging material


pigmented HDPE bottles with screwed flip top caps of pigmented PP.
Sizes: 100/500/1 000  ml
pigmented HDPE canister with screwed caps of pigmented HDPE.
Size: 5 000  ml




4.2.1.   Use-specific instructions for use

The ready-to-use product shall be rubbed undiluted in portions into the visibly clean and dry hands and forearms only.
Rub sufficient amount in portions of 3 ml (2 or 3 times) into hands and forearms and keep moist during the indicated minimum exposure time:






—


for the control of bacteria, mycobacteria and yeasts: 90 seconds




The product can be applied directly, or the product can be used in a dispenser or with a pump (use dispensers: e.g. set to 1,5 ml per stroke, 2 strokes for 3 ml).
Refilling/decanting of the product should only be done under aseptic conditions.
All materials must be fully compatible with the product. The dispenser or container, which is refilled, must have the following minimum labelling information: The authorisation number; The trade name of the biocidal product; The identity and content of each active ingredient; The instructions for use, including the incorporation time required for the biocidal action. The information according to CLP.
4.2.2.   Use-specific risk mitigation measures

For professional use only.
In case of skin dryness, use appropriate skin care lotion
Avoid contact with eyes.
Avoid unnecessary contact to skin.
Keep out of reach of children and pets.
The following personal protective equipment (PPE) is stipulated 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
During refilling: The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
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.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

5.1.   Instructions for use

See use-specific instructions for use.
5.2.   Risk mitigation measures

See use-specific risk mitigation measures.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See use-specific instructions and measures.
5.4.   Instructions for safe disposal of the product and its packaging

See use-specific instructions.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6.   OTHER INFORMATION

Please be aware of the European reference value 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.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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)


Softalind Pro gel


Market area: EU




Authorisation number


 


EU-0033840-0004 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


30 % (w/w)




Propan-2-ol


 


Active substance


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


H225: Highly flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye/face protection.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor.
P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Hygienic handrub







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 can be applied for hygienic handrub in all situations necessary, e.g.






—


hospitals and other health care institutions such as in ambulances, surgeries and nursing homes (incl. home-care of patients)










—


hospital canteens, large kitchens, pharmaceutical industries, production sites and laboratories.








Application method(s)


Method: Handrub
Detailed description:
It is a ready-to-use product which shall be rubbed undiluted into visibly clean and dry hands only.




Application rate(s) and frequency


Undiluted; ready-to-use product
Number and timing of application:
Application rate: 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strikes per 3 ml).
Frequency:
Professional user: Typically up to 25 applications per day
General public (home-dialysis): Once per day
General public (entering/leaving hospitals):
Adults: Typically up to 11 applications per day
Children: Typically up to 3 applications per day




Category(ies) of users


professional




Pack sizes and packaging material


500 ml pigmented HDPE bottles with screwed foam head of pigmented PP




4.1.1.   Use-specific instructions for use

The ready-to-use product shall be rubbed undiluted into visibly clean and dry hands only.
Rub sufficient amount (at least 3 ml) into hands and keep moist during the indicated minimum exposure time:






—


for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 30 seconds




The product is applied with a screwed foam head (1,5 ml per stroke, 2 strokes for 3 ml).
4.1.2.   Use-specific risk mitigation measures

In case of skin dryness, use appropriate skin care lotion
Use by children only under adult supervision when visiting hospitals.
Avoid contact with eyes.
Avoid unnecessary contact to skin.
Keep out of reach of children and pets.The following personal protective equipment (PPE) is stipulated 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
During refilling: The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
The product information (i.e. label and/or leaflet) shall clearly state that: for the following specific uses the product can be exceptionally used by the general public:






—


Hygienic hand rub during home dialysis.










—


Hygienic hand rub when entering/leaving hospitals.




Application by a non-professional is always carried out after professional instruction or under professional supervision.
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

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.
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.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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.
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

See use-specific risk mitigation measures.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See use-specific instructions and measures.
5.4.   Instructions for safe disposal of the product and its packaging

See use-specific instructions.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6.   OTHER INFORMATION

Please be aware of the European reference value 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.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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)


Softalind Pro foam


Market area: EU




Authorisation number


 


EU-0033840-0005 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


30 % (w/w)




Propan-2-ol


 


Active substance


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


H225: Highly flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye/face 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.
P312: Call a POISON CENTER/doctor if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor.
P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Surface disinfection RTU liquid







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: Mycobacteria
Common name: enveloped viruses




Field(s) of use


indoor use
The product is applied by spraying or pouring followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients (excluding food contact surfaces).




