Pesticide active substance and MRL application procedures

EU legislation explains the overall process, the steps in the authorisation procedure, and subsequent marketing of the product.

Legislation

• Regulation EC 1107/2009 concerning the placing of plant protection products on the market including basic substances
• Regulation EU 2020/1740 on the provisions for the implementation of the renewal procedure for active substances (repealing Regulation EU 844/2012)
• Regulation EU 284/2013 on data requirements for active substances, in accordance with Regulation EC 1107/2009 concerning the placing of plant protection products on the market
• Regulation EU 2021/428 adopting standard data formats for the submission of applications for the approval or the amendment to the conditions of approval of active substances
• Regulation EU 546/2011 implementing Regulation EC 1107/2009 as regards uniform principles for evaluation and authorisation of plant protection products

For Maximum Residue Levels (MRLs) you should check:

• Regulation EC 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin

It is also relevant to check the EC overview on the authorisation process. For any question on the authorisation and the legislation, please contact the sante-consult-e4 [at] ec.europa.eu (European Commission).

Please be aware that we are required by law to make the non-confidential version of your application publicly available in the course of the application process and to hold a public consultation. Consult this page for information on how to request confidentiality for specific information in your application.

Administrative guidance

EFSA’s administrative guidance documents describe in detail all the phases of the application life-cycle, from pre-submission to the conclusion of the evaluation. They specify the administrative requirements for preparing and submitting an application and provide practical tips and tools to support this process.

• Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances on the maximum residue level (MRL) application procedure (updated 3 June 2024)  

N.B. We regularly update our administrative guidance documents to take account of new working practices. Please check that you use the latest version of these documents before applying!

Scientific guidance documents tell you what scientific data and other information you need to include in your plant protection product application dossier.

Scientific guidance

An application dossier needs to contain information on the active substance under approval and on the formulated product for which the authorisation will be sought.

When preparing a dossier, you should consult the Commission’s database, which contains guidance documents, test methods and supporting documents relevant for the risk assessment processes for the (renewal) of approvals of chemical and microbiological active substances and for authorisations of chemical and microbiological plant protection products.

• EC guidance document database on Active substances (European Commission’s Standing Committee on Plants, Animals, Food and Feed – phytopharmaceuticals)

Revised scientific criteria for the determination of endocrine disrupting properties (ED) were introduced by Regulation EU 2018/605. As a consequence, all dossiers and assessment reports (DAR/RAR) must include an assessment of the substance’s ED properties. EFSA carries out an assessment to decide whether the ED criteria are met. You can read the ED procedure for new active substances here. The procedure for renewals is outlined in Regulation EU 2018/1659.

The overview of ED assessment of pesticide active substances is provided in a dedicated report, which is regularly updated and published on our website.

There are many additional resources that are relevant when preparing the scientific information to include in an active substance approval or renewal of approval dossier:

• Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods (published 23 April 2019)
• Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods (published 22 September 2025)
• Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology risk assessment (6 April 2020)
• Outcome of the pesticides peer review meeting on general recurring issues in ecotoxicology risk assessment (8 July 2019)
• Outcome of the Pesticide Peer Review Meeting on general issues for microorganisms (Fate-Ecotoxicology joint session) (1 April 2025)
• Recommendations on the use of the proportionally approach in the framework of risk assessment for pesticide residues (14 November 2018)
• Outcome of the pesticides peer review meeting on the OECD 106 evaluators checklist (20 November 2017)
• JRC FOCUS (the Forum for Co-ordination of pesticide fate models and their Use) webpage

For maximum residue levels you should check:

• EC guidance documents on MRLs (European Commission’s Standing Committee on Plants, Animals, Food and Feed - phytopharmaceuticals)

N.B. We sometimes update our scientific guidance documents to take account of new science, tools and working practices. Please check that you use the latest version of these documents before applying!

We strive for a customer-oriented approach and provide a range of support services, which are available to you throughout the application process – from pre-submission to post-adoption:

• Services to applicants – from pre-submission advice and responses to queries and clarification teleconferences at various stages of the application process.
• SME support services – in addition to the services for all applicants, we offer a range of services dedicated to Small and Medium-sized Enterprises (SMEs) preparing and submitting applications, including fast-tracking of queries and support for using IT tools.
• Frequently Asked Questions – to clarify any doubts about the applicable procedure.

• International Uniform Chemical Information Database (IUCLID) – a software application for recording, storing, maintaining and exchanging data on intrinsic and hazard A substance or activity which has the potential to cause adverse effects to living organisms or environments properties of chemical substances, and the standard data format agreed for pesticide applications.  

You need to create a legal entity to prepare your application for submission. The application is then submitted through the submission portal. Follow the instructions in the IUCLID manuals to learn how to proceed. A training course for applicants is also available.

Follow the steps described in the administrative guidance and ensure you provide scientific information in line with the requirements described in the legislation and scientific guidance. 

