What the FDA’s Recent Amendment to CFR Title 21 Means for Material Manufacturers

Regulatory requirements for food contact materials can be confusing. NSF explains the amendment to the FDA’s Code of Federal Regulations, Title 21.

When it comes to food contact materials, navigating regulatory requirements can sometimes be confusing. NSF is here to help. The FDA recently published an amendment to the FDA Code of Federal Regulations, Title 21 (21 CFR) regarding the use of certain phthalates in food contact applications.

About Food Additives

There are thousands of ingredients or substances added to food products. In its broadest sense, a food additive is any substance added to food. The legal definition of a food additive is: any substance the intended use of which results or may reasonably be expected to result – directly or indirectly – in its becoming a component or otherwise affecting the characteristics of any food.

Food additives can be grouped into the following types:

Direct: Additives that are added to a food for a specific purpose. For example, xanthan gum (used in salad dressings, chocolate milk, bakery fillings, pudding and other foods to add texture) is a direct additive. Most direct additives are identified on the ingredient label of foods.

Indirect: Additives that become part of the food in trace amounts due to packaging, storage or other handling. For instance, minute amounts of packaging substances may find their way into foods during storage. Plasticizers such as ortho-phthalates, used to make plastic soft, pliable, and flexible, are examples of indirect food additives since they can migrate into food when the plastic-containing phthalates are used to package or store the food. Phthalates are not authorized to be directly added to food.

All food additives in the United States are carefully regulated by the U.S. Food and Drug Administration (FDA) to ensure that foods are safe to eat and accurately labeled. Food packaging manufacturers must prove to the FDA that all materials in contact with food are safe before they are permitted for use in such a manner.

Authorized direct and indirect food additives can be found in the food additives regulations, Title 21 of the Code of Federal Regulations (CFR) Parts 170-189.

Phthalate and Food Safety

The original safety assessments that resulted in the authorized use of phthalates in food contact applications were based on dietary exposure and toxicological information and data provided from 1961 to 1985. Some of these substances were approved for food additive uses more than four decades ago.

The use of phthalates in food contact materials has evolved over the last few years.

The Flexible Vinyl Alliance (FVA), a coalition that represents the plasticizer and vinyl products industry, has submitted data to the FDA, showing that certain phthalates are no longer manufactured, imported, or otherwise marketed for the identified food contact applications in the U.S. market, thus the food contact uses of some phthalates are no longer relevant.

In addition to the evolving use of phthalates in food contact materials, available toxicological information on phthalates has expanded since the food contact uses of phthalates were initially authorized.

The FDA has stated that it is aware of concerns raised about the possible health effects of exposure to high levels of phthalates. However, at present, the FDA is not aware of any evidence that suggests that dietary exposure to phthalates as a result of their use in food contact materials poses a safety risk.

Recent FDA Amendment

On May 19, 2022, the FDA published an amendment to no longer allow most phthalates to be used in food contact applications. The FDA revoked authorizations for the food contact use of 23 phthalates and two other substances used as plasticizers, adhesives, defoaming agents, surface lubricants, resins, and slimicides. This action removes these phthalates from the list of substances authorized by regulations in Title 21 CFR, Parts 175-178.

This amendment was not based on safety but on the fact that regulatory authorization is no longer necessary because the use of these food additives has been completely or permanently abandoned.

View the list of the revoked phthalates.

What the Amendment Means for Material Formulators

This amendment means that effective immediately, material formulators can no longer use the revoked phthalates in the formulation and manufacture of food contact materials, components, and articles that are sold or marketed in the US.

FDA Request for Information on the Current Use and Safety of the Remaining Authorized Phthalates

The amendment also resulted in limiting the authorized use of phthalates in food contact applications to nine phthalates – eight for use as plasticizers and one for use as a monomer. The FDA is currently requesting information on the specific food contact uses, use levels, dietary exposure, and safety data for the remaining authorized eight ortho-phthalates:

  • Diisononyl phthalate (DINP, CAS No. 28553-12-0),
  • Diisodecyl phthalate (DIDP, CAS No. 26761-40-0),
  • Di(2-ethylhexyl) phthalate (DEHP, CAS No. 117-81-7),
  • Dicyclohexyl phthalate (DCHP, CAS No. 84-61-7),
  • Butylphthalyl butyl glycolate (BPBG, CAS No. 85-70-1),
  • Diethyl phthalate (DEP, CAS No. 84-66-2),
  • Ethylphthalyl ethyl glycolate (EPEG, CAS No. 84-72-0) and
  • Diisooctyl phthalate (DIOP, CAS No. 27554-26-3);

The FDA may use the information provided to update its dietary exposure estimates and safety assessments for the permitted food contact uses of phthalates.

The request for information initially appeared in the Federal Register on May 19, 2022, with comments due July 19, 2022. However, as a result of requests from stakeholders for more time to provide comments, the FDA will be reopening the comment period, with a new deadline expected to be published in an upcoming Federal Register notice. Once the comment period has reopened, comments must be submitted to Regulations.gov and identified with the docket number FDA-2022-N-0571.

We’re here to help. If this regulatory change impacts your formulation or product or you would like more information about the use of phthalates in food contact products, please reach out to us.

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