TPCH Regulations Update

Introduction to TPCH Regulations

TPCH (Toxics in Packaging Clearinghouse) was established in 1992. Its predecessor was CONEG. It is responsible for promoting the “Model Toxics in Packaging Legislation” in various states in the United States and supporting & coordinating the implementation of the regulation. Due to the successful promotion of this regulation by TPCH, people often refer to the US regulations for the control of hazardous substances in packaging materials as TPCH.

The TPCH regulation restricts the entire packaging supply chain, including manufacturers, suppliers of packaging and packaging components, and manufacturers or distributors of products that use packaging. This model regulation needs to be adopted by each state in the United States before it will take effect in the corresponding state. TPCH regulation have been adopted by 19 states in the United States, and packaging materials exported to these 19 states need to meet TPCH requirements. These 19 states include: California, Connecticut, Florida, Georgia, Illinois, Iowa, Maryland, Maine, Minnesota, Missouri, New Hampshire, New Jersey, New York,  Pennsylvania, Rhode Island, Vermont, Virginia, Washington and Wisconsin.

Package definition in TPCH regulation:

• A container providing a means of marketing, protection or handling of a product and shall include a unit package, an intermediate package and a shipping container as defined in American Society for Testing and Materials ASTM D996.
• Package shall also mean and include such unsealed receptacles as carrying cases, crates, cups, pails, rigid foil and other trays, wrappers and wrapping films, bags and tubs.

Packaging component definition in TPCH regulation:

• Any individual assembled part of a package such as, but not limited to, any interior or exterior blocking, bracing, cushioning, weatherproofing, exterior strapping, coatings, closures, inks and labels
• Tin-plated steel that meets the ASTM A623 shall be considered as a single package component. 
• Electro-galvanized coated steel and hot dipped coated galvanized steel that meets the ASTM A653, ASTM A924, ASTM A879 and ASTM A591 shall be treated in the same manner as tin-plated steel.

2021 Update to TPCH

On February 16, 2021, the “Model Toxics in Packaging Legislation” was updated (TPCH regulation). The 2021 update included the addition of the class of perfluoroalkyl and polyfluoroalkyl substances (PFAS) and ortho-phthalates as regulated chemicals on the original four heavy metal requirements.

2021 update to TPCH regulation link: https://toxicsinpackaging.org/model-legislation/model/

Each state will add corresponding newly identified chemical substances of concern for control based on their own circumstances, and formal implementation will begin two years after the announcement.

TPCH Updated Exemptions

All packages and packaging components shall be subject to this Act, unless, an individual state adopts into their law, any or all of the below exemptions, which shall then apply only in that state.

• Packaging or packaging components that intentionally add lead, cadmium, mercury, or hexavalent chromium to comply with health or safety requirements under state or federal law may apply for an exemption from the state administrative agency.

• There is no feasible alternative, an exemption may be requested from the state administrative agency.

Identification and Prohibition of packaging chemicals of high concern in the updated regulation:

• A carcinogen, a reproductive or developmental toxicant or an endocrine disruptor; or Persistent, bioaccumulative and toxic (PBT); or Very persistent and very bioaccumulative (vPvB); or Persistent mobile and toxic (PMT); or Very persistent and very mobile (vPvM);
• A state administrative agency determines that there is strong and reliable scientific evidence that the chemical is a reproductive or developmental toxicant, an endocrine disruptor, or a human carcinogen;
• The state administrative agency determines that there is strong credible scientific evidence that the chemical meets one or more of the following additional criteria:
  • The chemical has been found through biomonitoring studies to be present in human blood, human breast milk, human urine or other human bodily tissues or fluids;
  • The chemical has been found through sampling and analysis to be present in packaging;
  • The chemical has been added to or is present in a package.

TPCH Certificate of Compliance

A Certificate of Compliance stating that a package or packaging component is in compliance with the requirements of this Act shall be furnished by its manufacturer or supplier to the purchaser of the packaging or packaging component. Where compliance is achieved under any state exemption(s), the Certificate of Compliance shall state the specific basis upon which the exemption is claimed. Certificates must be supported by documentation demonstrating compliance (e.g. test reports).

Guidance Document for TPCH

In November 2023, TPCH issued guidance document on PFAS (perfluoroalkyl and polyfluoroalkyl substances) and Ortho-Phthalates in Packaging in Support of the 2021 Update to Toxics in Packaging Clearinghouse Model Legislation.

Guidance document link: https://toxicsinpackaging.org/guidance-for-tpch-2021-model-legislation-update/

The best source of information about whether a package contains intentionally added PFAS is likely to be the manufacturer or supplier of the packaging. To determine if PFAS is intentionally added to any of the materials in packaging/product, TPCH recommends the following three options:

1. Ask suppliers for full material disclosure—a list of all the materials and substances in the components or material.
2. Ask suppliers to disclose if PFAS chemicals are added. If full material disclosure isn’t possible, ask if any PFAS chemicals are added – they’re commonly used for oil and grease resistance. Some PFAS can also be added to plastics that are then added to packaging. Some high-density polyethylene (HDPE) and polypropylene (PP) containers are treated with fluorine gas and are known as ‘fluorinated containers.’ TPCH recommend ask if containers are fluorinated
3. Look for third-party certifications.

The PFAS guidance document also points out that if the total fluorine content of the package/product or component is tested, and the results are less than 100 ppm and quality control criteria are met, it is considered that PFAS may not be intentionally added and would likely comply with TPCH restrictions in packaging. But guidance suggests that regardless of the total fluorine (TF) or total organic fluorine (TOF) levels tested, manufacturers should confirm information with their suppliers:

• Confirm PFAS isn’t intentionally added.
• Identify unintentional sources of PFAS so they can try to reduce or eliminate them.
• Identify sources of inorganic fluorine (which are not PFAS).

Below are Ortho-Phthalates that are commonly analyzed using SW 846 Method 8270

The guidance document also suggests Ortho-phthalates are a subset of semivolatile organic compounds, and as such can be determined using SW 846 Method 8270.

Compliance Recommendations in TPCH Guidance Document

Compliance recommendations for product manufacturers, brand owners and retailers of packaging materials are:

• Require Certificate of Compliance for all packaging materials and their components from all suppliers in any contract or bid specification.
• Ask for criteria used to determine compliance.
• If material formulations change from suppliers require updated information.
• Prepare Certificate of Compliance based on packaging supply chain information and identify appropriate authorized signer.
• Maintain records indefinitely by working with your Risk Management policies.

Compliance recommendations for packaging material formulators and suppliers are:

• Identify regulated materials in chemical formulation or in the supplied chemical inputs.
• Identify potential incidental additions of regulated chemicals or contaminants in the manufacturing process.
• Test for baseline information on regulated chemicals or contaminants.
• Require Certificate of Compliance for all packaging materials and their components from all suppliers in any contract or bid specification.
• Ask for criteria used to determine compliance.
• If material formulations change from suppliers require updated information.
• Prepare Certificate of Compliance based on packaging supply chain information and identify appropriate authorized signer.
• Maintain records indefinitely by working with your Risk Management policies