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). Sumber
Ringkasan pihak kilang; teks rasmi adalah yang berkuat kuasa; bukan nasihat undang-undang.
- Pihak berkuasa
- European Commission (DG GROW) with Member State competent authorities
- Peraturan utama
- Regulation (EC) No 1223/2009 · Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
- Berkuat kuasa
- 2013-07-11
- Penembusan pasaran
- 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.
- Orang yang bertanggungjawab
- 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).
- Fail keselamatan
- 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.
- Pelabelan
- 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.
- Ujian haiwan
- 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.
- Senarai bahan
- Annex II (prohibited), Annex III (restricted), Annex IV (colorants), Annex V (preservatives), Annex VI (UV filters); CosIng database for INCI names.
- Nota
- 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).
- Lihat inventori ini di sini
- 欧盟 · CosIng — European Commission cosmetic ingredient database
- Teks rasmi
- https://eur-lex.europa.eu/eli/reg/2009/1223/oj
Perubahan 2025–2026
- Expanded EU fragrance-allergen labelling becomes mandatory for new products
Peraturan (EU) 2023/1545 menambah 56 alergen ke Lampiran III; produk yang ditempatkan di pasaran dari 31 Julai 2026 mesti menyebut nama alergen tersebut jika melebihi 0.001% (kawasan sentuhan) / 0.01% (bilas), dengan produk sedia ada perlu mematuhi sebelum 31 Julai 2028 — Switzerland menggunakan lampiran yang sama dan Canada mengikut senarai tersebut. Sumber
- Regulation (EU) 2026/909 ('Omnibus Act 2') enters into force
Dicetak pada 2026-04-28, ia mengehadkan alergen wangi-wangian (benzyl salicylate, citral/geranial/neral, minyak vetiver terasetil), sebatian aluminium, garam zink dan beberapa pewarna rambut, serta melarang triphenyl phosphate, dengan garis masa penempatan di pasaran 2027-01-01 dan penjualan akhir sehingga 2028-07-01 (citral 2028-08-01). Sumber
- EU Omnibus VIII (Regulation (EU) 2026/78) applies
Dicetak pada 2026-01-13, ia melarang nano dan perak besar, mengehadkan serbuk perak, hexyl salicylate dan o-phenylphenol, serta memaksa penarikan balik produk yang tidak mematuhi syarat pada 1 Mei 2026 tanpa tempoh pelupusan stok. Sumber
- EU Omnibus VII (Regulation (EU) 2025/877) bans TPO and other CMRs
TPO (penginduksi fotofil gincu kuku UV) dan bahan CMR yang baru diklasifikasikan telah ditambah ke Lampiran II tanpa jualan akhir: produk tidak boleh diletakkan atau disediakan di pasaran EU bermula 1 September 2025. Sumber
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).
Soalan pembeli berkaitan
- 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. Hantar Pertanyaan