Commission Implementing Regulation (EU) 2023/1091 of 5 June 2023 granting a Union authorisation for the single biocidal product ‘APESIN alcogel’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Commission Implementing Regulation (EU) 2023/1091of 5 June 2023granting a Union authorisation for the single biocidal product APESIN alcogel in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council(Text with EEA relevance) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal productsOJ L 167, 27.6.2012, p. 1., and in particular Article 44(5), first subparagraph, thereof,Whereas:(1)On 23 April 2019, Tana-Chemie GmbH submitted to the European Chemicals Agency ("the Agency") an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4). for Union authorisation of the same single biocidal product, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named "APESIN alcogel", of product-type 1, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-TV051115-15 in the Register for Biocidal Products ("the Register"). The application also indicated the application number of the related reference biocidal product family "Knieler & Team Propanol Family", recorded in the Register under case number BC-AQ050985-22.(2)The same single biocidal product "APESIN alcogel" contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1.(3)On 8 December 2021, the Agency submitted to the Commission an opinionECHA opinion on "APESIN alcogel" of 8 December 2021, https://echa.europa.eu/opinions-on-union-authorisation. and the draft summary of the biocidal product characteristics ("SPC") of "APESIN alcogel" in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.(4)The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4)., and that based on the assessment of the related reference biocidal product family "Knieler & Team Propanol Family" and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.(5)On 20 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.(6)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product "APESIN alcogel".(7)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,HAS ADOPTED THIS REGULATION:
Article 1A Union authorisation with authorisation number EU-0027672-0000 is granted to Tana-Chemie GmbH for the making available on the market and use of the same single biocidal product "APESIN alcogel" in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 26 June 2023 until 31 July 2032.
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.Done at Brussels, 5 June 2023.For the CommissionThe PresidentUrsula von der LeyenANNEXSummary of product characteristics for a biocidal productAPESIN alcogelProduct type 1 - Human hygiene (Disinfectants)Authorisation number: EU-0027672-0000R4BP asset number: EU-0027672-00001.ADMINISTRATIVE INFORMATION1.1.Trade name(s) of the product
Trade name(s)E-HDG
1.2.Authorisation holder
Name and address of the authorisation holderNametana-Chemie GmbH
AddressRheinallee 96, 55120 Mainz Germany
Authorisation numberEU-0027672-0000
R4BP asset numberEU-0027672-0000
Date of the authorisation26 June 2023
Expiry date of the authorisation31 July 2032
1.3.Manufacturer(s) of the product
Name of manufacturertana-Chemie GmbH
Address of manufacturerRheinallee 96, 55120 Mainz Germany
Location of manufacturing sitesWerner & Mertz GmbH & Co KG, Neualmerstr. 13, 5400 Hallein AustriaWerner & Mertz GmbH, Rheinallee 96, 55120 Mainz Germany
1.4.Manufacturer(s) of the active substance(s)
Active substancePropan-1-ol
Name of manufacturerOQ Chemicals GmbH (formerly Oxea GmbH)
Address of manufacturerRheinpromenade 4a, 40789 Monheim am Rhein Germany
Location of manufacturing sitesOQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States
Active substancePropan-1-ol
Name of manufacturerBASF SE
Address of manufacturerCarl-Bosch-Str. 38, 67056 Ludwigshafen Germany
Location of manufacturing sitesBASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany
Active substancePropan-1-ol
Name of manufacturerSASOL Chemie GmbH & Co. KG
Address of manufacturerSecunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa
Location of manufacturing sitesSecunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa
Active substancePropan-2-ol
Name of manufacturerINEOS Solvent Germany GmbH
Address of manufacturerRömerstrasse 733, 47443 Moers Germany
Location of manufacturing sitesINEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers GermanyINEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany
2.PRODUCT COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the product
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-1-olActive Substance71-23-8200-746-930,0
Propan-2-olActive Substance67-63-0200-661-745,0
2.2.Type of formulationAL - Any other liquid3.HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statementsHighly flammable liquid and vapour.Causes serious eye damage.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsKeep 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, gel
Product typePT01 - Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised useNot relevant
Target organism(s) (including development stage)Scientific name: no dataCommon name: BacteriaDevelopment stage: no dataScientific name: no dataCommon name: MycobacteriaDevelopment stage: no dataScientific name: no dataCommon name: YeastsDevelopment stage: no dataScientific name: no dataCommon name: Enveloped virusesDevelopment stage: no data
Field(s) of useIndoorhospitals 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 applicationDetailed description:Rubbing
Application rate(s) and frequencyApplication 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 sDilution (%): Ready-to-use productNumber 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 usersIndustrialProfessional
Pack sizes and packaging material100, 125, 500, 1000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps;5000 ml transparent/white HDPE canister with HDPE screwed cap.500 and 1000 ml in transparent HDPE lightweight bottle with integrated PP pump.
4.1.1.Use-specific instructions for useThe 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 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 use4.2.Use descriptionTable 2. Use # 2 – surgical handrub, gel
Product typePT01 - Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised useNot relevant
Target organism(s) (including development stage)Scientific name: no dataCommon name: BacteriaDevelopment stage: no dataScientific name: no dataCommon name: MycobacteriaDevelopment stage: no dataScientific name: no dataCommon name: YeastsDevelopment stage: no dataScientific name: no dataCommon name: enveloped virusesDevelopment stage: no data
Field(s) of useIndoorHospitals and other health care institutions: surgical handrub onto visibly clean and dry hands and forearms.For professional use only.
Application method(s)Method: Manual applicationDetailed description:Rubbing
Application rate(s) and frequencyApplication 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 sDilution (%): Ready-to-use productNumber 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 usersProfessional
Pack sizes and packaging material100, 125, 500, 1000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps;5000 ml transparent/white HDPE canister with HDPE screwed cap.500 and 1000 ml in transparent HDPE lightweight bottle with integrated PP pump.
4.2.1.Use-specific instructions for useThe 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 measuresSee general directions for use4.2.3.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 use4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use4.2.5.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.5.1.Instructions for useFor professional use only.5.2.Risk mitigation measuresAvoid 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 environmentFirst-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 packagingDisposal 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 storageShelf-life: 24 monthsStore in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.Recommended storage temperature: 0-30°CDo not store at temperatures below 0°CDo not store near food, drink and animal feedingstuff. Keep away from combustible material.6.OTHER INFORMATION