Commission Implementing Regulation (EU) 2026/488of 4 March 2026amending Implementing Regulation (EU) 2025/455 as regards minor change to the Union authorisation of the single biocidal product SatPax® 70/30 IPA(Text with EEA relevance)

Commission Implementing Regulation (EU) 2026/488 of 4 March 2026 amending Implementing Regulation (EU) 2025/455 as regards minor change to the Union authorisation of the single biocidal product SatPax® 70/30 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 OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. , and in particular Article 50(2) thereof, Whereas: (1) On 7 March 2025, Commission Implementing Regulation (EU) 2025/455 Commission Implementing Regulation (EU) 2025/455 of 7 March 2025 granting a Union authorisation for the single biocidal product SatPax® 70/30 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2025/455, 10.3.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/455/oj). granted a Union authorisation, under number EU-0032869-0000, to CSI-Ireland for the making available on the market and use of the single biocidal product SatPax® 70/30 IPA. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product. (2) On 30 April 2025, CSI-Ireland submitted to the European Chemicals Agency (Agency), in accordance with Article 12(1) of Commission Implementing Regulation (EU) No 354/2013 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). , an application for a minor change to the Union authorisation of the single biocidal product SatPax® 70/30 IPA, as referred to in Title 2 of the Annex to that Regulation. The application was recorded in the Register for Biocidal Products (the Register) under case number BC-QY105662-08. The proposed change to that authorisation concerns the extension of the shelf life of the product from 2 years to 3 years. (3) On 9 September 2025, the Agency submitted to the Commission, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, an opinion Biocidal Products Committee (BPC) opinion on the minor change to the Union authorisation of the single biocidal product SatPax® 70/30 IPA of 9 September 2025, ECHA/BPC/487/2025 https://echa.europa.eu/opinions-on-union-authorisation. on the applied minor change to the Union authorisation of the single biocidal product SatPax® 70/30 IPA together with a revised summary of product characteristics and a revised assessment report. The opinion concluded that the proposed change is a minor change as referred to in Article 50(3), point (b), of Regulation (EU) No 528/2012 and as specified in Title 2 of the Annex to Implementing Regulation (EU) No 354/2013, and that, after the implementation of the change, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(4) On 10 September 2025, the Agency transmitted to the Commission the revised summary of product characteristics of the Union authorisation of the single biocidal product SatPax® 70/30 IPA in all official languages of the Union, covering the minor change applied for, in accordance with Article 12(6) of Implementing Regulation (EU) No 354/2013. (5) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the single biocidal product SatPax® 70/30 IPA to introduce the minor change requested by CSI-Ireland. (6) Except for the amendments regarding the proposed minor change, all other information included in the summary of product characteristics of SatPax® 70/30 IPA, as set out in the Annex to Implementing Regulation (EU) 2025/455, 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 product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2025/455 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of product characteristics in the Register in February 2024, the summary of product characteristics in that Annex should also include some minor editorial and layout changes. (8) Implementing Regulation (EU) 2025/455 should therefore be amended accordingly, HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2025/455 is replaced by the text 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, 4 March 2026. For the Commission The President Ursula von der Leyen

Annex

ANNEX Summary of product characteristics for a biocidal product SatPax® 70/30 IPA Product type(s) PT02: Disinfectants and algaecides not intended for direct application to humans or animals Authorisation number: EU-0032869-0000 R4BP asset number: EU-0032869-0000

1. ADMINISTRATIVE INFORMATION 1.1. Trade name(s) of the product Trade name(s) SatPax® 70/30 IPA SatPax® Choice® 500 Sterile SatPax® Choice® 500 SatPax® 550 Sterile SatPax® 550 SatPax® 550 Low Endotoxin Sterile SatPax® 550 Low Endotoxin SatPax® Choice® 600 Sterile SatPax® Choice® 600 SatPax® 670 Sterile SatPax® 670 SatPax® 670A Sterile SatPax® 670A SatPax® 670-R Sterile SatPax® 670-R SatPax® 3000 Sterile SatPax® 3000 SatPax® Choice® 700 Sterile SatPax® Choice® 700 SatPax® Choice® 900 Sterile SatPax® Choice® 900 SatPax® 1000 Sterile SatPax® 1000 SatPax® S1200 Sterile SatPax® S1200 SatPax® Choice® SuperSorb Sterile SatPax® Choice® SuperSorb SatPax® MicroSeal SuperSorb® Sterile SatPax® MicroSeal SuperSorb® SatPax® Microseal®-VP Sterile SatPax® Microseal®-VP SatPax® Microseal®-VP Low Endotoxin Sterile SatPax® MicroSeal®-VP Low Endotoxin

