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 theDraft 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 thePeer review by European Food Safety Authority and conclusion
Publication
Based on the review report, a Regulation will be adopted according to the final decision (i.e. whether the substance is approved, not approved, or the application should be modified). All approved active substances are included in theRenewing 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 theProcedure 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 (Art. 29(1) and (2) of Regulation (EC) No 1107/2009 and Regulation (EC) No 284/2013). *Technical knowledge, including production, use, storage and residue handling. Moreover, in the authorisation it is necessary to define elements in which the PPP may be used. This includes, among others, non-agricultural areas, plant products or plants, and their purpose. Other information that can be included, cover the maximum dosage per hectare in each individual application, the period of time between the most recent application and harvest, and the maximum application numbers each year. 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 (see section “Requirements and content” above). 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 (EC) 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 (Art. 36-38 of Regulation (EC) No 1107/2009).Mutual recognition
A company or organization in possession of a valid authorisation for a PPP can apply for mutual recognition and obtain the approval for such products with the same use(s) under similar agricultural conditions. Requirements, contents and procedures for the recognition are stated in Articles 40-42 of Regulation (EU) 1107/2009. Mutual Recognition can only be applied if there is an existing authorisation for the PPP in another Member State. Applications can be made through the Plant Protection Products Application Management System for products that have been authorised via the system. Some parts of the application procedure are managed and handled outside of the Plant Protection Products Application Management System by manual or electronic processes in the Member States. The Plant Protection Products Application Management System is an online tool, thought to enable industry users to create applications for PPPs and submit these to Member States for evaluation and authorisation. The objectives of the system are: help harmonising the formal requirements for application among Member States, facilitate mutual recognition of authorisations between Member States in order to speed up time to market, improve the management of the evaluation of the authorisation process as wells as providing correct information to stakeholders on time.Renewal, withdrawal and amendment
After an active substance has been re-approved for use, all PPPs containing this active substance also have to be re-approved within three months. If the applicants do not hand in a re-application, their authorisation for the product will expire in accordance to Art. 32. If expired, the PPP is allowed to stay on the market for sale up to six months, and allowed to be stored and disposed up to a year. To re-apply for authorisation the applicant has to provide a Renewal Assessment Report which shall contain any newly submitted data supporting the re-approval, as well as the original data if still relevant. The Member States also conduct this evaluation, but in the future this will be done through the Plant Protection Products Application Management Systems. Any holder of authorisation can choose to withdraw or amend its application at any time, though the reason why should be stated. If there are acute concerns for human, animal and/or environmental health the PPPs should be immediately withdrawn from the market. A withdrawal can also be made on the base of false and misleading informations, and/or on improvements in scientific and technological knowledge. All information about renewal, amendment and withdrawal can be found in Art. 43 - 46 of Regulation 1107/2009.Special cases
When all active substances in a product are considered as low-risk active substances, a PPP will be approved as a low-risk PPP, except risk mitigation measures are required. The applicant of a PPP must demonstrate that all criteria for a low-risk PPP are met (Art. 47 of Regulation (EC) No 1107/2009). Among others, the criteria for consideration of low-risk active substances include not being classified as mutagenic, carcinogenic, toxic to reproduction, very toxic or toxic. Furthermore, they must not be persistent, deemed as endocrine disruptor or have neurotoxic or immunotoxic properties (Art. 47 and Annex II of Regulation (EC) No 1107/2009). Applicants are encouraged to make use of this special case through a prolonged approval duration of 15 years and the possibility of a fast-track authorisation in 120 days instead of one year to facilitate the placement on the market of such PPPs. Plant Protection Products comprising a genetically modified organism will also be examined in accordance to Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment. An authorisation will only be granted, when a written consent referring to this Directive is approved (Art. 48 of Regulation (EC) No 1107/2009). The use and placing on the market of PPP-treated seeds is regulated through Art. 49 of Regulation (EC) No 1107/2009 and will not be prohibited, when authorisation is granted by at least one other Member State. But, when there is substantial concern that PPPs from treated seeds pose a serious risk to animals, humans or the environment, and no adequate mitigation measures are available, measures