Document ID: 02018R1261-20201227
Language: ENG

02018R1261 — EN — 27.12.2020 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2018/1261</p><p>of 20&#160;September 2018</p><p>granting a Union authorisation for the biocidal product family Hypred's iodine based products</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 238 21.9.2018, p. 33)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2020/1995&#160;of 4 December 2020</a></p></td><td><p>&#160;&#160;L&#160;410</p></td><td><p>70</p></td><td><p>7.12.2020</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2018/1261
of 20 September 2018
granting a Union authorisation for the biocidal product family Hypred's iodine based products
(Text with EEA relevance)
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
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
<table><col/><col/><tbody><tr><td><p>Name</p></td><td><p>HYPRED's iodine based products</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
1.2. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
1.3. Authorisation holder
<table><col/><col/><col/><tbody><tr><td><p>Name and address of the authorisation holder</p></td><td><p>Name</p></td><td><p>HYPRED SAS &#8211; KERSIA Group</p></td></tr><tr><td><p>Address</p></td><td><p>55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex France</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0018397-0000</p></td></tr><tr><td><p><span>R4BP asset number</span></p></td><td><p>EU-0018397-0000</p></td></tr><tr><td><p>Date of the authorisation</p></td><td><p>11 October 2018</p></td></tr><tr><td><p>Expiry date of the authorisation</p></td><td><p>30 September 2028</p></td></tr></tbody></table>
1.4. Manufacturer(s) of the biocidal products
<table><col/><col/><tbody><tr><td><p>Name of manufacturer</p></td><td><p>HYPRED SAS &#8211; KERSIA Group</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>55, Boulevard Jules Verger - BP10180 35803 DINARD France</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>HYPRED SAS &#8211; KERSIA Group - 55, Boulevard Jules Verger - BP10180 35803 DINARD France</p><p>KERSIA POLSKA Sp.z.o.o. - NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland</p><p>KERSIA IBERICA SL - Pol. Miguel Egu&#237;a C/Zarapuz s/n</p><p>31200 ESTELLA (NAVARRA) Spain</p><p>KERSIA DEUTSCHLAND GmbH Marie-Curie-Stra&#223;e 23 53332 Bornheim &#8211; Sechtem Germany</p><p>HYPRED Italia s.r.l. &#8211; KERSIA Group Strada Montodine-Gombito Loc. C&#224; Nova 26010 Ripalta Arpina CR Italy</p><p>AG France S.A.S &#8211; KERSIA Group - Zone Industrielle Le Roineau, 72500 VAAS, FRANCE</p><p>KERSIA DEUTSCHLAND GmbH - OBERBR&#220;HLSTRA&#223;E 16-18, 87700 MEMMINGEN, GERMANY</p><p>KERSIA AUSTRIA GmbH - PFONGAUERSTRA&#223;E 17, 5202 NEUMARKT AM WALLERSEE, AUSTRIA</p><p>Kilco Holdings Ltd &#8211; KERSIA Group - Broomhouses 2 Industrial Estate, Old Glasgow Road, LOCKERBIE - DG11 2SD, UNITED KINGDOM</p><p>Kilco (International) Ltd &#8211; KERSIA Group - 1A Trench Road Mallusk, Newtownabbey, CO ANTRIM BT36 4TY, IRELAND</p><p>Medentech Ltd &#8211; KERSIA Group - Clonard Road, WEXFORD, Y35Y7WY, IRELAND</p></td></tr></tbody></table>
1.5. Manufacturer(s) of the active substance(s)
<table><col/><col/><tbody><tr><td><p>Active substance</p></td><td><p>Iodine</p></td></tr><tr><td><p>Name of manufacturer</p></td><td><p>COSAYACH : SCM C&#237;a. Cosayach Minera Negreiros, Rut. N&#176;96.625.710-5</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Terrenos de Elena S/N Terrenos de Elena S/N Huara, Regi&#243;n de Tarapac&#225; Chile</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Mined at: S.C.M. C&#237;a. Minera Negreiros, S.C.M. Cosayach Soledad.