
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.Done at Brussels, 29 November 2019.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

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
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
1.  1.1. 

Name Pal IPA Product Family
 1.2. 

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. 

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. 

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. 

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.  2.1. 

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. 

Formulation(s) AL (any other liquid) - RTU wipe

PART II
Meta SPC 1

1.  1.1. 

Identifier Meta SPC 1 — Pal IPA Product Family Wipes
 1.2. 

Number 1-1
 1.3. 

Product type(s) PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)PT04 — Food and feed area (Disinfectants)

2.  2.1. 

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. 

Formulation(s) AL (any other liquid) - RTU wipe

3. 

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.  4.1. 

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) BacteriaYeastMycobacteria
Field(s) of use IndoorDisinfectant 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 bacteria1 minute contact time for mycobacteria3 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. 
See general directions for use
 4.1.2. 
See general directions for use
 4.1.3. 
See general directions for use
 4.1.4. 
See general directions for use
 4.1.5. 
See general directions for use

5.  5.1. 
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. 
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. 
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. 
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. 
Store in a cool, dry, well-ventilated place in original container.

Keep container tightly closed.

Shelf-life: 2 years

6. 
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.  7.1. 

Trade name(s) Medipal Alcohol Disinfectant WipesPal Tech Precision 70 % IPA WipesPal 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
