Entering the European Union (EU) cosmetics market requires more than a strong formulation. It demands precise alignment with the EU’s labelling framework, where compliance expectations are centralized, highly technical, and actively enforced. Regulation (EC) No. 1223/2009 establishes harmonized requirements to protect consumers, support product traceability, and ensure transparent, consistent communication across all EU Member States.
This article outlines the core labelling obligations that apply to every cosmetic product entering the EU market, alongside connected compliance duties such as Responsible Person (RP) designation, product notification through the Cosmetic Products Notification Portal (CPNP), and evolving regulatory developments that continue to reshape ingredient, claims, and packaging requirements
- Regulatory Framework & Pre-Market Obligations
- Mandatory Label Information (Article 19 Requirements)
- Responsible Person (RP) Name and Address
- Country of Origin for Imported Cosmetic Products
- Nominal Content
- Date of Minimum Durability
- Period After Opening (PAO)
- Batch or Lot Number
- Product Function
- Precautions and Warnings
- Ingredients List
- Allergen Disclosure
- Nanomaterial Indication
- Placement of Mandatory Labelling Information
- Minimum Font Size and Legibility Requirements
- Cosmetic Claims on Labels
- Other Regulatory Marks and Considerations for EU Cosmetic Regulations
- Final Remarks
- FAQs
- What is the minimum font size for mandatory cosmetic labelling in the EU, and how is it measured?
- Can the ingredient list appear only on the outer carton, and what applies to samples and minis?
- When must fragrance allergens be listed individually instead of under “Parfum”?
- Is English alone acceptable on EU cosmetic labels?
- Are there marking requirements beyond Article 19 for cosmetic products?
Regulatory Framework & Pre-Market Obligations
Cosmetics sold in the EU are governed under a single, centralized legal framework, Regulation (EC) No. 1223/2009 on Cosmetic Products. This Regulation applies uniformly across all EU Member States and establishes the legal requirements for product safety, ingredient compliance, manufacturing under Good Manufacturing Practice (GMP), labelling, RP designation, product notification through the CPNP, and post-market surveillance. Products that do not meet these requirements cannot be legally placed on the EU market.
In addition to label and ingredient review, cosmetic companies must satisfy a defined suite of pre-market regulatory obligations that extend well beyond these core compliance steps. Each product must have an EU-established RP in place, a completed and signed Cosmetic Product Safety Report (CPSR), and a fully compiled Product Information File (PIF) maintained at the RP’s address. Manufacturing must be conducted under cosmetic GMP aligned with ISO 22716, and all product claims must be substantiated with appropriate scientific or technical evidence prior to market entry.
In parallel, every product must be notified through the CPNP prior to sale, and manufacturers must confirm that all mandatory labelling content and warnings, including any Member State-specific requirements, are correctly localized for each target market. Environmental and packaging compliance obligations, including Extended Producer Responsibility (EPR) requirements where applicable, must also be addressed prior to retail distribution.
Cosmetic Product Safety Obligations
Cosmetic product safety obligation is the cornerstone of EU cosmetic compliance and applies across the full product lifecycle, from raw material selection and formulation design through manufacturing, stability testing, packaging, labelling, and distribution.
Product safety must be demonstrated through a formal CPSR, which evaluates toxicological profiles, exposure scenarios, margin of safety, and any population-specific risks, including use by children or during pregnancy, where applicable.
In addition to a pre-market product safety assessment, cosmetic companies must ensure that there is continuous product oversight of the product once it enters the market. RP must actively monitor product performance through complaint handling, adverse reaction reporting, trend analysis, and corrective actions where necessary.
Cosmetic Product Safety Report (CPSR) Requirements for EU
CPSR is a formal scientific assessment that demonstrates a cosmetic product’s safety under EU law and is mandatory for every cosmetic formulation. The CPSR must be completed and signed by a qualified safety assessor with appropriate credentials in toxicology, pharmacy, medicine, or a related life science discipline. Without a valid CPSR in place, a product is not legally market-ready, regardless of how compliant the label or ingredients may appear.
The CPSR is structured in two parts. Part A contains the full safety data required for assessment, including the complete quantitative formulation, ingredient toxicology, impurity and contaminant profiles, microbiological quality, preservative efficacy, exposure conditions, and packaging compatibility. Part B is the safety assessor’s formal opinion, confirming whether the product is safe under normal and reasonably foreseeable conditions of use and identifying any required warnings or label statements.
