ANNEX

Summary of product characteristics for a biocidal product family

Iodine Teat dip products

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0020125-0000

R4BP asset number: EU-0020125-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

Name Iodine Teat dip products

1.2. Product type(s)

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

1.3. Authorisation holder

Name and address of the authorisation holder Name GEA Farm Technologies GmbH Address Siemensstraße 25-27, 59199, Bönen, Germany Authorisation number EU-0020125-0000 R4BP asset number EU-0020125-0000 Date of the authorisation 19 November 2019 Expiry date of the authorisation 31 October 2029

1.4. Manufacturer(s) of the biocidal products

Name of manufacturer GEA Farm Technologies Address of manufacturer Wylye Works, BA12 9HT Warminster United Kingdom Location of manufacturing sites Wylye Works, Watery Lane, BA12 9HT Warminster United Kingdom Gewerbestraße 5, 5325 Plainfeld Austria ul. Olowiana 10, 85-461 Bydgoszcz Poland

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

Active substance Iodine Name of manufacturer SQM Europe N.V. Address of manufacturer St Pietersvliet 7„ bus 8 2000 Antwerp Belgium Location of manufacturing sites Sociedad Quimica y Minera SA, Los Militares, Las Condes, 4290 Piso 4 Santiago Chile





Active substance Iodine Name of manufacturer Nihon Tennen Gas Co., Ltd (Via Mitsui & Co Europe PLC) Address of manufacturer Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun„ 299-4205 Chosei-Gun Japan Location of manufacturing sites Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun„ 299-4205 Chosei-Gun Japan





Active substance Iodine Name of manufacturer Norkem Ltd Address of manufacturer Norkem House, Bexton Lane„ WA16 9FB Knutsford United Kingdom Location of manufacturing sites OFICINA CALA CALA S/N, Unknown POZO ALMONTE Chile

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 0,16 2,47 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 0,0 2,35

2.2. Type(s) of formulation

Formulation(s) AL — Any other liquid SL — Soluble concentrate

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 — Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates

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 1,58 2,47 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 1,51 2,35

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

Formulation(s) SL — Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements Causes serious eye irritation. May cause damage to thyroid gland through prolonged or repeated exposure. May be corrosive to metals. Toxic to aquatic life with long lasting effects. Precautionary statements Do not breathe vapours. Wash hands thoroughly after handling. Wear protective gloves. Wear protective clothing. Wear eye protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if you feel unwell. If eye irritation persists: Get medical advice. Collect spillage. Dispose of container according to local regulations. Dispose of contents according to local regulations.

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

4.1. Use description

Table 1

Use # 1 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Dipping

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense diluted product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. Cups should be refilled with fresh solution before starting new milking session Application rate(s) and frequency Quantity of diluted product to be applied per application: — cows and buffaloes: 3 to 10 ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Product to be diluted by the relevant rate stated on the label. Either: 25 % (1 part product to 3 parts water) 20 % (1 part product to 4 parts water) 12,5 % (1 part product to 7 parts water) In use concentration of products between 0,29 and 0,52 % (w/w) iodine. 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.1.1. Use-specific instructions for use

Dip at least 2/3 of the teat length with diluted product immediately after milking

4.1.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves and eye protection when handling the concentrate

(glove material to be specified by the authorisation holder within the product information).

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 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Spraying

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the diluted product. The diluted product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the diluted product Application via manual trigger spray: Fill trigger spray bottle with diluted product. Use trigger spray to cover the bottom two thirds of each teat with diluted product Application rate(s) and frequency Quantity of diluted product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Product to be diluted by the relevant rate stated on the label. Either: 25 % (1 part product to 3 parts water) 20 % (1 part product to 4 parts water) 12,5 % (1 part product to 7 parts water) In use concentration of products between 0,29 and 0,52 % (w/w) iodine. 2 post﻿ milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.2.1. Use-specific instructions for use

Spray at least 2/3 of the teat length with diluted product immediately after milking

4.2.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves and eye protection when handling the concentrate

(glove material to be specified by the authorisation holder within the product information).

Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

A protective coverall (at least type 6, EN 13034) shall be worn.

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 3

Use # 3 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Foaming

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of diluted product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Product to be diluted by the relevant rate stated on the label. Either: 25 % (1 part product to 3 parts water) 20 % (1 part product to 4 parts water) 12,5 % (1 part product to 7 parts water) In use concentration of products between 0,29 and 0,52 % (w/w) iodine. 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.3.1. Use-specific instructions for use

Dip at least 2/3 of the teat length with diluted product immediately after milking

4.3.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves and eye protection when handling the concentrate

(glove material to be specified by the authorisation holder within the product information).

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.

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

5.1. Instructions for use

Keep out of reach of children

Always read the label or leaflet before use and follow all the instructions provided.

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

Dilute product before application according to the ratio specified on the product label

Formanual dilution of the concentrate; Add the ratio of concentrate and water, specified on the product label, to a suitably sized container to achieve the required dilution rate. Mix to a uniform solution.

Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow

For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

Product can be used during the entire lactation period

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

Remove and wash contaminated clothing before re-use.

After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.

If you feel unwell, seek medical advice.

After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.

After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.

After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.

Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.

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

At the end of the treatment, dispose of 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 farm based waste water treatment plant.

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

Protect from frost

Do not store at temperatures above 30 °C

Shelf life 12 months.

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) Ioklene Concentrate. Coars Dual Authorisation number EU-0020125-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 1,58 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 1,51

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

Trade name(s) Clinidip L Concentrate, Maxadine C, Diamond 3:1 Concentrate, Kristal 321, IO Spray 3:1 Concentrate, Coars Shield Authorisation number EU-0020125-0002 1-1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 2,06 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 1,96

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

Trade name(s) Clinidip Superconcentrate, Dunglinson Super IO 421 Concentrate, Ceanodine 4:1, Iodosan Authorisation number EU-0020125-0003 1-1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 2,47 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 2,35

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

Trade name(s) Priodine, Diamond Predip Authorisation number EU-0020125-0004 1-1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 2,32 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 2,21

META SPC 2

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier

Identifier Meta SPC 2 — RTU Products — Professional RTU Liquid for application pre and post milking

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 0,16 0,5 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 0,0 0,56

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

Formulation(s) AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements May be corrosive to metals. Harmful to aquatic life with long lasting effects. Precautionary statements Avoid release to the environment. Collect spillage. Dispose of contents in accordance with local regulations. Dispose of container in accordance with local regulations.

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

4.1. Use description

Table 4

Use # 1 – RTU Products — Professional RTU Liquid, for application pre-milking — Dipping

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation in use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.1.1. Use-specific instructions for use

See general directions for use.

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 post 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 5

Use # 2 – RTU Products — Professional RTU Liquid, for application pre milking — Spraying

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast All Field(s) of use Indoor Application method(s) Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.2.1. Use-specific instructions for use

See general directions for use.

4.2.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for post 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 6

Use # 3 – RTU Products — Professional RTU Liquid, for application pre milking – Foaming

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast All Field(s) of use Indoor Application method(s) Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation. In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.3.1. Use-specific instructions for use

See general directions for use.

4.3.2. 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 post 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 7

Use # 4 – RTU Products — Professional RTU Liquid, for application post milking – Dipping

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation. In use concentration 0,16-0,50 % (w/w) iodine. 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.4.1. Use-specific instructions for use

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

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 8

Use # 5 – RTU Products — Professional RTU Liquid, for application post milking – Spraying

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation. In use concentration 0,16-0,50 % (w/w) iodine. 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.5.1. Use-specific instructions for use

Spray at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.5.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

A protective coverall (at least type 6, EN 13034) shall be worn

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 9

Use # 6 – RTU Products — Professional RTU Liquid, for application post milking – Foaming

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16-0,50 % (w/w) iodine. 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.6.1. Use-specific instructions for use

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

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 10

Use # 7 – RTU Products — Professional RTU Liquid, for application pre and post milking-Dipping

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.7.1. Use-specific instructions for use

Post milking:

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.7.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by dipping (glove material to be specified by the authorisation holder within the product information).

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.

4.7.3. 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.

4.8. Use description

Table 11

Use # 8 – RTU Products — Professional RTU Liquid, for application pre and post milking- Spraying

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) – Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.8.1. Use-specific instructions for use

Post milking:

Spray at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.8.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

A protective coverall (at least type 6, EN 13034) shall be worn

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.

4.8.3. 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.

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

See general directions for use.

4.8.5. 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.

4.9. Use description

Table 12

Use # 9 – RTU Products — Professional RTU Liquid, for application pre and post milking — Foaming

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1.5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.9.1. Use-specific instructions for use

Post milking:

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.9.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by foaming application method (glove material to be specified by the authorisation holder within the product information).

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.

4.9.3. 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.

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

See general directions for use.

4.9.5. 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

Keep out of reach of children

Always read the label or leaflet before use and follow all the instructions provided.

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

Product can be used during the entire lactation period

Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow

For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds

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

Remove and wash contaminated clothing before re-use.

After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.

If you feel unwell, seek medical advice.

After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.

After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.

After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.

Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.

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

At the end of the treatment, dispose of 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 farm based waste water treatment plant.

