Danger to human health or safety assessment for products containing button or coin batteries and the packaging of button and coin batteries

Legislative background

The Canada Consumer Product Safety Act (CCPSA) addresses dangers to human health or safety posed by consumer products in Canada. Any person who manufactures, imports, advertises, sells or tests a consumer product must comply with all applicable requirements of the CCPSA and its regulations. Paragraphs 7(a) and 8(a) of the CCPSA prohibit the manufacture, importation, advertisement or sale of any consumer product that is a "danger to human health or safety". The CCPSA defines the term as follows:

Danger to human health or safety means any unreasonable hazard — existing or potential — that is posed by a consumer product during or as a result of its normal or foreseeable use and that may reasonably be expected to cause the death of an individual exposed to it or have an adverse effect on that individual's health — including an injury — whether or not the death or adverse effect occurs immediately after the exposure to the hazard, and includes any exposure to a consumer product that may reasonably be expected to have a chronic adverse effect on human health.

Definitions

Button and coin batteries:

Button and coin batteries are defined as small, single cell batteries having a diameter greater than its height. They are often powered by lithium, alkaline, silver oxide or zinc-air and range in size from 5 to 30 millimetres in diameter and 1 to 11 millimetres in height. They are used to power a wide range of consumer products (for example, watches, key fobs, remote controls and toys).

Older adults:

For the purposes of this document, the term "older adults" refers to adults over the age of 65.

Toy:

A product that is intended for use by a child under 14 years of age in learning or play.

Scope of affected products

For products containing button or coin batteries

Includes:

• Consumer products that incorporate or use button/coin batteries

Excludes:

• Consumer products that incorporate or use zinc-air button/coin batteries^{Footnote 1}

For the packaging of button and coin batteries

Includes:

• Packaging for lithium, alkaline, and silver oxide button/coin batteries

Excludes:

• Packaging for zinc-air button/coin batteries ^{Footnote 2}.

Hazards of concern

Ingesting a button/coin battery carries several risks. It may get stuck in the digestive system (for example, the esophagus, stomach, or gastrointestinal tract) creating an electric circuit through contact with saliva and tissue. This could trigger a chemical reaction that can burn through tissue. When the batteries are exposed to moisture and acid in the body, they can also corrode or rupture, releasing chemicals into the body. These reactions can lead to severe, and in some cases, fatal injuries within just 2 hours if immediate medical attention is not sought.

There is also the possibility that button/coin batteries could block the airway, leading to a child choking. In other circumstances, these batteries have been inserted into a child's ear or nostril. Insertions into these orifices can cause extensive damage to the eardrum or nasal septum. The burns can lead to infections and, in some cases, permanent breathing, olfactory or hearing disabilities.

A study conducted in 2018 ^{Footnote 3} found that children less than 6 years of age are the most prone to ingesting these batteries, with lithium coin batteries having a diameter of 20 millimeters or more being associated with most complications. They pose the greater likelihood of serious injury as they are typically larger in diameter (greater than 20 millimeters), meaning they are more likely to become stuck in a child's esophagus if ingested, and their higher voltage (3 volts) and current means they can cause tissue damage more quickly. While button batteries are smaller in diameter (less than 16 millimeters) and more likely to pass through the gastrointestinal tract, they can still produce damage if they become stuck in the esophagus and remain undetected. Even when they no longer have enough power to operate a device, these batteries can still cause serious harm when ingested. Both depleted lithium coin batteries and silver oxide button batteries retain enough electrical charge to trigger a dangerous internal reaction.

Children under three years of age are particularly vulnerable to injuries related to the ingestion of small objects within their reach due to their mouthing behavior, and their general inability to recognize a hazard. In the case of these batteries, they are shiny, round, small objects that attract a child's attention.

To a lesser extent, there have also been incidents related to adults and older adults ingesting button/coin batteries, usually related to confusing the loose battery with medication.

