The Authority are responding to an application made by Enteron Science in which the German-based firm plan to place these eggs on the European Union market as a Novel Food (NF).
Enteron suggest these eggs are able to boost the host immune system providing benefits to conditions such as inflammatory bowel disease, multiple sclerosis and allergic rhinitis.
“The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of Trichuris suis ova per day,” EFSA states.
“Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.”
Targeted at the general public, Enteron detail the supplement format as consisting of 250 viable embryonated eggs suspended in 15 millilitres (mL) of phosphate‐buffered solution (pH 2.4) with potassium sorbate as an antimicrobial preservative.
Eggs of T. suis are oval, of microscopic size (60 × 25 micrometres (μm)), brownish and lemon‐shaped with noticeable protruding polar caps at both ends. The shell of the eggs contain chitin.
In its assessment, EFSA outlined potential concerns associated with the NF relating to the human invasiveness or infestation by T. suis.
In addition, EFSA expressed concern at possible immunological reactions to excretory/secretory peptides as the Panel highlighted how hatched larvae excrete antigens in order to survive and persist in the host.
These peptides interact with the immune system of the host provoking measurable reactions of the immune system, EFSA said.
Amongst a host of safety data submitted by Enteron, human trials involving individuals suffering from inflammatory bowel disease, multiple sclerosis and allergic rhinitis were submitted.
However, no clinical trials were included that were performed in healthy individuals including children.
Despite the wealth of research submitted, the Panel considered the uncontrolled studies enrolling small numbers of subjects were not suitable for the assessment of this NF.
The Panel also notes that studies with patients suffering from inflammatory bowel disease have inherent limitations for their use in the safety assessment of a viable intestinal parasite.
In further discussing the conclusions reached, EFSA said case reports in the literature showed that under certain circumstances, T. suis is invasive in humans and can mature to adult size and reproduce in humans.
The potential infection of humans with T. suis has been confirmed in populations in Uganda and Thailand.
Several human studies investigating potential effects of viable T. suis in those with allergic rhinitis, inflammatory bowel disease or multiple sclerosis were considered “uncontrolled and enrolled only a low number of subjects”.
“The Panel also considers that studies with patients suffering from inflammatory bowel disease have inherent limitations mainly because of an overlap of effects of T. suis with symptoms related to the disease in the individuals tested and are not suitable to demonstrate the safety of this NF,” the Panel adds.
In summing up the Authority notes the intake of 250 viable embryonated eggs of T. suis ova per day as proposed by the applicant are at lower levels than those where gastrointestinal effects in trials were observed.
However, the Panel considered that there are no data available, which would allow the Panel to conclude that the reported gastrointestinal effects when dosing 2,500 eggs would not occur at the proposed intake of 250 eggs per day.