Commission Implementing Regulation (EU) 2021/1322 of 3 August 2021 amending Implementing Regulation (EU) 2019/2076 to make administrative changes to the Union authorisation of the biocidal product family ‘Contec IPA Product Family’ (Text with EEA relevance)

ANNEX
ANNEX
‘ANNEX II
Summary of product characteristics for a biocidal product family
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
FIRST INFORMATION LEVEL
1.   ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
Contec 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
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.    Manufacturer(s) of the biocidal products
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.    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
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 solution/trigger spray
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
Contec IPA Liquid Products
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 solution/trigger spray
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/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
Mycobacteria
Yeasts
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 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 m 2 of surface.
Wiping: 1 minute contact time for bacteria and myobacteria
3 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 L
HDPE capped refill bottle – 5 L
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
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.    Risk mitigation measures
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.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
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 hypoglycaemia.
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.    Instructions for safe disposal of the product and its packaging
Dispose of contents/container in accordance with local regulations.
Do not re-use empty container for any other purpose.
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 away from sources of ignition.
Keep away from direct sunlight.
Keep container tightly closed.
Shelf-life: 2 years
6.   OTHER INFORMATION
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)
Contec IPA
Contec Sterile IPA
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
META SPC 2
1.   META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
Contec IPA Wipes
1.2.    Suffix to the authorisation number
Number
1-2
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 2 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 2
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 2
Formulation(s)
AL (any other liquid) – RTU wipe
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
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.   AUTHORISED USE(S) OF THE META SPC 2
4.1.    Use description
Table 2
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
Mycobacteria
Yeasts
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 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 mycobacteria
3 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 wipes
Impregnated 100 % polyester wipes in:
—
HDPE canister with HDPE cap – 100 wipes (2,25 L)
—
PET/PE packet sealed with PET/PE flow wrap – 20 wipes
Impregnated 100 % knitted polyester wipes in:
—
PET/PE packet sealed with PET/PE flow wrap – 8, 10, 20, 30 or 50 wipes
Impregnated 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 wipes
Impregnated 50 % rayon/50 % polyester wipes in:
—
HDPE canister with HDPE cap – 700 wipes (11,4 L)
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  ( 2 ) OF THE META SPC 2
5.1.    Instructions for use
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.    Risk mitigation measures
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.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
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 hypoglycaemia.
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.    Instructions for safe disposal of the product and its packaging
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.    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 away from sources of ignition.
Keep away from direct sunlight.
Keep container tightly closed.
Shelf-life: 2 years
6.   OTHER INFORMATION
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/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 2
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
PROSAT EasyReach
PROSAT Sterile EasyReach
PROSAT Wipes
PROSAT Sterile Wipes
SATWipes Wipes
SATWipes Sterile Wipes
Cleanroom wipes, presaturated Spec-Wipe
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
’
( 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.
( 2 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.
Commission Implementing Regulation (EU) 2021/1322 of 3 August 2021 amending Implementing Regulation (EU) 2019/2076 to make administrative changes to the Union authorisation of the biocidal product family ‘Contec IPA Product Family’ (Text with EEA relevance)

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