SatPax® ValuSeal-HA® Sterile SatPax® ValuSeal-HA® SatPax® SPSE Sterile SatPax® SPSE SatPax® SPLWSE Sterile SatPax® SPLWSE SatPax® SPSWSE Sterile SatPax® SPSWSE SatPax® ValuSeal® IonX® Sterile SatPax® ValuSeal® IonX® 1.2. Authorisation holder Name and address of the authorisation holderNameCSI-IrelandAddressBlock C Ardilaun Court 112-114 St. Stephen’s Green D02 TD28 Dublin IrelandAuthorisation numberEU-0032869-0000R4BP asset numberEU-0032869-0000Date of the authorisation30.3.2025Expiry date of the authorisation28.2.2035 1.3. Manufacturer(s) of the product Name of manufacturerBerkshire International LtdAddress of manufacturerUnit A, The Apex, Farrier Close NR18 0WF Wymondham United Kingdom of Great Britain and Northern Ireland (the)Location of manufacturing sites Berkshire International Ltd site 1 Techtex, Units 7 & 8, Rhodes Business Park M24 4NE Middleton United Kingdom of Great Britain and Northern Ireland (the) Berkshire International Ltd site 2 Berkshire Corporation, 6509 Franz Warner Parkway NC 27377 Whitsett United States (the) Berkshire International Ltd site 3 Berkshire International Ltd. Unit A, The Apex, Farrier Close NR18 0WF Wymondham United Kingdom of Great Britain and Northern Ireland (the) 1.4. Manufacturer(s) of the active substance(s) Active substancePropan-2-olName of manufacturerIneos Solvents Germany GmbHAddress of manufacturerRömerstraße 733 47443 Moers GermanyLocation of manufacturing sitesIneos Solvents Germany GmbH site 1 Römerstraße 733 47443 Moers GermanyActive substancePropan-2-olName of manufacturerExxon Mobil Chemical EuropeAddress of manufacturerHermeslaan 2 1831 Machelen BelgiumLocation of manufacturing sitesExxon Mobil Chemical Europe site 1 Exxon Mobil Chemical Plant, 4999 Scenic Highway Louisiana 70897 Baton Rouge United States (the) 2. PRODUCT COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the product Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive substance67-63-0200-661-764,7 % (w/w) 2.2. Type(s) of formulation RTU wipe pre-saturated with a liquid formulation (AL) 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. P264: Wash hands thoroughly after handling. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection/face protection. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P337+P313: If eye irritation persists: Get medical advice. P312: Call a doctor if you feel unwell. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents to in accordance with all local, national and international regulations. 4. AUTHORISED USE(S) 4.1. Use description Table 1 Disinfection of smaller hard surface areas by wiping in cleanrooms and in similar controlled areas within manufacturing and industrial settings (e.g.: work benches in a cleanroom) Product typePT02: Disinfectants and algaecides not intended for direct application to humans or animalsWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: all Scientific name: no data Common name: Yeasts Development stage: all Field(s) of use indoor use Disinfection of smaller hard surface areas by wiping in cleanrooms and in similar controlled areas within manufacturing and industrial settings (e.g.: work benches in a cleanroom) Application method(s) Method: wiping Detailed description: Wiping. Direct application onto surfaces with a pre-saturated wipe. Application rate(s) and frequency Application Rate: 30-130 mL/m2 Number and timing of application: Ready to use product. Use sufficient wipes in order to maintain a wet surface for a contact time of 1 min. Each wipe contains 3,0- 56,3 ml of IPA: water 70:30 v/v % solution (2,1-39,4 ml or 1,6 to 30,9 g active substance). The application rate is depending on the wipe type (see below).

