The topic is short and compact
Two products with the same active ingredient differ in carrier system, encapsulation, particles, or film-forming agents, that is, in the formulation and not in the raw material.
According to Regulation (EU) No. 655/2013, a product may not claim unique properties that similar products also possess; the name of an active ingredient alone does not constitute a unique selling proposition.
A carrier system is only effective as long as its structure holds: vesicle size and active ingredient content must be measured throughout stability testing and after filling.
Synthetic polymer microparticles are restricted in rinse-off products from October 17, 2027, in leave-on products from 2029, and in makeup from 2035.
Under Article 16 of the Cosmetics Regulation, nanomaterials must be notified six months prior to being placed on the market; this deadline should be factored into the timeline from the very start.
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What does mechanism of action mean instead of active ingredient?
What is meant is a shift in perspective in product development: it is no longer just the question of which active ingredient is contained that determines positioning, but how the formulation makes it effective. A peptide in a simple aqueous solution and the same peptide in a nanoemulsion can hardly be distinguished on the label, but they behave differently on the skin.
The mechanism can reside in four areas of the formulation:
Delivery: a carrier system such as liposomes, niosomes, or a nanoemulsion that alters the distribution of an active ingredient in the stratum corneum.
Protection and release: an encapsulation that shields an unstable active ingredient in the formulation and only releases it upon application.
Physical action: exfoliating particles or sponge spicules that mechanically affect the skin surface.
Film and optics: film formers that make a skin tint transfer-resistant, or soft-focus powders that diffuse light in complexion products.
In all four cases, the difference arises through formulation work: selection and proportion of excipients, emulsification technology, particle size, manufacturing sequence, and filling.
Why does an active ingredient name hardly differentiate anymore?
Because well-known active ingredients are accessible to all brands and the regulation limits the scope for claims about individual ingredients. As soon as an active ingredient such as niacinamide, a peptide, or PDRN is available from multiple raw material suppliers, any brand can use it. The INCI list then displays the same name across many products.
In addition, there are the common criteria of Regulation (EU) No 655/2013. According to the criterion of truthfulness, claims about the properties of an ingredient must not imply that the finished product has the same properties when it does not (Annex No. 2.2). Anyone attributing properties of an ingredient to the product requires proof, such as an effective concentration in the product (No. 3.6). And according to the criterion of fairness, an advertising claim must not attribute unique properties to the product if similar products have the same properties (No. 4.2).
For positioning, this implies: An active ingredient name alone does not constitute a unique selling proposition. In contrast, proprietary formulation performance, such as a carrier system that demonstrates a measurably different distribution in the finished product, can be substantiated and communicated.
Which mechanisms can be designed in a formulation?
The following overview categorizes common approaches according to where the mechanism occurs and by typical formulation problem:
Mechanism | Examples | Typical formulation problem |
|---|---|---|
Carrier system | Liposomes, niosomes, ethosomes, nanoemulsions | Vesicle size and integrity during storage, skin compatibility with emulsifiers and thickeners |
Encapsulation | Microcapsules for unstable active ingredients or fragrances | Capsule material, release upon application, shear stress during manufacturing and filling |
Physical effect | Exfoliating particles, sponge spicules | Particle size and distribution, sedimentation, skin irritation |
Film and optics | Film formers in long-wear makeup, soft-focus powders in complexion products | Skin feel, transfer resistance, compatibility with pigments |
With carrier systems, the skin sets the boundary. A review article on cosmetic peptides identifies, among other factors, a molecular weight below 500 Daltons and a log P between 1 and 3 as favorable properties for skin permeation. Most peptides fall outside this range. According to the same review, conventional liposomes with diameters of 0.05 to 5 µm accumulate primarily in the stratum corneum due to their low deformability; deformable variants such as ethosomes contain high concentrations of ethanol (45%) to compensate for this. How carrier systems alter distribution and what this means for marketing claims is explored in detail in the article on carrier systems and penetration.
Physical mechanisms intervene more heavily. In an in vitro study using sponge spicules (Haliclona sp.), spicules increased the transdermal flux of the peptide insulin from 5.0 to 457.0 ng/cm² per hour; the spicules remained in the skin for more than 48 hours, whereas dermaroller microchannels close within about 20 minutes. The study stems from pharmaceutical research. For a cosmetic formulation, it primarily demonstrates that such a mechanism changes exposure to all other ingredients. What this means for the formulation is described in the article on sponge spicules.
