Table 1.
Comparison of the data requirements across the areas of most common global registration of active substances (a.s.) and formulated plant protection products (PPP)
Testing | Country | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Europe | USA | Brazil | India | China | ||||||
a.s. | PPP | a.s. | PPP | a.s. | PPP | a.s. | PPP | a.s. | PPP | |
Acute toxicity test | R | NRa | R | NR | R | R | R | R | R | R |
Avian dietary toxicity test | NR | NR | R | NR | R | NRb | NR | NR | R | NR |
Long-term reproduction test | R | NR | R | NR | R | NR | NR | NR | NR (Rc) | NR |
Required when toxicity cannot be reliably predicted from the constituent active substances.
Required if active substance LD50 ≤ 500 mg a.s./kg.
Possibility for requirement in new updates to guidance.
R = required; NR = not required; LD50 = median lethal dose.