A carton of Korean serums is open on the counter of a profumeria outside Bologna, a sheet of printed Italian stickers next to it, and the assistant is peeling off the first one. Nothing about that scene looks like a regulatory act. In Italy it is one.
The Decreto del Ministro della salute of 27 September 2018 closes its list of cosmetic manufacturing phases, at article 8(2), with "il confezionamento nell'imballaggio secondario e l'etichettatura". Secondary packaging and labelling. Article 9 then gives whoever performs one of those phases thirty days from the start of the activity to send a communication, per site, to the Ministero della Salute and the Region. A shop that stickers Korean packs in its back room has opened a cosmetics production site and owes that communication.
The short version
- Article 19(5) of Regulation (EC) No 1223/2009 lets Italy require Italian on every cosmetic pack for nominal content, durability or period after opening, precautions for use and product function, and Italy did so in the decree of 27 September 2018.
- Articles 8 and 9 of the Decreto del Ministro della salute of 27 September 2018 class labelling and secondary packaging as manufacturing, and each site doing it owes a communication to the Ministero della Salute and the Region within 30 days of starting.
- Article 1, comma 3-bis of D.Lgs. 127/2015 sends every purchase invoice from an EU wholesaler through the Sistema di Interscambio as a TD18 by the fifteenth of the month after receipt, while a direct import cleared on a customs bolletta is exempt.
The label is the part that is genuinely Italian
Article 19(5) of Regulation (EC) No 1223/2009 hands the language of four label elements to the member state where the product reaches the end user: nominal content, minimum durability or period after opening, precautions for use, and the function of the product. Italy took Italian, through the same decree of 27 September 2018. Multilingual packs are fine if the Italian is as legible as the other languages, and the ingredient list stays in INCI, which is harmonised EU wide.
Korean packs satisfy none of it, so the only open Italian question is who applies the label, and where.
There is a second cost to applying it yourself. Article 4(6) says translating a label does not make you the Responsible Person, and article 13(3) then requires a distributor who translates any labelling element on its own initiative, to make a product available in a second member state, to notify the Commission itself. Buy sealed stock from a French wholesaler, as many Italian shops do because the French market is where a lot of EU held Korean stock actually sits, print your own Italian sticker, and you have collected a notification duty and a production site communication for the sake of one sticker.
What the Ministero della Salute still wants, and what it no longer does
Italy does not run a national product register on top of CPNP, and has not since 6 January 2016, when D.Lgs. 4 dicembre 2015 n. 204 repealed Legge 713/1986 and the old Italian pre market communication with it. Notification happens once, in CPNP, by the Responsible Person, and who that person is depends on how the goods entered the EU.
What 204/2015 brought instead is a sanctions regime that splits by failure. Its article 17 shelters a trader selling in original, intact packs where the non conformity concerns intrinsic requirements, composition or the internal condition of the container, provided the trader did not know and the pack shows no sign of tampering. Formulation is not your problem.
The label is. A distributor who omits the checks prescribed for distributors faces an ammenda of €3,000 to €30,000, a criminal fine rather than an administrative one. Non conforming labelling costs the Responsible Person €500 to €4,000, failing to notify €1,000 to €6,000, and breaching the safety assessment and product information file duties an ammenda of €10,000 to €100,000.
Sistema di Interscambio catches the supplier, not the goods
Every Italian business with a foreign supplier meets this, and most meet it late. Article 1, comma 3-bis of D.Lgs. 127/2015 sends data on transactions with parties not established in Italy through the Sistema di Interscambio, for operations from 1 July 2022 onward. For purchases the deadline is the fifteenth of the month following receipt of the document.
The codes matter. TD18 covers goods from an EU supplier. TD17 covers services bought abroad, which is where your forwarder, your customs agent and any overseas warehousing land. TD19 covers goods sold by a non established seller but already sitting in Italy, and the Agenzia delle Entrate guide is explicit that it excludes imports.
Most Italian retailers get the consequence backwards. Comma 3-bis exempts operations covered by a customs bolletta, so a direct import from Korea generates no SdI transmission at all, while a routine invoice from a Dutch or Polish wholesaler generates a TD18 every month. Late transmission is €2 per invoice capped at €400 a month, halved if you fix it within fifteen days. A nuisance rather than a threat, which is why it gets forgotten for a year and arrives as a stack.
Where this actually sells in Italy
Cosmetica Italia's Centro Studi put Italian cosmetics consumption at €13,396 million for 2024, growing 6.9 %: mass market €5,507 million, profumeria €2,774 million and growing 9.5 %, farmacia €2,218 million, e-commerce €1,262 million and growing 13.5 %, erboristeria €446 million.