</p><p>Refined at: S.C.M. C&#237;a. Minera Negreiros. Pozo Almonte Chile</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Active substance</p></td><td><p>Iodine</p></td></tr><tr><td><p>Name of manufacturer</p></td><td><p>ACF MINERA SA</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>San Mart&#237;n 499 Iquique Chile</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Faena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Active substance</p></td><td><p>Iodine</p></td></tr><tr><td><p>Name of manufacturer</p></td><td><p>SOCIEDAD QUIMICA y MINERA SA</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>Los Militares 4290 SANTIAGO DE CHILE Chile</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Pedro de Valdivia (PV) Route B 180 Antofagasta Chile</p><p>Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Active substance</p></td><td><p>Iodine</p></td></tr><tr><td><p>Name of manufacturer</p></td><td><p>ISE Chemicals Corporation</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>3-1, Kyobashi 1-Chome, Chuo-ku, Tokyo Japan</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Shirasato Plant (3695 Kitaimaizumi, Oamishirasato City, Chiba, Japan)</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>Active substance</p></td><td><p>Iodine</p></td></tr><tr><td><p>Name of manufacturer</p></td><td><p>Nihon Tennen Gas Development Co., Ltd</p></td></tr><tr><td><p>Address of manufacturer</p></td><td><p>661 Mobara 297-8550 Mobara City, Chiba Japan</p></td></tr><tr><td><p>Location of manufacturing sites</p></td><td><p>Chiba Plant, 2508 Minami Hinata, 299-4205 Shirako-Machi, Chosei-Gun, Chiba Japan</p></td></tr></tbody></table>
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,25</p></td><td><p>2,5</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>2,697</p></td><td><p>24,199</p></td></tr></tbody></table>
2.2. Type(s) of formulation
<table><col/><col/><tbody><tr><td><p>Formulation(s)</p></td><td><p>AL - Any other liquid</p><p>SL - Soluble concentrate</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
PART II
SECOND INFORMATION LEVEL - META SPC(S)
META SPC 1
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 1 : Dipping products - ready to use</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-1</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,25</p></td><td><p>0,49</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>2,697</p></td><td><p>4,993</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 1
<table><col/><col/><tbody><tr><td><p>Formulation</p></td><td><p>AL - Any other liquid</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Causes serious eye irritation.</p><p>Harmful to aquatic life with long lasting effects.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep out of reach of children.</p><p>Wash hands thoroughly after handling.</p><p>Wear protective gloves.</p><p>Wear protective clothing.</p><p>Wear eye protection.</p><p>IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>If eye irritation persists: Get medical advice/attention.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 1
4.1. Use description
Table 1. Use # 1 – Manual or automated dipping after milking
<table><col/><col/><tbody><tr><td><p>Product Type</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Bacteria</p><p>Yeasts</p><p>Algae</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of teats of milk producing animals by dipping after milking</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Dipping -</p><p>Manual or automated disinfection of teats by dipping after milking.</p><p>Dipping cup or automated dipping machine.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><div><p>&#8212;&#160;cows and buffaloes (3 to 10ml : 5&#160;ml recommended)</p></div><div><p>&#8212;&#160;sheep (1.5 to 5&#160;ml : 1.5&#160;ml recommended)</p></div><div><p>&#8212;&#160;goats (2.5 to 6&#160;ml : 2.5&#160;ml recommended)</p></div><p>Frequency : 2 to 3 times per day</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>HDPE JERRYCAN 5, 10, 22 L</p><p>HDPE DRUM 60, 120, 220 L</p><p>HDPE CONTAINER 1000L</p></td></tr></tbody></table>
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
