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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.

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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.

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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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For decades, per- and polyfluoroalkyl substances, better known as PFAS, were treated as one of modern chemistry’s great success stories.

They helped cookware resist grease. They kept rain from soaking through clothing. They protected carpets from stains, improved the performance of firefighting foams and supported demanding applications across electronics, aerospace, construction and manufacturing.

The same chemical stability that made PFAS commercially valuable, however, created an environmental problem that the United States is only beginning to confront.

Many PFAS do not break down easily after entering the environment. They can travel through water, accumulate in people and animals, and remain present long after the product or industrial process that released them has disappeared. That persistence is why they are commonly called “forever chemicals.”

The United States now faces a complicated challenge. PFAS contamination has already reached drinking water, farmland, wastewater, food supplies and human blood. Regulators must therefore manage historic pollution while also deciding how much future PFAS use should be permitted.

A Chemical Family, Not a Single Chemical

PFAS is not the name of one substance. It describes a large and chemically diverse family containing thousands of synthetic compounds.

The National Institute of Environmental Health Sciences notes that PFAS have been used since roughly the 1950s. Applications include food packaging, nonstick cookware, stain-resistant carpets, water-resistant textiles and firefighting foam. The same source reports that the EPA’s CompTox database contains nearly 15,000 PFAS chemicals.

Not every PFAS has the same toxicity, mobility or persistence profile. Some have been studied extensively, while others have very limited publicly available health data.

This creates a fundamental regulatory difficulty. Studying, assessing and regulating thousands of substances one at a time could take decades. During that period, replacement chemicals may enter the market faster than regulators can evaluate them.

Several well-known PFAS, including PFOA and PFOS, have been largely phased out of domestic production. Their disappearance from some manufacturing processes has not removed them from the environment. They remain in contaminated soil, groundwater, wastewater, sediment and waste-disposal sites.

Meanwhile, shorter-chain PFAS and alternative substances such as HFPO-DA, commonly called GenX, have been introduced for some of the same performance purposes.

The result is not the end of PFAS exposure. It is a changing exposure profile.

Why PFAS Contamination Became So Widespread

PFAS contamination does not come from one industry or one type of product.

Manufacturing facilities may release PFAS through wastewater, emissions, spills or waste disposal. Airports, military installations and firefighting-training areas have historically used PFAS-containing aqueous film-forming foam. Landfills can generate contaminated leachate. Wastewater-treatment facilities may receive PFAS from industries, commercial operations and households.

Consumer products create additional pathways. PFAS-treated materials eventually become waste. They may be washed, discarded, recycled, incinerated or sent to landfills. At each stage, PFAS can move into another environmental system.

Once contamination reaches water, it can travel far beyond the original release point.

Human exposure can occur through drinking water, food, household dust, occupational contact and the use or disposal of PFAS-containing products. PFAS in contaminated soil or water may also enter crops, livestock, fish and other parts of the food chain.

The FDA confirms that environmental PFAS can reach food through crops and animals grown or raised in contaminated areas. Smaller amounts may also enter food through processing equipment and cookware.

The Contamination Is Already Inside Us

PFAS exposure is not limited to communities located beside chemical plants.

National biomonitoring data cited by the National Institute of Environmental Health Sciences found PFAS in the blood of approximately 97% of Americans. Blood levels of older chemicals such as PFOA and PFOS have fallen since major phase-outs began, but newer PFAS remain difficult to track comprehensively.

Drinking water is one of the most concerning exposure routes because it can create continuous, long-term contact.

A U.S. Geological Survey study estimated that at least 45% of American tap water could contain one or more of the PFAS included in its testing programme. The researchers tested only a fraction of the chemicals that fall within the broader PFAS family, meaning the study did not represent every possible PFAS contaminant.

Contamination is frequently associated with urban areas, industrial activity, wastewater facilities, airports, military sites and locations where firefighting foam has been used. Private-well users face an additional challenge because private wells are not regulated in the same way as public drinking-water systems.

What the Health Research Shows

PFAS science continues to develop, and it is important not to treat every compound as though it has an identical health profile.

Nevertheless, research on several widely detected PFAS has produced serious concerns.

The National Institute of Environmental Health Sciences reports possible links between exposure to certain PFAS and increased risks of some cancers, changes in metabolism and body-weight regulation, reduced immune-system function, thyroid effects and liver damage. The National Toxicology Program has concluded that PFOA and PFOS can suppress antibody responses and present a hazard to human immune-system function.

Health research does not mean that every exposed person will develop disease. Individual risk depends on the PFAS involved, exposure level, duration, age, occupation, health status and other environmental factors.

