How to Ensure Cosmetic Compliance in Finland – Guidelines from Finnish Medicines Agency

Summary: Cosmetic Regulatory Requirements in Finland

Cosmetic products placed on the Finnish market must comply with the European Cosmetics Regulation (EC) No. 1223/2009, which has been in force since 11 July 2013. This regulation replaced the earlier Cosmetics Directive 76/768/EEC and aims to ensure the safety of cosmetic products while harmonizing rules across the European Union.

Before a cosmetic product can be marketed in Finland, a safety assessment must be conducted by a qualified safety assessor. The safety report forms part of the Product Information File (PIF), which contains detailed documentation about the product, including the product description, manufacturing method, evidence supporting product claims, and information related to animal testing.

Cosmetic products must also be notified through the Cosmetic Products Notification Portal (CPNP) of the European Commission before they are placed on the market. This centralized system provides authorities with access to information about product composition and intended use for regulatory oversight and emergency purposes.

Manufacturers are required to follow Good Manufacturing Practices (GMP) in accordance with ISO 22716. These practices are intended to maintain a controlled and hygienic manufacturing environment and to reduce potential risks during production.

Cosmetic labeling must meet specific regulatory requirements. Labels must include the name and address of the responsible person, the country of origin for imported products, the nominal content, the expiration date or period after opening, precautions for use, the batch number, the product function, and the ingredient list. In Finland, this information must be provided in Finnish and Swedish, which are the official languages of the country.

Additional requirements apply to products containing nanomaterials. These substances must be clearly identified in the ingredient list, and their safety must be supported with additional data and assessments.

Market surveillance of cosmetic products in Finland is carried out by the Finnish Safety and Chemicals Agency (Tukes). This authority monitors compliance with regulations and may conduct inspections or investigate complaints and reports of undesirable effects.

In summary, cosmetic regulations in Finland follow the broader European regulatory framework. Manufacturers and importers must meet strict requirements related to safety, documentation, labeling, and manufacturing practices before cosmetic products can be legally sold on the Finnish market.