title: Commission Implementing Regulation (EU) 2018/1288 of 24 September 2018 granting a Union authorisation for the biocidal product family Prodhynet's iodine based products (Text with EEA relevance.)

text:
                  25.9.2018

                  EN

                  Official Journal of the European Union

                  L 240/35

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1288
         of 24 September 2018
         granting a Union authorisation for the biocidal product family Prodhynet'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 3 August 2015, Prodhynet SA submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of a same biocidal product family, as referred to in Article 1 of Regulation (EU) No 414/2013, named Prodhynet's iodine based products (‘the same product family’) of product-type 3, as described in Annex V to Regulation (EU) No 528/2012. The application for the same product family was recorded under the case number BC-YK019030-42 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference product family (Hypred's iodine based products), recorded in the Register under the case number BC-LC018584-49.

                     (2)

                     The same 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 (3) 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 biocidal products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.

                     (3)

                     On 26 January 2018, the Agency submitted to the Commission an opinion (4), including the draft summary of the biocidal product characteristics (‘SPC’), in accordance with Article 6(2) of Regulation (EU) No 414/2013. The opinion concluded that the same product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that the proposed differences between the same product family and the related reference biocidal product family are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the above-mentioned related reference product family and subject to compliance with the draft SPC, the same product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.

                     (4)

                     On 6 March 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.

                     (5)

                     The Commission concurs with the opinion of the Agency and considers therefore appropriate to grant a Union authorisation for the same product family, and to record the SPC in the Register in accordance with Article 71(6) of that Regulation.

                     (6)

                     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 Prodhynet SA for the same biocidal product family Prodhynet's iodine based products with authorisation number EU-0018497-0000.
            The Union authorisation is valid from 15 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, 24 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).

            (3)  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).

            (4)  ECHA opinion of 25 January 2018 on the Union authorisation of the same biocidal product family PRODHYNET'S iodine based products (UBP-C-1177988-02-00/F).

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

            ANNEX

               Summary of product characteristics for a biocidal product family

            PRODHYNET's iodine based products
            Product type 3 - Veterinary hygiene (Disinfectants)
            Authorisation number: EU-0018497-0000
            R4BP asset number: EU-0018497-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION

            1.1.   Family name

                        Name

                        PRODHYNET'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

                        PRODHYNET SA

                        Address

                        11 Avenue des châtelets, 22440, PLOUFRAGAN, France

                        Authorisation number

                        EU-0018497-0000

                           R4BP asset number

                        EU-0018497-0000

                        Date of the authorisation

                        15 October 2018

                        Expiry date of the authorisation

                        30 September 2028

                  1.4.   Manufacturer(s) of the biocidal products

                        Name of manufacturer

                        PRODHYNET SA

                        Address of manufacturer

                        11, Avenue des Châtelets 22440 PLOUFRAGAN France

                        Location of manufacturing sites

                        PRODHYNET SA - 11, Avenue des Châtelets 22440 PLOUFRAGAN France

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

                        Active substance

                        Iodine

                        Name of manufacturer

                        COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. No 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 directions for use 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)

                        IODO EP25
                        IODOGEL
                        PRO TI-N

                        Authorisation number

                        EU-0018497-0001 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

               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)

                        IODO FL25
                        PRO ROBO I-N

                        Authorisation number

                        EU-0018497-0002 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

               META SPC 3

            1.   META SPC 3 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 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 3ml recommended)

                                    —

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

                              Frequency: 2 to 3 times per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

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

                        PRMX
                        IODOSE

                        Authorisation number

                        EU-0018497-0003 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)

                        AGRI IODE EPAIS S
                        HYGIA IODE EPAIS S
                        IODE EPAIS
                        NETAIODE EPAIS S
                        TREMPAGE EPAIS IODE S
                        IODO EP50
                        ADIEL IODE EPAIS
                        LATI IODE
                        PRO TI
                        PROXA IODE EPAIS S
                        BREIZH-IODE EPAIS S
                        BRETAIODE EPAIS
                        DR16
                        PLUSAIOD EPAIS
                        HELIO FIRST EP
                        TECNO FIRST
                        LACTOIODE EPAIS
                        MAG IODE EPAIS S

                        Authorisation number

                        EU-0018497-0004 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)

