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Sulfoxaflor: ANSES examines the new data available

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News of 20/10/2017

By its decision dated 27 September 2017, ANSES issued marketing authorisations for two plant protection products containing the active substance sulfoxaflor, CLOSER and TRANSFORM, marketed by DOW Agroscience SAS, subject to strong restrictions on their conditions of use. Sulfoxaflor is an active substance in insecticides belonging to the class of chemicals called sulfoximines, approved at European level for the first time on 18 August 2015 for a period of 10 years, following a thorough risk assessment. While sulfoxaflor has a mode of action similar to that of the neonicotinoids, it differs in its very low persistence in the soil (1 to 4 days versus 120 to 520 days) and in plants. It is also less toxic to aquatic organisms and its metabolites are not toxic to pollinators.                                                                                                                                  

As regards the risk to bees, in the framework of the approval of the active substance at European level, the aspects assessed by EFSA, with regard to the acute and chronic risk to bees and bee colonies, do not reveal any unacceptable risk when exposure of pollinators to the substance is limited by appropriate management measures.


Restrictive conditions of use to prevent risks to bees

The two authorised plant protection products, CLOSER and TRANSFORM, are intended for use in the treatment of the above-ground parts of several specific crops and on small-grain cereals (wheat, spelt, triticale, barley) and flax. Their use is prohibited on the major pollinator-attracting crops. The assessment carried out by ANSES in the framework of European Regulation (EC) No 1107/2009 concluded that they were effective and that there was no risk to human health, flora and fauna or the environment, for the uses proposed and under the recommended conditions of use. The marketing authorisations are nevertheless subject to strong restrictions on their conditions of use, to protect bees and other pollinators. In particular, these restrictions include a ban on the use of products five days before and during flowering and the periods of the emission of exudates, or when weeds in flower are present.


New data to be assessed

The authorisation of the active substance sulfoxaflor at European level in 2015 stipulated, however, that the applicant should produce confirmatory data enabling the conditions of use to be refined, in the light of certain risks to honey bees and other pollinators. These data were transmitted to the rapporteur Member State responsible for assessing the active substance and are now accessible. ANSES today received a request from the Minister of State for Ecological and Inclusive Transition, and the Minister of Agriculture and Food, to assess these new data without delay to determine to what extent they may necessitate changes to the marketing authorisations of the two products CLOSER and TRANSFORM.

Furthermore, as these are the first marketing authorisations in France concerning this new substance, the Agency will be mobilising its phytopharmacovigilance network to enable it to establish any possible link between reports of the weakening or collapse of bee colonies and the use of products containing sulfoxaflor. The objective of phytopharmacovigilance is to detect as early as possible any signals that may require measures to be taken to prevent or limit the risks associated with plant protection products.