title: Commission Implementing Regulation (EU) 2020/1187 of 7 August 2020 granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’ (Text with EEA relevance)

text:
                  14.8.2020

                  EN

                  Official Journal of the European Union

                  L 268/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1187
         of 7 August 2020
         granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’
         (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 the first subparagraph of Article 44(5) thereof,
         Whereas:

                     (1)

                     On 13 August 2015, CID LINES NV submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Iodine based products – CID LINES NV’ of product-types 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-BY019142-30 in the Register for Biocidal Products.

                     (2)

                     ‘Iodine based products – CID LINES NV’ contains iodine including polyvinylpyrrolidone iodine, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, and the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2), the Commission is carrying out a review of the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will consider whether the Union authorisations for products containing the active substance have to be cancelled or amended in accordance with Article 48 of Regulation (EU) No 528/2012.

                     (3)

                     On 28 May 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

                     (4)

                     On 17 January 2020, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Iodine based products – CID LINES NV’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

                     (5)

                     The opinion concludes that ‘Iodine based products – CID LINES NV’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

                     (6)

                     On 4 February 2020 the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

                     (7)

                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Iodine based products – CID LINES NV’.

                     (8)

                     According to the opinion of the Agency, as regards the non-active substances sodium iodide and sodium iodate contained in ‘Iodine based products – CID LINES NV’, it was not possible to conclude whether they meet the scientific criteria for the determination of endocrine-disrupting properties set out in Delegated Regulation (EU) 2017/2100 within the period for the evaluation of the application. Further examination of sodium iodide and sodium iodate should therefore take place. If it is concluded that sodium iodide or sodium iodate or both are considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘Iodine based products – CID LINES NV’ in accordance with Article 48 of Regulation (EU) No 528/2012.

                     (9)

                     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
            A Union authorisation with authorisation number EU-0022265-0000 is granted to CID LINES NV for the making available on the market and use of the biocidal product family ‘Iodine based products – CID LINES NV’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 3 September 2020 until 31 August 2030.

            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, 7 August 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

            (3)  ECHA opinion of 11 December 2019 on the Union authorisation of ‘Iodine based products – CID LINES NV’ (ECHA/BPC/237/2019).

            ANNEX

               Summary of product characteristics for a biocidal product family

            Iodine based products – CID LINES NV
            Product type 3 – Veterinary hygiene (Disinfectants)
            Product type 4 – Food and feed area (Disinfectants)
            Authorisation number: EU-0022265-0000
            R4BP asset number: EU-0022265-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION

            1.1.   Family name

                        Name

                        Iodine based products – CID LINES NV

                  1.2.   Product type(s)

                        Product type(s)

                        PT03 – Veterinary hygiene (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)

                  1.3.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        CID LINES NV

                        Address

                        Waterpoortstraat 2, 8900, Ieper, Belgium

                        Authorisation number

                        EU-0022265-0000

                           R4BP asset number

                        EU-0022265-0000

                        Date of the authorisation

                        3 September 2020

                        Expiry date of the authorisation

                        31 August 2030

                  1.4.   Manufacturer(s) of the biocidal products

                        Name of manufacturer

                        CID LINES NV

                        Address of manufacturer

                        Waterpoortstraat 2, 8900 Ieper Belgium

                        Location of manufacturing sites

                        Waterpoortstraat 2, 8900 Ieper Belgium

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

                        Active substance

                        Iodine

                        Name of manufacturer

                        SQM S.A.

                        Address of manufacturer

                        Los Militares, Piso 4, 4290 Santiago Chile

                        Location of manufacturing sites

                        Nueva Victoria plant, 00 Pedro de Valdivia Chile

                        Active substance

                        Iodine

                        Name of manufacturer

                        Cosayach Nitratos S.A.

                        Address of manufacturer

                        Amunategui 178, 00 Santiago Chile

                        Location of manufacturing sites

                        Cala Cala, 00 Pozo Almonte Chile

                        Active substance

                        Iodine

                        Name of manufacturer

                        ACF Minera S.A.

                        Address of manufacturer

                        San Martin No 499, 00 Iquique Chile

                        Location of manufacturing sites

                        Lagunas mine, 00 Pozo Almonte Chile

                        Active substance

                        Iodine

                        Name of manufacturer

                        ISE Chemicals Corporation

                        Address of manufacturer

                        3-1, Kyobashi 1-Chome, 104-0031 Tokyo Japan

                        Location of manufacturing sites

                        3695 Kitaimaizumi, 299-3201 Oamishirasato city Japan

                        Active substance

                        Polyvinylpyrrolidone iodine

                        Name of manufacturer

                        ISP Chemicals LLC, Afiliate of Ashland Inc

                        Address of manufacturer

                        455 N. main st (HWY 95), KY 42029 Calvert City United States

                        Location of manufacturing sites

                        455 N. main st (HWY 95), KY 42029 Calvert City United States

                        Active substance

                        Polyvinylpyrrolidone iodine

                        Name of manufacturer

                        Pantheon FZE (DMCC branch)

                        Address of manufacturer

                        403, Reef Tower, Jumeira Lake Tower Shaikh Zayed Road, 00 Dubai United Arab Emirates

                        Location of manufacturing sites

                        Cala Cala, 00 Pozo Almonte Chile

                  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

                        0,0

                        3,0

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        10,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        0,0

                        21,0

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        30,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        12,5

                  2.2.   Type(s) of formulation

                        Formulation(s)

                        SL – Soluble concentrate
                        AL – Any other liquid

                  PART II

               SECOND INFORMATION LEVEL – META SPC(S)

               META SPC 1

            1.   META SPC 1 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 1 identifier

                        Identifier

                        metaSPC 1: PT3 Concentrated teat disinfectants Iodine

                  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

                        1,5

                        1,5

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        12,05

                        12,05

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        0,0

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

                        Formulation(s)

                        SL – Soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

                        Hazard statements

                        Causes serious eye damage.
                        Harmful to aquatic life with long lasting effects.
                        May cause damage to organs (thyroid) through prolonged or repeated exposure (oral).

