The EU's Chemical Strategy is Reshaping Beauty and Fragrance Regulation

by Eoghan Gallagher

Summary

Regulatory pressures in the European Union are rapidly reshaping the landscape for cosmetics and fragrance companies. New hazard classes under the CLP Regulation, early national classification proposals, and forthcoming reforms to REACH and the Cosmetics Regulation are accelerating restrictions on a wide range of ingredients, including many natural complex substances. This article explains how these developments are unfolding, why classification outcomes remain uncertain, and what companies should expect in the coming years as reformulation demands and supply-chain delistings increase. It also highlights how EU decisions often influence policy trends in the United States, particularly in California.

Discussion

Few sectors are feeling the effects of the European Union’s Chemical Strategy for Sustainability (CSS) as quickly or as directly as the beauty and fragrance industry. While companies in the United States are adapting to MoCRA and a growing patchwork of state chemical laws, nothing in the United States approaches the scale of the structural overhaul now underway in Europe.

The CSS is one component of the European Green Deal, which is the Union’s broader strategy for achieving climate neutrality and a zero-pollution economy by 2050. The Green Deal integrates initiatives on waste reduction, circular economy systems, emissions cuts, and pollution prevention. The CSS provides the chemical dimension of this framework. Its purpose is to reduce human and environmental exposure to harmful substances, support substitution of high-concern chemicals, and align chemical policy with long-term sustainability objectives. As a result, the CSS is not a standalone initiative. It is part of a coordinated regulatory plan intended to reorient multiple sectors of the economy, including cosmetics and fragrance.

The cosmetics industry is already dealing with accelerated hazard classifications, tightening fragrance restrictions, and supply-chain delistings. Yet some of the most consequential decisions that will define long-term ingredient viability have not yet taken effect.

Three developments in particular are driving the shift. These include major amendments to the CLP Regulation that introduce new hazard classes, CSS-driven legislative reforms such as the One Substance, One Assessment (OSOA) package and a forthcoming revision of REACH, and aggressive Member State classification activity that is moving faster than EU-level legislation.

1. CLP Has Entered a New Phase That Will Reshape Formulation

Commission Delegated Regulation (EU) 2023/707 introduced several new hazard classes into the CLP Regulation. These include endocrine disruptors for human health and for the environment, Persistent Bioaccumulative and Toxic (PBT and vPvB), and Persistent Mobile and Toxic (PMT and vPvM). The new classes are already law, and transitional deadlines run through 2026 to 2028.

The implications for beauty and fragrance are clear. More substances will meet high-concern hazard criteria. Many fragrance materials and natural constituents fall within structural groups that increase the likelihood of future classification. Even early proposals influence supplier behavior well before classifications become enforceable.

Suppliers and fragrance houses have already begun phasing out ingredients that may fall under these new hazard categories. This is occurring well in advance of legal deadlines and reflects a shift in perceived regulatory risk rather than final regulatory text.

Although the new hazard classes and their legal criteria are now defined in CLP, and ECHA has updated its guidance to explain how the criteria should be applied, practical implementation is at an early stage. Companies are only beginning to see how Member States and the Risk Assessment Committee will use these criteria in real cases. There is no single test that assigns a substance to an endocrine disruptor or PMT category. Instead, authorities rely on weight-of-evidence, environmental fate data, and existing test guidelines. This combination of binding rules and evolving practice makes forward planning difficult. Formulators know that more substances will be captured, but it is not yet clear which specific ingredients will be classified or how conservatively the new criteria will be interpreted.

2. Essential Use Is Not Binding Yet but Already Influencing Policy

The CSS commits Europe to phasing out the most harmful substances unless their use is considered essential for health, safety, or critical societal needs. In April 2024, the European Commission published a Communication outlining the guiding principles for the essential use concept. The Communication is not binding law, but it is already influencing regulatory discussions, particularly for PFAS and chemicals with endocrine-disruptor or environmental persistence concerns.

A revision of the Cosmetics Regulation is planned as part of the CSS. It is expected to align cosmetics legislation with the new CLP hazard classes, strengthen allergen and ingredient transparency requirements, modernize oversight of nanomaterials, and improve risk-management processes. The proposal has been delayed several times and is now expected during the 2025 to 2026 legislative window.

The forthcoming revision of REACH, although repeatedly delayed, is also expected to incorporate essential use logic into authorization and restriction decisions. Although details remain under negotiation, companies should anticipate a more structured link between hazard identification and market access.

3. Member States Are Moving Faster Than EU-Level Legislation

A defining feature of the CSS era is the speed at which Member States are submitting classification proposals intended to become Harmonised Classifications under CLP. France, Germany, Denmark, Sweden, and the Netherlands have been especially active. Their proposals often arrive years before EU-wide decisions and frequently apply the new hazard classes or grouping approaches that target entire families of structurally related chemicals.

These proposals can have immediate commercial consequences. Suppliers may delist or limit materials when a Member State signals concern. IFRA may adjust internal assessments. Brands receive early warnings about ingredient viability.

A broader challenge is the expanding use of grouping to evaluate and restrict chemicals. In principle, grouping can improve efficiency by examining structurally related chemicals together. In practice, grouping has at times given structural similarity more weight than actual toxicological evidence. The experience with the Lilial-adjacent substances illustrates this concern. Favorable or incomplete data has sometimes been treated as less influential than the assumption that structurally similar molecules must produce similar outcomes. This marks a departure from traditional EU practice, which historically emphasized substance-specific evaluation supported by measured toxicological endpoints.

