Cosmetic Regulatory Requirements in Finland complies with the EU regulation (Regulation (EC) No 1223/2009) without additional national requirements.
Finnish Safety and Chemicals Agency (Tukes)
In Finland, the regulatory authority responsible for overseeing cosmetic products is the Finnish Safety and Chemicals Agency (Tukes). Tukes ensures that cosmetic products placed on the Finnish market comply with the EU regulations and meet safety standards.
Language Requirements
According to Finnish regulations, the label information on cosmetic products must be provided in Finnish and Swedish. Finnish and Swedish are the two official languages of Finland, and products sold in Finland must have labels that are comprehensible to consumers in both languages.
Safety Assessment and Notification
Before placing a cosmetic product on the market in Finland, manufacturers or importers must conduct a safety assessment. This assessment ensures that the product is safe for consumers when used under normal or reasonably foreseeable conditions of use.
Cosmetic products must also be notified to the European Cosmetic Products Notification Portal (CPNP). This notification provides essential information about the product, including its composition and intended use.
Good Manufacturing Practices (GMP)
Manufacturers in Finland must adhere to Good Manufacturing Practices (GMP) as outlined in ISO 22716. These practices ensure that cosmetic products are produced under controlled and hygienic conditions, minimizing the risk of contamination or other hazards.
Nanomaterials Regulation
Specific provisions apply to cosmetic products containing nanomaterials. Nanomaterials must be explicitly indicated in the list of ingredients, and their safety must be substantiated through additional data and assessments.
Market Surveillance and Enforcement
Tukes conducts market surveillance to ensure compliance with cosmetic regulations in Finland. This includes random inspections of products on the market, as well as follow-up on consumer complaints and adverse reactions related to cosmetic products.
Key provisions of the Cosmetic Regulatory Requirements in Finland
The Regulation (EC) No 1223/2009 on cosmetic products, which came into effect on July 11, 2013, replaced the Cosmetics Directive 76/768/EEC. The main objectives of this regulation are to ensure the safety of cosmetic products and to streamline the requirements across the EU member states.
Key Elements of this Cosmetic Regulatory Requirements in Finland Include
Safety Assessment
Before a cosmetic product can be placed on the market, it must undergo a safety assessment conducted by a qualified safety assessor. The safety report is part of the Product Information File (PIF).
Product Information File (PIF)
Every cosmetic product must have a PIF, which includes detailed information about the product, such as the safety assessment, product description, manufacturing method, proof of the effects claimed, and data on any animal testing performed.
Notification
Cosmetic products must be notified to the EU Cosmetic Products Notification Portal (CPNP) before being marketed. This centralized database is accessible to competent authorities for market surveillance and emergency purposes.
Labelling
The product label must include the name and address of the responsible person, the country of origin for imported products, the nominal content, the date of minimum durability, precautions for use, the batch number, the product’s function, and a list of ingredients.
Cosmetic Good Manufacturing Practices (GMP)
Compliance with Good Manufacturing Practices, as outlined in ISO 22716, is mandatory to ensure the quality and safety of cosmetic products.
Nanomaterials
Special provisions apply to nanomaterials used in cosmetics, including specific labelling requirements and notification to the European Commission.
Conclusion
In conclusion, cosmetic regulatory requirements in Finland align with the EU regulations under Regulation (EC) No 1223/2009. The Finnish Safety and Chemicals Agency (Tukes) plays a crucial role in ensuring that cosmetic products placed on the market are safe and compliant with established standards.
Manufacturers and importers must adhere to stringent safety assessments, notification procedures, labelling requirements, and Good Manufacturing Practices (GMP) to market their products in Finland.
