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

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(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

Name	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
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Name and address of the authorisation holder	Name
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Address	Unit 5B & Unit 5H Fingal Bay Business Park K32 NY57 Balbriggan IE
Authorisation number
R4BP asset number
Date of the authorisation
Expiry date of the authorisation
Name of manufacturer	Pal International Limited
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Address of manufacturer	Unit 3 Mountpark, Victoria Road, Ellistown LE67 1FA Coalville, Leicestershire United Kingdom of Great Britain and Northern Ireland (the)
Location of manufacturing sites	Pal International Limited site 1 Unit 3 Mountpark, Victoria Road, Ellistown LE67 1FA Coalville, Leicestershire United Kingdom of Great Britain and Northern Ireland (the)
Active substance	Propan-2-ol
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Name of manufacturer	Brenntag GmbH
Address of manufacturer	Messeallee 11 45131 Essen Germany
Location of manufacturing sites	Brenntag GmbH site 1 Baton Rouge Chemical Plant (BRCP), Exxon Mobil Chemical Plant, 4999 Scenic Highway 70897 Baton Rouge, Louisiana United States (the)
Active substance	Propan-2-ol
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Name of manufacturer	Brenntag GmbH
Address of manufacturer	Messeallee 11 45131 Essen Germany
Location of manufacturing sites	Brenntag GmbH site 1 Haven 3222, Vondelingenweg 601 3196 KK Vondelingenplaat Netherlands (the)

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-2-ol		Active substance	67-63-0	200-661-7	62,9 - 62,9 % (w/w)
Formulation type(s)	AL (any other liquid) - RTU wipe
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PART II

SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

Identifier	Meta SPC: Meta SPC 1 - Pal IPA Product Family Wipes
Number	1-1
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Product type(s)	PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area
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2. META SPC 1 COMPOSITION

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-2-ol		Active substance	67-63-0	200-661-7	62,9 - 62,9 % (w/w)
Formulation type(s)	AL (any other liquid) - RTU wipe
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3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements

P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P370+P378: In case of fire: Use alcohol-resistant foam to extinguish. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents /container in accordance with local regulations.

4. AUTHORISED USE(S) OF THE META SPC

Product type	PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria Common name: Bacteria Development stage: - Scientific name: Yeast Common name: Yeast Development stage: - Scientific name: Mycobacteriaceae Common name: Mycobacteria Development stage: -
Field(s) of use	indoor use 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)	Method: Wiping Detailed description: -
Application rate(s) and frequency	Application Rate: - Number and timing of application: 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

See section 5.1

See section 5.2

See section 5.3

See section 5.4

See section 5.5

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

Do not use on surfaces sensitive to alcohol.

Acceptable use temperature (10-20°C)

For soiled surfaces, clean the surface carefully before application

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.

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

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.

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

Trade name(s)	Sirafan Alco Wipes	Market area: EU
Alcodes GF maxi wipes	Market area: EU
Medipal Alcohol Disinfectant Wipes	Market area: EU
Pal Tech Precision 70% IPA Wipes	Market area: EU
Pal TX IPA Surface Disinfectant Wipes	Market area: EU
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 % (w/w)