title: Commission Implementing Regulation (EU) 2020/1995 of 4 December 2020 amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ (Text with EEA relevance)

text:
                  7.12.2020

                  EN

                  Official Journal of the European Union

                  L 410/70

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1995
         of 4 December 2020
         amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 50(2) thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

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

                     (4)

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

                     (5)

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

                     (6)

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

                     (7)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Implementing Regulation (EU) 2018/1261 is amended as follows:

                        (1)

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

                        (2)

                        the Annex is replaced by the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 4 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

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

            ANNEX

               Summary of product characteristics for a biocidal product family

            HYPRED's iodine based products
            Product type 3 - Veterinary hygiene (Disinfectants)
            Authorisation number: EU-0018397-0000
            R4BP asset number: EU-0018397-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION
            1.1.   Family name

                        Name

                        HYPRED's iodine based products

                  1.2.   Product type(s)

                        Product type(s)

                        PT03 - Veterinary hygiene (Disinfectants)

                  1.3.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        HYPRED SAS – KERSIA Group

                        Address

                        55, Boulevard Jules Verger - BP10180 35803 DINARD Cedex France

                        Authorisation number

                        EU-0018397-0000

                           R4BP asset number

                        EU-0018397-0000

                        Date of the authorisation

                        11 October 2018

                        Expiry date of the authorisation

                        30 September 2028

                  1.4.   Manufacturer(s) of the biocidal products

                        Name of manufacturer

                        HYPRED SAS – KERSIA Group

                        Address of manufacturer

                        55, Boulevard Jules Verger - BP10180 35803 DINARD France

                        Location of manufacturing sites

                        HYPRED SAS – KERSIA Group - 55, Boulevard Jules Verger - BP10180 35803 DINARD France
                        KERSIA POLSKA Sp.z.o.o. - NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland
                        KERSIA IBERICA SL - Pol. Miguel Eguía C/Zarapuz s/n
                        31200 ESTELLA (NAVARRA) Spain
                        KERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany
                        HYPRED Italia s.r.l. – KERSIA Group Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy
                        AG France S.A.S – KERSIA Group - Zone Industrielle Le Roineau, 72500 VAAS, FRANCE
                        KERSIA DEUTSCHLAND GmbH - OBERBRÜHLSTRAßE 16-18, 87700 MEMMINGEN, GERMANY
                        KERSIA AUSTRIA GmbH - PFONGAUERSTRAßE 17, 5202 NEUMARKT AM WALLERSEE, AUSTRIA
                        Kilco Holdings Ltd – KERSIA Group - Broomhouses 2 Industrial Estate, Old Glasgow Road, LOCKERBIE - DG11 2SD, UNITED KINGDOM
                        Kilco (International) Ltd – KERSIA Group - 1A Trench Road Mallusk, Newtownabbey, CO ANTRIM BT36 4TY, IRELAND
                        Medentech Ltd – KERSIA Group - Clonard Road, WEXFORD, Y35Y7WY, IRELAND

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

                        Active substance

                        Iodine

                        Name of manufacturer

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

                        Address of manufacturer

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

                        Location of manufacturing sites

                        Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad.
                        Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile

                        Active substance

                        Iodine

                        Name of manufacturer

                        ACF MINERA SA

                        Address of manufacturer

                        San Martín 499 Iquique Chile

                        Location of manufacturing sites

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

                        Active substance

                        Iodine

                        Name of manufacturer

                        SOCIEDAD QUIMICA y MINERA SA

                        Address of manufacturer

                        Los Militares 4290 SANTIAGO DE CHILE Chile

                        Location of manufacturing sites

                        Pedro de Valdivia (PV) Route B 180 Antofagasta Chile
                        Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile

