Commission Implementing Regulation (EU) 2026/750of 31 March 2026granting a Union authorisation for the biocidal product family ECA Disinfect skin Product family 7 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council(Text with EEA relevance)

Commission Implementing Regulation (EU) 2026/750 of 31 March 2026 granting a Union authorisation for the biocidal product family ECA Disinfect skin Product family 7 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 products OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. , and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) On 3 June 2022, ECA consortium A/S submitted an application to the European Chemicals Agency (the Agency) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ECA Disinfect skin Product family 7 of product-types 1 and 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Denmark had agreed to evaluate the application. The application was recorded under case number BC-HJ075974-23 in the Register for Biocidal Products. (2) ECA Disinfect skin Product family 7 contains active chlorine released from hypochlorous acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 1 and 3. (3) On 12 November 2024, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. (4) On 5 June 2025, the Agency submitted to the Commission its opinion Opinion of 15 May 2025 on the Union authorisation of the biocidal product family ECA Disinfect skin Product family 7 (ECHA/BPC/476/2025), https://echa.europa.eu/opinions-on-union-authorisation. , the draft summary of the biocidal product characteristics (SPC) of ECA Disinfect skin Product family 7 and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012. (5) The opinion concludes that ECA Disinfect skin Product family 7 is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(6) of that Regulation. The Agency, however, recommends the biocidal product family to be authorised only for the use Hand disinfection non-medical application for product-type 1 as described under section 2.1 of the opinion. The other uses for product-type 1 and the use for product-type 3 applied for by the applicant are not recommended for authorisation by the Agency. (6) On 23 June 2025, 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.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ECA Disinfect skin Product family 7 only for the use Hand disinfection non-medical application for product-type 1. (8) 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 1

A Union authorisation with authorisation number EU-0035043-0000 is hereby granted to ECA consortium A/S for the making available on the market and use of the biocidal product family ECA Disinfect skin Product family 7 in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 21 April 2026 until 31 March 2036.

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, 31 March 2026. For the Commission The President Ursula von der Leyen

Annex

ANNEX Summary of product characteristics for a biocidal product family ECA Disinfect skin Product family 7 Product type(s) PT01: Human hygiene Authorisation number EU-0035043-0000 R4BP asset number EU-0035043-0000 PART I FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION 1.1. Family name NameECA Disinfect skin Product family 7 1.2. Product type(s) Product type(s)PT01: Human hygiene 1.3. Authorisation holder Name and address of the authorisation holderNameECA Consortium A/SAddressBlegen 9, 4.th 6400 Sønderborg DKAuthorisation numberEU-0035043-0000R4BP asset numberEU-0035043-0000Date of the authorisation21 April 2026Expiry date of the authorisation31 March 2036 1.4. Manufacturer(s) of the product Name of manufacturerECA ConsortiumAddress of manufacturerBlegen 9 4.th 6400 Sønderborg DenmarkLocation of manufacturing sitesECA Consortium, site 1 Åvej 19 2680 Solrød Strand DenmarkName of manufacturerACS B.V.Address of manufacturerOostergracht 17-11 3763 LX Soes Netherlands (the)Location of manufacturing sites ACS B.V., site 1 Oostergracht 17-11 3763 LX Soes Netherlands (the) ACS B.V., site 2 Sdr. Kajsgade 7-9 8500 Grenaa Denmark Name of manufacturerActalys FranceAddress of manufacturerZ.A du Haut ds Tappes, BP 70 065 54310 Homecourt FranceLocation of manufacturing sitesActalys site 1 Z.A du Haut ds Tappes, BP 70 065 54310 Homecourt FranceName of manufacturerBEULCO GmbH & Co. KGAddress of manufacturerKölner Str. 92 D-57439 Attendorn GermanyLocation of manufacturing sitesBEULCO GmbH & Co. KG site 1 Kölner Str. 92 D-57439 Attendorn GermanyName of manufacturerBriotech European Operations OyAddress of manufacturerTeknobulevardi 3-5 01530 Vantaa FinlandLocation of manufacturing sitesBriotech European Operations Oy Technopolis, site 1 Teknobulevardi 3-5 01530 Vantaa FinlandName of manufacturerCF PharmaAddress of manufacturer73B Hebron Industrial Estate R95 CKK2 Kilkenny IrelandLocation of manufacturing sitesCF Pharma, site 1 73B Hebron Industrial Estate R95 CKK2 Kilkenny IrelandName of manufacturerDanish Clean Water A/SAddress of manufacturerNørrekobbel 11 6400 Sønderborg DenmarkLocation of manufacturing sitesDanish Clean Water A/S, site 1 Nørrekobbel 11 6400 Sønderborg DenmarkName of manufacturerEcas Qauttro s.r.l.Address of manufacturerPietro Miliani 7 40132 Bologna ItalyLocation of manufacturing sitesEcas Quattro s.r.l., site 1 Pietro Miliani 7 40132 Bologna ItalyName of manufacturerecabiotec AGAddress of manufacturerStarkenburgstrasse 10 D-64546 Mörfelden GermanyLocation of manufacturing sitesEcabiotec AG, site 1 Starkenburgstrasse 10 D-64546 Mörfelden Germany

