CELEX: 32020R0202
Language: en
Date: 2019-10-04 00:00:00
Title: Commission Implementing Regulation (EU) 2020/202 of 4 October 2019 granting a Union authorisation for the biocidal product family ‘Iodine Teat Dip Products’ (Text with EEA relevance)

17.2.2020   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 43/1
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2020/202
         of 4 October 2019
         granting a Union authorisation for the biocidal product family ‘Iodine Teat Dip Products’
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5) thereof,
         Whereas:
         
                     (1)
                  
                  
                     On 20 August 2015, GEA Farm Technologies GmbH, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Iodine Teat Dip Products’ (‘the biocidal product family’) of product-type 3, as described in Annex V to that Regulation. The competent authority of United Kingdom agreed to evaluate the application as referred to in Article 43(1) of Regulation (EU) No 528/2012. The application was recorded under the case number BC-AL019223-55 in the Register for Biocidal Products.
                  
               
                     (2)
                  
                  
                     The biocidal 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 6 June 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).
                  
               
                     (4)
                  
                  
                     On 18 January 2019, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of the biocidal 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 biocidal product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, the biocidal product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.
                  
               
                     (5)
                  
                  
                     On 20 May 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 biocidal 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 is granted to GEA Farm Technologies GmbH for the making available on the market and use of the biocidal product family ‘Iodine Teat Dip Products’ with authorisation number EU-0020125-0000 in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 19 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, 4 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 14 December 2018 on the Union authorisation of ‘Iodine Teat Dip Products’ (ECHA/BPC/217/2018).
      
      
         
            ANNEX
            
               Summary of product characteristics for a biocidal product family
            
            Iodine Teat dip products
            Product type 3 — Veterinary hygiene (Disinfectants)
            Authorisation number: EU-0020125-0000
            R4BP asset number: EU-0020125-0000
            PART I
            
               FIRST INFORMATION LEVEL
            
            1.   ADMINISTRATIVE INFORMATION
            1.1.   Family name
            
            
                        Name
                     
                     
                        Iodine Teat dip products
                     
                  1.2.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  1.3.   Authorisation holder
            
            
                        Name and address of the authorisation holder
                     
                     
                        Name
                     
                     
                        GEA Farm Technologies GmbH
                     
                  
                        Address
                     
                     
                        Siemensstraße 25-27, 59199, Bönen, Germany
                     
                  
                        Authorisation number
                     
                     
                        EU-0020125-0000
                     
                  
                        
                           R4BP asset number
                        
                     
                     
                        EU-0020125-0000
                     
                  
                        Date of the authorisation
                     
                     
                        19 November 2019
                     
                  
                        Expiry date of the authorisation
                     
                     
                        31 October 2029
                     
                  1.4.   Manufacturer(s) of the biocidal products
            
            
                        Name of manufacturer
                     
                     
                        GEA Farm Technologies
                     
                  
                        Address of manufacturer
                     
                     
                        Wylye Works, BA12 9HT Warminster United Kingdom
                     
                  
                        Location of manufacturing sites
                     
                     
                        Wylye Works, Watery Lane, BA12 9HT Warminster United Kingdom
                        Gewerbestraße 5, 5325 Plainfeld Austria
                        ul. Olowiana 10, 85-461 Bydgoszcz Poland
                     
                  1.5.   Manufacturer(s) of the active substance(s)
            
            
                        Active substance
                     
                     
                        Iodine
                     
                  
                        Name of manufacturer
                     
                     
                        SQM Europe N.V.
                     
                  
                        Address of manufacturer
                     
                     
                        St Pietersvliet 7„ bus 8 2000 Antwerp Belgium
                     
                  
                        Location of manufacturing sites
                     
                     
                        Sociedad Quimica y Minera SA, Los Militares, Las Condes, 4290 Piso 4 Santiago Chile
                     
                  
               
            
                        Active substance
                     
                     
                        Iodine
                     
                  
                        Name of manufacturer
                     
                     
                        Nihon Tennen Gas Co., Ltd (Via Mitsui & Co Europe PLC)
                     
                  
                        Address of manufacturer
                     
                     
                        Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun„ 299-4205 Chosei-Gun Japan
                     