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>Dip-io 2500</p><p>JOD DIP</p><p>IODERM PSP</p><p>DERMINO FR</p><p>Iododip</p><p>IODEX EXTRA</p><p>Iodystrong</p><p>DERMIODE</p><p>INO IODE EPAIS</p><p>INO STAR +</p><p>IODACTIV 2500</p><p>IODIUM BX2500</p><p>Usual Iod Post</p><p>ASiRAL Dip Coat</p><p>IODOCAN EXTRA</p><p>UDDER PLUS</p><p>PRIMADIODE</p><p>CERTIODE EPAIS</p><p>IODIPACK GEL</p><p>HELIO IODE EPAIS</p><p>VAGEL</p><p>GELAPIS ACTIV</p><p>IOSAPIS GEL</p><p>ZENCARE FLASH</p><p>REPROGEL</p><p>DERMADINE +</p><p>KRONI Jod Dipp 2500</p><p>W&#220;BBELMANN JOD DIP</p><p>Iodine Cleaner&amp;Sanitizer</p><p>MUNGIFILM</p><p>ZEP FS FILMIODINE NIPPLE NP</p><p>IODOFILM</p><p>EMPRASAN UDDER SHIELD</p><p>ANGLIA FARMERS IO-FILM</p><p>BARRICADE</p><p>STANTON IODOFILM</p><p>WYNNSAN IOFILM TEAT DIP</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0018397-0001 1-1</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,25</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>2,697</p></td></tr></tbody></table>
7.2. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>Dip-io YB MAX</p><p>INO Io Dip MAX</p><p>JOD DIP YB MAX</p><p>IodoDip YB MAX</p><p>Iodium Dip YB MAX</p><p>JodyDip YB MAX</p><p>Delta IoDip YB MAX</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0018397-0002 1-1</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,49</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>4,993</p></td></tr></tbody></table>
META SPC 2
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 2 : Dipping, foaming, spraying products - Ready to use</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-2</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,25</p></td><td><p>0,49</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>2,697</p></td><td><p>4,69</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 2
<table><col/><col/><tbody><tr><td><p>Formulation</p></td><td><p>AL - Any other liquid</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Causes serious eye irritation.</p><p>Harmful to aquatic life with long lasting effects.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep out of reach of children.</p><p>Wash hands thoroughly after handling.</p><p>Wear protective gloves.</p><p>Wear protective clothing.</p><p>Wear eye protection.</p><p>IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>If eye irritation persists: Get medical advice/attention.</p></td></tr></tbody></table>
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
<table><col/><col/><tbody><tr><td><p>Product Type</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Bacteria</p><p>Yeasts</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Dipping, foaming or spraying before milking -</p><p>Manual or automated disinfection of teats by dipping, foaming or spraying before milking</p><p>Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><div><p>&#8212;&#160;cows and buffaloes (3 to 10ml : 5 to 8&#160;ml recommended)</p></div><div><p>&#8212;&#160;sheep (1.5 to 5&#160;ml : 1.5 to 3ml recommended)</p></div><div><p>&#8212;&#160;goats (2.5 to 6&#160;ml : 2.5 to 4&#160;ml recommended)</p></div><p>Frequency : 2 to 3 times per day</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>HDPE JERRYCAN 5, 10, 22 L</p><p>HDPE DRUM 60, 120, 220 L</p><p>HDPE CONTAINER 1000L</p></td></tr></tbody></table>
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
<table><col/><col/><tbody><tr><td><p>Product Type</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Bacteria</p><p>Yeasts</p><p>Algae</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Dipping, foaming, spraying after milking -</p><p>Manual or automated disinfection of teats by dipping, foaming or spraying after milking</p><p>Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><div><p>&#8212;&#160;cows and buffaloes (3 to 10ml : 5 to 8&#160;ml recommended)</p></div><div><p>&#8212;&#160;sheep (1,5 to 5&#160;ml : 1,5 to 3ml recommended)</p></div><div><p>&#8212;&#160;goats (2,5 to 6&#160;ml : 2,5 to 4&#160;ml recommended)</p></div><p>Frequency : 2 to 3 times per day</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>HDPE JERRYCAN 5, 10, 22 L</p><p>HDPE DRUM 60, 120, 220 L</p><p>HDPE CONTAINER 1000L</p></td></tr></tbody></table>
