The topic is short and compact
With Regulation 655/2013, the EU enforces six common criteria according to which every statement on the packaging must be legally compliant and honest.
Common claims such as paraben-free or preservative-free have been severely restricted since the technical document was enforced in 2019.
All efficacy claims, such as regarding moisture or long-lasting wear for makeup, must be supported by reliable evidence from laboratory tests.
Anyone operating in the regulatory environment of the European Union must transition from general marketing jargon to precise, laboratory-proven label texts. Article 20 of Regulation (EC) No 1223/2009 governs the use of product claims and stipulates that they must not mislead consumers or attribute properties to the product that it does not possess. For implementation, Regulation (EU) No 655/2013 defines six common criteria that every cosmetic claim must meet before a product enters the market. Instead of treating these rules as a downstream checklist, brands should integrate them early into product development.
Legal compliance: Claims must not suggest that a product has been officially approved, or present a legal obligation as a special product benefit.
Truthfulness: Claims must not be based on false or manipulated data. Raw material-related claims must reflect the actual formulation content.
Evidential support: All explicit or implicit efficacy claims must be backed by technical documentation, raw material data, or targeted tests.
Honesty: Marketing texts must not generalize laboratory results beyond the actual concentration, application, or efficacy of the formulation.
Fairness: Claims must remain objective, must not create confusion with competitors, and must not denigrate approved raw materials.
Informed decision-making: Labeling must be clear and understandable so that consumers can correctly assess the cosmetic benefit.
At Labtree, the substantiation of claims is directly integrated into the technical process. During formulation development in our own laboratory, we verify the feasibility of make-up and skincare formulations using physical laboratory samples. Early samples allow product performance and stability to be verified before serial production begins. By testing raw material efficacy and sensory profile early, we help brands secure their desired efficacy claims while remaining fully compliant. This paves the way for successful cosmetics manufacturing in Europe.
The legal framework: Regulations 1223/2009 and 655/2013
Anyone operating in the regulatory environment of the European Union must transition from general marketing jargon to precise, laboratory-proven label texts. Article 20 of Regulation (EC) No 1223/2009 governs the use of product claims and stipulates that they must not mislead consumers or attribute properties to the product that it does not possess. For implementation, Regulation (EU) No 655/2013 defines six common criteria that every cosmetic claim must meet before a product enters the market. Instead of treating these rules as a downstream checklist, brands should integrate them early into product development.
Legal compliance: Claims must not suggest that a product has been officially approved, or present a legal obligation as a special product benefit.
Truthfulness: Claims must not be based on false or manipulated data. Raw material-related claims must reflect the actual formulation content.
Evidential support: All explicit or implicit efficacy claims must be backed by technical documentation, raw material data, or targeted tests.
Honesty: Marketing texts must not generalize laboratory results beyond the actual concentration, application, or efficacy of the formulation.
Fairness: Claims must remain objective, must not create confusion with competitors, and must not denigrate approved raw materials.
Informed decision-making: Labeling must be clear and understandable so that consumers can correctly assess the cosmetic benefit.
At Labtree, the substantiation of claims is directly integrated into the technical process. During formulation development in our own laboratory, we verify the feasibility of make-up and skincare formulations using physical laboratory samples. Early samples allow product performance and stability to be verified before serial production begins. By testing raw material efficacy and sensory profile early, we help brands secure their desired efficacy claims while remaining fully compliant. This paves the way for successful cosmetics manufacturing in Europe.
The six common criteria: The legal limits of label copy
Label copy in the European Union must strictly comply with Regulation (EU) No 655/2013, which establishes six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. These boundaries dictate what brands are allowed to claim on their packaging. At Labtree, addressing these rules begins early in formulation development. Building the product chemistry with compliance in mind from the outset ensures that label claims are scientifically defensible before production even begins.
Legal compliance: Labels must not present minimum legal requirements as a special benefit, such as claiming a lotion contains no toxic substances.
Truthfulness: If a brand advertises that a facial oil contains nourishing argan oil, the raw material must actually be present in the batch.
Evidential support: Claims regarding specific effects, such as 12-hour wear for makeup or wrinkle reduction for skincare, require objective validation through studies or consumer tests.
Honesty: A product must not claim the benefits of an active ingredient if it is dosed below its effective threshold.
Fairness: Marketing copy must not disparage approved raw materials or depict competitors' products as unsafe.
Informed decision-making: Labels must provide clear, non-misleading information so that buyers and consumers can make informed choices.
