LegalizeCommission Implementing Regulation (EU) 2022/1391 of 26 July 2022 granting a Union authorisation for the biocidal product family ‘Lactic acid based products – CID Lines NV’ (Text with EEA relevance)
Article 1
A Union authorisation with authorisation number EU-0027740-0000 is granted to CID Lines NV for the making available on the market and use of the biocidal product family ‘Lactic acid based products – CID Lines NV’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.
The Union Authorisation is valid from 1 September 2022 to 31 August 2032.
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 I
TERMS AND CONDITIONS (EU-0027740-0000)
The authorisation holder shall conduct a long-term storage stability test at ambient temperature of ‘Lactic acid based products – CID Lines NV’ in commercial packaging in which the products in the family will be made available on the market. All relevant properties should be determined prior and after storage.
By 1 March 2023 the authorisation holder shall submit the results of the test to the Agency.
ANNEX II
Summary of product characteristics for a biocidal product family
Lactic acid based products – CID LINES NV
Product type 1 – Human hygiene (Disinfectants)
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 3 – Veterinary hygiene (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
Authorisation number: EU-0027740-0000
R4BP asset number: EU-0027740-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
| Name | Lactic acid based products – CID LINES NV |
1.2. Product type(s)
| Product type(s) | PT01 – Human hygiene (Disinfectants) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT03 – Veterinary hygiene (Disinfectants) PT04 – Food and feed area (Disinfectants) |
1.3. Authorisation holder
| Name and address of the authorisation holder | Name | CID LINES NV |
| Name and address of the authorisation holder | Address | Waterpoortstraat 2, 8900 Ieper Belgium |
| Authorisation number | EU-0027740-0000 | EU-0027740-0000 |
| R4BP asset number | EU-0027740-0000 | EU-0027740-0000 |
| Date of the authorisation | 31 December 2023 | 31 December 2023 |
| Expiry date of the authorisation | 31 August 2032 | 31 August 2032 |
1.4. Manufacturer(s) of the biocidal products
| Name of manufacturer | CID LINES NV |
| Address of manufacturer | Waterpoortstraat 2, 8900 Ieper Belgium |
| Location of manufacturing sites | Waterpoortstraat 2, 8900 Ieper Belgium |
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 Gorinchem Netherlands |
| Location of manufacturing sites | Arkelsedijk 46, 4206 Gorinchem Netherlands |
| --- | --- |
| Active substance | L-(+)-lactic acid |
| Name of manufacturer | Jungbunzlauer S.A. |
| Address of manufacturer | Z.I. et Portuaire, B.P. 32, 67390 Marckolsheim France |
| Location of manufacturing sites | Z.I. et 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 (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 2,0 | 70,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 0,0 | 12,0 |
| Sodium lauryl ether sulfate | Alcohols, C12-14, ethoxylated, sulfates, sodium salts | Non-active substance | 68891-38-3 | 500-234-8 | 0,0 | 8,4 |
| Sulfonic acids, C14-17-sec-alkane, sodium salts | Sulfonic acids, C14-17-sec-alkane, sodium salts | Non-active substance | 97489-15-1 | 307-055-2 | 0,0 | 2,25 |
| C6 alkyl glucoside | Hexyl D-Glucoside | Non-active substance | 54549-24-5 | 259-217-6 | 0,0 | 2,4 |
| Isopropanol | Propan-2-ol | Non-active substance | 67-63-0 | 200-661-7 | 0,0 | 5,0 |
| Methanesulfonic acid | Methanesulfonic acid | Non-active substance | 75-75-2 | 200-898-6 | 0,0 | 19,5 |
| Sulphuric acid | Sulphuric acid | Non-active substance | 7664-93-9 | 231-639-5 | 0,0 | 10,5 |
| Butyldiglycol | 2-(2-butoxyethoxy)ethanol | Non-active substance | 112-34-5 | 203-961-6 | 0,0 | 10,0 |
2.2. Type(s) of formulation
| Formulation(s) | AL – Any other liquid SL – Soluble concentrate WI – Wipes |
PART II
SECOND INFORMATION LEVEL – META SPC(S)
META SPC 1
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
| Identifier | Meta SPC 1: Ready to use hygienic handwash (PT1) |
1.2. Suffix to the authorisation number
| Number | 1-1 |
1.3. Product type(s)
| Product type(s) | PT01 – Human hygiene (Disinfectants) |
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 3,6 | 3,6 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 5,0 | 5,0 |
| Isopropanol | Propan-2-ol | Non-active substance | 67-63-0 | 200-661-7 | 4,0 | 4,0 |
2.2. Type(s) of formulation of the meta SPC 1
| Formulation(s) | AL – Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | Causes serious eye damage. |
| Precautionary statements | Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. |
4. AUTHORISED USE(S) OF THE META SPC 1
4.1. Use description
Table 1
Use # 1 – Hygienic handwash for professional use
| Product type | PT01 – Human hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Other: Bacteria Common name: Bacteria Development stage: Scientific name: Other: Yeast Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Food and feed industry, Public field and Kitchens: Hygienic handwash |
| Application method(s) | Method: - Detailed description: - |
