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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)

EU Regulation 2019/2029 · Adopted 29 November 2019 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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 productsf1, 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 opinionf2, 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:

Annotations to the whole text

Footnotes

f1

OJ L 167, 27.6.2012, p. 1.

f2

ECHA opinion of 28 February 2019 on the Union authorisation of ‘CVAS Disinfectant product based on Propan-2-ol’ (ECHA/BPC/222/2019).

Contents

  1. 1Article 1
  2. 2Article 2
  3. Signature
  4. Annex Summary of product characteristics for a biocidal product
  5. ADMINISTRATIVE INFORMATION
  6. 1.1Trade name(s) of the product
  7. 1.2Authorisation holder
  8. 1.3Manufacturer(s) of the product
  9. 1.4Manufacturer(s) of the active substance(s)
  10. PRODUCT COMPOSITION AND FORMULATION
  11. 2.1Qualitative and quantitative information on the composition of the product
  12. 2.2Type of formulation
  13. 3HAZARD AND PRECAUTIONARY STATEMENTS
  14. AUTHORISED USE(S)
  15. 4.1Use description
  16. 4.1.1Use-specific instructions for use
  17. 4.1.2Use-specific risk mitigation measures
  18. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  19. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  20. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  21. 4.2Use description
  22. 4.2.1Use-specific instructions for use
  23. 4.2.2Use-specific risk mitigation measures
  24. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  25. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  26. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  27. 4.3Use description
  28. 4.3.1Use-specific instructions for use
  29. 4.3.2Use-specific risk mitigation measures
  30. 4.3.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  31. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  32. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  33. 4.4Use description
  34. 4.4.1Use-specific instructions for use
  35. 4.4.2Use-specific risk mitigation measures
  36. 4.4.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  37. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  38. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  39. GENERAL DIRECTIONS FOR USE
  40. 5.1Instructions for use
  41. 5.2Risk mitigation measures
  42. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  43. 5.4Instructions for safe disposal of the product and its packaging
  44. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  45. 6OTHER INFORMATION

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.

2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Signature

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

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

1.1Trade 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

1.2Authorisation holder

Name and address of the authorisation holderNameCVAS Development GmbH
AddressDr Albert Reimann Str. 16a, 68526, Ladenburg, Germany
Authorisation numberEU-0020461-0000
R4BP asset number EU-0020461-0000
Date of the authorisation24 December 2019
Expiry date of the authorisation30 November 2029

1.3Manufacturer(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

1.4Manufacturer(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

2.1Qualitative and quantitative information on the composition of the product

Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-761,25

2.2Type of formulation

Any other liquid (ready-to-use)

3HAZARD 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.

4.1Use description

Table 1

Use # 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)

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 frequency40-50 mL/m2
Category(ies) of usersGeneral public (non-professional)
Pack sizes and packaging material
  1. 1..

    Bottle: High-density polyethylene (HDPE), 250 - 1 000 mL

  2. 2..

    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000 mL

4.1.1Use-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.

4.1.2Use-specific risk mitigation measures

See section 5.2.

4.1.3Where 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.

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

See section 5.4.

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

See section 5.5.

4.2Use description

Table 2

Use # 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)

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 frequency40-50 mL/m2
Category(ies) of usersProfessional
Pack sizes and packaging material
  1. 1..

    Bottle: HDPE, 250 - 1 000 mL

  2. 2..

    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000 mL

  3. 3..

    Intermediate bulk containers (IBC): HDPE, 720 L

  4. 4..

    Drum: Steel, zinc coated and painted, 200 - 220 L

  5. 5..

    Canister: HDPE, 5 - 50 L

4.2.1Use-specific instructions for use

See section 5.1.

4.2.2Use-specific risk mitigation measures

  1. 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. 2..

    The product must only be applied for disinfection of small surfaces.

4.2.3Where 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.

4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging

See section 5.4.

4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See section 5.5.

4.3Use description

Table 3

Use # 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)

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 frequency40-50 mL/m2
Category(ies) of usersGeneral public (non-professional)
Pack sizes and packaging material
  1. 1..

    Bottle: HDPE, 250 - 1 000 mL

  2. 2..

    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000 mL

4.3.1Use-specific instructions for use

  1. 1..

    For use at room temperature (20 ± 2 °C).

  2. 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. 3..

    Disinfection of gardening equipment for human hygiene purpose only.

  4. 4..

    Disinfect gardening equipment only indoors.

4.3.2Use-specific risk mitigation measures

See section 5.2.

4.3.3Where 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.

4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging

See section 5.4.

4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See section 5.5.

4.4Use description

Table 4

Use # 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)

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 frequency40-50 mL/m2
Category(ies) of usersProfessional
Pack sizes and packaging material
  1. 1..

    Bottle: HDPE, 250 - 1 000 mL

  2. 2..

    Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000 mL

  3. 3..

    IBC: HDPE, 720 L

  4. 4..

    Drum: Steel, zinc coated and painted, 200 - 220 L

  5. 5..

    Canister: HDPE, 5 - 50 L

4.4.1Use-specific instructions for use

  1. 1..

    For use at room temperature (20 ± 2 °C).

  2. 2..

    Disinfection of gardening equipment for human hygiene purpose only.

  3. 3..

    Disinfect gardening equipment only indoors.

4.4.2Use-specific risk mitigation measures

  1. 1..

    Provide adequate ventilation (industrial ventilation or keeping windows and doors open).

  2. 2..

    The product must only be applied for disinfection of small surfaces.

  3. 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.

4.4.3Where 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.

4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging

See section 5.4.

4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See section 5.5.

5.1Instructions for use

  1. 1..

    Clean surfaces before use.

  2. 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. 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. 4..

    Do not apply more than 50 mL/m2.

  5. 5..

    Used wipes must be disposed in a closed container.

  6. 6..

    For non-professional users only: Do not use more than 4 applications per day.

5.2Risk mitigation measures

  1. 1..

    Keep out of reach of children and pets.

  2. 2..

    Avoid contact with eyes.

  3. 3..

    Do not apply in the presence of small children.

  4. 4..

    Keep children and pets away from rooms, where disinfection is taking place. Provide adequate ventilation before children enter treated rooms.

  5. 5..

    For refilling a funnel must be applied.

5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

  1. 1..

    IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.

  2. 2..

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.

  3. 3..

    Call a POISON CENTER or doctor/physician if you feel unwell.

  4. 4..

    If eye irritation persists, get medical advice.

5.4Instructions 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.

5.5Conditions 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.

6OTHER 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.