Navigating Agrochemical Regulatory Compliance: How to Meet Global Crop Protection Requirements

In the 1880s, French winegrowers began using an agrochemical blend of copper sulphate and lime to stop children from stealing their grapes. But soon they noticed that this visual deterrent against cheeky urchins was also an effective control against grape powdery mildew. In fact, we find the use of agrochemicals as early as 400 BCE, when Persians used pyrethrum, derived from chrysanthemums, as an organic agrochemical. From the 1940s we witnessed strong growth in the synthesis and commercialization of pesticides. [1] Today, agrochemicals are an integral and growing part of productive farming. Alongside this growth, so too have regulations gradually grown to ensure the safety of chemicals in agriculture. Alongside consumer safety regulations, we are also seeing a focus on longer-term sustainability and environmental safety to protect ecosystems, as well as requirements for traceability.

Complexity and Agrochemical Regulatory Compliance

At the international level, much has been achieved in creating more-harmonized agrochemical regulations for classifying chemicals and labeling, and this has boosted trade. Although the trend is toward harmonization, very significant differences remain between countries and across jurisdictions. Increasingly, new layers of local regulations are being introduced, driven both by consumer and citizen expectations as well as country- or region-specific requirements linked to local conditions such as climate, fauna, and flora. For example, dosage requirements may vary depending on whether a field is flat or located on a slope with heavy rainfall.

A product launch often requires compliance with multiple regimes at the same time, and each typically demands its own localized dossier content, testing data, multilingual labeling, and warnings. Trade and the development of trading blocs have helped drive harmonization forward. The European Union (EU) is a good example of this. Similarly, the US has long had environmental and health protections in place through the US Environmental Protection Agency (EPA) pesticide rules and guidelines, and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), enacted in 1947.

Nevertheless, backlogs and delays in the US remain a feature of the agrochemicals regulatory landscape. In 2025, for instance, around 12,000 pesticide reviews were behind planned timelines, with a backlog of over 500 chemicals awaiting review by the EPA. While the complexity of regulations presents challenges and can lengthen regulatory processes for some companies, the sheer volume of reviews is also a cause of delay. (Resource constraints, including budget pressures, have further contributed to these bottlenecks.)

Key Trends in Agrochemical Regulations: Safety, Sustainability & Traceability

Throughout the history of agrochemical use, the curve has been one toward tighter regulation, and this is amplified by the growth in new products, all of which require evaluation and documentation. In recent years, we have also seen the implementation of tighter controls on pesticide residues in foods. Coupled with this, the agrochemical sector is also finding itself dealing with a political amplification. In just one example, the Make America Healthy Again (MAHA) commission is reported to have laid the blame for declining child health metrics in part on pesticide use. [3] The human safety issue is a slow burner, but we are also seeing bans and restrictions on some products for ecological reasons. One that has received a lot of attention lately is the ban or restriction placed on neonicotinoids in the EU and US. Policies in the EU set a target of halving chemical pesticide use by 2030, and reducing fertilizer use.

As technology improves, it has become easier to track chemical products throughout the entire supply chain. Regulators are responding by raising expectations for end-to-end traceability. from the manufacturer all the way to the end-user, with the goal of increasing safety. Serialization, scan codes, blockchain, RFID and other means are providing greater transparency, helping to prevent counterfeiting, and allowing products to be recalled faster in the event of a compliance failure. [4]

Crop Protection Compliance Is Your License to Operate

Put simply, compliance failures should never occur – this is not a choice. It provides the legitimacy of a company to operate in a market. As well as being a regulatory factor, it is also a moral factor that affects how a company and its products are perceived in the broader social – and increasingly, political – context. Key factors of compliance, and the consequences of non-compliance, include:

• Safety and environmental protection

Proper registration, testing, and monitoring to ensure that an agrochemical product does not present a danger to human wellbeing and the environment. Products must be correctly labeled to ensure safety and proper use, as well as to ensure traceability and to prevent counterfeiting. Regulations are safety driven. Your profitability depends on it.

• Market access and ROI

Non-compliance jeopardizes access to markets with delays or preventing product releases. The consequences are reduced return on investment, and other financial losses, especially with a stop-sale or if the product must be recalled. Non-compliance impacts profitability – unnecessarily and avoidably. Compliance is a controllable factor, especially given available technologies. Market conditions less so. Get the things you can control, right.    

