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Document 32020R1995

    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)

    C/2020/8483

    OJ L 410, 07/12/2020, p. 70–99 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    Legal status of the document In force

    ELI: http://data.europa.eu/eli/reg_impl/2020/1995/oj

    7.12.2020   

    EN

    Official Journal of the European Union

    L 410/70


    COMMISSION IMPLEMENTING REGULATION (EU) 2020/1995

    of 4 December 2020

    amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’

    (Text with EEA relevance)

    THE EUROPEAN COMMISSION,

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

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

    Whereas:

    (1)

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

    (2)

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

    (3)

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

    (4)

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

    (5)

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

    (6)

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

    (7)

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

    HAS ADOPTED THIS REGULATION:

    Article 1

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

    (1)

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

    (2)

    the Annex is replaced by the Annex to this Regulation.

    Article 2

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

    This Regulation shall be binding in its entirety and directly applicable in all Member States.

    Done at Brussels, 4 December 2020.

    For the Commission

    The President

    Ursula VON DER LEYEN


    (1)   OJ L 167, 27.6.2012, p. 1.

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

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


    ANNEX

    Summary of product characteristics for a biocidal product family

    HYPRED's iodine based products

    Product type 3 - Veterinary hygiene (Disinfectants)

    Authorisation number: EU-0018397-0000

    R4BP asset number: EU-0018397-0000

    PART I

    FIRST INFORMATION LEVEL

    1.   ADMINISTRATIVE INFORMATION

    1.1.   Family name

    Name

    HYPRED's iodine based products

     

     

    1.2.   Product type(s)

    Product type(s)

    PT03 - Veterinary hygiene (Disinfectants)

     

     

    1.3.   Authorisation holder

    Name and address of the authorisation holder

    Name

    HYPRED SAS – KERSIA Group

    Address

    55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex France

    Authorisation number

    EU-0018397-0000

    R4BP asset number

    EU-0018397-0000

    Date of the authorisation

    11 October 2018

    Expiry date of the authorisation

    30 September 2028

    1.4.   Manufacturer(s) of the biocidal products

    Name of manufacturer

    HYPRED SAS – KERSIA Group

    Address of manufacturer

    55, Boulevard Jules Verger - BP10180 35803 DINARD France

    Location of manufacturing sites

    HYPRED SAS – KERSIA Group - 55, Boulevard Jules Verger - BP10180 35803 DINARD France

    KERSIA POLSKA Sp.z.o.o. - NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland

    KERSIA IBERICA SL - Pol. Miguel Eguía C/Zarapuz s/n

    31200 ESTELLA (NAVARRA) Spain

    KERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany

    HYPRED Italia s.r.l. – KERSIA Group Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy

    AG France S.A.S – KERSIA Group - Zone Industrielle Le Roineau, 72500 VAAS, FRANCE

    KERSIA DEUTSCHLAND GmbH - OBERBRÜHLSTRAßE 16-18, 87700 MEMMINGEN, GERMANY

    KERSIA AUSTRIA GmbH - PFONGAUERSTRAßE 17, 5202 NEUMARKT AM WALLERSEE, AUSTRIA

    Kilco Holdings Ltd – KERSIA Group - Broomhouses 2 Industrial Estate, Old Glasgow Road, LOCKERBIE - DG11 2SD, UNITED KINGDOM

    Kilco (International) Ltd – KERSIA Group - 1A Trench Road Mallusk, Newtownabbey, CO ANTRIM BT36 4TY, IRELAND

    Medentech Ltd – KERSIA Group - Clonard Road, WEXFORD, Y35Y7WY, IRELAND

    1.5.   Manufacturer(s) of the active substance(s)

    Active substance

    Iodine

    Name of manufacturer

    COSAYACH : SCM Cía. Cosayach Minera Negreiros, Rut. N°96.625.710-5

    Address of manufacturer

    Terrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá Chile

    Location of manufacturing sites

    Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad.

    Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile


    Active substance

    Iodine

    Name of manufacturer

    ACF MINERA SA

    Address of manufacturer

    San Martín 499 Iquique Chile

    Location of manufacturing sites

    Faena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile


    Active substance

    Iodine

    Name of manufacturer

    SOCIEDAD QUIMICA y MINERA SA

    Address of manufacturer

    Los Militares 4290 SANTIAGO DE CHILE Chile

    Location of manufacturing sites

    Pedro de Valdivia (PV) Route B 180 Antofagasta Chile

    Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile


    Active substance

    Iodine

    Name of manufacturer

    ISE Chemicals Corporation

    Address of manufacturer

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

    Location of manufacturing sites

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


    Active substance

    Iodine

    Name of manufacturer

    Nihon Tennen Gas Development Co., Ltd

    Address of manufacturer

    661 Mobara 297-8550 Mobara City, Chiba Japan

    Location of manufacturing sites

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

    2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

    2.1.   Qualitative and quantitative information on the composition of the family

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Min

    Max

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,25

    2,5

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    2,697

    24,199

    2.2.   Type(s) of formulation

    Formulation(s)

    AL - Any other liquid

    SL - Soluble concentrate

     

     

    PART II

    SECOND INFORMATION LEVEL - META SPC(S)

    META SPC 1

    1.   META SPC 1 ADMINISTRATIVE INFORMATION

    1.1.   Meta SPC 1 identifier

    Identifier

    meta SPC 1 : Dipping products - ready to use

    1.2.   Suffix to the authorisation number

    Number

    1-1

    1.3.   Product type(s)

    Product type(s)

    PT03 - Veterinary hygiene (Disinfectants)

     

     

    2.   META SPC 1 COMPOSITION

    2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Min

    Max

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,25

    0,49

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    2,697

    4,993

    2.2.   Type(s) of formulation of the meta SPC 1

    Formulation

    AL - Any other liquid

     

     

    3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

    Hazard statements

    Causes serious eye irritation.

    Harmful to aquatic life with long lasting effects.

    Precautionary statements

    Keep out of reach of children.

    Wash hands thoroughly after handling.

    Wear protective gloves.

    Wear protective clothing.

    Wear eye protection.

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    If eye irritation persists: Get medical advice/attention.

    4.   AUTHORISED USE(S) OF THE META SPC 1

    4.1.   Use description

    Table 1. Use # 1 – Manual or automated dipping after milking

    Product Type

    PT03 - Veterinary hygiene (Disinfectants)

    Where relevant, an exact description of the authorised use

    -

    Target organism(s) (including development stage)

    Bacteria

    Yeasts

    Algae

    Field(s) of use

    Indoor

    Disinfection of teats of milk producing animals by dipping after milking

    Application method(s)

    Dipping -

    Manual or automated disinfection of teats by dipping after milking.

    Dipping cup or automated dipping machine.

    Application rate(s) and frequency

    cows and buffaloes (3 to 10ml : 5 ml recommended)

    sheep (1.5 to 5 ml : 1.5 ml recommended)

    goats (2.5 to 6 ml : 2.5 ml recommended)

    Frequency : 2 to 3 times per day

    Category(ies) of users

    Professional

    Pack sizes and packaging material

    HDPE JERRYCAN 5, 10, 22 L

    HDPE DRUM 60, 120, 220 L

    HDPE CONTAINER 1000L

    4.1.1.   Use-specific instructions for use

    See general directions for use of meta SPC 1

    4.1.2.   Use-specific risk mitigation measures

    See general directions for use of meta SPC 1

    4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    See general directions for use of meta SPC 1

    4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

    None: See general directions for use of meta SPC 1

    4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

    See general directions for use of meta SPC 1

    5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1

    5.1.   Instructions for use

    Always read the label or leaflet before use and follow all the instructions provided.

    The product must be brought to a temperature above 20°C before use.

    The use of a dosing pump for filling the product into the application equipment is recommended.

    Fill the dipping cup manually or automatically with the ready to use product.

    Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

    cows and buffaloes (3 to 10ml : 5 ml recommended)

    sheep (1.5 to 5 ml : 1.5 ml recommended)

    goats (2.5 to 6 ml : 2.5 ml recommended)

    Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

    At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

    Where necessary, repeat the application after each milking.

    Clean the application equipment regularly with warm water.

    5.2.   Risk mitigation measures

    Wear eye protection.

    In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

    5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

    FIRST AID INSTRUCTIONS

    In the event of inhalation: Bring to fresh air.

    In the event of contact with the skin: Wash with water.

    In the event of contact with the eyes :

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    If eye irritation persists: Get medical advice/attention.

    In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

    Refer to the safety data sheet available for professional user: it contains an emergency phone number.

    Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

    5.4.   Instructions for safe disposal of the product and its packaging

    At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

    The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

    5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

    Shelf life : 2 years in HDPE

    Do not store at a temperature higher than 30°C.

