Author: R&D Team, CUIGUAI Flavoring
Published by: Guangdong Unique Flavor Co., Ltd.
Last Updated: Sep 14, 2026
WhatsApp & Telegram: +86 189 2926 7983
Email: info@cuiguai.com
CMR stands for carcinogenic, mutagenic and reprotoxic — the three hazard families that European regulators treat with the least tolerance. A CMR substance is a chemical that may cause cancer, may induce genetic mutations, or may damage fertility or the unborn child. In the European Union these substances are not merely discouraged: their supply to the general public is restricted by law through the REACH Regulation, and the same logic flows directly into the rules that govern e-liquids and the flavoring compounds they contain.
For e-liquid brand owners, importers and compliance managers, the CMR ban is not an abstract Brussels policy. It decides which flavor concentrates may lawfully be sold in EU Member States, which ingredients must appear in the product notification required under the Tobacco Products Directive, and which suppliers are safe to work with. If you are new to the European market, our guide to EU TPD compliance and the forbidden ingredients list is a useful starting point, because the CMR restriction sits inside the same regulatory ecosystem and the two sets of rules are enforced together.
Definition: the “CMR ban” in the EU refers to the restriction in Annex XVII of Regulation (EC) No 1907/2006 (REACH) that prohibits placing on the market, or using for supply to the general public, any substance classified as carcinogenic, mutagenic or reprotoxic in category 1A or 1B — on its own, in a mixture, or in an article — when that substance is present at a concentration equal to or above 0.1% by weight. The restriction is implemented through three parallel entries: entry 28 (carcinogens), entry 29 (germ cell mutagens) and entry 30 (reprotoxicants). Because every e-liquid and every flavor concentrate is a mixture, this single threshold is the number every formulation team in the industry must know.
EU CMR Substances Ban: What E-Liquid Brands Must Know | CUIGUAI Flavor
The CMR restriction lives in Annex XVII to the REACH Regulation — the European Union’s core chemicals law, formally titled Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. Annex XVII contains the consolidated list of restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles. Entries 28, 29 and 30 are the CMR entries. When industry professionals say “the CMR ban”, they almost always mean these three entries read together, together with the annexes that list the individual restricted substances.
The categories come from the Classification, Labelling and Packaging (CLP) Regulation, Regulation (EC) No 1272/2008, which implements the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in the European Union. Category 1A covers substances known to be carcinogenic, mutagenic or reprotoxic in humans, based mainly on human evidence. Category 1B covers substances presumed to have such effects in humans, based mainly on animal evidence. The distinction matters because only 1A and 1B substances fall under the Annex XVII restriction — a substance classified only in category 2 is not caught by entries 28–30, although it may be restricted through other mechanisms or future amendments.
The restriction bites at 0.1% by weight. A mixture may not be supplied to the general public if it contains a CMR 1A/1B substance at or above 0.1% w/w. The threshold is applied to each restricted substance individually; it is not a sum of all CMR substances present. This detail matters enormously in flavor work, because a flavor concentrate is normally used at 5–15% in the finished e-liquid. A restricted substance at 0.5% in a flavor used at 10% in e-liquid ends up at 0.05% in the finished product — below the threshold. The same substance at 1.5% in the flavor would carry through to 0.15% in the e-liquid — above the threshold and therefore unlawful for consumer supply.
Two nuances complete the picture. First, the restriction targets supply to the general public: professional and industrial supply is outside its scope, so raw-material transactions between businesses are not the point of control — the consumer-facing product is. Second, the test is applied at the level of the mixture supplied to consumers. For finished e-liquids and refill containers that means the liquid as bottled; for flavor concentrates sold directly to consumers for DIY mixing, the concentrate itself must already pass the same 0.1% test.
The list of CMR substances covered by entries 28–30 is not static. The European Commission updates the annexes of these entries each time new harmonised classifications are adopted under CLP. Commission Regulation (EU) 2017/1510 added 23 substances; Commission Regulation (EU) 2021/2204 added a further batch with effect from 3 January 2022; and most recently Commission Regulation (EU) 2025/1731, applicable from 1 September 2025, added 16 new CMR substances to the annexes of entries 28, 29 and 30. For flavor houses this means a screening report dated last year may already be obsolete. Compliance must be a continuous process, not a one-time audit before launch.