                        Active substance

                        Iodine

                        Name of manufacturer

                        ISE Chemicals Corporation

                        Address of manufacturer

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

                        Location of manufacturing sites

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

                        Active substance

                        Iodine

                        Name of manufacturer

                        Nihon Tennen Gas Development Co., Ltd

                        Address of manufacturer

                        661 Mobara 297-8550 Mobara City, Chiba Japan

                        Location of manufacturing sites

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

                  2.   PRODUCT FAMILY COMPOSITION AND FORMULATION
            2.1.   Qualitative and quantitative information on the composition of the family

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,25

                        2,5

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

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

                        Non active substance

                        68439-50-9

                        2,697

                        24,199

                  2.2.   Type(s) of formulation

                        Formulation(s)

                        AL - Any other liquid
                        SL - Soluble concentrate

                  PART II

               SECOND INFORMATION LEVEL - META SPC(S)

               META SPC 1

            1.   META SPC 1 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 1 identifier

                        Identifier

                        meta SPC 1 : Dipping products - ready to use

                  1.2.   Suffix to the authorisation number

                        Number

                        1-1

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 - Veterinary hygiene (Disinfectants)

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,25

                        0,49

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

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

                        Non active substance

                        68439-50-9

                        2,697

                        4,993

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

                        Formulation

                        AL - Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

                        Hazard statements

                        Causes serious eye irritation.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep out of reach of children.
                        Wash hands thoroughly after handling.
                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        If eye irritation persists: Get medical advice/attention.

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

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

                        Product Type

                        PT03 - Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Algae

                        Field(s) of use

                        Indoor
                        Disinfection of teats of milk producing animals by dipping after milking

                        Application method(s)

                        Dipping -
                        Manual or automated disinfection of teats by dipping after milking.
                        Dipping cup or automated dipping machine.

                        Application rate(s) and frequency

                                    —

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

                                    —

                                    sheep (1.5 to 5 ml : 1.5 ml recommended)

                                    —

                                    goats (2.5 to 6 ml : 2.5 ml recommended)

                              Frequency : 2 to 3 times per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        HDPE JERRYCAN 5, 10, 22 L
                        HDPE DRUM 60, 120, 220 L
                        HDPE CONTAINER 1000L

                  4.1.1.   Use-specific instructions for use

            See general directions for use of meta SPC 1
            4.1.2.   Use-specific risk mitigation measures

            See general directions for use of meta SPC 1
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 1
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            None: See general directions for use of meta SPC 1
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

            Always read the label or leaflet before use and follow all the instructions provided.
            The product must be brought to a temperature above 20°C before use.
            The use of a dosing pump for filling the product into the application equipment is recommended.
            Fill the dipping cup manually or automatically with the ready to use product.
            Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

                        —

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

                        —

                        sheep (1.5 to 5 ml : 1.5 ml recommended)

                        —

                        goats (2.5 to 6 ml : 2.5 ml recommended)

                  Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
            At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
            Where necessary, repeat the application after each milking.
            Clean the application equipment regularly with warm water.
            5.2.   Risk mitigation measures

            Wear eye protection.
            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

                        —

                        In the event of inhalation: Bring to fresh air.

                        —

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

                        —

                        In the event of contact with the eyes :

                  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
            If eye irritation persists: Get medical advice/attention.

                        —

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

                  Refer to the safety data sheet available for professional user: it contains an emergency phone number.
            Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Shelf life : 2 years in HDPE
            Do not store at a temperature higher than 30°C.
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Dip-io 2500
                        JOD DIP
                        IODERM PSP
                        DERMINO FR
                        Iododip
                        IODEX EXTRA
                        Iodystrong
                        DERMIODE
                        INO IODE EPAIS
                        INO STAR +
                        IODACTIV 2500
                        IODIUM BX2500
                        Usual Iod Post
                        ASiRAL Dip Coat
                        IODOCAN EXTRA
                        UDDER PLUS
                        PRIMADIODE
                        CERTIODE EPAIS
                        IODIPACK GEL
                        HELIO IODE EPAIS
                        VAGEL
                        GELAPIS ACTIV
                        IOSAPIS GEL
                        ZENCARE FLASH
                        REPROGEL
                        DERMADINE +
                        KRONI Jod Dipp 2500
                        WÜBBELMANN JOD DIP
                        Iodine Cleaner&Sanitizer
                        MUNGIFILM
                        ZEP FS FILMIODINE NIPPLE NP
                        IODOFILM
                        EMPRASAN UDDER SHIELD
                        ANGLIA FARMERS IO-FILM
                        BARRICADE
                        STANTON IODOFILM
                        WYNNSAN IOFILM TEAT DIP

