The topic is short and compact
Article 19 of EU Cosmetics Regulation 1223/2009 strictly requires an INCI list, warnings, batch numbers and nominal contents.
Regulation (EU) 2023/1545 extends the individual labelling of fragrance allergens (declaration from 0.001 % in leave-on and 0.01 % in rinse-off products).
The official EU glossary of ingredient names was updated by Decision (EU) 2025/1175, which makes precise regulatory preparation essential.
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Placing cosmetic products on the European single market requires strict compliance with Chapter VI, Article 19 of Regulation (EC) No 1223/2009. It permits cosmetic products only if containers and packaging carry the mandatory information in indelible, easily legible and clearly visible lettering. Cosmetics labelling is not a decorative branding exercise but a legally binding technical declaration that guarantees consumer safety, ensures traceability and harmonises product information across the EU. For growing direct-to-consumer (D2C) and indie beauty brands, navigating these legal requirements is a critical hurdle before a retail launch.
Failing to follow harmonised labelling protocols has immediate market consequences. According to the European Commission's Safety Gate annual report for 2024, cosmetics were the most frequently notified category of dangerous non-food consumer products, accounting for 36 % of all validated alerts, ahead of toys (15 %) and electrical appliances (10 %). Chemical risks were behind 49 % of all alerts, and the main reason for cosmetics notifications was the presence of the banned fragrance BMHCA, which shows how quickly banned or undeclared substances lead to recalls from European shelves.
To avoid commercial disruption and regulatory bans, brands must treat packaging compliance as an integral part of cosmetics development. Technical standards under the EU Cosmetics Regulation require every physical container and every secondary pack to reflect exactly the chemical composition verified in lab testing and documented in the Product Information File (PIF). Building EU cosmetics compliance in from the earliest phase of formulation development removes the need for emergency artwork changes during industrial scale-up.
Regulatory objective | Legal basis (EC 1223/2009) | Operational impact on brands |
|---|---|---|
Consumer traceability | Article 19(1)(a), (e) | Mandatory name and address of the Responsible Person and the manufacturing batch number or identification code. |
Safety and safe use | Article 19(1)(d), (f) | Labelling of particular precautions for use and of the function of the product, unless it is clear from its presentation. |
Ingredient transparency | Article 19(1)(g) | List of ingredients (preceded by the term 'Ingredients') in descending order of weight at the time they are added. |
Alignment with the market notification | Article 13, Article 19 | Word-for-word match between the physical artwork and the submission in the Cosmetic Products Notification Portal (CPNP). |
Cosmetics labelling: what the EU requires
Placing cosmetic products on the European single market requires strict compliance with Chapter VI, Article 19 of Regulation (EC) No 1223/2009. It permits cosmetic products only if containers and packaging carry the mandatory information in indelible, easily legible and clearly visible lettering. Cosmetics labelling is not a decorative branding exercise but a legally binding technical declaration that guarantees consumer safety, ensures traceability and harmonises product information across the EU. For growing direct-to-consumer (D2C) and indie beauty brands, navigating these legal requirements is a critical hurdle before a retail launch.
Failing to follow harmonised labelling protocols has immediate market consequences. According to the European Commission's Safety Gate annual report for 2024, cosmetics were the most frequently notified category of dangerous non-food consumer products, accounting for 36 % of all validated alerts, ahead of toys (15 %) and electrical appliances (10 %). Chemical risks were behind 49 % of all alerts, and the main reason for cosmetics notifications was the presence of the banned fragrance BMHCA, which shows how quickly banned or undeclared substances lead to recalls from European shelves.
To avoid commercial disruption and regulatory bans, brands must treat packaging compliance as an integral part of cosmetics development. Technical standards under the EU Cosmetics Regulation require every physical container and every secondary pack to reflect exactly the chemical composition verified in lab testing and documented in the Product Information File (PIF). Building EU cosmetics compliance in from the earliest phase of formulation development removes the need for emergency artwork changes during industrial scale-up.