                        Precautionary statements

                        Wear eye protection.
                        Wear protective clothing.
                        Wear protective gloves.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Immediately call a doctor or a poison center.
                        Avoid release to the environment.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

            4.1.   Use description

               Table 1. Use # 1 – PT3– Concentrated Teat disinfectant, post-milking, Iodine

                        Product type

                        PT03 – Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Viruses

                        Field(s) of use

                        Indoor
                        Post-milking teat disinfection of milk producing animals

                        Application method(s)

                        Manual or automatic spraying on teats

                        Application rate(s) and frequency

                        Dilute the product to a final concentration of 0,3 % (w/w) available iodine.
                        Apply 2 times per day with manual sprayer and 3 times per day with a robot.

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE (High Density Polyethylene)

                  4.1.1.   Use-specific instructions for use

            See general directions for use.
            4.1.2.   Use-specific risk mitigation measures

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (1)
               OF THE META SPC 1

            5.1.   Instructions for use

            The product must be diluted before use with clean potable water to allow a final concentration of iodine of 0,3 % (200 ml product, add water up to 1 L).
            The diluted product must be brought to a temperature above 20 °C before use.
            Assume 5 mL diluted product per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended. Use gloves and eye protection during the dilution step. The diluted product can be kept and used during 1 week but do not prepare more fluid than necessary.
            Apply the diluted product on the teats with a manual sprayer or with an automatic sprayer.
            The product should be used directly after milking 2 times per day by using a manual sprayer and 3 times per day when using a robot (automatic sprayer).
            Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
            Do not mix with other chemicals.
            5.2.   Risk mitigation measures

                        —

                        For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection.

                        —

                        For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

                        —

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

                        —

                        Keep out of reach of children.

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

            After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.
            If medical advice is needed, have product container or label at hand.
            After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.
            Have product container or label at hand.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            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)

                        Kenodin SD 400
                        IodoSD 400
                        Velvet Concentrate
                        Wynnsan Iodine 3 – 1 conc
                        Iodin Teat Spray 400

                        Authorisation number

                        EU-0022265-0001 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        1,5

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        12,05

               META SPC 2

            1.   META SPC 2 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 2 identifier

                        Identifier

                        metaSPC 2: PT3 – Ready to Use (RTU) Teat disinfectants Iodine

                  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

                        0,3

                        0,3

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,1

                        2,9

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        0,0

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

                        Formulation(s)

                        AL – Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

                        Hazard statements

                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Avoid release to the environment.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

            4.1.   Use description

               Table 2. Use # 1 – PT3– RTU Teat disinfectant, post-milking, Iodine

                        Product type

                        PT03 – Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Viruses

                        Field(s) of use

                        Indoor
                        Post-milking teat disinfection of milk producing animals

                        Application method(s)

                        By dipping or spraying on teats

                        Application rate(s) and frequency

                        The product is ready to use.
                        Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

            See general directions for use.
            4.1.2.   Use-specific risk mitigation measures

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (2)
               OF THE META SPC 2

            5.1.   Instructions for use

            The product must be brought to a temperature above 20 °C before use.
            Apply the product by dipping or by spraying:

                        —

                           By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.

                        —

                           By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

                  Do not prepare more fluid than necessary; assume 5 mL solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.
            The product should be used immediately after each milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
            Do not mix with other chemicals.
            5.2.   Risk mitigation measures

                        —

                        For manual dipping application: No special protection equipment is recommended under normal conditions of use.

                        —

                        For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information.

                        —

                        If 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.

                        —

                        Keep out of reach of children.

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

            After eye contact: Rinse immediately with water.
            After ingestion: Rinse mouth. Spit.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            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)

                        IodoDip 3000
                        Bio Tec Jodip 3000
                        Recoïode
                        Stalosan Io Dip
                        Stalosan Super Dip
                        Velvet High Visco
                        Bühning Joddip 3000
                        Kenodin
                        Wynnsan trikill RTU
                        Wynnsan Iodine RTU teat dip
                        Wynnsan Iodine dip RTU
                        Iocid
                        Iodip+
                        Wynngold Iodine Dip
                        Pezerk iv plus
                        Iod protect 3000 Film
                        Seivit® Iode 3000
                        Kenostart
                        GAHERYOD
                        Kenodin 3000
                        Iodin Teat Dip 3000
                        Iod 3000 dip
                        Iodoschutz dip
                        Ioschutz dip
                        Iodocoop dip
                        Iodotech dip
                        Iodactiv’ dip
                        Iododip
                        MIROX Dip Jod
                        HCP Iodine Dip
                        Agib Jodium Dip
                        Jod 3000
                        Iod dip
                        Iode 3000
                        Iodoschutz
                        Coopjod
                        Coopiode
                        Coopiode épais
                        Semex jod
                        Iodotech
                        Iododip green
                        Iodip bio
                        Iododip bio
                        Iodactive épais
                        Iodactiv
                        Iodoactiv’
                        Bayley’s Premier Iodine Teat Dip
                        Pearce Premier Iodine Teat Dip
                        Diamond 1:3 Concentrate Iodine Post Dip Spray
                        JODOCARE
                        KENOSTART DYP
                        STREPTOFIT
                        Iodall Film

                        Authorisation number

                        EU-0022265-0002 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,3

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,17

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

                        Trade name(s)

