Regulatory requirements of bioactive peptides (protein hydrolysates) from food proteins

The global bioactive peptides' market has been rising steadily due to the increased awareness of consumers about the positive association between functional foods/health foods and health. Bioactive peptides are short sequences of food proteins, mostly composed of 2-20 amino acid residues, with demonstrated positive physiological effects on human health. Different countries have developed various regulatory frameworks in order to protect the consumers from risks, misleading and false claims of the bioactive peptides. Scientific substantiation of safety and efficacy of bioactive peptides is an important aspect that can significantly impact the approval of health claims of bioactive peptides for market release. For regulatory approvals, the data from in-vitro and animal studies are alone not adequate to claim health benefits of bioactive peptides. Health claims of bioactive peptides must be supported by substantial evidence from human studies. Bioactive peptides derived from various food protein sources such as milk, whey, fish, and soybean have been on market in several countries. This review summarizes the important regulatory policies related to the bioactive peptides in various major countries.