ANNEX

Summary of product characteristics for a biocidal product family

TEAT DISINFECTANTS BIOCIDAL PRODUCT FAMILY OF CVAS

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0018724-0000

R4BP 3 asset number: EU-0018724-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

Name TEAT DISINFECTANTS BIOCIDAL PRODUCT FAMILY OF CVAS

1.2. Product type(s)

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

1.3. Authorisation holder

Name and address of the authorisation holder Name CVAS Development GmbH Address Dr Albert Reimann Str. 16a, 68526 Ladenburg, Germany Authorisation number EU-0018724-0000 R4BP asset number EU-0018724-0000 Date of the authorisation 18 December 2018 Expiry date of the authorisation 30 November 2028

1.4. Manufacturer(s) of the biocidal products

Name of manufacturer Calvatis GmbH Address of manufacturer Dr Albert Reimann Str. 16a, 68526 Ladenburg, Germany Location of manufacturing sites Dr Albert Reimann Str. 16a, 68526 Ladenburg, Germany





Name of manufacturer Arthur Schopf Hygiene GmbH & Co. KG Address of manufacturer Pfaffensteinstr. 1, 83115 Neubeuern, Germany Location of manufacturing sites Pfaffensteinstr. 1, 83115 Neubeuern, Germany

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

Active substance Iodine Name of manufacturer Cosayach Nitratos S.A. Address of manufacturer Amunategui 178 Santiago Chile Location of manufacturing sites S.C.M. Cosayach Cala Cala Pozo Almonte Chile





Active substance Iodine Name of manufacturer ACF Minera S.A. Address of manufacturer San Martín No 499 Iquique Chile Location of manufacturing sites Lagunas mine Pozo Almonte Chile





Active substance Iodine Name of manufacturer SQM S.A. Address of manufacturer Los Militares 4290, Piso 4 Las Condes Chile Location of manufacturing sites Nueva Victoria plant Pedro de Valdivia plant Chile





Active substance Iodine Name of manufacturer Nihon Tennen Gas Co., Ltd/Kanto Natural Gas Development Co., Ltd Address of manufacturer 661 Mobara 297-8550 Mobara City, Chiba Japan Location of manufacturing sites Chiba Plant, 2508 Minami-Hinata 299-4205 Shirako-Machi, Chosei-Gun, Chiba Japan





Active substance Polyvinylpyrrolidone iodine Name of manufacturer Norkem Limited (manufacturer of PVP-iodine) Address of manufacturer Norkem House, Bexton Lane WA 16 9FB Knutsford, Cheshire United Kingdom Location of manufacturing sites Norkem House, Bexton Lane WA 16 9FB Knutsford, Cheshire United Kingdom

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 Iodine Active Substance 7553-56-2 231-442-4 0 0,54 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 0 4,16 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0 0,33

2.2. Type(s) of formulation

Formulation(s) AL — Any other liquid

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

1.2. Suffix to the authorisation number

Number 1-1

1.3. Product type(s)

Product type(s) PT03 — Veterinary 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 Iodine Active Substance 7553-56-2 231-442-4 0 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 1,16 1,5 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0 0

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

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements Precautionary statements If medical advice is needed, have product container or label at hand. Keep out of reach of children.

4. AUTHORISED USE(S) OF THE META SPC 1

4.1. Use description

Table 1. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual dipping using a dip cup Application rate(s) and frequency cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.1.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2. Use description

Table 2. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated dipping Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.2.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.2.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5. GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1

5.1. Instructions for use

See use specific instructions for use.

5.2. Risk mitigation measures

See use specific risk mitigation measures.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures: Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4. Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

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) Dip es barriere Dip es barriere 1.4 Iod Dip F 14 P Authorisation number EU-0018724-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 1,16 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0

META SPC 2

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier

Identifier meta SPC 2

1.2. Suffix to the authorisation number

Number 1-2

1.3. Product type(s)

Product type(s) PT03 — Veterinary hygiene (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 Iodine Active Substance 7553-56-2 231-442-4 0 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 1,56 2,5 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0 0

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

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements Harmful to aquatic life with long lasting effects. Precautionary statements If medical advice is needed, have product container or label at hand. Keep out of reach of children. Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to local/regional/national/international regulation.

