ANNEX

Summary of product characteristics for a biocidal product family

Ecolab Iodine PT3 Family

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0018398-0000

R4BP asset number: EU-0018398-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

Name Ecolab Iodine PT3 Family

1.2. Product type(s)

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

1.3. Authorisation holder

Name and address of the authorisation holder Name Ecolab Deutschland GmbH Address Ecolab-Allee 1, 40789 Monheim, Germany Authorisation number EU-0018398-0000 R4BP asset number EU-0018398-0000 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 Ecolab Europe GmbH Address of manufacturer Richtistrasse 7, 8304 Walliselen Switzerland Location of manufacturing sites Ecolab Baglan, ECOLAB CONTAMINATION CONTROL BRUNEL WAY, BAGLAN ENERGY PARK, NEATH, SA11 2GA South Wales United Kingdom Ecolab Leeds, LOTHERTON WAY, GARFORTH, LEEDS LS25 2JY Leeds United Kingdom Ecolab Rovigo, Viale del Lavoro 10, 45100 Rovigo Italy Ecolab Biebesheim Nalco Deutschland Manufacturing GmbH und Co.KG, Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany Ecolab NETHERLANDS BV, NL01ECOLAB, BRUGWAL 11 3432NZ NIEUWEGEIN Netherlands Ecolab Weavergate, ECOLAB WEAVERGATE PLANT WINNINGTON AVENUE, NORTHWICH CHESHIRE CW8 3AA NORTHWICH United Kingdom Ecolab Mullingar, Forest Park, Mullingar Ind. Estate, Mullingar, Co. Zone C Westmeath Ireland Ecolab Maribor, Ecolab d.o.o.,Vajngerlova 4 2000 Maribor Slovenia Ecolab Rozzano, VIA GRANDI 9/11 20089 ROZZANO Italy Ecolab B.V.B.A, Havenlaan: 4 3980 Tessenderlo Belgium Ecolab CELRA, Nalco Española Manufacturing, SLU C/Tramuntana s/n, Polígono Industrial de Celrà 17460 CELRÀ Spain Ecolab Chalons Ecolab production France SAS, BP509 Avenue de Général Patton 51006 Châlons-en-Champagne France Ecolab Mandra, 25km Old National Road Athens Mandra, oo Attica Greece NALCO FINLAND MANUFACTURING OY, Kivikummuntie 1 FIN-07955 Tesjoki Finland

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

Active substance Polyvinylpyrrolidone iodine Name of manufacturer ISP Chemicals LLC, Affiliate of Ashland Inc. Address of manufacturer 455 N. MAIN ST. (HWY 95) KY 42029 CALVERT CITY United States Location of manufacturing sites 455 N. MAIN ST. (HWY 95) KY 42029 CALVERT CITY United States





Active substance Iodine Name of manufacturer ACF Minera S.A. Address of manufacturer San Martín No 499 00 Iquique Chile Location of manufacturing sites Lagunas mine 00 Pozo Almonte Chile





Active substance Iodine Name of manufacturer SQM S.A. Address of manufacturer Los Militares 4290 Piso 4 Santiago Chile Location of manufacturing sites Nueva Victoria plant 00 Pedro de Valdivia Chile





Active substance Iodine Name of manufacturer Cosayach Nitratos S.A. Address of manufacturer Amunategui 178 00 Santiago Chile Location of manufacturing sites S.C.M. Cosayach Cala Cala 00 Pozo Almonte Chile





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

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 Polyvinylpyrrolidone iodine Active substance 25655-41-8 1 3 Iodine Active substance 7553-56-2 231-442-4 0,11 0,33

2.2. Type(s) of formulation

Formulation(s) AL — Any other liquid

PART II

SECOND INFORMATION LEVEL — META SPC(S)

META SPC 1

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

Identifier meta SPC 1

1.2. Suffix to the authorisation number

Number 1-1

1.3. Product type(s)

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

2. META SPC 1 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 1

Common name IUPAC name Function CAS number EC number Content (%) Min Max Polyvinylpyrrolidone iodine Active substance 25655-41-8 1 1 Iodine Active substance 7553-56-2 231-442-4 0,11 0,11

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

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements Precautionary statements

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

4.1. Use description

Table 1. Use # 1 – Teat dips for post-milking disinfection

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Enveloped viruses Field(s) of use Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) Application method(s) Manual dipping using a dip cup - 3-10 ml (dipping) 1-3 post-milking disinfections per day Application rate(s) and frequency 3-10 ml (dipping) Post-milking application 1x - 3x per day (apply after every milking). Per milking event 3-10 ml of product are needed (animals with four teats). Category(ies) of users Professional Pack sizes and packaging material container, Plastic: HDPE, 0,5-1 000 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

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.

Product to be applied post-milking by use of a dipping cup.

