The draft regulations update and supersede, in their entirety, the current regulations on food supplements, LIVSFS 2003:9, which transpose Directive 2002/46/EC. The purpose of the draft regulations is also to protect human health in Sweden by introducing maximum levels for vitamin D and iodine in the recommended daily dose. The Swedish Food Agency considers there is strong scientific support for the risks of consuming amounts of these substances over time that exceed the proposed maximum levels. Food supplements containing levels of these substances exceeding the proposed maximum levels are present on the market.

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.