Bisphenol A (BPA) Regulations in the United States: An Overview

Bisphenol A (BPA) is an organic chemical used to improve durability and heat resistance in plastics. As such, it has long been used when manufacturing plastic products, from kitchen utensils and toys to certain medical devices.

That said, studies show that BPA may interfere with hormones, and cause other damage to the human body. It’s therefore not surprising that BPA is regulated in the United States, especially in food contact products designed for children.

In this guide, we explain what importers and manufacturers must know about BPA restrictions, including FDA 21 CFR, California Proposition 65, and other state regulations.

What is Bisphenol A?

Bisphenol A, also known as BPA, is an organic chemical that plays an important role in the manufacturing of polycarbonates, epoxy resins, and other plastics.

It is used to enhance the durability and heat resistance of plastic products. The benefits are especially evident in the food contact materials industry, as BPA-based food containers feature better food preservation performance.

Here are some examples of categories of products that could contain BPA:

• Food contact materials
• Children’s toys
• Electronic components
• Medical devices

However, due to research in the 1990s associating BPA with development and functionality damage to the human hormone system, brain, and reproductive organs, more countries have in recent years started to restrict, or even ban, the use of BPA in certain products. This also includes the United States.

Is Bisphenol A banned in the United States?

The FDA approved the use of BPA for food contact materials during the 1960s, when it was first used, as new substances need to go through the premarket approval process. However, the use of BPA in food contact materials is controversial in the United States and many other countries. In recent years, the public and industry have raised concerns over BPA toxicity.

That said, BPA is still subject to ongoing research. According to a document called “Bisphenol A (BPA): Use in Food Contact Application” published by the FDA, the hazards caused by the BPA contained in food packaging need to be evaluated further.

Having said that, the FDA deauthorized the use of BPA for baby bottles, sippy cups, and packaging for infant formulas, after accepting two petitions on this matter. Additionally, many US states also have their own laws restricting the use of BPA – mainly in food contact materials intended for children.

Which products and materials may contain Bisphenol A?

Here are a few examples of products that may contain BPA:

• Reusable and disposable plastic food containers
• Children’s toys
• Sunglasses
• Safety helmets
• Medical equipment
• Electronics components
• Thermal paper receipts

That said, so far, the main focus of BPA regulations concerns food contact materials such as:

• Beverage cans
• Plastic lunch boxes
• Plastic films
• Baby bottles
• Water bottles

This could partly be explained by the danger represented by BPA migrating from the product to the food (e.g., when heated), which could be particularly harmful to pregnant women, infants, and young children.

Food Contact Materials: FDA 21 CFR

The FDA allows the use of BPA in food contact adhesives, coatings and polymers.

However, in recent years, it has twice granted petitions and subsequently amended two of its food additive regulations under FDA 21 CFR to prohibit the use of BPA in food contact materials designed for children’s products.

21 CFR Part 175

21 CFR Part 175 – Indirect Food Additives: Adhesives and Components of Coatings specifies conditions for the following forms of handling products with food contact product containing adhesives and coatings:

• Producing food
• Manufacturing food
• Packing food
• Processing food
• Preparing food
• Treating food
• Packaging food
• Transporting food
• Holding food

A the moment, adhesives and coatings can contain BPA-based epoxy resins (4,4′-Isopropylidenediphenol-epichlorohydrin).

BPA ban in infant formula packaging

As a result of a petition, in 2013 the FDA amended 21 CFR Part 175 to ban the use of BPA-based epoxy resin coatings in infant formula packaging.

21 CFR Part 177

BPA can be used in polymers as far the conditions set in 21 CFR Part 177 – Indirect Food Additives: Polymers are respected.

For example, 21 CFR Part 177.1440 sets nonvolatile extractives limitations for BPA resins with minimum molecular weight of 10,000.

BPA Ban in children bottles and cups

The FDA received a petition and in 2012 amended 21 CFR Part 177 to prohibit the use of polycarbonate resins containing BPA in the following products:

a. Infant feeding bottles (baby bottles).

b. Spill-proof cups (comprising their lids and closures, and that are designed to train infants to drink from sippy cups).

Toxic Substances Control Act

The Toxic Substances Control Act (TSCA) regulates the manufacture, importation, usage, and disposal of substances. The Environmental Protection Agency (EPA) lists these substances on the TSCA Inventory, which includes BPA (record ID number 692, listed as “Phenol, 4,4′-(1-methylethylidene)bis-”).

EPA regulatory “flags” on the TSCA Inventory identify substances subject to rules and exemptions regarding reporting and record-keeping requirements. BPA has no such flags on the Inventory, which implies that importers and manufacturers must only keep records and submit reports for this substance.

The EPA is considering further rulemaking regarding whether BPA presents, or does not present, a risk of harm to the environment near locations such as landfills or manufacturing facilities.

