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ANSES UPDATE: BIOCONTROL PRODUCTS

Review of categories and applications for authorisation of biocontrol products (fees, pre-submission and evaluation procedure)

On 19 July 2021, ANSES published a new version of its note on biocontrol products to the attention of applicants for marketing authorisations.

In its note dated 19 July 2021, 3rd version replacing the one dated March 2018, the French Agency (ANSES) reminds applicants for marketing authorisations that biocontrol products include the following categories of products:

 

  • macro-organisms, for which marketing authorisations are not needed
  • plant protection products based on micro-organisms, semiochemicals (e.g. pheromones and kairomones), natural substances of animal, vegetal or mineral origin, for which marketing authorisations are needed and which are regulated by Regulation (EC) 1107/2009.

In addition to the definitions of these categories, ANSES also reminds that a list of biocontrol products is updated by the French Ministry of Agriculture on a monthly basis. Moreover, biocontrol products from this list are not subject to same marketing and financial constraints as conventional PPPs. For instance, they benefit from a reduced tax on the sale allocated to financing the phytoparmacovigilance system.

Concerning application for marketing authorisation procedures, ANSES stresses the possibility to ask questions using the dedicated mailbox damm.uia@anses.fr and the need to notify Art. 33 applications where France is zRMS at least 6 months before the intended submission date by submitting the notification form to ppp.zonal.depr@anses.fr. ANSES also recalls the specific provisions of Order, dated 12 April 2017, establishing the fees related to applications for registration of biocontrol products. Last but not least, this note emphasises the difference of theoretical evaluation timelines between biocontrol and conventional PPPs: 6-8 months and 12 months, respectively.

For more details about biocontrol products definition, application procedure and fees contact our biocontrol team.

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