FDA Revokes 25 Phthalate and Plasticizer Uses in Food Packaging (2022)

On May 19, 2022, the U.S. Food and Drug Administration (FDA) announced three linked actions on phthalates, chemicals used to make plastics soft: a final rule that removed the food-contact authorizations for 23 phthalates and two other plasticizers because industry had abandoned those uses, a denial of a safety-based petition that had asked the agency to revoke 28 phthalates as one class, and a request for information on the eight phthalates still authorized as plasticizers. The documents were published in the Federal Register on May 20, 2022. The chemicals themselves are described on the site’s Phthalates page.

This page reports what the FDA’s own documents and Federal Register records say: what the agency did and when, what phthalates are used for in food contact materials, the abandonment rule, the phthalates still allowed, the petitions the agency denied, the request for information, what FDA testing of packaging found, what the actions do not do, their status as of October 18, 2026, and how they fit later FDA phthalate work. No company, trade group or advocacy organization is named here.

Table of Contents

  1. What the FDA Did on May 19–20, 2022
  2. What Phthalates Do in Food Contact Materials
  3. The Final Rule: 25 Abandoned Uses Removed
  4. The Nine Phthalates Still Authorized
  5. The Safety Petitions the FDA Denied
  6. The Request for Information on the Remaining Plasticizers
  7. What FDA Testing of Packaging Found
  8. What the 2022 Actions Do Not Do
  9. Dates and Legal Status as of October 18, 2026
  10. How It Fits Later FDA Phthalate and Food-Chemical Actions
  11. Primary Documents
  12. Key Research Papers
  13. Connections
  14. Featured Videos

1. What the FDA Did on May 19–20, 2022

The FDA’s constituent update of May 19, 2022 opens: “Today, the U.S. Food and Drug Administration (FDA) issued responses to two food additive petitions and a citizen petition requesting agency action on phthalates in food contact applications. We also issued a request for information about available safety data and current use information of certain phthalates in food contact applications.” The agency added that, although the petitions overlapped, it “evaluated and responded to each petition individually.”

Three Federal Register documents carried these actions on May 20, 2022:

On the same day the FDA also denied a related citizen petition from the same public interest groups (section 5). A citizen petition is a formal written request asking the FDA to take, or not take, an action; a food additive petition is the formal request used to ask the FDA to add, change or remove a listing in its food additive regulations. The Federal Register is the U.S. government’s daily publication of rules and official notices, and a docket is the public file for an action, where its documents and public comments are kept on regulations.gov.

Back to Table of Contents

2. What Phthalates Do in Food Contact Materials

The FDA’s program page on phthalates in food packaging explains that “Ortho-phthalates, often referred to as ‘phthalates,’ are chemicals used in plastic products (most commonly in the specific type of plastic named polyvinyl chloride, also known as PVC or vinyl) to make the material soft and less brittle.” That function, it says, is often called a plasticizer. The Federal Register notices use “phthalates” and “ortho-phthalates” interchangeably for the subset of phthalates substituted in the “ortho” position.

According to the same page, “Historically, certain phthalates have been used in food packaging or other minor food contact uses such as components of adhesives, lubricants, and sealants.” A food contact substance is a substance that touches food during manufacturing, packing, transport or storage without being intended as an ingredient. The FDA page states plainly that “Phthalates are not authorized to be directly added to food.”

The program page also notes that the original safety assessments behind these authorized uses “were based on dietary exposure and toxicological information and data provided during the period of 1961 through 1985,” and that “the food supply and packaging markets have changed over the years, and the use of phthalates in food contact materials has also evolved.”

Back to Table of Contents

3. The Final Rule: 25 Abandoned Uses Removed

The final rule removed 25 substances from the FDA’s food additive regulations. The constituent update describes them as “23 phthalates and two other substances used as plasticizers, adhesives, defoaming agents, surface lubricants, resins, and slimicides.” The authorizations were removed from Title 21 of the Code of Federal Regulations, parts 175 through 178 (21 CFR 175–178), the parts covering adhesives and coatings, paper and paperboard components, polymers, and adjuvants, production aids and sanitizers, as the rule’s title lists them.

The legal basis was abandonment, not safety. A vinyl-industry trade group filed its food additive petition on July 3, 2018, asking the FDA to remove these 25 food contact uses. In the FDA’s words, “The petitioners demonstrated that the uses of the 25 substances have been abandoned by industry.” The FDA therefore granted the petition and revoked the authorizations.