                        AGRI IODE FLUIDE
                        HYGIA IODE FLUIDE
                        IODE FLUIDE
                        IOSPRAY FLUIDE
                        PULVE IODE
                        IODO FL55
                        IODOLIN
                        ADIEL IODE FLUIDE
                        BOVI IODE SPRAY
                        PRO ROBO I
                        PROXA IODE FLUIDE
                        HELIODE FLUIDE
                        TECNO FLUIDE
                        DR15
                        GANAIODE FLUIDE
                        PLUSAIOD
                        PROTECTION FLUIDE IODE
                        BREIZH-IODE FLUIDE
                        BRETAIODE LQ
                        IODE NET FLUIDE
                        LACTOIODE FLUIDE
                        MAG IODE FLUIDE
                        NETAIODE FLUIDE
                        NETAIODE

                        Authorisation number

                        EU-0018497-0005 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) 2018/1286 of 24 September 2018 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

text:
                  25.9.2018

                  EN

                  Official Journal of the European Union

                  L 240/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1286
         of 24 September 2018
         amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1210/2003 of 7 July 2003 concerning certain specific restrictions on economic and financial relations with Iraq and repealing Regulation (EC) No 2465/96 (1), and in particular Article 11(b) thereof,
         Whereas:

                     (1)

                     Annex III to Regulation (EC) No 1210/2003 lists public bodies, corporations and agencies and natural and legal persons, bodies and entities of the previous government of Iraq covered by the freezing of funds and economic resources that were located outside Iraq on the date of 22 May 2003 under that Regulation.

                     (2)

                     On 19 September 2018, the Sanctions Committee of the United Nations Security Council decided to remove two entries from the list of persons or entities to whom the freezing of funds and economic resources should apply.

                     (3)

                     Annex III to Regulation (EC) No 1210/2003 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex III to Regulation (EC) No 1210/2003 is amended as set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the 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, 24 September 2018.

                  For the Commission,

                  On behalf of the President,

                  Head of the Service for Foreign Policy Instruments

            (1)  OJ L 169, 8.7.2003, p. 6.

            ANNEX
            In Annex III to Regulation (EC) No 1210/2003, the following entries are deleted:

                           ‘116.

                           STATE COMPANY FOR ELECTRICAL INDUSTRIES (alias (a) STATE ENTERPRISE FOR ELECTRICAL INDUSTRIES, (b) STATE ENTERPRISE FOR ELECTRICAL INDUSTRIES/ELECTRICAL LAMPS, (c) STATE ENTERPRISE FOR GENERATION AND TRANSMISSION OF ELECTRICITY). Addresses: (a) P.O. Box 1118, Waziria, Baghdad, Iraq; (b) P.O. Box 9145, Al-Kadhmiyah, Al-Taji, Baghdad, Iraq; (c) 4/356 Al Masbah Building, P.O. Box 1098, Baghdad, Iraq.’

                           ‘134.

                           STATE ENTERPRISE FOR DRUG INDUSTRIES (alias STATE COMPANY FOR DRUG PRODUCTS). Address: P.O. Box 271, Samara, Iraq.’


title: Council Implementing Regulation (EU) 2018/1284 of 24 September 2018 implementing Regulation (EU) 2017/1509 concerning restrictive measures against the Democratic People's Republic of Korea

text:
                  25.9.2018

                  EN

                  Official Journal of the European Union

                  L 240/2

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1284
         of 24 September 2018
         implementing Regulation (EU) 2017/1509 concerning restrictive measures against the Democratic People's Republic of Korea
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) 2017/1509 of 30 August 2017 concerning restrictive measures against the Democratic People's Republic of Korea and repealing Regulation (EC) No 329/2007 (1), and in particular Article 47(5) thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 30 August 2017 the Council adopted Regulation (EU) 2017/1509.

                     (2)

                     On 14 September 2018 the United Nations Security Council (‘UNSC’) Committee established pursuant to UNSC Resolution 1718 (2006) amended the listing of one vessel subject to restrictive measures.

                     (3)

                     Annex XIV to Regulation (EU) 2017/1509 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex XIV to Regulation (EU) 2017/1509 is amended as set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the date 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, 24 September 2018.

                  For the Council

                  The President

               J. BOGNER-STRAUSS

            (1)  OJ L 224, 31.8.2017, p. 1.

            ANNEX
            In Annex XIV to Regulation (EU) 2017/1509, entry 32 under the heading ‘B. Vessels which are prohibited entry into ports’ is replaced by the following:

                           ‘32.

