title: Commission Implementing Regulation (EU) 2018/1261 of 20 September 2018 granting a Union authorisation for the biocidal product family Hypred's iodine based products (Text with EEA relevance.)

text:
                  21.9.2018

                  EN

                  Official Journal of the European Union

                  L 238/33

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1261
         of 20 September 2018
         granting a Union authorisation for the biocidal product family Hypred's iodine based products
         (Text with EEA relevance)
         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 44(5) thereof,
         Whereas:

                     (1)

                     On 16 July 2015, Hypred SAS submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Hypred's iodine based products (‘the product family’) of product-type 3, as defined in Annex V to that Regulation. The Netherlands agreed that their competent authority referred to in Article 43(1) of Regulation (EU) No 528/2012 evaluate this application. The application was recorded under the case number BC-LC018584-49 in the Register for Biocidal Products (‘the Register’).

                     (2)

                     The biocidal product family contains iodine as 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, once the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2) will become applicable, the Commission will consider the need to review 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 then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.

                     (3)

                     On 6 June 2017 the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

                     (4)

                     On 12 January 2018, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (hereinafter ‘SPC’) and the final product assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concluded that the product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that it was found eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.

                     (5)

                     On 26 February 2018, 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.

                     (6)

                     The Commission concurs with the opinion of the Agency and considers therefore appropriate to grant a Union authorisation for the biocidal product family, and to record the SPC and the product assessment report on the product family in the Register in accordance with Article 71(6) of Regulation (EU) No 528/2012.

                     (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
            A Union authorisation is granted to Hypred SAS for the biocidal product family Hypred's iodine based products with authorisation number EU-0018397-0000.
            The Union authorisation is valid from 11 October 2018 until 30 September 2028.
            The Union authorisation is subject to compliance with the SPC set out in the Annex.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 20 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (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 12 December 2017 on the Union authorisation of Hypred's iodine based products (ECHA/BPC/178/2017).

            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

                        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

                        Address of manufacturer

                        55, Boulevard Jules Verger - BP10180 35803 DINARD France

                        Location of manufacturing sites

                        HYPRED SAS - 55, Boulevard Jules Verger - BP10180 35803 DINARD France
                        HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4 64320 Buk Poland
                        HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C no 32 31160 Orcoyen – NAVARRA Spain
                        HYPRED GmbH Marie-Curie-Straße 23 53332 Bornheim – Sechtem Germany
                        HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova 26010 Ripalta Arpina CR Italy

                  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

                  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 10 ml: 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 1 000  L

                  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 10 ml: 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

                        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 10 ml: 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 1 000  L

                  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 10 ml: 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 1 000  L

                  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

                        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 10 ml: 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 1 000  L

                  4.1.1.   Use-specific instructions for use

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

                                    —

                                    cows and buffaloes (3 to 10 ml: 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 1 000  L

                  4.2.1.   Use-specific instructions for use

            Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) for bactericidal, yeasticidal and algaecidal activity or 20 % (v/v: 20 ml product, add water up to 100 ml) 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

                        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 10 ml: 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 1 000  L

                  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 10 ml: 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 5 500  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 10 ml: 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 1 000  L

                  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 10 ml: 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 1 000  L

                  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

                        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.


title: Commission Implementing Regulation (EU) 2018/1266 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, carboxin, clethodim, cycloxydim, dazomet, diclofop, dithianon, dodine, fenazaquin, fluometuron, flutriafol, hexythiazox, hymexazol, indolylbutyric acid, isoxaben, lime sulphur, metaldehyde, paclobutrazol, pencycuron, sintofen, tau-fluvalinate and tebufenozide (Text with EEA relevance.)

text:
                  21.9.2018

                  EN

                  Official Journal of the European Union

                  L 238/81

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1266
         of 20 September 2018
         amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, carboxin, clethodim, cycloxydim, dazomet, diclofop, dithianon, dodine, fenazaquin, fluometuron, flutriafol, hexythiazox, hymexazol, indolylbutyric acid, isoxaben, lime sulphur, metaldehyde, paclobutrazol, pencycuron, sintofen, tau-fluvalinate and tebufenozide
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,
         Whereas:

                     (1)

                     Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

                     (2)

                     Applications for the renewal of the approval of 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, carboxin, clethodim, cycloxydim, dazomet, diclofop, dithianon, dodine, fenazaquin, fluometuron, flutriafol, hexythiazox, hymexazol, indolylbutyric acid, isoxaben, lime sulphur, metaldehyde, paclobutrazol, pencycuron, sintofen, tau-fluvalinate and tebufenozide were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (3). However, the approval of those substances is likely to expire for reasons beyond the control of the applicant before a decision has been taken on the renewal of their approval. It is therefore necessary to extend their approval periods in accordance with Article 17 of Regulation (EC) No 1107/2009.

