Cosmetic brands in the Nordic region will find Sweden a very appealing market. However, EU compliance alone does not complete every step of market entry. Businesses must also consider Sweden’s national language rules and local supervision. They should take care of distributor responsibilities and national provisions.
The product’s current regulatory status decides the process. A cosmetic that already meets EU requirements may need only a few additional steps before sale in Sweden. A product that has not yet completed EU compliance must first meet the EU requirements and undergo CPNP notification. This blog explains both situations. It focuses on the requirements that matter when placing cosmetics on the Swedish market.
Regulatory Authority for Cosmetics in Sweden
The Swedish Medical Products Agency (Läkemedelsverket) is the main authority responsible for cosmetics regulation. It supervises manufacturers, importers, and other businesses who want to put their cosmetics on the market.
Local municipalities also carry out market surveillance. Their environmental health departments mainly inspect those retailers and businesses that use cosmetics in professional services. These inspections may cover the following:
- Product labelling
- Ingredients
- Presence of an EU-based responsible person
The Swedish Chemicals Agency (Kemikalieinspektionen) looks after specific chemical-product rules that also affect cosmetics. These rules cover restrictions on particular substances and requirements for some imported chemical products. Dividing responsibilities is important. Businesses may have to deal with more than one authority. It depends on their activities.
Scenario 1: Selling Cosmetics in Sweden That Already Meet EU Requirements
The EU compliance process also applies to Sweden. So, a cosmetic already satisfying EU requirements and notifying through the Cosmetic Products Notification Portal (CPNP) need not repeat anything. However, a company must check the Swedish language rules and local distribution duties before selling the product. The main steps here include the following:
- Have a valid EU-based responsible person for your product
- Confirm that the CPNP notification is complete and accurate
- Review the product label for Swedish-language information
- Arrange any missing translations
- Notify CPNP if the distributor translates the label into Swedish
- Check Swedish national provisions and local business duties
Distributors importing products from another EU or EEA country must follow these.
Swedish-Language Labelling Requirements
Cosmetics sold in Sweden need to fulfil Swedish-language labelling. Section 4 of Swedish Regulation 2013:413 has information about it. It says specific information on cosmetic products must be in Swedish. The requirement covers four types of information.
Information That Must Be in Swedish
Have the following information in the Swedish language:
| Label information | What businesses must provide |
| Quantity or contents measurement |
The stated quantity or net contents information
|
| Durability information |
The date or reference indicating the product’s durability
|
| Precautions for use |
Safety warnings and instructions for use
|
| Product function |
The product’s purpose or function
|
Have the Swedish text on the product container and any outer packaging. You shouldn’t just translate the carton, especially if the container also carries the important information. For example, explain the functions of a face cream sold in Sweden in Swedish. Have the packaging, including precautions for use, in Swedish.
EU labelling rules also apply to other label elements. It involves the responsible person’s name and address, batch number, and ingredient list. Sweden’s national language provision specifically identifies the four categories above.
Parties Responsible for Translating the Label
The responsible person has the main responsibility for correct product labelling. However, a distributor also has specific duties when supplying cosmetics in Sweden.
Translate the missing details before selling a product that doesn’t have the required Swedish text. The distributor must also notify CPNP that it has translated the label.
This is important for businesses importing products from other EU countries. An existing CPNP notification does not remove the distributor’s responsibility for Swedish-language labelling.
Can Businesses Use Scandinavian Labelling?
Businesses sometimes use one label containing Swedish, Danish and Norwegian text. The Swedish Medical Products Agency says that they accept this format when the information is easy to read and understand.
However, warning statements must remain clear. The Agency requires the Swedish wording to be exactly as mentioned in the Annex for certain warnings linked to restricted ingredients under Annex III of the EU Cosmetics Regulation.
Distributor Responsibilities in Sweden
Swedish authorities expect distributors to check certain product information and respond when they identify compliance problems. Before making a cosmetic available on the Swedish market, distributors must check the following:
- The responsible person’s name and address on the product.
- Presence of a batch number
- Ingredient list.
