title: Commission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family BPF_Iodine_VET (Text with EEA relevance)

text:
                  5.11.2019

                  EN

                  Official Journal of the European Union

                  L 283/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1844
         of 22 October 2019
         granting a Union authorisation for the biocidal product family ‘BPF_Iodine_VET’
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) thereof,
         Whereas:

                     (1)

                     On 7 August 2015, Applied Biocide GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘BPF_Iodine_VET’ of product-type 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Austria had agreed to evaluate the application. The application was recorded under case number BC-XJ019074-33 in the Register for Biocidal Products.

                     (2)

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

                     (3)

                     On 22 August 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

                     (4)

                     On 4 April 2019, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘BPF_Iodine_VET’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that ‘BPF_Iodine_VET’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

                     (5)

                     On 4 June 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

                     (6)

                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘BPF_Iodine_VET’.

                     (7)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            A Union authorisation with authorisation number EU-0020540-0000 is granted to Applied Biocide GmbH for the making available on the market and use of the biocidal product family ‘BPF_Iodine_VET’, in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 25 November 2019 until 31 October 2029.

            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, 22 October 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

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

            (3)  ECHA opinion of 27 February 2019 on the Union authorisation of ‘BPF_Iodine_VET’ (ECHA/BPC/219/2019).

               ANNEX

               Summary of product characteristics for a biocidal product family

            BPF_Iodine_VET
            Product type 3 - Veterinary hygiene (Disinfectants)
            Authorisation number: EU-0020540-0000
            R4BP asset number: EU-0020540-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION
            1.1.   Family name

                        Name

                        BPF_Iodine_VET

                  1.2.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

                  1.3.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        Applied Biocide GmbH

                        Address

                        Sprl 31, Rue Jules Melotte, 4350, Remicourt, Belgium

                        Authorisation number

                        EU-0020540-0000

                           R4BP asset number

                        EU-0020540-0000

                        Date of the authorisation

                        25 November 2019

                        Expiry date of the authorisation

                        31 October 2029

                  1.4.   Manufacturer(s) of the biocidal products

                        Name of manufacturer

                        Ewabo Chemikalien GmbH & Co KG

                        Address of manufacturer

                        Kolpingstrasse 4, 49835 Wietmarschen Germany

                        Location of manufacturing sites

                        Kolpingstrasse 4, 49835 Wietmarschen Germany

                        Name of manufacturer

                        FINK TEC GmbH

                        Address of manufacturer

                        Oberster Kamp 23, 59069 Hamm Germany

                        Location of manufacturing sites

                        Oberster Kamp 23, 59069 Hamm Germany

                        Name of manufacturer

                        IRCASERVICE

                        Address of manufacturer

                        S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy

                        Location of manufacturing sites

                        S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy

                        Name of manufacturer

                        Laboratorios Maymo SA

                        Address of manufacturer

                        Via Augusta, 302, 08017 Barcelona Spain

                        Location of manufacturing sites

                        Via Augusta, 302, 08017 Barcelona Spain

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

                        Active substance

                        Iodine

                        Name of manufacturer

                        Cosayach S.A. Compania de Salitre y Yodo

                        Address of manufacturer

                        Amunátegui 178, 7th Floor, 8320000 Santiago Chile

                        Location of manufacturing sites

                        S.C.M. Cosayach Cala, 1180000 Pozo Almonte Chile Chile

                        Active substance

                        Iodine

                        Name of manufacturer

                        ACF Minera S.A.

