ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

Iodine based products – CID LINES NV

Product type(s)

PT03: Veterinary hygiene

Authorisation number: EU-0022265-0000

R4BP asset number: EU-0022265-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	Iodine based products – CID LINES NV

1.2.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	CID LINES NV
	Address	Waterpoortstraat 2 8900 Ieper Belgium
Authorisation number		EU-0022265-0000
R4BP asset number		EU-0022265-0000
Date of the authorisation		3 September 2020
Expiry date of the authorisation		31 August 2030

1.4.   Manufacturer(s) of the product

Name of manufacturer	CID LINES NV
Address of manufacturer	Waterpoortstraat 2 8900 Ieper Belgium
Location of manufacturing sites	CID LINES NV site 1 Waterpoortstraat 2 8900 Ieper Belgium

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

Active substance	Iodine
Name of manufacturer	SQM S.A.
Address of manufacturer	Los Militares, Piso 4 4290 Santiago Chile
Location of manufacturing sites	SQM S.A. site 1 Nueva Victoria plant 00 Pedro de Valdivia Chile

Active substance	Iodine
Name of manufacturer	Cosayach Nitratos S.A.
Address of manufacturer	Amunategui 178 00 Santiago Chile
Location of manufacturing sites	Cosayach Nitratos S.A. site 1 Cala Cala 00 Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	ACF Minera S.A.
Address of manufacturer	San Martin No 499 00 Iquique Chile
Location of manufacturing sites	ACF Minera S.A. site 1 Lagunas mine 00 Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	ISE Chemicals Corporation
Address of manufacturer	3-1, Kyobashi 1-Chome 104-0031 Tokyo Japan
Location of manufacturing sites	ISE Chemicals Corporation site 1 3695 Kitaimaizumi 299-3201 Oamishirasato city Japan

Active substance	Polyvinylpyrrolidone iodine
Name of manufacturer	ISP Chemicals LLC, Afiliate of Ashland Inc
Address of manufacturer	455 N. main st (HWY 95) KY 42029 Calvert City United States (the)
Location of manufacturing sites	ISP Chemicals LLC, Afiliate of Ashland Inc site 1 455 N. main st (HWY 95) KY 42029 Calvert City United States (the)

Active substance	Polyvinylpyrrolidone iodine
Name of manufacturer	Pantheon FZE (DMCC branch)
Address of manufacturer	403, Reef Tower, Jumeira Lake Tower Shaikh Zayed Road 00 Dubai United Arab Emirates (the)
Location of manufacturing sites	Pantheon FZE (DMCC branch) site 1 Cala Cala 00 Pozo Almonte Chile

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0 -3 % (w/w)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		0 -10 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated láite	Non-active substance	68131-39-5	500-195-7	0 -21 % (w/w)
Phosphoric acid	Phosphoric acid	Non-active substance	7664-38-2	231-633-2	0 -30 % (w/w)
Alcohol C9-11 +6 EO	Alcohol C9-11 +6 EO	Non-active substance	68439-46-3		0 -12,5 % (w/w)

2.2.   Type(s) of formulation

Formulation type(s)

AL Any other liquid SL Soluble concentrate

PART II

SECOND INFORMATION LEVEL META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier

Meta SPC: metaSPC 1: PT3 – Concentrated teat disinfectants Iodine

1.2.   Suffix to the authorisation number

Number

1-1

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.   META SPC 1 COMPOSITION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	1,5 -1,5 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	12,05 -12,05 % (w/w)

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

Formulation type(s)

SL Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

H318: Causes serious eye damage. H412: Harmful to aquatic life with long lasting effects. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral).

Precautionary statements

P280: Wear eye protection. P280: Wear protective clothing. P280: Wear protective gloves. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a doctor, a poison center. P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3 – Concentrated Teat disinfectant, post-milking, Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data
Field(s) of use	Indoor use Post-milking teat disinfection of milk producing animals
Application method(s)	Method: Manual or automatic spraying on teats Detailed description: –
Application rate(s) and frequency	Application Rate: Dilute the product to a final concentration of 0,3% (w/w) available iodine. Number and timing of application: Apply 2 times per day with manual sprayer and 3 times per day with a robot.
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

The product must be diluted before use with clean potable water to allow a final concentration of iodine of 0,3 % (200 ml product, add water up to 1 l).

