New Danish rules on the marketing of food supplements are on their way and may lead to the abolishment of some of the legal requirements under Danish law. However, the simplified rules will make further demands on food business operators and, in particular, their product knowledge. The proposed changes will quite possibly have a big impact on companies which market food supplements in Denmark.
New food supplement rules The Danish Veterinary and Food Administration (the DVFA) has put the proposed new Executive Order and guidelines on food supplements out to public consultation. The deadline for comments was 6 October 2017.
The following outlines the main changes:
- Maximum amounts of vitamins and minerals in food supplements (adults and children +11) will be abolished Contrary to most other EU Member States, Denmark has established national maximum amounts for vitamins and minerals which may be used in food supplements. This will now be changed. The argument for abolishing the maximum amounts is, among other things, that the present maximum limits which date back to 1996 are outdated given the latest scientific research. The Danish National Food Institute has prepared new amounts for vitamins and minerals which are to apply solely as guidance levels in future. The amounts will be listed in a new guidance document. If a food business operator adds vitamins or minerals of any amount exceeding the new guidance levels, the food business operator will be responsible for documenting the safety of such added amounts.
- Reference values of vitamins and minerals in food supplements for children (1-10 years) will be abolished The DVFA has argued that the reference values for children are outdated. In future, food business operators must use the reference values for adults listed in the Food Information Regulation (no. 1169/2011). The Danish Food Institute has prepared maximum amounts of vitamins and minerals for 1-2 and 3-10 year olds, which will be used solely for guidance.
- Minimum amounts of vitamins and minerals in food supplements (adults and children +11 ) will be abolished As the existing Danish minimum amounts are to be abolished, the future product compliance, as far as the amount of nutrients is concerned, will depend on an assessment as to whether the ban on misleading the consumer applies and the definition of a food supplement.
- The National labelling requirement that information stating that pregnant women and children under the age of 1 should not consume the food supplement without consulting a doctor or health visitor will be abolished
- The requirement that the Latin name of any plants must be included on the label will be abolished The DVFA argues that, since this requirement is provided for in the Food Information Regulation, there is no need to include the requirement in the Danish Executive Order on Food Supplement: As it is, it will still be necessary to include the Latin names of plants in future labelling.
- The national requirement that food supplements must be registered will continue to apply, however, it will be limited to cover registration of the mandatory food information only (including the name of the business operator, the ingredients list and the declaration of nutrients and other substances) The request for this national registration requirement has been made specifically by the Danish Government. According to the DVFA, the Danish EU implementation committee has stated that the requirement of digital registration must be maintained.
Changes to the food supplements guidelines The above-mentioned changes will furthermore be incorporated in the Danish food supplement guidelines. The new guidance amounts for nutrients will be listed in the guidelines only. In addition, the DVFA has decided to incorporate a new chapter in the guidelines dealing with risk analysis requirements and the requirement of conducting analyses of declared nutrient values.
Furthermore, the guidelines include an annex listing decisions by the Danish Environment and Food Board of Appeal on potentially harmful plant ingredients in food supplements.
Entry into force and transitional period The Executive Order and the guideline come into force 1 January 2018.
Food supplements produced and labelled before 1 January 2020 may be marketed according to present legislation until stocks are used up.
Comment from Bech-Bruun Guidance amounts of nutrients
In general, Bech-Bruun takes a positive stance on the abolition of national food supplement requirements as it will help reduce the duties and responsibilities of food business operators placed in Denmark and make it easier to promote the same product in several EU markets.
However, the proposed changes also entail a few food inspection issues. If food business operators market products containing nutrients by amounts higher than the new guidance amounts, it may be quite a challenge for them to show proper scientific documentation evidencing to the satisfaction of the DVFA inspectors that the products are safe to consume.
This may very well be a practical challenge as for some of the vitamins and minerals, the guidance amounts are well below the current maximum limits. For some of the nutrients, the guidance amounts are higher than their current limits.
In comparison, it may be noted that the Belgian government is adopting maximum limits for nutrients which seem to be somewhat higher than the Danish guidance amounts. This is quite surprising as the governments and authorities in both countries claim that the amounts are based on European Food Safety Authority (EFSA) opinions.
Moreover, we find that, for some of the minerals, the new guidance amounts are lower than the nutrient reference values. In reality, this means that it will no longer be possible to add nutrients equivalent to 100% of the nutrient reference value.
When the two-year transitional period has expired, there is a risk that the DVFA will demand documentation of the safety of the products for which the nutrient amounts exceed the guidance amounts.
Therefore, we envisage a need for the DVFA to give adequate guidance information on what kind of scientific documentation the DVFA will accept as sufficient product safety documentation.
One possibility will be to use the EFSA safety opinions. However, if a food business operator is not ready to take on this documentation responsibility and use the EFSA opinions, which we consider may pose a challenge, we would advise the food business operators to keep the nutrient amounts below the new guidance amounts.
Our initial assessment is that the new rules may entail the reformulation of the majority of the multi vitamin products on the market within the next two years.
Abolition of the reference values for children As mentioned above, the food business operators will have to use the adult reference values listed in the Food Information Regulation (no. 1169/2011) in future when adding vitamins and minerals to food, including food supplements for children (1-10 years).
When for instance labelling D-vitamin products in future, their current reference values being 10 µg for children and 5 µg for adults, food business operators will have to use the adult reference value and must label 10 µg D-vitamin as 200% of the adult reference value.
Therefore, we also predict a future need for informing parents that they must choose the products that have been labelled 200% and not 100% of the reference value in order for them to make sure that their children get the requisite amount of D-vitamin.
Requirement regarding analysis of the declared value In our opinion, the guidelines' chapter on the requirement for conducting analyses of the declared nutrient amounts (s. 11(3) of the new Executive Order) is not quite clear as to what part in the food chain the DVFA considers the proper food business operator responsible for conducting this analysis.
According to the guidelines, DVFA believes that a producer is ”the business operator conducting the final step in the production which is the one producing the final products” [our translation]. “Food business operator” is defined in the EU food regulation (no. 2002/178), however, there is no such EU definition of the term ”Producer”. Generally, though, a food business operator is responsible for the production, processing and distribution within the businesses under their control.
As we understand from the new guidelines, a business operator importing bulk food supplements tablets and repacking the tablets in smaller jars will be deemed to be a producer and must conduct the tablet analysis even though the business operator has no influence on the content of the product. From our perspective, it ought to be the business operator producing the actual tablet who should carry out the analysis.
In conclusion and links We find it interesting that a number of national food supplement requirements will be abolished. However, we also envisage potential challenges with the new guidance nutrient values. This may lead to uncertainty as to which kind of safety documentation will be needed.
The new rules will make demands not only on food business operators, but also on food inspectors. Since it is no longer possible to refer to legislative maximum limits, producing or marketing of food supplements will require in-depth knowledge of the content of the product, including the underlying scientific documentation.
The same situation applies to the DVFA food inspectors who will no longer have a legislation or benchmark to refer to when carrying out inspections. In future, the food inspectors must, to a certain degree, make a case-specific assessment of the product composition, marketing and consumer target group.
We will be following the area closely, including how food inspectors will interpret the new rules and conduct their product specific inspections accordingly.