Non-renewal of active substance approval in 2018
Regulation (EC) No 1107/2009 lays down rules for the authorisation of plant protection products in commercial form and their placing on the market, use and control within the European Community.
The Implementing Regulation (EU) No 540/2011 implements Regulation (EC) No 1107/2009 as regards the list of approved active substances.
In 2018, the Regulations listed below amended Implementing Regulation No 540/2011 by deleting certain active substances from the Annex of approved substances.
These active substances are now banned for use at European level, but additional time limits have been granted for the distribution and use of existing stocks of plant protection solutions containing them.
– Regulation No. 2018/309 : No renewal of Propineb approval.
Concerns related to the substance still remain, depending on the authority, related to the endocrine disrupting properties of the 4-methylimidazolidine-2-thione (PTU) metabolite, which is classified as a Category 2 reproductive toxicant and for which the thyroid is the target organ of toxicity.
Authorisations for plant protection products containing propineb have been withdrawn since 22 June 2018, with a grace period expiring no later than 22 June 2019.
– Regulation No. 2018/1019 : No renewal of the approval of Oxasulfuron.
Efsa concluded in its assessment report that concerns remain about overall consumer exposure and groundwater exposure, and about the risk to aquatic organisms, earthworms, macro-organisms and micro-organisms living in non-target terrestrial soil and plants.
Authorisations for plant protection products containing oxasulfuron have been withdrawn since 8 November 2018, with a grace period expiring no later than 8 November 2019.
– Regulation No. 2018/1043 : Non-renewal of approval of Fenamidone.
Efsa concluded in its renewal assessment report that concerns remain, in particular with regard to the genotoxic potential of the molecule, the risk of groundwater contamination and the risk of exposure of aquatic organisms.
Authorisations for plant protection products containing fenamidone must be withdrawn before 14 February 2019, with a grace period expiring no later than 14 November 2019.
– Regulation No. 2018/1500 : Non-renewal of Thirame approval.
Concerns remain about this active substance.
Authorisations for plant protection products containing thiram must be withdrawn before 30 January 2019, with a grace period expiring no later than 30 April 2019 for products used for foliar applications and 30 January 2020 for others, “including those used for seed treatment”. The use of seeds treated with products containing the molecule is prohibited as from 31 January 2020.
– Regulation No. 2018/1501 : Non-renewal of the approval of Pymetrozine.
Concerns remain about this active substance.
Authorisations for plant protection products containing pymetrozine must be withdrawn before 30 April 2019, with a grace period expiring no later than 30 January 2020.
– Regulation No. 2018/1532 : No renewal of Diquat approval.
Efsa confirmed, at the time of the renewal application, a “high risk for those present and residents in all scenarios”, as well as a high risk for birds.
Authorisations for plant protection products containing diquat must be withdrawn before 4 May 2019, with a grace period expiring no later than 4 February 2020.
– Regulation No. 2018/1865 : Non-renewal of Propiconazole approval.
Efsa confirmed during the evaluation of the renewal application that this molecule, classified as a Category 1B reproductive toxicant, raises many concerns for both human health and the environment.
Authorisations for plant protection products containing propiconazole must be withdrawn before 19 June 2019, with a grace period expiring on 19 March 2020 at the latest.
– Regulation No. 2018/1914 : Non-renewal of Quinoxyfen approval.
Efsa concluded that quinoxyfen is a substance with persistent, bioaccumulative and toxic properties and very persistent and very bioaccumulative properties.
Authorisations for plant protection products containing quinoxyfen must be withdrawn before 27 June 2019, with a grace period expiring no later than 27 March 2020.
– Regulation No. 2018/1917 : No renewal of approval of Flurtamone.
Efsa concluded that it is not possible, inter alia, to exclude the mutagenic potential of flurtamone.
Authorisations for plant protection products containing flurtamone must be withdrawn before 27 June 2019, with a grace period expiring no later than 27 March 2020.
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