The European Chemicals Agency (ECHA) operates the technical machinery behind the ban. ECHA maintains the Classification and Labelling (C&L) Inventory where classifications are notified by industry, supports the harmonisation of classifications through its scientific committees, and provides the databases that businesses use to check whether a substance carries a CMR 1A/1B classification. Consulting the ECHA C&L Inventory together with the latest consolidated text of Annex XVII is the correct first step in any screening exercise, and it should be repeated on a fixed schedule.
REACH Annex XVII Entries 28, 29, 30: CMR Restrictions Explained
REACH is the horizontal chemicals law, but e-liquids are also covered by sector-specific legislation: the Tobacco Products Directive (TPD), Directive 2014/40/EU. Under Article 20(2) of the TPD, manufacturers and importers of electronic cigarettes and refill containers must submit a notification to the competent authorities of each Member State where they intend to market the product, before it is placed on the market. Article 20(2)(b) and (c) require that notification to include a list of all ingredients in the product and toxicological data on the ingredients and their emissions, submitted in the common format established by Commission Implementing Decision (EU) 2015/2183 of 24 November 2015.
Article 20(3) of the TPD then pulls the CMR logic directly into e-liquid formulation: Member States must ensure that nicotine-containing liquid in electronic cigarettes and refill containers does not contain additives listed in Article 7(6) of the Directive and — with the exception of nicotine — contains only ingredients that do not pose a risk to human health in heated or unheated form. Article 7(6)(e) is explicit on the point that matters here: additives that have CMR properties in unburnt form are prohibited. In other words, a flavor component that is itself a CMR substance cannot be defended on the ground that it is diluted: the TPD excludes it outright.
In the United Kingdom, the post-Brexit implementation of the same framework is documented by the Medicines and Healthcare products Regulatory Agency (MHRA) in its published ingredient guidance for nicotine-containing liquids. That guidance lists substances that should not be included in e-liquids and refill containers, drawing on both the TPD and national standards: CMR category 1 and 2 substances; substances classified with specific target organ toxicity for the respiratory tract (STOT category 1); respiratory sensitisers; vitamins used as food supplements; stimulant additives such as caffeine and taurine; diacetyl; pentane-2,3-dione; diethylene glycol; ethylene glycol; formaldehyde; acetaldehyde; acrolein; and metals including cadmium, chromium, iron, lead, mercury and nickel. The guidance stresses that the list is not exhaustive and that absence from the list is not proof of safety.
A flavor concentrate is a formulated mixture of aromatic and flavouring substances, often combining twenty to sixty components to build a single profile. Each of those components is a distinct chemical substance with its own identity, and any one of them can carry a CMR 1A/1B classification. Screening therefore means running every component of the formula against three questions. First: is the substance listed in the current annexes of REACH Annex XVII entries 28, 29 or 30, or harmonised as CMR 1A/1B under CLP? Second: at what concentration does it appear in the flavor concentrate, and what dilution rate will the customer apply in the finished e-liquid? Third: does the substance appear on the TPD Article 7(6) prohibited-additives list or on any national prohibited list applicable in the target market?
For manufacturers of tobacco flavor concentrates the practical relevance is highest, because tobacco-style e-liquids carry a disproportionate share of regulatory attention in EU markets and their profiles have historically leaned on components that require careful checking against both the CMR lists and the TPD Annex of prohibited ingredients. The same discipline applies across fruit, dessert, beverage and cooling profiles — the CMR ban does not know flavor categories, it only knows substances.
A robust screening workflow for a flavor house or e-liquid brand can be built in six steps. Step one: request full formulation disclosure, or a verified compliance dossier, from every raw-material supplier, with CAS numbers for every component. Step two: run each CAS number against the current Annex XVII CMR lists and the CLP harmonised classification table. Step three: verify supplier safety data sheets against the ECHA C&L Inventory instead of trusting the SDS at face value — classifications can be outdated or simply wrong. Step four: calculate worst-case carry-over, multiplying the substance concentration in the flavor concentrate by the maximum use rate in the finished e-liquid. Step five: check the TPD Article 7(6) list and any national lists for the target market. Step six: re-run the entire screening whenever the formula changes and on a fixed calendar schedule — at least twice a year — because the restriction lists are amended regularly.
