CELEX: 32019R1794
Language: en
Date: 2019-10-22 00:00:00
Title: Commission Implementing Regulation (EU) 2019/1794 of 22 October 2019 granting a Union authorisation for the biocidal product family ‘Boumatic Iodine product family’ (Text with EEA relevance.)

29.10.2019   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 277/130
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1794
         of 22 October 2019
         granting a Union authorisation for the biocidal product family ‘Boumatic Iodine product family’
         (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 21 August 2015, Boumatic Gascoigne Melotte submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Boumatic Iodine product family’ of product-type 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-PG019260-52 in the Register for Biocidal Products.
                  
               
                     (2)
                  
                  
                     The ‘Boumatic Iodine product family’ 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 10 April 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 the ‘Boumatic Iodine product family’ 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 the ‘Boumatic Iodine product family’ 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 20 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 the ‘Boumatic Iodine product family’.
                  
               
                     (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-0020541-0000 is granted to Boumatic Gascoigne Melotte for the making available on the market and use of the biocidal product family ‘Boumatic Iodine product family’, in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 18 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 ‘Boumatic Iodine product family’ (ECHA/BPC/220/2019).
      
      
         
            ANNEX
            Summary of product characteristics for a biocidal product family
            Boumatic Iodine product family
            Product type 3 — Veterinary hygiene (Disinfectants)
            Authorisation number: EU-0020541-0000
            R4BP asset number: EU-0020541-0000
            PART I
            
               FIRST INFORMATION LEVEL
            
            1.   ADMINISTRATIVE INFORMATION
            
            1.1.   Family name
            
            
                        Name
                     
                     
                        Boumatic Iodine product family
                     
                  1.2.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  1.3.   Authorisation holder
            
            
                        Name and address of the authorisation holder
                     
                     
                        Name
                     
                     
                        Boumatic Gascoigne Melotte
                     
                  
                        Address
                     
                     
                        31, Rue Jules Melotte, 4350, Remicourt, Belgium
                     
                  
                        Authorisation number
                     
                     
                        EU-0020541-0000
                     
                  
                        
                           R4BP asset number
                        
                     
                     
                        EU-0020541-0000
                     
                  
                        Date of the authorisation
                     
                     
                        18 November 2019
                     
                  
                        Expiry date of the authorisation
                     
                     
                        31 October 2029
                     
                  1.4.   Manufacturer(s) of the biocidal products
            
            
                        Name of manufacturer
                     
                     
                        Christeyns n.v.
                     
                  
                        Address of manufacturer
                     
                     
                        Afrikalaan 182, 9000 Ghent Belgium
                     
                  
                        Location of manufacturing sites
                     
                     
                        Afrikalaan 182, 9000 Ghent Belgium
                     
                  1.5.   Manufacturer(s) of the active substance(s)
            
            
                        Active substance
                     
                     
                        Iodine
                     
                  
                        Name of manufacturer
                     
                     
                        Christeyns n.v.
                     
                  
                        Address of manufacturer
                     
                     
                        Afrikalaan 182, 9000 Ghent Belgium
                     
                  
                        Location of manufacturing sites
                     
                     
                        Cosayach Nitratos S.A, Oficina Cala Cala S/N, Pozo Almonte Iquique 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
                     
                     
                        0,26 
                     
                     
                        0,5 
                     
                  
                        Fatty alcohol ethoxylate
                     
                     
                         
                     
                     
                        Non-active substance
                     
                     
                        69011-36-5
                     
                     
                        500-241-6
                     
                     
                        1,0 
                     
                     
                        2,99 
                     
                  2.2.   Type(s) of formulation
            
            
                        Formulation(s)
                     
                     
                        AL — Any other liquid
                     
                  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
                     
                     
                        0,44 
                     
                     
                        0,5 
                     
                  
                        Fatty alcohol ethoxylate
                     
                     
                         
                     
                     
                        Non-active substance
                     
                     
                        69011-36-5
                     
                     
                        500-241-6
                     
                     
                        1,0 
                     
                     
                        2,99 
                     
                  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
                     
                     
                        Causes serious eye irritation.
                        Harmful to aquatic life with long lasting effects.
                     
