Summary

Following the restriction of intentionally added synthetic polymer microparticles under EU REACH Annex XVII Entry 78, supplier verification for cosmetic film formers, sensory powders, coated pigments, microcapsules, and decorative particles can no longer rely solely on INCI names, CAS numbers, or a “microplastic-free” statement.

Verification requires confirmation of the polymer identity, physical state, particle structure, particle size distribution, relevant concentration, exclusion criteria, and changes occurring under the intended end-use conditions. Film formers also require a distinction between the permanent change in physical properties specified under Paragraph 5(b) and permanent incorporation into a solid matrix under Paragraph 5(c), as the applicable use scenarios and supporting evidence differ between these two pathways.

Quick Answer: What Must Be Confirmed During Supplier Verification?

Supplier verification for cosmetic film formers and particulate ingredients should answer at least the following seven questions:

1. Does the raw material contain synthetic polymers?
2. Is the polymer liquid, dissolved, or present in solid particles?
3. Is the polymer located inside the particle, on the particle surface, or in the continuous phase?
4. Do the particle dimensions and weight percentage fall within the scope of Entry 78?
5. Does the relevant concentration in the final mixture reach 0.01% by weight?
6. Is there evidence supporting an exclusion based on natural origin, degradability, water solubility, or the absence of carbon atoms in the chemical structure?
7. During the intended end use, do the particles permanently change their physical properties or become incorporated into a long-lasting solid matrix?

These seven information categories should form a consistent and traceable body of evidence. A commercial statement without information on physical state, particle size, concentration, or testing basis is generally insufficient to support a reliable regulatory conclusion.

How EU REACH Defines Synthetic Polymer Microparticles

Commission Regulation (EU) 2023/2055 added the synthetic polymer microparticle restriction to REACH Annex XVII Entry 78, with application beginning on October 17, 2023.

The restriction does not cover all synthetic polymers. It applies to synthetic polymer microparticles, abbreviated as SPM, that meet specified composition, solid-state, and particle-size conditions.

Under Entry 78, the relevant assessment mainly includes the following:

• The polymer is contained in particles and constitutes at least 1% by weight of those particles, or the polymer forms a continuous surface coating on the particles;
• At least 1% by weight of the relevant particles meets the specified dimensional conditions;
• All dimensions of non-fibrous particles do not exceed 5 mm;
• Fibrous particles have a length not exceeding 15 mm and a length-to-diameter ratio greater than 3;
• The SPM is intentionally added to impart a specific characteristic to the mixture;
• The concentration of SPM in the mixture is equal to or greater than 0.01% by weight.

The regulation also excludes polymers that meet specified conditions, including:

• Polymers formed through polymerization processes that have taken place in nature, independently of the process through which they have been extracted, and that have not been chemically modified;
• Polymers demonstrated to be degradable in accordance with Appendix 15;
• Polymers demonstrated to have a solubility in water greater than 2 g/L in accordance with Appendix 16;
• Polymers that do not contain carbon atoms in their chemical structure.

Therefore, “synthetic polymer,” “polymer dispersion,” and “solid polymer microparticle” are not interchangeable terms. The regulatory assessment must be based on the actual physical state and particle structure of the raw material when it is placed on the market.

Cosmetic Transition Periods and Current Supply Chain Milestones

Different cosmetic uses are subject to different transition periods. A transition period only postpones the date on which the relevant placing-on-the-market restriction applies. It does not mean that supplier identification, formulation screening, and replacement validation can be postponed until immediately before the deadline.

Replacing a film former or particulate powder may simultaneously affect adhesion, water resistance, soft-focus performance, skin feel, oil absorption, rheological behavior, and storage stability. The regulatory timeline should therefore be coordinated with sample screening, formulation scale-up, stability testing, packaging compatibility, and inventory phase-out schedules.

Why Film Formers and Particulate Ingredients Frequently Lead to Different Interpretations

A Film Former’s Functional Name Cannot Determine Its Regulatory Status

Some cosmetic film formers are supplied as systems in which solid polymer particles are dispersed in water or another medium. After application, water or solvent evaporates, and the particles may coalesce, crosslink, or undergo another irreversible change to form a continuous film.

