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Own business: production of dietary supplements Sysoeva Lilia. Stages of dietary supplements registration. How to register dietary supplements on the territory of the Customs Union

How is the import and sale of dietary supplements regulated on the territory of the Russian Federation? How do small shops implement them: are these exclusively gray schemes or are there any ways? The crux of the matter: we have been preparing certificates for Japanese dietary supplements for a long time, while a lot of similar funds are sold by small online stores here and now. In the absence of serious budgets, how are they legalized in Russia? Are there any ways to simplify the procedures for preparing dietary supplements for sale? As an answer, it would be great to get 2-3 algorithms for bringing dietary supplements to the market with the least loss of budget and time.

Answer

Mikhail Bozhor,

Legal Counsel for Alta Via

In accordance with the norms of SanPiN 2.3.2.1290-03 "Hygienic requirements for the organization of production and circulation of biologically active food additives (BAA)" dated April 17, 2003, biologically active additives are natural (identical to natural) biologically active substances intended for consumption concurrently with food or introduction into the composition of food products. BAA are used as an additional source of food and biologically active substances to optimize carbohydrate, fat, protein, vitamin and other types of metabolism in various functional states, to normalize and / or improve the functional state of organs and systems of the human body, including products, providing a tonic, mild diuretic, tonic, sedative and other types of action in various functional states, to reduce the risk of diseases, as well as to normalize the microflora of the gastrointestinal tract, as enterosorbents.

According to Article 24 of the Technical Regulations of the Customs Union "On Food Safety" (hereinafter - TR), dietary supplements are allowed for production, storage, transportation and sale only after their state registration. When manufacturing dietary supplements on the territory of the Customs Union (hereinafter referred to as the CU), state registration is carried out at the stage of preparation for the production of products, and when importing dietary supplements - before they are imported into the territory of the CU. The authorized body for the registration of dietary supplements in the Russian Federation is Rospotrebnadzor. Registration is unlimited, but it can be terminated or suspended if the dietary supplement does not meet the requirements of TR. The detailed registration procedure is established by Article 25 of the TR and involves the submission to Rospotrebnadzor of an application in the prescribed form confirming the safety of dietary supplements, research results and additional documents, as well as information on the purpose of dietary supplements (a detailed list of the documents provided is established by clause 29 of the regulations approved by the Order of Rospotrebnadzor dated July 23 2012 N 781). The term for consideration of such an application is 5 working days, if Rospotrebnadzor accepts the applicant, a certificate of state registration of dietary supplements is issued.

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Registration and obtaining a certificate for the implementation of dietary supplements

In accordance with part 1 of article 21 of the TR, the assessment (confirmation) of the compliance of special food products, including dietary supplements, with the requirements of TR is carried out, including in the form of state registration. Thus, the obligatory receipt of a certificate of conformity or the submission of a declaration of conformity for dietary supplements is not provided for by the current legislation. At the same time, it should be borne in mind that, on the basis of Article 39 of the TR, the packaging of registered dietary supplements must necessarily contain the EAC marking - a single sign of product circulation on the market of the CU member states.

If the requirements for state registration are not met, for manufacturers and sellers of unregistered dietary supplements there is a risk of prosecution on the basis of Part 1 of Article 6.33 of the Administrative Code with the imposition of a fine on the legal entity in the amount of 1 million to 5 million rubles or administrative suspension of activities for up to ninety days. If the violation is committed on a large scale (the cost of sold dietary supplements exceeds 100 thousand rubles), then the seller risks being prosecuted on the basis of Article 238.1 of the Criminal Code of the Russian Federation - "Circulation of counterfeit, substandard and unregistered drugs, medical devices and circulation of counterfeit dietary supplements" ... The sale of dietary supplements without the required labeling creates for a legal entity the risk of a fine in the amount of 50 thousand to 300 thousand rubles with the confiscation of unmarked dietary supplements on the basis of Part 2 of Article 15.12 of the Administrative Code.

Rules for the sale of dietary supplements on the territory of Russia via the Internet

Remote sale of dietary supplements is not allowed. According to clause 7.4.1. SanPiN 2.3.2.1290-03, the retail trade of dietary supplements is carried out through pharmacies, specialized stores selling dietary products and grocery stores. Violation of the established rules for the sale of certain types of goods, in accordance with Article 14.15 of the Administrative Code, entails the imposition of an administrative fine on legal entities in the amount of ten thousand to thirty thousand rubles.

