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8.10. Reproductive toxicity For evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route The studies need not be conducted if: the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented including measures related to reproductive toxicity, or the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented including measures related to reproductive toxicity, or the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available provided that the dataset is sufficiently comprehensive and informative), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and the pattern of use indicates there is no or no significant human exposure If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as Reproductive toxicity Cat 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered If a substance is known to cause developmental toxicity, meeting the criteria for classification as Reproductive toxicity Cat 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.