Commission Implementing Regulation (EU) 2024/2651 of 10 October 2024 granting a Union authorisation for the biocidal product family Taski-Room Care-Suma Family based on Lactic Acid in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2024-10-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, animal welfare, biocide, chemical product, decontamination, food safety, market approval, organic acid, pharmaceutical product








L_202402651EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2651


11.10.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2651
of 10 October 2024
         
granting a Union authorisation for the biocidal product family ‘Taski-Room Care-Suma Family based on Lactic Acid’ 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 16 April 2019, Diversey Europe Operations B.V 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 ‘Taski-Room Care-Suma Family based on Lactic Acid’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Latvia had agreed to evaluate the application. The application was recorded under case number BC-FV051273-25 in the Register for Biocidal Products.












(2)


‘Taski-Room Care-Suma Family based on Lactic Acid’ contains L-(+)-Lactic acid 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, 3 and 4.












(3)


On 28 February 2023, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.












(4)


On 2 October 2023, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Taski-Room Care-Suma Family based on Lactic Acid’ 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 ‘Taski-Room Care-Suma Family based on Lactic Acid’ 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 18 October 2023, 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 ‘Taski-Room Care-Suma Family based on Lactic Acid’.












(8)


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





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0031644-0000 is hereby granted to Diversey Europe Operations B.V for the making available on the market and use of the biocidal product family ‘Taski-Room Care-Suma Family Based on Lactic Acid’ subject to compliance with the terms and conditions set out in the Annex.
The Union authorisation is valid from 31 October 2024 until 30 September 2034.


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, 10 October 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  ECHA opinion of 14/9/2023 on the Union authorisation of ‘Taski-Room Care-Suma Family based on Lactic Acid’ (ECHA/BPC/394/2023), https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
Summary of product characteristics for a biocidal product family
Taski-Room Care-Suma Family Based on Lactic Acid

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
PT03: Veterinary hygiene

Authorisation number EU-0031644-0000

R4BP asset number EU-0031644-0000
PART I.

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Taski-Room Care-Suma Family Based on Lactic Acid




1.2.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
PT03: Veterinary hygiene




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Diversey Europe Operations B.V.




Address


Regulatory team Maarssenbroeksedijk 2 3542 DN Utrecht NL




Authorisation number


EU-0031644-0000





R4BP asset number



EU-0031644-0000




Date of the authorisation


31 October 2024




Expiry date of the authorisation


30 September 2034




1.4.   Manufacturer(s) of the product







Name of manufacturer


Diversey Europe Operations B.V.




Address of manufacturer


Maarssenbroeksedijk 2 3542DN Utrecht Netherlands (the)




Location of manufacturing sites


Diversey Europe Operations B.V. site 1 Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy
Diversey Europe Operations B.V. site 2 Rembrandtlaan 414 7545 ZW Enschede Netherlands (the)
Diversey Europe Operations B.V. site 3 Cotes Park Industrial Estate DE55 4PA Somercotes Alfreton United Kingdom of Great Britain and Northern Ireland (the)
Diversey Europe Operations B.V. site 4 Avenida Conde Duque 5, 7 y 9 ; Poligono Industrial La Postura 28343 Valdemoro (Madrid) Spain
Diversey Europe Operations B.V. site 5 Morschheimer Strasse 12 67292 Kirchheimbolanden Germany













Name of manufacturer


Multifill B.V.




Address of manufacturer


Constructieweg 25-A 3641 SB Mijdrecht Netherlands (the)




Location of manufacturing sites


Multifill B.V. site 1 Constructieweg 25-A 3641 SB Mijdrecht Netherlands (the)













Name of manufacturer


Ionic Products Ltd




Address of manufacturer


Blaris Industrial Estate, Altona Road BT27 5QB Lisburn Ireland




Location of manufacturing sites


Ionic Products Ltd site 1 Blaris Industrial Estate, Altona Road BT27 5QB Lisburn Ireland













Name of manufacturer


Aerosol Service Sp. z o.o.




Address of manufacturer


Charnowo 3676-270 Ustka Poland




Location of manufacturing sites


Aerosol Service Sp. z o.o. site 1 Charnowo 3676-270 Ustka Poland













Name of manufacturer


Orvema B.V.




Address of manufacturer


Westkanaaldijk 26-I 3606 AM Maarssen Netherlands (the)




Location of manufacturing sites


Orvema B.V. site 1 Westkanaaldijk 26-I 3606 AM Maarssen Netherlands (the)













Name of manufacturer


Cheport spol s.r.o.




Address of manufacturer


Lhotsko 93 76312 Vizovice Czechia




Location of manufacturing sites


Cheport spol s.r.o. site 1 Lhotsko 93 76312 Vizovice Czechia













Name of manufacturer


Helichem B.V.




