Frequently Asked Questions

 

Model Toxics in Packaging Legislation

Q: What is the Model Toxics in Packaging Legislation?

A:  The Model Toxics in Packaging Legislation was jointly developed by representatives for the Governors of the nine (9) Northeast States, major national product producers, major national retailers and national and regional environmental organizations in 1989 working under the auspices of the Coalition of Northeast Governors (CONEG) Policy Research Center. The intent was for individual Northeast states to adopt the Model Legislation, and thereby, create consistent requirements for the reduction/elimination of four (4) specific toxics in packaging sold or distributed in the Northeast. Most of the Northeast states passed and implemented laws based on the model and in the subsequent years additional states outside of the region as well as other countries adapted similar laws based on the model.

Q: What is the relationship between the Model Legislation and state toxics in packaging laws?

A:  State toxics in packaging laws are consistent with the Model Legislation for the most part. For example, all U.S. state toxics in packaging laws have the same basic requirements – that is, no intentional use of any amount of the four restricted metals and a threshold level of 100 ppm for the total of the four metals combined. Where state laws may differ is in allowable exemptions and enforcement, for example. State laws take precedence over the Model Legislation. A comparison between the Model and the laws of TPCH member states is available.

Applicability of State Laws

Q: Do state toxics in packaging laws apply to my company?

A: Toxics in packaging requirements apply to the following responsible parties, which may vary by state:

  • Manufacturers of packaging, packaging components, and packaged products
  • Distributors of packaging, packaging components, and packaged products
  • Brand owners of packaging, packaging components, and packaged products
  • Retailers who sell packaging, packaging components, or packaged products

State laws prohibit the sale and distribution of non-compliant packaging components, packaging, or packaged products in or into states with legislation. For toxics in packaging requirements, click link.

For more information on individual state laws, click here.

Responsible parties and definitions vary by state. As a general rule, state laws apply to a person, firm, or corporation that takes title to the package, packaging component, or packaged product for sale or promotional purposes, which may include a manufacturer, distributor, importer, or retailer.  It does not include the consumer purchasing the end product or package.

Responsible parties must ensure that the package, packaging component, or packaged product offered for sale or for promotional purposes is in compliance with state laws.

Q: How can my company ensure compliance with toxics in packaging laws?

A: State laws require the provision of a Certificate of Compliance by the manufacturer or supplier of a packaging component, packaging, or packaged product to its purchaser. See the FAQs below on how to prepare a Certificate of Compliance. In addition, companies may choose to implement quality assurance programs for greater assurance that the packaging or packaged products they sell are in compliance with state laws. Quality assurance programs may include the provision of packaging specifications for toxics in packaging to suppliers and periodic testing of packaging materials for compliance with state laws. For additional guidance on quality assurance, click here.

Certification of Claims

Q: How do we get our packaging certified?

A: The Model Toxics in Packaging Legislation (formerly referred to as CONEG) and state laws based on the Model require the self-certification of packaging and packaging components using a Certificate of Compliance. Certificates of Compliance can be issued by packaging suppliers or product manufacturers or distributors. The Certificates of Compliance must be supported by documentation (such as analytical test reports) demonstrating compliance.

The Toxics in Packaging Clearinghouse and U.S. member states with toxics in packaging laws do NOT certify products or packaging. It is, therefore, inappropriate to claim on a package or in a press release or marketing materials that a package or product is certified by the Toxics in Packaging Clearinghouse.

Certificates of Compliance (section updated February 2010)

Important note: As with other aspects of the toxics in packaging requirements, individual states with toxics in packaging laws may have different or additional requirements applicable to the Certificate of Compliance.  A review of the pertinent states’ requirements may be necessary for a complete understanding of the requirements.

Q: What is the required content in a Certificate of Compliance?

A:  The Certificate of Compliance given to the purchaser of a package or packaging component is a statement that the package or packaging component is in compliance with the toxics in packaging requirements.  This necessarily means that the certifying entity is affirming that (a) none of the four regulated metals was intentionally introduced into the package or packaging component and (b) that the total incidental presence of the four metals does not exceed the maximum allowable concentrations. A sample Certificate of Compliance is provided on the TPCH website.

Q:  What is the required content of a Certificate of Compliance based on a claim that the package or packaging component is exempt from the toxics in packaging requirements?

A: If the basis for the Certificate of Compliance is that the package or packaging component is exempt from the toxics in packaging requirements, the Certificate of Compliance must state the specific basis upon which the exemption is claimed.  A sample Certificate of Compliance based on a claim of exemption is provided on the TPCH website.

Q: Who is required to sign the Certificate of Compliance?

A: The Certificate of Compliance must be signed by an authorized official of the manufacturer or supplier of the package or packaging component.