4. AUTHORISED USE(S) OF THE META SPC 2

4.1. Use description

Table 3. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual dipping using a dip cup Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.1.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2. Use description

Table 4. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated dipping Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.2.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.2.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5. GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

5.1. Instructions for use

See use specific instructions for use.

5.2. Risk mitigation measures

See use specific risk mitigation measures.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures: Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4. Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

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) Dip es Io-film Dip es Io-film 3.0 Iod-Dip Io-film 30 Authorisation number EU-0018724-0002 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 2,5 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0

META SPC 3

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 3 identifier

Identifier meta SPC 3

1.2. Suffix to the authorisation number

Number 1-3

1.3. Product type(s)

Product type(s) PT03 — Veterinary hygiene (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 Iodine Active Substance 7553-56-2 231-442-4 0 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 1,56 4,16 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0 0

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

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements Harmful to aquatic life with long lasting effects. Precautionary statements If medical advice is needed, have product container or label at hand. Keep out of reach of children. Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to local/regional/national/international regulation.

4. AUTHORISED USE(S) OF THE META SPC 3

4.1. Use description

Table 5. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual dipping using a dip cup Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.1.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2. Use description

Table 6. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated dipping Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.2.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.2.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5. GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

5.1. Instructions for use

See use specific instructions for use.

5.2. Risk mitigation measures

See use specific risk mitigation measures.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures: Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4. Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

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) Dip es barriere S Dip es barriere 3.0 Iod-Dip F 30 P Baktostop Barier color Authorisation number EU-0018724-0003 1-3 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 2,5 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0

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

Trade name(s) Dip es barriere RS Dip es barriere 5.0 Iod-Dip F 50 P BaktoStop barier Authorisation number EU-0018724-0004 1-3 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 4,16 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0

META SPC 4

1. META SPC 4 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 4 identifier

Identifier meta SPC 4

1.2. Suffix to the authorisation number

Number 1-4

1.3. Product type(s)

Product type(s) PT03 — Veterinary hygiene (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 Iodine Active Substance 7553-56-2 231-442-4 0 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 1,56 2,5 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0 0

2.2. Type(s) of formulation of the meta SPC 4

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements Harmful to aquatic life with long lasting effects. Precautionary statements If medical advice is needed, have product container or label at hand. Keep out of reach of children. Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to local/regional/national/international regulation.

4. AUTHORISED USE(S) OF THE META SPC 4

4.1. Use description

Table 7. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual dipping using a dip cup Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.1.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2. Use description

Table 8. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using a trigger sprayer

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual spraying using a trigger sprayer Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.2.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the top of the trigger sprayer on it. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, spray the disinfectant on the teats using the trigger sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Refill the reservoir of the trigger sprayer with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water.

4.2.2. Use-specific risk mitigation measures

Use chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) during postmilking teat disinfection by manual spraying using a trigger sprayer.

Avoid working in a spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.3. Use description

Table 9. Use # 3 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using an electronic sprayer

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual spraying using an electronic sprayer Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.3.1. Use-specific instructions for use

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

Open a can containing the RTU product assuming 5 mL product per cow and insert a sucking lance of the electronic sprayer. Avoid discharge of surplus fluids.

Clean carefully the teats by wiping with a single service paper towel/cloth before milking.

After milking, spray the disinfectant on the teats using the electronic sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Replace the empty can by a new can containing the RTU product as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, put the sucking lance system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.

4.3.2. Use-specific risk mitigation measures

Use chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) during postmilking teat disinfection by manual spraying using an electronic sprayer.

Avoid working in spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.4. Use description

Table 10. Use # 4 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated dipping Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.4.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.4.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.5. Use description

Table 11. Use # 5 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated spraying by robot

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated spraying by robot Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.5.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the robotic milking device. Avoid discharge of surplus fluids.

The teats are cleaned by robot with automatic brushes.

After robotic milking, the disinfectant is sprayed automatically onto teats from a cluster arm.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Rinsing of the sprayer is automatic.

4.5.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5. GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4

5.1. Instructions for use

See use specific instructions for use.