Address of manufacturer


Kozakkenberg 5 5951 DL Belfeld Netherlands (the)




Location of manufacturing sites


Helichem B.V. site 1 Kozakkenberg 5 5951 DL Belfeld Netherlands (the)













Name of manufacturer


Pluswipes LTD




Address of manufacturer


Pywell Rd, Willowbrook, East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Pluswipes LTD site 1 Pywell Rd, Willowbrook, East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)




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







Active substance


L-(+)-lactic acid




Name of manufacturer


Purac Biochem bv




Address of manufacturer


Arkelsedijk 46 4206 AC Gorinchem Netherlands (the)




Location of manufacturing sites


Purac Biochem bv site 1 Gran Vial 19-25 08160 Montmelo Spain













Active substance


L-(+)-lactic acid




Name of manufacturer


Jungbunzlauer S.A.




Address of manufacturer


Z.I. el Portuaire, B.P. 32 67390 Marckolsheim France




Location of manufacturing sites


Jungbunzlauer S.A. site 1 Z.I. el Portuaire, B.P. 32 67390 Marckolsheim France




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 (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


0,352  - 17,6  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


0  - 5,11  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


0  - 9  % (w/w)




Sulphonic acids, C14-17-sec-alkane, sodium salts


 


Non-Active substance


97489-15-1


307-055-2


0  - 3  % (w/w)




A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside


 


Non-Active substance


 


414-420-0


0  - 3,9  % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AL Any other liquid
SL Soluble concentrate




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)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
PT03: Veterinary 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 (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


17,6  - 17,6  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


5,11  - 5,11  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


9  - 9  % (w/w)




Sulphonic acids, C14-17-sec-alkane, sodium salts


 


Non-Active substance


97489-15-1


307-055-2


3  - 3  % (w/w)




A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside


 


Non-Active substance


 


414-420-0


3,9  - 3,9  % (w/w)




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







Formulation type(s)


SL Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


H314: Causes severe skin burns and eye damage.
H290: May be corrosive to metals.
EUH071: Corrosive to the respiratory tract.




Precautionary statements


P260: Do not breathe vapours.
P280: Wear protective gloves, protective clothing, eye protection, face protection.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
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 doctor or a physician.
P405: Store locked up.
P501: Dispose of contents in accordance with national regulations.
P501: Dispose of container in accordance with national regulations.
P234: Keep only in original packaging.
P321: Specific treatment (see instruction on this label).




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use # 1a - Disinfection of hard non-porous surfaces and small objects without food contact (e.g. industrial, institutional area (excluding healthcare area) and the use in vehicles for human transport)







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)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces and small objects without food contact (e.g. industrial, institutional area (excluding healthcare area) and the use in vehicles for human transport).




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,38% w/w. This is a 2% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): Dilute the product to 2% v/v (2 ml product, add water up to 100 ml).
Number and timing of application:
Contact time:
Bacteria – 5 minutes
Yeasts - 15 minutes
Enveloped viruses - 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5; 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene; PA - Polyamide)




4.1.1.   Use-specific instructions

Dilute the product with potable water to 2,0% (2 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 5 minutes against bacteria and enveloped viruses and 15 minutes against yeasts. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.1.2.   Use-specific risk mitigation measures

See general directions for use.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
4.2.   Use description


Table 2


Use # 1b – Disinfection of hard non-porous surfaces and small objects with food contact (food, industrial, institutional area and the use in vehicles for human transport)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Enveloped viruses only
Common name: Enveloped viruses only
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces and small objects with food contact (food, industrial, institutional area and the use in vehicles for human transport).




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,38% w/w. This is a 2% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): Dilute the product to 2% v/v (2 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 15 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5; 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE, 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.2.1.   Use-specific instructions

Dilute the product with potable water to 2,0% (2 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 15 minutes. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.2.2.   Use-specific risk mitigation measures

See general directions for use.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
4.3.   Use description


Table 3


Use # 2 - Disinfection of clean hard non-porous surfaces without and with food contact (food, industrial, institutional area including healthcare area)







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data
Scientific name: Enveloped viruses only
Common name: Enveloped viruses only
Development stage: no data




Field(s) of use


indoor use
Disinfection of clean hard non-porous surfaces without and with food contact (food, industrial, institutional area including healthcare area).




Application method(s)


Method: manual application
Detailed description: Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.




Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,38% w/w. This is a 2% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2).
Dilution (%): Dilute the product to 2% v/v (2 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5; 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.3.1.   Use-specific instructions

Remove gross soiling and pre-clean the surface before applying the product.
Dilute the product with potable water to 2,0% (2 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step.
Leave wet for 5 minutes. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.3.2.   Use-specific risk mitigation measures

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

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

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

See general directions for use.
4.4.   Use description


Table 4


Use # 3 - Disinfection of clean hard non-porous surfaces and small objects in a veterinary area







Product type


PT03: Veterinary hygiene




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of clean hard non-porous surfaces and small objects in a veterinary area.




