Labeling Requirements Under EU Cosmetics Regulation (EC) No 1223/2009: What Your CPSR Must Support

Many cosmetic brands assume EU labeling compliance is mostly about adding an ingredient list and placing a Responsible Person address on the packaging. 

 EU Cosmetics Regulation (EC) No 1223/2009, every label element must be backed by evidence inside the Cosmetic Product Safety Report, and the Product Information File (PIF). If your packaging says one thing but your safety documentation says another, regulators treat the product as non-compliant, even if the formula itself is safe.

This guide covers:

• Article 19 requirements for every mandatory labeling element are explained
• Annexes III–VI impact how they determine what must appear on your packaging
• CPSR validation, what must be supported, ingredient by ingredient and warning by warning

If you’re a brand owner preparing for EU launch, a formulator reviewing artwork, or a regulatory consultant double-checking compliance, here is everything you need.

What Is EU Regulation (EC) No 1223/2009, and What Does It Actually Cover?

EC Regulation 1223/2009 on cosmetics is the single legal framework governing every cosmetic product placed on the EU market. It came into full effect in July 2013, replacing the old Cosmetics Directive, and it hasn’t stopped evolving since.

It’s not just about safety testing. EU Cosmetics Regulation covers the entire compliance picture, product safety, restricted and prohibited ingredients, mandatory labeling, permitted claims, pre-market notification, and post-market surveillance. Every brand selling into the EU, regardless of where the product is made, is bound by it.

For cosmetic labels specifically, the most important section is Article 19, which defines the mandatory information every cosmetic product must display before it can legally be sold. 

EU Cosmetic Labeling Requirements Under Article 19 

Before anything else, here’s your full reference. Every mandatory element under the EU cosmetics regulation, what it requires, where it must appear, and where brands most commonly get it wrong.

Responsible Person Information: The Foundation of EU Cosmetic Compliance

Every cosmetic product sold in the EU must have a designated Responsible Person (RP), an entity legally established within the EU that takes full accountability for the product’s compliance with Regulation (EC) No 1223/2009.

Their full name and physical EU address must appear on both the container and the outer packaging. Not a registered agent’s mail forwarding address. 

For non-EU brands, this is one of the first things to resolve before labeling work even begins. Without an EU-based Responsible Person, you cannot legally place the product on the market. 

The RP also holds the Product Information File, ensures the CPSR is complete and signed, and handles CPNP notification. It’s not just a label element; it’s the compliance anchor for everything else.

EU Cosmetic Packaging Rules and Labeling Compliance: 

Country of Origin, Nominal Content, and Basic Identification

• Country of origin is only required for imported cosmetics, products manufactured outside the EU and brought in for sale. “Made in South Korea,” “Manufactured in the USA”, something clear and specific. EU-manufactured products are exempt, though some brands include them anyway for marketing purposes.
• Nominal content, the weight or volume, must be stated in metric units. Grams, millilitres, litres. Straightforward, but the format matters. And there are exemptions: products under 5g or 5ml, free samples, and single-application items don’t require it. Everything else does.

Date of Minimum Durability vs PAO: What Your CPSR Must Prove 

This is one of the most frequently confused areas in EU cosmetic packaging compliance, and it has direct consequences for your CPSR.

Here’s how to get it right:

• Products with a shelf life of 30 months or less → Display a “best used before” date, shown with the hourglass symbol. Your CPSR stability data must support the specific date printed.
• Products lasting more than 30 months → No best-before date needed, but a PAO symbol (open-jar icon) with a duration is mandatory. “6M,” “12M,” “24M.” Your CPSR must include stability testing that actually supports this period.

If your label says “24M” and your stability testing only covers twelve months, that’s not a gap you can paper over. It’s a safety documentation failure under EU cosmetics regulation provisions, and it makes the label non-compliant regardless of how safe the formula actually is.

Batch Numbers and Traceability Requirements 

The batch number allows a product to be traced back to its specific manufacturing run if a safety issue arises. It must appear on the container, the outer packaging, or both, and it must be legible.

Missing a batch number isn’t a minor formatting oversight. Under EU cosmetic packaging rules, it’s a traceability failure, the kind that can trigger a market withdrawal or enforcement action.

Product Function and Warning Statements Under EU Labeling Rules 

If the product’s purpose isn’t immediately obvious from its name or appearance, you must state it on the label. A translucent serum that could be mistaken for a primer? State the function. A multi-use oil? State all intended uses. “Obvious” is not a safe assumption when regulators are reviewing your pack.

For precautions and warnings, there are two distinct layers:

Layer 1: General safety precautions: Conditions relevant to your specific product. “Keep out of reach of children.” “Avoid contact with eyes.” These are determined by your safety assessor based on the formula and intended use.