| Application rate(s) and frequency | Application Rate: 10 mL of undiluted product (that is four pushes for both hands together) Dilution (%): - Number and timing of application: Apply 10 mL of undiluted product (that is four pushes for both hands together) and wash your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 50 mL, 75 mL, 100 mL, 150 mL, 500 mL, 1L, 5L, 10L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L HDPE (High Density Polyethylene) |
4.1.1. Use-specific instructions for use
see general directions for use for Meta SPC 1
4.1.2. Use-specific risk mitigation measures
/
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
see general directions for Meta SPC 1
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for Meta SPC 1
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 Meta SPC 1
5. GENERAL DIRECTIONS FOR USE ([^E0001])OF THE META SPC 1
5.1. Instructions for use
Wet your hands with clean, running water at room temperature
Turn off the tap
Apply 10 mL of undiluted product and rub your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry.
For professional use only
5.2. Risk mitigation measures
/
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur 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. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
5.4. Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6. OTHER INFORMATION
/
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) | Kenosan Hand Scrub | Kenosan Hand Scrub | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | EU-0027740-0001 1-1 | EU-0027740-0001 1-1 | EU-0027740-0001 1-1 | EU-0027740-0001 1-1 | EU-0027740-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 3,6 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 5,0 |
| Isopropanol | Propan-2-ol | Non-active substance | 67-63-0 | 200-661-7 | 4,0 |
META SPC 2
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
| Identifier | Meta SPC 2: Ready to use Algaecide |
1.2. Suffix to the authorisation number
| Number | 1-2 |
1.3. Product type(s)
| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 2,0 | 2,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 0,6 | 0,9 |
2.2. Type(s) of formulation of the meta SPC 2
| Formulation(s) | AL – Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
| Hazard statements | Causes serious eye irritation. |
| Precautionary statements | If medical advice is needed, have product container or label at hand. Keep out of reach of children. Read carefully and follow all instructions. Wash hands thoroughly after handling. Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. If skin irritation occurs:Get medical advice. If eye irritation persists:Get medical advice. Take off contaminated clothing.And wash it before reuse. |
4. AUTHORISED USE(S) OF THE META SPC 2
4.1. Use description
Table 2
Use # 1 – Ready to use algaecide for professional use
| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Scientific name: unicellular green algae and blue-green algae Common name: cyanobacteria Development stage: |
| Field(s) of use | Indoor Outdoor Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning. |
| Application method(s) | Method: By brushing, by spraying (low pressure) or pouring Detailed description: / |
| Application rate(s) and frequency | Application Rate: 100 mL/m2 Dilution (%): - Number and timing of application: Active against bacteria, yeasts and unicellular green algae and blue-green algae (cyanobacteria): With undiluted product at 20 – 25 °C In 3h contact time 100 mL/m2 The biocidal product is not intended to be used on surfaces that come into contact with food and feed. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg HDPE (High Density Polyethylene) |
4.1.1. Use-specific instructions for use
see general directions for use for Meta SPC 2
4.1.2. Use-specific risk mitigation measures
/
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
see general directions for use for Meta SPC 2
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 2
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 for Meta SPC 2
4.2. Use description
Table 3
Use # 2 – Ready to use algaecide for non-professional use
| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: Scientific name: unicellular green algae and blue-green algae Common name: Cyanobacteria Development stage: |
| Field(s) of use | Indoor Outdoor Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning. |
| Application method(s) | Method: By brushing, by spraying (low pressure) or pouring Detailed description: / |
| Application rate(s) and frequency | Application Rate: 100 mL/m2 Dilution (%): - Number and timing of application: Active against bacteria, yeasts and unicellular green algae and blue-green algae (cyanobacteria): With undiluted product at 20 – 25 °C In 3h contact time 100 mL/m2 The biocidal product is not intended to be used on surfaces that come into contact with food and feed. |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | 1 L, 5 L, 10 L 1 kg, 5 kg, 10 kg HDPE (High Density Polyethylene) |
4.2.1. Use-specific instructions for use
see general directions for use for Meta SPC 2
4.2.2. Use-specific risk mitigation measures
/
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 for Meta SPC 2
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 2
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 for Meta SPC 2
5. GENERAL DIRECTIONS FOR USE ([^E0002])OF THE META SPC 2
5.1. Instructions for use
Comply with the instructions for use
The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: ‘Make sure to wet surfaces completely’.
