Alina Kilasoniya

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.

The European Union classifies “novel foods” as those not widely consumed before 15 May 1997. This category includes recently created, innovative foods, as well as those made using new technologies and processes, and foods with a traditional consumption history outside the EU. Distinguishing between “novel” and “conventional” foods is legally significant, as the former require official authorization under the Novel Foods Regulation. The regulation prioritizes safety, accurate labeling, and nutritional parity with replaced foods. Regulation (EU) 2015/2283, effective from 1 January 2018, replaced prior regulations, facilitating access to the EU market for novel and innovative foods while maintaining high safety standards. Classifying botanical products as novel can be intricate. Safety assessments for plant products must consider diversity in species, varieties, ecotypes, and chemotypes, as cultivation practices influence chemical composition. The article reviews the legislation applicable to botanicals and proposes different ways to evaluate in advance whether a product is “novel” or not, emphasizing the evaluation of the origin and consumption history of foods of plant origin.

Plant-derived extracellular vesicles (PEVs) have gained attention as promising bioactive nutraceutical molecules; their presence in common fruit juices has increased their significance because human interaction is inevitable. The goal of this study was to evaluate the potential of PEVs derived from grapefruit and tomato juices as functional ingredients, antioxidant compounds, and delivery vehicles. PEVs were isolated using differential ultracentrifugation and were found to be similar in size and morphology to mammalian exosomes. The yield of grapefruit exosome-like vesicles (GEVs) was higher than that of tomato exosome-like vesicles (TEVs), despite the latter having larger vesicle sizes. Furthermore, the antioxidant activity of GEVs and TEVs was found to be low in comparison to their juice sources, indicating a limited contribution of PEVs to the juice. GEVs showed a higher efficiency in being loaded with the heat shock protein 70 (HSP70) than TEVs, as well as a higher efficiency than TEV and PEV-free HSP70 in delivering HSP70 to glioma cells. Overall, our results revealed that GEVs present a higher potential as functional ingredients present in juice and that they exert the potential to deliver functional molecules to human cells. Although PEVs showed low antioxidant activity, their role in oxidative response in cells should be further addressed.