Child Resistant Closure Guidance

Child Resistant Closure Definition

A child-resistant closure (CRC) is a specialized type of packaging designed to prevent young children from easily opening containers that hold potentially harmful substances, such as medications and household chemicals. The primary goal of a CRC is to make it significantly difficult for children under the age of five to access the contents while still allowing adults to open the package with relative ease.

Child Resistant Closure Certification

Child-resistant closure certification is essential for ensuring that packaging containing potentially hazardous substances is safe for children. This certification process involves rigorous testing and compliance with established standards to minimize the risk of accidental ingestion by young children. Here are the key aspects of child-resistant closure certification:

Regulatory Standards in US

Regulatory Framework in Europe

In Europe, child-resistant closures (CRCs) are regulated under the Classification, Labelling and Packaging (CLP) Regulation (EC No 1272/2008). This regulation mandates that certain hazardous substances and mixtures sold to the public must be equipped with CRCs to prevent accidental ingestion by children.

The CLP Regulation outlines the conditions under which CRCs are required. Specifically, CRCs must be used for packaging containing:

• Chemicals classified as having acute toxicity.
• Substances that pose systematic target organ toxicity.
• Products containing 3% or more methanol or 1% or more dichloromethane.

The Specific Standards Governing CRCs in Europe

EN ISO 8317: This standard pertains to reclosable child-resistant packaging and outlines testing procedures to ensure that such packaging is difficult for children under five years old to open while remaining accessible to adults.

EN 862: This standard applies to non-reclosable child-resistant packaging and sets forth similar requirements for ensuring safety.

EN 14375: This standard specifically addresses non-reclosable packaging used for pharmaceuticals

Differences between FDA and ISO standards for CRCs

The key differences between FDA regulations and ISO standards for child-resistant closures (CRCs) primarily revolve around testing protocols, regulatory oversight, and the specific requirements for certification

Regulatory Authority

ISO (International Organization for Standardization): ISO standards, particularly ISO 8317, are international guidelines that apply to child-resistant packaging across various products, including pharmaceuticals and chemicals. These standards are adopted by different countries, including those in the European Union.

Testing Requirements

FDA Testing Protocols:

• FDA Testing Protocols:👇
• For CRCs under the PPPA, at least 85% of children must be unable to open the package within 5 minutes, and at least 80% must remain unable after 10 minutes.
• At least 90% of adults must be able to open the package within 5 minutes.
• The testing must involve a minimum of 50 children across 5 different locations, with specific age distributions required (30% aged 42-44 months, 40% aged 45-48 months, and 30% aged 49-51 months)
• ISO Testing Protocols:👇
• ISO 8317 requires that a minimum of 30 children be tested at a minimum of 3 locations, without specific age distribution requirements
• The testing focuses on reclosable packaging, assessing both child resistance and adult usability but does not specify the same detailed age distribution as the FDA standards.

Certification Process

• FDA Certification：👇
• Manufacturers are responsible for ensuring compliance with FDA regulations. They must generate a General Certificate of Conformity (GCC) for their products, demonstrating that their packaging meets child-resistant requirements.
• There is no formal third-party certification process mandated by the FDA; however, manufacturers often use accredited laboratories for testing
• ISO Certification：👇
• Certification under ISO standards requires evaluation by recognized testing organizations. Successful completion of tests according to ISO protocols results in formal certification
• The ISO certification process is more standardized internationally, allowing for broader acceptance across different markets.

Focus on Packaging Types

• FDA Focus：👇
• Emphasizes that child-resistant mechanisms must be part of the primary packaging of the product. This requirement aims to ensure that hazardous substances are adequately secured from children’s access
• ISO Focus：👇
• Covers both reclosable and non-reclosable packaging types. Specific standards like EN 14375 apply to non-reclosable pharmaceutical packaging, while EN 862 addresses non-pharmaceutical products

Medications Requiring CRCs?

Many types of medication are required to be dispensed via child-resistant packaging. You can see the full list of regulated medications here. Below are some common medications that must be dispensed in child-resistant packaging:

• Acetaminophen: Commonly used for pain relief and fever reduction.
• Aspirin: Used for pain relief and anti-inflammatory purposes.
• Dietary Supplements: Certain supplements can pose risks if ingested in large quantities.
• Diphenhydramine: An antihistamine often used for allergies and sleep aids.
• Fluoride: Used in dental care products; excess ingestion can be harmful.
• Ibuprofen: A nonsteroidal anti-inflammatory drug (NSAID) for pain relief.
• Imidazolines: Often found in eye drops and nasal sprays.
• Lidocaine: A local anesthetic that can cause toxicity if ingested.
• Methyl Salicylate: Found in topical analgesics, it can be harmful if swallowed.
• Mouthwash: Some formulations contain alcohol or other harmful substances.
• Naproxen: Another NSAID used for pain relief.
• Over-the-Counter (OTC) Switch Medications: These are medications that have transitioned from prescription to OTC status and may pose risks.
• Prescription Medications: Most prescription drugs fall under this requirement due to their potential hazards

Medications Exempt from Child-Resistant Packaging

Certain medications are exempt from child-resistant packaging requirements under the Poison Prevention Packaging Act (PPPA). These exemptions are designed to ensure that individuals, especially those who are elderly or disabled, can easily access their medications without the hindrance of child-resistant containers. 

The exemptions were established to facilitate easier access for patients who may need immediate use of their medications, addressing concerns that child-resistant packaging could delay access during critical situations.

1. Sublingual Nitroglycerin: Commonly used for heart conditions, these tablets are exempt due to the need for quick access in emergencies.
2. Isosorbide Dinitrate: Sublingual and chewable forms of isosorbide dinitrate at dosages less than 10 mg per tablet are also exempt.
3. Oral Contraceptives: These medications do not require child-resistant packaging.
4. Hormone Replacement Therapies: Similar to oral contraceptives, these medications are exempt from child-resistant packaging requirements.
5. Effervescent Aspirin: This form of aspirin is not required to have child-resistant packaging.
6. Effervescent Acetaminophen: Like effervescent aspirin, this medication is also exempt.
7. Powdered Iron Preparations: These can be packaged without child-resistant features.
8. Anhydrous Cholestyramine Powder: This medication does not need child-resistant packaging.
9. Potassium Supplements in Unit Dose Form: These are packaged without child-resistant closures.

Child Resistant Closures Market Overview

• Market Size and Growth: The global child-resistant closures market was valued at approximately USD 22 billion in 2023 and is projected to grow at a CAGR of 6.5%from 2024 to 2032, reaching around USD 48.07 billion by 2032. Another report estimates the market will reach USD 2.4 billion by 2027, growing at a CAGR of 5.1% from 2022 to 2027.
• Key Drivers:
  • Regulatory Compliance: Stricter regulations governing the packaging of pharmaceuticals and hazardous materials are a major driver for the adoption of child-resistant closures.
  • Increased Awareness: Growing awareness about the dangers of accidental ingestion by children has heightened demand for safer packaging solutions.
  • Technological Advancements: Innovations in closure design and materials are making child-resistant closures more user-friendly while maintaining safety standards 

Child Resistant Closures Key Applications

• Pharmaceuticals: This sector remains the largest consumer of child-resistant closures due to stringent regulations on medication packaging.
• Household Chemicals: Products like cleaning agents and pesticides also require child-resistant features to prevent accidental ingestion.
• Cannabis and Vaping Industries: These sectors are increasingly adopting child-resistant packaging due to regulatory pressures regarding product safety.
• Cosmetics: There is a growing trend in using child-resistant closures for cosmetics containing potentially harmful ingredients.

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