The topic is short and compact
An active ingredient only supports a product if the body of research matches the concentration used, stability, EU status, and verifiable advertising claims.
Under Regulation (EU) 2024/996, retinol is limited to 0.05% retinol equivalent in body lotions and 0.3% in other products, and requires a vitamin A warning label.
Non-compliant retinol products may no longer be placed on the market as of November 1, 2025, and may no longer be made available as of May 1, 2027.
A raw material study proves the efficacy of the raw material, not the finished product: According to Regulation (EU) No. 655/2013, applying these claims requires supporting evidence, such as proof of the effective concentration in the final product.
Exosomes of human origin are prohibited under Annex II, entry 416; plant-based variants lack standards and larger clinical trials.
So läuft die Entwicklung bei Labtree
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Konzeptionierung
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Bemusterung – Standardmuster in 24 h
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Individualisierung
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Prototyping
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White Label 2–3 Monate · Private Label 3–6 Monate · Produktion ab 1.000 Stück
How do you recognize an active ingredient with substance?
An active ingredient only has substance if it passes all four test criteria simultaneously. A raw material supported by good studies that degrades in the planned emulsion after just a few weeks is as worthless to the product as a stable raw material without substantiation.
Test criterion | Guiding question | Basis |
|---|---|---|
Study data | Are there human studies with the active ingredient alone, in a comparable concentration and dosage form? | Specialist literature, raw material dossier |
Stability | Does the active ingredient remain stable in the formulation and sales packaging throughout the intended shelf life? | Safety report, Annex I |
Regulatory status | Is the substance prohibited, restricted, or subject to warnings? | Annexes II to VI |
Claim | Can the planned claim for the final product be substantiated? | Art. 20 (1), Regulation (EU) No 655/2013 |
Stability is not an optional extra: Annex I Part A No. 2 of Regulation (EC) No 1223/2009 requires information on the stability of the cosmetic product under reasonably foreseeable storage conditions in the safety report. Anyone choosing a sensitive active ingredient also determines which stability data must be generated in the final packaging.
Which active ingredients have robust study evidence?
Niacinamide, retinol, vitamin C, hyaluronic acid, and salicylic acid in particular have a solid database that has grown over years. Reliable does not mean that every concentration is effective, but rather that the conditions under which an effect was measured are known.
Niacinamide: The review by Boo (2021) describes human studies with 4 and 5 percent on pigment spots and wrinkles; in a dose-response study, 5 percent reduced pigment spots compared to the vehicle, whereas 2 percent did not do so significantly. Many studies tested combination products, so the contribution of niacinamide to the effect often remains unclear.
Retinol: According to the review by Mukherjee et al. (2006), retinol is significantly less irritating than tretinoin, but also about twenty times less potent, and it readily degrades into inactive forms under light and air. The formulation must therefore address efficacy, skin compatibility, and protection against oxidation at the same time.
Vitamin C: According to Pullar et al. (2017), ascorbic acid penetrates the skin appreciably only at a pH below 4. Phosphate derivatives are more stable, but are poorly absorbed and only slowly converted; for ascorbyl glucoside, the conversion rate is unknown. Stability and efficacy are a genuine trade-off here.
Hyaluronic acid: Molecular weight influences viscosity, film formation, and skin feel. For the formulation, the decisive factor is which quality is used for which claim, not the term on the label.
Salicylic acid: Well studied and strictly regulated: Annex III, entry 98 of the Cosmetics Regulation limits salicylic acid, when not used as a preservative, depending on the product type to 3.0% in rinse-off hair products, 0.5% in body lotions and lipsticks among others, and 2.0% in other products; it is excluded in products for children under three years of age.
Peptides are not a uniform class of active ingredients. The available data varies considerably from peptide to peptide; therefore, it is advisable to evaluate each individual raw material based on the studies provided by the supplier, rather than classifying the class as proven across the board.
Which limit values have applied to retinol and other active ingredients since 2025?
