Date: 2025-10-10Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2025/2034 of 9 October 2025 amending Implementing Regulation (EU) 2024/2189 as regards administrative changes to the Union authorisation for the single biocidal product ClearKlens wipes based on IPA
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
This document is Commission Implementing Regulation (EU) 2025/2034 of 9 October 2025, amending Implementing Regulation (EU) 2024/2189. It addresses administrative changes to the Union authorisation for the single biocidal product ‘ClearKlens wipes based on IPA'. The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
**Key Points / Main Content**
* **Amendment:**
* The Annex to Implementing Regulation (EU) 2024/2189 is replaced entirely by the text set out in the Annex to this Regulation, including administrative changes requested by Diversey Europe Operations B.V., concerning changes to the address of the authorisation holder and a change to the address of one of the biocidal product manufacturers.
* Except for these address amendments, all other information in the summary of the biocidal product characteristics remains unchanged.
* The amendment incorporates minor editorial and layout changes.
* **Product Information:**
* The biocidal product is ClearKlens wipes based on IPA.
* The product type is PT02: Disinfectants and algaecides not intended for direct application to humans or animals.
* Authorisation Number: EU-0032009-0000
* R4BP Asset Number: EU-0032009-0000
* Active Substance: Propan-2-ol, at 63.1% (w/w) concentration.
* Formulation: Presaturated wipes.
* **Authorisation Holder:**
* Name: Diversey Europe Operations B.V.
* Address: De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL
* **Manufacturers:** Includes Diversey Europe Operations B.V. and other manufacturers like Flexible Medical Packaging Ltd, Ardepharm, and others.
* **Authorised Uses:**
* Use #1: Hard surface disinfectant - professionals - wiping
* Use #2: Hard surface disinfectant - professionals - mopping
* Use #3: Hard surface disinfectant - professionals – wiping (equipment and small surfaces)
* **General Directions for Use:**
* The product must be applied only in a sufficiently ventilated room. Minimum air change rates are specified.
* Chemical-resistant gloves consistent with European Standard EN 374 must be worn during product handling.
* Avoid contact with eyes.
* Dispose of the product and container safely, following relevant legislation.
**Impact Analysis**
**Diversey Europe Operations B.V. (Authorisation Holder)**
* **Impact:** Changes to the authorisation due to address updates.
* **Action Required:** Ensure compliance with the amended authorisation and update product information accordingly. Specify the glove material to be used within the product information.
**Manufacturers of the Biocidal Product**
* **Impact:** Must comply with manufacturing requirements under the amended authorisation, including the address updates.
* **Action Required:** Update documentation and manufacturing processes to reflect any changes from this regulation.
**Users of the Biocidal Product (Professionals)**
* **Impact:** No significant changes to how the product is used, but awareness of ventilation requirements and glove usage is crucial.
* **Action Required:** Follow instructions for use, risk mitigation measures, and ensure proper disposal.
**European Chemicals Agency (ECHA)**
* **Impact**: Publishing the updated summary of biocidal product characteristics of 'ClearKlens wipes based on IPA'.
* **Action Required**: Publish the updated summary of biocidal product characteristics.
Key Entities Referenced
Regulation (EU) No 528/2012: Regulation concerning the making available on the market and use of biocidal products.
Commission Implementing Regulation (EU) 2024/2189: Regulation granting a Union authorisation for the single biocidal product ClearKlens wipes based on IPA.
ClearKlens wipes based on IPA: Single biocidal product subject to Union authorization.
European Chemicals Agency (ECHA): Agency that reviewed the administrative changes to the Union authorisation and submitted an opinion to the Commission.
Commission Implementing Regulation (EU) No 354/2013: Regulation on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012.
Official Journal EN
of the European Union L series
2025/2034 10.10.2025
COMMISSION IMPLEMENTING REGULATION(EU) 2025/2034
of 9 October 2025
amending Implementing Regulation (EU) 2024/2189 as regards administrative changes to the Union
authorisation for the single biocidal product ‘ClearKlens wipes based on IPA’
(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 products(1), and in particular Article 50(2) thereof,
Whereas:
(1) On 3 September 2024, Commission Implementing Regulation (EU) 2024/2189(2) granted a Union authorisation,
under number EU-0032009-0000, to Diversey Europe Operations B.V. for the making available on the market and
use of the single biocidal product ‘ClearKlens wipes based on IPA’. The Annex to that Implementing Regulation
provides a summary of biocidal product characteristics for that single biocidal product.
