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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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Changes over time for: Commission Implementing Regulation (EU) 2020/1995 (Annexes only)

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

HYPRED's iodine based products

Product type 3 - Veterinary hygiene (Disinfectants)

Authorisation number: EU-0018397-0000

R4BP asset number: EU-0018397-0000

PART IU.K. FIRST INFORMATION LEVEL

1.ADMINISTRATIVE INFORMATIONU.K.

1.1. Family name U.K.

NameHYPRED's iodine based products

1.2. Product type(s) U.K.

Product type(s)PT03 - Veterinary hygiene (Disinfectants)

1.3. Authorisation holder U.K.

Name and address of the authorisation holderNameHYPRED SAS – KERSIA Group
Address55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex France
Authorisation numberEU-0018397-0000
R4BP asset numberEU-0018397-0000
Date of the authorisation11 October 2018
Expiry date of the authorisation30 September 2028

1.4. Manufacturer(s) of the biocidal products U.K.

Name of manufacturerHYPRED SAS – KERSIA Group
Address of manufacturer55, Boulevard Jules Verger - BP10180 35803 DINARD France
Location of manufacturing sites

HYPRED SAS – KERSIA Group - 55, Boulevard Jules Verger - BP10180 35803 DINARD France

KERSIA POLSKA Sp.z.o.o. - NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland

KERSIA IBERICA SL - Pol. Miguel Eguía C/Zarapuz s/n

31200 ESTELLA (NAVARRA) Spain

KERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany

HYPRED Italia s.r.l. – KERSIA Group Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy

AG France S.A.S – KERSIA Group - Zone Industrielle Le Roineau, 72500 VAAS, FRANCE

KERSIA DEUTSCHLAND GmbH - OBERBRÜHLSTRAßE 16-18, 87700 MEMMINGEN, GERMANY

KERSIA AUSTRIA GmbH - PFONGAUERSTRAßE 17, 5202 NEUMARKT AM WALLERSEE, AUSTRIA

Kilco Holdings Ltd – KERSIA Group - Broomhouses 2 Industrial Estate, Old Glasgow Road, LOCKERBIE - DG11 2SD, UNITED KINGDOM

Kilco (International) Ltd – KERSIA Group - 1A Trench Road Mallusk, Newtownabbey, CO ANTRIM BT36 4TY, IRELAND

Medentech Ltd – KERSIA Group - Clonard Road, WEXFORD, Y35Y7WY, IRELAND

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

Active substanceIodine
Name of manufacturerCOSAYACH : SCM Cía. Cosayach Minera Negreiros, Rut. N°96.625.710-5
Address of manufacturerTerrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá Chile
Location of manufacturing sites

Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad.

Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile

Active substanceIodine
Name of manufacturerACF MINERA SA
Address of manufacturerSan Martín 499 Iquique Chile
Location of manufacturing sitesFaena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile
Active substanceIodine
Name of manufacturerSOCIEDAD QUIMICA y MINERA SA
Address of manufacturerLos Militares 4290 SANTIAGO DE CHILE Chile
Location of manufacturing sites

Pedro de Valdivia (PV) Route B 180 Antofagasta Chile

Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile

Active substanceIodine
Name of manufacturerISE Chemicals Corporation
Address of manufacturer3-1, Kyobashi 1-Chome, Chuo-ku, Tokyo Japan
Location of manufacturing sitesShirasato Plant (3695 Kitaimaizumi, Oamishirasato City, Chiba, Japan)
Active substanceIodine
Name of manufacturerNihon Tennen Gas Development Co., Ltd
Address of manufacturer661 Mobara 297-8550 Mobara City, Chiba Japan
Location of manufacturing sitesChiba Plant, 2508 Minami Hinata, 299-4205 Shirako-Machi, Chosei-Gun, Chiba Japan

2.PRODUCT FAMILY COMPOSITION AND FORMULATIONU.K.

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

Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive substance7553-56-2231-442-40,252,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-92,69724,199

2.2. Type(s) of formulation U.K.

Formulation(s)

AL - Any other liquid

SL - Soluble concentrate

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

META SPC 1 U.K.

1.META SPC 1 ADMINISTRATIVE INFORMATIONU.K.

1.1. Meta SPC 1 identifier U.K.
Identifiermeta SPC 1 : Dipping products - ready to use
1.2. Suffix to the authorisation number U.K.
Number1-1
1.3. Product type(s) U.K.
Product type(s)PT03 - Veterinary hygiene (Disinfectants)

2.META SPC 1 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 1 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive substance7553-56-2231-442-40,250,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-92,6974,993
2.2. Type(s) of formulation of the meta SPC 1 U.K.
FormulationAL - Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1U.K.