The concern is that exposure may begin before contamination is discovered and continue for years before a water system, community or household receives clear information.

The First Federal Drinking-Water Standards

In 2024, the EPA established the first nationally enforceable drinking-water limits for several PFAS.

The rule set maximum contaminant levels of 4 parts per trillion for PFOA and 4 parts per trillion for PFOS. It also established limits of 10 parts per trillion for PFHxS, PFNA and HFPO-DA, along with a hazard-index approach for mixtures containing two or more of PFHxS, PFNA, HFPO-DA and PFBS.

These concentrations are extremely small, but PFAS regulation operates at such low levels because of persistence, long-term exposure and the health evidence associated with specific compounds.

The rule required public water systems to monitor for regulated PFAS, report results and take corrective action where concentrations exceeded the applicable standards.

For communities that had spent years requesting federal action, the rule represented a major change. PFAS contamination was no longer only an advisory issue. It had become an enforceable drinking-water requirement.

The Federal Position Is Now Shifting

The regulatory direction changed again in 2025 and 2026.

The EPA announced that it would retain the 4-parts-per-trillion standards for PFOA and PFOS. However, in May 2026, the agency proposed two significant changes.

First, it proposed a framework that could give eligible public water systems additional time to meet the PFOA and PFOS standards. The existing compliance date is April 26, 2029. Under the proposed exemption framework, qualifying systems could receive up to two additional years, potentially moving their deadline into 2031. The EPA cited financing, infrastructure construction, operator availability and technical challenges, particularly for smaller and rural water systems.

Second, the EPA proposed removing the federal drinking-water standards for PFHxS, PFNA, HFPO-DA and the mixture-based hazard index that includes PFBS.

The agency argues that the earlier standards were adopted through an improper regulatory sequence under the Safe Drinking Water Act. Importantly, the proposal is based on the EPA’s current legal interpretation of the rulemaking process, not on a finding that the chemicals are harmless. The agency’s own proposal acknowledges evidence connecting these substances with developmental and reproductive toxicity, immune suppression, liver damage and thyroid disruption.

As of July 16, 2026, these remain proposed changes rather than fully completed reversals.

That distinction matters. It also demonstrates how PFAS protections can be influenced not only by toxicology, but by statutory interpretation, administrative procedure, implementation costs and changes in political leadership.

Why the Debate Extends Beyond PFOA and PFOS

PFOA and PFOS are the most recognised PFAS, but they represent only a small part of the chemical family.

PFHxS has raised concerns about thyroid, developmental and immune effects. PFNA has been studied for potential developmental, liver and reproductive effects. HFPO-DA, or GenX, was developed as an alternative processing chemical but has itself become a subject of health and environmental scrutiny. PFBS has frequently been used as a shorter-chain replacement, yet health assessments have also identified potential risks.

The larger policy question is therefore not simply whether PFOA and PFOS should be controlled.

It is whether regulators can prevent a repeating cycle in which one PFAS is restricted, another takes its place, and years pass before the replacement receives an equivalent level of scientific and regulatory attention.

Regulating individual chemicals may offer greater chemical-specific precision. Regulating PFAS as groups or classes may provide faster protection against regrettable substitution. Both approaches involve trade-offs, but the current system remains heavily fragmented.

PFAS Does Not Stop at the Water-Treatment Plant

Removing PFAS from finished drinking water is necessary, but water treatment addresses contamination after it has already entered the environment.

That creates two additional problems.

First, treatment technologies such as granular activated carbon, ion exchange and reverse osmosis capture PFAS rather than automatically destroying them. The contaminated material still requires management, disposal or destruction.

Second, wastewater-treatment plants generally receive PFAS from upstream sources. They were not originally designed to destroy this family of chemicals.

PFAS can therefore move from industrial or household wastewater into treated effluent and sewage sludge. When that sludge is applied to agricultural land, contamination may move into soil, groundwater, crops or livestock.

In January 2025, the EPA released a draft risk assessment examining PFOA and PFOS in sewage sludge that is applied to land, placed in sludge landfills or incinerated. The assessment reflects federal concern that biosolids management may create additional human and environmental exposure pathways.

The EPA has also recommended identifying industrial dischargers, monitoring sewage sludge and using pretreatment programmes to reduce PFAS before it reaches municipal wastewater systems.

This leads to a basic but important principle: controlling PFAS at the source is generally more effective than asking farms, municipalities and drinking-water systems to manage contamination after release.

Changes in Food Packaging

Some product categories have already begun moving away from PFAS.

The FDA announced in February 2024 that PFAS-containing grease-proofing agents were no longer being sold for use in paper and paperboard food packaging in the United States. In January 2025, the agency determined that 35 related food-contact notifications were no longer effective because manufacturers had abandoned those uses.