Incidents^{Footnote 4}

Health Canada is aware of 41 reports of incidents involving button/coin batteries from consumer products from June 2011 to June 2025. The severity of the incidents vary from near-miss/no injury to four reported deaths. In the cases Health Canada has received, the sources of these batteries also vary, however the majority were from toys.

The Canadian Hospitals Injury Reporting and Prevention Program (CHIRPP) is a surveillance system that collects injury and poisoning data from the emergency departments of participating hospitals across Canada. From 2011 to April 30, 2025, there were approximately 1,400 reports in CHIRPP involving the ingestion of button batteries. Of these cases, 79% of them involved children less than 5 years old. Approximately 560 (40%) received medical advice or observation, 490 (35%) received treatment in the emergency department, and 350 (25%) were admitted to the hospital.

The sources of these batteries varied; in most of these cases there were not enough details in the report to determine the source or the type of the button battery. The CHIRPP data shows that there was significant under-reporting of incidents to Health Canada.

In the United States (US), the National Capital Poison Center (NCPC) has been tracking button/coin battery ingestions since 1977 and reported 69 deaths due to ingestion of these batteries from 1977 to June 2022. From 1982 to June 2022, NCPC reported 267 cases of severe injury from button/coin battery ingestion. CHIRPP data was used in this section as it provides detailed national injury surveillance for ingestion cases. While Canadian poison centres respond to button/coin battery incidents, a consolidated national dataset is currently unavailable.

Based on incident information in the U.S. National Electronic Injury Surveillance System, the US Consumer Product Safety Commission (CPSC) estimates that from January 1, 2011, through December 31, 2021, there were 54,300 emergency department-treated incidents involving button/coin battery ingestion or insertion into the mouth, nose, or ear. This excludes cases involving ingestion of a battery in which the type of battery is not indicated. The CPSC estimates that of the 54,300 cases that were indicated to involve a button/coin battery, approximately 88% involved ingestion through the mouth, while the remainder arose from insertion into the ear or nose. The CPSC also estimates that 16,100 (30%) of the 54,300 incidents involved young children under the age of 2 years, and an estimated 26,900 (50%) incidents involved children between the ages of 2 and 6. In total, an estimated 43,000 (79%) of the incidents were associated with children 6 years of age or younger. Ingestions by adults and older adults is likely related to confusing loose batteries with medication.

Danger to human health or safety assessment

Danger to human health or safety considerations

Considerations for a product to pose a potential danger to human health or safety are outlined in Health Canada's Industry Guidance - "Danger to Human Health or Safety" Posed by Consumer Products. The main considerations assessed are:

1. Unreasonable hazard
2. Existing or potential hazard
3. Normal or foreseeable use
4. May reasonably be expected to cause
   1. Death
   2. Adverse effect on health

1. Unreasonable hazard

The consideration of unreasonable hazard includes the following components.

a. Inherent hazard

Products that contain button/coin batteries pose an inherent ingestion hazard. This hazard exists when the battery is easily accessible as a result of product design or product damage.

Some products may feature inadequate safety measures, such as easily removable or unlatched battery covers, which enable young children to gain access to the batteries. This inherent vulnerability can make it easy for young children to open the compartment, retrieve the batteries, and potentially swallow them, unaware of the risks involved. Both ANSI/UL 4200A and ASTM F963 have requirements for secure battery compartments, which can mitigate this hazard.

Damaging these products by either dropping or mishandling them can also cause this hazard. Impact or rough handling may lead to cracks or breaks in the product, which may cause damage or dislodgment of the battery compartment cover. In these situations, the battery may become exposed and easily accessible, increasing the likelihood of ingestion. ANSI/UL4200A and ATSM F963 have testing criteria which requires these products to pass a number of use and abuse tests in order to meet their safety standard.

