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Commission Implementing Regulation (EU) 2018/1287 of 24 September 2018 granting a Union authorisation for the biocidal product family Quat-Chem's iodine based products (Text with EEA relevance.)

Current text a fecha 2023-10-26

Article 1

A Union authorisation is granted to  Neogen Italia S.r.l. for the same biocidal product family Quat-chem's iodine based products with authorisation number EU-0018496-0000.

The Union authorisation is valid from 15 October 2018 until 30 September 2028.

The Union authorisation is subject to compliance with the SPC set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

Name QUAT-CHEM’s iodine based products
Product type(s) PT03 – Veterinary hygiene (Disinfectants)
--- ---
Name and address of the authorisation holder Name
--- ---
Address Via Agnello 8, 20121 Milano, Italy
Authorisation number EU-0018496-0000
R4BP asset number EU-0018496-0000
Date of the authorisation 15 October 2018
Expiry date of the authorisation 30 September 2028
Name of manufacturer QUAT-CHEM LTD
--- ---
Address of manufacturer Charter House 33 – Greek Street, SK3 8AX Stockport United Kingdom
Location of manufacturing sites QUAT-CHEM LTD – Charter House 33 – Greek Street, SK3 8AX Stockport United Kingdom
Active substance Iodine
--- ---
Name of manufacturer COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. No 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

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
Formulation(s) AL – Any other liquid SL – Soluble concentrate
--- ---

PART II

SECOND INFORMATION LEVEL – META SPC(S)

META SPC 1

Identifier meta SPC 1: Dipping products – ready to use
Number 1-1
--- ---
Product type(s) PT03 – Veterinary hygiene (Disinfectants)
--- ---
Common name IUPAC name
--- ---
Min Max
Iodine
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy
Formulation(s) AL – Any other liquid
--- ---
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. Get medical advice.
Product type PT03 – Veterinary hygiene (Disinfectants)
--- ---
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Algae Common name: Algae Development stage:
Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping after milking
Application method(s) Method: Dipping Detailed description: Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine.
Application rate(s) and frequency Application Rate: – 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) Dilution (%): Number and timing of application: 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

See general directions for use of meta SPC 1

See general directions for use of meta SPC 1

See general directions for use of meta SPC 1

None: see directions for use meta SPC 1

See general directions for use of meta SPC 1

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.

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.

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.

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.

Shelf life: 2 years in HDPE

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

Trade name(s) Teatsan 2500 Market area: EU
IODO GUARD 2500 Market area: EU
Authorisation number EU-0018496-0001 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

META SPC 2

Identifier meta SPC 2: Dipping, foaming, spraying products – Ready to use
Number 1-2
--- ---
Product type(s) PT03 – Veterinary hygiene (Disinfectants)
--- ---
Common name IUPAC name
--- ---
Min Max
Iodine
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy
Formulation(s) AL – Any other liquid
--- ---
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. Get medical advice.
Product type PT03 – Veterinary hygiene (Disinfectants)
--- ---
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage:
Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s) Method: Dipping, foaming or spraying before milking Detailed description: 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 Application Rate: – 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) Dilution (%): Number and timing of application: 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

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.

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.

See general directions for use of meta SPC 2

See general directions for use of meta SPC 2

See general directions for use of meta SPC 2

Product type PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Algae Common name: Algae Development stage:
Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s) Method: Dipping, foaming, spraying after milking Detailed description: 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 Application Rate: – 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) Dilution (%): Number and timing of application: 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

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.

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.

See general directions for use of meta SPC 2

See general directions for use of meta SPC 2

See general directions for use of meta SPC 2

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.

See use-specific risk mitigation measures for each use.

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.

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.

