What If Simplification Is Not Deregulation? Omnibus X and Pesticide MRLs

Simplification is not a synonym for deregulation.

Sometimes it removes obligations. Sometimes it shortens procedures. But it can also make a regulatory system more coherent, more enforceable—and substantively stricter.

The pesticide Maximum Residue Limit provisions in the European Commission’s Food and Feed Safety Simplification Package, commonly known as Omnibus X, are a clear example.

They do not merely simplify the machinery of Regulation (EC) No 396/2005. They alter the considerations that may justify an MRL decision, the relationship between EU and third-country production standards, and the interests the framework is expected to protect.

The JRC study maps a range—not a prediction

The newly published Joint Research Centre study on lowering pesticide MRLs is important precisely because it does not pretend that the economic consequences can be reduced to a single number.

The study examines what could happen if MRLs for the most hazardous pesticides banned in the EU were reduced to the limit of quantification. It identifies 18 relevant active substances, affecting 235 commodities and 86 exporting countries, and models three scenarios based on different assumptions about how third-country producers would respond.

The results are strikingly different.

In the upper-bound scenario, where affected exporters do not adapt, total EU agricultural imports fall by 41%. In the intermediate scenario, which assumes profit-driven adaptation and higher production costs, imports fall by 8%. In the lower-bound scenario, based on more limited exposure and lower adaptation costs, the reduction is 0.4%.

The direction of the modelled effects is broadly consistent: imports decline, EU crop production increases and consumer prices rise. Their magnitude is not.

That divergence is not a weakness hidden in the study. It is one of its principal findings. The economic outcome depends heavily on facts that are not yet known with precision: whether a particular substance is actually used on a particular crop in a particular country; whether an effective alternative exists; what substitution costs would be; how much time producers receive to adapt; and whether displaced exports can be redirected.

The JRC accordingly describes its scenarios as bounds around plausible outcomes, not forecasts. It also states that the report is not an impact assessment: it does not assess the environmental or social dimensions, has not undergone public consultation and is constrained by limited substance–commodity–country evidence.

That distinction matters.

The study can identify exposure, illuminate trade-offs and show where more granular evidence is needed. It cannot, by itself, determine which regulatory objective should prevail or what level of uncertainty is acceptable.

A range does not settle the policy choice. It locates it.

The proposal changes what counts as a sufficient reason

Under the existing MRL system, the central question is whether the residue level is safe for consumers. An import tolerance may be established on the basis of a good agricultural practice used in a third country, or by reference to a Codex maximum residue limit, provided the resulting exposure satisfies the EU risk assessment.

Omnibus X would preserve that architecture but add a different regulatory possibility.

For defined categories of hazardous active substances that are not approved in the EU, an MRL could be lowered to the limit of quantification even where the existing level has not been found to pose a consumer risk. The Commission presents this as laying the groundwork for the principle that the most hazardous pesticides banned in the EU should not return through imported products.

The amendment is therefore not simply administrative.

It changes the regulatory question from:

Is exposure at this residue level safe for the consumer?

to a wider question:

Should residues of this substance be accepted at all, given the hazard that led to its prohibition and the broader interests the EU seeks to protect?

That is a change in regulatory epistemology: a change in the knowledge and evidence considered sufficient to support a legitimate decision.

It has three connected dimensions.

From exposure-based assessment to hazard-based regulation

Risk and hazard are related, but they are not interchangeable.

A risk assessment asks whether a substance, at a particular level of exposure, is likely to cause harm. Hazard classification concerns the intrinsic properties of the substance. The existing MRL framework is predominantly exposure-based: the legal limit is set following an assessment of consumer exposure.

The Omnibus X proposal would allow hazard considerations to play an autonomous role for the most serious categories of substances.

For carcinogenic, mutagenic or toxic-for-reproduction substances, and certain endocrine disruptors affecting human health, the proposal is based on the position that no exposure should be permitted if a high level of consumer protection is to be ensured. For persistent organic pollutants, PBT and vPvB substances, and endocrine disruptors affecting non-target organisms, the rationale extends to environmental concerns of a global nature connected with the Union.

This does not abolish risk assessment. Nor does it mean that every non-approved substance would automatically be reduced to the limit of quantification.

It does, however, mean that a finding of consumer safety may no longer conclude the analysis.

The absence of an identified dietary risk would cease to be a complete answer where the regulator considers the intrinsic hazard, persistence or environmental reach of the substance sufficient to justify a lower MRL.

From import tolerances to a more unitary concept of good agricultural practice

The current import-tolerance system recognises that agricultural production conditions differ.

A pesticide may be needed for a crop in a tropical or subtropical region even though it is not authorised for the same use in Europe. Different climates, pest pressures, available alternatives and agronomic systems may support a third-country good agricultural practice. The MRL then regulates the residue on the imported product, not the production method in the exporting country as such.

Omnibus X begins to narrow that separation.

If an MRL derived from a third-country practice or a Codex limit can be reduced because the relevant active substance is banned in the EU, the Union’s internal production choices acquire greater influence over the conditions of market access.

The legal standard remains an MRL at the border. Its practical effect reaches further upstream.

Exporters may have to alter plant-protection programmes, substitute active substances, segregate EU-destined production or leave the EU market. In this sense, the proposal moves towards a more unitary understanding of acceptable agricultural practice: not full identity between EU and third-country production rules, but less willingness to recognise divergent practices for substances the Union regards as most hazardous.

That is a policy choice with distributional consequences.