From a regulatory standpoint, the CPSR is not a static, one-time document. It must be maintained as a living safety file throughout the product’s lifecycle. Any change to formulation, raw material supplier, manufacturing process, packaging system, or intended use can trigger a required review or update. The CPSR also forms a core component of the PIF and must be made available to EU authorities upon request. In practice, the CPSR is the scientific backbone of EU cosmetic compliance, linking formulation, labelling, claims, and post-market surveillance into a single, defensible safety framework.
The Product Information File (PIF): The Core Technical Dossier for EU Cosmetic Compliance
A PIF is the central technical dossier that substantiates a cosmetic product’s regulatory compliance and must be prepared in advance of the product being placed on the EU market. It must be kept on record by the company responsible for the product and the appointed RP. Each product is required to have its own dedicated PIF, and this file must be readily available for review at the time of regulatory inspection. As a result, proactive planning is essential to ensure uninterrupted compliance. The PIF must also be retained for a minimum of ten years after the last batch of the product is placed on the market.
Each PIF must contain a defined set of regulatory and technical documents, including a detailed product description, the full CPSR, details of the manufacturing method and cosmetic Good Manufacturing Practice compliance, evidence to substantiate cosmetic claims, and an animal testing declaration.
The CPSR functions as the scientific foundation of the PIF, while the PIF serves as the regulatory container that supports, controls, and contextualizes that safety conclusion across the product lifecycle. A CPSR without a PIF lacks regulatory standing. A PIF without a CPSR lacks scientific validity. Together, they form the regulatory backbone of EU cosmetic product safety and compliance.
Mandatory Label Information (Article 19 Requirements)
Cosmetic labelling requirements are a core regulatory obligation that must be fully met prior to EU market entry in addition to the considerations discussed above. EU regulations state that certain mandatory information must appear on the container and or outer packaging of all cosmetic products in lettering that is indelible, easily legible, and clearly visible. These required labelling elements include the following:
- Responsible Person (PR) Name and Address
- Country of Origin for Imported Cosmetic Products
- Nominal Count (by weight or volume)
- Date of Minimum Durability (if ≤ 30 months)
- Period After Opening (PAO)
- Batch of Lot Number
- Product Function (unless obvious)
- Precautions and Warnings
- Ingredient List
- Allergen Disclosure
- Nanomaterial Indication
While some non-EU jurisdictions require that all label text be fully translated into the national language, the EU applies a more structured language requirement under Regulation (EC) No. 1223/2009. All mandatory cosmetic labelling information that is consumer-facing must appear in the official language or languages of the target Member State, unless a standardized symbol is expressly permitted as a substitute. As such, product function, precautions and warnings, and any directions for safe use must always be localized for the country of sale.
Elements such as the ingredient list (INCI), nominal content expressed in metric units, and durability information displayed using approved symbols (hourglass for Date of Minimum Durability and open jar for Period After Opening) do not require translation. English is not universally accepted across the EU and is only legally sufficient in certain Member States. As a result, language compliance must be assessed on a country-by-country basis prior to market entry.
The following sections explore the above elements in-depth, providing additional context and conditional requirements.
Responsible Person (RP) Name and Address
The product label must display the name or registered trade name and full address of the EU-established RP. This entity is typically the manufacturer or the importer who has assumed legal responsibility for regulatory compliance. Only one RP address is required on the label. The inclusion of multiple addresses is not mandated and may create regulatory ambiguity. Where more than one economic operator is referenced on the packaging, the RP must be clearly identifiable as such.
Country of Origin for Imported Cosmetic Products
Where a cosmetic product is manufactured outside the EU, the country of origin must be declared on the label using an appropriate “Made in [Country]” statement. Cosmetic products manufactured within the EU do not require a country-of-origin declaration. The phrase “Made in” does not require translation, as it is universally recognized across Member States.
Nominal Content
Each cosmetic product label must declare the nominal quantity (net quantity) of product contained in the package, expressed in metric units by weight (grams) or volume (millilitres). Nominal quantity is the amount of product in the package or container at the time of filling.
