Evaluation and Authorization Procedures for Plant Protection Products

Overall educational project objective

Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market* has introduced a new legal framework in Europe for the assessment and approval of active substances and for authorisations of plant protection products containing them. Among the main provisions introduced: a full harmonisation for risk assessment, decision making, strict criteria for approval of active substances, the substitution principle to be applied to the substances identified as candidates for substitution, incentives for low risk active substances, the zonal system for the assessment and authorisations of plant protection products and the mutual recognition of such authorisations with strict deadlines.

Despite above-mentioned Regulation is fully applicable since June 2011, in several areas of risk assessment national requirements are still substantially hampering the functioning of the zonal system and the respect of set deadlines. The lack of proper implementation of zonal system and mutual recognition is thoroughly described in the recently published Overview Report on Plant Protection Products authorisations (SANTE/2017/6250**) where it is concluded "the majority of Member States fail to use the zonal authorisation system as envisaged in the regulation and fail to comply with almost all legal deadlines".

Currently, the degree of harmonisation is low concerning the mitigation techniques and measures available in the different Member States, their use by the Competent Authorities in granting authorisations and their documentation on the label. A legal obligation to notify PPP-specific, additional, national safety phrases ('precautionary statements' under GHS) to the Commission seems to be largely ignored by Member States, as so far only two of them have done so.

Therefore training is an essential tool in order to improve the spreading of knowledge and awareness and to promote a common understanding of the operation of EU and national control systems.

The workshops will allow an analysis and exchange on risk assessment methodologies applied at national level for the assessment of plant protection products and authorisations process performed in accordance with Uniform principles set under Regulation (EU) No 546/2011.

The environmental risk mitigation measures included in the risk assessment to define at higher tiers the safe use are fundamental to define the conditions for use of pesticides in each crop. Indeed, once defined they become part of the authorisation conditions and have to be reported on the labelling of the products in  the form of Safety Precaution Phrases (SP-phrase), according to Regulation (EU) No. 547/2011.

In this context, a part of the workshop will follow up on the results of MAgPIE project which provides the toolbox of risk mitigation measures designed for the use on the pesticides for agricultural purposes.

This course will generally focus on:

• deepen how Member States and/or zones implement the Uniform principles for evaluation and authorisation of plant protection products,

• examine national risk assessment methodologies and identify which degrees of flexibility in the model used could still be adjusted to not undermine potential mutual recognition,

• examine some specific cases of risk reduction goals deriving from the risk assessment and how they are pursued through identification of effective risk mitigation measures,

• compare and discuss possible equivalent risk mitigation measures,

• exchange on experience gained in implementing the Guidance SANCO/11244/2011 rev. 5 on the preparation and submission of dossiers for plant protection products according to the “risk envelope Approach”.  

The training sessions will be addressed to risk assessors and risk managers from the competent authorities of the Member States.