Netherlands Rapporteur Member State Zonal Application
Applications for new authorisations, major amendments to existing authorisations, extending the scope of the authorisation and extending the authorisation period must be submitted according to the zonal procedure. One Member State shall act as zonal rapporteur (zRMS); this Member State assesses the application on behalf of all Member States for which the application is intended (the concerned Member States or cMS).
The zonal process consists of a zRMS part and a cMS part, that strongly intertwined act together. For information on this process of zonal application and assessment see zonal application Netherlands Rapporteur Member State (NL=zRMS).
The regulation defines 3 zones based on the comparability of the agricultural, phytosanitary and ecological (including climatological) conditions: North, Central and South. The Netherlands is in the Central zone. For climate independent uses (e.g. indoor uses, seed treatment) the zonal partition is not used. For these uses all member states cooperate (“interzonal assessment”).
A company that wishes to place a plant protection product on the market in any EU member State, will first have to ensure that the active substance is approved, and submit a zonal application together with a complete dossier consisting of an active substance dossier for the active substances contained in the product and a product dossier to a Member State of his own choice. This member state will act as the reporting Member State (RMS). The RMS conducts a risk assessment based on active substance data and product data, the proposed instructions for use. The RMS takes a decision to grant or refuse the product authorisation applied for.
Companies can apply for product registration in other Member States at the same time an application for product registration is assessed by the Rapporteur memberstate. An application for authorisation of the product is submitted in a concerned memberstate (cMS), referring to the assessment that is carried out by the RMS (an application in concerned Member State).
Minor uses (art 51, PPPR 1107/2009) can be part of a zonal application.
An application for registration can be submitted at any point after the zonal application for initial authorisation has been granted by a zRMS (see mutual recognition).
Low risk product
An active substance can be approved as a low-risk substance if it meets the regular approval criteria and in addition meets the low-risk criteria as specified in Annex II, point 5 of Regulation (EC) 1107/2009. There are specific criteria for chemical substances and for micro-organisms.
Products that only contain low-risk active ingredients can then be authorised as a low risk plant protection product. Because of their favorable properties low-risk products should be preferred by farmers and other users in their approach to manage pests.
If the active ingredient is approved as a low risk substance under (EC) 1107/2009, the product registration process has a legal timeline of 120 days (Art . 47.3). The Ctgb will apply the same timelines for products based on substances which are mentioned on the list of potentially low risk active substances (Commission notice 2018/C265/02). On this list are active substances approved under Directive 91/414/EEC that are expected to meet the low risk criteria of Article 22 of the Regulation.
Unfortunately Ctgb is not able to realise these reduced timelines (120 days instead of one year) at the moment, however we try to prevent delays in these(inter)zonal product applications based on a (potential) low risk substance.
Not all product applications based on a low risk active ingredient will result in an authorisation as a low risk product. There are additional requirements as mentioned in Article 47. An important prerequisite is that no specific risk mitigation measures are needed following a risk assessment. This holds true for all uses of the product. If one use (e.g. upwards spraying, or the professional use) needs mitigation measures for a safe use, the product won’t be considered low risk. All product application types can result in a low risk product authorization. In the authorisation it will be mentioned that a product is authorised as a low risk product.
The development and placing on the market of low-risk substances and products is encouraged by several regulatory incentives. Low-risk substances are approved for 15 years instead of 10 years and data protection on the studies submitted for the approval and subsequent authorisation is prolonged from 10 to 13 years. The low-risk status of authorised low risk products can be used in advertising.
Please indicate in your application form for a zonal application that the active substance is of low risk, (or mentioned on the list of potentially low risk substances while the substance dossier is not yet renewed). It is recommended that the applicant proposes, where possible, the RMS as zRMS for the low-risk active substance. For the same reason, it is especially important that applicants use, where appropriate, the risk envelope approach when building their dossiers (please refer to guidance SANCO/13169/2010 Rev. 11 for explanation).
Many of the low risk substances (but certainly not all!) are based on a micro-organism, plant extract or pheromone. In these cases the Evaluation Manual Biopesticides is applicable (please keep in mind that also not all biopesticides will turn out to be low risk). For low risk substances based on chemical substances the ‘regular’ Evaluation Manual is applicable.