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    TPD Notification Portal: A Step-by-Step Guide for Flavor Entry

    Author: Команда исследований и разработок, CUIGUAI Flavoring Опубликовано:Гуанчжоуская компания уникальных ароматов, ООО Последнее обновление:  Октябрь 13, 2026 WhatsApp и Telegram: +86 189 2926 7983 Электронная почта:info@cuiguai.com The EU common entry gate — universally known as the EU-CEG portal — is the single electronic door through which every e-cigarette and refill container must pass before it can be lawfully placed on the market in a European Union member state. For a flavour house, it is the point at which a formula stops being a sensory concept and becomes a legally notifiable product. For an e-liquid brand, it is the step that determines whether a container clears customs or waits in a warehouse while paperwork is repaired. This guide walks through the notification process from the perspective of flavour entry: what Article 20 of the Tobacco Products Directive requires, how the portal is organised, which accounts and roles are needed, how each data field is populated, how ingredient and emission data must be structured for a flavoured liquid, and how UFI codes and CLP classification fit into the same submission. It is written for regulatory affairs managers, brand owners, and importers who need a working checklist rather than a legal treatise. Where procedures differ between member states, the variation is flagged explicitly, because notification under Article 20 is a national process channelled through a common format — not a single EU-wide approval. One point deserves emphasis before we begin. A TPD notification is a registration, not an authorisation. Authorities do not approve a product; they receive a dossier. The quality of that dossier is entirely the notifier's responsibility, and the consequences of an incomplete submission fall on the brand that placed the product on the market.
    A regulatory affairs specialist compiles ingredient and emission data for a TPD Article 20 notification on the EU common entry gate portal.

    Regulatory Affairs Specialist Preparing an EU-CEG Notification | CUIGUAI

    What the TPD Notification Portal Is and What It Covers

    The EU common entry gate is an information technology tool operated on behalf of the European Commission that receives product information for tobacco products and for electronic cigarettes and refill containers. For e-cigarette data, the technical specification is set by Commission Implementing Decision (EU) 2015/2183 of 24 November 2015, which established a common format for the notification of electronic cigarettes and refill containers. The common format is what makes a single submission model usable across twenty-plus national authorities with different internal processes.

    Article 20 of the TPD: The Legal Basis

    Article 20 of Directive 2014/40/EU sets out the substantive rules for e-cigarettes and refill containers: a maximum nicotine concentration of 20 mg/ml, a maximum refill container volume of 10 ml, a maximum cartridge or tank capacity of 2 ml, mandatory health warnings, child-resistant and tamper-evident closures, and a prohibition on additives that create the impression of a beneficial health effect or that have energising and vitalising effects. It also contains the notification obligation itself, which requires manufacturers and importers to submit product information to the competent authorities of the member states concerned before placing a product on the market. That final phrase — "the member states concerned" — is where most first-time notifiers stumble. There is no single European filing that covers the whole internal market. Each member state in which the product will be sold must be selected as an addressee, and each addressee may apply its own fee schedule, validation rules, and follow-up questions.

    Which Products and Which Flavours Must Be Notified

    The obligation attaches to each electronic cigarette and each refill container, which in practice means every SKU: every flavour, every nicotine strength, every bottle size, and every device configuration that is sold as a distinct product. A mango liquid at 10 mg/ml in a 10 ml bottle is a different notification from the same liquid at 18 mg/ml, and both are different again from the same formula in a 30 ml shortfill. Flavour houses should assume that a single new flavour profile launched across three strengths and two pack formats generates six notification records before a single unit ships. Nicotine-free liquids sit in a grey zone. Article 20 governs nicotine-containing products, but several member states have extended notification or registration duties to nicotine-free e-liquids through national law, and some have restricted them outright. The commercial lesson is to confirm the national position market by market rather than assuming that a zero-nicotine formula is free of filing obligations.

