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Document 32024R2651

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

C/2024/7006

OJ L, 2024/2651, 11.10.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2651/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force

ELI: http://data.europa.eu/eli/reg_impl/2024/2651/oj

European flag

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)


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