Name of manufacturerElements of Water GmbHAddress of manufacturerUnter dem Dostler 4 54296 Trier GermanyLocation of manufacturing sitesElements of Water, site 1 Unter dem Dostler 4 54296 Trier GermanyName of manufacturerElox GmbHAddress of manufacturerAuen Süduferstrasse 67 9220 Velden AustriaLocation of manufacturing sitesElox GmbH, site 1 Töschling 123 9212 Techelsberg AustriaName of manufacturerEnvira GmbHAddress of manufacturerKarl-Emminger-Str.14-16 A-5020 Salzburg AustriaLocation of manufacturing sitesEnvira GmbH, site 1 Karl-Emminger-Str.14-16 A-5020 Salzburg AustriaName of manufacturerHydroliq solutions GmbHAddress of manufacturerStaldenhof 17 CH 6014 Luzern SwitzerlandLocation of manufacturing sitesHydroliq solution AG, site 1 Hydroliq solution AG 6014 Luzern SwitzerlandName of manufacturerHyperDes Water TechnologyAddress of manufacturerBastenauer Strasse 11 91637 Wornitz GermanyLocation of manufacturing sitesHyperDES watertechnology, site 1 Bastenauer Strasse 11 91637 Wornitz GermanyName of manufacturerImpressio GmbHAddress of manufacturerSchäffergasse 20/26 1040 Vienna AustriaLocation of manufacturing sitesImpressio GmbH, site 1 Hallerstrasse 43 6020 Innsbruck AustriaName of manufacturerInnovacyn US / Costigan Scientific LtdAddress of manufacturer2 Barrack Street, Clarinbridge H91 XT44 Galway IrelandLocation of manufacturing sitesInnovacyn US / Constigan Scientific Ltd, site 1 2 Barrack Street 103 348 Clarinbridge, Galway Ireland Name of manufacturerInnowatech GmbHAddress of manufacturerAlte Kaserne 28 D-72186 Empfingen GermanyLocation of manufacturing sitesInnowatech GmbH, site 1 Alte Kaserne 28 72186 Empfingen GermanyName of manufacturerNoxefin GmbH & Co KsAddress of manufacturerWimmentaler strasse 36 74189 Weinsberg-Grantchen GermanyLocation of manufacturing sitesNoxefin GmbH & Co Ks, site 1 Wimmentaler strasse 36 7489 Weinsberg-Grantchen GermanyName of manufacturerNuova Control Systems SrlAddress of manufacturerViale Vittorio Veneto 60 59100 Prato ItalyLocation of manufacturing sitesNuova Control Systems Srl, site 1 Via Franco Vannetti Donnini 72/2 59100 Prato ItalyName of manufacturerNewtec Umwelttechnik GmbHAddress of manufacturerAm Borsigturm 62 13507 Berlin GermanyLocation of manufacturing sitesNewtec Umwelttechnik GmbH, site 1 Am Borsigturm 62 13507 Berlin GermanyName of manufacturerNPP IzumrudAddress of manufacturerPae tn 25-47, Harju county 11414 Tallinn EstoniaLocation of manufacturing sitesNPP Izumrud, site 1 Pae tn 25-47, Harju county 11414 Tallinn EstoniaName of manufacturerBBDistriluxAddress of manufacturer6 rue Henri M.Schnadt 2530 Luxembourg LuxembourgLocation of manufacturing sitesBBdistrilux, site 1 12 rue de l’industrie 3895 Foetz LuxembourgName of manufacturerPureClean.eu ApSAddress of manufacturerRunddelsvej 17 8930 Randers NØ DenmarkLocation of manufacturing sites PureClean.eu ApS, site 1 Runddelsvej 17 8930 Randers Denmark PureClean.eu ApS, site 2 Ruosilantie 7b 00390 Helsinki Finland Name of manufacturerGotika 1212 s.r.oAddress of manufacturerArbesova 751/9 46001 Liberec CzechiaLocation of manufacturing sitesGotika 1212 s.r.o, site 1 Majerská 3 821 07 Bratislava SlovakiaName of manufacturerVDH watertechnology BVAddress of manufacturerGlashorst 114 3925 BV Scherpenzeel Netherlands (the)Location of manufacturing sitesVDH Watertechnology B.V, site 1 Glashorst 114 3925 BV Scherpenzeel Netherlands (the)Name of manufacturerWatair GmbHAddress of manufacturerAebischen 41 3202 Frauenkoppelen SwitzerlandLocation of manufacturing sitesWatair GmbH, site 1 Aebischen 41 3202 Frauenkoppelen SwitzerlandName of manufacturerÖkopur GmbHAddress of manufacturerParkweg 10 D-74850 Schefflenz GermanyLocation of manufacturing sitesÖkopur GmbH, site 1 Parkweg 10 D-74850 Schefflenz GermanyName of manufacturerVeriforte GmbHAddress of manufacturerTobel 1505 8877 Murg SwitzerlandLocation of manufacturing sitesVeriforte GmbH, site 1 Katzmoosstraße 26a 5161 Elixhausen Austria