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,57% w/w. This is a 3% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected for 5 minutes and apply approx. 19 sprays /m2 or 25 ml/m2 for 30 minutes).
Dilution (%): Dilute the product to 3% v/v (3 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 5 minutes at room temperature (18-25 °C); 30 minutes at 10 °C




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5; 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.4.1.   Use-specific instructions

Remove gross soiling and pre-clean the surface before applying the product.
Dilute the product with potable water to 3,0% (3 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 5 minutes at room temperature or for 30 minutes at 10°C. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.4.2.   Use-specific risk mitigation measures

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

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

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

See general directions for use.
4.5.   Use description


Table 5


Use # 4 – Disinfection of hard non-porous surfaces (incl. machines and equipment) with dairy food contact (food, industrial, institutional area)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces (incl. machines and equipment) with dairy food contact (food, industrial, institutional area). For example, ice-cream and shake machines, open plant cleaning in food factories or hard surfaces in kitchens.




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,57% w/w. This is a 3% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): Dilute the product to 3% v/v (3 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5; 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.5.1.   Use-specific instructions

Dilute the product with potable water to 3,0% (3 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 5 minutes. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.5.2.   Use-specific risk mitigation measures

See general directions for use.
4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

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

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

Comply with the instructions for use.
Inform the authorisation holder if the treatment is ineffective.
5.2.   Risk mitigation measures

Wear protective chemical resistant gloves classified under EN 374 or equivalent, face protection consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full texts of the EN standards are available in Section 6. Personal protective equipment (PPE) material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to this act.
Do not breathe vapour.
Avoid contact with eyes and skin.
Avoid splashes and spills during mixing and loading (dilution).
Wash hands after handling.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a Poison Centre or a doctor.
IF ON SKIN: Immediately wash 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 or an ambulance for medical assistance.
Information to Healthcare personnel/doctor: the eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Do NOT induce vomiting. Give something to drink, if exposed person is able to swallow. Call 112 or an ambulance for medical assistance.
5.4.   Instructions for safe disposal of the product and its packaging

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

Store in original container tightly closed. Store protected from light.
Do not store above 40 °C.
Shelf- life: 2 years.
6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 “Risk mitigation measures” are:
EN 374 - Protective gloves against dangerous chemicals and micro-organisms
EN 16321 - Eye and face protection for occupational use
EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]).
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).
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)


TASKI Sani 4 in 1 Plus


Market area: EU




Authorisation number


 


EU-0031644-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


17,6  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


5,11  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


9  % (w/w)




Sulphonic acids, C14-17-sec-alkane, sodium salts


 


Non-Active substance


97489-15-1


307-055-2


3  % (w/w)




A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside


 


Non-Active substance


 


414-420-0


3,9  % (w/w)




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













Trade name(s)


ANDY MultiPower Conc Professional


Market area: EU




ANDYSAN MultiPower Conc Professional


Market area: EU




CIF MultiPower Conc Professional


Market area: EU




Cif 4in1 Cleaner Disinfectant Concentrate


Market area: EU




DOMESTOS MultiPower Conc Professional


Market area: EU




Domestos 4in1 Cleaner Disinfectant Concentrate


Market area: EU




FLORASZEPT MultiPower Conc Professional


Market area: EU




GLORIX MultiPower Conc Professional


Market area: EU




Glorix 4in1 Cleaner Disinfectant Concentrate


Market area: EU




JIF MultiPower Conc Professional


Market area: EU




KLINEX MultiPower Conc Professional


Market area: EU




Klinex 4in1 Cleaner Disinfectant Concentrate


Market area: EU




LIFEBUOY MultiPower Conc Professional


Market area: EU




LYSOFORM MultiPower Conc Professional


Market area: EU




Lysoform 4in1 Cleaner Disinfectant Concentrate


Market area: EU




Metro Prof. 4 in 1 Plus Conc


Market area: EU




OPTIMAX 4 in 1 Plus Conc


Market area: EU




SAVO MultiPower Conc Professional


Market area: EU




Suma San 4in1 D10.7


Market area: EU




SUPERANDY MultiPower Conc Professional


Market area: EU




TASKI Sani 4 in 1 Plus Conc


Market area: EU




VISS MultiPower Conc Professional


Market area: EU




Viss 4in1 Cleaner Disinfectant Concentrate


Market area: EU




We Clean 4 in 1 Plus Conc


Market area: EU




Authorisation number


 


EU-0031644-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


17,6  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


5,11  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


9  % (w/w)




Sulphonic acids, C14-17-sec-alkane, sodium salts


 


Non-Active substance


97489-15-1


307-055-2


3  % (w/w)




A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside


 


Non-Active substance


 


414-420-0


3,9  % (w/w)




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













Trade name(s)


Divosan Freed Conc


Market area: EU




SANO-Premium-Plus


Market area: EU




Suma Ice & Shake Sanitizer


Market area: EU




Sure Ice & Shake Sanitizer


Market area: EU




Sure Sanitizer


Market area: EU




SURE Sanitizer A


Market area: EU




TASKI Sani 4 in 1 FREE Conc


Market area: EU




TASKI Sani 4 in 1 ZERO Conc


Market area: EU




Authorisation number


 


EU-0031644-0003 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


17,6  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


5,11  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


9  % (w/w)




Sulphonic acids, C14-17-sec-alkane, sodium salts


 


Non-Active substance


97489-15-1


307-055-2


3  % (w/w)