This represents meaningful progress, but it does not eliminate PFAS exposure through food.

Food may still become contaminated through polluted water, soil, animal feed, processing environments or cookware. Imported articles and older products may also complicate enforcement and supply-chain control.

The packaging phase-out nevertheless shows that removing an unnecessary PFAS application is possible when regulators, manufacturers and downstream users act together.

States Are Moving Faster Than the Federal Government

With federal PFAS policy focused largely on specific chemicals and particular exposure routes, states have developed a much broader collection of restrictions.

State laws now address PFAS in apparel, carpets, cleaning products, cookware, cosmetics, dental floss, firefighting foam, food packaging, juvenile products, menstrual products, ski wax and textiles. Some states have adopted wider product-based restrictions that will be phased in over several years.

These laws are gradually changing national markets.

A manufacturer may decide that maintaining separate PFAS-containing and PFAS-free product lines for different states is commercially impractical. A restriction adopted in one large market can therefore influence products sold across the country.

The disadvantage is regulatory fragmentation. Definitions, exemptions, reporting requirements, testing methods and implementation dates may vary considerably between states.

For companies operating nationally, PFAS compliance is becoming a supply-chain and product-stewardship challenge, not simply a matter for the environmental department.

Who Should Pay for Cleanup?

PFAS remediation can be extremely expensive.

Communities may need new treatment plants, replacement wells, contaminated-soil management, long-term monitoring and medical or public-health support. Determining who should bear those costs has become a major legal and political question.

In 2024, the EPA designated PFOA and PFOS as hazardous substances under the federal Superfund law. The designation allows the agency to require reporting of qualifying releases and strengthens its ability to pursue parties responsible for investigation and cleanup costs.

The designation remains in place, although questions continue about how liability should apply to manufacturers, industrial users, landfills, wastewater facilities, water utilities and other organisations that received PFAS-containing materials without producing the chemicals themselves.

The principle that polluters should contribute to cleanup is widely supported. Applying that principle fairly across a complex, decades-old supply chain is much harder.

Treatment Cannot Replace Prevention

The United States cannot filter its way out of the PFAS problem without also reducing continuing releases.

Water treatment protects people after contamination reaches a public supply. Site remediation addresses damage after a release has occurred. Health monitoring identifies exposure after PFAS has entered the body.

Prevention must therefore become the central part of long-term policy.

That means identifying PFAS uses that are genuinely essential, eliminating uses for which safer alternatives already exist, requiring better disclosure from manufacturers and strengthening control of industrial discharges.

It also means treating substitution more carefully. Replacing a well-known PFAS with a less-studied fluorinated alternative should not automatically be described as progress.

Companies must understand not only the intentionally added PFAS in their formulations, but also processing aids, impurities, surface treatments, packaging, recycled materials and supplier-controlled components.

The Fight Is No Longer About Whether PFAS Exists

The basic facts are now difficult to dispute.

PFAS contamination is widespread. Exposure occurs through more than one route. Several PFAS have been associated with serious health effects. Removing the chemicals from water and contaminated land can be technically difficult and financially burdensome.

The unresolved questions concern the speed and scope of the response.

Should regulation continue chemical by chemical, or should PFAS be managed in groups? Which uses are essential enough to justify continued production? How should drinking-water systems finance treatment? What responsibility belongs to chemical manufacturers, product manufacturers, industrial users and waste operators? And how much evidence should be required before a replacement chemical is allowed to become widespread?

The longer those questions remain unsettled, the larger the eventual cleanup obligation may become.

PFAS earned their “forever chemical” name because of their environmental persistence. The policy response does not have to be equally permanent or equally slow.

The country already has enough evidence to reduce unnecessary uses, control emissions at their sources, improve transparency and protect communities before another generation inherits the contamination.

Knowing the PFAS Risk Is Only the Beginning

Understanding why PFAS contamination has become a global concern is important. For manufacturers, formulators and regulatory teams, however, the more difficult question is what comes next.

Which products in your portfolio are most exposed to upcoming restrictions? Where are PFAS still entering through additives, processing aids or supplier-controlled materials? Which non-fluorinated alternatives can maintain repellency, durability, barrier performance and process stability? And how can reformulation begin without creating another expensive cycle of failed substitutions?

The OnlyTRAININGS expert session, PFAS Phase-Out Strategies: Reformulation and Safer Alternatives for High-Performance Materials, is designed to help technical teams answer these questions.

