COMMISSION IMPLEMENTING REGULATION (EU) 2019/2076
of 29 November 2019
granting a Union authorisation for the biocidal product family ‘Contec IPA Product Family’
(Text with EEA relevance)
Article 1
Article 2
ANNEX I
TERMS AND CONDITIONS (EU-0020460-0000)
ANNEX II
Summary of product characteristics for a biocidal product family
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
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 m2 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
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
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 70 % IPA FBC570I Contec Sterile 70 % IPA SBT170IW Contec Sterile 70 % IPA SBT0570IW Contec 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 |
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
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:
Impregnated 100 % polyester wipes in:
Impregnated 100 % knitted polyester wipes in:
Impregnated 55 % cellulose/45 % polyester wipes in:
Impregnated 50 % rayon/50 % polyester wipes in:
|
4.1.1.
Use-specific instructions for use
4.1.2.
Use-specific risk mitigation measures
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
4.1.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.1.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
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 MBPP PS-840IR PROSAT MBPP PS-911 PROSAT MBPP PS-911EB PROSAT MBPP PS-LPP-7030 PROSAT MBPP PS-LPP-7030IR PROSAT MBPP PSPP0039 PROSAT MBPP PSPP0043 SATWipes MBPP SWPP0003 PROSAT Delta PS-7030IR SATWipes nonwoven polyester SAT-C3-7030 Spec-Wipe 4 115-0039 PROSAT Polynit Heatseal PS-HS9-7030 PROSAT EasyReach PSME0001 PROSAT Polynit Heatseal PSPS0047 PROSAT Polynit Heatseal PSPS0076 PROSAT Polynit Heatseal PSPS0091 PROSAT Polynit Heatseal PSWE0001 PROSAT Polynit Heatseal PSWE0002 PROSAT Polynit Heatseal PSWE0003 Spec-Wipe 3 115-0034 PROSAT Sigma PSC20001 PROSAT Sigma PSC20002 PROSAT Theta PSC20005 PROSAT Theta PSC20006 PROSAT Theta PSC20009 PROSAT Theta PSC20010 PROSAT Theta PSCP0001 PROSAT Theta PSCS1010 PROSAT Theta PSCS1010IR SATWipes polyester/cellulose SAT-C1-7030 SATWipes 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 |