The required contact time has to be respected until further treatments (for example brushing the surfaces).
Use 100 mL solution/m2
5.2. Risk mitigation measures
/
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: If symptoms occur 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 IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for five minutes. Call a POISON CENTRE or a doctor.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
If medical advice is needed, have product container or label at hand
5.4. Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
Keep out of reach of children and non-target animals/pets.
6. OTHER INFORMATION
/
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) | RTU Algaecide | RTU Algaecide | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | EU-0027740-0002 1-2 | EU-0027740-0002 1-2 | EU-0027740-0002 1-2 | EU-0027740-0002 1-2 | EU-0027740-0002 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 2,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 0,6 |
META SPC 3
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
| Identifier | Meta SPC 3: concentrated algaecide and hard surface disinfection in food industry |
1.2. Suffix to the authorisation number
| Number | 1-3 |
1.3. Product type(s)
| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 – Food and feed area (Disinfectants) |
2. META SPC 3 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 3
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 70,0 | 70,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 6,0 | 6,0 |
2.2. Type(s) of formulation of the meta SPC 3
| Formulation(s) | SL – Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
| Hazard statements | Causes severe skin burns and eye damage. Causes serious eye damage. |
| Precautionary statements | Do not breathe vapours. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eyes/face protection. IF SWALLOWED:Rinse mouth.Do NOT induce vomiting. IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. Wash contaminated clothing before reuse. Store locked up. Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. |
4. AUTHORISED USE(S) OF THE META SPC 3
4.1. Use description
Table 4
Use # 1 – concentrated algaecide
| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: unicellular green algae and blue-green algae Common name: Cyanobacteria Development stage: |
| Field(s) of use | Indoor Outdoor Food and feed industry; Public field: Concentrated algaecide, on hard/non-porous surfaces without prior cleaning. |
| Application method(s) | Method: By spraying (low pressure) or pouring Detailed description: / |
| Application rate(s) and frequency | Application Rate: 100 mL/m2 Dilution (%): 0,5 % Number and timing of application: Active against unicellular green algae and blue-green algae (cyanobacteria): 100 mL/m2 Dilute the product to 0,5 % in water, to reach an in use concentration of 0,35 % Lactic acid. at 20– 25 °C In 3h contact time |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg HDPE (High Density Polyethylene) |
4.1.1. Use-specific instructions for use
see general directions for use for Meta SPC 3
4.1.2. Use-specific risk mitigation measures
see general directions for use for Meta SPC 3
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 for Meta SPC 3
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 3
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 for Meta SPC 3
4.2. Use description
Table 5
Use # 2 – Disinfection of hard/non-porous surfaces in the food industry (for example processing machines)
| Product type | PT04 – Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Common name: Bacteria Development stage: Common name: Yeasts Development stage: |
| Field(s) of use | Indoor in Food/feed industry: Disinfection of hard/non-porous surfaces (for example processing machines) without prior cleaning |
| Application method(s) | Method: Spraying or soaking Detailed description: Spraying Soaking (the bath is intended to be used only once) |
| Application rate(s) and frequency | Application Rate: 100 mL/m2 Dilution (%): 4 % Number and timing of application: Active against bacteria and yeasts at +40 °C: Dilute the product to 4 % in water, to reach an in use concentration of 2,8 % Lactic acid. In five seconds contact time 100 mL/m2 |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg HDPE (High Density Polyethylene) |
4.2.1. Use-specific instructions for use
see general directions for use for Meta SPC 3
4.2.2. Use-specific risk mitigation measures
see general directions for use for Meta SPC 3
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 for Meta SPC 3
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 3
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 for Meta SPC 3
5. GENERAL DIRECTIONS FOR USE ([^E0003])OF THE META SPC 3
5.1. Instructions for use
Disinfection cycle:
- — Products must be diluted in potable water before use.