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
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>Liq-io 2500</p><p>JOD SPRAY</p><p>IODINE 3000 RTU</p><p>IODEX 2500</p><p>Usual Iod Liquid</p><p>Iodoliquid</p><p>Iodospray</p><p>DESINTEAT</p><p>IODYSPRAY</p><p>RBT 2500</p><p>IODY&#8217;FLASH</p><p>INO IODE SPRAY</p><p>IODYPRO 2500</p><p>IODYPRO BL2500</p><p>Robot Liq-io 25</p><p>ADF iDip+</p><p>ASiRAL Dip Spray J</p><p>IODIPACK</p><p>HELIO IODE LIQUIDE</p><p>POLY-IODE</p><p>CERTIODE LIQUIDE</p><p>IOSAPIS FLUID</p><p>GELAPIS ROBOT</p><p>ZENCARE SPRAY</p><p>HELIO IODE SPRAY +</p><p>IODIP +</p><p>KRONI Jod Spray 2500</p><p>W&#220;BBELMANN JOD LIQUID</p><p>PRECEPT</p><p>ANGLIA FARMERS PRECLENZ</p><p>H&amp;M PREDIP</p><p>FULLWOOD PRECLEANSE</p><p>M WILLIAMS PRECEPT</p><p>STANTON PREDIP RTU</p><p>WYNNSAN IODINE PREDIP RTU</p><p>PREMIER GOLD PRE-DIP</p><p>HODGES &amp; MOSS PREDIP</p><p>LANODIP PREPOST</p><p>DAIRYSAN MULTICARE</p><p>EMPRASAN ADVANCE</p><p>UDDERWASH IODINE</p><p>ANGLIA FARMERS PREPOST-IO</p><p>PREMIER GOLD PRE/POST</p><p>FULLWOOD PRE/POST IODINE</p><p>HODGES &amp; MOSS ADVANCE</p><p>WYNNSAN IODINE PREPOST</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0018397-0003 1-2</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,25</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>2,697</p></td></tr></tbody></table>
7.2. Trade name(s), authorisation number and specific composition of each individual product
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>Liq-io YB MAX</p><p>INO Io Liquid Max</p><p>Iodoliquid YB MAX</p><p>Iodospray YB MAX</p><p>Desinteat YB MAX</p><p>Iodium Spray YB MAX</p><p>JodySpray YB MAX</p><p>Delta IoSpray YB MAX</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0018397-0004 1-2</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,49</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>4,69</p></td></tr></tbody></table>
META SPC 3
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 3 : Dipping, foaming, spraying concentrated products</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-3</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
2. META SPC 3 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 3
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>2,5</p></td><td><p>2,5</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>24,199</p></td><td><p>24,199</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 3
<table><col/><col/><tbody><tr><td><p>Formulation</p></td><td><p>SL - Soluble concentrate</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Causes serious eye damage.</p><p>May cause damage to organs (thyroid) through prolonged or repeated exposure oral.</p><p>Toxic to aquatic life with long lasting effects.</p><p>May be corrosive to metals.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep out of reach of children.</p><p>Do not breathe mist.</p><p>Do not breathe vapours.</p><p>Do not breathe spray.</p><p>Wash hands thoroughly after handling.</p><p>Wear protective gloves.</p><p>Wear protective clothing.</p><p>Wear eye protection.</p><p>IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>Immediately call a poison center / doctor.</p><p>Get medical advice/attention if you feel unwell.</p><p>Dispose of contents to in accordance with local/ regional/ national/ international regulations. Dispose of container to in accordance with local/ regional/ national/ international regulations.</p><p>Keep only in original container.</p><p>Absorb spillage to prevent material damage.</p></td></tr></tbody></table>