With Regulation (EU) 2024/996, the Commission has added several previously unregulated active ingredients to Annex III. For product lines containing retinol, arbutin, or kojic acid, this means that the concentration and labelling of existing formulations must be reviewed.
Substance | Maximum concentration | Deadlines for non-compliant products |
|---|---|---|
Retinol, Retinyl Acetate, Retinyl Palmitate | 0.05% retinol equivalent in body lotion, 0.3% in other leave-on and rinse-off products | No placing on the market from 1 November 2025, no making available from 1 May 2027 |
Alpha-Arbutin | 2% in face cream, 0.5% in body lotion | No placing on the market from 1 February 2025, no making available from 1 November 2025 |
Arbutin | 7% in face cream | Same as alpha-arbutin |
Kojic Acid | 1% in face and hand products | Same as alpha-arbutin |
For retinol and its esters, the following warning is additionally required: "Contains Vitamin A. Consider your daily intake before use". For alpha-arbutin and arbutin, the hydroquinone content must remain as low as possible and must not exceed unavoidable traces. This affects raw material specifications and analytics, not just the label.
For planning, this means: A retinol product intended for body care has significantly tighter limits than a face serum. Anyone developing a line across both categories will need separate formulations and separate labelling.
How can hype active ingredients like exosomes be evaluated?
Hype active ingredients can be evaluated using the same four checkpoints, but frequently fail at the first or third. Typically, there is a gap between research interest and the data available for the specific cosmetic product.
Exosomes. Here, the origin is decisive in the first place. Cells, tissues, or products of human origin are listed in Annex II, entry 416 of Regulation (EC) No 1223/2009 and are therefore prohibited in cosmetic products. There is no separate entry for plant or other non-human vesicles; they are subject to the general safety assessment. The evidence is thin: The review by Bai et al. (2024) found only four prospective clinical studies with 16 to 56 participants, one of which was randomized, and describes a lack of standards for origin and preparation. Three of the four studies worked with exosomes of human origin, which are ruled out for EU cosmetics anyway; the only study with non-human vesicles from Lactobacillus plantarum included 16 participants. For raw material selection, this means: characterization, batch consistency, and proof of origin belong in the supplier documentation before advertising claims are discussed.
Stem cell extracts. The term is misleading. Plant cell culture extracts generally do not contain live stem cells, and products of human origin fall under the same ban as human exosomes. The advertising claim must not suggest more than what the raw material is.
Microbiome active ingredients. Claims regarding the barrier, moisture, or a skin-friendly pH value can usually be substantiated using established measurement methods. A targeted modification of the skin flora as a product effect is significantly more difficult to prove and should only be claimed with one's own data.
Which combinations of active ingredients cause problems in the formulation?
Problems arise primarily where active ingredients require different pH ranges, protective conditions, or viscosity systems. Each additional active ingredient increases the number of variables that must be verified in stability testing.
Ascorbic acid with other sensitive active ingredients: Because ascorbic acid only penetrates noticeably below pH 4 (Pullar et al.), it establishes a strongly acidic environment. Only testing shows whether a second active ingredient remains stable and well-tolerated in it; for retinol, separating them into two products is generally recommended.
Retinol and packaging materials: Since retinol degrades under light and air, open jars and transparent bottles are generally ruled out. Airless dispensers or light-tight tubes, in turn, alter filling processes, unit costs, and the selection of available packaging materials.
Hyaluronic acid with electrolytes: Salts and ionic active ingredients can significantly reduce the viscosity of a hyaluronic gel. This often only becomes evident in the laboratory sample with the final active ingredient combination.
AHA and BHA: Acid combinations require defined pH management because efficacy and skin compatibility depend on the pH value. The pH value therefore becomes part of the release specification for each batch.
Plant extracts: Multiple extracts in a single formulation introduce color, odor, and preservation challenges that no single extract would have on its own.
Which tests must be completed before the launch is described in the article on stability and safety testing for cosmetics. The specifics of individual active ingredients are explored in greater depth in the articles on the vitamin C serum and the retinol serum.
What does the choice of active ingredient mean for advertising claims?