Shelf life: 2 years in HDPE

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

Trade name(s) Teat Guard 2500 Market area: EU
IODO SPRAY 2500 Market area: EU
Authorisation number EU-0018496-0002 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

META SPC 3

Identifier meta SPC 3: Dipping, foaming, spraying concentrated products
Number 1-3
--- ---
Product type(s) PT03 – Veterinary hygiene (Disinfectants)
--- ---
Common name IUPAC name
--- ---
Min Max
Iodine
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy
Formulation(s) SL – Soluble concentrate
--- ---
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 if you feel unwell. Get medical 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 packaging. Absorb spillage to prevent material damage.
Product type PT03 – Veterinary hygiene (Disinfectants)
--- ---
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage:
Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s) Method: Dipping, foaming, spraying Detailed description: 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 Application Rate: 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) Dilution (%): Number and timing of application: 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

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.

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.

See general directions for use of meta SPC 3

See general directions for use of meta SPC 3

See general directions for use of meta SPC 3

Product type PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Algae Common name: Algae Development stage: Scientific name: Viruses Common name: Viruses Development stage:
Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s) Method: Dipping, foaming, spraying Detailed description: 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 Application Rate: 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) Dilution (%): Number and timing of application: 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

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.

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.

See general directions for use of meta SPC 3

See general directions for use of meta SPC 3

See general directions for use of meta SPC 3

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.

See use-specific risk mitigation measures for each use.

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.

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.

Shelf life: 2 years in HDPE

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

Trade name(s) Teat Guard Concentrate 1:4 Market area: EU
IODO GUARD CONCENTRATE 1:4 Market area: EU
Authorisation number EU-0018496-0003 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

Identifier meta SPC 4: Dipping products reaching virucidal activity – Ready to use
Number 1-4
--- ---
Product type(s) PT03 – Veterinary hygiene (Disinfectants)
--- ---
Common name IUPAC name
--- ---
Min Max
Iodine
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy
Formulation(s) AL – Any other liquid
--- ---
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. Get medical advice.
Product type PT03 – Veterinary hygiene (Disinfectants)
--- ---
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Algae Common name: Algae Development stage: Scientific name: Viruses Common name: Viruses Development stage:
Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping after milking
Application method(s) Method: Dipping Detailed description: Manual or automated disinfection of teats by dipping after milking. Dipping cup or automated dipping machine.
Application rate(s) and frequency Application Rate: – 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) Dilution (%): Number and timing of application: 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

See general directions for use of meta SPC 4

See general directions for use of meta SPC 4

See general directions for use of meta SPC 4

See general directions for use of meta SPC 4

See general directions for use of meta SPC 4

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.

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.

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.

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.

Shelf life: 2 years in HDPE

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

Trade name(s) Teatsan 5000 Market area: EU
IODO GUARD 5000 Market area: EU
Authorisation number EU-0018496-0004 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

Identifier meta SPC 5: Dipping, foaming, spraying products 5 500 ppm – Ready to use
Number 1-5
--- ---
Product type(s) PT03 – Veterinary hygiene (Disinfectants)
--- ---
Common name IUPAC name
--- ---
Min Max
Iodine
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy
Formulation(s) AL – Any other liquid
--- ---
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. Get medical advice.
Product type PT03 – Veterinary hygiene (Disinfectants)
--- ---
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage:
Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking
Application method(s) Method: Dipping, foaming, spraying Detailed description: 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 Application Rate: – 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) Dilution (%): Number and timing of application: 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

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.

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.

See general directions for use of meta SPC 5

See general directions for use of meta SPC 5

See general directions for use of meta SPC 5

Product type PT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage) Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Algae Common name: Algae Development stage: Scientific name: Viruses Common name: Viruses Development stage:
Field(s) of use Indoor Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking
Application method(s) Method: Dipping, foaming, spraying Detailed description: 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 Application Rate: – 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) Dilution (%): Number and timing of application: 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

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.

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.

See general directions for use of meta SPC 5

See general directions for use of meta SPC 5

See general directions for use of meta SPC 5

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.

See use-specific risk mitigation measures for each use.

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.

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.

Shelf life: 2 years in HDPE

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

Trade name(s) Teat Guard 5500 Market area: EU
IODO SPRAY 5500 Market area: EU
Authorisation number EU-0018496-0005 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