- — Final rinsing (with potable water): if required.
The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: ‘Make sure to wet surfaces completely’.
5.2. Risk mitigation measures
Gloves and goggles are needed during mixing and loading of the concentrated products.
Wear protective coverall (to be specified by the authorisation holder within the product information).
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/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
5.4. Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6. OTHER INFORMATION
/
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) | Concentrated Algaecide | Concentrated Algaecide | Market area: EU | Market area: EU | Market area: EU |
| Kenosan Lactic CONC | Kenosan Lactic CONC | Market area: EU | Market area: EU | Market area: EU | |
| Authorisation number | EU-0027740-0003 1-3 | EU-0027740-0003 1-3 | EU-0027740-0003 1-3 | EU-0027740-0003 1-3 | EU-0027740-0003 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 70,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 6,0 |
META SPC 4
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
| Identifier | Meta SPC 4: Concentrated surface disinfectants for sanitary hygiene and kitchens (PT2-PT4) |
1.2. Suffix to the authorisation number
| Number | 1-4 |
1.3. Product type(s)
| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 – Food and feed area (Disinfectants) |
2. META SPC 4 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 4
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 16,0 | 16,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 5,0 | 5,0 |
2.2. Type(s) of formulation of the meta SPC 4
| Formulation(s) | SL – Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
| Hazard statements | Causes skin irritation. Causes serious eye damage. Contains eucalyptus globulus oil (CAS-No 8000-48-4). May produce an allergic reaction. |
| Precautionary statements | If medical advice is needed, have product container or label at hand. Keep out of reach of children. Read carefully and follow all instructions. Wash hands thoroughly after handling. Wear protective gloves. Wear eyes/face protection. IF ON SKIN:Wash with plenty of water. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. If skin irritation occurs:Get medical advice. Take off contaminated clothing.And wash it before reuse. |
4. AUTHORISED USE(S) OF THE META SPC 4
4.1. Use description
Table 6
Use # 1 – Hard surface disinfection for sanitary hygiene, other than in healthcare, for professional use (PT2)
| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Public field (NOT in HEALTHCARE) Disinfection of hard/non-porous surfaces (for sanitary hygiene) by spraying without prior cleaning |
| Application method(s) | Method: By spraying (with wiping if needed, only after the end of the preconised contact time) Detailed description: / |
| Application rate(s) and frequency | Application Rate: 250 mL/m2 diluted product Dilution (%): 20 % Number and timing of application: Active against bacteria and yeasts at room temperature Dilute the product 20 % in water, to reach an in use concentration of 3,2 % Lactic acid. In 15 minutes contact time 250 mL/m2 diluted product |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg HDPE (High Density Polyethylene) |
4.1.1. Use-specific instructions for use
Comply with the instructions for use
4.1.2. Use-specific risk mitigation measures
Gloves and goggles are needed during handling of the products
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 for Meta SPC 4
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 4
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions for use for Meta SPC 4
4.2. Use description
Table 7
Use # 2 – Hard surface disinfection for hygiene in kitchens, for professional use (PT4)
| Product type | PT04 – Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: |
| Field(s) of use | Indoor in food/feed areas: Disinfection of hard/non-porous surfaces (for general hygiene) by spraying without prior cleaning |
| Application method(s) | Method: By spraying (with wiping if needed, only after the end of the preconised contact time) Detailed description: / |
| Application rate(s) and frequency | Application Rate: 100 mL/m2 Dilution (%): 20 % Number and timing of application: Active against bacteria and yeasts at room temperature Dilute the product 20 % in water, to reach an in use concentration of 3,2 % Lactic acid. In 15 minutes contact time 100 mL/m2 |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg HDPE (High Density Polyethylene) |
4.2.1. Use-specific instructions for use
Comply with the instructions for use
4.2.2. Use-specific risk mitigation measures
Gloves and goggles are needed during handling of the products.
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 for Meta SPC 4
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 4
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 for Meta SPC 4
4.3. Use description
Table 8
Use # 3 – Disinfection of toilet bowls, for professional use (PT2)
| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Public field Disinfection of hard/non-porous inside surfaces of toilets, without prior cleaning |
| Application method(s) | Method: By pouring (with brushing – only after the end of the preconised contact time) Detailed description: / |
| Application rate(s) and frequency | Application Rate: 250 mL/m2 Dilution (%): - Number and timing of application: Active against bacteria and yeasts at room temperature: With the undiluted product (with 16 % Lactic acid) In five minutes contact time |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 500 mL, 700 mL, 750 mL, 1L, 1.5 L, 2 L HDPE (High Density Polyethylene) Toilet Duck |
4.3.1. Use-specific instructions for use
Comply with the instructions for use
4.3.2. Use-specific risk mitigation measures
Gloves and goggles are needed during handling of the products.
