- Latest available (Revised)
- Point in Time (31/12/2020)
- Original (As adopted by EU)
Commission Implementing Regulation (EU) 2020/1995 of 4 December 2020 amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ (Text with EEA relevance)
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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:
Implementing Regulation (EU) 2018/1261 is amended as follows:
in Article 1, ‘HYPRED SAS’ is replaced by ‘HYPRED SAS – KERSIA Group’;
the Annex is replaced by the Annex to this Regulation.
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
HYPRED's iodine based products
Product type 3 - Veterinary hygiene (Disinfectants)
Authorisation number: EU-0018397-0000
R4BP asset number: EU-0018397-0000
Name | HYPRED's iodine based products |
Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
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 |
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 |
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 |
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 |
Formulation(s) | AL - Any other liquid SL - Soluble concentrate |
Identifier | meta SPC 1 : Dipping products - ready to use |
Number | 1-1 |
Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
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 |
Formulation | AL - Any other liquid |
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. |
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 |
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 |
See general directions for use of meta SPC 1
See general directions for use of meta SPC 1
See general directions for use of meta SPC 1
None: See general directions for use of meta SPC 1
See general directions for use of meta SPC 1
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.
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.
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.
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.
Shelf life : 2 years in HDPE
Do not store at a temperature higher than 30°C.
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 |
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 |
Identifier | meta SPC 2 : Dipping, foaming, spraying products - Ready to use |
Number | 1-2 |
Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
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 |
Formulation | AL - Any other liquid |
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. |
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 |
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 |
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.
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.
See general directions for use of meta SPC 2
See general directions for use of meta SPC 2
See general directions for use of meta SPC 2
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 |
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 |
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.
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.
See general directions for use of meta SPC 2
See general directions for use of meta SPC 2
See general directions for use of meta SPC 2
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.
See use-specific risk mitigation measures for each use.
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.
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.
Shelf life : 2 years in HDPE
Do not store at a temperature higher than 30°C.
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 |
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 |
Identifier | meta SPC 3 : Dipping, foaming, spraying concentrated products |
Number | 1-3 |
Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
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 |
Formulation | SL - Soluble concentrate |
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. |
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:
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 |
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.
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.
See general directions for use of meta SPC 3
See general directions for use of meta SPC 3
See general directions for use of meta SPC 3
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:
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 |
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
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.
See general directions for use of meta SPC 3
See general directions for use of meta SPC 3
See general directions for use of meta SPC 3
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.
See use-specific risk mitigation measures for each use.
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.
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.
Shelf life : 2 years in HDPE
Do not store at a temperature higher than 30°C.
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 |
Identifier | meta SPC 4 : Dipping products reaching virucidal activity – Ready to use |
Number | 1-4 |
Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
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 |
Formulation | AL - Any other liquid |
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. |
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 |
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 |
See general directions for use of meta SPC 4
See general directions for use of meta SPC 4
See general directions for use of meta SPC 4
See general directions for use of meta SPC 4
See general directions for use of meta SPC 4
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.
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.
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.
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.
Shelf life : 2 years in HDPE
Do not store at a temperature higher than 30°C.
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 |
Identifier | meta SPC 5 : Dipping, foaming, spraying products 5500 ppm – Ready to use |
Number | 1-5 |
Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
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 |
Formulation | AL - Any other liquid |
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. |
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 |
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 |
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.
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.
See general directions for use of meta SPC 5
See general directions for use of meta SPC 5
See general directions for use of meta SPC 5
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 |
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 |
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.
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.
See general directions for use of meta SPC 5
See general directions for use of meta SPC 5
See general directions for use of meta SPC 5
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.
See use-specific risk mitigation measures for each use.
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.
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.
Shelf life : 2 years in HDPE
Do not store at a temperature higher than 30°C.
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 |
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).
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).
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.
Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.
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