The diluted product must be brought to a temperature above 20 °C before use.

Assume 5 ml diluted product per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended. Use gloves and eye protection during the dilution step. The diluted product can be kept and used during 1 week but do not prepare more fluid than necessary.

Apply the diluted product on the teats with a manual sprayer or with an automatic sprayer.

The product should be used directly after milking 2 times per day by using a manual sprayer and 3 times per day when using a robot (automatic sprayer).

Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

—	For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection.

—	For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

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

—	Keep out of reach of children.

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

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

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

Trade name(s)			Kenodin SD 400		Market area: EU
			IodoSD 400		Market area: EU
			Velvet Concentrate		Market area: EU
			Wynnsan Iodine 3 - 1 conc		Market area: EU
			Iodin Teat Spray 400		Market area: EU
Authorisation number					EU-0022265-0001 1-1
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	1,5 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	12,05 % (w/w)

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

Meta SPC: metaSPC 2: PT3 – Ready to Use (RTU) Teat disinfectants Iodine

1.2.   Suffix to the authorisation number

Number

1-2

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.   META SPC 2 COMPOSITION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,3 -0,3 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	2,1 -2,9 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 2

Formulation type(s)

AL Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements	H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3– RTU Teat disinfectant, post-milking, Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data
Field(s) of use	Indoor use Post-milking teat disinfection of milk producing animals
Application method(s)	Method: By dipping or spraying on teats Detailed description: –
Application rate(s) and frequency	Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

The product must be brought to a temperature above 20 °C before use.

Apply the product by dipping or by spraying:

—	By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.

—	By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary; assume 5 ml solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.

The product should be used immediately after each milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

—	For manual dipping application: No special protection equipment is recommended under normal conditions of use.

—	For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information.

—	If 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.

—	Keep out of reach of children.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

/

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

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

Trade name(s)			IodoDip 3000		Market area: EU
			Bio Tec Jodip 3000		Market area: EU
			Recoïode		Market area: EU
			Stalosan Io Dip		Market area: EU
			Stalosan Super Dip		Market area: EU
			Velvet High Visco		Market area: EU
			Bühning Joddip 3000		Market area: EU
			Kenodin		Market area: EU
			Wynnsan trikill RTU		Market area: EU
			Wynnsan Iodine RTU teat dip		Market area: EU
			Wynnsan Iodine dip RTU		Market area: EU
			Iocid		Market area: EU
			Iodip+		Market area: EU
			Wynngold Iodine Dip		Market area: EU
			Pezerk iv plus		Market area: EU
			Iod protect 3000 Film		Market area: EU
			Seivit® Iode 3000		Market area: EU
			Kenostart		Market area: EU
			GAHERYOD		Market area: EU
			Kenodin 3000		Market area: EU
			Iodin Teat Dip 3000		Market area: EU
			Iod 3000 dip		Market area: EU
			Iodoschutz dip		Market area: EU
			Ioschutz dip		Market area: EU
			Iodocoop dip		Market area: EU
			Iodotech dip		Market area: EU
			Iodactiv’ dip		Market area: EU
			Iododip		Market area: EU
			MIROX Dip Jod		Market area: EU
			HCP Iodine Dip		Market area: EU
			Agib Jodium Dip		Market area: EU
			Jod 3000		Market area: EU
			Iod dip		Market area: EU
			Iode 3000		Market area: EU
			Iodoschutz		Market area: EU
			Coopjod		Market area: EU
			Coopiode		Market area: EU
			Coopiode épais		Market area: EU
			Semex jod		Market area: EU
			Iodotech		Market area: EU
			Iododip green		Market area: EU
			Iodip bio		Market area: EU
			Iododip bio		Market area: EU
			Iodactive épais		Market area: EU
			Iodactiv		Market area: EU
			Iodoactiv’		Market area: EU
			Bayley’s Premier Iodine Teat Dip		Market area: EU
			Pearce Premier Iodine Teat Dip		Market area: EU
			Diamond 1:3 Concentrate Iodine Post Dip Spray		Market area: EU
			JODOCARE		Market area: EU
			KENOSTART DYP		Market area: EU
			STREPTOFIT		Market area: EU
			Iodall Film		Market area: EU
Authorisation number					EU-0022265-0002 1-2
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	0,3 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2,17 % (w/w)