                  
                        Precautionary statements
                     
                     
                        Wash hands thoroughly after handling.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        If eye irritation persists: Get medical advice.
                        Avoid release to the environment.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 1
            
            4.1.   Use description
            
            
               Table 1. Use # 1 – Manual dip treatment, pre- or post-milking teat disinfectants
            
            
                        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
                        Teat disinfectants for pre- or post-milking manual dip treatment of cow teats
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        For pre-milking: min. 1 minute contact time
                        For post-milking min. 5 minutes contact time
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per treatment — Product is ready to use
                        Use 2 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg high-density polyethylene (HDPE) drum and 1 000 kg HDPE
                     
                  4.1.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by dipping before or after milking.
            Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.
            Fill the dipping cup with indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup. To reduce dermal exposure, the use of a dosing pump for filling the product into the application equipment is recommended.
            4.1.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information) and eye protection.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 1
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 1
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 1
            4.2.   Use description
            
            
               Table 2. Use # 2 – Manual spraying treatment pre- or post-milking teat disinfectants
            
            
                        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
                        Teat disinfectants for pre- or post-milking, manual spray treatment of cow teat
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        or pre-milking: min. 1 minute contact time
                        or post-milking min. 5 minutes contact time
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray — Product is ready to use
                        Use 2 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE Intermediate bulk containers (IBC)
                     
                  4.2.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by spraying before or after milking.
            Apply an amount of product that is sufficient to cover the entire teat at the maximum 15 ml per spray treatment.
            Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
            4.2.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information), protective clothing, chemical resistant boots, and eye protection.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 1
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 1
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 1
            4.3.   Use description
            
            
               Table 3. Use # 3 – Automated dip treatment, pre- or post-milking teat disinfectants
            
            
                        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
                        Teat disinfectants for pre- or post-milking, automated dip treatment of cow teat
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        For pre-milking: min. 1 minute contact time
                        For post-milking min. 5 minutes contact time
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip — Product is ready to use
                        Use 3 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
                     
                  4.3.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by dipping before or after milking.
            Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.
            Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
            4.3.2.   Use-specific risk mitigation measures
            
            See general directions for use of the meta SPC 1
            4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 1
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 1
            4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 1
            4.4.   Use description
            
            
               Table 4. Use # 4 – Automated spraying treatment, pre- or post-milking teat disinfectants
            
            
                        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
                        Teat disinfectants for pre- or post-milking, automated spray treatment of cow teat
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        or pre-milking: min. 1 minute contact time
                        or post-milking min. 5 minutes contact time
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray — Product is ready to use
                        Use 3 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
                     
                  4.4.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by spraying before or after milking.
            Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment.
            Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
            4.4.2.   Use-specific risk mitigation measures
            
            See general directions for use of the meta SPC 1
            4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 1
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 1
            4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 1
            5.   GENERAL DIRECTIONS FOR USE (1)
               OF THE META SPC 1
            
            5.1.   Instructions for use
            
            The products must be brought to temperatures above 20 °C before use.
            For pre-milking treatment: treat the entire teat with the product, let act 60 seconds and wipe teats dry using single-use towels to avoid any contamination of milk.
            For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes).
            5.2.   Risk mitigation measures
            
            In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered either for pre- or post-milking disinfection.
            Keep out of reach of children.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid: general information: immediately remove any clothing soiled by the product
            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin.
            After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing.
            After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention.
            If medical advice is needed, have product container or label at hand.
            Do not allow product to enter sewers surface or ground water.
            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.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach children.
            Shelf life: 2 years
            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)
                     
                     
                        Udder Dip
                        Udder Dip Max
                        Udder D Max
                        Udderdine Dip
                        Uddine Dip
                        Udderdine DP
                        Uddine DP
                        Udderdine DS
                     
                  
                        Authorisation number
                     
                     
                        EU-0020541-0001 1-1
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        0,5 
                     
                  
                        Fatty alcohol ethoxylate
                     
                     
                         
                     
                     
                        Non-active substance
                     
                     
                        69011-36-5
                     
                     
                        500-241-6
                     
                     
                        2,99 
                     
                  
               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
                     
                     
                        0,26 
                     
                     
                        0,38 
                     
                  
                        Fatty alcohol ethoxylate
                     
                     
                         
                     
                     
                        Non-active substance
                     
                     
                        69011-36-5
                     
                     
                        500-241-6
                     
                     
                        1,0 
                     
                     
                        2,99 
                     
                  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
                     
                     
                        Causes serious eye irritation.
                        Harmful to aquatic life with long lasting effects.
                     