                        Authorisation number

                        EU-0018397-0001 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,25

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

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

                        Non active substance

                        68439-50-9

                        2,697

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

                        Trade name(s)

                        Dip-io YB MAX
                        INO Io Dip MAX
                        JOD DIP YB MAX
                        IodoDip YB MAX
                        Iodium Dip YB MAX
                        JodyDip YB MAX
                        Delta IoDip YB MAX

                        Authorisation number

                        EU-0018397-0002 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,49

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

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

                        Non active substance

                        68439-50-9

                        4,993

               META SPC 2

            1.   META SPC 2 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 2 identifier

                        Identifier

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

                  1.2.   Suffix to the authorisation number

                        Number

                        1-2

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 - Veterinary hygiene (Disinfectants)

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,25

                        0,49

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

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

                        Non active substance

                        68439-50-9

                        2,697

                        4,69

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

                        Formulation

                        AL - Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

                        Hazard statements

                        Causes serious eye irritation.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep out of reach of children.
                        Wash hands thoroughly after handling.
                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        If eye irritation persists: Get medical advice/attention.

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

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

                        Product Type

                        PT03 - Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

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

                        Application method(s)

                        Dipping, foaming or spraying before milking -
                        Manual or automated disinfection of teats by dipping, foaming or spraying before milking
                        Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

                        Application rate(s) and frequency

                                    —

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

                                    —

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

                                    —

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

                              Frequency : 2 to 3 times per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        HDPE JERRYCAN 5, 10, 22 L
                        HDPE DRUM 60, 120, 220 L
                        HDPE CONTAINER 1000L

                  4.1.1.   Use-specific instructions for use

            Eliminate all visible dirt before applying the product.
            Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.
            Let the product act at least one minute.
            Use the teat cleaning and wiping method systematically before attaching the milking cluster.
            See also general instructions for use of meta SPC 2.
            4.1.2.   Use-specific risk mitigation measures

            For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/ eye protection.
            For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.
            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 2
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 2
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See general directions for use of meta SPC 2
            4.2.   Use description

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

                        Product Type

                        PT03 - Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Algae

                        Field(s) of use

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

                        Application method(s)

                        Dipping, foaming, spraying after milking -
                        Manual or automated disinfection of teats by dipping, foaming or spraying after milking
                        Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

                        Application rate(s) and frequency

                                    —

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

                                    —

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

                                    —

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

                              Frequency : 2 to 3 times per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        HDPE JERRYCAN 5, 10, 22 L
                        HDPE DRUM 60, 120, 220 L
                        HDPE CONTAINER 1000L

                  4.2.1.   Use-specific instructions for use

            Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.
            Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)
            At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
            See also general instructions for use of meta SPC 2.
            4.2.2.   Use-specific risk mitigation measures

            For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.
            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 2
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 2
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

            See use-specific instructions for each use.
            Always read the label or leaflet before use and follow all the instructions provided.
            The product must be brought to a temperature above 20°C before use.
            The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.
            Where necessary repeat the application at each milking
            Clean the application equipment regularly with warm water.
            5.2.   Risk mitigation measures

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

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

                        —

                        In the event of inhalation: Bring to fresh air.

                        —

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

                        —

                        In the event of contact with the eyes :

                  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
            If eye irritation persists: Get medical advice/attention.

