The topic is short and compact
Pregnancy, oral contraceptives, and hormone replacement therapy are the most frequently described triggers of melasma, with sun exposure being the most important environmental factor.
Hydroquinone is banned in cosmetics; a cosmetic pigmentation line may only address appearance, not the treatment of a medical condition.
Since Regulation (EU) 2024/996 came into force, fixed maximum limits apply: kojic acid 1%, alpha-arbutin 2% for the face and 0.5% for the body, and arbutin 7% in face creams.
A daily product with SPF—and with iron oxides in tinted formulas—belongs in the range because UV and visible light promote pigmentation.
Arbutin formulations require hydroquinone analysis for raw materials and finished products, as well as stability storage in the final packaging under heat and light.
So läuft die Entwicklung bei Labtree
1
Konzeptionierung
2
Bemusterung – Standardmuster in 24 h
3
Individualisierung
4
Prototyping
5
Produktion
White Label 2–3 Monate · Private Label 3–6 Monate · Produktion ab 1.000 Stück
What distinguishes hormonal pigment spots from other types of pigmentation?
Melasma differs from age spots or post-inflammatory pigmentation primarily by its triggers and its progression. The review by Liu, Chen, and Xia (2023) on the mechanisms of melasma identifies pregnancy, oral contraceptives, and hormone replacement therapy as the most frequently described triggers. Estrogen stimulates melanin production in cultured human melanocytes, whereas the role of progesterone remains unclear. The paper identifies sun exposure as the most important environmental factor, and in addition to UV radiation, visible light also contributes to pigmentation.
What the figures mean for the target audience
The studies cited in the review show how widespread hormonal triggers are: In a multicenter cross-sectional study from India, melasma began during pregnancy in 15.2 percent of those affected, and among women using oral contraceptives or hormone replacement therapy, the review reports that 8 to 34 percent develop melasma. This results in three life stages around which a brand can align a product line:
Pregnancy and the postpartum period: Pigmentation with a clearly defined onset. Claims regarding use during pregnancy may only go as far as the safety assessment of the finished product supports them.
Hormonal contraception: generally a younger target group, for whom lightweight daytime formats with sun protection are obvious choices.
Menopause and hormone replacement therapy: Pigmentation on more mature skin, where the line often additionally needs to meet demands for lipid systems and hydration.
Important for product development: The biological mechanism is similar across all three phases. The differences lie in target audience, texture, product format, and communication, not in a distinct active ingredient chemistry for each life stage. How menopause can be built as a standalone category is described in the article on perimenopause skincare.
Where does cosmetic care end and medical treatment begin?
Cosmetics may alter the appearance of the skin, but not treat a disease. According to Art. 2 para. 1 point a Regulation (EC) No 1223/2009, a cosmetic product is intended to be placed in contact with the external parts of the human body, exclusively or mainly with a view to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. A claim such as “treats melasma”, on the other hand, describes a therapy and places the product close to a medicinal product. Cosmetically viable formulations relate to appearance, such as “for a more even complexion” or “reduces the appearance of pigment spots”, provided they are substantiated.
Why the dermatological standard is not an option
Hydroquinone, used in dermatology against hyperpigmentation, is banned in cosmetics. The Opinion SCCS/1642/22 of the Scientific Committee on Consumer Safety summarizes the current status: Hydroquinone is listed in Annex II No. 1339 of the Cosmetics Regulation, the only exception being Annex III No. 14 for artificial nail systems in professional use up to a maximum of 0.02 percent. Oral tranexamic acid, which showed the most significant, albeit temporary, improvement in the evaluation by Wang, Jhawar, and Saedi (2019), is also a medicinal product. A cosmetic line therefore works with a different selection of active ingredients and must take this into account in its claims. The general rules on this are summarized in the article Cosmetic advertising claims in the EU.
Which brightening active ingredients are restricted in the EU?
Kojic acid, alpha-arbutin, and arbutin have been regulated with fixed maximum concentrations in Annex III (entries 375, 377, and 378) since 2024. With Regulation (EU) 2024/996, the Commission limited kojic acid, alpha-arbutin, and arbutin to the levels assessed as safe by the SCCS:
Substance | Permitted product type | Maximum concentration in ready-for-use preparation |
|---|---|---|
Kojic acid | Face and hand products | 1 % |
Alpha-arbutin | Face cream / body lotion | 2 % / 0.5 % |
Arbutin (beta-arbutin) | Face cream | 7 % |
In addition, for both arbutins, hydroquinone in the product must remain as low as possible and must not exceed unavoidable traces. Products that do not meet these conditions may no longer be placed on the market since 1 February 2025 and may no longer be made available on the market since 1 November 2025. Existing product ranges containing arbutin outside of face creams, alpha-arbutin above 0.5 percent in body lotions, or kojic acid outside of face and hand products are therefore subject to reformulation.
