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 m

•

Pump spray: Apply 3 jets per 100 cm

•

Bottle: Apply one measuring cup per m

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

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.

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

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

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 m

•

Pump spray: Apply 3 jets per 100 cm

•

Bottle: Apply one measuring cup per m

Disinfection of gardening equipment for human hygiene purpose only.

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

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

Disinfection of gardening equipment for human hygiene purpose only.

Disinfect gardening equipment only indoors.

4.4.2. Use-specific risk mitigation measures

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

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

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

Clean surfaces before use.

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

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.

Do not apply more than 50 mL/m

Used wipes must be disposed in a closed container.

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

5.2. Risk mitigation measures

Keep out of reach of children and pets.

Avoid contact with eyes.

Do not apply in the presence of small children.

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

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:

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

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 or doctor/physician if you feel unwell.

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/m

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.