The beauty industry has a new regulatory roadmap. The European Parliament and the Council reached this Tuesday the expected green light for the chemical simplification package known as "Omnibus VI", which directly affects cosmetics: it removes CMR substances from the market with more demanding deadlines than the Commission proposed, strengthens the control of nanomaterials, and opens the door (under some conditions) to digital labeling. The norm affects thousands of companies and millions of products circulating in the European market.
The starting point: a framework that needed renewal
To understand what changes, we must remember where we come from. The current Cosmetics Regulation (EC) 1223/2009 established the control system for hazardous substances in cosmetics that is still operating today. Its main axis is the mechanism of the so-called "Omnibus CMRs": periodic regulations that, as the Classification, Labeling and Packaging (CLP) Regulation updates the list of carcinogenic, mutagenic or toxic for reproduction substances, automatically transfer them to Annex II of the Cosmetics Regulation as prohibited ingredients.
This system has worked, but with a structural problem: market withdrawal deadlines were rigid and did not contemplate differentiated scenarios. A company that wanted to defend the continued use of a substance had no clear channels, and brands that needed to reformulate found themselves with tight time windows to withdraw stock, without distinguishing whether available alternatives existed or not. Furthermore, there was no regulated derogation mechanism or specific deadline to request exceptions.
In parallel, the debate on the modernization of labeling had been accumulating for years: physical formats are insufficient for small-format products, legibility is a recurring problem, and digitalization was advancing in other regulatory sectors without cosmetics benefiting from it.
Nor was there a prior notification obligation for nanomaterials that had survived intact: Regulation 1223/2009 provided for notification six months before commercialization, but practical application had generated uncertainties that the sector had long been demanding clarification on.
The debate: between simplification and protection
When the European Commission presented the Omnibus VI package in July 2025, a result of the impetus from the Draghi report on European competitiveness, reactions were swift. The Commission's original text proposed a measure that became the most controversial point of the entire negotiation: exempting CMR substances from the ban in cosmetics if their exposure pathway was solely oral or by inhalation, arguing that topically applied products presented a different risk profile.
Public health groups, United Nations experts, and several political groups in the European Parliament firmly opposed it. The reasoning was clear: introducing an exemption based on the exposure pathway would weaken the precautionary principle that has made the European cosmetic framework one of the most demanding in the world. Member States and MEPs from different political sensibilities agreed to reject the proposal, and both the Council and the Parliament built their negotiating mandates on that premise.
The debate on withdrawal periods was also intense. The Commission had proposed windows of 12 and 24 months to stop marketing and distributing products with prohibited substances, longer than the current ones, which do not contemplate a staggered transition. The Parliament considered these deadlines too generous and that they unnecessarily prolonged consumer exposure to ingredients already classified as dangerous.
What the agreement says: point by point
CMR substances: out sooner, with more nuances
The final agreement flatly rejects the proposed exemption based on the exposure pathway. The principle is the same as always: if a substance is CMR, it is prohibited in cosmetics. But a staggered and more nuanced system is introduced to manage transitions.
When a CMR substance cannot be defended for continued use, the company will have six months from the entry into force of the prohibition to stop marketing the affected product, and twelve months to completely withdraw it from the market. These deadlines are shorter than those proposed by the Commission (12 and 24 months), although somewhat longer than the current ones, which do not contemplate any staggered transition.
For those who wish to try to maintain the use of a substance through derogation, the agreement sets a clear deadline for the first time: up to twelve months from the new CMR classification to submit the application. While that application is being processed, the clock for the exit phase is paused.
If the derogation is denied for safety reasons, the deadlines are tight: three months to stop placing the product on the market and nine months for it to cease to be available. If the denial is due to the existence of viable alternatives, the deadlines are longer, 24 and 36 months, recognizing the time required for responsible reformulation.
Nanomaterials: prior notification returns
One of the most significant points for the sector is the restoration of the obligation to notify the Commission of cosmetics containing nanomaterials before marketing them. The Commission's proposal eliminated this requirement; the agreement reinstated it, although it removes the six-month advance notice period established by the original 2009 text. The objective is to maintain traceability and surveillance of these ingredients, whose behavior may differ from that of their conventional-scale equivalents.
Digital labeling: yes, but with clear limits
The agreement opens the door to digital labeling for chemical products in packages of 10 ml or less, allowing certain elements of the label to be transferred to a digital medium. There is, however, a red line: hazard pictograms must continue to appear on the physical packaging. There are no exceptions on this point.
Regarding legibility, the text sets minimum font size requirements for the first time: the x-height of the lowercase letter must be equal to or greater than 1.2 mm for general use products, and at least 0.9 mm in packages up to 125 ml.
A specific period of 15 months is also established for manufacturers to update labels when a new assessment leads to a more severe hazard classification. Until now, the regulation was limited to requiring it to be done "without undue delay," a wording that generated legal uncertainty.
The industry, in numbers
The weight of what is at stake is clear from the background data: the European chemical industry encompasses 29,000 companies, generates 1.2 million direct jobs, and supports another 19 million throughout its entire value chain. The Commission estimates that the simplification measures of Omnibus VI could save the sector at least 363 million euros per year.
The Voices of the Agreement
The rapporteur for the Environment Committee, Dimitris Tsiodras (EPP, Greece), emphasized that the text demonstrates that "simplification and a high level of protection can go hand in hand": burdens for companies are reduced, the visibility of safety information for consumers is improved, and greater legal certainty is provided to the industry. Piotr Müller (ECR, Poland), rapporteur for the Internal Market Committee, welcomed the agreement as "a real step forward" for European competitiveness, although he acknowledged that there is still ground to cover in future revisions.
From the sector, Cosmetics Europe had been asking for greater flexibility in transition periods and clarity in the derogation procedure. The agreement gives them part of what they were demanding, although not the exemptions by exposure route that would have meant a more radical change.
And now what?
The political agreement reached this Tuesday still needs to be formally ratified by the European Parliament in plenary and by the Council. Once published in the Official Journal of the EU, the regulation will enter into force 20 days later. For brands and manufacturers, the start of the 12-month period to request derogations and the new product withdrawal times will begin to run from that moment.
The CLP revision, the pillar on which the hazardous ingredient classification system pivots, has its own agenda: most of its modifications will apply from January 1, 2028, after the extension agreed last year to give more time to the industry, especially SMEs.