- The product’s durability date shouldn’t have passed
- Availability of the required Swedish-language information
- The product has been stored and transported under conditions that preserve its compliance
If a distributor translates the Swedish label information, it must also notify CPNP of that translation. Distributors must keep information that lets them recognise the businesses that supplied the products. Also, record the businesses to which they supplied. The supply-chain identification records must be retained for three years.
A product may have health risks or be non-compliant with the rules. If a distributor believes so, it must inform the responsible person. They must take the necessary corrective action. It must also cooperate with the authorities at the time of inspections.
Local Authority Supervision and Inspections
Cosmetics sold in Sweden are subject to market surveillance. This responsibility is with the Swedish Medical Products Agency and local municipalities. This agency supervises manufacturers and importers. Municipal authorities focus more on retail businesses. Also, the premises where cosmetics are used in professional treatments. During inspections, authorities may check whether the following is present/absent:
- Product information is available in Swedish
- Contains prohibited substances
- Identifies an EU-based responsible person
- Business follows its duties as a manufacturer, importer or distributor.
- Meets the rules for its ingredients and labelling
For example, a municipality may assess a shop selling imported skincare products. It may check the labels, ingredient declarations and responsible person’s details. The authority may inspect the importer or manufacturer behind those products.
So, keeping their product and supply-chain records organised is important. This makes responding to requests from local inspectors smooth.
Swedish National Rules That Also Affect Cosmetics
Apart from the national language rules, businesses must consider certain Swedish provisions and chemical product rules.
Swedish Rules on Cosmetic Product Information Documents
The responsible person must maintain a Product Information File (PIF). When the responsible person is established in Sweden and the document must be available there, the Swedish Medical Products Agency’s regulations allow the PIF to be written in Swedish or English. This is a practical point for companies that manage product documentation from Sweden. They can use an English-language PIF. A Swedish translation does not automatically become necessary.
Special Rules for Unpackaged Cosmetics
Sweden also has specific provisions for cosmetics sold without ordinary pre-packaging. These include solid soaps sold loose.
The regulations address how to provide product information when you cannot use the usual packaging-based labelling format. Businesses that sell unpackaged cosmetics should check these provisions before they place products on the market.
Chemical-Product Rules & Imported Cosmetics
The agency also looks after chemical-product legislation that works alongside cosmetics legislation. This distinction is crucial for importing cosmetics from outside the EU/EEA. For example, the REACH regulations may apply to the import of a cosmetic product. It may involve restrictions or authorisation requirements for specific substances.
REACH registration may also be needed for an ingredient imported at one tonne or more per year. In that situation, the obligation concerns the substance, not the finished cosmetic product as a whole.
Businesses should also check the Swedish Products Register rules before assuming that an imported product must be reported there. The reporting obligation depends on the product’s classification and customs tariff number. It is not a blanket registration requirement for every finished cosmetic.
Swedish Restrictions on Plastic Particles in Cosmetics
Sweden has also introduced a national restriction on cosmetic products that have plastic particles with cleansing, exfoliating or polishing effects. The restriction covers rinse-off products. And those products that are spat out after use on the skin, hair, mucous membranes or teeth. Their examples are exfoliating soaps and some toothpastes.
The Swedish Chemicals Agency asks to consider this national restriction alongside the EU’s later restriction on synthetic polymer microparticles. Businesses should review the current rules before they market plastic particles containing products in Sweden.
Which plastic particles are prohibited?
The restriction covers plastic particles that:
- Are in solid form
- Measure less than 5 mm in at least one dimension
- Are insoluble in water
There is no minimum particle-size limit. Therefore, plastic particles in nanoform are also covered.
Are naturally occurring polymers exempt?
Yes. Swedish prohibition excludes particles made entirely from naturally occurring polymers like cellulose. The exemption described by KemI applies to particles consisting solely of naturally occurring polymers.
Can a business apply for an exemption?
KemI can grant an exemption in individual cases. The agency may consider cosmetics made using naturally occurring polymers as raw materials if they break down quickly into monomers in aquatic environments and do not pose a risk to aquatic organisms. The application must include written proof that shows meeting the conditions in Section 4b of Regulation (1998:944). KemI lists an application fee of SEK 15,000.