When declaring the nominal count, imperial units may be included in addition to the metric declaration. However, the core requirement is that all products contain a declaration of net quantity in metric units. For instance, manufacturers can declare “100 mL / 3.38 fl oz” on a cosmetic label if they prefer to include both units.
Additionally, net content declarations are generally not required for single-use packs, products containing less than 5 g or 5 mL, or multi-item sets customarily sold as a single unit. On the other hand, full-size retail products must display the nominal content (for example, “50 mL”). The estimated sign (℮) may be used voluntarily to indicate compliance with EU average fill requirements.
Date of Minimum Durability
Where a cosmetic product has a minimum durability of 30 months or less, the label must display a date of minimum durability using either the wording “Best before end” followed by the relevant date, or the hourglass symbol (commonly referred to as an “egg timer” symbol) used in conjunction with the date. The date may be expressed as “month/year”, or as a full “day/month/year” where additional clarity is required. This declaration indicates the point up to which the product, when stored under appropriate conditions, is expected to remain safe and compliant for use.
Period After Opening (PAO)
Where the minimum durability of a cosmetic product exceeds 30 months, a fixed expiration date is not required. Instead, the label must display a PAO symbol in the form of an open-jar icon, accompanied by the number of months or years during which the product remains safe following first opening, such as “24 M.” The PAO is required for products that are susceptible to degradation after opening, including creams, lotions, makeup, and hair care products. Products that are not opened during use, are single-use, or are chemically stable and not subject to deterioration, such as alcohol-based perfumes, may be exempt from both PAO and expiration dating, provided stability criteria are met.
Batch or Lot Number
A batch number or lot code must be present on every cosmetic product to enable full traceability. This code allows identification of production history in the event of quality issues, complaints, or recalls. EU does not prescribe a specific format for batch or lot code declarations, and the batch code may be alphanumeric. It may appear on either the primary container or the outer packaging, provided that it is clearly legible and durable throughout the product’s lifecycle.
Product Function
Unless the product’s intended purpose is clearly evident from its presentation, the label must include a brief description of the cosmetic function. Acceptable examples include “Moisturizing hand cream” or “Shampoo for oily hair.” Where the product category or use is self-evident based on the product name, format, and presentation, a separate function statement may not be required. The objective is to ensure that the product’s identity and intended use are immediately clear to the end consumer, thereby reducing the risk of misuse and any associated safety concerns. The stated function must also remain strictly within the cosmetic definition and must not imply any medicinal, therapeutic, or disease-related effect, as this may trigger reclassification under a separate regulatory framework.
Function statements must appear in the appropriate official language or languages of the target Member State and must be consistent across the label, website, advertising, and all other promotional materials. Where the intended use may be ambiguous, involves sensitive application areas such as the eyes or lips, is directed at children, or is intended for professional use, the function must be clearly stated and supported within the safety assessment. Where any uncertainty exists, inclusion of a clear and conservative function statement is recommended to support safe and appropriate use and to mitigate enforcement risk.
Precautions and Warnings
All special precautions for use, safety warnings, and instructions required to ensure safe use of the product must be included on the label. This may include general warnings such as “avoid eye contact”, as well as specific mandatory warnings prescribed under regulatory annexes for certain ingredients or product categories.
Products for professional use must clearly state that restriction, and aerosol products must display the relevant pressurized container warnings. Where packaging size prevents direct inclusion of lengthy warning statements, a leaflet or insert may be used, provided that an appropriate symbol (hand-in-book) or statement is added to the label, directing users to additional information is displayed on the packaging.
Required precautions and warning statements are determined through a combination of ingredient regulatory status and formal safety assessment. Each formulation is assessed against the EU Regulation annexes, particularly Annex III, which prescribes mandatory warning statements for certain restricted substances and product categories. In parallel, the CPSR may impose additional warnings based on toxicological risk, exposure conditions, and target population.
Ingredients List
All cosmetic ingredients must be declared on the outer packaging under the heading “Ingredients.” Ingredients must be listed using standardized INCI nomenclature in descending order of weight at the time of manufacture. Manufacturers should adhere to the following when creating a list of ingredients:
- Ingredients present at concentrations below 1% may be listed in any order following those above 1%.
- Fragrance and flavour components may be collectively listed as “Parfum” or “Aroma,” except where individual allergen disclosure is required.
