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Document 32026R0750
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
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
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
C/2026/2049
OJ L, 2026/750, 1.4.2026, ELI: http://data.europa.eu/eli/reg_impl/2026/750/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
Date of entry into force unknown (pending notification) or not yet in force., Date of effect: 21/04/2026
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Official Journal |
EN L series |
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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:
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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
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Name |
ECA Disinfect skin Product family 7 |
1.2. Product type(s)
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Product type(s) |
PT01: Human hygiene |
1.3. Authorisation holder
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Name and address of the authorisation holder |
Name |
ECA Consortium A/S |
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Address |
Blegen 9, 4.th 6400 Sønderborg DK |
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Authorisation number |
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EU-0035043-0000 |
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R4BP asset number |
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EU-0035043-0000 |
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Date of the authorisation |
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21 April 2026 |
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Expiry date of the authorisation |
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31 March 2036 |
1.4. Manufacturer(s) of the product
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Name of manufacturer |
ECA Consortium |
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Address of manufacturer |
Blegen 9 4.th 6400 Sønderborg Denmark |
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Location of manufacturing sites |
ECA Consortium, site 1 Åvej 19 2680 Solrød Strand Denmark |
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Name of manufacturer |
ACS B.V. |
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Address of manufacturer |
Oostergracht 17-11 3763 LX Soes Netherlands (the) |
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Location of manufacturing sites |
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Name of manufacturer |
Actalys France |
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Address of manufacturer |
Z.A du Haut ds Tappes, BP 70 065 54310 Homecourt France |
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Location of manufacturing sites |
Actalys site 1 Z.A du Haut ds Tappes, BP 70 065 54310 Homecourt France |
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Name of manufacturer |
BEULCO GmbH & Co. KG |
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Address of manufacturer |
Kölner Str. 92 D-57439 Attendorn Germany |
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Location of manufacturing sites |
BEULCO GmbH & Co. KG site 1 Kölner Str. 92 D-57439 Attendorn Germany |
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Name of manufacturer |
Briotech European Operations Oy |
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Address of manufacturer |
Teknobulevardi 3-5 01530 Vantaa Finland |
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Location of manufacturing sites |
Briotech European Operations Oy Technopolis, site 1 Teknobulevardi 3-5 01530 Vantaa Finland |
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Name of manufacturer |
CF Pharma |
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Address of manufacturer |
73B Hebron Industrial Estate R95 CKK2 Kilkenny Ireland |
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Location of manufacturing sites |
CF Pharma, site 1 73B Hebron Industrial Estate R95 CKK2 Kilkenny Ireland |
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Name of manufacturer |
Danish Clean Water A/S |
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Address of manufacturer |
Nørrekobbel 11 6400 Sønderborg Denmark |
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Location of manufacturing sites |
Danish Clean Water A/S, site 1 Nørrekobbel 11 6400 Sønderborg Denmark |
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Name of manufacturer |
Ecas Qauttro s.r.l. |
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Address of manufacturer |
Pietro Miliani 7 40132 Bologna Italy |
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Location of manufacturing sites |
Ecas Quattro s.r.l., site 1 Pietro Miliani 7 40132 Bologna Italy |
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Name of manufacturer |
ecabiotec AG |
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Address of manufacturer |
Starkenburgstrasse 10 D-64546 Mörfelden Germany |
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Location of manufacturing sites |
Ecabiotec AG, site 1 Starkenburgstrasse 10 D-64546 Mörfelden Germany |
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Name of manufacturer |
Elements of Water GmbH |
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Address of manufacturer |
Unter dem Dostler 4 54296 Trier Germany |
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Location of manufacturing sites |
Elements of Water, site 1 Unter dem Dostler 4 54296 Trier Germany |
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Name of manufacturer |
Elox GmbH |
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Address of manufacturer |
Auen Süduferstrasse 67 9220 Velden Austria |
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Location of manufacturing sites |
Elox GmbH, site 1 Töschling 123 9212 Techelsberg Austria |
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Name of manufacturer |
Envira GmbH |
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Address of manufacturer |
Karl-Emminger-Str.14-16 A-5020 Salzburg Austria |
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Location of manufacturing sites |
Envira GmbH, site 1 Karl-Emminger-Str.14-16 A-5020 Salzburg Austria |
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Name of manufacturer |
Hydroliq solutions GmbH |
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Address of manufacturer |
Staldenhof 17 CH 6014 Luzern Switzerland |
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Location of manufacturing sites |
Hydroliq solution AG, site 1 Hydroliq solution AG 6014 Luzern Switzerland |
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Name of manufacturer |
HyperDes Water Technology |
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Address of manufacturer |
Bastenauer Strasse 11 91637 Wornitz Germany |
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Location of manufacturing sites |
HyperDES watertechnology, site 1 Bastenauer Strasse 11 91637 Wornitz Germany |
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Name of manufacturer |
Impressio GmbH |
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Address of manufacturer |
Schäffergasse 20/26 1040 Vienna Austria |
