Cosmetic Ingredient Regulations: 2026 Compliance Guide
Jenna
Summary
Cosmetic ingredient regulations demand absolute transparency before any product can be placed on the market. In practice, the mandatory INCI list categorizes components by decreasing order of concentration and requires all allergens to be declared if they exceed 0.01%. Understanding this structure allows you to verify the actual safety and compliance of a formulation, far beyond marketing claims.
European Cosmetic Regulation: The Basics of Regulation 1223/2009
Regulation EC 1223/2009 governs cosmetic product regulations within the European Union. This text applies to every actor, from large international groups to French manufacturing, as practiced at Elyara. Among the approximately 15,000 available molecules, this regulation precisely defines which cosmetic ingredient can be used in a formulation.
The Six Annexes Structuring Ingredient Regulation
Cosmetic regulation relies on six annexes that define the regulatory status of each component. This framework determines all our formulation choices. In practice, non-compliance with even one of these requirements is enough to render a product illegal.
- Annex II: approximately 1,730 prohibited substances, continuously updated according to REACH directives.
- Annex III: nearly 380 substances authorized under strict conditions of dosage or application.
- Annex IV: about 155 permitted colorants, with precise formulation restrictions.
- Annexes V and VI: preservatives and UV filters are subject to a restrictive positive list.
To act as a UV filter or preservative, a molecule must imperatively appear on these lists. Specifically, an active ingredient not on these lists cannot perform that function in the final composition, regardless of its intrinsic effectiveness. Regulation always takes precedence over the supposed properties of the ingredient.
CMR Substances and Absolute Prohibitions: What You Need to Know
The legislation automatically excludes Category 1 CMR substances, recognized as mutagenic or toxic for reproduction. This exclusion applies systematically, regardless of the intended dosage. The framework of European labeling thus locks down every decision made in the laboratory.
Category 2 substances are treated differently, with very strictly controlled exceptional authorizations. The Scientific Committee rarely approves these derogations, in the interest of health preservation. I prioritize proven plant-based alternatives to guarantee a perfectly neutral product for the scalp.
PIF, CPNP, and Responsibilities of the Responsible Person in France
Before any launch, the responsible person compiles a complete Product Information File (PIF). This document records the detailed formula, evaluations validated by a toxicologist, and rigorous production monitoring. It guarantees full traceability and compliance with good manufacturing practices.
In France, a notification on the CPNP portal is mandatory before any commercialization. This administrative step is in addition to registration with the competent national authorities. This strict system ensures the transparency you are entitled to demand through the INCI list and all labeling information on your products.
New Regulatory Restrictions in 2025 and 2026
The 2025 cosmetic regulations redefine authorized formulations by imposing new restrictions on active ingredients that have been widely used until now. UV filters and soy isoflavones will see their regulatory status modified in the coming months. This evolution reflects an increased demand for safety in commercialized formulas.
Prohibited and Restricted Substances from 2025
The European regulation confirms the withdrawal of three substances: Methylbenzylidene camphor, Dimethyltolylamine, and TPO. These prohibitions apply to the entire market from September 1st. A technical reformulation then becomes necessary to maintain the compliance of the affected products.
In fact, several cosmetic active ingredients will see their authorized concentration threshold lowered. Retinol and soy isoflavones fall under the category of restricted substances beyond specific percentages. The difference lies in the strict dosage that formulators must adhere to in the laboratory.
| Substance | Status from 2025 | Category |
| Methylbenzylidene camphor | Total ban | UV Filter |
| Dimethyltolylamine | Total ban | Miscellaneous |
| TPO (Trimethylbenzoyl DPP Oxide) | Banned from September 2025 | UV Filter |
| Homosalate | Maximum concentration lowered | UV Filter |
| Triclosan / Triclocarban | Reduced thresholds | Preservative |
| Kojic Acid / Arbutin / α-arbutin | New concentration restrictions | Depigmenting active |
| Genistein / Daidzein | New restrictions | Isoflavone |
| Vitamin A (retinol) | Controlled concentration | Anti-aging active |
Within this strict framework, verifying product information files becomes necessary before any market placement. Regulatory compliance is continuously evaluated for each developed reference. This is the position we hold at Elyara: integrating these standards from the initial product design.
Nanomaterials: Specific Regulations and Notification Obligations
Specifically, the use of nanomaterials is subject to reinforced regulation, with the prohibition of five specific components. Their presence is only tolerated if they appear in the annexes dedicated to the regulation of colorants or UV filters.