- Plant-derived ingredients are generally declared using their Latin botanical names.
- Colourants may appear at the end of the ingredient list using their Colour Index (CI) numbers and may be preceded by “+/–” where shade variability applies.
In addition to formatting and order, each ingredient must also be legally permitted for use under the EU Cosmetics Regulation and comply with any applicable conditions of use. Trace-level impurities and unavoidable residues may not require on-label declaration, but they must be assessed within the safety assessment and can influence warning requirements.
Lastly, where an outer package exists, the ingredient list is required to appear on that outer packaging and is not required to be repeated on the inner container. Where no outer packaging is present, the ingredient list must appear directly on the container. The ingredient list may only be placed on a leaflet or insert where space limitations make on-pack disclosure not feasible, and the appropriate symbol directing the consumer to additional information is used. While INCI names themselves are never translated, the “Ingredients” heading must still appear in a language understood by the consumer in the target Member State.
Allergen Disclosure
Where any of the specified fragrance allergens are present above EU-established thresholds, they must be individually declared within the ingredient list, even when they originate from a fragrance compound or essential oil. In these cases, the allergens cannot be grouped under the collective “Parfum” or “Aroma” designation and must appear as separate INCI entries.
Once disclosure is triggered, allergens must also follow standard INCI ordering rules. If an allergen is present at a concentration above 1%, it must appear in strict descending order by weight alongside the other ingredients. If it is present at 1% or less, it may be listed after all ingredients above 1% and may appear in any order within that lower-concentration section.
The disclosure thresholds remain 0.001% for leave-on products and 0.01% for rinse-off products. The current fragrance allergen list of 26 substances is being significantly expanded to 82 declarable allergens under upcoming regulatory amendments. New products placed on the EU market from July 31, 2026, and onward must comply with the expanded allergen disclosure requirements, while existing products will be required to update their labelling by July 31, 2028, to remain compliant.
Nanomaterial Indication
Where a cosmetic ingredient qualifies as a nanomaterial under EU law, the ingredient name in the INCI list must be followed by the term “(nano)” in brackets. In the EU, a nanomaterial is defined as an intentionally manufactured, insoluble or bio-persistent material with one or more external dimensions, or an internal structure, on the scale of approximately 1 to 100 nanometres. This definition captures certain forms of ingredients such as titanium dioxide, zinc oxide, and silica when they are engineered at the nanoscale to alter optical, sensory, or functional performance.
The “(nano)” designation serves two regulatory purposes. First, it provides transparency to consumers regarding the presence of nanoscale materials. Second, it flags the ingredient for enhanced regulatory oversight, as nanomaterials are subject to additional safety requirements due to their unique physicochemical properties and potential differences in biological behaviour compared to their non-nano counterparts.
In addition to on-label disclosure, certain nanomaterials require a separate pre-market notification via the CPNP, which must be submitted at least six months prior to market placement, along with submission of detailed characterization, toxicological, and exposure data. These requirements apply independently of the standard CPNP notification and must be satisfied before the nanomaterial-containing product can be legally placed on the EU market.
Placement of Mandatory Labelling Information
All mandatory labelling elements must appear on the immediate container and or the outer packaging where both are present, with the exception of the ingredient list, which may appear on the outer packaging only.
In practice, the outer packaging typically carries the full set of regulatory information, while the primary container includes core identifiers such as the product name, nominal content, Period After Opening (PAO), and batch code to ensure traceability at the unit level. This dual-level approach ensures that critical safety and identification information remains available even where the outer packaging is discarded after purchase.
Where space limitations, container shape, or packaging format prevent full disclosure of all mandatory elements directly on the container, the use of leaflets, inserts, tape labels, or fold-out labels is permitted. In such cases, an appropriate symbol must appear on the container to clearly direct the consumer to additional product information. This flexibility is intended to support compliance for small or uniquely shaped packaging without compromising consumer access to safety-critical information.
Minimum Font Size and Legibility Requirements
In addition to the content and placement of mandatory labelling elements, EU regulations also impose specific requirements related to font size and legibility. All mandatory cosmetic labelling information must be presented in lettering that is indelible, easily legible, and clearly visible under normal conditions of purchase and use. Beyond these general principles, Regulation (EC) No. 1223/2009 establishes minimum character height thresholds that must be respected to ensure consumer readability.