                        Address of manufacturer

                        San Martin 499, 1100000 Iquique Chile

                        Location of manufacturing sites

                        Lagunas mine, 1180000 Pozo Almonte Chile

                        Active substance

                        Iodine

                        Name of manufacturer

                        Sociedad Quimica y Minera SA

                        Address of manufacturer

                        Los Militares 4290, 7550000 Las Condes Chile

                        Location of manufacturing sites

                        Nueva Victoria, 1180000 Pozo Almonte Chile
                        Pedro de Valdivia, 1240000 Antofagasta 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

                        0,1

                        3,0

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,0

                        10,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        0,0

                        31,8

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Non-active substance

                        68439-46-3

                        614-482-0

                        0,0

                        31,8

                  2.2.   Type(s) of formulation

                        Formulation(s)

                        meta SPC 1-5: AL — any other liquid
                        meta SPC 6-8: SL — soluble concentrate

                  PART II

               SECOND INFORMATION LEVEL — META SPC(S)

               META SPC 1

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

                        Identifier

                        Meta SPC 1

                  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

                        0,15

                        0,15

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        0,0

                        0,0

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Non-active substance

                        68439-46-3

                        614-482-0

                        0,0

                        0,0

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

                        Formulation(s)

                        AL — any other liquid

                  3.   Hazard and precautionary statements of the meta SPC 1

                        Hazard statements

                        May be corrosive to metals.

                        Precautionary statements

                        Keep only in original packaging.
                        Absorb spillage to prevent material damage.
                        Store in corrosive resistant container with a resistant inner liner.

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

               Table 1

               Use # 1 — Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — spraying (post 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

                        Application method(s)

                        Open system: spray treatment
                        Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking)

                        Application rate(s) and frequency

                        Application rate: 10-15 ml per cow
                        Application frequency:
                        During lactation period:

                                    —

                                    manual: 2 applications per day (post-milking)

                                    —

                                    automated: 3 applications per day (post-milking)

                              During dry period: 1 application per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Bottle high-density polyethylene (HDPE): 1 liter, cap is made of PP
                        Jerry can HDPE: 5-60 liters
                        Drum HDPE: 200 liters
                        IBC HDPE: 600-1 000 liters

                  4.1.1.   Use-specific instructions for use

            ---
            4.1.2.   Use-specific risk mitigation measures

            ---
            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

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

            ---
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            ---
            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.
            Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
            Keep the cows standing until the product has dried (at least 5 minutes).
            Product can be applied manually or by means of automatic teat sprayer.
            Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
            Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
            5.2.   Risk mitigation measures

            Keep out of reach of children.
            Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information).
            In case a combination of pre- and post-milking disinfection is necessary, using another 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

            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Wash skin thoroughly.
            After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
            After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
            When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
            Environmental emergency measures:
            Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
            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.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
            Shelf-life: 12 months in HDPE.
            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)

                        FINK — Io Spray 15
                        FINK — Euter-DIP PVP-S
                        FINK Pattedyp PVP
                        IOSpray 15 PVP

                        Authorisation number

                        EU-0020540-0001 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,15

               META SPC 2

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

                        Identifier

                        Meta SPC 2

                  1.2.   Suffix to the authorisation number

                        Number

                        1-2

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,3

                        0,5

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        0,0

                        0,0

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Non-active substance

                        68439-46-3

                        614-482-0

                        0,0

                        0,0

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

                        Formulation(s)

                        AL — any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

                        Hazard statements

                        May be corrosive to metals.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep only in original packaging.
                        Avoid release to the environment.
                        Absorb spillage to prevent material damage.
                        Store in corrosive resistant container with a resistant inner liner.
                        Dispose of contents to/container in accordance with the local/national regulations.

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

               Table 2

               Use # 1 — Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — spraying (post 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

                        Application method(s)

                        Open system: spray treatment
                        Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking)

                        Application rate(s) and frequency

                        Application rate: 10-15 ml per cow
                        Application frequency:
                        During lactation period:

                                    —

                                    manual: 2 applications per day (post-milking)

                                    —

                                    automated: 3 applications per day (post-milking)

                              During dry period: 1 application per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Bottle HDPE: 1 liter, cap is made of PP
                        Jerry can HDPE: 5-60 liters
                        Drum HDPE: 200 liters
                        IBC HDPE: 600-1 000 liters

                  4.1.1.   Use-specific instructions for use

            --
            4.1.2.   Use-specific risk mitigation measures

            --
            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

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

            --
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            --
            5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
            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.
            Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
            Keep the cows standing until the product has dried (at least 5 minutes).
            Product can be applied manually or by means of automatic teat sprayer.
            Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
            Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
            5.2.   Risk mitigation measures

