Commission Implementing Regulation (EU) 2022/2127 of 4 November 2022 granting a Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

Article 1

A Union authorisation with authorisation number EU-0028430-0000 is granted to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘Ecolab UA BPF 1-Propanol’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 27 November 2022 to 31 October 2032.

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 family

Ecolab UA BPF 1-Propanol

Product type(s)

PT01: Human hygiene

Authorisation number EU-0028430-0000

R4BP asset number EU-0028430-0000

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 product

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)

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

4.1.   Use description

Table 1.

Hand disinfection

4.1.1.   Use-specific instructions for use

Refer to general measures (5.1)

4.1.2.   Use-specific risk mitigation measures

Refer to general measures (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

Refer to general measures (5.3)

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

Refer to general measures (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

Refer to general measures (5.5)

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

Use 1 – Hand disinfection

Hand Disinfection for food processing areas:

Apply 3 ml product on clean and dry hands for:

• — 30 seconds bacteria/yeast/ tuberculosis bacilli / enveloped viruses

• — 60 seconds viruses (limited spectrum virucidal activity)

Keep hands wet during whole contact time

5.2.   Risk mitigation measures

Avoid contact with eyes.

If refilling is needed, gloves and eye protection should be used.

In case of skin dryness, use appropriate skin care lotion.

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

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF SWALLOWED: Rinse mouth.

If symptoms: Call 112/ambulance for medical assistance.

If no symptoms: Call a POISON CENTRE or a doctor.

Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.

IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

Environmental precautions: do not allow contact with soil, surface or ground water.

5.4.   Instructions for safe disposal of the product and its packaging

Product and product residues: Do not allow the product to enter drains, water courses or the soil. Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of the product in compliance with local regulations. Dispose of wastes in an approved waste disposal facility

Packaging: Bring empty containers to an approved waste handling site for recycling or disposal. Dispose of packaging only if completely empty and closed. Do not re-use empty containers. Dispose of in accordance with local, regional, national regulations.

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

Keep away from heat and sources of ignition. Keep in a cool, well-ventilated place. Keep away from oxidizing agents. Keep out of reach of children. Keep container tightly closed. Store in suitable labelled containers. Store between 0 °C to 25 °C.

Shelf life: 4 years

6. OTHER INFORMATION

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