Bades: Legislative regulation and quality control

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Bades: Legislative regulation and quality control

Section 1: Definition and classification of dietary supplements in Russian legislation

1.1. Legal definition of dietary supplements:

In the Russian Federation, biologically active food supplements (dietary supplements) are determined by Federal Law No. 29-ФЗ dated January 2, 2000 “On the quality and safety of food products” (hereinafter-Law No. 29-ФЗ) and the Technical Regulations of the Customs Union TR TS 021/2011 “On the safety of food products” (hereinafter-TR TS 021/2011).

Bades are concentrates of natural or identical to natural biologically active substances intended for direct intake with food or introduction into food products in order to enrich the diet with individual food or biologically active substances and their complexes. Bades are not drugs and are used to maintain health and reduce the risk of diseases.

Key aspects of the definition:

  • Concentrate: Bades contain increased concentrations of biologically active substances in comparison with conventional foods.
  • Natural or identical to natural: Sources of active substances can be of natural origin (plants, animals, minerals) or synthesized chemically with an identical structure.
  • Addition to the diet: Bades do not replace full nutrition, but complement it, replenishing the deficiency of the necessary substances.
  • Are not medicines: Bades are not intended for the treatment of diseases, but are used to prevent and maintain health.

1.2. Classification of dietary supplements:

Russian legislation does not contain a clear, exhaustive classification of dietary supplements. However, in practice and in regulatory documents (guidelines, clarifications of Rospotrebnadzor), several types of dietary supplements are distinguished by various criteria:

  • By composition:
    • Monocomponent: Contain one biologically active ingredient (for example, vitamin D, omega-3 fatty acids).
    • Multicomponent: They contain several biologically active ingredients (for example, vitamin-mineral complexes, herbal fees).
  • By the form of release:
    • Tablets: A solid dosed form for oral use.
    • Capsules: A solid gelatin membrane containing powder, granules or liquid.
    • Powders: For dissolution in water or other liquids.
    • Liquid forms: Solutions, syrups, extracts.
    • Bars, chewing gums: Specialized forms for the convenience of use.
  • For the purpose: (The classification is conditional and often intersects)
    • Vitamin complexes: The deficiency of vitamins is replenished.
    • Mineral complexes: The deficit of minerals is replenished.
    • Amino acid complexes: Contain the necessary amino acids.
    • Probiotics and prebiotics: Support a healthy intestinal microflora.
    • Phytopreparations: Contain extracts of medicinal plants.
    • Bad for weight loss: Contribute to weight control.
    • Bad for athletes: Improve sports results.
    • Bades to improve the condition of the skin, hair and nails: Support for beauty and health.
    • Bades to maintain immunity: Strengthen the immune system.
  • By origin:
    • Vegetable: Based on plant materials.
    • Animals: Based on animal raw materials.
    • Mineral: Based on mineral raw materials.
    • Synthetic: Based on synthesized substances identical to natural.
    • Microbial: Based on microorganisms (probiotics).

1.3. Differences of dietary supplements and medicines:

The key difference between dietary supplements and drugs is their intended purpose and status.

Characteristic Bad Medicines
Purpose Enrichment of the diet, maintenance of health, prevention of diseases. Treatment, diagnosis and prevention of diseases.
Status Food product. Drug.
Regulation TR TS 021/2011, Law No. 29-FZ, SanPiN 2.3.2.1290-03, etc. Federal Law No. 61-ФЗ “On the Condition of Medicines” and others.
Preclinic and clinical research Not obligatory in full, as for drugs. Mandatory to confirm efficiency and safety.
Registration State registration (receipt of SGR). State registration (receipt of registration certificate).
Responsibility The manufacturer is responsible for safety and compliance. The manufacturer is responsible for efficiency, safety and quality.
Advertising It is regulated by the law on advertising, restrictions on therapeutic properties. Strict restrictions on advertising, only after registering the medicine.
Appointment Do not require a doctor’s appointment. Many drugs require a doctor’s prescription (prescription).

