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

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)

Preamble

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 .

Final provisions

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 .

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

1.2. Product type(s)

1.3. Authorisation holder

1.4. Manufacturer(s) of the product

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

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1. Qualitative and quantitative information on the composition of the family

2.2. Type(s) of formulation

PART II

SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

1.2. Suffix to the authorisation number

1.3. Product type(s)

2. META SPC 1 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 1

2.2. Type(s) of formulation of the meta SPC 1

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

4. AUTHORISED USE(S) OF THE META SPC

4.1. Use description

Table 1

1.1 Hand disinfection non-medical (PT1)

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

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

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

Footnotes

1. , ELI: . ↩ ↩²

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), . ↩ ↩²