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

Trade name(s)			Kenodin Film		Market area: EU
			IodoFilm		Market area: EU
			Wynnsan Iofilm teat dip		Market area: EU
			Kenodin Film Extra		Market area: EU
			Wynngold Film		Market area: EU
			Wynnsan trikill film teat dip		Market area: EU
			Kenodin Film Soft		Market area: EU
			Iocid Film		Market area: EU
			TOP Film		Market area: EU
			Seivit® Iode Gel		Market area: EU
			IOD protect 3000 Film		Market area: EU
			Iodin Film Teat Dip 3000		Market area: EU
			Iodin Barrier Teat Dip 3000		Market area: EU
			Iodin Film Teat Dip		Market area: EU
			Iodin Barrier Teat Dip		Market area: EU
			Iod 3000 film		Market area: EU
			Iodoschutz film		Market area: EU
			Ioschutz film		Market area: EU
			Iodocoop film		Market area: EU
			Iodotech film		Market area: EU
			Iodactiv’ film		Market area: EU
			Iodofilm		Market area: EU
			HCP Iodine Film		Market area: EU
			Iod 3000 film		Market area: EU
			Coopjod film		Market area: EU
			Coopiode film		Market area: EU
			Iodocoop film		Market area: EU
			Semex jod film		Market area: EU
			Iodofilm		Market area: EU
			Iodofilm bio		Market area: EU
			Iofilm bio		Market area: EU
			Iodactive film		Market area: EU
			Iodactiv film		Market area: EU
			Iodactiv’ film		Market area: EU
			SCUDO 3000		Market area: EU
Authorisation number					EU-0022265-0003 1-2
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	0,3 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2,9 % (w/w)

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier

Meta SPC: metaSPC 3: PT3 – RTU Udder disinfectant Iodine

1.2.   Suffix to the authorisation number

Number

1-3

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.   META SPC 3 COMPOSITION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,3 -0,99 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	2,17 -2,95 % (w/w)

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

Formulation type(s)

AL Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements	H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3 – RTU Udder disinfectants, Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data
Field(s) of use	Indoor use Skin disinfection only for use on intact skin of: — the udder of dairy and beef cattle before calving — the udder of sows before farrowing
Application method(s)	Method: spraying Detailed description: –
Application rate(s) and frequency	Application Rate: The product is ready to use. Number and timing of application: Apply to: — the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 ml per application) — the udder of sows: 15 to 20 ml per animal
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1.   Instructions for use

For disinfection of the skin:

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.

Apply by spraying on the animals’ intact skin for a topical disinfection:

—

on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 ml per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing at least 5 minutes);

—

on the udder of sows before farrowing: Assume 15 to 20 ml per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Only for use on intact skin.

Do not mix with other chemicals.

5.2.   Risk mitigation measures

For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections.

Keep out of reach of children.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

/

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

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

Trade name(s)			Animal Skin Disinfectant		Market area: EU
			Dermades 3000		Market area: EU
			Iodin Skin Disinfectant		Market area: EU
Authorisation number					EU-0022265-0004 1-3
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	0,3 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2,17 % (w/w)

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

Trade name(s)			Dermades		Market area: EU
			Animal skin disinfectant 1 %		Market area: EU
			Dermades Strong		Market area: EU
			Iodin Skin Disinfectant Strong		Market area: EU
Authorisation number					EU-0022265-0005 1-3
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	0,99 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2,95 % (w/w)

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier

Meta SPC: metaSPC 4: PT3 – RTU Udder and Teat disinfectants Iodine

1.2.   Suffix to the authorisation number

Number

1-4

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.   META SPC 4 COMPOSITION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,3 -0,3 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	2,17 -2,17 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 4

Formulation type(s)

AL Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements	H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3 – RTU Teat disinfectant, Post-milking, Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data
Field(s) of use	Indoor use Ready to use teat disinfectant to be used post milking on milk producing animals.
Application method(s)	Method: Dipping or Spraying Detailed description: –
Application rate(s) and frequency	Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.1.1.   Use-specific instructions for use

For disinfection of the teats:

The product must be brought to a temperature above 20 °C before use.