Bisphenol A State Regulations

Many states in the United States ban or restrict the use of BPA in consumer products. Here’s an overview:

• California
• Connecticut
• Delaware
• Washington, D.C.
• Illinois
• Maine
• Maryland
• Massachusetts
• Minnesota
• Nevada
• New York
• Vermont
• Wisconsin

In particular, most of these states have developed their own regulations restricting the use of BPA in food contact materials that are intended to be used by children younger than 3-4 years.

Below, we provide a summary of some of these regulations.

California Proposition 65

California Proposition 65 requires warning labels for products that contain an amount of restricted substances, as listed in the Proposition 65 List, above the permitted harbor levels.

BPA was included in the list for causing toxicity to development and the female reproductive system. The harbor level is a maximum allowable dose level (MADL) of 3µg/day, regarding skin-exposure to solid materials.

California — AB-1319: Product Safety: Bisphenol A

This Bill prohibits the manufacture or distribution of bottles and cups intended to be used by children under the age of 3 years old containing more than 0.1 parts per billion (ppb) of BPA.

Connecticut — HB 6572 and SB 210: Bisphenol A Ban on Children’s Products and Thermal Paper

In 2009, the state of Connecticut passed an act intended to ban:

a. Any children’s products containing BPA intended to be used by children under the age of 3 years.

b. Any reusable food containers, jars, or cans intended for food or beverage containing BPA.

Note that disposable products are exempted and that the act requires labeling for certain products that contain BPA.

In 2011, the state of Connecticut passed a second ban, concerning any thermal paper receipts containing BPA. The reason is that thermal paper receipts that contain BPA could pose a danger to the unborn children of pregnant cashiers who are forced to handle a high number of receipts at work.

Washington, D.C., — SB 6248: Restrictions on Bisphenol A

This regulation prohibits the manufacture, sale, or distribution of BPA-contained empty bottles, cups, or other containers that are designed to be filled with food, liquid, or beverage for consumption by a child under the age of 3.

Illinois — SB 2950: BPA-Free Kids Ordinance

This Ordinance bans the distribution and sale of empty containers (e.g. feeding bottles, cups, and sippy cups) meant to be filled with food or liquid serving children under the age of three that contains BPA.

In addition, the Ordinance requires a label indicating that the items are free of BPA.

Delaware — SB 70: Prohibiting Bisphenol-A in Products for Young Children

This bill prohibits importers and manufacturers from selling empty cups and bottles that contain BPA and are designed:

• To contain food or liquid, and
• For use by children aged under 4 years

Maine — LD 412: Regulation of Bisphenol A in Children’s Products

This regulation prohibits the sale of the following products that contain intentionally added BPA:

• Reusable beverage or food container
• Infant formula packaging
• Baby food packaging

It also requires manufacturers of such banned products to file a compliance plan. Importers or manufacturers of the prohibited products may file a waiver specifying the BPA usage.

Minnesota — HF 459 and SF 247: Prohibition of BPA-Contained Food Contact Products

The state of Minnesota prohibits the sale of food contact containers, as well as empty cups or bottles, intended to be used by children between 0–3 years old that contain BPA.

New York — S3296: Bisphenol A-Free Children and Babies Act

This act prohibits the manufacture or distribution of BPA-containing childcare products intended to be marketed to children aged under 3 years. Such products include:

• Pacifiers
• Feeding bottles
• Sippy cups
• Other beverage containers

This act allows regulated products that do not contain BPA to be labeled as “BPA-Free” or “Bisphenol A Free”.

BPA Lab Testing

Importers and manufacturers often need to have their products tested to ensure that said products comply with various regulations, such as California Proposition 65 (or other state regulations), or 21 CFR Parts 175 and 177.

They must also make sure that their products either do not contain BPA, or contain BPA in an amount not exceeding permitted limits (e.g., 0.1ppb, or MADL of 3µg/day).

When the importers and manufacturers pass lab testing, they receive a report that proves their product complies with relevant requirements and regulations (e.g., not exceeding the MADL regarding California Proposition 65).

Test methods

Here are several BPA test methods:

• UV absorbance
• Mass spectrometry
• Solid phase extraction (SPE)
• Multiple reaction monitoring mass spectrometry (MRM)
• Micellar liquid chromatography (MLC)

Test companies

We list below a few companies that offer to test products for BPA:

• SGS
• Intertek
• Eurofins
• QIMA
• Applied Technical Services
• Impact Analytical

Compliance Risks

BPA can still be found in plastics used to manufacture food contact materials, toys, and other products. Keep in mind that products manufactured for countries and markets with more lax (or non-existent) BPA restrictions often do contain the chemical.

Further, many suppliers simply lack information on the materials they procure from subcontractors – they simply don’t have a clue whether their materials contain BPA above the set limits or not.

We recommend that you take the following steps when sourcing suppliers in Asia and other locations outside the United States:

1. Contact suppliers that claim to have experience manufacturing products in compliance with US and EU BPA regulations.

2. Request existing lab test reports for the sake of verifying that the supplier does have experience manufacturing BPA-free products.

3. Submit a pre-production sample and a batch sample for BPA lab testing.