A pesticide, also called Plant Protection Product (PPP), which is a term used in regulatory documents, consists of several different components. The active ingredient in a pesticide is called “active substance” and these active substances either consist of chemicals or micro-organisms. The aims of these active substances are to specifically take action against organisms that are harmful to plants (Art. 2(2), Regulation (EC) No 1107/2009). In other words, active substances are the active components against pests and plant diseases. In the Regulation (EC) No 1107/2009, a pesticide is defined based on how it is used. Thus, pesticides have to fulfill certain criteria in order to be called pesticides. Among others, the criteria include that they either protect plants against harmful organisms - by killing or in other ways preventing the organism from performing harm, that they enhance the natural ability of plants to defend themselves against these harmful organisms, or that they kill off competing plants such as weeds. Within the European Union (EU) a 2-tiered approach is used for the approval and authorisation of pesticides. Firstly, before an actual pesticide can be developed and put on the European market, the active substance of the pesticide needs to be approved for the European Union. Only after approval of an active substance, a procedure of approval of the Plant Protection Product (PPP) can begin in the individual Member States. In case of approval, there is a monitoring programme to make sure the pesticide residues in food are below the limits set by the European Food Safety Authority (EFSA). The use of PPPs (i.e. pesticides) in the European Union is regulated by the Regulation No 1107/2009 on Plant Protection Products in cooperation with other EU Regulations and Directives (e.g. the regulation on maximum residue levels in food (MRL); Regulation (EC) No 396/2005, and the Directive on sustainable use of pesticides; Directive 2009/128/EC).
These regulatory documents are set to ensure safe use of pesticides in the EU regarding human health and environmental sustainability. The responsible authorities within the EU working with pesticide regulation are the European Commission, European Food Safety Authority (EFSA), European Chemical Agency (ECHA); working in cooperation with the EU Member States. Additionally, important stakeholders are the chemical producing companies, which develop PPPs and active substances that are to be evaluated by the regulatory authorities mentioned above. Conservative Agriculture Spokesman Anthea McIntyre MEP and colleague Daniel Dalton MEP were appointed to the European Parliament's special committee on pesticides on 16 March 2018. Sitting for nine months, the committee will examine the scientific evaluation of glyphosate, the world's most commonly used weed killer which was relicensed for five years by the EU in December after months of uncertainty. They will also consider wider issues around the authorisation of pesticides.
Procedure of active substance approval In the EU, there is a detailed procedure (Regulation (EC) No 1107/2009) to evaluate whether an active substance is regarded as safe for human health and the environment. The procedure of approving new substances follows the steps listed below.
Submission of the application and dossier The first step requires that an applicant (a company or association of producers) should submit a dossier to a Member State (called the Rapporteur Member State) in order to ask for the permission before putting an active substance on the market. The application must contain supporting scientific data and studies (i.e. toxicological and ecotoxicological relevance of metabolites, acceptable operator exposure level (AOEL), acceptable daily intake (ADI), genotoxicity testing etc. (Art. 4 and Annex II of Regulation (EC) No 1107/2009.) and Regulation (EC) No 283/2013)
Evaluation by the rapporteur member state The Rapporteur Member State evaluates the application and shall within 45 days communicate (Art. 9(1) Regulation (EC) No 1107/2009) to the applicant that submitted the dossier. Furthermore, they will check whether the dossier is complete. If elements are missing, the applicant has 3 months to complete the dossier, otherwise the application is not considered admissible. If the dossier is considered admissible, the Rapporteur Member State will notify the applicant and the competent authorities (other Member States, EFSA and the European Commission) and start evaluating the active substance. The applicant will then send the dossier to the three mentioned authorities. Moreover, EFSA will create a summary of the dossier and make it available for the public.
Draft Assessment Report from Rapporteur Member State Within 12 months after the notification of admissibility, the Rapporteur Member State produces a Draft Assessment Report. This report aims to check if the active substance satisfies the criteria for approval listed in the Regulation. This report is submitted to the European Commission and EFSA. If additional information is needed, the Rapporteur Member State will set a period of maximum 6 months for the submission of the revised application. In addition, the European Commission and EFSA shall be informed (Art. 11 Regulation (EC) No 1107/2009).
Peer review by European Food Safety Authority and conclusion European Food Safety Authority’s Pesticides Unit is responsible for the peer reviewing of the risk assessments on active substances. The EFSA is required to provide a conclusion on whether the active substance satisfies the criteria for approval. When the Draft Assessment Report from the Rapporteur Member State has been received by EFSA, the report will be shared among other Member States and the applicant within 30 days after it has been received, and it shall be made available for the public (Art. 12 Regulation (EC) No 1107/2009). The applicant, the Member State and the public have 60 days to provide comments. After that, EFSA has 120 days to submit a conclusion and forward it to the applicant, the Member States, and the European Commission. The EFSA will also make the conclusion available to the public (Art. 12 Regulation (EC) No 1107/2009). After the conclusion of EFSA, the European Commission presents a review report to the Standing Committee for Food Chain and Animal Health. This standing committee votes on approval or non-approval of the active substance.
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