The products must be brought to temperatures above 20 °C before use.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

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

5.2. Risk mitigation measures

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 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) Ioklar Super Dip D Authorisation number EU-0018398-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 1 Iodine Active substance 7553-56-2 231-442-4 0,11

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

Trade name(s) IoKlar Superdip Authorisation number EU-0018398-0002 1-1 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 1 Iodine Active substance 7553-56-2 231-442-4 0,11

META SPC 2

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier

Identifier meta SPC 2

1.2. Suffix to the authorisation number

Number 1-2

1.3. Product type(s)

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

2. META SPC 2 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 2

Common name IUPAC name Function CAS number EC number Content (%) Min Max Polyvinylpyrrolidone iodine Active substance 25655-41-8 1,35 1,35 Iodine Active substance 7553-56-2 231-442-4 0,15 0,15

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 Precautionary statements

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

4.1. Use description

Table 2. Use # 1 – Teat dips for post-milking disinfection

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Enveloped viruses Field(s) of use Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) Application method(s) Manual dipping using a dip cup Application rate(s) and frequency Post-milking application 1x - 3x per day (apply after every milking). Per milking event 3-10 ml of product are needed (animals with four teats). Category(ies) of users Professional Pack sizes and packaging material 0,5 l – 1 000 l HDPE container

4.1.1. Use-specific instructions for use

See general directions for use of meta SPC 2

4.1.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 2

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

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

5.1. Instructions for use

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

The products must be brought to temperatures above 20 °C before use.

Product to be applied post-milking by use of a dipping cup.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

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

5.2. Risk mitigation measures

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 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) Io-Shield D IoShield MEPA Barrier D BARIOPROTECT MS Cow Udder BLOCK Iodocop EXTRA Authorisation number EU-0018398-0003 1-2 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 1,35 Iodine Active substance 7553-56-2 231-442-4 0,15

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

Trade name(s) IoDark Iodocop EXTRA GREEN Mammizan Protect MS Cow Udder BLACK Authorisation number EU-0018398-0004 1-2 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 1,35 Iodine Active substance 7553-56-2 231-442-4 0,15

META SPC 3

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 3 identifier

Identifier meta SPC 3

1.2. Suffix to the authorisation number

Number 1-3

1.3. Product type(s)

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

2. META SPC 3 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 3

Common name IUPAC name Function CAS number EC number Content (%) Min Max Polyvinylpyrrolidone iodine Active substance 25655-41-8 2,45 2,45 Iodine Active substance 7553-56-2 231-442-4 0,27 0,27

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

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements Harmful to aquatic life with long lasting effects. Precautionary statements Avoid release to the environment.

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

4.1. Use description

Table 3. Use # 1 – Teat dips or sprays for post-milking disinfection

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Enveloped viruses Field(s) of use Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) Application method(s) Dipping or spraying: Manual dipping using a dip cup or Manual spraying using a trigger sprayer or Manual spraying using an electronic sprayer or Automated spraying by robot. Application rate(s) and frequency Post-milking application 1x – 3x per day Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats). Category(ies) of users Professional Pack sizes and packaging material 0,5 l – 1 000 l HDPE container

4.1.1. Use-specific instructions for use

Product to be applied by dipping or spraying on teats of milk-producing animals post-milking, using manual or automatic equipment. Post-milking: Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

See also general instructions for use of meta SPC 3.

4.1.2. Use-specific risk mitigation measures

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.

See also general risk mitigation measures of meta SPC 3.

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

See general directions for use 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 4. Use # 2 – Teat dips or sprays for pre-milking disinfection

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 Pre-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) Application method(s) Dipping or spraying: Manual dipping using a dip cup or Manual spraying using a trigger sprayer or Manual spraying using an electronic sprayer. Application rate(s) and frequency Pre-milking application 1x – 3x per day Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats). Category(ies) of users Professional Pack sizes and packaging material 0,5 l – 1 000 l HDPE container

4.2.1. Use-specific instructions for use

Product to be applied by dipping or spraying on teats of milk-producing animals pre-milking, using manual equipment.

Pre-milking: Clean teats by wiping with cloth before disinfection. Apply product on the whole teats and leave it for 1 min. Then wipe with a single use paper or a towel.

See also general instructions for use of meta SPC3.

4.2.2. Use-specific risk mitigation measures

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.

See also general risk mitigation measures of meta SPC3.

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 products must be brought to temperatures above 20 °C before use.

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

5.2. Risk mitigation measures

See use-specific risk mitigation measures for each use.

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application.

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 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) IoKlar Multi MEPA Iospray Plus D ASTRI-IO DESINTEC MH-Iodine S Authorisation number EU-0018398-0005 1-3 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 2,45 Iodine Active substance 7553-56-2 231-442-4 0,27

META SPC 4

1. META SPC 4 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 4 identifier

Identifier meta SPC 4

1.2. Suffix to the authorisation number

Number 1-4

1.3. Product type(s)

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

2. META SPC 4 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 4

Common name IUPAC name Function CAS number EC number Content (%) Min Max Polyvinylpyrrolidone iodine Active substance 25655-41-8 1 1 Iodine Active substance 7553-56-2 231-442-4 0,11 0,11

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 Precautionary statements

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

4.1. Use description

Table 5. Use # 1 – Teat dips or sprays for post-milking disinfection

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Enveloped viruses Field(s) of use Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) Application method(s) Dipping or spraying: Manual dipping using a dip cup or Manual spraying using a trigger sprayer or Manual spraying using an electronic sprayer or Automated spraying by robot. Application rate(s) and frequency Post-milking application 1x - 3x per day. Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats). Category(ies) of users Professional Pack sizes and packaging material 0,5 l – 1 000 l HDPE container

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 products must be brought to temperatures above 20 °C before use.

