Judgment_paragraph 35 · FMC Corporation v European Commission (T-719/17)

35Recitals 8 to 14 of the contested regulation state as follows:(8) On 30 September 2016 the [EFSA] communicated to the Commission its conclusion on whether [FPS could] be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. Based on the studies assessed, the [EFSA] concluded that the parent substance [had] certain intrinsic toxicological properties, in particular as regards to carcinogenicity and reproductive toxicity. In the view of the [EFSA] this information even justifies the classification as a category 2 carcinogen and as a reproductive toxicant category 2 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council. The [EFSA] concluded that considering the representative uses assessed, there [was] a high potential to result in groundwater exposure above the parametric drinking water limit of 0.1 μg/L by several metabolites of [FPS] in situations represented by all pertinent groundwater scenarios.(9) Regardless of the classification proposed by the [EFSA], given the intrinsic toxicological properties of the parent substance shown in the studies, in particular in relation to carcinogenicity and reproductive toxicity, the presence of the metabolites in groundwater is of particular concern since it has not been demonstrated that these metabolites do not share the same intrinsic properties. Therefore it cannot currently be established that the presence of the metabolites in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health.(10) Furthermore, the [EFSA] concluded that the groundwater exposure assessment could not be finalised based on the available information for metabolite IN‑JE127, the genotoxic potential of which cannot be excluded.(11) Given the uncertainty about the presence of that metabolite in groundwater, unacceptable effects on groundwater and harmful effects on human health cannot currently be excluded.(12) Moreover, the [EFSA] concluded that there is a high risk to aquatic organisms, in particular for algae and aquatic plants, from exposure to [FPS].(13) Based on these risks identified in recitals 9, 11 and 12, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of [FPS] in accordance with Article 20(1)(b) of that Regulation.(14) Given the risks detailed in recitals 9, 11 and 12, the derogation provided for in Article 4(7) of Regulation (EC) No 1107/2009 does not apply. The application of that derogation is also excluded on the grounds that it has not been established that any of the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II to Regulation (EC) No 1107/2009 are not satisfied.’