Active substances in plant protection products are assessed commonly in the EU. In order for a plant protection product to be authorised nationally, the active substance in the product must first be approved at EU level.
The assessment of active substances is done in accordance with the principles and criteria in the EU Plant Protection Products Regulation. The active substances that are assessed to be acceptable from a health and environmental perspective are listed in the implementing regulation on approved active substances.
Active substances are approved for a limited period of time, after which they are to be assessed again. You can find information about active substances and how long a substance is approved in the EU Pesticide Database.
Information about active substances that have not received a renewed approval, and that are of relevance for the Swedish market, can be found on our webpage about active substances with expiring approvals.
Application and assessment
If you want to apply for approval for a new active substance in a plant protection product, information on how to do is available from the EU Directorate General for Health and Consumer Protection.
Each active substance for which a company applies for approval is assessed by a designated member state. All member states have the opportunity to comment on the assessments. The European Food Safety Authority (EFSA) compiles a report that is submitted to the European Commission. Then the member states vote on whether or not a substance is to be approved. Reports on the risk assessments of substances are found on the EFSA website.
Low-risk active substances
If the EU evaluation of an active substance reveals that the substance presents considerable less risk than other substances, the substance may be approved as a low-risk active substance. A low-risk active substance shall, among others, meet the specific criteria set out in Annex II to the Plant Protection Products Regulation, in addition to the basic requirements for approving active substances. Low-risk active substances may be approved for a maximum period of 15 years instead of 10 years which normally applies.
The EU Commission updated in August 2017 the criteria for low-risk active substances in Annex II to the EU Plant Protection Products Regulation. The criteria imply, among others, that a substance shall not be regarded as a low-risk substance if it is classified for certain health or environmental hazards. You will find the new Annex II criteria in the amending Regulation (EU) No 2017/1432 to the EU Plant Protection Products Regulation.
Active substances that have been approved as low-risk substances are listed separately in the list of approved active substances in Regulation (EU) No 540/2011. The substances can also be searched in the EU Pesticide database. Until October 2018, thirteen substances have been approved as low-risk active substances, of which nine are microorganisms or viruses. The EU Commission has also published a preliminary list of substances, that are expected to meet the requirements for low-risk active substances, based on the new criteria.