                  
                        Location of manufacturing sites
                     
                     
                        Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun„ 299-4205 Chosei-Gun Japan
                     
                  
               
            
                        Active substance
                     
                     
                        Iodine
                     
                  
                        Name of manufacturer
                     
                     
                        Norkem Ltd
                     
                  
                        Address of manufacturer
                     
                     
                        Norkem House, Bexton Lane„ WA16 9FB Knutsford United Kingdom
                     
                  
                        Location of manufacturing sites
                     
                     
                        OFICINA CALA CALA S/N, Unknown POZO ALMONTE Chile
                     
                  2.   PRODUCT FAMILY COMPOSITION AND FORMULATION
            2.1.   Qualitative and quantitative information on the composition of the family
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Min
                     
                     
                        Max
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        0,16
                     
                     
                        2,47
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        0,0
                     
                     
                        2,35
                     
                  2.2.   Type(s) of formulation
            
            
                        Formulation(s)
                     
                     
                        AL — Any other liquid
                        SL — Soluble concentrate
                     
                  PART II
            
               SECOND INFORMATION LEVEL — META SPC(S)
            
            
               META SPC 1
            
            1.   META SPC 1 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 1 identifier
            
            
                        Identifier
                     
                     
                        Meta SPC 1 — Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates
                     
                  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
                     
                     
                        1,58
                     
                     
                        2,47
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        1,51
                     
                     
                        2,35
                     
                  2.2.   Type(s) of formulation of the meta SPC 1
            
            
                        Formulation(s)
                     
                     
                        SL — Soluble concentrate
                     
                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
            
                        Hazard statements
                     
                     
                        Causes serious eye irritation.
                        May cause damage to thyroid gland through prolonged or repeated exposure.
                        May be corrosive to metals.
                        Toxic to aquatic life with long lasting effects.
                     
                  
                        Precautionary statements
                     
                     
                        Do not breathe vapours.
                        Wash hands thoroughly after handling.
                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Get medical attention if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        Collect spillage.
                        Dispose of container according to local regulations.
                        Dispose of contents according to local regulations.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 1
            4.1.   Use description
            
            
               Table 1
            
            
               Use # 1 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Dipping
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via dip Cup: Using a traditional dip cup with non-return valves, dispense diluted product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking
                        The same solution can be applied to multiple animals during the same milking session. Cups should be refilled with fresh solution before starting new milking session
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of diluted product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10 ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Product to be diluted by the relevant rate stated on the label. Either:
                        25 % (1 part product to 3 parts water)
                        20 % (1 part product to 4 parts water)
                        12,5 % (1 part product to 7 parts water)
                        In use concentration of products between 0,29 and 0,52 % (w/w) iodine.
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.1.1.   Use-specific instructions for use
            
            Dip at least 2/3 of the teat length with diluted product immediately after milking
            4.1.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves and eye protection when handling the concentrate
            (glove material to be specified by the authorisation holder within 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
            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.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            4.2.   Use description
            
            
               Table 2
            
            
               Use # 2 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Spraying
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the diluted product. The diluted product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the diluted product
                        Application via manual trigger spray: Fill trigger spray bottle with diluted product. Use trigger spray to cover the bottom two thirds of each teat with diluted product
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of diluted product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Product to be diluted by the relevant rate stated on the label. Either:
                        25 % (1 part product to 3 parts water)
                        20 % (1 part product to 4 parts water)
                        12,5 % (1 part product to 7 parts water)
                        In use concentration of products between 0,29 and 0,52 % (w/w) iodine.
                        2 post﻿ milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.2.1.   Use-specific instructions for use
            
            Spray at least 2/3 of the teat length with diluted product immediately after milking
            4.2.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves and eye protection when handling the concentrate
            (glove material to be specified by the authorisation holder within the product information).
            Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
            A protective coverall (at least type 6, EN 13034) shall be worn.
            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
            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.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            4.3.   Use description
            
            
               Table 3
            
            
               Use # 3 – Concentrates — Professional concentrates with 1:3, 1:4 and 1:7 dilution rates, for post milking — Foaming
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of diluted product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Product to be diluted by the relevant rate stated on the label. Either:
                        25 % (1 part product to 3 parts water)
                        20 % (1 part product to 4 parts water)
                        12,5 % (1 part product to 7 parts water)
                        In use concentration of products between 0,29 and 0,52 % (w/w) iodine.
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.3.1.   Use-specific instructions for use
            