What is known about tranexamic acid and niacinamide
Topical tranexamic acid is mostly used in studies at 2, 3, or 5 percent over 12 weeks. However, the evaluation by Wang, Jhawar, and Saedi reveals small studies with 13 to 50 participants and usually no statistically significant difference compared to the active ingredient-free vehicle. Anyone who includes tranexamic acid in a skincare product therefore requires their own evidence on the finished product and cannot rely on data from oral intake. Niacinamide is not among the substances restricted by Regulation (EU) 2024/996 and is frequently combined with them. In practice, its use concentration is determined by skin compatibility, sensory profile, and safety assessment.
Why is stability a safety issue in arbutin formulations?
With arbutin formulations, stability is not only a matter of color and viscosity, but also of hydroquinone analysis. The SCCS attributes the effect of arbutins to a gradual hydrolysis and release of hydroquinone. Any release in the product during storage is therefore a safety issue that must be evaluated in the safety report.
What the SCCS data show
Opinion SCCS/1642/22 documents the storage of aqueous serums containing 0.5% and 2% alpha-arbutin over three months at 4 °C, room temperature, 40 °C, 50 °C, and under daylight. The pH value remained stable, the recovery of alpha-arbutin was at least 98.5%, and hydroquinone was below the limit of quantification of 3 ppm. At the same time, the 2% serum turned slightly yellowish at 40 °C and under daylight, more noticeably at 50 °C, and the viscosity decreased slightly in all samples. The fact that the result depends on the formulation is shown by an older study cited in the same opinion: In an O/W emulsion with 2% alpha-arbutin, the hydroquinone content rose, even in buffered batches, from below 1 to 3 ppm to around 13 ppm after 13 weeks at 40 °C. This results in three testing tasks:
Raw material specification: Test the hydroquinone content of each raw material batch using a validated method, and document the method's limit of quantification in the specification sheet.
Stability storage in the final container: Monitor color, pH, viscosity, and active ingredient content under heat and light, not just in laboratory glassware.
Packaging: Light-protected or opaque containers and airless systems reduce exposure to light and oxygen. Whether this is sufficient can only be determined by testing the skin compatibility between the formulation and the packaging material.
If a product line combines several hydroquinone-releasing substances, such as alpha-arbutin in a serum and arbutin in a cream, the SCCS has assessed the combined exposure at the maximum levels as safe. The safety assessment must nevertheless explicitly cover this combination. Which tests must be completed before launch is detailed in the article on stability and safety testing for cosmetics.
What role does sun protection play in a pigment line?
Without sun protection, a pigmentation range remains incomplete because sun exposure is the most important known environmental factor. The review by Liu and colleagues cites a study showing that sun protection reduced the incidence of melasma during pregnancy by almost 50 percent. In addition, the addition of iron oxides to broad-spectrum UVB-UVA protection prevented relapses, which the authors interpret as an indication of the role of visible light.
What this means for the product range
Day product with SPF: A brightening serum without day protection in the same line leaves the main cause unaddressed. The sun protection factor is determined on the finished product; a value from another formulation cannot be transferred, as filter distribution and film formation depend on the base.
Tinted formats with iron oxides: Skin tints or tinted SPF serums combine sun protection with pigments that shield against visible light. This is where skincare and makeup development meet: pigment dispersion, color shades for different skin tones, and batch consistency determine acceptance.
Label conditional efficacy: If the efficacy of a serum requires the daily use of a sun protection product, this must be clearly stated.
Technical questions regarding filters, pigments, and SPF verification are covered in the article Having tinted SPF serum produced.
How can efficacy claims for pigment spots be substantiated?
Efficacy claims regarding pigmentation spots require studies on the finished product, not just raw material data. Regulation (EU) No 655/2013 establishes the common criteria for this. Three of them are particularly relevant for a pigmentation line:
Truthfulness (Annex No. 2.2): Claims about the properties of an ingredient must not imply that the finished product has the same properties when it does not. A raw material study on alpha-arbutin does not prove the efficacy of a 1 percent serum.