            Keep out of reach of children.
            Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information).
            In case a combination of pre- and post-milking disinfection is necessary, using another 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

            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Wash skin thoroughly.
            After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
            After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
            When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
            Environmental emergency measures:
            Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
            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.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
            Shelf-life: 12 months in HDPE.
            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)

                        Fink Io Spray - 30
                        ST-Io Spray
                        DESINTEC MH Iodine S
                        DESINTEC MH Raidip plus
                        Iodine Spray 3000
                        Iodine Spray

                        Authorisation number

                        EU-0020540-0002 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,3

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

                        Trade name(s)

                        Fink — Io Spray 50
                        DESINTEC MH Raidip 5000
                        Iodine Spray 5000

                        Authorisation number

                        EU-0020540-0003 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,5

               META SPC 3

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

                        Identifier

                        Meta SPC 3

                  1.2.   Suffix to the authorisation number

                        Number

                        1-3

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,5

                        0,5

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        0,0

                        0,0

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Non-active substance

                        68439-46-3

                        614-482-0

                        0,0

                        0,0

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

                        Formulation(s)

                        AL — any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

                        Hazard statements

                        May be corrosive to metals.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep only in original packaging.
                        Avoid release to the environment.
                        Absorb spillage to prevent material damage.
                        Store in corrosive resistant container with a resistant inner liner.
                        Dispose of contents to/container in accordance with the local/national regulations.

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

               Table 3

               Use # 1 – Veterinary hygiene - animal husbandry - teat disinfectant - professional - indoors – spraying (post 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

                        Application method(s)

                        Open system: spray treatment
                        Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking)

                        Application rate(s) and frequency

                        Application rate: 10-15 ml per cow
                        Application frequency:
                        During lactation period:

                                    —

                                    manual: 2 applications per day (post-milking)

                                    —

                                    automated: 3 applications per day (post-milking)

                              During dry period: 1 application per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Bottle HDPE: 1 liter, cap is made of PP
                        Jerry can HDPE: 5-60 liters
                        Drum HDPE: 200 liters
                        IBC HDPE: 600-1 000 liters

                  4.1.1.   Use-specific instructions for use

            --
            4.1.2.   Use-specific risk mitigation measures

            ---
            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

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

            ---
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            ---
            5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3
            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.
            Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.
            Keep the cows standing until the product has dried (at least 5 minutes).
            Product can be applied manually or by means of automatic teat sprayer.
            Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
            Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).
            5.2.   Risk mitigation measures

            Keep out of reach of children.
            Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information).
            In case a combination of pre- and post-milking disinfection is necessary, using another 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

            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Wash skin thoroughly.
            After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
            After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
            When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
            Environmental emergency measures:
            Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
            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.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
            Shelf-life: 12 months in HDPE.
            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)

                        Fink — Io Spray 50 (Jodophor)
                        Fink — Io Spray 50 (Iodophor)

                        Authorisation number

                        EU-0020540-0004 1-3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,5

               META SPC 4

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

                        Identifier

                        Meta SPC 4

                  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

                        0,1

                        0,15

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        0,0

                        0,0

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Non-active substance

                        68439-46-3

                        614-482-0

                        0,0

                        0,0

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

                        Formulation(s)

                        AL — any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

                        Hazard statements

                        May be corrosive to metals.

                        Precautionary statements

                        Keep only in original packaging.
                        Absorb spillage to prevent material damage.
                        Store in corrosive resistant container with a resistant inner liner.

