
Article 1 
A Union authorisation with authorisation number EU-0020460-0000 is granted to Contec Europe for the making available on the market and use of the biocidal product family ‘Contec 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 Annex II.
The Union authorisation is valid from 26 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
Contec 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-0020460-0000
R4BP asset number: EU-0020460-0000

PART I
1.  1.1. 

Name Contec 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 Contec Europe
Address Zl Du Prat, Avenue Paul Duplaix, 56000, Vannes, France
Authorisation number EU-0020460-0000
R4BP asset number EU-0020460-0000
Date of the authorisation 26 December 2019
Expiry date of the authorisation 30 November 2029
 1.4. 

Name of manufacturer Contec Inc.
Address of manufacturer 525 Locust Grove, SC 29303 Spartanburg United States
Location of manufacturing sites 525 Locust Grove, SC 29303 Spartanburg United States


Name of manufacturer Contec Cleanroom Technology (Suzhou) Co., Ltd. China
Address of manufacturer 17 Longyun Road, Suzhou Industrial Park, 215024 Suzhou China
Location of manufacturing sites 17 Longyun Road, Suzhou Industrial Park, 215024 Suzhou China


Name of manufacturer Contec Cleanroom (UK) Ltd
Address of manufacturer Unit 6A, Wansbeck Business Park, Rotary Parkway, NE63 8QW Ashington, Northumberland United Kingdom
Location of manufacturing sites Unit 6A, Wansbeck Business Park, Rotary Parkway, NE63 8QW Ashington, Northumberland United Kingdom


Name of manufacturer Flexible Medical Packaging
Address of manufacturer Unit 8 Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom
Location of manufacturing sites Unit 8 Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire 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 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 solution/trigger sprayAL (any other liquid) – RTU wipe

PART II 1.  1.1. 

Identifier Contec IPA Liquid Products
 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 solution/trigger spray
 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/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) BacteriaMycobacteriaYeasts
Field(s) of use IndoorDisinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of medical devices, healthcare industries and other critical life science applications, and in industrial food and feed preparation areas.Acceptable use temperature: room temperature (20±2 °C)
Application method(s) Spraying and wiping
Application rate(s) and frequency 50 ml product per m2 of surface.Wiping: 1 minute contact time for bacteria and myobacteria3 minutes contact time for yeast
Category(ies) of users Professional
Pack sizes and packaging material High-density polyethylene (HDPE) trigger spray bottle -0,5 L – 1 LHDPE capped refill bottle – 5 L
 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. 
Use at room temperature. For visibly soiled surfaces, cleaning prior to disinfection is required.

Wiping: Apply/Spray product to a suitable quality cleanroom wipe. Ensure the wipe is sufficiently and uniformly saturated before wiping the surface to be disinfected.

Ensure the surface is uniformly covered with the product then wipe to dry with a sterile cleanroom wipe.

Contact times: Wiping 1 minute for bacteria and mycobacteria 3 minutes for yeast.

Used wipes must be disposed of in a closed container.
 5.2. 
Wash hands and exposed skin before meals and after use.

Avoid contact with eyes

‘For use in cleanrooms, adequate technical/engineering controls to remove airborne residues is mandatory e.g. room ventilation or LEV’
 5.3. 
Likely direct or indirect adverse effects:

Headache, vertigo, hallucinations, respiratory depression, CNS depression or coma.

Severe irritation of the eyes and or ocular damage.

Nausea, vomiting, diarrhoea and haemorrhagic gastritis.

Pulmonary aspiration hazard may induce pneumonitis, hypotension and hypoglycemia.

First aid measures:

Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

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

Skin contact; wash affected area with plenty of water and soap. No scrubbing.

In case of ingestion: Do NOT induce vomiting and never give anything by mouth to an impaired or unconscious individual; if the individual is unconscious place individual in left sideways (recovery) position with the head lowered and the knees bent.

Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

Take the individual to a healthcare centre and bring packaging or label whenever possible.

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

Advice for medical and healthcare personnel:

Monitor vital signs and provide symptomatic and supportive treatment.

Evaluate endoscopic procedure in case of ingestion.

Monitor glycaemia and ketones.

Ipecac use is contraindicated.

WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTRE [INSERT LOCAL NUMBER HERE].
 5.4. 
Dispose of contents/container in accordance with local regulations.

Do not re-use empty container for any other purpose.
 5.5. 
Store in a cool, dry, well-ventilated place in original container.

Keep away from sources of ignition.

Keep away from direct sunlight.

Keep container tightly closed.

Shelf-life: 2 years
 6. 
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) Contec 70 % IPA FBC570IContec Sterile 70 % IPA SBT170IWContec Sterile 70 % IPA SBT0570IWContec 70 % IPA FBT170I
Authorisation number EU-0020460-0001 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.  1.1. 

Identifier Contec IPA Wipes
 1.2. 

