Chemical name: (RS)-3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3- oxazolidine-2,4-dione

Final regulatory action has been taken for the category: Pesticide

Final regulatory action: The chemical is Banned

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:

Not relevant

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 famoxadone because famoxadone 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 famoxadone as active substance by 16 March 2022 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing famoxadone is prohibited as of 16 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 available information, on the basis of the representative uses submitted by the applicant and taking into account the technically available risk mitigation measures, it is concluded that plant protection products containing the active substance famoxadone are not 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 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:

the estimated worker exposure levels during crop hand-harvesting exceed the AOEL (112 % of the AOEL) even when the use of PPE (trousers, long-sleeved shirt and gloves) is considered;

Furthermore, it should be noted that concerning the use of famoxadone on table grapes in the northern residues zone, acute exposure (IESTI) for children is 120% of the Acute Reference Dose (ARfD), although there is no exceedance of the ARfD for use on wine grapes.

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 famoxadone.

Summary of known hazards and risks to the environment: In conclusion, from the assessments made on the basis of the available information, on the basis of the representative uses submitted by the applicant and taking into account the technically available risk mitigation measures, it is concluded that plant protection products containing the active substance famoxadone are not 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.

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 famoxadone.

Date of entry into force of the final regulatory action: 09/09/2021