An Overview of Cosmetics Regulations in Nordic Countries

The Nordic countries are a group of nations in Northern Europe and the North Atlantic characterized by their shared cultural, historical, and geographical features. This group includes five sovereign states—Denmark, Finland, Sweden, Iceland, and Norway—as well as their associated autonomous territories and regions.

Among Nordic countries, Denmark, Finland, and Sweden are EU members, while Iceland and Norway are not. However, both Iceland and Norway are part of the European Free Trade Association (EFTA). On January 1, 1994, the Agreement on the European Economic Area came into force, which established the European Economic Area (EEA), linking EU states and EFTA members, and allowing EFTA members to participate in the EU's internal market. This grants Iceland and Norway the free movement of persons, goods, services, and capital with EU states. In return, they have to adopt most EU legislation governing the single market, including Regulation (EC) No 1223/2009 on Cosmetic Products (Cosmetics Regulation). To conclude, all Nordic countries require cosmetics' compliance with the EU Cosmetics Regulation. In addition, each country has its own national requirements that complement and expand upon the EU Cosmetics Regulation.

In this article, ChemLinked explores the cosmetics regulatory landscape in Nordic countries, with an emphasis on their national requirements.

Denmark

In Denmark, the Danish Environmental Protection Agency (Danish EPA) is responsible for ensuring that cosmetic products on the market are safe for consumers. For regulatory compliance, all cosmetics shall conform to the EU Cosmetics Regulation, and three supplementary Danish executive orders on cosmetics.

The key points of the three executive orders are outlined in the table:  

Finland

The Finnish Safety and Chemicals Agency (Tukes) and Finnish Customs are the competent authorities overseeing the safety of cosmetic products sold in Finland. Tukes monitors the products, as well as the activities of manufacturers, importers, and distributors on the Finnish market, while Finnish Customs regulates the import of cosmetics from outside the EEA, and the storage of cosmetics dispatched from other EEA countries.  

In Finland, cosmetic products shall fulfil the requirements of the EU Cosmetics Regulation, and the Finnish national legislation, the Act on Cosmetic Products (the Act). The Act establishes the compulsion of the EU Cosmetics Regulation, and clarifies sanctions for non-compliance. Moreover, it sets language requirements for labelling and the product information file (PIF) kept in Finland. Specifically,

• The labelling information, including contents, date of minimum durability (or period after opening), special precautions, product function, and other details required in Article 19(2)-(4) of the EU Cosmetics Regulation, shall be presented in both Finnish and Swedish;

• The information contained in the PIF stored in Finland, shall be available to competent authorities in Finnish, Swedish, or English at the address indicated on the product's label. 

Sweden

In Sweden, the Swedish Medical Products Agency (Swedish MPA) safeguards the safety of cosmetic products in accordance with the EU Cosmetics Regulation, and the supplementary Swedish regulation, Ordinance (2013:413) on Cosmetic Products (the Ordinance).

As per the Ordinance, cosmetic products offered to consumers in Sweden shall have their labelling information, including contents, date of minimum durability (or period after opening), special precautions, and product function, presented in Swedish. The information specified in Article 19(2)-(4) of the EU Cosmetics Regulation, except for the full ingredient listing, shall also be stated in Swedish. The full ingredient list shall be expressed using the common ingredient names from the Glossary of Common Ingredient Name.

Notably, to finance market surveillance activities, the Swedish MPA charges an annual fee to Swedish companies that notify cosmetic products through the EU's centralized notification system, i.e., cosmetic products notification portal (CPNP). For distributors not obligated to notify through CPNP, an hourly fee is applied. The fees payable to the Swedish MPA for cosmetics are as follows: 

Iceland

The Environmental Agency of Iceland (EAI) is in charge of regulating cosmetics within the country. The Regulation on Cosmetics (No 577/2013) is a national regulation which incorporates the EU Cosmetics Regulation into Icelandic law, and sets additional requirements for product production and labelling beyond those established by the EU. It governs the production and marketing of cosmetics in Iceland.

1) Production

To protect the environment by reducing emissions and waste, Iceland requires all commercial activities to have a valid work permit from EAI or local health committees. In line with this requirement, companies manufacturing cosmetics shall register their activities on the island.is before starting production. The registration form should include information on the applicant and the activity operator, the type and scope of the activity, business location, and other relevant details. Upon receiving the application, the local health committee reviews it and informs the applicant of the decision.

2) Labelling

Regarding the labelling of cosmetic products, the Regulation on Cosmetics (No 577/2013) outlines the following requirements:

• The labelling information specified in Article 19 of the EU Cosmetics Regulation shall be in Icelandic, English, or a Nordic language other than Finnish;

• Use conditions and warnings specified in ingredient annexes III, V, and VI to the EU Cosmetics Regulation shall be in Icelandic. However, statements related to fluoride content in toothpaste or those indicating the presence of a certain ingredient can be in English or a Nordic language other than Finnish;

• Cosmetic aerosols shall have labels in Icelandic, English, or a Nordic language other than Finnish. Additionally, these products shall indelibly, legibly and visibly bear the information as follows: 

Aerosol Type	Labelling Information Required
All types of aerosols	− Pressurized container: may explode if heated. − The product shall be kept away from heat, hot surfaces, sparks, open flames, and other ignition sources. − No smoking. − The product shall be protected from sunlight. − Do not expose the product to temperatures over 50 °C. − Do not pierce or incinerate containers, even when empty.
Extremely flammable aerosols (Category 1*)	− Extremely flammable aerosols. − Do not spray the product on open flames or other ignition sources. − The hazard pictogram GHS02:
Flammable aerosols  (Category 2*)	− Flammable aerosols. − Do not spray the product on open flames or other ignition sources. − The hazard pictogram GHS02:
Notes: * Under the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), aerosols are classified into three categories based on their flammable components and chemical heat of combustion: Category 1: Extremely flammable aerosol Category 2: Flammable aerosol Category 3: Non-flammable aerosol

Norway

The Norwegian Food Safety Authority (NFSA) regulates cosmetics available on the Norwegian market, following a regulatory framework nearly identical to the EU Cosmetics Regulation, with only a few deviations.

Firstly, Norwegian importers and producers of cosmetics shall register their business with NFSA by completing a form and providing a Norwegian business address. Companies are also required to keep their business information updated and notify NFSA of any significant changes.

In addition, Norway has national language requirements regarding product labelling. The labelling information, including product function, special precautions, and details referred to in Article 19(2)-(4) of the EU Cosmetics Regulation shall be in Norwegian. Besides, information such as contents and date of minimum durability (or period after opening) shall be in Norwegian, or a language similar to Norwegian in spelling and meaning, such as Danish.

Lastly, for around 40 pharmacologically active substances used in cosmetics but not yet regulated in the EU, NFSA has evaluated their risks and is of the opinion that the unrestricted use of these substances may pose health risks, such as cancer, organ damage, fetal malformation, and skin irritation. To ensure their safe use in cosmetics, NFSA has recommended limits for these substances and urges the industry to follow.

Further Reading

• Pedia | EU Cosmetic Regulation

• Analysis | Borderline Products in the EU: Cosmetic Products or Not? 

• Analysis | Exploring EU's Animal Testing: From Bans to Regulatory Interfaces and Beyond