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  6. 2018 Food and Color Additive Final Rules
  1. Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory Information

2018 Food and Color Additive Final Rules

One of the charges of the Center for Food Safety and Applied Nutrition is to assure that the use of food ingredients and color additives is safe. The authority for this mission is derived from the 1958 food additive and 1960 color additive amendments to the Federal Food, Drug and Cosmetic Act. Towards this end, CFSAN evaluates new petitions to determine if substances are considered safe for addition to the food supply. When a petition for a food ingredient or color additive is approved, a regulation identifying the conditions of use is published in the Federal Register. For information about additional food ingredient review programs in the Office of Food Additive Safety, consult the Inventory of Effective Food Contact Substance (FCS) Notifications and the Summary of all GRAS Notices.

The following listing documents the Final rules issued by the Office of Food Additive Safety during calendar year 2018. The exact date of the Publication and the Federal Register citation is listed along with other identifying information that can be found in the published Federal Register document. A link in the column entitled Federal Register documents provides access to the text of the document.

For more information about the petition process, see Questions and Answers About the Petition Process.

Final rules for years 2000-present are also available.

DATE FEDERAL REGISTER CITATION PETITION NUMBER DOCKET NUMBER SUBJECT
5/21/2018 83 FR 23382 FAP 5A4811 FDA-2015-F-3663  Notification; Denial of petition: denying a food additive petition requesting that the food additive regulations be amended to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in certain food applications. We denied the petition because we have determined that the petitioner did not provide sufficient information for us to conclude that the requested uses of PHOs are safe.
6/7/2018
 
 
9/18/2018
83 FR 26356
 
83 FR 47069
CAP 7C0310 FDA-2017-C-0935 Final rule; amending the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non-absorbable sutures for use in general surgery. Effective on July 10, 2018.
Final rule; confirmation of effective date.
9/20/2018  83 FR 47557 FAP 7A4818  FDA-2017-F-3717 Final rule; amending the food additive regulation for vitamin D3 to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D3 specifications.
9/25/2018
12/17/2018
83 FR 48373
83 FR 48373
CAP 7C0311 FDA-2017-C-2902 Final rule; amending the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution. Effective on October 26, 2018. Final rule; confirmation of effective date.
10/9/2018 83 FR 50490 FAP 5A4810 FDA-2015-F-4317 Final rule; amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food and to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. We took this action because, despite our determination that these substances do not pose a risk to public health under the conditions of their intended use, the petitioners provided data demonstrating that these additives induce cancer in laboratory animals.

Notification of partial denial of petition; denying as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned.
10/9/2018 83 FR 50487 FAP 6A4817 FDA-2016-F-1444 Final rule; amending the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant for use in food because these uses have been abandoned.
10/31/2018
4/1/2019
83 FR 54665
84 FR 12081
CAP 7C0309 FDA-2017-C-1951 Final rule; amending the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp because new data available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive. We received objections and a request for a hearing on the objections. The filing of the objections stays the effective date of the final rule until FDA takes final action on the objections. Reinstatement of Color Additive Listing for Lead Acetate effective April 1, 2019.
11/1/2018
4/18/2019
83 FR 54869
84 FR 16205
CAP 7C0308 FDA-2017-C-6238 Final rule; amending the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules. Effective on December 4, 2018. Final rule; confirmation of effective date.