München, 23.01.2024
Breaking News in the World of Food Supplements!
Thrilled to share a little update from RDA Scientific Consultants GmbH! The new food additive Trimagnesiumdicitrate E 345(i) (TMDC) has been authorised by Commission Regulation (EU) 2024/346. It may be used as stabiliser and anti-caking agent in solid food supplements with a maximum limit of 100000 mg/kg.
The story behind: In 2015, we submitted an application for the approval of the new additive TMDC. Already in 2016, the respective EFSA Opinion has been published. Quoting the panel's conclusion:
„The Panel concluded that there was no safety concern from the proposed typical use levels of TMDC as a stabiliser and anticaking agent in food supplements, whereas at the proposed maximum use levels, the resulting exposure to magnesium in adults and the elderly at the high-level would be above the UL“ (EFSA 2016)
Here's the twist – TMDC has long been approved as a nutrient under Directive 2002/46/EC and Regulation 1925/2006 (magnesium salts of citric acid), with no specific requirements on specifications or maximum amounts. Curious, right?
Without delving into all the nitty-gritty details, we endured years of waiting for the Commission's response, despite numerous inquiries. It wasn't until the last two year that things started moving – thanks to our legal team from our sister company Meisterernst Rechtsanwälte PartG mbB efforts in reaching out on our behalf. And now, after nearly a decade, we proudly hold the Regulation granting approval for TMDC!
Patience truly pays off!