Dietary supplement VS Food additive
Author: Nechaeva Elena, expert
In this article, we have detailed key differences between dietary supplements and food additives and talked about assessing the conformity of dietary supplements, their marking requirements, and applicable regulations forming the basis for the technical regulation of this group of products.
What is the difference between a dietary supplement and a food additive?
A dietary supplement is a food product for special dietary use.
It is defined in several regulations:
— Technical Regulations of the Customs Union (TR CU) 021/2011 “On the Safety of Food Products”;
— GOST R (standard) 57079-2016 “Biotechnology. A classification of biotechnology products”;
— Guidelines on methods of control dated October 15, 1998 No. 2.3.2.721‐98 “Determination of safety and efficacy of dietary supplements to food”.
According to one of the definitions, dietary supplements are naturally occurring and (or) nature-identical bioactive substances, as well as probiotics, intended for consumption with food or incorporation into food products.
Depending on their type of action in the human body, dietary supplements are divided into three groups: nutraceuticals, parapharmaceuticals, and eubiotics. Parapharmaceuticals are intended for adjuvant therapy. Nutraceuticals supply food with additional proteins, amino acids, fats, carbohydrates, and vitamins. Eubiotics (probiotics) help normalize the composition and bioactivity of gut microbiota.
Thus, dietary supplements are used as an additional source of nutrients and bioactive substances to optimize and/or improve the functional state of organs and organ systems of the human body.
Dietary supplements should not be confused with fortified food products. The latter also contain bioactive components, just like dietary supplements. However, fortified food products are subject to legal regulations concerning threshold levels that must be observed.
The key distinguishing feature of a dietary supplement is that the pronounced biological activity of a group of substances making up the supplement is directed at the human body and its biological processes. In contrast, a food additive has a processing function and affects the food product.
Determining the scope of use for any food component falls under the responsibility of the manufacturer. The purpose of using a particular raw material, as well as its quantity, is determined as early as at the stage of setting up the product formula.
A food additive is any substance (or a mixture of substances) that has or does not have its own nutritional value, is typically not used for human consumption on its own and is intentionally incorporated into a food product for a processing purpose (function) at the stage of manufacturing (producing) the food product, commercial transportation (transportation by own means) and storage; this results or may result in the substance or its transformation products becoming components of the food product. The food additive may have a single or several processing functions.
Food additives and dietary supplements have different safety requirements, therefore an incorrect product identification leads to mistakes in assessing (confirming) its conformity with the established safety requirements.
What regulations apply to dietary supplements?
The technical regulation of dietary supplements is performed using the following regulations:
— Clauses 13 and 14, Article 8 of the Technical Regulations of the Customs Union (TR CU) 021/2011 establish the safety requirements and standardize the composition of dietary supplements and the quantity of plant components.
Appendix 7 hereto specifies a list of plants and plant-derived products, animal-derived objects, microorganisms, mushrooms, and bioactive substances not allowed for use in dietary supplements due to presenting a risk for the health and safety of humans.
In addition, doses for extracts of plants approved for use are limited by the percentage of the single therapeutic dose (10% to 50%) that is specified in the regulation for the medication in question.
— Appendix 5 to the Technical Regulations of the Customs Union (TR CU) 022/2011 “Food Products in Terms of Their Labeling” establishes maximum ranges in order to evaluate the level of dietary fibers, minerals, and vitamins in the food product.
— Appendix 2 to TR CU 022/2011 defines the required average daily intake of macronutrients and energy in order to apply marking to the food product.
Information on the percentage of the reference daily intake, as well as the adequate intake level, must always be specified on the packaging of a dietary supplement in accordance with the decision of the Eurasian Economic Union (EAEU).
The adequate intake level is calculated or determined experimentally based on the intake estimates for nutrients and bioactive substances by a group or groups of nearly healthy individuals. For the adult population, the daily intake figures for nutrients and bioactive substances contained in dietary supplements are standardized in the Appendix 5 to the Decision of the Commission of the Customs Union No. 299 dated May 28, 2010.
— The Decree of the Chief Medical Officer of the Russian Federation No. 28 dated May 2, 2012 prohibits the manufacturing and circulation in the territory of the Russian Federation of dietary supplements to food that contain plants possessing a psychotropic action and listed in the present Decree.
— The Federal Law No. 29-FZ dated January 2, 2000 “On the quality and safety of food products” contains the requirements for the quality of dietary supplements. In accordance with the norms of this law, dietary supplements are considered food.
Marking dietary supplements: what do I need to know?
As for any food product, in order to observe the marking requirements for dietary supplements Clause 4.10 of the Technical Regulations of the Customs Union (TR CU) 022/2011 “Food Products in Terms of Their Labeling” should be considered. This clause stipulates the list of mandatory information that must be present on the marking and confirmed. For instance, composition, manufacturing date, storage conditions, nutritional value, etc. Furthermore, dietary supplements need to be provided with the information on the presence of allergens and other substances affecting the activity of children.
In addition to the Eurasian Conformity Mark, dietary supplements may be provided with further product markings if these have been confirmed:
— the GLUTEN FREE mark. This is confirmed through voluntary certification or the product formula. Unfortunately, the protocol cannot serve as a document providing objective confirmation for the marking information, as it only confirms the absence of gluten in a particular product sample that completed testing. Moreover, the certification foresees a mandatory control of the food safety management system (FSMS) that guarantees the product being gluten-free.
— the ORGANIC mark. This is confirmed by a certificate of conformity with the GOST [standard] 33980-2016 issued by an accredited body for organic production.
