- The Ministero della Salute — DGSIAN is the competent authority for cosmetics in Italy under Regulation (EC) 1223/2009 — Italy is the EU's third-largest cosmetics market at €13.39 billion in 2024.
- Italian is mandatory for all consumer-facing label elements (Consumer Code + Ministerial Decree 27/09/2018); INCI ingredient names are exempt and QR-code-only solutions are not accepted.
- Cosmetics producers in Italy must notify the Ministry of Health of the manufacture site within 30 days of starting activity.
1. The EU framework applies — notify once, sell everywhere
Italy applies Regulation (EC) 1223/2009 directly — the harmonised rules that govern cosmetic products across the entire European Union. There is no parallel national regime: the safety, composition, and labelling rules are the same as in the rest of the EU.
In practice, selling in Italy within the EU framework means meeting four common obligations that are not specific to this country:
- A single CPNP notification covers the entire EU market, including Italy.
- A single EU-established Responsible Person is accountable for the product.
- A single product information file (PIF), which includes the cosmetic product safety report (CPSR).
This guide does not repeat that common framework — it focuses on what is specific to Italy. For the cross-cutting concepts, see also what the CosIng database is and how to use it.
2. The national competent authority
The competent authority for cosmetic products in Italy is the Ministero della Salute — Direzione Generale per l'igiene e la sicurezza degli alimenti e della nutrizione (DGSIAN) — Ministry of Health, Directorate General for Food Hygiene and Nutrition Safety. This directorate general is responsible for post-market surveillance, manufacture site notifications, cosmetovigilance, and issuance of free sale certificates (CLV) for export. Official URL: www.salute.gov.it/portale/cosmetici.
The ISS (Istituto Superiore di Sanità — National Institute of Health) collaborates with the Ministry on scientific assessment and regulatory guidance for the cosmetics sector, with the Ministry of Health retaining authority as the competent body.
3. Labelling language requirements
Italian is mandatory for consumer-facing cosmetic label elements in Italy. The legal bases are:
- Consumer Code (Codice del Consumo): all information for consumers and users must be provided, at minimum, in Italian.
- Ministerial Decree of 27 September 2018: specifies that the following elements must appear in Italian: nominal content, minimum durability date or PAO, precautions for use, and product function.
Where multiple languages appear on the label, the Italian text must not be smaller in font size than any other language. Translations must be faithful to the original and may not be abbreviated. QR-code-only solutions for mandatory information are not accepted in Italy.
INCI ingredient names are exempt from the language requirement, as throughout the EU. For ingredient identification using INCI nomenclature in the CosIng database, no Italian translation is needed.
4. National particularities
Manufacture site notification (Ministerial Decree 27/09/2018)
Cosmetics producers operating in Italy — whether producing under their own brand or on behalf of third parties — must notify the Ministry of Health of the start of activity at each production site within 30 days of commencement. The notification is submitted by certified email (PEC) using the official form approved on 30 November 2023, and must be sent simultaneously to:
- The Ministry's PEC address: dgfdm@postacert.sanita.it
- The competent regional authority
This obligation is separate from CPNP notification and does not replace it.
Certificate of Free Sale (CLV)
For export of Italian cosmetics to third countries, the Ministry of Health issues the Certificato di Libera Vendita (CLV — Certificate of Free Sale). Since 2 January 2024, CLV requests are processed through the PagoPA payment system.
Environmental packaging labelling (Legislative Decree 116/2020)
From 1 January 2022, Italy requires cosmetic product packaging to include:
- Disposal instructions by waste category, in accordance with municipal regulations.
- Material identification codes for each component of the packaging.
This requirement goes beyond the harmonised EU labelling rules and applies to all products placed on the Italian market.
For other markets in the region, see our guides to Germany, France, Spain, and Poland.
5. Market context
Italy is the third-largest cosmetics market in the European Union. According to the Cosmetics Europe Annual Report 2024 (published June 2025), retail sales of cosmetic and personal care products reached €13.39 billion, placing Italy third in the EU. Italy is also a significant cosmetics producer and exporter, with a well-established manufacturing base concentrated primarily in northern regions.
For companies accessing the Italian market, the environmental packaging labelling requirement (in force since 2022) and the manufacture site notification are the national aspects that most frequently require additional effort compared to the standard EU framework.
6. Frequently asked questions
Which authority regulates cosmetics in Italy? The Ministero della Salute — Direzione Generale per l'igiene e la sicurezza degli alimenti e della nutrizione (DGSIAN — Ministry of Health, Directorate General for Food Hygiene and Nutrition Safety) is the competent authority for cosmetics market surveillance in Italy, including manufacture site notifications and issuance of free sale certificates (CLV).
What language must cosmetic labels be in for Italy? Italian is mandatory for consumer-facing label elements under the Consumer Code (Codice del Consumo) and the Ministerial Decree of 27 September 2018. INCI ingredient names are exempt. Translations must be faithful to the original; QR-code-only solutions are not accepted.
Do I need a separate notification for Italy? No separate CPNP notification is needed — one notification covers the entire EU. However, anyone producing cosmetics in Italy or on behalf of third parties must notify the Ministry of Health of the start of activity at each production site within 30 days, by certified email (PEC).
Are there national particularities beyond Regulation 1223/2009? Yes. Italy requires manufacture site notification to the Ministry of Health (Ministerial Decree 27/09/2018), issuance of free sale certificates (CLV) for exports, and environmental packaging labelling with disposal instructions and material codes from 1 January 2022 (Legislative Decree 116/2020).
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