Comprehensive Model for the Analysis and Assessment of Regulatory Risk: Fundamentals, Mathematical Algorithm and Practical Application

Regulatory risk analysis allows you to anticipate the impact of regulatory changes on products and business strategies. The process is structured in nine steps: identification of the regulatory event, classification of the type of action, evaluation of the status of implementation, impact analysis, evaluation of international precedents, projection of future measures, identification of collateral risks, assignment of the level of risk and definition of recommendations for action. To quantify these risks, a mathematical algorithm is proposed where the Regulatory Risk (RR) is calculated as (I×G×T×P)×(1+L), combining intensity of the measure, degree of implementation, urgency, proportion of the affected portfolio and expected litigation. Each variable is scored on a standardized scale, and the outcome classifies the risk as low, moderate, high, or critical. The model is based on international standards such as the Codex Alimentarius, ISO 31000 and FDA frameworks. Its value lies in operational simplicity, adaptability to different types of regulatory changes, strategic prioritization capacity and technical robustness for audits or regulatory defenses. Applied to the elimination of synthetic dyes in the United States, the algorithm yielded a critical risk (RR = 450), recommending urgent action through reformulations, adaptation of labels and legal mitigation strategies.