By considering these six criteria early in lab work and sample testing, expensive redesigns can be avoided. When developing makeup or functional skincare, Labtree cross-references raw material documentation with these specifications before production begins. Fully supported claims protect the product during safety assessment and help brands meet demanding retail listing requirements of trade retailers right from the start.
The End of Free-From Claims: What You Are No Longer Allowed to Say
With the full enforcement of the technical document on cosmetic claims in July 2019, marketing in the EU has fundamentally changed. This guideline, which specifies Regulation 655/2013, targets the common industry practice of selling products via negative claims. Common claims such as free from parabens, free from silicones, or free from preservatives are now severely restricted or completely inadmissible. The logic is twofold: claims must neither denigrate legally approved, safe raw materials nor present compliance with legal obligations as a special advantage.
Denigration of authorized substances: The claim "paraben-free" or "silicone-free" is deemed unfair because it suggests that these approved and safe raw materials are harmful to health.
Advertising legal obligations: Claims such as "heavy metal-free" or "cruelty-free" are inadmissible if the practice is already mandatory under Regulation 1223/2009, as a minimum legal requirement is presented as an advantage.
Misleading raw material claims: Labeling a product as preservative-free is inadmissible if the formulation relies on undeclared multifunctional raw materials for microbial stability.
For cosmetic brands, this shift means that label compliance is decided in the laboratory rather than in the marketing department. During make-up or skincare development, formulation development must achieve the desired performance, stability, and sensory profile with a compliant raw material strategy. At Labtree, our own laboratory work and early sampling allow us to test how alternative raw material systems affect texture, stability, and manufacturability. This technical preparation is crucial for brands looking to meet the strict retail listing requirements of major European drugstore chains like dm or Rossmann, where documentation and label texts are audited before shelf release.
Verifiability: Translating laboratory data into compliant label copy
The journey from creative marketing ideas to regulatory-compliant packaging texts requires close coordination between laboratory work and legal requirements. Under Regulation (EU) No. 655/2013, every claim displayed on a cosmetic label must meet the six common criteria. As a reliable development partner, Labtree aligns early development with these parameters, ensuring that efficacy claims for private label cosmetics are technically and legally sound before mass production begins.
Two-stage validation: raw material versus overall formulation. Building a robust product information file requires different levels of substantiation. For efficacy claims such as long-wear makeup, intense hydration, or skin compatibility for sensitive skin, data sheets from raw material suppliers are rarely sufficient. A compliant strategy requires testing of the overall formulation to ensure that the active ingredients remain stable and functional within the specific formulation. In custom formulation development, our laboratory work focuses on creating early physical samples that can be clinically, instrumentally, or sensory-profile tested. This early validation ensures that claims remain valid even after scale-up.
Compilation of raw material data: Procurement of dossiers, in vitro efficacy reports, and safety certificates directly from raw material manufacturers.
Testing of the overall formulation: Clinical studies, patch tests, or instrumental measurements on the final formulation to verify performance metrics.
Stability and compatibility testing: Verification that active ingredients do not degrade, separate, or react with the packaging during shelf life.
Proof of manufacturability: Ensuring that the validated formulation retains its physical stability and sensory profile during the industrial manufacturing process.
Raw Material vs. Product Claims: Avoiding Misleading Copy
A common compliance error is to transfer test results of individual active ingredients unchanged to the final packaging. Even if a supplier presents clinical studies proving that a raw material reduces fine lines, Regulation (EU) No. 655/2013 makes it clear that raw material-related claims must not suggest that the finished product has the same properties, unless this has been proven in vivo on the overall formulation. Particularly in complex makeup and skincare applications, the final texture, pH value, and preservation systems can alter or cancel out the effect of a raw material. The mere presence of an active ingredient in the ingredient list therefore does not justify a product claim.
Interaction of formulation and packaging. Packaging can also alter performance and stability. A serum or liquid foundation with oxygen-sensitive antioxidants can degrade quickly in a classic pipette bottle, whereas an airless dispenser maintains efficacy. Labtree counters this with early physical testing. Its own laboratory work creates samples that evaluate formulation and packaging compatibility simultaneously, thereby converting a product concept into a stable, production-ready formulation.
Presence of active ingredient: The raw material must be intentionally used in an effective, stable concentration and not just serve as a marketing argument.
Testing of the formulation matrix: Lab-validated tests such as stability tests must show that other raw materials in the base do not inhibit the active ingredient.