            Dip at least 2/3 of the teat length with diluted product immediately after milking
            4.3.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves and eye protection when handling the concentrate
            (glove material to be specified by the authorisation holder within 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
            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.
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
            5.1.   Instructions for use
            
            Keep out of reach of children
            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.
            Dilute product before application according to the ratio specified on the product label
            Formanual dilution of the concentrate; Add the ratio of concentrate and water, specified on the product label, to a suitably sized container to achieve the required dilution rate. Mix to a uniform solution.
            Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow
            For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            Product can be used during the entire lactation period
            5.2.   Risk mitigation measures
            
            See use specific risk mitigation measures
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            Remove and wash contaminated clothing before re-use.
            After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.
            If you feel unwell, seek medical advice.
            After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.
            After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.
            After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.
            Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.
            5.4.   Instructions for safe disposal of the product and its packaging
            
            At the end of the treatment, dispose of 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 farm based waste water treatment plant.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Protect from frost
            Do not store at temperatures above 30 °C
            Shelf life 12 months.
            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)
                     
                     
                        Ioklene Concentrate. Coars Dual
                     
                  
                        Authorisation number
                     
                     
                        EU-0020125-0001 1-1
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        1,58
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        1,51
                     
                  7.2.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Clinidip L Concentrate, Maxadine C, Diamond 3:1 Concentrate, Kristal 321, IO Spray 3:1 Concentrate, Coars Shield
                     
                  
                        Authorisation number
                     
                     
                        EU-0020125-0002 1-1
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        2,06
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        1,96
                     
                  7.3.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Clinidip Superconcentrate, Dunglinson Super IO 421 Concentrate, Ceanodine 4:1, Iodosan
                     
                  
                        Authorisation number
                     
                     
                        EU-0020125-0003 1-1
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        2,47
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        2,35
                     
                  7.4.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Priodine, Diamond Predip
                     
                  
                        Authorisation number
                     
                     
                        EU-0020125-0004 1-1
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        2,32
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        2,21
                     
                  
               META SPC 2
            
            1.   META SPC 2 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 2 identifier
            
            
                        Identifier
                     
                     
                        Meta SPC 2 — RTU Products — Professional RTU Liquid for application pre and post milking
                     
                  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
                     
                     
                        0,16
                     
                     
                        0,5
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        0,0
                     
                     
                        0,56
                     
                  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
                     
                     
                        Avoid release to the environment.
                        Collect spillage.
                        Dispose of contents in accordance with local regulations.
                        Dispose of container in accordance with local regulations.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 2
            4.1.   Use description
            
            
               Table 4
            
            
               Use # 1 – RTU Products — Professional RTU Liquid, for application pre-milking — Dipping
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation in use concentration 0,16-0,30 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.1.1.   Use-specific instructions for use
            
            See general directions for use.
            4.1.2.   Use-specific 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 post milking disinfection
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            4.2.   Use description
            
            
               Table 5
            
            
               Use # 2 – RTU Products — Professional RTU Liquid, for application pre milking — Spraying
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                        All
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product
                        Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.2.1.   Use-specific instructions for use
            
            See general directions for use.
            4.2.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves when applying the product by manual spraying (glove material to be specified by the authorisation holder within 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 post milking disinfection
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            4.3.   Use description
            
            
               Table 6
            
            
               Use # 3 – RTU Products — Professional RTU Liquid, for application pre milking – Foaming
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                        All
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation. In use concentration 0,16-0,30 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.3.1.   Use-specific instructions for use
            
            See general directions for use.
            4.3.2.   Use-specific 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 post milking disinfection
            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.
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            4.4.   Use description
            
            
               Table 7
            
            
               Use # 4 – RTU Products — Professional RTU Liquid, for application post milking – Dipping
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation. In use concentration 0,16-0,50 % (w/w) iodine.
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.4.1.   Use-specific instructions for use
            
            Dip at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.4.2.   Use-specific 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
            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.
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            4.5.   Use description
            
