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English: These Regulations implement Council Directive 93-43-EEC of the 14th June 1993 on the hygiene of foodstuffs, except for the requirements of paragraphs 4 and 5 of Chapter IX of the Annex to that Directive (which relate to temperature controls) and for the requirements in that Directive which relate to imports which are likely to pose a serious risk to human health and which come from ...
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For substances used in food prior to January 1, 1958, a grandfather clause allows experience based on common use in food to be used in asserting an ingredient is safe under the conditions of their intended use. [3] The FDA can also explicitly withdraw the GRAS classification, as it did for trans fat in 2015. [6]
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However, additional specifications may be applied in national and continental contexts. In the United States, the Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications.
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