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.)

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)
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Name and address of the authorisation holder	Name
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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
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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
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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
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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
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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
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PART II

SECOND INFORMATION LEVEL – META SPC(S)

META SPC 1

Identifier	meta SPC 1: Dipping products – ready to use
Number	1-1
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Product type(s)	PT03 – Veterinary hygiene (Disinfectants)
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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.
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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
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Product type(s)	PT03 – Veterinary hygiene (Disinfectants)
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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