                        —

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

                  Refer to the safety data sheet available for professional user: it contains an emergency phone number.
            Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Shelf life : 2 years in HDPE
            Do not store at a temperature higher than 30°C.
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Liq-io 2500
                        JOD SPRAY
                        IODINE 3000 RTU
                        IODEX 2500
                        Usual Iod Liquid
                        Iodoliquid
                        Iodospray
                        DESINTEAT
                        IODYSPRAY
                        RBT 2500
                        IODY’FLASH
                        INO IODE SPRAY
                        IODYPRO 2500
                        IODYPRO BL2500
                        Robot Liq-io 25
                        ADF iDip+
                        ASiRAL Dip Spray J
                        IODIPACK
                        HELIO IODE LIQUIDE
                        POLY-IODE
                        CERTIODE LIQUIDE
                        IOSAPIS FLUID
                        GELAPIS ROBOT
                        ZENCARE SPRAY
                        HELIO IODE SPRAY +
                        IODIP +
                        KRONI Jod Spray 2500
                        WÜBBELMANN JOD LIQUID
                        PRECEPT
                        ANGLIA FARMERS PRECLENZ
                        H&M PREDIP
                        FULLWOOD PRECLEANSE
                        M WILLIAMS PRECEPT
                        STANTON PREDIP RTU
                        WYNNSAN IODINE PREDIP RTU
                        PREMIER GOLD PRE-DIP
                        HODGES & MOSS PREDIP
                        LANODIP PREPOST
                        DAIRYSAN MULTICARE
                        EMPRASAN ADVANCE
                        UDDERWASH IODINE
                        ANGLIA FARMERS PREPOST-IO
                        PREMIER GOLD PRE/POST
                        FULLWOOD PRE/POST IODINE
                        HODGES & MOSS ADVANCE
                        WYNNSAN IODINE PREPOST

                        Authorisation number

                        EU-0018397-0003 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,25

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

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

                        Non active substance

                        68439-50-9

                        2,697

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

                        Trade name(s)

                        Liq-io YB MAX
                        INO Io Liquid Max
                        Iodoliquid YB MAX
                        Iodospray YB MAX
                        Desinteat YB MAX
                        Iodium Spray YB MAX
                        JodySpray YB MAX
                        Delta IoSpray YB MAX

                        Authorisation number

                        EU-0018397-0004 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,49

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

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

                        Non active substance

                        68439-50-9

                        4,69

               META SPC 3

            1.   META SPC 3 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 3 identifier

                        Identifier

                        meta SPC 3 : Dipping, foaming, spraying concentrated products

                  1.2.   Suffix to the authorisation number

                        Number

                        1-3

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 - Veterinary hygiene (Disinfectants)

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        2,5

                        2,5

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

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

                        Non active substance

                        68439-50-9

                        24,199

                        24,199

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

                        Formulation

                        SL - Soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

                        Hazard statements

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

                        Precautionary statements

                        Keep out of reach of children.
                        Do not breathe mist.
                        Do not breathe vapours.
                        Do not breathe spray.
                        Wash hands thoroughly after handling.
                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Immediately call a poison center / doctor.
                        Get medical advice/attention if you feel unwell.
                        Dispose of contents to in accordance with local/ regional/ national/ international regulations. Dispose of container to in accordance with local/ regional/ national/ international regulations.
                        Keep only in original container.
                        Absorb spillage to prevent material damage.

