Commission Implementing Regulation (EU) 2018/1261 of 20 September 2018 granting a Union authorisation for the biocidal product family Hypred's iodine based products (Text with EEA relevance.)

ANNEX
ANNEX
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 I
FIRST INFORMATION LEVEL
1.    ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
HYPRED's iodine based products
1.2.    Product type(s)
Product type(s)
PT03 - Veterinary hygiene (Disinfectants)
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
Hypred SAS
Address
55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex France
Authorisation number
EU-0018397-0000
R4BP asset number
EU-0018397-0000
Date of the authorisation
11 October 2018
Expiry date of the authorisation
30 September 2028
1.4.    Manufacturer(s) of the biocidal products
Name of manufacturer
HYPRED SAS
Address of manufacturer
55, Boulevard Jules Verger - BP10180 35803 DINARD France
Location of manufacturing sites
HYPRED SAS - 55, Boulevard Jules Verger - BP10180 35803 DINARD France
HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland
HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C n o  32 31160 Orcoyen – NAVARRA Spain
HYPRED GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany
HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Iodine
Name of manufacturer
COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. N°96.625.710-5
Address of manufacturer
Terrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá Chile
Location of manufacturing sites
Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad.
Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile
Active substance
Iodine
Name of manufacturer
ACF MINERA SA
Address of manufacturer
San Martín 499 Iquique Chile
Location of manufacturing sites
Faena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile
Active substance
Iodine
Name of manufacturer
SOCIEDAD QUIMICA y MINERA SA
Address of manufacturer
Los Militares 4290 SANTIAGO DE CHILE Chile
Location of manufacturing sites
Pedro de Valdivia (PV) Route B 180 Antofagasta Chile
Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile
2.    PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1.    Qualitative and quantitative information on the composition of the family
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Iodine
Active substance
7553-56-2
231-442-4
0,25
2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
2,697
24,199
2.2.    Type(s) of formulation
Formulation(s)
AL - Any other liquid
SL - Soluble concentrate
PART II
SECOND INFORMATION LEVEL - META SPC(S)
META SPC 1
1.   META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
meta SPC 1: Dipping products - ready to use
1.2.    Suffix to the authorisation number
Number
1-1
1.3.    Product type(s)
Product type(s)
PT03 - Veterinary hygiene (Disinfectants)
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 (%)
Min
Max
Iodine
Active substance
7553-56-2
231-442-4
0,25
0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
2,697
4,993
2.2.    Type(s) of formulation of the meta SPC 1
Formulation
AL - Any other liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
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 1
4.1.    Use description
Table 1. Use # 1 – Manual or automated dipping after milking
Product Type
PT03 - 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 10 ml: 5 ml recommended)
—
sheep (1,5 to 5 ml: 1,5 ml recommended)
—
goats (2,5 to 6 ml: 2,5 ml recommended)
Frequency: 2 to 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
HDPE JERRYCAN 5, 10, 22 L
HDPE DRUM 60, 120, 220 L
HDPE CONTAINER 1 000  L
4.1.1.    Use-specific instructions for use
See general directions for use of meta SPC 1
4.1.2.    Use-specific risk mitigation measures
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
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
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
See general directions for use of meta SPC 1
5.   GENERAL DIRECTIONS FOR USE  ( 1 ) OF THE META SPC 1
5.1.    Instructions for 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 cup manually or automatically with the ready to use product.
Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.
—
cows and buffaloes (3 to 10 ml: 5 ml recommended)
—
sheep (1,5 to 5 ml: 1,5 ml recommended)
—
goats (2,5 to 6 ml: 2,5 ml recommended)
Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
Where necessary, repeat the application after each milking.
Clean the application equipment regularly with warm water.
