Maximum Residue Levels (MRLs) in the EU: What are they and why are they important?
June 6, 2025
Understanding EU Maximum Residue Levels (MRLs) is key to ensuring food safety, meeting regulatory obligations, and maintaining market access. Learn how they’re set, when they apply, and what to do if exceeded.
What are MRLs?
MRLs are trading limits, set at safe levels, to reflect the levels expected to arise from authorised uses in accordance with the critical good agricultural practice (cGAP). Default MRLs can also apply to non-authorised uses to monitor compliance. They are an essential element of pesticide* legislation, necessary to protect consumers, as well as producers and farmers by facilitating trade within the EU**.
Regulation (EC) No 396/2005 fully harmonises MRLs in the EU. Compliance with current MRLs is assessed in all new active substance (approval and renewal) and pesticide product applications and suitable MRLs must be in place for all relevant commodities before an authorisation can be granted.
The data requirements for an MRL application dossier arising from pesticide uses are indicated in Regulation (EU) No 283/2013 (“new” data requirements) setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 and in the Commission Regulation (EU) No 544/2011 (“old” data requirements) implementing Regulation (EC) No 1107/2009 as regards the data requirements for active substances.
What to do when current EU MRLs are exceeded?
If an MRL exceedance is noted but no adverse impact to human health is associated, then it is possible to increase the MRL to accommodate the new use. Under Reg 1107/2009, authorisation holders have a stewardship requirement to report adverse data and effects on the authorised uses of the product to the evaluating authority. In the EU, MRL increases can be requested by authorisation holders in Article 10 MRL applications to EU Member States, during or following active substance approval/renewal. If authorised, the new MRL will replace the current EU MRL listed in Annex II or III of Regulation (EC) No 396/2005.
Following the entry into force of the Transparency Regulation (Regulation (EU) 2019/1381) in the EU, the submission of MRL applications using IUCLID is now required. An MRL IUCLID dossier must contain all data supportive of the MRL and the cGAP it is derived from. IUCLID sections 4 and 6 (analytical methods and residues respectively) are mandatory, however other components (such as phys-chem, toxicology and environmental fate sections) may also be required if new information in these areas is necessary to support the MRL application.
How can TSG help?
MRL evaluations are multi-faceted, from deriving the critical residues values required to assess compliance, performing risk assessments to determine potential risks to consumers, to navigating an IUCLID data set. There are many intricacies to consider and get right when it comes to EU MRLs, and TSG are here to help.
With extensive experience in preparing MRL dossiers and core knowledge and expertise in the use of IUCLID, TSG is perfectly placed to help establish and maintain Maximum Residue Levels (MRLs). Our dedicated team can advise on the submission process, perform data gap assessments on MRL data packages, derive MRLs, determine compliance with existing MRLs, perform risk assessments and support on any data generation needs.
To learn more about how we can support you, contact TSG at [email protected], or reach out to your TSG consultant directly. Residues team lead: [email protected] or MRL lead: [email protected].
*Regulation (EC) No 396/2005 also applies to biocides uses – a biocides specific article is coming soon.
**Since EU-exit GB MRLs are independent from the EU, and a separate system is in place – a GB specific article is coming soon!
