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.