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

               Table 4

               Use # 1 – Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — dipping (post 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

                        Application method(s)

                        Open system: dip treatment
                        Teat-dipping: Manual non-medical disinfection of teats with a ready-to-use liquid (on cows, post-milking)

                        Application rate(s) and frequency

                        Application rate: 5-10 ml per cow
                        Application frequency:
                        During lactation period: 2 applications per day (post-milking)
                        During dry period: 1 application per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Bottle HDPE: 1 liter, cap is made of PP
                        Jerry can HDPE: 5-60 liters
                        Drum HDPE: 200 liters
                        IBC HDPE: 600-1 000 liters

                  4.1.1.   Use-specific instructions for use

            ---
            4.1.2.   Use-specific risk mitigation measures

            ---
            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

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

            ---
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            ---
            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 up a teat dipping cup with 2/3 of product. Immediately after each cow has been milked, dip each teat manually in the solution. Ensure that at least two thirds of the teats, preferably the entire teats, come in contact with the solution.
            Do not clean the teats directly after disinfection. Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
            Refill the cup as necessary.
            Teat dipping cups should be emptied after milking and washed before re-use. Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
            Application frequency must not exceed two applications per cow and day (post-milking).
            5.2.   Risk mitigation measures

            Keep out of reach of children.
            In case a combination of pre- and post-milking disinfection is necessary, using another 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

            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Wash skin thoroughly.
            After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
            After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
            When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
            Environmental emergency measures:
            Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
            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.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
            Shelf-life: 12 months in HDPE.
            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)

                        FINK — Io Dip 10
                        IODip 10 PVP

                        Authorisation number

                        EU-0020540-0005 1-4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,1

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

                        Trade name(s)

                        FINK — Io Dip Protect
                        DESINTEC MH Iodine Barrier
                        TvP — Barrier Dip

                        Authorisation number

                        EU-0020540-0006 1-4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,15

               META SPC 5

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

                        Identifier

                        Meta SPC 5

                  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

                        0,3

                        0,45

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,35

                        0,4

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        0,0

                        0,0

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Non-active substance

                        68439-46-3

                        614-482-0

                        0,0

                        0,0

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

                        Formulation(s)

                        AL — any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

                        Hazard statements

                        May be corrosive to metals.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep only in original packaging.
                        Avoid release to the environment.
                        Absorb spillage to prevent material damage.
                        Store in corrosive resistant container with a resistant inner liner.
                        Dispose of contents to / container in accordance with the local/national regulations.

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

               Table 5

               Use # 1 — Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — dipping (post 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

                        Application method(s)

                        Open system: dip treatment
                        Teat-dipping: Manual non-medical disinfection of teats with a ready-to-use liquid (on cows, post-milking)

                        Application rate(s) and frequency

                        Application rate: 5-10 ml per cow
                        Application frequency:
                        During lactation period: 2 applications per day (post-milking)
                        During dry period: 1 application per day

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Bottle HDPE: 1 liter, cap is made of PP
                        Jerry can HDPE: 5-60 liters
                        Drum HDPE: 200 liters
                        IBC HDPE: 600-1 000 liters

                  4.1.1.   Use-specific instructions for use
            ---
            4.1.2.   Use-specific risk mitigation measures

            ---
            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

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

            ---
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            ---
            5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5
            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 up a teat dipping cup with 2/3 of product. Immediately after each cow has been milked, dip each teat manually in the solution. Ensure that at least two thirds of the teats, preferably the entire teats, come in contact with the solution.
            Do not clean the teats directly after disinfection. Leave the product until next milking.
            Keep the cows standing until the product has dried (at least 5 minutes).
            Refill the cup as necessary.
            Teat dipping cups should be emptied after milking and washed before re-use. Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.
            Application frequency must not exceed two applications per cow and day (post-milking).
            5.2.   Risk mitigation measures

            Keep out of reach of children.
            In case a combination of pre- and post-milking disinfection is necessary, using another 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

            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Wash skin thoroughly.
            After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
            After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
            When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
            Environmental emergency measures:
            Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
            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.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
            Shelf-life: 12 months in HDPE.
            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)

                        Jodofilm 75/5 4 500  ppm

                        Authorisation number

                        EU-0020540-0007 1-5

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,45

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,4

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

                        Trade name(s)

