CMR Substances in EU Cosmetics: Article 15 Explained

Article 15 of Regulation (EC) No 1223/2009 is the shortest route from a chemical hazard classification to a cosmetics ban. It does not itself classify anything. It borrows a classification made under a different regulation - the CLP Regulation, (EC) No 1272/2008 - and turns that classification into an automatic consequence for cosmetic products. Understanding how that pipeline runs, and where it currently stands, matters more than memorising any single substance name, because the pipeline keeps producing new names.

What Article 15 actually says

Article 15 sets the default in two paragraphs. Article 15(1) prohibits the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) in category 2, and Article 15(2) prohibits those classified in category 1A or 1B - in both cases under Part 3 of Annex VI to the CLP Regulation. Category 1A and 1B substances are the ones with the strongest evidence - proven or presumed human CMRs. Category 2 covers substances where the evidence is suspected but less conclusive.

The article then carves out two narrow routes back into permitted use, and both routes run through the Cosmetics Regulation's own annexes rather than around them. A category 1A or 1B substance can continue to be used only if it meets all four of the cumulative exemption conditions Article 15(2) sets out and is then listed, with its conditions, in Annex III (restricted) or one of the permitted-substance annexes. A category 2 substance can be used only after the Scientific Committee on Consumer Safety (SCCS) has evaluated it and found it safe for use in cosmetic products, which is the Article 15(1) route. Neither route is self-executing - a formulator cannot decide a category 2 substance is fine because a food-contact or industrial-use SCCS-equivalent opinion exists elsewhere. It has to clear cosmetics-specific SCCS scrutiny and be written into the annex. The exact wording of the exemption conditions is dense; read Article 15 itself on EUR-Lex before relying on it for a specific substance rather than a summary of it.

The practical effect is that Article 15 does almost no independent scientific work. It is a legal switch. The science - is this substance CMR, and at what category - happens entirely inside the CLP classification process. Article 15 just says what follows once that switch is thrown.

CLP classification is the trigger, ATPs are how it moves

CLP harmonised classifications are not static. The European Chemicals Agency's Committee for Risk Assessment proposes new or revised harmonised classifications, and the Commission adopts them through Adaptation to Technical Progress regulations - ATPs - which amend Annex VI of the CLP Regulation. Each ATP can add newly classified CMR substances, or move a substance from one CMR category to another (for example category 2 to category 1B, which moves it from the Article 15(1) route to the stricter Article 15(2) prohibition and its four exemption conditions).

A new CLP classification does not, on its own, change a cosmetics annex. The Cosmetics Regulation and the CLP Regulation are separate legal instruments with separate amendment procedures. The Commission has to act a second time, specifically under the Cosmetics Regulation, to move a newly classified substance out of general permission and into Annex II, or to remove it from Annex III/IV/V/VI if it no longer qualifies for the conditions that kept it there. That second act is what the industry calls an "omnibus" regulation: a single Commission Regulation that processes a batch of recently CLP-classified CMR substances against the cosmetics annexes in one pass, rather than one regulation per substance.

Two recent omnibus acts illustrate the pattern. Commission Regulation (EU) 2021/1902, which applied from 1 March 2022, moved a batch of CLP-classified CMR substances into Annex II - butylphenyl methylpropional (BMHCA, widely known by the trade name Lilial, CAS 80-54-6) and zinc pyrithione (CAS 13463-41-7) among them - after both had picked up a category 1B reproductive-toxicant classification. Commission Regulation (EU) 2025/877, applying from 1 September 2025, did the same for a further batch that included trimethylbenzoyl diphenylphosphine oxide (TPO, CAS 75980-60-8), a photoinitiator used in UV/LED-cured gel nail products, following its own CLP reclassification as a category 1B reproductive toxicant. A further amending act, Commission Regulation (EU) 2026/78, published 13 January 2026, continues the same pattern against Annexes II-V. Each act is a separate legal instrument with its own application date; none of them retroactively changes what an earlier act already settled for a given entry.

Three worked examples from the live annex data

cosingchecker.com/annex/II/ carries the current text of every Annex II entry, each tagged with the regulation its present wording is attributed to. Querying the site's own records for the three substances above shows the mechanism in the actual data, not just in the legal narrative:

The zinc pyrithione entry is worth a second look because it shows the "moved into Annex II" mechanic directly rather than by inference. Annex III entry 24 covers water-soluble zinc salts generally, but its own text carves out an exception: "with the exception of ... zinc pyrithione (Annex II, entry 1670)". That single cross-reference is the annex system recording, in its own text, that a substance which used to sit under a restricted-substance entry no longer does - it was pulled out and given its own prohibited-substance entry once its CLP classification changed. That is what an omnibus regulation does in practice: not a rewrite of the whole annex, just a substance moved from one list to another, with the old entry's text updated to say so.

None of these three entries carries a populated CMR-classification tag in the site's own structured field for that entry - the field the site uses to record a classification string like "Repr. 1B" against an entry is populated for many Annex II records but not for every entry that was added because of a CMR classification, since the annex text itself does not always restate the classification inline. That is a reminder of the site's own stance: an imported annex record documents what the regulation currently says, not everything about why it says it. For the classification reasoning behind a specific entry, the CLP Annex VI classification table and the ATP that introduced it are the primary source, not the cosmetics annex text alone.