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
<table><col/><col/><tbody><tr><td><p>Product Type</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Bacteria</p><p>Yeasts</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Dipping, foaming, spraying -</p><p>Manual or automated disinfection of teats by dipping, foaming or spraying before milking.</p><p>Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>A dilution at 10% (v/v) should be prepared</p><p>Application rate for the diluted product:</p><div><p>&#8212;&#160;cows and buffaloes (3 to 10ml : 5 to 8&#160;ml recommended)</p></div><div><p>&#8212;&#160;sheep (1.5 to 5&#160;ml: 1.5 to 3&#160;ml recommended)</p></div><div><p>&#8212;&#160;goats (2.5 to 6&#160;ml: 2.5 to 4&#160;ml recommended)</p></div><p>Frequency: 2 to 3 times per day</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>HDPE JERRYCAN 5, 10, 22 L</p><p>HDPE DRUM 60, 120, 220 L</p><p>HDPE CONTAINER 1000L</p></td></tr></tbody></table>
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
<table><col/><col/><tbody><tr><td><p>Product Type</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Bacteria</p><p>Yeasts</p><p>Algae</p><p>Viruses</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Dipping, foaming, spraying -</p><p>Manual or automated disinfection of teats by dipping, foaming or spraying after milking.</p><p>Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><p>For disinfection of bacteria, yeasts and algae a dilution at 10% (v/v: 10&#160;ml product, add water up to 100ml) should be prepared.</p><p>For disinfection of viruses a dilution at 20% (v/v: 20&#160;ml product, add water up to 100ml) should be prepared</p><p>Application rate for the diluted product:</p><div><p>&#8212;&#160;cows and buffaloes (3 to 10ml : 5 to 8&#160;ml recommended)</p></div><div><p>&#8212;&#160;sheep (1,5 to 5&#160;ml : 1,5 to 3ml recommended)</p></div><div><p>&#8212;&#160;goats (2,5 to 6&#160;ml : 2,5 to 4&#160;ml recommended)</p></div><p>Frequency : 2 to 3 times per day</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>HDPE JERRYCAN 5, 10, 22 L</p><p>HDPE DRUM 60, 120, 220 L</p><p>HDPE CONTAINER 1000L</p></td></tr></tbody></table>
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
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>Liq-io concentrate</p><p>INO Jod Konzentrat</p><p>Usual Iod Concent</p><p>Iodoconcentrat</p><p>D 10 IODINE</p><p>D 5 IODINE</p><p>Liq-io C</p><p>INO IODE C</p><p>D 4 IODINE</p><p>ADF iDip+ concentrate</p><p>Mammizan Concentr&#233;</p><p>WYNNSAN IODINE CONCENTRATE</p><p>EMPRASAN OPTIMA</p><p>ANGLIA FARMERS CONC</p><p>PROLAC SENTINEL CONC</p><p>PREMIER GOLD CONCENTRATE</p><p>FULLWOOD IODINE CONC</p><p>H&amp;M OPTIMA</p><p>SENTINAL CONC</p><p>HARRY TRAVIS SUPER CONC TEAT DIP</p><p>LANODIP CONC</p><p>E/SAN SOVEREIGN</p><p>PROLAC SENTINEL CONC</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0018397-0005 1-3</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>2,5</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>24,199</p></td></tr></tbody></table>
META SPC 4
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 4 : Dipping products reaching virucidal activity &#8211; Ready to use</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-4</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
2. META SPC 4 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 4
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,5</p></td><td><p>0,5</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>4,993</p></td><td><p>4,993</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 4
<table><col/><col/><tbody><tr><td><p>Formulation</p></td><td><p>AL - Any other liquid</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Causes serious eye irritation.</p><p>Harmful to aquatic life with long lasting effects.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep out of reach of children.</p><p>Wash hands thoroughly after handling.</p><p>Wear protective gloves.</p><p>Wear protective clothing.</p><p>Wear eye protection.</p><p>IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>If eye irritation persists: Get medical advice/attention.</p></td></tr></tbody></table>
