PDA logoPDA
Back to Category Deep-Dives
500Module 2 of 6

Beauty Claims & INCI Practice

Compliant ingredient lists, handling allergens, and avoiding claim pitfalls.

20 minutes
beauty
Next: Food Packaging for Retail & DTC
Module Content

Executive Summary

Top insights (packaging-relevant).
  1. Ingredient lists are not the same across regions. EU/UK require the EU Glossary common names and allow "Parfum/Aroma" and "[nano]" tags; US requires established/common or usual names under 21 CFR 701.3 and generally expects "Water" not "Aqua" (parentheses may bridge: "Water (Aqua)"). [1][2][3][4][5]
  2. Fragrance allergen labelling in the EU expanded (2023/1545). 56+ additional allergens; list when ≥ 0.001% (leave-on) or ≥ 0.01% (rinse-off). Transition: place on market by 31 Jul 2026; sell-through until 31 Jul 2028. [6][7]
  3. US fragrance-allergen labelling pending under MoCRA. Proposed rule signalled; no final as of Aug 2025 (RIN 0910-AI90). [8]
  4. Claims must meet EU Common Criteria (655/2013) and guidance. Six criteria apply; the Technical Document addresses "free from" and "hypoallergenic" usage. [9][10]
  5. US "hypoallergenic" has no binding definition. Use only with robust evidence and clear consumer context; FTC deception rules apply. [11][12]
  6. Sunscreen claims diverge. EU sunscreens are cosmetics (Recommendation 2006/647/EC—UVA logo when UVA-PF ≥ 1/3 SPF; avoid "sunblock/waterproof"). US SPF/broad-spectrum are OTC drug claims with Drug Facts panel. [1][13]
  7. Green claims are tightening. EU Directive (EU) 2024/825 bans vague generics from 27 Sep 2026; UK follows CMA Code; US follows FTC Green Guides. [14][16][17]
Priority actions for design & pack copy.
  • Adopt an EU Glossary-first name map (EU/UK) and 21 CFR 701.3-conformant name map (US) with Water↔Aqua parenthetical handling and [nano] logic. [1][2][3][4]
  • Build fragrance allergen calculators (threshold + transition timers) and update master ingredient panels by 31 Jul 2026 (EU/EEA/NI). [6][7]
  • Gate "free from", "hypoallergenic", "clinically proven", and durability claims behind evidence checklists (EU 655/2013 + Technical Document; FTC evidence). [9][10][12]
  • Split sunscreen pack architecture by region (EU UVA logo vs US OTC Drug Facts). [1][13]
  • Align recyclability icons with OPRL (UK) and How2Recycle (US/CA); design for recycling via APR/CEFLEX. [18][19][20][21]
Risks to watch (12–24 months).
  • US fragrance allergen rule finalization (scope/list/thresholds). [8]
  • EU/UK divergence on allergens; maintain EU-level builds pending GB decisions. [22]
  • Green claims enforcement uptick (CMA/FTC; EU 2024/825 transpositions by Sep 2026). [14][17]

Definitions & Concepts

INCI/common ingredient name

Standardized label name. EU/UK use Commission Glossary; US uses established/common or usual names under 21 CFR 701.3 (often aligned to INCI). [2][3][4]

Fragrance (Parfum) / Flavor (Aroma)

Collective terms for complex mixtures; EU/UK: Parfum/Aroma; US: Fragrance/Flavor. EU requires explicit allergen listing above thresholds. [4][6][7][8]

[nano]

Bracket tag in EU/UK after an ingredient name when present as a nanomaterial, per Article 19(1)(g). [1]

Common Criteria (EU)

Six rules for cosmetic claims (655/2013): legal compliance, truthfulness, evidential support, honesty, fairness, informed decision-making. Technical Document adds guidance on "free from"/"hypoallergenic". [9][10]

OTC drug (US)

Over-the-counter drug category (e.g., SPF). Drug-type claims trigger Drug Facts and different label rules. [23]

