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 Address Waterpoortstraat 2, 8900 Ieper Belgium Authorisation number EU-0027740-0000 R4BP asset number EU-0027740-0000 Date of the authorisation 1 September 2022 Expiry date of the authorisation 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 (%) 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 I – 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 (%) 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 (1) 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 Market area: EU Authorisation number 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 (%) 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 (2) 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 Market area: EU Authorisation number 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 (%) 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 (3) 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 Market area: EU Kenosan Lactic CONC Market area: EU Authorisation number 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 (%) 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 (4) 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 Market area: EU Milcho Des Market area: EU Kenolens Market area: EU Kenolux S100 Market area: EU SANI-CAL Market area: EU Sani Super Market area: EU Scrub Market area: EU MiQro Sani Des Market area: EU Authorisation number 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 (%) 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 (5) 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 Market area: EU HCP Foam Concentrate Market area: EU Kenopro Lactic Market area: EU Reconet+ Market area: EU Kenopure Market area: EU MIROX Pre Lac Market area: EU Milchsäure Pre Market area: EU Milchsäure Pref Market area: EU Lactocid Pre Market area: EU Milcho Pre Market area: EU Preactive Market area: EU Precoop Market area: EU Lactipré Market area: EU Prelacti Market area: EU Prelak Market area: EU Power Prep Market area: EU Multicleaner Market area: EU Kenopure Strong Market area: EU Semex Pre Market area: EU MEPA Pure Market area: EU MEPA Foam Market area: EU Eco Lac Foam Market area: EU Authorisation number 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 (%) 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 (6) 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 Market area: EU Kenopure RTU Market area: EU HCP Foam RTU Market area: EU Kenoxypure RTU Market area: EU Kenopurox RTU Market area: EU Kenopure Ox RTU Market area: EU Kenopure Plus RTU Market area: EU Kenopure Extra RTU Market area: EU Kenopure oxylac RTU Market area: EU Kenoxylac predip RTU Market area: EU Kenoxilac predip RTU Market area: EU Kenopure H2O2 RTU Market area: EU Oxy Kenopure RTU Market area: EU Preactive RTU Market area: EU Precoop RTU Market area: EU Lactipré RTU Market area: EU Prelacti RTU Market area: EU Prelak RTU Market area: EU Power Prep RTU Market area: EU Prelacta Foam Market area: EU Authorisation number 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 (%) 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-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 105 wipes, 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-impregnated 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 105 wipes, 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 105 wipes, 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

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 7

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 7

4.4. Use description

Table 16

Use # 4 – Hard surface disinfection, use in healthcare, 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: 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) in healthcare area 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 General public (non-professional) Pack sizes and packaging material Box in HDPE with lid in HDPE with 105 wipes, 200 wipes, 280 wipes, 500 wipes

4.4.1. Use-specific instructions for use

Comply with the instructions for use

4.4.2. Use-specific risk mitigation measures

/

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 7

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.

4.5. Use description

Table 17

Use # 5 – Hard surface disinfection, use 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: 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 viruse: 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 105 wipes, 200 wipes, 280 wipes, 500 wipes

4.5.1. Use-specific instructions for use

See general directions for use for Meta SPC 7

4.5.2. Use-specific risk mitigation measures

/

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 for Meta SPC 7

4.5.4. 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

4.5.5. 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 for Meta SPC 7

4.6. Use description

Table 18

Use # 6 – Hard surface disinfection, use other than in healthcare, 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: 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 General public (non-professional) Pack sizes and packaging material Box in HDPE with lid in HDPE with 105 wipes, 200 wipes, 280 wipes, 500 wipes

4.6.1. Use-specific instructions for use

Comply with the instructions for use

4.6.2. Use-specific risk mitigation measures

/

4.6.3. 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.

4.6.4. 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

4.6.5. 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 (7) OF THE META SPC 7

5.1. Instructions for use

Comply with the instructions for use

First clean thoroughly the surfaces and materials to be disinfected and dry the surface or materials.

Disinfect the dry surface with a wipe. Make sure the surface remains completely wetted during the required contact time.

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. Store at ambient temperature. Do not store below 0 °C and above 40 °C.