1.4. Requirements for the composition of dietary supplements:

The composition of the dietary supplement is regulated by TR TS 021/2011 and other regulatory acts. The main requirements include:

  • Safety: The composition of the dietary supplement should not pose a threat to the health of the consumer.
  • Compliance with the declared composition: The actual content of biologically active substances must correspond to the label.
  • Lack of prohibited substances: Bad should not contain narcotic, psychotropic, toxic and other substances prohibited for use in food.
  • Normation of the content: The content of biologically active substances must comply with the established standards (upper permissible levels of consumption) in order to avoid overdose and negative consequences. These norms are established in various regulatory documents, including in unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary and epidemiological surveillance (control).
  • Quality of raw materials: The raw materials used for the production of dietary supplements must comply with the established safety and quality requirements.

Section 2: State registration of dietary supplements

2.1. State registration procedure:

In accordance with the legislation of the Customs Union, all dietary supplements produced and implemented in the territory of the Eurasian Economic Union (EAEU) are subject to mandatory state registration. State registration is carried out by the authorized body – Rospotrebnadzor.

The state registration procedure includes the following stages:

  1. Preparation of documents: The applicant (manufacturer or importer) collects the necessary package of documents confirming the security and compliance of the Bad with the established requirements.
  2. Application: An application for state registration is submitted to Rospotrebnadzor.
  3. Examination of documents: Rospotrebnadzor conducts an examination of the submitted documents, evaluating their completeness and reliability.
  4. Laboratory research: Samples of Bad are sent to accredited laboratories for testing for safety and quality indicators.
  5. Solution: Based on the results of the examination of documents and laboratory research, Rospotrebnadzor decides to state registration of dietary supplements or refusal to register.
  6. Issuance of a certificate of state registration (SGR): In the case of a positive decision, the applicant is issued by the SGR confirming that the dietary supplement meets the established requirements and may be allowed for production and implementation in the EAEU. The SGR is entered into a single register of certificates of state registration.

2.2. Necessary documents for state registration:

For state registration of dietary supplements, it is necessary to submit the following package of documents:

  • Application for state registration.
  • Copies of the constituent documents of the applicant (for legal entities) or copies of identification documents (for individual entrepreneurs).
  • A document confirming the powers of a person representing the interests of the applicant (power of attorney).
  • Normative and technical documentation for dietary supplements (technical conditions, technological instruction, recipe).
  • Specification for dietary supplements containing information about the composition, physicochemical indicators, microbiological purity, the content of biologically active substances.
  • Bad label label or layout.
  • Documents confirming the safety and quality of raw materials used for the production of dietary supplements (quality certificates, test protocols).
  • Protocols of laboratory tests of dietary supplements conducted in accredited laboratories (in terms of safety and quality).
  • Scientific report (rationale) on the safety and effectiveness of dietary supplements. May include data on the chemical composition, mechanism of action, effect on the human body.
  • A document confirming the availability of production that meets the requirements of sanitary norms and rules (act of sanitary and epidemiological survey).
  • Sample dietary supplement for laboratory research.
  • A copy of the document confirming the free appeal of the dietary supplement in the country-producer (for imported dietary supplements).
  • Other documents that can be requested by Rospotrebnadzor to confirm the safety and compliance of the dietary supplement with the established requirements.

2.3. Grounds for refusing state registration:

Rospotrebnadzor may refuse state registration of dietary supplements in the following cases:

  • Understructed or inaccurate documents are presented.
  • The dietary supplement does not meet the established safety and quality requirements.
  • The dietary supplement contains prohibited substances.
  • The composition of the dietary supplement does not correspond to the declared composition.
  • The bad label contains inaccurate information or misleads the consumer.
  • Bad is declared as a means for the treatment of diseases (violation of the definition of dietary supplements).
  • Violations of sanitary rules and norms in the production of dietary supplements have been identified.
  • Documents confirming the free appeal of Bad in the manufacturer (for imported dietary supplements) were not provided.

2.4. The validity of the certificate of state registration:

The validity of the SGR is set for the entire period of dietary supplements or supplies of dietary supplements to the EAEU. The renewal of the SGR is required in the case of a change in the composition of the dietary supplement, production technology or other significant changes that can affect the safety and quality of the product.

