License and audit of genetically modified organisms

Introduction

EU regulations mandate case-by-case risk assessment for the contained use of GMOs

Case metrics

Key statistics

months to go live

1990

Regulated for 35+ years

Each

EU Member States is responsible for conducting official controls to ensure compliance with GMO regulations

The challenge

Overcoming Regulatory Challenges with Digital GMO Management at the Danish EPA

The Danish Environmental Protection Agency (EPA) is responsible for regulating the use of genetically modified organisms (GMOs) to ensure safety, compliance, and environmental protection. In accordance with EU regulations, the agency must conduct case-by-case risk assessments, classify GMOs, and receive notifications from users before first-time use in any facility. To ensure compliance with these regulations, the Danish EPA oversees approvals and conducts inspections.

Without a digital system, users had to manually submit notifications, and authorities processed them using fragmented workflows, which made it difficult to track approvals, risk evaluations, and inspection results efficiently. The lack of a centralized system also created challenges in generating reports, maintaining transparency, and standardizing compliance procedures. Recognizing these inefficiencies, the Danish EPA sought a digital solution to improve case management, streamline regulatory workflows, and enhance oversight.

The solution

A Digital Platform to improve GMO approval and inspection processes

To address these challenges, the Danish Environmental Protection Agency (EPA) implemented cBrain’s F2 platform, a fully digital system designed to streamline the classification, approval, and monitoring of GMO use. The F2 solution replaced the manual, paper-based workflow with an integrated digital platform that handles case-by-case risk assessments, ensures compliance with regulatory requirements, and enhances efficiency. The system standardizes workflows for both granting approvals and conducting inspections, improving consistency and accuracy.

The system introduced risk-based scoring, prioritizing inspections based on predefined criteria, and digital case guides to standardize workflows. Pre-filled online forms automatically updated case records, reducing manual input and improving efficiency. A centralized digital archive allowed for structured searches, reporting, and transparency. Additionally, the platform enabled external expert reviews and fee management, ensuring accuracy and consistency in regulatory processes.

The result

Enhanced efficiency and compliance through F2

The implementation of cBrain’s F2 platform transformed the way the Danish Environmental Protection Agency (EPA) manages GMO approvals and inspections. Within a 9-month implementation period, the agency transitioned from a manual, paper-based system to a fully digitalworkflow, securing higher-quality inspections and a more efficient, structured approach to regulatory compliance.

The automation of risk assessments and approvals reduced administrative burden, while the centralized system improved transparency and oversight. The solution allowed for faster processing, streamlined inspections, and better regulatory enforcement, strengthening the agency’s ability to meet EU compliance requirements efficiently.

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