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Bemotrizinol - BEMT, commercially known as Tinosorb S or PARSOL Shield - is the UV filter that US sunscreen formulators have been watching for years while EU counterparts used it freely. Its regulatory position in the US has been a long-running frustration for sun care development teams who could see what it offered and could not access it under OTC monograph constraints.

That constraint is loosening. And the immediate response from US formulators has been, predictably, to reach for BEMT as the solution to high-SPF development problems that the existing approved filter toolkit makes genuinely difficult.

It is a reasonable instinct. BEMT is a genuinely capable filter with broad UVA and UVB absorption, strong intrinsic photostability, and the kind of versatility that opens formulation options that were previously closed. But the formulators now encountering it for the first time are discovering what their EU counterparts figured out some years ago: adding BEMT to a sunscreen formula is straightforward. Making that formula work is not.

What BEMT Actually Brings to High-SPF Formulation

Before getting into the problems, the capability is real and worth stating clearly.

BEMT absorbs across both UVA and UVB wavelengths with an extinction coefficient high enough that it contributes meaningfully to SPF without requiring the loading levels that push oil-phase composition into formulation difficulty. Its photostability is strong on its own terms - unlike avobenzone, which degrades under UV exposure and requires photostabiliser support to maintain performance over the duration of wear, BEMT retains its absorption profile under UV exposure without significant decomposition.

For high-SPF formulation, where the challenge is consistently reaching SPF 50+ or SPF 100+ without loading the oil phase to the point where emulsion stability, sensory performance, and film formation all start to fail simultaneously, a filter that delivers high efficiency at manageable concentrations is genuinely useful.

And for broad-spectrum formulation, where UVA protection across the full UVA range (UVA1 in particular, above 370nm) has been a persistent gap in US-approved filter chemistry, BEMT extends the absorption window in a way that avobenzone alone does not cover when that avobenzone is photodegrading.

So the filter is good. The formulation challenge is in what happens when it goes into a real sunscreen system.

The Crystallization Problem

BEMT is an oil-soluble filter. It needs to be dissolved in the oil phase of an emulsion to function, and it needs to stay dissolved across the shelf life of the product - through temperature cycling, through storage at elevated temperature, through the freeze-thaw conditions that stability testing imposes.

The solubility behaviour of BEMT is where most first-time encounters with the filter run into trouble. It dissolves adequately in many cosmetic oils at the concentrations needed for high-SPF work. And then, during stability testing, it comes out of solution. The crystals that form are visible under polarised light microscopy before they are visible to the naked eye, which means a formula can look stable for weeks before the crystallization problem becomes obvious in routine stability checks.

Crystallization is not a minor aesthetic issue in a sunscreen. UV filter crystals in a sunscreen film do not provide the same photoprotection as dissolved filter at the same total concentration. The SPF the formula was designed to deliver is not the SPF the crystallized formula actually delivers.

The variables that determine whether BEMT stays in solution through stability are not simply a matter of choosing a sufficiently good solvent. Oil phase composition, total filter loading, the presence and concentration of other oil-phase components including other UV filters, and the processing conditions that determine how the oil phase is assembled all interact with BEMT solubility in ways that require characterisation for each specific formula. There is no universal solvent selection that solves it.

[IMAGE: Polarised light microscopy image of UV filter crystallization in sunscreen emulsion. Alt text: BEMT crystallization sunscreen formulation stability UV filter sunscreen oil phase]

High-SPF Design and the Oil-Phase Loading Problem

The second formulation challenge with BEMT - or with high-SPF design generally - is that building a formula to SPF 50+ or higher requires enough UV filter mass in the formula that the oil phase becomes compositionally complex and physically challenging to stabilise.

Each UV filter added to the system contributes to oil-phase loading. Oil-phase loading affects emulsion droplet size, emulsifier demand, viscosity behaviour, film formation on the skin, and sensory performance. A formula that reaches the target SPF on paper, with the UV filters simply specified and everything else adjusted around them, often produces an emulsion that is either unstable, unacceptably heavy and greasy on application, or both.

The relationship between UV filter system design and the rest of the formula is bidirectional and cannot be managed by optimising each component independently. The emulsifier system that stabilises a low-filter-loading emulsion may not stabilise the same emulsion at high filter loading. The sensory profile acceptable at moderate SPF levels may not be achievable at SPF 100 without reformulation across multiple components simultaneously.

This is why high-SPF development with BEMT is a whole-formula problem, not a UV filter selection problem. The filter package creates the performance potential. Whether that potential is realised depends on how the rest of the formula is designed around it.

Photostability: When It Is Not the Filter That Is the Problem

BEMT is intrinsically photostable. This does not mean that a formula containing BEMT is automatically photostable.

Photostability failures in sunscreens containing BEMT typically do not come from BEMT degrading. They come from other components of the UV filter system degrading in ways that affect the formula's overall UV absorption profile. Avobenzone is the most common case. When avobenzone is present alongside BEMT and photostabilisers, the interactions between all three components under UV exposure determine the photostability of the complete system, not the photostability of any single filter in isolation.

A formula where BEMT and avobenzone are both present, where the avobenzone-BEMT interaction looks promising in isolation, and where photostability testing still shows SPF or UVA protection loss after UV exposure, is failing because the system has not been designed as a system. The concentrations, the ratios, the other oil-phase components that affect filter mobility and interaction, and the film thickness and distribution on the skin all contribute to the photostability outcome.

Getting consistent photostability in a high-SPF BEMT-containing formula requires understanding which variable is responsible for the inconsistency, and that requires a diagnostic framework rather than iterative reformulation without structural analysis.

The US vs EU Regulatory Dimension

For formulators developing products for both US and EU markets, BEMT introduces a regulatory asymmetry that has formulation consequences beyond label claims.