Under certain conditions, such materials may qualify under Paragraph 5(b). However, “film former” is only a functional description and does not automatically demonstrate that an exemption applies.

The supplier needs to explain:

• The physical state of the polymer when the raw material is placed on the market;
• Whether the polymer is present as discrete solid particles;
• The temperature, time, pH, or auxiliary components required to form a continuous film;
• Whether this change can occur under the actual intended end-use conditions;
• Whether the polymer still meets the SPM definition after film formation;
• How residual raw material that has not fully formed a film is used and disposed of.

The ability to form a continuous film under laboratory conditions does not mean that the same result will occur in every finished formulation or under actual use conditions. Co-solvents, plasticizers, powder content, oil-phase composition, and drying conditions may all affect the degree of particle coalescence.

A Liquid Raw Material Does Not Necessarily Mean That the Polymer Is Liquid or Dissolved

A commercial raw material presented as a liquid may be:

• A solution in which the polymer is genuinely dissolved;
• An aqueous dispersion of solid polymer particles;
• A polymer latex system;
• A suspension containing polymer-coated particles;
• A composite system containing both dissolved and particulate polymer.

Therefore, descriptions such as “aqueous polymer,” “dispersion,” “emulsion,” or “latex” in supplier documents cannot by themselves demonstrate that the material falls outside the SPM definition.

Particulate Ingredients Require Separate Assessment of the Particle Core and Surface Coating

Sensory powders, coated pigments, and composite particles used in cosmetics may have the following structures:

• The particle itself is composed of a synthetic polymer;
• An inorganic or naturally derived substrate has a continuous polymer coating on its surface;
• The polymer forms the wall material of a microcapsule;
• The polymer acts as an internal carrier for pigments or functional ingredients;
• The polymer is molecularly dissolved in the continuous phase.

Even when the main particle substrate is mineral or naturally derived, a continuous synthetic polymer coating on the surface may still fall within the scope of Entry 78. Describing only the particle substrate without disclosing the surface-treatment composition can leave a significant verification gap.

What Is the Difference Between Paragraph 5(b) and Paragraph 5(c)?

Film-forming materials frequently involve Entry 78 Paragraphs 5(b) and 5(c), but the two provisions are based on different principles.

Regulation (EU) 2026/1168 further limits Paragraph 5(c) to intended end uses expected to last for one year or longer. This amendment applies from June 22, 2028.

For most daily-use cosmetics, the film is washed off, removed, or reapplied within a relatively short period. It is therefore not appropriate to classify every film-forming process as “permanent incorporation into a solid matrix.” The assessment should focus more closely on whether a permanent change in physical properties occurs under Paragraph 5(b) and whether the polymer still qualifies as SPM after the change.

Which Raw Materials Should Be Prioritized for Verification?

The verification principles in this guide apply to a range of cosmetic ingredients and personal care materials, particularly film-forming dispersions, sensory powders, coated pigments, and encapsulated ingredients.

Five-Step Logic for Supplier Verification

Step 1: Confirm the Polymer Identity and Its Location in the Raw Material

The INCI name and CAS number may support preliminary identification, but they generally do not fully describe the particle structure or supply form.

Supplier documentation should explain:

• The general chemical identity of the polymer;
• The polymer’s primary function in the raw material;
• Whether it is formed through a synthetic process;
• Whether it has been chemically modified;
• Whether it is located inside the particle, on the particle surface, or in the continuous phase;
• Whether it is present to impart a specific characteristic to the product.

A CAS number may refer to the polymer itself, a monomer, a single component within a blended system, or a broadly defined registered substance. Without information on physical state and composition, the CAS number cannot independently support an SPM determination.

Step 2: Confirm the Actual Physical State When Placed on the Market

The following states need to be clearly distinguished:

• The polymer itself is liquid;
• The polymer is molecularly dissolved;
• Solid polymer particles are dispersed in a liquid;
• The polymer forms a continuous surface coating on other particles;
• The raw material contains both particulate and dissolved polymer.

Physical state affects regulatory applicability and also directly influences the order of addition, shear conditions, storage stability, and formulation viscosity.