                              Name: WAN HENG 11

                              Additional information

                           IMO: 8791667
                           M/V WAN HENG 11 engaged in a ship-to-ship transfer, likely for oil, with M/V RYE SONG GANG 1 on 13 February 2018.
                           Wan Heng 11, formerly a Belize-flagged vessel, is now operating as a DPRK-flagged vessel named the KUMJINGANG3 or Kum Jin Gang 3.’


title: Commission Implementing Regulation (EU) 2018/1294 of 26 September 2018 concerning the non-approval of Landes pine tar as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance.)

text:
                  27.9.2018

                  EN

                  Official Journal of the European Union

                  L 243/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1294
         of 26 September 2018
         concerning the non-approval of Landes pine tar as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
         (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 Article 23(5) in conjunction with Article 13(2) thereof,
         Whereas:

                     (1)

                     On 22 December 2015, the Commission received an application from Progarein France SAS for the approval of Landes pine tar as a basic substance. That application was accompanied by the information required under the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009.

                     (2)

                     The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance. The Authority provided the Commission with a technical report on Landes pine tar on 30 October 2017 (2). The Commission presented the review report (3) and the draft of this Regulation on the non-approval of Landes pine tar to the Standing Committee on Plants, Animals, Food and Feed on 24 May 2018 and finalised them for the meeting of that Committee on 20 July 2018.

                     (3)

                     The documentation provided by the applicant does not show that Landes pine tar fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4).

                     (4)

                     Specific concerns however were identified, in the technical report of the Authority, regarding Landes pine tar. Landes pine tar is a complex mixture, the exact composition of which is unknown. Landes pine tar should be considered as a substance of concern since it can contain substances of concern (e.g. furfurals, phenols). Furthermore the presence of substances of very high concern cannot be excluded (e.g. genotoxic carcinogens such as polycyclic aromatic hydrocarbons). Furthermore, assessment of the risk to operators, workers, bystanders and consumers could not be finalised based on the data available in the application.

                     (5)

                     No relevant evaluation, carried out in accordance with other Union legislation as referred to in Article 23(2) of Regulation (EC) No 1107/2009, was available.

                     (6)

                     The Commission invited the applicant to submit its comments on the technical report of the Authority and on the Commission's draft review report. The applicant submitted its comments, which have been carefully examined.

                     (7)

                     However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.

                     (8)

                     Consequently, as laid down in the Commission's review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve Landes pine tar as a basic substance.

                     (9)

                     This Regulation does not prejudice the submission of a further application for the approval of Landes pine tar as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

                     (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
            The substance Landes pine tar is not approved as a basic substance.

            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, 26 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA (European Food Safety Authority), 2017. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for Landes pine tar for use in plant protection as protectant and repellent. EFSA supporting publication 2017:EN-1311. 57 pp.

            (3)  http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN.

            (4)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).


title: Commission Implementing Regulation (EU) 2018/1476 of 3 October 2018 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

text:
                  4.10.2018

                  EN

                  Official Journal of the European Union

                  L 249/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1476
         of 3 October 2018
         amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1210/2003 of 7 July 2003 concerning certain specific restrictions on economic and financial relations with Iraq and repealing Regulation (EC) No 2465/96 (1), and in particular Article 11(b) thereof,
         Whereas:

                     (1)

                     Annex III to Regulation (EC) No 1210/2003 lists public bodies, corporations and agencies and natural and legal persons, bodies and entities of the previous government of Iraq covered by the freezing of funds and economic resources that were located outside Iraq on the date of 22 May 2003 under that Regulation.

                     (2)

                     On 28 September 2018, the Sanctions Committee of the United Nations Security Council decided to remove one entry from the list of persons or entities to whom the freezing of funds and economic resources should apply.

                     (3)

                     Annex III to Regulation (EC) No 1210/2003 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex III to Regulation (EC) No 1210/2003 is amended as set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the 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, 3 October 2018.

                  For the Commission,

                  On behalf of the President,

                  Head of the Service for Foreign Policy Instruments

            (1)  OJ L 169, 8.7.2003, p. 6.

            ANNEX
            In Annex III to Council Regulation (EC) No 1210/2003, the following entry is deleted:

                           ‘128.

                           STATE ENTERPRISE FOR AUTOMOTIVE INDUSTRY (alias STATE ENTERPRISE FOR AUTOMOTIVE INDUSTRIES). Address: P.O. Box 138, Iskandariya-Babylon, Iraq.’