LegalizeCommission Implementing Regulation (EU) 2018/1261 of 20 September 2018 granting a Union authorisation for the biocidal product family Hypred's iodine based products (Text with EEA relevance.)
Article 1
A Union authorisation is granted to HYPRED SAS – KERSIA Group for the biocidal product family Hypred's iodine based products with authorisation number EU-0018397-0000.
The Union authorisation is valid from 11 October 2018 until 30 September 2028.
The Union authorisation is subject to compliance with the SPC set out in the Annex.
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.
ANNEX
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
| Name | HYPRED's iodine based products |
|---|---|
| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| 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 |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
| 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 | |||||
| --- | --- | |||||
PART II
SECOND INFORMATION LEVEL - META SPC(S)
META SPC 1
| Identifier | meta SPC 1 : Dipping products - ready to use |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Common name | IUPAC name |
| --- | --- |
| Min | Max |
| Iodine | |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy |
| 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 | — 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 |
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 |
META SPC 2
| 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 |
| --- | --- |
| Min | Max |
| Iodine | |
| Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio) | Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy |
| 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 | — 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 |
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 | — 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 |
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.
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.