Labeling of Products Containing or Made With ODS
Section 611 of the Act, as amended, requires labeling of products made with or containing class I and class II ozone-depleting substances (ODS) . It also requires that containers containing class I or class II substances be labeled. This page offers manufacturers, distributors, wholesalers, and retailers information on how to comply with EPA’s labeling regulation for products made with or containing class I and class II ODS.
This page has recently been updated to better reflect the labeling requirements for products containing or made with class II controlled substances (i.e. HCFCs). These requirements begin January 1, 2015, and were established in the same February 11, 1993 rule that required labeling for products containing or made with class I controlled substances. For simplicity, the information below often refers to products manufactured with or containing ODS, instead of “class I and class II controlled substances.”
Also as of January 1, 2015 the Clean Air Act and EPA regulations greatly restrict the allowed uses of HCFCs. Statutory and regulatory requirements also limit the ability to sell nonessential products that were historically made with class I or class II substances. In addition, production and import of class I substances has been completely phased out (with limited exceptions) since the 1990’s. Given the very limited use of ODS in manufacturing products, EPA believes that the labeling requirements apply predominantly to HCFC product importers, effective January 1, 2015. Any imported products must be exempt from or non subject to the Nonessential Products Ban (see CCA section 610 and 40 CFR 82 Subpart C).
What the Label Must Say
The product label must be present prior to the product’s introduction into interstate commerce; for imported products, introduction into interstate commerce occurs when the product clears U.S. Customs. The label must include the following statement:
WARNING: [Contains / Manufactured with] [name of HCFC], a substance which harms public health and environment by destroying ozone in the upper atmosphere.
Regulatory Citation and EPA Contact
Labeling requirements can be found at 40 CFR Part 82 Subpart E (82.100 – 82.124), pursuant to section 611 of the Clean Air Act. For questions or additional clarification on labeling of HCFC products, please contact Liz Whiteley at email@example.com or 202-343-9310.
Key Features of Labeling Requirements
Products Manufactured with Class I or Class II Substances
Label Pass-through Requirement
Product manufacturers that use ODS during the manufacturing process must label their products. Such products manufactured with ODS may include electronic parts washed in ODS solvents, such as electrical components and metal products, plumbing fixtures, and products using ODS adhesives, such as some packaging, books, and sporting goods. If a manufacturer purchases a product "manufactured with” an ODS from a supplier, that product must have a label on it when the manufacturer purchases it; however, the manufacturer does not need to incorporate that label information into a label on its own final product. In other words, manufacturers need only label their products according to their own direct manufacturing process. However, labels on products or containers containing ODS must be passed through the stream of commerce to the ultimate consumer, since the ozone-depleting substance is contained in the final product at the time of purchase. An example of a “product containing” would be an imported refrigerator containing foam that was blown with HCFC-141b. Other “products containing” are applied by a manufacturer in the formation of a subsequent product. For example, an ODS adhesive must be labeled as a “product containing". When that product (i.e. the adhesive) is applied by a subsequent manufacturer in affixing a cushion to a seat, the seat must be labeled as a "product manufactured with" because the ODS has been released during the manufacture of the seat cushion. The subsequent sale of the seat to an automobile manufacturer would not result in labeling of a car based on the incorporated seat.
Subsidiaries and the Label Pass-through Requirement
The rule states that wholly-owned subsidiaries are part of a parent company and are required to pass the warning statement between subsidiaries. If a subsidiary is not 100 percent wholly-owned, the label is not required to be passed through from one subsidiary to another.
Incidental Uses of Class I or Class II Substances
Labeling is not required for non-contact incidental uses of ODS, including:
- A process in which ODS solvent is used to clean or maintain manufacturing equipment, where the surface area being cleaned has no direct contact with the product.
- Use of ODS in refrigeration equipment to keep food products cold; the ODS refrigerant does not come into direct contact with the food products and is therefore a non-contact incidental use.
Labeling is not required for some contact incidental uses. The examples below are not—or will no longer be—relevant to domestic manufacturing processes in 2015 and beyond, but may still apply to imported products from nations that do not have as stringent HCFC use restrictions. Example include:
- A process in which ODS is used intermittently, not routinely, as part of the direct manufacturing process, such as spot cleaning textiles, cleaning ink plates, or testing for leaks in a cooling system and condenser.
- A process in which there is an initial contact between the substance and the product, that occurs infrequently (typically as part of a maintenance process), and perhaps unintentionally. An example is the use of an ODS solvent as a spot remover in the textile industry; it is used infrequently and is not a routine part of the manufacturing process.
Labeling is required for uses that are not considered to be incidental. These include:
- Most mold release agents that are applied systemically throughout a manufacturing process.
- Defluxing of printed circuit boards during a continuous production process.
- Food processing, such as the manufacturing of some spices.
ODS Products versus ODS Containers
The Distinction Between Containers and “Products Containing”
Containers of ODS or mixtures containing an ODS must be labeled. A container contains an ODS if the substance must be transferred into another container, appliance or product in order to realize its intended use.