Q: How do we generate a Certificate of Compliance?

A: A Certificate of Compliance can be prepared in two ways. One option is to request Certificates of Compliance for each packaging component from your suppliers. Based on your suppliers’ certifications and your knowledge of your processing steps (that is, none of the regulated metals is intentionally added), you can prepare a Certificate of Compliance for your packaging. The other option is to test your packaging for the presence of the regulated metals. Testing will indicate if the sum of the regulated metals is below 100 ppm. If the regulated metals are detected, even if the sum of the four metals falls below 100 ppm, it is prudent to check with suppliers regarding intentional introduction.

Q: Who is responsible for providing a Certificate of Compliance?

A: The Model legislation states that a Certificate of Compliance shall be furnished by its manufacturer or supplier to its purchaser.  In addition, any member of the public may request a Certificate of Compliance from a manufacturer or supplier of packaging or of a packaging component.  “Manufacturer” is defined as “any person producing a packaging or packaging component” and “supplier” is defined as “any person who sells, offers for sale, or offers for promotional purposes packaging or packaging components which shall be used by any other person to package a product.”

Q: How does a manufacturer generate a Certificate of Compliance?

A: Manufacturers should secure Certificates of Compliance for each packaging component from their suppliers, then use these certifications and knowledge of its own processing steps (that is, none of the regulated metals is intentionally added) to prepare a Certificate of Compliance for its packaging.

Q: How does a packaging supplier obtain a Certificate of Compliance?

A: Packaging suppliers should secure Certificates of Compliance for each packaging component from the manufacturer or supplier of the packaging component.  The packaging supplier may choose to prepare a single Certificate of Compliance based on the certifications of its manufacturers or suppliers. If the manufacturer is the first supplier in the packaging supply chain, the packaging or packaging component should be tested to determine the presence of the regulated metals.

Q: How does a supplier generate a Certificate of Compliance if the manufacturer or supplier does not supply one?

A: If the manufacturer or supplier will not provide certification, the supplier must test the package for the presence of the regulated metals.   If the regulated metals are detected, even if the sum of the four metals falls below 100 ppm, it is prudent to discontinue the purchase of the package until the manufacturer or supplier certifies that the regulated metals are not due to intentional introduction.

Q: How long must the manufacturer or supplier of the packaging or packaging component keep the Certificate of Compliance?

A: According to the Model Legislation, the manufacturer or supplier of the package or packaging component must keep a copy of the Certificate of Compliance “on file.” Records retention requirements may differ from state to state. The TPCH recommends that the manufacturer or supplier retain the Certificate of Compliance for as long as the package or packaging component is in use by the purchaser of the package or packaging component.

Q: How long must the purchaser of the package or packaging component keep the Certificate of Compliance?

A: The purchaser of the package or packaging component must keep a copy of the Certificate of Compliance on file and retain it for as long as the package or packaging component is in use by that purchaser.

Q: Must the manufacturer or supplier produce a copy of the Certificate of Compliance to any government agency?

A: Yes, upon request.

Q: What requirements apply if a manufacturer or supplier of a package or packaging component reformulates or creates a new package or packaging component?

A: If the manufacturer or supplier of a package or packaging component reformulates or creates a new package or packaging component, the manufacturer or supplier must provide the purchaser with a new or amended certificate of compliance.

Q: What type of information or documentation must the supplier of a package or packaging component have as the basis for the Certificate of Compliance?

A: The model legislation does not specify the kind of information or documentation that must serve as the basis for the Certificate of Compliance. Of course, it is in the certifying company’s best interest to have complete and verifiable information that supports the contents of the Certificate of Compliance.  Companies should do what is reasonably necessary to stand behind their certification.  In cases where the company has existing documentation or analytic data to verify that the package complies, further testing may not be necessary and that documentation may be used to meet the Certificate of Compliance requirements.  A certification prepared without testing should be based on verifiable evidence that there has been “no intentional introduction” and no “incidental presence.” However, for those companies that cannot document the amount of heavy metals in their package or packaging components, or know them to be present as incidental trace contaminants, a certain level of testing will be necessary. The test method chosen and its lower detection limit are at the discretion of the company and may vary from company to company and from package type to package type, provided that the test is capable of demonstrating that the total of the four regulated metals is below regulatory limits. (See subsequent FAQ for more information on test methods.) It is not expected that each and every package will be individually tested, although that is certainly the company’s option. Instead, random sampling on a reasonable statistical basis is considered to be a sufficient level of testing to demonstrate compliance.  In certain instances, additional information may be required.

Q: Can a manufacturer or supplier use one Certificate of Compliance for all of its packages or packaging components, or is a separate Certificate of Compliance necessary for each type?

