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200Module 4 of 8

EU Cosmetics Regulation (1223/2009) + Claims (655/2013)

Responsible Person, PIF requirements, claims substantiation, and on-pack symbols like PAO.

7 minutes
EUcosmetics
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Lesson Video
EU Cosmetics Regulation (1223/2009) + Claims (655/2013)
Module Content

1) Executive Summary

5–7 key insights
  1. You cannot sell a cosmetic in the EU/NI without an EU‑established Responsible Person (RP). The RP ensures compliance with Articles 3, 8, 10–21, 23–24, and must take corrective/recall action if non‑compliant. [1]
  2. A PIF is mandatory per product and must be available at the RP address for 10 years after the last batch hits the market. It must include the Cosmetic Product Safety Report (CPSR), GMP statement (ISO 22716 presumption), and proof of effect for claims “where justified.” [1][5]
  3. Claims must meet six Common Criteria — legal compliance, truthfulness, evidential support, honesty, fairness, and enabling informed decisions — and be consistent with evidence in the PIF. [2]
  4. Label the right particulars on both container and packaging (with limited exceptions) and use Annex VII symbols correctly: PAO (>30‑month durability) and “refer to leaflet” only when information truly cannot fit. [1][4][7]
  5. CPNP notification is required before placing on the EU market; additional advance notification applies for certain nanomaterials. [1][11]
  6. GMP is legally required (Art. 8) and presumed when EN ISO 22716 is applied under the Commission’s harmonised standards listing. [1][5]
  7. GB (Great Britain) has retained these regimes in domestic law (including the Common Criteria), with its own online notification (SCPN) and a UK RP/address. NI aligns with EU rules. [8][9][10]
3–5 recommended actions for designers & RPs
  • Build label/PIF/claim gates into artwork workflow: no print until PIF Art. 11.2(d) claim evidence is attached and mapped to copy. [1][2]
  • Use an Annex VII symbol checklist (PAO vs DMD hourglass; “refer to leaflet” only when justified). [1][4]
  • Run a Common Criteria pre‑clear for every claim (and visuals) and keep traceable substantiation (study protocols, stats, raw data) in the PIF. [2][3]
  • Confirm language requirements per target Member State and place the RP’s address (the PIF address) on‑pack. [1]
  • For GB packs, substitute UK specifics (UK RP address; SCPN). [8][9]
Risks & next 12–24 months
  • Enforcement on “free‑from”/“hypoallergenic”‑style claims and improper use of “refer to leaflet.” [3][7]
  • Annex updates (restricted substances) can trigger relabel — track EUR‑Lex consolidated updates. [1]

2) Definitions & Concepts

  • Responsible Person (RP): EU/NI‑established legal/natural person ensuring compliance; address appears on pack. [1]
  • PIF (Product Information File): Dossier per product including CPSR, GMP statement, claim evidence; retained 10 years after last batch. [1]
  • CPSR: Annex I safety report (Part A info; Part B assessment). [1][6]
  • CPNP: EU Cosmetic Product Notification Portal (pre‑market). [11]
  • Common Criteria: Legal, truthful, evidenced, honest, fair, enabling informed decisions. [2]
  • DMD: Date of Minimum Durability (≤30 months). [1]
  • PAO: Period After Opening (e.g., “12M”) for >30‑month durability unless concept not relevant. [1][4][8]
  • “Refer to leaflet”: Hand‑with‑book symbol; only if info cannot fit on pack; not to external catalogues. [1][7]
  • GMP: Good Manufacturing Practice; EN ISO 22716 presumption. [5]
Concept map (bullet diagram)
  • 1223/2009 → RP (Art. 4–5) → PIF (Art. 11) → Labelling (Art. 19 & Annex VII) → Claims (Art. 20)
  • Claims → 655/2013 Common Criteria + Technical Document guidance → Evidence stored in PIF. [1][2][3]

3) Standards, Regulations, and Governance

Authoritative overview (EU/NI)
  • Regulation (EC) 1223/2009 governs safety, RP, PIF, notification (CPNP), labelling, and market surveillance. [1]
  • Regulation (EU) 655/2013 sets binding Common Criteria for all cosmetic claims and ties them to PIF evidence. [2]
  • Harmonised standard EN ISO 22716 underpins GMP compliance presumption. [5]
  • CJEU Case C‑667/19 clarifies function/precautions must be on container/packaging; “refer to leaflet” cannot point to a general catalogue. [7]
Per‑region notes
  • EU + NI: Follow 1223/2009 and 655/2013; CPNP notification is mandatory. [1][2]
  • GB (Great Britain): 1223/2009 retained in UK law; 655/2013 Common Criteria apply; notification via SCPN; UK RP/address required. [8][9][10]
What differs by region (summary)
TopicEU/NIGB (Great Britain)
RPEU/NI‑established RP; address on packUK‑established RP; UK address on pack
Pre‑marketCPNP notification (Art. 13)SCPN notification
Claims655/2013 Common CriteriaCommon Criteria retained & applied
SymbolsAnnex VII (same artwork)Same symbols; GB language specifics
Sources: [1][2][8][9][10][11]
Known upcoming changes
  • Substance annexes update periodically; track EUR‑Lex consolidated versions to catch trigger relabel timelines. [1]

