Answer: Compliance with good laboratory practices (GLPs) is required for each non-clinical lab study, if the study is essential to the safety evaluation of the food-contact substance. Part 58 of the GLP regulations specifies that this requirement only applies to in vitro and in vivo toxicity tests. GLP certification must be submitted with the report as part of the FCN.
Note that there is a new requirement: studies conducted after 1978 that are not in compliance with Part 58 of the GLP regulations must be validated by an independent third party prior to the results being submitted to the FDA.
Back to FAQs