Section 3: Requirements for the production of dietary supplements

3.1. Sanitary rules and norms for the production of dietary supplements:

The production of dietary supplements must comply with the requirements of sanitary rules and norms established for food industry enterprises. The main document regulating the sanitary requirements for the production of dietary supplements is SanPiN 2.3.2.1290-03 “Hygienic requirements for the organization of production and the circulation of biologically active food additives (BADs).”

The main requirements of SanPiN 2.3.2.1290-03 include:

  • Requirements for industrial premises: Production premises should be isolated from residential and public buildings, have sufficient area and lighting, are equipped with ventilation and water supply systems, and comply with sanitary treatment requirements.
  • Equipment requirements: The equipment used for the production of dietary supplements should be made of materials allowed for contact with food products, to be easily detergent and disinfect, comply with safety requirements.
  • Requirements for raw materials: The raw materials used for the production of dietary supplements must comply with the established safety and quality requirements, have documents confirming its origin and safety.
  • Requirements for the technological process: The technological process of production of dietary supplements should ensure the preservation of the biological activity of the ingredients, prevent the product pollution, and correspond to the approved technological documentation.
  • Personnel Requirements: Personnel engaged in the production of dietary supplements must undergo compulsory medical examinations, have a sanitary book, comply with personal hygiene rules.
  • Quality control requirements: At the production of dietary supplements, the quality of raw materials, semi -finished products and finished products should be organized, including laboratory tests, organoleptic assessment, verification of compliance with the requirements of regulatory documentation.
  • Storage and transportation requirements: Storage and transportation of dietary supplements should be carried out in conditions that ensure the safety of the product and prevent its pollution.

3.2. HACSP system at the production of dietary supplements:

In accordance with the TS TS 021/2011, the dietary supplement enterprises should be introduced and supported by the food safety management system based on the HAZARD ANALYSIS and Critical Control Points.

The HASSP system is a systematic approach to identifying, evaluating and managing dangers associated with food production. The purpose of the HASSP system is to ensure the safety of food products by preventing the occurrence of dangers or reducing them to an acceptable level.

The introduction of the HASSP system in the production of dietary supplements includes the following stages:

  1. Dangers identification: Determination of all potential dangers that can occur at each stage of dietary supplements (biological, chemical, physical).
  2. Determination of critical control points (CCP): Determination of the stages of production at which it is necessary to exercise control to prevent or eliminate dangers.
  3. Establishment of critical limits: Determination of the limit values ​​of the parameters (temperature, time, concentration, etc.), which must be observed in the CCP to ensure the safety of the product.
  4. Development of a monitoring system: Development of procedures for CCP monitoring, including parameters measurement, data registration and results analysis.
  5. Development of corrective actions: The development of actions that must be taken in case of deviation of the parameters in the CCP from the established limit values.
  6. Development of verification procedures: Development of procedures for checking the effectiveness of the HASSP system, including internal audits, analysis of monitoring data, documentation verification.
  7. Documentation Development: The development of documentation describing the HASSP system, including HASSP plans, monitoring procedures, corrective actions and verification.

3.3. Quality control at the production of dietary supplements:

Quality control at the production of dietary supplements is an important element of security and compliance with the product with the established requirements. Quality control is carried out at all stages of production, ranging from the input control of raw materials to the control of finished products.

The main types of quality control at the production of dietary supplements:

  • Input control of raw materials: Checking the compliance of raw materials with the requirements of regulatory documentation, including organoleptic assessment, physico-chemical and microbiological studies.
  • Operational control: Monitoring the parameters of the technological process at each stage of production, including temperature, time, concentration, humidity, etc.
  • Semi -finished control: Quality control of semi -finished products for compliance with the requirements of regulatory documentation.
  • General products control: Quality control of finished products for compliance with the requirements of regulatory documentation, including organoleptic assessment, physico-chemical and microbiological studies, verification of compliance of the composition of the declared on the label.

To conduct quality control at the production of dietary supplements, various methods and devices are used, including:

  • Organoleptic methods: Assessment of appearance, color, smell, taste of the product.
  • Physico-chemical methods: Determination of humidity, ash, acidity, content of vitamins, minerals, amino acids and other biologically active substances.
  • Microbiological methods: Determination of the total number of microorganisms, the presence of pathogenic microorganisms, yeast and mold.
  • Chromatographic methods: Separation and identification of components of a mixture of substances.
  • Spectrophotometric methods: Determination of the concentration of substances by their ability to absorb light.

