Regulation of pesticides in the European Union
A pesticide, also called Plant Protection Product, 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, Regulation. In other words, active substances are the active components against pests and plant diseases.
In the Regulation 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 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 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.
The use of PPPs in the European Union is regulated by the Regulation No 1107/2009 on Plant Protection Products in cooperation with other EU Regulations and Directives ; Regulation.
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 Chemical Agency ; 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 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 should submit a dossier to a 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, acceptable daily intake, genotoxicity testing etc. and RegulationEvaluation by the rapporteur member state
The Rapporteur Member State evaluates the application and shall within 45 days communicate Regulation 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 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.Peer review by European Food Safety Authority and conclusion
’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.
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.
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.
Publication
Based on the review report, a Regulation will be adopted according to the final decision.All approved active substances are included in the Official Journal of the European Union, which contains the list of active substances that have been already approved. The European Commission has subsequently the task of managing and updating the list of approved active substances, which is available online for the public.
Renewing the approval of active substances
Active substances may be approved for a maximum of up to 15 years. This approval period is proportional to the risks posed by the use of these substances.However, when an active substance is considered necessary by the European Commission, it could be approved for a maximum 5 years, even if not all approval criteria of the Regulation No 1107/2009 are met.
At the renewal time, new knowledge regarding the active substance will be taken into consideration.
Procedure of Plant Protection Product approval
The procedure of applying for an authorisation of a PPP begins with the applicant who wishes to produce a PPP. Authorisation for the product must be sought from every Member State that the applicant wants to sell the product to.The procedure and requirements for authorising a PPP are explained below.
Requirements and content
The authorisation of a PPP, its use and placing on the market is done by the Member States. For that, a PPP has to meet specific requirements:- Scientific and technical knowledge of its active substances, synergists, safeners, co-formulants.
- Scientific knowledge regarding toxicological, ecotoxicological and environmental aspects. For instance, the ecotoxicological data required consist of, among others, acute toxicity to fish, aquatic invertebrates or effects on aquatic algae and macrophytes. It also includes studies on earthworms and other terrestrial species and of Regulation No 1107/2009 and Regulation.
- Technical knowledge, including production, use, storage and residue handling.
The authorisation of a PPP shall not exceed one year, counting from the expire date of the approval for the active substances, synergists and safeners contained in the PPP. Re-evaluation of similar PPP for comparative assessment containing candidates for substitution may be granted.
The authorisation procedure of a Plant Protection Product (Pesticides)
The application for authorisation itself contains many parts and it should first and foremost clearly state where and how the PPP should be applied. Secondly, the applicants themselves should specify which Member State they wish, would carry out the evaluation of the PPP. If the PPP previously has been evaluated in another Member State, a copy of the conclusions from that evaluation should be attached. Moreover, the application should be accompanied by several dossiers containing, among other things, ecotoxicological data. One dossier for the PPP itself, and one for each active ingredient in the PPP is required. The applicant should also provide a draft of the product label clearly showing the hazard labels necessary for the specific product. There are several other things an application should include. This is more thoroughly described in Art. 33-35 of Regulation No 1107/2009.The Member State assessing the PPP needs to perform an objective evaluation and allow other Member States to express their opinions. The evaluation results in an authorisation or a rejection of the PPP. This assessment takes many things into consideration. Among others, the Member State specifically looks at all the ingredients in the PPP and assesses whether they are approved for this type of use or not. They further look at if the risks associated with the PPP are limited without compromising the function of the product. If a PPP is given authorisation, it often has certain restrictions regarding the distribution and use, like mentioned in the “Requirements and content” above, in order to protect human health and the environment. If the PPP is shown to pose an unacceptable risk to humans or nature, it is not authorised. No matter what the Member State decides on, they have to justify the outcome of the evaluation in a document and provide it to both the applicant seeking authorisation, and the European Commission.