A: The Model Legislation requires that manufacturers and suppliers of packaging and packaging components furnish a Certificate of Compliance to purchasers and to members of the public upon request.  Because the Model does not specify a separate Certificate of Compliance for each package, manufacturers and suppliers may include multiple packages on a single Certificate of Compliance, provided it is updated as required.

It may not be practical to group packaging certifications because of the differences in packaging composition.  If one COC is used to certify the compliance of many different packages or components and one of those components or packages later is found to be non- compliant, the Certificate of Compliance would be false.  Many states have monetary penalties for making false statements.  These penalties may be assessed for false Certificates of Compliance (e.g., certifying a material that is not compliant). It is up to the manufacturer or supplier and their level of comfort with relying on composite COCs (see sample Certificate of Compliance).

Q: What authority does the TPCH have in requesting Certificates of Compliance and test reports to prove packages are compliant with the state toxics in packaging laws?

A: The Toxics in Packaging Clearinghouse (TPCH) requests Certificates of Compliance from manufacturers and distributors of packaging, packaging components or packaged products on behalf of its member states. The authority of individual states to request such information can be found in the legislation and/or regulations of each state. One of the roles of the TPCH is to reduce the paperwork burden for both states and the regulated community by providing a single point of contact for such requests. If manufacturers or distributors do not respond to the TPCH request, the matter is referred to individual states for follow up action.

Q: What is the consequence or penalty if a company fails to present a Certificate of Compliance or supporting documentation such as actual test reports?

A: Enforcement is at the discretion of individual states and subject to the provisions of their statutes. Most states have penalties associated with making or submitting false or misleading statements or certificates of compliance.
Test reports are generally not required, however, if a complaint is received or if screening tests indicate a potential problem, then test reports may be required to confirm the basis for the Certificate of Compliance.

Q: If our packaging is in compliance with the European Union Packaging Directive and the European Union Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment (RoHS), can we assume that it is also in compliance with state toxics in packaging laws?

A: No.  State toxics in packaging laws are stricter than the EU Packaging and RoHS Directives. State toxics in packaging laws prohibit the intentional use of any amount of the four restricted heavy metals: lead, cadmium, mercury, and hexavalent chromium. In addition, the state toxics in packaging laws limit the sum of the incidental concentration of these metals to 100 ppm. The 100 ppm limit in state laws applies only to the incidental presence of the restricted metals. Incidental presence is defined as the presence of a regulated metal as an unintended or undesired ingredient of a package or packaging component. State toxics in packaging laws further require packaging manufacturers and suppliers to provide purchasers with a Certificate of Compliance with state laws.

The European Union Packaging Directive (94/62/EC, Article 11) restricts the same four heavy metals and includes the 100 ppm total concentration limit for the sum of the four metals but does NOT have the “no intentional use” requirement. Suppliers of packaging entering U.S. states with toxics in packaging laws must be aware of this stricter requirement. Further, when laboratory testing detects any of the restricted metals, member states recommend that companies contact their suppliers about the source of the detected metals to ensure that the restricted metals were not intentionally used.

The EU Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive (2002/95/EC) restricts the same four metals in homogeneous materials used in electrical and electronic components as state toxics in packaging laws; however, the limits are higher for three of the metals. The EU RoHS Directive restricts the concentration of lead, mercury, and hexavalent chromium to 1000 ppm, while restricting cadmium concentration to100 ppm. In addition, similar to the EU Packaging Directive, the RoHS Directive does not prohibit the intentional use of these metals.  If testing laboratories reference the RoHS Directive in testing protocols, it is important that test reports provide the actual concentrations detected in the sample to prove that the sum of the four restricted metals is below the 100 ppm limit of state toxics in packaging laws. Furthermore, companies must be able to certify that there was no intentional use of any of the four restricted metals.

State Toxics in Packaging Laws
EU Packaging Directive (94/62/EC,
Article 11)
EU RoHS Directive
(2002/95/EC)

Intentional Use of Any of the 4 Heavy Metals Identified Below

Prohibited at any level

Not addressed

Not addressed

Maximum Concentration Limit: Cadmium

< 100 ppm (0.01%) by weight for sum of 4 restricted metals in packaging or packaging components; applies only to incidental presence

< 100 ppm by weight for sum of 4 restricted metals in packaging or packaging components

< 0.01% by weight (100 ppm) in homogeneous materials

Maximum Concentration Limit: Hexavalent Chromium

< 100 ppm (0.01%) by weight for sum of 4 restricted metals in packaging or packaging components; applies only to incidental presence

< 100 ppm by weight for sum of 4 restricted metals in packaging or packaging components

< 0.1% by weight (1,000 ppm) in homogeneous materials

Maximum Concentration Limit: Lead

< 100 ppm (0.01%) by weight for sum of 4 restricted metals in packaging or packaging components; applies only to incidental presence