—	By dipping: Apply the product on the teats with a dip cup. Wash the dip cup with water after use.

—	By spraying: Apply the product on the teats with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary. Assume 5 ml solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.

The product should be used directly after milking by using a dipping cup or a manual or automatic sprayer. Ensure that the teat is completely covered to three quarters of its length.

The product is applied after milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

Let the product dry on the teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

4.1.2.   Use-specific risk mitigation measures

—	For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

—	For manual dipping application: no Personal Protection Equipment (PPE) is necessary for safe use.

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

—	Keep out of reach of children.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2.   Use description

Table 2

PT3 – RTU Udder disinfectant, Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Bacteria Development stage: no data
Field(s) of use	Indoor use Ready to use skin disinfectant, only for use on intact skin of: — the udder of dairy and beef cattle before calving — the udder of sows before farrowing
Application method(s)	Method: Application on animal skin: by spraying Detailed description: –
Application rate(s) and frequency	Application Rate: The product is ready to use. Number and timing of application: Apply to: — the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 ml per application) — the udder of sows: 15 to 20 ml per animal
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.2.1.   Use-specific instructions for use

For disinfection of the skin:

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.

Apply by spraying on the animals’ intact skin for a topical disinfection:

—

on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 ml per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes);

—

on the udder of sows before farrowing: Assume 15 to 20 ml per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Let the product dry on skin.

Only for use on intact skin.

Do not mix with other chemicals.

4.2.2.   Use-specific risk mitigation measures

—	For manual spraying application on cows and sows: no PPE is necessary for safe use.

—	Keep out of reach of children.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 4

5.1.   Instructions for use

See use-specific instructions for use.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

/

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

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

Trade name(s)			Kenodin SD		Market area: EU
			IodoSD 3000		Market area: EU
			Bio Tec Jodspray 3000		Market area: EU
			Q Farm Iodine Des		Market area: EU
			ANRO - Euterpflege Dip		Market area: EU
			Stalosan Io Spray		Market area: EU
			Stalosan Super Spray		Market area: EU
			IDip+		Market area: EU
			Bühning Jodspray 3000		Market area: EU
			Velvet RTU		Market area: EU
			Wynnsan trikill spray		Market area: EU
			Wynnsan Iodine spray RTU		Market area: EU
			Wynngold Iodine Dip and spray		Market area: EU
			Pezerk IL		Market area: EU
			Iod protect 3000 Sprüh		Market area: EU
			Seivit® Iode Spray		Market area: EU
			IOD protect 3000 Sprüh		Market area: EU
			Kenodin SprayFilm		Market area: EU
			Iodo SP		Market area: EU
			Kenostart SD		Market area: EU
			GAHERYOD SPRAY		Market area: EU
			Iodin Teat & Skin 3000		Market area: EU
			Iod 3000 sprüh		Market area: EU
			Iodoschutz sprüh		Market area: EU
			Ioschutz sprüh		Market area: EU
			Iodocoop sprüh		Market area: EU
			Iodotech sprüh		Market area: EU
			Iodactiv’ sprüh		Market area: EU
			Iodosprüh		Market area: EU
			MIROX Spray Jod		Market area: EU
			HCP Iodine SD		Market area: EU
			Agib Jodium Spray		Market area: EU
			Jod 3000 spray		Market area: EU
			Iod sprüh		Market area: EU
			Coopjod		Market area: EU
			Coopiode spray		Market area: EU
			Iodocoop spray		Market area: EU
			Semex jod spray		Market area: EU
			Iododip spray		Market area: EU
			Iododip spray green		Market area: EU
			Iodospray Bio		Market area: EU
			Iospray bio		Market area: EU
			Iodactive spray		Market area: EU
			Iodactiv spray		Market area: EU
			Iodactiv’ spray		Market area: EU
			Ark Iodine S+D		Market area: EU
			Agrihealth Iodine SD		Market area: EU
			AGRO LOGIC JODOCARE SPRAY		Market area: EU
			IODACTIVE		Market area: EU
Authorisation number					EU-0022265-0006 1-4
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	0,3 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2,17 % (w/w)

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

Identifier

Meta SPC: metaSPC 5: PT3 – RTU Teat disinfectants PVP-Iodine

1.2.   Suffix to the authorisation number

Number

1-5

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.   META SPC 5 COMPOSITION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		3 -3 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	1,5 -2,9 % (w/w)

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

Formulation type(s)

AL Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements	H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3 – RTU Teat disinfectant, post milking, PVP-Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data
Field(s) of use	Indoor use Post-milking disinfection on teats of milk producing animals
Application method(s)	Method: Dipping or spraying Detailed description: –
Application rate(s) and frequency	Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 5

5.1.   Instructions for use

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.