1. 55 % cellulose / 45 % polyester ml of formulated liquid/wipe: 9-18 wipes to keep 0,5 m2 wet: 2 ml of formulated liquid/wipe: 6-9 wipes to keep 0,5 m2 wet: 3 ml of formulated liquid/wipe: 4,5-6 wipes to keep 0,5 m2 wet: 4 ml of formulated liquid/wipe: 4-4,5 wipes to keep 0,5 m2 wet: 5 ml of formulated liquid/wipe: 3-4 wipes to keep 0,5 m2 wet: 6
2. 60 % cellulose / 40 % polyester ml of formulated liquid/wipe: 9-15 wipes to keep 0,5 m2 wet: 2 ml of formulated liquid/wipe: 5,75-9 wipes to keep 0,5 m2 wet: 3 ml of formulated liquid/wipe: 4,5-5,75 wipes to keep 0,5 m2 wet: 4 ml of formulated liquid/wipe: 3,75-4,5 wipes to keep 0,5 m2 wet: 5 ml of formulated liquid/wipe: 3-3,75 wipes to keep 0,5 m2 wet: 6 ml of formulated liquid/wipe: 2-3 wipes to keep 0,5 m2 wet: 7
3. 100 % polypropylene ml of formulated liquid/wipe: 7,5-15 wipes to keep 0,5 m2 wet: 2 ml of formulated liquid/wipe: 5-7,5 wipes to keep 0,5 m2 wet: 3 ml of formulated liquid/wipe: 3,5-5 wipes to keep 0,5 m2 wet: 4
4. 100 % polyester ml of formulated liquid/wipe: 16-56 wipes to keep 0,5 m2 wet: 1 ml of formulated liquid/wipe: 8-16 wipes to keep 0,5 m2 wet: 2 ml of formulated liquid/wipe: 7-8 wipes to keep 0,5 m2 wet: 3 Typical number of applications per day: 10 Category(ies) of usersprofessionalPack sizes and packaging material Pre-saturated Wipes – 55 % cellulose / 45 % polyester Canister/refill pouches 60, 75, 100, 125 wipes Wipe size (cm): 13 × 20, 15 × 23, 30 × 30

Tub material: HDPE (high density polyethylene) Lid material: PP (polypropylene) Pouch 25, 30, 50, 75 or 100 wipes Wipe size (cm): 15 × 23, 18 × 20, 23 × 23, 23 × 28, 30 × 30 Outer layer material: PET (polyethylene terephthalate) Inner Layer material: PE or LLDPE (polyethylene or linear low density polyethylene) Pre-saturated Wipes – 60 % cellulose / 40 % polyester Canister/refill pouch 75, 100, 125 or 150 wipes Wipe size (cm): 13 × 20, 15 × 23, 30 × 30 Tub material: HDPE Lid material: PP Pouch 30, 75, 90 or 100 wipes Wipe size (cm): 15 × 20, 18 × 20, 23 × 23, 23 × 28, 30 × 30 Outer layer material: PET Inner Layer material: PE or LLDPE Pre-saturated Wipes – 100 % polypropylene Canister/refill pouch 50, 75, 100, 125 or 150 wipes Wipe size (cm): 15 × 23, 23 × 30 Tub material: HDPE Lid material: PP Pouch 50, 75, 100 or 125 wipes Wipe size (cm): 18 × 28, 23 × 28, 28 × 36 Outer layer material: PET Inner Layer material: PE or LLDPE Pre-saturated Wipes – 100 % polyester Pouch 20, 25, 30, 50, 75, 100 wipes Wipe size (cm): 15 × 23, 18 × 20, 23 × 23, 30 × 30 Outer layer material: PET Inner Layer material: PE or LLDPE 4.1.1. Use-specific instructions for use Use at room temperature. Only use on clean surfaces. Remove one wipe from pack. Close pack. Quarter fold the wiper and refold as needed to use each surface of the wiper. Apply pre-saturated wipe directly to the surface to be disinfected. Ensure complete wetting of the surface. No additional wiping necessary. Allow contact time of 1 min for bacteria and yeast. Use wipe once. Dispose of the wipe immediately after use in a closed container. Do not mix with other products. 4.1.2. Use-specific risk mitigation measures See section 5.2. 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 section 5.3. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See section 5.4. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See section 5.5. 4.2. Use description Table 2 Disinfection of larger hard surface areas using wipes and a mop in cleanrooms and in similar controlled areas within manufacturing and industrial settings (e.g.: floors in a cleanroom) Product typePT02: Disinfectants and algaecides not intended for direct application to humans or animalsWhere relevant, an exact description of the authorised use-Target organism(s) (including development stage) Scientific name: no data Common name: Bacteria Development stage: all Scientific name: no data Common name: Yeasts Development stage: all Field(s) of use indoor use Disinfection of larger hard surface areas using wipes and a mop in cleanrooms and in similar controlled areas within manufacturing and industrial settings (e.g.: floors in a cleanroom) Application method(s) Method: mopping Detailed description: Mopping. Attach the pre-saturated wipe to a floor mop for application onto surfaces

