Cosmetics placed or made available on the Swedish market have to fulfil both the European and Swedish legislation on cosmetic products. The following English pages focus on explaining the specific Swedish legislation on cosmetics. The Swedish system of cosmetic-surveillance includes inspections of products and is financed through fees from cosmetic companies.
The Regulation (EC) 1223/2009 on cosmetic products provides the following definition:
‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours’
Note that cosmetic products shall be clearly separated from other product areas like for example medicinal products, medical devices (Medical Products Agency is competent authority) and biocides (Swedish Chemicals Agency is competent authority). This means for example that no medical statements or references to medical situations may be used for cosmetic products.
Are you a responsible person or a distributor?
If you are a manufacturer, importer or a distributor who changes products and places cosmetics on the Community market (that is making the product available for the first time within the Community) you shall be the ‘responsible person’, according to Regulation (EC) 1223/2009 on cosmetics. If you are neither a manufacturer nor importer and make cosmetic products available on the Community market, you are a ‘distributor’.
Responsible persons and distributors have to follow the cosmetic legislation
The responsible person has the main responsibility ensuring that the cosmetic product complies with the legislation, but also the distributors have responsibilities. Read more about such responsibilities on the page ‘Legislation’.
Serious undesirable effects must be reported
If a cosmetic product has caused serious undesirable effects (SUE) in Sweden both the responsible person and distributors (established in Sweden) have obligations to without delay report this to the Medical Products Agency. The definition of a SUE is as follows;
an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death. Read more about how to report SUE on the page ‘Reporting serious undesirable effects’.
As of 11th of July 2013 information about cosmetic products according to article 13 and 16 in Regulation (EC) 1223/2009 shall be notified to the Commission using Cosmetic product Notification Portal (CPNP). The Commission shall then make some of the notified information available for competent authorities and poison centres for the purposes of market surveillance and medical treatment. Note that aside from such notification there are many other responsibilities according to the cosmetic legislation. From the 11th of July 2013 the previous requirements of notifying cosmetics to the Medical Products Agency has ended. See also information about a possibility to voluntarily notify cosmetics to the Agency on the page ‘Legislation’.
The Medical Products Agency is the competent authority for cosmetics in Sweden but note that both the Agency and the local authorities control that the products comply with the legislation. The surveillance performed by the Agency consists of inspections of manufacturers, importers and distributors and may include control of product labelling, written questionnaires, chemical analyses of products, GMP-inspections etc. Furthermore, as the competent authority the Agency receives, investigates and transmits reports of serious undesirable effects to other Member states and to the responsible person. The Agency also investigates non-serious undesirable effects. Companies that do not comply with the legislation will be required to make corrections or to stop placing them or making them available on the market. The controlling authorities may in certain cases decide to impose a ban on the sale of a product.
To cover the costs of the Agency’s surveillance of cosmetic products, fees must be paid to the Agency according to ‘Läkemedelsverkets föreskrifter (LVFS 2013:10) om kosmetiska produkter’ (the Medical Products Agency´s provisions on cosmetics). Read more about this on the page ‘Legislation’. Note that the Agency
• does not carry out preliminary (premarket) examinations of cosmetic products
• does not issue product marketing licenses