title: Commission Implementing Regulation (EU) 2018/1287 of 24 September 2018 granting a Union authorisation for the biocidal product family Quat-Chem's iodine based products (Text with EEA relevance.)

text:
                  25.9.2018

                  EN

                  Official Journal of the European Union

                  L 240/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1287
         of 24 September 2018
         granting a Union authorisation for the biocidal product family Quat-Chem'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 24 July 2015, Quatchem Ltd 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 Quat-chem'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-YN018814-15 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 of the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will 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 (hereinafter ‘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 Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the abovementioned 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 13 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 Quatchem Ltd for the same biocidal product family Quat-chem's iodine based products with authorisation number EU-0018496-0000.
            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 QUAT-CHEM's iodine based products (UBP-C-1177989-01-00/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

            QUAT-CHEM's iodine based products
            Product type 3 — Veterinary hygiene (Disinfectants)
            Authorisation number: EU-0018496-0000
            R4BP asset number: EU-0018496-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION

            1.1.   Family name

                        Name

                        QUAT-CHEM'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

                        Quatchem Ltd

                        Address

                        4 Dodgson Street, OL16 5SJ, Rochdale, United Kingdom

                        Authorisation number

                        EU-0018496-0000

                           R4BP asset number

                        EU-0018496-0000

                        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

                        QUAT-CHEM LTD

                        Address of manufacturer

                        Charter House 33 - Greek Street SK3 8AX Stockport United Kingdom

                        Location of manufacturing sites

                        QUAT-CHEM LTD - Charter House 33 - Greek Street SK3 8AX Stockport United Kingdom

                  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 SPCs

               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)

                        Teatsan 2500
                        IODO GUARD 2500

                        Authorisation number

                        EU-0018496-0001 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)

                        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)

                        Teat Guard 2500
                        IODO SPRAY 2500

                        Authorisation number

                        EU-0018496-0002 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 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 100ml) for bactericidal and yeasticidal activity.
            Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.
            Eliminate all visible dirt before applying the product.
            Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.
            Let the product act at least one minute.
            Use the teat cleaning and wiping method systematically before attaching the milking cluster.
            See also general directions for use of meta SPC 3.
            4.1.2.   Use-specific risk mitigation measures

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

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

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

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

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

                        Product Type

                        PT03 - Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Algae
                        Viruses

                        Field(s) of use

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

                        Application method(s)

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

                        Application rate(s) and frequency

                        For disinfection of bacteria, yeasts and algae a dilution at 10 % (v/v: 10 ml product, add water up to 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 100ml) 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 SPC3
            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)

                        Teat Guard Concentrate 1:4
                        IODO GUARD CONCENTRATE 1:4

                        Authorisation number

                        EU-0018496-0003 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

            None: see directions for use 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)

                        Teatsan 5000
                        IODO GUARD 5000

                        Authorisation number

                        EU-0018496-0004 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)

                        Teat Guard 5500
                        IODO SPRAY 5500

                        Authorisation number

                        EU-0018496-0005 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 SPC2.


title: Council Implementing Regulation (EU) 2018/1285 of 24 September 2018 implementing Article 21(5) of Regulation (EU) 2016/44 concerning restrictive measures in view of the situation in Libya

text:
                  25.9.2018

                  EN

                  Official Journal of the European Union

                  L 240/4

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1285
         of 24 September 2018
         implementing Article 21(5) of Regulation (EU) 2016/44 concerning restrictive measures in view of the situation in Libya
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) 2016/44 of 18 January 2016 concerning restrictive measures in view of the situation in Libya and repealing Regulation (EU) No 204/2011 (1), and in particular Article 21(5) thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 18 January 2016 the Council adopted Regulation (EU) 2016/44.

                     (2)

                     On 17 September 2018 the United Nations Security Council (‘UNSC’) Committee established pursuant to UNSC Resolution 1970 (2011) amended the listings of five persons subject to restrictive measures.

                     (3)

                     Annex II to Regulation (EU) 2016/44 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex II to Regulation (EU) 2016/44 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 12, 19.1.2016, p. 1.

            ANNEX

                        1)

                        In Annex II to Regulation (EU) 2016/44, entry 21 is replaced by the following:

                                    ‘21.

