EFSA Assessment on Safety of Water Extract of Plant Stems as a Novel Food Ingredient

| Regulatory News | News
Posted By: Ognjen Djunisijevic

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On January 15, 2021, the European Food Safety Authority Scientific Panel on Nutrition, the Novel Foods and Food Allergens (NDA), delivered opinions on “Water extract of Cistanche tubulosa stems as a Novel Food (NF) pursuant to Regulation (EU) 2015/2283” for its use in food supplements (FS) and foods for special medical purposes (FSMP).

The document highlights the following:

  • The general adults are the target population. Pregnant and lactating women are excluded.
  • Proposed maximum daily intake of 2 g for FS and a maximum use level of 100g/kg in FSMP.
  • The characteristic components of the extract are phenylethanoid glycosides (at least 70% of the NF), in particular, Echinacoside (25–45% of the NF).
  • Safety concerns have been raised with inadequate analytical studies and limitations of the provided toxicological studies.
  • Non-compliance with the EFSA approach on the genotoxicity testing strategy and the non-compliance with good laboratory practice (GLP) and the respective OECD Guidance documents of the repeated dose toxicity studies.
  • In view of the adverse events in the human studies, the panel considers that additional toxicological studies would not be able to overcome the concerns raised from the human studies. The Panel concludes that the safety of the NF has not been established.

To view the complete safety assessment report, check out the Food News Monitoring System.

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