A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside


 


Non-Active substance


 


414-420-0


3,9  % (w/w)




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













Trade name(s)


SURE Sanitizer B


Market area: EU




Authorisation number


 


EU-0031644-0004 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


17,6  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


5,11  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


9  % (w/w)




Sulphonic acids, C14-17-sec-alkane, sodium salts


 


Non-Active substance


97489-15-1


307-055-2


3  % (w/w)




A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside


 


Non-Active substance


 


414-420-0


3,9  % (w/w)




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













Trade name(s)


SURE Sanitizer C


Market area: EU




Sure Sanitizer 4in1


Market area: EU




Sure Sanitizer 4in1 Fresh


Market area: EU




Authorisation number


 


EU-0031644-0005 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


17,6  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


5,11  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


9  % (w/w)




Sulphonic acids, C14-17-sec-alkane, sodium salts


 


Non-Active substance


97489-15-1


307-055-2


3  % (w/w)




A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside


 


Non-Active substance


 


414-420-0


3,9  % (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)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
PT03: Veterinary 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 (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


17,6  - 17,6  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


5,11  - 5,11  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


9  - 9  % (w/w)




Sulphonic acids, C14-17-sec-alkane, sodium salts


 


Non-Active substance


97489-15-1


307-055-2


3  - 3  % (w/w)




A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside


 


Non-Active substance


 


414-420-0


3,9  - 3,9  % (w/w)




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







Formulation type(s)


SL Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


H314: Causes severe skin burns and eye damage.
H290: May be corrosive to metals.
EUH071: Corrosive to the respiratory tract.
EUH208: Contains Ethyl 2,3-epoxy-3-phenylbutyrate, Delta-damascone and Damascone. May produce an allergic reaction.




Precautionary statements


P260: Do not breathe vapours.
P280: Wear protective gloves, protective clothing, eye protection, face protection.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
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 doctor or a physician.
P405: Store locked up.
P501: Dispose of contents in accordance with national regulations.
P501: Dispose of container in accordance with national regulations.
P234: Keep only in original packaging.
P321: Specific treatment (see instruction on this label).




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use # 1a - Disinfection of hard non-porous surfaces and small objects without food contact (e.g. industrial, institutional area (excluding healthcare area) and the use in vehicles for human transport)







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)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces and small objects without food contact (e.g. industrial, institutional area (excluding healthcare area) and the use in vehicles for human transport).




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,38% w/w. This is a 2% v/v dilution fo the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): Dilute the product to 2% v/v (2 ml product, add water up to 100 ml).
Number and timing of application:
Contact time:
Bacteria – 5 minutes
Yeasts - 15 minutes
Enveloped viruses - 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5; 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide)




4.1.1.   Use-specific instructions

Dilute the product with potable water to 2,0% (2 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 5 minutes against bacteria and enveloped viruses and 15 minutes against yeasts. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.1.2.   Use-specific risk mitigation measures

See general directions for use.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
4.2.   Use description


Table 2


Use # 1b – Disinfection of hard non-porous surfaces and small objects with food contact (food, industrial, institutional area and the use in vehicles for human transport)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Enveloped viruses only
Common name: Enveloped viruses only
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces and small objects with food contact (food, industrial, institutional area and the use in vehicles for human transport).




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,38% w/w. This is a 2% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): Dilute the product to 2% v/v (2 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 15 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5; 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.2.1.   Use-specific instructions

Dilute the product with potable water to 2,0% (2 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 15 minutes. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.2.2.   Use-specific risk mitigation measures

See general directions for use.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
4.3.   Use description


Table 3


Use # 2 – Disinfection of clean hard non-porous surfaces without and with food contact (food, industrial, institutional area including healthcare area)







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data
Scientific name: Enveloped viruses only
Common name: Enveloped viruses only
Development stage: no data




Field(s) of use


indoor use
Disinfection of clean hard non-porous surfaces without and with food contact (food, industrial, institutional area including healthcare area).




Application method(s)


Method: manual application
Detailed description:
Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.




Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,38% w/w. This is a 2% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2).
Dilution (%): Dilute the product to 2% v/v (2 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5; 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.3.1.   Use-specific instructions

Remove gross soiling and pre-clean the surface before applying the product.
Dilute the product with potable water to 2,0% (2 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step.
Leave wet for 5 minutes. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.3.2.   Use-specific risk mitigation measures

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

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

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

See general directions for use.
4.4.   Use description


Table 4


Use # 3 - Disinfection of clean hard non-porous surfaces and small objects in a veterinary area







Product type


PT03: Veterinary hygiene




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of clean hard non-porous surfaces and small objects in a veterinary area.