— the GMP (GOOD MANUFACTURING PRACTICE) mark. Dietary supplements are not considered a medication subject to mandatory compliance with GMP production standards, therefore one option is undergoing a voluntary production assessment to establish conformity with the Russian GOST R standard 56202‐2014 at an accredited body, including at ROSTEST. Following this, the GMP mark may be applied even though there are currently no official regulations for the use of the GMP mark on dietary supplements.
It would not be correct to apply marks confirming completed production certification or the presence of a quality management system, such as ISO or HACCP, as part of product marking, since in such a case, the products would not be the object of certification.
Traceability of dietary supplements
Since September 1, 2023, mandatory registration in the marking system for dietary supplements to food is required for all circulation participants in accordance with the Resolution of the Government of the Russian Federation No. 886 dated May 31, 2023 “On establishing rules for marking dietary supplements to food with means of identification and the introduction of a state monitoring system controlling the circulation of goods”. This document contains a list of codes under the Commodity Nomenclature of Foreign Economic Activities (TN VED) and the All-Russian Classifier of Products by Type of Economic Activity (OKPD 2) for products that require marking. Prior to submitting an application for marking, a Certificate of State Registration (SGR) needs to be obtained for the dietary supplement.
If “Chestny ZNAK” marking needs to be applied onto a product, the manufacturer or the importer should affix a mark containing a unique code to each item of the product or print the code on the label for each item of the product. The code makes it possible to trace who the product was manufactured by or imported into the country and when, as well as what sales stage it is currently in.
Starting from May 1, 2024, all circulation participants must submit information on the movements of marked products specifying product volume and identifier via the electronic document management system. Starting from September 1, 2025, complete per-item traceability should be achieved. Its goal is preventing the circulation of illegal and falsified products.
What information is not allowed when advertising a dietary supplement?
Requirements concerning dietary supplement advertising are stipulated in Article 25 of the Federal Law No. 38-FZ dated March 13, 2006 “On Advertising”.
Advertising should not:
— create the impression that dietary supplements are medications and (or) possess medicinal properties;
— contain references to specific cases where the consumer was healed or their condition improved as a result of using such dietary supplements;
— contain an expression of gratitude to persons in connection with using such dietary supplements;
— motivate consumers to refrain from maintaining a healthy diet;
— create an advantageous impression of such dietary supplements by referencing completed testing mandatory for the state registration of such dietary supplements, as well as use the results of other tests as direct recommendations to use such dietary supplements.
Conformity assessment of dietary supplements
Conformity assessment of dietary supplements can be mandatory and voluntary.
Food products for special dietary use, including dietary supplements, is subject to a conformity assessment in the form of state registration with the following technical regulations:
— Technical Regulations of the Customs Union (TR CU) 021/2011 “On the Safety of Food Products”;
— Technical Regulations of the Customs Union (TR CU) 022/2011 “Food Products in Terms of Their Labeling”;
— Technical Regulations of the Customs Union (TR CU) 029/2012 “Safety Requirements for Food Additives, Flavorings, and Technological Processing Aids” (applied depending on the composition of the dietary supplement).
Upon completion of testing, a certificate of state registration is issued, this document has no expiration date. The procedure for state registration and the form of state registration are specified in the Decision of the Board of the Eurasian Economic Commission No. 80 dated June 30, 2018 “On the Certificates of State Registration for Products”.
In addition, a dietary supplement may undergo a voluntary conformity assessment. In this case, a voluntary certificate of conformity is typically issued.
A voluntary assessment of a dietary supplement, apart from certifying product conformity with established requirements (for instance, via the manufacturer specification), may be performed as a production certification, which we have mentioned above, as well as an inspection of technical documentation, marking, a procedure establishing shelf life and storage conditions performed by an accredited inspection body, and many more options.
ROSTEST offers its clients the opportunity to perform testing confirming the efficacy of dietary supplements or cosmetic products. This service allows the manufacturer to openly state on the product marking the effects that may be achieved by taking or using the product. For instance, if the marking says that a course with this dietary supplement will help strengthen and thicken the consumer’s hair, this effect may be confirmed by testing at ROSTEST.
Stated efficacy is confirmed in accordance with the 1998 Guidelines “Determination of safety and efficacy of dietary supplements to food”. Mandatory stages include the recruitment of volunteers, the presence of a control group, and the confirmation of stated characteristics of the dietary supplement. In addition, a comprehensive assessment is performed, including a control of the chemical and biological safety for the product, its raw materials, packaging, marking evaluation, etc. The customer receives an assessment report specifying the presence and degree of stated effects in the dietary supplement, which may be further used to inform end consumers.
In conclusion, the mandatory document for a dietary supplement is the certificate of state registration. It cannot be replaced by either a declaration of conformity or a voluntary certificate.
Our expert Elena Nechaeva would like to draw your attention to the anticipated amendment of technical regulations TR CU 021/2011, TR CU 027/2011, TR CU 022/11, and other technical regulations applicable for food products.
Important changes will concern the implementation of conformity assessment forms, schemes, and procedures based on model schemes to assess conformity, approved by the Decision of the Council of the Eurasian Economic Commission No. 44 dated April 18, 2018.
In particular, the certificate of state registration does not currently have an expiration date; however, amendments to TR CU 021/2011 could limit its validity to five years, also limiting the validity of a testing protocol to one year. The same applies to schemes: there is currently a unified procedure of state registration for imported and locally made products. Decision No. 44 foresees a scheme 1 p for locally made products and a scheme 2p for products made outside of the customs territory of the Customs Union.
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