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Food Safety

Approval of active substances

Approval of pesticides and herbicides in the EU:

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About Approval

A plant protection product ("pesticide") usually contains more than one component. The component that works against pests/plant diseases is called an "active substance". Active substances can be chemicals or micro-organisms.

Active substances can only be approved for use in plant protection products if they fulfil the approval criteria that are laid down in Regulation (EC) No 1107/2009.

You can search here for active substances, safeners and synergists.

The Member States, the European Food Safety Authority (EFSA) and the Commission evaluate every active substance for safety before it can be placed on the market and used in a plant protection product.

At least one use of the substances in plant protection products must be proven safe for people's health, including their residues in food, for animal health and must not have any unacceptable effects on the environment before a substance can be approved, where relevant subject to conditions or restrictions. Companies may apply for amendments of conditions of approvals, which follow the same regulatory process.

The initial approval of an active substance is valid for a limited period and the approval of an active substance needs to be reviewed periodically. A renewal of approval is only granted after the substance is re-evaluated and at that occasion, at least one safe use of the substance is demonstrated.

The details of the renewal procedure are set out in Commission Implementing Regulation (EU) No 2020/1740 – that applies as from 27 March 2021 and replaces the previous procedure under Implementing Regulation (EU) No 844/2012.

All approved active substances are listed in Implementing Regulation (EU) No 540/2011 and included in the EU Pesticides Database. A Review or Renewal Report is also prepared for each active substance during the decision-making process, providing details of the evaluation process and outcome. These reports are also available in the database.

Depending on their characteristics, some active substances can be approved as so-called low risk substances or as candidates for substitution.

Once active substances are approved, companies can submit in the Member States applications for authorisation for placing on the market and use of plant protection products containing them.

A specific procedure is set out for the approval of so-called basic substances.

Before submitting an application, check whether your substance and its claimed function(s) are falling under the scope of (EC) Regulation No 1107/2009.

Procedural Steps

  1. An application for approval (or amendment of approval) is submitted in accordance with the applicable procedural rules to a Member State (the Rapporteur Member State (RMS)), which may be supported by a co-rapporteur Member State(co-RMS). The producer of an active substance applying for first EU approval can choose the RMS and should contact the national competent authority well before submitting an application. Member States may recover the costs associated with any work they carry out, by means of fees or charges.
  2. Prior to submission of the application, the applicant may request general pre-submission advice from EFSA and the RMS and must notify studies that it commissions or carries out. EFSA recommends submitting the request at least six months before the envisaged submission date of the application. Applicants (and laboratories) must notify information on studies commissioned or carried out to support a future application.
  3. In accordance with Implementing Regulation (EU) 2021/428, applications (dossiers) have to be submitted via IUCLID format, which allows to share them with Member States, EFSA and the Commission. Dossiers must comply with the data requirements set out in Regulation EU 283/2013 and its associated Communication and Regulation 284/2013 and its associated Communication, as last amended.
  4. After submission, the RMS verifies if the application is admissible ("admissibility check");
  5. The RMS prepares a draft assessment report (DAR) and delivers it to the European Food Safety Authority (EFSA) for peer-review. If necessary, the RMS can request the applicant to provide additional information during the evaluation. According to the legislation, the RMS has to submit its assessment to the Commission and to EFSA 1-1.5 years after the admissibility of the application for a first approval or 13 months for a renewal of approval. There is a common structure for the DAR/RAR agreed by the EU and OECD. The template can be found on the guidelines webpage;
  6. EFSA coordinates the peer-review process, which begins with a public consultation on the DAR prepared by the RMS. The applicant, EFSA and all Member States also comment on it;
  7. EFSA may organise expert discussion on aspects of the assessment and, if necessary, request the applicant to provide additional information in accordance with the rules laid down in the EU legislation;
  8. EFSA issues its conclusions on whether the active substance may be expected to meet the approval criteria;
  9. Based on the conclusions of EFSA, the assessment of the RMS, and other legitimate factors the Commission puts forward a draft Regulation for approval or non-approval and an accompanying Review Report;
  10. The Standing Committee on Plants, Animals, Food and Feed (ScoPAFF - made up of representatives from each EU Member State) delivers its opinion on the proposal put forward by the Commission;
  11. Following a favourable opinion of SCoPAFF, the Commission adopts the Regulation, which is published in the EU Offical Journal.
  12. The producer of an active substance applying for first EU approval can choose the RMS and should contact the national competent authority well before submitting an application.