                        Kenodin Film
                        IodoFilm
                        Wynnsan Iofilm teat dip
                        Kenodin Film Extra
                        Wynngold Film
                        Wynnsan trikill film teat dip
                        Kenodin Film Soft
                        Iocid Film
                        TOP Film
                        Seivit® Iode Gel
                        IOD protect 3000 Film
                        Iodin Film Teat Dip 3000
                        Iodin Barrier Teat Dip 3000
                        Iodin Film Teat Dip
                        Iodin Barrier Teat Dip
                        Iod 3000 film
                        Iodoschutz film
                        Ioschutz film
                        Iodocoop film
                        Iodotech film
                        Iodactiv’ film
                        Iodofilm
                        HCP Iodine Film
                        Iod 3000 film
                        Coopjod film
                        Coopiode film
                        Iodocoop film
                        Semex jod film
                        Iodofilm
                        Iodofilm bio
                        Iofilm bio
                        Iodactive film
                        Iodactiv film
                        Iodactiv’ film
                        SCUDO 3000

                        Authorisation number

                        EU-0022265-0003 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,3

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,9

               META SPC 3

            1.   META SPC 3 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 3 identifier

                        Identifier

                        metaSPC 3: PT3-RTU Udder disinfectants Iodine

                  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

                        0,3

                        0,99

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,17

                        2,95

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        0,0

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

                        Formulation(s)

                        AL – Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

                        Hazard statements

                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Avoid release to the environment.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

            4.1.   Use description

               Table 3. Use # 1 – PT3- RTU Udder disinfectant, Iodine

                        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
                        Skin disinfection only for use on intact skin of:

                                    —

                                    the udder of dairy and beef cattle before calving

                                    —

                                    the udder of sows before farrowing

                        Application method(s)

                        Spraying

                        Application rate(s) and frequency

                        The product is ready to use.
                        Apply to:

                                    —

                                    the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 mL per application)

                                    —

                                    the udder of sows: 15 to 20 mL per animal

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

            See general directions for use.
            4.1.2.   Use-specific risk mitigation measures

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (3)
               OF THE META SPC 3

            5.1.   Instructions for use

                  For disinfection of the skin:

            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.
            Apply by spraying on the animals’ intact skin for a topical disinfection:

                        —

                        on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing at least 5 minutes).

                        —

                        on the udder of sows before farrowing: Assume 15 to 20 mL per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

                  Only for use on intact skin.
            Do not mix with other chemicals.
            5.2.   Risk mitigation measures

            For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).
            In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections.
            Keep out of reach of children.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            After eye contact: Rinse immediately with water.
            After ingestion: Rinse mouth. Spit
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            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)

                        Animal Skin Disinfectant
                        Dermades 3000
                        Iodin Skin Disinfectant

                        Authorisation number

                        EU-0022265-0004 1-3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,3

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,17

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

                        Trade name(s)

                        Dermades
                        Animal skin disinfectant 1 %
                        Dermades Strong
                        Iodin Skin Disinfectant Strong

                        Authorisation number

                        EU-0022265-0005 1-3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,99

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,95

               META SPC 4

            1.   META SPC 4 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 4 identifier

                        Identifier

                        metaSPC 4: PT3 – RTU Udder and Teat disinfectants Iodine

                  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

                        0,3

                        0,3

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,17

                        2,17

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        0,0

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

                        Formulation(s)

                        AL – Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

                        Hazard statements

                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Avoid release to the environment.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

            4.1.   Use description

               Table 4. Use # 1 – PT3– RTU Teat disinfectant, Post-milking, Iodine

                        Product type

                        PT03 – Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Viruses

                        Field(s) of use

                        Indoor
                        Ready to use teat disinfectant to be used post milking on milk producing animals.

                        Application method(s)

                        Dipping or spraying

                        Application rate(s) and frequency

                        The product is ready to use.
                        Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

                  For disinfection of the teats:

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

                        —

                        By dipping: Apply the product on the teats with a dip cup. Wash the dip cup with water after use.

                        —

                        By spraying: Apply the product on the teats with a manual sprayer or with an automatic sprayer.

                  Do not prepare more fluid than necessary. Assume 5 mL solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.
            The product should be used directly after milking by using a dipping cup or a manual or automatic sprayer. Ensure that the teat is completely covered to three quarters of its length.
            The product is applied after milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.
            Let the product dry on the teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
            Do not mix with other chemicals.
            4.1.2.   Use-specific risk mitigation measures

                        —

                        For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

                        —

                        For manual dipping application: no Personal Protection Equipment (PPE) is necessary for safe use.

                        —

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

                        —

                        Keep out of reach of children.

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

            See general directions for use.
            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.
            4.2.   Use description

               Table 5. Use # 2 – PT3- RTU Udder disinfectant, Iodine

                        Product type

                        PT03 – Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Yeasts

                        Bacteria

                        Field(s) of use

                        Indoor
                        Ready to use skin disinfectant, only for use on intact skin of:

                                    —

                                    the udder of dairy and beef cattle before calving

                                    —

                                    the udder of sows before farrowing

                        Application method(s)

                        Application on animal skin: by spraying

                        Application rate(s) and frequency

                        The product is ready to use.
                        Apply to:

                                    —

                                    the udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 mL per application)

                                    —

                                    the udder of sows: 15 to 20 mL per animal

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.2.1.   Use-specific instructions for use

                  For disinfection of the skin:

            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.
            Apply by spraying on the animals’ intact skin for a topical disinfection:

                        —

                        on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

                        —

                        on the udder of sows before farrowing: Assume 15 to 20 mL per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

                  Let the product dry on skin.
            Only for use on intact skin.
            Do not mix with other chemicals.
            4.2.2.   Use-specific risk mitigation measures

                        —

                        For manual spraying application on cows and sows: no PPE is necessary for safe use.

                        —

                        Keep out of reach of children.