                        Jodofilm 75/5 3 000  ppm

                        Authorisation number

                        EU-0020540-0008 1-5

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        0,3

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,35

               META SPC 6

            1.   META SPC 6 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 6 identifier

                        Identifier

                        Meta SPC 6

                  1.2.   Suffix to the authorisation number

                        Number

                        1-6

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        1,75

                        2,4

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        3,0

                        10,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        0,0

                        25,6

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Non-active substance

                        68439-46-3

                        614-482-0

                        0,0

                        31,8

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

                        Formulation(s)

                        SL — soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

                        Hazard statements

                        May be corrosive to metals.
                        Harmful if swallowed.
                        Causes severe skin burns and eye damage.
                        Causes serious eye damage.
                        May cause damage to thyroid gland through prolonged or repeated exposure.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep only in original packaging.
                        Do not breathe mist.
                        Do not breathe spray.
                        Avoid release to the environment.
                        Wear protective gloves.
                        Wear protective clothing.
                        Wear face protection.
                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                        IF IN EYES: Rinse cautiously with water for several minutes.
                        Remove contact lenses, if present and easy to do. Continue rinsing.
                        Absorb spillage to prevent material damage.
                        Store locked up.
                        Keep out of reach of children.

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

               Table 6

               Use # 1 — Veterinary hygiene — animal husbandry — hard surface disinfectant — professional — indoors — spraying

                        Product type

                        PT03 — Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Viruses

                        Field(s) of use

                        Indoor

                        Application method(s)

                        Open system: spray treatment
                        Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar)

                        Application rate(s) and frequency

                        100 ml/m2— Concentration of Iodine in application solution: 750 ppm (0,075 % w/w).
                        Application frequency per year:
                        Dairy cows: 1
                        Beef cattle: 1
                        Veal calves: 4
                        Sows, in individual pens: 5
                        Sows in groups: 5
                        Fattening pigs: 3
                        Laying hens in battery cages without treatment: 1
                        Laying hens in battery cages with aeration (belt drying): 1
                        Laying hens in battery cages with forced drying (deep pit, high rise): 1
                        Laying hens in compact battery cages: 1
                        Laying hens in free range with litter floor (partly litter floor, partly slatted): 1
                        Broilers in free range with litter floor: 7
                        Laying hens in free range with grating floor (aviery system): 1
                        Parent broilers in free range with grating floor: 1
                        Parent broilers in rearing with grating floor: 3
                        Turkeys in free range with litter floor: 2
                        Ducks in free range with litter floor: 13
                        Geese in free range with litter floor: 6

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Bottle HDPE: 1 liter, cap is made of PP
                        Jerry can HDPE: 5-60 liters
                        Drum HDPE: 200 liters
                        IBC HDPE: 600-1 000 liters

                  4.1.1.   Use-specific instructions for use

            Iodosan 30: Mix 29 ml product with 971 ml water to obtain 1 l application solution.
            Iodosan 18: Mix 40 ml product with 960 ml water to obtain 1 l application solution.
            4.1.2.   Use-specific risk mitigation measures

            ---
            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

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

            ---
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

               ---

            5.   GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6
            5.1.   Instructions for use

            Always read the label or leaflet before use and follow all the instructions provided.
            To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product.
            Use max. 100 ml application solution per m2 treated area. Do not prepare more fluid than strictly necessary.
            The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner.
            Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36 h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off.
            5.2.   Risk mitigation measures

            Keep out of reach of children.
            The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product.

               During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory.

               During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift.
            Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes.
            Only use one kind of Iodine-containing product per day.
            Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Immediately take off contaminated clothing and wash skin thoroughly.
            After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
            After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
            In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual
            When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
            Environmental emergency measures:
            Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
            Methods and material for containment and cleaning up:
            Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local / national regulations.
            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.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
            Shelf-life: 24 months in HDPE
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        IODOSAN 30
                        IODOSAN
                        IODAT
                        DESINTEC FL-JODES
                        ROTIE-SOL J
                        Disinfect Jod
                        FINK — Jodophos 15
                        Jod-Reiniger sauer
                        Tankrein extra

                        Authorisation number

                        EU-0020540-0009 1-6

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        2,4

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        10,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        25,6