(2) On 24 March 2025, Diversey Europe Operations B.V. submitted to the European Chemicals Agency (‘the Agency’), in
accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013(3), a notification of
administrative changes to the Union authorisation for the single biocidal product ‘ClearKlens wipes based on IPA’, as
referred to in Title 1 of the Annex to that Regulation. The notification was recorded in the Register for Biocidal
Products (‘the Register’) under case number BC-KA104994-50. The notified proposed changes to that authorisation
concern a change to the address of the authorisation holder and a change to the address of one of the biocidal
product manufacturers.
(3) On 11 April 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing
Regulation (EU) No 354/2013, an opinion(4)on the notified administrative changes to the Union authorisation for
the single biocidal product ‘ClearKlens wipes based on IPA’. In the opinion, the Agency concludes that the proposed
changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as
specified in Title 1, Section 1 and Section 2, of the Annex to Implementing Regulation (EU) No 354/2013, and that
after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still
be met.
(4) On 11 April 2025, the Agency transmitted to the Commission a revised summary of the biocidal product
characteristics of the Union authorisation for the single biocidal product ‘ClearKlens wipes based on IPA’ in all
official languages of the Union, covering the administrative changes applied for, in accordance with Article 11(6) of
Implementing Regulation (EU) No 354/2013.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2024/2189 of 3 September 2024 granting a Union authorisation for the single biocidal
product ClearKlens wipes based on IPA in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the
Council (OJ L, 2024/2189, 4.9.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2189/oj).
(3) Commission 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, ELI: http://data.europa.
eu/eli/reg_impl/2013/354/oj).
(4) ECHA opinion UAD-C-1816018-33-00/F of 11 April 2025 on administrative changes of the Union authorisation of the single
biocidal product ‘ClearKlens wipes based on IPA’, https://echa.europa.eu/documents/10162/95571017/ua_adc_echa-
opinion_bc_ka104994-50_en.pdf/2fbd4613-be26-677d-bd13-126bc0f613f5?t=1744701310955.
ELI: http://data.europa.eu/eli/reg_impl/2025/2034/oj 1/14EN
OJ L, 10.10.2025
(5) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union
authorisation for the single biocidal product ‘ClearKlens wipes based on IPA’ to introduce the administrative changes
requested by Diversey Europe Operations B.V.
(6) Except for the amendments regarding the administrative changes, all other information included in the summary of
the biocidal product characteristics of ‘ClearKlens wipes based on IPA’ as set out in the Annex to Implementing
Regulation (EU) 2024/2189 remains unchanged.
(7) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the
summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing
Regulation (EU) 2024/2189 should be replaced in its entirety. Due to a change in the format used for the generation
of the summary of biocidal product characteristics in the Register in February 2024, the summary of biocidal product
characteristics in that Annex should also include some minor editorial and layout changes.
(8) Implementing Regulation (EU) 2024/2189 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Implementing Regulation (EU) 2024/2189 is replaced by the text set out in the Annex to this Regulation.
