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ANNEXU.K. 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 IU.K. FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION U.K.

1.1. Family name U.K.

NameEcolab Iodine PT3 Family

1.2. Product type(s) U.K.

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

1.3. Authorisation holder U.K.

Name and address of the authorisation holderNameEcolab Deutschland GmbH
AddressEcolab-Allee 1, 40789 Monheim, Germany
Authorisation numberEU-0018398-0000
R4BP asset numberEU-0018398-0000
Date of the authorisation11 October 2018
Expiry date of the authorisation30 September 2028

1.4. Manufacturer(s) of the biocidal products U.K.

Name of manufacturerEcolab Europe GmbH
Address of manufacturerRichtistrasse 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) U.K.

Active substancePolyvinylpyrrolidone iodine
Name of manufacturerISP Chemicals LLC, Affiliate of Ashland Inc.
Address of manufacturer455 N. MAIN ST. (HWY 95) KY 42029 CALVERT CITY United States
Location of manufacturing sites455 N. MAIN ST. (HWY 95) KY 42029 CALVERT CITY United States
Active substanceIodine
Name of manufacturerACF Minera S.A.
Address of manufacturerSan Martín No 499 00 Iquique Chile
Location of manufacturing sitesLagunas mine 00 Pozo Almonte Chile
Active substanceIodine
Name of manufacturerSQM S.A.
Address of manufacturerLos Militares 4290 Piso 4 Santiago Chile
Location of manufacturing sitesNueva Victoria plant 00 Pedro de Valdivia Chile
Active substanceIodine
Name of manufacturerCosayach Nitratos S.A.
Address of manufacturerAmunategui 178 00 Santiago Chile
Location of manufacturing sitesS.C.M. Cosayach Cala Cala 00 Pozo Almonte Chile
Active substanceIodine
Name of manufacturerNihon Tennen Gas Development Co., Ltd/ Kanto Natural Gas Development Co., Ltd
Address of manufacturer661 Mobara Chiba 297-8550 Mobara City Japan
Location of manufacturing sitesChiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun 299-4205 Chiba Japan

2. PRODUCT FAMILY COMPOSITION AND FORMULATION U.K.

2.1. Qualitative and quantitative information on the composition of the family U.K.

Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Polyvinylpyrrolidone iodineActive substance25655-41-813
IodineActive substance7553-56-2231-442-40,110,33

2.2. Type(s) of formulation U.K.

Formulation(s)AL — Any other liquid

PART IIU.K. SECOND INFORMATION LEVEL — META SPC(S)

META SPC 1 U.K.

1.META SPC 1 ADMINISTRATIVE INFORMATIONU.K.

1.1. Meta SPC 1 identifier U.K.
Identifiermeta SPC 1
1.2. Suffix to the authorisation number U.K.
Number1-1
1.3. Product type(s) U.K.
Product type(s)PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 1 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 1 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Polyvinylpyrrolidone iodineActive substance25655-41-811
IodineActive substance7553-56-2231-442-40,110,11
2.2. Type(s) of formulation of the meta SPC 1 U.K.
FormulationAL — Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1U.K.

Hazard statements
Precautionary statements

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

4.1. Use description U.K.
Table 1. Use # 1 – Teat dips for post-milking disinfection
Product TypePT03 — 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 usersProfessional
Pack sizes and packaging materialcontainer, Plastic: HDPE, 0,5-1 000 l
4.1.1. Use-specific instructions for use U.K.

See general directions for use of meta SPC 1

4.1.2. Use-specific risk mitigation measures U.K.

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 U.K.

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 U.K.

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 U.K.

See general directions for use of meta SPC 1

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

5.1. Instructions for use U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 INFORMATIONU.K.

7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1U.K.

7.1. Trade name(s), authorisation number and specific composition of each individual product U.K.
Trade name(s)Ioklar Super Dip D
Authorisation numberEU-0018398-0001 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Polyvinylpyrrolidone iodineActive substance25655-41-81
IodineActive substance7553-56-2231-442-40,11
7.2. Trade name(s), authorisation number and specific composition of each individual product U.K.
Trade name(s)IoKlar Superdip
Authorisation numberEU-0018398-0002 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Polyvinylpyrrolidone iodineActive substance25655-41-81
IodineActive substance7553-56-2231-442-40,11

META SPC 2 U.K.

