The new legal regime for food supplementsFood 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", which means that they are treated by the law more leniently.

Looking back, we can actually see that the first regulatory attempts with regards to food supplements (on EU-level) go all the way back to Directive 2009/39/EC from 2009. the Directive analysed the idea of “sports food” and classified it as ”foodstuff intended for particular nutritional uses” . The Directive, distinguished sports food from foodstuffs for normal consumption, by establishing that it had to be suitable for its “claimed nutritional purpose, to be ” marketed in a specific way so that such suitability is indicated”etc. A bit later, however, Directive 2000/13/EC was replaced by Regulation (EU) No 1169/2011, which didn’t envision, nor adopt any specific rules for sports food. As a result, the concept of “sports food as foodstuff intended for particular nutritional uses” was abandoned and currently we could classify it in different ways, including as “food supplements”

But enough with the historical roots of the legal regime of food supplements! In this article, we’ll concentrate on the relatively new Bulgarian Food Act (from June 2020), which repealed the 1999 Act and which forms an important part of the Bulgarian legislation on food supplements. This article will present a brief analysis of the legal regime of food supplements in Bulgaria and the changes that the new Food Act introduced this summer.

The new registration regime for food supplements

According to Art. 79, para 2 of the Food Act and unlike the previous “notification” regime, when a food supplement is placed on the Bulgarian market, it must be registered in accordance with the new procedure provided by the Act.

1. What does "placing on the market" mean?

A product is “placed on the market” when it is made available for the first time on the Bulgarian market, i.e. when it is first supplied for distribution, consumption or use. In practice, this means that if a particular food supplement is already circulating the Bulgarian market, it won’t fall under the scope of the new Food Act and it won’t have to be registered.

2. Who and / or what should be registered?

2.1. The physical outlet for production, processing and / or distribution of food supplements

If the food supplements are sold through physical outlets, the latter must be registered under the new Food Act. Just like the previous regime (the 1999 Act), according to art. 24, para. 1 of the new Food Act, the Bulgarian Food Safety Agency (BFSA) has the obligation to maintain on its website a public national register of the physical outlets for the production, processing and / or distribution of food supplements.

2.2. The entity that offers food supplements for sale by means of distance communication

Online sales of food supplements, according to the previous legislation (Article 5, para 1 of Ordinance №47 of 2004) were not prohibited or restricted provided the content, manufacture, specifications, presentation or labeling of the food supplements met the requirements of the law. In other words, food supplements could be sold both through physical outlets and online by means of distance communication.

In the new 2020 Act, distance selling is explicitly regulated in Chapter II, Section IV, which stipulates that distance selling can be carried out by either:

А) business operators which have at least one registered and approved physical outlet; or

Б) online information society service providers

In other words, owners of e-commerce stores that sell food supplements through their website will have an obligation to register under Art. 61 of the new Food Act, just like the business operators, who carry out their activities through physical outlets.

It seems as if only the online platforms that connect retailers of food supplements with consumers will be exempted from the obligation to register with the RFSD. This is because their legal regime, as well as their liability is governed by a specific European act, namely Directive 2000/31 / EC (the "E-Commerce Directive";).

2.3. Registration of the food supplement

Unlike the previous regime, according to which producers or distributors had to notify the regional health inspectorates ("RHI";) before placing a food supplement on the market (Article 4, paragraph 1 of Ordinance №47 of 2004), under Art. 79 of the new Food Act, they must register the food supplement by submitting an "application" to the executive director of the relevant regional directorate for food safety ("RFSD";).

This is a significant difference as opposed to the previous notification regime, under which the RHI specialists were able to suspend the marketing/distribution of a specific non-compliant food supplement only after the latter has been placed on the market.

According to Art. 79, para. 7 of thie new Food Act, during the process of registration of the food supplement, the competent authority could require the applicant to submit:

a) research or data that establish the compliance of the food supplement with the requirements for its composition;
b) its characteristics and purpose;
c) other necessary information.

Further, the competent body could request an opinion about the compliance of the food supplement with the legal requirement from:

a) the Ministry of Health;
b) the Center for Risk Assessment in the Food Chain;
c) the National Center for Public Health and Analysis
d) the Anti-Doping Center;
e) the Executive Agency for Medicines;
f) other institutions and organizations

In the event of a discrepancy between the registration application and the actual composition of the food supplement, the competent authority will refuse to register the product.

2.4. What documents will be necessary for the registration of the food supplement?

When a food supplement is placed for the first time on the Bulgarian market, except for the application to the Executive Director of RFSD, according to Art. 79, para 4 of the Food Act, the applicant must also provide:

a) the label with which the food supplement will be placed on the market;
b) the original label (if the product is not produced in Bulgaria);
c) a statement that the composition of the food supplement corresponds to the information on the label.

If the application documents are accurate and duly sumbitted, the food supplement will be registered in the public national register (available on the BFSA website). Under the previous regime (the 1999 Act) it was the RHI that maintained a database, as well as the Ministry of Health.

3. Final thoughts

According to Article 81 of the new Food Act, a new ordinance is soon to be adopted. Until it clarifies further the new registration regime for food supplements, a list of all newly approved samples of registration applications can be found here:

Elitsa Tchobanova

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Tags: Foods.Supplements