Green claims

Environmental benefit statements governed by EU 2024/825 (from 2026), UK CMA Code, and US FTC Green Guides. [14][16][17]

Concept map (bullet view).
  • Ingredient identity → name source (EU Glossary vs US 701.3) → ordering (>1% descending; ≤1% any order; colors last in US) → special tags (Parfum/Aroma, [nano]). [1][2][4]
  • Fragrance mix → allergen screening → thresholds (EU 0.001%/0.01%) → transition control (2026/2028) → artwork migration plan. [6][7]
  • Claim → classification (cosmetic vs drug; EU vs US) → evidence design (EU 655/2013; FTC standard) → copy rules (ban misleading generics; sunscreen do’s/don’ts). [9][10][12][13][14]
  • Recycling icons → market (OPRL vs How2Recycle) → design for recycling (APR/CEFLEX) → EPR/fee impacts. [18][19][20][21]

Standards, Regulations, and Governance

EU/EEA (including NI)
  • Reg. (EC) 1223/2009 (labelling Art. 19; [nano]; ingredient list rules). Glossary names via Decision (EU) 2019/701 and updates. [1][2]
  • Claims: Reg. (EU) 655/2013 + Technical Document (free from; hypoallergenic). [9][10]
  • Fragrance allergens: Reg. (EU) 2023/1545; thresholds 0.001%/0.01%; transitions 2026/2028. [6][7]
  • Sunscreens: Recommendation 2006/647/EC (UVA logo; no "sunblock/waterproof"). [13]
  • Green claims: Directive (EU) 2024/825 from 27 Sep 2026. [14][15]
United Kingdom (GB)
  • Retained EU 1223/2009 with OPSS guidance; UK Responsible Person rules. NI follows EU under Windsor Framework. [25][22]
  • Allergens: monitor GB alignment to 2023/1545; divergence possible. [22]
  • Green claims: CMA Green Claims Code; ASA/CAP may apply to ads. [16]
  • Recycling icons: OPRL; mandatory labelling linked to UK EPR 2026–2027. [18][26]
United States
  • 21 CFR 701 (ingredient designation; ≤1% grouping; Fragrance/Flavor; colors last); FDA Cosmetics Labeling Guide. [4][3]
  • Claims boundary: cosmetic vs drug (e.g., SPF). [23]
  • Substantiation: 21 CFR 740.10 warning if safety not substantiated; FTC evidence standard for claims. [27][12]
  • Fragrance allergens: MoCRA rule pending; no final as of Aug 2025. [8]
  • Recycling icons: How2Recycle; APR Design Guide; FTC Green Guides. [19][20][17]
TopicEU/EEA (incl. NI)GB (UK)US
Ingredient namesEU Glossary names mandatory. [2]Retained; OPSS guidance; practice aligned to EU Glossary. [25]21 CFR 701.3 established/common or usual; "Water" preferred; INCI often used. [4][3]
Fragrance allergensExpanded list; 0.001%/0.01%; 2026/2028 transition. [6][7]Alignment TBD; maintain EU-level builds. [22]MoCRA rule pending; as of Aug 2025 none final. [8]
SunscreensCosmetics; 2006/647/EC rec; UVA logo. [13]Generally mirrors EU practice.OTC drug; Drug Facts label required. [23]
Green claimsDirective (EU) 2024/825 from 27 Sep 2026. [14]CMA Green Claims Code. [16]FTC Green Guides. [17]

