Table 5.
Comparison of reference standards and methods in the United States and Europe.
| United States | Europe | ||
|---|---|---|---|
| number of allergen standards | 19 standard extracts (see Table 3) |
2 rec. allergens | 5 standard extracts (see Table 2) |
| unitage of standards | potency (depending on allergen, see Table 3) |
µg single allergen molecule | international units |
| responsible authority | FDA/CBER | EDQM/NCAs | |
| main regulatory document | 21 CFR 680.3(e) | Ph. Eur. (Monograph on Allergen Products) |
|
| provision of reference method materials | CBER | commercial sources | |
| provision of reference standards | CBER | EDQM | |
| mandatory use | yes | (yes)* | |
| option to use alternative method | yes | yes | |
*after adoption of respective general texts in Ph. Eur.