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,57% w/w. This is a 3% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected for 5 minutes and apply approx. 19 sprays /m2 or 25 ml/m2 for 30 minutes).
Dilution (%): Dilute the product to 3% v/v (3 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 5 minutes at room temperature (18-25 °C); 30 minutes at 10 °C




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5; 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.4.1.   Use-specific instructions

Remove gross soiling and pre-clean the surface before applying the product.
Dilute the product with potable water to 3,0% (3 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product.The solution for dipping shall be used only once.
Leave wet for 5 minutes at room temperature or for 30 minutes at 10°C. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.4.2.   Use-specific risk mitigation measures

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

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

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

See general directions for use.
4.5.   Use description


Table 5


Use # 4 – Disinfection of hard non-porous surfaces (incl. machines and equipment) with dairy food contact (food, industrial, institutional area)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces (incl. machines and equipment) with dairy food contact (food, industrial, institutional area). For example, ice-cream and shake machines, open plant cleaning in food factories or hard surfaces in kitchens.




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,57% w/w. This is a 3% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): Dilute the product to 3% v/v (3 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5 and 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.5.1.   Use-specific instructions

Dilute the product with potable water to 3,0% (3 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 5 minutes. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.5.2.   Use-specific risk mitigation measures

See general directions for use.
4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

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

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

5.1.   Instructions for use

Comply with the instructions for use.
Inform the authorisation holder if the treatment is ineffective.
5.2.   Risk mitigation measures

Wear protective chemical resistant gloves classified under EN 374 or equivalent, face protection consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full texts of the EN standards are available in Section 6. Personal protective equipment (PPE) material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to this act.
Do not breathe vapour.
Avoid contact with eyes and skin.
Avoid splashes and spills during mixing and loading (dilution).
Wash hands after handling.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a Poison Centre or a doctor.
IF ON SKIN: Immediately wash 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 or an ambulance for medical assistance.
Information to Healthcare personnel/doctor: the eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Do NOT induce vomiting. Give something to drink, if exposed person is able to swallow. Call 112 or an ambulance for medical assistance.
5.4.   Instructions for safe disposal of the product and its packaging

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

Store in original container tightly closed. Store protected from light.
Do not store above 40 °C.
Shelf- life: 2 years.
6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 “Risk mitigation measures” are:
EN 374 - Protective gloves against dangerous chemicals and micro-organisms
EN 16321 - Eye and face protection for occupational use
EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]).
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).
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)


Sure Freshener Conc


Market area: EU




Sure Freshener 7X Conc


Market area: EU




Sure Sanitiser Conc


Market area: EU




Sure Sanitiser 2X Conc


Market area: EU




TASKI Sani 4 in 1 Freshener Conc


Market area: EU




TASKI Sani 4 in 1 Freshener Concentrate


Market area: EU




Zenith Freshener Conc


Market area: EU




Zenith Freshener 7X Conc


Market area: EU




Zenith Sanitiser Conc


Market area: EU




Zenith Sanitiser 2X Conc


Market area: EU




7X FRESHENER CONCENTRATE


Market area: EU




Authorisation number


 


EU-0031644-0006 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


17,6  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


5,11  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


9  % (w/w)




Sulphonic acids, C14-17-sec-alkane, sodium salts


 


Non-Active substance


97489-15-1


307-055-2


3  % (w/w)




A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside


 


Non-Active substance


 


414-420-0


3,9  % (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)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
PT03: Veterinary 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 (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


8,8  - 8,8  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


2,56  - 2,56  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


4,5  - 4,5  % (w/w)




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







Formulation type(s)


SL Soluble concentrate




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


H314: Causes severe skin burns and eye damage.
H290: May be corrosive to metals.
EUH071: Corrosive to the respiratory tract.




Precautionary statements


P260: Do not breathe vapours.
P280: Wear protective gloves, protective clothing, eye protection, face protection.
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
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 doctor or a physician.
P405: Store locked up.
P501: Dispose of contents in accordance with national regulations.
P501: Dispose of container in accordance with national regulations.
P234: Keep only in original packaging.
P321: Specific treatment (see instruction on this label).




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use # 1a - Disinfection of hard non-porous surfaces and small objects without food contact (e.g. industrial, institutional area (excluding healthcare area) and the use in vehicles for human transport)







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)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Enveloped viruses
Common name: Enveloped viruses
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces and small objects without food contact (e.g. industrial, institutional area (excluding healthcare area) and the use in vehicles for human transport).




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,38% w/w. This is a 4% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): Dilute the product to 4% v/v (4 ml product, add water up to 100 ml).
Number and timing of application:
Contact time:
Bacteria – 5 minutes
Yeasts - 15 minutes
Enveloped viruses - 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5 and 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide)




4.1.1.   Use-specific instructions

Dilute the product with potable water to 4,0% (4 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 5 minutes against bacteria and enveloped viruses and 15 minutes against yeasts. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.1.2.   Use-specific risk mitigation measures

See general directions for use.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
4.2.   Use description


Table 2


Use # 1b – Disinfection of hard non-porous surfaces and small objects with food contact (food, industrial, institutional area and the use in vehicles for human transport)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Enveloped viruses only
Common name: Enveloped viruses only
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces and small objects with food contact (food, industrial, institutional area and the use in vehicles for human transport).




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,38% w/w. This is a 4% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): Dilute the product to 4% v/v (4 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 15 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5 and 3,0 litres
Canister, HDPE: 2,0; 2,5: 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - poylamide).




