FDA issues Final Rule clarifying Gras

The US Food and Drug Administration (FDA) has published a new law aimed at better explaining the process and criteria it uses to evaluate substances under its Generally Recognized As Safe (Gras) programme.

The Final Rule was published on 17 August in the Federal Register.  It will become effective in two months’ time, on 17 October 2016.

The FDA states: ‘The clarified criteria for Gras status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies.’

Gras provides a mechanism for the food contact industry to bypass premarket notification for a substance where scientific data indicates a risk does not exist. The new publication outlines the format an organisation should use when submitting this, and the type of information it should include to adequately demonstrate its safety.

The rule will also replace the voluntary GRAS affirmation petition process with a voluntary notification procedure.

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