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ANNEXU.K. Summary of product characteristics for a biocidal product family

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

META SPC 4 U.K.

1. META SPC 4 ADMINISTRATIVE INFORMATION U.K.

1.1. Meta SPC 4 identifier U.K.
IdentifiermetaSPC 4: PT3 – RTU Udder and Teat disinfectants Iodine
1.2. Suffix to the authorisation number U.K.
Number1-4
1.3. Product type(s) U.K.
Product type(s)PT03 – Veterinary hygiene (Disinfectants)

2. META SPC 4 COMPOSITION U.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 4 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive Substance7553-56-2231-442-40,30,3
Polyvinylpyrrolidone iodineActive Substance25655-41-80,00,0
Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active Substance68131-39-5500-195-72,172,17
Phosphoric acidPhosphoric acidNon-active Substance7664-38-2231-633-20,00,0
Alcohol C9-11 + 6 EOAlcohol C9-11 + 6 EONon-active Substance68439-46-30,00,0
2.2. Type(s) of formulation of the meta SPC 4 U.K.
Formulation(s)AL – Any other liquid

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

Hazard statementsHarmful to aquatic life with long lasting effects.
Precautionary statements

Avoid release to the environment.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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 U.K.

4.1. Use description U.K.
Table 4. Use # 1 – PT3– RTU Teat disinfectant, Post-milking, Iodine
Product typePT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)

Bacteria

Yeasts

Viruses

Field(s) of use

Indoor

Ready to use teat disinfectant to be used post milking on milk producing animals.

Application method(s)Dipping or spraying
Application rate(s) and frequency

The product is ready to use.

Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

Category(ies) of usersProfessional
Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.1.1. Use-specific instructions for use U.K.
For disinfection of the teats: U.K.

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2. Use description U.K.
Table 5. Use # 2 – PT3- RTU Udder disinfectant, Iodine
Product typePT03 – Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)

Yeasts

Bacteria

Field(s) of use

Indoor

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)Application on animal skin: by spraying
Application rate(s) and frequency

The product is ready to use.

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 usersProfessional
Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L

HDPE

4.2.1. Use-specific instructions for use U.K.
For disinfection of the skin: U.K.

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:

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5. GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 4 U.K.

5.1. Instructions for use U.K.

See use-specific instructions for use.

5.2. Risk mitigation measures U.K.

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 U.K.

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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

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

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

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 U.K.

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

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

Kenodin SD

IodoSD 3000

Bio Tec Jodspray 3000

Q Farm Iodine Des

ANRO – Euterpflege Dip

Stalosan Io Spray

Stalosan Super Spray

IDip+

Bühning Jodspray 3000

Velvet RTU

Wynnsan trikill spray

Wynnsan Iodine spray RTU

Wynngold Iodine Dip and spray

Pezerk IL

Iod protect 3000 Sprüh

Seivit® Iode Spray

IOD protect 3000 Sprüh

Kenodin SprayFilm

Iodo SP

Kenostart SD

GAHERYOD SPRAY

Iodin Teat & Skin 3000

Iod 3000 sprüh

Iodoschutz sprüh

Ioschutz sprüh

Iodocoop sprüh

Iodotech sprüh

Iodactiv’ sprüh

Iodosprüh

MIROX Spray Jod

HCP Iodine SD

Agib Jodium Spray

Jod 3000 spray

Iod sprüh

Coopjod

Coopiode spray

Iodocoop spray

Semex jod spray

Iododip spray

Iododip spray green

Iodospray Bio

Iospray bio

Iodactive spray

Iodactiv spray

Iodactiv’ spray

Ark Iodine S+D

Agrihealth Iodine SD

AGRO LOGIC JODOCARE SPRAY

IODACTIVE

Authorisation numberEU-0022265-0006 1-4
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive Substance7553-56-2231-442-40,3
Polyvinylpyrrolidone iodineActive Substance25655-41-80,0
Alcohols, C12-15, ethoxylatedAlcohols, C12-15, ethoxylatedNon-active Substance68131-39-5500-195-72,17
(1)

Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.