In the EU, BEMT is approved under the Cosmetics Regulation at concentrations up to 10%. The regulatory pathway is established, and EU formulators have years of formulation experience with it at a range of concentrations. In the US, the regulatory position under the OTC sunscreen monograph framework has been the source of the long exclusion. The pathway for BEMT and other non-monograph filters in the US runs through the New Sunscreen Ingredient Application (NSIA) process under the Sunscreen Innovation Act, and the requirements for safety and efficacy data under that route are different from EU approval requirements.

A formulation designed for EU compliance may not translate directly to US market without reformulation, because the approved concentrations, the co-formulable filters, the testing requirements, and the label claims that are permissible differ between the two frameworks. Building a global sunscreen strategy with BEMT at the centre requires navigating both regulatory systems simultaneously, which affects formulation decisions at the development stage rather than the registration stage.

Where the Formula Actually Gets Built

The problems above are not novel for experienced sun care formulators. They are the standard formulation challenges that BEMT-containing high-SPF systems present, and they are solvable with the right framework for working through them.

What they are not is solvable by treating BEMT as a drop-in addition to existing high-SPF formula approaches. The filter changes the formulation space enough that the frameworks that work for existing filter systems need deliberate adjustment to work with BEMT effectively.

US formulators encountering BEMT for the first time now have the same opportunity that EU counterparts recognised years ago: a genuinely capable filter that, when formulated well, produces high-SPF broad-spectrum systems that outperform what was achievable with the previous toolkit. Getting there requires working through the solubility, crystallization, oil-phase composition, photostability, and sensory decisions as a connected system rather than individually.

That is where the formulation work actually is, and it is more specific than most general sunscreen formulation guidance addresses.

About the Expert-led Training

The BEMT High-SPF Sunscreen Formulation Training on OnlyTRAININGS is built for sunscreen formulation scientists, sun care R&D chemists, and development managers working on high-SPF and broad-spectrum systems who need to work with BEMT effectively across US and EU markets.

It covers BEMT formulation strategy, high-SPF UV filter system design, photostability and performance optimisation, emulsion and sensory engineering, hybrid and water-resistant systems, processing and scale-up, SPF and UVA testing, troubleshooting, and US/EU regulatory strategy. Delivered for experienced formulation professionals. Not an introduction to UV filters.

Full training of access. Downloadable training materials. Expert connect via discussion forum for technical solutions and formulation troubleshooting. Training certificate on completion.

Access the Training

Frequently Asked Questions

• Why does BEMT crystallize in sunscreen formulations that initially look stable?
• Is BEMT photostable enough to use without a photostabiliser?
• Can a formula developed for EU compliance with BEMT be used in the US without reformulation?
• What is the most common reason high-SPF BEMT formulas fail sensory performance despite good SPF results?

OnlyTRAININGS delivers specialist technical training for the chemical and allied industries. Trusted by 5,000+ companies globally. View all trainings.

By OnlyTRAININGS | EU Cosmetics Compliance Training

Most cosmetic products that fail EU regulatory review are not poorly formulated. The chemistry works. The performance is there. What fails is the safety documentation - the CPSR is not structured to withstand toxicologist review, the PIF has gaps that surface only during inspection, or the safety assessment does not align with the formulation decisions made three months earlier.

EU Regulation 1223/2009 is not ambiguous about what is required. The difficulty is not knowing the rules. It is translating those rules into safety justification, exposure calculations, and documentation that holds up under real scrutiny, not just paper compliance.

This article covers where experienced teams get this wrong, and why getting it right requires more than reading the regulation.

What EU 1223/2009 Actually Demands

Every cosmetic product placed on the EU market must be safe for human health under normal or reasonably foreseeable conditions of use. That sentence sounds straightforward. The compliance machinery behind it is not.

The regulation requires a Cosmetic Product Safety Report (CPSR) prepared and signed by a qualified safety assessor. It requires a Product Information File (PIF) maintained by the Responsible Person and available to competent authorities on request. It requires CPNP notification before market entry. It requires labeling that aligns with the formulation and the safety assessment. It requires that any claim made for the product is substantiated.

None of these elements can be treated as a final step before launch. Each one depends on decisions made during formulation - which means compliance problems that appear at documentation stage were usually created in the lab weeks or months earlier.

The CPSR: Where Most Products Actually Fail

The Cosmetic Product Safety Report is divided into two parts. Part A is the safety information: the qualitative and quantitative composition, the physicochemical and microbiological specifications, the impurity and trace substance profile, the exposure assessment, the toxicological profile of the ingredients, and the undesirable effects data. Part B is the safety assessor's evaluation: the conclusion on safety, the labeling warnings, the reasoning behind the assessment, and the assessor's credentials and signature.

The document looks structured. The failure modes are not obvious until you understand what a qualified assessor is actually evaluating.

Exposure calculation errors. Margin of Safety calculations depend on getting exposure right. The exposure estimate for a leave-on facial product is not the same as for a rinse-off body wash, and using a generic systemic exposure dose across product categories is one of the most common technical weaknesses in CPSR submissions. When MoS values are borderline, the quality of the exposure reasoning determines whether the assessor can sign or cannot.

Data gap management. Very few formulations have complete toxicological datasets for every ingredient at every relevant endpoint. The accepted approaches for handling data gaps - read-across from structurally similar substances, weight-of-evidence arguments, QSAR predictions - each require specific justification that most documentation teams do not structure clearly. An unsupported data gap is not a minor deficiency. It is a reason the assessor cannot sign Part B.

Impurity and trace substance handling. Raw materials carry impurities. Processing generates trace contaminants. Fragrance mixtures carry undisclosed components. Each of these needs to be identified, characterised, and addressed in the safety assessment. Formulators who treat the declared ingredient list as the complete scope of the CPSR are leaving the most unpredictable risk sources unexamined.