Examples are a 30-lb cylinder of HCFC-22, or a drum of HCFC-225 solvent, which would eventually be transferred into other vessels, such as refrigeration equipment or degreasing units, for their intended use. The containers have required labels since 1993, regardless of whether the container contains a class I or class II controlled substance. Readers should note that containers of HCFCs cannot be introduced into interstate commerce or used after 2014 unless the intended use of the HCFC meets one of the exemptions in section 605(a) of the Clean Air Act, which states: Effective January 1, 2015, it shall be unlawful for any person to introduce into interstate commerce or use any class II substance unless such substance—(1) has been used, recovered, and recycled; (2) is used and entirely consumed (except for trace quantities) in the production of other chemicals; (3) is used as a refrigerant in appliances manufactured prior to January 1, 2020; or 4) is listed as acceptable for use as a fire suppression agent for nonresidential applications in accordance with section 7671k (c) of this title.
Products containing class I substances must have been labeled as of May 15, 1993. Products containing class II substances will be required to be labeled as of January 1, 2015.
A product contains an ODS if the substance is used in the container or equipment without having to be transferred. Examples include some aerosols, technical aerosol solvents, and closed-cell foams.
Upon subsequent use of these products to manufacture other products, however, a company would label its new products "manufactured with" (see the example above).
Treatment of Containers of Recaptured Substances and Waste
Companies are exempt from labeling waste that is to be discarded, i.e., landfilled or incinerated. Waste that is to be recycled or reclaimed still requires a label.
Companies that destroy controlled substances used in their manufacturing processes with 98 percent destruction efficiency are exempt from the labeling requirements, provided they use one of the following destruction technologies: liquid injection incineration, reactor cracking, gaseous/fume oxidation, rotary kiln incineration, cement kiln and radio frequency plasma and municipal waste incinerators (but only for the destruction of foams).
Trace Quantities of Impurities Resulting from Inadvertent Production, Unreacted Feedstocks, and Process Agents
EPA realizes there are circumstances in which an ODS is formed from a chemical reaction that takes place in a manufacturing process, such as the formation of carbon tetrachloride in the chlorination of drinking water. Such production is unintentional, resulting in trace quantities of an ODS remaining in the final product, and therefore does not trigger any labeling requirements. Exemptions for trace quantities are exemptions only for products "containing" trace quantities and not for products "manufactured with" trace quantities. Only products "containing" can actually "contain" trace quantities. Products “manufactured with” trace quantities of an ODS must still be labeled as such.
Feedstocks & Process Agents
In addition, when manufacturers use an ODS as a feedback or a process agent in their manufacturing processes and insignificant or trace quantities of the substance remain in the final product, the product is exempt from the labeling requirements for a "product containing".
For example, carbon tetrachloride is used as a catalyst in producing chlorinated rubber; the remaining trace amounts in final product would not trigger the labeling requirements for a "product containing." This introduction of the substance is essential to the process and is neither consumed nor inadvertently produced, thus the final product would be labeled as a "product manufactured with."
In the case where a process agent is introduced, then removed from a product--such as in the case of many explosion suppressants--the product would still require a label indicating it was "manufactured with a class I [or class II] substance," unless the removed substance is subsequently transformed.
Treatment of the Use of ODS for Repairs, Used Products and Spare Parts
If a company sells solvent-cleaning products that do not contain ODS, and those products are used by manufacturers who may use ODS in their processes and then return the used solvent product for recycling, any contamination of those used ODS solvents resulting in trace amounts of ODS in the recycled product would not trigger labeling.
If a company recycles chemical products that contain ODS as a necessary part of their composition, the company must label the new (recycled) product as a "product containing" ODS, since the ODS contained therein is necessary to the functioning of the product.
If a company sells used products, it is not required to relabel them, because they have already been introduced into interstate commerce.
If a company performs repairs or upgrades on products using ODS, it is not required to label them; however, if it purchases components made with ODS, those components should be labeled, but the label is not required to be passed through with the product. Products being upgraded, for example, would not require a new label on the final product, because they are not being introduced into interstate commerce.
A company is exempt from the labeling pass-through requirement for spare parts that are purchased from another manufacturer and intended solely for repair purposes. Spare parts manufactured with an ODS would require a label; however, once these parts are sold to a distributor, the distributor may sell the parts without a label, so long as the parts are being sold to person who are using them for repair purposes.
Label Appearance and Placement
How the Labels Must LookFormat the labels so that they are in a square or rectangular area with or without a border. The word "WARNING" must be in capital letters. See rule for type size requirements.
The warning statement must be in strong contrast against its background. For example, black on white or red on white present strong contrasts; however, yellow on white or dark blue on green do not. The key is that the warning statement be "clearly legible and conspicuous."
The warning statement may be printed directly on a product or its outer packaging, or on alternative labeling; actual adhesive labels, although an option, are not required.
Where the Labels Should Appear
Principal Display Panel (PDP) or a Display Panel Area
Placing the warning statement on any of these display panels clearly meets the mandate that the statement be clearly legible and conspicuous.
These may be used, as long as the statement is clearly legible and conspicuous. Examples are hang tags, tape, cards, stickers, and other similar types of overlabeling.
