Legislation

This page focuses to explain the Swedish cosmetic legislation which is only available in Swedish. References are also given to the European cosmetic legislation which is available in English for you to read.

If you place or make available cosmetics on the Swedish market they have to fulfil the legislation in the following table:

LegislationComment

English consolidated version

 Regulation (EC) 1223/2009 on cosmetic products

The consolidated version shall be read with the following amendments:

Regulation (EU) 2015/1190 

Regulation (EU) 2015/1298

 

European Commission Regulation
 Regulation (EC) 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products
European Commission Regulation
Förordning (2013:413) om kosmetiska produkter The Swedish ordinance on cosmetics (only available in Swedish)
 Läkemedelsverkets föreskrifter (LVFS 2013:10) om kosmetiska produkter The Swedish Medical Products Agency´s provisions on cosmetics (only available in Swedish)

 

The main objective of Regulation (EC) 1223/2009 is that cosmetics made available on the market must be safe for human health. According to Regulation (EC) 1223/2009 both responsible persons (manufacturers, importers, distributors changing cosmetics or other designated persons) and distributors have responsibilities they must follow. Note that according to Regulation (EC) 1223/2009, the responsibilities for the responsible person (see articles 5, 7 and 25.3) are more extensive than the responsibilities for the distributor (see articles 6, 7 and 23). The information that must be notified to the Commission according to articles 13 and 16 shall be notified using the Cosmetic Products Notification Portal (CPNP). Regulation (EC) 655/2013 has been developed due to article 20 in Regulation (EC) 1223/2009 to control which product claims that may be used marketing cosmetics.

Aside from Regulations (EC) 1223/2009 and 655/2013, responsible persons and distributors placing or making cosmetics available on the Swedish market must also follow the Swedish cosmetic legislation.

The Swedish cosmetic legislation

‘Förordning (2013:413) om kosmetiska produkter’ (the Swedish ordinance on cosmetics) and ‘Läkemedelsverkets föreskrifter (LVFS 2013:10) om kosmetiska produkter’ (the Swedish Medical Products Agency´s provisions on cosmetics), complement Regulation (EC) 1223/2009. These Swedish legislations include for example requirements for Swedish labeling, rules for products which are not pre-packed, language requirements for product information files kept in Sweden and fees for cosmetic companies established in Sweden.

Some labelling has to be in Swedish

For cosmetics placed or made available on the Swedish market the labelling information referred to in article 19.5 in Regulation (EC) 1223/2009, has to be in Swedish. This rule is found in 4 § ‘Förordning (2013:413) om kosmetiska produkter’ (the Swedish ordinance on cosmetics).

Specific rules for product which are not pre-packaged

Sweden has a specific rule for cosmetic products which are not pre-packaged, see 2 § in ‘Läkemedelsverkets föreskrifter (LVFS 2013:10) om kosmetiska produkter’ (the Swedish Medical Products Agency´s provisions on cosmetics). This rule means that for products that are not pre-packaged, labelling according to article 19.1 in Regulation (EC) 1223/2009 has to be given in writing to the buyer of such products.
Note that this information also has to fulfil the requirement of Swedish labelling as stated above.

Language requirements for product information files

Responsible persons shall keep product information files for each cosmetic product according to article 11 in Regulation (EC) 1223/2009. Responsible persons established in Sweden shall keep product information files available written in Swedish or English according to 3 § ‘Läkemedelsverkets föreskrifter (LVFS 2013:10) om kosmetiska produkter’ (the Swedish Medical Products Agency´s provisions on cosmetics).

Products containing alcohol

Cosmetic products containing more than 2,25 % ethanol are regarded as alcoholic preparations according to first chapter 10 § ‘alkohollagen (2010:1622)’ (the Swedish law of alcohol).
A permit is no longer needed for the import of such products to Sweden but the rules for denaturation of the ethanol must be followed. For more information please contact the competent authority Folkhälsomyndigheten (The Public Health Agency of Sweden).

Fees

To cover the costs of the Medical Products Agency’s surveillance of cosmetic products, fees must be paid to the Agency according to ‘Läkemedelsverkets föreskrifter (LVFS 2013:10) om kosmetiska produkter’ (the Swedish Medical Products Agency´s provisions on cosmetics).

Companies obliged to notify to the Cosmetic Product Notification Portal (CPNP) - manufacturers, importers, distributors changing products or other designated responsible persons:
• Annual fee of SEK 4 000 and an annual fee for each product of SEK 600 (up to 200 products).

Companies that are not obliged to notify to the CPNP – distributors that do not have to alter the product to fulfil Swedish labelling requirements:
• Hourly fee or SEK 750 for the actual surveillance work
or
• Annual fee of SEK 4 000 and an annual fee for each product of SEK 600 (up to 200 products) provided that the product is voluntarily notified (see below) at the time the surveillance work begins.

Possibility for a voluntarily notification of cosmetics to the Swedish Medical Products Agency

Distributors which are not obliged to notify cosmetics to the CPNP, may to avoid the hourly market surveillance fee, by notifying their products voluntarily to the Swedish Medical Products Agency. Such notification entails paying the annual fees of SEK 4 000 and SEK 600 for each product (up to 200 products). Notification forms called 'Blankett frivillig anmälan' are available here. Note that from 11th of July 2013 there are no obligations to notify cosmetics to the Swedish Medical Products Agency. The possibility to notify cosmetics described above is voluntarily.

 
 

External links

 

Related information

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information