4.2.1.   Use-specific instructions

Dilute the product with potable water to 4,0% (4 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 15 minutes. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.2.2.   Use-specific risk mitigation measures

See general directions for use.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
4.3.   Use description


Table 3


Use # 2 – Disinfection of clean hard non-porous surfaces without and with food contact (food, industrial, institutional area including healthcare area)







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data
Scientific name: Enveloped viruses only
Common name: Enveloped viruses only
Development stage: no data




Field(s) of use


indoor use
Disinfection of clean hard non-porous surfaces without and with food contact (food, industrial, institutional area including healthcare area).




Application method(s)


Method: manual application
Detailed description:
Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.




Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,38% w/w. This is a 4% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2).
Dilution (%): Dilute the product to 4% v/v (4 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5 and 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.3.1.   Use-specific instructions

Remove gross soiling and pre-clean the surface before applying the product.
Dilute the product with potable water to 4,0% (4 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step.
Leave wet for 5 minutes. Wipe dry or let air dry. No rinsing of surface required.Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.3.2.   Use-specific risk mitigation measures

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

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

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

See general directions for use.
4.4.   Use description


Table 4


Use # 3 - Disinfection of clean hard non-porous surfaces and small objects in a veterinary area







Product type


PT03: Veterinary hygiene




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of clean hard non-porous surfaces and small objects in a veterinary area.




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,57% w/w. This is a 6% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected for 5 minutes and apply approx. 19 sprays /m2 or 25 ml/m2 for 30 minutes).
Dilution (%): Dilute the product to 6% v/v (6 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 5 minutes at room temperature (18-25 °C); 30 minutes at 10 °C




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5 and 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.4.1.   Use-specific instructions

Remove gross soiling and pre-clean the surface before applying the product.
Dilute the product with potable water to 6,0% (6 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 5 minutes at room temperature or for 30 minutes at 10°C. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.4.2.   Use-specific risk mitigation measures

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

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

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

See general directions for use.
4.5.   Use description


Table 5


Use # 4 – Disinfection of hard non-porous surfaces (incl. machines and equipment) with dairy food contact (food, industrial, institutional area)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces (incl. machines and equipment) with dairy food contact (food, industrial, institutional area). For example, ice-cream and shake machines, open plant cleaning in food factories or hard surfaces in kitchens.




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: The product should be applied in active substance concentration 0,57% w/w. This is a 6% v/v dilution of the product. Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): Dilute the product to 6% v/v (6 ml product, add water up to 100 ml).
Number and timing of application:
Contact time: 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5 and 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Bottle J-flex/ Smartdose, HDPE: 1,4 and 1,5 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.5.1.   Use-specific instructions

Dilute the product with potable water to 6,0% (6 ml product, add water up to 100 ml). Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in freshly diluted product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 5 minutes. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.5.2.   Use-specific risk mitigation measures

See general directions for use.
4.5.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

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

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1.   Instructions for use

Comply with the instructions for use.
Inform the authorisation holder if the treatment is ineffective.
5.2.   Risk mitigation measures

Wear protective chemical resistant gloves classified under EN 374 or equivalent, face protection consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full texts of the EN standards are available in Section 6. Personal protective equipment (PPE) material to be specified by the authorisation holder within the product information.
This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to this act.
Do not breathe vapour.
Avoid contact with eyes and skin.
Avoid splashes and spills during mixing and loading (dilution).
Wash hands after handling.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or an ambulance for medical assistance. If no symptoms: Call a Poison Centre or a doctor.
IF ON SKIN: Immediately wash 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 or an ambulance for medical assistance.
Information to Healthcare personnel/doctor: the eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Do NOT induce vomiting. Give something to drink, if exposed person is able to swallow. Call 112 or an ambulance for medical assistance.
5.4.   Instructions for safe disposal of the product and its packaging

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

Store in original container tightly closed. Store protected from light.
Do not store above 40 °C.
Shelf- life: 2 years.
6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 “Risk mitigation measures” are:
EN 374 - Protective gloves against dangerous chemicals and micro-organisms
EN 16321 - Eye and face protection for occupational use
EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]).
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).
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)


ANDY MultiPower Plus Professional


Market area: EU




ANDYSAN MultiPower Plus Professional


Market area: EU




CIF MultiPower Plus Professional


Market area: EU




DOMESTOS MultiPower Plus Professional


Market area: EU




FLORASZEPT MultiPower Plus Professional


Market area: EU




GLORIX MultiPower Plus Professional


Market area: EU




JIF MultiPower Plus Professional


Market area: EU




KLINEX MultiPower Plus Professional


Market area: EU




LIFEBUOY MultiPower Plus Professional


Market area: EU




LYSOFORM MultiPower Plus Professional


Market area: EU




Room Care R9.1 Des-Plus


Market area: EU




SAVO MultiPower Plus Professional


Market area: EU




SUPERANDY MultiPower Plus Professional


Market area: EU




VISS MultiPower Plus Professional


Market area: EU




Authorisation number


 


EU-0031644-0007 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


8,8  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


2,56  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


4,5  % (w/w)




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













Trade name(s)


Room Care R9 Des-Plus


Market area: EU




Authorisation number


 


EU-0031644-0008 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


8,8  % (w/w)




Methanesulfonic acid


 


Non-Active substance


75-75-2


200-898-6


2,56  % (w/w)




Alkyl ether carboxylic acid


 


Non-Active substance


53563-70-5


 


4,5  % (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 (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


0,352  - 0,352  % (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.


