The new harmonized standard for protective goggles in the European Union is about to be implemented compulsorily.
Emergency Compliance Alert: The new mandatory standard EN ISO 16321-1:2022 for protective goggles in the EU is about to come into effect.
To all manufacturers and traders of goggles:
Please note that the harmonization standard for goggles under the EU Personal Protective Equipment (PPE) regulations is about to undergo a major update. The new standard EN ISO 16321-1:2022 will officially fully replace the old standard EN 166:2001 on November 11, 2024. This means that from this date onward, all goggles entering the EU market must undergo testing and evaluation in accordance with the new standard for obtaining CE certification.
The goggles fall under the category of Class II products regulated by the EU PPE Directive (EU) 2016/425. They are subject to mandatory conformity assessment through an EU notified body and must be affixed with the CE mark before they can be sold. Similar regulations exist in the UK and Northern Ireland markets, corresponding to the UKCA and UKNI marks respectively. If the products enter the market without obtaining valid certification, they will face high risks such as product notification, mandatory recall, legal penalties, and damage to brand reputation.
Key Reminder: Certification Cycle
The CE, UKCA, and UKNI certifications involve sample testing, technical document review, and possibly factory production control audits. The entire process usually takes anywhere from 1 to several months. It is strongly recommended that all relevant enterprises immediately review the current product certification status and re-plan the testing certification and logistics schedules. It is essential to complete the transition before the new regulations come into effect to avoid losses in orders and business risks due to certification delays.
Core changes of the new standard and requirements for testing and certification
EN ISO 16321-1:2022 and its amendment A1:2024 are the latest eye-protection equipment technical standards adopted by the European Union, setting out more explicit and modern requirements for the design, performance and safety of the products.
I. Update of Main Test Contents
The new version of the standard includes laboratory tests for the following key performance indicators:
Structural and mechanical properties: Enhanced the assessment of the integrity of the lens and frame structure, including impact resistance, durability, and strength tests of the wearing system.
Optical performance: Strictly stipulates requirements such as light transmittance, anti-fog performance, and UV resistance, ensuring clear vision and protecting eyesight.
Material and chemical tolerance: Assess the durability of the lens material against chemicals, high temperatures, and environmental aging.
Protection performance: The testing methods for protection against liquid splashes, dust particles and mechanical impacts have been updated.
Human factors and adaptability: A more detailed examination was conducted on the wearing comfort, size compatibility, and field of vision of the product.
II. Certification Model and Process
According to the PPE regulations, the CE certification for goggles typically adopts the Model B (type test) + Model C2 (product verification based on random production supervision) or Model D (compliance based on production quality assurance) model. The core process includes:
Preliminary assessment and sample testing: The manufacturer is required to submit product technical documents and samples to the EU notified body. The body or its accredited third-party laboratory will conduct a complete type testing based on the new standards.
Technical document review: The conformity assessment body's review includes all technical documents such as design drawings, risk analysis, test reports, and user manuals.
Factory production control audit (if applicable): For models such as Module D, the notified body may conduct on-site inspections to assess whether the manufacturer's quality management system can ensure the continuous production of products that meet the certified models.
Issuance of EU Type Examination Certificate (EC Type Examination Certificate): After the tests and reviews are passed, the notified body issues the certificate. The manufacturer then signs the Declaration of Conformity (DoC) and affixes the CE mark to the product.
Action suggestion: How to ensure a smooth transition
In the face of an imminent compliance deadline, it is recommended that enterprises take the following steps immediately:
Immediately initiate the gap analysis: In accordance with the new requirements of EN ISO 16321-1:2022, conduct a comprehensive review of the existing product designs and technical documents.
Contact the certification body and testing laboratory: Contact the qualified EU certification body and professional third-party testing and certification service providers as soon as possible to initiate the testing and certification application process under the new standards.
Synchronize the update of supply chain quality documents: Pass the new standard requirements to the raw material suppliers, and possibly add corresponding verification items during the supplier inspection or incoming material inspection process.
Planning inventory and production: Based on the certified estimated completion time, reasonably arrange the inventory clearance of old standard products and the production and launch plan of new standard products.
+Conclusion
This standard update represents a mandatory upgrade of the safety requirements for goggles in the EU market. For the relevant enterprises, time is of the essence and actions must be taken promptly. By cooperating early with professional inspection, testing and certification service providers to systematically complete the product certification and compliance procedures under the new standards, it is the only way to ensure the continuous and legal entry of products into the EU and UK markets, avoid trade risks, and safeguard business interests. Please consider this as the top priority and start preparing immediately.
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The new harmonized standard for protective goggles in the European Uni
Emergency Compliance Alert: The new mandatory standard EN ISO 16321-1:2022 for protective goggles in the EU is about to come into effect.