Guide

Cosmetic Labeling: INCI, Claims and the 80-Allergen World

Cosmetic labeling is the most visible compliance surface and the one that triggers the largest share of retailer-led delistings and competent-authority interventions. EU Article 19 sets mandatory label content; Regulation 655/2013 polices claims; Annex III (and its 2023 expansion) governs labelled fragrance allergens. The UK runs a parallel regime under Schedule 34 with its own evolving allergen list. MoCRA Section 609 imposes the Responsible Person contact on US labels and directs FDA to issue fragrance allergen disclosure rules. With the EU expanding labelled allergens from 26 to over 80 (Regulation 2023/1545, effective 31 July 2026 for placing on the market, 31 July 2028 for sell-through), the artwork backlog is the operational risk most brands underestimate. This guide is written for QA, regulatory and packaging leads at multi-market cosmetics brands.

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EU Article 19: the mandatory label content

Article 19(1) requires, on the container and the outer packaging: name and address of the Responsible Person, country of origin for imported products, nominal content, minimum durability or PAO, particular precautions, batch number or reference, function of the product if not obvious, and the list of ingredients in INCI nomenclature in descending order of weight at the time of incorporation (ingredients under 1% in any order after the 1% threshold). Mandatory information must be in the language(s) of each Member State where the product is marketed — in practice, multilingual stickers or symbol-led artwork. The recurring finding is INCI lists rebuilt at artwork time from memory instead of bound to the formula of record.

Regulation 655/2013: claims that survive challenge

Regulation 655/2013 sets six common criteria for cosmetic claims: legal compliance, truthfulness, evidence-supported, honesty, fairness, informed decision-making. Competent authorities run themed market surveillance — sun protection, anti-ageing, free-from claims, hypoallergenic — and a claim without a contemporaneous, dated evidence record in the PIF is treated as non-compliant regardless of how widely the same claim is used in the category. 'Free-from' claims for substances that are not permitted in cosmetics anyway (parabens that are banned, sulphates as a category) are increasingly challenged as denigrating. 'Hypoallergenic' requires evidence of significantly reduced allergic risk. 'Clinically proven' requires a study traceable to the specific finished product, not the active ingredient.

The 2023 fragrance allergen expansion — from 26 to 80+

Regulation (EU) 2023/1545 amended Annex III to expand the list of labelled fragrance allergens from 26 (in force since 2005) to 80+ substances. Products placed on the EU market from 31 July 2026 must label the new allergens above the thresholds (0.001% leave-on, 0.01% rinse-off). Products already on the market may continue to be made available until 31 July 2028. The list adds named substances (limonene-related compounds, specific aldehydes, plant extracts) and new generic groups. Each fragrance house must provide updated IFRA / IOFI declarations with the full allergen breakdown — collect this data per ingredient now, not at artwork time. The UK is implementing a parallel but not identical list with its own deadlines.

UK Schedule 34 and MoCRA Section 609

The UK's mandatory label content under Schedule 34 of the Cosmetic Products Enforcement Regulations 2013 mirrors EU Article 19 with UK-specific RP address and language requirements (English mandatory; bilingual permitted). MoCRA Section 609 requires the US Responsible Person's domestic address, phone number or electronic contact (website) on the label and directs FDA to issue regulations on fragrance allergen disclosure. The expected FDA list will converge toward the EU's expanded list but is not identical and has its own thresholds. Multi-market artwork must accommodate three RP blocks, two-to-three allergen lists, and 30+ language permutations.

Symbols, the PAO icon and on-pack space

Cosmetic labels rely on standardised symbols to compress information: the open-jar PAO icon (with the period inside, e.g. '12M'), the hourglass (minimum durability), the 'refer to leaflet' (hand-on-book), the green dot (where required for packaging recovery), the recycling Möbius loop. The PAO icon is only valid if the SKU has supporting in-use study data (covered in the stability and PET guide). The hourglass is only used when minimum durability is under 30 months. Symbol misuse — PAO without backing data, or hourglass omitted on a sub-30-month SKU — is a routine inspection finding.

A 90-day artwork readiness path to 31 July 2026

Days 1–15: portfolio impact assessment — which SKUs contain any of the new 80+ allergens above threshold; pull fragrance house IFRA declarations and validate. Days 16–45: re-issue artwork for the affected SKUs (typically 40–70% of a fragranced portfolio), update CPNP/SCPN notified composition where needed, refresh the PIF allergen records. Days 46–70: claim dossier review against Regulation 655/2013 themed sweeps; close 'hypoallergenic' / 'free-from' / 'clinically proven' gaps. Days 71–90: full retail-print run; sell-through plan to clear pre-amendment stock by 31 July 2028.

Standards covered in this guide

Each standard, retailer code or assurance scheme referenced above has its own deep-dive page with scope, audit detail and common pitfalls.

Where this lives in V5 Ultimate

The clauses above aren't theoretical — every one maps to a shipped module and an industry profile. Jump to the parts of the product that turn this guide into evidence on a Monday morning.

Modules that do the work

Label design

INCI from formula, allergens recalculated per SKU.

Supplier portal

Fragrance allergen data from every fragrance house.

Claims evidence

Every claim bound to a dated evidence record.

Industries this hits hardest

Cosmetics

Frequently asked

When exactly must we have the new 80+ allergen labels on shelf?

Under Regulation (EU) 2023/1545: from 31 July 2026, products placed on the EU market for the first time must comply. Until 31 July 2028, products already placed on the market before 31 July 2026 may continue to be made available. 'Placed on the market' means the first making available — once a batch crosses into EU distribution, it is fixed in time. Plan production transitions to hit the placing-on-the-market date, not the sell-through date.

How do we get fragrance allergen data from a fragrance supplier that refuses on IP grounds?

Fragrance houses are obliged under the EU Cosmetics Regulation supply chain to provide the information needed for compliance. They typically supply the allergen breakdown without revealing the full fragrance formula — the labelled allergens are above threshold in the finished product, not the full fragrance composition. If a supplier refuses, escalate to a senior commercial conversation; in practice every credible fragrance supplier (IFF, Givaudan, Firmenich/dsm-firmenich, Symrise, Mane, Robertet) provides the data routinely.

Is 'fragrance' or 'parfum' alone still acceptable on the ingredient list?

Yes, for the fragrance composition itself, but the labelled allergens above threshold must additionally appear by name in the ingredient list. After 31 July 2026 the additional named allergens on the EU list expand from 26 to 80+. On a typical fragranced product this means the ingredient list lengthens noticeably; some brands restructure artwork ahead of time to accommodate.

Do 'free-from' and 'natural' claims still survive?

With evidence and within the Regulation 655/2013 criteria. 'Free-from parabens' is challenged as denigrating a category of ingredients deemed safe; 'free-from a specific substance restricted in Annex III' is permitted with substantiation. 'Natural' has no harmonised definition in EU cosmetics law; brands generally reference ISO 16128 (natural and natural-origin cosmetic ingredients) to substantiate the claim. Each claim needs a dated evidence file in the PIF — without it, the claim does not survive a competent authority challenge.

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