Agrochemicals are vital for improving farming efficiency. They include key products like pesticides, herbicides, and fertilizers, which help farmers boost crop yields and protect against pests. In order to minimize environmental and health risks, strict regulations govern the agrochemical industry. Agrochemical industry labeling compliance is essential for safety, sustainability and consumer trust, while allowing company products to compete in the market.
Key Drivers of Regulatory Change
Evolving Regulations
Growing concerns about the effects of agrochemicals on the environment and human health have prompted significant changes in regulatory practices. Pesticides, herbicides, plant growth hormones, and fertilizers have long been scrutinized for their potential risks to water supplies, biodiversity, and public health. As our understanding of these risks has evolved and new products have emerged, regulations have adapted to address these challenges more effectively.
Global Harmonization
One of the biggest challenges has been to harmonize labeling requirements for pesticides across different jurisdictions. Companies must often deal with conflicting national or regional rules. [1] The United Nations (UN) has been a major force in pushing for global standards, particularly through the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Since the early 2000s, GHS has aimed to create a unified system for classifying chemicals and for labels. An important goal is to facilitate international trade by providing clear standards for labels and accompanying labeling. [2] Furthermore, in the European Union (EU), regulations are also promoting agrochemical regulatory harmonization in Europe.
Industry Trends affecting Compliance
Bans and Restrictions
One of the major trends in the agrochemical industry is the growing number of bans or restrictions on certain chemicals. Glyphosate and neonicotinoids are prime examples. In many regions, the herbicide glyphosate is banned, restricted in public spaces, or being phased out. [3] Neonicotinoids, a widely used class of insecticides in the US [4], are being restricted due to risks to pollinators, especially bees. In the EU, neonicotinoid restrictions apply to three substances, which have been banned for outdoor use. [5]
Along with EU measures, US pesticide ban regulations or restrictions are incentives for agrochemical companies to reformulate their products or develop new products as safer alternatives.
Enhancing Agrochemical Chemical Labeling Compliance
Regulatory agencies and the UN are today asking for clearer, more detailed labels on agrochemical products. In this regard, the US Environmental Protection Agency (EPA) pesticide rules and guidelines are being constantly updated in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Among more recent change are for the inclusion of signal words in both Spanish and English for certain toxicity classes. Recent EPA guidance also focuses on false or misleading claims for pesticide devices. [6] The EPA is also targeting claims suggesting that products without certain ingredients are safer than those that contain them. [7] Once again, the overriding aim is for labels that are clear, accurate, and consistent with rules in both text and graphic content and presentation. [8] However, the EPA is also facing claims that it is not doing enough to protect public health, adding to the pressure for stricter regulations and better enforcement. [9]
Digital Compliance Tools for Agrochemicals
Against this backdrop of evolving regulations, digital tools are changing how companies manage and track compliance across different jurisdictions. Compliance management platforms bring together regulatory data, automate workflows, and provide real-time updates on changes like product registration and labeling rules. Agrochemical compliance software helps with risk assessment, predictive compliance, and better traceability. Mobile apps also help track pesticide use in the field and verify compliance with local laws. Modeling software and services are available on the market in Europe and elsewhere to model environmental and safety impact. [10]
At a fundamental level for the EPA pesticide review process, the EPA offers an online tool to work out the Action Code for pesticide registration, which then determines the content required on a label. Furthermore, the EPA has an electronic submissions process for registrants and is testing a fully electronic labeling process called the Office of Pesticide Program Electronic Label (OPPEL). This pilot aims at replacing paper and PDF submissions with electronic label and labeling submissions. [11] A Pesticide Product Label System (PPLS) allows registrants to search for “me too” products, speeding up submission approvals for registrants. [12]
Beyond these measures, workflow-integrated tools are available to ensure efficient version management and reduce the risk of error associated with manual proofreading. Automating workflow processes makes it easier to manage versions for different regions, like for US states or countries and regions with unique label requirements.