The warning statement may be placed in the product's outer packaging if the product is sold in its packaging, or if the consumer is able to read and understand the warning statement on such packaging at the time of purchase.
Supplemental Printed Materials
Placing the warning statement conspicuously in supplemental printed information that accompanies the product or container, such as invoices, bills of lading, package inserts, and Material Safety Data Sheets (MSDS) at the time of purchase meets the requirements as long as the purchaser can read the warning statement upon purchase.
For products purchased through telephone or mail orders, print the warning statement in a conspicuous place in sales promotional literature, journals, newspapers, or displays so the warning statement is available before the time of purchase. A company could include an insert in such printed material bearing the warning statement. Another option would be the use of supplemental printed materials that accompany the product at the time of delivery. With this option, the consumer must be able to return the product if, at the time of delivery or payment, they choose not to make the purchase based on the warning statement.
Products that are labeled in any one of the above methods do not require additional labeling.
Treatment of Products Manufactured for Export
Products manufactured for export are not required to be labeled, but there must be sound evidence that such products are intended for export. This could include:
- Clear identification of an export area in a warehouse.
- Destination papers, shipping papers, or other documentation indicating that the products are intended for export. This information must be readily available on site upon request by EPA.
Treatment of Products Manufactured for Import
The importer will be held liable for all products subject to the labeling requirements imported into the United States. These products are introduced into interstate commerce at the site of U.S. Customs clearance and include products manufactured with controlled substances.
Importers must have a reasonable belief that products introduced into interstate commerce are accurately labeled. In order to have a reasonable belief, importers may investigate at least one step back into the manufacturing process or develop a contractual agreement with its supplier indicating whether the products have been made with ozone-depleting substances. An MSDS would be another option for establishing a reasonable belief.
An importer planning to incorporate its imported product made with class I substances into a new product must label the import; however, it is not required to label its final product if no class I substance is used in the manufacture of the final product. If the product contains a class I substance, such as an air conditioner to be installed into an automobile, the importer must label the final product (the vehicle) as a product containing upon its introduction into interstate commerce.
Imports and products introduced "in bond" at the U.S./Mexico border are considered imports and subject to the labeling rule, regardless of "Maquiladora" status.
Labeling of Packaging Materials
Manufacturing of Packaging Materials Made With Class I Substances Must Label
If a company makes or imports packaging materials using an ODS, it must label its products as "manufactured with a class I [or class II] substance." The company's customer, however, is not required to pass the label on the packaging materials through with its product. Examples of these products include some corrugated packaging or materials that contain open cell foam where the foam blowing agent was an ODS.
Manufacturers of Packaging Materials Used to Package Other Products Made by That Company
If a company makes its own packaging materials using an ODS and it also makes a product using no ODS to be sold in those packaging materials, its final package must be labeled based on its use of ODS in the packaging materials.
Products and Processes Under Research & Development
The use of ODS in the research and development of a product or process does not require labeling, since no product has been introduced into interstate commerce. Upon a new product's introduction into interstate commerce, labeling would be required.
Introduction into Interstate Commerce
There are three entry points into interstate commerce for purposes of labeling requirements:
- Site of U.S. Customs (Customs) clearance
Labeling may occur: (1) at the foreign production facility per agreement between manufacturer and importer, while in transit, or another location before U.S. Customs inspects goods; (2) in supplemental printed material prior to the products' entering the location in which Customs inspection occurs.
- Introduction into manufacturer's, distributor's, wholesaler's or retailer's warehouse
- Labeling may occur at manufacturer's production facility, or upon entry into manufacturer's warehouse. Distributors, wholesalers, and retailers must pass labeling information through to the customer. Labeling information received from a manufacturer must remain with products in the warehouse until the distributor, wholesaler, or retailer distributes or sells them. If the labeled products are repackaged or require new labels, such labeling must be secured prior to the release of the products from the warehouse.
For example, a distributor purchases a bulk shipment of nuts and bolts that are labeled on supplemental printed material as products manufactured CFCs. The supplemental printed material must remain with the products in inventory until the distributor is ready to sell them. Prior to the sale, the distributor may repackage the products into smaller boxes and label the individual boxes. The labeling must be secured prior to the release of the products.
- Release from manufacturer's production facility where manufacturer has no warehouse
Labeling may occur during production on production line, at end of production line, or any time prior to release of products from production facility.
Labeling Charged Containers
A container charged with an ODS must be labeled either when it leaves the place where it was charged, when it enters storage for further sale, or when it enters a site of U.S. customs clearance. Containers kept within a facility for a company's own manufacturing purposes need not be labeled because they are not being introduced into interstate commerce.
Recharging "Products Containing"
A halon manufacturer or distributor refills a fire extinguisher for use in a customer's facility. The container discharging the halon would be labeled as a "container containing;", however, the fire extinguisher, already purchased, would not require additional labeling. Fire extinguishers would be labeled as "products containing" when they are sold. Subsequent labeling upon refilling activity would not be required.
Servicing of "products containing" such as degreasers, fire extinguisher, and air conditioners would not require relabeling by distributors or manufacturers.