                     (3)

                     In view of the time and resources necessary for completing the assessment of applications for renewal of approval of a large number of active substances the approvals of which are expiring between 2019 and 2021, Commission Implementing Decision C(2016) 6104 (4) established a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.

                     (4)

                     As the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, carboxin, clethodim, cycloxydim, dazomet, diclofop, dithianon, dodine, fenazaquin, fluometuron, flutriafol, hexythiazox, hymexazol, indolylbutyric acid, isoxaben, lime sulphur, metaldehyde, paclobutrazol, pencycuron, sintofen, tau-fluvalinate and tebufenozide do not fall in the prioritised categories of Implementing Decision C(2016) 6104, their approval period should be extended by either two or three years, taking into account the current date of expiry, the fact that in accordance with Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance is to be submitted no later than 30 months before expiry of the approval, the need to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making.

                     (5)

                     It is therefore appropriate to extend the approval period for the active substances carboxin, clethodim, cycloxydim, dazomet, diclofop, fenazaquin, hymexazol, indolylbutyric acid, metaldehyde, and paclobutrazol by two years, and the approval period of the active substances 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, dithianon, dodine, fluometuron, flutriafol, hexythiazox, isoxaben, lime sulphur, pencycuron, sintofen, tau-fluvalinate and tebufenozide by three years.

                     (6)

                     Where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the expiry date should remain the same as before this Regulation or it should be set at the earliest date thereafter.

                     (7)

                     Where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission will adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

                     (8)

                     Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

                     (9)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with 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, 20 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

            (3)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

            (4)  Commission Implementing Decision of 28 September 2016 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2019, 2020 and 2021 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (OJ C 357, 29.9.2016, p. 9).

            ANNEX
            Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                        (1)

                        in the sixth column, expiration of approval, of row 316, Cycloxydim, the date is replaced by ‘31 May 2023’;

                        (2)

                        in the sixth column, expiration of approval, of row 317, 6-Benzyladenine, the date is replaced by ‘31 May 2024’;

                        (3)

                        in the sixth column, expiration of approval, of row 322, Hymexazol, the date is replaced by ‘31 May 2023’;

                        (4)

                        in the sixth column, expiration of approval, of row 323, Dodine, the date is replaced by ‘31 May 2024’;

                        (5)

                        in the sixth column, expiration of approval, of row 326, Indolylbutyric acid, the date is replaced by ‘31 May 2023’;

                        (6)

                        in the sixth column, expiration of approval, of row 328, Tau-fluvalinate, the date is replaced by ‘31 May 2024’;

                        (7)

                        in the sixth column, expiration of approval, of row 329, Clethodim, the date is replaced by ‘31 May 2023’;

                        (8)

                        in the sixth column, expiration of approval, of row 330, Bupirimate, the date is replaced by ‘31 May 2024’;

                        (9)

                        in the sixth column, expiration of approval, of row 333, 1-decanol, the date is replaced by ‘31 May 2024’;

                        (10)

                        in the sixth column, expiration of approval, of row 334, Isoxaben, the date is replaced by ‘31 May 2024’;

                        (11)

                        in the sixth column, expiration of approval, of row 335, Fluometuron, the date is replaced by ‘31 May 2024’;

                        (12)

                        in the sixth column, expiration of approval, of row 337, Carboxin, the date is replaced by ‘31 May 2023’;

                        (13)

                        in the sixth column, expiration of approval, of row 339, Dazomet, the date is replaced by ‘31 May 2023’;

                        (14)

                        in the sixth column, expiration of approval, of row 340, Metaldehyde, the date is replaced by ‘31 May 2023’;

                        (15)