            
               Table 8
            
            
               Use # 5 – RTU Products — Professional RTU Liquid, for application post milking – Spraying
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product
                        Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation. In use concentration 0,16-0,50 % (w/w) iodine.
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.5.1.   Use-specific instructions for use
            
            Spray at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.5.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
            A protective coverall (at least type 6, EN 13034) shall be worn
            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
            4.5.3.   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.
            4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            4.5.5.   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.
            4.6.   Use description
            
            
               Table 9
            
            
               Use # 6 – RTU Products — Professional RTU Liquid, for application post milking – Foaming
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16-0,50 % (w/w) iodine.
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.6.1.   Use-specific instructions for use
            
            Dip at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.6.2.   Use-specific 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
            4.6.3.   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.
            4.6.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            4.6.5.   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.
            4.7.   Use description
            
            
               Table 10
            
            
               Use # 7 – RTU Products — Professional RTU Liquid, for application pre and post milking-Dipping
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.7.1.   Use-specific instructions for use
            
            Post milking:
            Dip at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.7.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves when applying the product by dipping (glove material to be specified by the authorisation holder within the product information).
            This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
            4.7.3.   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.
            4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            4.7.5.   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.
            4.8.   Use description
            
            
               Table 11
            
            
               Use # 8 – RTU Products — Professional RTU Liquid, for application pre and post milking- Spraying
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product
                        Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended) –
                                 
                              Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.8.1.   Use-specific instructions for use
            
            Post milking:
            Spray at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.8.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
            A protective coverall (at least type 6, EN 13034) shall be worn
            This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
            4.8.3.   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.
            4.8.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            4.8.5.   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.
            4.9.   Use description
            
            
               Table 12
            
            
               Use # 9 – RTU Products — Professional RTU Liquid, for application pre and post milking — Foaming
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1.5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16-0,30 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.9.1.   Use-specific instructions for use
            
            Post milking:
            Dip at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.9.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves when applying the product by foaming application method (glove material to be specified by the authorisation holder within the product information).
            This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
            4.9.3.   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.
            4.9.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            4.9.5.   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.
            5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
            5.1.   Instructions for use
            
            Keep out of reach of children
            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.
            Product can be used during the entire lactation period
            Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow
            For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds
            5.2.   Risk mitigation measures
            
            See use specific risk mitigation measures.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            Remove and wash contaminated clothing before re-use.
            After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.
            If you feel unwell, seek medical advice.
            After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.
            After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.
            After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.
            Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.
            5.4.   Instructions for safe disposal of the product and its packaging
            
            At the end of the treatment, dispose of 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 farm based waste water treatment plant.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Protect from frost
            Do not store at temperatures above 30 °C
            Shelf life 12 months
            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)
                     
                     
                        LuxSpray 30, Ioklene RTU, Corston Pre/Post Sprayable, Kristal Iocare Plus, PrePost, Autodine, Coars Super Pre
                     
                  
                        Authorisation number
                     
                     
                        EU-0020125-0005 1-2
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        0,3
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        0,305
                     
                  7.2.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        LuxSpray 50, Silkidip, Ceanodine, IoSpray 10, Maxadine RTU, Diamond Superdip, Kristal Iocare Post, KiwiDip, Superdip Excel, Ioguard RTU, Shepherd’s IoSpray 50
                     
                  
                        Authorisation number
                     
                     
                        EU-0020125-0006 1-2
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        0,5
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        0,56
                     
                  7.3.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        LuxDip 50B, Postguard
                     
                  
                        Authorisation number
                     
                     
                        EU-0020125-0007 1-2
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        0,5
                     
                  7.4.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        LuxDip 25, Kote It, Corston Barracide Post Film Forming Dip, Pro-Tect, Kristal Iocare Film, Coars Iodinegel, Coars Iodogel, LuxDip 20B
                     
                  
                        Authorisation number
                     
                     
                        EU-0020125-0008 1-2
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        0,25
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        0,5
                     
                  
               META SPC 3
            
            1.   META SPC 3 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 3 identifier
            
            
                        Identifier
                     
                     
                        Meta SPC 3 — RTU Products — Professiona RTU Liquid for application pre and post milking (LuxSpray 15)
                     
                  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
                     
                     
                        0,16
                     
                     
                        0,16
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        0.166
                     
                     
                        0.166
                     
                  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.
                     