Exposure assessment One of the key steps in risk assessment, this relates to a thorough evaluation of who, or what, has been exposed to a hazard and a quantification of the amounts involved tools

Estimating the chronic and acute dietary consumer exposure to pesticide residues is a necessary step for the dietary risk assessment of maximum residue levels (MRLs). We provide a tool to help you do this – the Pesticide Residue Intake Module (PRIMo) is based on national food consumption data and implements methodologies to assess the short-term (acute) and long-term (chronic) dietary consumer exposure.

When preparing an application, it is also important to assess the exposure of operators, workers, residents and bystanders to pesticides. We provide you the OPEX calculation tool in an annex to the guidance document on non-dietary exposure to pesticides. The calculator provides real-time estimates of non-dietary exposure under specific conditions for the different population Community of humans, animals or plants from the same species groups.

Harmonising the calculation of predicted environmental concentrations (PEC) of active substances is also a necessary step. For this purpose, the Forum for the co-ordination of pesticide fate models and their use (FOCUS DG SANTE) was created.

How does it work? FOCUS simulation models and scenarios help you calculate the concentrations of plant protection products in groundwater and surface water. You can obtain the currently approved versions of the models and scenarios at this link.

Hazard assessment part of a risk assessment that involves identifying and characterising potential hazards associated with biological, chemical and physical agents that may be present in food tools

When preparing your application, you will also need to calculate dermal absorption from in vitro Research method which involves testing cells or tissues extracted from living organisms studies. The guidance document on dermal absorption includes in an annex, a calculation tool available as a free download, provided by the German Federal Institute for Risk Assessment (BfR).

Assessing the risk of plant protection products and bees is also a necessary step during the scientific risk assessment. To achieve this, the guidance document suggests a tiered approach A way of organising toxicology assessments to maximise efficiency and minimise the use of animals. It involves a hierarchy (tiers) of tests, starting with those that use existing information or simple biological methods before moving onto tests using cells and eventually live animals only as necessary. Annexed to the guidance, there is a calculation tool that helps you provide the necessary data for the screening step of the first tier of the process.

When preparing an application under Regulation EC 1107/2009 or Regulation EC 396/2005, you are required to provide data on metabolism The total sum of physical and chemical processes that occur within living organisms for residues and mammalian toxicology. We provide a tool to help you do this – the MetaPath composer software has been developed to collect, organise and analyse experimental data on metabolism or catabolism, observed biotransformation pathways and crucial supporting metadata. This tool allows you to build custom databases and import existing ones, such as EFSA’s public MetaPath database.

The submission process takes place entirely online. Once you have created your application and uploaded all the required information and documents, your application is ready for submission. The application is submitted to the competent authority of an EU Member State of your choice. You can consult the list of competent authorities at this link.

Before submitting your application, it is important that you follow two verification steps that will help you successfully complete your submission:

• Run the validation assistant in IUCLID to ensure that your dossier is complete. This tool will also be used by the MS during the admissibility check so you should ensure you address any warnings that it highlights
• Run the Dissemination preview in IUCLID and generate an advanced copy of the filtered dossier. This will enable you to cross-check that no confidential business information will be disclosed when your dossier is published

Once you’ve submitted your application, the RMS/EMS performs the admissibility check and verifies the notified studies. The RMS/EMS may contact you to request further information if anything is missing or incorrectly submitted. This may also include additional information needed in relation to confidentiality and sanitisation.

When the application is considered complete, the RMS/EMS notifies the applicant, EFSA, the Commission and the other EU Member States of the admissibility of the application.

After the application is declared admissible, the RMS/EMS assesses your application. During this phase, we hold a public consultation on the non-confidential version of your application dossier on Connect.EFSA.

If the RMS/EMS requires additional information during the risk assessment, you will have to update your IUCLID dossier. Once the RMS/EMS assessment is finalised and an Assessment Report (DAR/RAR) with the outcome of the risk assessment is drafted, this is made available to EFSA and checked for completeness. 

Together with the DAR/RAR, the RMS is strongly encouraged to submit a proposal for Harmonised Classification and Labelling (CLH) of your active substance to ECHA, to allow alignment of EFSA’s peer review and ECHA’s classification. 

In the case of a MRL application, the EMS drafts an Evaluation Report with the outcome of the exposure assessment and recommendations on the setting of MRLs, that is made available to EFSA. 

When the assessment report is considered complete, our scientists perform a peer review of the assessment report in consultation with experts from the Member States. During this phase we launch a consultation on the assessment report with the public, the applicant and the Member States.

You can monitor the progress of your application on our Open.EFSA Portal, a publicly available platform where users can follow the life cycle of all our ongoing and completed scientific activities.

During the peer review phase, our scientists may require additional information from you. If we request additional information, the clock is stopped to allow you time to provide it.

The peer review is complete when EFSA issues a conclusion which describes the outcome of the peer review process. 

EFSA in cooperation with the EMS assesses the application, performs a consumer risk assessment and determines the recommended MRLs.  

You can monitor the progress of your application on our Open.EFSA Portal.

During the assessment, our scientists may require additional information from you. If we request additional information, the clock is stopped to allow you time to provide it.  

EFSA’s assessment is complete when EFSA delivers an opinion on the risks associated with the setting, modification or deletion of an MRL.