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, 9 October 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/14 ELI: http://data.europa.eu/eli/reg_impl/2025/2034/ojEN
OJ L, 10.10.2025
ANNEX
Summary of product characteristics for a biocidal product
ClearKlens wipes based on IPA
Product type(s)
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
Authorisation number:EU-0032009-0000
R4BP asset number:EU-0032009-0000
1. ADMINISTRATIVE INFORMATION
1.1. Trade name(s) of the product
Trade name(s) ClearKlens IPA 70 % non sterile WW
ClearKlens IPA 70 % v/v wipes
ClearKlens IPA 70 % wipes
ClearKlens IPA 70 % wipes non sterile
ClearKlens IPA 70 % wipes non sterile VH1
ClearKlens IPA 70 % wipes VH1
ClearKlens IPA 70 % WW
ClearKlens IPA 70 % WW VH1
ClearKlens IPA 70 % non sterile wipes
ClearKlens IPA 70 % non sterile wipes VH1
ClearKlens IPA wipe
ClearKlens IPA Wipes
ClearKlens IPA WW
Divodes IPA WW
IPA 70 % v/v WW
IPA 70 % wipes
IPA 70 % WW
IPA 70 % WW VH1
IPA wipes
IPA WW
Divodes IPA Wipes
Soft Care IPA Desinfection Wipes
TASKI Sprint IPA Wipes
TASKI Sani IPA Wipes
TASKI Jontec IPA Wipes
TechniSat® DES
TexVantage™ DES
PolySat® DES
AlphaSat™ DES
ThermaSat DES
TechniScrub™ DES
HoneyComb® DES
AlphaSat™ 10 DES
ClearKlens IPA 70 % v/v WW
Suma IPA Wipes
Vectra Honeycomb 10
TechniSat DCO
TechniSat MDC
TexVantage DCO
TexVantage MDC
PolySat DCO
PolySat MDC
AlphaSat DCO
ELI: http://data.europa.eu/eli/reg_impl/2025/2034/oj 3/14EN
OJ L, 10.10.2025
AlphaSat MDC
ThermaSat DCO
ThermaSat MDC
TechniScrub DCO
TechniScrub MDC
HoneyComb DCO
HoneyComb MDC
AlphaSat 10 DCO
AlphaSat 10 MDC
1.2. Authorisation holder
Name Diversey Europe Operations B.V.
Name and address of the authorisation holder
Address De Corridor 4 (Regulatory team) 3621 ZB
Breukelen NL
Authorisation number EU-0032009-0000
R4BP asset number EU-0032009-0000
Date of the authorisation 24.9.2024
Expiry date of the authorisation 31.8.2034
1.3. Manufacturer(s) of the product
Name of manufacturer Diversey Europe Operations B.V.
Address of manufacturer De Corridor 4 (Regulatory team) 3621 ZB Breukelen
Netherlands (the)
Location of manufacturing sites Diversey Europe Operations B.V. site 1 Avenida
Conde Duque 5, 7 y 9; Poligono Industrial La Postura
28343 Valdemoro (Madrid) Spain
Diversey Europe Operations B.V. site 2
Strada Statale 235 26010 Bagnolo Cremasco (CR) Italy
Diversey Europe Operations B.V. site 3 Cotes Park
Industrial Estate DE55 4PA Somercotes Alfreton United
Kingdom of Great Britain and Northern Ireland (the)
Diversey Europe Operations B.V. site 4
Rembrandtlaan 414 7545 ZW Enschede Netherlands
(the)
Diversey Europe Operations B.V. site 5
Morschheimer Strasse 12 D-67292
Kirchheimbolanden Germany
4/14 ELI: http://data.europa.eu/eli/reg_impl/2025/2034/ojEN
OJ L, 10.10.2025
Name of manufacturer Flexible Medical Packaging Ltd
Address of manufacturer Unit 8, Hightown, White Cross Industrial Estate
LA1 4XS Lancanter, Lancashire United Kingdom of
Great Britain and Northern Ireland (the)
Location of manufacturing sites Flexible Medical Packaging Ltd site 1 Unit 8,
Hightown, White Cross Industrial Estate LA1 4XS
Lancanter, Lancashire United Kingdom of Great Britain
and Northern Ireland (the)
Name of manufacturer Ardepharm
Address of manufacturer Les Iles Ferays 07300 Tournon-sur-Rhône France
Location of manufacturing sites Ardepharm site 1 Les Iles Ferays 07300
Tournon-sur-Rhône France
Name of manufacturer Entegris Cleaning Process (ECP) S.A.S
Address of manufacturer 395 rue Louis Lépine 34000 Montpellier France
Location of manufacturing sites Entegris Cleaning Process (ECP) S.A.S site 1 395 rue
Louis Lépine 34000 Montpellier France
Name of manufacturer Pluswipes Ltd
Address of manufacturer Pywell Rd, Willowbrook East Industrial Estate
NN17 5XJ Corby United Kingdom of Great Britain and
Northern Ireland (the)
Location of manufacturing sites Pluswipes Ltd site 1 Pywell Rd, Willowbrook East
Industrial Estate NN17 5XJ Corby United Kingdom of
Great Britain and Northern Ireland (the)
Name of manufacturer ITW Contamination Control BV
