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
Date: 2026-03-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, biocide, chemical product, chlorine, decontamination, market approval, pharmaceutical product








L_202600750EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/750


1.4.2026







            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 (1), 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 (2), 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
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  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.




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







Name


ECA 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 holder


Name


ECA Consortium A/S




Address


Blegen 9, 4.th 6400 Sønderborg DK




Authorisation number


 


EU-0035043-0000





R4BP asset number



 


EU-0035043-0000




Date of the authorisation


 


21 April 2026




Expiry date of the authorisation


 


31 March 2036




1.4.   Manufacturer(s) of the product







Name of manufacturer


ECA Consortium




Address of manufacturer


Blegen 9 4.th 6400 Sønderborg Denmark




Location of manufacturing sites


ECA Consortium, site 1 Åvej 19 2680 Solrød Strand Denmark













Name of manufacturer


ACS B.V.




Address of manufacturer


Oostergracht 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 manufacturer


Actalys France




Address of manufacturer


Z.A du Haut ds Tappes, BP 70 065 54310 Homecourt France




Location of manufacturing sites


Actalys site 1 Z.A du Haut ds Tappes, BP 70 065 54310 Homecourt France













Name of manufacturer


BEULCO GmbH & Co. KG




Address of manufacturer


Kölner Str. 92 D-57439 Attendorn Germany




Location of manufacturing sites


BEULCO GmbH & Co. KG site 1 Kölner Str. 92 D-57439 Attendorn Germany













Name of manufacturer


Briotech European Operations Oy




Address of manufacturer


Teknobulevardi 3-5 01530 Vantaa Finland




Location of manufacturing sites


Briotech European Operations Oy Technopolis, site 1 Teknobulevardi 3-5 01530 Vantaa Finland













Name of manufacturer


CF Pharma




Address of manufacturer


73B Hebron Industrial Estate R95 CKK2 Kilkenny Ireland




Location of manufacturing sites


CF Pharma, site 1 73B Hebron Industrial Estate R95 CKK2 Kilkenny Ireland













Name of manufacturer


Danish Clean Water A/S




Address of manufacturer


Nørrekobbel 11 6400 Sønderborg Denmark




Location of manufacturing sites


Danish Clean Water A/S, site 1 Nørrekobbel 11 6400 Sønderborg Denmark













Name of manufacturer


Ecas Qauttro s.r.l.




Address of manufacturer


Pietro Miliani 7 40132 Bologna Italy




Location of manufacturing sites


Ecas Quattro s.r.l., site 1 Pietro Miliani 7 40132 Bologna Italy













Name of manufacturer


ecabiotec AG




Address of manufacturer


Starkenburgstrasse 10 D-64546 Mörfelden Germany




Location of manufacturing sites


Ecabiotec AG, site 1 Starkenburgstrasse 10 D-64546 Mörfelden Germany













Name of manufacturer


Elements of Water GmbH




Address of manufacturer


Unter dem Dostler 4 54296 Trier Germany




Location of manufacturing sites


Elements of Water, site 1 Unter dem Dostler 4 54296 Trier Germany













Name of manufacturer


Elox GmbH




Address of manufacturer


Auen Süduferstrasse 67 9220 Velden Austria




Location of manufacturing sites


Elox GmbH, site 1 Töschling 123 9212 Techelsberg Austria













Name of manufacturer


Envira GmbH




Address of manufacturer


Karl-Emminger-Str.14-16 A-5020 Salzburg Austria




Location of manufacturing sites


Envira GmbH, site 1 Karl-Emminger-Str.14-16 A-5020 Salzburg Austria













Name of manufacturer


Hydroliq solutions GmbH




Address of manufacturer


Staldenhof 17 CH 6014 Luzern Switzerland




Location of manufacturing sites


Hydroliq solution AG, site 1 Hydroliq solution AG 6014 Luzern Switzerland













Name of manufacturer


HyperDes Water Technology




Address of manufacturer


Bastenauer Strasse 11 91637 Wornitz Germany




Location of manufacturing sites


HyperDES watertechnology, site 1 Bastenauer Strasse 11 91637 Wornitz Germany













Name of manufacturer


Impressio GmbH




Address of manufacturer


Schäffergasse 20/26 1040 Vienna Austria




Location of manufacturing sites


Impressio GmbH, site 1 Hallerstrasse 43 6020 Innsbruck Austria













Name of manufacturer


Innovacyn US / Costigan Scientific Ltd




Address of manufacturer


2 Barrack Street, Clarinbridge H91 XT44 Galway Ireland




Location of manufacturing sites


Innovacyn US / Constigan Scientific Ltd, site 1 2 Barrack Street 103 348 Clarinbridge, Galway Ireland













Name of manufacturer


Innowatech GmbH




Address of manufacturer


Alte Kaserne 28 D-72186 Empfingen Germany




Location of manufacturing sites


Innowatech GmbH, site 1 Alte Kaserne 28 72186 Empfingen Germany













Name of manufacturer


Noxefin GmbH & Co Ks




Address of manufacturer


Wimmentaler strasse 36 74189 Weinsberg-Grantchen Germany




Location of manufacturing sites


Noxefin GmbH & Co Ks, site 1 Wimmentaler strasse 36 7489 Weinsberg-Grantchen Germany