The training covers:

• Emerging PFAS regulations across major global markets
• Targeted testing versus total-fluorine analysis
• Hidden PFAS sources across material supply chains
• Silicone, hydrocarbon and other non-fluorinated alternatives
• Application-specific reformulation and substitution strategies
• Performance trade-offs and validation requirements
• PFAS-free claims, documentation and supplier transparency
• Practical phase-out examples from industrial applications

Rather than discussing only why PFAS are being restricted, the session focuses on how R&D, regulatory, sustainability and procurement teams can build a coordinated transition plan without unnecessarily sacrificing product performance.

PFAS Restrictions Are Advancing. Is Your Product Portfolio Ready?

Explore the PFAS Phase-Out and Safer Alternatives Training

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If you manufacture or supply food contact materials for more than one market, you already know the frustrating truth: passing FDA review doesn't mean you're compliant in the EU, and EU compliance doesn't carry over to China. Each system evaluates safety differently, uses different documentation, and fails materials for different reasons.

This isn't a regulatory footnote. It's the single biggest reason multi-region product launches get delayed — not because the material is unsafe, but because a team optimized for one region's logic runs into another region's blind spot.

Here's how the three major systems actually compare, and where the real compliance risk sits in each one.

The Three Systems at a Glance

United States: A Pathway Problem, Not a Listing Problem

Most teams assume FDA compliance is about checking whether a substance appears on a list. In practice, the harder decision is choosing the right pathway — Food Contact Notification (FCN), GRAS, Prior Sanction, or Threshold of Regulation (TOR) exemption — and defending that choice if it's challenged.

Each pathway carries different assumptions about migration, different timelines, and different levels of regulatory scrutiny. Choosing the wrong one, or leaning on an exemption that doesn't actually apply to the use case, is one of the most common causes of late-stage compliance failures — often after testing is already complete.

See the full FDA compliance framework, including FCN vs. GRAS decision logic →

European Union: Self-Declaration Puts the Burden on You

Unlike the US notification model, the EU runs on self-declaration. There's no "EU approval" — manufacturers must produce a Declaration of Compliance (DoC) demonstrating that a material meets Regulation (EU) 10/2011 (for plastics) and the broader Framework Regulation 1935/2004.

The EU's positive list (the "Union list" in Annex I) is under continuous revision — Commission Regulation (EU) 2026/245, which entered into force in February 2026, added and revised authorizations for several substances used in polyolefins, polyamides, PET, PLA, and PVC materials. Bisphenol A rules have also tightened substantially under Regulation (EU) 2024/3190, with transitional provisions running through September 2026 for products already on the market.

The technical risk that trips up most non-EU manufacturers isn't the positive list itself — it's Non-Intentionally Added Substances (NIAS): breakdown products, impurities, and reaction by-products that aren't deliberately added but still have to be risk-assessed. NIAS evaluation is where "compliant on paper" and "compliant in practice" most often diverge.

China: Fast-Moving Standards, Material-Specific Rules

China's GB 4806 series governs food contact materials by material type — separate standards exist for plastics, coatings, rubber, silicone rubber, paper, adhesives, and more, each with its own positive list under GB 9685.

This system has moved quickly in the past two years. Revised standards for coatings (GB 4806.10-2025) and silicone rubber (GB 4806.16-2025) take effect September 2026, expanding the approved substance list for coatings from 105 to 346 entries and cutting the BPA specific migration limit tenfold, from 0.6 mg/kg to 0.05 mg/kg. A draft standard for food-contact regenerated cellulose materials was also opened for consultation in 2026.

For international manufacturers, the practical risk in China isn't unfamiliarity with the concept of a positive list — it's the pace of standard revisions and the requirement to track which GB standard version applies to a specific material category, since older versions are explicitly invalidated once revisions take effect.

Why This Matters for Multi-Region Launches

The teams that get burned aren't the ones who don't know the regulations exist — they're the ones who apply one region's compliance logic to another region's system. FDA's notification model, the EU's self-declaration burden, and China's material-specific GB standards each require a different verification approach, different documentation, and different technical justification.

Getting this right up front — before formulation is locked and before submission timelines are set — is what separates a smooth multi-region launch from a late-stage scramble.

Go Deeper

This overview is intentionally high-level. For a full, decision-focused breakdown of FDA compliance specifically — including FCN vs. GRAS vs. Prior Sanction decision criteria, migration and exposure assessment logic, and the functional barrier assumptions that most often fail under review — see the complete training:

FDA Compliance for Food Contact Materials: Migration Risk, FCN/GRAS & Informed Compliance Decisions →

Sources: European Commission Food Safety Directorate; UL Solutions; SGS Safeguards; knoell regulatory updates; SESEC; ChemLinked; Kelley Drye & Warren (KHLaw) regulatory analysis.