5.2. Risk mitigation measures

See use specific risk mitigation measures.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures:

Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4. Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

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) Dip es silver Authorisation number EU-0018724-0005 1-4 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 2,5 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0

META SPC 5

1. META SPC 5 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 5 identifier

Identifier meta SPC 5

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 Iodine Active Substance 7553-56-2 231-442-4 0 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 1,16 1,16 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0 0

2.2. Type(s) of formulation of the meta SPC 5

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements Precautionary statements If medical advice is needed, have product container or label at hand. Keep out of reach of children.

4. AUTHORISED USE(S) OF THE META SPC 5

4.1. Use description

Table 12. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual dipping using a dip cup Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.1.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2. Use description

Table 13. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using a trigger sprayer

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual spraying using a trigger sprayer Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.2.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the top of the trigger sprayer on it. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, spray the disinfectant on the teats using the trigger sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Refill the reservoir of the trigger sprayer with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water.

4.2.2. Use-specific risk mitigation measures

Avoid working in a spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.3. Use description

Table 14. Use # 3 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using an electronic sprayer

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual spraying using an electronic sprayer Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.3.1. Use-specific instructions for use

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

Open a can containing the RTU product assuming 5 mL product per cow and insert a sucking lance of the electronic sprayer. Avoid discharge of surplus fluids.

Clean carefully the teats by wiping with a single service paper towel/cloth before milking.

After milking, spray the disinfectant on the teats using the electronic sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Replace the empty can by a new can containing the RTU product as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, put the sucking lance system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.

4.3.2. Use-specific risk mitigation measures

Avoid working in a spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.4. Use description

Table 15. Use # 4 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated dipping Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.4.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.4.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.5. Use description

Table 16. Use # 5 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated spraying by robot

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated spraying by robot Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.5.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the robotic milking device. Avoid discharge of surplus fluids.

The teats are cleaned by robot with automatic brushes.

After robotic milking, the disinfectant is sprayed automatically onto teats from a cluster arm.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Rinsing of the sprayer is automatic.

4.5.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

5.1. Instructions for use

See use specific instructions for use.

5.2. Risk mitigation measures

See use specific risk mitigation measures.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures: Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4. Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

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) Dip es SF Dip es SF 3.0 Iod Dip S 30 P Dip es SF 1.4 Iod-Dip S 14 P EUTADIPP Authorisation number EU-0018724-0006 1-5 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 1,16 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0

META SPC 6

1. META SPC 6 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 6 identifier

Identifier meta SPC 6

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 Iodine Active Substance 7553-56-2 231-442-4 0 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 1,16 1,16 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0 0

2.2. Type(s) of formulation of the meta SPC 6

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements Precautionary statements If medical advice is needed, have product container or label at hand. Keep out of reach of children.

4. AUTHORISED USE(S) OF THE META SPC 6

4.1. Use description

Table 17. Use # 1 — Teat disinfection of milkable animals: Pre-milking teat disinfection by manual foaming

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use before milking Application method(s) Manual foaming using a foam cup Application rate(s) and frequency Cows: 5 mL per treatment Pre-milking application: 2-3×/day (before each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.1.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the foam cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth before pre-milking disinfection.

Before milking, squeeze the reservoir and put the foam cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Leave the product on the teats for at least 60 seconds.

Refill the cup of the foaming unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After disinfection, empty the reservoir and clean reservoir and foam cup by rinsing with water.

4.1.2. Use-specific risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2. Use description

Table 18. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual foaming

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual foaming using a foam cup Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.2.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the foam cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the foam cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the foaming unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and foam cup by rinsing with water.

4.2.2. Use-specific risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.3. Use description

Table 19. Use # 3 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated foaming

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria- Yeasts- Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated foaming Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2 - 3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.3.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the automated foaming-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat disinfectant is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of foam when the teat foam cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated foaming-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.3.2. Use-specific risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.4. Use description

Table 20. Use # 4 — Teat disinfection of milkable animals: Pre- and post-milking teat disinfection by manual foaming

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use before and after milking Application method(s) Manual foaming using a foam cup Application rate(s) and frequency Cows: 5 mL per treatment Pre- and post-milking application: 4-6 times per day (before and after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.4.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the foam cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth before pre-milking disinfection.

Before milking, squeeze the reservoir and put the foam cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Leave the product on the teats for at least 60 seconds.

Clean the teats carefully by wiping with a cloth immediately before milking. After milking, repeat the disinfection by foaming as described above.

