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UKCA Marking for Vapes: Key Updates and Compliance Strategies for 2025

Views: 148 Author: VAPEURS Publish Time: 2025-04-23 Origin: www.vapeurstech.com

1. Regulatory Timeline and Compliance Essentials

The UKCA (UK Conformity Assessed) marking became mandatory for most products sold in Great Britain (England, Wales, and Scotland) from January 1, 2025 . For vaping devices and e-liquids, compliance involves:

Safety Testing: Devices must meet UK-specific standards, such as BS EN 61010 (electrical safety) and BS EN 300 440 (emissions testing) .
Labeling Requirements: Products must display the UKCA logo (minimum 5mm height) and health warnings like “Contains nicotine – a highly addictive substance” .
Documentation: A UK Declaration of Conformity (DoC) must be maintained, outlining compliance with UK regulations (e.g., Tobacco and Related Products Regulations 2016) .

2. UKCA vs. CE: Navigating Dual Compliance

While the UK government extended the recognition of CE marking until December 31, 2024 (and indefinitely for certain products), businesses targeting both EU and UK markets must adopt a dual compliance strategy:

EU Markets: Continue using CE marking under EU regulations (e.g., TPD 2014/40/EU).
UK Markets: Transition to UKCA marking, which aligns with UK-specific standards (e.g., nicotine limits of 20mg/ml and 2ml tank sizes) .
Northern Ireland: Requires CE marking due to its EU single market alignment .

3. 2025 Regulatory Shifts and Industry Impact

a) Disposable Vape Ban

The UK government’s 2025 ban on disposable vapes (effective June 1, 2025) adds urgency to compliance. Manufacturers must prioritize reusable devices and refillable systems, which require UKCA certification. For example:

Refillable Pod Kits: Must comply with child-resistant mechanisms (EN 12387:2015) and battery safety standards (UN38.3) .
E-Liquids: Ensure nicotine content (≤20mg/ml) and packaging (≤10ml bottles) align with UKCA and TPD rules .

b) MHRA’s International Reliance Scheme

The Medicines and Healthcare Products Regulatory Agency (MHRA) is introducing an International Reliance Procedure (IRP) in 2025, allowing certain devices approved by regulators in Australia, Canada, the EU, or the US to enter the UK market faster . While primarily targeting medical devices, this could streamline compliance for vaping products in the future.

4. Compliance Best Practices

a) Partner with Accredited Bodies

Testing: Work with UK-approved bodies (e.g., BSI, Intertek) for safety and emissions testing .
Documentation: Use templates like the UK DoC and Technical File (TCF) to demonstrate compliance .

b) Supply Chain Transparency

Raw Materials: Source nicotine and components from approved suppliers to avoid CMR substances (e.g., caffeine, taurine) .
Logistics: Ensure customs documentation (e.g., UKCA certificates) is readily available for EU/UK border checks .

c) Post-Market Surveillance

Product Monitoring: Conduct quarterly audits to check nicotine levels and labeling accuracy .
Recall Plans: Develop protocols to address non-compliant products, as seen in UK market 抽查案例 .

5. FAQs for Businesses

Q: Do I need UKCA for nicotine-free vapes?
A: Yes, if the device is sold in Great Britain. Non-nicotine e-liquids may require additional testing for safety .
Q: Can I use CE marking in the UK after 2024?
A: CE marking remains valid until December 31, 2024, for most products. After this date, UKCA is mandatory .
Q: How long does UKCA certification take?
A: Typically 8–12 weeks, depending on testing complexity and third-party approval .

6. Future Outlook

By 2026, the MHRA plans to update medical device regulations, potentially affecting vaping products classified as “medical devices” (e.g., nicotine cessation aids) . Businesses should monitor these changes and invest in sustainable design (e.g., recyclable materials) to align with evolving consumer and regulatory expectations.

Key Resources:

This news article is for informational purposes only. Always consult legal and regulatory experts for specific compliance advice.