Sell Cosmetics in the Czech Republic: Regulatory Compliance Guide

• The Ministerstvo zdravotnictví (Ministry of Health) is the competent authority for cosmetics under Regulation (EC) 1223/2009.
• Czech is mandatory for the Art. 19(5) elements: nominal content, minimum durability date, warnings, product function, and ingredient list; INCI names are exempt.
• The Ministry issues Free Sale Certificates (CFS/FSC) for cosmetics exporters targeting non-EU markets.

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

The Czech Republic 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 the Czech Republic 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 the Czech Republic.
• 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 the Czech Republic. 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 the Czech Republic is the Ministerstvo zdravotnictví České republiky (Ministry of Health of the Czech Republic), with its dedicated cosmetics section at mzd.gov.cz.

The Ministry of Health administers Regulation 1223/2009, acts as the national contact point with the European Commission, receives cosmetovigilance notifications under Article 23, and issues Free Sale Certificates for companies exporting cosmetics to countries outside the European Union.

The Státní zdravotní ústav (National Institute of Public Health, szu.gov.cz) provides scientific and technical support to the Ministry on ingredient safety and risk assessments.

The Ministerstvo zdravotnictví is the competent authority for cosmetics in the Czech Republic. SÚKL (Státní ústav pro kontrolu léčiv — State Institute for Drug Control) covers medicinal products and medical devices exclusively.

3. Labelling language requirements

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

The Ministry of Health specifies that the distributor placing the product on the Czech market is responsible for ensuring the mandatory Czech labelling. In practice, this means an importer or local distributor may apply an additional label with the required elements in Czech if the original label is in another EU language.

INCI ingredient names are exempt from the language requirement: as internationally standardised nomenclature, they may appear in their original form without Czech translation. For ingredient composition queries and applicable restrictions, the CosIng database is the reference resource.

In practical terms, the distributor placing the product on the Czech market bears full responsibility for ensuring that a Czech-language label is present before the product reaches the retail point. This is typically achieved by applying an additional label or an inserted leaflet that covers the mandatory elements in Czech, without modifying the manufacturer's primary packaging. The Ministry of Health has confirmed this approach in its guidance documentation, aligning it with Article 19(5) of the Regulation and the general practice followed across multilingual EU distribution chains.

4. National particularities

No pre-market authorisation: CPNP notification is sufficient

The Czech Republic requires no additional national authorisation or registration before placing a cosmetic product on the market. CPNP notification is the only market-entry step, as in the rest of the EU. There is no parallel Czech cosmetics register.

Free Sale Certificates for exporters

A notable feature of the Czech system is that the Ministry of Health issues Free Sale Certificates (CFS/FSC) for companies exporting cosmetics from the Czech Republic to non-EU countries. These certificates attest that the product is freely marketed within the EU and complies with Regulation 1223/2009. For companies with export activities targeting third-country markets, obtaining a CFS from the Ministry of Health is a standard step in the market-entry process for countries outside the EU that require documentary proof of the product's regulatory status in its country of origin.

Cosmetovigilance

Serious undesirable effect notifications under Article 23 of Regulation 1223/2009 are directed to the Ministry of Health, which processes them and feeds them into the European surveillance system. There is no separate national portal beyond the European channel. Companies operating in the Czech market should maintain internal records of any such notifications, as the Ministry may request supporting documentation as part of a market surveillance procedure.

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

5. Frequently asked questions

Which authority regulates cosmetics in the Czech Republic? The Ministerstvo zdravotnictví (Ministry of Health of the Czech Republic) is the competent authority for cosmetic products. It administers Regulation 1223/2009, handles cosmetovigilance notifications, and issues Free Sale Certificates for exporters.

What language must cosmetic labels be in for the Czech Republic? Czech is mandatory for the Art. 19(5) elements of Regulation 1223/2009: nominal content, minimum durability date, relevant warnings, product function, and ingredient list. INCI ingredient names are exempt as international nomenclature.

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

Are there national particularities beyond Regulation 1223/2009? The Ministry of Health issues Free Sale Certificates (CFS/FSC) for companies exporting cosmetics to non-EU countries. This is the most notable national differentiator in the Czech market.