Application method(s)


Method: spraying or pouring followed by wiping
Detailed description:
The ready-to-use product is applied by pouring or trigger spraying followed by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18-21 ml per m2 of surface.
For trigger spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2.
Frequency: Typical application frequency in a patient room: 1-2 times per day




Category(ies) of users


professional




Pack sizes and packaging material


pigmented/transparent HDPE bottles, closed with screwed flip top caps of pigmented PP.
Sizes: 250/500/1 000 ml
(accessory: PP spray head)
pigmented/transparent HDPE canister with screwed caps of pigmented HDPE.
Sizes: 5 000  ml




4.1.1.   Use-specific instructions for use

It is a ready-to-use surface disinfectant.
Surfaces should be visibly clean prior to disinfection.
The entire surface to be disinfected is wetted with a sufficient amount of the product by pouring or spraying from short distance with a pump spray head as a possible application aid and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (20°C):






—


for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute




Do not apply more than: 21 ml per m2.
4.1.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 2


Surface disinfection RTU liquid







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




Field(s) of use


indoor use
The product is applied by spraying or pouring followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling).




Application method(s)


Method: spraying or pouring followed by wiping
Detailed description:
The ready-to-use product is applied by pouring or trigger spraying followed by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18-21 ml per m2 of surface.
For trigger spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2.
Frequency: Typical application frequency in a kitchen: 1-2 times per day




Category(ies) of users


professional




Pack sizes and packaging material


pigmented/transparent HDPE bottles, closed with screwed flip top caps of pigmented PP.
Sizes: 250/500/1 000 ml
(accessory: PP spray head)
pigmented/transparent HDPE canister with screwed caps of pigmented HDPE.
Sizes: 5 000  ml




4.2.1.   Use-specific instructions for use

It is a ready-to-use surface disinfectant.
Surfaces should be visibly clean prior to disinfection.
The entire surface to be disinfected is wetted with a sufficient amount of the product by pouring or spraying from short distance with a pump spray head as a possible application aid and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (4°C, 10°C and 20°C):






—


for the control of bacteria and yeasts: 2 minutes




Do not apply more than 21 ml per m2.
4.2.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces (up to 1 m2).
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 4.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 4

5.1.   Instructions for use

See use-specific instructions for use.
5.2.   Risk mitigation measures

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

See use-specific instructions and measures.
5.4.   Instructions for safe disposal of the product and its packaging

See use-specific instructions.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6.   OTHER INFORMATION

Please be aware of the European reference value 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.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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)


Meliseptol Pro pure 88319


Market area: EU




Authorisation number


 


EU-0033840-0006 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


30 % (w/w)




Propan-2-ol


 


Active substance


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


20 - 20 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


10 - 10 % (w/w)




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







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5







Hazard statements


H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye/face protection.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor.
P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Surface disinfection RTU foam







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: Mycobacteria
Common name: enveloped viruses
Common name: viruses (limited spectrum virucidal activity)




Field(s) of use


indoor use
The product is applied by foaming followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients (excluding food contact surfaces).




Application method(s)


Method: foaming followed by wiping
Detailed description:
The ready-to-use product is applied by foaming followed by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18 -21 ml per m2 of surface.
For foam spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2.
Frequency: Typical application frequency in a patient room: 1-2 times per day.




Category(ies) of users


professional




Pack sizes and packaging material


pigmented/transparent HDPE bottle with screwed foam head of pigmented PP
Sizes: 750 ml
pigmented/transparent HDPE canister with screwed caps of pigmented HDPE.
Sizes: 5 000  ml




4.1.1.   Use-specific instructions for use

It is a ready-to-use surface disinfectant.
Surfaces should be visibly clean prior to disinfection. For limited spectrum virucidal activity the surfaces should be cleaned before using the product and excessive amount of water should be removed prior to disinfection.
The entire surface to be disinfected is wetted with a sufficient amount of the product by spraying from short distance with a pump spray head and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (20°C):






—


for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute










—


limited spectrum virucidal activity: 5 minutes




Do not apply more than 21 ml per m2.
4.1.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 2


Surface disinfection RTU foam







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




Field(s) of use


indoor use
The product is applied by foaming followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces in food contact (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling).