The program page spells out what this means for any future use: “If, in the future, a manufacturer wants to use any of the revoked phthalates for use in food contact applications, we expect the manufacturer to submit either a food additive petition or a food contact substance notification to the agency because these intended uses were previously authorized under our food additive authorities.” In other words, the revoked uses can return only through a new FDA review.

The rule’s dates section states that it was effective May 20, 2022, and that objections and requests for a hearing could be submitted by June 21, 2022.

Back to Table of Contents

4. The Nine Phthalates Still Authorized

The constituent update states that the rule “also results in limiting the use of phthalates in food contact applications to nine phthalates – eight authorized for use as plasticizers and one authorized for use as a monomer.” A monomer is a building-block molecule that is chemically linked into a plastic’s structure, rather than mixed in to soften it.

The program page adds that the eight plasticizer phthalates are authorized “through either a food additive regulation or a prior-sanctioned use.” A prior-sanctioned use is a separate category of authorization in the FDA’s rules (listed in 21 CFR part 181), distinct from the food additive regulations the 2022 rule amended.

The FDA’s later documents name four of the remaining plasticizers: di(2-ethylhexyl) phthalate (DEHP), dicyclohexyl phthalate (DCHP), diisooctyl phthalate (DIOP) and diisononyl phthalate (DINP), the four the agency proposed in May 2026 to group for a future cumulative risk assessment (section 10).

Back to Table of Contents

5. The Safety Petitions the FDA Denied

The food additive petition. The FDA filed a food additive petition from several public interest groups on May 20, 2016. According to the program page, it asked the FDA to end the food contact use of 28 phthalates, proposing “to group all 28 phthalates as a single class and remove the listings for those phthalates from the FDA’s food additive regulations based on alleged safety concerns for the proposed class.” The FDA denied it on May 19, 2022. The agency “determined that the petition does not support grouping the 28 phthalates into a single class, and that the petition also did not demonstrate the proposed class of phthalates is no longer safe for the approved food additive uses.” The constituent update notes that the Federal Register notice “includes our response to the assertions included in the petition.”

The two petitions overlapped heavily. The FDA wrote that granting the abandonment petition “resulted in removing food additive authorizations for 23 of the 28 phthalates addressed by the public interest groups’ food additive petition.” So most of the phthalates that petition named lost their authorizations anyway, but on abandonment grounds, not on the safety grounds the petition argued.

The citizen petition. The program page states that on April 16, 2016 the FDA received a citizen petition from the same groups, which “requested a ban on the food contact use for certain phthalates and revocation of the prior sanctioned authorization of other phthalates based on alleged safety concerns.” The FDA denied it on May 19, 2022 “because the petition did not demonstrate through scientific data or information that these actions are warranted.” The response is filed in Docket No. FDA-2016-P-1171.

The denial notice’s dates section states that it applied from May 20, 2022, “except as to any provisions that may be stayed by the filing of proper objections,” with objections and hearing requests due June 21, 2022.

Back to Table of Contents

6. The Request for Information on the Remaining Plasticizers

The third document opened a public docket on the phthalates still in use. The constituent update says the FDA sought “scientific data and information on the specific current food contact uses, use levels, dietary exposure, and safety data for the remaining eight phthalates that are still authorized for use as plasticizers,” and that “We may use this information to update the dietary exposure estimates and safety assessments for the permitted food contact uses of phthalates.”

The agency explained why it asked: “The FDA is generally aware of updated toxicological and use information on phthalates that is publicly available. Nevertheless, stakeholders may have access to information that is not always made public.” The request did not cover the monomer phthalate, “since any exposure resulting from this use is expected to be negligible.”

Comments were first due July 19, 2022. A correction to the notice was published on June 16, 2022 (87 FR 36332). On September 27, 2022 the FDA reopened the comment period to December 27, 2022 (87 FR 58502), “in response to a request from stakeholders to extend the comment period to allow additional time for interested parties to develop and submit data, other information, and comments.” The program page reports that the FDA “received more than 23,900 comments submitted in the docket.”

Back to Table of Contents

7. What FDA Testing of Packaging Found

The program page describes the agency’s own laboratory work: “Over the last few years, we have analyzed numerous samples of PVC and non-PVC fast food packaging and food contact articles (for example, gaskets, tubing, and conveyer belts) available on the U.S. market for the presence of phthalates.” The results, published in 2018, 2021 and 2022 (the first three papers under Key Research Papers), “suggest that manufacturers have been replacing phthalates as their primary plasticizer with alternative compounds.”

