The Novel Food application, made by Medfiles on behalf of Norwegian-based Marealis AS, refers to a shrimp peptide concentrate aimed at adults at a maximum dose of 1,200 milligrams per day (mg/day).
EFSA could find no safety concerns for the concentrate adding that its conclusion could not have been reached “without the data from the repeated‐dose 90‐day oral toxicity study report and from the unpublished study reports on two human studies”.
Marealis’ application began in September last year, when EFSA received a proposal from the European Commission on the possibilities of shrimp peptide concentrate use as a novel food.
This was after the Finnish Food Safety Authority (Evira), as the initial assessor, requested further information on the astaxanthin content of the product, because shrimps are a natural source of this carotenoid, which gives them their reddish colour.
Marealis provided analyses made for three product batches, in which the astaxanthin content, both free astaxanthin and astaxanthin esters, were below 1 g/100 g and below 3 mg/kg, respectively.
The Panel considered that the potential content of astaxanthin in the novel food would be low and of no concern.
After a number of requests to Marealis for more data, the scientific evaluation was restarted by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), who in April adopted a scientific opinion on the safety of shrimp peptide concentrate as a NF pursuant to Regulation (EU) 2015/2283.
Marealis’ plan of action
Further details proposed by Marealis reveal their intention to use the concentrate only as an ingredient of food supplement applications such as tablets, capsules, powder, and not as an ingredient in any other food products.
The maximum daily dose of 1,200 mg corresponds to 17 mg/kg body weight (bw) per day for adults), e.g. two tablets per day, each tablet containing 600 mg of the concentrate.
The concentrate is obtained by enzymatic proteolysis from the shells and heads of northern shrimp (Pandalus borealis). It contains over 87% peptides with less than 1% of both fat and carbohydrates.
According to EFSA sequencing results, the concentrate contains more than 25,000 peptides in the range of 2–24 amino acids. 670 peptides were identified as being common for all tested batches.
Human data included two clinical trials, which assessed safety‐related end points such as biometrics, clinical biochemistry and urine analysis parameters as well as recordings of adverse events.
No statistically significant difference was observed between the treatment and placebo groups in regards to safety‐related end points when the NF was taken in doses of 1,200 mg/day, over a treatment period of 8 weeks.
No safety concerns
The Panel considers that observed changes in blood pressure do not pose safety concerns in subjects with mild or moderate hypertension.
“The nature of the novel food and the exposure of humans to the large variety of proteins and peptides in the customary diet, as well as their fate in the intestine (hydrolysis), and because the changes on the blood pressure in mild and moderate hypertensive subjects were not of safety concern,” the NDA Panel said.
“The Panel considers that it is unlikely that the novel food would have safety relevant effects in normo‐ or hypotensive subjects.”