    The Six-Month Advance Notification, Fees, and Annual Reporting

    Notification must be submitted before the product is placed on the market, and Article 20 specifies a lead time of six months for products containing nicotine. That six-month window exists so that authorities can review the dossier, request clarification, and prepare market surveillance. It is not a consultation period after which the product is approved; it is a deadline that must be respected if the launch calendar is to hold. Member states may charge fees for processing notifications, and the amount is set nationally. Article 20 also requires manufacturers and importers to report annual sales data, by brand name and product type, so the notification record is not a one-off filing but the opening entry in a continuing reporting relationship. Budget for both the notification fee and the annual reporting workload before committing to a multi-market launch.

    Before You Start: Accounts, Roles, and Access Rights

    EU Login and Company Registration

    Access to the portal is controlled through the European Commission's authentication service, EU Login. Every individual who needs to create or submit a notification must hold a personal EU Login account, and each account must then be linked to the company record registered in the portal. Business registration is a separate step from personal registration, and the company details entered there — legal name, registered address, contact persons — are the details that appear on every notification the company files. Set this up early. Company registration can take days if the supporting documentation has to be clarified, and the credentials are a prerequisite for every other task in this guide. A brand that discovers its access rights are missing on the day of a launch has already lost the six-month lead time.

    Manufacturer, Importer, and Authorised Submitter Roles

    The portal distinguishes between the economic operators who carry the legal obligation and the individuals who perform the clerical work. Manufacturers established in the EU and importers into the EU are the operators responsible for notification. Where the manufacturer sits outside the union, the importer that places the goods on the EU market typically holds the notification duty, and some member states also require a responsible person established in the union for enforcement contact. Within a company, the portal allocates different levels of access, so that a regulatory manager can draft while a designated signatory submits, and an external consultant can be given limited drafting rights without the ability to file. Agree the role matrix before onboarding a third-party consultancy, and record who holds submission rights — because every submitted record carries the identity of the submitting account.
    CAS-level ingredient specifications and concentrations are compiled from CUIGUAI flavour documentation before an EU-CEG dossier is drafted.

    Compiling Ingredient Data for a TPD Flavour Notification | CUIGUAI

    The Step-by-Step Flavour Entry Walkthrough

    The following sequence reflects the order in which the data should be prepared. Working in this order means the portal session is spent entering verified information rather than hunting for missing values mid-form.

    Step 1 — Assemble the Ingredient and Emission Data Set

    Before logging in, build the data pack. For each flavoured liquid you will need the complete list of ingredients with their chemical names and CAS numbers, the concentration of each ingredient by weight and by volume, the nicotine content expressed as a concentration, the carrier composition of propylene glycol and vegetable glycerine, any additives, and the toxicological information available for each substance in both heated and non-heated form. Emissions data and the nicotine dose and uptake characteristics under normal conditions of use are also required for nicotine-containing products. The flavour component is the most laborious part. A single flavour concentrate can contain dozens of individual flavouring substances, and each must be declared by its own identity rather than hidden behind a trade name. This is where a flavour supplier's documentation standard shows its commercial value: a concentrate delivered with a CAS-level specification, a stability summary, and a retention sample policy can be transcribed into a notification dossier in an afternoon, while a concentrate supplied with only a product code can stall a submission for weeks.

    Step 2 — Create the Product Record and Choose the Addressee Member State

    Inside the portal, create a new product notification and select the member states in which the product will be placed on the market. Each selected state becomes an addressee, receives the dossier, and may raise its own fees and queries. Then complete the identification block: brand name, product category, product type, whether the product is disposable or refillable, and the packaging description including unit count, dimensions, and colours. Product photographs are requested in the common format, so prepare clean images of the container and the packaging artwork before starting. Naming discipline matters here more than it appears. The brand and product names entered now are the names that authorities will use in market surveillance and in any future correspondence, and a product renamed later generates an administrative problem rather than a simple edit.

    Step 3 — Enter the Ingredient Composition

    Ingredient entry is the technical heart of the notification. Each substance is added individually with its CAS number, its function, and its concentration, and the platform aggregates the composition to confirm that the declared quantities reconcile to 100 percent of the formulation. For nicotine-containing liquids, the nicotine concentration must be declared precisely and must sit at or below the 20 mg/ml ceiling; nicotine purity and source information are also requested. Two quality controls prevent most rejections at this stage. First, reconcile the weight-percentage and volume-percentage columns against the laboratory formulation sheet, because rounding differences between the two columns are a common source of validation errors. Second, declare the flavouring substances individually rather than declaring a "flavour blend" as a single line item. The UFI and poison centre documentation for European markets requires the same granularity, so building the ingredient table once in the correct structure serves both obligations and avoids doing the work twice.