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

                        Trade name(s)

                        IODOSAN 18

                        Authorisation number

                        EU-0020540-0010 1-6

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        1,75

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        3,0

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Non-active substance

                        68439-46-3

                        614-482-0

                        31,8

               META SPC 7

            1.   META SPC 7 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 7 identifier

                        Identifier

                        Meta SPC 7

                  1.2.   Suffix to the authorisation number

                        Number

                        1-7

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        3,0

                        3,0

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        10,0

                        10,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        31,8

                        31,8

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Non-active substance

                        68439-46-3

                        614-482-0

                        0,0

                        0,0

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

                        Formulation(s)

                        SL — soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

                        Hazard statements

                        May be corrosive to metals.
                        Harmful if swallowed.
                        Causes severe skin burns and eye damage.
                        Causes serious eye damage.
                        May cause damage to thyroid gland through prolonged or repeated exposure.
                        Toxic to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep only in original packaging.
                        Do not breathe mist.
                        Do not breathe spray.
                        Avoid release to the environment.
                        Wear protective gloves.
                        Wear protective clothing.
                        Wear face protection.
                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Absorb spillage to prevent material damage.
                        Store locked up.
                        Keep out of reach of children.

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

               Table 7

               Use # 1 — Veterinary hygiene — animal husbandry — hard surface disinfectant — professional — indoors — spraying

                        Product type

                        PT03 — Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Viruses

                        Field(s) of use

                        Indoor

                        Application method(s)

                        Open system: spray treatment
                        Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar)

                        Application rate(s) and frequency

                        100 ml/m2 - Concentration of Iodine in application solution: 750 ppm (0,075 % w/w).
                        Application frequency per year:
                        Dairy cows: 1
                        Beef cattle: 1
                        Veal calves: 4
                        Sows, in individual pens: 5
                        Sows in groups: 5
                        Fattening pigs: 3
                        Laying hens in battery cages without treatment: 1
                        Laying hens in battery cages with aeration (belt drying): 1
                        Laying hens in battery cages with forced drying (deep pit, high rise): 1
                        Laying hens in compact battery cages: 1
                        Laying hens in free range with litter floor (partly litter floor, partly slatted): 1
                        Broilers in free range with litter floor: 7
                        Laying hens in free range with grating floor (aviery system): 1
                        Parent broilers in free range with grating floor: 1
                        Parent broilers in rearing with grating floor: 3
                        Turkeys in free range with litter floor: 2
                        Ducks in free range with litter floor: 13
                        Geese in free range with litter floor: 6

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Bottle HDPE: 1 liter, cap is made of PP
                        Jerry can HDPE: 5-60 liters
                        Drum HDPE: 200 liters
                        IBC HDPE: 600-1 000 liters

                  4.1.1.   Use-specific instructions for use

            Iodosan 30 plus: Mix 23 ml product with 977 ml water to obtain 1 l application solution.
            4.1.2.   Use-specific risk mitigation measures

            ---
            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

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

            ---
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            ---
            5.   GENERAL DIRECTIONS FOR USE (7) OF THE META SPC 7
            5.1.   Instructions for use

            Always read the label or leaflet before use and follow all the instructions provided.
            To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product.
            Use max. 100 ml application solution per m2 treated area. Do not prepare more fluid than strictly necessary.
            The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner.
            Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36 h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off.
            5.2.   Risk mitigation measures

            Keep out of reach of children.
            The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product.
            During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory.
            During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift.
            Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes.
            Only use one kind of Iodine-containing product per day.
            Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Immediately take off contaminated clothing and wash skin thoroughly.
            After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
            After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
            In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual.
            When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
            Environmental emergency measures:
            Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
            Methods and material for containment and cleaning up:
            Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local / national regulations.
            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.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
            Shelf-life: 24 months in HDPE
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        IODOSAN 30 Plus
                        YODO CONTROL
                        YODIVEN

                        Authorisation number

                        EU-0020540-0011 1-7

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        3,0

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        10,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        31,8