Annex misinterpretation. Annexes II through VI define what is prohibited, what is restricted, which colorants are permitted, which preservatives are permitted, and which UV filters are permitted. The restrictions in Annexes III, IV, V, and VI are product-type and concentration-specific. A preservative that is compliant in a rinse-off product may be non-compliant at the same concentration in a leave-on product. These distinctions have to be resolved at formulation stage, not documentation stage.

The PIF: What Inspectors Actually Look For

The Product Information File is not a folder of supporting documents. It is a structured record that must allow a competent authority to assess the product's safety and regulatory status without requiring anything additional from the Responsible Person.

In practice, PIF inspections surface three categories of weakness consistently.

Claim substantiation that does not support the label. If the product label claims "dermatologically tested," "hypoallergenic," or a specific efficacy outcome, the PIF must contain evidence that substantiates the claim with appropriate methodology. Consumer perception data does not substantiate a clinical claim. A single irritation patch test result does not substantiate a broad "suitable for sensitive skin" claim. The gap between what is on the label and what is in the PIF is where brand reputation and regulatory risk converge.

Stability and microbiological data that does not cover the shelf life claimed. Stability studies need to support the period of time after opening (PAO) marked on the product. Microbiological challenge testing needs to meet the criteria in ISO 11930 and align with the product's preservative system. Stability data generated on a different formula version from the one being launched, or using accelerated conditions only, frequently does not satisfy inspection requirements.

Manufacturing and GMP documentation that cannot be traced. The PIF must include evidence that the product was manufactured in accordance with EU GMP standards (ISO 22716). Where manufacturing is outsourced, the Responsible Person must hold GMP certification for the manufacturer and be able to demonstrate oversight. This is the area where smaller brands and contract manufacturers most commonly leave audit exposure.

The Responsible Person: More Than a Named Contact

Under EU 1223/2009, every cosmetic product placed on the EU market must have a designated Responsible Person established within the EU. This is not a legal technicality. The Responsible Person carries substantive obligations.

The Responsible Person must ensure the CPSR is complete and accurate. They must maintain the PIF and make it available within 10 working days of a competent authority request. They must report serious undesirable effects. They must notify on CPNP. They must ensure that GMP was followed and that the labeling is compliant.

For companies outside the EU using an EU-based Responsible Person under a mandate, the practical question is whether the Responsible Person has sufficient access to the documentation and the manufacturing evidence to actually discharge these obligations. A Responsible Person holding a mandate without visibility into the CPSR quality, PIF completeness, or manufacturing controls is carrying liability they cannot manage.

SCCS Opinions: How to Use Them and When They Create Complexity

The Scientific Committee on Consumer Safety publishes safety opinions on specific cosmetic ingredients, fragrances, nanomaterials, and broader safety topics. These opinions are the primary reference standard for safety assessors evaluating those ingredients.

Using them correctly is not simply a matter of checking whether the SCCS has evaluated an ingredient. The opinion has to be read in full. SCCS opinions frequently contain Notes that restrict the scope of the conclusion, define the exposure scenarios that were evaluated, or identify data gaps that limit the conclusion's applicability. A safety assessor who cites an SCCS opinion as supporting safety without applying the Notes may be relying on a conclusion that does not apply to their specific formulation, product type, or consumer population.

For borderline ingredients, fragrance allergens under the current restriction framework, and nanomaterials, SCCS opinions are not simplifying documents. They are the starting point for a more complex assessment.

CPNP Notification: Where Administrative Errors Create Market Access Risk

The Cosmetic Products Notification Portal notification is required before placing a product on the EU market. The notification is product-specific and must accurately reflect the formulation, the product category, the frame formulation if applicable, the presence of nanomaterials, and the Responsible Person details.

Administrative errors in CPNP notification are more consequential than they appear. An incorrect product category affects which regulatory requirements apply. A missing nanomaterial notification is a direct compliance breach with specific enforcement implications. A mismatch between the notified formulation and the marketed product creates audit exposure. These errors are not difficult to make and are not automatically detected before market entry.

Why Compliance Built Late Always Costs More

The consistent pattern in EU cosmetics regulatory problems is timing. A formulation is developed. At some point before launch, compliance documentation begins. The safety assessor reviews the CPSR draft and identifies that a restricted substance is present above the permitted concentration for the intended product type. Or that the exposure assumptions used for MoS calculation do not match the product's intended use. Or that a key ingredient lacks adequate toxicological data for the relevant endpoint.

At that point, the options are reformulation, additional testing, or revised justification - all of which take time and money that would not have been spent if the regulatory constraints had been applied at the formulation design stage.

EU cosmetics compliance built into the development workflow from the beginning is not more complex than compliance built at the end. It is substantially less expensive, faster to market, and more defensible under inspection.

What the Training Covers

The EU Cosmetics Regulation 1223/2009 Training on OnlyTRAININGS focuses on exactly the gap described above: not the regulation as text, but how experienced professionals translate regulatory expectations into CPSR documentation, PIF structure, and risk-based safety assessment workflows that withstand audit and market scrutiny.

It covers practical CPSR construction including exposure estimation, MoS calculations, toxicological profile evaluation, and data gap management. It covers PIF structure that integrates formulation data, stability, microbiological quality, claim support, and manufacturing controls. It addresses how to interpret Annex II through VI restrictions in formulation decisions, how to apply SCCS guidance to real ingredient scenarios, and how safety assessor decision liability affects documentation practice.

The training includes real case scenarios from industry, CPNP notification strategy, Responsible Person obligations, and a compliance workflow designed for faster, repeatable EU market access across multiple product launches.

Six months of access. Downloadable training materials including slides, Q&A, and FAQ PDFs. Expert connect via discussion forum. Training certificate on completion.

