ANNEX

Summary of product characteristics for a biocidal product

Chemisept IPA-N

Product type 1 – Human hygiene (Disinfectants)

Authorisation number: EU-0027678-0000

R4BP asset number: EU-0027678-0000

1.   ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product

Trade name(s)

Chemisept IPA-N

1.2.   Authorisation holder

Name and address of the authorisation holder	Name	Chemi-Pharm AS
	Address	Tänassilma tee 11, 76406 Tänassilma küla, Saku vald Estonia
Authorisation number	EU-0027678-0000
R4BP asset number	EU-0027678-0000
Date of the authorisation	2.7.2023
Expiry date of the authorisation	31.7.2032

1.3.   Manufacturer(s) of the product

Name of manufacturer	AS Chemi-Pharm
Address of manufacturer	Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia
Location of manufacturing sites	AS Chemi-Pharm, Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia

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

Active substance	Propan-1-ol
Name of manufacturer	OQ Chemicals GmbH (formerly Oxea GmbH)
Address of manufacturer	Rheinpromenade 4a, 40789 Monheim am Rhein Germany
Location of manufacturing sites	OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States

Active substance	Propan-1-ol
Name of manufacturer	BASF SE
Address of manufacturer	Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany
Location of manufacturing sites	BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany

Active substance	Propan-1-ol
Name of manufacturer	SASOL Chemie GmbH & Co. KG
Address of manufacturer	Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa
Location of manufacturing sites	Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa

Active substance	Propan-2-ol
Name of manufacturer	INEOS Solvent Germany GmbH
Address of manufacturer	Römerstrasse 733, 47443 Moers Germany
Location of manufacturing sites	INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany

2.   PRODUCT COMPOSITION AND FORMULATION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-1-ol		Active Substance	71-23-8	200-746-9	30,0
Propan-2-ol		Active Substance	67-63-0	200-661-7	45,0

2.2.   Type of formulation

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS

Hazard statements

Flammable liquid and vapour. Causes serious eye damage. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. Avoid breathing vapours. Use only outdoors or in a well-ventilated area. 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. Immediately call a POISON CENTER/doctor. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of container to an authorised waste collection point.

4.   AUTHORISED USE(S)

4.1.   Use description

Table 1

Use # 1 – hygienic handrub, liquid

Product type	PT01 – Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	Not relevant
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Mycobacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Enveloped viruses Development stage: no data
Field(s) of use	Indoor — hospitals and other health care institutions, ambulances, surgeries, nursing homes (including home-care of patients) — hospital canteens, large kitchens, pharmaceutical industries, production sites, laboratories: hygienic handrub onto visibly clean and dry hands — for professional use only
Application method(s)	Method: Manual application Detailed description: Rubbing
Application rate(s) and frequency	Application Rate: Dosage: At least 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml) Contact time: 30 s Dilution (%): Ready-to-use product Number and timing of application: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required.
Category(ies) of users	Industrial Professional
Pack sizes and packaging material	100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap.

4.1.1.   Use-specific instructions for use

The products can be applied directly or the products can be used in a dispenser or with a pump.

For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.

Do not refill.

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.

4.2.   Use description

Table 2

Use # 2 – surgical handrub, liquid

Product type	PT01 – Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised use	Not relevant
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Mycobacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: enveloped viruses Development stage: no data
Field(s) of use	Indoor Hospitals and other health care institutions: surgical handrub onto visibly clean and dry hands and forearms. For professional use only.
Application method(s)	Method: Manual application Detailed description: Rubbing
Application rate(s) and frequency	Application Rate: Dosage: Rub sufficient amount in portions of 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Contact time: 90 s Dilution (%): Ready-to-use product Number and timing of application: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required.
Category(ies) of users	Professional
Pack sizes and packaging material	100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap.

4.2.1.   Use-specific instructions for use

The products can be applied directly or the products can be used in a dispenser or with a pump.

For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.

Do not refill.

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

4.2.3.   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.

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

See general directions for use.

4.2.5.   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)

5.1.   Instructions for use

For professional use only.

5.2.   Risk mitigation measures

Avoid contact with eyes.

Keep out of reach of children.

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

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.

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

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

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.

Information to Healthcare personnel/doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Accidental release measures:

Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.

Prevent entry to sewers and public waters.

Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.

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

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.

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

Shelf-life: 24 months

Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.

Recommended storage temperature: 0– 30 °C

Do not store at temperatures below 0 °C

Do not store near food, drink and animal feedingstuff. Keep away from combustible material.

6.   OTHER INFORMATION

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(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.