 




Precautionary statements


 




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use # 1a - Disinfection of hard non-porous surfaces and small objects without food contact (e.g. industrial, institutional area (excluding healthcare area) and the use in vehicles for human transport)







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)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: enveloped viruses
Common name: enveloped viruses
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces and small objects without food contact (e.g. industrial, institutional area (excluding healthcare area) and the use in vehicles for human transport).




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): ready to use products
Number and timing of application:
Contact time:
Bacteria – 5 minutes
Yeasts - 15 minutes
Enveloped viruses - 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5 and 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Spray bottles, HDPE: 0,75 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide)




4.1.1.   Use-specific instructions

Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in the product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 5 minutes against bacteria and enveloped viruses and 15 minutes against yeasts. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.1.2.   Use-specific risk mitigation measures

See general directions for use.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
4.2.   Use description


Table 2


Use # 1b – Disinfection of hard non-porous surfaces and small objects with food contact (food, industrial, institutional area and the use in vehicles for human transport)







Product type


PT04: Food and feed area




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Enveloped viruses only
Common name: Enveloped viruses only
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data




Field(s) of use


indoor use
Disinfection of hard non-porous surfaces and small objects with food contact (food, industrial, institutional area and the use in vehicles for human transport).




Application method(s)


Method: manual application
Detailed description:






1.


Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.










2.


Dipping to wet small objects.








Application rate(s) and frequency


Application rate: Apply the product by fully wetting the surface (apply approx. 10 sprays /m2 or 13 ml/m2 or fully cover the object to be disinfected).
Dilution (%): Ready to use products
Number and timing of application:
Contact time: 15 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5 and 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Spray bottles, HDPE: 0,75 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.2.1.   Use-specific instructions

Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step. In case of small objects, dip the objects completely in the product to wet the surface. The solution for dipping shall be used only once.
Leave wet for 15 minutes. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.2.2.   Use-specific risk mitigation measures

See general directions for use.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
4.3.   Use description


Table 3


Use # 2 – Disinfection of clean hard non-porous surfaces without and with food contact (food, industrial, institutional area including healthcare area)







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: Bacteria
Development stage: no data
Scientific name: Yeast
Common name: Yeast
Development stage: no data
Scientific name: Enveloped viruses only
Common name: Enveloped viruses only
Development stage: no data




Field(s) of use


indoor use
Disinfection of clean hard non-porous surfaces without and with food contact (food, industrial, institutional area including healthcare area).




Application method(s)


Method: manual application
Detailed description: Surface disinfection by pouring or foam spraying. Cloth, brush, sponge, mop or wipe should be used to distribute on surface.




Application rate(s) and frequency


Application rate: Apply the product by fully wetting all surface (apply approx. 10 sprays /m2 or 13 ml/m2).
Dilution (%): Ready to use product
Number and timing of application:
Contact time: 5 minutes




Category(ies) of users


professional




Pack sizes and packaging material


Soft Pouch, PET/PE and LLDPE/PA: 0,1; 0,8; 1,0; 1,5; 2,0; 2,5 and 5,0 litres
Bottle, HDPE: 1,0; 2,0; 2,5 and 3,0 litres
Canister, HDPE: 2,0; 2,5; 3,0; 5,0; 10,0 and 20,0 litres
Spray bottles, HDPE: 0,75 litres
(PET – polyethylene terephthalate; PE – Polyethylene; HDPE – High density polyethylene; LLDPE - Linear low density polyethylene, PA - polyamide).




4.3.1.   Use-specific instructions

Remove gross soiling and pre-clean the surface before applying the product.
Apply, e.g. spray, pour product onto the surface and then use a cloth, brush, sponge, mop or wipe for product distribution. Ensure that the surface is completely wet after the treatment step.
Leave wet for 5 minutes. Wipe dry or let air dry. No rinsing of surface required. Disinfect surfaces and objects as frequently as required by the hygiene protocol in place.
4.3.2.   Use-specific risk mitigation measures

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

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

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

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 4

5.1.   Instructions for use

Comply with the instructions for use.
Inform the authorisation holder if the treatment is ineffective.
5.2.   Risk mitigation measures

Not relevant.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

If medical advice is needed, have product container or label at hand
IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.   Instructions for safe disposal of the product and its packaging

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

Store in original container tightly closed. Store protected from light.
Do not store above 40 °C.
Shelf- life: 2 years.
6.   OTHER INFORMATION

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)


Room Care R9 RTU


Market area: EU




Room Care R9.1 Des


Market area: EU




Authorisation number


 