Name of manufacturer


Nuova Control Systems Srl




Address of manufacturer


Viale Vittorio Veneto 60 59100 Prato Italy




Location of manufacturing sites


Nuova Control Systems Srl, site 1 Via Franco Vannetti Donnini 72/2 59100 Prato Italy













Name of manufacturer


Newtec Umwelttechnik GmbH




Address of manufacturer


Am Borsigturm 62 13507 Berlin Germany




Location of manufacturing sites


Newtec Umwelttechnik GmbH, site 1 Am Borsigturm 62 13507 Berlin Germany













Name of manufacturer


NPP Izumrud




Address of manufacturer


Pae tn 25-47, Harju county 11414 Tallinn Estonia




Location of manufacturing sites


NPP Izumrud, site 1 Pae tn 25-47, Harju county 11414 Tallinn Estonia













Name of manufacturer


BBDistrilux




Address of manufacturer


6 rue Henri M.Schnadt 2530 Luxembourg Luxembourg




Location of manufacturing sites


BBdistrilux, site 1 12 rue de l’industrie 3895 Foetz Luxembourg













Name of manufacturer


PureClean.eu ApS




Address of manufacturer


Runddelsvej 17 8930 Randers NØ Denmark




Location 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 manufacturer


Gotika 1212 s.r.o




Address of manufacturer


Arbesova 751/9 46001 Liberec Czechia




Location of manufacturing sites


Gotika 1212 s.r.o, site 1 Majerská 3 821 07 Bratislava Slovakia













Name of manufacturer


VDH watertechnology BV




Address of manufacturer


Glashorst 114 3925 BV Scherpenzeel Netherlands (the)




Location of manufacturing sites


VDH Watertechnology B.V, site 1 Glashorst 114 3925 BV Scherpenzeel Netherlands (the)













Name of manufacturer


Watair GmbH




Address of manufacturer


Aebischen 41 3202 Frauenkoppelen Switzerland




Location of manufacturing sites


Watair GmbH, site 1 Aebischen 41 3202 Frauenkoppelen Switzerland













Name of manufacturer


Ökopur GmbH




Address of manufacturer


Parkweg 10 D-74850 Schefflenz Germany




Location of manufacturing sites


Ökopur GmbH, site 1 Parkweg 10 D-74850 Schefflenz Germany













Name of manufacturer


Veriforte GmbH




Address of manufacturer


Tobel 1505 8877 Murg Switzerland




Location of manufacturing sites


Veriforte GmbH, site 1 Katzmoosstraße 26a 5161 Elixhausen Austria




1.5.   Manufacturer(s) of the active substance(s)







Active substance


Active chlorine released from hypochlorous acid




Name of manufacturer


Innowatech GmbH




Address of manufacturer


Alte Kaserne 28 D-72186 Empfingen Germany




Location of manufacturing sites


Innowatech 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 name


IUPAC name


Function


CAS number


EC number


Content (%)




Hypochlorous acid


Hypochlorous acid


Releaser


7790-92-3


232-232-5


0,075  - 0,1  % (w/w)




Active chlorine released from hypochlorous acid


Active chlorine released from hypochlorous acid


Active substance


 


 


0,075  - 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







Identifier


Meta SPC: Skin disinfection




1.2.   Suffix to the authorisation number







Number


1-1




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 name


IUPAC name


Function


CAS number


EC number


Content (%)




Hypochlorous acid


Hypochlorous acid


Releaser


7790-92-3


232-232-5


0,075  - 0,1  % (w/w)




Active chlorine released from hypochlorous acid


Active chlorine released from hypochlorous acid


Active substance


 


 


0,075  - 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 statements


H290: 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 type


PT01: Human hygiene




Target 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 use


indoor use




Application 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 750


Market area: EU




Authorisation number


 


EU-0035043-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hypochlorous acid


Hypochlorous acid


Releaser


7790-92-3


232-232-5


0,075 % (w/w)




Active chlorine released from hypochlorous acid


Active chlorine released from hypochlorous acid


Active substance


 


 


0,075 % (w/w)




7.2.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


ECA Disinfect skin 800


Market area: EU




Authorisation number


 


EU-0035043-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hypochlorous acid


Hypochlorous acid


Releaser


7790-92-3


232-232-5


0,08 % (w/w)




Active chlorine released from hypochlorous acid


Active chlorine released from hypochlorous acid


Active substance


 


 


0,08 % (w/w)




7.3.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


ECA Disinfect skin 1000


Market area: EU




Authorisation number


 


EU-0035043-0003 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Hypochlorous acid


Hypochlorous acid


Releaser


7790-92-3


232-232-5


0,1 % (w/w)




Active chlorine released from hypochlorous acid


Active chlorine released from hypochlorous acid


Active substance


 


 


0,1 % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2026/750/oj
ISSN 1977-0677 (electronic edition)