< 100 ppm by weight for sum of 4 restricted metals in packaging or packaging components

< 0.1% by weight (1000 ppm) in homogeneous materials

Maximum Concentration Limit: Mercury

< 100 ppm (0.01%) by weight for sum of 4 restricted metals in packaging or packaging components; applies only to incidental presence

< 100 ppm by weight for sum of 4 restricted metals in packaging or packaging components

< 0.1% by weight (1000 ppm) in homogeneous materials

Maximum Concentration Limit: Total of All 4 Metals

< 100 ppm (0.01%) by weight in packaging or packaging components; applies only to incidental presence

<100 ppm by weight in packaging or packaging components

Not addressed

Enforcement

Q: How is enforcement coordinated by the states?

A: Enforcement is on a state-by-state basis.  However, the states have established the Clearinghouse for the purpose of leading a coordinated effort on implementation and enforcement of the toxics in packaging legislation.

Self-Discovery

Q: What actions should a manufacturer, distributor, or retailer take if they discover that one or more of their packages are not in compliance with state toxics in packaging laws?

A: We encourage manufacturers, distributors and retailers to incorporate the model purchasing specifications into all contracts and institute appropriate checks and balances to prevent potential violations. However, we also recognize that there will be times when manufacturers, distributors, and/or retailers discover that their packaging may not be in compliance with toxics in packaging laws even though they have been diligent with quality specifications and audit procedures.

Many of the member states have self-disclosure/discovery policies in place and these policies differ from one state to another. Voluntary action to come into compliance by manufacturers, distributors, and retailers may be taken into consideration by the States; however, such actions do not preclude states from following their own regulatory enforcement procedures. Interested parties should contact representatives of the states in which they do business for more specific information regarding the self-disclosure policies of specific TPCH member states.

The following may provide some guidance to companies on what to do when they self-discover a problem. When the TPCH discovers that a package is not in compliance (as opposed to self discovery by a company), it directs that the distribution and/or sale of that packaging immediately be discontinued and that the company document their steps to accomplish this.  We request that, within a specified period of time, the company develop and submit to the TPCH a written compliance action plan. The plan should outline: the steps the company has taken or will take to remove or recall any package or packaging component in violation of these state laws from stores in member states; the steps taken to recycle or dispose of the packaging in accordance with federal and state requirements; the timing of such actions; and the steps taken to prevent such a violation in the future.

It must be stressed that membership in the TPCH does not preclude states from taking further actions or imposing fines or penalties even when a company takes the steps identified above. (Posted August  2008)

Exemptions – General

Q: Which exemptions require petitioning to the States and which are automatic, simply requiring mention in the Certificate of Compliance?

A: The exemption for package and packaging components involving date of manufacture prior to the effective date of the legislation (a), use of recycled material (c), and vitrified labels (g) do not require petitions, but must be cited in the Certificate of Compliance and must be verifiable. All other exemptions require a petition and must include supporting documentation.

Exemptions – Effective Date

Q: Is packaging manufactured before the effective date exempt even if it is sold after the effective date?

A: Yes. If the package has a date of manufacture or the producing company can provide documentation that the package in question was manufactured prior to the effective date, or was in the process of being manufactured prior to the effective date, it is exempt. Situations that are beyond the control of the manufacturer — e.g., old stock being held by retailers — should be dealt with on a case-by-case basis by the States. In all cases, packaging that was manufactured after the effective date must be in compliance or else it cannot be sold or distributed in that State. Packaging that does not bear a date of manufacture on its label, and would be considered out of compliance due to its regulated metals content, may be sold only if the manufacturer can supply other supporting documentation to the State that it was manufactured prior to the effective date.

Exemptions – Recycled Content

Q: Q: If a packaging component contains recycled content, what is the threshold limit for the regulated metals?

A: The Model Toxics in Packaging Legislation currently provides an exemption for the use of recycled content (exemption 5c) with a threshold limit of 200 ppm. In December of 2008 the Model Legislation threshold limit for recycled content was increased from 100 to 200 ppm and the expiration date for this exemption was removed.

States are not bound by the Model but are strongly encouraged to adopt revised provisions to stay in sync. However, since 2008, only one TPCH member state (New Hampshire) has adopted these revisions, and all other member state exemptions for recycled content have been phased out.

State toxics in packaging laws that provide for a recycled content threshold of 100 ppm prevail over the Model Legislation. Please contact state representatives for further information on variations in individual state toxics in packaging laws.

Q: What is meant by the term “recycled materials” as used in Section 5, paragraph c?

