Tobacco

PLM for tobacco manufacturers

Regulatory and R&D teams managing TPD data in a governed PLM record

When one product record holds your ingredient and emission data alongside the data for labelling, you can produce TPD compliance from that record. You no longer rebuild it for every regulator. Tobacco manufacturers set up the record per product and per market so that it can supply EU Common Entry Gate (EU-CEG) submissions and pack artwork. Your first step is to map where that data lives today and which teams retype it.

What is different about tobacco

Tobacco differs from other consumer goods because one EU directive sets the floor and each member state builds on it. The Tobacco Products Directive 2014/40/EU (TPD) applied from 20 May 2016. National laws have spread out from that common base ever since. Nicotine pouches are banned in the Netherlands and Belgium, while Austria moved them into its tobacco framework in April 2026. So a single SKU can need several regulatory records.

For C+P Consulting, tobacco products are one of 9 manufacturing sectors it serves. In that sector, the product record has to hold ingredient and emission data per product and per market. It also has to keep health warnings and market variants under control as the portfolio expands into heated tobacco alongside vapes and pouches. Each sector problem in the table is paired with the PLM programme stage that addresses it.

Sector problemProgramme stage that solves it
Ingredient data spread across spreadsheets per marketAssess: map current-state data and quantify the cost
EU-CEG fields with no owner in the data modelDesign: fit-gap and signed-off blueprint
Market variants that drift from the master recipeBuild: standard configuration tested in conference-room pilots
Legacy specifications with gaps or duplicatesMigrate: structured migration with integrity analytics
Regulatory teams going back to spreadsheets after launchAdopt: training, hypercare and handover to a steady-state team

TPD ingredient requirements

Article 5 of the TPD requires you to report every ingredient, by brand name and type, before a product goes on sale. The list gives the quantity and purpose of each ingredient, along with its toxicological data. Additives get extra scrutiny. Commission Implementing Decision (EU) 2016/787 put 15 additives on a priority list for cigarettes and roll-your-own tobacco. Comprehensive studies are required for products that contain these additives.

A flavour supplied as a compound requires a deeper breakdown into its own ingredients, and a supplier that won't disclose them leaves a hole in your filing. Check that your record stores ingredients at that broken-down level, with a link to each supplier's declaration.

TPD emission requirements

For cigarettes on the EU market, the limits per cigarette are 10 mg of tar and 1 mg of nicotine. Carbon monoxide is limited to 10 mg per cigarette. Article 3 sets those maximum emission levels. Ireland's transposition specifies ISO standard 4387 for tar. It specifies ISO 10315 for nicotine and ISO 8454 for carbon monoxide.

Emission results come from accredited labs, and they belong to a specific product version. A change to the paper or the filter requires a check that the old result still applies. So store each lab report against the exact version it tested, and flag any later change to that version for retesting.

TPD reporting requirements

TPD compliance requires a report before launch and an update whenever the product changes. You must also file annual sales data for each brand and type. The UK's Tobacco and Related Products Regulations 2016 show the full scope. They have separate parts for ingredients and emissions. Priority additives have their own part, as do sales and market research data. Another part covers novel product notifications.

Updates wear teams down because a filing is only correct until someone changes a supplier or a pack size. Check whether a change to a specification in your system creates a reporting task on its own, or whether it relies on somebody remembering to raise one.

EU-CEG submission from the record

To build EU-CEG ingredient submissions, map each field in the Commission's format to an attribute in your product record, then export XML from that record. The format comes from Implementing Decision (EU) 2015/2186. Smaller companies can use the Commission's XML creator. Larger ones connect system to system over the e-Delivery network.

  1. Register for a Submitter ID and send the company XML once.
  2. Map every EU-CEG field to a single owned attribute in the product data model.
  3. Send attachments such as toxicology files first, then the product XML, in the order the EU-CEG user guide.pdf requires.
  4. Store the submission ID against the product version it describes.

To avoid the project problems that occur at Step 2, C+P Consulting settles that mapping in the blueprint before anything gets configured. A field nobody owns costs little to fix in a design workshop and a lot to fix in user acceptance testing.

Heated tobacco

Heated tobacco now faces flavour and labelling rules close to those for cigarettes. Commission Delegated Directive (EU) 2022/2100 withdrew its exemptions and entered into force on 23 November 2022. Characterising flavours are banned in these sticks, and the packs carry the full health warnings.

The device and the consumable are distinct products, which complicates their data requirements. The stick goes through tobacco reporting, while the device has its own technical file. Check that your record links each stick to the devices it works with, without merging the two.

Vapes

Nicotine vapes come under Article 20 of the TPD, which caps e-liquid at 20 mg/ml of nicotine. Refill bottles can hold no more than 10 ml, and tanks no more than 2 ml. You must also notify each product before it goes on sale. In the UK, that means waiting six months after submission.

The largest differences between countries concern flavour rules. The Netherlands and Denmark restrict which flavours can be sold. Estonia also imposes flavour restrictions. If you sell one liquid in 6 markets, the record needs a market status for each flavour. A single global "approved" flag won't do.

Nicotine pouches

National law decides whether tobacco-free nicotine pouches are legal because they fall outside the TPD's scope. France banned oral nicotine products under Decree 2025-898 from 1 April 2026. The Council of State then suspended parts of the ban in December 2025.

Because market legality can change within months, record it as a dated attribute with the legal source attached and check it before every launch plan.

Which PLM fits tobacco

A PLM suited to tobacco manufacturers needs a data model that holds versions per market and exports regulatory formats from structured data. Brand name matters less. Food and chemicals platforms already handle formulation and specifications, so the real gap is regulatory output.

What the product record must hold

The record needs ingredients at component level and emission results tied to versions. Each attribute also needs a market status. It also needs links between devices and consumables.

What the platform must produce

It should produce EU-CEG XML and the data that drives labels, and it should leave an audit trail. Ask for a demo built on your own SKU.

How far to customise

C+P Consulting uses the platform's standard capabilities as its starting point and makes changes only when a real business reason calls for them. One team handles both process design and the technical build. The blueprint you sign off is the one the platform runs.

Health warnings

Combined health warnings and pack artwork driven from structured product data

The TPD requires combined health warnings to cover 65% of the front and back of the pack. Each one combines a picture and a text warning with information on how to stop smoking. Countries add their own cessation lines and languages, so one pack design can produce dozens of artwork variants.

Generating labels from structured data keeps those variants under control. C+P Consulting applied this approach at an ingredients manufacturer whose broad portfolio changed rapidly and whose labelling was manual. It used structured specification data to automate the labelling calculations, which accelerated the compliance cycle across the whole range.

How to get started in tobacco products

Start by choosing one product family and tracing its EU-CEG filing back to the source data. Note every spreadsheet and every retyped value along the way. That trace gives you the fit-gap list for any PLM selection. It also shows which data has to be cleaned before migration. Do it now while the TPD revision is under consultation, because a record that's structured by attribute absorbs new rules faster than a document does. C+P Consulting runs PLM programmes for tobacco and nicotine product manufacturers, from selection through adoption. Talk to us about your programme.

FAQ

The TPD sets a common EU baseline, while national laws add market-specific requirements. Flavour restrictions and pack language requirements can differ, so a single approval flag isn't enough. Track each product's status by market, with dated legal sources for rules that change.

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