                  
                        Precautionary statements
                     
                     
                        Avoid release to the environment.
                        Collect spillage.
                        Dispose of contents in accordance with local regulations.
                        Dispose of container in accordance with local regulations.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 3
            4.1.   Use description
            
            
               Table 13
            
            
               Use # 1 – RTU Products — Professional RTU Liquid, for application pre-milking — Dipping
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation. In use concentration 0,16 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.1.1.   Use-specific instructions for use
            
            See general directions for use.
            4.1.2.   Use-specific 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 post milking disinfection
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            4.2.   Use description
            
            
               Table 14
            
            
               Use # 2 – RTU Products — Professional RTU Liquid, for application pre milking — spraying
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product
                        Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.2.1.   Use-specific instructions for use
            
            See general directions for use.
            4.2.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves when applying the product by manual spraying (glove material to be specified by the authorisation holder within 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 post milking disinfection
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            4.3.   Use description
            
            
               Table 15
            
            
               Use # 3 – RTU Products — Professional RTU Liquid, for application pre milking – Foaming
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.3.1.   Use-specific instructions for use
            
            See general directions for use.
            4.3.2.   Use-specific 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 post milking disinfection
            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.
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            4.4.   Use description
            
            
               Table 16
            
            
               Use # 4 – RTU Products — Professional RTU Liquid, for application post milking – Dipping
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16 % (w/w) iodine.
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.4.1.   Use-specific instructions for use
            
            Dip at least 2/3 of the teat length with diluted product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.4.2.   Use-specific 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
            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.
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            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.
            4.5.   Use description
            
            
               Table 17
            
            
               Use # 5 – RTU Products — Professional RTU Liquid, for application post milking – Spraying
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                        All
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product
                        Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16 % (w/w) iodine.
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.5.1.   Use-specific instructions for use
            Spray at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.5.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
            A protective coverall (at least type 6, EN 13034) shall be worn
            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
            4.5.3.   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.
            4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            4.5.5.   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.
            4.6.   Use description
            
            
               Table 18
            
            
               Use # 6 – RTU Products — Professional RTU Liquid, for application post milking – Foaming
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16 % (w/w) iodine.
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.6.1.   Use-specific instructions for use
            Dip at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.6.2.   Use-specific 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
            4.6.3.   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.
            4.6.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            4.6.5.   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.
            4.7.   Use description
            
            
               Table 19
            
            
               Use # 7 – Use # 3.7 – RTU Products — Professional RTU Liquid, for application pre and post milking-Dipping
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via dip Cup: Using a traditional dip cup with non-return valves, dispense RTU product into the reservoir. Screw down the applicator portion. Squeeze the reservoir to fill the applicator. Cover the bottom two thirds of each teat with material. Dispose of unused material after each milking
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.7.1.   Use-specific instructions for use
            
            Post milking:
            Dip at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.7.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves when applying the product by dipping (glove material to be specified by the authorisation holder within the product information).
            This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
            4.7.3.   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.
            4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            4.7.5.   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.
            4.8.   Use description
            
            
               Table 20
            
            
               Use # 8 – RTU Products — Professional RTU Liquid, for application pre and post milking- Spraying
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: spray treatment
                        Application via pneumatic sprayer: Uptake lance of spray system is placed in the container of the RTU product. The RTU product is then pumped to a spray lance located in the milking parlour. The spray lance is then used to cover the bottom two thirds of teats in the RTU product
                        Application via manual trigger spray: Fill trigger spray bottle with RTU product. Use trigger spray to cover the bottom two thirds of each teat with RTU product
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.8.1.   Use-specific instructions for use
            
            Post milking:
            Spray at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.8.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves and boots when applying the product by manual spraying (glove material to be specified by the authorisation holder within the product information)
            A protective coverall (at least type 6, EN 13034) shall be worn
            This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
            4.8.3.   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.
            4.8.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            4.8.5.   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.
            4.9.   Use description
            
            
               Table 21
            
            
               Use # 9 – RTU Products — Professional RTU Liquid, for application pre and post milking — Foaming
            