Requirements for advertising stimulating the sale of dietary supplements

  1. create the impression that they are drugs and / or have medicinal properties;
  2. contain links to specific cases of curing people, improving their condition as a result of the use of such additives;
  3. contain expressions of gratitude by individuals in connection with the use of such additives;
  4. encourage the rejection of a healthy diet;
  5. create an impression of the benefits of such additives by referring to the fact that research is required for state registration of such additives, and also use the results of other studies in the form of a direct recommendation for the use of such additives.

In addition, an advertisement for dietary supplements in each case must be accompanied by a warning that the advertised object is not a drug; the above article also establishes additional requirements for the format of advertisements. In case of violation of the requirements for advertising dietary supplements, the advertiser or advertising distributor may be held liable under Part 5 of Article 14.3 of the Administrative Code with a fine from 200 thousand to 500 thousand rubles.

Of course, there are "gray" schemes for the implementation of dietary supplements in a remote way. Sites for the sale of dietary supplements can be registered on front persons, and the sale of goods can be carried out on behalf of an individual or without specifying the sender of the dietary supplement at all. Some of the existing stores can operate according to an agency scheme, ordering unregistered dietary supplements on behalf of and at the expense of a buyer abroad for a certain percentage of the cost of the goods, while others can provide exclusively intermediary services involving the sale of registered dietary supplements to the end customer through large stores. But all these schemes carry serious risks of prosecution, including criminal liability, for the seller acting in the legal field.

If a person receives state payments for old age, and at the same time carries out custody of children, then he can count on fixed amounts. They are calculated based on different criteria and can vary between 1600-7686 rubles. Dependents, people who cannot provide for themselves, are:

  • young children who have not reached the age of majority;
  • disabled persons with disabilities;
  • full-time students.

What affects the size of the supplement Such supplements to the pension are calculated on the basis of different circumstances, individually in each case. When calculating the amounts, the following is taken into account:

  • the age of the person applying for the supplement;
  • number of dependents;
  • how old is the caregiver.

Depending on the territorial coefficients, the allowances may be different.

Who is entitled to a supplement to the pension for children born before 1990

Hello, dear readers of ProfiComment magazine. Today we decided to deal with the news, actively circulated in recent months, about additional payments to pensions for children born before 1990.


Important

Is this so and is there really such a premium? In order to find out the answer to this question, visit the official sources. The content of the article:

  • 1. Pension supplement for children born before 1990 in 2017 - law

When will the pension be paid to women who gave birth to children before 1990

Pension supplement for children born before 1990 in 2017 - law A detailed study of the official website of the Pension Fund of Russia found only information that employees of the regional offices of the PF RF have recently faced a flurry of questions about supplementary payments to pensions for children born in the USSR.

Pension supplement for children born before 1990

Attention

For children born before 1990 Since now the basis of all payments are special points, the addition to the pension for children can be significant for women whose labor activity fell on the "Soviet" period, when maternity leave was not recorded in the work book, was not included in general work experience, and was not paid. Now the time of caring for a child is considered a non-insurance period, certain accrued points are paid for it, and if a woman has several children, and her work experience was interrupted by caring for them, then the additional premium can be very significant.


Who is entitled to a fixed supplement to the pension for a minor child Do not confuse the current innovation on the additional accrual of funds for children, and the fixed supplements to the pension assigned to elderly people in their care of minors.

403 forbidden

After recalculation, there may be different options, the pension may increase insignificantly and may even become smaller, in which case you can refuse the pension "in a new way" and receive it according to the old calculation, as before. Who is entitled to recalculation of pensions for children born before 1990 Not everyone is entitled to recalculation, this must be taken into account.


There are certain categories of pensioners who are not allowed to recalculate their pension according to the law. All this needs to be recognized in the PF. So, according to the explanations in the Pension Fund, all retired women can apply to them.

The recalculation will be beneficial for those who have left to take a break from work before 2015. All other pensioners were immediately recalculated their pensions in the best way for them.

Also, the person who applied must have a small pension, otherwise there is simply no point in counting “for children”, well, the number of children must exceed one person - that is, two or more.

Pension supplement for children born before 1990 - what documents are needed?

Home Finance Among pensioners, the innovation about the recalculation of pension amounts caused a stir, according to which it became possible to pay an additional pension to women for children. A decrease in purchasing power, an economic crisis, lead to the fact that any additional charges to the existing pension can become a significant increase in the budget of people of old age.
All pensioners, especially women, are interested in the question - who is entitled to a supplement to the pension for children born in 1990, how the recalculation will be carried out, and how to arrange payments. What is the supplement to the pension for children? Employees of the Pension Fund explain that the supplement to pensioners for children is not a literal payment of money to all women who have children. It's just a different way of calculating the amounts. With this calculation, it does not matter in what period the child was born - before 1990 or after it.

Who is entitled to a supplement to the pension for children born before 1990

For some categories of citizens, such accrual conditions will be beneficial, but not always. It should be borne in mind that if points are awarded according to daylight saving time, then it leaves the total length of service, and a situation is possible when the amount of the pension as a whole becomes lower than it was before the recalculation.

In addition, if a person has not reached retirement age, but receives government contributions ahead of schedule, then leaving a certain number of years from service will deprive him of the right to the due pension. Who can apply for recalculation If the calculations show that it is unprofitable for a citizen to transfer maternity time from the general experience to point calculations, then the amount paid does not change, because the PF RF has no right to worsen a person's financial situation.

For one and a half maternity years, 2.7 points will be awarded for the first child, for 2 - 5.4, for 3 and 4 - 8.1.

The whole truth about the supplement to the pension for women who gave birth to children in the ussr before 1990

The amounts of such additional payments are different, depending on the specific circumstances, about which it is necessary to notify the local authorities of the PF. For example, for a pensioner raising a child who is studying full-time, an increase in his pension is established at a fixed level (this is 1,500 rubles).

But, as soon as the educated person stops studying or reaches 23 years of age, such payments stop. FEDERAL PENSION SUPPLEMENT LAW FOR CHILDREN BORN BEFORE 1990: NEW REGULATION Government representatives have developed an appropriate order, thanks to which monthly additional payments to pensions have become possible. Women whose children were born before 1990, in other words, during the Soviet era, can count on such an increased pension.

True, there is one more additional condition: the woman had to retire no later than 2015.
This can be done in person by coming through the portal of public services - or using the services of the Russian Post. Is there a supplement to the pension for children born before 1990 or before 1980? The increase is calculated for children who were born earlier than the specified years. The calculation will not be beneficial for all pensioners, but only for those who:

  1. Didn't have an official job.
  2. Had little income or wages.

It makes no sense to apply for recalculation in such cases:

  1. Retirement took place in 2015-2018. This calculation option is not economically feasible. The size of the increase is equal to zero or even goes to minus.
  2. The pensioner has one child.

What documents are needed to supplement a pension born before 1990

A pension supplement cannot be issued to a pensioner if he receives an insurance payment for a disabled person who was dependent. In general, it will be up to the FIU specialist to determine whether a citizen can receive additional points. As a rule, pensioners actually receive an increase in monthly payments for children born before 1990 or before 1980.

The size of the increase to the pension for women with children - an example of the recalculation of the pension for children born during the USSR period and later The size of the point increase, which will then be recalculated into the monetary equivalent, is influenced by the individual factors of the applicant. The calculation depends on: 1. The number of children. Note that point allowances can only be awarded for 6 years, that is, for four children, and no more.

Note that if, with such a recalculation, it turns out that the woman's pension has only become less, then you will be left with the one that was. To recalculate, you need to contact the local Pension Fund, and already there write a corresponding application. FEDERAL PENSION SUPPLEMENT LAW FOR CHILDREN BORN UNDER 1990: WHAT DOCUMENTS ARE NECESSARY To receive a copayment, you will need the following documents: first, an application for a copayment, in which you indicate your personal data, place of residence, as well as information about the child. secondly, the child's birth certificate. thirdly, a work book or other document on labor activity. fourthly, a certificate stating that you have not previously applied for such a payment. fifth, form number 9, which is issued at the passport office.