Address of manufacturer Saffierlaan 5 2132 VZ Hoofddorp Netherlands (the)
Location of manufacturing sites ITW Contamination Control BV site 1 Saffierlaan 5
2132 VZ Hoofddorp Netherlands (the)
ELI: http://data.europa.eu/eli/reg_impl/2025/2034/oj 5/14EN
OJ L, 10.10.2025
Name of manufacturer ITW Texwipe
Address of manufacturer 1210 South Park Drive 27284 North Caroline
Kernersville United States (the)
Location of manufacturing sites ITW Texwipe site 1 1210 South Park Drive 27284
North Caroline Kernersville United States (the)
Name of manufacturer ITW Contamination Control (Wujiang) Co., LTD
Address of manufacturer No. 4660 Pangjin Road Wujiang Economic &
Technological Development Zone Suzhou, Jiangsu
province 215021 Suzhou China
Location of manufacturing sites ITW Contamination Control (Wujiang) Co., LTD site 1
No. 4660 Pangjin Road Wujiang Economic &
Technological Development Zone Suzhou, Jiangsu
province 215021 Suzhou China
1.4. Manufacturer(s) of the active substance(s)
Active substance Propan-2-ol
Name of manufacturer INEOS Solvents Germany GmbH
Address of manufacturer Anckelmannplatz D-20537 Hamburg Germany
Location of manufacturing sites INEOS Solvents Germany GmbH site 1
Shamrockstrasse 88 D-44623 Herne Germany
INEOS Solvents Germany GmbH site 2 Römerstrasse
733 D-47443 Moers Germany
Active substance Propan-2-ol
Name of manufacturer Shell Chemicals Europe B.V.
Address of manufacturer Postbus 2334 3000 CH Rotterdam Netherlands (the)
Location of manufacturing sites Shell Chemicals Europe B.V. site 1 Vondelingenweg 601
3196 KK Rotterdam-Pernis Netherlands (the)
Active substance Propan-2-ol
Name of manufacturer Exxon Mobil Chemicals
Address of manufacturer Hermeslaan 2 1831 Machelen Belgium
6/14 ELI: http://data.europa.eu/eli/reg_impl/2025/2034/ojEN
OJ L, 10.10.2025
Location of manufacturing sites Exxon Mobil Chemicals site 1 4045 Scenic Hailway
LA 70805 Baton Rouge United States (the)
Exxon Mobil Chemicals site 2 Southampton SO45
1TX Hampshire United States (the)
Active substance Propan-2-ol
Name of manufacturer Novapex
Address of manufacturer 21 Chemin de la Sauvegarde 21 Écully Park CS 33167
69134 Écully France
Location of manufacturing sites Novapex site 1 Rue Gaston Monmousseau 38556
Saint Maurice l’Exil France
2. PRODUCT COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the product
Common name IUPAC name Function CAS number EC number Content (%)
Propan-2-ol Active 67-63-0 200-661-7 63,1 % (w/w)
substance
2.2. Type(s) of formulation
xx- presaturated wipes
3. HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or
cracking.
Precautionary statements P210: Keep away from heat, hot surfaces, sparks, open
flames and other ignition sources. No smoking.
P261: Avoid breathing vapours.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear protective eye protection/face protection.
P304+P340: IF INHALED: Remove person to fresh air
and keep comfortable for breathing.
ELI: http://data.europa.eu/eli/reg_impl/2025/2034/oj 7/14EN
OJ L, 10.10.2025
P312: Call a POISON CENTER if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with
water for several minutes. Remove contact lenses,
ifpresent and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical
advice.
P403+P235: Store in a well-ventilated place. Keep cool.
P370+P378: In case of fire: Use water to extinguish.
P264: Wash hands thoroughly after handling.
P501: Dispose of contents to, in accordance with local
regulations.
P405: Store locked up.
4. AUTHORISED USE(S)
4.1. Use description
Table 1
Use #1 PT02: Hard surface disinfectant - professionals - wiping
Product type PT02: Disinfectants and algaecides not intended for direct
application to humans or animals
Where relevant, an exact description of the -
authorised use
Target organism(s) (including development Scientific name: no data
stage) Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use indoor use
Ready-to-use (RTU) pre-saturated wipes for the disinfection of pre-
cleaned non-porous hard surfaces in laboratories, cleanrooms and
pharmaceutical and cosmetics manufacturing facilities.
