On 10 December 2021 the Bulgarian government issued a new Food Supplements Ordinance (State Gazette No 106 of 15 December 2021). The legal regime for food supplements envisaged in the Food Act of 2020 remains the same. The new Food Supplements Ordinance further details the legal requirements at the stage of food supplements production, in particular what substances (vitamins and minerals, substances with nutritious or physiological effect, etc.) can and cannot be used in food supplements upon production as well as the purity criteria on food ingredients and additives. There is also a list of herbal substances and products that cannot be used in food supplements.
A central part of the present material is the provision of food information to consumers on labeling, marketing and advertising of food supplements and the respective legal requirements envisaged in the Food Supplements Ordinance. The said activities concern not only manufacturers but also business operators of food supplements in relation to distribution and sales.
Food supplements are concentrated sources of nutrients that supplement the normal human diet. They have become a lucrative business, with an increasing market size due to their affordability and good marketing. Dietary (food) supplements are regulated as "foods" and not as "medicinal products." In this regard, the requirements set in Regulation (EU) No 1169/2011 on the provision of food information to consumers apply to food supplements as well.
If you have food supplements-related business, you need to know that there is mandatory information under the said EU Regulation which you are obliged to provide the end consumers with. The food information must be accurate, clear and easy to understand for the consumer and must not be misleading. It includes, without limitation, the list of ingredients, their quantity, the ‘use by’ date, any special storage conditions and/or conditions of use, the name or business name and address of the food business operator (manufacturer, distributor), etc.
In addition, pursuant to the Ordinance, the following information shall also be provided to the consumer:
1. the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances;
2. the portion of the product recommended for daily consumption;
3. a warning not to exceed the stated recommended daily dose;
4. a statement to the effect that food supplements should not be used as a substitute for a varied diet;
5. a statement to the effect that the products should be stored out of the reach of young children;
6. a reference number and data of official entry into the register at the Bulgarian Food Safety Agency.
The aforementioned information shall be provided upon food supplements labeling as well as advertising.
As a manufacturer and/or business operator, you should know that the labeling, presentation and advertising of food supplements should not:
- attribute properties to prevent, treat or cure human diseases, nor invoke such properties;
- contain any text or suggest that a balanced and varied diet cannot provide the necessary amounts of nutrients.
Regarding what the Food Act envisages for the registration of food supplements, the requirements for business operators, including entities offering food supplements for sale by means of distance communication, etc., you can learn more in the article "The new legal regime for food supplements" or contact us.
For legal advice and assistance in connection with e-shops and drugstore registration, do not hesitate to contact us here.
Pavla Tsvetkova
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