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

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

                        Product Type

                        PT03 - Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

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

                        Application method(s)

                        Dipping, foaming, spraying -
                        Manual or automated disinfection of teats by dipping, foaming or spraying before milking.
                        Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

                        Application rate(s) and frequency

                        A dilution at 10% (v/v) should be prepared
                        Application rate for the diluted product:

                                    —

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

                                    —

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

                                    —

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

                              Frequency: 2 to 3 times per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        HDPE JERRYCAN 5, 10, 22 L
                        HDPE DRUM 60, 120, 220 L
                        HDPE CONTAINER 1000L

                  4.1.1.   Use-specific instructions for use

            Prepare a dilution at 10% (v/v: 10 ml product, add water up to 100ml) for bactericidal and yeasticidal activity.
            Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.
            Eliminate all visible dirt before applying the product.
            Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.
            Let the product act at least one minute.
            Use the teat cleaning and wiping method systematically before attaching the milking cluster.
            See also general directions for use of meta SPC 3.
            4.1.2.   Use-specific risk mitigation measures

            For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.
            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 3
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 3
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See general directions for use of meta SPC 3
            4.2.   Use description

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

                        Product Type

                        PT03 - Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Algae
                        Viruses

                        Field(s) of use

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

                        Application method(s)

                        Dipping, foaming, spraying -
                        Manual or automated disinfection of teats by dipping, foaming or spraying after milking.
                        Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

                        Application rate(s) and frequency

                        For disinfection of bacteria, yeasts and algae a dilution at 10% (v/v: 10 ml product, add water up to 100ml) should be prepared.
                        For disinfection of viruses a dilution at 20% (v/v: 20 ml product, add water up to 100ml) should be prepared
                        Application rate for the diluted product:

                                    —

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

                                    —

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

                                    —

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

                              Frequency : 2 to 3 times per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        HDPE JERRYCAN 5, 10, 22 L
                        HDPE DRUM 60, 120, 220 L
                        HDPE CONTAINER 1000L

                  4.2.1.   Use-specific instructions for use

            Prepare a dilution at 10% (v/v: 10 ml product, add water up to 100ml) for bactericidal, yeasticidal and algaecidal activity or 20% (v/v: 20 ml product, add water up to 100ml) in case virucidal activity is also needed.
            Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.
            Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.
            Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
            At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
            See also general directions for use of meta SPC 3
            4.2.2.   Use-specific risk mitigation measures

            For manual spraying applications wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) /protective clothing/eye protection.
            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 3
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 3
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

            See use-specific instructions for each use.
            Always read the label or leaflet before use and follow all the instructions provided.
            The product must be brought to a temperature above 20°C before use.
            The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping / foaming cup / sprayer manually or automatically with the prepared dilution.
            Where necessary, repeat the application at each milking
            Clean the application equipment regularly with warm water.
            5.2.   Risk mitigation measures

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

            Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
            In case of faintness, get medical advice/attention. Show this safety data sheet to the doctor.
            FIRST AID INSTRUCTIONS

                        —

                        In the event of inhalation: Bring to fresh air.

                        —

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

                        —

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

                  Remove contact lenses if present and easy to do. Continue rinsing.
            Immediately call a POISON CENTER or doctor/physician.

                        —

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

                  Refer to the safety data sheet available for professional user: it contains an emergency phone number.
            Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Shelf life : 2 years in HDPE
            Do not store at a temperature higher than 30°C.
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Liq-io concentrate
                        INO Jod Konzentrat
                        Usual Iod Concent
                        Iodoconcentrat
                        D 10 IODINE
                        D 5 IODINE
                        Liq-io C
                        INO IODE C
                        D 4 IODINE
                        ADF iDip+ concentrate
                        Mammizan Concentré
                        WYNNSAN IODINE CONCENTRATE
                        EMPRASAN OPTIMA
                        ANGLIA FARMERS CONC
                        PROLAC SENTINEL CONC
                        PREMIER GOLD CONCENTRATE
                        FULLWOOD IODINE CONC
                        H&M OPTIMA
                        SENTINAL CONC
                        HARRY TRAVIS SUPER CONC TEAT DIP
                        LANODIP CONC
                        E/SAN SOVEREIGN
                        PROLAC SENTINEL CONC

                        Authorisation number

                        EU-0018397-0005 1-3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        2,5

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

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

                        Non active substance

                        68439-50-9

                        24,199

               META SPC 4

            1.   META SPC 4 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 4 identifier

                        Identifier

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

                  1.2.   Suffix to the authorisation number

                        Number

                        1-4

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 - Veterinary hygiene (Disinfectants)

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,5

                        0,5

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

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

                        Non active substance

                        68439-50-9

                        4,993

                        4,993

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

                        Formulation

                        AL - Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

                        Hazard statements

                        Causes serious eye irritation.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep out of reach of children.
                        Wash hands thoroughly after handling.
                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        If eye irritation persists: Get medical advice/attention.