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (4)
               OF THE META SPC 4

            5.1.   Instructions for use

            See use-specific instructions for use.
            5.2.   Risk mitigation measures

            See use-specific risk mitigation measures
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            After eye contact: Rinse immediately with water.
            After ingestion: Rinse mouth. Spit.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            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)

                        Kenodin SD
                        IodoSD 3000
                        Bio Tec Jodspray 3000
                        Q Farm Iodine Des
                        ANRO – Euterpflege Dip
                        Stalosan Io Spray
                        Stalosan Super Spray
                        IDip+
                        Bühning Jodspray 3000
                        Velvet RTU
                        Wynnsan trikill spray
                        Wynnsan Iodine spray RTU
                        Wynngold Iodine Dip and spray
                        Pezerk IL
                        Iod protect 3000 Sprüh
                        Seivit® Iode Spray
                        IOD protect 3000 Sprüh
                        Kenodin SprayFilm
                        Iodo SP
                        Kenostart SD
                        GAHERYOD SPRAY
                        Iodin Teat & Skin 3000
                        Iod 3000 sprüh
                        Iodoschutz sprüh
                        Ioschutz sprüh
                        Iodocoop sprüh
                        Iodotech sprüh
                        Iodactiv’ sprüh
                        Iodosprüh
                        MIROX Spray Jod
                        HCP Iodine SD
                        Agib Jodium Spray
                        Jod 3000 spray
                        Iod sprüh
                        Coopjod
                        Coopiode spray
                        Iodocoop spray
                        Semex jod spray
                        Iododip spray
                        Iododip spray green
                        Iodospray Bio
                        Iospray bio
                        Iodactive spray
                        Iodactiv spray
                        Iodactiv’ spray
                        Ark Iodine S+D
                        Agrihealth Iodine SD
                        AGRO LOGIC JODOCARE SPRAY
                        IODACTIVE

                        Authorisation number

                        EU-0022265-0006 1-4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,3

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,17

               META SPC 5

            1.   META SPC 5 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 5 identifier

                        Identifier

                        metaSPC 5: PT3 – RTU Teat disinfectants PVP-Iodine

                  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

                        0,0

                        0,0

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        3,0

                        3,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        1,5

                        2,9

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        0,0

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

                        Formulation(s)

                        AL – Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

                        Hazard statements

                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Avoid release to the environment.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

            4.1.   Use description

               Table 6. Use # 1 – PT3 – RTU Teat disinfectant, post milking, PVP-Iodine

                        Product type

                        PT03 – Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Viruses

                        Field(s) of use

                        Indoor
                        Post-milking disinfection on teats of milk producing animals

                        Application method(s)

                        Dipping or spraying

                        Application rate(s) and frequency

                        The product is ready to use.
                        Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

            See general directions for use.
            4.1.2.   Use-specific risk mitigation measures

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (5)
               OF THE META SPC 5

            5.1.   Instructions for use

            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.
            Apply the product by dipping or by spraying:

                        —

                           By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.

                        —

                           By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

                  Do not prepare more fluid than necessary. Assume 5 mL solution per cow per treatment.
            The product should be used immediately after each milking, two times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
            Do not mix with other chemicals.
            5.2.   Risk mitigation measures

                        —

                        For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information.

                        —

                        For manual dipping application: no PPE is necessary for safe use.

                        —

                        If 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.

                        —

                        Keep out of reach of children.

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

            After eye contact: Rinse immediately with water.
            After ingestion: Rinse mouth. Spit.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 18 months.
            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)

                        Iodo PVP
                        Iodin Teat Dip 3000 PVP

                        Authorisation number

                        EU-0022265-0007 1-5

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,0

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        3,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,5

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

                        Trade name(s)

                        Iodo SD PVP
                        Iodin Teat Spray & Dip 3000 PVP

                        Authorisation number

                        EU-0022265-0008 1-5

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,0

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        3,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,5

               META SPC 6

            1.   META SPC 6 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 6 identifier

                        Identifier

                        metaSPC 6: PT3- RTU Udder disinfectants PVP-Iodine

                  1.2.   Suffix to the authorisation number

                        Number

                        1-6

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 – Veterinary hygiene (Disinfectants)

                  2.   META SPC 6 COMPOSITION

            2.1.   Qualitative and quantitative information on the composition of the meta SPC 6

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,0

                        0,0

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        10,0

                        10,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,0

                        2,0

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        0,0

                  2.2.   Type(s) of formulation of the meta SPC 6

                        Formulation(s)

                        AL – Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

                        Hazard statements

                        Harmful to aquatic life with long lasting effects.
                        May cause damage to organs (thyroid) through prolonged or repeated exposure (oral).

                        Precautionary statements

                        Avoid release to the environment.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Do not breathe spray.

                  4.   AUTHORISED USE(S) OF THE META SPC 6

            4.1.   Use description

               Table 7. Use # 1 – PT3- RTU Udder disinfectant PVP-Iodine

                        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
                        Ready to use skin disinfectant, only for use on intact skin of:

                                    —

                                    the udder of dairy and beef cattle: before calving

                                    —

                                    the udder of sows: before farrowing

                        Application method(s)

                        Spraying

                        Application rate(s) and frequency

                        The product is ready to use.
                        Apply to:

                                    —

                                    The udder of dairy and beef cattle: 1 spray on each teat (equivalent to 4,8 mL per application)

                                    —

                                    The udder of sows: 15 to 20 mL per animal

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

            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.

                        —

                        Dairy and beef cattle: Apply the product by spraying on the udder before calving (1 spray/teat equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

                        —

                        Sows, on the udder before farrowing: Assume 15 to 20 mL per animal. Disinfection takes place once, one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

                  Only for use on intact skin.
            Do not mix with other chemicals.
            4.1.2.   Use-specific risk mitigation measures

                        —

                        For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

                        —

                        In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections.

                        —

                        Keep out of reach of children.