Number 1-2
 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/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) BacteriaMycobacteriaYeasts
Field(s) of use IndoorDisinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of medical devices, healthcare industries and other critical life science applications, and in industrial food and feed preparation areas.Acceptable use temperature: room temperature (20±2 °C)
Application method(s) Wiping
Application rate(s) and frequency 1 minute contact time for bacteria and mycobacteria3 minutes contact time for yeast
Category(ies) of users Professional
Pack sizes and packaging material Impregnated 100 % polypropylene wipes in:
— HDPE canister with HDPE cap – 150 wipes (1,7 L or 2,15 L)
— Polyethylene terephthalate (PET)/polyethylene (PE) packet sealed with PET/PE flow wrap – 30, 40 or 50 wipesImpregnated 100 % polyester wipes in:
— HDPE canister with HDPE cap – 100 wipes (2,25 L)
— PET/PE packet sealed with PET/PE flow wrap – 20 wipesImpregnated 100 % knitted polyester wipes in:
— PET/PE packet sealed with PET/PE flow wrap – 8, 10, 20, 30 or 50 wipesImpregnated 55 % cellulose/45 % polyester wipes in:
— HDPE canister with HDPE cap – 100 wipes (2,25 L)
— PET/PE packet sealed with PET/PE flow wrap – 24, 30, 50 or 75 wipesImpregnated 50 % rayon/50 % polyester wipes in:
— HDPE canister with HDPE cap - 700 wipes (11,4 L)
 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. 
For soiled surfaces, cleaning prior to disinfection is required.

Ensure the surface is uniformly covered with the product, allow to act for a contact time of 1 minute for bactericidal and mycobactericidal action and 3 minutes for yeasticidal action
 5.2. 
Wash hands and exposed skin before meals and after use.

Avoid contact with eyes

‘For use in cleanrooms, adequate technical/engineering controls to remove airborne residues is mandatory e.g. room ventilation or LEV’
 5.3. 
Likely direct or indirect adverse effects:

Headache, vertigo, hallucinations, respiratory depression, CNS depression or coma.

Severe irritation of the eyes and or ocular damage.

Nausea, vomiting, diarrhoea and haemorrhagic gastritis.

Pulmonary aspiration hazard may induce pneumonitis, hypotension and hypoglycemia.

First aid measures:

Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

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

Skin contact; wash affected area with plenty of water and soap, No scrubbing.

In case of ingestion; Do NOT induce vomiting and never give anything by mouth to an impaired or unconscious individual; if the individual is unconscious place individual in left sideways (recovery) position with the head lowered and the knees bent.

Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

Take the individual to a healthcare centre and bring packaging or label whenever possible.

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

Advice for medical and healthcare personnel:

Monitor vital signs and provide symptomatic and supportive treatment.

Evaluate endoscopic procedure in case of ingestion.

Monitor glycaemia and ketones.

Ipecac use is contraindicated.

WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTRE [INSERT LOCAL NUMBER HERE].
 5.4. 
Dispose of contents/container in accordance with local regulations.

Do not re-use empty container for any other purpose.

Used wipes must be disposed in a closed container

Dispose of used wipes by dry waste to landfill
 5.5. 
Store in a cool, dry, well-ventilated place in original container.

Keep away from sources of ignition.

Keep away from direct sunlight.

Keep container tightly closed.

Shelf-life: 2 years
 6. 
Polypropylene, polyester, kitted polyester, 55 % cellulose/45 % polyester or 50 % rayon/50 % polyester wipes, 34-240 gsm, containing 5 - 38 ml product (2,75 – 20,9 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) PROSAT MBPP PS-840IRPROSAT MBPP PS-911PROSAT MBPP PS-911EBPROSAT MBPP PS-LPP-7030PROSAT MBPP PS-LPP-7030IRPROSAT MBPP PSPP0039PROSAT MBPP PSPP0043SATWipes MBPP SWPP0003PROSAT Delta PS-7030IRSATWipes nonwoven polyester SAT-C3-7030Spec-Wipe 4 115-0039PROSAT Polynit Heatseal PS-HS9-7030PROSAT EasyReach PSME0001PROSAT Polynit Heatseal PSPS0047PROSAT Polynit Heatseal PSPS0076PROSAT Polynit Heatseal PSPS0091PROSAT Polynit Heatseal PSWE0001PROSAT Polynit Heatseal PSWE0002PROSAT Polynit Heatseal PSWE0003Spec-Wipe 3 115-0034PROSAT Sigma PSC20001PROSAT Sigma PSC20002PROSAT Theta PSC20005PROSAT Theta PSC20006PROSAT Theta PSC20009PROSAT Theta PSC20010PROSAT Theta PSCP0001PROSAT Theta PSCS1010PROSAT Theta PSCS1010IRSATWipes polyester/cellulose SAT-C1-7030SATWipes presaturated wipes SWNW0013
Authorisation number EU-0020460-0002 1-2
Common name IUPAC name Function CAS number EC number Content (%)
Propan-2-ol  Active Substance 67-63-0 200-661-7 62,9
