Elena Rinaldi, a student of the 2nd Level Master in Innovation in Food Science and Technology – Michele Ferrero at Università Cattolica del Sacro Cuore of Cremona, has presented an important thesis titled “Health Claims’ Legal Framework: A Comparative Analysis of the EU and US Legislations. Protein Claims as a Case Study.” Supervised by Prof. Beatrice La Porta and Dr. Elisa Occelli, her research offers a critical look at how the European Union and the United States regulate health and nutrition claims (H&N claims) in food products.
Rinaldi’s work explores how nutrition and health claims have become essential communication tools in the modern food industry, especially as consumer demand for protein-enriched and functional foods continues to rise. Her thesis investigates the legal frameworks governing such claims, highlighting both the opportunities for innovation and the challenges of ensuring regulatory compliance.
The EU Approach: Precaution and Scientific Rigor
In the European Union, the system is characterized by a precautionary approach, with a positive list of pre-approved health claims under Regulations (EC) 1924/2006 and (EU) 432/2012. Each claim must undergo scientific evaluation by the European Food Safety Authority (EFSA) and formal approval by the European Commission. This structure ensures consumer protection but can result in a lengthy and bureaucratic process for companies seeking to innovate.
The US Model: Flexibility and Post-Market Control
In contrast, the United States follows a more preventive and flexible approach. Under the Nutrition Labeling and Education Act (NLEA), claims are often self-regulated, with post-market notifications to the Food and Drug Administration (FDA). The use of disclaimers and “qualifying language” allows companies to communicate health benefits with fewer procedural barriers—though at the risk of less uniformity and potential consumer confusion.
Protein Claims as a Case Study
Rinaldi’s case study on protein claims underscores these differences. While the EU defines clear quantitative thresholds for “high” or “source of protein,” the US system permits greater flexibility in claim wording, relying on broader standards such as Daily Reference Values. She also notes the emergence of “grey areas”—for example, claims related to protein quality or sustainability—that challenge both legislators and manufacturers.
Her conclusion calls for balanced frameworks that combine scientific rigor with regulatory adaptability, ensuring that health claims genuinely inform consumers while supporting responsible innovation in the global food industry.