COMMISSION IMPLEMENTING REGULATION (EU) 2023/2087

of 28 September 2023

granting a Union authorisation for the biocidal product family ‘Lysoform IPA Surface’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(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 Article 44(5), first subparagraph, thereof,

Whereas:

(1) On 25 November 2022, Lysoform Dr Hans Rosemann GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of a same biocidal product family, as referred to in Article 1 of that Regulation, named ‘Lysoform IPA Surface’, for product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-DP082158-26 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Lyso IPA Surface Disinfection’, recorded in the Register under case number BC-GX025200-35.

(2) The same biocidal product family ‘Lysoform IPA Surface’ contains propan-2-ol as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.

(3) On 31 March 2023, the Agency submitted to the Commission its opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Lysoform IPA Surface’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

(4) The opinion concludes that the proposed differences between the same biocidal product family and the related reference biocidal product family are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Lyso IPA Surface Disinfection’ and subject to compliance with the draft SPC, the same biocidal product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.

(5) On 31 March 2023, 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 the same biocidal product family ‘Lysoform IPA Surface’.

(7) The expiry date of this authorisation is aligned to the expiry date of the reference biocidal product family ‘Lyso IPA Surface Disinfection’.

(8) 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-0030790-0000 is hereby granted to Lysoform Dr Hans Rosemann GmbH for the making available on the market and use of the same biocidal product family ‘Lysoform IPA Surface’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 19 October 2023 until 30 November 2030.

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, 28 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

(1)  

OJ L 167, 27.6.2012, p. 1

.

(2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (

OJ L 125, 7.5.2013, p. 4

).

(3)  ECHA opinion for ‘Lysoform IPA Surface’, 31 March 2023, https://echa.europa.eu/opinions-on-union-authorisation.

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (

OJ L 109, 19.4.2013, p. 4

).

ANNEX

Summary of product characteristics for a biocidal product family

Lysoform IPA Surface

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-0030790-0000

R4BP asset number: EU-0030790-0000

PART I

FIRST INFORMATION LEVEL

1.   

ADMINISTRATIVE INFORMATION

1.1.   

Family name

1.2.   

Product type(s)

1.3.   

Authorisation holder

1.4.   

Manufacturer(s) of the biocidal products

1.5.   

Manufacturer(s) of the active substance(s)

2.   

PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   

Qualitative and quantitative information on the composition of the family

2.2.   

Type(s) of formulation

PART II

SECOND INFORMATION LEVEL – META SPC(S)

META SPC 1

1.   

META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 1 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 1 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 1

2.2.   

Type(s) of formulation of the meta SPC 1

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

4.   

AUTHORISED USE(S) OF THE META SPC 1

4.1.   

Use description

Table 1

Use # 1 disinfection of surfaces – spraying

4.1.1.   

Use-specific instructions for use

Spray ready-to-use product onto the surfaces and allow to take effect for at least 1 minute at room temperature (20 ± 2 °C).

4.1.2.   

Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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 general directions for use.

4.1.4.   

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

4.1.5.   

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

See general directions for use.

4.2.   

Use description

Table 2

Use # 2 – disinfection of surfaces – wiping

4.2.1.   

Use-specific instructions for use

Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).

4.2.2.   

Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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 general directions for use.

4.2.4.   

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

4.2.5.   

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

See general directions for use.

4.3.   

Use description

Table 3

Use # 3 – disinfection of surfaces with food and feed contact – spraying

4.3.1.   

Use-specific instructions for use

Spray ready-to-use product onto the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).

4.3.2.   

Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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 general directions for use.

4.3.4.   

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

4.3.5.   

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

See general directions for use.

4.4.   

Use description

Table 4

Use # 4 – disinfection of surfaces with food and feed contact – wiping

4.4.1.   Use-specific instructions for use

Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).

4.4.2.   

Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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 general directions for use.

4.4.4.   

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

4.4.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (1)

OF THE META SPC 1

5.1.   

Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Do not apply more than 25 ml/m

2

.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   

Risk mitigation measures

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

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Apply a funnel for refilling.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   

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

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

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

5.4.   

Instructions for safe disposal of the product and its packaging

- 5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   

OTHER INFORMATION

The product contains propan-2-ol (CAS No: 67-63-0), for which a European reference value of 129,28 mg/m

3

for the professional user was agreed and used for the risk assessment of the product.

7.   

THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   

Trade name(s), authorisation number and specific composition of each individual product

7.2.   

Trade name(s), authorisation number and specific composition of each individual product

META SPC 2

1.   

META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 2 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 2 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 2

2.2.   

Type(s) of formulation of the meta SPC 2

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

4.   

AUTHORISED USE(S) OF THE META SPC 2

4.1.   

Use description

Table 5

Use # 1 – disinfection of surfaces – wiping

4.1.1.   

Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).

4.1.2.   

Use-specific risk mitigation measures

See general directions for use.

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 general directions for use.

4.1.4.   

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

4.1.5.   

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

See general directions for use.

4.2.   

Use description

Table 6

Use # 2 – disinfection of surfaces with food and feed contact – wiping

4.2.1.   

Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).

4.2.2.   

Use-specific risk mitigation measures

See general directions for use.

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 general directions for use.

4.2.4.   

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

4.2.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (2)

OF THE META SPC 2

5.1.   

Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   

Risk mitigation measures

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

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   

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

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

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

5.4.   

Instructions for safe disposal of the product and its packaging

- 5.5.   

Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   

OTHER INFORMATION

The product contains propan-2-ol (CAS No: 67-63-0), for which a European reference value of 129,28 mg/m

3

for the professional user was agreed and used for the risk assessment of the product.

7.   

THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   

Trade name(s), authorisation number and specific composition of each individual product

7.2.   

Trade name(s), authorisation number and specific composition of each individual product

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.