Simplification of rules on pesticide MRLs and approvals

Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements

Update

The European Commission has published a proposal to simplify the rules on setting pesticide maximum residue levels (MRLs) in products imported into the European Union (EU) from non-EU countries (Regulation 396/2005), and on the approval of pesticides for use in the EU (Regulation 1107/2009).

The Commission aims to align the rules that apply to imported products more closely with those that apply to EU production. In particular, the proposed changes create the possibility to reduce existing MRLs to 0.01 mg/kg (the limit of quantification, LOQ) on pesticides not approved in the EU where they are categorised as particularly hazardous for public health or the environment. This, in turn, could potentially reduce the pesticide options currently available to non-EU suppliers to the EU market.

It is also proposed to clarify the rules on transition periods, allowing products that were compliant with the EU MRLs at the time of production or placement on the EU market to be sold through to the end of their shelf life. This would avoid products being removed and destroyed as a result of changes to MRLs.

Changes are proposed to the rules for approving the use of pesticides in the EU. The current requirement to re-evaluate all approved pesticides every 10 years will be lifted, although reapproval can still be required in specific cases. The primary aim is to allow the authorities that evaluate pesticide authorisations and renewals more time to focus on the assessment of biopesticides.

The Commission also proposes to clarify the definition of biopesticides (as “biocontrol substances”), and to allow EU Member States to grant provisional approval of these substances on the basis of draft assessments, to encourage a transition from chemical pesticides to more sustainable solutions.

What is changing?

Pesticide maximum residue levels (Regulation 396/2005)

The European Commission proposes the following changes.

Import tolerances

Under current rules, where pesticides have certain harmful characteristics (e.g. mutagenic, carcinogenic, or reprotoxic properties; are endocrine disruptors; or are particularly damaging to the environment, such as persistent organic pollutants), (re-)authorisation for use in the EU is automatically excluded (see Background). These are not approved, regardless of actual consumer exposure to the pesticide.

Where there is no risk to consumers, MRLs can be set on pesticides that are not approved in the EU but are used in non-EU countries. These are known as “import tolerances”, and are set on the basis of consumer exposure to the pesticide. Therefore they can apply to imported products, even if these pesticides are not approved for use in the EU.

The European Commission proposes to change this and to align rules for EU production and imports by setting MRLs for hazardous pesticides not approved in the EU at the default level of 0.01 mg/kg. This will not be done automatically, but on the basis of an impact assessment. If the characteristics of a pesticide have not been assessed in the course of an EU approval, the European Food Safety Authority (EFSA) will be asked to evaluate it. The Commission has launched a study on the potential impact of such measures on trade flows (see Background).

The Commission also proposes to remove the term “import tolerances” as it can create confusion. For pesticides not identified as hazardous, the EU will still have the possibility to set MRLs for those authorised in a non-EU country on the basis of Codex Alimentarius MRLs or good agricultural practice (GAP) (changes to Art. 14).

Transition periods

Current rules allow the EU to set “transition periods” when changing MRLs – a period that allows time for operators to adjust to the introduction of reduced EU MRLs. However, these periods do not always take account of a product’s shelf life, which can lead to it being withdrawn from the market and destroyed. The Commission proposes a new approach that allows the marketing of products to the end of their shelf life, if the crop was compliant with the MRLs in place when the product was put on the EU market or put into storage after production. Operators will have the burden of proving compliance (Art. 14).

Setting MRLs on the basis of monitoring data

MRLs are normally set on the basis of residue trials. However, in certain circumstances, MRLs can be set on the basis of monitoring data, for example, for:

• pesticides historically used but no longer approved which remain in the soil as a contaminant
• products that only make up a minor part of the consumer diet
• honey or herbal infusions (Art. 16).

These MRLs currently must be reviewed every 10 years, although their presence in the environment is stable. The Commission considers this to be unnecessary and proposes to remove this requirement. A review of these MRLs can still be initiated at any time.

Limit of determination

Regulation 396/2005 currently refers to the term “limit of determination" (LOD), the lowest residue concentration that can be quantified and reported through routine monitoring. Internationally, this is typically referred to as the “limit of quantification" (LOQ). The Commission proposes to replace the term LOD with LOQ.

Approval of pesticides for use in the EU (Regulation 1107/2009)

Changes to the EU approval process proposed by the European Commission include the following.

Renewal procedures

Pesticides that have already been approved for use in the EU currently have to be reassessed and reapproved every 10 years. The Commission proposes that authorisation should be for an unlimited time period, although time limits could still be set on a case-by-case basis, and pesticides can be targeted for reassessment (changes to Arts. 5 and 27a).

Low-risk substances

The current criteria for identifying a pesticide as low-risk are difficult to meet, especially at the time of the approval/renewal procedure. The Commission proposes to simplify these criteria, and to introduce the possibility of applying for an approved pesticide to be recognised as low-risk once information is available to demonstrate that the pesticide meets the low-risk criteria (Art. 22).

Grace periods

When a pesticide is not renewed, EU Member States must withdraw all product authorisations, but can establish “grace periods” to allow farmers the time to use existing stocks and find alternatives. The Commission proposes to double the length of grace periods to 3 years (Art. 46).

Pesticides for minor uses

There are currently specific rules for the approval of pesticides that are for minor crops. However, the conditions in which these specific rules apply are considered to be too restrictive, and the Commission proposes to remove them (Art. 51).

Biopesticides (biocontrol substances)

Proposed amendments regarding biopesticides include:

• harmonisation of the legal definition of “biocontrol substances”, as different approaches to categorising substances by EU Member State authorities currently lead to divergent data demands and delays in dossier approvals (Art. 3)
• prioritisation of evaluation of biopesticides over chemical substances applications (Art. 11)
• possibility to provisionally grant approval of biopesticides on the basis of draft assessments (Art. 30)
• removal of the obligation to keep records of biopesticide use to reduce the administrative burden on farmers (Art. 67).

Why?

This proposal broadly aims to reduce regulatory burdens while maintaining high standards of food and feed safety. In particular, the simplification of procedures is expected to benefit both the food industry and the public authorities.

Alignment of EU production and import rules

EU non-governmental organisations (NGOs) and some farmers have called for a stricter approach to imports of products containing pesticides not approved in the EU, due to concerns about consumer health and the competitive disadvantage this may create for EU farmers (European Commission 2025b).

Biopesticides

The Commission seeks to encourage the transition from chemical pesticides to more sustainable biocontrol substances (e.g. microorganisms, pheromones, and plant extracts). A long-standing criticism of current procedures is that EU Member States have too limited expertise and capacity to assess new biocontrol products, and that the time to market is too long. Removing the need for 10-yearly renewals (including of already approved pesticides) is expected to increase the capacity for processing biopesticide authorisations (European Commission 2025b).

Timeline

This proposal will be discussed by the Council of the EU (Member States) and the European Parliament, a process that can take up to 2 years. So its application is possible in the second half of 2027.

What are the major implications for exporting countries?

Regulation 396/2025 allows for the adoption of import tolerances on the basis of assessed risk to the consumer. Setting or maintaining MRLs for pesticides not approved in the EU would still be possible under the proposed rules, but the range of pesticide solutions may well be reduced with the elimination of those not approved in the EU due to specific hazardous characteristics.

The proposed changes to Regulation 1107/2009 may have an indirect impact on non-EU suppliers, as more rapid approval of biopesticides may extend the range of approved solutions for suppliers to the EU market seeking non-chemical alternatives.

Recommended Actions

For an understanding of the potential impact of the proposed rules on MRLs/import tolerances, suppliers exporting products to the EU can verify the categorisation of pesticides in the following way.

1. Check whether a pesticide is approved for use in the EU using EU Pesticide Database – Active substances – type the name of the substance into the search box.
2. If “not approved” (marked in a red box), check the categorisation of the pesticide using the ECHA database.

Background

Which pesticide characteristics are considered “hazardous”?

Regulation 1107/2009 (Annex II) sets out criteria for the approval of pesticides. Under the European Commission's proposal, existing MRLs can be revoked when a pesticide has been assessed to be one of the following:

• mutagen category 1A or 1B (Annex II, 3.6.2)
• carcinogen category 1A or 1B (Annex II, 3.6.3)
• toxic for reproduction category 1A or 1B (3.6.4)
• endocrine-disrupting properties that may cause adverse effects in humans (3.6.5)
• persistent organic pollutant (POP) (3.7.1)
• persistent, bioaccumulative, and toxic (PBT) substance (3.7.2)
• very persistent and very bioaccumulative substance (vPvB) (3.7.3)
• endocrine-disrupting properties that may cause adverse effects in non-target organisms (3.9.2).

The categorisation of many chemicals that are used as pesticides can be found in the European Chemicals Agency (ECHA) database. When no categorisation is available, the Commission can ask for a specific evaluation by EFSA.

Context: EU Vision for Agriculture and Food

In March 2025, the European Commission set out a roadmap for EU activities for the period 2025–2029 (see EU Vision for Agriculture and Food 2025–2029).

The Vision sets the following four priority areas for EU interventions:

• making agri-food an attractive and predictable sector that ensures a fair standard of living and leverages new income opportunities
• ensuring the competitiveness and resilience of the agri-food sector
• ensuring the agri-food sector contributes to preserving healthy soils, clean water and air, and protecting and restoring biodiversity
• valuing food and promoting fair living and working conditions in vibrant rural areas.

The Vision focuses primarily on EU farmers, and how to ensure that they get sufficient revenue and the right public financial support. But it also emphasises the EU food sector’s competitiveness versus food imports, and announces a further evaluation of whether the EU food sector is disadvantaged by food imports due to more stringent EU rules, in particular relating to pesticides and animal welfare.

In November 2025, the European Commission announced the launch of an impact assessment on imported products containing hazardous pesticides (European Commission 2025a). The results of this assessment are expected to feed into discussions on the Commission proposal.

Import tolerances

For further information on how import tolerances are currently set, see Pesticide residue import tolerance MRLs explained.

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