Regulatory objective | Legal basis (EC 1223/2009) | Operational impact on brands |
|---|---|---|
Consumer traceability | Article 19(1)(a), (e) | Mandatory name and address of the Responsible Person and the manufacturing batch number or identification code. |
Safety and safe use | Article 19(1)(d), (f) | Labelling of particular precautions for use and of the function of the product, unless it is clear from its presentation. |
Ingredient transparency | Article 19(1)(g) | List of ingredients (preceded by the term 'Ingredients') in descending order of weight at the time they are added. |
Alignment with the market notification | Article 13, Article 19 | Word-for-word match between the physical artwork and the submission in the Cosmetic Products Notification Portal (CPNP). |
Cosmetics labelling and mandatory information under Article 19
While the ingredient list is often scrutinised most closely, Article 19(1) of Regulation (EC) No 1223/2009 names the mandatory particulars that must appear on the container (in direct contact with the formulation) and the packaging (outer carton) in indelible, easily legible and clearly visible lettering, from the address of the Responsible Person to the ingredient list. Omitting a single mandatory element makes the batch legally non-compliant, regardless of the inherent stability or safety of the formulation.
Mandatory structural labelling elements
The legal framework sets out explicit requirements that brand operators and packaging designers must build into physical artwork layouts:
Responsible Person (RP): name and registered EU address of the legal or natural person established in the Community who guarantees compliance. For products imported into the EU, the country of origin must be stated (e.g. 'Made in Germany').
Nominal content: net content at the time of filling, stated by weight (g) or volume (ml), with minimum font sizes based on the net quantity (e.g. 3 mm for containers from 50 g to 200 g).
Date of minimum durability / PAO: if the minimum durability is 30 months or less, an explicit expiry date ('best used before the end of') must be given. If durability exceeds 30 months, the period-after-opening symbol (PAO, open jar) must state how long the product remains safe after opening (e.g. '12M').
Particular precautions and warnings: specific conditions for safe use, especially for professional products, aerosols or formulas containing restricted substances listed in Annexes III to VI of the Regulation.
Batch number: an indelible manufacturing batch code or reference that ensures full traceability back to the production bulk batch and the raw material lots.
Function of the product: the clear functional purpose of the cosmetic product (e.g. 'foundation', 'cleansing gel'), unless it is evident from the presentation of the container.
Managing these requirements becomes exceptionally demanding on compact packaging formats such as make-up sticks, 15 ml concealers, 30 ml skin tints or eye drops. Artwork and print file coordination has to close the gap between regulatory text length and physical printable areas. Where it is impossible for practical reasons to print the precautions or the full ingredient list on the packaging, Article 19(2) allows the information to be given on an enclosed or attached leaflet, label, tape, tag or card, referred to by the symbol in point 1 of Annex VII. In addition, all cosmetic product claims on the packaging must remain strictly verifiable against the technical dossiers created during product development.
The INCI declaration for cosmetics: order, thresholds and exceptions
The ingredient declaration is governed by Article 19(1)(g) of Regulation (EC) No 1223/2009, which requires a list of ingredients preceded by the term 'Ingredients' and expressed using the common ingredient names from the official glossary. In practice this means a standardised nomenclature under the International Nomenclature of Cosmetic Ingredients (INCI), which gives consumers and medical professionals an unambiguous breakdown of the formulation. Proprietary marketing names, chemical trade names or informal translations are strictly prohibited in this section.
Concentration rules and formatting hierarchy
The order of ingredients in the INCI list is determined by exact weight percentages fixed during lab batch formulation:
Ingredients in concentrations above 1 %: the list is drawn up in descending order of the weight of the ingredients at the time they are added to the cosmetic product.
Ingredients in concentrations below 1 %: may be listed in any order after those present at more than 1 %. This lets cosmetics developers format active ingredients and functional boosters cleanly while protecting proprietary concentration ratios.
Colourants and pigments: colourants other than those intended to colour hair may be listed in any order after the other ingredients, using the Colour Index (CI) nomenclature where applicable (e.g. CI 77891 for titanium dioxide, CI 77491 for iron oxides). For decorative products marketed in several shades, such as complexion skin tints, concealers and blush, all colourants used in the range may be listed, provided the words 'may contain' or the symbol '+/-' are added, which allows one packaging carton for all shade variants.
Accurate nomenclature requires continuous regulatory upkeep. On 16 June 2025 the European Commission adopted Commission Implementing Decision (EU) 2025/1175, which establishes an updated glossary of common ingredient names for the labelling of cosmetic products and repeals the previous Implementing Decision (EU) 2022/677. The revised glossary comprises 30,419 entries; it entered into force on 30 July 2025 and applies in full from 30 July 2026, with the year in between serving as a transition period in which operators may already use the new names. Precise regulatory preparation while the formulation is being finalised ensures that raw material suppliers' breakdowns and the naming of botanical extracts match the latest official entries exactly.
