Food Supplements

Starting a new business? Here's how

All food business operators must be registered or approved by the Danish Veterinary and Food Administration. This also applies for importers of food from other EU Member States or third countries and producers/importers of food contact materials (FCM).

You will find more information about starting a new food business in Denmark here.

Marketing of food supplements in Denmark

If you change the composition of a food supplement, the product must be registered once again as if it were a new product. An exception to this rule concerns a change in the amount of technological additives. This will not need to be registered.

Fee for product safety checks

Companies that have registered one or more food supplements in Denmark and that have an annual turnover exceeding 50,000 DKK must pay an annual fee of 9,321 DKK as well as an annual fee of746 DKK per registered food supplement.

These fees are used to cover the expenses in relation to product safety checks. The payment is charged for companies and products registered as of September 1that year.

When your food supplement is no longer marketed

Unregistered supplements are not allowed to be marketed neither from the wholesale company, websites, nor retail stores.

Which products can be marketed as food supplements?

The most common food supplements consist of vitamins and/or minerals. However, they can also consist of dietary fibers, essential fatty acids, animal ingredients (e.g. fish oil), or plant ingredients (e.g. extracts of garlic). Food supplements must contain the ingredients in quantities that are able to exert an effect on the body.

Moreover, it is required that food supplements are sold in smaller quantities (e.g. as pills, fluids, or powder) and that they are labelled with information about the recommended daily dose.

Regulations on the composition of food supplements

The guidance on food supplements contains an overview of the amounts of vitamins and minerals that the DVFA recommend for food supplementsnot tosurpass.If a company wishes to exceed these levels, they must be responsible for documenting the safety of the food supplement.The DVFA typically considers a level above the Tolerable Upper Intake Level(UL) set by EFSA as a potential health risk.

General principles and requirements of food law

It is required that the labelling contains a list of ingredients, the name of the food as well as the name of the company producing it.

In addition to the general requirements mentioned above, food supplements should also be labelled with the following:

Information stating that the product is a food supplement.

Information about which vitamins, minerals, or other ingredients the product contains.

Information about the amount of vitamins, minerals, or other ingredients in the product.

The Danish and Latin name of any herbal ingredients.

The recommended daily dose.

A warning not to consume more than the recommended daily dose.

Information to the consumer stating that food supplements should not replace a healthy and varied diet.

A warning to keep the product out of reach of children.

Information about the amount of nutrients or other substances expressed as a percentage of the recommended daily dose.

The content of vitamins and minerals should be expressed as a percentage of the reference values set out in Annex XIII, Part A, Point 1 in Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers.

Nutrition and health claims on food supplements

Products claimed to be able to prevent or cure diseases are considered to be medicinal products and are therefore controlled by the Danish Medicines Agency. Follow this link to view their homepage.

If your company sells and/or produces food products, you must have a plan that shows how you regularly ensure that your business complies with the rules. This is called self-regulation and such a plan is called a self-regulation program.

The self-regulation program deals with foodstuffs as well as with cleaning, machinery, and premises.

The program must be plainly written to ensure that all employees can understand it and have no doubt as to what needs to be done.

Additional food regulations

In addition to the above-mentioned rules and regulations there are more specific rules for some types of food products:

Go here to see the original:

Food Supplements

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