Key Takeaways:

. The EU's Omnibus VI chemicals regulation package will be written into law at the end of 2026.
. Changes to cosmetics regulations regarding Carcinogenic, Mutagenic, and Reprotoxic (CMR) substances are largely long-term and positive.
. The industry welcomes the package and expects it will support innovation, competition, and influence global stances.

The European Union's move to amend legislation on chemicals, cosmetics, and fertilizing products under its Omnibus VI package is due to be adopted in October and likely written into law by the end of the year. The package is part of wider EU goals to simplify regulatory frameworks and improve competitiveness across various industries, in this case, tackling chemical regulation.

So, what do these amendments mean for the cosmetics industry operating in the EU? And how much will the proposed changes impact day-to-day business?

Hazardous or Safe: A Spotlight on CMRs

For cosmetics, the main legislative change under Omnibus VI is the regulation of carcinogenic, mutagenic, and reprotoxic (CMR) substances, which fall under Article 15 of the EU's Cosmetic Products Regulation (CPR) EC No. 1223/2009. CMR substances in the EU are classified into different hazard categories: Category 1A (known human hazard), Category 1B (presumed human hazard), and Category 2 (suspected human hazard)—all of which are prohibited in cosmetics.

Under existing frameworks, rare exemptions exist for CMRs in cosmetics and require a substance to pass a rigorous scientific safety review by the EU's Scientific Committee on Consumer Safety (SCCS),  and proof that it complies with food safety requirements, and that no alternative substances exist.

What the Omnibus VI package will do is ensure ingredients that can be safely used in cosmetics are not automatically banned following a hazard classification for other uses—providing the industry with simpler measures to obtain approvals for cosmetic formats when a substance is banned elsewhere.

Sodium fluoride, for example, is currently going through the hazard classification process and could potentially be banned, despite the ingredient having a clear health function, inclusion on the World Health Organization's (WHO) list of essential substances, and wide and safe usage in toothpaste and other oral care products. Heliotropin, or piperonal, a synthetic compound used in perfumes and food for its sweet, powdery, floral scent, is also being considered for CMR classification, though the SCCS has issued an opinion stating the substance is safe in perfumes at levels of up to 1.8%. Ethanol is another substance under scrutiny and could eventually be classified as a CMR under the EU's Classification, Labeling, and Packaging (CLP) Regulation. Ethanol, however, is one of the most widely used ingredients in cosmetic formulations, valued for its solvent properties, antimicrobial action, and power to enhance absorption. If this substance becomes a classified CMR substance under existing frameworks, the cosmetics industry would have to go through Article 15's complex derogation process to continue approved use; the Omnibus VI package would ease such a burden.

The Wider EU Goal of Simplification

Beyond CMRs, the Omnibus VI chemicals package also establishes a procedure to streamline the process of approving and using new cosmetic ingredients like colorants, preservatives, and UV filters, and eliminates the need to pre-notify cosmetic products containing nanomaterials under Article 16 of the CPR—removing a duplication of notification requirements already conducted under Article 13. The Omnibus VI package will also digitize the European Commission glossary of common ingredient names to ensure accurate labeling and reduction of compliance errors.

Overall, the new package is good news for the cosmetics industry and should reduce administrative burdens and speed up approvals of innovative ingredients that are safe.

“The Omnibus VI is part of a whole string of measures which are about simplification,” explained John Chave, Director General of industry association Cosmetics Europe. The EU, Chave said, is conducting a very broad look at existing regulations to determine which areas are considered too complex and therefore incompatible with the region's competitiveness aims. “Our arguments about the unworkability of the CMR derogations were captured by this discussion,” he told BeautyMatter.

Existing rules for CMR substances in cosmetics under Article 15 of the CPR, such as requiring a food criterion for derogation, “don't make sense,” the Director General said. There is also no real definition of suitable alternatives or consideration around affordability and whether alternatives are technically feasible or functionally comparable. Deadlines on derogation measures are also murky, he said.

No other sector has to go through such a burdensome and complex administrative process to achieve derogation than when a chemical substance is classified as a CMR in the EU, Chave said. The Omnibus VI, which aims to address this, is therefore widely welcomed by the industry. “The Omnibus VI, as agreed, makes it easier for us to get derogations, and therefore makes it easier for us to continue to innovate with those ingredients, helps us avoid the high costs of reformulation, and helps us to avoid having to replace safe ingredients with inferior alternatives. It's very much welcomed by the industry and a positive development for us.”