Application method(s)


Method: foaming followed by wiping
Detailed description:
The ready-to-use product is applied by foaming followed by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18-21 ml per m2 of surface.
For foam spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2.
Frequency: Typical application frequency in a kitchen: 1-2 times per day




Category(ies) of users


professional




Pack sizes and packaging material


pigmented/transparent HDPE bottle with screwed foam head of pigmented PP
Sizes: 750 ml
pigmented/transparent HDPE canister with screwed caps of pigmented HDPE.
Sizes: 5 000  ml




4.2.1.   Use-specific instructions for use

It is a ready-to-use surface disinfectant.
Surfaces should be visibly clean prior to disinfection.
The entire surface to be disinfected is wetted with a sufficient amount of the product by spraying from short distance with a pump spray head and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (20°C):






—


for the control of bacteria and yeasts: 1 minute




Do not apply more than 21 ml per m2.
4.2.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces (up to 1 m2).
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 OF THE META SPC 5

5.1.   Instructions for use

See use-specific instructions for use.
5.2.   Risk mitigation measures

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

See use-specific instructions and measures.
5.4.   Instructions for safe disposal of the product and its packaging

See use-specific instructions.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6.   OTHER INFORMATION

Please be aware of the European reference value 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.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicalst.
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)


Meliseptol Pro foam


Market area: EU




Authorisation number


 


EU-0033840-0007 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


20 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


10 % (w/w)




1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier







Identifier


Meta SPC: 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
PT04: Food and feed area




2.   META SPC 6 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 6











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


20 - 20 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


10 - 10 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 6







Formulation type(s)


Impregnated wipes




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6







Hazard statements


H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye/face protection.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P310: Immediately call a POISON CENTER/doctor.
P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Surface disinfection RTU wipes







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: Mycobacteria
Common name: enveloped viruses
Common name: viruses (limited spectrum virucidal activity)




Field(s) of use


indoor use
The product is applied by wipe disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients (excluding food contact surfaces).




Application method(s)


Method: wiping
Detailed description:
The ready-to-use product is applied by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18,0 × 20,0 cm wipe – 2-4 wipes per m2

24,0 × 30,0 cm wipe – 1-2 wipe per m2

Frequency: reasonable application frequency in a patient room: 1-2 times per day.




Category(ies) of users


professional




Pack sizes and packaging material


HDPE Dispenser box with PP closure including a polyethylene terephthalate/ polyethylene (PET/PE) flow pack with 60 PET wipes (with refill pack)
PET/PE Flow-pack with 100 PET wipes and PP flap cover
PET/PE Flow-pack XL with 42 PET wipes and PP flap cover




4.1.1.   Use-specific instructions for use

It is a ready-to-use pre-soaked disinfectant wipe. Surfaces should be visibly clean prior to disinfection. For limited spectrum virucidal activity the surfaces should be cleaned before using the product and excessive amount of water should be removed prior to disinfection.
The surface to be disinfected is wetted with a sufficient amount of wipes to completely wet the surface during the indicated exposure time. Only wet wipes shall be used.
Minimum exposure time (20°C):






—


for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute










—


limited spectrum virucidal activity: 5 minutes




18,0 × 20,0 cm wipe – 2-4 wipes per m2

24,0 × 30,0 cm wipe – 1-2 wipe per m2

4.1.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 6.
4.2.   Use description


Table 2


Surface disinfection RTU wipes







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




Field(s) of use


indoor use
The product is intended to be used for the control of bacteria and yeasts.
The product is applied for wipe disinfection of alcohol-resistant small hard non-porous surfaces in food contact (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling).




Application method(s)


Method: wiping
Detailed description:
The ready-to-use product is applied by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18,0 × 20,0 cm wipe – 2-4 wipes per m2

24,0 × 30,0 cm wipe – 1-4 wipe per m2

Frequency: Typical application frequency in a kitchen: 1-2 times per day.




