Commission Implementing Regulation (EU) 2023/364 of 16 February 2023 granting a Union authorisation for the biocidal product family ‘IPA Family 1’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Date: 2023-02-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_2023050EN.01002801.xml










17.2.2023   


EN


Official Journal of the European Union


L 50/28








            COMMISSION IMPLEMENTING REGULATION (EU) 2023/364
of 16 February 2023
         
granting a Union authorisation for the biocidal product family ‘IPA Family 1’ 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 10 June 2016, Ecolab Deutschland GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘IPA Family 1’ of product-types 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-HN024859-20 in the Register for Biocidal Products.












(2)


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












(3)


On 25 August 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 23 March 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘IPA Family 1’ 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 ‘IPA Family 1’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.












(6)


On 12 April 2022, 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 ‘IPA Family 1’.












(8)


In its opinion, the Agency recommends that the authorisation holder conducts a long-term ambient storage stability test of ‘Klercide 70/30 IPA Aerosol’ of meta-SPC 1.3 in the commercial packaging in which the product is to be made available on the market, as a condition in the authorisation. The test should address the relevant physical, chemical and technical properties of that product both prior to and after storage to confirm a shelf life of 24 months. The authorisation holder should include in the test report information about the packaging stability, the spray characteristics and internal pressure before and after storage. 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 ‘IPA Family 1’ 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 the 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-0028425-0000 is hereby granted to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘IPA Family 1’ 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 March 2023 to 28 February 2033.


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 February 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  ECHA opinion of 1 March 2022 on the Union authorisation of “IPA Family 1” (ECHA/BPC/316/2022), https://echa.europa.eu/bpc-opinions-on-union-authorisation.




ANNEX I

Terms and conditions (EU-0028425-0000)

The authorisation holder shall conduct a long-term ambient storage stability test of ‘Klercide 70/30 IPA Aerosol’ of meta-SPC 1.3 in the commercial packaging in which the product will be made available on the market. The long-term ambient storage stability test shall address the relevant physical, chemical and technical properties of that product both prior to and after storage in accordance with section 2.6.4 of the Guidance on the Biocidal Products Regulation Volume I: Identity of the active substance/physico-chemical properties/analytical methodology – Information Requirements, Evaluation and Assessment (ECHA, March 2022) (1), in order to confirm a shelf life of 24 months. The authorisation holder shall include in the study report information about the packaging stability, the spray characteristics and internal pressure before and after storage.
By 9 January 2024 the authorisation holder shall submit the results of the study to the Agency.


(1)  https://echa.europa.eu/documents/10162/23036412/bpr_guidance_vol_i_parts_abc_en.pdf/31b245e5-52c2-f0c7-04db-8988683cbc4b





ANNEX II

Summary of product characteristics for a biocidal product family

IPA Family 1
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
Authorisation number: EU-0028425-0000
R4BP asset number: EU-0028425-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION
1.1.   Family name







Name


IPA Family 1




1.2.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT04 – Food and feed area (Disinfectants)




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Ecolab Deutschland GmbH




Address


Ecolab Allee 1, 40789 Monheim am Rhein Germany




Authorisation number


EU-0028425-0000





R4BP asset number



EU-0028425-0000




Date of the authorisation


9 March 2023




Expiry date of the authorisation


28 February 2033




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


Ecolab Europe GmbH




Address of manufacturer


Richtistrasse, 7, 8304 Walliselen Switzerland




Location of manufacturing sites


Richtistrasse, 7, 8304 Walliselen Switzerland













Name of manufacturer


Ecolab Limited




Address of manufacturer


Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom




Location of manufacturing sites


Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom













Name of manufacturer


Laboratoires Prodene Klint




Address of manufacturer


Rue Denis Papin, 2 Z.I. Mitry Compans, F-77290 Mitry Mory France




Location of manufacturing sites


Rue Denis Papin, 2 Z.I. Mitry Compans, F-77290 Mitry Mory France













Name of manufacturer


Ecolab Leeds




Address of manufacturer


Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom




Location of manufacturing sites


Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom













Name of manufacturer


Esoform S.p.A.