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 for Meta SPC 4
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 4
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 for Meta SPC 4
4.4. Use description
Table 9
Use # 4 – Disinfection of toilet bowls, for non-professional use (PT2)
| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Public field Disinfection of hard/non-porous inside surfaces of toilets, without prior cleaning |
| Application method(s) | Method: By pouring (with brushing – only after the end of the preconised contact time) Detailed description: / |
| Application rate(s) and frequency | Application Rate: 250 mL/m2 Dilution (%): - Number and timing of application: Active against bacteria and yeasts at room temperature: With the undiluted product (with 16 % Lactic acid) In five minutes contact time |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | 500 mL, 700 mL, 750 mL, 1L, 1.5 L, 2 L HDPE (High Density Polyethylene) Toilet Duck |
4.4.1. Use-specific instructions for use
Comply with the instructions for use
4.4.2. Use-specific risk mitigation measures
Avoid contact with eyes
A child proof closure is required
The product must be fitted with a pouring spout, the product must be poured gently on the wall of the toilet bowl to avoid the formation of splashes.
Wash hands after application
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
If medical advice is needed, have product container or label at hand
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 4
4.4.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children and non-target animals/pets.
5. GENERAL DIRECTIONS FOR USE ([^E0004])OF THE META SPC 4
5.1. Instructions for use
The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: ‘Make sure to wet surfaces completely’.
5.2. Risk mitigation measures
/
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. If skin irritation occurs: Get medical advice.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4. Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two 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) | Sanifresh | Sanifresh | Market area: EU | Market area: EU | Market area: EU |
| Milcho Des | Milcho Des | Market area: EU | Market area: EU | Market area: EU | |
| Kenolens | Kenolens | Market area: EU | Market area: EU | Market area: EU | |
| Kenolux S100 | Kenolux S100 | Market area: EU | Market area: EU | Market area: EU | |
| SANI-CAL | SANI-CAL | Market area: EU | Market area: EU | Market area: EU | |
| Sani Super | Sani Super | Market area: EU | Market area: EU | Market area: EU | |
| Scrub | Scrub | Market area: EU | Market area: EU | Market area: EU | |
| MiQro Sani Des | MiQro Sani Des | Market area: EU | Market area: EU | Market area: EU | |
| Authorisation number | EU-0027740-0004 1-4 | EU-0027740-0004 1-4 | EU-0027740-0004 1-4 | EU-0027740-0004 1-4 | EU-0027740-0004 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 16,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 5,0 |
META SPC 5
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 5 identifier
| Identifier | Meta SPC 5: Concentrated pre-dips (PT3) |
1.2. Suffix to the authorisation number
| Number | 1-5 |
1.3. Product type(s)
| Product type(s) | PT03 – Veterinary hygiene (Disinfectants) |
2. META SPC 5 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 5
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 8,0 | 8,0 | |
| Sodium lauryl ether sulfate | Alcohols, C12-14, ethoxylated, sulfates, sodium salts | Non-active substance | 68891-38-3 | 500-234-8 | 8,4 | 8,4 |
| Sulfonic acids, C14-17-sec-alkane, sodium salts | Sulfonic acids, C14-17-sec-alkane, sodium salts | Non-active substance | 97489-15-1 | 307-055-2 | 2,25 | 2,25 |
2.2. Type(s) of formulation of the meta SPC 5
| Formulation(s) | SL – Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
| Hazard statements | Causes serious eye damage. |
| Precautionary statements | Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. |
4. AUTHORISED USE(S) OF THE META SPC 5
4.1. Use description
Table 10
Use # 1 – Teat disinfection, before milking
| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Veterinary field Teat disinfection before milking with concentrated product (to be diluted before disinfection procedure), without prior cleaning |
| Application method(s) | Method: By dipping, by spraying with spray flacon or spray installation and by wiping with a towel Detailed description: By dipping By spraying with spray flacon or spray installation By wiping with a towel soaking with the diluted product |
| Application rate(s) and frequency | Application Rate: 5 – 15 mL Dilution (%): 40 % Number and timing of application: Active against bacteria and yeasts: Dilution: 40 % The product must be diluted with RT potable water. In one minute contact time |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg HDPE (High Density Polyethylene) |
4.1.1. Use-specific instructions for use
Application rates:
Dilution: 40 % (with 3,2 % LA) – The product must be diluted with RT potable water.