4. AUTHORISED USE(S) OF THE META SPC 4
4.1. Use description
Table 6. Use # 1 – Manual or automated dipping after milking
<table><col/><col/><tbody><tr><td><p>Product Type</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Bacteria</p><p>Yeasts</p><p>Algae</p><p>Viruses</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of teats of milk producing animals by dipping after milking</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Dipping -</p><p>Manual or automated disinfection of teats by dipping after milking.</p><p>Dipping cup or automated dipping machine.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><div><p>&#8212;&#160;cows and buffaloes (3 to 10ml : 5&#160;ml recommended)</p></div><div><p>&#8212;&#160;sheep (1,5 to 5&#160;ml : 1,5&#160;ml recommended)</p></div><div><p>&#8212;&#160;goats (2,5 to 6&#160;ml : 2,5&#160;ml recommended)</p></div><p>Frequency : 2 to 3 times per day</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>HDPE JERRYCAN 5, 10, 22 L</p><p>HDPE DRUM 60, 120, 220 L</p><p>HDPE CONTAINER 1000L</p></td></tr></tbody></table>
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
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>Dip-io 5000</p><p>IODIUM TX</p><p>INO JOD 50 DIP</p><p>Usual Iod Post +</p><p>IODIUM PRO DIP</p><p>IODERM PSP +</p><p>IODEX EXTRA +</p><p>Iododip +</p><p>IODYSTRONG PLUS</p><p>INO TREMP</p><p>INO STAR</p><p>IODACTIV 5000</p><p>DERMINO</p><p>IODERM 5000</p><p>IODIUM BX5000</p><p>HOEVE-PLUS DIP</p><p>TREMPASEPT IODE</p><p>DERMADINE</p><p>MAMMO-DERM</p><p>KRONI Jod Dipp 5000</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0018397-0006 1-4</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,5</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>4,993</p></td></tr></tbody></table>
META SPC 5
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 5 identifier
<table><col/><col/><tbody><tr><td><p>Identifier</p></td><td><p>meta SPC 5 : Dipping, foaming, spraying products 5500&#160;ppm &#8211; Ready to use</p></td></tr></tbody></table>
1.2. Suffix to the authorisation number
<table><col/><col/><tbody><tr><td><p>Number</p></td><td><p>1-5</p></td></tr></tbody></table>
1.3. Product type(s)
<table><col/><col/><tbody><tr><td><p>Product type(s)</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
2. META SPC 5 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 5
<table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Min</p></td><td><p>Max</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,55</p></td><td><p>0,55</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>4,69</p></td><td><p>4,69</p></td></tr></tbody></table>
2.2. Type(s) of formulation of the meta SPC 5
<table><col/><col/><tbody><tr><td><p>Formulation</p></td><td><p>AL - Any other liquid</p></td></tr><tr><td><p>&#160;</p><div/></td><td><p>&#160;</p><div/></td></tr></tbody></table>
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
<table><col/><col/><tbody><tr><td><p>Hazard statements</p></td><td><p>Causes serious eye irritation.</p><p>Harmful to aquatic life with long lasting effects.</p></td></tr><tr><td><p>Precautionary statements</p></td><td><p>Keep out of reach of children.</p><p>Wash hands thoroughly after handling.</p><p>Wear protective gloves.</p><p>Wear protective clothing.</p><p>Wear eye protection.</p><p>IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.</p><p>If eye irritation persists: Get medical advice/attention.</p></td></tr></tbody></table>
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
