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)

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.

ANNEX

Summary of product characteristics for a biocidal product

CVAS Disinfectant product based on Propan-2-ol

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

PT04: Food and feed area

Authorisation number: EU-0020461-0000

R4BP asset number: EU-0020461-0000

1. ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product

1.2.   Authorisation holder

1.3.   Manufacturer(s) of the product

1.4.   Manufacturer(s) of the active substance(s)

2. PRODUCT COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the product

2.2.   Type(s) of formulation

Any other liquid (ready-to-use)

3. HAZARD AND PRECAUTIONARY STATEMENTS

4. AUTHORISED USE(S)

4.1.   Use description

Table 1

Use 1 – Disinfection of small surfaces in product type 2 by non-professional users

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 in product type 2 by professional users

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.

• 1. 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 in product type 4 by non-professional users

4.3.1.   Use-specific instructions for use

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

• 1. 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

• 1. Disinfection of gardening equipment for human hygiene purpose only.

• 1. 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 in product type 4 by professional users

4.4.1.   Use-specific instructions for use

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

• 1. Disinfection of gardening equipment for human hygiene purpose only.

• 1. 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).

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

• 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.

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 ([^E0001])

5.1.   Instructions for use

• 1. Clean surfaces before use.

• 1. Apply the product to the surface undiluted by spraying. Make sure to wet surfaces completely. Allow to take effect for at least 15 minutes.

• 1. 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.

• 1. Do not apply more than 50 mL/m².

• 1. Used wipes must be disposed in a closed container.

• 1. 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.

• 1. Avoid contact with eyes.

• 1. Do not apply in the presence of small children.

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

• 1. 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.

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

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

• 1. If eye irritation persists, get medical advice/attention.

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 month.

6. OTHER INFORMATION

• 1. 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. Information on hazard and precautionary statements: In fact H319 would trigger P280 (Wear eye protection/face protection.). However, for non-professional use correct use of personal protective equipment cannot be assumed. Based on a qualitative risk assessment an additional advice (labelling) with ‘Avoid contact with eyes’ and the other precautionary statements P305 + P351 + P338 and P337 + P313 are considered sufficient to protect the non-professional user from the corresponding risk. H319 also triggers P264 (Wash … thoroughly after handling.). This precautionary statement is also not required since propan-2-ol and the formulated biocidal product is very volatile and will evaporate from contaminated skin rapidly. Thus, washing of hands or other body parts is not necessary. H336 would trigger P304 + P340 (IF INHALED: Remove person to fresh air and keep comfortable for breathing.). According to the Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 (2016) this precautionary statement is considered as optional. Based on the low hazard from acute inhalation of the biocidal product this precautionary statement is not required.

[^E0001]: Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.