            
                        Product type
                     
                     
                        PT03 — Veterinary hygiene (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        —
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeast
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                     
                  
                        Application method(s)
                     
                     
                        Open system: dip treatment
                        Application via foaming Dip cup: As for dip cup, however, when squeezed, the liquid is forced through a fine mesh, mixing with air and forming foam. This is then applied to the bottom two thirds of the cow’s udder
                        The same solution can be applied to multiple animals during the same milking session.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Quantity of RTU product to be applied per application:
                        
                                    —
                                 
                                 
                                    cows and buffaloes: 3 to 10ml (5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    sheep 1,5 to 5 ml (1,5 ml recommended)
                                 
                              
                                    —
                                 
                                 
                                    goats 2,5 to 6 ml (2,5 ml recommended)
                                 
                              Ready to use formulation In use concentration 0,16 % (w/w) iodine.
                        2 pre milking applications per animal, per day
                        2 post milking applications per animal, per day
                     
                  
                        Category(ies) of users
                     
                     
                        Trained professional
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Drum, Plastic: HDPE, 10 l
                        Drum, Plastic: HDPE, 20 l
                        Drum, Plastic: HDPE, 25 l
                        Drum, Plastic: HDPE, 200 l
                        IBC (intermediate bulk container), Plastic: HDPE, 1000 l
                        Drum, Plastic: HDPE, 5 l
                        All drums excepting 200 l (200 kg) and 1000 l (1000 kg) could be either silver or natural (white translucent) in colour. 200 l (200 kg) drums are either silver or blue in colour. IBCs are natural coloured.
                        All drums are capped with tamper evident caps or bungs and are UN certified.
                     
                  4.9.1.   Use-specific instructions for use
            
            Post milking:
            Dip at least 2/3 of the teat length with RTU product immediately after milking
            To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing at least 5 minutes).
            4.9.2.   Use-specific risk mitigation measures
            
            Wear protective chemical resistant gloves when applying the product by foaming application method
            (glove material to be specified by the authorisation holder within the product information).
            This product can be used for pre- and post-milking disinfection in combination. However, it should not be used in combination with a different iodine-based product.
            4.9.3.   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.
            4.9.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See general directions for use.
            4.9.5.   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.
            5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3
            5.1.   Instructions for use
            
            Keep out of reach of children
            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.
            Product can be used during the entire lactation period
            Before attaching the milking cluster, all teat-dip residues should be removed with either a single use towel or re-usable cloth. One cloth should be used per cow
            For effective use against bacteria and yeast, product must be left in contact with the skin for at least 60 seconds
            5.2.   Risk mitigation measures
            
            See use specific risk mitigation measures.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            Remove and wash contaminated clothing before re-use.
            After inhalation: Move to fresh air in case of accidental inhalation of fumes from overheating or combustion.
            If you feel unwell, seek medical advice.
            After contact with skin: Wash with water and soap as a precaution. Consult a doctor if skin irritation persists.
            After contact with eyes: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical treatment by eye specialist.
            After ingestion: Rinse out mouth and give plenty of water to drink. Never give anything by mouth to an unconscious person. Consult a physician.
            Large spills should be contained using a chemical spill kit, soaked up using absorbent material such as kieselguhr and disposed of as hazardous waste.
            5.4.   Instructions for safe disposal of the product and its packaging
            
            At the end of the treatment, dispose of 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 farm based waste water treatment plant.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Protect from frost
            Do not store at temperatures above 30 °C
            Shelf life 12 months
            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)
                     
                     
                        LuxSpray 15 — Priodine RTU/Kristal Iocare Pre/Super Pre
                     
                  
                        Authorisation number
                     
                     
                        EU-0020125-0009 1-3
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Iodine
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        7553-56-2
                     
                     
                        231-442-4
                     
                     
                        0,16
                     
                  
                        C9-11 Alcohol Ethoxylate
                     
                     
                        C 9-11 alcohol with 6 moles of ethoxylate. Various brand names available including Imbentin C-91-060
                     
                     
                        Non-active substance
                     
                     
                        68439-46-3
                     
                     
                        614-482-0
                     
                     
                        0,166
                     
                  
               (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.