                  
                        Precautionary statements
                     
                     
                        Wash hands thoroughly after handling.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        If eye irritation persists: Get medical advice.
                        Avoid release to the environment.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 2
            
            4.1.   Use description
            
            
               Table 5. Use # 1 – Manual dip treatment, post milking teat disinfectants
            
            
                        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
                        Teat disinfection for post –milking, manual dip treatment of cow teats
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        For post-milking min. 5 minutes contact time
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per treatment — Product is ready to use
                        Use 2 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
                     
                  4.1.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by dipping after milking.
            Fill the dipping cup with the indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
            4.1.2.   Use-specific risk mitigation measures
            
            Wear eye protection.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 2
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 2
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 2
            4.2.   Use description
            
            
               Table 6. Use # 2 – Manual spraying treatment, post milking teat disinfectants
            
            
                        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
                        Teat disinfection for post – milking, anual spray treatment of cow teats
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        For post-milking min. 5 minutes contact time
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray treatment — Product is ready to use
                        Use 2 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
                     
                  4.2.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by spraying after milking.
            Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15 ml per spray treatment.
            Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
            4.2.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye protection.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 2
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 2
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 2
            4.3.   Use description
            
            
               Table 7. Use # 3 – Automated dip treatment, post-milking teat disinfectants
            
            
                        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
                        Teat disinfection for post – milking, utomated dip treatment of cow teats
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        For post-milking min. 5 minutes contact time.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10ml per dip treatment — Product is ready to use.
                        Use 3 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
                     
                  4.3.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by dipping after milking.
            Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.
            Use the undiluted product straight from the original packaging. To reduce dermal exposure, the use of a dosing pump for filling the product into the application equipment is recommended.
            4.3.2.   Use-specific risk mitigation measures
            
            See general directions for use of the meta SPC 2
            4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 2
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 2
            4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 2
            4.4.   Use description
            
            
               Table 8. Use # 4 – Automated spraying treatment, post-milking teat disinfectants
            
            
                        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
                        Teat disinfection for postmilking, utomated spray treatment of cow teats
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        For post-milking min. 5 minutes contact time
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray treatment — Product is ready to use
                        Use 3 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
                     
                  4.4.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by spraying, after milking.
            Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment
            Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
            4.4.2.   Use-specific risk mitigation measures
            
            See general directions for use of the meta SPC 2
            4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 2
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 2
            4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 2
            5.   GENERAL DIRECTIONS FOR USE (2)
               OF THE META SPC 2
            
            5.1.   Instructions for use
            
            The products must be brought to temperatures above 20 °C before use.
            For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes).
            5.2.   Risk mitigation measures
            
            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.
            Keep out of reach of children.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid: general information: immediately remove any clothing soiled by the product
            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin.
            After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing.
            After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention.
            If medical advice is needed, have product container or label at hand.
            Do not allow product to enter sewers surface or ground water.
            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.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach of children.
            Shelf life: 1 year
            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)
                     
                     
                        Gladiator RTU
                        Udder Max Barrier
                        Gladiator Max Barrier
                        Udderdine BARRIER
                        Uddine BARRIER
                        Udderdine RTU
                        Uddine RTU
                        Udderdine BR
                     
                  
                        Authorisation number
                     
                     
                        EU-0020541-0002 1-2
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        0,26 
                     
                  
                        Fatty alcohol ethoxylate
                     
                     
                         
                     
                     
                        Non-active substance
                     
                     
                        69011-36-5
                     
                     
                        500-241-6
                     
                     
                        1,2 
                     
                  7.2.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Udder Star Spray
                        Udder Spray Max
                        Udderdine Spray
                        Uddine Spray
                        Udderdine SP
                        Uddine SP
                     
                  
                        Authorisation number
                     
                     
                        EU-0020541-0003 1-2
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        0,29 
                     
                  
                        Fatty alcohol ethoxylate
                     
                     
                         
                     
                     
                        Non-active substance
                     
                     
                        69011-36-5
                     
                     
                        500-241-6
                     
                     
                        2,99 
                     
                  
               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
                     
                     
                        0,43 
                     
                     
                        0,5 
                     
                  
                        Fatty alcohol ethoxylate
                     
                     
                         
                     
                     
                        Non-active substance
                     
                     
                        69011-36-5
                     
                     
                        500-241-6
                     
                     
                        1,0 
                     
                     
                        2,99 
                     
                  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
                     
                     
                        Causes serious eye irritation.
                        Harmful to aquatic life with long lasting effects.
                     