Apply the product by dipping or by spraying:

—	By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.

—	By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary. Assume 5 ml solution per cow per treatment.

The product should be used immediately after each milking, two times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

—	For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information.

—	For manual dipping application: no PPE is necessary for safe use.

—	If 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.

—	Keep out of reach of children.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 18 months.

6.   OTHER INFORMATION

/

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

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

Trade name(s)			Iodo PVP		Market area: EU
			Iodin Teat Dip 3000 PVP		Market area: EU
Authorisation number					EU-0022265-0007 1-5
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance		25655-41-8			3 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2,5 % (w/w)

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

Trade name(s)			Iodo SD PVP		Market area: EU
			Iodin Teat Spray & Dip 3000 PVP		Market area: EU
Authorisation number					EU-0022265-0008 1-5
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance		25655-41-8			3 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2,5 % (w/w)

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

Identifier

Meta SPC: metaSPC 6: PT3 – RTU Udder disinfectants PVP-Iodine

1.2.   Suffix to the authorisation number

Number

1-6

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.   META SPC 6 COMPOSITION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance	25655-41-8		10 -10 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	2 -2 % (w/w)

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

Formulation type(s)

AL Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements	H412: Harmful to aquatic life with long lasting effects. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral).
Precautionary statements	P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P260: Do not breathe spray.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3 – RTU Udder disinfectant PVP-Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data
Field(s) of use	Indoor use Ready to use skin disinfectant, only for use on intact skin of: — the udder of dairy and beef cattle: before calving — the udder of sows: before farrowing
Application method(s)	Method: spraying Detailed description: –
Application rate(s) and frequency	Application Rate: The product is ready to use. Number and timing of application: Apply to: — The udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 ml per application) — The udder of sows: 15 to 20 ml per animal
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.1.1.   Use-specific instructions for use

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.

—

Dairy and beef cattle: Apply the product by spraying on the udder before calving (1 spray/teat equivalent to 4,8 ml per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

—

Sows, on the udder before farrowing: Assume 15 to 20 ml per animal. Disinfection takes place once, one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Only for use on intact skin.

Do not mix with other chemicals.

4.1.2.   Use-specific risk mitigation measures

—	For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

—	In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections.

—	Keep out of reach of children.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 6

5.1.   Instructions for use

See use-specific instructions for use.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

/

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

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

Trade name(s)			Dermades PVP		Market area: EU
			Wynngold 10 % Iodine Solution		Market area: EU
			Iodin Skin Disinfectant PVP		Market area: EU
Authorisation number					EU-0022265-0009 1-6
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Polyvinylpyrrolidone iodine		Active substance		25655-41-8			10 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2 % (w/w)

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier

Identifier

Meta SPC: metaSPC 7: PT3 – Concentrated Surface disinfectants Iodine

1.2.   Suffix to the authorisation number

Number

1-7

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.   META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	1,8 -2,49 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	3,15 -9,45 % (w/w)
Alcohol C9-11 + 6 EO	Alcohol C9-11 + 6 EO	Non-active substance	68439-46-3		2,5 -12,5 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 7

Formulation type(s)

SL Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

Hazard statements

H318: Causes serious eye damage. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral). H290: May be corrosive to metals. H411: Toxic to aquatic life with long lasting effects.

Precautionary statements

P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a doctor or a POISON CENTER. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P391: Collect spillage. P273: Avoid release to the environment.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3 – Concentrated Surface disinfectant for veterinary use, Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data
Field(s) of use	Indoor use Non-porous surface disinfection in veterinary field
Application method(s)	Method: By spraying with a manual or an automatic sprayer Detailed description: /
Application rate(s) and frequency	Application Rate: Assume 0,04 l solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine Number and timing of application: See use-specific risk mitigation measures
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.1.1.   Use-specific instructions for use

Use in veterinary field (PT3), surface disinfection:

Product should be diluted with water before use (according to table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

The product is used to disinfect animal housings of pigs, cows and poultry.

Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and animals can re-enter 24h after the end of the application.

Example for a product containing 2,49 % iodine (*1)	Dilution of the product	Contact time
Bactericidal and yeasticidal activity Virucidal activity	1 % (10ml product, add water up to 1 l)	30 min
	1,4 % (14ml product, add water up to 1 l)	30 min

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

4.1.2.   Use-specific risk mitigation measures

—	During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coated coverall (material to be specified by the authorisation holder within the product information) and eye/face protection.

—	During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information).

—	Only use one kind of Iodine-containing product per day.

—	Due to potential concern for human health, the same professional user shall not carry out animal house disinfection more than 3 times per month and shall not use Iodine products for other purposes during that period.

—	Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application.

—	Keep out of reach of children.

—	The general public and animals should be kept away from treated areas until surfaces are dry.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 7

5.1.   Instructions for use

See use-specific instructions for use.

5.2.   Risk mitigation measures

See use-specific risk mitigation measures.

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

/

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

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

Trade name(s)			Dodin 20		Market area: EU
			Iodo 20		Market area: EU
			Bio Tec Joddesinfektion		Market area: EU
			Dufa dine 1,8 %		Market area: EU
			Alfasan super disinfectant		Market area: EU
			Iodes		Market area: EU
			Streptoclean		Market area: EU
			Iodin Surface Disinfectant 1,8 %		Market area: EU
			IODINE		Market area: EU
Authorisation number					EU-0022265-0010 1-7
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	1,8 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	5,29 % (w/w)
Alcohol C9-11 + 6 EO	Alcohol C9-11 + 6 EO	Non-active substance		68439-46-3			5 % (w/w)

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier

Identifier

Meta SPC: metaSPC 8: PT3 – Concentrated Surface disinfectants Iodine

1.2.   Suffix to the authorisation number

Number

1-8

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.   META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	2,5 -3 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	3,15 -9,45 % (w/w)
Phosphoric acid	Phosphoric acid	Non-active substance	7664-38-2	231-633-2	5 -12 % (w/w)
Alcohol C9-11 + 6 EO	Alcohol C9-11 + 6 EO	Non-active substance	68439-46-3		2,5 -12,5 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 8

Formulation type(s)

SL Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

Hazard statements

H290: May be corrosive to metals. H315: Causes skin irritation. H318: Causes serious eye damage. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral). H411: Toxic to aquatic life with long lasting effects.

Precautionary statements

P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P310: Immediately call a POISON CENTER or doctor/physician. P342+P311: If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. P273: Avoid release to the environment. P391: Collect spillage. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3 – Concentrated Surface disinfectant for veterinary use, Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data
Field(s) of use	Indoor use Non-porous surface disinfection in veterinary field
Application method(s)	Method: By spraying with a manual or an automatic sprayer Detailed description: /
Application rate(s) and frequency	Application Rate: Assume 0,04 l solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine Number and timing of application: See use-specific risk mitigation measures.
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.1.1.   Use-specific instructions for use

Use in veterinary field (PT3), surface disinfection:

Product must be diluted with water before use (according to table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

The product is used to disinfect animal housings of pigs, cows and poultry.

Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and re-entry of animals can be done 24h after the end of the application.

Example for a product containing 2,5% iodine (*2)	Dilution of the product	Contact time
Bactericidal and yeasticidal activity Virucidal activity	1 % (10ml product, add water up to 1 l)	30 min
	1,4% (14 ml product, add water up to 1L)	30 min

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

4.1.2.   Use-specific risk mitigation measures

—	During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coverall (material to be specified by the authorisation holder within the product information)and eye/face protection.

—	During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information).

—	Only use one kind of Iodine-containing product per day.

—	Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shall not use Iodine products for other purposes during that period.

—	Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application.

—	Keep out of reach of children.

—	The general public and animals should be kept away from treated areas until surfaces are dry.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 8

5.1.   Instructions for use

See use-specific instructions for use

5.2.   Risk mitigation measures

See use-specific risk mitigation measures.