- — 5 mL per cow per application for use by dipping
- — 7.5 mL per cow per application for use by spray flacon
- — 15 mL per cow per application for use by spray installation
- — For use by wiping with a towel: prepare 10 L working solution for 25 towels.
Use one towel per cow.
4.1.2. Use-specific risk mitigation measures
see general directions for use for Meta SPC 5
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 for Meta SPC 5
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 5
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 for Meta SPC 5
4.2. Use description
Table 11
Use # 2 – Intact skin wash/disinfection (of the udder of dairy and beef cattle before calving and of the udder of sows before farrowing)
| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Veterinary field |
| Application method(s) | Method: Spraying Detailed description: / |
| Application rate(s) and frequency | Application Rate: 5 – 20 mL Dilution (%): 40 % Number and timing of application: Active against bacteria and yeasts: Dilution: 40 % The product must be diluted with Room Temperature potable water. In one minute contact time 1) dairy and beef cattle on the udder before calving: 5 mL (1 spray) on each teat 2) sows on the udder before farrowing: 20 mL The animals should be kept standing on a clean floor for at least five minutes. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg HDPE (High Density Polyethylene) |
4.2.1. Use-specific instructions for use
see general directions for use for Meta SPC 5
4.2.2. Use-specific risk mitigation measures
see general directions for use for Meta SPC 5
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 for Meta SPC 5
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 5
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 for Meta SPC 5
5. GENERAL DIRECTIONS FOR USE ([^E0005])OF THE META SPC 5
5.1. Instructions for use
See use specific instructions for use
5.2. Risk mitigation measures
Chemical goggles need to be worn.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
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. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4. Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6. OTHER INFORMATION
/
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Kenopro Lactic | Kenopro Lactic | Market area: EU | Market area: EU | Market area: EU |
| HCP Foam Concentrate | HCP Foam Concentrate | Market area: EU | Market area: EU | Market area: EU | |
| Kenopro Lactic | Kenopro Lactic | Market area: EU | Market area: EU | Market area: EU | |
| Reconet+ | Reconet+ | Market area: EU | Market area: EU | Market area: EU | |
| Kenopure | Kenopure | Market area: EU | Market area: EU | Market area: EU | |
| MIROX Pre Lac | MIROX Pre Lac | Market area: EU | Market area: EU | Market area: EU | |
| Milchsäure Pre | Milchsäure Pre | Market area: EU | Market area: EU | Market area: EU | |
| Milchsäure Pref | Milchsäure Pref | Market area: EU | Market area: EU | Market area: EU | |
| Lactocid Pre | Lactocid Pre | Market area: EU | Market area: EU | Market area: EU | |
| Milcho Pre | Milcho Pre | Market area: EU | Market area: EU | Market area: EU | |
| Preactive | Preactive | Market area: EU | Market area: EU | Market area: EU | |
| Precoop | Precoop | Market area: EU | Market area: EU | Market area: EU | |
| Lactipré | Lactipré | Market area: EU | Market area: EU | Market area: EU | |
| Prelacti | Prelacti | Market area: EU | Market area: EU | Market area: EU | |
| Prelak | Prelak | Market area: EU | Market area: EU | Market area: EU | |
| Power Prep | Power Prep | Market area: EU | Market area: EU | Market area: EU | |
| Multicleaner | Multicleaner | Market area: EU | Market area: EU | Market area: EU | |
| Kenopure Strong | Kenopure Strong | Market area: EU | Market area: EU | Market area: EU | |
| Semex Pre | Semex Pre | Market area: EU | Market area: EU | Market area: EU | |
| MEPA Pure | MEPA Pure | Market area: EU | Market area: EU | Market area: EU | |
| MEPA Foam | MEPA Foam | Market area: EU | Market area: EU | Market area: EU | |
| Eco Lac Foam | Eco Lac Foam | Market area: EU | Market area: EU | Market area: EU | |
| Authorisation number | EU-0027740-0005 1-5 | EU-0027740-0005 1-5 | EU-0027740-0005 1-5 | EU-0027740-0005 1-5 | EU-0027740-0005 1-5 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 8,0 | |
| Sodium lauryl ether sulfate | Alcohols, C12-14, ethoxylated, sulfates, sodium salts | Non-active substance | 68891-38-3 | 500-234-8 | 8,4 |
| Sulfonic acids, C14-17-sec-alkane, sodium salts | Sulfonic acids, C14-17-sec-alkane, sodium salts | Non-active substance | 97489-15-1 | 307-055-2 | 2,25 |
META SPC 6
1. META SPC 6 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 6 identifier
| Identifier | Meta SPC 6: Ready to use Pre-dips (PT3) |
