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). Fonte
Resumo do lado da fábrica; o texto oficial prevalece; não constitui aconselhamento jurídico.
- Autoridade
- European Commission (DG GROW) with Member State competent authorities
- Regulamentação principal
- Regulation (EC) No 1223/2009 · Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- Vigente
- 2013-07-11
- Entrada no mercado
- 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.
- Pessoa responsável
- 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).
- Dossiê de segurança
- 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.
- Etiquetagem
- 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.
- Testes em animais
- 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.
- Listas de ingredientes
- Annex II (prohibited), Annex III (restricted), Annex IV (colorants), Annex V (preservatives), Annex VI (UV filters); CosIng database for INCI names.
- Notas
- 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).
- Pesquisar este inventário aqui
- 欧盟 · CosIng — European Commission cosmetic ingredient database
- Texto oficial
- https://eur-lex.europa.eu/eli/reg/2009/1223/oj
Alterações 2025–2026
- Expanded EU fragrance-allergen labelling becomes mandatory for new products
O Regulamento (UE) 2023/1545 adiciona 56 alérgenos ao Anexo III; os produtos colocados no mercado a partir de 31 de julho de 2026 devem nomeá-los acima de 0.001% (produtos de contacto prolongado) / 0.01% (produtos de enxágue), e os produtos existentes devem cumprir até 31 de julho de 2028 — a Suíça aplica o mesmo anexo e o Canadá espelha a lista. Fonte
- Regulation (EU) 2026/909 ('Omnibus Act 2') enters into force
Publicado em 2026-04-28, restringe alérgenos de fragrância (benzil salicilato, citral/geranial/neral, óleo de vetiver acetilado), compostos de alumínio, sais de zinco e várias tinturas capilares e proíbe o fosfato de trifenil, com prazo de colocação no mercado até 2027-01-01 e escoamento de estoque até 2028-07-01 (citral 2028-08-01). Fonte
- EU Omnibus VIII (Regulation (EU) 2026/78) applies
Publicado em 2026-01-13, proíbe prata nano e massiva, restringe pó de prata, hexil salicilato e o-fenilfenol, e exigiu a retirada de produtos não conformes até 1 de maio de 2026, sem período de escoamento de estoque. Fonte
- EU Omnibus VII (Regulation (EU) 2025/877) bans TPO and other CMRs
O TPO (fotoiniciador de gel de unhas UV) e outras substâncias CMR recém-classificadas foram adicionadas ao Anexo II sem período de escoamento: os produtos não podem ser colocados nem disponibilizados no mercado da UE a partir de 1 de setembro de 2025. Fonte
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).
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