5.2.    Risk mitigation measures
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
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 1
7.1.    Trade name(s), authorisation number and specific composition of each individual product
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
Authorisation number
EU-0018397-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active substance
7553-56-2
231-442-4
0,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
2,697
7.2.    Trade name(s), authorisation number and specific composition of each individual product
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 number
EU-0018397-0002 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active substance
7553-56-2
231-442-4
0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
4,993
META SPC 2
1.   META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
meta SPC 2: Dipping, foaming, spraying products - Ready to use
1.2.    Suffix to the authorisation number
Number
1-2
1.3.    Product type(s)
Product type(s)
PT03 - Veterinary hygiene (Disinfectants)
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 (%)
Min
Max
Iodine
Active substance
7553-56-2
231-442-4
0,25
0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
2,697
4,69
2.2.    Type(s) of formulation of the meta SPC 2
Formulation
AL - Any other liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
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 2
4.1.    Use description
Table 2. Use # 1 – Manual or automated dipping, foaming or spraying before milking
Product Type
PT03 - 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 10 ml: 5 to 8 ml recommended)
—
sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)
—
goats (2,5 to 6 ml: 2,5 to 4 ml recommended)
Frequency: 2 to 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
HDPE JERRYCAN 5, 10, 22 L
HDPE DRUM 60, 120, 220 L
HDPE CONTAINER 1 000 L
4.1.1.    Use-specific instructions for use
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
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 2
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 2
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 2
4.2.    Use description
Table 3. Use # 2 – Manual or automated dipping, foaming or spraying after milking
Product Type
PT03 - 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 10 ml: 5 to 8 ml recommended)
—
sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)
—
goats (2,5 to 6 ml: 2,5 to 4 ml recommended)
Frequency: 2 to 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
HDPE JERRYCAN 5, 10, 22 L
HDPE DRUM 60, 120, 220 L
HDPE CONTAINER 1 000 L
4.2.1.    Use-specific instructions for use
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
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 2
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 2
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 2
5.   GENERAL DIRECTIONS FOR USE  ( 2 ) OF THE META SPC 2
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. 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
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 2
7.1.    Trade name(s), authorisation number and specific composition of each individual product
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
Authorisation number
EU-0018397-0003 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active substance
7553-56-2
231-442-4
0,25
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
2,697
7.2.    Trade name(s), authorisation number and specific composition of each individual product
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 number
EU-0018397-0004 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active substance
7553-56-2
231-442-4
0,49
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
4,69
META SPC 3
1.   META SPC 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
meta SPC 3: Dipping, foaming, spraying concentrated products
1.2.    Suffix to the authorisation number
Number
1-3
1.3.    Product type(s)
Product type(s)
PT03 - Veterinary hygiene (Disinfectants)
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 (%)
Min
Max
Iodine
Active substance
7553-56-2
231-442-4
2,5
2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
24,199
24,199
2.2.    Type(s) of formulation of the meta SPC 3
Formulation
SL - Soluble concentrate
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
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 3
4.1.    Use description
Table 4. Use # 1 – Manual or automated dipping, foaming or spraying before milking
Product Type
PT03 - 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 10 ml: 5 to 8 ml recommended)
—
sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)
—
goats (2,5 to 6 ml: 2,5 to 4 ml recommended)
Frequency: 2 to 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
HDPE JERRYCAN 5, 10, 22 L
HDPE DRUM 60, 120, 220 L
HDPE CONTAINER 1 000 L
4.1.1.    Use-specific instructions for use
Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) 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
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 3
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 3
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 3
4.2.    Use description
Table 5. Use # 2 – Manual or automated dipping, foaming or spraying after milking
Product Type
PT03 - 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 100 ml) should be prepared.
For disinfection of viruses a dilution at 20 % (v/v: 20 ml product, add water up to 100 ml) should be prepared
Application rate for the diluted product:
—
cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)
—
sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)
—
goats (2,5 to 6 ml: 2,5 to 4 ml recommended)
Frequency: 2 to 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
HDPE JERRYCAN 5, 10, 22 L
HDPE DRUM 60, 120, 220 L
HDPE CONTAINER 1 000 L
4.2.1.    Use-specific instructions for use
Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal, yeasticidal and algaecidal activity or 20 % (v/v: 20 ml product, add water up to 100 ml) 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
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
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
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
See general directions for use of meta SPC 3
5.   GENERAL DIRECTIONS FOR USE  ( 3 ) OF THE META SPC 3
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. 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
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.