Application rate(s) and frequency Application Rate: 17 mL/m2 Number and timing of application: Ready to use product. Use sufficient wipes in order to maintain a wet surface for a contact time of 1 min. Each floor wipe contains 22,0 to 24,7 ml of IPA:water 70:30 v/v % solution (15,4 to 17,3 ml or 12,4 to 13,9 g active substance). ml of formulated liquid/per wipe: 25 wipes to keep 25 m2 wet:17 ml of formulated liquid/wipe: 22 wipes to keep 25 m2 wet: 19 Typical number of applications per day: 1 Category(ies) of usersprofessionalPack sizes and packaging material Pre-saturated Wipes – 55 % cellulose / 45 % polyester Pouch 25, 30, 50, 75 wipes Wipe size (cm): 23 × 58 Product saturation: 60 % Outer layer material: PET (polyethylene terephtalate) Inner Layer material: PE or LLDPE (polyethylene or linear low density polyethylene) 4.2.1. Use-specific instructions for use Use at room temperature. Only use on clean surfaces. Remove wipe(s) from pack. Close pack. Attach 4 layers on the mop head and refold or rotate wipers as needed to maintain a wet surface for a contact time of 1 minute. Apply wipe directly to the surface to be disinfected. Use sufficient wipes in order to maintain a wet surface for a contact time of 1 min. No additional wiping necessary. Allow contact time of 1 min for bacteria and yeast. Use wipe once. Dispose of the wipe immediately after use in a closed container. Do not mix with other products. 4.2.2. Use-specific risk mitigation measures See section 5.2. 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 section 5.3. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See section 5.4. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See section 5.5. 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses. 5.1. Instructions for use See section 4.1.1 and 4.2.1 5.2. Risk mitigation measures Avoid contact with eyes. Ensure that application is carried out in areas with a minimum ventilation rate of 20 air changes/hour. Wear protective chemical resistant gloves meeting the requirements of 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 by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See Section 6 for information on the EN standard and the Council Directive. Keep in the original container, kept tightly closed when not in use. Empty containers retain product residue and can be hazardous. Do not reuse container. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid instructions 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. 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 SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor. Emergency measures Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). Small spill: Vacuum or sweep up material and place in a designated, labelled waste container. Dispose of via a licensed waste disposal contractor Large spill: Stop leak if without risk. Move containers from spill area. Use spark-proof tools and explosion-proof equipment. Approach the release from upwind. Prevent entry into sewers, soil, water courses, basements or confined areas. Contain and collect spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in container for disposal according to local regulations. Dispose of via a licensed waste disposal contractor. Contaminated absorbent material may pose the same hazard as the spilt product. 5.4. Instructions for safe disposal of the product and its packaging The generation of waste should be avoided or minimised wherever possible. Disposal of this product should comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Dispose of surplus and non-recyclable products via a licensed waste disposal contractor. Waste should not be disposed to the sewer. Do not flush wipes down the toilet. Do not macerate. Disposal of packaging: The generation of waste should be avoided or minimised wherever possible. Waste packaging should be recycled. Incineration or landfill should only be considered when recycling is not feasible. This material and its container must be disposed of in a safe way. Empty containers or liners may retain some product residues. Residual alcohol should be emptied prior to disposal of container. 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 container tightly closed. Store at temperatures not exceeding 40 °C. Protect from frost. Store protected from direct sunlight. Shelf-life: 3 years 6. OTHER INFORMATION The product contains wipes of four types of material impregnated with IPA:water (64,7:35,3 % w/w) solution. The materials are cellulose/polyester (55 %/45 %), cellulose/polyester (60 %/40 %), polypropylene (100 %) and polyester (100 %). The sizes of the wipes range from 13 × 20 cm to 23 × 58 cm. More detailed information on the sizes of the wipes is included under the title Pack sizes and packaging material in Sections 4.1 and 4.2.

Please be aware of the European reference value of 129,28 mg/m3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for this product. Full titles of EN standards and legislation mentioned in Section 5.2: 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). With respect to the Category(ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation.