Bades: Regulation and quality control

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Bades: Regulation and quality control

I. Definition and classification of dietary supplements

Dietary supplements (biologically active food additives) are concentrated sources of biologically active substances designed for direct intake of food or introduction into food products in order to enrich the diet with individual food or biologically active substances and their complexes. It is important to emphasize that dietary supplements are not drugs and do not replace good nutrition.

A. The legal basis for the definition of dietary supplements:

The definition of dietary supplements, their status and circulation rules are regulated at the legislative level. Key regulatory documents that determine the requirements for dietary supplements include:

  • Technical Regulation of the Customs Union TR TS 021/2011 “On food safety”. This regulation establishes general safety requirements for all food products, including dietary supplements.
  • Technical regulations of the Customs Union TR TS 022/2011 “Food products regarding its marking.” Determines the requirements for the labeling of dietary supplements, including mandatory information about the composition, purpose, method of application, contraindications and other important information for the consumer.
  • Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary and epidemiological surveillance (control). Hygienic requirements for dietary supplements are established, including the requirements for the content of harmful substances, microbiological indicators and radiological safety.
  • Federal Law of 02.01.2000 N 29-ФЗ “On the quality and safety of food products”. Determines the basic principles for ensuring the quality and safety of food products, including dietary supplements, in the territory of the Russian Federation.
  • Order of Rospotrebnadzor dated 07.23.2012 N 781 “On state registration of products to be sanitary and epidemiological surveillance (control) in the customs territory of the Customs Union”. Regulates the procedure for state registration of dietary supplements.

B. Classification of dietary supplements:

Classification of dietary supplements can be carried out according to various criteria:

  1. In composition and purpose:

    • Nutricevtiki: Dietary supplements, which are sources of the necessary dietary substances (proteins, fats, carbohydrates, vitamins, minerals, dietary fibers, etc.). They are designed to correct the food diet, the prevention of nutrient deficiency and maintain the normal functioning of the body. Examples: vitamin complexes, mineral additives, protein cocktails.
    • Parafarmetzetics: Bades containing biologically active substances that have a regulatory effect on various organs and systems of the body. They are used to prevent diseases, maintain the functional activity of organs and systems, and enhance the body’s defenses. Examples: plant extracts, probiotics, prebiotics, antioxidants.
    • Ebiotics (probiotics and prebiotics): Bades containing living microorganisms (probiotics) or substances, stimulating the growth and activity of beneficial intestinal microflora (prebiotics). They are used to normalize intestinal microflora, improve digestion and strengthen immunity.

  2. By the form of release:

    • Tablets
    • Capsules
    • Powders
    • Liquids (solutions, syrups, concentrates)
    • Tea drinks
    • Baors
    • Gelatin capsules

  3. By origin of components:

    • Plant dietary supplements (based on medicinal herbs, fruits, vegetables, etc.)
    • Animal dietary supplements (based on animal products, for example, fish oil, cartilage)
    • Mineral dietary supplements (based on mineral salts and compounds)
    • Synthetic dietary supplements (based on substances obtained by chemically)
    • Microbial dietary supplements (based on microorganisms, for example, probiotics)

II. Regulatory organs and their functions

Control over the production and turnover of dietary supplements in Russia is carried out by several state bodies, each of which performs certain functions:

A. The Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotrebnadzor):

  • State registration of dietary supplements: Rospotrebnadzor carries out state registration of dietary supplements, which is a prerequisite for their production, import and turnover in the territory of the Russian Federation. In the process of registration, an examination of documents confirming the safety and efficiency of dietary supplements is carried out, as well as compliance with the requirements of technical regulations.
  • Sanitary and epidemiological supervision: Rospotrebnadzor supervises compliance with sanitary and epidemiological requirements for the production, storage, transportation and sale of dietary supplements. As part of the supervision, inspections of enterprises engaged in activities with dietary supplements, selection of products for laboratory research and take measures to eliminate the identified violations are carried out.
  • Marking control: Rospotrebnadzor controls the compliance of dietary supplements with the requirements of technical regulations, in particular, TR TS 022/2011 “Food products in terms of its marking.” This includes a verification of the presence of mandatory information about the composition, purpose, method of application, contraindications and other important information for the consumer.
  • Consideration of consumer complaints: Rospotrebnadzor considers consumer complaints about the quality and safety of dietary supplements, as well as violations of consumer rights during their implementation. Based on the results of the consideration of complaints, measures can be taken to protect consumer rights and bring guilty persons accountable.