Application method(s) Method: Wiping using RTU pre-saturated wipes
Detailed description:
-
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Application rate(s) and frequency Application Rate:
Use X per 0,5 m2. Where X is
1 wipe; for wipes with the size 20-46 cm × 38-68 cm
2 wipes; for wipes with the size 15-31 cm × 20-31 cm
3 wipes; for wipes with the size 15 cm × 15 cm
4 wipes; for wipes with the size 10 cm × 10 cm
Ready-to-use
Number and timing of application:
Apply according to disinfection protocols up to 20 times a day
Contact time: allow to take effect for at least 5 minutes.
Category(ies) of users industrial
professional
Pack sizes and packaging material Packaging:
Slider bag Polyethylene terephthalate (PET)/ Low-density
polyethylene (LDPE)/ High-density polyethylene (HDPE) with
co-extruded (COEX) barrier layer
Flex pack bag PET/LDPE/ HDPE with COEX barrier layer
Bucket - HDPE
Tub - HDPE
Each package can contain between 5 to 500 wipes, the bucket
(HDPE) can contain up to 1000 wipes.
Wipes:
100 % Polyester
100 % Polypropylene
50/50 % Polyester/Cellulose or
45/55 % Polyester/Cellulose
4.1.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection. Fold wipe in mid-
air into quarter folds. Wipe in one direction with overlapping strokes. Wet the surface completely. Allow to take
effect for at least 5 minutes.
Only use wet wipes. Close the package after use.
Dispose used wipes immediately after application into a closed container.
4.1.2. Use-specific risk mitigation measures
See general direction 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.
ELI: http://data.europa.eu/eli/reg_impl/2025/2034/oj 9/14EN
OJ L, 10.10.2025
4.2. Use description
Table 2
Use #2 PT02: Hard surface disinfectant - professionals - mopping
Product type PT02: Disinfectants and algaecides not intended for direct
application to humans or animals
Where relevant, an exact description of the -
authorised use
Target organism(s) (including development Scientific name: no data
stage) Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use indoor use
Ready to use (RTU) pre-saturated wipes for the disinfection of pre-
cleaned non-porous hard surfaces in cleanrooms and
pharmaceutical and cosmetics manufacturing facilities.
Application method(s) Method: mopping using RTU pre-satured wipes
Detailed description:
-
Application rate(s) and frequency Application Rate:
Use X per 1 m2. Where X is
1 wipe for wipes with the size 25-38 cm × 38-68 cm;
2 wipes for wipes with the size 20-46 cm × 31-46 cm;
3 wipes for wipes with the size 15-23 cm × 20-28 cm;
Ready-to-use
Number and timing of application:
Apply according to disinfection protocols up to 2 times a day
Contact time: allow to take effect for at least 5 minutes.
Category(ies) of users industrial
professional
Pack sizes and packaging material Packaging:
Slider bag Polyethylene terephthalate (PET)/ Low-density
polyethylene (LDPE)/ High-density polyethylene (HDPE) with
co-extruded (COEX) barrier layer
Flex pack bag PET/LDPE/ HDPE with COEX barrier layer
Bucket - HDPE
Tub - HDPE
Each package can contain between 5 to 500 wipes, the bucket
(HDPE) can contain up to 1 000 wipes.
Wipes:
100 % Polyester
100 % Polypropylene
50/50 % Polyester/Cellulose or
45/55 % Polyester/Cellulose
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4.2.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection. Attach wipe onto
the mopping tool. Wipe systematically with overlapping strokes. Wet the surface completely. Allow to take effect for
at least 5 minutes.
Only use wet wipes.
Close the package after use.
Dispose used wipes immediately after application into a closed container.
4.2.2. Use-specific risk mitigation measures
See general direction for use
4.2.3. 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.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. 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.