                  
                        Precautionary statements
                     
                     
                        Wash hands thoroughly after handling.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        If eye irritation persists: Get medical advice.
                        Avoid release to the environment.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 3
            
            4.1.   Use description
            
            
               Table 9. Use # 1 – Manual dip treatment, post milking teat disinfectants
            
            
                        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
                        Teat disinfection for post –milking, manual dip treatment of cow teats
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        For post-milking min. 5 minutes contact time
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per treatment — Product is ready to use
                        Use 2 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
                     
                  4.1.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by dipping after milking.
            Fill the dipping cup with the indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
            4.1.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information) and eye protection.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 3
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 3
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 3
            4.2.   Use description
            
            
               Table 10. Use # 2 – Manual spraying treatment, post milking teat disinfectants
            
            
                        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
                        Teat disinfection for post – milking, manual spray treatment of cow teats
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        For post-milking min. 5 minutes contact time
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15ml per spray treatment — Product is ready to use
                        Use 2 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
                     
                  4.2.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by spraying after milking.
            Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15 ml per spray treatment
            Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
            4.2.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information), protective clothing, chemical resistant boots, and eye protection.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 3
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 3
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 3
            4.3.   Use description
            
            
               Table 11. Use # 3 – Automated dip treatment, post-milking teat disinfectants
            
            
                        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
                        Teat disinfection for post – milking, automated dip treatment of cow teats
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        For post-milking min. 5 minutes contact time.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10ml per dip treatment — Product is ready to use
                        Use 3 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
                     
                  4.3.1.   Use-specific instructions for use
            
            Productfor disinfection of cow teat by dipping after milking.
            Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.
            Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
            4.3.2.   Use-specific risk mitigation measures
            
            See general directions for use of the meta SPC 3
            4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 3
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 3
            4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 3
            4.4.   Use description
            
            
               Table 12. Use # 4 – Automated spraying treatment, post-milking teat disinfectants
            
            
                        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
                        Teat disinfection for postmilking, automated spray treatment of cow teats
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        For post-milking min. 5 minutes contact time
                     
                  
                        Application rate(s) and frequency
                     
                     
                        15 ml per spray treatment — Product is ready to use
                        Use 3 times per day
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        20kg, 60kg, 200kg, 210kg HDPE drum and 1 000 kg HDPE IBC
                     
                  4.4.1.   Use-specific instructions for use
            
            Product for disinfection of cow teat by spraying after milking.
            Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment.
            Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.
            4.4.2.   Use-specific risk mitigation measures
            
            See general directions for use of the meta SPC 3
            4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use of the meta SPC 3
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use of the meta SPC 3
            4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use of the meta SPC 3
            5.   GENERAL DIRECTIONS FOR USE (3)
               OF THE META SPC 3
            
            5.1.   Instructions for use
            
            The products must be brought to temperatures above 20 °C before use.
            For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes).
            5.2.   Risk mitigation measures
            
            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.
            Keep out of reach of children.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid: general information: immediately remove any clothing soiled by the product
            After inhalation: Supply fresh air; consult doctor in case of complaints.
            After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin.
            After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing.
            After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention.
            If medical advice is needed, have product container or label at hand.
            Do not allow product to enter sewers surface or ground water.
            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.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach of children.
            Shelf life: 2 years.
            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)
                     
                     
                        Udder Star
                        Udder Star Max
                        Udder S Max
                        Udderdine Star
                        Uddine Star
                        Udderdine ST
                        Uddine ST
                     
                  
                        Authorisation number
                     
                     
                        EU-0020541-0004 1-3
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        0,5 
                     
                  
                        Fatty alcohol ethoxylate
                     
                     
                         
                     
                     
                        Non-active substance
                     
                     
                        69011-36-5
                     
                     
                        500-241-6
                     
                     
                        2,5 
                     
                  
               (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.