INCI category | Formatting rule | Standard example |
|---|---|---|
Main ingredients (> 1 %) | Strict descending order by weight (w/w) | Aqua, Caprylic/Capric Triglyceride, Glycerin |
Minor additives & actives (≤ 1 %) | Any order after the > 1 % threshold | Sodium Hyaluronate, Tocopherol, Xanthan Gum |
Aroma and fragrance components | Declared generically as 'Parfum' or 'Aroma' | Parfum |
Pigments for complexion products | CI numbers at the end in a bracketed suffix | [+/- CI 77891, CI 77492, CI 77491, CI 77499] |
Cosmetics labelling: mandatory INCI information for fragrances and allergens
Fragrance and aroma compositions pose unique regulatory hurdles in cosmetics labelling. Under Article 19, perfume and aromatic compositions and their raw materials are referred to collectively by the terms 'Parfum' or 'Aroma'. However, substances whose mention is required in the 'Other' column of Annex III must be named in the ingredient list in addition to these generic terms whenever they exceed the legal concentration thresholds.
Extension through Regulation (EU) 2023/1545
For years, European labelling rules required the individual declaration of only 24 specific fragrance allergens listed in Annex III of the EU Cosmetics Regulation. This framework was fundamentally updated by Commission Regulation (EU) 2023/1545 of 26 July 2023, which extended the list of fragrance allergens to be declared individually to more than 80 different substances and natural extracts (adding 56 newly identified allergens such as Linalyl Acetate, Vanillin, Camphor, Menthol and Benzaldehyde).
The legal disclosure thresholds remain clearly defined according to how the cosmetic formula is used:
Leave-on products (e.g. skin tints, concealers, face creams, serums): the stricter threshold applies, so an individual declaration is required as soon as the allergen exceeds 0.001 % (10 ppm) of the finished product.
Rinse-off products (e.g. facial cleansers, shampoos, shower gels): the threshold is ten times higher, so an individual declaration is only required when the allergen exceeds 0.01 % (100 ppm) of the finished product.
This extension directly affects formulation development, especially for brands using essential oils, botanical distillates or multi-component fragrance oils. Because natural essential oils (such as citrus peel, lavender or rose oils) naturally contain complex mixtures of several regulated allergens (e.g. Limonene, Linalool, Citral, Geraniol), certificates of analysis (CoA) of raw materials and allergen declarations have to be aggregated mathematically to assess cumulative concentrations. Transition periods under Regulation (EU) 2023/1545 require newly placed products to comply by 31 July 2026, while existing products must be brought into line or withdrawn from the market by 31 July 2028.
Common errors in artwork review and print files
In cosmetics manufacturing, the physical artwork review is the last line of defence before commercial printing plates are made and the primary packaging is filled. Minor layout oversights frequently lead to significant commercial losses when finished packaging is rejected in quality control or market inspections. Typical errors range from typographical slips to discrepancies between technical lab batch sheets and graphic design files.
Common pitfalls in packaging layouts
Illegible font sizes: European packaging standards set minimum x-height rules for typography (generally no less than 1.2 mm for mandatory text) to ensure legibility. Designers often reduce font sizes below the legal limits to fit multilingual declarations onto compact make-up sticks, concealers or tubes.
Inaccurate allergen and INCI breakdowns: graphic designers typing ingredient lists by hand from outdated raw material briefings instead of using the finalised, approved formulation breakdown from the Cosmetic Product Safety Report (CPSR).
Unregistered address formatting: stating a commercial marketing office or PO box instead of the physical address of the EU Responsible Person verified in the CPNP.
Missing variable print windows: failing to reserve an unvarnished, high-contrast print window on primary bottles, tubes or jars for later thermal transfer or inkjet batch coding and PAO/expiry printing during filling.
Incorrect symbol scaling: distorting or undersizing official legal symbols such as the estimated sign ('e-mark' under Directive 76/211/EEC), the open jar symbol (PAO) or the warnings for flammable aerosols.
When artwork errors are found late, operational bottlenecks arise that disrupt supplier and supply chain coordination and trigger avoidable launch delays. Packaging suppliers cannot start their presses without finally approved files, and contract fillers cannot begin filling without compliant primary packaging. Early technical validation of die lines, print areas and text documents prevents costly container rejections and downstream repacking.
Consequences of incorrect labelling: recalls and delays
The financial and commercial consequences of non-compliant cosmetics packaging go far beyond minor administrative fines. When market surveillance authorities find mislabelled cosmetics or undeclared allergens in retail sampling, the legal enforcement mechanisms under Article 25 of Regulation (EC) No 1223/2009 and national enforcement rules take effect immediately.
