(1)

On 4 November 2022, Commission Implementing Regulation (EU) 2022/2127 (2) granted a Union authorisation, under authorisation number EU-0028430-0000, to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘Ecolab UA BPF 1-Propanol’. The Annex to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for that biocidal product family.

(2)

Commission Implementing Regulation (EU) No 354/2013 (3) lays down the procedural rules for the different categories of changes referred to in Article 50(3) of Regulation (EU) No 528/2012.

(3)

On 8 August 2025, Ecolab Deutschland GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, an application for a minor change to the Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’, as referred to in Title 2 of the Annex to that Regulation. The application was recorded in the Register for Biocidal Products under case number BC-EW109476-15. The proposed minor change to that authorisation concerns the addition of a new product. However, this product would contain a new, non-active substance that has been intentionally added, and which is not present in the composition of the biocidal product family already authorized.

(4)

Within the same application, Ecolab Deutschland GmbH submitted to the Agency, in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013, a notification for an administrative change to the Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’, as referred to in Title 1 of the Annex to that Regulation. The notified change concerns the addition of trade names. These trade names are directly linked to the product proposed for authorisation under the minor change application.

(5)

On 12 March 2026, the Agency submitted to the Commission, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, an opinion (4) on the applied minor change to the Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’.

In accordance with Title 2, point 2 of the Annex to Implementing Regulation (EU) No 354/2013, the intentional addition of a non-active substance into a biocidal product family outside the authorized range may be considered a minor change only if certain conditions are fulfilled, including that the physical-chemical properties and the shelf-life of the products of the biocidal product family remain the same.

In its opinion, the Agency clarifies that the data submitted by the applicant does not demonstrate that the proposed new product would have the same physical-chemical properties as those of the already authorized products of the biocidal product family, because the intentionally added non-active substance increases viscosity. The data also did not demonstrate that the authorized shelf-life of 4 years would still be maintained. The Agency concluded that the condition set out in Title 2, point 2, of the Annex to Implementing Regulation (EU) No 354/2013 concerning unchanged physical-chemical properties and shelf-life is not fulfilled. Therefore, the change cannot be considered a minor change and should be rejected.

(6)

In its opinion, as regards the notified administrative change to the Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’, the Agency concluded that the proposed change is an administrative change as defined in Article 3(1), point (aa), of Regulation (EU) No 528/2012 and as specified in Title 1, Section 1, of the Annex to Implementing Regulation (EU) No 354/2013. However, since the Agency could not give a favourable opinion on the new biocidal product proposed to be added to the biocidal product family, as described in the minor change application, the Agency concluded that the addition of tradenames for that new product should likewise not be authorised.

(7)

In light thereof, it is not appropriate to amend the Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’ to introduce the minor and administrative changes requested by Ecolab Deutschland GmbH.

(8)

Implementing Regulation (EU) 2022/2127 should therefore not be amended,