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 7

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

Trade name(s) Kenopure wipes Market area: EU EP-460 Wipes Market area: EU Sani Wipes Market area: EU Lactides Wipes Market area: EU Keno Lac Wipes Market area: EU KL Wipes Market area: EU Kenolux Wipes Market area: EU Power Des Wipes Market area: EU Keno L Wipes Market area: EU Keno Des Wipes Market area: EU RĘCZNIKI PAPIEROWE MYJĄCO-DEZYNFEKUJĄCE FARMA Market area: EU RĘCZNIKI PAPIEROWE MYJĄCO-DEZYNFEKUJĄCE VITTRA Market area: EU Ręczniki myjąco-dezynfekujące AGROD Market area: EU Authorisation number EU-0027740-0007 1-7 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 8

1. META SPC 8 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 8 identifier

Identifier Meta SPC 8: Ready to use post-dips by dipping (PT3)

1.2. Suffix to the authorisation number

Number 1-8

1.3. Product type(s)

Product type(s) PT03 – Veterinary hygiene (Disinfectants)

2. META SPC 8 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 8

Common name IUPAC name Function CAS number EC number Content (%) Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 7,5 Sodium Lauryl sulphate Sulfuric acid, mono-C12-14-alkyl esters, sodium salts Non-active substance 85586-07-8 287-809-4 1,3 1,3 Isopropanol Propan-2-ol Non-active substance 67-63-0 200-661-7 1,0 3,0

2.2. Type(s) of formulation of the meta SPC 8

Formulation(s) AL – Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

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 8

4.1. Use description

Table 19

Use # 1 – Teat disinfection after milking by dipping

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: (Ready-To-Use) RTU post-dip for teat disinfection, after milking, without prior cleaning Application method(s) Method: By dipping Detailed description: / Application rate(s) and frequency Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must ‘return’ to RT before use. Dilution (%): - Number and timing of application: Active against bacteria and yeasts: RTU (with 3,6 – 7,5 % Lactic acid depending on the product considered) In five minutes contact time The product must ‘return’ to room temperature 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

See general directions for use for Meta SPC 8

4.1.2. Use-specific risk mitigation measures

See general directions for use for Meta SPC 8

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 8

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 8

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 8

5. GENERAL DIRECTIONS FOR USE (8) OF THE META SPC 8

5.1. Instructions for use

Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup with the desired amount of product, but do not use more fluid than necessary. Assume 5 mL per cow per treatment. Respect a contact time of five minutes. The product must be brought to a temperature above 20 °C before use. In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.

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 8

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

Trade name(s) Kenolac Market area: EU Kenolac Red Market area: EU Kenodip 200 Market area: EU Stalosan Lac Dip Market area: EU HCP Dip Market area: EU PEZERK LV PLUS Market area: EU MIROX Dip Lac Market area: EU Milchsäure Dip Market area: EU Milchsäure Tauche Market area: EU Lactocid Dip Market area: EU GAHERLAC Market area: EU Lactidip Market area: EU Lacticoop Market area: EU Lactactiv Market area: EU Laktotop Market area: EU Superlac Market area: EU MilchsäureFilmdip Super Market area: EU MEPA Lac Market area: EU Eco Lac Market area: EU BluGard Dip Market area: EU Blu-Gard Dip Market area: EU Authorisation number EU-0027740-0008 1-8 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 1,3 Isopropanol Propan-2-ol Non-active substance 67-63-0 200-661-7 1,0

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

Trade name(s) Kenolac Forte W Market area: EU Authorisation number EU-0027740-0009 1-8 Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 7,5 Sodium Lauryl sulphate Sulfuric acid, mono-C12-14-alkyl esters, sodium salts Non-active substance 85586-07-8 287-809-4 1,3 Isopropanol Propan-2-ol Non-active substance 67-63-0 200-661-7 3,0

META SPC 9

1. META SPC 9 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 9 identifier

Identifier Meta SPC 9: Ready to use post-dips by spraying (PT3)

1.2. Suffix to the authorisation number

Number 1-9

1.3. Product type(s)

Product type(s) PT03 – Veterinary hygiene (Disinfectants)

2. META SPC 9 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 9

Common name IUPAC name Function CAS number EC number Content (%) Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 3,6 7,5 Sodium Lauryl sulphate Sulfuric acid, mono-C12-14-alkyl esters, sodium salts Non-active substance 85586-07-8 287-809-4 0,5 1,3 Isopropanol Propan-2-ol Non-active substance 67-63-0 200-661-7 3,0 3,0

2.2. Type(s) of formulation of the meta SPC 9

Formulation(s) AL – Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

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 9

4.1. Use description

Table 20

Use # 1 – Teat disinfection after milking by spraying or dipping

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: RTU spray or dip for teat disinfection, after milking, without prior cleaning Application method(s) Method: by spraying or dipping Detailed description: By spraying or dipping Application rate(s) and frequency Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must ‘return’ to RT before use. Dilution (%): - Number and timing of application: Active against bacteria and yeasts: RTU (with 3,6 – 7,5 % Lactic acid depending on the product considered) In five minutes contact time The product must return to Room temperature 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

See general directions for use for Meta SPC 9

4.1.2. Use-specific risk mitigation measures

See general directions for use for Meta SPC 9

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 9

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 9

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 9

5. GENERAL DIRECTIONS FOR USE (9) OF THE META SPC 9

5.1. Instructions for use

Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup or spraying flacon with the desired amount of the product, but do not use more fluid that necessary. Assume 5 mL per cow per treatment. Respect a contact time of five minutes.

