Changes to maximum amounts of vitamins and minerals in food supplements and fortified foods expected in the EU – Sweden preparing national regulation

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At the moment, the EU legislation does not specify any upper limits or maximum amounts for vitamins and minerals in food supplements and fortified foods. This means that food business operators themselves are responsible for ensuring that the amounts of vitamins and minerals in their food products are at a safe level. Some EU countries have set national limits for vitamins and minerals.

Now a new EU regulation concerning maximum amounts of vitamins and minerals in food supplements and fortified foods is currently being prepared. In addition, the regulation will also define the minimum amounts for vitamins and minerals in food supplements. Once the draft regulation is published, which will most likely be during 2021, operators in the industry will have a chance to give comments on the draft. The regulation is to enter into force in 2024.

Sweden is also preparing a national regulation concerning maximum amounts of vitamins and mineral in food supplements. The Swedish draft regulation was open for feedback until April 2020 and received plenty of comments. For this reason, the preparation of the regulation is temporarily suspended, without any specific information as regards its future implementation. According to the Swedish draft regulation, operators would have the possibility to apply for an exemption for food supplements the vitamin or mineral content of which exceeds the set maximum limit. The application would be subject to a fee and it should contain detailed information about the food supplement as well as scientific evidence proving that the product is not a safety risk for human health with the amount of vitamins or minerals it contains.

Food business operators have now plenty of time to prepare for the coming changes in the requirements for amounts of vitamins and minerals. The draft regulation for EU countries concerning maximum amounts of vitamins and minerals is yet to be published, but the amounts planned in the Swedish draft regulation are already available in Swedish. Be prepared and take these upcoming changes in legislation into account already when planning new products.

 

If you need assistance in these matters, Medfiles’ experts are at your disposal!

Mari Lyyra
Regulatory Affairs Manager, Food & Nutrition
mari.lyyra@medfiles.eu

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