Title of document
Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance fenamiphos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (5 page(s), in English)
This draft Commission Implementing Regulation provides that the approval of the active substance fenamiphos is not renewed in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing fenamiphos as active substance. The non-renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/ EEC.
This decision only concerns the placing on the market of this substance and plant protection products containing it. Following non-approval and the expiry of all grace periods for stocks of products containing this substance, separate action will likely be taken on MRLs and a separate notification will be made in accordance with SPS procedures.
Notifying member: European Union
Protection of human health or safety; Protection of animal or plant life or health; Protection of the environment
In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II) which must be met to enable approval.
During the evaluation and peer-review of fenamiphos, a number of concerns and areas that could not be finalised were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA).
The risk to consumers. The overall consumer risk assessment is provisional since the data package for M01 and M02 on genotoxicity was incomplete and the expression of the risk assessment residue definition for primary crops is provisional. Moreover, the risk assessment residue definition in rotational crops is provisional. However, even if the consumer risk assessment could not be finalised, an acute consumer risk was identified for all fruiting vegetables representative uses while for the ornamentals and nursery stock, which may be grown in rotation with food crops, an acute consumer risk cannot be excluded. (Although herbaceous ornamentals and nursery stock are not foodstuff, they could be grown in rotation with foodcrops. Thus, based on rotational metabolism studies in fruiting vegetables conducted at 1N application rate, when compared with the annual application rate from the representative GAP in ornamentals and nursery stock and also in view of the very low toxicological reference values of fenamiphos, an acute consumer risk cannot be excluded. Moreover, the provisional residue definition for rotational crops includes metabolites M01 and M02 for which further data to exclude a genotoxic potential is required.) Furthermore, for the chronic intake consumer exposure, if the calculated Maximum Residue Levels (MRLs) resulting from the available residue dataset submitted for the renewal process are used in the exposure assessment, the maximum TMDI would account for 172% of the ADI.
The risk assessment to unique human metabolites could not be finalised whilst an in vitro comparative metabolism study was not submitted.
The potential for groundwater contamination and the consumer risk assessment through exposure to metabolites from drinking water. While monitoring data from three vulnerable regions in Greece indicate that the potential for groundwater exposure above the parametric drinking water limit of 0.1 µg/L was concluded to be low for fenamiphos and metabolites M01, M02, M12, M13 and M14 in the geoclimatic conditions that are represented in Greece, modelling data indicates that there is potential for exceedance of the limit of 0.1 µg/L by M14 (well above 10 µg/L in all scenarios, even at the lower rate of application). An assessment of the consumer intake could not be carried out for this metabolite since an ADI could not be established based on the data submitted.
These concerns mean that fenamiphos does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently.
Existing authorisations will need to be withdrawn; EU Member States must withdraw existing plant protection products containing picoxystrobin at the latest by 6 months from the date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is allowed for and shall expire at the latest 12 months from the entry into force (allowing for a final season of use).
- Submission: 04/03/2020
- Reception: 04/03/2020
- Distribution: 05/03/2020
- Final date for comments: 04/05/2020
- Proposed date of adoption: N/A