Zonal approach – How it works

Date: 14 April 2020

As mentioned in one of our previous Online Academy posts, the placing of plant protection product (PPP) on the market is a two-step approach in Europe. Once, the first barrier has been taken and your active substance (a.s) is approved, products containing this a.s. have to be authorized in each member state (MS), before “placing on market” is allowed. This latter procedure is described in detail in the Zonal Approach, referred in Articles 28 to 57 of REGULATION (EC) No 1107/2009, as well as the corresponding guidance document of the Commission Services (SANCO/13169/2010).

All MS are grouped in one of three political zones – the Northern (NEZ), the Central (CEZ) and the Southern (SEZ) Zone. When an application for a PPP is submitted, one MS in each zone is chosen to conduct the assessment as zonal Rapporteur Member State (zonal RMS). The other concerned MS (cMS) in the same zone to which an application has been submitted “shall refrain from proceeding to avoid duplication of work”, unless zonal RMS requests for their cooperation “to ensure a fair division of the workload”. In case an application for authorization is submitted to more than one zone, the zonal RMS in the different zones have to come to an agreement as to which MS will evaluate the data which are not related to the environmental and agricultural conditions within in the different zones.

Nevertheless, during the assessment, the zonal RMS shall give all MS in the same zone the opportunity to submit comments for consideration in the assessment. For the assessment itself, the Uniform Principles, described in REGULATION (EC) No. 546/2011 apply and the zonal RMS shall decide within twelve month of receiving the application, whether the requirements for authorization are met. A maximum extension period of 6 months is granted in cases where additional data are requested by the zonal RMS and shall cease at the moment when this additional information is received. Once the zonal RMS has concluded its assessment, it shall make available the conclusion in form of an assessment report to the other MS of the zone. On this basis the cMS shall grant or refuse an authorization at the latest within 120 days of receipt of the assessment report and the copy of the authorization of the zonal RMS.

When this authorization is granted, the second and final barrier has been taken and your product can be placed on the market. There are special rules and timeframes according to the re-authorization process which apply under Article 43 of REGULATION (EC) No 1107/2009. In cases of indoor and seed treatment uses the zonal concept is not applicable and an application can be evaluated by the zonal RMS on behalf of all EU-MS.

Sandra Rollar