Step 3: Review the Particle Size Distribution and Relevant Concentration

A single mean particle size is insufficient to represent the complete particle size distribution. Verification documents should explain:

• Whether the measured object is the complete composite particle, the polymer particle, or the particle after surface coating;
• The particle size testing method used;
• Whether the data are expressed by number, volume, or weight;
• Whether the lower detection limit is sufficient to support the regulatory conclusion;
• The SPM content or concentration range in the raw material;
• The calculated concentration in the finished product based on the actual addition level.

Common errors include treating total polymer content as equivalent to SPM content, overlooking carriers and inorganic components in blended systems, and providing only a typical value without a specification range.

Step 4: Verify the Basis for Exclusion

“Natural origin,” “biodegradable,” “water-dispersible,” and “environmentally friendly” are not independent regulatory conclusions.

Water dispersibility means that particles can be distributed or suspended in water. It does not mean that the polymer has dissolved at the molecular level. The water-solubility exclusion under Entry 78 must be demonstrated in accordance with Appendix 16, with a water solubility greater than 2 g/L.

Degradability must likewise be demonstrated using the methods and pass criteria specified in Appendix 15. The tested sample should be representative of the commercial raw material, particularly with respect to polymer composition, particle size, surface treatment, and manufacturing process.

Step 5: Confirm What Occurs During the Intended End Use

Where Paragraph 5(b) or 5(c) is involved, the supplier’s conclusion must be connected to the actual product use scenario:

• Can a continuous film form at the actual use level?
• Do oils, powders, waxes, or solvents in the formulation affect particle coalescence?
• Is a specific temperature or period required to complete the change?
• Do discrete particles remain in the final film?
• How long is the film expected to remain in place?
• What occurs during washing, makeup removal, or peeling?
• How are packaging residues, production cleaning waste, and unused raw material disposed of?

A change that can only be achieved under extreme laboratory conditions cannot automatically be considered representative of normal intended end use.

Supplier Evidence and Its Application Significance

SPM evidence should also be reviewed alongside the broader compliance and quality documentation for personal care raw materials, including product specifications, batch records, technical data, and document revision history.

How to Evaluate the Supplier’s Conclusion

A supplier should not respond only that a raw material “contains microplastics” or “does not contain microplastics.” A more complete conclusion will generally fall into one of the following categories:

How Supplier Evidence Can Be Classified

Different documents do not provide the same level of evidentiary support. Treating all supplier statements as equivalent may lead to inappropriate supplier qualification decisions.

When a supplier cannot disclose the full structure to an ordinary customer because of commercial confidentiality, it should still provide sufficient general polymer identity, function, and physical-state information to enable an assessment. Where a competent authority lawfully requests specific identity information, the relevant information may be provided through the procedures established under Entry 78.

How Sample Validation Supports Supplier Verification

Supplier documentation addresses raw material identity and the regulatory pathway, while sample validation confirms whether the material can achieve the supplier-described state and function in the target formulation.

Consistency between the sample and commercial batches also needs to be confirmed for the manufacturing process and critical specifications. A laboratory sample that meets requirements does not automatically mean that subsequent bulk material will maintain the same particle size, solids content, or film-forming behavior.

Which Changes Should Trigger Reverification?

The following changes may affect the original SPM conclusion and should trigger reassessment:

• A change in the polymer grade, structure, or modification method;
• A change in the particle size range or testing method;
• A change in the polymer coating ratio or surface-treatment process;
• A change in solids content, carrier, or blending ratio;
• A change in manufacturing site or major upstream raw material source;
• A change in film-forming temperature, curing mechanism, or minimum film-forming conditions;
• A change in the sample used for water-solubility or degradability testing;
• Expansion of the raw material from one cosmetic product category to another;
• A change in the regulatory provision or transition period cited by the supplier.

The purpose of change notification is not limited to document management. It ensures that an existing conclusion continues to cover subsequent commercial batches.

Common Verification Errors and Their Impact

Practical Impact on R&D, Production, and the Supply Chain

R&D

Raw material screening needs to establish both a regulatory assessment pathway and an application-performance pathway. Film formers should be compared not only in terms of whether they involve SPM, but also in terms of minimum film-forming conditions, flexibility, tack, water resistance, and removability. Powder replacements should be evaluated simultaneously for skin feel, oil absorption, soft-focus effect, dispersibility, and stability.