B. Federal Customs Service (FCS):

  • Control over the import and removal of dietary supplements: The FCS exercises control over the import and export of dietary supplements in the customs territory of the Russian Federation. When importing the databases, the availability of the necessary documents confirming their safety and compliance with the requirements of technical regulations, including certificates of state registration, is checked.
  • Suppressing smuggling of dietary supplements: The FCS takes measures to suppress the smuggling of dietary supplements, including the identification and detention of illegally imported goods.

C. Federal Accreditation Service (Rosakkreditation):

  • Accreditation of certification bodies and testing laboratories: Rosakcreditation is accredited by certification bodies and testing laboratories that evaluate the compliance of dietary supplements with the requirements of technical regulations. Accreditation confirms the competence of certification bodies and testing laboratories carry out work assessment of conformity and issue relevant documents.

D. Other organs:

  • Ministry of Health of the Russian Federation: Participates in the development of regulatory legal acts governing the appeal of dietary supplements, and also carries out a scientific justification for the use of dietary supplements in various fields of medicine.
  • Federal Research Center for food, biotechnology and food safety: He conducts scientific research in the field of food and food safety, including in relation to dietary supplements. Research results are used to substantiate dietary supplements and evaluate their effectiveness.

III. State Bades Registration Procedure

State registration of dietary supplements is a mandatory procedure preceding their release in the Russian Federation. The aim of state registration is to confirm the safety and compliance of the Bad with the established requirements.

A. Stages of state registration:

  1. Application and documents submitting: The applicant (the manufacturer or importer of the BAA) submits an application for state registration of dietary supplements to Rospotrebnadzor, as well as a set of documents confirming the security and compliance of the Bad with the established requirements.

  2. Examination of documents: Rospotrebnadzor conducts an examination of the submitted documents, including an assessment of the composition of the dietary supplement, its physicochemical, microbiological and toxicological indicators, as well as an assessment of the effectiveness of dietary supplements (in the presence of relevant data).

  3. Laboratory research: If necessary, Rospotrebnadzor may prescribe laboratory tests of dietary supplements in accredited testing laboratories. Laboratory studies are carried out to confirm the compliance of the BAD with the established requirements for safety and quality indicators.

  4. Making a decision on state registration: Based on the results of the examination of documents and laboratory tests, Rospotrebnadzor decides to state registration of dietary supplements or refusal to state registration.

  5. Issuance of a certificate of state registration: In the case of a decision on state registration, Rospotrebnadzor issues a certificate of state registration of Bad, which confirms his security and compliance with the established requirements. The certificate of state registration is unlimited.

B. The list of necessary documents for state registration:

  • Application for state registration of dietary supplements.
  • Copies of documents confirming the state registration of the applicant as a legal entity or individual entrepreneur.
  • Normative and technical documentation for dietary supplements (technical conditions, recipe, technological instruction).
  • Documents confirming the composition of the Bad (specifications for raw materials, raw materials test protocols).
  • Documents confirming the safety of Bad (protocols of toxicological studies, sanitary and epidemiological conclusion for production).
  • Documents confirming the effectiveness of dietary supplements (clinical test reports, scientific publications).
  • Sample of the Bad label.
  • A copy of the certificate of state registration of dietary supplements issued in the country-manufacturer (for imported dietary supplements).
  • A document confirming the powers of a person representing the interests of the applicant.

C. Criteria for refusing state registration:

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

  • Presentation of an incomplete set of documents.
  • Identification of the discrepancy between the Bad with the established requirements for safety and quality indicators.
  • The presentation of inaccurate information about the dietary supplement.
  • Lack of documents confirming the safety and effectiveness of dietary supplements.
  • The presence of contraindications for the use of dietary supplements.
  • Identification of the harmful effects of dietary supplement on human health.

IV. Dad production requirements

The production of dietary supplements must comply with certain requirements that ensure safety and product quality.

A. GMP (Good Manufacturing Practice):

  • GMP principles: GMP is a system of norms, rules and instructions regarding the production of medicines, dietary supplements and other products, which regulates the requirements for the organization of production and quality control. The GMP principles are aimed at ensuring the production in accordance with established quality and safety standards.
  • Basic GMP requirements:
    • Ensuring the cleanliness and safety of premises and equipment.
    • Quality control of raw materials and materials.
    • Monitoring the process of production.
    • Quality control of finished products.
    • Ensuring personnel qualifications.
    • Documentation.
    • Organization of the quality management system.
  • Implementation of GMP: The introduction of GMP in enterprises producing dietary supplements is an important condition for ensuring the quality and safety of products. Compliance with GMP requirements is confirmed by a GMP certificate issued by the authorized body.

B. Requirements for premises and equipment:

  • Premises: Production rooms should be clean, dry, well -lit and ventilated. They must be designed and equipped in such a way as to prevent products pollution.
  • Equipment: Equipment used for the production of dietary supplements should be made of materials that do not affect the quality of products. It should be easily cleansed and disinfect. The equipment should regularly undergo maintenance and calibration.

C. Requirements for raw materials and materials:

  • Raw materials: The raw materials used for the production of dietary supplements must comply with the established requirements for quality and safety indicators. It should be checked for the presence of pollutants, such as heavy metals, pesticides and microorganisms.
  • Materials: Packaging materials in contact with dietary supplements should be made of materials allowed for contact with food products. They must ensure the safety of products and prevent their pollution.

D. Personnel Requirements:

  • Qualification: Personnel engaged in the production of dietary supplements must have appropriate qualifications and work experience. It must be trained in GMP rules and safety requirements.
  • Hygiene: The staff must comply with the rules of personal hygiene. He must wear special clothes and shoes, as well as wash his hands regularly.

V. Quality Control

Quality control of dietary supplements is carried out at all stages of production, from the purchase of raw materials to the production of finished products.

A. Types of control:

  • Input control: Quality control of raw materials and materials entering production.
  • Operational control: Product quality control at various stages of the process.
  • Office control: Quality control of finished products before releasing.

B. Methods of control:

  • Physico-chemical methods: Determination of the physicochemical properties of dietary supplements, such as humidity, ash content, acidity, content of active substances.
  • Microbiological methods: Determination of microbiological purity of dietary supplements, identification of pathogenic microorganisms.
  • Toxicological methods: Determination of the toxicity of dietary supplements, the identification of harmful substances.
  • Organoleptic methods: Assessment of appearance, smell, taste and consistency of dietary supplements.

C. Laboratory research:

  • Accredited laboratories: Laboratory studies of dietary supplements should be carried out in accredited testing laboratories licensed to conduct appropriate types of research.
  • Test protocols: The results of laboratory tests should be drawn up in the form of test protocols, which indicate research methods, the results and conclusion on the compliance of the BAD with the established requirements.

VI. Bades labeling

The marking of dietary supplements must comply with the requirements of technical regulations, in particular, TR TS 022/2011 “Food products regarding its marking.”

A. Mandatory information on the label:

  • The name of the dietary supplement.
  • The composition of the dietary supplement (indicating all the ingredients).
  • Information about the nutritional value (calorie content, content of proteins, fats, carbohydrates).
  • Information about biologically active substances (content of vitamins, minerals, other biologically active substances).
  • Recommendations for use (dosage, method of application, duration of admission).
  • Contraindications for use.
  • Warnings (for example, “not a drug”).
  • Best before date.
  • Storage conditions.
  • Name and location of the manufacturer (importer).
  • Party number.
  • Information about state registration.
  • A sign of conformity (if the dietary supplement has passed the confirmation of conformity).