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After skin (or hair) contact: Remove contaminated clothing and shoes. Wash the affected area thoroughly with plenty of soap and water. Get medical attention if symptoms occur.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

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

Trade name(s)			Iocid 30		Market area: EU
			Iodo 30		Market area: EU
			Dufa dine		Market area: EU
			Iodin Surface Disinfectant 2,8 %		Market area: EU
Authorisation number					EU-0022265-0011 1-8
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	2,8 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	7,93 % (w/w)
Phosphoric acid	Phosphoric acid	Non-active substance		7664-38-2		231-633-2	11,25 % (w/w)
Alcohol C9-11 + 6 EO	Alcohol C9-11 + 6 EO	Non-active substance		68439-46-3			12,5 % (w/w)

1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier

Identifier

Meta SPC: metaSPC 10: PT3 – Concentrated teat disinfectants Iodine

1.2.   Suffix to the authorisation number

Number

1-10

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygien ve

2.   META SPC 9 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 9

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	2,8 -2,8 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	21 -21 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 9

Formulation type(s)

SL Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

Hazard statements

H318: Causes serious eye damage. H411: Toxic to aquatic life with long lasting effects. H373: May cause damage to organs (thyroid) through prolonged or repeated exposure (oral route).

Precautionary statements

P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a doctor or a poison center. P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P391: Collect spillage.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3 – Concentrated teat disinfectant, Post-milking, Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data
Field(s) of use	Indoor use Post-milking teat disinfection of milk producing animals
Application method(s)	Method: By spraying with a manual sprayer or with an automatic sprayer on teats. Detailed description: /
Application rate(s) and frequency	Application Rate: The product must be diluted before use in order to allow a final concentration of iodine of 0,3 % Number and timing of application: Apply 2 times per day by using a manual sprayer and 3 times per day when using a robot (or automatic sprayer).
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 9

5.1.   Instructions for use

The product must be diluted before use in order to allow a final concentration of iodine of 0,3 %. The product should be diluted to 11 % (110 ml product, add water up to 1 l).

Do not prepare more fluid than necessary. Assume 5 ml solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.

Use gloves and eye protection during the dilution step. The diluted product can be kept and used for 1 week.

The product must be brought to a temperature above 20 °C before use.

Apply the diluted product on the teats with a manual sprayer or with an automatic sprayer.

The product should be used directly after milking 2 times per day by using a manual sprayer and 3 times per day by using a robot (automatic sprayer). Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

—	For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection.

—	For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection.

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

—	Keep out of reach of children.

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

Dilutions of the product(s) are stable for 1 week.

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9

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

Trade name(s)			Kenodin SD 900		Market area: EU
			IodoSD 900		Market area: EU
			IDip+ concentrate		Market area: EU
			Jodkonzentrat 1:9		Market area: EU
			Bühning Jodkonzentrat 1:9		Market area: EU
			Wynnsan Iodine Conc dip 9-1		Market area: EU
			Kenodin 900		Market area: EU
			Dufa Dip		Market area: EU
			Kenostart 900		Market area: EU
			Iodin Teat Spray 900		Market area: EU
			HCP Iodine Concentrate		Market area: EU
			Maxi Subliem CP		Market area: EU
			Subliem Koncentrat Plus		Market area: EU
Authorisation number					EU-0022265-0013 1-10
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	2,8 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	21 % (w/w)

1.   META SPC 10 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 10 identifier

Identifier

Meta SPC: metaSPC 11: PT3 – RTU Teat disinfectants Iodine

1.2.   Suffix to the authorisation number

Number

1-11

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.   META SPC 10 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 10

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,25 -0,25 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	2,1 -2,1 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 10

Formulation type(s)

AL Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10

Hazard statements	H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3 – RTU teats disinfectant, Post-milking, Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data
Field(s) of use	Indoor use Post-milking teat disinfection of milk producing animals
Application method(s)	Method: By dipping or spraying on teats Detailed description: /
Application rate(s) and frequency	Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day when using a manual sprayer and 3 times per day when using a dip cup or a robot (automatic sprayer).
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 10

5.1.   Instructions for use

Apply the product by dipping or by spraying:

—	By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.

—	By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary; assume 5 ml solution per cow per treatment. 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.