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

Protect from frost

Do not store at temperatures above 30 °C

Shelf life 12 months

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) LuxSpray 30, Ioklene RTU, Corston Pre/Post Sprayable, Kristal Iocare Plus, PrePost, Autodine, Coars Super Pre Authorisation number EU-0020125-0005 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0,3 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 0,305

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

Trade name(s) LuxSpray 50, Silkidip, Ceanodine, IoSpray 10, Maxadine RTU, Diamond Superdip, Kristal Iocare Post, KiwiDip, Superdip Excel, Ioguard RTU, Shepherd’s IoSpray 50 Authorisation number EU-0020125-0006 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0,5 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 0,56

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

Trade name(s) LuxDip 50B, Postguard Authorisation number EU-0020125-0007 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0,5

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

Trade name(s) LuxDip 25, Kote It, Corston Barracide Post Film Forming Dip, Pro-Tect, Kristal Iocare Film, Coars Iodinegel, Coars Iodogel, LuxDip 20B Authorisation number EU-0020125-0008 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0,25 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 0,5

META SPC 3

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 3 identifier

Identifier Meta SPC 3 — RTU Products — Professiona RTU Liquid for application pre and post milking (LuxSpray 15)

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 0,16 0,16 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 0.166 0.166

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

Formulation(s) AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements May be corrosive to metals. Precautionary statements Avoid release to the environment. Collect spillage. Dispose of contents in accordance with local regulations. Dispose of container in accordance with local regulations.

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

4.1. Use description

Table 13

Use # 1 – RTU Products — Professional RTU Liquid, for application pre-milking — Dipping

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation. In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.1.1. Use-specific instructions for use

See general directions for use.

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 post 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 14

Use # 2 – RTU Products — Professional RTU Liquid, for application pre milking — spraying

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.2.1. Use-specific instructions for use

See general directions for use.

4.2.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for post 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 15

Use # 3 – RTU Products — Professional RTU Liquid, for application pre milking – Foaming

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.3.1. Use-specific instructions for use

See general directions for use.

4.3.2. 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 post 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 16

Use # 4 – RTU Products — Professional RTU Liquid, for application post milking – Dipping

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.4.1. Use-specific instructions for use

Dip at least 2/3 of the teat length with diluted product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

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 17

Use # 5 – RTU Products — Professional RTU Liquid, for application post milking – Spraying

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast All Field(s) of use Indoor Application method(s) Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.5.1. Use-specific instructions for use

Spray at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.5.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

A protective coverall (at least type 6, EN 13034) shall be worn

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 18

Use # 6 – RTU Products — Professional RTU Liquid, for application post milking – Foaming

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.6.1. Use-specific instructions for use

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

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 19

Use # 7 – Use # 3.7 – RTU Products — Professional RTU Liquid, for application pre and post milking-Dipping

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.7.1. Use-specific instructions for use

Post milking:

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.7.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by dipping (glove material to be specified by the authorisation holder within the product information).

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.

4.7.3. 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.

4.8. Use description

Table 20

Use # 8 – RTU Products — Professional RTU Liquid, for application pre and post milking- Spraying

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: spray treatment Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.8.1. Use-specific instructions for use

Post milking:

Spray at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.8.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)

A protective coverall (at least type 6, EN 13034) shall be worn

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.

4.8.3. 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.

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

See general directions for use.

4.8.5. 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.

4.9. Use description

Table 21

Use # 9 – RTU Products — Professional RTU Liquid, for application pre and post milking — Foaming

Product type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeast Field(s) of use Indoor Application method(s) Open system: dip treatment Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder The same solution can be applied to multiple animals during the same milking session. Application rate(s) and frequency Quantity of RTU product to be applied per application: — cows and buffaloes: 3 to 10ml (5 ml recommended) — sheep 1,5 to 5 ml (1,5 ml recommended) — goats 2,5 to 6 ml (2,5 ml recommended) Ready to use formulation In use concentration 0,16 % (w/w) iodine. 2 pre milking applications per animal, per day 2 post milking applications per animal, per day Category(ies) of users Trained professional Professional Pack sizes and packaging material Drum, Plastic: HDPE, 10 l Drum, Plastic: HDPE, 20 l Drum, Plastic: HDPE, 25 l Drum, Plastic: HDPE, 200 l IBC (intermediate bulk container), Plastic: HDPE, 1000 l Drum, Plastic: HDPE, 5 l All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured. All drums are capped with tamper evident caps or bungs and are UN certified.

4.9.1. Use-specific instructions for use

Post milking:

Dip at least 2/3 of the teat length with RTU product immediately after milking

To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).

4.9.2. Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by foaming application method

(glove material to be specified by the authorisation holder within the product information).

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.

4.9.3. 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.

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

See general directions for use.

4.9.5. 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

Keep out of reach of children

Always read the label or leaflet before use and follow all the instructions provided.

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

Product can be used during the entire lactation period

Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow

For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds

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

Remove and wash contaminated clothing before re-use.

After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.

If you feel unwell, seek medical advice.

After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.

After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.

After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.

Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.

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

At the end of the treatment, dispose of 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 farm based waste water treatment plant.

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

Protect from frost

Do not store at temperatures above 30 °C

Shelf life 12 months

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) LuxSpray 15 — Priodine RTU/Kristal Iocare Pre/Super Pre Authorisation number EU-0020125-0009 1-3 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active Substance 7553-56-2 231-442-4 0,16 C9-11 Alcohol Ethoxylate C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060 Non-active substance 68439-46-3 614-482-0 0,166

(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.