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Commission Implementing Regulation (EU) 2020/1995Show full title

Commission Implementing Regulation (EU) 2020/1995 of 4 December 2020 amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ (Text with EEA relevance)

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META SPC 5

1.META SPC 5 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 5 identifier
Identifiermeta SPC 5 : Dipping, foaming, spraying products 5500 ppm – Ready to use
1.2. Suffix to the authorisation number
Number1-5
1.3. Product type(s)
Product type(s)PT03 - Veterinary hygiene (Disinfectants)

2.META SPC 5 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 5
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive substance7553-56-2231-442-40,550,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-94,694,69
2.2. Type(s) of formulation of the meta SPC 5
FormulationAL - Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements

Causes serious eye irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep out of reach of children.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

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

4.1. Use description
Table 7. Use # 1 – Manual or automated dipping, foaming or spraying before milking
Product TypePT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Target organism(s) (including development stage)

Bacteria

Yeasts

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking

Application method(s)

Dipping, foaming, spraying -

Manual or automated disinfection of teats by dipping, foaming or spraying before milking

Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

Application rate(s) and frequency
  • cows and buffaloes (3 to 10ml : 5 to 8 ml recommended)

  • sheep (1,5 to 5 ml : 1,5 to 3ml recommended)

  • goats (2,5 to 6 ml : 2,5 to 4 ml recommended)

Frequency : 2 to 3 times per day

Category(ies) of usersProfessional
Pack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L

HDPE DRUM 60, 120, 220 L

HDPE CONTAINER 1000L

4.1.1. Use-specific instructions for use

Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product.

Eliminate all visible dirt before applying the product.

Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat before milking.

Let the product act at least one minute.

Use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC5.

4.1.2. Use-specific risk mitigation measures

For manual dipping/foaming application : Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/ eye protection.

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.

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

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 of meta SPC 5

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

See general directions for use of meta SPC 5

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

See general directions for use of meta SPC 5

4.2. Use description
Table 8. Use # 2 – Manual or automated dipping, foaming or spraying after milking
Product TypePT03 - Veterinary hygiene (Disinfectants)
Where relevant, an exact description of the authorised use-
Target organism(s) (including development stage)

Bacteria

Yeasts

Algae

Viruses

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking

Application method(s)

Dipping, foaming, spraying -

Manual or automated disinfection of teats by dipping, foaming or spraying after milking.

Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.

Application rate(s) and frequency
  • cows and buffaloes (3 to 10ml : 5 to 8 ml recommended)

  • sheep (1,5 to 5 ml : 1,5 to 3ml recommended)

  • goats (2,5 to 6 ml : 2,5 to 4 ml recommended)

Frequency : 2 to 3 times per day

Category(ies) of usersProfessional
Pack sizes and packaging material

HDPE JERRYCAN 5, 10, 22 L

HDPE DRUM 60, 120, 220 L

HDPE CONTAINER 1000L

4.2.1. Use-specific instructions for use

Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product.

Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.

Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)

At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

See also general instructions for use of meta SPC 5.

4.2.2. Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

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

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 of meta SPC 5

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

See general directions for use of meta SPC 5

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 of meta SPC 5

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

5.1. Instructions for use

See use-specific instructions for each use.

Always read the label or leaflet before use and follow all the instructions provided.

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

The use of a dosing pump for filling the product into the application equipment is recommended.

Where necessary repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures

See use-specific risk mitigation measures for each use.

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

FIRST AID INSTRUCTIONS

  • In the event of inhalation: Bring to fresh air.

  • In the event of contact with the skin: Wash with water.

  • In the event of contact with the eyes :

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice/attention.

  • In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

Refer to the safety data sheet available for professional user: it contains an emergency phone number.

Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

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.

The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

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

Shelf life : 2 years in HDPE

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

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)

Liq-io 5500

IODYPRO

INO JOD 50 Liquid

Usual Iod Liquid +

IODIUM PRO SPRAY

IODEX

Iodoliquid +

Iodospray Plus

DESINTEAT PLUS

ROBOSPRAY IODE

INOTRAYON

IODYPRO 5500

Robot Liq-io 55

IODYPRO BL5500

ADF iDip+ 5500

HOEVE-JODIUM SPRAY

GRUPAIODE

IODOCAN

JOFO

JODI PLUS

K-AGRO PRODIP ID

IODIP

HELIO IODE SPRAY

MAMMO-JOD

KRONI Jod Spray 5500

MUNGI-IOD

LELY QUARESS-Iodine

GOLD GLYCODIP

EMPRASAN EXTRA CARE

H&M RTU IODINE

ANGLIA FARMERS SUPPLEDIP-IO

PROLAC RTU IODINE TEAT DIP

PREMIER GOLD POST DIP

FULLWOOD IODINE EXTRA

H&M EXTRACARE

M WILLIAMS TEAT DIP

PLATINUM

WDH GOLD DIP RTU

WYNNSAN IODINE HE RTU

Authorisation numberEU-0018397-0007 1-5
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive substance7553-56-2231-442-40,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-94,69
(1)

Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.

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