Button/coin batteries in their packaging also pose an inherent ingestion hazard if the packaging is not secure. These batteries are often sold in clear packaging that is not child-resistant. This means that young children can easily access the batteries if they come into contact with the packaging. Children may also be drawn to the shiny appearance of these batteries, increasing the risk of them opening the packaging and accessing the batteries. There are several consensus-based industry standards that can mitigate this hazard.

b. Severity of hazard

The severity of the button/coin battery ingestion hazard can vary widely, ranging from mild discomfort and irritation to severe, life-threatening injuries or death. One of the immediate dangers is the risk of choking, particularly in young children, if the battery becomes lodged in the airway. Other factors influencing the severity include the size of the battery, its chemical composition, and its location and the duration for which it stays within the body. Smaller batteries may cause less immediate harm, while larger ones, especially those composed of lithium, can lead to more extensive injuries. Batteries stuck in the esophagus can result in serious burns and perforations. Although batteries that pass into the stomach may not present an immediate danger, they can still lead to long-term complications. Prompt medical attention can minimize damage, but if a battery is not removed quickly, it can continue to release harmful chemicals, causing more injuries.

c. Intended and foreseeable users

Button/coin batteries are designed for a wide range of intended users and applications due to their small size, low power output, and portability. Adult consumers are among the primary users of products containing these batteries, but they are also used by children and older adults.

These batteries power many consumer electronics such as watches, remote controls, calculators, greeting cards, and key fobs. They are also found in electronic toys, clothing, and games designed for children. It is also foreseeable that an adult would allow a child to play/hold small consumer electronic products, especially low cost novelty items such as mini flashlights or keychains. Finally, button/coin batteries power devices such as hearing aids, medical alarms, and other assistive technologies that cater to the needs of older adults.

The intended and foreseeable users of button/coin batteries in their packaging are adults and older adults. Adults purchase these products to replace the batteries in their consumer electronics and toys for their children. Similarly, older adults and caregivers purchase these batteries for their medical devices.

d. Obviousness of hazard

The ingestion hazard posed by products containing button/coin batteries is not obvious, especially if the consumer is not properly informed about the risk. While some risks may be slightly more obvious, such as the choking hazard for small children, other risks related to battery ingestion and chemical burns may not be apparent.

Consumers may also not realize the importance of proper battery installation, and the risks associated with using products with damaged or improperly secured battery compartments. The effectiveness of the compartment design in preventing easy access to children may also not be obvious.

Furthermore, most products containing these batteries are used every day, such as watches, small electronics and toys; these may not be items that adults consider hazardous. Many of these devices come with batteries already installed and have limited warnings on the product or in the instructions, which could also give consumers a false sense of safety. There are several safety standards that address this hazard by requiring warning labels on the button/coin battery, the consumer product and packaging containing button/coin batteries along with instruction requirements that can help to inform consumers about these hazards. Appendix C provides a list of safety standards for the labelling of consumer products containing button/coin batteries or button batteries sold alone.

There is reasonable expectation that an adult would be slightly more aware of the hazard posed by button/coin batteries in their packaging versus in a product and may take some precautions to ensure batteries are not accessible to a child. However, it may not be as reasonable to expect that an adult would know if the product packaging was child resistant. Furthermore, there are limited warnings of the ingestion hazard on the packaging for these batteries and they also may not have instructions on what to do in the event of ingestion.

e. Social utility

Products containing button/coin batteries have very high social utility. There are a wide variety of products that contain these batteries:

• Button/coin batteries power a wide range of consumer electronic products such as calculators, watches, remote controls and key fobs.
• Button/coin batteries power a wide range of products used by children including electronic toys, games, clothing and gadgets.
• Many medical implants, sensors, hearing aids and monitoring devices use button/coin batteries due to their small size and long shelf life.

