Commission Implementing Regulation (EU) 2019/2030 of 29 November 2019 granting a Union authorisation for the biocidal product family Pal IPA Product Family (Text with EEA relevance)

Article 1

A Union authorisation with authorisation number EU-0020463-0000 is granted to Pal Hygiene Products Limited for the making available on the market and use of the biocidal product family ‘Pal IPA Product Family’, subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in the Annex II.

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 I

TERMS AND CONDITIONS

(EU-0020463-0000)

The authorisation holder shall conduct a long-term storage test at ambient temperature for wipes in their commercial packaging.

By 31 July 2021 the authorisation holder shall submit the results of the test to the Agency.

ANNEX II

Summary of product characteristics for a biocidal product family

Pal IPA Product Family

Product type(s)

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

PT04: Food and feed area

Authorisation number: EU-0020463-0000

R4BP asset number: EU-0020463-0000

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

Professional use

4.1.1.   Use-specific instructions for use

See section 5.1

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

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

Do not use on surfaces sensitive to alcohol.

Acceptable use temperature (10-20°C)

For soiled surfaces, clean the surface carefully before application

• 1. Follow agreed risk assessment policy guidelines regarding the use of Personal Protective Equipment (PPE).

• 1. Choose the dispenser type and dispense the wipe.

• 1. Wipe the surface in an S Shape moving from clean to dirty. Use the wipe flat not scrunched. Do not go over the same area twice with the same wipe.

• 1. Use a fresh wipe if your wipe becomes soiled or dry.

• 1. Make sure to wet surfaces completely

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

• 1. Allow the surface to dry before use.

5.2.   Risk mitigation measures

Wash hands and exposed skin before meals and after use.

Avoid contact with eyes.

When performing disinfection in areas where members of the public may be present, persons should be prevented from entering the room until the room has been well ventilated.

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

Eye contact: 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

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

Dispose of contents/container in accordance with local regulations.

Do not flush wipes down the toilet. Do not macerate.

Residual alcohol should be emptied prior to disposal of container.

Discard used wipes in the appropriate waste bin following local agreed guidelines.

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

Store in a cool, dry, well-ventilated place in original container.

Keep container tightly closed.

Shelf-life: 2 years

6. OTHER INFORMATION

Polypropylene or polyester wipes, 20-45 gsm, containing 1.7 – 7.5 ml product (0.93 – 4.12 g propan-2-ol)

The product contains propan-2-ol (CAS No: 67-63-0), for which an European reference value of 129.28 mg/m3 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