Evidence Base & Benchmarks

Core sources (authoritative).
  • EU 1223/2009; 2019/701 Glossary; 655/2013 Common Criteria; Technical Document; 2023/1545 allergens; 2006/647/EC sunscreen rec. [1][2][6][9][10][13]
  • US 21 CFR 701/740; FDA Cosmetics Labeling Guide; FTC Health Products Compliance Guidance; FTC Green Guides. [3][4][12][17]
  • UK OPSS guidance; CMA Green Claims Code; OPRL scheme rules. [16][18][25]
Table A — Ingredient list mechanics (evidence tags)
  • Ordering (EU/UK): > 1% descending; ≤ 1% any order; colorants by CI numbers. [1][2]
  • Ordering (US): same > 1% / ≤ 1%; color additives grouped last; Fragrance/Flavor allowed collectively. [4]
  • Name source: EU/UK Glossary; US established/common (often INCI), "Water" preferred (parenthetical bilingual ok). [2][3][4]
  • Nanomaterials tag (EU/UK): add [nano] after ingredient name. [1]
Table B — EU fragrance allergen thresholds & timing
  • Thresholds: 0.001% (leave-on), 0.01% (rinse-off) per Annex III. [6]
  • Transition: place compliant products by 31 Jul 2026; sell-through until 31 Jul 2028. [7]
Where data conflict or evolve.
  • US allergens list/thresholds: pending FDA rule; divergence from EU possible. [8]
  • UK alignment to EU allergens: unconfirmed until OPSS publishes GB timetable. [22]
  • EU Green Claims Directive scope/fate: uncertain; treat 2024/825 as current baseline. [14][15]

Design & Production Implications

Rules of thumb (embed into artwork specs).
  • Ingredient panels — EU/UK: pull names from the EU Glossary; apply [nano]; use Parfum/Aroma for complex mixes; list CI numbers. US: enforce 701.3 formatting (≤ 1% group, colors last), use Water not Aqua (parenthetical bilingual allowed). [1][2][4][3]
  • Allergen handling (EU): compute finished-level allergens from all inputs; flag if ≥ 0.001%/0.01% and append to ingredient list; add transition timers per SKU (2026/2028). [6][7]
  • Claims guardrails (EU): do not imply regulatory approval; avoid "free from [banned]" or "free from perfume" when perfuming function exists; use "hypoallergenic" only with strict evidence and explanation. [9][10]
  • US claims guardrails: treat "clinically proven" as high-substantiation; build dossiers to FTC standard; avoid drug-type claims unless compliant. [12][23]
  • Sunscreens: EU uses UVA logo when UVA-PF ≥ 1/3 SPF and avoids "waterproof/sunblock"; US requires OTC Drug Facts. Never share EU sunscreen copy on US packs. [13][23]
Material/format and manufacturability notes.
  • Small formats: plan leaflets/fold-outs; QR does not replace legally required on-pack statements. [1]
  • Label space: manage ingredients vs multi-language vs icons (OPRL/How2Recycle/UVA symbol) via regional matrices.
  • Common pitfalls: mis-mapped INCI/common names (e.g., Aqua on US SKU); missing [nano]; non-compliant "free from"; mixing EU UVA symbol with US Drug Facts. [1][3][10][13][23]
Supplier perspective

Provide final ingredient strings per region, allergen trigger outputs, claim substantiation summaries, and icon matrix at brief.

Sustainability & Compliance Considerations

  • EU: From 27 Sep 2026, Directive (EU) 2024/825 bans generic environmental claims absent recognized excellence; polices unverified labels and future-performance claims. [14]
  • UK: CMA Green Claims Code applies now; ensure specificity, lifecycle context where implied, and avoid omissions. [16]
  • US: FTC Green Guides benchmark “recyclable/compostable/biodegradable” claims. [17]
Recyclability markings interplay.
  • OPRL (UK): binary Recycle/Do Not Recycle; ISO 14021 aligned. [18]
  • How2Recycle (US/CA): Pro label rollout 2025–2026; watch milestone dates and CA SB 343 impacts. [19]
  • Design for recycling: follow APR (rigids) and CEFLEX D4ACE (flexibles). [20][21]
Claims risk (safer alternatives).
  • Avoid: "eco-friendly", "chemical-free", "non-toxic", "planet-safe".
  • Prefer: precise, scope-bounded statements with standard references (e.g., "Widely recyclable in GB per OPRL 2025"; "Designed to CEFLEX D4ACE mono-PE guidance"). [14][18][21]