If your team is preparing CPSRs, building PIFs, or managing EU market entry for cosmetic products and finding that the documentation does not hold up the way it should, this training gives you the practical framework to change that.

Access the EU Cosmetics Compliance Training

Frequently Asked Questions

Why does a technically compliant formulation still fail EU regulatory review?
Because EU compliance depends on safety assessment quality and documentation structure, not formulation performance. A product with an acceptable safety profile can fail review if the CPSR does not adequately justify the MoS, handle data gaps, or address impurities. The formulation and the documentation have to tell the same story.

What makes a CPSR fail toxicologist review even when it looks complete?
The most common reasons are MoS calculations based on incorrect or generic exposure assumptions, unresolved data gaps without adequate justification, impurities and trace substances not addressed in the toxicological profile, and Annex restrictions applied at product category level without resolving product-type-specific concentration limits. A CPSR that satisfies a checklist but cannot be defended under questioning is a CPSR that will not get signed.

What does the Responsible Person actually need to be able to do?
The Responsible Person must be able to make the complete PIF available within 10 working days of a competent authority request, report serious undesirable effects within 10 days of becoming aware, and ensure the CPSR is accurate and the product is manufactured to GMP standards. This requires active oversight of documentation quality, not just a named contact on a label.

How do SCCS opinions affect safety assessment for specific ingredients?
SCCS opinions are the primary reference standard for safety assessors evaluating ingredients that the SCCS has reviewed. But the opinion has to be read in full, including any Notes that restrict the scope or define the exposure scenarios evaluated. A conclusion that applies to rinse-off products only, or to specific concentration ranges, does not automatically support a leave-on application at a higher concentration. Misapplying SCCS opinions is one of the technical weaknesses that most commonly undermines otherwise solid CPSR documentation.

When should EU compliance considerations enter the formulation process?
From the beginning, not at documentation stage. Annex restrictions, preservative and UV filter permitted lists, impurity thresholds, and exposure constraints that affect MoS calculation all have direct implications for formulation decisions. Identifying these constraints after a formulation is finalized leads to reformulation, additional testing, or launch delays. Building them into the development workflow from the start eliminates most of the cost and timeline risk of late-stage compliance failures.

OnlyTRAININGS delivers specialist technical training for the chemical and allied industries. Trusted by 5,000+ companies globally. View all trainings.

A significant new package of EU cosmetic ingredient amendments has moved into the formal regulatory process.

On 8 July 2026, the European Union notified the World Trade Organization of draft Commission Regulation G/TBT/N/EU/1219, proposing amendments to Annexes II, III and V of Regulation (EC) No 1223/2009 on cosmetic products. The proposal combines newly harmonised CMR classifications with the outcome of several recent Scientific Committee on Consumer Safety assessments. 

The package has been described within the cosmetics industry as a combination of Omnibus CMR IX and Omnibus Ingredients III. It would introduce new ingredient prohibitions, establish concentration limits for previously unregulated substances, revise the conditions for certain preservatives and remove the remaining cosmetic preservative exemptions for mercury compounds.

However, one point must remain clear from the beginning:

The notified text is still a draft. It has not yet been adopted or published in the Official Journal of the European Union.

The draft still contains placeholders for dates and annex entry numbers. Cosmetic companies should therefore begin preparing for the proposed changes, but final legal decisions should be based on the adopted Regulation when it is published. 

What the draft would change

The proposed Regulation covers four main areas:

1. New Annex II prohibitions resulting from recent CMR classifications.
2. Prohibitions based on SCCS opinions for benzophenones, hair dyes and prostaglandins.
3. New Annex III restrictions for CBD, BHA and nano-hydroxyapatite.
4. Revised Annex V conditions for Butylparaben and Propylparaben, together with removal of mercury-containing preservatives.

The commercial impact will vary considerably by product category. Eyelash serums, CBD skincare, children’s cosmetics, oral-care products, non-oxidative hair dyes and formulas containing BHA are likely to require the most immediate attention.

New CMR-related prohibitions

Article 15 of the EU Cosmetics Regulation generally prohibits substances classified as carcinogenic, mutagenic or toxic for reproduction under the CLP Regulation, unless the strict conditions for an exemption are fulfilled.

Commission Delegated Regulation (EU) 2025/1222 introduced new harmonised classifications. According to the cosmetic draft, no requests were submitted to continue cosmetic use of the affected CMR substances under the exemption provisions. The substances that are not already covered would therefore be added to Annex II of the Cosmetics Regulation. 

The proposed Annex II additions include substances such as:

• Ozone
• Dinitrogen oxide, commonly known as nitrous oxide
• Trimethyl phosphate
• Tetrahydrofurfuryl methacrylate
• Fluoroethylene
• 2-phenylpropene, also known as α-methylstyrene
• 2,3-epoxypropyl isopropyl ether
• Several additional industrial chemical substances covered by the new classifications

These may not appear frequently as intentionally added ingredients in mainstream finished cosmetics. Nevertheless, companies should consider their possible presence in raw materials, processing aids, propellants, monomers, impurities or supplier blends.

Benzophenone-1 would be prohibited

Benzophenone-1 is used as a light stabiliser to protect cosmetic formulations from deterioration caused by ultraviolet radiation.

The SCCS concluded in March 2025 that Benzophenone-1 could not be considered safe for use as a cosmetic light stabiliser. The Committee identified genotoxicity concerns and evidence of endocrine activity, including estrogenic and weak anti-androgenic activity. The draft therefore proposes adding Benzophenone-1 to Annex II as a prohibited cosmetic substance. 

This could affect more than products where Benzophenone-1 is presented as an active or prominent ingredient. It may also appear in:

• Fragrance compositions
• Colour cosmetics
• Formulation stabiliser systems
• UV-sensitive product bases
• Supplier blends intended to protect colour or fragrance stability

Finished-product manufacturers will need to check both their own formulas and the detailed composition of purchased blends.

