Renewals of plant protection products based on AIR2, AIR3 and AIR4 active substances follow the zonal procedure.
- Expiration of the PPP authorization in case no application for renewal was or can be submitted
- Administrative extension
Plant protection products are authorised at the national level. The PPPR (EC) 1107/2009 introduced a zonal system, encouraging cooperation and work sharing between Member States with comparable climatic conditions for the evaluation of PPP authorisations. The regulation establishes 3 (climatic/regulatory) zones: North, Central and South. The Netherlands belongs to the Central zone. Applications for climate-independent uses (e.g. greenhouse, indoor uses, seed treatment) should be combined for all 3 zones in an interzonal evaluation.
Per zone, one member state acting as the so-called zonal Rapporteur Member State (zRMS) is responsible for conducting the assessments. Assessment is based on the assessment report prepared by the applicant, resulting in a comprehensive assessment report (draft Registration Report, dRR) for all uses applied for in the zone. The dRR prepared by the zRMS is then given to the other concerned member states (cMS) for commenting. The zRMS finalises the Registration Report (RR) considering the comments received. The finalised RR then forms the base for national product authorisations with complementing assessments for national aspects in the zRMS and cMSs.
The legal base
The legal base for renewal of the authorisation of a plant protection product following active substance renewal, is laid down in article 43 of the PPP Regulation (EC) 1107/2009 and in the EU GD art. 43 PPP renewals (SANCO/2010 13170 rev. 14, 7 October 2016). The zonal procedure is based on articles 33-39 of PPPR (EC) 1107/2009.
Expiration of the authorization in case no application for renewal was or can be submitted
Existing authorisations expire in case no application for renewal is or can be submitted. Read further about timelines of expiration.
Administrative extension of the current authorization of PPPs
In practice the date of expiry of active substances is often postponed by the EC. Therefore, PPP authorizations may need to be extended accordingly, as renewal applications cannot yet be submitted. Also, once an application is submitted, PPPR (EC) 1107/2009, Article 43.6 states that Member States can issue extensions for the current authorization in case the reason for delay in the evaluation process is beyond control of the authorization holder/applicant. Ctgb considers several reasons valid for considering an administrative extension for PPP authorizations around active substance and PPP renewals.
Application type criteria
The procedure for renewal of the authorisation of plant protection products applies to existing product authorisations and existing uses; the reference date is the date of submission of the application, ultimately Date of Application (DoA) + 3 months. Ctgb will not accept a mixed application for new uses or new CMSs (article 33) and renewal of existing uses (article 43).
Ctgb does accept to act as zRMS for renewal of products and uses not currently authorized in the Netherlands but only authorized in other CMSs. However this renewal application cannot be used to seek authorization of new uses in The Netherlands.
Renewal application for each active substance
Application for PPP renewals are triggered by the renewal of the active substance contained in the PPP. Article 43 of PPPR (EC) 1107/2009 states that PPP renewals should be submitted by the applicant within 3 months after the Date of Application (DoA) stated in the EU renewal regulation of the active substance. In case a PPP contains more than one active substance, each individually triggers a separate PPP renewal evaluation after the active substance approval has been renewed. Refer to the EU Pesticides database to check the current status of active substances and follow the official EU publications website (EUR-lex).
The EU GD art 43 PPP renewals makes an exception for PPPs with more than one active substance that are renewed within a period of 12 months. According to the Guidance Document the re-evaluation of such a PPP may be executed with a single dRR and in a single evaluation. For more information see: Renewal for 2 actives in a single evaluation:
Maximum Residue Limits (MRLs)
For use on feed or food crops, an MRL that covers the requested use, has to be established and published in the EU in order to receive an authorization for that use. Applicants are advised to check that authorized uses are covered by the current MRL. See our pages about Application for setting MRL for more information on the options in case (sufficient) MRLs are not yet established.
In the EU Pesticides database MRL's can be found for all crops and all pesticides.
No voluntary amendmends
In contrast with the procedures for PPP reregistration after the first approval of the active substances, the EU Guidance on art. 43 PPP renewals does explicitly exclude any voluntary amendments from the current authorization on a national level, even if the use is already authorized in another member state and included in the Core dossier. This rule can be explained as the evaluation for a renewal is focussing on the changed details of the dossier for only a single active substance, and not on all aspects of the PPP as a whole. Forced amendments are however allowed, in case a product or use otherwise cannot be continued under the new List of endpoints or new Guidance.
In some cases amendments are accepted. Read more about these possible amandments to the authorisation within renewal applications and for alternatives on how to apply for amendments and label extensions.
Duration Period Product Authorisation
PPPR 1107/2009, art.32 gives outlines for the duration of PPP authorizations before and after renewal.
Based on the PPPR (EC) 1107/2009, art.32, and the EU GD on renewal of PPP authorisations, section 3.4, a PPP authorization will expire 1 year after the Date of Application (DoA) stated in the renewal regulation of the first active substance in a PPP, even if the PPP authorization was originally issued for a longer time.
Authorisations may be granted for shorter periods to synchronise the re-evaluation of similar products for the purposes of a comparative assessment of products containing candidates for substitution.
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Coordination zonal applications: Central zone Steering Committee
Ctgb has reserved ample capacity for zRMS renewal dossiers, but ultimately this capacity is limited. In case the workload for Ctgb becomes unbalanced, Ctgb may propose a re-division of zRMS evaluations among member states via the Central Zone Steering Committee (czSC). The czSC may also ask Ctgb to take over zRMS evaluations from other member states within the Central Zone.
For AIR-3 and AIR-4 PPP renewals, the division of PPP renewal evaluations among member states will be coordinated by the czSC through an inventory, and preferably grouped and assigned to the RMS or coRMS for the renewal of the active substance if member of the zone.