Risk assessment and approval of active substances

Approval can only be issued for active substances used in plant protection products that are safe to health and the environment.

The risks of active substances used in plant protection products are assessed and the active substances are approved within the EU. One EU Member State prepares a draft assessment report of the active substance and proposes its approval or non-approval. Other Member States have the possibility to comment the draft assessment report and the draft report can also be reviewed by consultations of experts organised by the European Food Safety Authority (EFSA), where appropriate. The assessment process is concluded in accordance with the uniform principles for evaluation and authorisation of plant protection products pursuant to the European Plant Protection Product Regulation.

Based on the discussions in the consultations of experts, EFSA issues its conclusions on the assessment report. Based on the conclusions, the EU Commission proposes approval or non-approval of the active substance. The Member States vote on the proposal.

The approval of an active substances is granted for a defined number of years after which they must be re-evaluated.

The active substance must be authorised within the EU before a Member State can approve a plant protection product containing the substance for national use. You can search information on active substances and the duration of their approval on the EU Pesticides Database.

Finland is responsible for preparing assessment reports for the following active substances:

  • aminopyralid AIR V
  • amidosulfuron AIR III
  • desmedipham (not approved)
  • phenmedipham AIR III
  • flonicamid AIR IV
  • hexythiazox AIR IV
  • clopyralid AIR III
  • quizalofop-P-ethyl AIR IV
  • mepiquat chloride AIR IV
  • propiconazole (not approved).

You will find the instructions on how to apply for approval for a new active substance on the Commission website.

When you initiate an approval process for an active substance, please contact Tukes at ppp.activesubstance (at) tukes.fi. Tukes provides advice on matters related to submitting a dossier, or the material required for approval.

Please see current fees for the risk assessment of the active substances.

Low-risk active substances

Active substances can be approved as low-risk substances when, during the assessments process, they turn out to pose a lesser risk to human and animal health and the environment than other similar substances (Regulation on Plant Protection Products, Art. 22 and 47). The criteria  for low-risk active substances were adopted in August 2017.

A total of 10 active substances have been approved as low-risk, according to situation in February 2018. The approved low-risk active substances can be found on the EU Pesticides Database using advanced search: Advanced search -> Type -> low risk active substances.

Basic substances

Basic substances do not require a separate approval, but they are authorised for use in the EU Pesticides Database in accordance with the instructions below. Basic substances can be found in the database as follows: Advanced search -> Type -> Basic substances.

Basic substances refer to active substances not predominantly used as plant protection products, such as sunflower oil, fructose and beer.

The label text on a basic substance may only read: “Approved as basic substance under Regulation 1107/2009”, without any closer instructions for use. The EU Pesticides Database provides information on which plant protection purposes the basic substance in question may be used for. The information is included in the Review Report of the basic substance.

An active substance can be approved as a basic substance if it meets the following criteria (Regulation  on Plant Protection Products, Art. 23):

  • is not a substance of concern according to CLP Regulation
  • does not have an inherent capacity to cause endocrine disrupting effects
  • does not have an inherent capacity to cause neurotoxic or immunotoxic effects
  • is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent
  • is not placed on the market as a plant protection product.
  • The substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment.

Application for a basic substance:

  • The applicant, which can be either an EU Member State or a company, must submit to the Commission an application for the approval of the basic substance.
  • The Commission shall ask the EFSA for an opinion.
  • The Commission may review the approval of a basic substance at any time.
  • Information on basic substances on the Commission website.

This is how the risk assessment and approval of active substances process proceeds

Safe to health and the environment
The active substances approved for use must be safe to health and the environment.

Draft assessment report
Within EU, the risk assessment and approval of active substances are always based on the draft assessment report drawn up by one Member State, the rapporteur Member State.

Conclusions drawn by consultations of experts
The draft assessment reports are discussed in consultations of experts organised by the European Food Safety Authority (EFSA). EFSA issues its conclusions on the draft assessment report.

Vote on the Commission proposal
The Commission prepares a proposal on which the EU Member States vote.

EU Pesticides Database
The active substances and the duration of their approval periods are entered into the EU Pesticides Database.