ANNEX

Summary of product characteristics for a biocidal product family

HYPRED's iodine based products

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0018397-0000

R4BP asset number: EU-0018397-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

Name HYPRED's iodine based 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 Hypred SAS Address 55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex France Authorisation number EU-0018397-0000 R4BP asset number EU-0018397-0000 Date of the authorisation 11 October 2018 Expiry date of the authorisation 30 September 2028

1.4. Manufacturer(s) of the biocidal products

Name of manufacturer HYPRED SAS Address of manufacturer 55, Boulevard Jules Verger - BP10180 35803 DINARD France Location of manufacturing sites HYPRED SAS - 55, Boulevard Jules Verger - BP10180 35803 DINARD France HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C no 32 31160 Orcoyen – NAVARRA Spain HYPRED GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy

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

Active substance Iodine Name of manufacturer COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. N°96.625.710-5 Address of manufacturer Terrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá Chile Location of manufacturing sites Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad. Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile





Active substance Iodine Name of manufacturer ACF MINERA SA Address of manufacturer San Martín 499 Iquique Chile Location of manufacturing sites Faena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile





Active substance Iodine Name of manufacturer SOCIEDAD QUIMICA y MINERA SA Address of manufacturer Los Militares 4290 SANTIAGO DE CHILE Chile Location of manufacturing sites Pedro de Valdivia (PV) Route B 180 Antofagasta Chile Nueva Victoria (NV) Route 5 North, Km 1925 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 0,25 2,5 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 2,697 24,199

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: Dipping products - ready to use

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 0,25 0,49 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 2,697 4,993

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 Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. 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. If eye irritation persists: Get medical advice/attention.

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

4.1. Use description

Table 1. Use # 1 – Manual or automated dipping after milking

Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Algae Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping after milking Application method(s) Dipping - Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine. Application rate(s) and frequency — 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) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.1.1. Use-specific instructions for use

See general directions for use of meta SPC 1

4.1.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 1

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 of meta SPC 1

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

None: See general directions for use of meta SPC 1

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

See general directions for use of meta SPC 1

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

5.1. Instructions for use

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.

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

Fill the dipping cup manually or automatically with the ready to use product.

Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

— 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)

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures

Wear eye protection.

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

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

— In the event of inhalation: Bring to fresh air.

— In the event of contact with the skin: Wash with water.

— In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

— In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

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-io 2500 JOD DIP IODERM PSP DERMINO FR Iododip IODEX EXTRA Iodystrong DERMIODE INO IODE EPAIS INO STAR + IODACTIV 2500 IODIUM BX2500 Usual Iod Post ASiRAL Dip Coat IODOCAN EXTRA UDDER PLUS PRIMADIODE CERTIODE EPAIS IODIPACK GEL HELIO IODE EPAIS VAGEL GELAPIS ACTIV IOSAPIS GEL ZENCARE FLASH REPROGEL DERMADINE + KRONI Jod Dipp 2500 WÜBBELMANN JOD DIP Iodine Cleaner&Sanitizer MUNGIFILM ZEP FS FILMIODINE NIPPLE NP Authorisation number EU-0018397-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,25 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 2,697

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

Trade name(s) Dip-io YB MAX INO Io Dip MAX JOD DIP YB MAX IodoDip YB MAX Iodium Dip YB MAX JodyDip YB MAX Delta IoDip YB MAX Authorisation number EU-0018397-0002 1-1 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,49 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 4,993

META SPC 2

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier

Identifier meta SPC 2: Dipping, foaming, spraying products - Ready to use

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 0,25 0,49 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 2,697 4,69

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 Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. 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. If eye irritation persists: Get medical advice/attention.

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

4.1. Use description

Table 2. Use # 1 – Manual or automated dipping, foaming or spraying before milking

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 Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking Application method(s) Dipping, foaming or spraying before milking - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.1.1. Use-specific instructions for use

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 2.

4.1.2. Use-specific risk mitigation measures

For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/eye protection.

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal 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 of meta SPC 2

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

See general directions for use of meta SPC 2

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

See general directions for use of meta SPC 2

4.2. Use description

Table 3. Use # 2 – Manual or automated dipping, foaming or spraying after milking

Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Algae Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking Application method(s) Dipping, foaming, spraying after milking - Manual or automated disinfection of teats by dipping, foaming or spraying after milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.2.1. Use-specific instructions for use

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 2.

