Regulatory Integrity in Crop Protection

Regulation of chemical or biological products, such as pesticides, used in agriculture aims to reduce the risk of pesticides and to sustainably manage pests.

Before pesticides can be placed on the market they need to be registered in the country of use. To obtain a pesticide registration, the competent regulatory agencies review hundreds of studies and tests conducted under Good Laboratory Practice (GLP), as well as research published in scientific peer reviewed journals. Regulatory authorities evaluate the data to ensure the pesticide has no unacceptable risks (or unintended adverse effects) to human and animal health and the environment from its intended use.

The competent authorities approve how and when a pesticide can be used; this information is provided on the pesticide label together with how to safely handle the pesticide. The pesticide label also provides information on health, physical, and environmental hazards of the pesticide product. CropLife International supports the use of the United Nation’s Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

CropLife International advocates for state-of-the-art and fit-for-purpose regulatory frameworks that evolve with science alongside the development of innovative products and technologies such as precision agriculture and biologicals.

Regulatory Principles

There are a number of common principles, many of which are reflected in the International Code of Conduct on Pesticide Management, and are recognized as forming the basis of a sound regulatory environment. These include a policy framework that:

  1. Ensures high standards of protection for human health and the environment.
  2. Ensures transparency and quality of data throughout the regulatory process, including the protection of that data, and safeguarding confidential business information and intellectual property.
  3. When possible, encourages international harmonization, while still taking local needs and conditions into account.
  4. Reflects application of scientific principles throughout the risk/benefit assessment.
  5. Demonstrates a commitment to responsible action of each party throughout the production, supply, and use of the product.
  6. Includes a compliance monitoring system and an active response process to deal with adverse incidents.
  7. Includes a process to ensure current standards are applied to all approved products.
  8. Conducts an impact assessment of any major changes to/revisions of the regulations.

Learn more in this fact sheet and test your knowledge of the Code in this e-learning module.

Time & Cost to Market for a New Crop Protection Product

Innovation in agriculture is crucial to support global food production. Pesticides play a vital role in protecting crops against pests and diseases, reducing the risk of food loss and waste. As climate change progresses, managing pests is expected to become more challenging. Therefore, it is crucial to equip farmers with the necessary tools and resources to effectively manage pest populations. New pesticide innovations are carefully reviewed by the competent authorities before they are placed on the market. The results of a 2024 study from AgbioInvestor show that the time and cost to bring a new pesticide to market has increased to, on average, 12.3 years and $301 million. These results illustrate a challenge as the time and cost to bring a new pesticide to market steadily rise, delaying availability of innovative solutions to enhance the farmers’ toolbox.

The study highlights shifts in discovery, development, and registration time and expenditure to bring a new pesticide to market, increasing from 11.3 years in 2014 to 12.3 years in 2019 and rising from $286 million to $301 million over that same period. The survey findings reveal an 8.8% increase in the average time frame between the initial synthesis of a novel crop protection molecule and its eventual market launch, which continues a 25-year trend of increased timelines.

Innovation is needed to ensure productivity on existing farmland and to improve global food security. As a global advocate for the plant science industry, CropLife International champions innovative technologies that help farmers grow crops sustainably and productively. We encourage governments to work together to reduce the time it takes to get innovation to market. Regulatory cooperation and consistent data requirements are two examples of ways this can be accomplished. It is vital to work with regulatory systems and ensure that farmers have new crop protection solutions today – not in a dozen years.

Regulatory Resources

Paper

Time and Cost to Market for a New Crop Protection Product

Document

Ensuring the Sound Management of Pesticides

Document

Principles for the Approach to Safety Assessments of Living Microbial Products

Brochure

Safe Transport of Crop Protection Products

Document

CRISTAL Onboarding

Document

Effective Management of Highly Hazardous Pesticides (HHPs)

Document

Tracking the Implementation of SAICM

Guidance

Chemical Exposure and Risk Assessment During the Manufacturing Process

Document

The Implementation of the Globally Harmonised System of Classification and Labeling of Chemicals

Maximum Residue Limits

Using pesticides on crops can result in traces of pesticide remaining on the crop at the time of harvest. In many countries, pesticides are only authorized if an independent, expert risk assessment – undertaken under a set of unfavorable circumstances and incorporating high safety margins – consistently verifies that any residues remaining after proper use of the pesticide are well below the safety levels for consumers.

The residue levels are strictly regulated and can be monitored through the Maximum Residue Limits (MRLs) trade standards used to ensure food is safe for consumption. MRLs represent the maximum amount of pesticide residue legally allowed to be present on food products when placed on the market. MRLs are set based on the approved pesticide use in the specific country and often vary between countries, which can lead to trade disruptions.

Take our MRL e-learning course to learn more.

The European Union (EU) Pesticide Renewal Monitor is a document that provides an overview of active ingredients that are currently undergoing or are scheduled for periodic active ingredient renewal in the European Union and it is prepared based on publicly available information. It lists active ingredients that have expired or are expected to expire, at the time of publication.

The latest issue of the Monitor is listed below. For back issues of the Monitor, please visit our Resource Library and sort by Topic/Renewal Monitor.

Renewal Monitor December 2023 [English version | Spanish version | Portuguese version | French version]

Codex Maximum Residues Limits

The Codex Committee on Pesticide Residues (CCPR) sets pesticide MRLs for food commodities in international trade. The CCPR was established by the Food and Agriculture Organization and World Health Organization to ensure globally accepted standards.

Our industry supports the CCPR in setting global MRLs by submitting comprehensive data sets on human toxicology and pesticide residues in agricultural commodities. CropLife International advocates for sustainable resources and more efficient processes for CCPR and its scientific expert body, the Joint Meeting on Pesticide Residues (JMPR) in order to meet the ever-growing demand for Codex MRLs needed for food trade.

CropLife International also encourages Codex member states to adopt Codex standards for international food trade.

MRL Resources

Article

Summary of Global Workshop on Codex CCPR/JMPR Enhancement

Guidance

Working with the JMPR and CCPR: A Manual for the Agrochemical Industry

Document

European Union Pesticide Renewal Monitor – June 2023 (EN)

Document

European Union Pesticide Renewal Monitor – March 2023 (EN)