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)
Commission Implementing Regulation (EU) 2019/2029of 29 November 2019granting 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 productsOJ L 167, 27.6.2012, p. 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 opinionECHA opinion of 28 February 2019 on the Union authorisation of "CVAS Disinfectant product based on Propan-2-ol" (ECHA/BPC/222/2019)., 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 1A 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 2This 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 CommissionThe PresidentJean-Claude JunckerANNEXSummary of product characteristics for a biocidal productCVAS Disinfectant product based on Propan-2-olProduct 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-0020461-0000R4BP asset number: EU-0020461-00001.ADMINISTRATIVE INFORMATION1.1.Trade name(s) of the product
Trade name(s)CVAS Disinfectant product based on Propan-2-olcalgonit DS 622R 3000 SCHNELLDESINFEKTIONIPADES 70Alpha SeptinBlu-SeptDisinfect homeSchnell DesDisinfect RapidBakt-Ex PurBakt-Ex RapidROTIE-DES quickBactazol IDezynfektatorEOSSAN-Desinfektionsspray-FluidFS-7-SprayGartengeräte Hygiene SprayNeudoClean Hygiene Spray
1.2.Authorisation holder
Name and address of the authorisation holderNameCVAS Development GmbH
AddressDr Albert Reimann Str. 16a, 68526, Ladenburg, Germany
Authorisation numberEU-0020461-0000
R4BP asset numberEU-0020461-0000
Date of the authorisation24 December 2019
Expiry date of the authorisation30 November 2029
1.3.Manufacturer(s) of the product
Name of manufacturerBrenntag GmbH
Address of manufacturerMesseallee 11, 45131 Essen, Germany
Location of manufacturing sitesAm Nordseekai 22, 73207 Plochingen Germany
Name of manufacturerCalvatis GmbH
Address of manufacturerDr Albert Reimann Str. 16a, 68526 Ladenburg Germany
Location of manufacturing sitesDr Albert Reimann Str. 16a, 68526 Ladenburg Germany
Name of manufacturerArthur Schopf Hygiene GmbH & Co. KG
Address of manufacturerPfaffensteinstr. 1, 83115 Neubeuern Germany
Location of manufacturing sitesPfaffensteinstr. 1, 83115 Neubeuern Germany
1.4.Manufacturer(s) of the active substance(s)
Active substancePropan-2-ol
Name of manufacturerShell Nederland Raffinaderij B.V.
Address of manufacturerVondelingenweg 601, 3196 KK, Vodelingenenplaat Rotterdam Netherlands
Location of manufacturing sitesVondelingenweg 601, 3196 KK, Vodelingenenplaat Rotterdam Netherlands
Active substancePropan-2-ol
Name of manufacturerExxonMobil
Address of manufacturer4999 Scenic Highway, LA 70897 Baton Rouge, Louisana United States
Location of manufacturing sites4999 Scenic Highway, LA 70897 Baton Rouge, Louisana United States
Active substancePropan-2-ol
Name of manufacturerINEOS Solvents Germany GmbH
Address of manufacturerRömerstraße 733, 47443 Moers Germany
Location of manufacturing sitesRömerstraße 733, 47443 Moers Germany
2.PRODUCT COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the product
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-761,25
2.2.Type of formulationAny other liquid (ready-to-use)3.HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsIf 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 1Use # 1 — Disinfection of small surfaces by non-professional users (product-type 2)
Product typePT02 — 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)BacteriaYeasts
Field(s) of useIndoorDisinfection of non-porous surfaces in domestic areas.
Application method(s)SprayingSpraying with trigger sprayer or pump spraySpraying and wipingSpraying with trigger sprayer or pump spray and wipingPouring and wiping
Application rate(s) and frequency40-50 mL/m2
Category(ies) of usersGeneral public (non-professional)
Pack sizes and packaging material1.Bottle: High-density polyethylene (HDPE), 250 - 1000 mL2.Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL
4.1.1.Use-specific instructions for useThe 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 measuresSee 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 environmentSee section 5.3.4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee 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 storageSee section 5.5.4.2.Use description
Table 2Use # 2 — Disinfection of small surfaces by professional users (product-type 2)
Product typePT02 — 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)BacteriaYeasts
Field(s) of useIndoorDisinfection of non-porous surfaces in industry, small enterprises, institutions and domestic areas.
Application method(s)SprayingSpraying with trigger sprayer or pump spraySpraying and wipingSpraying with trigger sprayer or pump spray and wipingPouring and wiping
Application rate(s) and frequency40-50 mL/m2
Category(ies) of usersProfessional
Pack sizes and packaging material1.Bottle: HDPE, 250 - 1000 mL2.Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL3.Intermediate bulk containers (IBC): HDPE, 720 L4.Drum: Steel, zinc coated and painted, 200 - 220 L5.Canister: HDPE, 5 - 50 L
4.2.1.Use-specific instructions for useSee section 5.1.4.2.2.Use-specific risk mitigation measures1.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 environmentSee section 5.3.4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee 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 storageSee section 5.5.4.3.Use description
Table 3Use # 3 — Disinfection of small surfaces by non-professional users (product-type 4)
Product typePT04 — Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use-
Target organism(s) (including development stage)BacteriaYeasts
Field(s) of useIndoorDisinfection of non-porous surfaces in kitchens.Disinfection of gardening equipment for human hygiene purpose only.
Application method(s)SprayingSpraying with trigger sprayer or pump spraySpraying and wipingSpraying with trigger sprayer or pump spray and wipingPouring and wiping
Application rate(s) and frequency40-50 mL/m2
Category(ies) of usersGeneral public (non-professional)
Pack sizes and packaging material1.Bottle: HDPE, 250 - 1000 mL2.Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL
4.3.1.Use-specific instructions for use1.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 m23.Disinfection of gardening equipment for human hygiene purpose only.4.Disinfect gardening equipment only indoors.4.3.2.Use-specific risk mitigation measuresSee 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 environmentSee section 5.3.4.3.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee 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 storageSee section 5.5.4.4.Use description
Table 4Use # 4 — Disinfection of small surfaces by professional users (product-type 4)
Product typePT04 — Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use-
Target organism(s) (including development stage)BacteriaYeasts
Field(s) of useIndoorDisinfection 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)SprayingSpraying with trigger sprayer or pump spraySpraying and wipingSpraying with trigger sprayer or pump spray and wipingPouring and wiping
Application rate(s) and frequency40-50 mL/m2
Category(ies) of usersProfessional
Pack sizes and packaging material1.Bottle: HDPE, 250 - 1000 mL2.Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1000 mL3.IBC: HDPE, 720 L4.Drum: Steel, zinc coated and painted, 200 - 220 L5.Canister: HDPE, 5 - 50 L
4.4.1.Use-specific instructions for use1.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 measures1.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 environmentSee section 5.3.4.4.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee 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 storageSee section 5.5.5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.5.1.Instructions for use1.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 measures1.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 environmentFirst 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 packagingAt 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 storageStore cool (not above 30 °C) and protect from frost.Shelf-life: 24 months.6.OTHER INFORMATIONPlease 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.