The supplement to the pension for children in the Russian Federation is carried out for each child if he is a person who does not have his own income, that is, he is fully supported by the pensioner. This is material assistance. The size of pension additional payments is different, depending on the specific circumstances, which must be notified to the local authorities of the Pension Fund.

For example, for a pensioner raising a child who is studying full-time, an increase in his pension is established at a fixed level (this is 1,500 rubles). But, as soon as the educated person stops studying or reaches the age of 23, such payments stop.
The government decree on a pension supplement for women who gave birth to children before 1990 has already entered into force and it is already possible to apply for a pension recalculation (in August 2017, but it is possible later).

Documents required for the sale of food products in the retail network and public catering

In connection with the numerous incoming requests regarding the documents required at the present time for the sale of food products in the trade network and public catering, we inform you the following.

From July 1, 2013 On the territory of the Customs Union, the Technical Regulations of the Customs Union TR CU 021/2011 "On food safety" (hereinafter referred to as TR CU 021/2011), approved by the decision of the Customs Union Commission dated 09.12.2011, are in force.

From 15 February 2015 all food products, with the exception of fish and fish products, released into circulation on the territory of the Customs Union (Russia, Belarus, Kazakhstan), are subject to mandatory confirmation of conformity in the manner established by TR CU 021/2011.

According to the requirements of TR CU 021/2011, the main form of confirmation of the conformity of food products is obligatory declaration its compliance with the legislation of the Customs Union with registration and registration declaration of conformity with the technical regulations of the Customs Union() - a document confirming compliance with the mandatory safety requirements for products and their compliance with the requirements of the Customs Union.

According to article 23 of TR CU 021/2011: “Food products put into circulation in the customs territory of the Customs Union shall be subject to declaration of conformity, with the exception of:

1) unprocessed food products of animal origin (subject to veterinary and sanitary examination with the issuance of a veterinary certificate (certificate);

2) specialized and new food products (subject to state registration with a certificate of state registration);

3) vinegar (not subject to any form of conformity assessment (confirmation)) ".

The declaration of conformity of the Customs Union is accepted (drawn up) by the manufacturer or supplier of products and is submitted for registration to an accredited certification body.

An applicant (declarant) when declaring compliance with the requirements of the Technical Regulations of the Customs Union can only be an organization registered in the territory of the Customs Union.

Declaration of conformity of food products to the requirements of TR CU 021/2011 and (or) technical regulations of the Customs Union for certain types of food products is carried out by accepting, at the option of the applicant, a declaration of conformity based on their own evidence and (or) evidence obtained with the participation of a third party.

The declaration of conformity of food products is carried out according to one of the declaration schemes established by TR CU 021/2011, at the choice of the applicant for food products. The procedure for declaring conformity under the CU TR includes several stages: preparation and collection of a complete package of documents for submission to the registering authority, execution and acceptance of the declaration, registration of the declaration in the Unified Register of Registered Declarations of the Customs Union.

The sale of goods without a declaration of conformity to the technical regulations of the Customs Union in cases where the products fall under the declaration according to the requirements of the technical regulations of the Customs Union is prohibited, subject to forced recall from the market and is punishable by a fine.

Veterinary and sanitary examination subject to unprocessed food products of animal origin, which, upon being released into circulation, is accompanied by a document containing information confirming safety (Article 30 of CU TR 021/2011).

By virtue of Article 4 of CU TR 021/2011, unprocessed food products of animal origin - unprocessed (processed) carcasses (carcasses) of productive animals of all types, parts thereof (including blood and offal), raw milk, raw skim milk, raw cream, beekeeping products, eggs and egg products, catch of aquatic biological resources, aquaculture products. The technical regulation of the Customs Union TR CU 034/2013 "On the safety of meat and meat products" specifies the list of products subject to veterinary and sanitary examination: slaughter products - unprocessed food products of animal origin, obtained as a result of industrial slaughter of productive animals and used for further processing (processing) and (or) sales, including meat, offal, raw fat, blood, bone, mechanically deboned meat (additional deboning), collagen-containing and intestinal raw materials.

The veterinary and sanitary examination and registration of its results are carried out in accordance with the legislation of a member state of the Customs Union, as well as the Agreement of the Customs Union on veterinary and sanitary measures.

