TPD3 and Nicotine Pouches: What Has Actually Been Proposed

The European Commission has not proposed a nicotine limit for pouches. As of August 2026 there is no TPD3 text, no draft article, and no number on the table. What exists is a live revision workstream with an indicative target date and a consultation that has just closed.

That distinction is commercial, not academic. Reformulation programs, dilution specifications, and stability work built around a figure nobody has proposed are built on nothing. What follows is what the Commission has actually put in writing, what binds your customers today at national level, and what an ingredient buyer can reasonably plan around.

Where the TPD3 Workstream Actually Stands

The revision is real and it is moving. The stages so far are documented on the Commission's own initiative page for the revision of EU rules on tobacco products and tobacco advertising:

• April 2, 2026. The Commission published its evaluation of the EU tobacco control legislative framework (SWD(2026) 111 final). It concluded that the existing directives cut smoking prevalence, and flagged the rapid emergence of novel tobacco and nicotine products as an unresolved problem.
• May 18 to June 15, 2026. A four-week call for evidence for an impact assessment. It drew 82,168 submissions.
• May 22 to August 14, 2026. A twelve-week public consultation, which closed with 41,694 responses.
• Next. The Commission's call for evidence gives an indicative timetable of December 2026 for a legislative initiative, and states in terms: "This document is for information purposes only. It does not prejudge the final decision of the Commission on whether this initiative will be pursued or on its final content. All elements of the initiative described, including its timing, are subject to change."

Two things follow. First, the widely repeated line that a proposal was due in the first half of 2026 was never accurate, and the first half of 2026 has now passed with nothing tabled. Second, December 2026 is a planning date on a Commission work program, not a commitment. Directives have slipped from indicative dates before.

What the Commission Has Actually Said About Pouches

The call for evidence is the only document in which the Commission has set out the scope of the revision. On pouches it says two useful things.

On market fragmentation, it identifies divergent national rules on "nicotine products other than e-cigarettes and refill containers (such as nicotine pouches)" as a barrier to the internal market. On public health, it states plainly that "several of those novel products, such as nicotine pouches and heated herbal products, are currently not covered by the Directives."

It then lists the areas around which the Commission will develop policy options:

• introducing further requirements for products already covered by the directives
• extending the scope of the legislation to cover novel products, and adding flexibility to address rapid product developments
• introducing rules on flavors in e-cigarettes, disposable e-cigarettes, tobacco heating devices, and other novel products such as nicotine pouches
• strengthening rules on labeling and packaging, including plain packaging
• strengthening rules on digital marketing and advertising
• simplifying certain provisions to reduce complexity

Read that list against what circulates in trade coverage. It names subject areas, not values. There is no concentration ceiling in it, no flavor list, no packaging specification, no child-resistant closure requirement, and no extension of tobacco track-and-trace to pouches. Every one of those has been reported somewhere as a "TPD3 provision." None of them has been proposed. The legal basis will be Article 114 TFEU, the internal market article, which tells you the Commission's framing is harmonization of divergent national rules rather than prohibition.

Where the 20 mg/g Figure Comes From

The number has a plausible origin, which is why it spreads. Article 20 of Directive 2014/40/EU caps nicotine-containing e-liquid at 20 mg/ml. Extending the same figure to pouches on a per-gram basis is an obvious analogy, and it appears in industry submissions and trade commentary as a proposed landing point.

It appears in no Commission document. Treat 20 mg/g as one scenario among several, not as a rule, and do not let a supplier or consultant sell you reformulation work on the strength of it.

One related development is real and worth noting. Austria now requires nicotine pouch notifications to state nicotine concentration in mg/g of product, in the EU-CEG field E-Cigarette_Nicotine_Concentration. Concentration-per-gram is becoming the reporting unit in EU systems even in a market that sets no ceiling. That affects how you specify and document material, regardless of where any future limit lands.

What Actually Binds Today

While the EU workstream runs, member states have already acted, and these are the rules your customers are formulating against right now.

Three member states prohibit sale outright. France's Décret n° 2025-898 of September 5, 2025 took effect on April 1, 2026 and bans sale, possession and use, though the Conseil d'Etat suspended the manufacture, production and export provisions in December 2025. Belgium has banned sales since 2023. The Netherlands banned sales from January 1, 2025.

At the permissive end, Sweden sets no concentration limit. Germany still handles pouches under food law rather than tobacco law. Austria brought pouches under tobacco law on August 20, 2026 without setting any concentration ceiling.

Per Gram Versus Per Pouch: the Unit Is the Specification

This is the part of the old "20 mg/g" conversation that survives contact with the facts, because the split between per-gram and per-pouch limits already exists in binding national law.

A per-gram limit is a concentration ceiling. Pouch weight is a lever: adding filler lowers concentration without changing the dose. A per-pouch limit is a dose ceiling. Pouch weight is irrelevant, and the only lever is total nicotine.

The arithmetic is worth doing before you commit to a specification:

The same 9 mg dose passes in Denmark at any weight, passes in Finland only if the pouch is heavy enough, and fails in Latvia at every weight a consumer would tolerate. There is no single European specification, and there will not be one until a harmonized instrument is adopted and transposed. Anyone planning a multi-market portfolio needs nicotine dilution specifications precise enough to convert cleanly between the two bases, and an assay they can defend to the milligram.

The Track That Is Actually Moving Is Taxation

While the product-rules revision is still at consultation stage, a separate EU instrument covering pouches has already been tabled. On July 16, 2025 the Commission proposed a revision of the Tobacco Taxation Directive, COM(2025) 580, which would bring e-liquids, heated tobacco and nicotine pouches into the harmonized EU excise framework for the first time.

