Commission Implementing Regulation (EU) 2025/1248 of 26 June 2025 renewing the approval of epsilon-metofluthrin 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) 2025/1248
• Articles: 3

Article 1

The approval of epsilon-metofluthrin 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

epsilon-metofluthrin

IUPAC name:

2,3,5,6-tetrafluoro-4-(methoxymethyl)benyzl-(1R,3R)-2,2-dimethyl-3-[(Z)-prop-1-enyl]cyclopropane carboxylate

EC No: none

CAS No: 240494-71-7

sum of all isomers: 946 g/kg RTZ (1 R, 3R = Trans, Z -2,3,5,6-tetrafluoro-4-(methoxymethyl)benyzl-(1R,3R)-2,2-dimethyl-3-[(Z)-prop-1-enyl]cyclopropane carboxylate) isomer: 870 g/kg

31 May 2032

18

1.

Epsilon-metofluthrin 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 epsilon-metofluthrin as an active substance is subject to the following conditions:

(a)

the product assessment pays 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 assessment of the active substance;

(b)

for products that may lead to residues in food or feed, it is assessed whether new maximum residue limits or maximum residue levels need to be set or the existing maximum residue limits or maximum residue levels need to be amended respectively 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 are taken to ensure that such maximum residue limits or maximum residue levels are not exceeded;

(c)

Member States’ competent authorities or, in the case of a Union authorisation, the Commission, specify in the summary of the biocidal product characteristics 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 December 2025, the person responsible for the placing on the market of a treated article treated with or incorporating epsilon-metofluthrin 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 may 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 ).