B. Requirements for the design of marking:

  • The marking should be clear, selective and easily readable.
  • Information should be presented in Russian.
  • The marking should be applied to the package so that it is not washed and damaged during transportation and storage.

VII. Advertisement BADov

Advertising of dietary supplements must comply with the requirements of advertising legislation.

A. Forbidden information in the advertising of dietary supplements:

  • Indication of the healing properties of dietary supplements.
  • Comparison of dietary supplements with drugs.
  • The assertion that dietary supplement is a full -fledged substitute for food.
  • The use of inaccurate or misleading information.
  • Advertising of dietary supplements who have not passed state registration.

B. Requirements for Advertising of dietary supplements:

  • Advertising should contain a warning that dietary supplements are not a drug.
  • Advertising should contain recommendations on the use of dietary supplements.
  • Advertising must comply with the requirements of the law on the protection of consumer rights.

VIII. Responsibility for violations of dietary supplements

Violation of the requirements for the production, circulation and advertising of dietary supplements entails administrative, and in some cases criminal liability.

A. Types of responsibility:

  • 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 sanitary and epidemiological requirements for food products, violation of the rules for the sale of certain types of goods, violation of advertising rules.
  • Criminal liability: It is provided for by the Criminal Code of the Russian Federation (Criminal Code of the Russian Federation) for the production, storage, transportation or sale of goods and products, the performance of work or the provision of services that do not meet safety requirements if these acts resulted in negligence causing serious harm to human health or death.

B. Bodies authorized to hold accountable:

  • Rospootrebnadzor: It is brought to administrative responsibility for violation of sanitary and epidemiological requirements and requirements for the labeling of dietary supplements.
  • Federal Antimonopoly Service (FAS): He is attracting to administrative responsibility for violation of advertising legislation.
  • Internal affairs bodies: Criminal cases are initiated for the production, storage, transportation or sale of goods and products that do not meet security requirements.

IX. Harmonization of Russian legislation with international standards

Russian legislation in the field of regulation of dietary supplements is gradually harmonized with international standards, such as:

  • Codex Alimentarius: A collection of international standards, developed by the World Health Organization (WHO) and Food and Agricultural Organization of the UN (FAO).
  • Directives of the European Union: Adjust the appeal of dietary supplements in the territory of the European Union.
  • Recommendations of the World Health Organization (WHO): Relate to the safety and efficiency of dietary supplements.

The harmonization of the legislation is aimed at ensuring a high level of consumer health protection and creating favorable conditions for the development of the basket market.

X. Prospects for the development of dietary supplement regulation in Russia

In the future, further improvement of the system of regulation of dietary supplements in Russia, including:

  • Strengthening control over the quality and safety of dietary supplements: The introduction of new methods of control and tightening the requirements for the production and circulation of dietary supplements.
  • Development of a confirmation of the conformity of dietary supplements: The introduction of voluntary certification of dietary supplements for compliance with quality and safety standards.
  • Increasing consumer awareness about dietary supplements: Conducting information campaigns aimed at increasing the literacy of consumers in relation to dietary supplements and their proper application.
  • Development of a scientific substantiation of the use of dietary supplements: Conducting scientific research aimed at studying the effectiveness and safety of dietary supplements in various health conditions.
  • Development of new regulatory legal acts: Clarification of the requirements for dietary supplements and their appeal, as well as the harmonization of Russian legislation with international standards.

Improving the system of regulation of dietary supplements will contribute to improving the quality and safety of products, protecting consumer rights and developing the market market in Russia.

XI. Risks associated with uncontrolled dietary supplements

Despite the fact that dietary supplements are not drugs, their uncontrolled consumption can lead to certain health risks.

A. Overdose:

Bades, especially containing vitamins and minerals, with excessive use can lead to an overdose. Hypervitaminosis and excess minerals can cause various side effects, such as nausea, vomiting, headache, skin rashes and even more serious disorders in the work of organs and systems.