Note what it is and what it is not. It is a taxation instrument concerning excise duty, not concentration limits, and the two are frequently conflated. Its legal basis is Article 113 TFEU, which means the Council must act unanimously under a special legislative procedure with Parliament merely consulted. That is a materially harder bar than the qualified-majority route the product directive will take, and the proposal includes a four-year transitional period for the newly covered products. It is not adopted.

National excise on pouches, by contrast, is already live and already mass-based:

• Austria. Nicotine pouches entered the tobacco tax on April 1, 2026 at EUR 35 per kilogram, rising to EUR 40 per kilogram from February 2027 and EUR 45 per kilogram from February 2028.
• Portugal. A specific duty of EUR 0.065 per gram applies from 2026, with the taxable unit being the gram of product.

Mass-based tax and per-gram concentration caps pull in opposite directions. A weight tax rewards the lightest possible pouch. A per-gram ceiling rewards the heaviest. A manufacturer selling into both Austria and Finland is optimizing against that tension on every SKU, and resolving it requires precise control of the nicotine loading rather than guesswork at the blending stage.

What Dual-Market Supply Chains Actually Require

A manufacturer serving both the US and Europe faces two different regulatory philosophies, and neither of them currently includes an EU-wide concentration ceiling.

United States. No federal mg/g cap. FDA regulates by product authorization, and the PMTA pathway requires extensive ingredient documentation including purity verification, impurity characterization, and supply chain traceability. The market trends toward higher strengths and smaller formats.

European Union. No harmonized limit for pouches. National limits differ in both value and unit. Where a member state has brought pouches into a notification regime, ingredient data becomes a market-access input rather than a quality nicety.

Supporting both from a single nicotine source needs four things from a supplier:

Multiple concentration specifications from one qualified source. A US-market high-strength mini pouch and a Latvia-compliant version of the same brand are not the same formulation. Requalifying a new supplier for each is expensive; adjusting dilution within a qualified source is not.

Dual pharmacopoeia documentation. USP and EP both support high-purity specifications, but the testing protocols and documentation formats differ. A supplier holding both removes a requalification step every time a formulation moves between markets. Our comparison of USP and EP nicotine standards covers where they diverge.

Assay precision you can defend. In a per-pouch market like Denmark the legal ceiling is 9.0 mg and manufacturers formulate to roughly 8.5 mg for margin. That margin only exists if the assayed nicotine content of the USP/EP grade nicotine is genuinely what the certificate of analysis says, batch after batch.

Format and salt-form support. Because concentration is a function of loading and pouch weight together, nicotine salt selection, dilution ratio and pouch mass interact. A supplier who can model that with a customer is worth more than one who ships to a spec sheet.

Traceability: Build It for the Rules That Exist

TPD3 has not proposed extending tobacco track-and-trace to nicotine pouches. The unique-identifier and supply-chain security regime in Articles 15 and 16 of the TPD applies to tobacco products, and pouches are not currently within the directives at all. Anyone telling you a TPD3 traceability mandate is coming for pouches is describing a possibility, not a provision.

The documentation pressure is real anyway, and it comes from national regimes that already exist. Austria requires manufacturers and importers to notify tobacco-free nicotine products through EU-CEG at least six months before placing them on the market, under section 8d of the TNRSG as amended by BGBl. I Nr. 68/2026, at a fee of EUR 3,000 per product variant. Denmark operates a pre-market registration regime for oral nicotine products. Both are fed by ingredient data that ultimately comes from the nicotine supplier.

The practical consequence for ingredient buyers is unchanged by the TPD3 uncertainty: lot-level tracking, batch-specific certificates of analysis with real analytical results, and a documentation package that arrives in days rather than weeks. The same state-level fragmentation in the US is pushing manufacturers toward the same standard from the other direction.

Planning Horizon: What to Watch, and When

If the Commission tables a proposal in December 2026, the ordinary legislative procedure under Article 114 TFEU requires Parliament readings, Council negotiations and trilogue. That has historically taken two to three years for tobacco files. Add a transposition period for 27 member states and the earliest realistic window for any harmonized pouch rule to bite is 2028 to 2029. TPD2 itself was published in April 2014 with a transposition deadline of May 2016, which is the closest available precedent.

That gives a workable sequence:

Now through the end of 2026. Audit your portfolio against the limits that are actually in force, market by market, and note the unit each one uses. Watch for the Commission proposal in December and read the actual text rather than the coverage. Ask your ingredient supplier for assay and lot-consistency data at the concentrations you are shipping today.

2027. Once a proposal exists, the negotiating positions of Parliament and Council become the signal worth tracking, because that is where numbers get inserted and moved. Complete any reformulation driven by national rules already in force. Build EP-mapped documentation alongside existing USP records if you are not already carrying both.

2028 and beyond. If a directive is adopted, transposition detail will vary by member state, exactly as it did under TPD2. Manufacturers whose documentation already satisfies Austrian and Danish notification standards will have most of the package.

The honest summary is that the EU is going to regulate nicotine pouches, that nobody yet knows how, and that the national patchwork will govern your customers' formulations for at least the next two years. Build for the rules that exist and stay liquid on the ones that do not.

NicAlliance supplies USP/EP grade nicotine with flexible dilution specifications and batch-specific documentation supporting both US and European requirements. If you are modeling multiple national limits across a European portfolio, request a documentation review or sample package.

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