Category(ies) of users


professional




Pack sizes and packaging material


HDPE Dispenser box with PP closure including a PET/PE flow pack with 60 PET wipes (with refill pack)
PET/PE Flow-pack with 100 PET wipes and PP flap cover
PET/PE Flow-pack XL with 42 PET wipes and PP flap cover




4.2.1.   Use-specific instructions for use

It is a ready-to-use pre-soaked disinfectant wipe. Surfaces should be visibly clean prior to disinfection. The surface to be disinfected is wetted with a sufficient amount of wipes to completely wet the surface during the indicated exposure time. Only wet wipes shall be used.
Minimum exposure time (20°C):
— for the control of bacteria and yeasts: 1 minute
18,0 × 20,0 cm wipe – 2-4 wipes per m2

24,0 × 30,0 cm wipe – 1-2 wipes per m2

4.2.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces (up to 1m2).
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 OF THE META SPC 6

5.1.   Instructions for use

See use-specific instructions for use.
5.2.   Risk mitigation measures

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

See use-specific instructions and measures.
5.4.   Instructions for safe disposal of the product and its packaging

See use-specific instructions.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6.   OTHER INFORMATION

Please be aware of the European reference value 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.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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)


Meliseptol Pro wipes


Market area: EU




Authorisation number


 


EU-0033840-0008 1-6




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


20 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


10 % (w/w)




1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier







Identifier


Meta SPC: 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
PT04: Food and feed area




2.   META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


25 - 25 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


20 - 20 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 7







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7







Hazard statements


H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye/face protection.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor.
P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Surface disinfection RTU liquid







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: Mycobacteria
Common name: enveloped viruses
Common name: viruses (limited spectrum virucidal activity)




Field(s) of use


indoor use
The product is applied by spraying or pouring followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients (excluding food contact surfaces).




Application method(s)


Method: spraying or pouring followed by wiping
Detailed description:
The ready-to-use product is applied by pouring or trigger spraying followed by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18-21 ml per m2 of surface.
For trigger spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2.
Frequency: Typical application frequency in a patient room: 1-2 times per day




Category(ies) of users


professional




Pack sizes and packaging material


pigmented/transparent HDPE bottles, closed with screwed flip top caps of pigmented PP.
Sizes: 250/500/1 000 ml
(accessory: PP spray head)
pigmented/transparent HDPE canister with screwed caps of pigmented HDPE.
Sizes: 5 000  ml




4.1.1.   Use-specific instructions for use

It is a ready-to-use surface disinfectant. Surfaces should be visibly clean prior to disinfection. For limited spectrum virucidal activity the surfaces should be cleaned before using the product and excessive amount of water should be removed prior to disinfection. The entire surface to be disinfected is wetted with a sufficient amount of the product by pouring or spraying from short distance with a pump spray head as a possible application aid and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (20°C):






—


for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute










—


limited spectrum virucidal activity: 2 minutes




Do not apply more than 21 ml per m2.
4.1.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 2


Surface disinfection RTU liquid







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




Field(s) of use


indoor use
The product is applied by spraying or pouring followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling).




Application method(s)


Method: spraying or pouring followed by wiping
Detailed description:
The ready-to-use product is applied by pouring or trigger spraying followed by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18-21 ml per m2 of surface.
For trigger spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2.
Frequency: Typical application frequency in a kitchen: 1-2 times per day




Category(ies) of users


professional




Pack sizes and packaging material


pigmented/transparent HDPE bottles, closed with screwed flip top caps of pigmented PP.
Sizes: 250/500/1 000 ml
(accessory: PP spray head)
pigmented/transparent HDPE canister with screwed caps of pigmented HDPE.
Sizes: 5 000  ml




4.2.1.   Use-specific instructions for use

It is a ready-to-use surface disinfectant. Surfaces should be visibly clean prior to disinfection. The entire surface to be disinfected is wetted with a sufficient amount of the product by pouring or spraying from short distance with a pump spray head as a possible application aid and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (4°C, 10°C, 20°C):






—


for the control of bacteria and yeasts: 1 minute




Do not apply more than 21 ml per m2.
4.2.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces (up to 1 m2).
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 7.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 7

5.1.   Instructions for use

See use-specific instructions for use.
5.2.   Risk mitigation measures

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

See use-specific instructions and measures.
5.4.   Instructions for safe disposal of the product and its packaging

See use-specific instructions.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6.   OTHER INFORMATION

Please be aware of the European reference value 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.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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)


Meliseptol Pro rapid


Market area: EU




Authorisation number


 


EU-0033840-0009 1-7




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


25 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


20 % (w/w)




1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier







Identifier


Meta SPC: 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
PT04: Food and feed area




2.   META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


25 - 25 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


20 - 20 % (w/w)




2.2.   Type(s) of formulation of the meta SPC 8







Formulation type(s)


impregnated wipes




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8







Hazard statements


H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye/face.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P310: Immediately call a POISON CENTER/doctor.
P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Surface disinfection RTU wipes







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: Mycobacteria
Common name: enveloped viruses
Common name: viruses (limited spectrum virucidal activity)




Field(s) of use


indoor use
The product is applied by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients
(excluding food contact surfaces).