                  4.   AUTHORISED USE(S) OF THE META SPC 4
            4.1.   Use description

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

                        Product Type

                        PT03 - Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Algae
                        Viruses

                        Field(s) of use

                        Indoor
                        Disinfection of teats of milk producing animals by dipping after milking

                        Application method(s)

                        Dipping -
                        Manual or automated disinfection of teats by dipping after milking.
                        Dipping cup or automated dipping machine.

                        Application rate(s) and frequency

                                    —

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

                                    —

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

                                    —

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

                              Frequency : 2 to 3 times per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        HDPE JERRYCAN 5, 10, 22 L
                        HDPE DRUM 60, 120, 220 L
                        HDPE CONTAINER 1000L

                  4.1.1.   Use-specific instructions for use

            See general directions for use of meta SPC 4
            4.1.2.   Use-specific risk mitigation measures

            See general directions for use of meta SPC 4
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 4
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 4
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

            Always read the label or leaflet before use and follow all the instructions provided.
            The product must be brought to a temperature above 20°C before use.
            The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping cup manually or automatically with the ready to use product.
            Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.

                        —

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

                        —

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

                        —

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

                  Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
            At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
            Where necessary, repeat the application after each milking.
            Clean the application equipment regularly with warm water.
            5.2.   Risk mitigation measures

            Wear eye protection.
            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

                        —

                        In the event of inhalation: Bring to fresh air.

                        —

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

                        —

                        In the event of contact with the eyes :

                  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
            If eye irritation persists: Get medical advice/attention.

                        —

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

                  Refer to the safety data sheet available for professional user: it contains an emergency phone number.
            Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Shelf life : 2 years in HDPE
            Do not store at a temperature higher than 30°C.
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Dip-io 5000
                        IODIUM TX
                        INO JOD 50 DIP
                        Usual Iod Post +
                        IODIUM PRO DIP
                        IODERM PSP +
                        IODEX EXTRA +
                        Iododip +
                        IODYSTRONG PLUS
                        INO TREMP
                        INO STAR
                        IODACTIV 5000
                        DERMINO
                        IODERM 5000
                        IODIUM BX5000
                        HOEVE-PLUS DIP
                        TREMPASEPT IODE
                        DERMADINE
                        MAMMO-DERM
                        KRONI Jod Dipp 5000

                        Authorisation number

                        EU-0018397-0006 1-4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,5

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

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

                        Non active substance

                        68439-50-9

                        4,993

               META SPC 5

            1.   META SPC 5 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 5 identifier

                        Identifier

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

                  1.2.   Suffix to the authorisation number

                        Number

                        1-5

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 - Veterinary hygiene (Disinfectants)

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,55

                        0,55

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

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

                        Non active substance

                        68439-50-9

                        4,69

                        4,69

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

                        Formulation

                        AL - Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

                        Hazard statements

                        Causes serious eye irritation.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep out of reach of children.
                        Wash hands thoroughly after handling.
                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        If eye irritation persists: Get medical advice/attention.

