Threshold of Regulation (ToR)
A threshold of regulation is an official exemption of the FDA for a component of a material is migration in significantly low amounts.
21CFR 174.6: "Substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate, or that may be expected to migrate, into food at negligible levels may be re-viewed under § 170.39 of this chapter. The Food and Drug Administration will exempt substances whose uses it determines meet the criteria in § 170.39 of this chapter from regulation as food additives and, therefore, a food additive petition will not be required for the exempted use."
A threshold of Regulation status can be obtain from the FDA. Legislation on
this subject is mentioned in several paragraphs:
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21 CFR 170.39 | Threshold of regulation for substances used in food-contact articles. |
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21 CFR 171.8 | Threshold of regulation for substances used in food-contact articles. |
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21 CFR 174.6 | Threshold of regulation for substances used in food-contact articles |
If you want to submit a dossier for a ToR status you should read the guidance: Submitting Requests Under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food Contact Articles.
If a petition is submitted and was approved for exemption, it will be mentioned on the FDA internet website.