    Step 4 — Upload Emissions, Nicotine, and Toxicological Data

    Beyond ingredients, the common format asks for emission data and for toxicological information on the ingredients when heated. For nicotine products, the dossier must also describe nicotine doses and uptake under normal conditions of use, and the design features of the device that influence them — including the refilling mechanism and any child-resistance features. Where a member state has issued national guidance on acceptable emission test methods, follow that guidance rather than a generic protocol, because a dossier built on an unrecognised method will be queried. Attach documents in the formats the portal accepts and name them consistently, using the brand, SKU, and document type in the file name. Reviewers work through dozens of attachments per notification, and clear file naming reduces the chance of a clarification request that costs a launch week.

    Step 5 — Validate, Submit, and Archive the Notification ID

    When the record is complete, run the portal's validation routine and clear every flagged field before submitting. On successful submission the portal issues a notification identifier; record it against the SKU in your regulatory database, together with the submission timestamp, the list of addressee states, the fee references, and the identity of the submitting account. That identifier is the evidence a retailer, a customs officer, or a distributor will ask for when a product is questioned. Archive the exact dossier version that was submitted. A live portal record can be amended, and an archived snapshot is the only reliable way to demonstrate what was declared on a given date. Keep it for at least as long as the product remains on the market, and longer if the market's general record-retention rules require it.

    Step 6 — After Submission: Annual Reporting, Changes, and Withdrawals

    Submission ends the filing, not the obligation. Annual sales data must be reported by brand name and product type, and the figures must be traceable to commercial records. Any change to the product that affects the declared data — a reformulation, a new nicotine strength, a changed pack size, a revised label — requires the record to be updated or a new notification to be filed, depending on the nature of the change and the practice of the addressee state. If a product is discontinued, notify the addressee states and close out the record so that surveillance queries stop arriving. Flavour changes are the most frequent trigger in practice: substituting one aroma chemical for another to improve a sensory profile changes the ingredient declaration, which changes the notification. Build that dependency into product development so that reformulation and regulatory filing are treated as one project rather than two.
    Laboratory testing of flavour concentrate purity and batch consistency produces the data that supports TPD ingredient and emission declarations.

    Emission and Purity Testing for TPD Notification Dossiers | CUIGUAI

    Flavour-Specific Data: UFI Codes, CLP, and Poison Centres

    Classifying a Flavoured Refill Container Under CLP

    A refill container is a mixture for the purposes of the Classification, Labelling and Packaging Regulation, and its nicotine content usually drives a health hazard classification. The classification determines the pictograms, the signal word, and the hazard statements that must appear on the label, and it also determines whether the harmonised information requirements for emergency health response apply. Getting the classification wrong affects three separate obligations at once: the label, the safety data sheet, and the notification dossier. Flavour components matter to that analysis because some flavouring substances carry their own hazard classifications, and the mixture rules must be applied to the concentrate as it appears in the finished liquid. A flavour house that supplies classification data for its concentrates removes a significant burden from its customers and reduces the risk of inconsistent classification across a product range.

    Linking the UFI to the Notification

    Where a mixture requires a unique formula identifier, the UFI must be generated for the specific formula, printed on the label, and submitted to the poison centre appointed bodies of the member states in which the product is placed on the market. The UFI and the TPD notification are separate legal instruments with separate portals, but they describe the same liquid, and a discrepancy between them is exactly the kind of inconsistency that triggers questions during an inspection. Reconcile the formula version, the concentration table, and the pack sizes across both filings. Our detailed explanation of how UFI codes work for European poison centre notification covers the generation and labelling steps in full.

