Commission Implementing Regulation (EU) 2026/473 of 14 October 2025 amending Implementing Regulation (EU) 2020/1187 granting a Union authorisation for the biocidal product family Iodine based products – CID LINES NV

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 (a), thereof,

Whereas:

(1) On 7 August 2020, a Union authorisation was granted to CID Lines NV for the making available on the market and use of the biocidal product family ‘Iodine based products – CID LINES NV’ (‘biocidal product family’) by Commission Implementing Regulation (EU) 2020/1187 (2) for use of the products in product-types 3 and 4 as specified in the summary of product characteristics (‘SPC’) in the Annex to that Regulation.

(2) The biocidal product family contains the active substances iodine and polyvinylpyrrolidone iodine. Both active substances were approved, among others, for product-types 3 and 4 by Commission Implementing Regulation (EU) No 94/2014 (3) which provided the expiry date of approval of 31 August 2025.

(3) For iodine and polyvinylpyrrolidone iodine, for product-type 4, no applications for renewal were submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 by the deadline. Therefore, the approval of both active substances for use in products for product-type 4 will expire on 31 August 2025.

(4) Consequently, for the uses of the biocidal product family belonging to product-type 4 the condition for authorisation of Article 19(1), point (a), of Regulation (EU) No 528/2012 requiring that the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met, will not be fulfilled as of 1 September 2025.

(5) All the indications of product-type 4, including the related uses and the related information should therefore be removed from the SPC in initial meta SPCs 7 and 8, and the initial meta SPC 9 should be removed completely. The Union authorisation should be amended accordingly.

(6) On 2 April 2025, the Commission informed CID Lines NV of its intention to amend the Union authorisation for the biocidal product family and gave it the opportunity to submit comments or additional information in accordance with Article 48(2) of Regulation (EU) No 528/2012. On 16 April 2025, CID Lines NV responded that it takes note of the information and does not have comments.

(7) It is therefore appropriate to grant a period of grace for the making available on the market and the use of the existing stocks in accordance with Article 52 of Regulation (EU) No 528/2012.

(8) In order to enhance clarity and ease the access of users and interested parties to the final version of the SPC which is to be published in the register of biocidal products, the Annex to Implementing Regulation (EU) 2020/1187 should be replaced in its entirety.

(9) Implementing Regulation (EU) 2020/1187 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2020/1187 is replaced by the text set out in the Annex to this Regulation.

Article 2

Biocidal products of the biocidal product family ‘Iodine based products – CID LINES NV’ may be made available on the market for uses belonging to product-type 4 until 27 February 2026 and such biocidal products may be used until 26 August 2026.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 September 2025.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 October 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) 2020/1187 of 7 August 2020 granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’ (OJ L 268, 14.8.2020, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2020/1187/oj).

(3) Commission Implementing Regulation (EU) No 94/2014 of 31 January 2014 approving iodine, including polyvinylpyrrolidone iodine, as an existing active substance for use in biocidal products for product-types 1, 3, 4 and 22 (OJ L 32, 1.2.2014, p. 23, ELI: http://data.europa.eu/eli/reg_impl/2014/94/oj).