The EU’s Omnibus VI update

The European Commission originally published the Omnibus Act VI (Commission Regulation (EU) 2023/1490) on July 19, 2023, prohibiting the use of CMR (carcinogenic, mutagenic, and reprotoxic) substances. Last year, on July 8, 2025, it announced a proposal to reduce excessive administrative and compliance burdens for businesses.  

The move forms part of a wider effort to simplify EU laws and ease administrative burdens, helping businesses innovate and grow in line with the Draghi report on EU competitiveness. Key concerns raised in the September 2024 report included closing the innovation gap with the US and China; a joint plan for decarbonization and competitiveness; and increasing security while reducing dependencies.  

In line with these goals, the Omnibus VI package seeks to streamline, simplify and clarify EU legislation, including Regulation (EC) No 1223/2009, also known as the Cosmetic Products Regulation. 

This latest development has pleased cosmetics industry stakeholders, with the Director General of industry association Cosmetics Europe, John Chave, commenting that the agreement “shows that Europe can streamline the regulatory framework and reduce administrative burden while maintaining the highest consumer safety standards.”  

But what exactly have the EU’s decision-makers agreed on? How do these differ from the Commission’s earlier recommendations, and how will these changes benefit cosmetics companies compared with the here and now? 

Significantly, June’s deal saw the co-legislators agree to phase out cosmetics containing prohibited CMR substances much faster than the Commission’s proposal. Where a substance is not defended for continued use, companies will – once the ban takes effect – have six months to stop placing affected products on the market, and 12 months before they can no longer be made available. In contrast, the Commission had proposed 12 and 24 month long transition periods. Both timelines are more generous than current rules, which set no staggered transition.  

Companies wanting to keep using a substance will have up to 12 months from its new classification to request a derogation, and the phase-out clock starts only once that request is decided. If a derogation is refused on safety grounds, the company will then have three months to stop placing products on the market and nine months before they can no longer be made available. If the refusal is due to the availability of a suitable alternative substance, meanwhile, the timelines will be 24 and 36 months. 

The Council and Parliament also decided against exempting CMR substances based on oral or inhalation exposure, as proposed by the Commission. Further, the co-legislators reintroduced the requirement for cosmetic products containing nanomaterials to be notified to the Commission prior to being placed on the market – but not six months prior, as is currently mandated.  

The Commission will also develop guidance specifying the analysis of alternatives one year after entry into force of this legislation in a bid to accelerate the replacement of hazardous substances in cosmetic products. 

Other agreed-upon revisions to the Commission’s proposal apply to the recently amended CLP Regulation, which allows for more flexible rules for the classification and labelling of chemicals. These include easy-to-read labels, wider use of digital labelling, and the easing of advertising rules to reduce costs and complexity, while ensuring consumer protection. 

It was decided – understandably – that label elements should be legible for consumers. As a result, where the substance is placed on the market for the public, the text of the label must use a font size where the x-height is equal to or greater than 1.2mm. When the contents of the package of the substance do not exceed 125ml, the x-height must be equal to or greater than 0.9mm. For chemical products in containers of 10ml or less, some label elements (though not the hazard pictograms) may be provided on a digital label. This ensures that full hazard information remains available on the outer packaging while resolving practical labelling challenges. 

Meanwhile, to bring regulatory clarity and address possible public health concerns, the co-legislators introduced a 15-month deadline for suppliers to update labels when a new evaluation leads to a more severe classification; this is instead of “without undue delay,” as proposed by the Commission. 

To prevent fragmented implementation timelines, last year, Parliament postponed the application of most parts of the revised regulation on the classification, labelling, and packaging of chemicals to January 1, 2028. 

Beyond Regulation (EC) No 1223/2009 and CLP, the Omnibus VI package also includes simplification measures impacting the EU fertilizers industry, which do not directly affect cosmetics companies.  

So, what can cosmetics makers expect next? According to Parliament, the next step in the Omnibus VI simplification process will involve this informal agreement being endorsed by both the Parliament and Council, following which it will enter into force 20 days after it has been published in the EU Official Journal. 

Because of the complexity of keeping on top of ever-improving legislation, both in the EU and elsewhere, PLM, or Product Lifecycle Management, has become indispensable in the cosmetics industry. Coptis’ Cosmetics PLM software helps manufacturers ensure compliance with local and international regulations.  

PLM software helps to avoid costly mistakes, meet tight deadlines, and facilitate collaboration between different teams for greater efficiency. Moreover, every component of the development cycle – not just regulations – is connected, including raw materials, formulas, test results, budgets, and packaging. And all information is accessible in a single location, significantly reducing errors and information loss, and ensuring data traceability. 

If you are looking to equip your team with Cosmetics PLM software, contact Coptis to discover what they can offer your laboratory.