Refill the cup of the foaming unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and foam cup by rinsing with water.

4.4.2. Use-specific risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5. GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6

5.1. Instructions for use

See use specific instructions for use.

5.2. Risk mitigation measures

See use specific risk mitigation measures.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

If medical advice is needed, have product container or label at hand.

Stability and reactivity

Reactivity: No dangerous reactions known.

Chemical stability: The product is chemically stable under normal surroundings terms (ambient temperature).

Possibility of hazardous reactions: By designated use no dangerous reactions are to be expected.

Conditions to avoid: Not determined.

Incompatible materials: Not determined.

Hazardous decomposition products: No dangerous decomposition products known.

Accidental release measures

Personal precautions, protective equipment and emergency procedures:

Wear protective clothing.

Ensure adequate ventilation.

Keep ignition sources away — Do not smoke.

Environmental precautions: Do not allow to enter drainage system, surface or ground water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4. Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods: Hazardous waste (AVV). Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Must be specially treated under adherence to official regulations.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if needed detergent.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 18 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

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) Dip es Io-foam Dip es Io-foam 1.4 Iod-Dip Io-foam BaktoStop foam Authorisation number EU-0018724-0007 1-6 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 1,16 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0

META SPC 7

1. META SPC 7 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 7 identifier

Identifier meta SPC 7

1.2. Suffix to the authorisation number

Number 1-7

1.3. Product type(s)

Product type(s) PT03 — Veterinary hygiene (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 Iodine Active Substance 7553-56-2 231-442-4 0,14 0,14 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 0 0 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0,11 0,33

2.2. Type(s) of formulation of the meta SPC 7

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

Hazard statements Harmful to aquatic life with long lasting effects. Precautionary statements Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to local/regional/national/international regulation.

4. AUTHORISED USE(S) OF THE META SPC 7

4.1. Use description

Table 21. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual dipping using a dip cup Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.1.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the dip cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the dip cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the dipping unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and dip cup by rinsing with water.

4.1.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2. Use description

Table 22. Use # 2 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual foaming

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual foaming using a foam cup Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.2.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the foam cup on top. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, squeeze the reservoir and put the foam cup over each teat from below making sure that about 3 cm of the teat are immersed into the disinfectant.

Refill the cup of the foaming unit with fresh disinfectant by squeezing the reservoir as needed. Refill the reservoir with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and foam cup by rinsing with water.

4.2.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.3. Use description

Table 23. Use # 3 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using a trigger sprayer

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual spraying using a trigger sprayer Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.3.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw the top of the trigger sprayer on it. Avoid discharge of surplus fluids.

Clean the teats carefully by wiping with a single service paper towel/cloth immediately before milking.

After milking, spray the disinfectant on the teats using the trigger sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Refill the reservoir of the trigger sprayer with fresh disinfectant as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, empty the reservoir and clean reservoir and trigger sprayer by rinsing with water.

4.3.2. Use-specific risk mitigation measures

Use chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) during postmilking teat disinfection by manual spraying using a trigger sprayer.

Avoid working in spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.4. Use description

Table 24. Use # 4 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual spraying using an electronic sprayer

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual spraying using an electronic sprayer Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.4.1. Use-specific instructions for use

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

Open a can containing the RTU product assuming 5 mL product per cow and insert a sucking lance of the electronic sprayer. Avoid discharge of surplus fluids.

Clean carefully the teats by wiping with a single service paper towel/cloth before milking.

After milking, spray the disinfectant on the teats using the electronic sprayer making sure that about 3 cm of the teat around the streak canal are covered with the disinfectant.

Replace the empty can by a new can containing the RTU product as needed.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection, put the sucking lance system into a bucket of water and rinse the sprayer by pumping the water through the sprayer.

4.4.2. Use-specific risk mitigation measures

Use chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) during post/milking teat disinfection by manual spraying using an electronic sprayer.

Avoid working in spray mist.

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.5. Use description

Table 25. Use # 5 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated dipping Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.5.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the automated dipping-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat dip is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of dip when the teat cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated dipping-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.5.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.6. Use description

Table 26. Use # 6 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated foaming

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated foaming Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.6.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the automated foaming-system. Avoid discharge of surplus fluids.

