EN ISO 8317 Requirements and Test Procedures for Child-Resistant Reclosable Packaging

Based on a European standard and later adopted by the International Organization for Standardization (ISO) published “EN ISO 8317 Child-resistant packaging - Requirements and test procedures for reclosable packaging” The standard specifies performance requirements and test methods for resealable packages designated as child-resistant.

This standard includes acceptance criteria when packages are tested using specified methods. These methods not only provide a measure of the packaging's effectiveness in restricting access from children but also cover adult access to the contents. This standard applies to resealable packages for any product intended to be removed from or exposed to the packaging during normal use. However, this standard is intended for type approval and is not intended for quality assurance purposes.

For the purposes of this standard, the following terms and definitions apply:

• A container is a container made of glass, metal, plastic or a combination of materials designed to provide suitable packaging for a product and having a suitable neck finish for the proper fitting of a closure.
• A closure is a cover or fastening device made of metal, plastic or a combination of materials designed to fit a suitable container, providing a secure seal against environmental challenges.
• Child-resistant packaging is packaging consisting of a container and a suitable closure that is difficult for children under 52 months to open or access the contents, but is not difficult for adults to use properly.
• A reclosable packaging is a packaging that can be resealed with a similar degree of security after being opened for the first time and used a sufficient number of times to dispense the total contents without loss of security.
• A substitute product is an inert substitute that is similar to the product it replaces. Solid substitutes for child-resistant packaging typically consist of powder, granules, or similarly shaped and sized units (anywhere between 5 mm and 30 mm, preferably neutral in color and non-harmful in any way). A liquid substitute is always uncolored water.
• Mechanical testing is a documented and repeatable test method intended to measure the resistance of relevant features of a child-resistant packaging system.
• Mechanical test data are data generated by mechanical testing. These data can be used to verify the equivalence of a child-resistant packaging system to a type-approved package.
• A liner is the media used to create a seal between a lid and a container.
• Essential features are those elements, features, or attributes of the container/closure system that are critical to maintaining child-resistant functionality.
• Minor changes are those that do not have a potentially significant impact on child-resistant functionality.

Only new packages should be submitted for testing. The container and closure system tested should be representative of those in normal use and include any buffers or liners if they are an integral part of the closure system. Packages may be tested individually or as part of a series of similar packages shipped simultaneously. When testing a series of similar packages, the requirements described in the "Evaluation of a series of similar packages" section should be applied. When specifying a series of similar packages, the following key characteristics should be considered (this list is not intended to be exhaustive):

• CR system
  • Press down and turn
  • Squeeze and turn
• Cape
  • Critical dimensions
  • Material: glass, metal, different polymers and so on
  • Shape: round, square, rectangle, oval and so on
  • Use: handle position, handle design and so on
  • Tooth: shape, position
  • Neck: location, orientation, design, etc.
  • Hardness
• Closing
  • Critical dimensions
  • Material: metal, different polymers and so on
  • Shape: round, square, rectangle, oval and so on
  • Usage: external grip feature
  • Tooth: shape, position
  • Sealing feature: stopper and so on

Tests are conducted by a two-person panel:

• A test with young children aged 42-51 months inclusive
• A test with adults aged 50-70 (inclusive)

The EN ISO 8317 standard is necessary because it defines the requirements and test methods for child-resistant packaging, especially resealable packaging (such as bottles or jars with safety closures) containing potentially hazardous substances such as medicines, cleaning products or chemicals.

This standard is deemed necessary for the following reasons:

• Child safety: Children, especially those under 5, are naturally curious and may try to open containers. This standard reduces the risk of accidental poisoning or injury by ensuring that packaging is difficult enough for children to open.
• Consumer usability: While packaging may be difficult for children, it must also be accessible to adults, including older adults who may have limited dexterity or strength. This standard balances safety with usability.
• Legal compliance: Many countries require manufacturers to follow this standard for certain products by law. It helps businesses comply with safety regulations by providing a harmonized approach, particularly in the European Union and internationally.
• Liability protection: Compliance with this standard helps manufacturers demonstrate due diligence in product safety, which reduces legal risks in the event of an accident or lawsuit.
• Quality assurance: This standard includes rigorous testing methods that ensure consistent, repeatable safety performance across product batches.

If a package passes both child and adult tests, it is certified in accordance with this standard and can be marketed as child-resistant packaging.

Our organization, which has been supporting businesses across all sectors for years through a wide range of testing, measurement, analysis, and evaluation activities, has a strong team of employees who closely follow global developments in science and technology and are constantly improving themselves. In this context, we also provide testing services in accordance with the EN ISO 8317 Child-resistant packaging - Requirements and test procedures for reclosable packaging.