Reference Values for Regulation

ENDPOINTSFORREGULATIONTests for crop protection active ingredients and products look at a variety of parameters to determine their potential adverse impacts for humans (most often in laboratory animals) and wildlife (using a number of sentinel species like fish). Based on the findings, the most sensitive and relevant parameters form the basis of the safety evaluation in each case.

The level at which no effect is observed is typically divided by a number of safety factors to establish a protective exposure level – one that is sufficiently low to give assurance that no adverse effects will occur. This value becomes the endpoint for regulation. These endpoints for regulation are globally accepted.

Endpoints for crop protection products (e.g., acceptable daily intake) ensure public welfare because they are set well below levels where no adverse effects are observed and include a safety margin. For human health, the typical safety margin is at least 100 times lower than the no adverse effect level in toxicity tests.

Existing test methods allow for the establishment of regulatory endpoints and existing parameters in toxicity tests for crop protection products ensure human and environmental safety. They include endpoints relevant to sensitive populations and windows of exposure, and measure adverse effects that can be induced by a variety of modes of action, including interaction with the endocrine system.

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What is the Endocrine System?

The endocrine system is a set of glands that produce hormones throughout the body, regulating growth, development, metabolism, tissue and sexual function, mood, sleep, behavior and the body's internal environment.