1. there is a sufficient degree of potentisation, which involves a sequential series of dilutions or succussions, to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more than one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor's prescription."

1a. Was unter einer ernsthaften Gefahr für die öffentliche Gesundheit zu verstehen ist, ist in entsprechenden Leitlinien zu definieren, die von der Kommission zu verabschieden sind."