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Registration of Plant Protection Products in Slovenia and the EU


The Ministry of Agriculture, Forestry and Food (MAFF), Administration of the Republic of Slovenia for Food Safety, Veterinary and Plant Protection, in cooperation with the Office of the Republic of Slovenia for Chemicals, is the responsible body for registration, trade and use of plant protection products (PPPs) in Slovenia.

Following authorization, MAFF has authorized IHPS on the basis of the Law on Plant Protection Products (Official Gazette of RS, no. 83/12) for the purpose of registration of PPP in Slovenia and the EU, for the expert task of evaluating PPP, which is carried out in accordance with Directives of the European Union, such as Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117 / EEC and 91/414 / EEC.

In the process of authorisation of PPP (plant protection products) application and efficacy data are assessed. In this context, in addition to preliminary tests, the minimum effective dose and effectiveness of PPP to control individual harmful organisms, as well as the potential effects on the yield and quality of the treated crops are assessed. In addition, the phytotoxicity to the treated plants, undesirable and unintended side effects of PPP, and risk to resistance development are verified.

Based on the above mention parameters the nature and benefit of using the PPP is assessed. The assessment is done at the national level or in relation to the zonal division of Europe.

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The assessment of Application and Efficacy Data of PPP (plant protection products) includes an assessment of the following areas:

  • Data on application
  • Preliminary tests
  • Minimum effective dose
  • Efficacy tests
  • Effects on yield and quality
  • Phytotoxicity to host crop
  • Side effects
  • Resistance development

Before a pesticide is approved, the risk to non-target organisms has to be assessed. This assessment, if it is positive, ensures that there are no significant long term changes to the population or to the function of the ecosystem.

Certain other effects may also be unacceptable, e.g., vertebrate mortalities. The information provided must be sufficient to allow an assessment of the impact on non-target organisms likely to be at risk from exposure to the active substance and relevant metabolites.

The environmental fate and behaviour of pesticides can be thought of simplistically as the effect that the environment has on the pesticide, and where the pesticide and its breakdown products go in the environment after application.

Three key elements for assessing the potential environmental contamination from the pesticide are:

  • the routes and rates and dissipation of an active substance (a.s.) and its metabolites in the environment
  • the mobility/transport of the a.s. and metabolites in the environment
  • the likelihood and levels of exposure in the various environmental compartments from the proposed use(s).

For authorisation of plant protection products within the European Regulatory system, the data requirements were first defined in Commission Directive 95/36/EC of 14 July 1995 amending Council Directive 91/414/EEC[1].  Plant protection products are regulated in the EU by Regulation (EC) No 1107/2009[2], which repealed and replaced Council Directive 91/414/EEC on 14 June 2011.

The environmental fate and behaviour data requirements under Regulation (EC) No 1107/2009[3] are as follows:

  • Active substance data requirements are presented in Regulation (EC) No 283/2013[4] with data requirements as well as test methods and guidance documents[5].
  • Product data requirements are presented in Regulation (EC) No 284/2013[6] with data requirements as well as test methods and guidance documents[7].

The output from the fate and behaviour assessment is used to inform risk assessments performed by other specialist evaluators (for example, ecotoxicology and consumer exposure).  These outputs are typically Predicted Environmental Concentrations (PEC’s) in soil, surface water (water and sediment), groundwater and air.

A number of environmental exposure modelling tools and guidance documents for use in the EU have been produced by the FOCUS initiative, (FOrum for the Co-ordination of Pesticide Fate Models and their USe[10]), the goal of which has been to develop standardised worst-case scenarios relevant to EU agriculture, for use with computer modelling, to provide exposure estimates in various environmental compartments.

Assessment of physico-chemical and technical properties of active substances and plant protection products includes an overview of the basic parameters, such as appearance, acidity, oxidation potential, explosive and fire safety features, all of which have a potential impact on humans and the environment in which preparations are used. At the same time, an assessment is made of the technical characteristics of products that affect correct and efficient application in practice. The stability of the active substances and preparations, including the original packaging when stored in different periods and in different environmental conditions, is also checked.

Evaluation in the field of analytical methods for appraisal of the analytical methods intended for identification and monitoring of relevant residues in human food and animal feed of plant and animal tissues and in environmental samples of water, soil and air.

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