Following a request from the European Commission, the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on shrimp peptide concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The assessment of the safety of this NF, which follows the methodology set out in the EFSA Guidance on the preparation and presentation of an application for authorisation of a novel food Regulation (EU) 2015/2283 (EFSA NDA Panel, 2016) and in the Commission Implementing Regulation (EU) 2017/2469, is based on the data supplied in the original application, the initial assessment by the competent authority of Finland, the concerns and objections of a scientific nature raised by the other Member States and information submitted by the applicant following an EFSA request for supplementary information and additional data identified by the Panel.
The ‘Refined shrimp peptide concentrate’ is a peptide mixture, obtained by enzymatic proteolysis from northern shrimp (Pandalus borealis) shells and heads. It contains more than 87% peptides (> 99.9% of peptides have molecular weight (MW) < 2 kDa), with less than 1% of both fat and carbohydrates. According to results of de novo sequencing, the NF contains more than 25,000 peptides in the range of 2–24 amino acids and 670 peptides were identified as being common for all tested batches. The information provided on the composition, the specifications, the batch‐to‐batch variability, stability and production process of the NF are sufficient and do not raise concerns about the safety of the NF.
The NF is proposed to be used only as an ingredient in food supplements, with the intention of the applicant to market it to consumers who want to control their blood pressure. The maximum proposed level of intake is 1,200 mg/day (corresponding to 17 mg/kg body weight (bw) per day for a 70 kg person). It can be assumed that a large portion of the peptides would be hydrolysed to the individual constituent amino acids prior to absorption and only a small fraction would be available for systemic uptake.
There are no concerns with regard to genotoxicity given the nature of the NF and on the basis of the studies provided by the applicant. The no observed adverse effect level (NOAEL) in a 90‐day repeated‐dose oral toxicity study was 2,000 mg/kg bw per day, the highest dose of the NF tested.
Human data included two clinical trials which, as primary endpoints, assessed potential effects of the NF on blood pressure in subjects with mild or moderate hypertension. These studies also 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. The Panel considers that observed changes in blood pressure do not pose safety concerns in subjects with mild or moderate hypertension. Also, considering the nature of the NF 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 Panel considers that it is unlikely that the NF would have safety relevant effects in normo‐ or hypotensive subjects.
Taking into account the NOAEL of 2,000 mg/kg bw per day and maximum proposed level of intake of 17 mg/kg bw per day for adults, the Panel considers the resulting margin of exposure (117) to be 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, shrimp peptide concentrate, could not have been reached without the data from the unpublished study report on repeated dose 90‐day oral toxicity (2011c), and from the unpublished study reports on two human studies (2013, 2016).
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