The choice of active ingredients determines which advertising claims can be substantiated later on. According to Article 20(1) of the Cosmetics Regulation, labelling and advertising must not imply characteristics or functions that the product does not possess. The common criteria of Regulation (EU) No 655/2013 make this specific for active ingredients:
Truthfulness: If an ingredient is claimed, it must be deliberately present. Claims regarding the properties of an ingredient must not imply that the finished product has the same properties if this is not the case.
Substantiation: If a claim transfers the properties of an ingredient to the finished product, it requires adequate and verifiable evidence, such as proof of an effective concentration in the product.
Fairness: The presented effect must not go beyond what the evidence substantiates.
In practice, this means: A raw material study proves the raw material, not the serum. Anyone claiming "with 5% niacinamide" should check whether the cited effect was measured in studies with this concentration and a comparable base. For product-related claims, instrumental measurements on volunteers, user tests under dermatological control, or consumer tests come into consideration; which method is appropriate depends on the claim. The specific rules are explained in the article on cosmetic advertising claims in the EU.
The choice of active ingredients becomes a manufacturable formulation when positioning, active ingredient system, test plan, and claims are decided in a fixed order:
Define the product promise: moisture, barrier, even complexion, or anti-aging, for serum, cream, or a hybrid product between skincare and makeup such as a skin tint.
Select one to two lead active ingredients: with study data at the planned concentration and within the scope of the annexes.
Add accompanying active ingredients: for skin compatibility, barrier, or sensory profile, only as many as stability can support.
Define the test plan: stability in the final packaging, preservative challenge test according to ISO 11930, skin compatibility, packaging compatibility.
Assign claims: each planned claim backed by supporting evidence before artwork and packaging are ordered.
Labtree is a B2B cosmetic developer and cosmetic manufacturer with its own laboratory. Active ingredient concepts are translated there into formulation development and sampling into lab samples, manufacturability is tested already during development, and approved formulations move into in-house cosmetic production. Samples of pre-qualified formulations typically leave the sample warehouse within 24 hours. The page Having cosmetics developed describes the process from conceptualization to production.
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FAQ
Is retinol in cosmetics still allowed in the EU?
Yes. Retinol, Retinyl Acetate, and Retinyl Palmitate remain permitted, but under Regulation (EU) 2024/996, they are limited to 0.05% retinol equivalent in body lotion and 0.3% in other products. Additionally, the label warning "Contains vitamin A. Consider your daily intake before use" is mandatory.
By when must existing retinol products be reformulated?
Products that do not meet the new requirements can no longer be placed on the market as of November 1, 2025. Starting May 1, 2027, they may also no longer be made available on the market, meaning retail sales will no longer be permitted either. It is therefore recommended to review the concentration and labeling of remaining stock and subsequent production runs.
Can exosomes be used in EU cosmetics?
Not exosomes of human origin: Products of human origin are listed in Annex II, Entry 416 of the Cosmetics Regulation. Plant-based or other non-human vesicles are not specifically regulated and are subject to the general safety assessment. Proof of origin, characterization, and batch consistency should be documented prior to use.
Is the raw material supplier's study sufficient evidence for an advertising claim?
Usually not on its own. According to Regulation (EU) No 655/2013, any claim that attributes the properties of an ingredient to the finished product must be supported by evidence, such as proof of an effective concentration within the product. The magazine article on cosmetic advertising claims in the EU explains which tests support which claims.
Which form of vitamin C is suitable for a stable serum?
That depends on whether stability or penetration takes priority. Pure ascorbic acid requires a pH level below 4 and is susceptible to oxidation, whereas phosphate derivatives are more stable but less readily absorbed. The article Manufacturing Vitamin C Serum explores this trade-off in greater depth.
How long does the development of an active ingredient product take?
At Labtree, a new private label development usually takes three to six months to reach market readiness. An adapted white-label formulation with standard packaging is generally ready for delivery in two to three months. Sensitive active ingredients and special packaging materials primarily extend the stability and packaging phase.
