Maximum residue level (MRL)
Plant protection products are used on farms to control pests and regulate plant growth to ensure that the yield obtained for human consumption is as large and safe as possible. The use of plant protection products is strictly regulated. Even if plant protection products are used correctly, residues of the active substance contained in the plant protection product may remain in treated products.
If necessary, a maximum residue level (MRL) will be set for the active substance contained in a plant protection product based on a comprehensive assessment. MRL means the legal upper limit set for residues in food or feed products. MRL is indicated in milligrams per one kilogram of food product (mg/kg).
Maximum levels must be safe for consumers
MRLs are based on good agricultural practice. This means the permitted use of plant protection products in accordance with their instructions for use.
Dietary exposure to residues is assessed by combining food consumption information with residue level. This concentration is obtained from field trials, in which the crop has been treated with a plant protection product in accordance with good agricultural practice. The exposure results are compared to the toxicological reference values set for the active substance.
ADI (Acceptable Daily Intake) means an estimate of the amount of a substance in a food product, to which people can be exposed every day throughout their lives without any appreciable risk. ADI is indicated in milligrams per one kilogram of body weight per day.
ARfD (Acute Reference Dose) means an estimate of the content of a substance in a food product which can be consumed over a short period, regularly during one day, without any appreciable risk. ARfD is indicated in milligrams per one kilogram of body weight.
ADI and ARfD are based on the lowest dosage level of a substance that has not been identified to have any harmful effects in animal testing. These values are determined using a safety factor which covers any differences in sensitivity to potential harmful effects between different species and individuals. Normally, the safety factor is 100.
When setting the MRL, these toxicological reference values cannot be exceeded. Certain active substances have been assessed so safe that no toxicological reference values or MRLs need to be set for them.
MRLs are often set significantly lower than what is required by consumer safety. In other words, any values above the MRL do not automatically mean a risk for consumers.
The Finnish Food Authority coordinates the surveillance of plant protection product residues in Finland.
How MRLs are set in the EU
The use of a plant protection product in a certain application cannot be authorised until a valid MRL has been set for the active substance it contains, covering any residues in food products resulting from the use of the plant protection product. If the valid MRL needs to be modified, the applicant must submit an MRL application.
Applicants include companies that are applying for an authorisation of a plant protection product. Applicants must submit the MRL application and extensive data to the Member State in which they are applying for the approval of a plant protection product, or to the designated Rapporteur Member State for the active substance. The Member State will prepare an evaluation report. The evaluation report will be forwarded to the European Food Safety Authority (EFSA), and the EFSA will issue a reasoned opinion on the report.
Once the EFSA has issued its reasoned opinion, the European Commission will prepare a regulatory proposal for modifying the MRL. The MRL will only be proposed to be modified if the strict data requirements are met and the EFSA has not identified any risks posed to consumer health. Representatives of the Member States will vote on the regulatory proposal. The regulatory proposal will then be submitted to the European Parliament and Council for scrutinity. The approved regulation will be published in the Official Journal of the European Union.
The EU’s MRL database
MRLs set in the EU are available in the MRL database maintained by the European Commission.
Tukes is responsible for evaluating MRL applications in Finland. If you want to submit an MRL application to us, please contact [email protected]
Instructions for preparing an MRL application are available on the European Commission’s website.