Workflow & Tooling

A. Checklists (extract-ready)
  • Print-ready ingredient panel (EU/UK): Glossary name check → order (> 1% desc; ≤ 1% any order) → Parfum/Aroma → [nano] → CI numbers → multi-language review. [1][2]
  • Print-ready ingredient panel (US): 701.3 order (≤ 1% group + colors last) → Fragrance/Flavor usage → "Water (Aqua)" parenthetical if bilingual → net contents/PDP sizing per 21 CFR 701. [4][3]
  • Allergen gate (EU): sum allergens → compare to 0.001%/0.01% → append to ingredient list → start timers (2026/2028). [6][7]
  • Claim substantiation pack: define claim → evidence plan (design, N, endpoints) → test results → consumer understanding → copy/legal sign-off (EU 655/2013 / FTC). [9][12]
  • Sunscreen split: EU UVA logo criteria + recommended wording; US OTC monograph & Drug Facts layout. [13][23]
  • Green claims: verify scheme (OPRL/How2Recycle), data support, scope boundaries, and avoid generic terms. [14][16][17]
B. Decision trees
  1. Cosmetic or drug? → Mentions structure/function or disease? → if yes, route to drug rules (US); EU remains cosmetic but apply sunscreen rec as needed. [23][13]
  2. List an allergen (EU)? → Ingredient contributes named allergen → compute finished level → compare with 0.001%/0.01% → if ≥ threshold, append to ingredient list. [6]
  3. Can I say "free from X"? → Is X banned? then no → Does any function of X exist via another ingredient? then no → Does claim imply superior safety without evidence? then no. [10]
  4. Green claim check → Generic wording? then no (unless recognized excellence) → Third-party label verified? → Lifecycle implied? ensure data coverage. [14][16][17]
C. Calculator blueprints
  1. Allergen accumulator: inputs = fragrance comps, botanical extracts, dosage, raw-material allergen specs; output = listed allergen % vs 0.001%/0.01%; with region toggle (EU on; US pending). [6][8]
  2. Ingredient list generator: inputs = batch formula with %; outputs = EU/UK string (Glossary names, [nano], Parfum/Aroma, CI) and US string (701.3 rules; Water). [2][4]
  3. Claim evidence planner: inputs = claim; output = minimum study design for EU 655/2013/Technical Document or FTC standard (flags for "clinically proven", "hypoallergenic"). [9][10][12]
D. Templates (fields)
  • RFQ pack: Regions & languages; ingredient name source; allergen thresholds; nano presence; claim list with substantiation refs; icon set (UVA/OPRL/How2Recycle).
  • Artwork naming/versioning: include region code (EU/GB/US), claim set ID, INCI build ID, allergen build version, icon pack version.

Category-Specific Guidance

Skincare (leave-ons)
  • Run the 0.001% EU threshold rigorously; avoid "hypoallergenic" unless evidence supports reduced allergenic potential with consumer-understandable context. [6][10][11]
Haircare (rinse-offs)
  • 0.01% EU threshold applies; watch fragrance allergens introduced via botanicals. Handle Annex III hair colourant warnings via separate regulatory text where applicable. [6]
Suncare
  • EU: adhere to 2006/647/EC (UVA ≥ 1/3 SPF; avoid "waterproof/sunblock"). US: OTC Drug Facts—keep cosmetic claims separate. [13][23]
Colour cosmetics
  • US: color additives grouped last; "may contain" convention for shade ranges per 21 CFR 701.3(g). [4]

Case Studies (Problem → Approach → Result)

CS1 — Pan‑EU moisturiser, legacy labels
Problem: Labels lack expanded allergens; non-compliance risk post 31 Jul 2026.
Approach: Built allergen accumulator; regenerated ingredient strings; updated artworks; documented in PIF. [6][7]
Result: All SKUs compliant; no out‑of‑stocks; transparent consumer comms on longer lists.
CS2 — "Hypoallergenic" cleanser US/EU
Problem: Global "hypoallergenic" proposal.
Approach: EU: applied Technical Document criteria; US: changed to "tested under dermatological control" with method summary; avoided "hypoallergenic" on pack. [10][11][12]
Result: Lower legal risk; QR link to study synopsis.
CS3 — Sunscreen day cream line extension
Problem: One artwork for EU & US.
Approach: Split packs: EU used UVA logo and 2006/647 wording; US created OTC Drug Facts and removed EU sunscreen phrasing. [13][23]
Result: Clean audits; no import holds.