A: Recycled materials are those materials generated by a business or a consumer that have been separated from solid waste for the purpose of recycling as a secondary material feedstock. For purposes of this legislation, recycled materials include paper, plastic, wood, glass or ceramics, metals such as steel, aluminum, stainless steel or copper, and other materials. However, recycled materials under the toxics in packaging law do not include the four regulated metals (lead, cadmium, hexavalent chromium and mercury) when the metals have been separated into their elemental or other chemical state for recycling as a secondary material feedstock. For example, lead processed from used automotive batteries and intentionally added as a component to manufacture an ink pigment that is then used to print labels on packaging would not be a “recycled” material for the purposes of Section 5 paragraph c.

Q: Would a package or package component be exempt from the law if it were made wholly or in part from post-industrial waste (e.g., metal scrap purchased from automobile manufacturing plants that was subsequently made into cans or other packaging components)?

A: Yes. The exemption applies to both post-consumer and post-industrial waste. This example illustrates post-industrial waste. It should be noted that packages or packaging components manufactured from non-packaging post-consumer materials (e.g., used appliances and automobiles made into cans) would also be eligible for this exemption.

Q: Would lead chromate pigment be exempt if it were made from post-consumer recycled materials, such as scrap automobile batteries?

A: No. The exemption applies only to recycled composite materials such as plastic or paper, which might coincidentally contain a regulated metal but are being reprocessed for their primary material content, and not to the four regulated metals or their compounds that have been separated or isolated from recycled materials. This includes pigments.

Q: If a regulated metal were deliberately added to a package otherwise made of totally recycled material, for example a cadmium pigment added to change the color of a pail made of recycled plastic, would the package be exempt based on recycled content?

A: No. The intentional addition of a regulated metal to change the appearance or characteristics of a final package is not permitted, regardless of the source of starting material used to manufacture the package, unless the package qualifies under the “reuse” exemption whereby each individual package is reused many times and its distribution and retrieval are closely controlled and documented throughout its lifetime. To qualify for the recycling exemption, the regulated metal in question must have been present as a minor ingredient in the discarded waste material before that waste material was designated for recycling.

Q: For the recycled content exemption, does the exemption/definition apply to the complete package, or only that portion of the package that is made from post- consumer recycled material?

A: The model legislation language differentiated between the package and packaging components; therefore, the exemption could apply to either or both. For a package where all components contain post consumer recycled content that exceeds the compliance level, the entire package is exempt. However, in the case where one packaging component contains post consumer recycled content and the other components do not, only the component containing post consumer recycled content would be exempt and not the entire package.

Exemptions – Vitrified Labels

Q: Are ceramic enamels or decals that have been vitrified, such that they become part of the glass or ceramic matrix, subject to the toxics in packaging requirements?

A: Yes, each packaging component (i.e., enamel used to create a vitrified label) is considered a distinct packaging component for the purposes of the Model Legislation (the basis for states’ toxics in packaging laws). Each packaging component is subject to the 100 ppm concentration limit for the sum of the four regulated metals incidentally present. Further, each component (e.g., each enamel) is also subject to the “no intentional introduction” requirement.

Two of the member states’ laws (NH and CT) currently recognize an exemption from the restriction on “intentional use” of the regulated metals for glass and ceramic containers with vitrified labels or decorations that can pass the leachability test specified in the Model Toxics in Packaging Legislation. The exemption applies when the sample is prepared according to ASTM C1606-04 and tested in accordance with the Toxicity Characteristic Leaching Procedures of US EPA Test Method and publication SW 846, 3rd edition, Test Methods for Evaluating Solid Waste, and does not exceed 1.0 ppm for cadmium, 5.0 ppm for hexavalent chromium and 5.0 ppm for lead. Mercury is not exempt.

Imports

Q: What about packaging, including cans or other containers imported from outside the United States?

A:  All packaging, including cans or other containers, imported from outside the country into states that have passed the legislation must be in full compliance with the limits on the regulated metals. It should be further noted that on June 21, 1993 the Food and Drug Administration announced that it was promulgating regulations to ban the use of lead solder in food cans sold anywhere within the United States. This regulation applies equally to imported cans that might still contain lead solder as well as domestically produced cans. It is the responsibility of the importer to test or otherwise ensure that any such cans proposed to be brought anywhere into the United States have not been fabricated with lead-containing solder.

Q: How are importers subject to the state toxics in packaging laws?

A: Packaging, packaging components or products in packaging are subject to toxic in packaging laws upon entering any state with toxics in packaging legislation. If a company imports packaging, packaging components or a product in a package directly into a state with legislation, then the state has authority to request a Certificate of Compliance from the importer. If, however, the packaging, packaging components or packaged products are imported into a state without legislation by Company A and ownership is transferred to Company B, who subsequently distributes such packaging into a state with legislation, it is the responsibility of Company A to provide a Certificate of Compliance to Company B since the Model Legislation and state laws require manufacturers or suppliers to provide a Certificate of Compliance to its purchaser. An importer is considered a supplier to its purchaser.