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (6)
               OF THE META SPC 6

            5.1.   Instructions for use

            See use-specific instructions for use.
            5.2.   Risk mitigation measures

            See use-specific risk mitigation measures.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            After eye contact: Rinse immediately with water.
            After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.
            Have product container or label at hand.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            6.   OTHER INFORMATION

            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

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

                        Trade name(s)

                        Dermades PVP
                        Wynngold 10 % Iodine Solution
                        Iodin Skin Disinfectant PVP

                        Authorisation number

                        EU-0022265-0009 1-6

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,0

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        10,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,0

               META SPC 7

            1.   META SPC 7 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 7 identifier

                        Identifier

                        metaSPC 7: PT3 and PT4 – Concentrated Surface disinfectants Iodine

                  1.2.   Suffix to the authorisation number

                        Number

                        1-7

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 – Veterinary hygiene (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)

                  2.   META SPC 7 COMPOSITION

            2.1.   Qualitative and quantitative information on the composition of the meta SPC 7

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        1,8

                        2,49

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        3,15

                        9,45

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        2,5

                        12,5

                  2.2.   Type(s) of formulation of the meta SPC 7

                        Formulation(s)

                        SL – Soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

                        Hazard statements

                        Causes serious eye damage.
                        May cause damage to organs (thyroid) through prolonged or repeated exposure (oral).
                        May be corrosive to metals.
                        Toxic to aquatic life with long lasting effects.

                        Precautionary statements

                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear face 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 doctor or a POISON CENTER.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Collect spillage.
                        Avoid release to the environment.

                  4.   AUTHORISED USE(S) OF THE META SPC 7

            4.1.   Use description

               Table 8. Use # 1 – PT 4 – Concentrated Surface disinfectant in kitchens and in food industry, Iodine

                        Product type

                        PT04 – Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Field(s) of use

                        Indoor
                        Non-porous surface disinfection in professional kitchens and in food industry

                        Application method(s)

                        By spraying with a manual or an automatic sprayer

                        Application rate(s) and frequency

                        Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,015 % iodine
                        Frequency is once per day.

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

            Use in professional kitchens (PT4) and in food industry (PT4):
            The product must be diluted with water before use (according to the table below).
            Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.
            The product is used in professional kitchens (surface disinfection): Frequency is once per day.
            The product is used in food industry (surface disinfection): Frequency is once per day.
            Use at room temperature.
            Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 15 minutes and rinse the surfaces afterwards with clean water.

                           Example for a product containing 1 % iodine (*1)

                        Dilution of the product

                        Contact time

                        Bactericidal and yeasticidal activity

                        1,5 % (15 ml product, add water up to 1 L)

                        15 min

                  Do not mix with other chemicals.
            Do not prepare more fluid than necessary.
            4.1.2.   Use-specific risk mitigation measures

                        —

                        During pouring and pumping of the concentrated product: Wear chemical resistant gloves (material to be specified by the authorisation holder within the product information) and eye/face protection.

                        —

                        During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information).

                        —

                        Keep out of reach of children.

                        —

                        The general public and animals should be kept away from treated areas until surfaces are dry.

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

            See general directions for use.
            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.
            4.2.   Use description

               Table 9. Use # 2 – PT3 – Concentrated Surface disinfectant for veterinary use, Iodine

                        Product type

                        PT03 – Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Viruses

                        Field(s) of use

                        Indoor
                        Non-porous surface disinfection in veterinary field

                        Application method(s)

                        By spraying with a manual or an automatic sprayer

                        Application rate(s) and frequency

                        Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.2.1.   Use-specific instructions for use

            Use in veterinary field (PT3), surface disinfection:
            The product should be diluted with water before use (according to table below).
            Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.
            The product is used to disinfect animal housings of pigs, cows and poultry.
            Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and animals can re-enter 24h after the end of the application.

                           Example for a product containing 2,49 % iodine (*2)

                        Dilution of the product

                        Contact time

                        Bactericidal and yeasticidal activity

                           1 % (10ml product, add water up to 1 L)

                        30 min

                        Virucidal activity

                        1,4 % (14ml product, add water up to 1 L)

                        30 min

                  Do not mix with other chemicals.
            Do not prepare more fluid than necessary.
            4.2.2.   Use-specific risk mitigation measures

                        —

                        During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coated coverall (material to be specified by the authorisation holder within the product information) and eye/face protection.

                        —

                        During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information).

                        —

                        Only use one kind of Iodine-containing product per day.

                        —

                        Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shll not use Iodine products for other purposes during that period.

                        —

                        Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application.

                        —

                        Keep out of reach of children.

                        —

                        The general public and animals should be kept away from treated areas until surfaces are dry.

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (7)
               OF THE META SPC 7

            5.1.   Instructions for use

            See use-specific instructions for use.
            5.2.   Risk mitigation measures

            See use-specific risk mitigation measures.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.
            If medical advice is needed, have product container or label at hand.
            After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.
            Have product container or label at hand.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            6.   OTHER INFORMATION

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

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

                        Trade name(s)

                        Dodin 20
                        Iodo 20
                        Bio Tec Joddesinfektion
                        Dufa dine 1,8 %
                        Alfasan super disinfectant
                        Iodes
                        Streptoclean
                        Iodin Surface Disinfectant 1,8 %
                        IODINE

                        Authorisation number

                        EU-0022265-0010 1-7

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        1,8

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        5,29

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        5,0

               META SPC 8

            1.   META SPC 8 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 8 identifier

                        Identifier

                        metaSPC 8: PT3 and PT4 – Concentrated Surface disinfectants Iodine

                  1.2.   Suffix to the authorisation number

                        Number

                        1-8

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 – Veterinary hygiene (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)

                  2.   META SPC 8 COMPOSITION

            2.1.   Qualitative and quantitative information on the composition of the meta SPC 8

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        2,5

                        3,0

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        3,15

                        9,45

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        5,0

                        12,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        2,5

                        12,5

                  2.2.   Type(s) of formulation of the meta SPC 8

                        Formulation(s)

                        SL – Soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

                        Hazard statements

                        May be corrosive to metals.
                        Causes skin irritation.
                        Causes serious eye damage.
                        May cause damage to organs (thyroid) through prolonged or repeated exposure (oral).
                        Toxic to aquatic life with long lasting effects.