• Reputation

Compliance failures have short-term and long-term impacts on brand and company reputation, ultimately costing your company markets and profits.

• Operational disruptions

Non-compliance costs time and production or workforce capacity. Labeling may need to be revised and reprinted. Resources need to be diverted to correct errors.

• Workforce reputation

No one wants to belong to a company with a reputation for inefficiency and non-compliance. As well as damaging the company, it damages the reputation of those employed by a company. Best-in-class is where you want to be, not a cog in the wheel of a company with sloppy compliance practices. It is therefore in your self-interest as a team member to maintain high compliance standards and implement best practices.

• Financial penalties

Non-compliance can be costly in terms of direct penalties, stop-sales and litigation.

Ensuring Strong Agrochemical Regulatory Compliance

Here we focus on three fundamental starting points:

1. Understanding Agrochemical Regulations

Stay informed, and make sure the processes are in place to do this. Without regulatory understanding and intelligence, regulatory change will take you by surprise – and by then it may be too late. In a global industry, that means regional knowledge and responsible persons in all markets to feed back potential or recent regulatory and market changes, and being able to implement changes in a timely fashion.

2. Planning & risk management

Regardless of whether on the regulatory office, the factory floor or in the artwork department responsible for producing labeling, you need to understand your own processes, where the risks of non-compliance might lurk, mitigate the risk, and create a proactive crisis management and action plan for non-compliance. Your risk might be in workflow steps, the absence or inefficient use of technology to mitigate the risk of human error, poor communication, knowledge gaps, lack of accountability, too few resources, or any number of other reasons. Understand your processes and seek to improve them. This is a standard on the agrochemical production floor, and it should be one in all areas of a company.

3. Ongoing Training and Audit Readiness

Training employees on current agrochemical regulations, GxP requirements and running regular internal/external audits maintains compliance standards across your organization.

The Role of Technology in Agrochemical Compliance

Over the years, new and better ways of applying pesticides have emerged—such as using drones for more precise spraying. In the same way, technology has also transformed other parts of the workflow. AI is allowing larger datasets to be examined quickly and efficiently (although transparency is still a question whenever AI is involved). As mentioned earlier, traceability has become simpler due to the development of methods such as scan codes, RFID, real-time tracking in the supply chain, and the use of various other digital technologies (e.g. blockchain). These guard against counterfeiting and create transparent supply chain audit trails to track the movement of goods.

On the production floor, sensors and IIoT are integral to preventive maintenance, quality assurance and compliance. They provide real-time transparency and feedback on processes. Do you have anything equivalent integrated into your labeling and packaging artwork workflow? How might this look?

Overcoming Regulatory Complexity in Labeling & Packaging

Oddly, in the area of labeling and packaging some agrochemical companies continue to lag behind other functions in their use of technology. For instance, the sheer complexity of regulations can lead to regions in a global company becoming isolated and bogged down in their own processes, technologies and regulations – and failing to exploit available technological synergies.

Let’s take a practical example of proofreading label versions, irrespectively of their language, which is a key aspect of labeling and packaging in agrochemicals, and just one feature of the document comparison software TVT. Let’s also say that you are dealing with different jurisdictions, different languages, and you might even be dealing with different scripts (e.g., Latin, Cyrillic, Greek, Asian…) or reading directions (Arabic, Hebrew). As a first step, the Artworker (internal or external) might run a preliminary comparison of foreign-language PDF Artwork (such as a State Registered Label, or Supplemental Distributor Label, or the Final Printed Label) against an approved original document (which could be Master label, a Print Restricted Label, or a Draft Label for example). Text Deviations from the approved original, incorrect barcodes or pictograms are immediately highlighted allowing for immediate correction. Assuming this first verification is done, the PDF Artwork can be sent to the local affiliate with the language and regulatory skills for a final review. Any additional discrepancies, formatting issues, or misspellings will be marked and sent back to the Artworker with a full audit trail. Automated proofreading software such as TVT has allowed to save time, reduce unnecessary correction cycles, prevent expensive errors into one simple, transparent process.

The challenges in the agrochemical environment are many. Tighter and rapidly evolving regulations. New social expectations. Unsteady demand. Supply fluctuations and price instability. As a result, agrochemical companies – and departments within them – are being called upon to find new efficiencies in workflows. In the area of labeling and packaging compliance, this can be achieved by automating and integrating workflows to reduce cycle times and ensure accuracy and compliance.

Find out how we can help you achieve this here.