How does the Swedish restriction relate to EU microplastics rules?
The EU has introduced a separate restriction on synthetic polymer microparticles. It is under REACH, Annex XVII, Entry 78. It covers a wider range of products. Both rinse-off and leave-on cosmetics are under it.
To keep track of changes in cosmetic regulations in Sweden and other markets, use Artixio’s QuriousRI regulatory intelligence platform for personalized alerts and expert-reviewed regulatory updates.
Swedish Notification Duties and Regulatory Fees
CPNP notification is an EU-level notification. It is not a separate Swedish product approval. However, businesses established in Sweden that have to notify products to CPNP may also have to pay national supervision fees to the Swedish Medical Products Agency.
Under the Agency’s published fee provisions, the charges include the following:
- An annual business fee of SEK 2,100.
- An annual fee of SEK 300 per product.
- No additional product fee for products above 200 when the business has already paid the annual fees for 200 products.
The fee provisions also explain how product variants are counted. Colour variants, fragrance variants and different package sizes of the same product are treated as one product for fee purposes.
The CPNP notification itself is free. The Swedish fees cover the Agency’s supervision of cosmetics on the Swedish market. Companies should check the current fee provisions before budgeting because of constant changes in national fees.
Selling Cosmetics That Are Not Yet EU-Compliant or Notified
A cosmetic that has not completed EU compliance cannot enter the Swedish market. The business must first complete the EU cosmetics compliance process. This includes the following:
- Appointing an EU-based responsible person
- Completing the product safety assessment
- Preparing the Product Information File
- Meeting manufacturing and labelling requirements
- Notifying the product through CPNP before placing it on the market
The responsible person has to ensure that the required product information is included in the CPNP notification. CPNP should know about the translation through the notification if a Swedish distributor later translates the label. After completing the steps, the business can prepare the Swedish version of the label. They can address the national obligations explained above. You should read EU Cosmetics Regulations: Registration Process and CPNP Notification for the full EU compliance process.
Post-Market Responsibilities in Sweden
Cosmetics entering the Swedish market should continue to follow regulatory duties. The responsible person and distributor must monitor product safety. They must respond to complaints or reports of adverse effects. The responsible person and distributor must report serious adverse effects to the Swedish Medical Products Agency. They must also cooperate with the authorities and take corrective action when a product is non-compliant.
Inform the responsible person and the competent authority when a distributor believes that a product is a health risk. The business must also keep supply chain records. It is to allow tracing of the products. These duties help authorities investigate safety concerns and take action when necessary.
Conclusion
Entering Sweden requires complying with EU cosmetic rules and a completed CPNP notification. Also, meet the Swedish language rules and understand the duties of local distributors. Prepare for supervision by national and municipal authorities. Clearly understanding these steps can help brands avoid labelling problems. Delays and enforcement action when launching cosmetics in Sweden can also be prevented.
Artixio supports businesses with cosmetics regulatory compliance and market entry planning. So, get our assistance with Swedish cosmetics requirements by contacting info@artixio.com.
FAQs
1. Can cosmetics be sold online to customers in Sweden without a physical presence in the country?
Yes. A business can sell cosmetics to Swedish customers through an online store without operating a physical shop in Sweden. However, online sales must meet the same cosmetics requirements as sales through physical stores. Products supplied to Swedish end users must also carry the required Swedish-language information.
2. Do free cosmetic samples and promotional products need to comply with Swedish cosmetics regulations?
Yes. Cosmetics supplied free of charge are also covered by the rules. This includes promotional samples and products distributed during marketing campaigns. Businesses must ensure that these products meet the relevant safety and labelling requirements before distribution.
3. What should a Swedish cosmetics business do if a customer reports a serious adverse effect?
The responsible person and distributor must report serious undesirable effects to the Swedish Medical Products Agency without delay. The report must identify the product, describe the serious effect and include any corrective measures taken. The distributor must also inform the responsible person.
