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Designing a Package to Meet U.S. and EU Safety Standards

Designing a Package to Meet U.S. and EU Safety Standards

Expanding into global markets opens up opportunities to grow your business and reach new customers. Child-resistant packaging (CRP) is a regulatory requirement for product categories that may be harmful to young children, including cannabis, nicotine, and certain household products. CRP compliance also spans multiple markets, each with distinct testing standards.

If you’re launching consumer products in both the U.S. and the European Union, you need to demonstrate compliance with Consumer Product Safety Commission (CPSC) protocols and European Committee for Standardization (CEN) standards. While both frameworks share the same goal of preventing children from accessing potentially harmful products, their testing methodologies, acceptance criteria, and documentation requirements differ significantly. Understanding these distinctions early in your development cycle can prevent costly redesigns and market entry delays.

Key Differences in U.S. and EU Child-Resistant Testing

The CRP testing protocols in the United States rely on CPSC protocols established under Title 16, Code of Federal Regulations Part 1700. The European Union may require compliance with various international CRP testing protocols, including the ISO 8317:2015 standard for reclosable packages. While both U.S. and EU standards test child resistance and adult accessibility, their specific requirements create distinct compliance pathways.

If you plan to sell products in both regions, your packaging needs to be tested for specific protocols. The core requirements of two distinct protocols provide an overview of the differences between U.S. and European child-resistant package testing:

FeatureU.S. Standard – 16 CFR 1700.20EU Standard – EN ISO 8317:2015
Child age range42-51 months42-51 months (children under 52 months)
Number of children tested50 (or 30 in some cases)Minimum 50
Test time per child5 minutes5 minutes initially, 10 minutes with re-closure check
Adult panel requirement100 adults (ages 50–70)Used in some cases, but not always required
Pass criteria (children)At least 85% of children must fail to open without being given a demonstration, and 80% must fail to open after a demonstrationDepends on the number of children who can open, and uses a statistical calculation
Pass criteria (adults)90% of adults must open and re-close successfullyNot applicable for all ISO 8317:2015 tests

These distinctions affect how packaging gets designed, tested, and certified for each market.

Why You Need Separate Packaging Tests for the EU Market

There is no single test that satisfies both U.S. and EU child-resistant packaging regulations. The official protocols differ significantly, making separate testing a mandatory requirement for gaining market access in Europe.

U.S. Approval Does Not Transfer to the EU

Approval for one region does not automatically meet the requirements of another. The testing process, sample sizes, and acceptance criteria also differ enough that brands cannot assume that U.S. child-resistant packaging is compliant in Europe.

Test Protocols Cannot Be Combined

Companies need a separate child-resistant package test for the EU market because protocols cannot be combined into a single test. The significant differences in test duration, demonstration procedures, adult panel composition, and documentation requirements cannot satisfy both standards in a single testing session.

EU Authorities Require Specific Documentation

The European Commission may reference CEN standards for child-resistant closures, which national standardization bodies adopt across member states. This regulatory structure requires manufacturers to conduct distinct testing for each market. A package tested only under CPSC protocols lacks the specific data points and documentation required by EU authorities for market access.

Streamlining Your Path to Global Compliance

Perritt Laboratories offers child-resistant packaging testing services for both U.S. CPSC and EU CEN standards. We help manufacturers plan efficient testing timelines that address both markets without creating bottlenecks in product development. By conducting both tests through a single cGMP-compliant laboratory, you gain consistent communication, unified documentation, and coordinated delivery of results. You reduce administrative overhead and ensure your packaging design addresses the requirements of both standards before finalizing production tooling.

Why Partner With Perritt Laboratories for CRP Testing?

Perritt Laboratories offers proven expertise in both U.S. and international child-resistant packaging testing. As pioneers in the field since 1973, we combine a legacy of trust with the specialized expertise needed to streamline your global launch:

  • Dual expertise under one roof: Our lab has hands-on experience in both U.S. and international protocol testing for CRP, giving you a holistic view of global compliance.
  • A single point of contact: One expert team manages your U.S. and EU package testing strategy, from design review to final submission.
  • Strategic testing guidance: We provide proactive feedback on your packaging design to identify potential issues early and maintain compliance with regulatory requirements on both sides of the Atlantic.
  • Defensible data for both markets: Our facility delivers the rigorous, defensible documentation that supports regulatory submissions in the U.S. and the EU.

Plan Your U.S. and EU Launch With Confidence

Perritt Laboratories makes multi-market child-resistant packaging compliance straightforward. Whether you’re launching in the United States or in Europe, we can assess your packaging design, conduct required testing, and deliver the documentation necessary for market entry. Contact us today to learn more about our CRP testing services. Our experts are ready to discuss your product launch timeline and CRP design testing requirements.

Plan Your U.S. and EU Launch With Confidence
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