4) Evidence Base & Benchmarks

Core legal anchors
  • PIF content & retention: Art. 11; 10 years after last batch. [1]
  • GMP: Art. 8 + EN ISO 22716 presumption. [1][5]
  • Claims: 655/2013 (Annex — Common Criteria). [2]
  • Technical Claims Guidance: EC SWG “Technical document on cosmetic claims” (e.g., free‑from, hypoallergenic, dermatologically tested, clinically proven examples). [3]
Benchmarks: evidence types commonly accepted under 655/2013
  • Instrumental/clinical testing on the finished product with valid, reliable, reproducible methodology; statistics matched to claim strength. [2][3]
  • Consumer perception tests for subjective claims with design avoiding bias; not a substitute for safety/efficacy where risk exists. [2][3]
  • In‑vitro/ex‑vivo and literature: acceptable where relevant and bridged to the finished product. [2][3]

Evidence gap: No codified numeric sample‑size/statistical thresholds; define SOPs aligned to 655/2013 principles and EC Technical Document examples. [2][3]

5) Design & Production Implications

Label copy that must appear (Art. 19(1)) — design checklist
  • RP name & address (highlight the PIF address if multiple). [1]
  • Nominal content (weight/volume; optional e‑mark under 76/211/EEC for average fill).
  • DMD (hourglass or text) if ≤30 months; PAO if >30 months (unless PAO not relevant, e.g., single‑use/aerosol‑type use). [1][4]
  • Precautions (per Annexes and CPSR). [1]
  • Batch code (traceability). [1]
  • Function of the product (unless obvious). [1][7]
  • Ingredients list (INCI; “parfum/aroma”; fragrance allergen disclosures per Annex III). [1]
Symbols (Annex VII) & usage
  • PAO (open‑jar “nM”): For >30‑month durability; “nM” states safe‑use period after opening. [1][4][8]
  • DMD (hourglass) or textual date: For ≤30‑month products; may include conditions for durability. [1][4]
  • Refer to leaflet (hand‑with‑book): Only when it’s impracticable to fit mandatory info on pack; cannot redirect to a general catalogue. [1][7]
Designer tip

No EU‑wide minimum font size is prescribed; Article 19 requires indelible, easily legible, visible information — test legibility on smallest SKUs and assess multilingual crowding.

GMP touches packaging too

Keep a GMP statement in the PIF and align packaging change‑control, print inspections, and LOT/batch traceability to ISO 22716. [5]

6) Sustainability & Compliance Considerations

  • Claims risk: “Free‑from” statements that denigrate lawful ingredients, imply superior safety without evidence, or confuse consumers can breach Common Criteria/EC guidance (e.g., “free from preservatives” where preservation is via hurdle technology). [2][3]
  • Animal testing claims: Reg. 1223/2009 bans certain animal testing/marketing; related claims must remain truthful and not imply regulatory approval (see Art. 18 + Common Criteria: legal compliance). [1][2]

Note: Recyclability logos (Green Dot, Mobius, etc.) are voluntary and outside 1223/2009; confirm local packaging/EPR rules separately.

7) Workflow & Tooling

A. Checklists (to print‑ready)
RP & PIF gate
  • RP designated (EU/NI or UK as applicable); on‑pack address set. [1][8]
  • PIF complete: CPSR (Annex I), GMP statement, claim evidence, product description, animal‑testing info. [1]
  • Retention timer set (10 years after last batch). [1]
  • CPNP (EU/NI) or SCPN (GB) notification confirmed pre‑launch. [11][9]
Label & symbols gate
  • All Art. 19 particulars present and in correct languages. [1]
  • DMD vs PAO decision correct; Annex VII symbols used appropriately; “refer to leaflet” only if justified. [1][4][7]
  • Nominal content & optional e‑mark if using average fill rules. [12][13]
Claims gate
  • Every claim mapped to PIF evidence; 6‑point Common Criteria check. [2][3]
  • No implication of regulatory approval; no denigration; clarity for decisions. [2]
B. Decision trees (sketches)
  1. DMD vs PAO: ≤30 months → DMD (hourglass or text; include conditions if relevant). >30 months → PAO (e.g., 12M) unless concept not relevant. [1][4]
  2. “Refer to leaflet”: Can required info fit legibly on container/pack? If yes → print on pack. If no (impracticable) → use symbol and provide enclosed/attached leaflet (not general catalogue/website). [1][7]
  3. Claim acceptance: Legal? truthful? evidenced? honest? fair? helpful? If any “no” → revise wording/evidence; if all “yes” → lock artwork and archive substantiation in PIF. [2][3]
C. Calculator blueprints (to‑be)
  • PAO/pack copy planner: inputs durability, pack size, opening mode, stability → output DMD vs PAO and draft symbol/text. [1]
  • Claims‑evidence matrix: inputs claim type & study design metadata → output minimum evidence package and PIF index. [2][3]
D. Template specs (to‑be)
  • RP & PIF RFQ fields: safety assessor credentials, ISO 22716 certificate/attestation, stability summary, claim evidence inventory. [1][5]
  • Artwork naming/versioning: include claim IDs that match PIF sections.