Benzophenone-2 would also be prohibited

Benzophenone-2 has been used as a UV filter, light stabiliser and fragrance-related ingredient.

The SCCS was unable to conclude that Benzophenone-2 was safe because its genotoxic potential could not be excluded. The Committee also noted limited or unavailable repeated-dose and reproductive-toxicity data, together with clear evidence of estrogenic activity.

The draft responds by proposing a complete Annex II prohibition rather than a concentration restriction. 

This distinction matters. The proposal does not create a lower acceptable use level for Benzophenone-2. Under the notified text, reformulation or removal would be required.

Basic Brown 16 and Basic Blue 99 would be banned

The draft proposes prohibiting two colourants used in non-oxidative hair dye products:

• Basic Brown 16
• Basic Blue 99

The SCCS concluded that the weight of evidence for Basic Brown 16 indicated mutagenic potential. For Basic Blue 99, the available evidence indicated potential genotoxicity. Both substances would consequently be added to Annex II. 

Hair-colour manufacturers should review not only finished formulas but also premixed colour systems and supplier shade blends. A colour mixture may contain one of the affected dyes even where it is not obvious from the commercial name of the blend.

Prostaglandins and their analogues face a broad class prohibition

One of the most commercially important parts of the draft concerns prostaglandins and prostaglandin analogues used in eyelash and eyebrow enhancement products.

The proposal is not limited to one named substance. It would add “prostaglandins and their analogues” as a broad Annex II entry.

The SCCS reviewed ingredients including ethyl tafluprostamide, methylamido-dihydro-noralfaprostal and isopropyl cloprostenate. It concluded that these substances raised safety concerns because of their pharmacological activity, even at very low concentrations, and their potential to cause serious undesirable effects, particularly involving ocular health.

The Committee also highlighted insufficient evidence to exclude reproductive and developmental toxicity concerns. This was considered especially relevant because many users of lash and brow products are women of childbearing age. No conditions of cosmetic use could be established under which the assessed substances were considered safe. 

This means lash and brow brands should not limit their review to ingredients explicitly labelled as “prostaglandin.”

A proper screening exercise should include:

• INCI names
• CAS numbers
• Supplier trade names
• Eyelash-conditioning active blends
• Ingredients making growth or density claims
• Compounds with prostaglandin-like pharmacological activity

The breadth of the proposed wording could make this one of the most disruptive changes in the entire package.

Mercury-containing preservatives would lose their remaining exemptions

Mercury and its compounds are already generally prohibited under Annex II. However, Annex V currently contains limited preservative allowances for Thiomersal and certain phenylmercuric salts.

The draft would remove Annex V entries 16 and 17 and revise the general Annex II mercury entry so that it no longer refers to exceptions for the special cases listed in Annex V. 

The SCCS concluded that the currently permitted preservative uses could not be considered safe. Its assessment identified an inadequate margin of safety based on renal toxicity, while the genotoxicity evidence remained unclear.

These preservatives are unlikely to be widely used in modern cosmetic portfolios, but companies should still check:

• Legacy eye-area products
• Old formulas still marketed in limited volumes
• Specialist preservative systems
• Long-standing supplier specifications
• Products acquired through mergers or brand purchases

CBD would become expressly restricted at 0.19%

The proposal does not impose a general ban on Cannabidiol.

Instead, CBD would be added to Annex III and permitted in:

• Leave-on products
• Rinse-off products
• Oral-care products

The proposed maximum concentration would be 0.19% in the ready-for-use cosmetic product.

The presence of delta-9-tetrahydrocannabinol as an impurity would be limited to 0.00025%, equivalent to 2.5 ppm. 

This would give CBD a clearer ingredient-specific regulatory framework, but it would also introduce demanding impurity controls.

A simple supplier statement declaring a raw material “THC-free” may not provide sufficient evidence. Brands and Responsible Persons may need:

• A quantitative THC specification
• A validated analytical method
• Appropriate limits of detection and quantification
• Batch-specific or risk-based certificates of analysis
• Confirmation of the botanical source and extraction route
• Calculation of CBD concentration in the finished product
• Assessment of every cannabis-derived ingredient contributing THC

The 0.19% limit applies to the ready-for-use finished cosmetic, not merely to the CBD concentration in the purchased raw material.

BHA would be limited to dermal products at 0.07%

Butylated Hydroxyanisole, commonly known as BHA, is used as an antioxidant and may also be present in fragrance compositions or stabilised raw-material blends.

The draft would permit BHA at a maximum concentration of 0.07% in leave-on and rinse-off cosmetic products.

It would not be permitted in:

• Oral-care products
• Products that may expose the end user’s lungs through inhalation

The SCCS assessment addressed dermal use and did not support oral or inhalation-related applications. 

The practical challenge is that BHA may enter a formula indirectly through:

• Fragrances
• Essential-oil blends
• Oil-soluble active preparations
• Colourant dispersions
• Stabilised oils
• Supplier antioxidant packages

Companies may therefore need full compositional information rather than relying only on the finished product’s intentionally added ingredient list.

Sprays, aerosols, powders and other products capable of generating inhalable exposure deserve particular attention.

Nano-hydroxyapatite receives updated permitted conditions

The nano-hydroxyapatite amendment should not be presented simply as a new restriction or prohibition.

The proposal would permit Hydroxyapatite in nano form at:

• Up to 29.5% in toothpaste
• Up to 10% in mouthwash

These concentrations would be subject to strict particle specifications. The permitted material must be composed of rod-shaped particles, with at least 87% by particle number having an aspect ratio of three or less. The remaining particles must have an aspect ratio not exceeding nine.