Confirmation of compliance fish and fish products on the basis of the Decree of the Government of the Russian Federation dated 01.12.2009. No. 982 "On approval of a unified list of products subject to mandatory certification, and a unified list of products, the conformity of which is confirmed in the form of a declaration of conformity" is carried out in the form adoption of a declaration of conformity.

In addition to documents confirming the compliance of food products with the requirements of the technical regulations of the Customs Union, food products in circulation, including food (food) raw materials, must be accompanied by shipping documentation ensuring the traceability of this product(Article 5 of TR CU 021/2011). Traceability of food products - the ability to documentary (on paper and (or) electronic media) establish the manufacturer and subsequent owners of the food products in circulation, except for the end consumer, as well as the place of origin (production, manufacture) of food products and (or) food (food) raw materials (Article 4 of CU 021/2011).

Thus, food products may be in legal circulation accompanied by the following documents:

3) veterinary certificate (veterinary certificate) (unprocessed food products of animal origin);

4) certificate of state registration (new and specialized food products);

5) shipping documentation ensuring the traceability of food products (all food products).

As defined in the Technical Regulations,

Biologically active food additives (BAA)- natural and(or) biologically active substances identical to natural, andprobiotic microorganisms intended for consumptionsimultaneously with food or introduction into food products

The dietary supplement includes exactly ready-to-use forms (in tablets, capsules, in the form of syrups, jellies, powders, etc.), which are used either directly or diluted with a liquid, and do not require additional procedures for preparation.

How to register dietary supplements on the territory of the Customs Union

Here you will find up-to-date and useful information on the registration of dietary supplements in Russia and other EurAsEC countries.

Where to register dietary supplements?

On the territory of the Eurasian Economic Union, dietary supplements are registered:
... in RF - Federal Service of Rospotrebnadzor
... in Belarus - Republican Center for Hygiene and Public Health
... in Kazakhstan - by the Committee on Consumer Rights Protection of the Ministry of National Economy of the Republic of Kazakhstan
... in Kyrgyzstan - by the Department of Disease Prevention and State Sanitary and Epidemiological Surveillance of the Ministry of Health of the Kyrgyz Republic
The registration procedure itself is the same and differs only in price and timing.

Requirements for dietary supplements

All requirements for dietary supplements and their production processes are set out in the Technical Regulations.

Stages of dietary supplements registration

Registration includes 3 main stages:
1.Testing samples
2.examination of documentation
3. execution of a certificate of state registration

What is tested during testing?

Safety of dietary supplements
... Authenticity (compliance of declared and actually present components)
Sometimes - GMO status

After research and expertise, a decision is made on the state registration of dietary supplements.

What happens with a negative opinion?

If you receive a negative expert opinion in the Russian Federation, then a copy of it will also go to Rospotrebnadzor. This will greatly complicate its further registration, or even make it impossible. To register, you will have to change the name of the dietary supplement and re-go through the entire procedure from scratch. Similar procedures are in place in Belarus and Kazakhstan.

Do you want to register a dietary supplement without any problems the first time?

Then we draw your attention to the key requirements:

BAA - an additional source of biologically active substances / microorganisms

Your product can be considered a dietary supplement only if it contains biologically active substances / microorganisms in an amount of more than 10% of the adequate level of consumption per day, but not more than the upper permissible level of consumption. It is these components that are indicated in the certificate of state registration of dietary supplements in the formulation "... an additional source ...".
If your dietary supplement also contains biologically active components in an amount from 5% to 10% of an adequate level of consumption, such components are also indicated in the SGR on the dietary supplement, but with the wording "... contains ...".

Safety

During the registration tests of dietary supplements, the following safety indicators are checked:
... microbiological indicators
... Content of toxic elements
... Pesticides (for dietary supplements with herbal ingredients)
... Permissible levels of radionuclides

Do you want to avoid unnecessary costs and make sure in advance that your product, according to its properties, can really be registered as a dietary supplement?

We will conduct pre-registration tests, according to the results of which you can correct the recipe, technology, or simply gain confidence that your dietary supplement can be successfully registered without modifications.
We ensure that pre-registration tests are carried out only in accredited laboratories and, in case of positive results, the obtained protocols can be used directly in the registration process.