EU-0031644-0009 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


0,352  % (w/w)




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













Trade name(s)


Taski Sani 4 in 1 Plus Spray


Market area: EU




Authorisation number


 


EU-0031644-0010 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


0,352  % (w/w)




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













Trade name(s)


ANDY MultiPower Professional


Market area: EU




ANDYSAN MultiPower Professional


Market area: EU




CIF MultiPower Professional


Market area: EU




Cif 4in1 Cleaner Disinfectant


Market area: EU




DOMESTOS MultiPower Professional


Market area: EU




Domestos 4in1 Cleaner Disinfectant


Market area: EU




FLORASZEPT MultiPower Professional


Market area: EU




GLORIX MultiPower Professional


Market area: EU




Glorix 4in1 Cleaner Disinfectant


Market area: EU




JIF MultiPower Professional


Market area: EU




KLINEX MultiPower Professional


Market area: EU




Klinex 4in1 Cleaner Disinfectant


Market area: EU




LIFEBUOY MultiPower Professional


Market area: EU




LYSOFORM MultiPower Professional


Market area: EU




Lysoform 4in1 Cleaner Disinfectant


Market area: EU




Metro Prof. 4 in 1 Plus RTU


Market area: EU




OPTIMAX 4 in 1 Plus RTU


Market area: EU




SAVO MultiPower Professional


Market area: EU




Suma San 4in1 D10.7 Spray


Market area: EU




SUPERANDY MultiPower Professional


Market area: EU




Taski Sani 4 in 1 Plus RTU


Market area: EU




VISS MultiPower Professional


Market area: EU




Viss 4in1 Cleaner Disinfectant


Market area: EU




We Clean 4 in 1 Plus RTU


Market area: EU




Authorisation number


 


EU-0031644-0011 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


0,352  % (w/w)




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













Trade name(s)


ANDY MultiPower FREE Professional


Market area: EU




ANDY MultiPower ZERO Professional


Market area: EU




ANDYSAN MultiPower FREE Professional


Market area: EU




ANDYSAN MultiPower ZERO Professional


Market area: EU




CIF MultiPower FREE Professional


Market area: EU




CIF MultiPower ZERO Professional


Market area: EU




Divosan Freed RTU


Market area: EU




DOMESTOS MultiPower FREE Professional


Market area: EU




DOMESTOS MultiPower ZERO Professional


Market area: EU




FLORASZEPT MultiPower FREE Professional


Market area: EU




FLORASZEPT MultiPower ZERO Professional


Market area: EU




GLORIX MultiPower FREE Professional


Market area: EU




GLORIX MultiPower ZERO Professional


Market area: EU




JIF MultiPower FREE Professional


Market area: EU




JIF MultiPower ZERO Professional


Market area: EU




KLINEX MultiPower FREE Professional


Market area: EU




KLINEX MultiPower ZERO Professional


Market area: EU




LIFEBUOY MultiPower FREE Professional


Market area: EU




LIFEBUOY MultiPower ZERO Professional


Market area: EU




LYSOFORM MultiPower FREE Professional


Market area: EU




LYSOFORM MultiPower ZERO Professional


Market area: EU




SAVO MultiPower FREE Professional


Market area: EU




SAVO MultiPower ZERO Professional


Market area: EU




SUPERANDY MultiPower FREE Professional


Market area: EU




SUPERANDY MultiPower ZERO Professional


Market area: EU




Sure Sanitizer A-RTU


Market area: EU




Sure Sanitizer Spray


Market area: EU




TASKI Sani 4 in 1 FREE


Market area: EU




TASKI Sani 4 in 1 ZERO


Market area: EU




VISS MultiPower FREE Professional


Market area: EU




VISS MultiPower ZERO Professional


Market area: EU




Authorisation number


 


EU-0031644-0012 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


0,352  % (w/w)




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













Trade name(s)


Sure Sanitizer B-RTU


Market area: EU




Authorisation number


 


EU-0031644-0013 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


0,352  % (w/w)




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













Trade name(s)


Sure Sanitizer C-RTU


Market area: EU




Sure Sanitizer 4in1 Spray


Market area: EU




Sure Sanitizer 4in1 Fresh Spray


Market area: EU




Authorisation number


 


EU-0031644-0014 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


0,352  % (w/w)




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













Trade name(s)


Sure Freshener RTU


Market area: EU




Sure Freshener 7X RTU


Market area: EU




Sure Sanitiser RTU


Market area: EU




Sure Sanitiser 2X RTU


Market area: EU




TASKI Sani 4 in 1 Freshener


Market area: EU




Taski Sani 4 in 1 Freshener


Market area: EU




Zenith Freshener RTU


Market area: EU




Zenith Freshener 7X RTU


Market area: EU




Zenith Sanitiser RTU


Market area: EU




Zenith Sanitiser 2X RTU


Market area: EU




Authorisation number


 


EU-0031644-0015 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




L-(+)-lactic acid


 


active substance


79-33-4


201-196-2


0,352  % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2024/2651/oj
ISSN 1977-0677 (electronic edition)