Commission Implementing Regulation (EU) 2025/457 of 10 March 2025 renewing the approval of dinotefuran as an active substance for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

• CELEX: Implementing Regulation (EU) 2025/457
• Articles: 3

Article 1

The approval of dinotefuran as an active substance for use in biocidal products of product-type 18 is renewed, subject to the conditions set out in the Annex.

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 .

Schedules & Appendices

ANNEX

ANNEX

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance  ( 1 )

Expiry date of approval

Product type

Specific conditions

Dinotefuran

IUPAC name:

(RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine

EC No: 605-399-0

CAS No: 165252-70-0

991 g/kg

30 November 2031

18

1.

Dinotefuran is a candidate for substitution in accordance with Article 10(1), point (d), of Regulation (EU) No 528/2012.

2.

The authorisation of biocidal products containing dinotefuran as an active substance is subject to the following conditions:

(1)

the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance;

(2)

for products that may lead to residues in food or feed, it shall be assessed whether new maximum residue levels or maximum residue limits need to be set or the existing maximum residue levels or maximum residue limits need to be amended in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council  ( 2 ) or Regulation (EC) No 396/2005 of the European Parliament and of the Council  ( 3 ) , and any appropriate risk mitigation measures shall be taken to ensure that such maximum residue levels or maximum residue limits are not exceeded.

(3)

Member States’ competent authorities or, in the case of a Union authorisation, the Commission, shall specify in the summary of the biocidal product characteristics of a biocidal product containing dinotefuran the relevant instructions for use and precautions to be indicated on the label of the treated articles under Article 58(3), second subparagraph, point (e), of Regulation (EU) No 528/2012.

3.

The placing on the market of treated articles is subject to the following condition: as from 1 May 2025, the person responsible for the placing on the market of a treated article treated with or incorporating dinotefuran shall ensure that the label of that treated article provides the information listed in Article 58(3), second subparagraph, of Regulation (EU) No 528/2012.

( 1 )   The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product made available on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

( 2 )   Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council ( OJ L 152, 16.6.2009, p. 11 , ELI: http://data.europa.eu/eli/reg/2009/470/oj ).

( 3 )   Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/396/oj ).