CMR Screening for Flavor Houses: A Step-by-Step Workflow
If you buy finished e-liquid or flavor concentrates for resale, the REACH restriction and the TPD notification duty land on your desk, not on your supplier’s. As the importer or brand owner you are the party placing the product on the market, which makes you the notifier under Article 20(2) of the TPD and the party that must be able to justify every ingredient in the file. That implies contractual due diligence: written undertakings from suppliers that no CMR 1A/1B substance is present above the applicable thresholds, obligations to notify formula changes in advance, access to updated safety data sheets, and the right to audit the supplier’s own screening records.
Record keeping is the second half of compliance. The competent authorities can request toxicological data and full composition at any point in the product’s life, and a notification that cannot be backed by documentation is a liability, not a compliance file. Keep the master formulation per SKU, the CAS-keyed component list, the screening results with the date of each check, and the supplier correspondence — all versioned, so that a future audit can reconstruct exactly what was declared and why.
One more practical point for multi-market brands: the CMR framework is not the only ingredient regime you will face. If you also sell into China, the national standard GB 41700-2022 imposes its own additive restrictions on e-liquids; our guide to GB 41700-2022 compliance for e-liquid additives maps the overlaps and the differences. And if your formulas rely on cooling flavor concentrates for the cold-sensation profile consumers expect from menthol and ice-style products, remember that the cooling agents themselves must pass the same screening as every other component — a single overlooked ingredient is enough to break a whole product line.
Finally, plan for market surveillance. National enforcement authorities sample e-liquids at retail and in import warehouses, and laboratory results travel fast between Member States through the EU’s administrative cooperation networks. A product found to contain a CMR 1A/1B substance above the threshold faces withdrawal from the market, notification through the rapid alert systems, and potentially corrective actions that apply to the whole batch family. That is why the compliance file should live with the product manager, not only with the regulatory specialist: formula changes, supplier substitutions and cost-reduction projects are exactly where undocumented CMR exposure tends to slip in.
Entries 28, 29 and 30 of REACH Annex XVII restrict substances classified as CMR in category 1A or 1B only. Substances classified in category 2 are not covered by these three entries, although they can be addressed through other restriction entries or through future amendments as classifications are upgraded. Always check the harmonised classification of each component rather than assuming a category from a trade name.
The restriction applies to mixtures supplied to the general public, so the controlling number is the concentration in the finished e-liquid as sold to consumers. The practical consequence is that the permitted level inside a flavor concentrate depends on the use rate: a flavor dosed at 10% may contain a restricted substance at up to 1% and still deliver 0.1% in the e-liquid — but the same concentrate sold to consumers for DIY mixing must itself comply at the 0.1% level. Conservative brands apply the 0.1% test to the concentrate as well, which removes all doubt.
Three official sources cover the ground: the ECHA C&L Inventory for notified and harmonised classifications, the harmonised classification annex of the CLP Regulation, and the consolidated text of REACH Annex XVII on EUR-Lex. Cross-checking all three is recommended because notifications in the C&L Inventory are legally effective even when they differ from supplier documents.
Yes, and they matter. The restriction targets supply to the general public, so occupational and industrial supply is generally outside its scope. Individual entries can also carry their own conditions and derogations, and concentration limits may differ for specific uses. The correct approach is to read the exact wording of the relevant entry and its annex table before concluding that an exemption applies — assumptions here are how recalls happen.
E-Liquid CMR Compliance: Duties of Brand Owners and Importers
Need a CMR-compliance review of your flavor formulas? It is free and confidential. Our technical compliance team helps e-liquid brands select, document and validate flavors for the European market — and we send free samples so your own laboratory can run the screening before you commit. Contact us:
📞 Phone: +86 0769 8838 0789
🌐 Website: https://www.cuiguai.com
📧 Email: info@cuiguai.com
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