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Location of manufacturing sites |
Impressio GmbH, site 1 Hallerstrasse 43 6020 Innsbruck Austria |
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Name of manufacturer |
Innovacyn US / Costigan Scientific Ltd |
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Address of manufacturer |
2 Barrack Street, Clarinbridge H91 XT44 Galway Ireland |
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Location of manufacturing sites |
Innovacyn US / Constigan Scientific Ltd, site 1 2 Barrack Street 103 348 Clarinbridge, Galway Ireland |
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Name of manufacturer |
Innowatech GmbH |
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Address of manufacturer |
Alte Kaserne 28 D-72186 Empfingen Germany |
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Location of manufacturing sites |
Innowatech GmbH, site 1 Alte Kaserne 28 72186 Empfingen Germany |
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Name of manufacturer |
Noxefin GmbH & Co Ks |
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Address of manufacturer |
Wimmentaler strasse 36 74189 Weinsberg-Grantchen Germany |
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Location of manufacturing sites |
Noxefin GmbH & Co Ks, site 1 Wimmentaler strasse 36 7489 Weinsberg-Grantchen Germany |
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Name of manufacturer |
Nuova Control Systems Srl |
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Address of manufacturer |
Viale Vittorio Veneto 60 59100 Prato Italy |
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Location of manufacturing sites |
Nuova Control Systems Srl, site 1 Via Franco Vannetti Donnini 72/2 59100 Prato Italy |
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Name of manufacturer |
Newtec Umwelttechnik GmbH |
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Address of manufacturer |
Am Borsigturm 62 13507 Berlin Germany |
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Location of manufacturing sites |
Newtec Umwelttechnik GmbH, site 1 Am Borsigturm 62 13507 Berlin Germany |
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Name of manufacturer |
NPP Izumrud |
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Address of manufacturer |
Pae tn 25-47, Harju county 11414 Tallinn Estonia |
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Location of manufacturing sites |
NPP Izumrud, site 1 Pae tn 25-47, Harju county 11414 Tallinn Estonia |
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Name of manufacturer |
BBDistrilux |
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Address of manufacturer |
6 rue Henri M.Schnadt 2530 Luxembourg Luxembourg |
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Location of manufacturing sites |
BBdistrilux, site 1 12 rue de l’industrie 3895 Foetz Luxembourg |
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Name of manufacturer |
PureClean.eu ApS |
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Address of manufacturer |
Runddelsvej 17 8930 Randers NØ Denmark |
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Location of manufacturing sites |
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Name of manufacturer |
Gotika 1212 s.r.o |
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Address of manufacturer |
Arbesova 751/9 46001 Liberec Czechia |
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Location of manufacturing sites |
Gotika 1212 s.r.o, site 1 Majerská 3 821 07 Bratislava Slovakia |
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Name of manufacturer |
VDH watertechnology BV |
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Address of manufacturer |
Glashorst 114 3925 BV Scherpenzeel Netherlands (the) |
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Location of manufacturing sites |
VDH Watertechnology B.V, site 1 Glashorst 114 3925 BV Scherpenzeel Netherlands (the) |
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Name of manufacturer |
Watair GmbH |
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Address of manufacturer |
Aebischen 41 3202 Frauenkoppelen Switzerland |
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Location of manufacturing sites |
Watair GmbH, site 1 Aebischen 41 3202 Frauenkoppelen Switzerland |
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Name of manufacturer |
Ökopur GmbH |
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Address of manufacturer |
Parkweg 10 D-74850 Schefflenz Germany |
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Location of manufacturing sites |
Ökopur GmbH, site 1 Parkweg 10 D-74850 Schefflenz Germany |
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Name of manufacturer |
Veriforte GmbH |
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Address of manufacturer |
Tobel 1505 8877 Murg Switzerland |
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Location of manufacturing sites |
Veriforte GmbH, site 1 Katzmoosstraße 26a 5161 Elixhausen Austria |
1.5. Manufacturer(s) of the active substance(s)
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Active substance |
Active chlorine released from hypochlorous acid |
|
Name of manufacturer |
Innowatech GmbH |
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Address of manufacturer |
Alte Kaserne 28 D-72186 Empfingen Germany |
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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
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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 |
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Application method(s) |
Method: pouring Detailed description: Pour 3 ml onto clean and dry hands, rub hands thoroughly for 30 seconds. Repeat application. |
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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
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Trade name(s) |
ECA Disinfect skin 750 |
Market area: EU |
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Authorisation number |
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EU-0035043-0001 1-1 |
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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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
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Trade name(s) |
ECA Disinfect skin 800 |
Market area: EU |
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Authorisation number |
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EU-0035043-0002 1-1 |
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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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
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Trade name(s) |
ECA Disinfect skin 1000 |
Market area: EU |
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Authorisation number |
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EU-0035043-0003 1-1 |
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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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) |
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ELI: http://data.europa.eu/eli/reg_impl/2026/750/oj
ISSN 1977-0677 (electronic edition)