Address of manufacturer


Viale del Lavoro 10, 45100 Rovigo Italy




Location of manufacturing sites


Viale del Lavoro 10, 45100 Rovigo Italy













Name of manufacturer


Nalco Deutschland Manufacturing GmbH und Co.KG




Address of manufacturer


Justus-von-Liebig-Str. 11, D-64584 Biebesheim Germany




Location of manufacturing sites


Justus-von-Liebig-Str. 11, D-64584 Biebesheim Germany













Name of manufacturer


Ecolab NETHERLANDS BV




Address of manufacturer


Brugwal 11, 3432NZ Nieuwegein Netherlands




Location of manufacturing sites


Brugwal 11, 3432NZ Nieuwegein Netherlands













Name of manufacturer


Ecolab Weavergate




Address of manufacturer


Winnington Avenue, CW8 3AA Northwich Cheshire United Kingdom




Location of manufacturing sites


Winnington Avenue, CW8 3AA Northwich Cheshire United Kingdom













Name of manufacturer


Ecolab Mullingar, Ireland




Address of manufacturer


Forest Park, Zone C Mullingar Ind. Estate, – Mullingar, Co. Westmeath, Ireland




Location of manufacturing sites


Forest Park, Zone C Mullingar Ind. Estate, – Mullingar, Co. Westmeath, Ireland













Name of manufacturer


Ecolab d.o.o.




Address of manufacturer


Vajngerlova 4, 2000 Maribor Slovenia




Location of manufacturing sites


Vajngerlova 4, 2000 Maribor Slovenia













Name of manufacturer


Ecolab Rozzano, Italy




Address of manufacturer


Via A. Grandi 9/11, 20089 Rozzano (MI) Italy




Location of manufacturing sites


Via A. Grandi 9/11, 20089 Rozzano (MI) Italy













Name of manufacturer


Ecolab B.V.B.A




Address of manufacturer


Havenlaan 4, 3980 Tessenderlo Belgium




Location of manufacturing sites


Havenlaan 4, 3980 Tessenderlo Belgium













Name of manufacturer


Nalco Española Manufacturing, SLU




Address of manufacturer


C/Tramuntana s/n Polígono Industrial de Celrà, 17460 Celrà Spain




Location of manufacturing sites


C/Tramuntana s/n Polígono Industrial de Celrà, 17460 Celrà Spain













Name of manufacturer


Ecolab production France SAS




Address of manufacturer


BP509, Avenue de Général Patton, 51006 Châlons-en-Champagne France




Location of manufacturing sites


BP509, Avenue de Général Patton, 51006 Châlons-en-Champagne France













Name of manufacturer


Ecolab Mandra, Greece




Address of manufacturer


25km Old National Road Athens- Theve, – Mandra Attica Greece




Location of manufacturing sites


25km Old National Road Athens- Theve, – Mandra Attica Greece













Name of manufacturer


NALCO FINLAND MANUFACTURING OY




Address of manufacturer


Kivikummuntie 1, FIN-07955 Tesjoki Finland




Location of manufacturing sites


Kivikummuntie 1, FIN-07955 Tesjoki Finland













Name of manufacturer


Manufacturing Plant Cisterna Nalco




Address of manufacturer


Via Ninfina II, 4012 Cisterna Di Latina, Italy




Location of manufacturing sites


Via Ninfina II, 4012 Cisterna Di Latina Italy













Name of manufacturer


Manufacturing Plant Fawley Nalco




Address of manufacturer


One business center 1180, SO45 3NP Hardley Hants United Kingdom




Location of manufacturing sites


One business center 1180, SO45 3NP Hardley Hants United Kingdom













Name of manufacturer


Nalco Champion Plant, Tooling Plant, Aberdeen Nalco




Address of manufacturer


Minto Avenue, Alten Industrial Estate, AB12 3JZ Aberdeen United Kingdom




Location of manufacturing sites


Minto Avenue, Alten Industrial Estate, AB12 3JZ Aberdeen United Kingdom













Name of manufacturer


Microtek Medical B.V.