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 1U.K.

4.1. Use description U.K.
Table 1. Use # 1 – Manual or automated dipping 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

Field(s) of use

Indoor

Disinfection of teats of milk producing animals by dipping after milking

Application method(s)

Dipping -

Manual or automated disinfection of teats by dipping after milking.

Dipping cup or automated dipping machine.

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

  • sheep (1.5 to 5 ml : 1.5 ml recommended)

  • goats (2.5 to 6 ml : 2.5 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 U.K.

See general directions for use of meta SPC 1

4.1.2. Use-specific risk mitigation measures U.K.

See general directions for use of meta SPC 1

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 of meta SPC 1

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

None: See general directions for use of meta SPC 1

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 of meta SPC 1

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

5.1. Instructions for use U.K.

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

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

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

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

Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

  • cows and buffaloes (3 to 10ml : 5 ml recommended)

  • sheep (1.5 to 5 ml : 1.5 ml recommended)

  • goats (2.5 to 6 ml : 2.5 ml recommended)

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

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

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures U.K.

Wear eye protection.

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

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

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 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.

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 U.K.

Shelf life : 2 years in HDPE

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

6.OTHER INFORMATIONU.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

Dip-io 2500

JOD DIP

IODERM PSP

DERMINO FR

Iododip

IODEX EXTRA

Iodystrong

DERMIODE

INO IODE EPAIS

INO STAR +

IODACTIV 2500

IODIUM BX2500

Usual Iod Post

ASiRAL Dip Coat

IODOCAN EXTRA

UDDER PLUS

PRIMADIODE

CERTIODE EPAIS

IODIPACK GEL

HELIO IODE EPAIS

VAGEL

GELAPIS ACTIV

IOSAPIS GEL

ZENCARE FLASH

REPROGEL

DERMADINE +

KRONI Jod Dipp 2500

WÜBBELMANN JOD DIP

Iodine Cleaner&Sanitizer

MUNGIFILM

ZEP FS FILMIODINE NIPPLE NP

IODOFILM

EMPRASAN UDDER SHIELD

ANGLIA FARMERS IO-FILM

BARRICADE

STANTON IODOFILM

WYNNSAN IOFILM TEAT DIP

Authorisation numberEU-0018397-0001 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive substance7553-56-2231-442-40,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-92,697
7.2. Trade name(s), authorisation number and specific composition of each individual product U.K.
Trade name(s)

Dip-io YB MAX

INO Io Dip MAX

JOD DIP YB MAX

IodoDip YB MAX

Iodium Dip YB MAX

JodyDip YB MAX

Delta IoDip YB MAX

Authorisation numberEU-0018397-0002 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive substance7553-56-2231-442-40,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-94,993

META SPC 2 U.K.

1.META SPC 2 ADMINISTRATIVE INFORMATIONU.K.

1.1. Meta SPC 2 identifier U.K.
Identifiermeta SPC 2 : Dipping, foaming, spraying products - Ready to use
1.2. Suffix to the authorisation number U.K.
Number1-2
1.3. Product type(s) U.K.
Product type(s)PT03 - Veterinary hygiene (Disinfectants)

2.META SPC 2 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 2 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive substance7553-56-2231-442-40,250,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-92,6974,69
2.2. Type(s) of formulation of the meta SPC 2 U.K.
FormulationAL - Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2U.K.

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 2U.K.

4.1. Use description U.K.
Table 2. 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 or spraying before milking -

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 U.K.

Eliminate all visible dirt before applying the product.

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

Let the product act at least one minute.

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

See also general instructions for use of meta SPC 2.

4.1.2. Use-specific risk mitigation measures U.K.

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 U.K.

See general directions for use of meta SPC 2

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 of meta SPC 2

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 of meta SPC 2

4.2. Use description U.K.
Table 3. 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

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 after milking -

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 U.K.

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

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

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

See also general instructions for use of meta SPC 2.

4.2.2. Use-specific risk mitigation measures U.K.

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 U.K.

See general directions for use of meta SPC 2

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 of meta SPC 2

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 of meta SPC 2

5.GENERAL DIRECTIONS FOR USE(2) OF THE META SPC 2U.K.

5.1. Instructions for use U.K.

See use-specific instructions for each use.

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

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

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

Where necessary repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures U.K.

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 U.K.

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 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.

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 U.K.