    6.   OTHER INFORMATION

    7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

    7.1.   Trade name(s), authorisation number and specific composition of each individual product

    Trade name(s)

    Dip-io 2500

    JOD DIP

    IODERM PSP

    DERMINO FR

    Iododip

    IODEX EXTRA

    Iodystrong

    DERMIODE

    INO IODE EPAIS

    INO STAR +

    IODACTIV 2500

    IODIUM BX2500

    Usual Iod Post

    ASiRAL Dip Coat

    IODOCAN EXTRA

    UDDER PLUS

    PRIMADIODE

    CERTIODE EPAIS

    IODIPACK GEL

    HELIO IODE EPAIS

    VAGEL

    GELAPIS ACTIV

    IOSAPIS GEL

    ZENCARE FLASH

    REPROGEL

    DERMADINE +

    KRONI Jod Dipp 2500

    WÜBBELMANN JOD DIP

    Iodine Cleaner&Sanitizer

    MUNGIFILM

    ZEP FS FILMIODINE NIPPLE NP

    IODOFILM

    EMPRASAN UDDER SHIELD

    ANGLIA FARMERS IO-FILM

    BARRICADE

    STANTON IODOFILM

    WYNNSAN IOFILM TEAT DIP

    Authorisation number

    EU-0018397-0001 1-1

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,25

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    2,697

    7.2.   Trade name(s), authorisation number and specific composition of each individual product

    Trade name(s)

    Dip-io YB MAX

    INO Io Dip MAX

    JOD DIP YB MAX

    IodoDip YB MAX

    Iodium Dip YB MAX

    JodyDip YB MAX

    Delta IoDip YB MAX

    Authorisation number

    EU-0018397-0002 1-1

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,49

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    4,993

    META SPC 2

    1.   META SPC 2 ADMINISTRATIVE INFORMATION

    1.1.   Meta SPC 2 identifier

    Identifier

    meta SPC 2 : Dipping, foaming, spraying products - Ready to use

    1.2.   Suffix to the authorisation number

    Number

    1-2

    1.3.   Product type(s)

    Product type(s)

    PT03 - Veterinary hygiene (Disinfectants)

     

     

    2.   META SPC 2 COMPOSITION

    2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Min

    Max

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,25

    0,49

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    2,697

    4,69

    2.2.   Type(s) of formulation of the meta SPC 2

    Formulation

    AL - Any other liquid

     

     

    3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

    Hazard statements

    Causes serious eye irritation.

    Harmful to aquatic life with long lasting effects.

    Precautionary statements

    Keep out of reach of children.

    Wash hands thoroughly after handling.

    Wear protective gloves.

    Wear protective clothing.

    Wear eye protection.

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    If eye irritation persists: Get medical advice/attention.

    4.   AUTHORISED USE(S) OF THE META SPC 2

    4.1.   Use description

    Table 2. Use # 1 – Manual or automated dipping, foaming or spraying before milking

    Product Type

    PT03 - Veterinary hygiene (Disinfectants)

    Where relevant, an exact description of the authorised use

    -

    Target organism(s) (including development stage)

    Bacteria

    Yeasts

    Field(s) of use

    Indoor

    Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking

    Application method(s)

    Dipping, foaming or spraying before milking -

    Manual or automated disinfection of teats by dipping, foaming or spraying before milking

    Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

    Application rate(s) and frequency

    cows and buffaloes (3 to 10ml : 5 to 8 ml recommended)

    sheep (1.5 to 5 ml : 1.5 to 3ml recommended)

    goats (2.5 to 6 ml : 2.5 to 4 ml recommended)

    Frequency : 2 to 3 times per day

    Category(ies) of users

    Professional

    Pack sizes and packaging material

    HDPE JERRYCAN 5, 10, 22 L

    HDPE DRUM 60, 120, 220 L

    HDPE CONTAINER 1000L

    4.1.1.   Use-specific instructions for use

    Eliminate all visible dirt before applying the product.

    Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

    Let the product act at least one minute.

    Use the teat cleaning and wiping method systematically before attaching the milking cluster.

    See also general instructions for use of meta SPC 2.

    4.1.2.   Use-specific risk mitigation measures

    For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/ eye protection.

    For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.