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
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 3
7.1.    Trade name(s), authorisation number and specific composition of each individual product
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
Authorisation number
EU-0018397-0005 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active substance
7553-56-2
231-442-4
2,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
24,199
META SPC 4
1.   META SPC 4 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 4 identifier
Identifier
meta SPC 4: Dipping products reaching virucidal activity – Ready to use
1.2.    Suffix to the authorisation number
Number
1-4
1.3.    Product type(s)
Product type(s)
PT03 - Veterinary hygiene (Disinfectants)
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 (%)
Min
Max
Iodine
Active substance
7553-56-2
231-442-4
0,5
0,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
4,993
4,993
2.2.    Type(s) of formulation of the meta SPC 4
Formulation
AL - Any other liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
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 4
4.1.    Use description
Table 6. Use # 1 – Manual or automated dipping after milking
Product Type
PT03 - 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 10 ml: 5 ml recommended)
—
sheep (1,5 to 5 ml: 1,5 ml recommended)
—
goats (2,5 to 6 ml: 2,5 ml recommended)
Frequency: 2 to 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
HDPE JERRYCAN 5, 10, 22 L
HDPE DRUM 60, 120, 220 L
HDPE CONTAINER 1 000 L
4.1.1.    Use-specific instructions for use
See general directions for use of meta SPC 4
4.1.2.    Use-specific risk mitigation measures
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
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
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
See general directions for use of meta SPC 4
5.   GENERAL DIRECTIONS FOR USE  ( 4 ) OF THE META SPC 4
5.1.    Instructions for 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 cup manually or automatically with the ready to use product.
Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.
—
cows and buffaloes (3 to 10 ml: 5 ml recommended)
—
sheep (1,5 to 5 ml: 1,5 ml recommended)
—
goats (2,5 to 6 ml: 2,5 ml recommended)
Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
Where necessary, repeat the application after each milking.
Clean the application equipment regularly with warm water.
5.2.    Risk mitigation measures
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
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 4
7.1.    Trade name(s), authorisation number and specific composition of each individual product
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 number
EU-0018397-0006 1-4
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active substance
7553-56-2
231-442-4
0,5
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
4,993
META SPC 5
1.   META SPC 5 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 5 identifier
Identifier
meta SPC 5: Dipping, foaming, spraying products 5 500  ppm – Ready to use
1.2.    Suffix to the authorisation number
Number
1-5
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 name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Iodine
Active substance
7553-56-2
231-442-4
0,55
0,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
4,69
4,69
2.2.    Type(s) of formulation of the meta SPC 5
Formulation
AL - 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 Type
PT03 - 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 10 ml: 5 to 8 ml recommended)
—
sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)
—
goats (2,5 to 6 ml: 2,5 to 4 ml recommended)
Frequency: 2 to 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
HDPE JERRYCAN 5, 10, 22 L
HDPE DRUM 60, 120, 220 L
HDPE CONTAINER 1 000 L
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 Type
PT03 - 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 10 ml: 5 to 8 ml recommended)
—
sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)
—
goats (2,5 to 6 ml: 2,5 to 4 ml recommended)
Frequency: 2 to 3 times per day
Category(ies) of users
Professional
Pack sizes and packaging material
HDPE JERRYCAN 5, 10, 22 L
HDPE DRUM 60, 120, 220 L
HDPE CONTAINER 1 000 L
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  ( 5 ) 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
Authorisation number
EU-0018397-0007 1-5
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Iodine
Active substance
7553-56-2
231-442-4
0,55
Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)
Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy
Non active substance
68439-50-9
4,69
( 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.
Commission Implementing Regulation (EU) 2018/1261 of 20 September 2018 granting a Union authorisation for the biocidal product family Hypred's iodine based products (Text with EEA relevance.)

Schedules & Appendices

Cite this act
