Commission Implementing Regulation (EU) 2025/1491 of 24 July 2025 amending Implementing Regulation (EU) 2024/267 as regards administrative and minor changes to the Union authorisation of the single biocidal product DEC-SPORE 200 Plus

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 48(1), point (b), and Article 50(2) thereof,

Whereas:

(1) On 17 January 2024, Commission Implementing Regulation (EU) 2024/267 (2) granted a Union authorisation under number EU-0030727-0000 to Veltek Associates Inc. Europe for the making available on the market and use of the single biocidal product ‘DEC-SPORE 200 Plus’. A summary of products characteristics (‘SPC’) was annexed to the authorisation.

(2) On 12 August 2024, Veltek Associates Inc. Europe submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 12(1) of Commission Implementing Regulation (EU) No 354/2013 (3), an application for a minor change and two administrative changes to the Union authorisation of the single biocidal product ‘DEC-SPORE 200 Plus’, recorded in the Register for Biocidal Products under case number BC-XW099513-89. The notified proposed changes concern the addition of a non-active substance and the removal and addition of product manufacturers.

(3) On 1 November 2024, the Competent Authority of Switzerland informed the Commission that for use 2 – Surface disinfectant indoors, sporicidal use, a risk mitigation measure was missing for the diluted product (6,7 %) in case of a ventilation rate of 30 air changes per hour (ACH).

(4) On 7 November 2024, the evaluating competent authority for the initial authorisation confirmed that that risk mitigation measure had been removed from the SPC by mistake after the Biocidal Products Committee meeting of 2 March 2022.

(5) On 26 November 2024, the Commission informed the authorisation holder of its intention to include the missing risk mitigation measure in the authorisation and gave the authorisation holder an opportunity to submit comments or additional information within 10 days.

(6) On 28 November 2024, the authorisation holder informed that it had no comments to the inclusion of that missing risk mitigation measure. In addition, the authorisation holder submitted a request to correct a mistake in the instructions for the dilution of the product for use 2 and to include a packaging size mentioned in the product assessment report but not included in the SPC for uses 1 and 2.

(7) On 30 December 2024, the evaluating competent authority of the initial authorisation informed the Commission that it supported the additional request.

(8) On 17 January 2025, the Agency submitted to the Commission an opinion (4) of the Biocidal Products Committee on the administrative and minor changes in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised SPC and a revised product assessment report. In the opinion, the Agency concludes that the proposed changes are administrative and minor changes as referred to in Article 50(3), points (a) and (b), of Regulation (EU) No 528/2012 and as specified in Titles 1 and 2 of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.

(9) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to amend the Union authorisation of the single biocidal product ‘DEC-SPORE 200 Plus’. After consulting the evaluating competent authority, it also considers it appropriate to include the missing risk mitigation measure and to add the missing packaging size and correct the dilution instructions of products.

(10) Except for the abovementioned amendments, all the other information included in the SPC of ‘DEC-SPORE 200 Plus’ as set out in the Annex to Implementing Regulation (EU) 2024/267 remains unchanged.

(11) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2024/267 should be replaced in its entirety. Due to a change in the format used for the generation of the SPC in the Register for Biocidal Products in 2024, the SPC in that Annex should also include some minor editorial and layout changes.

(12) Implementing Regulation (EU) 2024/267 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2024/267 is replaced by the text set out in the Annex to this Regulation.

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, 24 July 2025.

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) Commission Implementing Regulation (EU) 2024/267 of 17 January 2024 granting a Union authorisation for the single biocidal product ‘DEC-SPORE 200 Plus’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2024/267, 18.1.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/267/oj).

(3) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4; ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).

(4) Opinion of the Biocidal Products Committee (BPC) of 17 January 2025 on the minor change to the Union authorisation of the biocidal product ‘DEC-SPORE 200 Plus’, ECHA/BPC/457/2025, https://echa.europa.eu/documents/10162/79839763/dec-spore_200_plus_ua-mic_bc-xw099513-89_final_bpc_opinion_en.pdf/8d1bda1b-b245-b71d-d5d3-410ba54996f5?t=1737453874969.