Chemical name: methyl (S)-N-[7-chloro-2,3,4a,5-tetrahydro-4a- (methoxycarbonyl)indeno[1,2-e][1,3,4]oxadiazin-2- ylcarbonyl]-4’-(trifluoromethoxy)carbanilate

Final regulatory action has been taken for the category: Pesticide

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

All applications as a plant protection product.

Not relevant

Use or uses that remain allowed:

Not relevant

Pesticide use or uses that remain allowed:

Use of indoxacarb as biocidal active substance for product-type 18 (Insecticides, acaracides and products to control other arthropods).

Indoxacarb is only approved for use in biocidal products under Regulation (EU) No 528/2012 of the European Parliament and of the Council for product-type 18 (insecticides, acaricides and products to control other arthropods). The expiry date of that approval of indoxacarb is 30 June 2024. An application for the renewal of the approval has been submitted and is currently under evaluation by the corresponding Member State competent authority.

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 (OJ L 167, 27.6.2012, p. 1). http://data.europa.eu/eli/reg/2012/528/oj

The specifications of the approved active substance for its use in biocidal products are defined in Directive 98/8/EC: http://data.europa.eu/eli/dir/1998/8/2013-08-20

Common name: Indoxacarb (enantiomeric reaction mass S:R 75:25).

IUPAC Name; Identification Numbers: Reaction mass of methyl (S)- and methyl(R)-7-chloro-2.3,4a,5-tetrahydro-2-[methoxycarbonyl-(4-trifluoromethoxyphenyl) carbamoyl]indeno[1,2-e][1.3,4]oxadiazine-4a-carboxylate (This entry covers the 75:25 reaction mass of the S and R enantiomers). EC No: n/a CAS No: S-enantiomer: 173584-44-6 and R-enantiomer: 185608-75-7).

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

It is prohibited to place on the market or use plant protection products containing indoxacarb because indoxacarb is not approved as an active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market.

EU Member States had to withdraw all authorisations for plant protection products containing indoxacarb as active substance by 19 March 2022 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing indoxacarb is prohibited as of 19 September 2022.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

In conclusion from the assessments made on the basis of the submitted information, no plant protection products containing indoxacarb are expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EU) No 546/2011.

The overall conclusion of the evaluation, based on the information available and the proposed conditions of use, is that the information available indicates that the approval criteria as set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009 are not satisfied as concerns were identified with regards to:

High risk to consumers and workers for the representative use in lettuce.

In addition, the information available is insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009, in particular:

The overall consumer exposure assessment could not be finalised in view of missing data regarding the metabolism in poultry, the magnitude of residues in primary and rotational crops and regarding the effect of water treatment processes on the nature of residues in drinking water.

The need for further tests and risk assessment to unique human metabolites could not be finalised whilst an in vitro comparative metabolism study was not submitted.

The ground water exposure assessment could not be finalised considering the lack of data for metabolite IN-U8E24.

Expected effect of the final regulatory action in relation to human health:

Reduction of risk for human health from the use of plant protection products containing indoxacarb.

Summary of known hazards and risks to the environment:

In conclusion from the assessments made on the basis of the submitted information, no plant protection products containing indoxacarb are expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EU) No 546/2011.

The overall conclusion of this evaluation, based on the information available and the proposed conditions of use, is that the information available indicates that the approval criteria as set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009 are not satisfied as concerns were identified with regards to:

High long-term risk to wild mammals, in particular to small herbivorous mammals;

High risk to bees for the representative use in maize, sweet corn and lettuce for seed production.

In addition, the information available is insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009, in particular:

The risk assessment to birds and mammals from secondary poisoning for relevant metabolites could not be finalised.

The risk to sediment dwelling organisms cannot be finalised for the metabolites IN-JU873, IN-MK638, IN-MK643, IN-KB687 and IN-ML438.

The risk to aquatic organisms could not be finalised for the major photolysis metabolites IN-MF014, IN-C0639, IN-MA573 and IN-MH304.

Expected effect of the final regulatory action in relation to the environment:

Reduction of risk for the environment from the use of plant protection products containing indoxacarb.

Date of entry into force of the final regulatory action: 19/12/2021