                                    Name: 1: ERMIAS 2: ALEM 3: na 4: na

                                       Title: na Designation: Leader of a transnational trafficking network DOB: Approximately 1980 POB: Eritrea Good quality a.k.a.: Ermias Ghermay, Guro Low quality a.k.a.: a) Ermies Ghermay b) Ermias Ghirmay Nationality: Eritrea Passport no: na National identification no: na Address: (Known address: Tripoli, Tarig sure no. 51, likely moved to Sabratha in 2015.) Listed on:7 June 2018Other information: Listed pursuant to paragraphs 15 and 17 of resolution 1970 (Travel Ban, Asset Freeze)
                                    Listed pursuant to paragraph 22(a) of resolution 1970 (2011); paragraph 4(a) of resolution 2174 (2014); paragraph 11(a) of resolution 2213 (2015).
                                    Additional information
                                    Ermias Alem is extensively documented by multiple reliable sources, including criminal investigations, identifying him as one of the most important sub-Saharan actors involved in the illicit trafficking of migrants in Libya. Ermias Alem is a leader of a transnational network responsible for trafficking and smuggling tens of thousands of migrants, mainly from the Horn of Africa to the coast of Libya and onwards to destination countries in Europe and the United States. He has armed men at his disposal, as well as warehouses and detention camps where serious human rights abuses are reportedly being committed against migrants. He works in close cooperation with Libyan smuggling networks like that of Mustafa, and he is considered their ‘Eastern supply chain’. His network stretches from Sudan to the coast of Libya and to Europe (Italy, France, Germany, the Netherlands, Sweden, the United Kingdom) and the United States. Alem controls private detention camps around the Libyan northwest coast where migrants are detained, and where serious abuses against migrants have taken place. From these camps, migrants are transported to Sabratha or Zawiya. In recent years, Alem has organised countless perilous journeys across the sea, exposing migrants (including numerous minors) to the risk of death. The Court of Palermo (Italy) issued arrest warrants in 2015 against Ermias Alem in relation to the smuggling of thousands of migrants under inhumane circumstances, including the shipwrecking on 13 October 2013 near Lampedusa in which 266 people died.’

                        2)

                        In Annex II to Regulation (EU) 2016/44, entry 22 is replaced by the following:

                                    ‘22.

                                    Name: 1: FITIWI 2: ABDELRAZAK 3: na 4: na

                                       Title: na Designation: Leader of a transnational trafficking network DOB: Approximately (30-35 years old) POB: Massaua, Eritrea Good quality a.k.a.: Abdurezak, Abdelrazaq, Abdulrazak, Abdrazzak Low quality a.k.a.: Fitwi Esmail Abdelrazak Nationality: Eritrea Passport no: na National identification no: na Address: na Listed on:7 June 2018Other information: Listed pursuant to paragraphs 15 and 17 of resolution 1970 (Travel Ban, Asset Freeze)
                                    Listed pursuant to paragraph 22(a) of resolution 1970 (2011); paragraph 4(a) of resolution 2174 (2014); paragraph 11(a) of resolution 2213 (2015).
                                    Additional information
                                    Fitiwi Abdelrazak is a leader of a transnational network responsible for trafficking and smuggling tens of thousands of migrants, mainly from the Horn of Africa to the coast of Libya and onwards to destination countries in Europe and the United States. Fitiwi Abdelrazak has been identified in open sources and in several criminal investigations as one of the top-level actors responsible for the exploitation and abuse of a large number of migrants in Libya. Abdelrazak has extensive contacts within Libyan smuggling networks and has accumulated immense wealth through the illicit trafficking of migrants. He has armed men at his disposal, as well as warehouses and detention camps where serious human rights abuses are being committed. His network is composed of cells reaching from Sudan, Libya, Italy and onwards to destination countries for migrants. Migrants in his camps are also bought from other parties, such as other local detention facilities. From these camps, migrants are transported to the Libyan coast. Abdelrazak has organised countless perilous maritime journeys, exposing migrants (including minors) to the risk of death. Abdelrazak is linked to at least two shipwrecks with fatal consequences between April 2014 and July 2014.’

                        3)

                        In Annex II to Regulation (EU) 2016/44, entry 23 is replaced by the following:

                                    ‘23.

