IPEC e-newsletter - Excipients Insight February 2018 - 28-02-18


Inside this issue


EU nanotech consultation - potential impact on excipients?

The European Food Safety Agency (EFSA) has published draft guidance on nanotechnology which will have a significant impact on the types of evaluations that have to be carried out on food and colour additives with nanoparticles present and could potentially also affect pharmaceutical excipients.

The extensive and wide-ranging guidance runs to around 100 pages and provides an overview on information requirements and how to perform risk assessment of nanomaterials in food and feed. It is notable that the scope of the guidance covers extends to substances not engineered as nanomaterial but which contain a fraction of nanoparticles, less than 50% in the number-size distribution, with one or more external dimensions in the size range of 1-100nm.

It is possible that the premises laid out in this document may have an impact on discussions around nanotechnology as it relates to excipients, so we would encourage IPEC Federation members to take a look at the document and if appropriate comment during the consultation period, which comes to an end on 4 March. The guidance may have an impact on the studies that are currently going on within various consortia on Titanium Dioxide (E171) and Iron Oxide (E172).

The US FDA recently published a guidance on nanotech which IPEC-Americas is just starting to review, and there may be advantages to combining efforts at the Federation level so that the US and EU guidance can be considered in tandem.




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