    Why Flavour Documentation Decides Your Timeline

    In practice, the notifications that move fastest are not the simplest products; they are the ones whose suppliers provided clean, complete, machine-readable data. The slowest are those where a flavour concentrate arrived described only by trade name, forcing an expensive and belated exercise in reverse-engineering the composition. The procurement question therefore changes. Instead of asking only for a price per kilogram and a sensory profile, buyers should request the regulatory data package at the sample stage: full ingredient list with CAS numbers, concentration ranges, allergen and restricted-substance declarations, CLP classification of the concentrate, stability data, and a specification sheet tied to a version number. A supplier who delivers that package is giving a brand something worth more than a discount — a shorter path to market. This is also where flavour quality and regulatory readiness converge. A documented milk flavour concentrate and a documented orange flavour concentrate share the same documentation architecture, which means a brand can add new profiles to a portfolio without rebuilding its notification workflow each time. Standardised documentation is what makes a multi-SKU launch financially viable. Compliance failures in this area also travel. A single unsupported claim on a product page can create problems under tobacco law and under consumer protection rules simultaneously, as the FDA warning letters to wellness vape marketers demonstrated in the United States. Our breakdown of the most common flavour-related citations in FDA warning letters shows how quickly a marketing sentence becomes an enforcement exhibit, and why the language used on European labels deserves the same discipline.

    Common Rejections and How to Avoid Them

    • Composition that does not reconcile to 100 percent, usually caused by rounding between weight and volume columns.
    • Flavouring substances declared as a single blend rather than individual CAS-level entries.
    • Missing toxicological data for heated-form exposure, particularly for newer aroma chemicals.
    • Emissions data generated with a method that the addressee state does not recognise.
    • Product photographs or packaging artwork that do not match the declared pack size, unit count, or label text.
    • Nicotine concentration declared above the 20 mg/ml ceiling, or declared inconsistently across related SKUs.
    • Notification filed fewer than six months before the intended launch date for a nicotine-containing product.
    • UFI missing from the label, or a UFI generated for a formula version that no longer matches the notified composition.

    Pre-Submission Checklist

    • Confirm which member states will be served, and confirm each state's current fee and validation requirements.
    • Verify that the flavour concentrate is supported by a CAS-level specification with a version number.
    • Reconcile the ingredient table against the laboratory formulation sheet in both weight and volume terms.
    • Confirm the CLP classification of the finished liquid and check that the label artwork matches it.
    • Confirm the UFI requirement and generate the identifier for the correct formula version.
    • Prepare device and packaging photographs that match the declared product record.
    • Set up EU Login credentials and company registration, and agree who holds submission rights.
    • Diarise the six-month deadline, the annual sales report, and the review date for any reformulation in the pipeline.
    Documented flavour batches leave CUIGUAI with specification sheets, certificates of analysis, and retention samples ready for EU notification files.

    Released Flavour Batch Documentation Ready for Market Entry | CUIGUAI

    Request a Flavour Sample with a Regulatory Data Package

    CUIGUAI supplies flavour concentrates with the documentation that makes EU notification straightforward: CAS-level ingredient lists, concentration tables, CLP classification data for the concentrate, stability summaries, specification sheets with version control, and certificates of analysis for every batch. 📞 Телефон: +86 0769 8838 0789 🌐 Веб-сайт: https://www.cuiguai.com 📧 Электронная почта: info@cuiguai.com 💬WhatsApp и Telegram: +86 189 2926 7983 Send us your target market and flavour brief, and we will return samples together with the data package your regulatory team needs to build the notification file.

    Источники

    1. Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products, and repealing Directive 2001/37/EC, Article 20 — https://eur-lex.europa.eu/eli/dir/2014/40/oj
    2. Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers — https://eur-lex.europa.eu/eli/dec_impl/2015/2183/oj/eng
    3. European Commission, EU common entry gate (EU-CEG) — Frequently Asked Questions — https://health.ec.europa.eu/eu-common-entry-gate-eu-ceg/frequently-asked-questions-faq_en
    4. Regulation (EU) 2017/542 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures by adding an Annex on harmonised information relating to emergency health response (unique formula identifier and poison centre notification) — https://eur-lex.europa.eu/eli/reg/2017/542/oj
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