                        Precautionary statements

                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear face protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                        Immediately call a a POISON CENTER or doctor/physician.
                        If experiencing respiratory symptoms: Call a a POISON CENTER or doctor/physician.
                        Avoid release to the environment.
                        Collect spillage.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

                  4.   AUTHORISED USE(S) OF THE META SPC 8

            4.1.   Use description

               Table 10. Use # 1 – PT4 – Concentrated Surface disinfectant in kitchens and in food industry, Iodine

                        Product type

                        PT04 – Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Field(s) of use

                        Indoor
                        Non-porous surface disinfection in professional kitchens and in food industry

                        Application method(s)

                        By spraying with a manual or an automatic sprayer

                        Application rate(s) and frequency

                        Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,015 % iodine
                        Daily use

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

                        —

                        Use in professional kitchens (PT4) and in food industry (PT4):

                        —

                        The product must be diluted with water before use (according to table below).

                        —

                        Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

                        —

                        The product is used in professional kitchens (surface disinfection): Frequency is once per day.

                        —

                        The product is used in food industry (surface disinfection): Frequency is once per day.

                        —

                        Use at room temperature.

                        —

                        The product is applied by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 15 minutes, and rinse the surfaces afterwards with clean water.

                           Example for a product containing 3 % iodine (*3)

                        Dilution of the product

                        Contact time

                        Bactericidal and yeasticidal activity

                        0,5 % (5 ml product, add water up to 1 L)

                        15 min

                  Do not mix with other chemicals.
            Do not prepare more fluid than necessary.
            4.1.2.   Use-specific risk mitigation measures

                        —

                        During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coverall (material to be specified by the authorisation holder within the product information) and eye/face protection.

                        —

                        During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information).

                        —

                        Keep out of reach of children.

                        —

                        The general public and animals should be kept away from treated areas until surfaces are dry.

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

            See general directions for use.
            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.
            4.2.   Use description

               Table 11. Use # 2 – PT3 – Concentrated Surface disinfectant for veterinary use, Iodine

                        Product type

                        PT03 – Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Viruses

                        Field(s) of use

                        Indoor
                        Non-porous surface disinfection in veterinary field

                        Application method(s)

                        By spraying with a manual or an automatic sprayer

                        Application rate(s) and frequency

                        Assume 0,04 L solution for every square meter that has to be disinfected. Bactericidal and yeasticidal activity: 0,025 % in-use iodine Virucidal activity: 0,035 % in-use iodine

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.2.1.   Use-specific instructions for use

            Use in veterinary field (PT3), surface disinfection:
            The product must be diluted with water before use (according to table below).
            Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.
            The product is used to disinfect animal housings of pigs, cows and poultry.
            Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and re-entry of animals can be done 24h after the end of the application.

                           Example for a product containing 2,5 % iodine (*4)

                           Dilution of the product

                        Contact time

                        Bactericidal and yeasticidal activity

                           1 % (10ml product, add water up to 1 L)

                        30 min

                        Virucidal activity

                           1,4 % (14ml product, add water up to 1 L)

                        30 min

                  Do not mix with other chemicals.
            Do not prepare more fluid than necessary.
            4.2.2.   Use-specific risk mitigation measures

                        —

                        During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coverall (material to be specified by the authorisation holder within the product information)and eye/face protection.

                        —

                        During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information).

                        —

                        Only use one kind of Iodine-containing product per day.

                        —

                        Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shall not use Iodine products for other purposes during that period.

                        —

                        Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application.

                        —

                        Keep out of reach of children.

                        —

                        The general public and animals should be kept away from treated areas until surfaces are dry.

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (8)
               OF THE META SPC 8

            5.1.   Instructions for use

            See use-specific instructions for use
            5.2.   Risk mitigation measures

            See use-specific risk mitigation measures.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.
            If medical advice is needed, have product container or label at hand.
            After skin (or hair) contact: Remove contaminated clothing and shoes. Wash the affected area thoroughly with plenty of soap and water. Get medical attention if symptoms occur.
            After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.
            Have product container or label at hand.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            6.   OTHER INFORMATION

            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

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

                        Trade name(s)

                        Iocid 30
                        Iodo 30
                        Dufa dine
                        Iodin Surface Disinfectant 2,8 %

                        Authorisation number

                        EU-0022265-0011 1-8

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        2,8

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        7,93

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        11,25

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        12,5

               META SPC 9

            1.   META SPC 9 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 9 identifier

                        Identifier

                        metaSPC 9: PT4 – Concentrated CIP disinfectants Iodine

                  1.2.   Suffix to the authorisation number

                        Number

                        1-9

                  1.3.   Product type(s)

                        Product type(s)

                        PT04 – Food and feed area (Disinfectants)

                  2.   META SPC 9 COMPOSITION

            2.1.   Qualitative and quantitative information on the composition of the meta SPC 9

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,5

                        0,99

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        0,0

                        0,0

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        25,0

                        30,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        0,0

                  2.2.   Type(s) of formulation of the meta SPC 9

                        Formulation(s)

                        SL – Soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

                        Hazard statements

                        Causes severe skin burns and eye damage.
                        Harmful to aquatic life with long lasting effects.
                        May be corrosive to metals.

                        Precautionary statements

                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear face protection.
                        Avoid release to the environment.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                        If experiencing respiratory symptoms: Call a doctor.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Immediately call a doctor.

                  4.   AUTHORISED USE(S) OF THE META SPC 9

            4.1.   Use description

               Table 12. Use # 1 – PT4 – Concentrated Cleaning in place disinfectant, Iodine

                        Product type

                        PT04 – Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Field(s) of use

                        Indoor
                        Cleaning in place (CIP) disinfection for milking equipment and CIP installations in food industry

                        Application method(s)

                        CIP disinfection

                        Application rate(s) and frequency

                        Apply the product in the automatic system with an end concentration of 0,00125 % available iodine
                        The product is used once per day in food industry and up to 2 times per day in milking parlours.

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

            See general instructions.
            4.1.2.   Use-specific risk mitigation measures

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (9)
               OF THE META SPC 9

            5.1.   Instructions for use

                        —

                        Disinfection of milking machines or CIP installations in food industry

                        —

                        Clean first the CIP installation.

