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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk.” This guidance is intended to provide industry with our current thinking on how to prepare a food contact notification (FCN) submission for our review and evaluation of the safety of food contact substances (FCSs) used in contact with infant formula and/or human milk.
The announcement of the guidance is published in the Federal Register on May 9, 2019.
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2016-D-1814 for “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the guidance to Division of Food Contact Notifications/Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.
Vanee Komolprasert, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1217.
We are announcing the availability of a guidance for industry entitled “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk.” We are issuing the guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348) establishes an FCN process as the primary method by which we regulate food additives that are FCSs. As defined in section 409(h)(6) of the FD&C Act, the term “food contact substance” means any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.
Pursuant to section 409(h) of the FD&C Act and FDA's implementing regulations [1] , FCN submissions must contain a comprehensive discussion of the basis for the manufacturer's or supplier's determination that the use of the FCS that is the subject of the notification is safe. This guidance contains recommendations regarding how the scientific information in FCNs for infant food use should demonstrate that the FCS is safe for the specific intended use in contact with infant food. For purposes of the guidance, infant food is limited to infant formula and/or human milk, and this guidance focuses on infants 0-6 months in age. The guidance discusses our recommendations and provides information for: A. Chemistry Recommendations, including Migration Testing and Exposure Estimation; B. Toxicology Recommendations including Exposure Based Testing Tiers, Minimum Testing Recommendations, and Age Dependent Cancer Risk Analysis of Carcinogenic Constituents; and C. Administrative Recommendations including Acknowledgment of an FCN, Non-acceptance of an FCN, Final Letter, Inventory of Effective FCNs, and Premarket Notification Consultations (PNCs).
In the Federal Register of December 9, 2016 (81 FR 89110), we announced a draft guidance for industry and gave interested parties an opportunity to submit comments by February 7, 2017, for us to consider before beginning work on the final version of the guidance. We received a few comments on the draft guidance and have modified the final guidance where appropriate. Changes to the guidance include modifying the Exposure Based Testing Tiers 2 and 3 to be consistent with FDA's “Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. Specifically, the upper bound of Tier 2 now includes an exposure equal to or less than 2.5 micrograms per kilogram of body weight per day (µg/kg bw/day) and lower bound of Tier 3 is now greater than 2.5 µg/kg bw/day. The guidance announced in this notice finalizes the draft guidance dated December 2016.
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under OMB control number 0910-0495.
Persons with access to the internet may obtain the guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.
Dated: May 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09530 Filed 5-8-19; 8:45 am]
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