Europe · European Union
What does it take to sell cosmetics in European Union? Entry route, responsibility, labeling
Pre-market electronic notification of every product in the Cosmetic Products Notification…; Responsible person: A Responsible Person established in the EU is mandatory — b…; Labeling: Language(s) fixed by each Member State.
Latest change 2026-04-28 — Commission Regulation (EU) 2026/909 ('Omnibus Act 2') published (in force 2026-05-18) restricting fragrance allergens such as benzyl salicylate and citral, aluminium compounds, zinc salts and hair dyes and banning triphenyl phosphate, with placing-on-market deadline 2027-01-01 and sell-through to 2028-07-01; Omnibus VIII (EU) 2026/78 applied from 2026-05-01 (nano/massive silver banned, hexyl salicylate and o-phenylphenol restricted). Source
Factory-side digest; the official text prevails; not legal advice.
- Authority
- European Commission (DG GROW) with Member State competent authorities
- Main regulation
- Regulation (EC) No 1223/2009 · Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- In force
- 2013-07-11
- Market entry
- Pre-market electronic notification of every product in the Cosmetic Products Notification Portal (CPNP) by the Responsible Person before placing on the market (Art. 13); no approval.
- Responsible person
- A Responsible Person established in the EU is mandatory — by default the EU manufacturer or importer, or a third party appointed by written mandate (Art. 4).
- Safety file
- Product Information File (PIF) kept 10 years, containing the Cosmetic Product Safety Report (CPSR, Annex I Parts A/B) signed by a qualified safety assessor, GMP (ISO 22716) statement, manufacturing description and proof of claims.
- Labeling
- Language(s) fixed by each Member State; INCI ingredient list; fragrance allergens named above 0.001% (leave-on) / 0.01% (rinse-off) — Regulation (EU) 2023/1545 adds 56 allergens to the historic 26, mandatory for products placed on the market from 2026-07-31 and for all products from 2028-07-31.
- Animal testing
- Full testing and marketing bans since 2013-03-11 (Art. 18): cosmetics or ingredients tested on animals for cosmetic purposes cannot be marketed in the EU.
- Ingredient lists
- Annex II (prohibited), Annex III (restricted), Annex IV (colorants), Annex V (preservatives), Annex VI (UV filters); CosIng database for INCI names.
- Notes
- EUR-Lex pages for 2026/78 and 2026/909 were not machine-readable at fetch time; their OJ dates (2026-01-13 and 2026-04-28) and deadlines are taken from Complife and Cosmeservice regulatory bulletins and should be cross-checked against the OJ text. Omnibus VII = Regulation (EU) 2025/877 (TPO ban applied 2025-09-01, no sell-through).
- Look up this inventory here
- 欧盟 · CosIng — European Commission cosmetic ingredient database
- Official text
- https://eur-lex.europa.eu/eli/reg/2009/1223/oj
Changes 2025–2026
- Expanded EU fragrance-allergen labelling becomes mandatory for new products
Regulation (EU) 2023/1545 adds 56 allergens to Annex III; products placed on the market from 31 July 2026 must name them above 0.001% (leave-on) / 0.01% (rinse-off), with existing products to comply by 31 July 2028 — Switzerland applies the same annex and Canada mirrors the list. Source
- Regulation (EU) 2026/909 ('Omnibus Act 2') enters into force
Published 2026-04-28, it restricts fragrance allergens (benzyl salicylate, citral/geranial/neral, acetylated vetiver oil), aluminium compounds, zinc salts and several hair dyes and bans triphenyl phosphate, with a placing-on-market deadline of 2027-01-01 and sell-through to 2028-07-01 (citral 2028-08-01). Source
- EU Omnibus VIII (Regulation (EU) 2026/78) applies
Published 2026-01-13, it bans nano and massive silver, restricts silver powder, hexyl salicylate and o-phenylphenol, and required withdrawal of non-compliant products by 1 May 2026 without a stock-clearance period. Source
- EU Omnibus VII (Regulation (EU) 2025/877) bans TPO and other CMRs
TPO (UV nail-gel photoinitiator) and other newly classified CMR substances were added to Annex II with no sell-through: products may neither be placed nor made available on the EU market from 1 September 2025. Source
FAQ
Does European Union require notification or registration before sale?
Pre-market electronic notification of every product in the Cosmetic Products Notification Portal (CPNP) by the Responsible Person before placing on the market (Art. 13); no approval.
Is a local responsible person mandatory in European Union?
A Responsible Person established in the EU is mandatory — by default the EU manufacturer or importer, or a third party appointed by written mandate (Art. 4).
What are the labeling requirements in European Union?
Language(s) fixed by each Member State; INCI ingredient list; fragrance allergens named above 0.001% (leave-on) / 0.01% (rinse-off) — Regulation (EU) 2023/1545 adds 56 allergens to the historic 26, mandatory for products placed on the market from 2026-07-31 and for all products from 2028-07-31.
What changed recently in European Union cosmetic regulation?
2026-04-28 Commission Regulation (EU) 2026/909 ('Omnibus Act 2') published (in force 2026-05-18) restricting fragrance allergens such as benzyl salicylate and citral, aluminium compounds, zinc salts and hair dyes and banning triphenyl phosphate, with placing-on-market deadline 2027-01-01 and sell-through to 2028-07-01; Omnibus VIII (EU) 2026/78 applied from 2026-05-01 (nano/massive silver banned, hexyl salicylate and o-phenylphenol restricted).
Related buyer questions
- For a spray-based cleanser containing 75% alcohol exported to Europe, it must comply with IATA DG shipping regulations. Can the factory provide the latest MSDS and assist in planning FBA inbound clearance and temperature control?
- For sunscreen entering the EU and UK, what are the differences in SPF testing standards (ISO 24444) between CPNP and SCPN?
- If we audit for a major European retailer, what specific SOPs and deviation management documents can you provide to meet the audit requirements?
- We plan to use recycled plastic packaging across the line and claim 'cruelty-free,' but we fear European buyers will label this as 'greenwashing.' Beyond obtaining Leaping Bunny certification, what additional validation tests are required for packaging traceability and recyclability claims?
- When using biodegradable packaging and bio-based ingredients for cleansing products, how can a brand verify and meet environmental compliance claims in EU and US markets?
- How can sunscreen or makeup formulations be adjusted to ensure stability and meet local import standards in extreme heat and humidity climates of the Middle East?
Entering European Union? Send the product type and we reply with the factory-side document list and lead time. Send an inquiry