Packaging compatibility: Physical sampling must prove that the primary packaging protects the active ingredient over the specified shelf life.
Substantiation of the claim: Clear, objective evidence such as scientific publications, in-vitro assays, or clinical end-product tests must support the specific wording.
From concept to compliant formulation: The role of Labtree
As a B2B cosmetics developer and manufacturer, Labtree integrates regulatory compliance checks directly into the early stages of product development. Every advertising claim on a cosmetic label must comply with Regulation 655/2013, which requires strict technical substantiation, truthfulness, and evidential support. Instead of formulating in isolation and treating compliance as an afterthought, our laboratory team assesses the feasibility of claims right at the start of formulation development.
Our in-house laboratory work allows us to translate a brand's concept into physical laboratory samples at an early stage. This step is crucial for validating claims regarding texture, wear time, and performance. For example, if a brand wants a long-lasting liquid concealer or a serum for sensitive skin, we conduct early sampling and stability tests to prove that the active ingredients remain stable and active in the base emulsion. Identifying stability issues or incompatibilities during the sampling phase prevents costly reformulations just prior to clinical or consumer testing.
Review of raw material dossiers for compliance with EU purity standards and origin declarations.
Physical sampling to evaluate sensory profile, viscosity, and application behavior under realistic laboratory conditions.
Internal testing protocols, including accelerated stability testing over 12 weeks at 40 degrees Celsius, to ensure formulation stability.
Compatibility tests with the target packaging to rule out chemical interactions and loss of efficacy.
By securing manufacturability and claim substantiation early on, we prepare the product for a smooth transition into serial production. This structured approach is particularly important when preparing documentation for retail listings, where major European distributors require a complete Product Information File and fully substantiated claims before placing products on shelves.
Handling cosmetic claims in the European Union requires shifting from general marketing terms to precise, laboratory-proven label copy. Under Regulation (EC) No 1223/2009, every claim on a label must be supported by technical evidence. Labtree integrates this validation directly into the formulation development. Our in-house laboratory work ensures that the formulation is built with compliant raw materials from the very first sample, enabling a seamless transition into production.
Creation of the Product Information File (PIF): This legal dossier contains the qualitative and quantitative formulation, safety data sheets of the raw materials, and a 12-week stability protocol at 40 degrees Celsius.
Cosmetic Product Safety Report (CPSR): Prepared by an independent toxicologist. Part A documents the exposure and safety data including the margin of safety, while Part B contains the actual safety assessment.
CPNP Notification: The final step before production. The formulation, labeling details, and packaging specifications are registered in the Cosmetic Products Notification Portal.
Brands must review this technical dossier with their designated Responsible Person before launching. This step secures final approval, especially when preparing for complex retail listings. Whether it is sophisticated makeup development or highly active skincare: early laboratory validation ensures a stable formulation from the start. By addressing raw material impurities, packaging compatibility, and preservative efficacy (such as via a challenge test according to ISO 11930) early in our own laboratory, we ensure that every formulation is manufacturable, compliant, and ready for commercial production.
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FAQ
What are the six common criteria for cosmetic claims in the EU?
According to Regulation 655/2013, every cosmetic claim in the EU market must meet six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. These rules prevent consumers from being misled by unsubstantiated claims.
Can I write "paraben-free" on a cosmetic label in the EU?
In most cases, no. According to the technical document on cosmetic claims, "free-from" claims are inadmissible if they disparage legally authorized raw materials. Since parabens are approved preservatives in the EU, the claim "paraben-free" is considered unfair competition.
Is preservative-free a permissible claim in Europe?
The claim "preservative-free" is only permissible if the formulation contains no antimicrobial ingredients at all. If the formulation uses unlisted alternative preservative systems for stabilization, the statement is considered untrue and misleading.
What is the difference between a raw material claim and a product claim?
An ingredient claim describes the property of an individual raw material, such as in vitro studies on a peptide. In contrast, a product claim asserts that the finished makeup or skincare formulation delivers this benefit in vivo. Product claims require direct evidence.
How does Labtree support brands with EU cosmetics compliance?
As an experienced development partner, Labtree integrates the verifiability of claims and regulatory feasibility directly into formulation development and sample sampling. This physical validation prevents compliance and production delays.
Who is legally responsible in the EU for verifying cosmetic claims?
The designated Responsible Person of the brand, located in the EU, is legally responsible for ensuring that the product information file and the safety assessment substantiate every claim before the product is notified in the CPNP.