Section 4: Requirements for Bad label

4.1. Mandatory information on the Bad label:

Information on the Bad label should be reliable, understandable and easily read for the consumer. The label should contain the following mandatory information:

  • Bad name: It must be clear and understandable, reflect the composition and purpose of Bad.
  • Composition: A complete list of ingredients in decreasing their mass fraction, including the name of biologically active substances, auxiliary substances, food additives.
  • Food value information: The content of proteins, fats, carbohydrates, energy value (calorie content) per 100 g or 100 ml of product.
  • Information about biologically active substances: The content of biologically active substances in one portion (recommended dose) and percentage of the recommended level of daily consumption.
  • Recommendations for use: Recommended dose, method of application, duration of admission.
  • Contraindications: The list of states in which it is not recommended to take dietary supplements (pregnancy, breastfeeding, individual intolerance, etc.).
  • Warning: Information about possible side effects, interaction with drugs, etc.
  • Best before date: The date to which the dietary supplement retains its properties.
  • Storage conditions: Requirements for temperature, humidity and other storage conditions.
  • Name and location of the manufacturer: Full name and address of a legal entity or individual entrepreneur engaged in the production of dietary supplements.
  • The name and location of the organization authorized by the manufacturer to accept claims from consumers: Information about the organization to which the consumer can apply with claims on the quality of the dietary supplement.
  • Net mass or volume: The amount of the product in the package.
  • Party number: The identification number that allows you to track a batch of products.
  • Certificate of state registration (SGR): The number of the SGR confirming that the dietary supplement has passed state registration.
  • The inscription “Biologically active additive to food. It is not a drug.” It should be applied with a clear font, clearly visible on the label.

4.2. Prohibited information on the Bad label:

On the Bad label, it is forbidden to indicate the following information:

  • Information about the healing properties of Bad: It is forbidden to indicate that the dietary supplement is designed to treat diseases or relieve their symptoms.
  • The consumer information is misleading: It is forbidden to indicate inaccurate information about the composition, properties and effectiveness of Bad.
  • Information discrediting other foods: It is forbidden to indicate that the dietary supplement exceeds other foods in its properties.
  • Information that prompts to refuse full nutrition: It is forbidden to indicate that dietary supplements can replace good nutrition.
  • Information that encourage self -medication: It is forbidden to indicate that dietary supplements can replace a doctor’s consultation or treatment with drugs.

4.3. Requirements for the design of the Bad label:

Bad label should be decorated in accordance with the requirements of TR TS 022/2011 “Food products in terms of its marking”. The label should be:

  • Selective and easily readable: Information should be applied with a clear font, clearly visible on the label.
  • In Russian: Information should be presented in Russian. Duplication of information in other languages ​​is allowed.
  • Resistant to external factors: The label should be made of material resistant to moisture, temperature, light and other factors.
  • Reliably fixed on the package: The label should be reliably fixed on the package to exclude its peelation or damage.

Section 5: Control over the turnover of dietary supplement

5.1. Bades control bodies:

Control over the turnover of dietary supplements in the territory of the Russian Federation is carried out by the following bodies:

  • Rospootrebnadzor: Carries out state sanitary and epidemiological supervision of production, storage, transportation, sale and use of dietary supplements. Rospotrebnadzor conducts inspections of enterprises manufacturing and selling dietary supplements, selects products for laboratory research, considers consumer complaints, and takes administrative measures if violations are detected.
  • Federal Customs Service (FCS): Customs control over the import and export of dietary supplements from the territory of the Russian Federation. The FCS checks the compliance of the accompanying documents with the requirements of the legislation, selects product samples for the examination.
  • Federal Antimonopoly Service (FAS): Exercises control over compliance with law on advertising of dietary supplements. The FAS identifies and suppresses cases of unscrupulous competition, the spread of inaccurate advertising of dietary supplements.
  • Ministry of Health of the Russian Federation: He pursues a state policy in the field of healthcare, including in the field of regulation of the turnover of dietary supplements. The Ministry of Health is developing regulatory legal acts establishing safety requirements and the quality of dietary supplements, conducts scientific research in the field of application of dietary supplements.