Additionally, there is high social utility for the sale of button/coin batteries on their own. Consumers often need to replace depleted batteries in their devices. Selling these batteries on their own allows people to purchase replacements at relatively low costs without needing to buy an entire new device. This is cost-effective and reduces electronic waste. By offering replacement batteries, manufacturers and retailers help extend the life of devices that would otherwise become unusable once the original batteries are depleted.

f. Available alternatives

There are a number of alternatives to button/coin batteries, depending on the application and specific requirements. While these may not be appropriate alternatives for many specific products, some of these alternatives include:

Lithium-ion Rechargeable Batteries: These batteries are commonly used in devices like smartphones, laptops, and cameras. They offer higher capacity and can be recharged multiple times, reducing waste compared to disposable button/coin batteries. However, given the small size of many products that contain button/coin batteries, this may not be feasible or cost effective.

AA or AAA Rechargeable Batteries: For devices that can accommodate larger battery sizes, rechargeable AA or AAA batteries can be a suitable alternative. They are available in various chemistries, including nickel-metal hydride (NiMH), which offers good capacity and rechargeability.

Solar-Powered Batteries: Solar-rechargeable batteries can be recharged using solar panels.

g. Consensus-based safety standards or government regulations

There are a number of international consensus-based safety standards and government regulations that apply to products containing button/coin batteries. Two of these standards are ASTM F963-23 – Standard Consumer Safety Specification for Toys Safety which apply to toys and playthings, while ANSI/UL 4200A – Standard for Safety of Products Incorporating Button Batteries or Coin Cell Batteries applies to all other consumer electronic products containing button/coin batteries. ANSI C18.3M Part 2-2024 Portable Lithium Primary Cells and Batteries applies to lithium battery products only. These standards set out criteria that address the ingestion hazard, including, but not limited to:

• Battery compartment construction requirements
• Performance requirements
• Labelling, marking and instruction requirements

There are many different international consensus-based safety standards applicable to the packaging for button/coin batteries in either reclosable or non-reclosable packaging.

For reclosable packaging, this includes:

• CAN/CSA Z76.1-99 (R2003) Reclosable Child-Resistant Packages and
• ISO 8317:2015 – Child resistant packaging – Requirements and testing procedures for reclosable packages.

For non-reclosable packaging, this includes:

• CSA C22.2 NO. 60086-4:19 (R2024) Primary batteries - Part 4: Safety of lithium batteries (Adopted IEC/CEI 60086-4:2014, 4th Edition, 2014-09, with Canadian deviations)
• IEC/CEI 60086-5:2021 Primary batteries Part 5: Safety of batteries with aqueous electrolyte, and
• ISO 28862:2018 – Packaging – Child-resistant packaging – Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products.

These standards set out criteria that address the ingestion hazard posed by button/coin batteries in their packaging, including but not limited to: Child-resistant packaging.

On August 16, 2022, the United States signed Reese's Law, a rule created by the CPSC in order to eliminate or reduce the risk of injury from ingestion of button cell or coin batteries. Reese's Law sets rules on the safety requirements for the performance, labelling and certification for button/coin batteries as well as consumer products that contain or use button/coin batteries.

The Australian Competition and Consumer Commission (ACCC) and the United Kingdom also introduced mandatory standards for button and coin batteries. The ACCC created mandatory standards which require consumer goods containing button/coin batteries to have secure battery compartment, battery compartments that are resistant to being opened by a child, captive fasteners and secure batteries if they are non-replaceable but accessible.

In addition, these mandatory standards list requirements for warnings and information on the product packaging and instructions, while recommending that warnings also be placed on the product. Requirements for child resistant packaging, blister packaging and warnings for packaging of batteries are also covered by these standards.

The United Kingdom developed the Publicly Available Specification (PAS) 7055:2021, entitled Button and Coin Batteries- Safety Requirements- Specification. The PAS specifies safety requirements for button/coin batteries and covers testing requirements, labelling, instructions and packaging requirements.

There are products containing button/coin batteries and button/coin batteries in child-resistant packaging available in the Canadian marketplace that appear to conform to the applicable criteria outlined above.

