Food supplements placed on the Swedish market.

The Swedish Food Agency's regulations on food supplements

These draft regulations will supersede the Swedish Food Agency's current regulations (LIVSFS 2003:9) on food supplements, which transpose Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. The draft regulations contain updated references to other provisions and are linguistically closer to the wording of the Directive than those currently in force. The Swedish Food Agency is also using the possibility provided for in the Directive to introduce maximum levels for certain vitamins and minerals in food supplements. The draft regulations specify that the recommended daily dose of a food supplement may not contain levels of vitamin D exceeding 100 micrograms or levels of iodine exceeding 200 micrograms. The maximum values will apply to all food supplements that are intended to be placed on the market in Sweden. However, the draft regulations provide the option to apply for an exemption from the maximum levels for individual products, and for exemptions to be granted if the applicant is able to submit scientific evidence demonstrating that the level of vitamin D or iodine, in the product in question, proposed by the applicant does not present a risk to human health.

As regards national maximum levels for vitamin D and iodine: The Commission has the power, under the provisions of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, to lay down maximum levels for vitamins and minerals in food supplements. This has not been done and Sweden (the Swedish Food Agency) has therefore opted, on the basis of the Directive, to introduce national maximum levels for vitamin D and iodine, pending a possible decision by the Commission. The national maximum levels shall apply from 1 January 2024.
Therefore, to protect the health of Swedish consumers, food supplements with excessive levels of vitamin D and/or iodine from other EU countries cannot be marketed in Sweden.
Sections 11-13 of the draft regulations constitute special Swedish provisions.