4.2.2. Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal 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 of meta SPC 2

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

See general directions for use of meta SPC 2

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

See general directions for use of meta SPC 2

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

5.1. Instructions for use

See use-specific instructions for each use.

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.

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Where necessary repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures

See use-specific risk mitigation measures for each use.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

— In the event of inhalation: Bring to fresh air.

— In the event of contact with the skin: Wash with water.

— In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

— In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

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) Liq-io 2500 JOD SPRAY IODINE 3000 RTU IODEX 2500 Usual Iod Liquid Iodoliquid Iodospray DESINTEAT IODYSPRAY RBT 2500 IODY'FLASH INO IODE SPRAY IODYPRO 2500 IODYPRO BL2500 Robot Liq-io 25 ADF iDip+ ASiRAL Dip Spray J IODIPACK HELIO IODE LIQUIDE POLY-IODE CERTIODE LIQUIDE IOSAPIS FLUID GELAPIS ROBOT ZENCARE SPRAY HELIO IODE SPRAY + IODIP + KRONI Jod Spray 2500 WÜBBELMANN JOD LIQUID Authorisation number EU-0018397-0003 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,25 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 2,697

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

Trade name(s) Liq-io YB MAX INO Io Liquid Max Iodoliquid YB MAX Iodospray YB MAX Desinteat YB MAX Iodium Spray YB MAX JodySpray YB MAX Delta IoSpray YB MAX Authorisation number EU-0018397-0004 1-2 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,49 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 4,69

META SPC 3

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 3 identifier

Identifier meta SPC 3: Dipping, foaming, spraying concentrated products

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 2,5 2,5 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 24,199 24,199

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

Formulation SL - Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements Causes serious eye damage. May cause damage to organs (thyroid) through prolonged or repeated exposure oral. Toxic to aquatic life with long lasting effects. May be corrosive to metals. Precautionary statements Keep out of reach of children. Do not breathe mist. Do not breathe vapours. Do not breathe spray. 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. Immediately call a poison center/doctor. Get medical advice/attention if you feel unwell. Dispose of contents to in accordance with local/regional/national/international regulations. Dispose of container to in accordance with local/regional/national/international regulations. Keep only in original container. Absorb spillage to prevent material damage.

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

4.1. Use description

Table 4. Use # 1 – Manual or automated dipping, foaming or spraying before milking

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 Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying before milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency A dilution at 10 % (v/v) should be prepared Application rate for the diluted product: — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.1.1. Use-specific instructions for use

Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal and yeasticidal activity.

Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general directions for use of meta SPC 3.

4.1.2. Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal 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 of meta SPC 3

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

See general directions for use of meta SPC 3

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

See general directions for use of meta SPC 3

4.2. Use description

Table 5. Use # 2 – Manual or automated dipping, foaming or spraying after milking

Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Algae Viruses Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency For disinfection of bacteria, yeasts and algae a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) should be prepared. For disinfection of viruses a dilution at 20 % (v/v: 20 ml product, add water up to 100 ml) should be prepared Application rate for the diluted product: — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.2.1. Use-specific instructions for use

Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal, yeasticidal and algaecidal activity or 20 % (v/v: 20 ml product, add water up to 100 ml) in case virucidal activity is also needed.

Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general directions for use of meta SPC 3.

4.2.2. Use-specific risk mitigation measures

For manual spraying applications wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal 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 of meta SPC 3

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

See general directions for use of meta SPC 3

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

See general directions for use of meta SPC 3

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

5.1. Instructions for use

See use-specific instructions for each use.

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.

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.

Where necessary, repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures

See use-specific risk mitigation measures for each use.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

In case of faintness, get medical advice/attention. Show this safety data sheet to the doctor.

FIRST AID INSTRUCTIONS

— In the event of inhalation: Bring to fresh air.

— In the event of contact with the skin: Wash with water.

— In the event of contact with the eyes: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.

— In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

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) Liq-io concentrate INO Jod Konzentrat Usual Iod Concent Iodoconcentrat D 10 IODINE D 5 IODINE Liq-io C INO IODE C D 4 IODINE ADF iDip+ concentrate Mammizan Concentré Authorisation number EU-0018397-0005 1-3 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 2,5 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 24,199

META SPC 4

1. META SPC 4 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 4 identifier

Identifier meta SPC 4: Dipping products reaching virucidal activity – Ready to use

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 0,5 0,5 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 4,993 4,993

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 Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. 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. If eye irritation persists: Get medical advice/attention.

