WARNING: THIS PRODUCTS CONTAINS NICOTINE,WHICH IS A HIGHLY ADDICTIVE SUBSTANCE.

UKCA Certification Process: A Step-by-Step Guide for Vape Manufacturers in 2025

Views: 141 Author: Site Editor Publish Time: Origin: Site

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.

1. Understand UKCA Eligibility and Scope

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:

 

  • Hardware: Mods, pod systems, disposable vapes, batteries, and chargers.
  • Consumables: E-liquids (nicotine-containing or not), coils, and tanks.
  • Key Standards: Products must comply with UK-specific safety norms, such as:
    • Electrical Safety: BS EN 61010 (for devices with batteries).
    • Emissions Testing: BS EN 300 440 (to measure harmful substances in vapor).
    • Child Resistance: EN 12387:2015 (for devices with refillable tanks).

2. Step 1: Product Classification and Testing

a. Classify Your Product

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).

b. Conduct Mandatory Testing

Engage a UK-approved notified body (e.g., BSI, Intertek, SGS UK) to test:

 

  • Device Safety: Battery stability (UN38.3), leak resistance, and electrical insulation.
  • E-Liquid Composition: Nicotine concentration (≤20mg/ml), banned additives (e.g., caffeine, taurine), and heavy metal levels (EN 12846).
  • Labeling Compliance: Health warnings (e.g., “Contains nicotine – addictive substance”) and UKCA logo placement (minimum 5mm height, permanent marking).

 

Timeline: Testing typically takes 4–8 weeks, depending on product complexity.

3. Step 2: Prepare Technical Documentation

Compile a Technical File (TCF) to demonstrate compliance. Required documents include:

 

  • Product Design Specs: Drawings, schematics, and material lists (e.g., tank capacity ≤2ml for devices).
  • Test Reports: Certificates from notified bodies for safety, emissions, and ingredient analysis.
  • Risk Assessment: A detailed evaluation of hazards (e.g., nicotine toxicity, electrical faults) and mitigations (child locks, overcharge protection).
  • User Manuals: Instructions in English, including safety warnings and disposal guidelines.

4. Step 3: Draft the UK Declaration of Conformity (DoC)

Sign a DoC as the manufacturer (or importer if based outside the UK), declaring your product meets all UKCA requirements. The DoC must include:

 

  • Product model, description, and intended use.
  • Notified body details and test report references.
  • Your company name, address, and contact information.
  • Date of compliance and signature (electronic signatures are accepted).

 

Tip: Maintain the DoC for 10 years post-market release for MHRA audits.

5. Step 4: Apply UKCA Marking to Products and Packaging

Labeling Rules:

  • Device Labeling: Affix the UKCA logo on the product itself (if physically possible) or its immediate packaging.
  • E-Liquid Packaging: Include nicotine concentration (e.g., “10mg/ml”), volume (≤10ml), and ingredient list (INCI names).
  • Prohibited Claims: Avoid phrases like “safer than cigarettes” or unapproved health benefits.

Northern Ireland Exception:

Products sold in Northern Ireland must also carry the CE mark (due to EU single market rules), requiring dual labeling for cross-border sales.

6. Step 5: Submit to the MHRA (if Required)

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.

7. Post-Certification: Maintain Compliance

  • Annual Audits: Regularly test batches for consistency (e.g., nicotine levels, tank capacity).
  • Supply Chain Control: Ensure raw material suppliers (e.g., nicotine, packaging) meet UK safety standards.
  • Update Documentation: Revise the TCF and DoC if product designs or regulations change (e.g., 2025 disposable vape ban).

Common Challenges and Solutions

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.

FAQ: Your UKCA Certification Questions Answered

  • 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.

Expert Advice: Start Early to Avoid Disruptions

“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.”

Key Resources for Compliance

 

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.

×

Contact Us

captcha