Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283

Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on shrimp peptide concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a peptide mixture obtained by an enzymatic proteolysis from northern shrimp (Pandalus borealis) shells and heads. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of the NF is sufficient and does not raise safety concerns. The intention of the applicant is to use this NF as an ingredient in food supplements and to market it to adult consumers at a maximum proposed level of intake of 1,200 mg/day (corresponding to 17 mg/kg body weight (bw) per day for a 70 kg person). There are no concerns with regard to genotoxicity. The available human data do not raise safety concerns. Considering the no observed adverse effect level (NOAEL) of 2,000 mg/kg bw per day from a 90-day repeated-dose oral toxicity study, the maximum proposed level of intake and the nature of the NF, the Panel concludes that the margin of exposure (of 117) is sufficient. The Panel concludes that the NF, shrimp peptide concentrate, is safe to be used as a food supplement at the proposed maximum dose of 1,200 mg/day. The target population is adults. The Panel considered that the conclusion on the safety of the NF could not have been reached without the data from the unpublished study report on repeated-dose 90-day oral toxicity and from the unpublished study reports on two human studies.

Characterisation of Seasonal Mytilus edulis By-Products and Generation of Bioactive Hydrolysates

“…Hydrolysates showing superior techno-functional properties and specific bioactivities can be incorporated into functional food products for human use or can be used to develop nutraceutical supplements with targets against specific diseases associated with cardiovascular diseases (CVDs) and inflammation. One such novel food product approved by the European food safety authority (EFSA) recently is PreCardix ® , a hydrolysate made from shrimp by-products which is effective against hypertension [22].There are many nutraceutical products on the market made from green-lipped mussel lipids, but no such regulatory approved product currently exists from blue mussels.…”

Novel foods, food enzymes, and food additives derived from food by-products of plant or animal origin: principles and overview of the EFSA safety assessment

“…Moreover, applicants should specify the organ, tissue, or part of the organism sourced. For example, shrimp peptide concentrates as an NF was obtained from the shells and heads of shrimps of the species Pandalus borealis , serving as a by-product of the production of cooked and peeled shrimps ( 34 ). For animal-derived FE, the genus and species of the FE source should be identified using the most recently accepted nomenclature.…”

“…The highest estimated daily intake (i.e., at least the 95th percentile) among the population groups from a representative database (e.g., EFSA Comprehensive European Food Consumption Database or national dietary surveys) is recommended to be used as the starting point for the safety evaluation. For NF used as food supplements, i.e., shrimp peptide concentrate or egg membrane hydrolysate, the intake was directly derived from the maximum daily use levels proposed by the applicant ( 34 , 35 ).…”

“…In the case of the shrimp peptide concentrate, for example, the applicant provided studies on genotoxicity, acute oral toxicity, and subchronic toxicity conducted with an intermediate product of the manufacturing process, which differed from the NF only in the peptide size. The Panel considered that it was appropriate for the toxicological test, and no toxicological concerns were raised ( 34 ).…”

“…Human studies are not required by default, but if they are available, they constitute supporting evidence to demonstrate the safety of by-products, as was the case for the shrimp peptide concentrate and the egg membrane hydrolysate ( 34 , 35 ).…”