CELEX: 32019R2029
Language: en
Date: 2019-11-29 00:00:00
Title: Commission Implementing Regulation (EU) 2019/2029 of 29 November 2019 granting a Union authorisation for the single biocidal product CVAS Disinfectant product based on Propan-2-ol (Text with EEA relevance)

4.12.2019   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 313/41
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2019/2029
         of 29 November 2019
         granting a Union authorisation for the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) thereof,
         Whereas:
         
                     (1)
                  
                  
                     On 29 June 2016, SCC GmbH (on behalf of CVAS Development GmbH), submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named ‘CVAS Disinfectant product based on Propan-2-ol’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-DH025620-60 in the Register for Biocidal Products.
                  
               
                     (2)
                  
                  
                     ‘CVAS Disinfectant product based on Propan-2-ol’ contains propan-2-ol, 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.
                  
               
                     (3)
                  
                  
                     On 17 August 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).
                  
               
                     (4)
                  
                  
                     On 25 March 2019, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘CVAS Disinfectant product based on Propan-2-ol’ and the final assessment report on the single biocidal product in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that ‘CVAS Disinfectant product based on Propan-2-ol’ is a ‘single biocidal product’ within the meaning of Article 3(1)(r) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.
                  
               
                     (5)
                  
                  
                     On 3 June 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.
                  
               
                     (6)
                  
                  
                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘CVAS Disinfectant product based on Propan-2-ol’.
                  
               
                     (7)
                  
                  
                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
                  
               HAS ADOPTED THIS REGULATION:
         
            Article 1
            A Union authorisation with authorisation number EU-0020461-0000 is granted to CVAS Development GmbH for the making available on the market and use of the single biocidal product ‘CVAS Disinfectant product based on Propan-2-ol’, in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 24 December 2019 until 30 November 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, 29 November 2019.
            
               
                  For the Commission
               
               
                  The President
               
               Jean-Claude JUNCKER
            
         
         
            (1)  OJ L 167, 27.6.2012, p. 1.
         
            (2)  ECHA opinion of 28 February 2019 on the Union authorisation of ‘CVAS Disinfectant product based on Propan-2-ol’ (ECHA/BPC/222/2019).
      
      
         
            ANNEX
            
               Summary of product characteristics for a biocidal product
            
            CVAS Disinfectant product based on Propan-2-ol
            Product type 2 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
            Product type 4 — Food and feed area (Disinfectants)
            Authorisation number: EU-0020461-0000
            R4BP asset number: EU-0020461-0000
            1.   ADMINISTRATIVE INFORMATION
            1.1.   Trade name(s) of the product
            
            
                        Trade name(s)
                     
                     
                        CVAS Disinfectant product based on Propan-2-ol
                        calgonit DS 622
                        R 3000 SCHNELLDESINFEKTION
                        IPADES 70
                        Alpha Septin
                        Blu-Sept
                        Disinfect home
                        Schnell Des
                        Disinfect Rapid
                        Bakt-Ex Pur
                        Bakt-Ex Rapid
                        ROTIE-DES quick
                        Bactazol I
                        Dezynfektator
                        EOSSAN-Desinfektionsspray-Fluid
                        FS-7-Spray
                        Gartengeräte Hygiene Spray
                        NeudoClean Hygiene Spray
                     
                  1.2.   Authorisation holder
            
            
                        Name and address of the authorisation holder
                     
                     
                        Name
                     
                     
                        CVAS Development GmbH
                     
                  
                        Address
                     
                     
                        Dr Albert Reimann Str. 16a, 68526, Ladenburg, Germany
                     
                  
                        Authorisation number
                     
                     
                        EU-0020461-0000
                     
                  
                        
                           R4BP asset number
                        
                     
                     
