LegalizeCommission 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
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.
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. |
| Name and address of the authorisation holder | Address | De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL |
| Authorisation number | EU-0031644-0000 | EU-0031644-0000 |
| R4BP asset number | EU-0031644-0000 | EU-0031644-0000 |
| Date of the authorisation | 31/10/2024 | 31/10/2024 |
| Expiry date of the authorisation | 30/09/2034 | 30/09/2034 |
1.4. Manufacturer(s) of the product
| Name of manufacturer | Diversey Europe Operations B.V. |
| Address of manufacturer | De Corridor 4 (Regulatory team) 3621 ZB Breukelen 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 to in accordance with national regulations. P501: Dispose of container to 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). 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 for use
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). 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 for use
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). 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 for use
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). 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 for use
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). 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 for use
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) | Trade name(s) | Trade name(s) | TASKI Sani 4 in 1 Plus | TASKI Sani 4 in 1 Plus | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0031644-0001 1-1 | EU-0031644-0001 1-1 | EU-0031644-0001 1-1 | EU-0031644-0001 1-1 | EU-0031644-0001 1-1 |
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active substance | Active substance | 79-33-4 | 79-33-4 | 201-196-2 | 17,6 % (w/w) | |
| Methanesulfonic acid | Non-active substance | Non-active substance | 75-75-2 | 75-75-2 | 200-898-6 | 5,11 % (w/w) | |
| Alkyl ether carboxylic acid | Non-active substance | Non-active substance | 53563-70-5 | 53563-70-5 | 9 % (w/w) | ||
| Sulphonic acids, C14-17-sec-alkane, sodium salts | Non-active substance | Non-active substance | 97489-15-1 | 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 | 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) | Trade name(s) | Trade name(s) | ANDY MultiPower Conc Professional | ANDY MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ANDYSAN MultiPower Conc Professional | ANDYSAN MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | CIF MultiPower Conc Professional | CIF MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Cif 4in1 Cleaner Disinfectant Concentrate | Cif 4in1 Cleaner Disinfectant Concentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | DOMESTOS MultiPower Conc Professional | DOMESTOS MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Domestos 4in1 Cleaner Disinfectant Concentrate | Domestos 4in1 Cleaner Disinfectant Concentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | FLORASZEPT MultiPower Conc Professional | FLORASZEPT MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GLORIX MultiPower Conc Professional | GLORIX MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Glorix 4in1 Cleaner Disinfectant Concentrate | Glorix 4in1 Cleaner Disinfectant Concentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | JIF MultiPower Conc Professional | JIF MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | KLINEX MultiPower Conc Professional | KLINEX MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Klinex 4in1 Cleaner Disinfectant Concentrate | Klinex 4in1 Cleaner Disinfectant Concentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | LIFEBUOY MultiPower Conc Professional | LIFEBUOY MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | LYSOFORM MultiPower Conc Professional | LYSOFORM MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Lysoform 4in1 Cleaner Disinfectant Concentrate | Lysoform 4in1 Cleaner Disinfectant Concentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Metro Prof. 4 in 1 Plus Conc | Metro Prof. 4 in 1 Plus Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | OPTIMAX 4 in 1 Plus Conc | OPTIMAX 4 in 1 Plus Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | SAVO MultiPower Conc Professional | SAVO MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Suma San 4in1 D10.7 | Suma San 4in1 D10.7 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | SUPERANDY MultiPower Conc Professional | SUPERANDY MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | TASKI Sani 4 in 1 Plus Conc | TASKI Sani 4 in 1 Plus Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | VISS MultiPower Conc Professional | VISS MultiPower Conc Professional | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Viss 4in1 Cleaner Disinfectant Concentrate | Viss 4in1 Cleaner Disinfectant Concentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | We Clean 4 in 1 Plus Conc | We Clean 4 in 1 Plus Conc | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0031644-0002 1-1 | EU-0031644-0002 1-1 | EU-0031644-0002 1-1 | EU-0031644-0002 1-1 | EU-0031644-0002 1-1 |
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active substance | Active substance | 79-33-4 | 79-33-4 | 201-196-2 | 17,6 % (w/w) | |
| Methanesulfonic acid | Non-active substance | Non-active substance | 75-75-2 | 75-75-2 | 200-898-6 | 5,11 % (w/w) | |
| Alkyl ether carboxylic acid | Non-active substance | Non-active substance | 53563-70-5 | 53563-70-5 | 9 % (w/w) | ||