1.META SPC 2 ADMINISTRATIVE INFORMATIONU.K.

1.1. Meta SPC 2 identifier U.K.
Identifiermeta SPC 2
1.2. Suffix to the authorisation number U.K.
Number1-2
1.3. Product type(s) U.K.
Product type(s)PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 2 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 2 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Polyvinylpyrrolidone iodineActive substance25655-41-81,351,35
IodineActive substance7553-56-2231-442-40,150,15
2.2. Type(s) of formulation of the meta SPC 2 U.K.
FormulationAL — Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2U.K.

Hazard statements
Precautionary statements

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

4.1. Use description U.K.
Table 2. Use # 1 – Teat dips for post-milking disinfection
Product TypePT03 — 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 usersProfessional
Pack sizes and packaging material0,5 l – 1 000 l HDPE container
4.1.1. Use-specific instructions for use U.K.

See general directions for use of meta SPC 2

4.1.2. Use-specific risk mitigation measures U.K.

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 U.K.

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 U.K.

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 U.K.

See general directions for use of meta SPC 2

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

5.1. Instructions for use U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 INFORMATIONU.K.

7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2U.K.

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

Io-Shield D

IoShield

MEPA Barrier D

BARIOPROTECT

MS Cow Udder BLOCK

Iodocop EXTRA

Authorisation numberEU-0018398-0003 1-2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Polyvinylpyrrolidone iodineActive substance25655-41-81,35
IodineActive substance7553-56-2231-442-40,15
7.2. Trade name(s), authorisation number and specific composition of each individual product U.K.
Trade name(s)

IoDark

Iodocop EXTRA GREEN

Mammizan Protect

MS Cow Udder BLACK

Authorisation numberEU-0018398-0004 1-2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Polyvinylpyrrolidone iodineActive substance25655-41-81,35
IodineActive substance7553-56-2231-442-40,15

META SPC 3 U.K.

1.META SPC 3 ADMINISTRATIVE INFORMATIONU.K.

1.1. Meta SPC 3 identifier U.K.
Identifiermeta SPC 3
1.2. Suffix to the authorisation number U.K.
Number1-3
1.3. Product type(s) U.K.
Product type(s)PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 3 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 3 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Polyvinylpyrrolidone iodineActive substance25655-41-82,452,45
IodineActive substance7553-56-2231-442-40,270,27
2.2. Type(s) of formulation of the meta SPC 3 U.K.
FormulationAL — Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3U.K.

Hazard statementsHarmful to aquatic life with long lasting effects.
Precautionary statementsAvoid release to the environment.

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

4.1. Use description U.K.
Table 3. Use # 1 – Teat dips or sprays for post-milking disinfection
Product TypePT03 — 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 usersProfessional
Pack sizes and packaging material0,5 l – 1 000 l HDPE container
4.1.1. Use-specific instructions for use U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

See general directions for use of meta SPC 3

4.2. Use description U.K.
Table 4. Use # 2 – Teat dips or sprays for pre-milking disinfection
Product TypePT03 — 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 usersProfessional
Pack sizes and packaging material0,5 l – 1 000 l HDPE container
4.2.1. Use-specific instructions for use U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

See general directions for use of meta SPC 3

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

5.1. Instructions for use U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 INFORMATIONU.K.

7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3U.K.

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

IoKlar Multi

MEPA Iospray Plus D

ASTRI-IO

DESINTEC MH-Iodine S

Authorisation numberEU-0018398-0005 1-3
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Polyvinylpyrrolidone iodineActive substance25655-41-82,45
IodineActive substance7553-56-2231-442-40,27

META SPC 4 U.K.

1.META SPC 4 ADMINISTRATIVE INFORMATIONU.K.