Packaging – Definition

For a definition of “package” and “packaging component”, see the Model Legislation, Section 3.

Packaging – Clarifications

Q: Are mugs, steins, tumblers, vases and similar items subject to the law when holding candy, beverages, flowers or other products?

A: In cases where the items are manufactured as products (e.g., decorative mugs) and only incidentally hold other items during final distribution to the end user, the product is not considered a package. One or more of the following would have to apply.  The items: are not designed solely to contain and protect the goods inside for transport and handling during distribution; have intrinsic value as an artistic or useful object in themselves which is often reflected in the selling price if sold; and are intended to be retained beyond the life of the item inside and not promptly discarded after the contents have been consumed or used. Some states, however, may consider these items packaging, if they are used for marketing (e.g., a mug with a company logo or treat bags with brand names printed on them).

In cases where the item is used solely to deliver another product (e.g., a beverage sold at a food counter), the item is considered a package. An exemption for “controlled distribution and reuse” may apply if the item is not normally discarded after the product inside has been consumed.  Further, a container sold without being filled with a product, such as an empty coffee cup or empty decanter for home use, is a product itself and not subject to the law.

Q: Does the law apply to gift-wrapping paper (and related items) — items purchased solely for the use of individual consumers to wrap presents in the home, or to be attached to those presents?

A: No. Wrapping paper, ribbons or tape, items attached to a product and related items are products, not packages, if sold to the consumer for home use and as such are not subject to the law. Packages that are sold to the consumer as “gift-wrapped” items would be subject to the law. Promotional items such as candy or toys that are attached externally to “gift-wrapped” packages are not considered part of the package and are not subject to the law (except, of course, for any additional packaging which might surround those items themselves).

Q: Are envelopes used by a business considered to be a “package” under the law?

A: Yes. The definition of a package in the law under ASTM D-996 includes the term “envelope” (85a, page 222, ASTM D-996). This would include envelopes or shipping cartons supplied by Federal or Airborne Express, U.P.S. and others. It is recommended that users of such packaging ask their respective express carrier agencies for Certificates of Compliance.

Q: Are reusable bags that are sold or distributed and designed for repeated use considered “packaging,” and therefore, subject to the Model Toxics in Packaging Legislation?

A: Yes, reusable bags are subject to toxics in packaging requirements under the Model Toxics in Packaging Legislation. The Model  and state laws based on the Model  apply to the distribution and sale of packaging and packaging components. The Model Toxics in Packaging Legislation defines “package” as a container providing a means of marketing, protection or handling of a product, including unsealed receptacles such as carrying cases, crates, bags, and tubs. Therefore, toxics in packaging requirements would apply to a reusable bag when sold or distributed (e.g., as a promotion) to a customer. Regulated entities should also check the laws of states, where reusable bags are sold or distributed, for specific exemptions or additional requirements. For example, in California reusable bags that meet certain design parameters are exempt from toxics in packaging requirements.

Q: Does the law apply to stickers, labels, tags or protective films which are: 1) affixed directly to the product; and 2) not required to remain affixed for proper or safe functioning or use of the product?

A: Yes. These stickers, labels, tags and protective films are considered packaging under this legislation, with the exception of stickers, labels or tags required by Federal or state health and safety or transportation requirements.

Q: Does the law apply to all such cans, regardless of size or use?

A: Yes. The definition of a package under the law includes all steel cans and, therefore, the law applies regardless of size or use.

Q: Are railroad tank or box cars, refillable propane tanks, chlorine cylinders, bulk tank trucks/trailers and shipping containers considered packages under the legislation?

A: Railroad tank or box cars and bulk tank trucks/trailers are not packages, while refillable propane tanks, chlorine cylinders and shipping containers are considered packages under the legislation. These distinctions are based on the definition of “package” in the law under ASTM D 996.

Restrictions on the Use of Heavy Metals

Q: May a manufacturer sell a package or packaging component that has 100 parts per million or less of the regulated metal that resulted from deliberate addition during the manufacturing process, with the knowledge and intent that its presence would change the appearance or characteristics of the final package or packaging component?

A: No. The intent of the law is to prohibit any intentional addition of the four heavy metals in packaging, even if the concentration levels are below the threshold for incidental amounts.

Q: In a situation where one or more of the heavy metals were used in the manufacturing process but were not intended to be part of the final package (i.e., used as a cleaning or oxidizing agent), would the package be in compliance with the law if it contained trace amounts of heavy metal below 100 parts per million?