As a general rule, the minimum font x-height for mandatory labelling text is 1.2 mm, as measured by the lowercase “x.” This requirement applies to all consumer-facing mandatory elements, including product function, warnings, precautions, Responsible Person details, country of origin where applicable, and nominal content. For small packaging with a largest surface area of less than 80 cm², the minimum font height may be reduced to 0.9 mm, but only where the size of the packaging genuinely prevents compliance with the standard 1.2 mm requirement.
These font size thresholds are among the most frequently cited technical deficiencies during market surveillance inspections, particularly for small-format packaging, promotional sizes, and travel products. From a regulatory standpoint, font compliance must be assessed at the artwork stage and verified on physical production proofs. Failure to meet minimum character size requirements can render an otherwise compliant label technically non-compliant, even where all mandatory elements are present.
Cosmetic Claims on Labels
Although cosmetic claims fall outside the strict content requirements of Article 19, they remain a core pillar of EU cosmetic compliance and must be carefully assessed in parallel with label development. All claims appearing on product labels, packaging, marketing materials, or advertising are governed by Regulation (EU) No. 655/2013, which establishes the EU Common Criteria for cosmetic claims.
The EU Common Criteria require that claims be legally compliant, truthful, evidence-based, honest, fair, and enable informed consumer decision-making. As such, every claim must be supported by appropriate substantiation, whether in the form of test data, clinical results, in vitro studies, or well-founded scientific literature. This is particularly critical for performance and comparative claims, such as “visibly reduces wrinkles in four weeks” or “gentler than the leading brand.”
Absolute or exaggerated statements that cannot be substantiated present a high enforcement risk. For example, claims such as “100% hypoallergenic” are discouraged, as no cosmetic product can be guaranteed to cause zero sensitization in all users. Similarly, “free-from” claims must be used with caution and cannot imply that legally permitted ingredients are unsafe or inferior. The EU has issued specific guidance on the appropriate use of “free-from” and “hypoallergenic” positioning to prevent misleading impressions.
In addition, while animal testing for cosmetic products and ingredients is prohibited in the EU, claims such as “cruelty-free” must not suggest that only certain products comply with this legal requirement, as compliance is mandatory for all cosmetics placed on the EU market. From a regulatory perspective, claims should always be reviewed alongside label design, with full substantiation maintained within the PIF to ensure they remain defensible during inspection or market surveillance.
Other Regulatory Marks and Considerations for EU Cosmetic Regulations
Beyond the core cosmetics-specific labelling requirements, manufacturers must also be mindful of additional symbols and marks that frequently appear on cosmetic packaging. While these marks do not fall under Regulation (EC) No. 1223/2009, they are often legally required under other EU frameworks and are routinely assessed during market surveillance.
“℮” Mark
The estimated sign (℮) may be used voluntarily following the nominal content declaration to indicate that the product complies with EU average fill requirements under weights and measures legislation. While its use is not mandatory, the symbol confirms that the product meets prescribed tolerances for quantity control and is widely used across EU consumer goods as a signal of regulatory conformity.
Recycling Symbols
Recycling and disposal symbols are governed by packaging and environmental legislation rather than cosmetic law. Depending on the Member State, this may include general recycling indications such as the Mobius loop, national waste sorting icons, or specific mandatory marks.
For example, France requires the “Triman” symbol and associated sorting instructions to indicate that the packaging is subject to organized recycling. These requirements are closely tied to Extended Producer Responsibility obligations, under which brands must register their packaging and finance recycling schemes. While such symbols are typically country-specific rather than harmonized at EU level, failure to include them where required can result in enforcement action unrelated to cosmetic compliance.
Aerosol “Φ” Mark
Cosmetic products presented in aerosol dispensers are subject to the EU Aerosol Dispensers Directive in addition to cosmetic regulations. These products must display the required pressurized container marking and associated safety warnings in the appropriate local language, including heat exposure and puncture risks. This applies to products such as deodorant sprays, hairsprays, and spray-on sunscreens, and is assessed independently of cosmetic ingredient or claims compliance.
Product Specific Requirements
Certain cosmetic categories are also subject to additional, product-specific labelling rules. For instance:
- Toothpaste containing fluoride must declare the fluoride content and carry age-related safety advisories above prescribed thresholds.