Allowed components

The components that are allowed to be used in dietary supplements in the territory of the Customs Union differ from other countries. Prohibited ones include, for example, Tribulus Terrestris, which is popular with athletes and freely distributed in many countries, and, for example, - unexpectedly - nutmeg, which is freely sold as a spice. The list of prohibited components can be found in Appendix 7 to the Technical Regulations of the Customs Union "On Food Safety" (TR CU 021/2011).

The presence of dyes or preservatives

The content of dyes and / or preservatives in the dietary supplement you are registering must comply with the Technical Regulations of the Customs Union "Requirements for the Safety of Food Additives, Flavors and Technological Aids (TR CU 029/2012).
If the permissible limits are exceeded, you will have to adjust the recipe.

Do you have any doubts that the composition of dietary supplements fully meets the requirements?

A recipe indicating the quantitative content of ALL, incl. auxiliary, components. If there are plant components in the composition, be sure to indicate their Latin name and from which parts of the plant these components are obtained. Our experts will conduct a preliminary examination of the composition of your dietary supplement and, if necessary, give recommendations on adjusting the recipe and / or technology.
You will not lose anything, tk. the price of the preliminary examination will be deducted from the cost of services for supporting the registration of dietary supplements, but you can gain time and save money, because in the event of a negative result of the official examination, the money for it will not be returned.

Food Traditions

For registration in the Russian Federation, a dietary supplement must contain only components that have a tradition of food use at least in the country of origin (according to the Decree of the Chief State Sanitary Doctor of the Russian Federation No. 2 of 01/17/2013).

The presence of oils in the composition

If your dietary supplement contains oil, you may need to check its compliance with the requirements of the Technical Regulations of the Customs Union "Technical Regulations for Fat and Oil Products" (TR CU 024/2011).

Marking

The labeling of dietary supplements is regulated by the requirements of the Technical Regulations "Food products in terms of their labeling" (TR CU 022/2011).

Explanatory note

To register a dietary supplement, you must also provide an explanatory note with the seal and signature of an authorized person from the manufacturer
We can help you draw up the necessary explanatory note that justifies the properties of dietary supplements due to the presence of certain components in the composition.

Each dietary supplement has its own testimony

If you register several dietary supplements, even very similar in composition, you will need to receive a separate certificate for each dietary supplement.
An exception is the registration of dietary supplements in various forms (for example, powder, capsules, tablets).
When registering dietary supplements in Russia, it is highly likely that you will be able to receive one certificate of state registration for dietary supplements with different tastes. When registering in Belarus, even the difference in tastes is considered significant, and you will have to issue as many certificates of state registration for dietary supplements as you declare. In Kazakhstan, the issue of combining dietary supplements with different tastes into one certificate of state registration does not have an unambiguous solution, and remains at the discretion of experts.

What is required for registration of dietary supplements

For state registration of dietary supplements, it is necessary to submit a set of documents for examination (see the requirements for sets of documents for the registration of imported dietary supplements and for the registration of dietary supplements produced in the territory of the Customs Union).

To register a dietary supplement on the territory of the Russian Federation, you will need to provide all documents in 2 copies (one in the dossier for examination, the second in the dossier for state registration), for registration of a dietary supplement in Belarus or Kazakhstan, one set of documents will be enough.

Documents submitted for state registration of dietary supplements in a foreign language must be accompanied by a translation into Russian, notarized or signed by a translator with a copy of the translator's diploma.

The presence of foreign test reports, certificates of analysis and reports is taken into account, but does not obviate the need for testing in a laboratory accredited by the Customs Union.

We recommend that you pay special attention to the labeling of the dietary supplement: in order to avoid unnecessary costs, you should not order the printing of labels before the layout has been confirmed by experts, so that later you do not have to make additional stickers and / or pay fines.

One of the mandatory documents for the registration of dietary supplements is an explanatory note substantiating the properties of dietary supplements due to the presence of certain components in the composition. Our experts will help you compose it, if necessary. But our team can also organize and conduct clinical studies of dietary supplements so that both you and your consumers can be really confident in the effectiveness of dietary supplements. Then, in addition to the certificate of state registration of products, you will be able to receive a research report and a voluntary certificate.

For Russian manufacturers of dietary supplements, it will be required to provide a sample selection certificate, certified by the seal of the local territorial FBUZ. Even if this document is not required when accepting documents for examination, registration documents will not be accepted without such an act.