A: Yes. The package would be in compliance since the regulated heavy metal was used only to aid in a step of the manufacturing process, and any residual metal would be incidentally present if it is neither desired in, nor its continued presence imparts any desirable characteristic or appearance to, the final package. Trace amounts of residual metal resulting from the use of a processing aid or similar material during production of a product from which a package or packaging component is manufactured, and which processing aid is reasonably expected to be consumed, transformed into a non-regulated chemical during the process, washed or dissolved away, or otherwise nearly all removed during processing, would not make the final package or packaging component non-compliant if the total residual metal level were below 100 ppm, as this is not considered intentional addition of the regulated heavy metal.

Q: What is meant by “sum of the concentration levels” for single-component vs. multi-component packages?

A: Single-component Package — The concentration level, expressed in parts per million (ppm), should be determined for each of the four metals and these numbers added together (summed). This summation must be within the limit of 100 ppm. Multi-component Package — The four regulated metals are not summed or averaged across all packaging components that together comprise a package. Rather, the concentration level, expressed in ppm, should be individually determined for each metal and summed for each packaging component within the package. Each packaging component must comply individually with the legal limit of 100 ppm.

Q: Does the law apply equally to water-soluble or insoluble forms of the four heavy metals?   Does it make a difference with regard to soluble vs. insoluble forms if the package is incinerated?

A: The law applies to both soluble and insoluble forms of the four heavy metals and no distinction is made between them.   For example, the effects of lead uptake in the human body due to ingestion of paint chips, ink, etc. are essentially the same for the various forms of lead regardless of their initial water solubility. With regard to incineration, it is well documented that maximizing the removal of heavy metals in waste prior to incineration reduces air emissions and leachate problems from ash (bottom ash and fly ash), including when such ash is subsequently disposed of on land. High-temperature combustion normally converts the heavy metal compounds (whether initially water-soluble or insoluble) in the waste being burned into other compounds, primarily oxides, hydroxides, chlorides or other salts, or into metallic particulates, which can enter either the stack gas or the ash streams. The sole exception demonstrated to date is vitrified labels on glass or ceramic packaging, provided that such packaging has passed the test methods specified in the law. This unique behavior of vitrified glass and ceramic labels during incineration, which thus far has not been satisfactorily demonstrated for other materials, is recognized by an exemption for these labels. The exemption does not apply to non-vitrified labels or to mercury and its compounds.

Q: Is there an exemption for packaging that is manufactured using solder that contains lead?

A: No. The Model Legislation specifically prohibits the intentional introduction of the four regulated heavy metals into packaging such as from leaded solder. Originally there was a four-year period allowed for cans and other containers to achieve compliance. During that period both the can industry and the solder industry were able to come up with technical breakthroughs (i.e., deep-drawn seamless cans and lead-free tin solder, respectively) that negated any future need to exempt lead-containing solder.

Q: Is hexavalent chromium more toxic than other forms of chromium?

A: The toxicological information available on chromium compounds clearly indicates that the hexavalent form is more toxic than other forms.

Test Methods

Q: What test procedure should the laboratory perform to determine compliance with toxics in packaging laws?

A:It is important to note that the goal of analytical testing is to determine the total concentration of the four regulated metals. State toxics in packaging laws specify NO intentional use of the four regulated metals. If the metals are incidentally present (defined as an unintended or undesired ingredient) in the packaging component or material, state toxics in packaging laws restrict the total concentration of the sum of the four metals to less than 100 parts per million. For any analytical method to accurately measure the total concentration of metal, the metal must be completely liberated from the matrix. To achieve this, the matrix must be completely digested, dissolved, or broken down. Therefore, proper sample preparation is critical to obtain meaningful results. The choice of sample preparation depends on the type of sample (matrix). All methods used must carefully document the amount of sample digestion, with 100% dissolution as the goal.

Sample Preparation Methods
Plastics, Some Inks: Many labs use EPA SW-846 Methods 3050B or 3051 for sample preparation. These methods are described as providing “total metals;” however, the methods were designed for hazardous waste and site characterizations. For the purposes of product or package component testing, the goal is to determine the true presence and total concentration of metals in the component. In practice, TPCH has found that these methods are NOT sufficiently aggressive to completely digest/dissolve plastic matrices. In fact, the method summary for EPA Method 3050B states that it is NOT the proper method for preparing samples where total metals concentration is desired. Instead, EPA SW-846 Method 3052 provides an aggressive acid and microwave energy combination to effectively break down the organic matrices such as plastics and some inks. Although EPA Method 3052 prescribes the use of hydrofluoric acid (HF) in some instances, HF is not required for effective digestion of typical plastic/PVC type package components. Rather, HF is required ONLY if the matrix is siliceous (i.e., contains silica) in nature.

