Question 3580 — dangerous products

Summary

European regulations relating to plant protection products provide for a two-step approach to ensure the effectiveness of products placed on the market and their absence of risks for human health and the environment. Firstly, the active substances are evaluated and then approved at European level. Secondly, commercial preparations, which can only contain one or more substances approved at European level, are authorized by the Member States. This authorization is issued on the basis of an application submitted by a marketer, after an evaluation carried out in accordance with European guidelines. As marketing authorizations (MA) are national, the list of authorized products and uses may differ from one Member State to another. In order to facilitate harmonization and improve availability of products authorized in countries with comparable eco-climatic characteristics, the European Union has been divided into three geographical zones (France is in the South zone), and a mutual recognition procedure allows countries in the same zone to pool evaluation and issuance of marketing authorization operations. In France, it is the national agency for food, environmental and health safety. work (ANSES) which evaluates plant protection products and issues marketing authorizations, except in the case of emergency authorizations of a maximum duration of 120 days, which are issued by the ministry responsible for agriculture. Azadirachtin A was approved at European level in 2011 as an active phytopharmaceutical substance with insecticidal activity, for a period of ten years. However, the applicant was asked to provide data additional information regarding other neem extract compounds, including their quantity, biological activity and persistence, to confirm that an assessment focused on azadirachtin correctly reflects the properties of neem extract. These data have been transmitted and are still being evaluated at European level. The benefit of azadirachtin in fruit growing and crops vegetable and ornamental is well known. Due to its natural origin, this substance can also be used in organic farming. Thus, authorization requests for several preparations based on azadirachtin A have been submitted to ANSES, for use in the treatment of aphids on apple, pear, peach, apricot and nectarine trees. The procedure is being finalized and a decision is expected shortly. It should be noted that azadirachtin is the subject of a proposed toxicological classification as a category 2 (R2) reproductive toxicant, to be linked to a potential for endocrine disruption, which justifies that products containing azadirachtin be used with caution. Pending ANSES's decision, based on current information available, and to the extent that the substance has been approved at European level, the Ministry of Agriculture and Food has authorized for a period of 120 days a product containing azadirachtin to combat apple and pear aphids, until June 26, 2018. The producers concerned are therefore not in a situation of lack of solution.

Machine translation from French. The official text remains authoritative.

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