Sell Cosmetics in Sweden: Compliance Guide

• Läkemedelsverket (Medical Products Agency) is the competent authority for cosmetics in Sweden under Regulation (EC) 1223/2009, with full market surveillance powers.
• Required labelling must be in Swedish under Ordinance SFS 2013:413 and provisions LVFS 2013:10; INCI ingredient names are exempt.
• Sweden's national framework operates on two tiers: the primary Ordinance SFS 2013:413 and the supplementary Läkemedelsverket provisions LVFS 2013:10.

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

Sweden 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 Sweden 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 Sweden.
• 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 Sweden. 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 cosmetics in Sweden is Läkemedelsverket — the Medical Products Agency (MPA). Läkemedelsverket regulates cosmetics, medicinal products, and medical devices: it is the reference agency with full legal competence across all three sectors.

Its official website — lakemedelsverket.se/en/cosmetics — publishes guidance for businesses, notification requirements, and the regulatory provisions applicable to cosmetic products.

Läkemedelsverket participates actively in EU cosmetics market surveillance coordination bodies, ensuring that Swedish oversight is aligned with common European priorities.

3. Labelling language requirements

Swedish is mandatory for the required labelling elements of cosmetic products placed on the Swedish market. The elements that must appear in Swedish include: the nominal content, the minimum durability date or period after opening (PAO), usage precautions, the product's function, and the information required by Articles 19(2) to 19(4) of Regulation 1223/2009.

The legal basis is the Ordinance on Cosmetic Products (SFS 2013:413) — the Swedish national ordinance implementing Regulation 1223/2009 — supplemented by Läkemedelsverket provisions LVFS 2013:10, which specify, among other things, the language requirements applicable to the product information file (PIF) and the rules for non-pre-packaged products.

INCI ingredient names are exempt from the language requirement as internationally standardised nomenclature. You can look up ingredient names and their applicable restrictions in the CosIng database.

4. National particularities

Two-tier framework: SFS 2013:413 + LVFS 2013:10

The most distinctive feature of the Swedish system is its two-tier normative structure:

• SFS 2013:413 — the Ordinance on Cosmetic Products, the higher-ranking national instrument that implements Regulation 1223/2009 in Swedish law and establishes the core obligations for manufacturers, importers, and distributors.
• LVFS 2013:10 — Läkemedelsverket's own provisions that complement the ordinance; they include language requirements for the PIF, specific rules for non-pre-packaged bulk products, and additional obligations.

This two-instrument structure differentiates the Swedish system from member states that apply Regulation 1223/2009 directly without national implementing ordinances.

Läkemedelsverket and multi-sector regulation

Läkemedelsverket regulates medicinal products, medical devices, and cosmetics. This multi-sector coverage does not limit its competence over cosmetics: the agency holds full market surveillance powers and regulatory authority in this area. For companies accustomed to dealing with cosmetics-only agencies in other countries, it is worth noting that in Sweden the regulatory contact point is the same agency that supervises medicinal products.

Sweden Poison Centre and CLP notifications

The Swedish Poison Information Centre is Giftinformationscentralen (GIC), located in Stockholm. From 1 January 2024, ECHA's submission portal is the sole accepted route for CLP Regulation Article 45 hazardous mixture notifications in Sweden, as in all EU member states. However, cosmetic products are exempt from CLP Article 45 Poison Centre Notification (PCN) requirements: sector-specific legislation under Regulation 1223/2009 takes precedence. Operators placing cosmetics on the Swedish market do not need to submit a CLP-format PCN to GIC.

Practical steps for entering the Swedish market

For a business already compliant with Regulation 1223/2009 across the EU, entering Sweden requires attention to three specific points:

1. Language check on all required labelling elements: nominal content, minimum durability date or PAO, usage precautions, product function, and any Article 19(2)-(4) information must be in Swedish. Review packaging against the LVFS 2013:10 requirements, not only Article 19 of the Regulation.
2. PIF language: LVFS 2013:10 sets language requirements for the product information file applicable in Sweden. While the Regulation does not prescribe a single EU-wide PIF language, Läkemedelsverket's provisions clarify what applies nationally. If Läkemedelsverket requests the PIF during a market surveillance inspection, you should be prepared to provide it in a language accessible to Swedish authorities.
3. Non-pre-packaged products: LVFS 2013:10 contains specific rules for cosmetic products not sold in pre-packaged form — relevant for bulk or sample distribution channels.

For other markets in the Nordic and Baltic region, see our guides to Denmark, Finland, Estonia, Latvia, and Lithuania.

5. Frequently asked questions

Which authority regulates cosmetics in Sweden? The Läkemedelsverket (Medical Products Agency, MPA) is the competent authority for cosmetics in Sweden. In addition to cosmetics, Läkemedelsverket regulates medicinal products and medical devices — it is the public health agency with full legal competence across all three sectors.

What language must cosmetic labels be in for Sweden? Swedish is mandatory for required labelling elements, under Ordinance SFS 2013:413 and Läkemedelsverket provisions LVFS 2013:10. INCI ingredient names are exempt as internationally standardised nomenclature.

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

Are there national particularities beyond Regulation 1223/2009? Yes. Sweden operates a two-tier national framework: Ordinance SFS 2013:413 as the primary national instrument and Läkemedelsverket provisions LVFS 2013:10, which specify language requirements for the product information file (PIF), rules for non-pre-packaged products, and additional obligations.