| Sulphonic acids, C14-17-sec-alkane, sodium salts | Non-active substance | Non-active substance | 97489-15-1 | 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 | 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) | Trade name(s) | Trade name(s) | Divosan Freed Conc | Divosan Freed Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | SANO-Premium-Plus | SANO-Premium-Plus | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Suma Ice & Shake Sanitizer | Suma Ice & Shake Sanitizer | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sure Ice & Shake Sanitizer | Sure Ice & Shake Sanitizer | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sure Sanitizer | Sure Sanitizer | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | SURE Sanitizer A | SURE Sanitizer A | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | TASKI Sani 4 in 1 FREE Conc | TASKI Sani 4 in 1 FREE Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | TASKI Sani 4 in 1 ZERO Conc | TASKI Sani 4 in 1 ZERO Conc | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0031644-0003 1-1 | EU-0031644-0003 1-1 | EU-0031644-0003 1-1 | EU-0031644-0003 1-1 | EU-0031644-0003 1-1 |
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active substance | Active substance | 79-33-4 | 79-33-4 | 201-196-2 | 17,6 % (w/w) | |
| Methanesulfonic acid | Non-active substance | Non-active substance | 75-75-2 | 75-75-2 | 200-898-6 | 5,11 % (w/w) | |
| Alkyl ether carboxylic acid | Non-active substance | Non-active substance | 53563-70-5 | 53563-70-5 | 9 % (w/w) | ||
| Sulphonic acids, C14-17-sec-alkane, sodium salts | Non-active substance | Non-active substance | 97489-15-1 | 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 | 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) | Trade name(s) | Trade name(s) | SURE Sanitizer B | SURE Sanitizer B | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0031644-0004 1-1 | EU-0031644-0004 1-1 | EU-0031644-0004 1-1 | EU-0031644-0004 1-1 | EU-0031644-0004 1-1 |
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active substance | Active substance | 79-33-4 | 79-33-4 | 201-196-2 | 17,6 % (w/w) | |
| Methanesulfonic acid | Non-active substance | Non-active substance | 75-75-2 | 75-75-2 | 200-898-6 | 5,11 % (w/w) | |
| Alkyl ether carboxylic acid | Non-active substance | Non-active substance | 53563-70-5 | 53563-70-5 | 9 % (w/w) | ||
| Sulphonic acids, C14-17-sec-alkane, sodium salts | Non-active substance | Non-active substance | 97489-15-1 | 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 | 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) | Trade name(s) | Trade name(s) | SURE Sanitizer C | SURE Sanitizer C | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sure Sanitizer 4in1 | Sure Sanitizer 4in1 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sure Sanitizer 4in1 Fresh | Sure Sanitizer 4in1 Fresh | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0031644-0005 1-1 | EU-0031644-0005 1-1 | EU-0031644-0005 1-1 | EU-0031644-0005 1-1 | EU-0031644-0005 1-1 |
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active substance | Active substance | 79-33-4 | 79-33-4 | 201-196-2 | 17,6 % (w/w) | |
| Methanesulfonic acid | Non-active substance | Non-active substance | 75-75-2 | 75-75-2 | 200-898-6 | 5,11 % (w/w) | |
| Alkyl ether carboxylic acid | Non-active substance | Non-active substance | 53563-70-5 | 53563-70-5 | 9 % (w/w) | ||
| Sulphonic acids, C14-17-sec-alkane, sodium salts | Non-active substance | Non-active substance | 97489-15-1 | 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 | 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 to in accordance with national regulations. P501: Dispose of container to 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). 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 for use
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). 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 for use
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). 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 for use
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). 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 for use
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). 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 for use
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) | Trade name(s) | Trade name(s) | Sure Freshener Conc | Sure Freshener Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sure Freshener 7X Conc | Sure Freshener 7X Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sure Sanitiser Conc | Sure Sanitiser Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sure Sanitiser 2X Conc | Sure Sanitiser 2X Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | TASKI Sani 4 in 1 Freshener Conc | TASKI Sani 4 in 1 Freshener Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | TASKI Sani 4 in 1 Freshener Concentrate | TASKI Sani 4 in 1 Freshener Concentrate | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Zenith Freshener Conc | Zenith Freshener Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Zenith Freshener 7X Conc | Zenith Freshener 7X Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Zenith Sanitiser Conc | Zenith Sanitiser Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Zenith Sanitiser 2X Conc | Zenith Sanitiser 2X Conc | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | 7X FRESHENER CONCENTRATE | 7X FRESHENER CONCENTRATE | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0031644-0006 1-2 | EU-0031644-0006 1-2 | EU-0031644-0006 1-2 | EU-0031644-0006 1-2 | EU-0031644-0006 1-2 |
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active substance | Active substance | 79-33-4 | 79-33-4 | 201-196-2 | 17,6 % (w/w) | |
| Methanesulfonic acid | Non-active substance | Non-active substance | 75-75-2 | 75-75-2 | 200-898-6 | 5,11 % (w/w) | |
| Alkyl ether carboxylic acid | Non-active substance | Non-active substance | 53563-70-5 | 53563-70-5 | 9 % (w/w) | ||
| Sulphonic acids, C14-17-sec-alkane, sodium salts | Non-active substance | Non-active substance | 97489-15-1 | 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 | 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 to in accordance with national regulations. P501: Dispose of container to 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).
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