The vaping industry spans a patchwork of regulatory landscapes, demanding that international brands master distinct standards for electronic cigarettes (devices/hardware) and e-liquids (consumables). As of December 2025, the EU’s Tobacco Products Directive (TPD III), the UK’s UKCA marking paired with MHRA notifications, and the Gulf Cooperation Council’s (GCC) unified conformity systems stand out as critical frameworks. These prioritize user safety, quality assurance, and youth deterrence, with TPD III’s July rollout enhancing emissions scrutiny and GCC’s GSO 2805 standard finalizing regional harmonization. While variances exist—such as nicotine thresholds and labeling languages—compliance unlocks a €15+ billion market. This guide separates requirements for devices and e-liquids, corrects outdated details (e.g., health warning coverage now at 65%, not 30%), and offers strategies for seamless multi-market entry.

 1. The EU Tobacco Products Directive (TPD III) Enacted July 2025, TPD III regulates both e-liquids and devices as tobacco-related products, mandating notifications, testing, and design limits to mitigate risks like addiction and exposure to harmful emissions. It targets disposables and heated variants, closing prior gaps, with non-compliance leading to withdrawals and fines up to €500,000.

For E-Liquids:

• Maximum nicotine strength: 20 mg/ml.
• Maximum bottle capacity: 10 ml, with child-resistant caps and tamper-evident seals.
• Ingredient disclosure: Full lists via national portals, plus toxicological profiles.
• Notification: Six months pre-launch through EU NCA portals, including stability data.
• Health warnings: Covering 65% of two principal faces, with pictorials and multilingual text.

For Devices:

• Maximum tank/pod size: 2 ml for refillables and disposables.
• Leak-proof refilling: Mandatory to prevent spills.
• Emissions testing: CORESTA-standardized protocols to cap harmful constituents (e.g., formaldehyde <50% of cigarette levels).
• CE marking: Required for electrical safety under the Low Voltage Directive.

Emissions and toxicology assessments pose the steepest hurdles, demanding accredited lab reports simulating real-use scenarios. Brands must embed compliance in R&D—e.g., modular tanks for easy swaps—to evade rejections, as seen in Germany’s Q3 2025 sweep invalidating 200+ filings. Consistent formulations and digital traceability tools are vital.

 2. UKCA Requirements in the United Kingdom Post-Brexit, the UK mandates UKCA marking for devices since January 2025, while e-liquids adhere to Tobacco and Related Products Regulations (TRPR) via MHRA notifications—diverging slightly from TPD but aligning on core limits. The June 2023 disposable ban persists, with Q4 2025 inspections exceeding 1,000, emphasizing traceability. Fines reach £2,500 per violation for labeling errors, which comprised 32% of MHRA citations this year.

For E-Liquids:

• Maximum nicotine: 20 mg/ml; bottles ≤10 ml.
• MHRA notification: Annual by January 31 via digital portal, with emissions reports and ingredient details.
• Health warnings: 65% coverage, including pregnancy-specific advisories.

For Devices:

• UKCA marking: On product and packaging, attested by Approved Bodies for conformity.
• Electrical safety: Compliance with 2016 Regulations, including BS EN 62133 battery testing.
• Technical file: Retained 10 years, covering risk assessments and Declarations of Conformity (DoC).

MHRA’s 2025 hub streamlines guidance, but eight-week processing delays necessitate early submissions. Integrate UK-specific labels early to align with TRPR’s youth-proofing ethos.

 3. GCC Conformity Systems (UAE, Saudi Arabia, Bahrain, Oman, Kuwait) GCC standards, unified under GSO TC16/FDS1 2805:2025 (adopted January), regulate both devices and e-liquids—extending to zero-nicotine variants—focusing on safety, taxation, and cultural norms. UAE’s ECAS certification and Saudi’s SFDA tightened post-July 2024, with 40% more seizures in UAE; a 100% excise tax applies in Saudi. Approvals take 3-6 months, valid five years in UAE (€5,000 fee).

For E-Liquids:

• Nicotine cap: 20 mg/ml (UAE); full testing for heavy metals and emissions.
• Packaging: Bilingual warnings (Arabic/English) at 50% coverage; halal flavor certifications.
• Registration: Via ESMA (UAE) or SFDA (Saudi) portals, including sample submissions.

For Devices:

• Battery safety: GSO 1959 and IEC 62133 compliance.
• Electrical standards: Low-voltage directive alignment.
• Conformity: ECAS/SASO marking post-lab verification.

Zero-nic shortfills require full assessments, unlike TPD’s nicotine focus. Prioritize GSO-accredited labs for faster clearance amid GCC’s 2026 TPD-mirroring push on tank sizes.

 4. Managing Multi-Market Compliance Efficiently Balancing global entry means reconciling disparities—like TPD/UK’s 65% warnings vs. GCC’s 50%—while localizing for languages and taxes. In 2025, 70% of brands leverage AI compliance software, trimming costs 25%.

Best practices:

• Master file: Centralized repo with variant DoCs and reports.
• Traceability: Blockchain batch tracking for recalls.
• Modular design: Peelable labels for bilingual overlays.
• Partnerships: Long-term labs like Intertek for cross-standard tests.
• Calendar: RegTech tools for deadlines, e.g., MHRA renewals.

 5. The Future of Global Standards Convergence accelerates: Asia and Latin America adopt TPD-inspired emissions rules, while WHO’s FCTC eyes 2027 traceability mandates. GCC’s unification and UK’s UDI pilots signal streamlined tech integration. Proactive brands—investing in low-emission R&D—gain edges in this €20 billion arena.

Mastering TPD, UKCA, and GCC demands precision, but structured docs, ethical manufacturing, and vigilant updates empower confident expansion. Separate device and e-liquid pipelines from inception to thrive. What’s your 2025 compliance win? Share below.