Production

Changes in particle size, solids content, and dispersion state may affect the order of addition, shear intensity, filtration, filling, and equipment cleaning. A raw material with a clear regulatory status may still create scale-up risks if its processing compatibility is insufficient.

Procurement

The same INCI name may correspond to different supply forms, coating processes, or polymer states. Supplier comparison should therefore include physical state, SPM concentration, particle size data, applicable provisions, sample-to-commercial-batch correspondence, and change-notification capability, rather than focusing only on name, price, and lead time.

Supply Chain

As the 2027 milestone for rinse-off products and the 2029 milestone for leave-on products approach, some materials may enter a period of concentrated replacement and documentation updates. Establishing dual supply sources also requires more than finding the same INCI name. The regulatory conclusion and application performance must also be comparable.

How ChemicalCell Supports Raw Material Documentation Review

ChemicalCell can help organize specification requirements for film formers, sensory powders, coated materials, microcapsules, and related alternative materials according to the finished product category, raw material function, and target regulatory market.

During sample requests or inquiries, the following information can be prioritized:

• General polymer identity and supply form;
• Particle structure, particle size range, and active content;
• Film-forming, sensory, or dispersion performance required by the target formulation;
• Available technical, testing, and regulatory documentation;
• Correspondence between the sample grade and commercial batches;
• Packaging, lead time, and change-notification requirements.

This information can improve the efficiency of supplier communication and material screening, but it does not replace a company’s own regulatory applicability assessment, cosmetic safety assessment, or conclusions issued by competent authorities.

FAQ

Are All Synthetic Polymers Covered by the EU Microplastics Restriction?

No. Entry 78 mainly applies to synthetic polymer microparticles that meet specified conditions relating to solid state, particle structure, dimensions, and composition. Liquid polymers, genuinely dissolved polymers, and polymers meeting the prescribed conditions for natural origin, degradability, water solubility, or carbon-free structure may fall outside the SPM definition.

Should a Cosmetic Film Former Be Assessed Under Paragraph 5(b) or Paragraph 5(c)?

If polymer particles permanently change their physical properties during actual intended end use and no longer qualify as SPM after the change, Paragraph 5(b) may apply. Paragraph 5(c) requires the particles to be permanently incorporated into a solid matrix. From June 22, 2028, the intended end use must also be expected to last for one year or longer. Cosmetic films used in daily applications are generally washed off or removed frequently, so the formation of a solid film alone is not sufficient to demonstrate applicability under Paragraph 5(c).

Is a Water-Dispersible Polymer the Same as a Water-Soluble Polymer?

No. Water dispersibility means that solid particles can be distributed or suspended in water. Water solubility means that the polymer enters the solution at the molecular level. The water-solubility exclusion under Entry 78 must be demonstrated in accordance with Appendix 16, with a solubility greater than 2 g/L.

What Should a Usable Supplier SPM Statement Contain?

The statement should at least specify the applicable regulatory definition, general polymer identity, physical state, particle structure, relevant concentration, and assessment conclusion. Where the conclusion relies on natural origin, degradability, water solubility, Paragraph 5(b), or Paragraph 5(c), the relevant test, use conditions, or scientific basis should also be identified. A “microplastic-free” conclusion without a defined assessment scope and supporting evidence is generally insufficient for downstream verification.

RFQ Information

When requesting a quotation for film formers, particulate powders, coated raw materials, microcapsules, or alternative materials, the following information may be provided:

• Whether the finished product is a rinse-off, leave-on, makeup, lip, or nail product;
• The function the raw material needs to perform;
• The target INCI or acceptable material category;
• The formulation system, pH, processing temperature, and order of addition;
• Required particle size, skin feel, oil absorption, or film-forming performance;
• Target supply form and active content;
• Expected addition level;
• Target sales market and planned launch date;
• Requirements for evidence relating to water solubility, degradability, or final-state change;
• Sample quantity, initial purchase volume, and packaging specification;
• Required technical documents and regulatory information;
• Delivery destination and expected purchasing schedule.

Clear application conditions and documentation requirements help identify materials with insufficient regulatory evidence, limited formulation compatibility, or uncertain commercial-batch consistency during the sample stage.To submit a Specification Request, Sample Request, or Documentation Request, include the target function, product category, expected volume, and required document checklist to reduce repeated follow-up communication.