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)

• CELEX: Implementing Regulation (EU) 2019/2030
• Articles: 4

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 .

Schedules & Appendices

ANNEX I TERMS AND CONDITIONS

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

ANNEX II

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

Pal IPA Product Family

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-0020463-0000

R4BP asset number: EU-0020463-0000

PART I

FIRST INFORMATION LEVEL

1.    Administrative information

1.1.    Family name

Name

Pal IPA Product Family

1.2.    Product type(s)

Product type(s)

PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 — Food and feed area (Disinfectants)

1.3.    Authorisation holder

Name and address of the authorisation holder

Name

Pal Hygiene Products Limited

Address

Unit 5B & Unit 5H Fingal Bay Business Park, K32 NY57, Balbriggan, Co. Dublin, Ireland

Authorisation number

EU-0020463-0000

R4BP asset number

EU-0020463-0000

Date of the authorisation

24 December 2019

Expiry date of the authorisation

30 November 2029

1.4.    Manufacturer(s) of the biocidal products

Name of manufacturer

Pal International Limited

Address of manufacturer

Bilton Way, LE17 4JA Lutterworth, Leicestershire, United Kingdom

Location of manufacturing sites

Bilton Way, LE17 4JA Lutterworth, Leicestershire, United Kingdom

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

Active substance

Propan-2-ol

Name of manufacturer

Brenntag GmbH

Address of manufacturer

Messeallee 11, 45131 Essen, Germany

Location of manufacturing sites

Baton Rouge Chemical Plant (BRCP), Exxon Mobil Chemical Plant, 4999 Scenic Highway, 70897 Baton Rouge, Louisiana, United States

Active substance

Propan-2-ol

Name of manufacturer

Brenntag GmbH

Address of manufacturer

Messeallee 11, 45131 Essen, Germany

Location of manufacturing sites

Haven 3222, Vondelingenweg 601, 3196 KK Vondelingenplaat, Netherlands

2.    Product family composition and formulation

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,9

62,9

2.2.    Type(s) of formulation

Formulation(s)

AL (any other liquid) - RTU wipe

PART II

SECOND INFORMATION LEVEL — META SPC(S)

Meta SPC 1

1.    Meta SPC 1 administrative information

1.1.    Meta SPC 1 identifier

Identifier

Meta SPC 1 — Pal IPA Product Family Wipes

1.2.    Suffix to the authorisation number

Number

1-1

1.3.    Product type(s)

Product type(s)

PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 — Food and feed area (Disinfectants)

2.    Meta SPC 1 Composition

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,9

62,9

2.2.    Type(s) of formulation of the meta SPC 1

Formulation(s)

AL (any other liquid) - RTU wipe

3.    Hazard and precautionary statements of the meta SPC 1

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.

Wash hands thoroughly after handling.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

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.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTRE if you feel unwell.

If eye irritation persists: Get medical advice.

In case of fire: Use alcohol-resistant foam to extinguish.

Store in a well-ventilated place. Keep cool.

Store locked up.

Dispose of contents to/container in accordance with local regulations.

4.    Authorised use(s) of the meta SPC 1

4.1.    Use description

Table 1. Use # 1 — Professional use

Product type

PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 — Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Bacteria

Yeast

Mycobacteria

Field(s) of use

Indoor

Disinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of non-invasive medical devices, healthcare industries and other critical life science applications, and in industrial food and feed preparation areas

Application method(s)

Wiping

Application rate(s) and frequency

1 minute contact time for bacteria

1 minute contact time for mycobacteria

3 minute contact time for yeast

Category(ies) of users

Professional

Pack sizes and packaging material

Impregnated 100 % polypropylene wipes in:

—

High-density polyethylene (HDPE) canister with Polypropylene (PP) lid – 150 wipes (0,5 L), 200 wipes (2 L), 240 wipes (2 L)

—

PP bucket with PP lid – 500 wipes (8 L), 1 000 wipes (8 L), 1 500 wipes (8 L)

Impregnated 100 % polyester wipes in:

—

laminate film flow wrap packet sealed with PET/PE – 25, 50 or 100 wipes

—

Aluminium foil – 1 wipe

4.1.1.    Use-specific instructions for use

See general directions for use

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

See general directions for use

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

5.    General directions for use   ( 1 )

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.

2.

Choose the dispenser type and dispense the wipe.

3.

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.

4.

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

5.

Make sure to wet surfaces completely

6.

Used wipes must be disposed in a closed container

7.

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/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

Trade name(s)

Medipal Alcohol Disinfectant Wipes

Pal Tech Precision 70 % IPA Wipes

Pal TX IPA Surface Disinfectant Wipes

Authorisation number

EU-0020463-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,9

( 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.