Layer 2: Annex III mandatory warning phrases: These are pre-written in the regulation. If you’re using a restricted substance from Annex III, certain hair dye components, hydrogen peroxide, or specific preservatives, the exact warning phrase set out in the annex must appear on the label. You cannot paraphrase it. You cannot summarise it. You use the prescribed wording, verbatim, in the language of the market.

Your CPSR must confirm the concentration is within the Annex III limit and that the correct warning phrase is present on the label. Both things. Not one or the other.

Ingredient Labeling Under Annexes III–VI: EU Cosmetic Label Requirements Explained 

The INCI ingredient list is the most scrutinized part of any EU cosmetic label, and the rules around it are specific.

Under EU cosmetics regulation, the ingredient list must follow this structure:

• All ingredients are listed in descending order by weight at the time of manufacture
• INCI nomenclature throughout, not trade names, not chemical aliases
• Ingredients at 1% or less can appear in any order, but only after all ingredients above 1%
• Colorants from Annex IV can be listed at the end in any order, using Colour Index (CI) numbers
• Fragrances are listed collectively as “Parfum” or “Aroma”, not broken out by individual components, with one significant exception

Fragrance Allergen Disclosure Under EU Regulation 2023/1545 

Under Commission Regulation (EU) 2023/1545, an expanded list of fragrance allergens must be individually named in the ingredient list when present above specific concentration thresholds:

• Leave-on products: above 0.001%
• Rinse-off products: above 0.01%

This is a significant update from the previous rules. The list of allergens requiring individual disclosure is considerably longer now, and “Parfum” alone is no longer enough to cover them when they exceed these thresholds.

Your CPSR safety assessor must check every fragrance component against this updated list. If that check isn’t documented in the CPSR, your ingredient labeling compliance is incomplete, even if the label itself looks fine.

Nanomaterial Labeling Requirements:

If your formula contains intentionally used nanomaterials, nano zinc oxide in a mineral SPF, for example, each one must appear in the ingredient list followed by the word (nano) in brackets. “Zinc Oxide (nano).”

This connects directly to Article 16 of the EU Cosmetics Regulation, which imposes additional pre-market notification requirements for nanomaterial-containing products through the CPNP. Your CPSR must identify these materials, confirm their nano status, and document the specific safety assessment for each one.

How Annexes III–VI Shape Cosmetic Packaging Compliance and Label Content 

The annexes of Regulation (EC) No 1223/2009 aren’t separate documents; they’re part of the regulation itself, and they directly affect your label content.

If any ingredient in your formula falls under Annex III, the regulation tells you exactly what warning must appear on your label. The CPSR must confirm you’re within the permitted limit. Both the label and the CPSR must reflect this consistently.

CPSR Labeling Requirements: The Direct Link to Cosmetic Packaging Compliance 

Here’s what most brand owners don’t fully grasp until it causes a problem: the CPSR isn’t just background documentation sitting in your PIF. It’s the active proof behind every claim on your cosmetic label. If the label and the CPSR don’t align, the product isn’t compliant, even if the formula is safe.

The CPSR has two parts:

• Part A: Cosmetic Product Safety Information: all the technical data, formula, ingredient profiles, stability results, microbiological data, and packaging compatibility
• Part B: Cosmetic Product Safety Assessment: the qualified assessor’s conclusions, including any label warnings and conditions of safe use

Both parts must speak directly to what’s printed on your packaging.

How the CPSR Safety Assessment Supports Your Ingredient List

Part A must assess every ingredient at the actual concentration used in the formula. At your specific concentration, for your specific product, applied to your specific target population.

For any ingredient from Annexes III–VI, Part A must document that the concentration stays within the permitted limit. If it doesn’t, the formula needs to change. You cannot compensate for an out-of-limit concentration by adding a stronger warning to the label.

And critically: if the formulation changes after the CPSR is signed, even a small adjustment, both the CPSR and the INCI list need to be updated. Brands frequently update labels after reformulation and forget the CPSR. That misalignment makes both documents non-compliant.

How CPSR Part B Validates Your Label Warnings and Precautions

Part B is where the qualified safety assessor draws their conclusions, and every label warning must be traceable to something in Part B.

If Part B identifies a precaution, “not recommended for use around the eye contour”, that warning must appear on the label. In the language of the market. In legible text.

It also works in reverse. If your label carries a warning that isn’t referenced or justified in Part B, regulators will treat that as a consistency failure. Your label and CPSR must agree on every safety condition, not approximately, but precisely.

Stability Testing in the CPSR: The Evidence Behind Your PAO or Durability Date

Your CPSR stability data must directly support the durability claim on your EU cosmetic packaging. This is not an area where “close enough” works.