Evidential support (Annex No. 3.3 and 3.6): Studies must be relevant to the product and the claimed benefit. If the effect of an ingredient is extrapolated to the finished product, an effective concentration in the product must be demonstrated, for example.
Honesty (Annex No. 4.1 and 4.3): Presentations must not go beyond the available evidence. If the effect is tied to specific conditions, such as daily sun protection, this must be clearly stated.
What study duration is realistic
The tranexamic acid studies show the framework: Topical applications were mostly studied over 12 weeks, and pigmentation frequently returned after discontinuing oral tranexamic acid. An application study for a pigmentation skincare product should therefore run for several weeks, include instrumental skin color measurement against the baseline value, and limit the claim to the appearance. Claims such as “permanent” or “removes pigmentation spots” can generally not be substantiated with such data.
Labtree is a B2B cosmetics developer and cosmetics manufacturer from Hamburg with its own laboratory and production facilities in Germany. Formulation development, in-house laboratory work, sampling, manufacturability testing, and cosmetics production fall under a single responsibility, so that laboratory samples, a manufacturable formulation, and the finished product emerge from the concept of a pigment line. The process follows the steps of conceptualization, sampling, individualization, prototyping, and production.
Sampling: Samples of pre-qualified formulations usually leave the sample warehouse within 24 hours. This allows texture, skin feel, and color to be assessed on the physical sample before the active ingredient system is determined.
White Label: A tested Labtree formulation is adapted for the brand and, with standard packaging, is usually ready for delivery in 2 to 3 months. The formulation remains with Labtree.
Private Label: New development according to the brand's requirements, typically 3 to 6 months to market readiness; formulation rights or exclusivity can be contractually transferred to the brand. Decisive time factors are stability tests as well as raw material and packaging availability. For arbutin formulations, the hydroquinone analysis described above is added as a testing step.
Minimum order quantity: usually 1,500 units per product, depending on product type, fill size, and packaging.
The page Have cosmetics developed shows the sequence of a project with a schedule.
Quellen
More useful links
FAQ
Is a melasma treatment considered a cosmetic or a medicine?
This is primarily determined by the intended purpose and the presentation. A product that reduces the appearance of pigment spots or ensures a more even skin tone can be considered a cosmetic product. However, if it is advertised as a treatment for a medical condition, it falls outside the cosmetic scope of Regulation (EC) No 1223/2009.
What does Regulation (EU) 2024/996 change for existing products?
Kojic acid is now only permitted up to 1 percent in face and hand products, alpha-arbutin up to 2 percent in face creams and 0.5 percent in body lotions, and arbutin up to 7 percent in face creams. Non-compliant products may no longer be made available as of November 1, 2025. Existing formulations should therefore be checked for concentration and product type.
Can kojic acid be used in a body lotion?
No. Regulation (EU) 2024/996 only permits kojic acid in face and hand products up to 1 percent. For body care products targeting dark spots, other ingredients are an option, such as alpha-arbutin up to 0.5 percent in body lotions.
Can tranexamic acid be used in cosmetics?
Tranexamic acid is not among the substances restricted by Regulation (EU) 2024/996; whether and in what concentration it is used must be supported by the safety assessment of the finished product. Studies on its topical application are small and often show no significant difference compared to a placebo base. Marketing claims must not rely on data regarding oral intake that pertain to a medicinal product.
Which packaging is suitable for light-sensitive brightening serums?
Light-protected or opaque containers and airless systems limit exposure to light and oxygen, which promotes discoloration and the degradation of active ingredients. Whether the selected packaging material is sufficient is demonstrated by stability storage in the final container. For vitamin C, another light-sensitive active ingredient in brightening serums, the magazine article 'Having Vitamin C Serum Produced' explores this in greater depth.
How long does it take to develop a skincare line for pigmentation spots?
The largest portion of time is usually taken up by stability testing, challenge testing (PET), and, if applicable, a clinical study to substantiate claims. At Labtree, a customized white-label formulation with standard packaging is typically ready for delivery in 2 to 3 months, while a new private-label development usually takes 3 to 6 months to reach market readiness. The article "Cosmetic Development: Realistic Timelines and What Factors Determine Them" describes the influencing factors.