1.2. Suffix to the authorisation number
| Number | 1-6 |
1.3. Product type(s)
| Product type(s) | PT03 – Veterinary hygiene (Disinfectants) |
2. META SPC 6 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 6
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 3,6 | 3,6 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 5,25 | 5,25 |
2.2. Type(s) of formulation of the meta SPC 6
| Formulation(s) | AL – Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
| Hazard statements | Causes serious eye damage. |
| Precautionary statements | Wear eye/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a doctor. |
4. AUTHORISED USE(S) OF THE META SPC 6
4.1. Use description
Table 12
Use # 1 – Teat disinfection, before milking
| Product type | PT03 – Veterinary hygiene (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeast Common name: Yeasts Development stage: |
| Field(s) of use | Indoor Veterinary field |
| Application method(s) | Method: By dipping, by spraying with spray flacon or spray installation, by wiping with a towel Detailed description: By dipping By spraying with spray flacon or spray installation By wiping with a towel soaking with the diluted product |
| Application rate(s) and frequency | Application Rate: Active against bacteria and yeasts: (Ready-To-Use) RTU In one minute contact time. The product must ‘return’ to room temperature before use. Dilution (%): - Number and timing of application: Active against bacteria and yeasts: RTU (with 3,6 % Lactic acid) In one minute contact time The product must ‘return’ to RT before use |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L 1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg HDPE (High Density Polyethylene) |
4.1.1. Use-specific instructions for use
Application rates:
- — 5 mL per cow per application for use by dipping
- — 7,5 mL per cow per application for use by spray flacon
- — 15 mL per cow per application for use by spray installation
- — One towel per cow for use by wiping
4.1.2. Use-specific risk mitigation measures
see general directions for use for Meta SPC 6
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 for Meta SPC 6
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 6
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 for Meta SPC 6
5. GENERAL DIRECTIONS FOR USE ([^E0006])OF THE META SPC 6
5.1. Instructions for use
/
5.2. Risk mitigation measures
Chemical goggles need to be worn.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
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. Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
5.4. Instructions for safe disposal of the product and its packaging
The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
The shelf-life of the products is two years.
6. OTHER INFORMATION
/
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Kenopure R | Kenopure R | Market area: EU | Market area: EU | Market area: EU |
| Kenopure RTU | Kenopure RTU | Market area: EU | Market area: EU | Market area: EU | |
| HCP Foam RTU | HCP Foam RTU | Market area: EU | Market area: EU | Market area: EU | |
| Kenoxypure RTU | Kenoxypure RTU | Market area: EU | Market area: EU | Market area: EU | |
| Kenopurox RTU | Kenopurox RTU | Market area: EU | Market area: EU | Market area: EU | |
| Kenopure Ox RTU | Kenopure Ox RTU | Market area: EU | Market area: EU | Market area: EU | |
| Kenopure Plus RTU | Kenopure Plus RTU | Market area: EU | Market area: EU | Market area: EU | |
| Kenopure Extra RTU | Kenopure Extra RTU | Market area: EU | Market area: EU | Market area: EU | |
| Kenopure oxylac RTU | Kenopure oxylac RTU | Market area: EU | Market area: EU | Market area: EU | |
| Kenoxylac predip RTU | Kenoxylac predip RTU | Market area: EU | Market area: EU | Market area: EU | |
| Kenoxilac predip RTU | Kenoxilac predip RTU | Market area: EU | Market area: EU | Market area: EU | |
| Kenopure H2O2 RTU | Kenopure H2O2 RTU | Market area: EU | Market area: EU | Market area: EU | |
| Oxy Kenopure RTU | Oxy Kenopure RTU | Market area: EU | Market area: EU | Market area: EU | |
| Preactive RTU | Preactive RTU | Market area: EU | Market area: EU | Market area: EU | |
| Precoop RTU | Precoop RTU | Market area: EU | Market area: EU | Market area: EU | |
| Lactipré RTU | Lactipré RTU | Market area: EU | Market area: EU | Market area: EU | |
| Prelacti RTU | Prelacti RTU | Market area: EU | Market area: EU | Market area: EU | |
| Prelak RTU | Prelak RTU | Market area: EU | Market area: EU | Market area: EU | |
| Power Prep RTU | Power Prep RTU | Market area: EU | Market area: EU | Market area: EU | |
| Prelacta Foam | Prelacta Foam | Market area: EU | Market area: EU | Market area: EU | |
| Authorisation number | EU-0027740-0006 1-6 | EU-0027740-0006 1-6 | EU-0027740-0006 1-6 | EU-0027740-0006 1-6 | EU-0027740-0006 1-6 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 3,6 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 5,25 |