1.1. Meta SPC 4 identifier U.K.
Identifiermeta SPC 4
1.2. Suffix to the authorisation number U.K.
Number1-4
1.3. Product type(s) U.K.
Product type(s)PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 4 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 4 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Polyvinylpyrrolidone iodineActive substance25655-41-811
IodineActive substance7553-56-2231-442-40,110,11
2.2. Type(s) of formulation of the meta SPC 4 U.K.
FormulationAL — Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4U.K.

Hazard statements
Precautionary statements

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

4.1. Use description U.K.
Table 5. Use # 1 – Teat dips or sprays for post-milking disinfection
Product TypePT03 — 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 usersProfessional
Pack sizes and packaging material0,5 l – 1 000 l HDPE container
4.1.1. Use-specific instructions for use U.K.

See general directions for use of meta SPC 4

4.1.2. Use-specific risk mitigation measures U.K.

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 U.K.

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 U.K.

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 U.K.

See general directions for use of meta SPC 4

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

5.1. Instructions for use U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 INFORMATIONU.K.

7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4U.K.

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

Veloucid Spray D

VelouCid Spray

MEPA Soft Spray D

ASTRI-UC

SAC WINTERSPRAY

Authorisation numberEU-0018398-0006 1-4
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Polyvinylpyrrolidone iodineActive substance25655-41-81
IodineActive substance7553-56-2231-442-40,11

META SPC 5 U.K.

1.META SPC 5 ADMINISTRATIVE INFORMATIONU.K.

1.1. Meta SPC 5 identifier U.K.
Identifiermeta SPC 5
1.2. Suffix to the authorisation number U.K.
Number1-5
1.3. Product type(s) U.K.
Product type(s)PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 5 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 5 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Polyvinylpyrrolidone iodineActive substance25655-41-811
IodineActive substance7553-56-2231-442-40,110,11
2.2. Type(s) of formulation of the meta SPC 5 U.K.
FormulationAL — Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5U.K.

Hazard statements
Precautionary statements

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

4.1. Use description U.K.
Table 6. Use # 1 – Teat dips for post-milking disinfection
Product TypePT03 — 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 usersProfessional
Pack sizes and packaging material0,5 l – 1 000 l HDPE container
4.1.1. Use-specific instructions for use U.K.

See general directions for use of meta SPC 5

4.1.2. Use-specific risk mitigation measures U.K.

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 U.K.

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 U.K.

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 U.K.

See general directions for use of meta SPC 5

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

5.1. Instructions for use U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 INFORMATIONU.K.

7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5U.K.

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

Veloucid D

VelouCid

MEPA Care D

Cremadip

MS Cow Udder SEPIA

Authorisation numberEU-0018398-0007 1-5
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Polyvinylpyrrolidone iodineActive substance25655-41-81
IodineActive substance7553-56-2231-442-40,11

META SPC 6 U.K.

1.META SPC 6 ADMINISTRATIVE INFORMATIONU.K.

1.1. Meta SPC 6 identifier U.K.
Identifiermeta SPC 6
1.2. Suffix to the authorisation number U.K.
Number1-6
1.3. Product type(s) U.K.
Product type(s)PT03 — Veterinary hygiene (Disinfectants)

2.META SPC 6 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 6 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Polyvinylpyrrolidone iodineActive substance25655-41-81,351,35
IodineActive substance7553-56-2231-442-40,150,15
2.2. Type(s) of formulation of the meta SPC 6 U.K.
FormulationAL — Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6U.K.

Hazard statements
Precautionary statements

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

4.1. Use description U.K.
Table 7. Use # 1 – Teat dips or sprays for post-milking disinfection
Product TypePT03 — 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 usersProfessional
Pack sizes and packaging material0,5 l – 1 000 l HDPE container
4.1.1. Use-specific instructions for use U.K.

See general directions for use of meta SPC 6

4.1.2. Use-specific risk mitigation measures U.K.

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 U.K.

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 U.K.

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 U.K.

See general directions for use of meta SPC 6

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

5.1. Instructions for use U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 INFORMATIONU.K.

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

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

MEPA Barrier Spray D

IoShield Spray

QUARESS-Barrier

Authorisation numberEU-0018398-0008 1-6
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Polyvinylpyrrolidone iodineActive substance25655-41-81,35
IodineActive substance7553-56-2231-442-40,15
(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.