                        in the sixth column, expiration of approval, of row 341, Sintofen, the date is replaced by ‘31 May 2024’;

                        (16)

                        in the sixth column, expiration of approval, of row 342, Fenazaquin, the date is replaced by ‘31 May 2023’;

                        (17)

                        in the sixth column, expiration of approval, of row 343, Azadirachtin, the date is replaced by ‘31 May 2024’;

                        (18)

                        in the sixth column, expiration of approval, of row 344, Diclofop, the date is replaced by ‘31 May 2023’;

                        (19)

                        in the sixth column, expiration of approval, of row 345, Lime sulphur, the date is replaced by ‘31 May 2024’;

                        (20)

                        in the sixth column, expiration of approval, of row 346, Aluminium sulfate, the date is replaced by ‘31 May 2024’;

                        (21)

                        in the sixth column, expiration of approval, of row 348, Paclobutrazol, the date is replaced by ‘31 May 2023’;

                        (22)

                        in the sixth column, expiration of approval, of row 349, Pencycuron, the date is replaced by ‘31 May 2024’;

                        (23)

                        in the sixth column, expiration of approval, of row 350, Tebufenozide, the date is replaced by ‘31 May 2024’;

                        (24)

                        in the sixth column, expiration of approval, of row 351, Dithianon, the date is replaced by ‘31 May 2024’;

                        (25)

                        in the sixth column, expiration of approval, of row 352, Hexythiazox, the date is replaced by ‘31 May 2024’;

                        (26)

                        in the sixth column, expiration of approval, of row 353, Flutriafol, the date is replaced by ‘31 May 2024’.


title: Commission Implementing Regulation (EU) 2018/1293 of 26 September 2018 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food lactitol (Text with EEA relevance.)

text:
                  27.9.2018

                  EN

                  Official Journal of the European Union

                  L 243/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1293
         of 26 September 2018
         amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food lactitol
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) was adopted, which establishes a Union list of authorised novel foods.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

                     (4)

                     Commission Implementing Decision (EU) 2017/450 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market of lactitol as a novel food to be used in capsule or tablet in food supplements intended for the adult population.

                     (5)

                     On 22 March 2018, the company DuPont Nutrition Biosciences ApS made a request to the Commission to change the conditions of use of the novel food lactitol within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to include powder as an allowed form of lactitol to be used in food supplements.

                     (6)

                     The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) as the amendment of the conditions of use of the novel food lactitol by including powder, as an allowed form of lactitol to be used in food supplements is not liable to have an effect on human health.

                     (7)

                     The maximum level of lactitol authorised by Implementing Decision (EU) 2017/450 as a novel food to be used in capsule or tablet in food supplements is 20 g/day. The proposed use level of the novel food lactitol in powder form in the same food category corresponds to the maximum level that is currently authorized. Therefore, it is appropriate to amend the conditions of use of lactitol to authorise its use in powder form at the existing maximum authorised level.

                     (8)

                     The information provided in the application gives sufficient grounds to establish that the application for changing of the conditions of use of the novel food lactitol by including powder, as an allowed form of lactitol to be used in food supplements, comply with Article 12(2) of Regulation (EU) 2015/2283.

                     (9)

                     Directive 2002/46/EC of the European Parliament and of the Council (5) lays down requirements on food supplements. The additional form of lactitol to be used in food supplements should be authorised without prejudice to that Directive.

                     (10)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   The entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to the substance lactitol shall be amended as specified in the Annex to this Regulation.

               2.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

               3.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.

            Article 2
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 3
            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, 26 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (3)  Commission Implementing Decision (EU) 2017/450 of 13 March 2017 authorising the placing on the market of lactitol as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 69, 15.3.2017, p. 31).

            (4)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

            (5)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

            ANNEX
            The entry for ‘Lactitol’ in Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the following:

                           Authorised novel food

                           Conditions under which the novel food may be used

                           Additional specific labelling requirements

                           Other requirements

                           ‘Lactitol

                              Specified food category

                              Maximum levels

                           The designation of the novel food on the labelling of the food supplements containing it shall be “Lactitol”’

                           Food Supplements as defined in Directive 2002/46/EC (capsules, tablets or powder) intended for the adult population

                           20 g/day