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

4.1. Use description

Table 6. Use # 1 – Manual or automated dipping after milking

Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Algae Viruses Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping after milking Application method(s) Dipping - Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine. Application rate(s) and frequency — 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) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.1.1. Use-specific instructions for use

See general directions for use of meta SPC 4

4.1.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 4

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 of meta SPC 4

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

See general directions for use of meta SPC 4

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

See general directions for use of meta SPC 4

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

5.1. Instructions for use

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.

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping cup manually or automatically with the ready to use product.

Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

— 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)

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures

Wear eye protection.

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

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

— In the event of inhalation: Bring to fresh air.

— In the event of contact with the skin: Wash with water.

— In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

— In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

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-io 5000 IODIUM TX INO JOD 50 DIP Usual Iod Post + IODIUM PRO DIP IODERM PSP + IODEX EXTRA + Iododip + IODYSTRONG PLUS INO TREMP INO STAR IODACTIV 5000 DERMINO IODERM 5000 IODIUM BX5000 HOEVE-PLUS DIP TREMPASEPT IODE DERMADINE MAMMO-DERM KRONI Jod Dipp 5000 Authorisation number EU-0018397-0006 1-4 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,5 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 4,993

META SPC 5

1. META SPC 5 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 5 identifier

Identifier meta SPC 5: Dipping, foaming, spraying products 5 500 ppm – Ready to use

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 0,55 0,55 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 4,69 4,69

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 Causes serious eye irritation. Harmful to aquatic life with long lasting effects. Precautionary statements Keep out of reach of children. 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. If eye irritation persists: Get medical advice/attention.

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

4.1. Use description

Table 7. Use # 1 – Manual or automated dipping, foaming or spraying before milking

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 Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying before milking Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine Application rate(s) and frequency — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.1.1. Use-specific instructions for use

Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Eliminate all visible dirt before applying the product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC5.

4.1.2. Use-specific risk mitigation measures

For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/eye protection.

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal 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 of meta SPC 5

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

See general directions for use of meta SPC 5

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

See general directions for use of meta SPC 5

4.2. Use description

Table 8. Use # 2 – Manual or automated dipping, foaming or spraying after milking

Product Type PT03 - Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Algae Viruses Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking Application method(s) Dipping, foaming, spraying - Manual or automated disinfection of teats by dipping, foaming or spraying after milking. Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine. Application rate(s) and frequency — cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended) — sheep (1,5 to 5 ml: 1,5 to 3 ml recommended) — goats (2,5 to 6 ml: 2,5 to 4 ml recommended) Frequency: 2 to 3 times per day Category(ies) of users Professional Pack sizes and packaging material HDPE JERRYCAN 5, 10, 22 L HDPE DRUM 60, 120, 220 L HDPE CONTAINER 1 000 L

4.2.1. Use-specific instructions for use

Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 5.

4.2.2. Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

In case a combination of pre- and post-milking disinfection is necessary, using another biocidal 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 of meta SPC 5

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

See general directions for use of meta SPC 5

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

See general directions for use of meta SPC 5

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

5.1. Instructions for use

See use-specific instructions for each use.

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.

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

Where necessary repeat the application at each milking.

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures

See use-specific risk mitigation measures for each use.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

— In the event of inhalation: Bring to fresh air.

— In the event of contact with the skin: Wash with water.

— In the event of contact with the eyes: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

— In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life: 2 years in HDPE

Do not store at a temperature higher than 30 °C.

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) Liq-io 5500 IODYPRO INO JOD 50 Liquid Usual Iod Liquid + IODIUM PRO SPRAY IODEX Iodoliquid + Iodospray Plus DESINTEAT PLUS ROBOSPRAY IODE INOTRAYON IODYPRO 5500 Robot Liq-io 55 IODYPRO BL5500 ADF iDip+ 5500 HOEVE-JODIUM SPRAY GRUPAIODE IODOCAN JOFO JODI PLUS K-AGRO PRODIP ID IODIP HELIO IODE SPRAY MAMMO-JOD KRONI Jod Spray 5500 MUNGI-IOD LELY QUARESS-Iodine Authorisation number EU-0018397-0007 1-5 Common name IUPAC name Function CAS number EC number Content (%) Iodine Active substance 7553-56-2 231-442-4 0,55 Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy Non active substance 68439-50-9 4,69

(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.

(2) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.

(3) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.

(4) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.

(5) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.