How to Prepare a Food Contact Substance Notification for USA

Food Contact

How to Prepare a Food Contact Substance Notification for USA

Little Pro on 2017-07-10

In the USA, you need to submit a food contact substance notification to the FDA if the substance has not been cleared for use as a component of food contact material. In this article, we will summarize how to prepare a food contact notification for USA including administrative procedure, the composition of a technical dossier and toxicological data requirements. [Read more: how to comply with food contact regulations in USA]

Procedure of Food Contact Substance Notification for USA

A manufacturer or supplier of a food contact substance shall submit food contact notification to the following FDA address. 5 hard copies and 1 electronic copy shall be submitted.

Notifications Control Assistant,
Office of Food Additive Safety, HFS-275
Center for Food Safety & Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740

FDA usually responds within 30 days since receiving a notification dossier.

Structure of A Technical Dossier

The technical dossier consists of the following parts.

Section	Detailed Requirements
A Comprensive Summary	A summary and comprehensive discussion of the basis for the notifier's determination that the use of the FCS is safe.
B Chemical Indentity	Detailed information on the chemical identity of the FCS and the impurities and residual reactants from the production of the FCS, including the chemical and structural formulas and CAS Registry No.
C Intended Conditions of Use	Detailed information on the intended conditions of use of the food contact material(s) manufactured with the FCS. (e.g., maximum use temperature, type of food that the substance is intended to contact, duration of the contact, and whether the food contact material is intended for repeated or single use application)
D Intended Technical Effect	A statement of the intended technical effect of the FCS and data to establish the minimum amount of the substance that will achieve the intended technical effect.
E Estimation of Intake	Information on levels of residual reactants and impurities and the notifier's estimate of the CEDI from all food uses of the FCS. This includes migration studies, analytical methods and estimation of cummulative estimated daily intake (CEDI). Read more: chemistry requirement
F Toxicity Information	Summary of toxicological profiles, genotoxicity studies, subchronic oral toxicity studies and other available toxicity studies. Read more: toxicology recommendations
G Environmental Information	Either an environmental assessment (EA) or a claim for categorical exclusion from the requirement of an EA
H FDA Form No. 3480	A completed and signed FDA form.

Tiered Toxicity Data Requirements

There are minimum requirements on toxicological data (as recommended by FDA). The recommended test requirements increase with estimated exposure levels.

Tier	Toxicity data required	Other Considerations
Incremental exposure at or less than 0.5 ppb (i.e., 1.5 ug/person/day) in the diet	No safety studies are required Available information on the potential carcinogenicity of such substances should be discussed	For a carcinogenic constituent of an FCS, the CTP should contain an estimate of the potential human cancer risk from the constituent due to the proposed use of the FCS
Cumulative exposure greater than 0.5 ppb (i.e., 1.5 ug/person/day) but not exceeding 50 ppb (i.e., 150 ug/person/day)	+ gene mutations in bacteria; + in vitro test with cytogenetic evaluation of chromosomal damage using mammalian cells or an in vitro mouse lymphoma tk± assay (recommended)
Cumulative exposure between 50 ppb (i.e., 150 ug/person/day) and 1 part per million (ppm) (i.e., 3 mg/person/day)	+ in vivo test for chromosomal damage using rodent hematopoietic cells + two subchronic oral toxicity tests, one in a rodent species and one in a non-rodent species.	The results of subchronic studies may trigger longer-term or specialized safety tests (e.g., metabolism studies, teratogenicity studies, reproductive toxicity studies, neurotoxicity studies, and immunotoxicity studies).
Cumulative exposure at or greater than 1 ppm (i.e., 3 mg/person/day)	FDA recommends that a food additive petition be submitted for the FCS	Data requirement follows food additive petition.

Reference

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