Investigational
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Are there alternative concepts for acceptable limits?<br />
NOVARTIS<br />
Acceptable level of intake of genotoxic impurities should be<br />
set in relation to daily intake of food mutagens (1g/day)<br />
‣ “no risk“ level for a genotoxin: 10 - 100 µg/day<br />
(“safety margin“ of 4 -5 orders of magnitude below the “daily<br />
mutagenic burden“!)<br />
Fiori & Meyerhoff (Eli Lilly): “Extending the Threshold of<br />
Regulation Concept: De Minimis Limits for Carcinogens and<br />
Mutagens“<br />
(Regul. Toxicol. Pharmacol. 35, 2002, 209-216)<br />
‣ “no risk“ level for a genotoxin: 90 ng/day<br />
‣ “no risk“ level for a carcinogen: 9 ng/day<br />
These are no real alternatives!<br />
L. Müller, Swissmedic, 21-Oct-2003
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