8) Category‑Specific Guidance (Beauty)

High‑claim categories (anti‑ageing, scalp, skin tone): expect instrumental/clinical evidence for performance claims; avoid overbroad claims implying medicinal effects. [2][3]
Fragrances & allergens: check Annex III thresholds for 26 fragrance allergens in ingredient lists. [1]
Small packs (minis, samples): plan multilingual space early; “refer to leaflet” is not a shortcut unless truly impracticable. [1][7]

9) Case Studies (Problem → Approach → Result)

1. Missing function on pack (C‑667/19)
Problem: Imported cosmetics lacked “function” in local language; pack pointed to a catalogue via the hand‑and‑book symbol.
Approach: Court held function & key info must be on container/pack (or enclosed leaflet only if info cannot fit).
Result: Reinforced strict on‑pack requirements; avoid relying on external materials. [7][1]
2. “Free‑from” claims audit
Problem: “Free from parabens” + “0% preservatives” on an emulsion preserved by hurdle technology.
Approach: Assessed against Common Criteria/Technical Document; risk of misleading denigration and ambiguity.
Result: Revised to factual, contextualized copy; PIF updated with clear preservation rationale. [2][3]
3. DMD vs PAO error on long‑life product
Problem: A >36‑month shelf‑stable product used DMD instead of PAO.
Approach: Corrected to PAO symbol (“36M”) per Art. 19(1)(c).
Result: Updated artwork & PIF; reduced regulatory exposure. [1][4]
Replication plan (internal QA): pull 50 SKUs; verify Art. 19 particulars; DMD/PAO logic; symbol use; claim‑to‑evidence mapping; RP address & CPNP/SCPN proof. [1][2][11]

10) Common Pitfalls & Red Flags

  1. No EU‑established RP or wrong address on pack. [1]
  2. PIF missing claim evidence (Art. 11.2(d)) or GMP attestation. [1][5]
  3. Misuse of “refer to leaflet” to offload core info to websites/catalogues. [7]
  4. Claims implying regulatory approval or denigrating lawful ingredients. [2][3]
  5. Wrong DMD/PAO choice; PAO shown when concept not relevant. [1][4]
  6. Language coverage gaps for target markets. [1]
  7. CPNP/SCPN not completed before market placement. [11][9]

References

Primary law & standards
  1. Regulation (EC) No 1223/2009 on cosmetic products (consolidated text; Articles 3–5, 8, 10–11, 13, 18–21, 23; Annex I & VII). CELEX 32009R1223.
  2. Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products. CELEX 32013R0655.
  3. European Commission, Technical document on cosmetic claims (latest consolidated guidance). Sub‑Working Group on Claims.
  4. Annex VII (symbols) to Reg. 1223/2009 — official UK publication of symbol set. Legislation.gov.uk (Annex VII).
  5. European Commission, Harmonised standards supporting the Cosmetics Regulation (EN ISO 22716 — GMP).
  6. SCCS, Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 12th rev. (CPSR context).
  7. CJEU Press Release No 165/20, Case C‑667/19 (A.M. v E.M.): function and precautions must be on container/pack; “refer to leaflet” limits.
  8. UK OPSS/GOV.UK, Regulation 2009/1223 and the Cosmetic Products Enforcement Regulations 2013 (Great Britain) — claims & RP duties.
  9. Business Companion (UK Trading Standards), Cosmetic products — claims (Assimilated Reg. 655/2013).
  10. GOV.UK, Northern Ireland guidance mirroring EU rules.
  11. CPNP User Manual — Responsible Persons & Distributors (Art. 13 notification; label photos, etc.).
  12. Your Europe (EU), “e” mark for estimated fill — Directive 76/211/EEC context.
  13. Directive 76/211/EEC (consolidated), Prepackages; nominal quantities; e‑mark schema.

Sidebars

Designer tip: When multilingual space is tight, prioritize mandatory particulars and consider QR for non‑mandatory marketing content. Mandatory particulars stay on pack or enclosed materials as permitted. [1][7]
Compliance watch: Translating for new markets can trigger distributor duties/notifications under Art. 13(3)–(4). Coordinate with the RP. [11]
Manufacturing note: Lock an SOP that freezes claims text at design freeze, links it to PIF evidence IDs, and re‑opens only via change control with re‑signoff against 655/2013. [2]
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