                        —

                        Apply the product in the automatic system with a dilution of the product (according to table below) with water.

                        —

                        Use at room temperature.

                        —

                        Respect a contact time according to the table below.

                        —

                        Rinse the installation with water.

                           Example for a product containing 0,5 % iodine (*5)

                        Dilution of the product

                        Contact time

                        Bactericidal and yeasticidal activity

                        0,25 % (2,5 ml product, add water up to 1 L)

                        15 min

                  Do not mix with other chemicals.
            5.2.   Risk mitigation measures

            During pouring and pumping of the concentrated product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information) and eye/face protection.
            Keep out of reach of children.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            After inhalation: Remove person to fresh air and keep comfortable for breathing. Obtain medical attention if breathing difficulty persists.
            After skin (or hair) contact: Remove contaminated clothing and shoes. Wash the affected area thoroughly with plenty of soap and water. Get medical attention if symptoms occur.
            After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.
            After ingestion: Rinse mouth. Do NOT induce vomiting and immediately get medical advice.
            Have product container or label at hand.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            6.   OTHER INFORMATION

            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9

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

                        Trade name(s)

                        Iodo CIP
                        Iocip
                        Bio Tec Jodreiniger
                        JODOPHOS SUPER 4001
                        Bühning Jodreiniger
                        Wynnsan Ice bank Tank Cleaner
                        Bulk Tank Sanitizer
                        Iodin CIP Disinfectant

                        Authorisation number

                        EU-0022265-0012 1-9

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,5

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        26,3

               META SPC 10

            1.   META SPC 10 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 10 identifier

                        Identifier

                        metaSPC 10: PT3 – Concentrated teat disinfectants Iodine

                  1.2.   Suffix to the authorisation number

                        Number

                        1-10

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 – Veterinary hygiene (Disinfectants)

                  2.   META SPC 10 COMPOSITION

            2.1.   Qualitative and quantitative information on the composition of the meta SPC 10

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        2,8

                        2,8

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        21,0

                        21,0

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        0,0

                  2.2.   Type(s) of formulation of the meta SPC 10

                        Formulation(s)

                        SL – Soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10

                        Hazard statements

                        Causes serious eye damage.
                        Toxic to aquatic life with long lasting effects.
                        May cause damage to organs (thyroid) through prolonged or repeated exposure (oral route).

                        Precautionary statements

                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear face 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 doctor or a poison center.
                        Avoid release to the environment.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Collect spillage.

                  4.   AUTHORISED USE(S) OF THE META SPC 10

            4.1.   Use description

               Table 13. Use # 1 – PT3 – Concentrated teat disinfectant, Post-milking, Iodine

                        Product type

                        PT03 – Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Viruses

                        Field(s) of use

                        Indoor
                        Post-milking teat disinfection of milk producing animals

                        Application method(s)

                        By spraying with a manual sprayer or with an automatic sprayer on teats.

                        Application rate(s) and frequency

                        The product must be diluted before use in order to allow a final concentration of iodine of 0,3 %.
                        Apply 2 times per day by using a manual sprayer and 3 times per day when using a robot (or automatic sprayer).

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

            See general directions for use.
            4.1.2.   Use-specific risk mitigation measures

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (10)
               OF THE META SPC 10

            5.1.   Instructions for use

            The product must be diluted before use in order to allow a final concentration of iodine of 0,3 %. The product should be diluted to 11 % (110mL product, add water up to 1 L).
            Do not prepare more fluid than necessary. Assume 5 mL solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.
            Use gloves and eye protection during the dilution step. The diluted product can be kept and used for 1 week.
            The product must be brought to a temperature above 20 °C before use.
            Apply the diluted product on the teats with a manual sprayer or with an automatic sprayer.
            The product should be used directly after milking 2 times per day by using a manual sprayer and 3 times per day by using a robot (automatic sprayer). Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
            Do not mix with other chemicals.
            5.2.   Risk mitigation measures

                        —

                        For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection.

                        —

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

                        —

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

                        —

                        Keep out of reach of children.

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

            After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.
            If medical advice is needed, have product container or label at hand.
            After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.
            Have product container or label at hand.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            6.   OTHER INFORMATION

            Dilutions of the product(s) are stable for 1 week.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10

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

                        Trade name(s)

                        Kenodin SD 900
                        IodoSD 900
                        IDip+ concentrate
                        Jodkonzentrat 1:9
                        Bühning Jodkonzentrat 1:9
                        Wynnsan Iodine Conc dip 9-1
                        Kenodin 900
                        Dufa Dip
                        Kenostart 900
                        Iodin Teat Spray 900
                        HCP Iodine Concentrate
                        Maxi Subliem CP
                        Subliem Koncentrat Plus

                        Authorisation number

                        EU-0022265-0013 1-10

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        2,8

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        21,0

               META SPC 11

            1.   META SPC 11 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 11 identifier

                        Identifier

                        metaSPC 11: PT3 – RTU Teat disinfectants Iodine

                  1.2.   Suffix to the authorisation number

                        Number

                        1-11

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 – Veterinary hygiene (Disinfectants)

                  2.   META SPC 11 COMPOSITION

            2.1.   Qualitative and quantitative information on the composition of the meta SPC 11

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,25

                        0,25

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,1

                        2,1

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        0,0

                  2.2.   Type(s) of formulation of the meta SPC 11

                        Formulation(s)

                        AL – Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11

                        Hazard statements

                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Avoid release to the environment.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

                  4.   AUTHORISED USE(S) OF THE META SPC 11

            4.1.   Use description

               Table 14. Use # 1 – PT3 – RTU teats disinfectant, Post-milking, Iodine

                        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
                        Post-milking teat disinfection of milk producing animals

                        Application method(s)

                        By dipping or spraying on teats

                        Application rate(s) and frequency

                        The product is ready to use.
                        Apply 2 times per day when using a manual sprayer and 3 times per day when using a dip cup or a robot (automatic sprayer).