Address of manufacturer


Hekkehorst, 24, 7207 BN Zutphen Netherlands




Location of manufacturing sites


Hekkehorst, 24, 7207 BN Zutphen Netherlands













Name of manufacturer


Microtek Medical Malta Ltd.




Address of manufacturer


Sorbonne Centre F20 Mosta Technopark, MST 3000 Mosta Malta




Location of manufacturing sites


Sorbonne Centre F20 Mosta Technopark, MST 3000 Mosta Malta













Name of manufacturer


Innovate GmbH




Address of manufacturer


Am Hohen Stein, 11, 06618 Naumburg Germany




Location of manufacturing sites


Am Hohen Stein, 11, 06618 Naumburg Germany













Name of manufacturer


CHRISTEYNS FRANCE S.A.




Address of manufacturer


31 rue de la Maladrie, 44120 Vertou France




Location of manufacturing sites


54 avenue de la Plaine – ZI, 13106 Rousset France













Name of manufacturer


Techtex




Address of manufacturer


Units 7 & 8, Rhodes Business Park, Silbum Way, M24 4NE Middelton, Manchester United Kingdom




Location of manufacturing sites


Units 7 & 8, Rhodes Business Park, Silbum Way, M24 4NE Middelton, Manchester United Kingdom




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







Active substance


Propan-2-ol




Name of manufacturer


Ineos Solvents Germany GmbH




Address of manufacturer


Römerstrasse 733, 47443 Moers Germany




Location of manufacturing sites


Shamrockstrasse 88, D-44623 Herne Germany
Romestrasse, 733, D-47443, D-47443 Moers Germany













Active substance


Propan-2-ol




Name of manufacturer


Shell Chemicals Europe B.V.




Address of manufacturer


Postbus 2334, 3000 CH Rotterdam Netherlands




Location of manufacturing sites


Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis, Netherlands













Active substance


Propan-2-ol




Name of manufacturer


ExxonMobil Chemical Europe




Address of manufacturer


Hermeslaan 2, 1831 Machelen, Belgium




Location of manufacturing sites


Fawley Refinery and Petrochemical Plant, Fawley, SO45 1TX Southampton United Kingdom
Baton Rouge Chemical Plant 4999 Scenic Highway, 70805-3359 LA United States




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 (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


30,3 


65,66 




2.2.   Type(s) of formulation







Formulation(s)


AL – Any other liquid
AE – Aerosol dispenser
XX – Ready to use wipe impregnated with water based liquid




PART II

SECOND INFORMATION LEVEL – META SPC(S)


META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 1 identifier







Identifier


Meta-SPC 1.1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




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 (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


60,61 


65,66 




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







Formulation(s)


AL – Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1






Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Wear eye protection.
Wear face protection.




4.   AUTHORISED USE(S) OF THE META SPC 1
4.1.   Use description


Table 1. Use # 1 – Use # 1.1 – Disinfection of surfaces in cleanrooms by spraying or mopping







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Fungi
Development stage:
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Disinfection of cleanroom hard non-porous surfaces in life sciences industry.




Application method(s)


Method: Trigger spraying or mopping
Detailed description:
Direct application onto surfaces by trigger spraying followed by wiping with a dry wipe for distribution or mopping.