Alexander Mohr, President of the Swiss-headquartered International Fragrance Association (IFRA), said the Omnibus VI “matters a great deal” because it shows how decisions on cosmetic or fragrance safety can, and should, be “grounded in robust scientific evidence and transparent processes.”

Under existing frameworks, Mohr said fragrance houses have been dedicating large budgets to reformulation due to ingredient bans that are safe for use in cosmetics, an issue the Omnibus VI addresses by offering a “targeted fix for a non-functional derogation process.”

Under the new framework, the hope, he said, is for fewer procedural bottlenecks, better-targeted decisions on individual ingredients, and less risk that safe materials are removed based on criteria unrelated to actual exposure. “Omnibus VI gives the fragrance industry in Europe legal certainty and provides a perspective to keep innovating with safely used ingredients.”

Omnibus VI Should “Support Innovation”

Dr. Florian Stintzing, President of the international natural and organic cosmetics association NATRUE and CEO of German pharmaceutical and natural cosmetics company Wala Heilmittel, said the Omnibus VI also provides greater legal clarity around Natural Complex Substances (NCSs), such as essential oils and plant extracts, which are central to natural and organic cosmetics.

“These ingredients can contain constituents classified as CMRs, even at very low levels, creating significant uncertainty under the existing framework. The new approach provides a clearer, science-based route for assessing these constituents individually and recognizes that replacing naturally occurring constituents is not always technically or economically feasible,” Stintzing said.

For NATRUE, he said the Omnibus VI package represents “an important step towards a more coherent and workable regulatory framework while maintaining the EU's high level of consumer safety.” The continued role of independent scientific assessment and move towards science-based, proportionate regulation is particularly welcome, he said, alongside efforts to reduce “unnecessary administrative burdens.”

Looking ahead, Stintzing said the Omnibus VI will be beneficial for the industry. “In the EU, we expect greater legal clarity and predictability, particularly around naturally occurring complex substances and the assessment of their constituents. This should support innovation and help companies avoid unnecessary reformulation where safe use can be demonstrated.” Effective implementation, however, will be crucial, he added, so manufacturers should continue to “closely follow regulatory developments.”

Importantly, Chave said the Omnibus VI package is a “pro-competitiveness measure, which does not in any aspect mean deregulation or dilution of consumer protection.”

The European Parliament went ahead and voted in approval of the measures in April 2026, despite widespread fear and misinformation campaigns around CMRs in cosmetics, he said, which is “significant.” “There's always the fear that misinformation can impact these complex decisions, but science came out the winner in this discussion, and I think that's reason for some degree of optimism.”

Wider Impact: Markets and Regulations

For the time being, the UK will not automatically adopt EU Omnibus VI changes. This may, therefore, create some divergence between EU and UK regulatory systems for cosmetic businesses.

According to Stintzing, however, at a global level, the EU framework remains “highly influential,” and could have wider relevance for companies operating internationally in the future.

Mohr agrees that a global impact will likely be seen. “European rules are widely referenced by regulators elsewhere, including in the UK, so a framework anchored in scientific evidence sets a useful precedent internationally. We hope that the principles underpinning Omnibus VI will also be reflected and considered by regulators in the UK and worldwide, reinforcing a shared, science-based approach to cosmetic and fragrance safety.”

Chave said that beyond market influence, the Omnibus VI may also influence other ongoing EU-level regulatory changes. The EU's ongoing evaluation of the Cosmetic Products Regulation (CPR), for example, could potentially be halted given that the Omnibus VI has now addressed the “glaring weaknesses in the CPR and its Article 15,” he said.

“There is no obvious compelling reason from [the] industry's point of view to revise the CPR now that the Article 15 problem has been addressed,” Chave said. “That doesn't mean that improvements can't be made; improvements can be made, but we need to distinguish between the kinds of regulatory changes that are prioritized," and those that are not.

The broader question, said the Director General, is: Does the Omnibus VI signal a wider culture shift in the EU, or is it a very specific example of the European Commission delivering on the competitiveness agenda? For now, he said, “it's too early to tell.”