The key parameter to be reported is the extent of dissolution of the matrix, with 100% being the acceptable target. Some trial and error may be expected when testing a new packaging component.

Papers, Cardboards, Metals, Some Inks: The objective is total dissolution of the sample. An example of a test method that may accomplish total dissolution is EPA Method 3052. See above for additional information. For some matrices EPA Method 3050B may totally dissolve the sample. However, Method 3052 may be necessary in order to completely break down organic matrices of some inks and other matrices. Laboratory reports should specify what method was used to prepare the sample and indicate whether the matrix was completely dissolved.

Glass & Ceramics: Based on the findings of its glass matrix test method evaluation study, TPCH recommends the use of EPA SW-846 Method 3052 or comparable method using hydrofluoric acid (HF) for the analysis of glass matrices when traditional laboratory “wet” chemistry analysis is required. The analysis method should include the application of an external heat source (e.g., microwave digestion) to assist in acid digestion. Method 3052 and comparable sample preparation methods using HF effectively liberate lead (Pb) and cadmium (Cd) from the glass matrix for the determination of total metals concentration. Sample preparation methods using HF without the application of an external heat source such as microwave, oven bomb or hot plate do not perform as well. EPA Method 3050B, which is designed to measure “total recoverable metals” is inadequate in the liberation of Pb and Cd from glass matrix samples, and in the TPCH study, consistently failed to accurately measure Pb or Cd in glass matrices. Method 3052 requires the use of HF for silica-based materials, such as glass. Laboratories capable of performing Method 3052 are commercially available in the U.S. and globally.

To qualify for the exemption for glass and ceramic packages with vitrified labels in section 5g of the Model Legislation, the sample must be prepared according to ASTM C1606-04; and tested in accordance with the Toxicity Characteristic Leaching Procedure of US EPA Test Method; publication SW-846, 3rd edition, Test Method for Evaluating Solid Waste. The concentration of metals in packaging cannot exceed 1.0 ppm for cadmium, 5.0 ppm for hexavalent chromium and 5.0 ppm for lead to qualify for this exemption. Mercury is not exempted by this provision.

Laboratory Choice
Regardless of test method used or material type tested, TPCH recommends that the laboratory selected to perform the analysis be accredited by a nationally recognized accrediting organization and have demonstrated proficiency in analyzing the type of materials or packaging components.

Note: The US Consumer Product Safety Commission has published guidance on their test method, CPSC-CH-E1002-08, Standard Operating Procedure for Determining Total Lead (Pb) in Non-Metal Children’s Products, February 1, 2009, on their website: http://www.cpsc.gov/ABOUT/Cpsia/cpsia.HTML.

TPCH notes that while this method is similar to EPA Method 3052, complete sample digestion is not explicitly described. States may accept test results from this method if the laboratory is able to sufficiently document that complete sample digestion of the matrix occurred.

For plastics, see

For glass matrices, see

 

Q: Is X-ray Fluorescence (XRF) an acceptable method for determining compliance?

A: XRF is an excellent tool for screening, however, the results should be carefully evaluated for false positives as well as false negatives. Obtaining accurate results using XRF on packaging can be very challenging because there are many variables that can affect the results, including sample matrix, sample thickness, sample homogeneity, chemical interferences, and instrumental errors. Positive results should be followed up with definitive testing by an accredited laboratory with demonstrated proficiency in testing the type of material. An effective quality assurance program for compliance screening may include XRF, but should also include a method demonstrated to completely digest the sample, followed by definitive testing such as inductively coupled plasma (ICP) analysis. Incomplete digestion of the sample will not provide a measure of total metals.

ASTM recently released Method F 2617-08 for measuring cadmium, lead, and mercury in polymeric material using XRF.1 It is critical to note that this XRF method is applicable to specific sample conditions, including homogeneity and “infinite thickness.” The ideal sample is a solid piece of polymer or plastic of uniform thickness. The optimum sample conditions are often not met when trying to analyze typical packaging samples, for example, a single thin plastic bag with several colored inks. In order to obtain best conditions, a sample is often folded over several times to obtain a thicker sample. However, air pockets or different color inks on the package can create non-homogenous sample that can skew results. ASTM Method F2617-08 should provide accurate results when screening bulk components (sheets/layers of plastic, or resin pellets). For samples of less than optimum sample conditions, results should be verified by definitive testing.


1 XRF does not differentiate between types of chromium, for example, trivalent chromium (Cr+3) and hexavalent chromium (Cr+6) so it can only be used to screen for the presence of total chromium. However, if no chromium is found to be present, then it follows that there is no hexavalent chromium. Conversely, if chromium is found, further testing or examination of the manufacturing process would be needed to determine if it is hexavalent chromium.

 

 

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