2. Existing or potential hazard

Incident reports from Canada and the United States indicate the presence of an existing or potential button/coin battery ingestion hazard from both products containing button/coin batteries and from button/coin batteries in their packaging.

3. Normal or foreseeable use (including foreseeable misuse)

The ingestion hazard is related to the unintended but reasonably foreseeable use of products containing button/coin batteries or from these batteries in their packaging. There are many consumer products, such as children's toys and electronics that contain button/coin batteries, and it is reasonably foreseeable that a child may play with or access them. There are four scenarios of concern:

• Children could gain access to button/coin batteries from a product whose battery compartment opens easily. In addition, children could remove batteries that are non-replaceable (for example, in a greeting card or in products where the battery is soldered or held in place with fasteners such as rivets) but are inadvertently accessible within the product.
• Children could gain access to button/coin batteries when a product is dropped/impacted/broken and the battery compartment cover gets dislodged or damaged, causing the battery to become accessible.
• Children could gain access to button/coin batteries directly from battery packaging that is not child-resistant. This may occur with batteries purchased separate from a product or batteries supplied with a product that are without child-resistant packaging. In addition, this may occur if more than one battery is accessible from a package at a time.
• Children gain access to button/coin batteries that are stored loosely or are easily accessible. This situation can arise when batteries are kept in a location accessible to children, such as within their reach or in a container that is not child-resistant. Additionally, improper disposal of batteries removed from a product can contribute to this risk.

4. May reasonably be expected to cause

a. Death

The result of ingesting a button/coin battery can be very serious and even fatal. The risk of death is particularly high when a button/coin battery becomes lodged in the esophagus, as it is a narrow passage that can quickly be damaged by the corrosive chemicals and electrical currents. The resulting injuries can lead to internal bleeding, infection, and other complications that can be fatal.

It is therefore reasonable to expect that:

• certain products containing button/coin batteries, and
• packaging containing button/coin batteries

that do/does not conform to the applicable criteria outlined above may cause death.

Health Canada is aware of one death caused by button/coin battery ingestion in Canada from June 2011 to June 2025.

b. Adverse effect on health

The circumstances that may reasonably be expected to cause death may also reasonably be expected to cause adverse effects on health.

Health Canada is aware of 27 reports of adverse effects on health in Canada related to the ingestion of button/coin batteries from products containing button/coin batteries, and from these batteries in their packaging from June 2011 to June 2025. The severity of the incidents varies from near-miss to death.

When swallowed and lodged in the esophagus or gastrointestinal tract, these small batteries can create electrical and chemical hazards. The electrical circuit formed by the battery can result in electrical burns, while the leakage of corrosive alkaline chemicals from the battery can cause chemical burns, tissue damage, inflammation, ulceration, and even tissue necrosis. In severe cases, the tissue damage can progress to perforation, leading to life-threatening conditions. Internal bleeding and respiratory complications are also possible. Even prompt removal of the battery may not prevent all potential complications, and systemic toxicity is a rare but serious concern.

There is also the possibility that button/coin batteries could block the trachea (for example, occlude the airway), leading to a child choking. In other circumstances, these batteries have been inserted into a child's ear or nostril. Insertions into these orifices can cause extensive damage to structures such as the eardrum or nasal septum. The burns can lead to infections and, in some cases, permanent breathing, olfactory and hearing disability.

It is therefore reasonable to expect that certain products containing button/coin batteries, and certain packaging containing button/coin batteries, that do not conform to the applicable criteria outlined above, may cause an adverse effect on human health.

For more information

If you require additional information regarding this Danger to Human Health or Safety Assessment, please contact a Health Canada Consumer Product Safety Office via email (ccpsa-lcspc@hc-sc.gc.ca) or telephone at 1-866-662-0666 (toll-free within Canada and the United States).

Appendices

Appendix A

Appendix B

Appendix C