After milking, the vacuum is shut off and the teat disinfectant is injected into a manifold on the clawpiece. The teats are coated with ca. 5 mL of foam when the teat foam cup is withdrawn by the Automatic Cluster Removal (ACR). After the removal of the ACR, every liner of the automated foaming-system is thoroughly rinsed with water and blown out with compressed air.

In a final cleaning step after each milking session of the herd, the liners are disinfected (e.g. with a chlorine-based product) and blown out again with compressed air.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Afterwards, the milking system is ready for the next milking event.

The whole process is automated.

4.6.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

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

See general directions for use.

4.6.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.6.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.7. Use description

Table 27. Use # 7 — Teat disinfection of milkable animals: Post-milking teat disinfection by automated spraying by robot

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Automated spraying by robot Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.7.1. Use-specific instructions for use

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

Open a can containing the RTU product and insert a suction tube of the robotic milking device. Avoid discharge of surplus fluids.

The teats are cleaned by robot with automatic brushes.

After robotic milking, the disinfectant is sprayed automatically onto teats from a cluster arm.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

Rinsing of the sprayer is automatic.

4.7.2. Use-specific risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

4.7.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.7.4. Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.7.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5. GENERAL DIRECTIONS FOR USE (7) OF THE META SPC 7

5.1. Instructions for use

See use specific instructions for use.

5.2. Risk mitigation measures

See use specific risk mitigation measures.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Mentioned in the MSDS

Description of first aid measures

After inhalation: Supply fresh air; consult doctor in case of symptoms.

After skin contact: Wash with water and soap.

After eye contact: Rinse opened eye for several minutes under running water. Then consult doctor.

After swallowing: Rinse out mouth and then drink plenty of water. Seek immediate medical advice.

Stability and reactivity

Possibility of hazardous reactions: Reaction with oxidant- and reducing agent.

Conditions to avoid: No further relevant information available.

Incompatible materials: No further relevant information available.

Hazardous decomposition products: iodine (when warming up).

Accidental release measures

Personal precautions, protective equipment and emergency procedures: No special measures required.

Environmental precautions: Do not allow product to reach sewage systems or water bodies in great quantities.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected according to regulations.

5.4. Instructions for safe disposal of the product and its packaging

Mentioned in the MSDS

Waste treatment methods

Recommendation: Must be specially treated with regard to official regulations.

Waste disposal key number: Corresponding to the regulation of the European Waste catalogue the relation of the waste key numbers has to be made specific to industry and process.

European waste catalogue: Corresponding to the regulation of the EWC the relation of the waste key numbers has to be made specific to industry and process.

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

Recommended cleaning agent: Water, if necessary with cleaning agent.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Products need to be protected from frost, stored at temperatures not exceeding 30 °C and away from direct sunlight.

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) calgodip D 1200 Jod-Dip S 12 Dip es SF 1200 Authorisation number EU-0018724-0008 1-7 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0,14 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 0 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0,15

META SPC 8

1. META SPC 8 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 8 identifier

Identifier meta SPC 8

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 Iodine Active Substance 7553-56-2 231-442-4 0,14 0,54 Polyvinylpyrrolidone iodine Active Substance 25655-41-8 0 0 Acetic acid Acetic acid Non active substance 64-19-7 200-580-7 0,11 0,33

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

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

Hazard statements Harmful to aquatic life with long lasting effects. Precautionary statements Avoid release to the environment. Dispose of contents to local/regional/national/international regulation. Dispose of container to local/regional/national/international regulation.

4. AUTHORISED USE(S) OF THE META SPC 8

4.1. Use description

Table 28. Use # 1 — Teat disinfection of milkable animals: Post-milking teat disinfection by manual dipping

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Field(s) of use Indoor Teat disinfection for milkable animals (dairy cows) for use after milking Application method(s) Manual dipping using a dip cup Application rate(s) and frequency Cows: 5 mL per treatment Post-milking application: 2-3×/day (after each milking) Category(ies) of users Professional Pack sizes and packaging material Jerrycan (HDPE): 5 – 60 kg Drum (HDPE): 60 – 200 kg IBC (HDPE): 600 – 1 000 kg

4.1.1. Use-specific instructions for use

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Fill the reservoir with the RTU product assuming 5 mL product per cow and screw