Child Resistant Packaging - What is it?

Author: becky

May. 13, 2024

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Child-Resistant Packaging - What is it?

Child-resistant packaging is essential for any company that sells and distributes potentially toxic products. According to Safe Kids Worldwide, the majority of poisoning cases in children are caused by the accidental ingestion of medication. In fact, it's found that one child dies every 12 days because of this issue.

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Furthermore, approximately 60,000 emergency department visits result from accidental medication ingestion and overdose for kids under 5 years of age, according to the CDC. Various legislation and regulations surrounding child-resistant packaging aim to reduce these numbers and keep the fatality rate as low as possible.

This piece will explain everything you need to know about child-resistant packaging and all the things you must be aware of.

What is Child-Resistant Packaging?

This type of packaging is often called CR packaging, and it's specially designed to prevent children from ingesting harmful materials, such as prescription drugs. The most proven way to achieve this is by using a special safety cap. Young children are unable to take the cap off because it has a unique mechanism that requires thought and strength to undo.

However, these caps are designed so adults can access the package without problems. A typical safety cap requires the user to push down on the top and twist it open. This differs from a non-child-resistant safety cap, which any child could potentially twist or lift off.

There are hundreds of other designs, generally split into two categories: reclosable and non-reclosable.

A reclosable pack can be safely opened by an adult and then re-secured, maintaining its safety features. Children shouldn't be able to open it even after the pack has been opened. Common examples include liquid medication in bottles, household bleach, and abrasive cleaning products.

Non-reclosable refers to any packaging that is only opened once and then disposed of. The most common example is blister packs containing prescription drugs.

Why Do You Need Child-Resistant Packaging?

Firstly, it is proven to help reduce the number of medication-related fatality cases around the world. The World Health Organization states it is one of the most successful ways to prevent accidental poisoning in children. In the UK alone, 74% of all drug poisonings are accidental. A large proportion of these could be prevented with the right packaging materials in place.

Moreover, governments have rules that demand certain companies use child-resistant packaging when distributing their goods. Failure to do so can result in legal issues and significant penalties for your business. It's vital to be aware of whether your company is required to have this special packaging.

What Are the Benefits of Child-Resistant Packaging?

There are benefits for both businesses distributing potentially harmful drugs/products and the people using them. The fundamental aim of these products is to save lives. The statistics indicate that large numbers of children are put in danger every day because of improper packaging materials. There's a danger group of children between 42 and 51 months old, who are known to be extremely curious and willing to open anything they find. This often results in them opening medication or hazardous cleaning products, causing harm to themselves.

Evidence supports the claim that child-resistant packaging saves lives. The World Health Organization looked at figures relating to unintentional poisoning deaths in children under the age of 10. In 1968, 151 out of 100,000 children died of unintentional poisoning in England and Wales. This figure dropped to just 23 per 100,000 in the year 2000, coinciding with the introduction of this particular packaging.

They don't just help prevent deaths; numerous cases involve children harming their skin or creating health problems by accessing harmful substances. Proper safety packaging prevents these instances from becoming frequent as well.

From a business standpoint, manufacturers can benefit from this packaging as it ensures they comply with specific regulations. Therefore, if anything happened to a child and they ingested something harmful, it would not be the fault of your company as you took the right steps to ensure utmost safety.

What Are the Requirements for Child-Resistant Packaging?

A business can't just use any safety cap and claim it's child-resistant. There are specific requirements and standards that must be met. Primarily, the requirements revolve around protocol tests, ensuring a product has been thoroughly tested and can pass as child-resistant.

If a piece of packaging is to be classed as child-resistant, it needs to meet one of the following certification standards:

  • BS EN ISO 8317:2004 - Covers reclosable packaging and is known as the international standard.
  • 16 CFR 1700.20 - Covers both reclosable and non-reclosable packaging for medicines and non-medicines. It's an American regulation for products sold in the US but has recently been adopted by other countries.
  • BS EN 14375:2003 - Covers non-reclosable packaging for medicines. It's the European standard.
  • BS EN 862:2005 - Covers non-reclosable packaging for non-medicines. It's also the European standard.

These standards detail that child-resistant packaging must be tested with both young children and adults. The requirements for testing include:

  • A testing group of children between 42 and 51 months old. Each child is given the packaging and tasked with opening it. They're given five minutes to do so, after which they're shown how to open it and tested again.
  • For packaging to be classed as child-resistant, 85% of the testing group must not be able to open it in the initial five minutes. At least 80% of the participants mustn't be able to open it even after being shown how.
  • The same pack needs to be tested by adults aged 50-70 years old. This ensures at least 90% of participants can open and reclose the packaging. If a non-reclosable pack is tested, 90% need to be able to open it and take out what's inside. This ensures the product is both safe for children and accessible for adults.
  • Numerous tests must be carried out with different groups of varying sizes. There should be no fewer than 30 and no more than 60 kids in one group. Overall, it's advised that hundreds of children and adults are tested to get a clear picture.

For any form of child-resistant packaging to meet these standards, they need to display clear testing results and prove the product has reached these requirements.

How Does Child-Resistant Testing Work?

The testing process works by identifying if something is nearly impossible for a young child to open. The aim is not to make something entirely child-proof, as this is very difficult to achieve. Still, it must show that the children in the testing groups struggle to open the packaging even after being shown how to do it.

It's also essential to test that the packaging is easy for adults to access. If something has passed the child tests, it still must be presented to adults before officially passing the regulation requirements detailed above.

Additionally, mechanical testing is now used in a lot of child-safety packaging. This involves using machines to test the strength of certain aspects of the packaging. For example, a mechanism is used to see how much force is required to squeeze the cap and twist it off. While this gives a good indication of the security of a safety cap, it's still vital to put it through human testing as well.