                        EU-0020461-0000
                     
                  
                        Date of the authorisation
                     
                     
                        24 December 2019
                     
                  
                        Expiry date of the authorisation
                     
                     
                        30 November 2029
                     
                  1.3.   Manufacturer(s) of the product
            
            
                        Name of manufacturer
                     
                     
                        Brenntag GmbH
                     
                  
                        Address of manufacturer
                     
                     
                        Messeallee 11, 45131 Essen, Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Am Nordseekai 22, 73207 Plochingen Germany
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Calvatis GmbH
                     
                  
                        Address of manufacturer
                     
                     
                        Dr Albert Reimann Str. 16a, 68526 Ladenburg Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Dr Albert Reimann Str. 16a, 68526 Ladenburg Germany
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Arthur Schopf Hygiene GmbH & Co. KG
                     
                  
                        Address of manufacturer
                     
                     
                        Pfaffensteinstr. 1, 83115 Neubeuern Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Pfaffensteinstr. 1, 83115 Neubeuern Germany
                     
                  1.4.   Manufacturer(s) of the active substance(s)
            
            
                        Active substance
                     
                     
                        Propan-2-ol
                     
                  
                        Name of manufacturer
                     
                     
                        Shell Nederland Raffinaderij B.V.
                     
                  
                        Address of manufacturer
                     
                     
                        Vondelingenweg 601, 3196 KK, Vodelingenenplaat Rotterdam Netherlands
                     
                  
                        Location of manufacturing sites
                     
                     
                        Vondelingenweg 601, 3196 KK, Vodelingenenplaat Rotterdam Netherlands
                     
                  
               
            
                        Active substance
                     
                     
                        Propan-2-ol
                     
                  
                        Name of manufacturer
                     
                     
                        ExxonMobil
                     
                  
                        Address of manufacturer
                     
                     
                        4999 Scenic Highway, LA 70897 Baton Rouge, Louisana United States
                     
                  
                        Location of manufacturing sites
                     
                     
                        4999 Scenic Highway, LA 70897 Baton Rouge, Louisana United States
                     
                  
               
            
                        Active substance
                     
                     
                        Propan-2-ol
                     
                  
                        Name of manufacturer
                     
                     
                        INEOS Solvents Germany GmbH
                     
                  
                        Address of manufacturer
                     
                     
                        Römerstraße 733, 47443 Moers Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Römerstraße 733, 47443 Moers Germany
                     
                  2.   PRODUCT COMPOSITION AND FORMULATION
            2.1.   Qualitative and quantitative information on the composition of the product
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        61,25
                     
                  2.2.   Type of formulation
            
            Any other liquid (ready-to-use)
            3.   HAZARD AND PRECAUTIONARY STATEMENTS
            
                        Hazard statements
                     
                     
                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.
                     
                  
                        Precautionary statements
                     
                     
                        If medical advice is needed, have product container or label at hand.
                        Keep out of reach of children.
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Avoid breathing vapours.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container in accordance with local regulations.
                        Wash hands thoroughly after handling.
                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                        In case of fire: Use alcohol-resistant foam to extinguish.
                     
                  4.   AUTHORISED USE(S)
            4.1.   Use description
            
            
               Table 1
            
            
               Use # 1 — Disinfection of small surfaces by non-professional users (product-type 2)
            
            
                        Product type
                     
                     
                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeasts
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of non-porous surfaces in domestic areas.
                     
                  
                        Application method(s)
                     
                     
                        Spraying
                        Spraying with trigger sprayer or pump spray
                        Spraying and wiping
                        Spraying with trigger sprayer or pump spray and wiping
                        Pouring and wiping
                     
                  
                        Application rate(s) and frequency
                     
                     
                        40-50 mL/m2
                        
                     
                  
                        Category(ies) of users
                     
                     
                        General public (non-professional)
                     
                  
                        Pack sizes and packaging material
                     
                     
                        
                                    1.
                                 
                                 
                                    Bottle: High-density polyethylene (HDPE), 250 - 1 000  mL
                                 
                              
                                    2.
                                 
                                 
                                    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000  mL
                                 
                              
                  4.1.1.   Use-specific instructions for use
            
            The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:
            
                        •
                     
                     
                        Trigger spray: Apply 20 spray strokes per 0,5 m2.
                     
