Toxicology Requirements

Are there any additional data requirements for biocides?

Mar 2001

Question: Are there any additional data requirements for biocides?

Answer: The testing requirements for biocides are the same, but biocides are held to lower thresholds. For a biocide with an EDI under 0.5 ppb, no toxicology data is required. For exposures between 0.5 ppb and 10 ppb, only in vitro genotoxicity testing is required. Where the EDI is between 10 ppb and 200 ppb, both in vitro and in vivo genotoxicity tests, plus two 90-day studies are required. In the event that the EDI for a biocide is greater than 200 ppb, a Food Additive Petition is usually required, and the full complement of toxicology tests is required.

Back to FAQs