The product should be used immediately after each milking, two times per day when using a manual sprayer or three times per day when using a dip cup or a robot (automatic sprayer). Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

—	For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

—	For manual dipping application: no PPE is necessary for safe use.

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

—	Keep out of reach of children.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10

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

Trade name(s)			Kenodin 2500		Market area: EU
			Iodin Teat Dip 2500		Market area: EU
			Jod 2500		Market area: EU
Authorisation number					EU-0022265-0014 1-11
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	0,25 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2,1 % (w/w)

1.   META SPC 11 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 11 identifier

Identifier

Meta SPC: meta SPC 12: PT3 – RTU Teat disinfectants Iodine

1.2.   Suffix to the authorisation number

Number

1-12

1.3.   Product type(s)

Product type(s)

PT03: Veterinary hygiene

2.   META SPC 11 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 11

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Iodine		Active substance	7553-56-2	231-442-4	0,3 -0,5 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance	68131-39-5	500-195-7	2,1 -2,9 % (w/w)

2.2.   Type(s) of formulation of the meta SPC 11

Formulation type(s)

AL Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11

Hazard statements	H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P273: Avoid release to the environment. P501: Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. P501: Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

PT3 – RTU Teat disinfectant, Post-milking, Iodine

Product type	PT03: Veterinary hygiene
Where relevant, an exact description of the authorised use	–
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data
Field(s) of use	Indoor use Post-milking teat disinfection of milk producing animals
Application method(s)	Method: By dipping or spraying on teats Detailed description: /
Application rate(s) and frequency	Application Rate: The product is ready to use. Number and timing of application: Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.
Category(ies) of users	Professional
Pack sizes and packaging material	1 l, 5 l, 10 l, 20 l, 25 l, 30 l, 60 l, 200 l, 600 l, 1 000  l HDPE

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 11

5.1.   Instructions for use

The product must be brought to a temperature above 20 °C before use.

Apply the product by dipping or by spraying:

—	By dipping: Apply the product with a dip cup. Wash the dip cup with water after use

—	By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary; assume 5 ml solution per cow per treatment.

The product should be used immediately after each milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   Risk mitigation measures

—	For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

—	For manual dipping application: no PPE is necessary for safe use.

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

—	Keep out of reach of children.

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

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7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11

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

Trade name(s)			Kenodin 5000		Market area: EU
			IodoDip 5000		Market area: EU
			JOD 5000		Market area: EU
			Bio Tec Jodip 5000		Market area: EU
			Bühning Jodfilmdip-Super		Market area: EU
			Iocid 5000		Market area: EU
			Iod protect 5000 Film		Market area: EU
			IOD protect 5000 Film		Market area: EU
			Iocid		Market area: EU
			Iodip+		Market area: EU
			Protetos cua		Market area: EU
			Iodin Teat Dip 5000		Market area: EU
Authorisation number					EU-0022265-0015 1-12
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	0,5 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2,9 % (w/w)

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

Trade name(s)			Kenodin SD 5000		Market area: EU
			IodoSD 5000		Market area: EU
			IODOSPRAY 5000		Market area: EU
			Bio Tec Jodspray 5000		Market area: EU
			IDip+ 5000		Market area: EU
			Bühning Jodspray 5000		Market area: EU
			Iod protect 5000 Sprüh		Market area: EU
			Kenodin Film Spray		Market area: EU
			IOD protect 5000 Sprüh		Market area: EU
			Iodin Spray & Dip 5000		Market area: EU
Authorisation number					EU-0022265-0016 1-12
Common name	IUPAC name	Function		CAS number		EC number	Content (%)
Iodine		Active substance		7553-56-2		231-442-4	0,5 % (w/w)
Alcohols, C12-15, ethoxylated	Alcohols, C12-15, ethoxylated	Non-active substance		68131-39-5		500-195-7	2,9 % (w/w)

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(*1)  Each product label should give information on how the dilution should be made. Since the concentration iodine in products within this meta SPC can range from 1,8 to 2,49 % it is not possible to indicate all product dilutions here.

(*2)  Each product label should give information on how the dilution should be made. Since the concentration iodine in products within this meta SPC can range from 1,8 to 2,49 % it is not possible to indicate all product dilutions here.