    In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

    4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    See general directions for use of meta SPC 2

    4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

    See general directions for use of meta SPC 2

    4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

    See general directions for use of meta SPC 2

    4.2.   Use description

    Table 3. Use # 2 – Manual or automated dipping, foaming or spraying after milking

    Product Type

    PT03 - Veterinary hygiene (Disinfectants)

    Where relevant, an exact description of the authorised use

    -

    Target organism(s) (including development stage)

    Bacteria

    Yeasts

    Algae

    Field(s) of use

    Indoor

    Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking

    Application method(s)

    Dipping, foaming, spraying after milking -

    Manual or automated disinfection of teats by dipping, foaming or spraying after milking

    Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

    Application rate(s) and frequency

    cows and buffaloes (3 to 10ml : 5 to 8 ml recommended)

    sheep (1,5 to 5 ml : 1,5 to 3ml recommended)

    goats (2,5 to 6 ml : 2,5 to 4 ml recommended)

    Frequency : 2 to 3 times per day

    Category(ies) of users

    Professional

    Pack sizes and packaging material

    HDPE JERRYCAN 5, 10, 22 L

    HDPE DRUM 60, 120, 220 L

    HDPE CONTAINER 1000L

    4.2.1.   Use-specific instructions for use

    Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.

    Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)

    At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

    See also general instructions for use of meta SPC 2.

    4.2.2.   Use-specific risk mitigation measures

    For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.

    In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

    4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    See general directions for use of meta SPC 2

    4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

    See general directions for use of meta SPC 2

    4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

    See general directions for use of meta SPC 2

    5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

    5.1.   Instructions for use

    See use-specific instructions for each use.

    Always read the label or leaflet before use and follow all the instructions provided.

    The product must be brought to a temperature above 20°C before use.

    The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.

    Where necessary repeat the application at each milking

    Clean the application equipment regularly with warm water.

    5.2.   Risk mitigation measures

    See use-specific risk mitigation measures for each use.

    5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

    FIRST AID INSTRUCTIONS

    In the event of inhalation: Bring to fresh air.

    In the event of contact with the skin: Wash with water.

    In the event of contact with the eyes :

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    If eye irritation persists: Get medical advice/attention.

    In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

    Refer to the safety data sheet available for professional user: it contains an emergency phone number.

    Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

    5.4.   Instructions for safe disposal of the product and its packaging

    At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

    The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

    5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

    Shelf life : 2 years in HDPE

    Do not store at a temperature higher than 30°C.

    6.   OTHER INFORMATION

    7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

    7.1.   Trade name(s), authorisation number and specific composition of each individual product

    Trade name(s)

    Liq-io 2500

    JOD SPRAY

    IODINE 3000 RTU

    IODEX 2500

    Usual Iod Liquid

    Iodoliquid

    Iodospray

    DESINTEAT

    IODYSPRAY

    RBT 2500

    IODY’FLASH

    INO IODE SPRAY

    IODYPRO 2500

    IODYPRO BL2500

    Robot Liq-io 25

    ADF iDip+

    ASiRAL Dip Spray J

    IODIPACK

    HELIO IODE LIQUIDE

    POLY-IODE

    CERTIODE LIQUIDE

    IOSAPIS FLUID

    GELAPIS ROBOT

    ZENCARE SPRAY

    HELIO IODE SPRAY +

    IODIP +

    KRONI Jod Spray 2500

    WÜBBELMANN JOD LIQUID

    PRECEPT

    ANGLIA FARMERS PRECLENZ

    H&M PREDIP

    FULLWOOD PRECLEANSE

    M WILLIAMS PRECEPT

    STANTON PREDIP RTU

    WYNNSAN IODINE PREDIP RTU

    PREMIER GOLD PRE-DIP

    HODGES & MOSS PREDIP

    LANODIP PREPOST

    DAIRYSAN MULTICARE

    EMPRASAN ADVANCE

    UDDERWASH IODINE

    ANGLIA FARMERS PREPOST-IO

    PREMIER GOLD PRE/POST

    FULLWOOD PRE/POST IODINE

    HODGES & MOSS ADVANCE

    WYNNSAN IODINE PREPOST

    Authorisation number

    EU-0018397-0003 1-2

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,25

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    2,697

    7.2.   Trade name(s), authorisation number and specific composition of each individual product

    Trade name(s)

    Liq-io YB MAX

    INO Io Liquid Max

    Iodoliquid YB MAX

    Iodospray YB MAX

    Desinteat YB MAX

    Iodium Spray YB MAX

    JodySpray YB MAX

    Delta IoSpray YB MAX

    Authorisation number

    EU-0018397-0004 1-2

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,49

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    4,69

    META SPC 3

    1.   META SPC 3 ADMINISTRATIVE INFORMATION

    1.1.   Meta SPC 3 identifier

    Identifier

    meta SPC 3 : Dipping, foaming, spraying concentrated products

    1.2.   Suffix to the authorisation number

    Number

    1-3

    1.3.   Product type(s)

    Product type(s)

    PT03 - Veterinary hygiene (Disinfectants)

     

     

    2.   META SPC 3 COMPOSITION

    2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Min

    Max

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    2,5

    2,5

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    24,199

    24,199

    2.2.   Type(s) of formulation of the meta SPC 3

    Formulation

    SL - Soluble concentrate

     

     

    3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

    Hazard statements

    Causes serious eye damage.