META SPC 7
1. META SPC 7 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 7 identifier
| Identifier | Meta SPC 7: Ready to use wipes (PT2, PT4) |
1.2. Suffix to the authorisation number
| Number | 1-7 |
1.3. Product type(s)
| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 – Food and feed area (Disinfectants) |
2. META SPC 7 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 7
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | Content (%) |
|---|---|---|---|---|---|---|
| Common name | IUPAC name | Function | CAS number | EC number | Min | Max |
| L-(+)-lactic acid | Active Substance | 79-33-4 | 201-196-2 | 2,0 | 2,0 | |
| Sodium Lauryl sulphate | Sulfuric acid, mono-C12-14-alkyl esters, sodium salts | Non-active substance | 85586-07-8 | 287-809-4 | 0,6 | 0,9 |
2.2. Type(s) of formulation of the meta SPC 7
| Formulation(s) | WI – Wipes |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
| Hazard statements | Causes serious eye irritation. |
| Precautionary statements | If medical advice is needed, have product container or label at hand. Keep out of reach of children. Read carefully and follow all instructions. Wash hands thoroughly after handling. Wear eyes/face protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. If skin irritation occurs:Get medical advice. If eye irritation persists:Get medical advice. Take off contaminated clothing.And wash it before reuse. |
4. AUTHORISED USE(S) OF THE META SPC 7
4.1. Use description
Table 13
Use # 1 – Hard surface disinfection in Food and Feed industry, for professional use (PT4)
| Product type | PT04 – Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeasts Common name: Yeasts Development stage: Scientific name: other: viruses Common name: Viruses Development stage: |
| Field(s) of use | Indoor Food/feed areas Disinfection of hard/non-porous surfaces and objects, with prior cleaning |
| Application method(s) | Method: With pre-impragnated wipes Detailed description: / |
| Application rate(s) and frequency | Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time Dilution (%): - Number and timing of application: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes |
4.1.1. Use-specific instructions for use
see general directions for use for Meta SPC 7
4.1.2. Use-specific risk mitigation measures
/
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
see general directions for use for Meta SPC 7
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 7
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 for Meta SPC 7
4.2. Use description
Table 14
Use # 2 – Hard surface disinfection in food and feed area, for non-professional use (PT4)
| Product type | PT04 – Food and feed area (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeasts Common name: Yeasts Development stage: Scientific name: other: viruses Common name: Viruses Development stage: |
| Field(s) of use | Indoor Food/feed areas Disinfection of hard/non-porous surfaces and objects, with prior cleaning |
| Application method(s) | Method: With pre-impragnated wipes Detailed description: Wipes |
| Application rate(s) and frequency | Application Rate: One wipe/m2 Dilution (%): - Number and timing of application: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes |
4.2.1. Use-specific instructions for use
Comply with the instructions for use
4.2.2. Use-specific risk mitigation measures
/
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
If medical advice is needed, have product container or label at hand
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use for Meta SPC 7
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
Keep out of reach of children and non-target animals/pets.
4.3. Use description
Table 15
Use # 3 – Hard surface disinfection, use in healthcare, for professional use (PT2)
| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: other: bacteria Common name: Bacteria Development stage: Scientific name: other: yeasts Common name: Yeasts Development stage: Scientific name: other: viruses Common name: Viruses Development stage: |
| Field(s) of use | Indoor Public field: Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning |
| Application method(s) | Method: With pre-impregnated wipes Detailed description: / |
| Application rate(s) and frequency | Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time Dilution (%): - Number and timing of application: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes |
4.3.1. Use-specific instructions for use
see general directions for use for Meta SPC 7
4.3.2. Use-specific risk mitigation measures
/
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 for Meta SPC 7
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