One example the FDA gives: “no phthalates were detected in representative samples of food contact tubing used by industry that were obtained and analyzed in 2021.” The agency concludes that this evidence “suggests that at this time the use of phthalates in food contact applications is limited and consumer exposure to phthalates from food contact uses is decreasing.”

The FDA also evaluated portable devices for identifying plasticizers, including phthalates, in PVC tubing, and reported that “some portable devices may be a valuable phthalate screening tool for both the food industry and regulators.”

Back to Table of Contents

8. What the 2022 Actions Do Not Do

Back to Table of Contents

9. Dates and Legal Status as of October 18, 2026

Status as of October 18, 2026: final and in force. The 2022 rule removing the 25 abandoned uses stands, its effective date confirmed in October 2024, and the petition denials stand after the FDA rejected the objections and the reconsideration request. A check of the Federal Register API for FDA documents on phthalates published from May 21, 2022 through October 18, 2026 found no document that changes the 2022 actions; the related documents found were the correction, the reopening and the two October 2024 responses described above. The FDA’s post-market safety assessment of the remaining food contact uses, for which the 2022 request for information gathered data, was still to come as of this date.

Back to Table of Contents

10. How It Fits Later FDA Phthalate and Food-Chemical Actions

The 2022 request for information fed directly into the FDA’s 2026 work. The May 27, 2026 constituent update says the FDA “released a scientific evaluation of the eight ortho-(o)-phthalates (‘phthalates’) currently authorized as plasticizers for food contact use to determine if they should be grouped together for the purpose of a cumulative risk assessment,” and that the agency “received and reviewed approximately 24,000 comments in response to the RFI,” information that “was considered when conducting the evaluation.”

The question of grouping is the same one the 2022 petition denial turned on. In 2022 the FDA found the petition did not support treating all 28 phthalates as one class. In 2026 the agency proposed its own, narrower grouping: its findings “support CPR grouping for DEHP, DCHP, DIOP and DINP for a future cumulative risk assessment.” CPR stands for chemically or pharmacologically related substances; the FDA explains that “Grouping similar chemicals as CPR enables assessment of their combined risk to consumers in a cumulative risk assessment.” The program page says the evaluation, together with the 2022 request-for-information data, “will inform the agency’s upcoming post market safety assessment of the food contact uses of phthalates.”

The program page also places the work in the FDA’s general approach: “Industry must ensure the food contact substances they sell are safe and otherwise meet legal requirements administered by the FDA. The FDA evaluates safety data before authorizing food contact substances and may re-evaluate substances on its own initiative if new scientific information becomes available.”

Other FDA actions on food packaging and food chemicals are reported on their own pages: the 2024 end of PFAS grease-proofing in U.S. food packaging, the 2024 revocation of brominated vegetable oil, the 2025 revocation of Red No. 3, the 2025 moves on self-affirmed GRAS and chemical reviews and the 2026 safety reassessments of BHA, BHT and ADA. Among the 2022 actions, the draft action levels for lead in juice and the bottled water fluoride limit also concern substances in what people eat and drink.