- Sunscreen products must comply with EU guidance on SPF presentation and include standardized safety statements regarding sun exposure.
- Children’s cosmetics and kit-based products may also attract supplementary warnings depending on their format and components.
While these requirements extend beyond the general rules applicable to all cosmetics, they are routinely captured during label review and must be assessed on a case-by-case basis.
In summary, cosmetic labelling compliance in the EU extends beyond the items listed under Article 19. A fully compliant label reflects not only adherence to cosmetic legislation, but also proper integration of packaging, environmental, safety, and product-category-specific requirements. For industry professionals, early cross-functional review of all applicable marking obligations is essential to avoid last-minute redesigns, delayed launches, and market enforcement risk.
Final Remarks
EU cosmetic labelling is not a standalone design exercise. It is the outward expression of a much broader regulatory framework that integrates product safety, ingredient compliance, manufacturing controls, claims substantiation, and post-market surveillance into a single, enforceable system. Article 19 establishes the baseline labelling obligations, but true compliance is achieved only when those visible requirements are fully aligned with the CPSR, PIF, CPNP notification, and ongoing safety monitoring activities. Every element on a cosmetic label must be defensible, technically accurate, and supported by underlying regulatory documentation.
As regulatory expectations continue to evolve, particularly in areas such as fragrance allergen disclosure, nanomaterial oversight, environmental marking, and claims enforcement, label compliance must be treated as a dynamic, lifecycle obligation rather than a one-time approval step. For manufacturers, importers, and RPs, early regulatory scoping, disciplined documentation control, and proactive label review remain the most effective tools for avoiding enforcement risk, launch delays, and costly rework. When executed correctly, EU cosmetic labelling not only satisfies legal requirements but also reinforces consumer trust, brand credibility, and long-term market access across all Member States.
Need Support With EU Cosmetic Labelling and Regulatory Compliance?
Bringing a cosmetic product to the EU market demands alignment across formulation, safety assessment, claims substantiation, Responsible Person designation, CPNP notification, and precise execution of every Article 19 labelling element. At SNI, we provide end-to-end regulatory support to ensure your cosmetic products are market-ready and fully aligned with Regulation (EC) No. 1223/2009.
To learn how Source Nutraceutical Inc. can support your team with regulatory planning, product reformulation, or cross-border labelling compliance, contact us today. Our experts are here to help ensure your food products remain competitive, compliant, and market ready.
🧴More about our services here.
💡 Compliance is easy with the right support!
📩 info@sourcenutra.com
⬇️ Send us a request for support or an introductory call
FAQs
What is the minimum font size for mandatory cosmetic labelling in the EU, and how is it measured?
Mandatory text must meet a minimum x-height of 1.2 mm, or 0.9 mm where the largest surface of the packaging is under 80 cm². Font size is measured on the printed package, not by point size in the design file.
Can the ingredient list appear only on the outer carton, and what applies to samples and minis?
Yes. Where an outer package exists, the ingredient list may appear only on the outer packaging. For samples, minis, and sachets, full labelling is still required and may be provided via a leaflet, tag, or card, using the hand-in-book symbol.
When must fragrance allergens be listed individually instead of under “Parfum”?
When a declarable allergen exceeds 0.001% in leave-on products or 0.01% in rinse-off products, it must be listed individually in the ingredient list and cannot remain grouped under “Parfum.”
Is English alone acceptable on EU cosmetic labels?
No. Mandatory consumer-facing information such as product function, warnings, and directions for use must appear in the official language(s) of the country of sale. English alone is only acceptable in limited Member States.
Are there marking requirements beyond Article 19 for cosmetic products?
Yes. Additional marking may be required under aerosol safety rules, packaging and recycling legislation, and Extended Producer Responsibility programs, depending on the product format and country of sale.
✷ The content on this website, including information presented in this post, is provided for general informational purposes only and does not constitute legal, regulatory, or professional advice. While efforts are made to ensure accuracy, laws and regulations vary by jurisdiction and may change over time. Readers should not rely on this information as a substitute for advice from qualified legal or regulatory professionals. We disclaim any liability for actions taken based on this content, and users are encouraged to seek guidance specific to their circumstances.