What formulation problems arise with carrier systems and particles?
A mechanism only works as long as its structure remains intact. This results in problems that do not occur in a formulation with freely dissolved active ingredient:
Structural stability: Vesicles can fuse during storage, lose active ingredient, or be dissolved by surfactants and emulsifiers in the base. A size measurement directly after manufacturing therefore says little about the product at the end of its shelf life.
Process control: Liposomes and microcapsules are usually only incorporated during the cooling phase and under low shear. The homogenizer, agitator, and pumps of the filling line can destroy capsules that remained intact on a laboratory scale.
Ethanol and skin compatibility: Systems rich in ethanol, such as ethosomes, alter odor, evaporation, and skin feel, and can only be combined with polymer thickeners to a limited extent.
Preservation: Phospholipids and aqueous vesicle cores provide a breeding ground for microorganisms; preservatives can also incorporate into the lipid membrane. A preservation system that is sufficient in a simple emulsion can therefore be less effective in a vesicle formulation.
Particles in the base: Exfoliating particles and spicules sediment in low-viscosity formulations. The viscosity must support the particles and still allow uniform dosing from a tube or dispenser.
Packaging materials: Airless dispensers protect oxidation-sensitive systems, but have narrow nozzles; coarse particles and highly viscous gels can clog them.
These points determine manufacturability. A mechanism that works in a laboratory batch must be reconfirmed in the production vessel with different shear forces, heating, and cooling times.
Which EU regulations apply to particles and carrier systems?
Three regulatory frameworks directly influence the choice of mechanism. First, Regulation (EC) No 1223/2009: According to Art. 2(1)(k), a nanomaterial is an insoluble or biopersistent, intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nanometres. Pursuant to Art. 16(3), cosmetic products containing such nanomaterials must be notified to the Commission six months prior to being placed on the market, in addition to the CPNP notification, unless the nanomaterial is regulated as a colorant, UV-filter, or preservative. In the list of ingredients, the name must be followed by the word 'nano' in brackets (Art. 19(1)(g)). The European Commission maintains a catalogue of all nanomaterials used in cosmetics for this purpose and can request an assessment from the SCCS in case of safety concerns.
Whether a vesicle or a nanoemulsion falls under this definition depends on whether the material is insoluble or biopersistent. The classification should be clarified with the supplier for each raw material before finalizing the timeline, as the notification delays market launch by six months.
Second, the restriction of synthetic polymer microparticles under Regulation (EU) 2023/2055 (REACH Annex XVII, entry 78). It applies to microparticles present at 0.01% or more by weight. Microbeads used as exfoliants have been covered without a transitional period since it entered into force on October 17, 2023. For rinse-off products, the restriction applies from October 17, 2027; for leave-on products and the encapsulation of fragrances, from October 17, 2029; and for lip, nail, and makeup products, from October 17, 2035. Exceptions include, among others, natural polymers that have not been chemically modified, as well as demonstrably degradable or sufficiently soluble polymers. Anyone selecting an encapsulation or a soft-focus powder today should assess the raw material against these exceptions.
Third, the boundary of the definition of a cosmetic: According to Art. 2(1)(a), a cosmetic product is intended to come into contact with the external parts of the body, such as the skin, hair, nails, or lips, exclusively or mainly to clean them, perfume them, change their appearance, protect them, or keep them in good condition. If a mechanism is advertised with a therapeutic effect or an effect inside the body, the product may exceed this scope; penetration claims should therefore remain closely aligned with the stratum corneum and measurement data.
How is a mechanism tested and verified?
With a test plan that measures the mechanism itself and not just the product as a whole. According to Annex I of the Cosmetics Regulation, the cosmetic product safety report requires the physical/chemical characteristics and the stability of the product in Part A, Point 2; Point 8 requires that all significant toxicological absorption routes as well as potential effects on the toxicological profile due to particle sizes, including nanomaterials, and interactions of substances be taken into account. A carrier system that alters penetration is therefore part of the safety assessment.
A practical scope of testing includes:
Characterization: particle or vesicle size and size distribution, and in the case of encapsulation, the proportion of encapsulated active ingredient.
Stability: accelerated storage at elevated temperature, thermal cycling, and storage in final packaging, each with repeated size measurement and active ingredient assay.
Preservation: preservation challenge test on the finished formulation, typically according to ISO 11930.
