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Posts Tagged ‘food supplements’

Amendment of the lists on food supplements’ additives

October 26, 2018


Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council has been revised by the European Commission (COMMISSION REGULATION (EU) 2018/1497). This regulation lists the food additives that are authorized to be used in food supplements and categorizes them according to the food supplements to which they may be added:

  • Subcategory 17.1: Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms
  • Subcategory 17.2: Food supplements supplied in a liquid form
  • Subcategory 17.3: Food supplements supplied in a syrup-type or chewable form

After discussions with Member States, it was found that food subcategory 17.3 often led to misinterpretation. As a result, it was decided that syrup- and chewable-forms should be categorized as liquid and solid forms, respectively.

So, the food subcategories have been renamed as follows:

  • Subcategory 17.1: Food supplements supplied in a solid form, excluding food supplements for infants and young children
  • Subcategory 17.2: Food supplements supplied in a liquid form, excluding food supplements for infants and young children

As a result of the deletion of food subcategory 17.3 food additives’ entries which were included in that food subcategory should be transferred to either food subcategory 17.1 or 17.2 to ensure that there is transparency and legal certainty regarding the use of food additives in those foods.

Furthermore, it was decided to introduction section should be included for each food category clarifying that the maximum (use) level for the food additives refer to the food supplements as ready for consumption.

This amendment will clarify the questions that remained regarding authorized additives for use in food supplements.

New list of recommended analysis methods for botanicals

October 23, 2018


A new list of recommended analysis methods for the use of certain botanicals in food supplements has been published by the Belgian Federal Public Service Health, Food Chain Safety and Environment. A list of 119 plants has been drawn up based on the scientific advice of the Advisory Commission on Botanicals. The methods listed in this document are to be used to check, among others, whether the food supplements comply with the maximum levels or whether the substances are below the threshold values as laid down in the Belgian Royal Decree on Botanicals.

More information can be found here.

Prohibition of medical claims for health products also applies to (specific combinations of) ingredients

May 23, 2018

The Netherlands

It is forbidden to make medical claims for healthcare products that are not registered as medicines such as food supplements. Only claims that are approved by European Food Safety Authority (EFSA), including ‘on hold’ claims for botanicals, can be used.

The prohibition of medical claims for health products also applies if medical claims are made on the website of a foundation for specific ingredients or a specific combination thereof. The Dutch Advertising Code Committee (Reclame Code Commissie, RCC) believes that descriptions of the combinations that exactly match certain products and claims that contain direct and indirect references to those products fall under inadmissible advertising. As a consequence, the RCC judges that such discussions of the individual ingredients are not neutral and not purely informative.

Therefore, the RCC has decided that also the sponsor of a website can be held responsible for the claims on the website. The RCC judges that the (content of) claims by third parties on a website, such as testimonials from physicians and reactions of consumers, fall under the responsibility of both the foundation and the sponsor.

This independent judgment of the RCC provides more clarity about the way in which advertising rules must be interpreted and applied, which is in the interest of public health and combats unfair competition.

More information can be found here.

New Royal Decree on nutrients

December 5, 2017

The Royal Decree (RD) of 3 March 1992 on food supplements and ordinary foodstuffs enriched with nutrients has been revised and amended.

In this amendment, the list of vitamins, minerals and oligo-elements has been updated, and new maximum levels of these nutrients have been introduced. These are listed in appendix 1 of the RD. Also, the section on mandatory mentions on the packaging has been extended. If particular amounts of certain nutrients are present in the food supplement (e.g. nicotinic acid, or more than 1000 mg of daily potassium), specific warnings have to be added onto the packaging. In addition, percentages of the reference intake of specific vitamins or minerals as determined in the RD, should be mentioned on the packaging as from now.

Amendments included in the new version of the RD have been published in the Belgian Official Gazette on 31 October 2017 and can be found here.

New Swiss legal regime on food supplements expands the market

September 28, 2017

Switzerland and EU

Switzerland has updated its legal regime on food supplements (FS) resulting in a better alignment with the food regulations applicable in the European Union (EU). These new rules facilitate marketing of FS originating from EU member states in Switzerland and vice versa. As a consequence, drastic changes to the products are no longer needed and authorization procedures have become less complicated. In addition, the Swiss orders on food labeling and claims and the use of food additives have been revised. These are now almost fully in agreement with EU regulations.

FS legislation in EU did not reach full harmonization between all member states. For example, each EU member has set its own maximum levels for nutrients and has its own rules on the use of botanical preparations and other substances. As a result, Switzerland also maintained its own maximum levels for vitamins and minerals. These, however, are in line with the EU trend.

One of the major benefits of targeting the Swiss market is the absence of the obligation to register or notify FS. Together with the fact that the new legislation is now more or less in line with EU regulations, it makes commercialization in Switzerland very attractive as it is not accompanied by additional notification burdens or costs. However, verification of compliance of a FS’s composition and labeling remains necessary when introducing the FS onto the Swiss versus EU market.

More information can be found here.