The product must be brought to a temperature above 20 °C before use.

In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.

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 9

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

Trade name(s) Kenolac SD Market area: EU HCP Spray Market area: EU Lactospray Market area: EU Zitzentop Market area: EU Lactosilk Market area: EU Milchsäure Spray Bühning Market area: EU Lacto SP Market area: EU Stalosan Lac Spray Market area: EU MIROX Spray Lac Market area: EU Milchsäure Sprühe Market area: EU Lactocid Spray Market area: EU Milcho Spray Market area: EU GAHERLAC SPRAY Market area: EU Lactispray Market area: EU Lacticoop Spray Market area: EU Lactactiv Spray Market area: EU Laktotop Spray Market area: EU Superlac Spray Market area: EU Robolac Market area: EU MEPA Lac SD Market area: EU Eco Lac SD Market area: EU Lely Quaress Circum Market area: EU BluGard Spray Market area: EU Blu-Gard Spray Market area: EU Authorisation number EU-0027740-0010 1-9 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 1,3 Isopropanol Propan-2-ol Non-active substance 67-63-0 200-661-7 3,0

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

Trade name(s) Kenolac Forte SD Market area: EU Authorisation number EU-0027740-0011 1-9 Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 7,5 Sodium Lauryl sulphate Sulfuric acid, mono-C12-14-alkyl esters, sodium salts Non-active substance 85586-07-8 287-809-4 1,3 Isopropanol Propan-2-ol Non-active substance 67-63-0 200-661-7 3,0

META SPC 10

1. META SPC 10 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 10 identifier

Identifier Meta SPC 10: Ready to use post-dips by spraying and dipping (PT3)

1.2. Suffix to the authorisation number

Number 1-10

1.3. Product type(s)

Product type(s) PT03 – Veterinary hygiene (Disinfectants)

2. META SPC 10 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 10

Common name IUPAC name Function CAS number EC number Content (%) 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 0,05 0,05

2.2. Type(s) of formulation of the meta SPC 10

Formulation(s) AL – Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10

Hazard statements Flammable liquid and vapour. Causes serious eye damage. Contains menthan-3-one (CAS-No 14073-97-3). May produce an allergic reaction. Precautionary statements Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. 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. In case of fire:Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide to extinguish. Store in a well-ventilated place.Keep cool. 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 10

4.1. Use description

Table 21

Use # 1 – Teat disinfection after milking by spraying or dipping

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: RTU spray/dip for teat disinfection, after milking, without prior cleaning Application method(s) Method: By spraying or dipping Detailed description: / Application rate(s) and frequency Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must ‘return’ to RT before use Dilution (%): - Number and timing of application: Active against bacteria and yeasts: RTU (with 3,6 % Lactic acid) In five minutes 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:

— 7,5 mL per cow working solution for use by spraying with flacon

— 15 mL per cow working solution for use by spraying in installation

— 15 mL per cow by for use by spraying with robot

— 2,5-5 mL per cow for use by dipping/foaming

4.1.2. Use-specific risk mitigation measures

See general directions for use for Meta SPC 10

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 10

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 10

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 10

5. GENERAL DIRECTIONS FOR USE (10) OF THE META SPC 10

5.1. Instructions for use

Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup or spraying flacon with the desired amount of product, but do not use more fluid that necessary. The product must be brought to a temperature above 20 °C before use.

In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.

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 INHALED: If symptoms occur 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 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

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 10

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

Trade name(s) Kenocool Market area: EU PEZERK LI PLUS Market area: EU Milcho Dip Market area: EU Authorisation number EU-0027740-0012 1-10 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 0,05

META SPC 11

1. META SPC 11 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 11 identifier

Identifier Meta SPC 11: Concentrated Surface and equipment disinfectants (PT3 and PT4)

1.2. Suffix to the authorisation number

Number 1-11

1.3. Product type(s)

Product type(s) PT04 – Food and feed area (Disinfectants) PT03 – Veterinary hygiene (Disinfectants)

2. META SPC 11 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 11

Common name IUPAC name Function CAS number EC number Content (%) Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 24,0 24,0 Sodium Lauryl sulphate Sulfuric acid, mono-C12-14-alkyl esters, sodium salts Non-active substance 85586-07-8 287-809-4 12,0 12,0 Isopropanol Propan-2-ol Non-active substance 67-63-0 200-661-7 5,0 5,0

2.2. Type(s) of formulation of the meta SPC 11

Formulation(s) SL – Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11

Hazard statements Causes skin irritation. Causes serious eye damage. Precautionary statements 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. 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 11