The particles must also be uncoated, not surface modified and have a specified maximum length of approximately 122 ± 43 nanometres. Applications that may expose the lungs through inhalation would not be permitted. 

For oral-care manufacturers, this may create useful formulation opportunities. At the same time, compliance cannot be demonstrated through a document that simply states “nano-hydroxyapatite.”

Supplier evidence should cover:

• Particle shape
• Particle-number distribution
• Aspect-ratio distribution
• Maximum particle length
• Coating status
• Surface-modification status
• Test methods and representative batch data

These characteristics should also be reflected in the Product Information File and Cosmetic Product Safety Report.

Butylparaben would receive separate and tighter conditions

The draft would separate Butylparaben and Propylparaben into individual Annex V entries.

For Propylparaben, the familiar maximum of 0.14%, expressed as acid, would broadly continue, subject to the existing combined paraben limits and restrictions involving leave-on products for the nappy area of children under three.

Butylparaben would receive its own entry. The general maximum of 0.14% would remain, but products intended for children under ten would be subject to tighter product-specific limits:

• 0.14% in rinse-off products
• 0.002% in leave-on products
• 0.092% in oral-care products

The SCCS conclusion would not apply to sprayable products, including mouth sprays, capable of exposing the lungs. The draft therefore proposes prohibiting Butylparaben in those applications. 

The 0.002% limit for children’s leave-on products is particularly significant. A formula that complies with the general Butylparaben limit could still fail the more specific condition when intended or marketed for children under ten.

Companies should review more than products explicitly labelled “children’s cosmetics.” Relevant products may include:

• Family skincare
• Sensitive-skin lotions
• Multi-age personal-care products
• Products visually marketed toward children
• Products included in children’s gift sets
• Leave-on products routinely promoted for use by the whole family

The intended user group should be assessed through the complete product presentation, not only a single statement on the label.

Two different transition systems are proposed

The draft creates an important distinction between the CMR amendments and the remaining ingredient measures.

CMR-related measures

The amendments linked to classifications under Delegated Regulation (EU) 2025/1222 are intended to apply from 1 February 2027.

Companies should not assume that the longer general transition periods will apply to these CMR prohibitions. 

Other ingredient measures

For the non-CMR ingredient changes, the notified annex proposes:

• A 12-month transition after entry into force for placing non-compliant products on the Union market.
• A 24-month transition after entry into force for continuing to make those products available on the Union market.

The first deadline concerns the initial placement of a product on the EU market. The later deadline concerns continued distribution and sale within the market.

The Regulation would enter into force on the twentieth day following publication in the Official Journal. Because publication has not yet occurred, the final calendar deadlines for these measures cannot currently be calculated. 

The WTO notification process indicates a proposed adoption timetable during late 2026. That timetable remains provisional until the final Regulation is adopted and published. 

What cosmetic companies should do now

Waiting for the final publication before beginning any review could leave insufficient time for reformulation, testing and supply-chain changes.

A practical preparation programme should begin with six activities.

1. Screen the complete portfolio

Search formulas using INCI names, chemical names and CAS numbers.

Do not limit the review to ingredients deliberately added by the finished-product manufacturer. Include fragrance mixtures, colour blends, active preparations, preservatives, impurities and processing-related substances.

2. Prioritise high-impact product groups

The first review should cover:

• Eyelash and eyebrow serums
• CBD skincare and oral-care products
• Children’s leave-on products containing Butylparaben
• Non-oxidative hair dyes
• Products containing Benzophenone-1 or Benzophenone-2
• Formulas containing BHA
• Nano-hydroxyapatite oral-care products
• Legacy products containing mercury preservatives

3. Request more precise supplier declarations

Broad declarations such as “EU compliant,” “THC-free” or “cosmetic grade” may not address the new requirements.

Supplier questionnaires should request substance-specific concentration, impurity and particle-characterisation data.

4. Assess reformulation consequences

Removing an ingredient can affect more than regulatory compliance.

Reformulation may require:

• Stability testing
• Preservative efficacy testing
• Packaging compatibility studies
• Colour-performance testing
• Updated exposure calculations
• Claim substantiation review
• New supplier qualification
• Revised manufacturing instructions

5. Update compliance documentation

Affected products may require changes to:

• Cosmetic Product Safety Reports
• Product Information Files
• Raw-material specifications
• Safety assessment calculations
• CPNP information
• Labels and warnings
• Internal regulatory databases
• Distributor and Responsible Person documentation

6. Separate regulatory dates by substance

Do not create one general deadline for the entire package.

CMR substances, prohibited SCCS-assessed ingredients and restricted ingredients may follow different compliance pathways. Each substance should have its own internal regulatory record, deadline and product-impact assessment.

Final perspective

This draft is more than another routine cosmetics annex update.

It could remove entire ingredient classes from cosmetic use, particularly prostaglandins used in lash and brow products. It would also create precise new limits for CBD and BHA, materially tighten the use of Butylparaben in children’s products and demand much stronger nanomaterial evidence for Hydroxyapatite.

For regulatory and formulation teams, the main lesson is simple: compliance will depend increasingly on what is hidden inside raw-material blends, supplier preparations and impurity profiles, not only on the ingredients deliberately added at the finished-product stage.

The final Regulation may still differ from the WTO-notified draft. Companies should therefore prepare against the proposed requirements while keeping final reformulation, withdrawal and market-transition decisions aligned with the adopted Official Journal text.

Regulatory Updates Matter Only When Teams Can Act on Them

Changes such as these do not affect regulatory teams alone. They influence formulation decisions, raw-material selection, supplier documentation, product safety assessments, testing programmes, claims and market-transition planning.

That is where OnlyTRAININGS helps.

OnlyTRAININGS provides advanced, expert-led training for cosmetic formulators, R&D professionals, regulatory specialists, product developers and technical decision-makers who need more than a summary of changing regulations.