Common Pitfalls & Red Flags

  1. Printing "Aqua" on US-only packs. [3]
  2. Missing [nano] tag in EU/UK. [1]
  3. "Free from parabens" next to unrelated safety insinuations → fairness/honesty breach. [10]
  4. Sunscreen wording "waterproof"/"sunblock". [13]
  5. Wrong ingredient order (≤ 1% group or colors mishandled). [4]
  6. "Clinically proven" with underpowered study → FTC risk. [12]
  7. "Hypoallergenic" without stringent design and evidence. [11]
  8. EU allergens not rolled in by 31 Jul 2026 (sell-through by 31 Jul 2028). [7]
  9. Vague green claims ("eco", "planet-safe"). [14][16][17]
  10. Mixing OPRL and How2Recycle icons across regions improperly. [18][19]

References

  1. Regulation (EC) No 1223/2009 (consolidated). [1]
  2. Commission Decision (EU) 2019/701 — Glossary of common ingredient names (and updates). [2]
  3. FDA — Ingredients’ Names (US common/established; Water vs Aqua).
  4. 21 CFR 701.3 — Designation of ingredients (US). [3]
  5. CosIng/Glossary of ingredients (EU). [5]
  6. Commission Regulation (EU) 2023/1545 — fragrance allergens (Annex III). [6]
  7. European Commission Q&A on fragrance allergens — 2026/2028 dates. [7]
  8. FDA Unified Agenda — MoCRA fragrance allergen labelling (RIN 0910-AI90). [8]
  9. Commission Regulation (EU) 655/2013 — Common Criteria. [9]
  10. Technical Document on Cosmetic Claims — free from & hypoallergenic. [10]
  11. FDA — “Hypoallergenic” Cosmetics. [11]
  12. FTC — Health Products Compliance Guidance. [12]
  13. Commission Recommendation 2006/647/EC — Sunscreen efficacy & claims. [13]
  14. Directive (EU) 2024/825 — Greenwashing. [14]
  15. Green Claims Directive — status, 2025 uncertainty. [15]
  16. CMA — Green Claims Code (UK). [16]
  17. FTC Green Guides (US). [17]
  18. OPRL — scheme rules. [18]
  19. How2Recycle — 2025 Guidelines & Pro label rollout. [19]
  20. APR Design Guide — plastics recyclability. [20]
  21. CEFLEX D4ACE — flexibles design guidance. [21]
  22. CTPA — GB/EU/NI labelling & RP guidance. [22]
  23. FDA — Cosmetic vs Drug. [23]
  24. 21 CFR 740.10 — safety substantiation warning. [27]
  25. OPSS (GB) Guidance — UK Responsible Person. [25]
  26. UK EPR — labelling 2026–27 timeline (industry summary). [26]
Designer tip

When space is tight post-2023/1545, do not shrink type below legibility standards—use fold-outs or multi-panel labels. Legibility beats minimalism when law changes.

Compliance watch

Maintain a living Regulatory Deltas sheet by SKU: EU allergens (on/off), UK RP address (GB), US 701.3 grouping validated, green claim wording linked to evidence, sunscreen variant (EU vs US).

Manufacturing note

Generate EU/US ingredient strings from one system of record. Auto-generate pre-press PDFs with a traceable hash of the formula snapshot used to compile each panel.

Previous: Beauty Packaging SystemsNext: Food Packaging for Retail & DTC