4.3. Use description
Table 3
Use #3 PT02: Hard surface disinfectant - professionals – wiping (equipment and small surfaces)
Product type PT02: Disinfectants and algaecides not intended for direct
application to humans or animals
Where relevant, an exact description of the -
authorised use
Target organism(s) (including development Scientific name: no data
stage) Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Field(s) of use indoor use
Ready-to-use (RTU) pre-saturated wipes for the disinfection of
equipment and small non-porous hard surfaces in facilities
(including hospitals, nursing homes and medical practices)
ELI: http://data.europa.eu/eli/reg_impl/2025/2034/oj 11/14EN
OJ L, 10.10.2025
Application method(s) Method: Wiping using RTU pre-saturated wipes
Detailed description:
-
Application rate(s) and frequency Application Rate:
Use X per 0,5 m2. Where X is
1 wipe; for wipes with the size 20-46 cm × 38-68 cm
2 wipes; for wipes with the size 15-31 cm × 20-31 cm
3 wipes; for wipes with the size 15 cm × 15 cm
4 wipes; for wipes with the size 10 cm × 10 cm
Ready-to-use
Number and timing of application:
Apply according to disinfection protocols up to 20 times a day
Contact time: allow to take effect for at least 5 minutes.
Category(ies) of users industrial
professional
Pack sizes and packaging material Packaging:
Slider bag Polyethylene terephthalate (PET)/ Low-density
polyethylene (LDPE)/ High-density polyethylene (HDPE) with
co-extruded (COEX) barrier layer
Flex pack bag PET/LDPE/ HDPE with COEX barrier layer
Bucket - HDPE
Tub - HDPE
Each package can contain between 5 to 500 wipes, the bucket
(HDPE) can contain up to 1 000 wipes.
Wipes:
100 % Polyester
100 % Polypropylene
50/50 % Polyester/Cellulose or
45/55 % Polyester/Cellulose
4.3.1. Use-specific instructions for use
Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection. Fold wipe in mid-
air into quarter folds and wipe in one direction with overlapping strokes. Wet the surface completely.
Allow to take effect for at least 5 minutes.
Only use wet wipes.
Close the package after use.
Dispose used wipes immediately after application into a closed container
4.3.2. Use-specific risk mitigation measures
See general direction for use.
Keep children away from treated surfaces until dried.
4.3.3. 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.
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OJ L, 10.10.2025
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.3.5. 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)
5.1. Instructions for use
See use-specific instructions for use.
5.2. Risk mitigation measures
The product must be applied only in a sufficiently ventilated room. The minimum air change rates required are:
— 8/h in laboratories
— 60/h in pharmaceutical and cosmetics manufacturing facilities
— 20/h in cleanrooms
— 1,5/h in other areas (including hospitals, nursing homes and medical practices)
Wear chemical resistant gloves consistent with European Standard EN 374 or equivalent during product handling
phase (glove material to be specified by the authorisation holder within the product information). This is without
prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and
safety at work. See section 6 for the full references.
Avoid contact with eyes.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the
environment
Inhalation: May cause drowsiness or dizziness.
Eye contact: Causes severe irritation.
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: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation
occurs: Get medical advice.
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call
a POISON CENTRE or a doctor.
Environmental precautions
Shall not be released to the ground, watercourses, pipes and sewers. Do not allow to enter the drainage system.
Methods and material for containment and cleaning up. Absorb with liquid-binding material (sand, diatomite,
universal binders, sawdust).
5.4. Instructions for safe disposal of the product and its packaging
The product and its container must be disposed of in a safe way, in compliance with any relevant legislation on the
disposal of hazardous waste. Perform disposal or incineration in accordance with the local legislation and
requirements.
(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
ELI: http://data.europa.eu/eli/reg_impl/2025/2034/oj 13/14EN
OJ L, 10.10.2025
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
2 years shelf life.
Keep only in original packaging.
Store away from direct sunlight and below 40 °C.
Store in a closed container
6. OTHER INFORMATION
The active substance concentration expressed as percent volume is 70 % v/v.
The full titles of the references in section 5.2 ‘Risk mitigation measures’ are: EN 374 – Protective gloves against
dangerous chemicals and micro-organisms
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks
related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of
Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11; ELI: http://data.europa.eu/eli/dir/1998/24/oj).
14/14 ELI: http://data.europa.eu/eli/reg_impl/2025/2034/oj