Sell Cosmetics in Romania: Regulatory Compliance Guide

• The Ministerul Sănătății (Ministry of Health) is the primary authority for cosmetics under Regulation (EC) 1223/2009, with ANPC co-enforcing labelling and distribution compliance.
• Romanian is mandatory for all consumer-facing label information; ANPC has an active enforcement record for non-compliant labelling.
• ANPC published a dedicated Cosmetics Labelling Regulations Guide in January 2024, the key reference document for market inspections.

1. The EU framework applies — notify once, sell everywhere

Romania 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 Romania 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 Romania.
• 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 Romania. For the cross-cutting concepts, see also what the CosIng database is and how to use it.

2. The national competent authority

Romania's cosmetics supervisory system is organised around two authorities with complementary roles.

The Ministerul Sănătății (Ministry of Health, ms.ro) is the primary competent authority under Regulation 1223/2009. It manages market regulation, control inspections, cosmetovigilance, and reporting to the European Commission. It is the official contact point for all matters relating to product safety.

The Autoritatea Națională pentru Protecția Consumatorilor (ANPC) — National Consumer Protection Authority — has specific enforcement powers over cosmetics labelling and compliance obligations at the distribution level. ANPC has an active record of enforcement proceedings against companies marketing cosmetics with non-compliant labelling or missing Romanian-language information.

The Ministerul Sănătății is the competent authority for cosmetics in Romania under Regulation 1223/2009. ANMDMR (Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România) covers medicinal products and medical devices.

For ingredient composition and applicable restrictions, the CosIng database is the reference resource.

3. Labelling language requirements

Romanian is mandatory for all consumer-facing label information in Romania. Elements that must appear in Romanian include: product function, warnings and instructions for use, the INCI ingredient list, Responsible Person details, batch number, shelf life or period after opening (PAO), and nominal content.

ANPC is the authority with the most active enforcement role in this area. ANPC inspections focus specifically on verifying that all mandatory information is provided in Romanian and that distributors comply with their obligations under the supply chain. A common enforcement finding is the use of labels that contain Romanian translations only for some elements, omitting others — all Article 19(5) elements must be present in Romanian, without exception.

For imported products, the standard practice is to apply an additional Romanian-language label or insert before the product is placed on the Romanian market. The Responsible Person and the importer or distributor bear joint responsibility for ensuring this labelling is in place and correct. Non-compliant labelling can result in administrative sanctions from ANPC and, in more serious cases, a withdrawal order from the Ministry of Health.

INCI ingredient names, as internationally standardised nomenclature, are exempt from the language requirement and may appear in their original form.

4. National particularities

ANPC Cosmetics Labelling Guide (January 2024)

In January 2024, ANPC published a Guide on Cosmetics Labelling Regulations (anpc.ro). This document sets out the authority's expectations on labelling presentation, language, and content for cosmetic products. Any company distributing cosmetics in Romania should review this guide as the reference for market inspections.

Dual-authority structure

The Ministry of Health — ANPC duality means a company may receive inspections from both authorities with different focuses: the Ministry centres on product safety and market surveillance under Regulation 1223/2009; ANPC operates in the consumer law domain, with particular attention to labelling and distribution practices.

Cosmetovigilance

Serious undesirable effect notifications (Article 23 of Regulation 1223/2009) are directed to the Ministry of Health, which processes them and feeds them into the European surveillance system. Companies operating in Romania should maintain clear internal procedures for cosmetovigilance reporting, as both the Ministry and ANPC may request documentation as part of their respective inspection activities.

Product information file accessibility

The product information file (PIF) must be accessible to the competent authority at the address of the Responsible Person established in the EU. Although Romanian is not required for the PIF itself — technical documentation in English is generally accepted — consumer-facing elements of the safety report (CPSR) and labelling must comply with the Romanian-language requirements described above.

For other markets in the region, see our guides to the Czech Republic, Slovakia, Hungary, Bulgaria, Croatia, and Slovenia.

5. Frequently asked questions

Which authority regulates cosmetics in Romania? The Ministerul Sănătății (Ministry of Health) is the primary competent authority for cosmetics in Romania. The ANPC (National Consumer Protection Authority) has enforcement powers over labelling compliance and distribution-related obligations.

What language must cosmetic labels be in for Romania? Romanian is mandatory for all consumer-facing label information: product function, warnings, INCI ingredient list, Responsible Person details, batch number, shelf life/PAO, and nominal content. ANPC has an active enforcement record for non-compliant labelling.

Do I need a separate notification for Romania? No. A single CPNP notification covers the entire EU market, including Romania. There is no national cosmetics register separate from the CPNP.

Are there national particularities beyond Regulation 1223/2009? The ANPC published a dedicated Cosmetics Labelling Regulations Guide in January 2024, setting out enforcement expectations. The dual-authority structure — Ministry of Health for product safety and ANPC for market compliance — is the most distinctive feature of the Romanian system.