Improving the assessment of compliance of biologically active food additives with established quality and safety requirements (literature review)

Introduction. Federation is aimed at ensuring sustainable natural population growth and reducing the detection of alimentary-dependent pathologies. Biologically active food additives (dietary supplements) play an important role in achieving these goals, the use of which helps to compensate for the deficiency in the intake of vitamins, minerals, and other biologically active substances into the human body.

Objective. Substantiation of methodological approaches to the algorithm of sanitary, epidemiological, and hygienic assessment (examination) of biologically active food additives in the territory of the Russian Federation (RF) and the Eurasian Economic Union (EAEU),

In the course of the work, scientific literature sources from electronic databases (Elibrary, Pubmed, Scopus, Web of Science), legislative and regulatory acts of the Russian Federation, the EAEU and other countries were used, materials of own research.

The analysis showed that the lack of a uniform approach by all EAEU member states to conducting sanitary, epidemiological, and hygienic assessments (expertise) leads to the sale of dietary supplements that do not comply with the established regulatory and legislative documents of the Russian Federation and the EAEU, and the falsification of this type of food.

Conclusion. Due to the urgency of the issue of quality and safety of dietary supplements in circulation, and the need to unify the requirements for the examination of dietary supplements, scientifically based approaches have been developed to conduct sanitary, epidemiological, and hygienic assessment (examination) of biologically active food additives, which include the procedure for assessing the compliance of dietary supplements with established quality requirements. and security.

Contribution:
Setko A.G. – editing, collection, analysis, processing of materials, systematization and generalization of data from literary sources;
Bagriantseva O.V. – editing, concept and design of the review and analytical research;
Bessonov V.V. – collection of material, processing and analysis of data from literary sources;
Yuskina O.N. – editing, material collection and data processing of literary sources.
All authors are responsible for the integrity of all parts of the manuscript and approval of the manuscript final version

Conflict of interest. The authors declare no conflict of interest.

Funding. The study had no sponsorship.

Received: February 25, 2025 / Revised: May 21, 2025 / Accepted: June 26, 2025 / Published: August 20, 2025

1. Tutelyan V.A., Nikityuk D.B. Key challenges in the dietary intake structure and cutting edge technologies for optimizing nutrition to protect the health of the Russian population. Voprosy pitaniya. 2024; 93(1): 6–21. https://doi.org/10.33029/0042-8833-2024-93-1-6-21 (in Russian)

2. Wojteczek A., Chmielewski M., Zdrojewski Z. Nutritional disorders and nutrition-related conditions: an underestimated clinical problem in systemic sclerosis. Reumatologia. 2024; 62(5): 368–80. https://doi.org/10.5114/reum/194035

3. Kawabata K., Nakamura K., Kanda N., Hemmi M., Suganuma S., Muto Y., et al. Risk factors for long-term nutritional disorders one year after COVID-19: A post hoc analysis of COVID-19 recovery study II. Nutrients. 2024; 16(23): 4234. https://doi.org/10.3390/nu16234234

4. Tutelyan V.A., Nikityuk D.B., Sharafetdinov Kh.Kh. Healthy nutrition as a basis for a healthy lifestyle and prevention of chronic non-communicable diseases. In: Youth Health: New Challenges and Prospects. Volume 3 [Zdorov’e molodezhi: novye vyzovy i perspektivy. Tom 3]. Moscow: Nauchnaya Kniga; 2019. https://elibrary.ru/xdshem (in Russian)

5. SRO «Union of producers of dietary supplements». In: "What’s Going on in the Dietary Supplements Market?": Proceedings of the VI International Conference ["Chto proiskhodit na rynke BAD?": Materialy VI mezhdunarodnaya konferentsiya.]. M.; 2024. (in Russian)

6. Perova I.B., Eller K.I., Musatov A.V., Tumol’skaya E.V. Synephrine in biologically active food additives and specialized food products: biological activity, safety and methods of analysis. Voprosy pitaniya. 2021; 90(6): 101–13. https://doi.org/10.33029/0042-8833-2021-90-6-101-113 https://elibrary.ru/vbjtmj (in Russian)

7. Rizzo S., Weesepoel Y., Erasmus S., Sinkeldam J., Piccinelli A.L., van Ruth S. A multi-analyte screening method for the rapid detection of illicit adulterants in dietary supplements using a portable SERS analyzer. Heliyon. 2023; 9(8): e18509. https://doi.org/10.1016/j.heliyon.2023.e18509

8. The Rapid Alert System for Food and Feed (RASFF.) Annual Report 2013. European Commission, Health and Food Safety; 2014: 15–7.