                  
                        •
                     
                     
                        Pump spray: Apply 3 jets per 100 cm2.
                     
                  
                        •
                     
                     
                        Bottle: Apply one measuring cup per m2.
                     
                  4.1.2.   Use-specific risk mitigation measures
            
            See section 5.2.
            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 section 5.3.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See section 5.4.
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See section 5.5.
            4.2.   Use description
            
            
               Table 2
            
            
               Use # 2 — Disinfection of small surfaces by professional users (product-type 2)
            
            
                        Product type
                     
                     
                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeasts
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of non-porous surfaces in industry, small enterprises, institutions and domestic areas.
                     
                  
                        Application method(s)
                     
                     
                        Spraying
                        Spraying with trigger sprayer or pump spray
                        Spraying and wiping
                        Spraying with trigger sprayer or pump spray and wiping
                        Pouring and wiping
                     
                  
                        Application rate(s) and frequency
                     
                     
                        40-50 mL/m2
                        
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        
                                    1.
                                 
                                 
                                    Bottle: HDPE, 250 - 1 000  mL
                                 
                              
                                    2.
                                 
                                 
                                    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000  mL
                                 
                              
                                    3.
                                 
                                 
                                    Intermediate bulk containers (IBC): HDPE, 720 L
                                 
                              
                                    4.
                                 
                                 
                                    Drum: Steel, zinc coated and painted, 200 - 220 L
                                 
                              
                                    5.
                                 
                                 
                                    Canister: HDPE, 5 - 50 L
                                 
                              
                  4.2.1.   Use-specific instructions for use
            
            See section 5.1.
            4.2.2.   Use-specific risk mitigation measures
            
            
                        1.
                     
                     
                        The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during handling of the product is recommended.
                     
                  
                        2.
                     
                     
                        The product must only be applied for disinfection of small surfaces.
                     
                  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 section 5.3.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See section 5.4.
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See section 5.5.
            4.3.   Use description
            
            
               Table 3
            
            
               Use # 3 — Disinfection of small surfaces by non-professional users (product-type 4)
            
            
                        Product type
                     
                     
                        PT04 — Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeasts
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of non-porous surfaces in kitchens.
                        Disinfection of gardening equipment for human hygiene purpose only.
                     
                  
                        Application method(s)
                     
                     
                        Spraying
                        Spraying with trigger sprayer or pump spray
                        Spraying and wiping
                        Spraying with trigger sprayer or pump spray and wiping
                        Pouring and wiping
                     
                  
                        Application rate(s) and frequency
                     
                     
                        40-50 mL/m2
                        
                     
                  
                        Category(ies) of users
                     
                     
                        General public (non-professional)
                     
                  
                        Pack sizes and packaging material
                     
                     
                        
                                    1.
                                 
                                 
                                    Bottle: HDPE, 250 - 1 000  mL
                                 
                              
                                    2.
                                 
                                 
                                    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000  mL
                                 
                              
                  4.3.1.   Use-specific instructions for use
            
            
                        1.
                     
                     
                        For use at room temperature (20 ± 2 °C).
                     
                  
                        2.
                     
                     
                        The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:
                        
                                    •
                                 
                                 
                                    Trigger spray: Apply 20 spray strokes per 0,5 m2.
                                 
                              
                                    •
                                 
                                 
                                    Pump spray: Apply 3 jets per 100 cm2.
                                 
                              
                                    •
                                 
                                 
                                    Bottle: Apply one measuring cup per m2
                                    
                                 
                              
                  
                        3.
                     
                     
                        Disinfection of gardening equipment for human hygiene purpose only.
                     
                  
                        4.
                     
                     
                        Disinfect gardening equipment only indoors.
                     