What the coverage numbers show

cosingchecker.com/api/v1/stats/ reports 1,028 entries across all six annexes currently carrying a populated CMR-classification value, out of 2,353 total annex entries. The concentration is heavily in Annex II: 1,018 of its 1,739 entries (about 59%) carry a CMR tag, against 9 of Annex III's 373 entries, 1 of Annex V's 54, and none in Annex IV or VI. That distribution is exactly what Article 15's mechanics predict - a category 1A/1B classification defaults to prohibition (Annex II), and only the substances that clear the SCCS-evaluation route for category 2, or meet the narrow 1A/1B exemption conditions, end up with a restricted-use entry instead (Annex III or another permitted-use annex).

cosingchecker.com/amendments/ tracks which act each current annex entry cites for its present text: 47 distinct acts are cited across the 2,353 entries, and the original 2009 regulation itself still accounts for 1,574 entries that no later amendment has touched. A CMR-driven omnibus act is one contributor among those 47, alongside acts addressing colorants, UV filters, fragrance allergens and other restriction updates that have nothing to do with Article 15. Filtering that list by act is the fastest way to see exactly which substances one specific omnibus regulation moved, rather than relying on a news summary of how many substances a given act affected.

What to actually monitor

The sequence a formulator or regulatory affairs contact needs to track has three stages, and each one has a different lead time and a different place to check it.

1. ATP publication under CLP: a substance in your supply chain gets a new or revised harmonised CMR classification in Annex VI to Regulation (EC) 1272/2008. This is the earliest warning - it precedes any change to the cosmetics annexes, sometimes by a year or more, and it is worth screening your own ingredient list against ECHA's classification and labelling inventory rather than waiting for a cosmetics-specific announcement.
2. The cosmetics omnibus regulation: the Commission adopts a Regulation amending Regulation (EC) 1223/2009 to move the newly classified substance into Annex II, or into a restricted-use annex with SCCS-set conditions if it qualified for the category 2 or exemption route. This is a distinct legal act with its own publication date in the Official Journal, and it is the point at which the cosmetics-specific prohibition or restriction becomes law.
3. The application date: the omnibus regulation itself states when the new rule takes effect, and that date is often months after publication (1 March 2022 for the 2021/1902 batch, 1 September 2025 for the 2025/877 batch) to give the supply chain time to reformulate. Check the specific act for any transitional wording on placing on the market versus making available, since omnibus acts vary in how they phrase the cutover and some have separate dates for manufacture and for retail sell-through - read the application-date article of the specific regulation rather than assuming a uniform rule across acts.

cosingchecker.com/cmr/ lists every current annex entry carrying a populated CMR-classification value, filterable by annex, and each entry links to the regulation that set its present text - a starting point for building a watch list of CAS numbers against your own formulations. cosingchecker.com/amendments/ is the complementary view: pick an act and see every substance it currently accounts for, which is the more useful direction when a new omnibus regulation is published and you need to know its full substance list rather than the two or three examples a trade press summary chose to mention.

Reading an entry correctly

An Annex II entry citing a CMR-driven omnibus regulation tells you that substance is currently prohibited, and which act made it so. It does not tell you whether a structurally similar substance, a different salt, or a related isomer is covered by the same entry unless the entry's chemical name or CAS group says so explicitly - annex entries are drafted around specific substance identities, and a near-miss on structure is not evidence either way. It also does not tell you whether that substance has since picked up a further CLP reclassification that has not yet reached a cosmetics omnibus act; the interval between ATP publication and the corresponding cosmetics amendment is exactly the gap where a substance can be CLP-classified as CMR without yet appearing as such in the cosmetics annexes. An annex record is identity evidence for what the regulation currently says - not a substitute for checking the CLP classification directly, and not proof that everything not yet listed is permitted.

Sources

• Regulation (EC) No 1223/2009, Article 15 (CMR substances) — https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20250301
• Regulation (EC) No 1272/2008 (CLP), Annex VI, Part 3 (harmonised classifications) — https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02008R1272-20240701
• Commission Regulation (EU) 2021/1902 amending Annexes II, III and V to Regulation (EC) No 1223/2009 — https://eur-lex.europa.eu/eli/reg/2021/1902/oj/eng
• Commission Regulation (EU) 2025/877 amending Annexes II and III to Regulation (EC) No 1223/2009 — https://eur-lex.europa.eu/eli/reg/2025/877/oj/eng
• European Commission, CMR substances in cosmetic products (policy summary page) — https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-products-specific-topics/cmr-substances_en
• cosingchecker.com CMR substances list — https://cosingchecker.com/cmr/
• cosingchecker.com amending acts index — https://cosingchecker.com/amendments/
• cosingchecker.com Annex II browse — https://cosingchecker.com/annex/II/
• cosingchecker.com public API, stats and entries endpoints — https://cosingchecker.com/api/v1/stats/ , https://cosingchecker.com/api/v1/entries/