    May cause damage to organs (thyroid) through prolonged or repeated exposure oral.

    Toxic to aquatic life with long lasting effects.

    May be corrosive to metals.

    Precautionary statements

    Keep out of reach of children.

    Do not breathe mist.

    Do not breathe vapours.

    Do not breathe spray.

    Wash hands thoroughly after handling.

    Wear protective gloves.

    Wear protective clothing.

    Wear eye protection.

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    Immediately call a poison center / doctor.

    Get medical advice/attention if you feel unwell.

    Dispose of contents to in accordance with local/ regional/ national/ international regulations. Dispose of container to in accordance with local/ regional/ national/ international regulations.

    Keep only in original container.

    Absorb spillage to prevent material damage.

    4.   AUTHORISED USE(S) OF THE META SPC 3

    4.1.   Use description

    Table 4. Use # 1 – Manual or automated dipping, foaming or spraying before milking

    Product Type

    PT03 - Veterinary hygiene (Disinfectants)

    Where relevant, an exact description of the authorised use

     

    Target organism(s) (including development stage)

    Bacteria

    Yeasts

    Field(s) of use

    Indoor

    Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking

    Application method(s)

    Dipping, foaming, spraying -

    Manual or automated disinfection of teats by dipping, foaming or spraying before milking.

    Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

    Application rate(s) and frequency

    A dilution at 10% (v/v) should be prepared

    Application rate for the diluted product:

    cows and buffaloes (3 to 10ml : 5 to 8 ml recommended)

    sheep (1.5 to 5 ml: 1.5 to 3 ml recommended)

    goats (2.5 to 6 ml: 2.5 to 4 ml recommended)

    Frequency: 2 to 3 times per day

    Category(ies) of users

    Professional

    Pack sizes and packaging material

    HDPE JERRYCAN 5, 10, 22 L

    HDPE DRUM 60, 120, 220 L

    HDPE CONTAINER 1000L

    4.1.1.   Use-specific instructions for use

    Prepare a dilution at 10% (v/v: 10 ml product, add water up to 100ml) for bactericidal and yeasticidal activity.

    Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.

    Eliminate all visible dirt before applying the product.

    Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.

    Let the product act at least one minute.

    Use the teat cleaning and wiping method systematically before attaching the milking cluster.

    See also general directions for use of meta SPC 3.

    4.1.2.   Use-specific risk mitigation measures

    For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.

    In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

    4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    See general directions for use of meta SPC 3

    4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

    See general directions for use of meta SPC 3

    4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

    See general directions for use of meta SPC 3

    4.2.   Use description

    Table 5. Use # 2 – Manual or automated dipping, foaming or spraying after milking

    Product Type

    PT03 - Veterinary hygiene (Disinfectants)

    Where relevant, an exact description of the authorised use

    -

    Target organism(s) (including development stage)

    Bacteria

    Yeasts

    Algae

    Viruses

    Field(s) of use

    Indoor

    Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking

    Application method(s)

    Dipping, foaming, spraying -

    Manual or automated disinfection of teats by dipping, foaming or spraying after milking.

    Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

    Application rate(s) and frequency

    For disinfection of bacteria, yeasts and algae a dilution at 10% (v/v: 10 ml product, add water up to 100ml) should be prepared.

    For disinfection of viruses a dilution at 20% (v/v: 20 ml product, add water up to 100ml) should be prepared

    Application rate for the diluted product:

    cows and buffaloes (3 to 10ml : 5 to 8 ml recommended)

    sheep (1,5 to 5 ml : 1,5 to 3ml recommended)

    goats (2,5 to 6 ml : 2,5 to 4 ml recommended)

    Frequency : 2 to 3 times per day

    Category(ies) of users

    Professional

    Pack sizes and packaging material

    HDPE JERRYCAN 5, 10, 22 L

    HDPE DRUM 60, 120, 220 L

    HDPE CONTAINER 1000L

    4.2.1.   Use-specific instructions for use

    Prepare a dilution at 10% (v/v: 10 ml product, add water up to 100ml) for bactericidal, yeasticidal and algaecidal activity or 20% (v/v: 20 ml product, add water up to 100ml) in case virucidal activity is also needed.

    Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.

    Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.

    Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

    At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

    See also general directions for use of meta SPC 3

    4.2.2.   Use-specific risk mitigation measures

    For manual spraying applications wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) /protective clothing/eye protection.

    In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

    4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    See general directions for use of meta SPC 3

    4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

    See general directions for use of meta SPC 3

    4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

    See general directions for use of meta SPC 3

    5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

    5.1.   Instructions for use

    See use-specific instructions for each use.

    Always read the label or leaflet before use and follow all the instructions provided.

    The product must be brought to a temperature above 20°C before use.

    The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.

    Where necessary, repeat the application at each milking

    Clean the application equipment regularly with warm water.

    5.2.   Risk mitigation measures

    See use-specific risk mitigation measures for each use.

    5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

    In case of faintness, get medical advice/attention. Show this safety data sheet to the doctor.

    FIRST AID INSTRUCTIONS

    In the event of inhalation: Bring to fresh air.

    In the event of contact with the skin: Wash with water.

    In the event of contact with the eyes: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open.

    Remove contact lenses if present and easy to do. Continue rinsing.

    Immediately call a POISON CENTER or doctor/physician.

    In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

    Refer to the safety data sheet available for professional user: it contains an emergency phone number.

    Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

    5.4.   Instructions for safe disposal of the product and its packaging

    At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

    The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

    5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

    Shelf life : 2 years in HDPE

    Do not store at a temperature higher than 30°C.

    6.   OTHER INFORMATION

    7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

    7.1.   Trade name(s), authorisation number and specific composition of each individual product

    Trade name(s)

    Liq-io concentrate

    INO Jod Konzentrat

    Usual Iod Concent

    Iodoconcentrat

    D 10 IODINE

    D 5 IODINE

    Liq-io C

    INO IODE C

    D 4 IODINE

    ADF iDip+ concentrate

    Mammizan Concentré

    WYNNSAN IODINE CONCENTRATE

    EMPRASAN OPTIMA

    ANGLIA FARMERS CONC

    PROLAC SENTINEL CONC

    PREMIER GOLD CONCENTRATE

    FULLWOOD IODINE CONC

    H&M OPTIMA

    SENTINAL CONC

    HARRY TRAVIS SUPER CONC TEAT DIP

    LANODIP CONC

    E/SAN SOVEREIGN

    PROLAC SENTINEL CONC

    Authorisation number

    EU-0018397-0005 1-3

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    2,5

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    24,199

    META SPC 4

    1.   META SPC 4 ADMINISTRATIVE INFORMATION

    1.1.   Meta SPC 4 identifier

    Identifier

    meta SPC 4 : Dipping products reaching virucidal activity – Ready to use

    1.2.   Suffix to the authorisation number

    Number

    1-4

    1.3.   Product type(s)

    Product type(s)

    PT03 - Veterinary hygiene (Disinfectants)

     

     

    2.   META SPC 4 COMPOSITION

    2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Min

    Max

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,5

    0,5

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    4,993

    4,993

    2.2.   Type(s) of formulation of the meta SPC 4

    Formulation

    AL - Any other liquid

     

     

    3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

    Hazard statements

    Causes serious eye irritation.

    Harmful to aquatic life with long lasting effects.

    Precautionary statements

    Keep out of reach of children.

    Wash hands thoroughly after handling.

    Wear protective gloves.

    Wear protective clothing.

    Wear eye protection.

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    If eye irritation persists: Get medical advice/attention.

    4.   AUTHORISED USE(S) OF THE META SPC 4

    4.1.   Use description

    Table 6. Use # 1 – Manual or automated dipping after milking

    Product Type

    PT03 - Veterinary hygiene (Disinfectants)

    Where relevant, an exact description of the authorised use

    -

    Target organism(s) (including development stage)

    Bacteria

    Yeasts

    Algae

    Viruses

    Field(s) of use

    Indoor

    Disinfection of teats of milk producing animals by dipping after milking

    Application method(s)

    Dipping -

    Manual or automated disinfection of teats by dipping after milking.

    Dipping cup or automated dipping machine.