                  4.3.2.   Use-specific risk mitigation measures
            
            See section 5.2.
            4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See section 5.3.
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See section 5.4.
            4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See section 5.5.
            4.4.   Use description
            
            
               Table 4
            
            
               Use # 4 — Disinfection of small surfaces by professional users (product-type 4)
            
            
                        Product type
                     
                     
                        PT04 — Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Bacteria
                        Yeasts
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of non-porous surfaces in canteens or kitchens, food processing industry (including breweries).
                        Disinfection of gardening equipment for human hygiene purpose only.
                     
                  
                        Application method(s)
                     
                     
                        Spraying
                        Spraying with trigger sprayer or pump spray
                        Spraying and wiping
                        Spraying with trigger sprayer or pump spray and wiping
                        Pouring and wiping
                     
                  
                        Application rate(s) and frequency
                     
                     
                        40-50 mL/m2
                        
                     
                  
                        Category(ies) of users
                     
                     
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        
                                    1.
                                 
                                 
                                    Bottle: HDPE, 250 - 1 000  mL
                                 
                              
                                    2.
                                 
                                 
                                    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000  mL
                                 
                              
                                    3.
                                 
                                 
                                    IBC: HDPE, 720 L
                                 
                              
                                    4.
                                 
                                 
                                    Drum: Steel, zinc coated and painted, 200 - 220 L
                                 
                              
                                    5.
                                 
                                 
                                    Canister: HDPE, 5 - 50 L
                                 
                              
                  4.4.1.   Use-specific instructions for use
            
            
                        1.
                     
                     
                        For use at room temperature (20 ± 2 °C).
                     
                  
                        2.
                     
                     
                        Disinfection of gardening equipment for human hygiene purpose only.
                     
                  
                        3.
                     
                     
                        Disinfect gardening equipment only indoors.
                     
                  4.4.2.   Use-specific risk mitigation measures
            
            
                        1.
                     
                     
                        Provide adequate ventilation (industrial ventilation or keeping windows and doors open).
                     
                  
                        2.
                     
                     
                        The product must only be applied for disinfection of small surfaces.
                     
                  
                        3.
                     
                     
                        The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during handling of the product is recommended.
                     
                  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 section 5.3.
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            See section 5.4.
            4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See section 5.5.
            5.   GENERAL DIRECTIONS FOR USE (1)
            
            5.1.   Instructions for use
            
            
                        1.
                     
                     
                        Clean surfaces before use.
                     
                  
                        2.
                     
                     
                        Apply the product to the surface undiluted by spraying. Make sure to wet surfaces completely. Allow to take effect for at least 15 minutes.
                     
                  
                        3.
                     
                     
                        Apply the product to the surface undiluted by spraying/pouring the product and wiping of the surface afterwards. Make sure to wet surfaces completely. Allow to take effect for at least 5 minutes.
                     
                  
                        4.
                     
                     
                        Do not apply more than 50 mL/m2.
                     
                  
                        5.
                     
                     
                        Used wipes must be disposed in a closed container.
                     
                  
                        6.
                     
                     
                        For non-professional users only: Do not use more than 4 applications per day.
                     
                  5.2.   Risk mitigation measures
            
            
                        1.
                     
                     
                        Keep out of reach of children and pets.
                     
                  
                        2.
                     
                     
                        Avoid contact with eyes.
                     
                  
                        3.
                     
                     
                        Do not apply in the presence of small children.
                     
                  
                        4.
                     
                     
                        Keep children and pets away from rooms, where disinfection is taking place. Provide adequate ventilation before children enter treated rooms.
                     
                  
                        5.
                     
                     
                        For refilling a funnel must be applied.
                     
                  5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid:
            
                        1.
                     
                     
                        IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
                     
                  
                        2.
                     
                     
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.
                     
                  
                        3.
                     
                     
                        Call a POISON CENTER or doctor/physician if you feel unwell.
                     
                  
                        4.
                     
                     
                        If eye irritation persists, get medical advice.
                     
                  5.4.   Instructions for safe disposal of the product and its packaging
            
            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Store cool (not above 30 °C) and protect from frost.
            Shelf-life: 24 months.
            6.   OTHER INFORMATION
            Please be aware of the European reference value of 129,28 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the product.
            
               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.