Distribution: for penetration claims, in vitro permeation measurements on skin models compared to the formulation without carrier system.
Efficacy and skin compatibility: user trials with test subjects for the specific claim.
For the claim, Regulation (EU) No 655/2013 requires studies that are relevant to the product and the claimed benefit and are based on valid, reliable, and reproducible methodologies (Point 3.3). Data from the raw material supplier on a liposome concentrate are therefore generally not sufficient as evidence for a cream in which this concentrate has been formulated with other emulsifiers. The article on stability and safety testing for cosmetics outlines which tests must be completed prior to launch; the criteria for claims are examined in depth in the article on cosmetic claims in the EU.
A mechanism is created during formulation development and must be preserved from the laboratory sample through to the batch. Labtree is a B2B cosmetics developer and cosmetics manufacturer with its own laboratory and production capacities in Germany, covering makeup and skincare. The process follows the steps of conceptual design, sampling, customization, prototyping, and production; manufacturability is already verified during development and not just upon transfer to production scale. This is crucial for a mechanism, because incorporation temperature, shear, and filling determine the preservation of the structure.
Samples of pre-qualified formulations usually leave the sample warehouse within 24 hours, allowing texture, skin feel, and film formation to be evaluated early on real samples. In white label, a tested Labtree formulation is adapted and usually deliverable in 2 to 3 months with standard packaging; the formulation remains with Labtree. A proprietary carrier system or a new physical effect is typically a case for private label: The formulation is newly developed according to the brand's requirements, usually reaching market readiness in 3 to 6 months; formulation rights or exclusivity can be transferred contractually. If the formulation contains a nanomaterial subject to notification, the six-month notification lead time is added. The minimum order quantity is generally 1,500 units per product, depending on product type, fill size, and packaging. The detailed process is described on the page Have cosmetics developed.
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FAQ
What is a carrier system in cosmetics?
A carrier system is a structure in the formulation that absorbs an active ingredient and alters its distribution on and in the stratum corneum, such as liposomes, niosomes, ethosomes, or nanoemulsions. It can additionally protect an unstable active ingredient. Whether it works in the finished product is only shown by testing the finished formulation.
Are liposomes considered nanomaterials?
That depends on the material. The Cosmetics Regulation only covers insoluble or biopersistent, intentionally manufactured materials ranging from 1 to 100 nanometres. Whether a specific liposome or nanoemulsion raw material falls under this definition should be clarified with the supplier before scheduling, as notification would be required six months prior to placing it on the market.
Are scrubs still allowed to contain plastic particles?
Synthetic polymer microparticles used as exfoliating agents, so-called microbeads, have been restricted at concentrations of 0.01% by weight or more since October 17, 2023. Exceptions include naturally occurring, chemically unmodified polymers, as well as polymers that are verifiably degradable or soluble. For a new scrub, an abrasive that clearly falls outside this definition is therefore recommended.
What changes for encapsulated fragrances and makeup?
For synthetic polymer microparticles used for the encapsulation of fragrances, the restriction will apply from October 17, 2029, and for lip, nail, and makeup products from October 17, 2035. Brands currently developing products with polymer capsules or synthetic soft-focus powders should already incorporate the switch to permitted raw materials into their product line planning.
Can a product advertise deeper penetration?
Such a claim requires evidence relevant to the finished product, such as in vitro permeation measurements compared to the formulation without a delivery system. At the same time, a cosmetic product remains restricted to external application and purposes such as care and protection; an advertised therapeutic effect or an effect inside the body can take the product outside this scope. The magazine article "Cosmetic Advertising Claims in the EU" delves deeper into these rules.
Can a known active ingredient be repositioned using a carrier system?
Yes, provided that the carrier system shows a measurable difference in the finished product, such as in terms of stability or distribution. For large molecules such as PDRN, the skin barrier limits penetration, so any claims should closely adhere to the measured data. The magazine article "PDRN in Cosmetics" contextualizes the active ingredient itself.
Are liposomes and microcapsules covered by the microplastics ban?
The restriction under Regulation (EU) 2023/2055 covers synthetic polymer microparticles. Liposomes made from phospholipids are not polymers and therefore generally do not fall under this restriction; however, microcapsules with a shell made of synthetic polymers do, unless an exemption applies. The supplier should provide data to prove whether a capsule shell is naturally occurring and not chemically modified, demonstrably biodegradable, or sufficiently soluble.