                                    Name: 1: AHMAD 2: OUMAR 3: IMHAMAD 4: AL-FITOURI

                                       Title: na Designation: Commander of the Anas al-Dabbashi militia, Leader of a transnational trafficking network DOB:7 May 1988POB: (possibly Sabratha, Talil neighbourhood) Good quality a.k.a.: na Low quality a.k.a.: a) Al-Dabachi b) Al Ammu c) The Uncle d) Al-Ahwal e) Al Dabbashi Nationality: Libya Passport no: na National identification no: na Address: a) Garabulli, Libya b) Zawiya, Libya Listed on:7 June 2018Other information: Listed pursuant to paragraphs 15 and 17 of resolution 1970 (Travel Ban, Asset Freeze)
                                    Listed pursuant to paragraph 22(a) of resolution 1970 (2011); paragraph 4(a) of resolution 2174 (2014); paragraph 11(a) of resolution 2213 (2015). INTERPOL-UN Security Council Special Notice web link: https://www.interpol.int/en/notice/search/un/
                                    Additional information
                                    Ahmad Imhamad is the commander of the Anas al-Dabbashi militia, formerly operating in the coastal area between Sabratha and Melita. Imhamad is a significant leader in illicit activities related to the trafficking of migrants. The al-Dabbashi clan and militia also cultivate relationships with terrorist and violent extremist groups. Imhamad is currently active around Zawiya, after violent clashes broke out with other militia and rivalling smuggling organisations around the coastal area in October 2017, resulting in over 30 deaths including civilians. In response to his ouster, Ahmad Imhamad on 4 December 2017 publicly vowed to return to Sabratha with weapons and force. There is extensive evidence that Imhamad's militia has been directly involved in the illicit trafficking and smuggling of migrants, and that his militia controls departure areas for migrants, camps, safe houses and boats. There is information that supports the conclusion that Imhamad has exposed migrants (including minors) to brutal conditions and sometimes fatal circumstances on land and at sea. After violent clashes between Imhamad's militia and other militia in Sabratha, thousands of migrants were found (many in serious condition), most of them held in centres of the Martyrs Anas al-Dabbashi brigade and al-Ghul militia. The al-Dabbashi clan, and the connected Anas al-Dabbashi militia, have long-standing links with Islamic State in the Levante (ISIL) and its affiliates.
                                    Several ISIL operatives have been in their ranks, including Abdallah al-Dabbashi, the ISIL ‘caliph’ of Sabratha. Imhamad was also allegedly involved in orchestrating the murder of Sami Khalifa al-Gharabli, who was appointed by the Sabratha municipal council to counter migrant smuggling operations in July 2017. Imhamad's activities largely contribute to the mounting violence and insecurity in western Libya and threaten peace and stability in Libya and neighbouring countries.’

                        4)

                        In Annex II to Regulation (EU) 2016/44, entry 24 is replaced by the following:

                                    ‘24.

                                    Name: 1: MUS'AB 2: MUSTAFA 3: ABU AL QUASSIM 4: OMAR

                                       Title: na Designation: Leader of a transnational trafficking network DOB:19 Jan. 1983POB: Sabratha, Libya Good quality a.k.a.: Mus'ab Abu Qarin Low quality a.k.a.: a) ABU-AL QASSIM OMAR Musab Boukrin b) The Doctor c) Al-Grein Nationality: Libya Passport no: a) 782633, issued on 31 May 2005b) 540794, issued on 12 Jan. 2008National identification no: na Address: na Listed on:7 June 2018Other information: Listed pursuant to paragraphs 15 and 17 of resolution 1970 (Travel Ban, Asset Freeze)
                                    Listed pursuant to paragraph 22(a) of resolution 1970 (2011); paragraph 4(a) of resolution 2174 (2014); paragraph 11(a) of resolution 2213 (2015). INTERPOL-UN Security Council Special Notice web link: https://www.interpol.int/en/notice/search/un/
                                    Additional information
                                    Mus'ab Mustafa is seen as a central actor in human trafficking and migrant smuggling activities in the area of Sabratha, but also works from Zawiya and Garibulli. His transnational network covers Libya, European destinations, sub-Saharan countries for the recruitment of migrants and Arab countries for the financial sector. Reliable sources have documented his collusion in human trafficking and smuggling with Ermias Alem, who takes care of the ‘Eastern supply chain’ on behalf of Mustafa. There is evidence that Mustafa has cultivated relationships with other actors in the trafficking business, notably Mohammed al-Hadi (cousin and head of the al-Nasr brigade, also proposed for listing) in Zawiya. A former accomplice of Mustafa, who is now cooperating with the Libyan authorities, claims that Mustafa organised journeys over sea for 45 000 people in 2015 alone, exposing migrants (including minors) to the risk of death. Mustafa is the organiser of a journey on 18 April 2015 ending in a shipwrecking in the Sicilian Canal that caused the death of 800 people. Evidence, including from the UN Panel of Experts, documents that he is responsible for the detention of migrants under brutal conditions, including in Tripoli near the al-Wadi area and seaside resorts near Sabratha where migrants are held. Mustafa is reported to have been close to the al-Dabbashi clan in Sabratha, until a conflict broke out over a ‘protection tax’. Sources have reported that Mustafa has paid persons close to violent extremists in the Sabratha area, in exchange for the approval to smuggle migrants on behalf of violent extremist circles, that financially benefit from the exploitation of illegal immigration. Mustafa is connected to a network of smugglers composed of Salafi armed groups in Tripoli, Sebha and Kufra.’

                        5)

                        In Annex II to Regulation (EU) 2016/44, entry 25 is replaced by the following:

                                    ‘25.

