Sell cosmetics in Croatia: regulatory guide

• The Ministarstvo zdravstva (Ministry of Health of Croatia) is the competent authority for cosmetics under Regulation (EC) 1223/2009; HALMED, the medicines agency, covers medicinal products and medical devices exclusively.
• Croatian is mandatory for all Article 19(5) elements; imported products must also include the country-of-origin declaration in Croatian.
• Croatia has a national implementing law: Zakon o provedbi Uredbe (EZ) br. 1223/2009 (NN 18/13, amended NN 115/18).

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

Croatia 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 Croatia 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 Croatia.
• 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 Croatia. 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 Croatia is the Ministarstvo zdravstva Republike Hrvatske (Ministry of Health of the Republic of Croatia), with sector information available at zdravlje.gov.hr.

The Ministry of Health is the primary body under the national implementing law. It manages the cosmetovigilance function and acts as the contact point to the European Commission. Physical market inspections under Regulation 1223/2009 are conducted by sanitary inspectors from the State Inspectorate (Državni inspektorat).

HALMED (Agencija za lijekove i medicinske proizvode — Agency for Medicinal Products and Medical Devices, halmed.hr) is the regulatory authority for medicinal products and medical devices in Croatia — not for cosmetics. The competent authority for cosmetics is the Ministry of Health.

3. Labelling language requirements

Croatian is mandatory in Croatia for all Article 19(5) elements of Regulation 1223/2009: nominal content, minimum durability date or period-after-opening (PAO), relevant warnings and precautions, product function, and the ingredient list.

For imported products, there is an additional requirement: the country-of-origin declaration (for example, "Made in France") must also appear in Croatian. This requirement, which goes beyond the European minimum standard, is a feature of the Croatian implementation and should be factored into labelling preparation for products imported from outside the EU or from other member states where the original label does not include this information in Croatian.

INCI ingredient names are exempt from the language requirement: as internationally standardised nomenclature, they may appear in their original form without translation into Croatian. To verify ingredient composition and applicable restrictions under the annexes of Regulation 1223/2009, the CosIng database is the reference resource.

4. National particularities

National implementing law

Croatia has adopted a specific national implementing law for Regulation 1223/2009: the Zakon o provedbi Uredbe (EZ) br. 1223/2009 Europskog parlamenta i Vijeća od 30. studenoga 2009. o kozmetičkim proizvodima (NN 18/13, amended by NN 115/18). This law, published in the Narodne novine (Official Gazette), establishes the national application framework, designates the Ministry of Health as the competent authority, and sets out the responsibilities of economic operators on the Croatian market.

Country-of-origin declaration for imported products

As noted in the labelling section, imported products must include the country-of-origin declaration in Croatian. This obligation, derived from the national implementing framework, applies to products from third countries as well as those imported from other EU member states when the original labelling does not include this information in Croatian.

Cosmetovigilance

Serious undesirable effect notifications under Article 23 of Regulation 1223/2009 are directed to the Ministry of Health through the dedicated cosmetovigilance channel: kozmetovigilancija@miz.hr. This direct contact facilitates reporting by economic operators and healthcare professionals. The Ministry processes incoming notifications and integrates them into the EU-wide surveillance system managed by the European Commission. The Responsible Person must notify the Ministry without delay upon becoming aware of a serious undesirable effect — a requirement that applies across all EU markets but is enforced through this specific contact point in Croatia.

Practical labelling compliance for imports

For products manufactured outside Croatia, the standard approach is to apply an additional Croatian-language label or insert that covers the Article 19(5) mandatory elements and the country-of-origin declaration before the product is placed on the Croatian market. The distributor or importer responsible for placing the product is accountable for this compliance step. State Inspectorate sanitary inspectors performing on-site checks will verify label completeness, including the Croatian-language country-of-origin statement, as this is a distinct and frequently inspected requirement under the national implementing law.

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

5. Frequently asked questions

Which authority regulates cosmetics in Croatia? The Ministarstvo zdravstva Republike Hrvatske (Ministry of Health of the Republic of Croatia) is the competent authority for cosmetic products. It applies Regulation 1223/2009 and manages cosmetovigilance in Croatia.

What language must cosmetic labels be in for Croatia? Croatian is mandatory for the Article 19(5) elements of Regulation 1223/2009: nominal content, minimum durability date, warnings, product function, and the ingredient list. For imported products, the country-of-origin declaration must also appear in Croatian. INCI ingredient names are exempt as international nomenclature.

Do I need a separate notification for Croatia? No. A single CPNP notification covers the entire EU market, including Croatia. There is no additional national cosmetic product register.

Are there national particularities beyond Regulation 1223/2009? Croatia has a national implementing law (Zakon o provedbi Uredbe (EZ) br. 1223/2009, NN 18/13, amended NN 115/18). For imported products, the country-of-origin declaration in Croatian is required. Cosmetovigilance notifications go to kozmetovigilancija@miz.hr.