Application method(s)


Method: wiping
Detailed description:
The ready-to-use product is applied by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18,0 × 20,0 cm wipe – 2-4 wipes per m2

24,0 × 30,0 cm wipe – 1-2 wipe per m2

Frequency: Typical application frequency in a patient room: 1-2 times per day.




Category(ies) of users


professional




Pack sizes and packaging material


HDPE Dispenser box with PP closure including a PET/PE flow pack with 60 PET wipes (with refill pack)
PET/PE Flow-pack with 100 PET wipes and PP flap cover
PET/PE Flow-pack XL with 42 PET wipes and PP flap cover




4.1.1.   Use-specific instructions for use

It is a ready-to-use pre-soaked disinfectant wipe. Surfaces should be visibly clean prior to disinfection. For limited spectrum virucidal activity the surfaces should be cleaned before using the product and excessive amount of water should be removed prior to disinfection.The surface to be disinfected is wetted with a sufficient amount of wipes to completely wet the surface during the indicated exposure time. Only wet wipes shall be used.
Minimum exposure time (20°C):






—


for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute










—


limited spectrum virucidal activity: 2 minutes




18,0 × 20,0 cm – 2-4 wipes per m2

24,0 × 30,0 cm wipe – 1-2 wipe per m2

4.1.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 2


Surface disinfection RTU wipes







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




Field(s) of use


indoor use
The product is applied by wiping for disinfection of alcohol-resistant small hard non-porous surfaces in food contact (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling).




Application method(s)


Method: wiping
Detailed description:
The ready-to-use product is applied by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18,0 × 20,0 cm – 2-4 wipes per m2

24,0 × 30,0 cm wipe – 1-2 wipe per m2

Frequency: Typical application frequency in a kitchen: 1-2 times per day.




Category(ies) of users


professional




Pack sizes and packaging material


HDPE Dispenser box with PP closure including a PET/PE flow pack with 60 PET wipes (with refill pack)
PET/PE Flow-pack with 100 PET wipes and PP flap cover
PET/PE Flow-pack XL with 42 PET wipes and PP flap cover




4.2.1.   Use-specific instructions for use

It is a ready-to-use pre-soaked disinfectant wipe. Surfaces should be visibly clean prior to disinfection.The surface to be disinfected is wetted with a sufficient amount of wipes to completely wet the surface during the indicated exposure time. Only wet wipes shall be used.
Minimum exposure time (4°C, 10°C, 20°C):






—


for the control of bacteria and yeasts: 1 minute




18,0 × 20,0 cm – 2-4 wipes per m2

24,0 × 30,0 cm wipe – 1-2 wipe per m2

4.2.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces (up to 1 m2).
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 OF THE META SPC 8

5.1.   Instructions for use

See use-specific instructions for use.
5.2.   Risk mitigation measures

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

See use-specific instructions and measures.
5.4.   Instructions for safe disposal of the product and its packaging

See use-specific instructions.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6.   OTHER INFORMATION

Please be aware of the European reference value 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.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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)


Meliseptol Pro wipes rapid


Market area: EU




Authorisation number


 


EU-0033840-0010 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


25 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


20 % (w/w)




1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier







Identifier


Meta SPC: 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
PT04: Food and feed area




2.   META SPC 9 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 9











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 9







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9







Hazard statements


H226: Flammable liquid and vapour.
H318: Causes serious eye damage.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P240: Ground and bond container and receiving equipment.
P241: Use explosion-proof electrical equipment.
P242: Use non-sparking tools.
P243: Take actions to prevent static discharges.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear eye/face protection.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310: Immediately call a POISON CENTER/doctor.
P370+P378: In case of fire: Use water spray/dry powder/carbon dioxide/alcohol resistant foam to extinguish.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P403+P235: Store in a well-ventilated place. Keep cool.
P405: Store locked up.
P501: Dispose of contents to hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Surface disinfection RTU liquid







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: Mycobacteria
Common name: enveloped viruses




Field(s) of use


indoor use
The product is applied by spraying or pouring followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other health care institutions such as in patient-near surrounding, ambulances, surgeries and nursing homes, e.g. incl. home-care of patients (excluding food contact surfaces).




