New Regulation on Food Supplements in Bulgaria

On 30 December 2021, the new Regulation on food supplements entered into force. The regulation introduces the requirements laid down under 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 regulation is also brought in line with Directive 2006/37/EC of 30 March 2006, amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances. 

For further clarifications regarding the new Regulation, manufacturers and traders can contact pharma lawyers.

Provisions under the regulation

The Regulation specifies:

1.       The nutrients that can be used for the production of food supplements -these substances include vitamins and minerals. 

2.      The substances having a nutritional or physiological effect, which manufacturers can use for the production of food supplements. 

3.      The purity criteria that substances should meet to be added to food supplements.

4.      The plants and their parts, as well as the substances that cannot be added to food supplements. 

For supplements to be placed on the market, they should comply with all rules laid down in the Regulation. 

Information regarding labeling and pre-packaging 

An important requirement under the Regulation concerns the pre-packaging of food supplements for these products to be placed on the market. 

The regulation also specifies the particulars that must be present on supplement package labels, as well as in the advertising and presentation of supplements. The provision of information is in line with 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. Recommending food supplements for the prevention or treatment of human disease is therefore prohibited. 

For each food supplement, the labeling should bear the following particulars:

·    Recommended daily dose;

·    Number and date of registry of a supplement in line with art. 4, para 1 of the Bulgarian Food Act 

The labelling must include the following warnings: 

·    Not to exceed the recommended daily dose;

·    The food supplement should not be used as a substitute for a varied diet; 

·    The food supplement should be stored out of reach of young children

Amounts of vitamins and minerals per recommended daily dose 

In line with Annex XIII, Part A, item 1 of Regulation (EU) No 1169/201, the regulation stipulates that the minimum amounts of vitamins and minerals per recommended daily dose should be no less than 15% of the nutrient reference value.

Requirements for applications by business operators seeking to register food supplements 

The regulation stipulates that business operators cannot submit one application to register more than one specific supplement, i.e. for each supplement they should file a separate application.

Sell-by date for offering food supplements placed on the market before the Regulation entry into force

The Transitional and Final Provisions of the Regulation stipulate that food supplements placed on the market before the Regulation's entry into force, which are non-compliant with the requirements under art. 8 for maximum amounts of vitamins and minerals, may continue to be sold until stocks are exhausted. 

The sell-by date cannot exceed 24 months as of the date of the Regulation's entry into force. 

Stoeva, Tchompalov & Znepolski law firm is at your disposal for any questions or consultations regarding the Regulation on food supplements.