4.1. Use description

Table 22

Use # 1 – Hard surface disinfection in food and feed industry

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 industry + Public field: Disinfection of hard/non-porous surfaces by spraying or soaking with prior cleaning Application method(s) Method: By spraying or by immersion Detailed description: Spraying Immersion (the bath is intended to be used only once) Application rate(s) and frequency Application Rate: 100 mL/m2 Dilution (%): 1 % or 3 % Number and timing of application: Active against bacteria and yeasts at room temperature: — 3 % (with 0,72 % Lactic acid) in two minutes contact time — 1 % (with 0,24 % Lactic acid) in 15 minutes 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 11

4.1.2. Use-specific risk mitigation measures

See general directions for use for Meta SPC 11

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 11

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 11

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 11

4.2. Use description

Table 23

Use # 2 – Equipment disinfection by soaking in food and feed industry

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 Indoor – in Food/feed industry + Public field: Disinfection of hard/non-porous surfaces (for example processing machines) by spraying or soaking without prior cleaning Application method(s) Method: By spraying or immersion Detailed description: / Application rate(s) and frequency Application Rate: 100 mL/m2 Dilution (%): 8 % or 15 % Number and timing of application: Active against bacteria and yeasts at +7 °C: — By soaking: 15 % (with 3,6 % Lactic acid) in 30 seconds contact time — By spraying: 8 % (with 1,92 % Lactic acid) in two minutes 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)

4.2.1. Use-specific instructions for use

See general directions for use for Meta SPC 11

4.2.2. Use-specific risk mitigation measures

See general directions for use for Meta SPC 11

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 11

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 11

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 11

4.3. Use description

Table 24

Use # 3 – Hard surface disinfection for veterinary hygiene

Product type PT03 – Veterinary hygiene (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 Veterinary field: Disinfection of hard/non-porous surfaces by spraying or soaking with prior cleaning Application method(s) Method: By spraying or immersion Detailed description: Spraying Immersion (the bath is intended to be used only once) Application rate(s) and frequency Application Rate: Active against bacteria and yeasts at +10 °C: 4 % in 30 minutes contact time Dilution (%): 4 % Number and timing of application: Active against bacteria and yeasts at +10 °C: 4 % (with 0,96 % Lactic acid) in 30 minutes 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)

4.3.1. Use-specific instructions for use

Animal houses must be empty of animals during disinfection. The product is used to disinfect animal housings of pigs, cows, poultry. Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

Mixing and loading: container is opened manually and emptied into the reservoir or connected to a pump, which pumps the product into the reservoir of the spraying device which is then filled up with water in order to achieve the correct concentration of use. Apply the product by spraying or immersion. Use as much solution as needed to keep the surfaces wet during the complete contact time. It is not necessary to spray during the complete contact time.

4.3.2. Use-specific risk mitigation measures

See general directions for use for Meta SPC 11

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 11

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 11

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 11

5. GENERAL DIRECTIONS FOR USE (11) OF THE META SPC 11

5.1. Instructions for use

Disinfection procedures by spraying: 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’.

Products must be diluted in potable water before use.

5.2. Risk mitigation measures

Gloves and goggles are needed during mixing and loading.

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: 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

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 11

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

Trade name(s) Kenosan Lactic Market area: EU Lacto Des Market area: EU Bio Des 100 Market area: EU Bio Lac Market area: EU Authorisation number EU-0027740-0013 1-11 Common name IUPAC name Function CAS number EC number Content (%) L-(+)-lactic acid Active Substance 79-33-4 201-196-2 24,0 Sodium Lauryl sulphate Sulfuric acid, mono-C12-14-alkyl esters, sodium salts Non-active substance 85586-07-8 287-809-4 12,0 Isopropanol Propan-2-ol Non-active substance 67-63-0 200-661-7 5,0

META SPC 12

1. META SPC 12 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 12 identifier

Identifier Meta SPC 12: Inner surface disinfectants by CIP with and without circulation and crate wash (PT4)

1.2. Suffix to the authorisation number

Number 1-12

1.3. Product type(s)

Product type(s) PT04 – Food and feed area (Disinfectants)

2. META SPC 12 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 12

Common name IUPAC name Function CAS number EC number Content (%) Min Max L-(+)-lactic acid Active Substance 79-33-4 201-196-2 22,0 22,0 C6 alkyl glucoside Hexyl D-Glucoside Non-active substance 54549-24-5 259-217-6 2,4 2,4 Methanesulfonic acid Methanesulfonic acid Non-active substance 75-75-2 200-898-6 0,0 10,5 Sulphuric acid Sulphuric acid Non-active substance 7664-93-9 231-639-5 0,0 10,5

2.2. Type(s) of formulation of the meta SPC 12

Formulation(s) SL – Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12

Hazard statements Causes severe skin burns and eye damage. May be corrosive to metals. Precautionary statements Keep only in original packaging. Do not breathe vapours. Wash hands thoroughly after handling. Wear protective glove