B. Interaction with drugs:

Some components of dietary supplements can interact with drugs, enhancing or weakening their effect, as well as causing undesirable side effects. It is especially important to consider the interaction of dietary supplements with anticoagulants, antidepressants, drugs for the treatment of cardiovascular diseases and other drugs affecting metabolism and excretion from the body.

C. Allergic reactions:

Bades containing plant extracts, beekeeping products, seafood and other potential allergens can cause allergic reactions in people with increased sensitivity. Allergic reactions can appear in the form of skin rashes, itching, Quincke’s edema, anaphylactic shock and other symptoms.

D. Lack of proven effectiveness:

Many dietary supplements are advertised as means to improve health, preventing diseases and improving immunity, but their effectiveness is not always confirmed by clinical research. In some cases, dietary supplements can be ineffective, and their use – an empty waste of money and time.

E. The content of hazardous substances:

Some dietary supplements, especially produced by unscrupulous manufacturers, may contain hazardous substances, such as heavy metals, pesticides, microorganisms, and even drugs that are not declared. The use of such dietary supplements can cause serious harm to health.

F. Masks of symptoms of diseases:

Reception of dietary supplements to alleviate the symptoms of diseases without consulting a doctor can lead to disguise of serious diseases and delaying the necessary treatment. As a result, the disease can progress and lead to severe complications.

XII. Recommendations for the safe use of dietary supplements

To minimize the risks associated with the use of dietary supplements, the following recommendations must be observed:

  • Consult a doctor: Before taking any dietary supplement, consult a doctor, especially if you have any chronic diseases, you take medications or pregnant/breastfeed.
  • Choose dietary supplements from trusted manufacturers: Buy dietary supplements only from trusted manufacturers with a good reputation and comply with GMP requirements.
  • Read the label carefully: Before using the dietary supplement, read the label carefully, paying attention to the composition, recommendations for use, contraindications and warning.
  • Follow the recommended dosage: Do not exceed the recommended dosage of the dietary supplement indicated on the label.
  • Pay attention to side effects: If after the start of taking Bad you felt any side effects, stop taking it and consult a doctor.
  • Do not take dietary supplements with an expired expiration date: Do not use dietary supplements with an expired expiration date.
  • Do not use dietary supplements as a replacement for good nutrition: Bades are not a full -fledged substitute for food and cannot provide the body with all the necessary nutrients.
  • Tell the doctor about the admission of dietary supplements: When visiting a doctor, be sure to report all the dietary supplements you accept.

Compliance with these recommendations will help you safely use dietary supplements to maintain health and prevent diseases.

XIII. The role of the public in the control of the quality of dietary supplements

The public also plays an important role in monitoring the quality of dietary supplements. Consumers can:

  • Study information about dietary supplements: Before you purchase dietary supplements, study information about it, read the reviews of other consumers, check the availability of state registration certificate.
  • Report on the identified violations: If you are faced with poor -quality dietary supplements, you found violations in the marking or advertising, inform you to Rospotrebnadzor or other authorized bodies.
  • Participate in public discussions: Take part in public discussions on the regulation of dietary supplements, express your opinion and suggestions.
  • Support organizations that protect consumer rights: Support organizations engaged in the protection of consumer rights that help consumers to defend their rights and fight with unscrupulous manufacturers and sellers of dietary supplements.

Active participation of the public in the control of the quality of dietary supplements will help to increase the responsibility of manufacturers and sellers, protect consumer rights and ensure the safety of products.

XIV. Conclusion on the current state of affairs

The dietary supplement market in Russia is characterized by dynamic development and growing demand from consumers. At the same time, there are certain problems associated with quality, safety and regulation of dietary supplements. Improving the regulatory system, strengthening quality control, increasing consumer awareness and the active participation of the public in controlling the quality of dietary supplements are important conditions for ensuring the safety of products and the development of the market of DBAD in Russia.

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