In practice, the integration of these particles requires a six-month prior notification to the competent authorities. The INCI name must mandatorily include the mention [nano] within the list of ingredients. This labeling requirement ensures complete transparency when reading the bottle.
Substances Under Increased Scrutiny: PFAS, Microplastics, and Endocrine Disruptors
The regulation of microplastics and PFAS is subject to continuous monitoring, based on the latest available toxicological data. While not every chemical substance in these groups is yet prohibited, their use will be restricted in the short term. Scientific committees regularly update usage limits based on this data.
I favor a preventive exclusion method to anticipate these constraints related to cosmetic regulations. Foreseeing future restrictions avoids having to reformulate under the pressure of an imminent deadline. The Elyara method relies on this rigorous ingredient selection, long before the law requires it.
INCI List and Cosmetic Labeling Regulations
The nomenclature of an ingredient list adheres to a strict hierarchy imposed by European regulation since 1999. Specifically, mastering this reading changes the approach to a care composition. It is at this level that you identify the true concentration of a repairing active ingredient, without relying on marketing discourse.
Reading and Understanding the INCI List: Rules and Ingredient Order
In practice, the INCI list designates botanical extracts in Latin and synthetic molecules in English. Labeling imposes a rigorous decreasing classification. The difference lies in the first three components, which often represent over 80% of the formula.
- Strict weight order: each cosmetic ingredient appears according to its initial incorporation weight.
- 1% threshold: below this limit, components can be listed freely, which preserves the manufacturing secret.
- Aqueous predominance: water almost systematically occupies the first position in a rinse-off product.
- Fragrances and compounds: aromas remain grouped under a generic name, but identified allergens are subject to a mandatory individual mention.
The first five elements define the actual architecture of a product. That said, a component in tenth position is not necessarily negligible. Phytokeratin, for example, reconstructs the hair fiber with real effectiveness even at very low dosages.
Allergens and Fragrances: Specific Disclosure Obligations
Cosmetic labeling compliance requires precise display of allergenic substances according to the product's rinse-off type. A raw natural extract is not exempt from this safety requirement. Regulation strictly governs essential oils, whose aromatic fractions require clear identification.
Claims on packaging must be based on verifiable analytical reality. Claiming a pure formula commits the brand's responsibility regarding cosmetic product control. This is the position we hold at Elyara: every plant-based claim is based on rigorous traceability of our active ingredients.
Mandatory Labeling: BBE, PAO, and Regulatory Mentions
The cosmetic regulation sets the requirements applicable to cosmetic product labeling throughout the European Union. Each printed mention complies with a precise nomenclature, whose objective is the direct protection of the user.
- Best Before End Date (BBE): indicated by an hourglass for products with a shelf life of less than thirty months.
- Period After Opening (PAO): identified by an open jar, it indicates the optimal use window expressed in months.
- Complete traceability: the batch number guarantees the monitoring of the product's sanitary compliance throughout its commercialization.
Product labeling includes only one of these two time markers, depending on the formula's shelf life. Cosmetic regulation also requires indicating the country of origin when it is outside the European market, a constraint that our local production immediately bypasses.
Toxicological databases allow for deeper analysis beyond the legal framework. An alert on a component often justifies targeted vigilance when purchasing. While the law validates the use of certain molecules, I prioritize an approach that leaves no doubt about your scalp's tolerance.
Frequently Asked Questions
What is Regulation EC No 1223/2009 and to whom does it apply?
Regulation EC No 1223/2009 forms the common basis for cosmetic product regulation within the European Union. This text precisely defines the conditions for placing on the market, establishing the list of prohibited substances and applicable labeling rules. Specifically, each formulation must meet these safety requirements to ensure risk-free use.
How to check the regulatory status of a cosmetic ingredient before formulation?
The regulatory status of each cosmetic ingredient is determined by the restrictive annexes of the European text. In practice, this framework sets precise dosage thresholds, notably limiting the use of certain colorants and preservatives to well-defined functions. The compliance of our formulas is based on this scientific validation, systematically carried out before any product proposal.
What are the regulatory obligations for nanomaterials in cosmetics?
Any use of nanomaterials requires the explicit mention "[nano]" in the INCI list of the product concerned. This regulation also requires mandatory notification to the European authorities, to be submitted six months before the introduction of any new compound. The difference here lies in the transparency due regarding the molecular dimension of the active ingredients used.