What Industries Are Required to Use Child-Resistant Packaging?

Contrary to what you might believe, the need for child-resistant packaging isn't confined to the pharmaceutical industry. In fact, not all medicines need this level of safety on their packaging. Only items that contain aspirin and paracetamol or more than 24mg of iron are required to have child-resistant packaging.

Legal requirements state that any substances potentially poisonous when ingested need child-safety packaging. If the substance can burn or corrode the skin, it also needs this packaging. This means items like bleach, weed killer, toiletries, etc., must have child-resistant packaging.

Therefore, the following industries can be affected:

  • Pharmaceutical
  • Cosmetics & Toiletries
  • Gardening Products
  • Household

If your company makes any products that fall into these categories, you must ensure you're using the correct packaging that abides by the standards listed earlier. This also includes the vaping and cannabidiol industries.

What is the Child-Resistant Packaging Legislation in America?

In the US, the Consumer Product Safety Commission (CPSC) is responsible for regulating child-resistant packaging according to the Poison Prevention Packaging Act (PPPA).

This act has been in place since 1972 to help protect young children from accidental poisoning, which can lead to fatalities. Any company that sells products potentially harmful when ingested by children must use C-R packaging and ensure it meets the 16 CFR 1700.20 certification standard.

Failing to provide the right packaging for your product could result in being taken to court and sued on behalf of anyone endangered by your negligence. Section 9 of the PPPA states that State Attorney Generals can bring action on behalf of the residents of any state suffering due to a lack of child-resistant packaging.

What is the Child-Resistant Packaging Legislation in the UK?

In the UK, it is a legal obligation for manufacturers to package particular household items in child-resistant packaging, according to The Human Medicines Regulations 2012 and the CLP Regulation, which involves the classification and labeling of chemicals hazardous substances.

If a company is found to sell a product potentially poisonous when ingested or can cause corrosion to a child's skin, they will face legal action from the courts.

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What is the Value of the Child-Resistant Packaging Market?

In 2017, the global child-resistant packaging market was valued at 17,650.9 million dollars. Recent reports suggest this figure will rise by 6.1% between 2018-2020, indicating the essential nature of this type of packaging worldwide.

How Do You Ensure Your Packaging is Child-Resistant?

When finding the right packaging for your product, it's essential not to cut corners in ensuring it's child-resistant. Refer back to the list of standards outlined earlier. A manufacturer of child-resistant packaging should display that their product meets at least one of these standards. If they can't prove they've gone through the proper testing protocols, the product isn't classified as officially child-resistant.

Unfortunately, many manufacturers claim their products are CR compliant, but they aren't. Take extra care, as the fault can fall on you if you don't use the correct packaging and something happens as a result.

We have over 55 years of experience in child-resistant design and delivery within pharmaceutical and healthcare packaging. Take a look below to see how we've become market leaders in child-resistant packaging.

Child-resistant Packaging

A bottle of aspirin with a child-resistant cap bearing the instruction "push down & turn to open" Opening many C-R packages involves two dissimilar motions.

Child-resistant packaging or CR packaging is special packaging used to reduce the risk of children ingesting hazardous materials. This is often accomplished by the use of a special safety cap. It is required by regulation for prescription drugs, over-the-counter medications, Nicotine Containing Electronic Cigarette devices or Refill containers that can contain Nicotine, pesticides, and household chemicals. In some jurisdictions, unit packaging such as blister packs is also regulated for child safety.

The U.S. Consumer Product Safety Commission has stated in a press release that "There is no such thing as child-proof packaging. So you shouldn't think of packaging as your primary line of defense. Rather, you should think of packaging, even child-resistant packaging, as your last line of defense."

Background

The child-resistant locking closure for containers was invented in 1967 by Dr. Henri Breault. A history of accidents involving children opening household packaging and ingesting the contents led the United States Congress to pass the Poison Prevention Packaging Act of 1970, authored by U.S. Senator Frank E. Moss of Utah. This gave the U.S. Consumer Product Safety Commission the authority to regulate this area. Additions throughout the decades have increased the initial coverage to include other hazardous items, including chemicals regulated by the Environmental Protection Agency. Although child-resistant lids are not perfect, there is strong evidence that their use has substantially reduced child poisoning rates in the United States. Coordination exists for improving international standards on requirements and protocols.

Difficulty Opening

Child-resistant packaging can be a problem for some aged individuals or people with disabilities. Regulations require designs to be tested to verify that most adults can access the package. Some jurisdictions allow pharmacists to provide medications in non-CR packages when there are no children in the same house.

Requirements

The regulations are based on performance tests of packages with actual children, determining if the packages can be opened. More recently, additional package testing is used to determine if aged individuals or people with disabilities can open the same packages.

Often, CR requirements are met by package closures requiring two dissimilar motions for opening. Hundreds of package designs are available for packagers to consider.

Standards

  • ISO 8317 Child-resistant packaging - Requirements and testing procedures for reclosable packages.
  • ISO 13127 Packaging - Child-resistant packaging - Mechanical test methods for reclosable child-resistant packaging systems.
  • ASTM D3475, Standard Classification for Child-Resistant Packages.
  • ASTM F3159, Consumer Safety Specification for Liquid Laundry Packets.
  • ASTM F2517-17 Standard Specification for Determination of Child Resistance of Portable Fuel Containers for Consumer Use.

See Also

Citations

General and Cited References

  • Lockhart, H., and Paine, F.A., Packaging of Pharmaceuticals and Healthcare Products, 2006, Blackie, ISBN 0-7514-0167-6
  • Yam, K. L., Encyclopedia of Packaging Technology, John Wiley & Sons, 2009, ISBN 978-0-470-08704-6

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