Application rate(s) and frequency


Application Rate: c.a. 18 ml/m2

Dilution (%): 0
Number and timing of application:
As required




Category(ies) of users


Professional




Pack sizes and packaging material


0,5 liter – 10 liters Polyvinylpyrrolidone (PVP) or (High density polyetheylene (HDPE) bottle/container (with and without trigger spray)




4.1.1.   Use-specific instructions for use

Clean and dry surfaces prior to disinfection.
Application by trigger spraying directly onto the surface: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (max. 18 ml/m2, corresponding to 20 strokes/m2) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Always close the nozzle after use. Do not transfer the product to a trigger sprayer, but apply from a package delivered with trigger sprayer.
Application on surfaces by Mopping: Impregnate the clean mop with the liquid using a mop bucket and apply to the surface to be disinfected. Ensure complete wetting of the surface (max. 18 mL/m2). Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. No additional wiping necessary.
Do not mix product with other products. Do not pour any unused product back into the original container.
4.1.2.   Use-specific risk mitigation measures

Avoid contact with eyes.
Gloves, eye protection and respiratory protection equipment (RPE) of protection factor of 10 should be worn during mopping. Unprotected personnel should not be present in the room during disinfection by mopping.
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



Potential Health Effects



Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.


First Aid Measures



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

IF ON SKIN: Take-off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use (5.5).
5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.   Instructions for use

Please refer to specific instructions for use for meta-SPC 1
5.2.   Risk mitigation measures

Please refer to specific Risk mitigation measures for meta-SPC 1
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 1
5.4.   Instructions for safe disposal of the product and its packaging



Product


Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.


Contaminated packaging


Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national, and/or international regulations.


Product residues


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0 °C to 25 °C
Shelf life: 24 months
6.   OTHER INFORMATION
Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg body weight (bw)/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report on Propan-2-ol in PT2 – Germany – (January 2015).
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)


Klercide 70/30 IPA


Market area: EU




Authorisation number


EU-0028425-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,27 





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 2 identifier







Identifier


Meta-SPC 1.2




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




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 (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


60,61 


65,66 




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







Formulation(s)


XX – Ready to use wipe impregnated with water based liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2






Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.




4.   AUTHORISED USE(S) OF THE META SPC 2
4.1.   Use description


Table 2. Use # 1 – Use # 2.1 – Disinfection of surfaces in cleanroom by wiping







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Fungi
Development stage:
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Disinfection of cleanroom hard non-porous surfaces in life sciences industry by wiping.




Application method(s)


Method: Wiping
Detailed description:
Direct application onto surfaces by wiping with pre-wetted wipes.




Application rate(s) and frequency


Application Rate: c.a. 10 ml/m2

Dilution (%): 0
Number and timing of application:
Tub (200 wipes/pack, 230x200, Synthetic/cellulose blend): c.a. 0,13 m2 can be disinfected with 1 wipe
Tub (100 wipes/pack, 200x230, Synthetic/cellulose blend): c.a. 0,23 m2 can be disinfected with 1 wipe
Mop (10 wipes/pack, 420x250, Polyester/cellulose): c.a. 1,1 m2 can be disinfected with 1 wipe
Pouch (15 wipes/pack, 200x200, Polyester/cellulose): c.a. 0,33 m2 can be disinfected with 1 wipe
Pouch (10 wipes/pack, 200x200, 100 % polyester): c.a. 0,51 m2 can be disinfected with 1 wipe
Pouch (15 wipes/pack, 300x300, Polyester/cellulose): c.a. 0,47 m2 can be disinfected with 1 wipe
Pouch (10 wipes/pack, 300x300, 100 % polyester): c.a. 0,73 m2 can be disinfected with 1 wipe




Category(ies) of users


Professional




Pack sizes and packaging material


Tub (HDPE) (100-200 wipes/pack, 200x230, Synthetic/cellulose blend)
Pouch (10-30 wipes/pack, 200x200, Polyester/cellulose, 100 % polyester)
Pouch (10-30 wipes/pack, 300x300, Polyester/cellulose, 100 % polyester)
Mop wipe (10-30 wipes/pack, 420x250, Polyester/cellulose)




4.1.1.   Use-specific instructions for use

Clean and dry surfaces prior to disinfection.
Wiping: Wipe surface to be disinfected. Use wipe once. Ensure complete wetting of the surface (max. 10 ml/m2).
About 0,13-1,1 m2 can be disinfected with 1 wipe depending on the wipe.
Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Dispose of the wipes in the appropriate closed waste bin immediately after use. No additional wiping necessary.
For multipack wipes, close the package after opening.
Do not mix with other products.
4.1.2.   Use-specific risk mitigation measures

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



Potential Health Effects



Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.