               META SPC 8

            1.   META SPC 8 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 8 identifier

                        Identifier

                        Meta SPC 8

                  1.2.   Suffix to the authorisation number

                        Number

                        1-8

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 - Veterinary hygiene (Disinfectants)

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        1,5

                        1,5

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        3,0

                        3,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        18,0

                        18,0

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate

                        Non-active substance

                        68439-46-3

                        614-482-0

                        0,0

                        0,0

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

                        Formulation(s)

                        SL - soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

                        Hazard statements

                        May be corrosive to metals.
                        Causes severe skin burns and eye damage.
                        Causes serious eye damage.
                        May cause damage to thyroid gland through prolonged or repeated exposure.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep only in original packaging.
                        Do not breathe mist.
                        Do not breathe spray.
                        Avoid release to the environment.
                        Wear protective gloves.
                        Wear protective clothing.
                        Wear face protection.
                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Absorb spillage to prevent material damage.
                        Store locked up.
                        Keep out of reach of children.

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

               Table 8

               Use # 1 — Veterinary hygiene — animal husbandry — hard surface disinfectant — professional — indoors — spraying

                        Product type

                        PT03 — Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Viruses

                        Field(s) of use

                        Indoor

                        Application method(s)

                        Open system: spray treatment
                        Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar)

                        Application rate(s) and frequency

                        100 ml/m2— Concentration of Iodine in application solution: 750 ppm (0,075 % w/w).
                        Application frequency per year:
                        Dairy cows: 1
                        Beef cattle: 1
                        Veal calves: 4
                        Sows, in individual pens: 5
                        Sows in groups: 5
                        Fattening pigs: 3
                        Laying hens in battery cages without treatment: 1
                        Laying hens in battery cages with aeration (belt drying): 1
                        Laying hens in battery cages with forced drying (deep pit, high rise): 1
                        Laying hens in compact battery cages: 1
                        Laying hens in free range with litter floor (partly litter floor, partly slatted): 1
                        Broilers in free range with litter floor: 7
                        Laying hens in free range with grating floor (aviery system): 1
                        Parent broilers in free range with grating floor: 1
                        Parent broilers in rearing with grating floor: 3
                        Turkeys in free range with litter floor: 2
                        Ducks in free range with litter floor: 13
                        Geese in free range with litter floor: 6

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Bottle HDPE: 1 liter, cap is made of PP
                        Jerry can HDPE: 5-60 liters
                        Drum HDPE: 200 liters
                        IBC HDPE: 600-1 000 liters

                  4.1.1.   Use-specific instructions for use

            Iodosan 15: Mix 46 ml product with 954 ml water to obtain 1 l application solution.
            4.1.2.   Use-specific risk mitigation measures

            ---
            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

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

            ---
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

               ---

            5.   GENERAL DIRECTIONS FOR USE (8) OF THE META SPC 8
            5.1.   Instructions for use

            Always read the label or leaflet before use and follow all the instructions provided.
            To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product.
            Use max. 100 ml application solution per m2 treated area. Do not prepare more fluid than strictly necessary.
            The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner.
            Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36 h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off.
            5.2.   Risk mitigation measures

            Keep out of reach of children.
            The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product.
            During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory.
            During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift.
            Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes.
            Only use one kind of Iodine-containing product per day.
            Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Immediately take off contaminated clothing and wash skin thoroughly.
            After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor.
            After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately.
            In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual.
            When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here].
            Environmental emergency measures:
            Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed.
            Methods and material for containment and cleaning up:
            Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local / national regulations.
            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.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed.
            Shelf-life: 24 months in HDPE.
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        IODOSAN 15

                        Authorisation number

                        EU-0020540-0012 1-8

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Iodine

                        Active Substance

                        7553-56-2

                        231-442-4

                        1,5

                        Phosphoric Acid

                        Trihydroxidooxidophosphorus phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        3,0

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched

                        Non-active substance

                        69011-36-5

                        500-241-6

                        18,0

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

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

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

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

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

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

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

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