Product to be applied by dipping or spraying on teats of milk-producing animals post-milking using manual or automatic equipment.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

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

5.2. Risk mitigation measures

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application.

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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 municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

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) Veloucid Spray D VelouCid Spray MEPA Soft Spray D ASTRI-UC SAC WINTERSPRAY Authorisation number EU-0018398-0006 1-4 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 1 Iodine Active substance 7553-56-2 231-442-4 0,11

META SPC 5

1. META SPC 5 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 5 identifier

Identifier meta SPC 5

1.2. Suffix to the authorisation number

Number 1-5

1.3. Product type(s)

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

2. META SPC 5 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 5

Common name IUPAC name Function CAS number EC number Content (%) Min Max Polyvinylpyrrolidone iodine Active substance 25655-41-8 1 1 Iodine Active substance 7553-56-2 231-442-4 0,11 0,11

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

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements Precautionary statements

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

4.1. Use description

Table 6. Use # 1 – Teat dips for post-milking disinfection

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Enveloped viruses Field(s) of use Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) Application method(s) Dipping Manual dipping using a dip cup. Application rate(s) and frequency Post-milking application 1x – 3x per day Per milking event 3-10 ml of product are needed (animals with four teats). Category(ies) of users Professional Pack sizes and packaging material 0,5 l – 1 000 l HDPE container

4.1.1. Use-specific instructions for use

See general directions for use of meta SPC 5

4.1.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 5

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

See general directions for use 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

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

5.1. Instructions for use

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

The products must be brought to temperatures above 20 °C before use.

Product to be applied post-milking by use of a dipping cup.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

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

5.2. Risk mitigation measures

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 18 months

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) Veloucid D VelouCid MEPA Care D Cremadip MS Cow Udder SEPIA Authorisation number EU-0018398-0007 1-5 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 1 Iodine Active substance 7553-56-2 231-442-4 0,11

META SPC 6

1. META SPC 6 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 6 identifier

Identifier meta SPC 6

1.2. Suffix to the authorisation number

Number 1-6

1.3. Product type(s)

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

2. META SPC 6 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 6

Common name IUPAC name Function CAS number EC number Content (%) Min Max Polyvinylpyrrolidone iodine Active substance 25655-41-8 1,35 1,35 Iodine Active substance 7553-56-2 231-442-4 0,15 0,15

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

Formulation AL — Any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements Precautionary statements

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

4.1. Use description

Table 7. Use # 1 – Teat dips or sprays for post-milking disinfection

Product Type PT03 — Veterinary hygiene (Disinfectants) Where relevant, an exact description of the authorised use — Target organism(s) (including development stage) Bacteria Yeasts Enveloped viruses Field(s) of use Indoor Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep) Application method(s) Dipping or spraying: Manual dipping using a dip cup or Manual spraying using a trigger sprayer or Manual spraying using an electronic sprayer or Automated spraying by robot. Application rate(s) and frequency Post-milking application 1x – 3x per day Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats). Category(ies) of users Professional Pack sizes and packaging material 0,5 l – 1 000 l HDPE container

4.1.1. Use-specific instructions for use

See general directions for use of meta SPC 6

4.1.2. Use-specific risk mitigation measures

See general directions for use of meta SPC 6

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

See general directions for use of meta SPC 6

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

See general directions for use of meta SPC 6

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

See general directions for use of meta SPC 6

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

5.1. Instructions for use

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

The products must be brought to temperatures above 20 °C before use.

Product to be applied by dipping or spraying post-milking using manual or automatic equipment.

Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.

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

5.2. Risk mitigation measures

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

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

Potential Health Effects

Eyes: Health injuries are not known or expected under normal use.

Skin: Health injuries are not known or expected under normal use.

Ingestion: Health injuries are not known or expected under normal use.

Inhalation: Health injuries are not known or expected under normal use.

Chronic Exposure: Health injuries are not known or expected under normal use.

First Aid Measures:

Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.

Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.

Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.

Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.

Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.

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 municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.

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

Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.

Shelf life: 24 months

6. OTHER INFORMATION

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

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

Trade name(s) MEPA Barrier Spray D IoShield Spray QUARESS-Barrier Authorisation number EU-0018398-0008 1-6 Common name IUPAC name Function CAS number EC number Content (%) Polyvinylpyrrolidone iodine Active substance 25655-41-8 1,35 Iodine Active substance 7553-56-2 231-442-4 0,15

(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.

(6) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC6.