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Plant Protection Products (PPPs) are preparations containing at least one active substance intended for protecting plants or plant products against pest and diseases, promoting or regulating plant life processes, preserving plant products and controlling weeds growth.
Before a PPP may be authorized at Member State (MS) level and placed on the market, the active substances contained in the formulated product must be approved at European Union (EU) level.
The evaluation of the active substance is carried out by the Authority of a designated Member State (RMS) which arranges a Draft Assessment Report (DAR) of the data submitted.
EFSA peer-reviews the report and presents its conclusions to the Standing Commitee of Food Chain and Animal Health, formed by MS experts, which votes on the approval.
After the EU approval of the active substance, the data concerning the formulated product containing the approved active substance has to be considered. Each MS, where the product use is required, takes the decision to give the full or conditional authorization or not to grant it. The evaluation process for the authorization is based on the EU harmonized principles taking into account specific and local situations.
The "new" Regulation (EC) N. 1107/2009 entered into force in June 2011 and it lays down harmonized rules for the approval of active substances and the placing on the market of PPPs. The main changes introduced are the cut-off criteria for an exclusion beforehand of the hazardous substances, a simplified authorization procedure for the substances identified as low risk and the zonal authorization of the products for the mutual recognition in the EU MSs. The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community. To facilitate such mutual recognition the European Commission was divided into 3 zones with comparable conditions, thus, the authorizations granted by one MS should be accepted by other MSs where agricultural, plant health and environmental (including climatic) conditions are similar, avoiding any work duplication and providing more harmonized availability of PPPs. The aim of this Regulation is to ensure that active substances and products do not have any harmful effect on human or animal health or any unacceptable effects on the environment preserving meantime the competitiveness of European agriculture.
Biopesticides are PPPs which contain Biological Control Agents (BCAs) as microbials, pheromones and plant extracts (botanicals).
The actual demand to use environment-friendly methods to control plant pests and diseases has resulted in an increase of the Biopesticides market. Biopesticides are typically used in combination with conventional chemical pesticides in the framework of the Pest Integrated Management (IPM) in order to safeguard the health of the roots, the plant growth, the quality of the crop, to reduce the occurrence of resistance and to lower residue levels.
Biopesticides, as PPPs, fall within the scope of the Regulation (EC) N. 1107/2009, nevertheless the risk assessment methodologies used for chemicals substances are not fully adapted to the very complex task of evaluating the safety and risks concerning such living substances and there is the need to develop a guidance on how to conduct risk assessment of BCAs. BioTecnologie BT has 20 years experienced in the research and development of Biopesticides. As a matter of fact, BioTecnologie B.T. was born as a company dealing with the research of microbiological new active ingredients (bacteria, viruses, yeasts) for use in agriculture. For this reason our laboratories can support Companies with the registration iter of a Biopesticide: from the characterization of the active substance (identification and effectiveness assessment), passing by the development of fermentation and formulation processes, to GLP services.