Two of those should change what you buy. Fragrance concentrates 80 % of profumeria traffic, so a Korean skincare wall in a profumeria is not fed by the people already walking in. It needs its own reason to exist, which in practice means routines and testers rather than a long brand list. And erboristeria is now 3.3 % of Italian cosmetics consumption against 4.1 % before the pandemic, because natural positioning stopped being that channel's private property. A Korean range pitched into an erboristeria on a clean beauty story is competing with the same story in five other channels.
Our position for an Italian independent: buy inside the EU from a supplier whose packs already carry Italian compliant text and an EU Responsible Person address, and apply nothing yourself. Direct Korean sourcing looks cheaper per unit and the real landed cost of importing from Korea usually eats the difference before the compliance work starts. The Italian layer then adds a production site communication, a CPNP notifier duty and a criminal fine range attached to label checks, all of which scale with the number of references rather than with volume per reference. Two hundred Korean references selling modestly is the worst possible shape for that arithmetic. Owning the role pays only with a narrow range, high volume per line and a safety assessor already on contract.
Italy readiness checklist, and what to make the supplier confirm in writing
Work through it per reference, before the purchase order.
- Nominal content, durability or PAO, precautions and function are printed in Italian, as legibly as the other languages.
- The pack carries an EU Responsible Person name and complete address, plus the country of origin.
- Batch number and INCI list are on the pack, and the durability date leaves a sellable window.
- Nobody in the chain, you included, restickered anything after the goods were placed on the market. If someone did, find out who filed the article 13(3) notification.
- You do no labelling or secondary packaging on your own premises. If you do, file the article 9 communication to the Ministero della Salute and your Region within thirty days of starting.
- Your accountant knows which supplier invoices are TD18 and which TD17, and transmits by the fifteenth of the following month.
- Supplier invoices carry batch numbers, so an article 7 traceability request does not send you through delivery notes.
Send this to a prospective supplier, and ask for written answers:
Buongiorno, before we open an account, please confirm in writing: 1. Which legal entity is the EU Responsible Person for these products, and what name and address is printed on the pack? 2. Are the packs supplied to us already labelled in Italian for nominal content, durability or PAO, precautions and function? 3. Was any labelling element translated after the products were placed on the EU market, and if so who filed the article 13(3) notification? 4. Are the products notified in CPNP, and by which Responsible Person? 5. Will your invoices to us show batch numbers per line? 6. Will you invoice us from an EU VAT number, and from which country? Grazie.
A supplier that answers all six in writing is selling you goods. A supplier that answers two and offers a discount is selling you the compliance work as well.
Questions buyers ask
Do I need to be in VIES to buy Korean cosmetics from an EU wholesaler?
Yes. An Italian partita IVA is not enabled for intra-EU trade on its own; you ask the Agenzia delle Entrate for inclusion in the VIES archive, and until your number shows up in the Commission's VIES checker a wholesaler in another member state cannot invoice you VAT free. Once it does, the invoice arrives without VAT, you integrate it as a TD18 with Italian VAT and deduct that VAT in the same return. Check your own number on the VIES site before the first order rather than after the first invoice.
Can I sell Korean sunscreen in Italy?
Only if every UV filter in the formula is listed in Annex VI of Regulation (EC) No 1223/2009. A sunscreen built on a filter that is not in that annex cannot be placed on the EU market at all, and no Italian sticker or Responsible Person changes that. Ask the supplier for the full INCI list of each sun product before ordering and check the filters against Annex VI yourself.
Do I have to notify Korean cosmetics in CPNP myself?
Not when you buy from an EU supplier whose Responsible Person has already notified the product; article 13(1) of Regulation (EC) No 1223/2009 puts the notification on the Responsible Person, and it happens once. You become the Responsible Person, and therefore the notifier, when you import the goods from Korea yourself under article 4(5) or sell them under your own name. Ask the supplier for the CPNP reference per product rather than a general assurance that everything is notified.
Sources
- EUR-Lex, Regulation (EC) No 1223/2009 on cosmetic products, 2009
- Gazzetta Ufficiale, Decreto del Ministro della salute 27 settembre 2018, 2018
- Gazzetta Ufficiale, D.Lgs. 4 dicembre 2015 n. 204, 2015
- Agenzia delle Entrate, D.Lgs. 5 agosto 2015 n. 127, 2015
- Agenzia delle Entrate, Guida alla compilazione delle fatture elettroniche e dell'esterometro v1.9, 2024
- Cosmetica Italia Centro Studi, I numeri della cosmetica, 2025
Articles, decrees, sanction ranges and channel figures above were read on EUR-Lex, the Gazzetta Ufficiale, the Agenzia delle Entrate site and the Cosmetica Italia Centro Studi report on 1 September 2026. General information, not legal or tax advice; check a specific assortment or route with your commercialista or the Ministero della Salute.
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