9. Food Fraud Network Activity Report; 2014. Available at: https://food.ec.europa.eu/system/files/2016-10/official-controls_food-fraud_network-activity-report_2014_0.pdf

10. Arnautov O.V., Bagryantseva O.V., Bessonov V.V. On the need to improve the food adulteration prevention system in the Eurasian Economic Union. Voprosy pitaniya. 2016; 85(2): 104–15. https://elibrary.ru/tplyct (in Russian)

11. Perova I.B., Eller K.I., Tumolskaya E.V. Results of screening of undeclared addition of synthetic phosphodiesterase-5 inhibitors to dietary supplements of plant origin. Health risk analysis. 2019; (3): 50–9. https://doi.org/10.21668/health.risk/2019.3.06.eng https://elibrary.ru/mcaghp

12. Costa J.G., Vidovic B., Saraiva N., do Céu Costa M., Del Favero G., Marko D., et al. Contaminants: a dark side of food supplements? Free Radic. Res. 2019; 53(Suppl. 1): 1113–35. https://doi.org/10.1080/10715762.2019.1636045

13. Pawar R.S., Sagi S., Leontyev D. Analysis of bitter orange dietary supplements for natural and synthetic phenethylamines by LC-MS/MS. Drug Test. Anal. 2020; 12(9): 1241–51. https://doi.org/10.1002/dta.2871

14. Sukhanova A.M., Ponomareva N.I., Perova I.B., Zhilyaev D.I., Gegechkori I., Eller K.I., et al. Determination of the medicinal substance sibutramine by physico-chemical methods as part of multicomponent biologically active food additives. Khimiko-farmatsevticheskii zhurnal. 2020; 54(11): 57–61. https://doi.org/10.30906/0023-1134-2020-54-11-57-61 https://elibrary.ru/lvlhpc (in Russian)

15. Kozhuharov V.R., Ivanov K., Ivanova S. Dietary supplements as source of unintentional doping. Biomed. Res. Int. 2022; 2022: 8387271. https://doi.org/10.1155/2022/8387271

16. Sukhanova A.M., Gegechkori V.I., Rodionova G.M. Anorexic drug sibutramine. Possible falsification of dietary supplements. Meditsinskoe obrazovanie i VUZovskaya nauka. 2018; (3–4): 157–9. https://elibrary.ru/avoxgh (in Russian)

17. Jagim A.R., Harty P.S., Erickson J.L., Tinsley G.M., Garner D., Galpin A.J. Prevalence of adulteration in dietary supplements and recommendations for safe supplement practices in sport. Front. Sports Act. Living. 2023; 5: 1239121. https://doi.org/10.3389/fspor.2023.1239121

18. Ahmad S.B., Ali A., Bilal M., Rashid S.M., Wani A.B., Bhat R.R., et al. Melatonin and health: insights of melatonin action, biological functions, and associated disorders. Cell. Mol. Neurobiol. 2023; 43(6): 2437–58. https://doi.org/10.1007/s10571-023-01324-w

19. Koutsoumanis K., Allende A., Alvarez-Ordóñez A., Bolton D., Bover-Cid S., Chemaly M., et al. Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 14: suitability of taxonomic units notified to EFSA until March 2021. EFSA J. 2021; 19(7): e06689. https://doi.org/10.2903/j.efsa.2021.6689

20. Younes M., Aggett P., Aguilar F., Crebelli R., Dusemund B., Filipič M., et al. Scientific opinion on the safety of monacolins in red yeast rice. EFSA J. 2018; 16(8): e05368. https://doi.org/10.2903/j.efsa.2018.5368

21. Decision of the Board of the Eurasian Economic Commission № 8. "On the Procedure for Introducing Amendments to the Technical Regulations of the Customs Union"; 2024.

22. TR CU 029/2012 «Safety Requirements for Food Additives, Flavors and Technological Aids»; 2012. (in Russian)

23. Kyodo News+. Kobayashi Pharma looking into 76 more deaths linked to supplements; 2024. Available at: https://english.kyodonews.net/articles/-/48326

24. Shur P.Z., Suvorov D.V., Zelenkin S.E., Lir D.N. Identification of the potential danger of consuming new types of food products for public health (a systematic review). Gigiena i Sanitaria (Hygiene and Sanitation, Russian journal). 2023; 102(5): 495–501. https://doi.org/10.47470/0016-9900-2023-102-5-495-501 https://elibrary.ru/xaqnpz (in Russian)

25. Kuzmin S.V., Rusakov V.N., Setko A.G. Assessment of the state of the actual nutrition of the population of the Russian Federation. Gigiena i Sanitaria (Hygiene and Sanitation, Russian journal). 2024; 103(1): 58–66. https://doi.org/10.47470/0016-9900-2024-103-1-58-66 https://elibrary.ru/kjseuh (in Russian)