Our cosmetics training programmes focus on the practical questions professionals face every day:

• How should an affected formulation be screened?

• Which supplier documents are no longer sufficient?

• When is reformulation actually required?

• What evidence should be added to the CPSR and PIF?

• How can regulatory, safety and performance requirements be managed together?

Whether you are developing a new cosmetic product, reviewing an existing portfolio or preparing for upcoming EU requirements, OnlyTRAININGS helps your team move from regulatory awareness to informed technical action.

Build Stronger Cosmetic Formulation and Compliance Decisions

Explore advanced cosmetics training programmes covering formulation, ingredient safety, regulatory compliance, product performance, scale-up and troubleshooting.

Explore Cosmetics Trainings at OnlyTRAININGS

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Regulatory status checked on 17 July 2026. This article discusses a draft regulatory measure and should not be treated as legal advice.

EU cosmetics regulation 2026, EU cosmetic ingredient restrictions, Omnibus CMR IX, Omnibus Ingredients III, cosmetic ingredient bans EU, prostaglandins cosmetics ban, CBD cosmetics EU limit, BHA cosmetics restriction, Butylparaben children products, Benzophenone-1 ban, Benzophenone-2 ban, nano hydroxyapatite cosmetics

Responsible sourcing is no longer limited to choosing a supplier with the right certificate.

For a global chemical company, it now involves tracing raw materials back through complex supply networks, examining environmental and human-rights risks, supporting suppliers that need to improve and determining whether renewable or circular alternatives can be introduced without disrupting production.

BASF’s latest responsible-sourcing activities show how this transition is taking shape across palm oil, coconut oil, castor oil and circular chemical feedstocks.

The company’s approach also demonstrates something procurement teams across the chemical industry are increasingly discovering: sustainability cannot be managed as a separate reporting exercise. It must be built into supplier selection, purchasing conditions, risk assessments, technical decisions and long-term supply relationships.

Traceability Comes Before Improvement

A company cannot properly manage a raw-material risk when it cannot identify where that material originated.

This is particularly important for palm oil and palm kernel oil. These renewable raw materials are widely used to manufacture ingredients for personal care products, detergents, cleaning formulations and other chemical applications. Their supply chains can extend from small agricultural producers to mills, processors, traders and chemical manufacturers.

In 2025, BASF traced 97.7% of its palm-based raw-material volume back to the oil-mill level. The company describes this level of visibility as an important contribution to supply-chain transparency and risk management.

Traceability does not automatically prove that every stage of the supply chain is sustainable. It does, however, give procurement teams a clearer foundation for identifying high-risk locations, examining sourcing practices and engaging suppliers where problems are found.

Without that visibility, sustainability commitments remain difficult to verify.

Certification Progress Has Not Followed a Straight Line

BASF’s 2025 results also reveal the practical difficulty of meeting responsible-sourcing targets when certified raw materials are not available in sufficient quantities.

The company reported that 79.2% of the palm oil and palm kernel oil it purchased during 2025 came from certified sources. That was significantly below the 98.1% recorded in 2024.

BASF attributed the reduction partly to limited availability of Roundtable on Sustainable Palm Oil-certified palm kernel oil. The company also said that the implementation of the EU Deforestation Regulation had contributed to shortages of materials suitable for the European market.

Rather than abandoning its commitment, BASF says it intends to continue increasing certified volumes where commercially and technically possible. RSPO certification remains its preferred standard.

The company has also moved its target for sourcing fully certified key palm derivatives to 2030. Those derivatives present an additional challenge because the palm material may have passed through several processing and transformation stages before entering a chemical formulation.

This is a useful reality check for the wider industry.

Responsible sourcing targets are necessary, but they cannot be achieved through procurement policy alone. Availability, regional regulation, supplier capability, segregation systems, certification capacity and commercial viability all influence whether a company can obtain compliant material at the required scale.

Responsible Sourcing Extends Beyond Palm Oil

BASF’s Care Chemicals business also uses other renewable oils, including coconut and castor oil, in products for cosmetics, personal care, detergents and industrial applications.

Each raw material presents a different set of sourcing risks.

Coconut supply chains often involve smallholders and geographically fragmented production. Responsible sourcing therefore requires more than checking the country of origin. It may involve certification, agricultural practices, working conditions and the economic resilience of farming communities.

Castor oil presents another distinct challenge.

India is central to the global supply of castor beans, while the oil itself is used across plastics, coatings, cosmetics, pharmaceuticals and several specialty chemical applications. BASF has participated in the Sustainable Castor Initiative, known as Project Pragati, since 2016.

The initiative brings BASF together with Arkema, Jayant Agro-Organics and the civil-society organisation Solidaridad. Its purpose is to address social, environmental, health and safety risks associated with castor cultivation.

Participating farmers receive training in areas such as:

• Safer use of crop-protection products

• Improved agricultural and cultivation practices

• Soil protection and crop management

• Occupational health and field safety

• Personal protective equipment

• Social and labour-related expectations

The work contributed to the development of SuCCESS, or Sustainable Castor Caring for Environment and Social Standards. The independently auditable framework covers 11 principles related to responsible castor production.

This approach goes beyond demanding compliance from farmers. It attempts to increase the capability of the supply chain to meet the required standard.

That difference matters.

A procurement system based only on supplier exclusion may remove an immediate risk from one company’s portfolio, but it does not necessarily improve conditions at the source. Supplier development, technical support and farmer training can create a more durable improvement.

Supplier Expectations Must Be Built Into Procurement

BASF’s wider procurement model requires suppliers to comply with applicable laws and internationally recognised environmental, social and governance standards.