Back to Table of Contents

11. Primary Documents

  1. Food and Drug Administration, HHS (2022). Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers. Final rule. Federal Register 87 FR 31080, May 20, 2022. Docket No. FDA-2018-F-3757 — FR Doc. 2022-10531
  2. Food and Drug Administration, HHS (2022). [Public interest groups], et al.; Denial of Food Additive Petition; Denial Without Prejudice of Food Additive Petition. Notification; denial of petition (FAP 6B4815). Federal Register 87 FR 31066, May 20, 2022. Docket No. FDA-2016-F-1253 — FR Doc. 2022-10530
  3. Food and Drug Administration, HHS (2022). Ortho-phthalates for Food Contact Use; Request for Information. Notice. Federal Register 87 FR 31090, May 20, 2022 (published title spelled “Ortho-phthlates”). Docket No. FDA-2022-N-0571 — FR Doc. 2022-10532
  4. Food and Drug Administration, HHS (2022). Ortho-phthalates for Food Contact Use; Request for Information. Correction. Federal Register 87 FR 36332, June 16, 2022. Docket No. FDA-2022-N-0571 — FR Doc. C1-2022-10532
  5. Food and Drug Administration, HHS (2022). Ortho-phthalates for Food Contact Use; Reopening of Comment Period; Request for Information. Notice. Federal Register 87 FR 58502, September 27, 2022. Docket No. FDA-2022-N-0571 — FR Doc. 2022-20832
  6. Food and Drug Administration, HHS (2024). Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers. Final rule; response to objection; confirmation of effective date. Federal Register 89 FR 86239, October 30, 2024. Docket No. FDA-2018-F-3757 — FR Doc. 2024-25122
  7. Food and Drug Administration, HHS (2024). [Public interest groups], et al.; Response to Objections and Requests for a Public Hearing. Notification; response to objections and denial of public hearing requests. Federal Register 89 FR 86290, October 30, 2024. Docket No. FDA-2016-F-1253 — FR Doc. 2024-25120
  8. U.S. Food and Drug Administration. FDA Limits the Use of Certain Phthalates in Food Packaging and Issues Request for Information About Current Food Contact Uses and Safety Data. Constituent Update, May 19, 2022 (updated July 19 and September 26, 2022) — fda.gov constituent update
  9. U.S. Food and Drug Administration. Phthalates in Food Packaging and Food Contact Applications. Program page, content current as of June 24, 2026 — fda.gov phthalates page
  10. U.S. Food and Drug Administration. FDA Advances Post-Market Review of Phthalates Used in Food Contact Materials. Constituent Update, May 27, 2026 — fda.gov constituent update
  11. Public dockets: regulations.gov FDA-2022-N-0571 (request for information); regulations.gov FDA-2016-P-1171 (citizen petition and response); FDA-2018-F-3757 (abandonment petition and final rule) and FDA-2026-N-5776 (2026 scientific evaluation), both on regulations.gov.

Back to Table of Contents

Key Research Papers

  1. Carlos KS, de Jager LS, Begley TH (2018). Investigation of the primary plasticisers present in polyvinyl chloride (PVC) products currently authorised as food contact materials. Food Additives & Contaminants: Part A 35(6):1214-1222 — PubMed PMID: 29510083
  2. Carlos KS, de Jager LS, Begley TH (2021). Determination of phthalate concentrations in paper-based fast food packaging available on the U.S. market. Food Additives & Contaminants: Part A 38(3):501-512 — PubMed PMID: 33493086
  3. Yakes BJ, Moskowitz J, Crump E, Ellsworth Z, Carlos K, Begley T (2022). Evaluation of portable vibrational spectroscopy for identifying plasticizers in dairy tubing. Food Additives & Contaminants: Part A 39(4):817-827 — PubMed PMID: 35107413
  4. Serrano SE, Braun J, Trasande L, Dills R, Sathyanarayana S (2014). Phthalates and diet: a review of the food monitoring and epidemiology data. Environmental Health 13(1):43 — PubMed PMID: 24894065
  5. Rudel RA, Gray JM, Engel CL, Rawsthorne TW, Dodson RE, Ackerman JM, Rizzo J, Nudelman JL, Brody JG (2011). Food packaging and bisphenol A and bis(2-ethyhexyl) phthalate exposure: findings from a dietary intervention. Environmental Health Perspectives 119(7):914-920 — PubMed PMID: 21450549
  6. Zota AR, Phillips CA, Mitro SD (2016). Recent Fast Food Consumption and Bisphenol A and Phthalates Exposures among the U.S. Population in NHANES, 2003-2010. Environmental Health Perspectives 124(10):1521-1528 — PubMed PMID: 27072648
  7. Varshavsky JR, Morello-Frosch R, Woodruff TJ, Zota AR (2018). Dietary sources of cumulative phthalates exposure among the U.S. general population in NHANES 2005-2014. Environment International 115:417-429 — PubMed PMID: 29605141

The first three papers are the FDA laboratory studies its program page cites: tests of PVC food contact products, of paper-based fast food packaging, and of portable devices for identifying plasticizers in food-processing tubing. The fourth is a review of food monitoring and epidemiology data on phthalates and diet. The last three study how food and packaging relate to phthalate exposure in people: a dietary intervention study, and two analyses of U.S. national survey (NHANES) data.

PubMed Topic Searches

  1. PubMed: phthalates and food packaging
  2. PubMed: phthalates and dietary exposure
  3. PubMed: phthalates and cumulative risk assessment

Back to Table of Contents

Connections

Back to Table of Contents