5.2. Types of control measures:

The bodies exercising control over the turnover of dietary supplements are carried out by the following types of control measures:

  • Planned checks: They are carried out in accordance with the inspection plan approved by Rospotrebnadzor. The frequency of scheduled inspections depends on the category of the enterprise.
  • Unscheduled checks: Are carried out on the basis of information about violations of the requirements of the legislation received from consumers, authorities, organizations.
  • Documentary checks: It is carried out by analyzing the documents submitted by enterprises without going to the place.
  • Exit inspections: They are carried out with a departure to the place of implementation of the enterprise.
  • Selection of products for laboratory research: It is carried out to verify the compliance of dietary supplements with safety and quality requirements.
  • Administrative investigation: It is carried out in case of violations of the requirements of the legislation.

5.3. Responsibility for violation of dietary supplements:

For violation of the requirements for dietary supplements, administrative and criminal liability is provided.

  • Administrative responsibility: It is provided for by the Code of the Russian Federation on administrative offenses (Code of Administrative Offenses of the Russian Federation). For violation of the requirements for dietary supplements, fines are provided for legal entities, officials and individual entrepreneurs. Types of violations and the sizes of fines are established in Articles 6.3, 6.4, 6.6, 14.2, 14.4, 14.7, 14.8 of the Administrative Code of the Russian Federation.
  • Criminal liability: It is provided for by the Criminal Code of the Russian Federation (Criminal Code of the Russian Federation). Criminal liability may occur if the violation of the requirements for dietary supplements entailed grave consequences for human health or death. Types of crimes and the amount of punishment are established in Articles 238, 238.1 of the Criminal Code of the Russian Federation.

Section 6: Advertising of Dads

6.1. Requirements for dietary supplements:

Advertising of dietary supplements is regulated by the Federal Law of 13.03.2006 No. 38-ФЗ “On Advertising”. Advertising of dietary supplements must comply with the general requirements for advertising, as well as the special requirements established for food advertising.

Basic requirements for dietary supplements:

  • Reliability: Advertising should contain reliable information about the composition, properties and effectiveness of Bad.
  • The inadmissibility of misleading: Advertising should not contain information that can mislead the consumer regarding the properties and efficiency of dietary supplements.
  • The mandatory indication that dietary supplement is not a drug: In a dietary supplement advertising, the inscription “Biologically active additive for food should be clearly indicated. It is not a drug.”
  • Lack of references to therapeutic properties: Advertising should not contain references to the healing properties of dietary supplements, with the exception of cases when such properties are confirmed by clinical studies and are allowed to indicate the label.
  • Compliance with ethical norms: Advertising should not violate the ethical norms and principles adopted in society.
  • Coordination with Rospotrebnadzor: In some cases, advertising of dietary supplements may be subject to preliminary coordination with Rospotrebnadzor.

6.2. Forbidden techniques in the advertisement of dietary supplements:

The following techniques are prohibited in the advertising of dietary supplements:

  • Allegations that dietary supplement is a drug: Advertising should not contain statements that the dietary supplement is intended to treat diseases or relieve their symptoms.
  • Guarantees of a positive effect: Advertising should not contain guarantees of a positive effect on the use of dietary supplements, since the effectiveness of dietary supplements can depend on the individual characteristics of the body.
  • Comparison with drugs: Advertising should not contain comparisons of dietary supplements with drugs.
  • Using images of medical workers: In the advertising of dietary supplements, the use of images of medical workers is not allowed, with the exception of cases where they are authors of scientific research confirming the effectiveness of dietary supplements.
  • Creating an impression of the need to use dietary supplements: Advertising should not give impressions of the need to use dietary supplements to maintain health.
  • The use of statements based on unproven facts: Advertising should not contain statements based on unproven facts or scientific theories.