The OSOA legislative package will reinforce this acceleration. OSOA reorganizes the way EU agencies conduct chemical evaluations and is intended to eliminate duplicate assessments across ECHA, EFSA, and other bodies. As OSOA is implemented, hazard classifications are expected to move through the system more quickly and with greater alignment across regulatory sectors.

In practice, the regulatory market now moves ahead of the law. Companies that wait for final EU decisions often find themselves reacting rather than planning.

4. The Fragrance Palette Is Contracting and This Is Only the Beginning

New hazard classes, Member State actions, and anticipated REACH changes have already begun to narrow the range of viable fragrance materials. The 51st Amendment to the IFRA Standards is the most recent update to fragrance restrictions. While it is not directly driven by the CSS, it illustrates the ongoing reduction of available fragrance materials. This trend is expected to accelerate in future IFRA amendments as new EU hazard classes and regulatory pressures are integrated. Final transition deadlines for the 51st Amendment run through October 30, 2025.

The regulatory pressure on fragrance materials, particularly those with endocrine-disruptor potential or environmental persistence characteristics, is structural rather than temporary. Further contraction is expected.

This dynamic is especially visible with naturals and natural complex substances.

5. Naturals at Risk: How CSS and CLP Are Reframing Botanical Ingredients

For many years, natural ingredients were regarded as inherently safer and less controversial than synthetics. The CSS has reversed that assumption. Many naturals and natural complex substances, including essential oils, oleoresins, CO2 extracts, absolutes, resinoids, tinctures, and other botanical materials, contain constituents that may qualify for endocrine-disruptor or PMT or PBT classification.

Hazard classification applies to the substance itself. Its origin, whether natural or synthetic, does not alter the classification. This places botanical materials squarely within the scope of CSS implementation.

The result is a widening gap between hazard-based classification and risk-based fragrance and botanical safety assessments that consider real-world exposure. This tension is visible in regulatory working groups, and one example illustrates the issue clearly.

Case Study: p-Cymene and the Collision Between CSS and Naturals

p-Cymene is a naturally occurring aromatic hydrocarbon found in dozens of natural complex substances used in perfumery, cosmetics, and foods. These include cumin seed oil, certain oregano oils, ajowan, thyme, tea tree, black pepper, basil, coriander, marjoram, caraway, orange, bergamot, grapefruit, lemon, nutmeg, fennel, and angelica root.

In some chemotypes, particularly black cumin seed oil, p-cymene has been reported at concentrations approaching the mid-thirty percent range. In more common fragrance materials, such as oregano or thyme oils, p-cymene levels typically fall into the low double-digit range.

Sweden has submitted a proposal to classify p-cymene as a Reproductive Toxicant Category 1B under the CLP Regulation. The proposal remains under review. If adopted and implemented in a future CMR Omnibus, p-cymene would normally be prohibited for use as an intentionally added cosmetic ingredient under Article 15 of the Cosmetics Regulation unless a derogation is granted.

Because Article 15 applies to the classified constituent rather than its natural origin, any botanical material intentionally added to a cosmetic formulation that contains p-cymene could also fall within scope. This includes essential oils, CO2 extracts, oleoresins, and other botanical preparations.

The European Commission’s Cosmetics Working Group is evaluating how to address natural materials that contain constituents proposed for CMR 1B classification. No final regulatory approach has been adopted.

This situation highlights a regulatory divergence. The risk from dietary exposure to p-cymene in foods such as cumin, citrus peels, herbs, and spices is likely to exceed the risk from dermal exposure arising from cosmetic use. Yet cosmetics would be the first category required to remove these materials if p-cymene receives a CMR 1B classification.

6. What to Expect Over the Next Several Years

A. Transition to New CLP Hazard Classes and the Reformulation Burden

Companies will need to reclassify mixtures, update labels and safety documents, and integrate the new hazard classes into safety assessments. As substances are reclassified or withdrawn by suppliers, reformulation will become the most significant consequence. Many fragrance materials, solvents, and naturals may no longer remain commercially viable, which will force brands to redesign products and manage long development timelines with limited alternatives. As more materials are withdrawn or restricted, perfumers will face a shrinking palette and increasing difficulty recreating established fragrance profiles. Substitutions can maintain safety and compliance, but they cannot always replicate the original olfactive character, which means some fragrances may begin to smell different over time.

B. A REACH Revision That Reshapes Market Access

The revision is expected to expand grouping, broaden generic risk management, and integrate essential use logic. It will likely introduce new data requirements and accelerate restrictions on high-concern substances.

C. Continued Early Activity from Member States

National authorities will continue submitting early classification proposals that influence supply chains and formulation decisions long before EU-wide classifications are finalized.

D. Ongoing Supply-Chain Self-Regulation

Suppliers will continue removing or limiting ingredients before legal deadlines. Many materials will become commercially unavailable rather than explicitly prohibited.

Conclusion

The Chemical Strategy for Sustainability represents a significant shift in European chemical policy. Hazard-first classification, new CLP hazard classes, expanded grouping, and essential use logic will continue to influence ingredient viability. However, the future for natural complex substances remains uncertain. Strong industry advocacy, a growing awareness of the economic and cultural importance of botanicals, and a recent political shift toward more industry-aware policymaking may moderate how CSS principles are ultimately applied to naturals.

Industry engagement and scientific debate are likely to play important roles in shaping the final framework. Companies should prepare for scrutiny of natural materials while recognizing that the eventual policy direction remains open. It is also important to consider that regulatory developments in the European Union often influence the United States. California in particular has a long history of adopting chemical policies and ingredient restrictions that mirror or draw upon EU precedents, which means that CSS-related decisions may ultimately affect the U.S. market as well. In this environment, monitoring, engagement, and regulatory forecasting will be essential for maintaining EU and U.S. market access.