According to the timelines set out in Regulation (EC) No 1107/2009, completing the evaluation of applications for first approval of an active substance should take between 2.5 to 3.5 years from the date of admissibility of the application to the publication of a Regulation on the approval or non-approval of the active substance.

However, experience has shown that the procedure on average takes 3 years and 7 months.

For renewals of approval, applications must be submitted at the latest 3 years before the expiry of the current approval of the active substance.

In May 2020, the Commission published a report on the evaluation of the EU legislation on plant protection products and pesticides residues.

Candidates for Substitution

Active substances with certain properties defined in Regulation (EC) No 1107/2009 are considered as candidates for substitution.

For plant protection products (PPPs) containing these active substances, Member States are required, when assessing an application for an authorisation, to evaluate if they can be replaced (substituted) by other adequate solutions (chemical or non-chemical).

Since 2015, substances that have been approved for the first time, under Regulation (EC) No 1107/2009, or for which the renewal of approval was granted, as candidates for substitution, are listed in Part E of the Annex to Regulation 540/2011.

In time, Part E will identify all substances that are candidates for substitution. Therefore, the first list that identified substances that are candidates for substitution in 2015 will become obsolete.

Currently, Part E and the first list should be considered together for a complete view of the candidates for substitution.

More information on the process for the establishment of the first list of active substances that are candidates for substitution can be found below:

Basic substances

Basic substances are active substances, not predominantly used as plant protection products but which may be of value for plant protection and for which the economic interest in applying for approval may be limited.

Criteria for their approval are laid down and specific provisions are set to ensure that such active substances, as far as they do not have an immediate or delayed harmful effect on human and animal health nor an unacceptable effect on the environment, can be legally used in the EU after having been approved as "basic" under Regulation 1107/2009.

Substances that have been approved as basic substances are listed in Part C of the Annex to Regulation 540/2011 and included in the Pesticides Database. Substances for which the dossier has been considered valid, but the approval is still pending, are also included in this database.

A summary of the approved uses and conditions of approval, such as the purity and the preparation to be used, for a basic substance can be found in the Review Report for each substance. This report is uploaded on the page showing the details of that substance in the database.

Applications concerning basic substances have to be submitted using the IUCLID format via the EFSA submission portal.

The rules governing the procedure of approval apply as set out in the following document: Working document on the procedure for application of basic substances to be approved in compliance with Article 23 of Regulation (EC) No 1107/2009; SANCO/10363/2012 rev.11

In accordance with the provisions set out in the General Food Law, applicants for basic substance approvals may request general and non-committing pre-submission advice from EFSA. EFSA recommends submitting the request at least six months before the envisaged submission date of the application.

Applicants (and laboratories) must submit information on studies commissioned or carried out to support a future application.

Further information on pre-submission advice, notification of studies and on confidentiality can be found in the EFSA Practical Arrangements.

The Commission checks if the applicant has fulfilled all required pre-submission requirements, and has provided all required tests and study reports before confirming that the application is valid.

Renewal of approval

Active substances are first approved for up to a maximum period of 15 years (depending on the type of substance). Approval may be renewed for a period not exceeding 15 years upon application.

The rules governing the renewal of approval of active substances have been revised in order to align them with the provisions of the Transparency Regulation

Read more

A non-paper on possible options for obtaining studies submitted in previous dossiers, for use as required under Commission Implementing Regulation (EU) 2020/1740, was endorsed by the Standing Committee on Plants, Animals, Food and Feed in January 2024.

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Guidelines for preparing applications for the approval or renewal of approval of Active Substances

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