First Aid Measures



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

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use (5.5).
5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
5.1.   Instructions for use


Please refer to specific instructions for use for meta-SPC 2

5.2.   Risk mitigation measures


Please refer to specific risk mitigation measures for meta-SPC 2

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

Please refer to specific information for meta-SPC 2
5.4.   Instructions for safe disposal of the product and its packaging



Product


Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.


Contaminated packaging


Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.


Product residues


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0 °C to 25 °C
Shelf life: 24 months
6.   OTHER INFORMATION
Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 Germany – (January 2015).
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)


Klerwipe 70/30 IPA


Market area: EU




Authorisation number


EU-0028425-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,27 





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 3 identifier







Identifier


Meta-SPC 1.3




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




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 (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


60,61 


65,66 




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







Formulation(s)


AE – Aerosol dispenser




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3






Hazard statements


Extremely flammable aerosol.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Pressurised container: May burst if heated
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Wear eye protection.
Wear face protection.
Do not spray on an open flame or other ignition source.
Do not pierce or burn, even after use.
Protect from sunlight. Do not expose at temperatures exceeding 50 °C/122 °F.




4.   AUTHORISED USE(S) OF THE META SPC 3
4.1.   Use description


Table 3. Use # 1 – Use # 3.1 – Disinfection of surfaces in cleanroom by aerosols







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Fungi
Development stage:
Common name: Enveloped viruses
Development stage:




Field(s) of use


Indoor
Disinfection of cleanroom hard non-porous surfaces in life sciences industry.




Application method(s)


Method: Aerosol spraying
Detailed description:
Direct application onto surfaces by aerosol spraying followed by wiping with a dry wipe for distribution.




Application rate(s) and frequency


Application Rate: c.a. 18 ml/m2

Dilution (%): 0
Number and timing of application:
As required




Category(ies) of users


Professional




Pack sizes and packaging material


0,2 liter – 0,5 liter aluminium can




4.1.1.   Use-specific instructions for use

Clean and dry surfaces prior to disinfection.
Application by aerosol spraying: For optimum results hold can upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (max. 18 ml/m2, corresponding to 7,2 seconds/m2 spraying) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi.
Do not mix product with other products.
4.1.2.   Use-specific risk mitigation measures

Avoid contact with eyes.
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



Potential Health Effects



Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects. Intentional misuse by deliberate inhalation may be harmful or fatal.

Chronic Exposure – Health injuries are not known or expected under normal use.


First Aid Measures



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

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use (5.5).
5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3
5.1.   Instructions for use

Please refer to specific instructions of use for meta-SPC 3
5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 3
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 3
5.4.   Instructions for safe disposal of the product and its packaging



Product


Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.


Contaminated packaging


Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.


Product residues


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0 °C to 25 °C
Shelf life: 24 months
6.   OTHER INFORMATION
Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).
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)


Klercide 70/30 IPA Aerosol


Market area: EU




Authorisation number


EU-0028425-0003 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,269 





META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 4 identifier







Identifier


Meta-SPC 1.4




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 (Disinfectants)
PT04 – Food and feed area (Disinfectants)




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 (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


30,3 


30,3 




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







Formulation(s)


XX – Ready to use wipe impregnated with water based liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4






Hazard statements


Flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.




