WARNING: THIS PRODUCTS CONTAINS NICOTINE,WHICH IS A HIGHLY ADDICTIVE SUBSTANCE.
LONDON, 2025 – With the UKCA (UK Conformity Assessed) marking now mandatory for vaping products sold in Great Britain, manufacturers and importers must navigate a structured certification process to ensure compliance with UK regulations. This guide breaks down the key stages of obtaining UKCA certification, helping businesses avoid delays and market access issues as the 2025 deadline fully takes effect.
First, confirm if your product requires UKCA certification. All vaping devices and e-liquids sold in England, Wales, and Scotland (excluding Northern Ireland, which follows EU CE rules) must bear the UKCA mark. This includes:
Determine the risk category of your vape product (e.g., low-risk consumer device vs. medical device). Most standard vapes fall under General Product Safety Regulations, but nicotine-based products may also require compliance with the Tobacco and Related Products Regulations (TRPR).
Engage a UK-approved notified body (e.g., BSI, Intertek, SGS UK) to test:
Timeline: Testing typically takes 4–8 weeks, depending on product complexity.
Compile a Technical File (TCF) to demonstrate compliance. Required documents include:
Sign a DoC as the manufacturer (or importer if based outside the UK), declaring your product meets all UKCA requirements. The DoC must include:
Tip: Maintain the DoC for 10 years post-market release for MHRA audits.
Products sold in Northern Ireland must also carry the CE mark (due to EU single market rules), requiring dual labeling for cross-border sales.
While most vaping products do not need pre-market approval, nicotine-containing e-liquids must be notified to the MHRA’s Tobacco Products Database (similar to the EU’s TPD portal). Submit ingredient lists, nicotine concentrations, and safety data within 6 months of market launch.
Challenge | Solution |
---|---|
Long Testing Delays | Choose notified bodies with fast turnaround times (e.g., SGS UK offers expedited service for £5,000+). |
Dual Compliance (EU + UK) | Design products to meet both TPD (2ml tanks, 20mg/ml nicotine) and UKCA standards from the outset. |
Labeling Mistakes | Use free templates from the MHRA portal and conduct pre-printing reviews. |
Q: How much does UKCA certification cost?
A: Costs range from £3,000–£10,000+, depending on product type, testing complexity, and notified body fees.
Q: Can I self-certify without a notified body?
A: No. High-risk products (e.g., rechargeable mods) require third-party testing. Low-risk disposables may qualify for self-certification, but consult a lawyer first.
Q: What if my product was CE-certified before 2025?
A: CE marking is valid until December 31, 2024. After that, a UKCA-compliant retest or “transfer of compliance” from a UK notified body is needed.
“Many businesses wait until the last minute, leading to supply chain delays,” warns Jane Smith, regulatory consultant at Broughton Group. “Begin testing by Q3 2025 to secure certification before peak demand. Use the UK Government’s Transition Tool to map your product’s compliance gaps.”
By following this step-by-step process, manufacturers can ensure their vaping products meet UKCA standards, maintain market access, and build consumer trust in the post-Brexit regulatory landscape. Don’t wait—start your certification journey today to avoid penalties and shipment delays.
This article is for informational purposes only. Always consult a qualified regulatory expert to ensure full compliance with your specific product requirements.