To register dietary supplements, you will also need to provide samples for testing - 6-8 pcs. (depending on the standard packing, ~ 200-300 g).

Prices and terms of registration of dietary supplements

The price for the examination and testing of dietary supplements depends on the number of dietary supplements components.

In the Russian Federation, the price of examination and testing of dietary supplements is regulated by the Order of Rospotrebnadzor dated September 17, 2012 N 907 "On approval of the methodology for determining the size of the fee and the maximum amount of payment for sanitary and epidemiological examinations, investigations, examinations, studies, tests, toxicological, hygienic and other types of assessments in the field of sanitary and epidemiological human welfare ".

According to the Order, dietary supplements are divided into 5 groups of complexity. Approximate prices of tests and expertise for dietary supplements of the 1st complexity group - single-component dietary supplements ~ 45 thousand rubles, for dietary supplements of the 5th complexity group - dietary supplements, in which 11 or more components are ~ 100 thousand rubles.

The standard term for testing / examination of dietary supplements is 60 days, registration - 30 days, provided that there are no comments from the experts to the submitted documents. If necessary, we can help to optimize the timing.

When registering multicomponent dietary supplements in Belarus, more modest budgets are required, but the period is much longer.

You can see the approximate terms and prices for registration of dietary supplements in Belarus and the Russian Federation on a turnkey basis in the section.

Data on dietary supplements that have passed the state registration procedure are entered into the Unified Register of State Registration Certificates (if the Unified Register is inoperable, see the national parts of the Unified Register of the Russian Federation, the Republic of Belarus, and the Republic of Kazakhstan).

In order to avoid receiving a refusal in registration, we strongly recommend that you check BEFORE submitting an application for registration of products, whether it is in the registers of certificates of state registration of products, because under the law, a specific product of a specific manufacturer is registered only once, the applicant is not important!

Nutritional supplements are used to impart certain properties and qualities to food: achieving product resistance to certain types of spoilage, changing the appearance of the product and its organoleptic properties, increasing the shelf life of the product, imparting a certain taste to the product, etc. For the convenience of classification and labeling of products, all food additives are assigned special digital three-digit codes starting with the Latin letter E (from E100 to E800).

In Russia, the design of a hygienic certificate for food additives(Sanitary and Epidemiological Conclusion, FEZ) and Declaration of Conformity are mandatory. In our country, the use of food processing additives is also regulated by SanPiN 2.3.2.1078-01 and GOST for specific products.

Food additives include defoamers, sweeteners, sealants, gelling agents, leavening agents, enzymes, surfactants, organic acids, mineral salts, and antibiotics (used in the food industry). But amino acids, vitamins and trace elements, as well as juices, syrups, cognacs, liqueurs and spices that are used in food production, do not belong to food additives. As well as all kinds of auxiliary materials used in the process of food production, but they are ultimately not included in them, or included in food products in trace quantities.

In accordance with the Order of the Ministry of Health of Russia dated July 19, 2007 N 224 "On sanitary and epidemiological examinations, examinations, studies, tests and toxicological, hygienic and other types of assessments"(Clause 1 of Appendix No. 2) hygienic - a sanitary and epidemiological conclusion (SEZ) must be drawn up without fail.

The number of food additives (permitted for use) today reaches 500 items. For any of them you can order a hygienic food additives certificate in the Certification Center "Certification". Our experts will also help you with registration of food additives produced (imported) by you in the Department of the Ministry of Health of the Russian Federation, except for those prohibited for use in Russia:

  • calcium bromate (E924b),
  • food dye citrus red (E121),
  • amaranth (E123),
  • potassium bromate (E924a),
  • formaldehyde (E240).

A certificate of state registration of a food additive is required to be presented during customs clearance.

You can order hygienic food additives certificate(SEZ) and the Declaration of Conformity for both single-component and complex food additives (for example, snack mixes, curries, hops-suneli). Our experts will help you with certification of artificial food additives such as vanillin, pectin (issued voluntary food additives certificate in accordance with GOST 29186-91), monosodium glutamate, citric acid, vinegar, fructose. And, if you decide to confirm the quality of your products, we will help you to issue a voluntary food additives certificate your production. Contact professionals - save your time and money.