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

            See general instructions.
            4.1.2.   Use-specific risk mitigation measures

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

            See general instructions.
            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 instructions.
            5.   GENERAL DIRECTIONS FOR USE (11)
               OF THE META SPC 11

            5.1.   Instructions for use

            Apply the product by dipping or by spraying:

                        —

                        By dipping: Apply the product with a dip cup. Wash the dip cup with water after use.

                        —

                        By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

                  Do not prepare more fluid than necessary; assume 5 mL solution per cow per treatment. 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.
            The product should be used immediately after each milking, two times per day when using a manual sprayer or three times per day when using a dip cup or a robot (automatic sprayer). Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
            Do not mix with other chemicals.
            5.2.   Risk mitigation measures

                        —

                        For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

                        —

                        For manual dipping application: no PPE is necessary for safe use.

                        —

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

                        —

                        Keep out of reach of children.

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

            After eye contact: Rinse immediately with water.
            After ingestion: Rinse mouth. Spit.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            6.   OTHER INFORMATION

            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11

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

                        Trade name(s)

                        Kenodin 2500
                        Iodin Teat Dip 2500
                        Jod 2500

                        Authorisation number

                        EU-0022265-0014 1-11

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,25

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,1

               META SPC 12

            1.   META SPC 12 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 12 identifier

                        Identifier

                        meta SPC 12: PT3 – RTU Teat disinfectants Iodine

                  1.2.   Suffix to the authorisation number

                        Number

                        1-12

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 – Veterinary hygiene (Disinfectants)

                  2.   META SPC 12 COMPOSITION

            2.1.   Qualitative and quantitative information on the composition of the meta SPC 12

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,3

                        0,5

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,1

                        2,9

                        Phosphoric acid

                        Phosphoric acid

                        Non-active Substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Alcohol C9-11 + 6 EO

                        Alcohol C9-11 + 6 EO

                        Non-active Substance

                        68439-46-3

                        0,0

                        0,0

                  2.2.   Type(s) of formulation of the meta SPC 12

                        Formulation(s)

                        AL – Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12

                        Hazard statements

                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Avoid release to the environment.
                        Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
                        Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

                  4.   AUTHORISED USE(S) OF THE META SPC 12

            4.1.   Use description

               Table 15. Use # 1 – PT3– RTU Teat disinfectant, Post-milking, Iodine

                        Product type

                        PT03 – Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria

                        Yeasts

                        Viruses

                        Field(s) of use

                        Indoor
                        Post-milking teat disinfection of milk producing animals

                        Application method(s)

                        By dipping or spraying on teats

                        Application rate(s) and frequency

                        The product is ready to use.
                        Apply 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 600 L, 1000 L
                        HDPE

                  4.1.1.   Use-specific instructions for use

            See general directions for use.
            4.1.2.   Use-specific risk mitigation measures

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

            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (12)
               OF THE META SPC 12

            5.1.   Instructions for use

            The product must be brought to a temperature above 20 °C before use.
            Apply the product by dipping or by spraying:

                        —

                        By dipping: Apply the product with a dip cup. Wash the dip cup with water after use

                        —

                        By spraying: Apply the product with a manual sprayer or with an automatic sprayer.

                  Do not prepare more fluid than necessary; assume 5 mL solution per cow per treatment.
            The product should be used immediately after each milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).
            Do not mix with other chemicals.
            5.2.   Risk mitigation measures

                        —

                        For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

                        —

                        For manual dipping application: no PPE is necessary for safe use.

                        —

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

                        —

                        Keep out of reach of children.

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

            After eye contact: Rinse immediately with water.
            After ingestion: Rinse mouth. Spit.
            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.

                        —

                        —

                        —

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

            Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.
            Protect from frost. Do not expose to temperatures > 40 °C.
            The shelf-life of the products is 2 years.
            6.   OTHER INFORMATION

            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12

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

                        Trade name(s)

                        Kenodin 5000
                        IodoDip 5000
                        JOD 5000
                        Bio Tec Jodip 5000
                        Bühning Jodfilmdip-Super
                        Iocid 5000
                        Iod protect 5000 Film
                        IOD protect 5000 Film
                        Iocid
                        Iodip+
                        Protetos cua
                        Iodin Teat Dip 5000

                        Authorisation number

                        EU-0022265-0015 1-12

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,5

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,9

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

                        Trade name(s)

                        Kenodin SD 5000
                        IodoSD 5000
                        IODOSPRAY 5000
                        Bio Tec Jodspray 5000
                        IDip+ 5000
                        Bühning Jodspray 5000
                        Iod protect 5000 Sprüh
                        Kenodin Film Spray
                        IOD protect 5000 Sprüh
                        Iodin Spray & Dip 5000

                        Authorisation number

                        EU-0022265-0016 1-12

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,5

                        Polyvinylpyrrolidone iodine

                        Active Substance

                        25655-41-8

                        0,0

                        Alcohols, C12-15, ethoxylated

                        Alcohols, C12-15, ethoxylated

                        Non-active Substance

                        68131-39-5

                        500-195-7

                        2,9

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

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

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

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

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

               (6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.

               (*1)  Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 1,8 to 2,49 % it is not possible to indicate all product dilutions here.

               (*2)  Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 1,8 to 2,49 % it is not possible to indicate all product dilutions here.

               (7)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.

               (*3)  Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 2,5 to 3 % it is not possible to indicate all product dilutions here.

               (*4)  Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 2,5 to 3 % it is not possible to indicate all product dilutions here.

               (8)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.

               (9)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.

               (*5)  Each product label should give information on how the dilution should be made. Since the concentration of iodine in products within this meta SPC can range from 0,5 to 0,99 % it is not possible to indicte all product dilutions here. An example is given for products with 0,5 % iodine.

               (10)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 10.

               (11)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 11.

               (12)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 12.