<table><col/><col/><tbody><tr><td><p>Product Type</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>&#160;</p><div/></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Bacteria</p><p>Yeasts</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Dipping, foaming, spraying -</p><p>Manual or automated disinfection of teats by dipping, foaming or spraying before milking</p><p>Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><div><p>&#8212;&#160;cows and buffaloes (3 to 10ml : 5 to 8&#160;ml recommended)</p></div><div><p>&#8212;&#160;sheep (1,5 to 5&#160;ml : 1,5 to 3ml recommended)</p></div><div><p>&#8212;&#160;goats (2,5 to 6&#160;ml : 2,5 to 4&#160;ml recommended)</p></div><p>Frequency : 2 to 3 times per day</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>HDPE JERRYCAN 5, 10, 22 L</p><p>HDPE DRUM 60, 120, 220 L</p><p>HDPE CONTAINER 1000L</p></td></tr></tbody></table>
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
<table><col/><col/><tbody><tr><td><p>Product Type</p></td><td><p>PT03 - Veterinary hygiene (Disinfectants)</p></td></tr><tr><td><p>Where relevant, an exact description of the authorised use</p></td><td><p>-</p></td></tr><tr><td><p>Target organism(s) (including development stage)</p></td><td><p>Bacteria</p><p>Yeasts</p><p>Algae</p><p>Viruses</p></td></tr><tr><td><p>Field(s) of use</p></td><td><p>Indoor</p><p>Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking</p></td></tr><tr><td><p>Application method(s)</p></td><td><p>Dipping, foaming, spraying -</p><p>Manual or automated disinfection of teats by dipping, foaming or spraying after milking.</p><p>Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.</p></td></tr><tr><td><p>Application rate(s) and frequency</p></td><td><div><p>&#8212;&#160;cows and buffaloes (3 to 10ml : 5 to 8&#160;ml recommended)</p></div><div><p>&#8212;&#160;sheep (1,5 to 5&#160;ml : 1,5 to 3ml recommended)</p></div><div><p>&#8212;&#160;goats (2,5 to 6&#160;ml : 2,5 to 4&#160;ml recommended)</p></div><p>Frequency : 2 to 3 times per day</p></td></tr><tr><td><p>Category(ies) of users</p></td><td><p>Professional</p></td></tr><tr><td><p>Pack sizes and packaging material</p></td><td><p>HDPE JERRYCAN 5, 10, 22 L</p><p>HDPE DRUM 60, 120, 220 L</p><p>HDPE CONTAINER 1000L</p></td></tr></tbody></table>
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
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Trade name(s)</p></td><td><p>Liq-io 5500</p><p>IODYPRO</p><p>INO JOD 50 Liquid</p><p>Usual Iod Liquid +</p><p>IODIUM PRO SPRAY</p><p>IODEX</p><p>Iodoliquid +</p><p>Iodospray Plus</p><p>DESINTEAT PLUS</p><p>ROBOSPRAY IODE</p><p>INOTRAYON</p><p>IODYPRO 5500</p><p>Robot Liq-io 55</p><p>IODYPRO BL5500</p><p>ADF iDip+ 5500</p><p>HOEVE-JODIUM SPRAY</p><p>GRUPAIODE</p><p>IODOCAN</p><p>JOFO</p><p>JODI PLUS</p><p>K-AGRO PRODIP ID</p><p>IODIP</p><p>HELIO IODE SPRAY</p><p>MAMMO-JOD</p><p>KRONI Jod Spray 5500</p><p>MUNGI-IOD</p><p>LELY QUARESS-Iodine</p><p>GOLD GLYCODIP</p><p>EMPRASAN EXTRA CARE</p><p>H&amp;M RTU IODINE</p><p>ANGLIA FARMERS SUPPLEDIP-IO</p><p>PROLAC RTU IODINE TEAT DIP</p><p>PREMIER GOLD POST DIP</p><p>FULLWOOD IODINE EXTRA</p><p>H&amp;M EXTRACARE</p><p>M WILLIAMS TEAT DIP</p><p>PLATINUM</p><p>WDH GOLD DIP RTU</p><p>WYNNSAN IODINE HE RTU</p></td></tr><tr><td><p>Authorisation number</p></td><td><p>EU-0018397-0007 1-5</p></td></tr><tr><td><p>Common name</p></td><td><p>IUPAC name</p></td><td><p>Function</p></td><td><p>CAS number</p></td><td><p>EC number</p></td><td><p>Content (%)</p></td></tr><tr><td><p>Iodine</p></td><td><p>&#160;</p><div/></td><td><p>Active substance</p></td><td><p>7553-56-2</p></td><td><p>231-442-4</p></td><td><p>0,55</p></td></tr><tr><td><p>Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)</p></td><td><p>Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy</p></td><td><p>Non active substance</p></td><td><p>68439-50-9</p></td><td><p>&#160;</p><div/></td><td><p>4,69</p></td></tr></tbody></table>
<note>
( 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.
</note>