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

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

                        Product Type

                        PT03 - Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

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

                        Application method(s)

                        Dipping, foaming, spraying -
                        Manual or automated disinfection of teats by dipping, foaming or spraying before milking
                        Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine

                        Application rate(s) and frequency

                                    —

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

                                    —

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

                                    —

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

                              Frequency : 2 to 3 times per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        HDPE JERRYCAN 5, 10, 22 L
                        HDPE DRUM 60, 120, 220 L
                        HDPE CONTAINER 1000L

                  4.1.1.   Use-specific instructions for use

            Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product.
            Eliminate all visible dirt before applying the product.
            Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat before milking.
            Let the product act at least one minute.
            Use the teat cleaning and wiping method systematically before attaching the milking cluster.
            See also general instructions for use of meta SPC5.
            4.1.2.   Use-specific risk mitigation measures

            For manual dipping/foaming application : Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/ eye protection.
            For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing /eye protection.
            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 5
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 5
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See general directions for use of meta SPC 5
            4.2.   Use description

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

                        Product Type

                        PT03 - Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Algae
                        Viruses

                        Field(s) of use

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

                        Application method(s)

                        Dipping, foaming, spraying -
                        Manual or automated disinfection of teats by dipping, foaming or spraying after milking.
                        Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine.

                        Application rate(s) and frequency

                                    —

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

                                    —

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

                                    —

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

                              Frequency : 2 to 3 times per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        HDPE JERRYCAN 5, 10, 22 L
                        HDPE DRUM 60, 120, 220 L
                        HDPE CONTAINER 1000L

                  4.2.1.   Use-specific instructions for use

            Fill the dipping / foaming cup / sprayer manually or automatically with the ready to use product.
            Manual or automatic dipping / foaming / spraying on animal's teats on the full length of the teat after milking.
            Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)
            At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
            See also general instructions for use of meta SPC 5.
            4.2.2.   Use-specific risk mitigation measures

            For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.
            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 5
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 5
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

            See use-specific instructions for each use.
            Always read the label or leaflet before use and follow all the instructions provided.
            The product must be brought to a temperature above 20°C before use.
            The use of a dosing pump for filling the product into the application equipment is recommended.
            Where necessary repeat the application at each milking
            Clean the application equipment regularly with warm water.
            5.2.   Risk mitigation measures

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

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

                        —

                        In the event of inhalation: Bring to fresh air.

                        —

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

                        —

                        In the event of contact with the eyes :

                  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
            If eye irritation persists: Get medical advice/attention.

                        —

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

                  Refer to the safety data sheet available for professional user: it contains an emergency phone number.
            Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Shelf life : 2 years in HDPE
            Do not store at a temperature higher than 30°C.
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Liq-io 5500
                        IODYPRO
                        INO JOD 50 Liquid
                        Usual Iod Liquid +
                        IODIUM PRO SPRAY
                        IODEX
                        Iodoliquid +
                        Iodospray Plus
                        DESINTEAT PLUS
                        ROBOSPRAY IODE
                        INOTRAYON
                        IODYPRO 5500
                        Robot Liq-io 55
                        IODYPRO BL5500
                        ADF iDip+ 5500
                        HOEVE-JODIUM SPRAY
                        GRUPAIODE
                        IODOCAN
                        JOFO
                        JODI PLUS
                        K-AGRO PRODIP ID
                        IODIP
                        HELIO IODE SPRAY
                        MAMMO-JOD
                        KRONI Jod Spray 5500
                        MUNGI-IOD
                        LELY QUARESS-Iodine
                        GOLD GLYCODIP
                        EMPRASAN EXTRA CARE
                        H&M RTU IODINE
                        ANGLIA FARMERS SUPPLEDIP-IO
                        PROLAC RTU IODINE TEAT DIP
                        PREMIER GOLD POST DIP
                        FULLWOOD IODINE EXTRA
                        H&M EXTRACARE
                        M WILLIAMS TEAT DIP
                        PLATINUM
                        WDH GOLD DIP RTU
                        WYNNSAN IODINE HE RTU

                        Authorisation number

                        EU-0018397-0007 1-5

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,55

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

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

                        Non active substance

                        68439-50-9

                        4,69

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

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

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

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

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