will be taken immediately, that is restricting or prohibiting the use of the respective PPP. For PPPs containing candidates for substitution, a comparative assessment will be conducted. An authorisation will not be granted where the assessment of risks and benefits concludes that – among others – a substitution of the PPP is significantly safer for the environment, humans and animals, and not economically or practically disadvantageous (Art. 50 of Regulation (EC) No 1107/2009). An applicant may ask for an extension to minor uses of PPPs (Art. 51 of Regulation (EC) No 1107/2009). This procedure is a facilitated way for the authorisation of a PPP. Lists on what minor uses in a specific Member State are provided by the European Minor Uses Database (EUMUDA). A PPP already approved in one Member State will be permitted for parallel trade, thus the introduction, placement on the market, and uses in another Member State. Following Art. 52 of Regulation (EC) No 1107/2009, the application will be authorised - provided the applicant demonstrates that the PPP meets the requirements to be identical to the already authorised one.Derogation
By partial suppression of Article 28, which states that a PPP will not be marketed or used in a Member State without authorisation, derogation states that such a PPP can be used under limited and controlled conditions where it appears necessary. A Member State authorising such a product will inform other Member States with detailed information that led to such a decision. It may be for purposes of research and development (Art. 53, 54 Regulation (EC) No 1107/2009).Use and information
To ensure that PPPs are handled properly, a considerable amount of information is to be provided by the holder of an authorisation for such a product (Art. 56 Regulation (EC) No 1107/2009). New information on potential harmful effects on human or animal health concerning the PPP itself, its active substances, any associated metabolites, safeners or co-formulants have to be reported immediately to the Member State(s) that granted its authorisation. In such a case, it is up to the first Member State in a zone that granted the product's authorisation to evaluate and assess this information and come to a decision whether the product should be withdrawn or its conditions for use should be amended. The same Member State is also responsible for communicating this information to other Member States that might be concerned. Information on PPPs authorised for use or that have been withdrawn shall also be available to the public in electronic form and updated every three months. This information shall at the very least include the business name of the holder of the product's authorisation, the trade name of the product, its type of preparation, its composition, its authorised uses (including minor uses) and its safety classifications. As well as this, information on withdrawal of a product's authorisation should be provided to the public if it is related to safety concerns.Monitoring of Plant Protection Products
Monitoring of pesticide residues in food products
In order to protect human health and the environment, monitoring of PPP residues in food is a crucial step. With this process the EU can check the prediction of the safe use of respective PPPs. In September 2008, the European Union issued new and revisedHow Maximum Residue Levels are monitored
The monitoring of the determined Maximum Residue Levels (MRLs) of pesticides in food is the duty of the responsible authorities of the Member States. In addition to the national monitoring programmes, all reporting countries are requested to monitor and analyse food products and processed cereal-based baby food according to the Regulation ((EU) No 400/2014) for the European monitoring programme. Annually, the EFSA is modelling and assessing the risk of residues of pesticides in food. In this process, short-term (acute) exposure and long-term (chronic) exposure scenarios are analysed. A risk assessment based on a short-term exposure includes mainly the comparison of the estimated uptake and/or exposure of pesticide residues via food in a short time period (one meal or within 24-hours). The chronic risk assessment is the estimated uptake and/or exposure levels of pesticide residues via food for a long-term period (predicted lifetime of a human). The evaluated data from the calculation models are compared to the experimental data (ecotoxicological reference data) for acute and chronic toxicity, to establish a safe level for human health. There is not a high probability of health risk for consumers if the modelled values are equal or lower than the reference data. The modelling starts with a conservative approach (e.g. consumers do not wash and/or cook the products) which may result in an overestimation of the actual toxicity of the respective pesticide.Results of recent (2015) Maximum Residue Level monitoring
Recent results of the European monitoring programme were presented byMonitoring of pesticides in the environment
The concentrations of pesticides alongside other chemical substances that pose a significant risk to the environment or to human health in surface waters in the European Union are limited to Environmental Quality Standards. These are defined in the Directive on Environmental Quality Standards in the Field of Water Policy. This Directive covers a total of 45 priority substances as defined by theReferences
{{ReflistFurther reading
* SAPEA. (2018) Improving Authorisation Processes for Plant Protection Products in Europe: A scientific perspective on the assessment of potential risks to human health. doi:10.26356/plantprotectionproducts