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EU Announce Non-renewal Of Approval Of The Active Substance Propiconazole
Dec 26, 2018

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 Commission Implementing Regulation (EU) No 540/2011, EU announce non-renewal of approval of the active substance propiconazole.

The Main problem are:

 MRLs issue

Based on the data available in the dossier the Authority concluded that Maximum Residue Levels (‘MRLs’) in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council (10) could not be confirmed for plant and animal products since data on the magnitude and toxicity of metabolites that are included in the residue definition for risk assessment was not available. The current MRLs for the proposed uses of propiconazole are above the default value in the meaning of Article 18(1)(b) of Regulation (EC) No 396/2005. For those reasons, it cannot be considered that exposure of humans to the active substance is negligible. Therefore, the requirements set out in Point 3.6.4 of Annex II to Regulation (EC) No 1107/2009 are not fulfilled.


Groundwater contamination

A critical concern was identified by the Authority in relation to the contamination of groundwater by metabolites of propiconazole. In particular, metabolite NOA436613 is predicted to occur above the parametric value of 0,1 μg/L in all pertinent scenarios for all proposed uses of propiconazole, even when the substance is used biennially. Two other metabolites are predicted to occur in groundwater above 0,1 μg/L in the majority of pertinent scenarios. These metabolites are considered a priori of concern since it can not be excluded that they do not share the same potential for reproductive toxicity as parent propiconazole. Therefore, it cannot currently be established that the presence of metabolites of propiconazole in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health in the meaning of Article 4(3)(b) and (e) of Regulation (EC) No 1107/2009.


Endocrine issue

Additionally, the Authority concluded that propiconazole caused toxic effects on endocrine organs. However, the scientific assessment to determine the endocrine disrupting potential of propiconazole could not be finalised by the Authority based on the information available in the dossier. Furthermore, the assessment of several aspects necessary to conclude on the risk to consumers through dietary intake could not be finalised based on the information available in the dossier.


Withdraw time:

Member States shall withdraw authorisations for plant protection products containing propiconazole as active substance by 19 June 2019 at the latest.


Grace period:

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 19 March 2020 at the latest.

Source: EU website