6.3. Responsibility for violation of law on advertising of dietary supplements:

For violation of law on advertising of dietary supplements, administrative liability is provided in accordance with the Administrative Code of the Russian Federation. The sizes of fines for violation of advertising legislation are established in Article 14.3 of the Administrative Code of the Russian Federation. When identifying violations of advertising legislation, the FAS issues instructions on eliminating violations and imposes fines for advertisers, advertising producers and advertisers.

Section 7: International Dietary Bad Management Experience

7.1. USA:

In the United States, dietary supplements are regulated as food products in accordance with the Law on Food Addles, Health and Education of 1994 (Dietary Supplement Health and Education Act – DSHEA). DShea establishes that dietary supplements do not require preliminary approval of FDA (Food and Drug Administration) before entering sale. However, dad manufacturers are required to guarantee the safety of their products and compliance with the requirements for marking. FDA may take measures against dietary supplements that pose a threat to consumer health. In the United States, strict rules apply to statements about the benefits of health bases. Manufacturers can make allegations of the effect of dietary supplements on the structure or function of the body, but cannot argue that dietary supplements are treated or preventing diseases.

7.2. European Union:

In the European Union, the regulation of dietary supplements is carried out at the level of individual member states. However, there are general rules established by the Directive of 2002/46/EC on the convergence of the legislation of member states regarding biologically active food additives. The directive establishes the requirements for the composition, labeling and safety of dietary supplements. The EU has a list of vitamins and minerals that can be used in dietary supplements. Applications on the benefits of bases for health should be scientifically substantiated and approved by the European Food Safety Agency (European Food Safety Authority – EFSA).

7.3. Canada:

In Canada, dietary supplements are regulated as natural Health Products (NHPS) in accordance with the rules on natural Health Products Regulations). NHPS should have a license for the sale issued by the Ministry of Health (Health Canada). To obtain a license, manufacturers must provide evidence of the safety, efficiency and quality of their products. In Canada, strict rules apply to statements about the benefits of NHPS for health.

7.4. Australia:

In Australia, dietary supplements are regulated as additional drugs (Complementary Medicines) in accordance with the 1989 drug Law (Therapeutic Goods Act 1989). Additional drugs should be registered in the management of therapeutic goods (Therapeutic Goods Administration – TGA). For registration, manufacturers must provide evidence of the safety, quality and efficiency of their products. In Australia, strict rules apply to statements about the benefits of additional health medicines.

Section 8: Trends and prospects for the development of legislation on dietary supplements

8.1. Harmonization of legislation within the framework of the EAEU:

Within the framework of the EAEU, work continues to harmonize legislation on dietary supplements. It is planned to develop unified technical regulations and standards establishing safety requirements, quality and labeling of dietary supplements. Harmonization of legislation will simplify the procedure for state registration of dietary supplements and ensure free circulation of products in the EAEU.

8.2. Tight toughening control over the turnover of dietary supplements:

Due to the growth of the popularity of dietary supplements and an increase in the number of unscrupulous manufacturers, it is planned to tighten control over the turnover of dietary supplements. Strengthening state sanitary and epidemiological supervision of the production and sale of dietary supplements, an increase in the number of inspections of enterprises, and the selection of products for laboratory research. It is also planned to strengthen control over the advertising of dietary supplements and suppress cases of the spread of inaccurate information.

8.3. Expansion of the list of allowed ingredients:

Currently, the list of ingredients allowed for use in dietary supplements is limited. It is planned to expand the list of permitted ingredients, including due to the inclusion of new biologically active substances obtained from plant and animal raw materials. The expansion of the list of allowed ingredients will allow manufacturers to create new and innovative products that meet the needs of consumers.

8.4. Implementation of a traceability system of dietary supplements:

To increase the safety and quality of dietary supplements, it is planned to introduce a traceability system of dietary supplements. The traceability system will monitor the movement of dietary supplements at all stages of production, storage, transportation and sale. The introduction of a traceability system will promptly identify and seize poor -quality and falsified products from circulation.

8.5. The development of a scientific base to justify the effectiveness of dietary supplements:

To increase consumers’ trust in dietary supplements, the development of a scientific base is necessary to justify their effectiveness. It is necessary to conduct clinical studies confirming the effectiveness and safety of dietary supplements. The results of scientific research should be published in scientific journals and are available to the general public.

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