1.5. Manufacturer(s) of the active substance(s) Active substanceActive chlorine released from hypochlorous acidName of manufacturerInnowatech GmbHAddress of manufacturerAlte Kaserne 28 D-72186 Empfingen GermanyLocation of manufacturing sitesInnowatech GmbH site 1 Alte Kaserne 28 72186 Empfingen Germany 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hypochlorous acidHypochlorous acidReleaser7790-92-3232-232-50,075 - 0,1 % (w/w)Active chlorine released from hypochlorous acidActive chlorine released from hypochlorous acidActive substance0,075 - 0,1 % (w/w) 2.2. Type(s) of formulation Formulation type(s)AL Any other liquid PART II SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier IdentifierMeta SPC: Skin disinfection 1.2. Suffix to the authorisation number Number1-1 1.3. Product type(s) Product type(s)PT01: Human hygiene
2. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hypochlorous acidHypochlorous acidReleaser7790-92-3232-232-50,075 - 0,1 % (w/w)Active chlorine released from hypochlorous acidActive chlorine released from hypochlorous acidActive substance0,075 - 0,1 % (w/w) 2.2. Type(s) of formulation of the meta SPC 1 Formulation type(s)AL Any other liquid
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1 Hazard statementsH290: May be corrosive to metals.Precautionary statements P390: Absorb spillage to prevent material damage. P234: Keep only in original packaging.
4. AUTHORISED USE(S) OF THE META SPC 4.1. Use description Table 1 1.1 Hand disinfection non-medical (PT1) Product typePT01: Human hygieneTarget organism(s) (including development stage) Common name: Bacteria Development stage: no data Common name: Yeasts Development stage: no data Common name: Viruses Development stage: no data Field(s) of useindoor useApplication method(s) Method: pouring Detailed description: Pour 3 ml onto clean and dry hands, rub hands thoroughly for 30 seconds. Repeat application. Application rate(s) and frequency Application Rate: 2 x 3 ml. The products are ready to use (RTU) Number and timing of application: 3 ml for 30 seconds performed twice. Maximum 25 times per day (professional use). Maximum 10 times per day (non-professional use). Contact time: 2 x 30 seconds. Product must be formulated to pH 4-8. Category(ies) of users professional general public (non-professional) Pack sizes and packaging material Bottle and IBC tank: High density polyethylene (HDPE)/ polyethylene terephtalate (PET) Sizes: Non-professional users: Bottle: 500 ml; 750 ml; 1 L Professional users: Bottle: 500 ml; 750 ml; 1 L; 2,5 L; 5 L; 7,5 L; 10 L; 20 L. IBC-Tank: 500 L; 600 L; 1000 L 4.1.1. Use-specific instructions for use Apply 3 ml onto clean and dry hands, and rub hands thoroughly for 30 seconds. Perform twice.

4.1.2. Use-specific risk mitigation measures See general directions 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. 5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1 5.1. Instructions for use Comply with instructions for use. 5.2. Risk mitigation measures No risk mitigation measures needed 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment IF INHALED: If symptoms occur call a POISON CENTRE or a doctor. IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water. IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor. If medical advice is needed, have product container or label at hand. 5.4. Instructions for safe disposal of the product and its packaging Dispose of content/container in accordance with local/national/international regulations 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage Shelf life: 18 months. Must be stored at a temperature of maximum 20 °C. Protect from frost. Protect from light. Keep out of reach of children and non-target animals/pets 6. OTHER INFORMATION With respect to the Category (ies) of users note: Professionals (including industrial users) means trained professionals if this is required by national legislation. 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)ECA Disinfect skin 750Market area: EUAuthorisation numberEU-0035043-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hypochlorous acidHypochlorous acidReleaser7790-92-3232-232-50,075 % (w/w)Active chlorine released from hypochlorous acidActive chlorine released from hypochlorous acidActive substance0,075 % (w/w) 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)ECA Disinfect skin 800Market area: EUAuthorisation numberEU-0035043-0002 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Hypochlorous acidHypochlorous acidReleaser7790-92-3232-232-50,08 % (w/w)Active chlorine released from hypochlorous acidActive chlorine released from hypochlorous acidActive substance0,08 % (w/w) 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)ECA Disinfect skin 1000Market area: EUAuthorisation numberEU-0035043-0003 1-1