European Union Pesticide Regulations and Compliance
In the EU, pesticide authorization involves member states, the European Commission, and the European Food Safety Authority (EFSA). [13] In terms of EU agrochemical regulations, plant protection products must comply with two key regulations: the EU Plant Protection Products Regulation (PPPR) and the Classification, Labelling and Packaging Regulation (CLP Regulation). Labels must include details like authorized uses, conditions of use, and dose rates, as specified in Annex I of the PPPR. CLP regulations require labeling to inform users about hazardous properties and protective measures. Companies must ensure accurate labeling, and users must follow the specified conditions to protect health and the environment. [14]
European Pesticide Regulations 2030
The EU has launched an ambitious plan called the Framework for Sustainable Food Systems (FSFS) as part of its Farm to Fork Strategy compliance. [15] This strategy covers pesticide use along with aspects like healthier diets, biodiversity, and sustainable food sources and logistics. Among the EU’s aims are to reduce the use and risk of chemical pesticides by 50% by 2030, and fertilizer use by 20%.
Meeting Evolving Labeling Requirements
Evolving labeling rules are leading to more frequent updates to pesticide product labels. These changes, along with the need to tailor labels to different markets, can impact revenues, incentivizing companies to find new efficiencies. Failure to keep up can lead to non-compliance, revenue losses or even loss of market access.
How can the risk of labeling errors be mitigated in the proofreading workflow?
Agricultural manufacturers and distributors can reduce risk by using qualified service providers and by automating workflows. More frequent label revision increases the workload for those updating and proofreading labels. TVT Text Verification Tool and its add-on modules, TVT Artwork®, TVT Spelling®, and TVT Barcode®, automate and optimize this label revision process. This saves time and cost, and avoids the risks associated with manual proofreading. Once you have a revised master labeling document that is compliant, you can compare all downstream labeling versions against this compliant master. Any discrepancies will be promptly highlighted, all actions will be documented, and you can generate and print a final report. This creates a comprehensive audit trail, and increases transparency and accountability within your labeling workflow. Schlafender Hase is ISO 9001:2015 certified for Design and Software Development for Regulated Environments.
Conclusion
Agrochemical industry compliance is becoming more complex, with stricter standards and greater focus on environmental and health impacts. Staying ahead of these changes is critical for businesses to keep market access, avoid fines, and protect reputation. By embracing innovations in compliance and labeling, agrochemical companies can turn regulatory challenges into growth opportunities, ensuring sustained competitiveness in the market.
- https://www.agribusinessglobal.com/special-sections/harmonizing-regulations-in-the-global-agrochemical-industry/
- https://unece.org/about-ghs and https://www.fao.org/pesticide-registration-toolkit/special-topics/globally-harmonized-system-of-classification-and-labelling-of-chemicals-ghs/introduction-to-the-ghs/en/
- https://phys.org/news/2023-09-glyphosate-restricted.html
- https://entomology.umd.edu/news/neonicotinoids-the-good-the-bad-and-the-ugly
- https://food.ec.europa.eu/plants/pesticides/approval-active-substances-safeners-and-synergists/renewal-approval/neonicotinoids_en
- https://www.insideenergyandenvironment.com/2023/02/epa-releases-new-guidance-on-pesticide-devices/?__cf_chl_tk=QVDX8C2OgEmKgt3hGUj8C8CosQacOTpA8OMsp9ewhyE-1727172679-0.0.1.1-4585
- https://www.bdlaw.com/publications/epa-begins-accepting-absence-of-an-ingredient-claims-for-some-pesticide-products/
- https://www.epa.gov/pesticide-labels/label-review-training-module-1-label-basics-page-2
- https://www.brookings.edu/articles/how-the-epas-lax-regulation-of-dangerous-pesticides-is-hurting-public-health-and-the-us-economy/
- https://www.knoell.com/en/solutions/regulatory-software-solutions
- https://www.epa.gov/pesticide-registration/office-pesticide-program-electronic-label-oppel-pilot
- https://www.epa.gov/pesticide-labels/pesticide-product-label-system-ppls-more-information
- https://multimedia.efsa.europa.eu/pesticides-authorisation/index.htm
- https://www.kemi.se/en/pesticides-and-biocides/plant-protection-products/labelling-of-plant-protection-products
- https://food.ec.europa.eu/horizontal-topics/farm-fork-strategy/legislative-framework_en