Application method(s)


Method: spraying or pouring followed by wiping
Detailed description:
The ready-to-use product is applied by pouring or trigger spraying followed by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18-21 ml per m2 of surface.
For trigger spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2.
Frequency: Typical application frequency in a patient room: 1-2 times per day




Category(ies) of users


professional




Pack sizes and packaging material


pigmented/transparent HDPE bottles, closed with screwed flip top caps of pigmented PP.
Sizes: 250/500/1 000 ml
(accessory: PP spray head)
pigmented/transparent HDPE canister with screwed caps of pigmented HDPE.
Sizes: 5 000  ml




4.1.1.   Use-specific instructions for use

It is a ready-to-use surface disinfectant.
Surfaces should be visibly clean prior to disinfection.
The entire surface to be disinfected is wetted with a sufficient amount of the product by pouring or spraying from short distance with a pump spray head as a possible application aid and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (20°C):






—


for the control of bacteria, mycobacteria, yeasts and enveloped viruses: 1 minute




Do not apply more than 21 ml per m2

4.1.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
In case of skin dryness, use appropriate skin care lotion.
Only for treatment of small surfaces.
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
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

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 2


Surface disinfection RTU liquid







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: yeasts
Common name: bacteria




Field(s) of use


indoor use
The product is applied by spraying or pouring followed by wiping for disinfection of alcohol-resistant small hard non-porous surfaces (disinfection in the presence of soiling) in hospitals and other healthcare institutions, incl. hospital canteens and large kitchens (e.g. food processing, preparation and handling).




Application method(s)


Method: spraying or pouring followed by wiping
Detailed description:
The ready-to-use product is applied by pouring or trigger spraying followed by wiping.




Application rate(s) and frequency


undiluted; ready-to-use product
Number and timing of application:
Application rate: Use sufficient product to ensure complete coverage.
18-21 ml per m2 of surface.
For trigger spraying this corresponds to approximately 23 - 26 sprays per m2 or 12 - 13 sprays per 0,5 m2.
Frequency: Typical application frequency in a kitchen: 1-2 times per day




Category(ies) of users


professional




Pack sizes and packaging material


pigmented/transparent HDPE bottles, closed with screwed flip top caps of pigmented PP.
Sizes: 250/500/1 000 ml
(accessory: PP spray head)
pigmented/transparent HDPE canister with screwed caps of pigmented HDPE.
Sizes: 5 000  ml




4.2.1.   Use-specific instructions for use

It is a ready-to-use surface disinfectant.
Surfaces should be visibly clean prior to disinfection.
The entire surface to be disinfected is wetted with a sufficient amount of the product by pouring or spraying from short distance with a pump spray head as a possible application aid and subsequently thoroughly wiped with a cloth.
Make sure that the surface to be disinfected is completely wetted.
Minimum exposure time (4°C, 10°C and 20°C):






—


for the control of bacteria and yeasts: 2 minutes
Do not apply more than:










—


21 ml per m2





4.2.2.   Use-specific risk mitigation measures

For professional use only.
Avoid contact with eyes.
Only for treatment of small surfaces (up to 1 m2).
The following personal protective equipment (PPE) is stipulated 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
The use of eye protection (goggles) [consistent with the European standard EN 166] during handling of the product is mandatory.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect effects: May cause drowsiness or dizziness. Causes serious eye damage
General information: Remove contaminated soaked clothing immediately.
If you feel unwell, seek medical advice.
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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.
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.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Can be disposed of as a solid waste or burned in a suitable installation subject to local regulations.
Contaminated packaging: Re-using the polluted packaging materials is not allowed.
Packaging that cannot be cleaned should be disposed of like the product.
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 9.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 9

5.1.   Instructions for use

See use-specific instructions for use.
5.2.   Risk mitigation measures

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

See use-specific instructions and measures.
5.4.   Instructions for safe disposal of the product and its packaging

See use-specific instructions.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months.
Requirements for storage rooms and vessels:
Keep container tightly closed in a dry, cool and well-ventilated place.
Further information on storage conditions: Keep away from food, drink and animal feeding stuffs.
Store below 40°C.
6.   OTHER INFORMATION

Please be aware of the European reference value 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.
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category(ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full title of the EN standard referenced in the Risk mitigation measures is:
EN 166 – Eye protection against chemicals
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)


Meliseptol Pro pure 88321


Market area: EU




Authorisation number


 


EU-0033840-0011 1-9




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-1-ol


 


Active substance


71-23-8


200-746-9


30 % (w/w)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


45 % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2025/2074/oj
ISSN 1977-0677 (electronic edition)