The JRC study shows why those consequences cannot be assumed to be uniform. Some exporters may adapt at limited cost. Others may face materially higher production costs, reduced yields or the loss of a market. EU crop producers may benefit from reduced import competition, while livestock producers may face higher feed costs. Consumers may see little price movement in one scenario and substantial increases for particular products in another.

“Alignment” is therefore not a neutral technical exercise. It reallocates costs, opportunities and regulatory burdens across supply chains.

From consumer protection to environmental protection

Regulation (EC) No 396/2005 was constructed principally around human and animal health and the functioning of the internal market.

The Omnibus X provisions introduce a broader environmental logic.

For persistent and bioaccumulative substances, persistent organic pollutants and certain environmental endocrine disruptors, the concern is not confined to the residue’s effect on the person consuming the imported food. It includes environmental harm associated with the use and persistence of the substance, including effects that may have a global dimension or a connection with the Union’s territory.

That extension is legally and politically significant.

The MRL becomes capable of serving not only as a food-safety threshold but also as an instrument influencing how food placed on the EU market is produced abroad.

There may be strong policy reasons for doing so. Persistent pollutants do not respect borders. European consumption can contribute to production practices and externalities outside Europe. EU farmers also question why substances they are prohibited from using may remain part of the production systems of competing imports.

But the broader the objective, the more carefully the causal connection, evidentiary basis and proportionality of the measure must be explained.

A food-safety instrument cannot simply acquire an environmental function through assertion. The relationship between the substance’s use abroad, the environmental interest invoked and the MRL imposed at the EU border must be made visible and assessable.

Simplification can tighten the regulatory framework

Seen from this perspective, the MRL amendment illustrates a feature of the wider Omnibus agenda that is easily missed.

A measure can simplify one part of a regulatory system while tightening another.

Omnibus X may make the legal route more direct. It may create a clearer basis for acting on specific hazardous substances and reduce the need to construct each decision through a framework designed primarily for consumer-exposure assessment.

Yet the resulting rule can be more demanding for regulated actors.

The acceptable evidentiary basis changes. A safe exposure finding may no longer be sufficient. The range of protected interests expands. Third-country production decisions become more relevant to market access. Exporters may bear a greater burden of adaptation even though the EU procedure has become more streamlined.

Simplification describes the architecture of decision-making. Deregulation describes the intensity or extent of control.

They are not the same thing.

The international dimension cannot be an afterthought

The proposal also raises questions that cannot be resolved solely within EU food law.

Codex MRLs provide internationally developed reference points. Under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures, members may adopt a higher level of protection than the international standard, but the measure must be supported by the applicable scientific and risk-assessment disciplines and must not operate as an unjustifiable restriction on trade.

The relevant question is not whether the EU may choose a high level of protection. It may.

The question is how the Union defines the risk or concern being addressed, what evidence supports the measure, how consistently the principle is applied and whether the resulting restriction is proportionate to the objective.

This requires early and serious engagement with trade partners, particularly through the shared frameworks of Codex Alimentarius and the WTO SPS Agreement.

It also requires differentiation.

The JRC’s central lesson is that substances, commodities and countries cannot realistically be treated as if exporters all use the same products, face the same pest pressures or have the same capacity to substitute. Case-by-case impact assessment is therefore not a procedural detail. It is essential to the credibility of the approach.

What the impact assessment must now answer

Before individual MRLs are lowered, the analysis should address at least five questions.

First, what is the precise regulatory objective?

Is the measure directed at consumer health, environmental persistence, ecological effects connected to the Union, reciprocity of production standards, the competitive position of EU farmers—or a defined combination of these aims?

Second, what evidence connects the substance, commodity and exporting country?

Authorisation of an active substance in a third country does not necessarily establish its use on every crop exported to Europe.

Third, what realistic alternatives exist?

Substitution must be assessed within the relevant crop-protection strategy, including efficacy, resistance management, cost, yield and local pest pressure.

Fourth, what adaptation period is proportionate?

The JRC notes that the time allowed for producers to respond can materially affect the plausibility of its scenarios, but does not model that variable.

Fifth, how will the EU engage internationally?

Codex departures, SPS notifications, technical exchanges and transition arrangements should be considered before supply chains are confronted with a final limit.

These questions do not argue against lower MRLs. They define the work needed to justify them.

A new regulatory balance

The MRL provisions of Omnibus X move beyond the balance originally struck when Regulation (EC) No 396/2005 was adopted.

They place greater weight on hazard, reduce the autonomy of third-country good agricultural practices and expand the framework towards environmental considerations. Cumulatively, they increase the external reach of EU regulatory choices.

That may be defensible. It may also reflect a political demand for greater consistency between the standards imposed on EU farmers and the conditions attached to imported products.

But it should be recognised for what it is.

This is not merely a cleaner procedure for applying the existing logic. It is a change in the logic itself.

The JRC study helps to describe the possible economic consequences. It also demonstrates why the final decision cannot be outsourced to a model. Where plausible outcomes range from negligible disruption to major trade displacement, the selection of the regulatory objective, the evidentiary threshold and the acceptable uncertainty remains a responsibility of policymakers.

Simplification, in this case, does not mean less regulation.

It means a more direct route to a potentially stricter and more far-reaching rule.

A fuller legal analysis appears in my article published in Issue 3/2026 of the European Food and Feed Law Review: read the EFFL article.

Do you want to learn more? Contact Nexum EU Strategies