Regulatory enforcement typically follows a stepwise escalation path:
Immediate sales stops: retail partners, national distribution centres and online platforms receive official orders prohibiting further commercial distribution until compliance is proven.
Customs seizures and import bans: shipments from non-EU manufacturing sites without a verified RP address, correct INCI nomenclature or proper batch codes are seized at European borders.
Official Safety Gate alerts: serious breaches lead to public notifications in the European Commission's Safety Gate and cause lasting reputational damage. In 2024 the main reason for cosmetics notifications was the banned synthetic fragrance BMHCA, prohibited on the EU market since March 2022.
Mandatory product recalls: brands are legally obliged to carry out public product recalls, including return logistics, consumer refunds and destruction costs for the affected production batches.
Beyond the direct cost of a recall, non-compliant labelling damages retailer trust. Large drugstore chains and international beauty retailers require full regulatory consistency across all product dossiers and carton barcodes before approving shelf placements. A single missing allergen declaration can invalidate an entire seasonal retail rollout and leave brands with unsellable stock. Strict regulatory oversight and disciplined supply chain coordination are indispensable investments in protecting production capital.
Level of non-compliance | Authority action | Commercial risk for the brand |
|---|---|---|
Minor technical error (e.g. font size below 1.2 mm) | Warning, mandatory artwork correction in the next production run | Reprint costs, possible delay to subsequent batches. |
Significant declaration error (e.g. allergen above the threshold missing) | Immediate sales stop, temporary delisting at retail | Loss of shelf placement, rework costs for over-stickering or repacking. |
Critical safety breach (e.g. banned substance, false claims) | Public EU Safety Gate notification, market withdrawal and consumer recall | Total loss of the batch investment, regulatory penalties, severe reputational damage. |
Eliminating labelling risk requires an integrated development workflow in which chemical formulation, packaging development and regulatory documentation run in parallel rather than as isolated, consecutive steps. When the formulation is adjusted in the lab, whether refining pigment dispersions for skin tints or adjusting preservative boosters in emulsions, the corresponding INCI declarations, allergen thresholds and print files must be updated at the same time.
As a B2B cosmetics developer and cosmetics manufacturer, Labtree structures cosmetics development so that structural handover errors between lab research and industrial large-scale filling are ruled out. Labtree turns cosmetics concepts into lab samples, manufacturable formulations, production-ready recipes and finished cosmetic products. With its own lab and direct production oversight, technical parameters such as physical packaging compatibility, filling tolerances and legal INCI declarations are settled well before commercial batch production begins.
At scale-up, integrated filling and packaging execution ensures that primary containers (such as airless pumps, tubes, dropper bottles and make-up sticks) are mechanically matched to the specific bulk viscosities, fill weights and batch coding systems. Linking formulation design directly to manufacturing reality lets growing beauty brands and established portfolio operators work with competent manufacturing partners and ensures that every finished cosmetic product reaches retail in full compliance with European regulatory standards.
Sources: health.ec.europa.eu · mpo.gov.cz · eur-lex.europa.eu · eur-lex.europa.eu · cirs-group.com · eur-lex.europa.eu
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FAQ
What does Article 19 of EU Cosmetics Regulation 1223/2009 require?
Article 19 sets the mandatory labelling requirements for cosmetics in the EU, including the ingredient list, details of the Responsible Person, nominal content, date of minimum durability or period after opening (PAO), batch number, particular precautions and the function of the product.
How must the INCI declaration on cosmetics packaging be formatted?
Ingredients must be listed in descending order of weight down to the 1 % threshold, using the common names from the official EU glossary. The glossary was updated by Decision (EU) 2025/1175 and from 30 July 2026 is the only permitted basis for labelling.
What are the updated rules for labelling fragrance allergens?
Under Regulation (EU) 2023/1545, 56 additional fragrance allergens must be declared individually. An allergen must be listed when its concentration in the finished product exceeds 0.001 % (10 ppm) in leave-on formulas (such as skin tints) or 0.01 % (100 ppm) in rinse-off products.
What are the most common errors in cosmetics labelling?
Common errors are outdated INCI names, illegible font sizes, missing batch numbers and generic warnings instead of the specific legal texts required for the product type.
How can labelling errors affect a product launch?
Non-compliant labelling can lead to blocked market access, sales bans or costly product recalls.
