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)
Date: 2020-12-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal welfare, chemical product, decontamination, iodine, market approval








L_2020410EN.01007001.xml










7.12.2020   


EN


Official Journal of the European Union


L 410/70








            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)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 50(2) thereof,

Whereas:







(1)


On 20 September 2018, a Union authorisation with authorisation number EU-0018397-0000 was granted by Commission Implementing Regulation (EU) 2018/1261 (2) to HYPRED SAS for the making available on the market and use of the biocidal product family ‘Hypred’s iodine based products‘.












(2)


On 04 April 2019, HYPRED SAS submitted a notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), in respect of administrative changes to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ as described in Title 1, Sections 1 and 2 of the Annex to that Regulation.












(3)


HYPRED SAS proposed the following changes to the summary of the product characteristics for the biocidal product family ‘Hypred’s iodine based products’, as set out in the Annex to Implementing Regulation (EU) 2018/1261: (a) the addition of names for the biocidal product family in Section 7.1 of the third information level: individual products in the meta SPCs 1, 2, 3 and 5; (b) the change of the name of the authorisation holder in Section 1.3; (c) the addition of two manufacturers for the active substance and their respective manufacturing sites in Section 1.5; (d) the change of administrative details of the manufacturer in Section 1.4; (e) changes of administrative details of the location of existing manufacturing sites, and addition of location of new manufacturing sites in Section 1.4. The notification was recorded under case number BC-KC049719-36 in the Register for Biocidal Products.












(4)


On 19 June 2019, the Agency submitted to the Commission an opinion on the proposed changes, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder falls under the category of change set out in Article 50(3)(a) of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 to that Regulation are still met.












(5)


On 28 June 2019, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.












(6)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to amend the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’.












(7)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS REGULATION:



Article 1
Implementing Regulation (EU) 2018/1261 is amended as follows:






(1)


in Article 1, ‘HYPRED SAS’ is replaced by ‘HYPRED SAS – KERSIA Group’;










(2)


the Annex is replaced by the Annex to this Regulation.






Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 December 2020.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  Commission Implementing Regulation (EU) 2018/1261 of 20 September 2018 granting a Union authorisation for the biocidal product family Hypred’s iodine based products (OJ L 238, 21.9.2018, p. 33).

(3)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).




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 – KERSIA Group




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 – KERSIA Group




Address of manufacturer


55, 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)







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













Active substance


Iodine




Name of manufacturer


ISE Chemicals Corporation




Address of manufacturer


3-1, Kyobashi 1-Chome, Chuo-ku, Tokyo Japan




Location of manufacturing sites


Shirasato Plant (3695 Kitaimaizumi, Oamishirasato City, Chiba, Japan)













Active substance


Iodine




Name of manufacturer


Nihon Tennen Gas Development Co., Ltd




Address of manufacturer


661 Mobara 297-8550 Mobara City, Chiba Japan




Location of manufacturing sites


Chiba Plant, 2508 Minami Hinata, 299-4205 Shirako-Machi, Chosei-Gun, Chiba Japan




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 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 users


Professional




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

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 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

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
IODOFILM
EMPRASAN UDDER SHIELD
ANGLIA FARMERS IO-FILM
BARRICADE
STANTON IODOFILM
WYNNSAN IOFILM TEAT DIP




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 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 users


Professional




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

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 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 users


Professional




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

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
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 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 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 users


Professional




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

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

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 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 users


Professional




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

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

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
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 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 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 users


Professional




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

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 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

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 5500 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 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 users


Professional




Pack sizes and packaging material


HDPE JERRYCAN 5, 10, 22 L
HDPE DRUM 60, 120, 220 L
HDPE CONTAINER 1000L




4.1.1.   Use-specific instructions for use

Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product.
Eliminate all visible dirt before applying the product.
Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat before milking.
Let the product act at least one minute.
Use the teat cleaning and wiping method systematically before attaching the milking cluster.
See also general instructions for use of meta SPC5.
4.1.2.   Use-specific risk mitigation measures

For manual dipping/foaming application : Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/ eye protection.
For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.
In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5
4.2.   Use description


Table 8. Use # 2 – Manual or automated dipping, foaming or spraying after milking







Product 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 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 users


Professional




Pack sizes and packaging material


HDPE JERRYCAN 5, 10, 22 L
HDPE DRUM 60, 120, 220 L
HDPE CONTAINER 1000L




4.2.1.   Use-specific instructions for use

Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product.
Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.
Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
See also general instructions for use of meta SPC 5.
4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.
In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use of meta SPC 5
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5
5.   GENERAL DIRECTIONS FOR USE (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
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 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.