Stability testing that belongs in Part A:

• Physical stability: appearance, texture, colour, viscosity, phase separation
• Chemical stability: active ingredient or preservative concentration over time
• Microbiological stability: preservative efficacy testing, particularly for water-containing products
• Packaging compatibility: interaction between the formula and the container material

If the label says “12M”, the stability data must support 12 months. Extrapolating from shorter test periods requires specific scientific justification, documented in Part A. Without it, the PAO claim isn’t defensible.

Packaging Compatibility: The CPSR Requirement Brands Consistently Overlook

EU cosmetic packaging compliance isn’t just about what’s printed on the pack; it’s about whether the pack itself is safe for the product inside.

Your CPSR must confirm that no harmful substances migrate from the container into the formula. That the plastic, the lining, the pump mechanism, none of it degrades in a way that compromises product safety over the stated shelf life.

This matters especially for high-fragrance products in plastic packaging, water-based formulas in flexible tubes, and preservative-sensitive formulations. The safety assessor must document packaging compatibility in Part A, and if it’s not there, the CPSR is incomplete.

Language and Legibility Under Cosmetics Europe Labelling Guidelines and EU Rules 

1. Local Language
   Under EU cosmetics regulation, all mandatory label information must be in a language that consumers in the country of sale can understand. Selling in France, use French. Germany, German. Spain, Spanish. If you sell across multiple EU markets, you’ll need either separate label versions or one multi-language label.
2. INCI Exception
   The INCI ingredient list is the most important part. It’s the same worldwide, so it doesn’t need translation. But everything else, warnings, precautions, and product use, must always be in the local language.
3. Font Size
   Cosmetics Europe labelling guidelines recommend a minimum font size of 0.9mm (based on lowercase “x-height”). All mandatory text must be clear and easy to read.
4. Text Durability
   Label text must be indelible. It shouldn’t fade, smudge, or become unreadable during normal storage or use.
5. Leaflet Option
   If the packaging is too small, some information, especially the ingredient list,t can go on an enclosed leaflet. The outer packaging must show the open-book symbol, and the leaflet must be included in every unit.

The Real Point: Your Label and Your CPSR Are One Compliance System

They’re not two separate workstreams. Every element on your EU cosmetic label under Regulation (EC) No 1223/2009 needs something in the CPSR to support it: the ingredient list, the PAO, the allergen disclosures, the Annex III warnings, all of it.

Brief your safety assessor and your artwork team at the same time. And every time the formula changes, update both documents before anything goes to print.

That’s not just good practice. Under EU cosmetics regulation, it’s the only approach that actually holds up.

FAQs: EU Cosmetic Labeling and CPSR Requirements

What information is required on cosmetic labels in the EU according to Regulation 1223/2009?

Under Article 19, mandatory elements include the Responsible Person’s EU name and address, nominal content, date of minimum durability or PAO symbol, batch number, product function (where not obvious), precautions and warnings, and a full INCI ingredient list in descending order by weight. Imported products must also state the country of origin. All text must be indelible, legible, and visible.

What is EC Regulation 1223/2009 on cosmetics?

It’s the primary EU law governing cosmetic products, covering safety requirements, ingredient restrictions, labeling, claims, pre-market notification, and market surveillance. It replaced the old Cosmetics Directive and applies to every cosmetic product placed on the EU market, regardless of where it was manufactured.

What are the requirements for cosmetic labeling under EU law?

Article 19 sets out every mandatory labeling element. Labels must be in the language of the market where the product is sold, follow INCI nomenclature for ingredients, include verbatim Annex III warning phrases where applicable, and be directly supported by a valid, signed CPSR. Font must be legible, text indelible, and all elements present on the correct surfaces.

What is Annex II of the EU Cosmetics Regulation?

Annex II is the EU’s list of prohibited substances, ingredients that cannot legally appear in any cosmetic product sold in the EU market. Your CPSR must confirm none are present. Annexes III through VI cover restricted ingredients (with permitted conditions), permitted colorants, permitted preservatives, and permitted UV filters, respectively.

Who can prepare and sign a CPSR under the EU Cosmetics Regulation?

Only a qualified safety assessor, someone holding a relevant degree in pharmacy, toxicology, medicine, or a closely related discipline, with appropriate professional experience. Their qualifications must be documented within the CPSR itself. Brand owners cannot self-certify.

Does reformulation require a new CPSR?

Yes. Any change to the formula, even a minor one, requires the CPSR to be reviewed and updated. A label reflecting a new ingredient list but referencing an outdated CPSR is a compliance failure, regardless of how safe the reformulated product actually is.