                                    Name: 1: MOHAMMED 2: AL-HADI 3: AL-ARABI 4: KASHLAF

                                       Title: na Designation: Commander of the Shuhada al-Nasr brigade, Head of the Petrol Refinery Guard of Zawiya's refinery DOB:15 November 1988POB: Zawiya, Libya Good quality a.k.a.: na Low quality a.k.a.: a) Kashlaf b) Koshlaf c) Keslaf d) al-Qasab Nationality: Libya Passport no: HR8CHGP8; Date of issue: 27 April 2015; Place of issue: Zawiyah National identification no: a) 119880210419 b) Personal Identification Card no: 728498; Date of issue: 24 February 2007 Address: Zawiya, Libya Listed on:7 June 2018Other information: Listed pursuant to paragraphs 15 and 17 of resolution 1970 (Travel Ban, Asset Freeze)
                                    Listed pursuant to paragraph 22(a) of resolution 1970 (2011); paragraph 4(a) of resolution 2174 (2014); paragraph 11(a) of resolution 2213 (2015).
                                    Additional information
                                    Mohammed al-Hadi is the head of the Shuhada al Nasr brigade in Zawiya, Western Libya. His militia controls the Zawiya refinery, a central hub of migrant smuggling operations. Al-Hadi also controls detention centres, including the Nasr detention centre – nominally under the control of the DCIM. As documented in various sources, the network of al-Hadi is one of the most dominant in the field of migrant smuggling and the exploitation of migrants in Libya. Al-Hadi has extensive links with the head of the local unit of the coast guard of Zawiya, al-Rahman al-Milad, whose unit intercepts boats with migrants, often of rivalling migrant smuggling networks. Migrants are then brought to detention facilities under the control of the Al Nasr militia, where they are reportedly held in critical conditions. The Panel of Experts for Libya collected evidence of migrants that were frequently beaten, while others, notably women from sub-Saharan countries and Morocco, were sold on the local market as ‘sex slaves’. The Panel has also found that al-Hadi collaborates with other armed groups and has been involved in repeated violent clashes in 2016 and 2017.’

                        6)

                        In Annex II to Regulation (EU) 2016/44, entry 26 is replaced by the following:

                                    ‘26.

                                    Name: 1: ABD 2: AL-RAHMAN 3: AL-MILAD 4: na

                                       Title: na Designation: Commander of the Coast Guard in Zawiya DOB: Approximately (29 years old) POB: Tripoli, Libya Good quality a.k.a.: na Low quality a.k.a.: a) Rahman Salim Milad b) al-Bija Nationality: Libya Passport no: na National identification no: na Address: Zawiya, Libya Listed on:7 June 2018Other information: Listed pursuant to paragraphs 15 and 17 of resolution 1970 (Travel Ban, Asset Freeze)
                                    Listed pursuant to paragraph 22(a) of resolution 1970 (2011); paragraph 4(a) of resolution 2174 (2014); paragraph 11(a) of resolution 2213 (2015).
                                    Additional information
                                    Abd al Rahman al-Milad heads the regional unit of the Coast Guard in Zawiya that is consistently linked with violence against migrants and other human smugglers. The UN Panel of Experts claims that Milad, and other coastguard members, are directly involved in the sinking of migrant boats using firearms. Al-Milad collaborates with other migrant smugglers such as Mohammed al-Hadi (also proposed for listing) who, sources suggest, is providing protection to him to carry out illicit operations related to the trafficking and smuggling of migrants. Several witnesses in criminal investigations have stated they were picked up at sea by armed men on a Coast Guard ship called Tallil (used by al-Milad) and taken to the al-Nasr detention centre, where they are reportedly held in brutal conditions and subjected to beatings.’


title: Commission Implementing Regulation (EU) 2018/1494 of 8 October 2018 amending for the 291st time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations

text:
                  8.10.2018

                  EN

                  Official Journal of the European Union

                  LI 252/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1494
         of 8 October 2018
         amending for the 291st time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations (1), and in particular Article 7(1)(a) and Article 7a(1) thereof,
         Whereas:

                     (1)

                     Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

                     (2)

                     On 4 October 2018, the Sanctions Committee of the United Nations Security Council decided to add one entry to the list of persons, groups and entities to whom the freezing of funds and economic resources should apply. Annex I to Regulation (EC) No 881/2002 should therefore be amended accordingly.

                     (3)

                     In order to ensure that the measures provided for in this Regulation are effective it should enter into force immediately,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the day 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, 8 October 2018.

                  For the Commission,

                  On behalf of the President,

                  Head of the Service for Foreign Policy Instruments

            (1)  OJ L 139, 29.5.2002, p. 9.

            ANNEX
            In Annex I to Regulation (EC) No 881/2002 the following entry is added under the heading ‘Legal persons, groups and entities’:

               ‘Jama'a Nusrat ul-Islam wa al-Muslimin (JNIM). Date of designation referred to in Article 7d(2)(i): 4.10.2018.’