Its Supplier Code of Conduct covers areas including:

• Environmental protection

• Human and labour rights

• Child and forced labour

• Occupational and social standards

• Anti-discrimination

• Anti-corruption

• Expectations for subcontractors and upstream suppliers

BASF states that suppliers are evaluated on more than price and commercial performance. The company also examines environmental, social and governance factors and expects suppliers to promote similar principles within their own supply chains.

The company uses a risk-based approach rather than treating every supplier identically. Country risk, industry risk, material criticality and BASF’s ability to influence the supplier can all affect the level of scrutiny applied.

Evaluations are conducted through mechanisms including EcoVadis assessments, Together for Sustainability audits and selected Responsible Care audits. When weaknesses are identified, corrective-action plans and follow-up reviews are used to track improvement.

In 2025, BASF reported that 100 sustainability audits were conducted at raw-material supplier sites on its behalf. It also received EcoVadis assessments for 257 suppliers considered to have potential sustainability risks.

The model combines four elements:

Define the expectation. Suppliers need clear environmental, ethical and social requirements.

Identify the risk. Procurement teams must know which materials, countries and suppliers require greater attention.

Verify performance. Questionnaires alone may be insufficient where the exposure is significant.

Correct or escalate. Findings must lead to improvement plans, commercial consequences or, in serious cases, termination of the relationship.

Collaboration Can Reduce Repeated Supplier Assessments

BASF is also a founding member of Together for Sustainability, an initiative created by chemical companies to improve and standardise sustainability assessments across the industry.

Under the model, suppliers can be assessed using a shared framework rather than repeatedly completing different questionnaires and audits for every customer. Participating procurement teams can use recognised assessment information through a common system.

This offers two potential benefits.

First, it reduces duplicated work for suppliers serving multiple chemical companies.

Second, it creates greater consistency in how environmental, social, labour and governance performance is evaluated.

For responsible sourcing to scale across the chemical industry, this type of shared infrastructure may be essential. Thousands of suppliers cannot practically respond to entirely different assessment methods, evidence requests and audit expectations from every customer.

Standardisation does not remove the need for company-specific due diligence, but it can make the underlying process more efficient.

Circular Feedstocks Are Becoming a Sourcing Decision

Responsible sourcing is also beginning to influence the type of carbon and feedstock entering chemical manufacturing.

In 2024, BASF and Encina Development Group announced a long-term agreement for the supply of circular benzene produced from post-consumer plastic waste. BASF intends to use the chemically recycled material within its Ccycled product portfolio.

This expands the procurement question beyond whether a conventional feedstock was sourced responsibly.

Companies must now also consider:

• Whether recycled or renewable feedstocks are available

• How their origin and chain of custody will be verified

• Whether the material meets process and purity requirements

• How circular content will be allocated and documented

• Whether supply is sufficient for commercial production

• How sustainability claims will be supported

Circular sourcing therefore requires close coordination among procurement, R&D, production, quality, sustainability and regulatory teams.

A material may appear attractive from a sustainability perspective but still require extensive technical qualification before it can enter a chemical process. Similarly, a technically suitable material may not support a defensible sustainability claim if its sourcing and allocation records are inadequate.

Procurement Partnerships Can Enable Lower-Carbon Production

BASF’s work with Siemens Energy provides another example of procurement supporting a wider production transition.

In March 2025, BASF commissioned a 54-megawatt proton-exchange-membrane water electrolyser at its Ludwigshafen site. The system was built in cooperation with Siemens Energy and has an annual production capacity of up to 8,000 metric tonnes of hydrogen.

The electrolyser is integrated directly into the site’s chemical-production infrastructure. Hydrogen produced using renewable electricity can be supplied through the existing hydrogen network and used as a raw material for chemical products with a reduced carbon footprint.

BASF estimates that the project has the potential to reduce greenhouse-gas emissions at the Ludwigshafen site by up to 72,000 metric tonnes annually.

Although this is a manufacturing project, it also illustrates the strategic role of sourcing and supplier collaboration.

The transition to lower-carbon chemicals depends not only on laboratory innovation. It requires companies to procure new technologies, secure alternative energy and feedstock inputs, establish qualified partnerships and integrate them into existing production systems without compromising continuity.

What Other Chemical Companies Can Learn

BASF’s approach does not suggest that responsible sourcing has become simple or that every target has been achieved.

Its 2025 palm-certification result shows the opposite. Even a large global organisation can face shortages, regulatory complications and limited availability of materials that meet the preferred sustainability standard.

The more important lesson lies in how responsible sourcing is being managed.

It is increasingly treated as a continuous operating system built around:

• Supply-chain traceability

• Material-specific sourcing policies

• Supplier codes and contractual expectations

• Risk-based assessments and audits

• Corrective-action management

• Smallholder and supplier development

• Cross-industry assessment frameworks

• Circular and renewable feedstock qualification

• Collaboration between procurement and technical teams

For chemical companies, the challenge is no longer deciding whether sustainability belongs in procurement.

The challenge is converting broad commitments into repeatable sourcing decisions that can survive technical review, supplier disruption, regulatory scrutiny and commercial pressure.

Turn Industry Developments Into Better Technical Decisions

Responsible sourcing, circular feedstocks and supply-chain transparency are changing how chemical companies select materials, qualify suppliers, manage compliance and plan future products.

Keeping up with these developments is useful. Knowing how to apply them within R&D, procurement, regulatory, quality and manufacturing decisions is what creates business value.

OnlyTRAININGS provides expert-led technical training for professionals across the chemical and allied industries. Its training portfolio covers sustainability and green chemistry, formulation, materials, regulatory compliance, processing, industrial problem-solving, artificial intelligence and emerging technologies.

Whether your team is responding to new sourcing requirements, evaluating alternative raw materials, strengthening regulatory capability or preparing for the next shift in chemical manufacturing, the platform is designed to help turn industry knowledge into practical action.

The Chemical Industry Is Changing. Is Your Team Keeping Up?

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