{"id":3334,"date":"2021-04-06T17:45:00","date_gmt":"2021-04-06T15:45:00","guid":{"rendered":"https:\/\/amoeba-nature.com\/?p=3334"},"modified":"2021-04-07T09:58:43","modified_gmt":"2021-04-07T07:58:43","slug":"submission-of-the-biocide-application-in-the-usa","status":"publish","type":"post","link":"https:\/\/amoeba-nature.com\/en\/submission-of-the-biocide-application-in-the-usa\/","title":{"rendered":"Submission of the biocide application in the USA"},"content":{"rendered":"
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Information of the timetable for the other regulatory dossiers<\/strong>:<\/h3>\n<\/div><\/div><\/div>\n\n
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Chassieu (France), April 6, 2021\u00a0\u2013\u00a05.45 pm- AMOEBA (FR0011051598 – ALMIB)<\/strong>, producer of a biological biocide capable of eliminating the risk in water and human wounds, and of a biocontrol product for plant protection, still in a development phase,\u00a0has submitted today the application for approval of the biocidal active substance, the living amoeba\u00a0Willaertia magna\u00a0<\/em>C2c Maky, and the biocidal products containing it, to the U.S. Environmental Protection Agency (U.S. EPA).<\/p>\n<\/div><\/div><\/div>\n\n

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Amo\u00e9ba reminds that in August 2019, it had decided to voluntarily withdraw its application for approval of the biocidal active substance, the living amoeba Willaertia magna <\/em>C2c Maky, and biocidal products containing it, and to submit a new application for approval at a later stage.<\/p>\n<\/div><\/div><\/div>\n\n

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During a pre-submission meeting in November 2019 between Amo\u00e9ba and the U.S. EPA, requests for clarification were raised about the scientific elements that led to the withdrawal of the dossier and the way in which Amo\u00e9ba planned to respond.<\/p>\n<\/div><\/div><\/div>\n\n

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Amo\u00e9ba was therefore able to submit a new application today, with the additional studies required by the U.S. EPA.<\/p>\n<\/div><\/div><\/div>\n\n

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Once the active substance and biocidal product registrations are obtained, expected by mid- 2022 subject to approval by the US EPA, registration (notification and payment of fees) will be required at the state level, which will take about two months (except for California, which requires a full dossier evaluation of about 12 months). Once registration is obtained at the local level, marketing may be possible in the State.<\/p>\n<\/div><\/div><\/div>\n\n

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Amo\u00e9ba thus envisages the first sales of its biocide product in the United States from the second half of 2022<\/strong>, subject to a positive decision by the U.S. EPA.<\/p>\n<\/div><\/div><\/div>\n\n

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Information on the timetable for other biocidal and phytosanitary regulatory dossiers:<\/strong><\/h3>\n<\/div><\/div><\/div>\n\n
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Amo\u00e9ba also provides information on the regulatory timetable for the various regulatory dossiers:<\/p>\n<\/div><\/div><\/div>\n\n

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Biocide application (biocidal active substance, living <\/strong>Willaertia magna <\/em><\/strong>C2c Maky):<\/strong><\/p>\n<\/div><\/div><\/div>\n\n

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