IPEC e-newsletter - Excipients Insight September 2017 - 19-09-17


Inside this issue


EFSA review on food additives raises pharma questions

The European Food Safety Agency's (EFSA) risk-assessment review of certain food additives continues, with the agency completing its re-evaluation of food colourants in July having assessed 41 colours. As a result of this work, the maximum levels of three colours (E 104, E 110, E 124) were lowered and the colour Red 2G (E 128) was removed from the market.

IPEC Europe has been monitoring the EFSA activities to see whether these have any impact on the use of those same materials in pharmaceuticals. We recently shared the planned actions related to the use of iron oxides (E172), whereby EFSA has requested more safety data to support its continued use as a food additive. If EFSA removed E172 from the EU food additives list, legislation governing colouring matters which may be added to medicinal products (Directive 2009/35/EC) could also be affected which would be a major issue.  As it stands E172 is not on the EFSA's tentative work programme for 2017.

On 24 November, EFSA will host a one-day workshop on the status of the EU re-evaluation programme of food additives. The day before, observers will have the opportunity to attend the open plenary of the Authority’s Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS).




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