Shelf life : 2 years in HDPE

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

6.OTHER INFORMATIONU.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

Liq-io 2500

JOD SPRAY

IODINE 3000 RTU

IODEX 2500

Usual Iod Liquid

Iodoliquid

Iodospray

DESINTEAT

IODYSPRAY

RBT 2500

IODY’FLASH

INO IODE SPRAY

IODYPRO 2500

IODYPRO BL2500

Robot Liq-io 25

ADF iDip+

ASiRAL Dip Spray J

IODIPACK

HELIO IODE LIQUIDE

POLY-IODE

CERTIODE LIQUIDE

IOSAPIS FLUID

GELAPIS ROBOT

ZENCARE SPRAY

HELIO IODE SPRAY +

IODIP +

KRONI Jod Spray 2500

WÜBBELMANN JOD LIQUID

PRECEPT

ANGLIA FARMERS PRECLENZ

H&M PREDIP

FULLWOOD PRECLEANSE

M WILLIAMS PRECEPT

STANTON PREDIP RTU

WYNNSAN IODINE PREDIP RTU

PREMIER GOLD PRE-DIP

HODGES & MOSS PREDIP

LANODIP PREPOST

DAIRYSAN MULTICARE

EMPRASAN ADVANCE

UDDERWASH IODINE

ANGLIA FARMERS PREPOST-IO

PREMIER GOLD PRE/POST

FULLWOOD PRE/POST IODINE

HODGES & MOSS ADVANCE

WYNNSAN IODINE PREPOST

Authorisation numberEU-0018397-0003 1-2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive substance7553-56-2231-442-40,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-92,697
7.2. Trade name(s), authorisation number and specific composition of each individual product U.K.
Trade name(s)

Liq-io YB MAX

INO Io Liquid Max

Iodoliquid YB MAX

Iodospray YB MAX

Desinteat YB MAX

Iodium Spray YB MAX

JodySpray YB MAX

Delta IoSpray YB MAX

Authorisation numberEU-0018397-0004 1-2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive substance7553-56-2231-442-40,49
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

META SPC 3 U.K.

1.META SPC 3 ADMINISTRATIVE INFORMATIONU.K.

1.1. Meta SPC 3 identifier U.K.
Identifiermeta SPC 3 : Dipping, foaming, spraying concentrated products
1.2. Suffix to the authorisation number U.K.
Number1-3
1.3. Product type(s) U.K.
Product type(s)PT03 - Veterinary hygiene (Disinfectants)

2.META SPC 3 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 3 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive substance7553-56-2231-442-42,52,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-924,19924,199
2.2. Type(s) of formulation of the meta SPC 3 U.K.
FormulationSL - Soluble concentrate

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

Hazard statements

Causes serious eye damage.

May cause damage to organs (thyroid) through prolonged or repeated exposure oral.

Toxic to aquatic life with long lasting effects.

May be corrosive to metals.

Precautionary statements

Keep out of reach of children.

Do not breathe mist.

Do not breathe vapours.

Do not breathe spray.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear protective clothing.

Wear eye protection.

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

Immediately call a poison center / doctor.

Get medical advice/attention if you feel unwell.

Dispose of contents to in accordance with local/ regional/ national/ international regulations. Dispose of container to in accordance with local/ regional/ national/ international regulations.

Keep only in original container.

Absorb spillage to prevent material damage.

4.AUTHORISED USE(S) OF THE META SPC 3U.K.

4.1. Use description U.K.
Table 4. 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

A dilution at 10% (v/v) should be prepared

Application rate for the diluted product:

  • cows and buffaloes (3 to 10ml : 5 to 8 ml recommended)

  • sheep (1.5 to 5 ml: 1.5 to 3 ml recommended)

  • goats (2.5 to 6 ml: 2.5 to 4 ml recommended)

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 U.K.

Prepare a dilution at 10% (v/v: 10 ml product, add water up to 100ml) for bactericidal and yeasticidal activity.

Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.

Eliminate all visible dirt before applying the product.

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

Let the product act at least one minute.

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

See also general directions for use of meta SPC 3.

4.1.2. Use-specific risk mitigation measures U.K.

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 U.K.

See general directions for use of meta SPC 3

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 of meta SPC 3

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 of meta SPC 3

4.2. Use description U.K.
Table 5. 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

For disinfection of bacteria, yeasts and algae a dilution at 10% (v/v: 10 ml product, add water up to 100ml) should be prepared.

For disinfection of viruses a dilution at 20% (v/v: 20 ml product, add water up to 100ml) should be prepared

Application rate for the diluted product:

  • 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 U.K.

Prepare a dilution at 10% (v/v: 10 ml product, add water up to 100ml) for bactericidal, yeasticidal and algaecidal activity or 20% (v/v: 20 ml product, add water up to 100ml) in case virucidal activity is also needed.

Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.

