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)
Modified by
  • Commission Implementing Regulation (EU) 2021/1322of 3 August 2021amending 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), 32021R1322, August 11, 2021
Commission Implementing Regulation (EU) 2019/2076of 29 November 2019granting a Union authorisation for the biocidal product family Contec IPA Product Family(Text with EEA relevance)
Article 1A 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 2This 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 ITERMS AND CONDITIONS (EU-0020460-0000)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 IISummary of product characteristics for a biocidal product familyContec IPA Product FamilyProduct 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-0020460-0000R4BP asset number: EU-0020460-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name
NameContec 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 holderNameContec Europe
AddressZl Du Prat, Avenue Paul Duplaix, 56000, Vannes, France
Authorisation numberEU-0020460-0000
R4BP asset numberEU-0020460-0000
Date of the authorisation26 December 2019
Expiry date of the authorisation30 November 2029
1.4.Manufacturer(s) of the biocidal products
Name of manufacturerContec Inc.
Address of manufacturer525 Locust Grove, SC 29303 Spartanburg United States
Location of manufacturing sites525 Locust Grove, SC 29303 Spartanburg United States
Name of manufacturerContec Cleanroom Technology (Suzhou) Co., Ltd. China
Address of manufacturer17 Longyun Road, Suzhou Industrial Park, 215024 Suzhou China
Location of manufacturing sites17 Longyun Road, Suzhou Industrial Park, 215024 Suzhou China
Name of manufacturerContec Cleanroom (UK) Ltd
Address of manufacturerUnit 6A, Wansbeck Business Park, Rotary Parkway, NE63 8QW Ashington, Northumberland United Kingdom
Location of manufacturing sitesUnit 6A, Wansbeck Business Park, Rotary Parkway, NE63 8QW Ashington, Northumberland United Kingdom
Name of manufacturerFlexible Medical Packaging
Address of manufacturerUnit 8 Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom
Location of manufacturing sitesUnit 8 Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom
1.5.Manufacturer(s) of the active substance(s)
Active substancePropan-2-ol
Name of manufacturerBrenntag GmbH
Address of manufacturerMesseallee 11, 45131 Essen, Germany
Location of manufacturing sitesHaven 3222, Vondelingenweg 601, 3196 KK Vondelingenplaat Netherlands
2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the family
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-762,962,9
2.2.Type(s) of formulation
Formulation(s)AL (any other liquid) – RTU solution/trigger sprayAL (any other liquid) – RTU wipe
PART IISECOND INFORMATION LEVEL – META SPC(S)META SPC 11.META SPC 1 ADMINISTRATIVE INFORMATION1.1.Meta SPC 1 identifier
IdentifierContec IPA Liquid Products
1.2.Suffix to the authorisation number
Number1-1
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-762,962,9
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 statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsIf 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 14.1.Use description
Table 1Use # 1 – Professional use
Product typePT02 – 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 useIndoorDisinfectant 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 frequency50 ml product per m2 of surface.Wiping: 1 minute contact time for bacteria and myobacteria3 minutes contact time for yeast
Category(ies) of usersProfessional
Pack sizes and packaging materialHigh-density polyethylene (HDPE) trigger spray bottle – 0,5 L – 1 LHDPE capped refill bottle – 5 L
4.1.1.Use-specific instructions for useSee general directions for use4.1.2.Use-specific risk mitigation measuresSee general directions for use4.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. OF THE META SPC 15.1.Instructions for useUse 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 measuresWash 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 environmentLikely 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/attentionSkin 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 packagingDispose 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 storageStore 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 years6.OTHER INFORMATIONThe 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 17.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Contec IPAContec Sterile IPA
Authorisation numberEU-0020460-0001 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-762,9
META SPC 21.META SPC 2 ADMINISTRATIVE INFORMATION1.1.Meta SPC 2 identifier
IdentifierContec IPA Wipes
1.2.Suffix to the authorisation number
Number1-2
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-762,962,9
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 statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsIf 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 24.1.Use description
Table 2Use # 1 – Professional use
Product typePT02 – 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 useIndoorDisinfectant 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 frequency1 minute contact time for bacteria and mycobacteria3 minutes contact time for yeast
Category(ies) of usersProfessional
Pack sizes and packaging materialImpregnated 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.Use-specific instructions for useSee general directions for use4.1.2.Use-specific risk mitigation measuresSee general directions for use4.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. OF THE META SPC 25.1.Instructions for useFor 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 action5.2.Risk mitigation measuresWash 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 environmentLikely 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/attentionSkin 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 packagingDispose 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 containerDispose of used wipes by dry waste to landfill5.5.Conditions of storage and shelf-life of the product under normal conditions of storageStore 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 years6.OTHER INFORMATIONPolypropylene, 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.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 27.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)PROSAT EasyReachPROSAT Sterile EasyReachPROSAT WipesPROSAT Sterile WipesSATWipes WipesSATWipes Sterile WipesCleanroom wipes, presaturated Spec-Wipe
Authorisation numberEU-0020460-0002 1-2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-762,9
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