    Application rate(s) and frequency

    cows and buffaloes (3 to 10ml : 5 ml recommended)

    sheep (1,5 to 5 ml : 1,5 ml recommended)

    goats (2,5 to 6 ml : 2,5 ml recommended)

    Frequency : 2 to 3 times per day

    Category(ies) of users

    Professional

    Pack sizes and packaging material

    HDPE JERRYCAN 5, 10, 22 L

    HDPE DRUM 60, 120, 220 L

    HDPE CONTAINER 1000L

    4.1.1.   Use-specific instructions for use

    See general directions for use of meta SPC 4

    4.1.2.   Use-specific risk mitigation measures

    See general directions for use of meta SPC 4

    4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    See general directions for use of meta SPC 4

    4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

    See general directions for use of meta SPC 4

    4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

    See general directions for use of meta SPC 4

    5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4

    5.1.   Instructions for use

    Always read the label or leaflet before use and follow all the instructions provided.

    The product must be brought to a temperature above 20°C before use.

    The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping cup manually or automatically with the ready to use product.

    Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

    cows and buffaloes (3 to 10ml : 5 ml recommended)

    sheep (1,5 to 5 ml : 1,5 ml recommended)

    goats (2,5 to 6 ml : 2,5 ml recommended)

    Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).

    At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

    Where necessary, repeat the application after each milking.

    Clean the application equipment regularly with warm water.

    5.2.   Risk mitigation measures

    Wear eye protection.

    In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

    5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

    FIRST AID INSTRUCTIONS

    In the event of inhalation: Bring to fresh air.

    In the event of contact with the skin: Wash with water.

    In the event of contact with the eyes :

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    If eye irritation persists: Get medical advice/attention.

    In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

    Refer to the safety data sheet available for professional user: it contains an emergency phone number.

    Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

    5.4.   Instructions for safe disposal of the product and its packaging

    At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

    The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

    5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

    Shelf life : 2 years in HDPE

    Do not store at a temperature higher than 30°C.

    6.   OTHER INFORMATION

    7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

    7.1.   Trade name(s), authorisation number and specific composition of each individual product

    Trade name(s)

    Dip-io 5000

    IODIUM TX

    INO JOD 50 DIP

    Usual Iod Post +

    IODIUM PRO DIP

    IODERM PSP +

    IODEX EXTRA +

    Iododip +

    IODYSTRONG PLUS

    INO TREMP

    INO STAR

    IODACTIV 5000

    DERMINO

    IODERM 5000

    IODIUM BX5000

    HOEVE-PLUS DIP

    TREMPASEPT IODE

    DERMADINE

    MAMMO-DERM

    KRONI Jod Dipp 5000

    Authorisation number

    EU-0018397-0006 1-4

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,5

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    4,993

    META SPC 5

    1.   META SPC 5 ADMINISTRATIVE INFORMATION

    1.1.   Meta SPC 5 identifier

    Identifier

    meta SPC 5 : Dipping, foaming, spraying products 5500 ppm – Ready to use

    1.2.   Suffix to the authorisation number

    Number

    1-5

    1.3.   Product type(s)

    Product type(s)

    PT03 - Veterinary hygiene (Disinfectants)

     

     

    2.   META SPC 5 COMPOSITION

    2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Min

    Max

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,55

    0,55

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    4,69

    4,69

    2.2.   Type(s) of formulation of the meta SPC 5

    Formulation

    AL - Any other liquid

     

     

    3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

    Hazard statements

    Causes serious eye irritation.

    Harmful to aquatic life with long lasting effects.

    Precautionary statements

    Keep out of reach of children.

    Wash hands thoroughly after handling.

    Wear protective gloves.

    Wear protective clothing.

    Wear eye protection.

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    If eye irritation persists: Get medical advice/attention.

    4.   AUTHORISED USE(S) OF THE META SPC 5

    4.1.   Use description

    Table 7. Use # 1 – Manual or automated dipping, foaming or spraying before milking

    Product Type

    PT03 - Veterinary hygiene (Disinfectants)

    Where relevant, an exact description of the authorised use

     

    Target organism(s) (including development stage)

    Bacteria

    Yeasts

    Field(s) of use

    Indoor

    Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking

    Application method(s)

    Dipping, foaming, spraying -

    Manual or automated disinfection of teats by dipping, foaming or spraying before milking

    Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

    Application rate(s) and frequency

    cows and buffaloes (3 to 10ml : 5 to 8 ml recommended)

    sheep (1,5 to 5 ml : 1,5 to 3ml recommended)

    goats (2,5 to 6 ml : 2,5 to 4 ml recommended)

    Frequency : 2 to 3 times per day

    Category(ies) of users

    Professional

    Pack sizes and packaging material

    HDPE JERRYCAN 5, 10, 22 L

    HDPE DRUM 60, 120, 220 L

    HDPE CONTAINER 1000L

    4.1.1.   Use-specific instructions for use

    Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product.

    Eliminate all visible dirt before applying the product.

    Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat before milking.

    Let the product act at least one minute.

    Use the teat cleaning and wiping method systematically before attaching the milking cluster.

    See also general instructions for use of meta SPC5.

    4.1.2.   Use-specific risk mitigation measures

    For manual dipping/foaming application : Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/ eye protection.

    For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.

    In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.

    4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    See general directions for use of meta SPC 5

    4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

    See general directions for use of meta SPC 5

    4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

    See general directions for use of meta SPC 5

    4.2.   Use description

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

    Product Type

    PT03 - Veterinary hygiene (Disinfectants)

    Where relevant, an exact description of the authorised use

    -

    Target organism(s) (including development stage)

    Bacteria

    Yeasts

    Algae

    Viruses

    Field(s) of use

    Indoor

    Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking

    Application method(s)

    Dipping, foaming, spraying -

    Manual or automated disinfection of teats by dipping, foaming or spraying after milking.

    Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.

    Application rate(s) and frequency

    cows and buffaloes (3 to 10ml : 5 to 8 ml recommended)

    sheep (1,5 to 5 ml : 1,5 to 3ml recommended)

    goats (2,5 to 6 ml : 2,5 to 4 ml recommended)

    Frequency : 2 to 3 times per day

    Category(ies) of users

    Professional

    Pack sizes and packaging material

    HDPE JERRYCAN 5, 10, 22 L

    HDPE DRUM 60, 120, 220 L

    HDPE CONTAINER 1000L

    4.2.1.   Use-specific instructions for use

    Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product.

    Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.

    Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)

    At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.

    See also general instructions for use of meta SPC 5.

    4.2.2.   Use-specific risk mitigation measures

    For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.

    In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.

    4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    See general directions for use of meta SPC 5

    4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

    See general directions for use of meta SPC 5

    4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

    See general directions for use of meta SPC 5

    5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5

    5.1.   Instructions for use

    See use-specific instructions for each use.

    Always read the label or leaflet before use and follow all the instructions provided.

    The product must be brought to a temperature above 20°C before use.

    The use of a dosing pump for filling the product into the application equipment is recommended.

    Where necessary repeat the application at each milking

    Clean the application equipment regularly with warm water.

    5.2.   Risk mitigation measures

    See use-specific risk mitigation measures for each use.

    5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.

    FIRST AID INSTRUCTIONS

    In the event of inhalation: Bring to fresh air.

    In the event of contact with the skin: Wash with water.

    In the event of contact with the eyes :

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    If eye irritation persists: Get medical advice/attention.

    In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.

    Refer to the safety data sheet available for professional user: it contains an emergency phone number.

    Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.

    5.4.   Instructions for safe disposal of the product and its packaging

    At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

    The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.

    5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

    Shelf life : 2 years in HDPE

    Do not store at a temperature higher than 30°C.

    6.   OTHER INFORMATION

    7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

    7.1.   Trade name(s), authorisation number and specific composition of each individual product

    Trade name(s)

    Liq-io 5500

    IODYPRO

    INO JOD 50 Liquid

    Usual Iod Liquid +

    IODIUM PRO SPRAY

    IODEX

    Iodoliquid +

    Iodospray Plus

    DESINTEAT PLUS

    ROBOSPRAY IODE

    INOTRAYON

    IODYPRO 5500

    Robot Liq-io 55

    IODYPRO BL5500

    ADF iDip+ 5500

    HOEVE-JODIUM SPRAY

    GRUPAIODE

    IODOCAN

    JOFO

    JODI PLUS

    K-AGRO PRODIP ID

    IODIP

    HELIO IODE SPRAY

    MAMMO-JOD

    KRONI Jod Spray 5500

    MUNGI-IOD

    LELY QUARESS-Iodine

    GOLD GLYCODIP

    EMPRASAN EXTRA CARE

    H&M RTU IODINE

    ANGLIA FARMERS SUPPLEDIP-IO

    PROLAC RTU IODINE TEAT DIP

    PREMIER GOLD POST DIP

    FULLWOOD IODINE EXTRA

    H&M EXTRACARE

    M WILLIAMS TEAT DIP

    PLATINUM

    WDH GOLD DIP RTU

    WYNNSAN IODINE HE RTU

    Authorisation number

    EU-0018397-0007 1-5

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    Iodine

     

    Active substance

    7553-56-2

    231-442-4

    0,55

    Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)

    Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl--hydroxy

    Non active substance

    68439-50-9

     

    4,69


    (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.

    (2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.

    (3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.

    (4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.

    (5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.


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