4.   AUTHORISED USE(S) OF THE META SPC 4
4.1.   Use description


Table 4. Use # 1 – Use # 4.1 – Disinfection of non-food and food contact surfaces by pre-wetted wipes







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices.




Application method(s)


Method: Wiping
Detailed description:
Direct application onto hard non-porous surfaces by wiping.




Application rate(s) and frequency


Application Rate: c.a. 10 ml/m2 at room temperature
Dilution (%): 0
Number and timing of application:
Wiping with two superposed wipes.
About 0,074-0,222 m2 can be disinfected with two superposed wipes depending on the size of wipe used.




Category(ies) of users


Professional




Pack sizes and packaging material


Container (PP) (100 wipes 130x210)
Container (HDPE) (150 wipes 180x300)
Bucket (PP) (1 500  wipes 150x210)
Pouch (PET/PE) (200 wipes 130x210)
Wipe material (all packagings): blend of Pulp, Polyester, Binder




4.1.1.   Use-specific instructions for use

Wiping: Clean and dry surfaces prior to disinfection.
Wipe surface to be disinfected with two superposed wipes. Use the wipes once. For optimum results ensure complete wetting of the surface (max. 10 ml/m2), about 0,074-0,222 m2 can be disinfected with two superposed wipes depending on the size of wipe used. Allow to take effect for 15 minutes for bacteria and yeast. Dispose the wipes in the appropriate closed waste bin immediately after use. No additional wiping necessary.
For multipack wipes, close the package after opening.
Do not mix product with other products.
4.1.2.   Use-specific risk mitigation measures

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



Potential Health Effects



Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.


First Aid Measures



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

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use (5.5).
5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4
5.1.   Instructions for use

Please refer to specific instructions of use for meta-SPC 4
5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 4
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 4
5.4.   Instructions for safe disposal of the product and its packaging



Product


Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.


Contaminated packaging


Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.


Product residues


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0 °C to 25 °C
Shelf life: 24 months
6.   OTHER INFORMATION
Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).
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)


Eco-Bac Wipes


Market area: EU




Authorisation number


EU-0028425-0004 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


30,3 





META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 5 identifier







Identifier


Meta-SPC 1.5




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 (Disinfectants)
PT04 – Food and feed area (Disinfectants)




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 (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


30,3 


30,3 




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







Formulation(s)


AL – Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5






Hazard statements


Flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Wear eye protection.
Wear face protection.




4.   AUTHORISED USE(S) OF THE META SPC 5
4.1.   Use description


Table 5. Use # 1 – Use # 5.1 – Disinfection of non-food and food contact surfaces by trigger spray







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices.




Application method(s)


Method: Trigger spraying
Detailed description:
Direct application onto hard non-porous surfaces by trigger spraying.




Application rate(s) and frequency


Application Rate: c.a. 18 ml/m2 at room temperature
Dilution (%): 0
Number and timing of application:
As required




Category(ies) of users


Professional




Pack sizes and packaging material


0,5 liter – 10 liter HDPE container (with trigger spray)




4.1.1.   Use-specific instructions for use

Application by trigger spraying: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (max. 18 ml/m2, corresponding to 29 strokes/m2). Allow to take effect for 30 seconds for bacteria and yeast. Always close the nozzle after use.
Do not mix product with other products. Do not pour any unused product back into the original container.
4.1.2.   Use-specific risk mitigation measures

Avoid contact with eyes.
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



Potential Health Effects



Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.


First Aid Measures



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

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use (5.5).
5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5
5.1.   Instructions for use

Please refer to specific instructions of use for meta-SPC 5
5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 5
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 5
5.4.   Instructions for safe disposal of the product and its packaging



Product


Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.


Contaminated packaging


Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.


Product residues


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0 °C to 25 °C
Shelf life: 24 months
6.   OTHER INFORMATION
Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).
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)


Sirafan Speed-FR


Market area: EU




Authorisation number


EU-0028425-0005 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


30,3 






(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.