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EFSA requires every novel food application to demonstrate the material does not contain fractions of small particles below 100 nm in size. This applies to every submission, even those not formally categorised as an engineered nano material or produced using nanotechnology.
Assessing the water solubility of the novel material is a crucial part of the nano assessment process, but it must be carried out according to specific guidelines set out by the European regulator. The client had misinterpreted these requirements in its novel food submission and now urgently needed RSSL’s analytical expertise to submit additional data that would satisfy EFSA.
Despite the novel material having a solubility of around 200 g/L – well above the 33.3 g/L safety threshold - EFSA’s scientific panel had challenged the initial data presented by the client on two grounds.
First, the chosen method was not designed specifically to quantify the material in solution. Second, the client had not performed the necessary ultrafiltration step which mandates that solubility is evaluated after the novel material is passed through a 10-kDa membrane to remove any suspended solids. This oversight raised concerns that the reported solubility could be an overestimation.
Our analytical team quickly realised that the EFSA suggested OECD solubility method could not be used verbatim. As the method involves working at high concentrations; approximately five times the solubility of the novel material, the viscosity of the resulting dispersions and presence of a large amount of solid material would make direct ultrafiltration impossible.
We solved this challenge by lowering the concentration of the material to workable (but still meaningful) limits, in addition we successfully implementing extra filtration steps to remove the excess solids and used filters of specific geometry and membrane composition to allow sufficient material to be collected for quantification.
RSSL carried out a thorough water solubility assessment that successfully met EFSA’s expectations. This also involved developing and validated an HPLC method suitable for the client’s novel material and optimising the ultrafiltration step within a tight timeframe.
Repeated tests indicated a solubility value of 42 g/L, significantly lower than the client’s initial results but still above EFSA’s safety threshold.
When bringing new ingredients to market, we understand that constantly shifting regulatory rules are challenging. Our specialist team interprets and understands complex requirements to ensure your product is fully compliant, and has the experience and technical capabilities to deliver it.