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

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

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

See also general directions for use of meta SPC 3

4.2.2. Use-specific risk mitigation measures U.K.

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

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

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 of meta SPC 3

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 of meta SPC 3

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 of meta SPC 3

5.GENERAL DIRECTIONS FOR USE(3) OF THE META SPC 3U.K.

5.1. Instructions for use U.K.

See use-specific instructions for each use.

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

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

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.

Where necessary, repeat the application at each milking

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures U.K.

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 U.K.

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

In case of faintness, get medical advice/attention. Show this safety data sheet to the doctor.

FIRST AID INSTRUCTIONS

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

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

  • In the event of contact with the eyes: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open.

Remove contact lenses if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER or doctor/physician.

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

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

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

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.

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 U.K.

Shelf life : 2 years in HDPE

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

6.OTHER INFORMATIONU.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

Liq-io concentrate

INO Jod Konzentrat

Usual Iod Concent

Iodoconcentrat

D 10 IODINE

D 5 IODINE

Liq-io C

INO IODE C

D 4 IODINE

ADF iDip+ concentrate

Mammizan Concentré

WYNNSAN IODINE CONCENTRATE

EMPRASAN OPTIMA

ANGLIA FARMERS CONC

PROLAC SENTINEL CONC

PREMIER GOLD CONCENTRATE

FULLWOOD IODINE CONC

H&M OPTIMA

SENTINAL CONC

HARRY TRAVIS SUPER CONC TEAT DIP

LANODIP CONC

E/SAN SOVEREIGN

PROLAC SENTINEL CONC

Authorisation numberEU-0018397-0005 1-3
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive substance7553-56-2231-442-42,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-924,199

META SPC 4 U.K.

1.META SPC 4 ADMINISTRATIVE INFORMATIONU.K.

1.1. Meta SPC 4 identifier U.K.
Identifiermeta SPC 4 : Dipping products reaching virucidal activity – Ready to use
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 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 4 U.K.
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
IodineActive substance7553-56-2231-442-40,50,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-94,9934,993
2.2. Type(s) of formulation of the meta SPC 4 U.K.
FormulationAL - Any other liquid

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

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 4U.K.

4.1. Use description U.K.
Table 6. Use # 1 – Manual or automated dipping 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 after milking

Application method(s)

Dipping -

Manual or automated disinfection of teats by dipping after milking.

Dipping cup or automated dipping machine.

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

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

  • goats (2,5 to 6 ml : 2,5 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 U.K.

See general directions for use of meta SPC 4

4.1.2. Use-specific risk mitigation measures U.K.

See general directions for use of meta SPC 4

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 of meta SPC 4

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 of meta SPC 4

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 of meta SPC 4

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

5.1. Instructions for use U.K.

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

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

The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping cup manually or automatically with the ready to use product.

Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

  • cows and buffaloes (3 to 10ml : 5 ml recommended)

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

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

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

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

Where necessary, repeat the application after each milking.

Clean the application equipment regularly with warm water.

5.2. Risk mitigation measures U.K.

Wear eye protection.

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

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

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 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.

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 U.K.

Shelf life : 2 years in HDPE

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

6.OTHER INFORMATIONU.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

Dip-io 5000

IODIUM TX

INO JOD 50 DIP

Usual Iod Post +

IODIUM PRO DIP

IODERM PSP +

IODEX EXTRA +

Iododip +

IODYSTRONG PLUS

INO TREMP

INO STAR

IODACTIV 5000

DERMINO

IODERM 5000

IODIUM BX5000

HOEVE-PLUS DIP

TREMPASEPT IODE

DERMADINE

MAMMO-DERM

KRONI Jod Dipp 5000

Authorisation numberEU-0018397-0006 1-4
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
IodineActive substance7553-56-2231-442-40,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxyNon active substance68439-50-94,993

META SPC 5 U.K.

1.META SPC 5 ADMINISTRATIVE INFORMATIONU.K.

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

2.META SPC 5 COMPOSITIONU.K.

2.1. Qualitative and quantitative information on the composition of the meta SPC 5 U.K.
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 U.K.
FormulationAL - Any other liquid

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5U.K.

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 5U.K.

4.1. Use description U.K.
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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

See general directions for use of meta SPC 5

4.2. Use description U.K.
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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

See general directions for use of meta SPC 5

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

5.1. Instructions for use U.K.

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 U.K.

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 U.K.

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 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.

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 U.K.

Shelf life : 2 years in HDPE

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

6.OTHER INFORMATIONU.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

7.1. Trade name(s), authorisation number and specific composition of each individual product U.K.
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 SPC1.

(2)

Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.

(3)

Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.

(4)

Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.

(5)

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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