THE STATE REGISTRATION OF BIOLOGICALLY ACTIVE FOOD ADDITIVES (BAA) Contacting BAA on the territory of Republic of Belarus is carried out exclusively by a document confirming safety, issued by the authorized body (certificate of state registration of the Unified form, certificate of state hygienic registration of Republic of Belarus).
Certificate of state registration of food additives has the same legal effect in any of the countries of the Customs Union. This certificate confirms the safety of dietary supplements for humans and their compliance with uniform sanitary requirements of the Customs Union. It does not matter who issued the document, Republic of Belarus, Russian Federation and Republic of Kazakhstan.
Powers Maintenance activities of the Commission to determine the procedure for registration and sale of dietary supplements of the Ministry of Health of Republic of Belarus on the state agency charged with “Republican Center for Hygiene, Epidemiology and Public Health” (Decree of the Ministry of Health of Republic of Belarus of August, 1 N 879 "On amendments and additions to the decree of Ministry of health of Republic of Belarus of January 1, 2011 N 1).
Conducting laboratory determination of biologically active substances, in accordance with Annex N 5 of Section I of Chapter II of the Uniform Requirements, carried by state institute “Republican Scientific and Practical Centre of Hygiene,” “Center for examination and tests in health service” (Laboratory of pharmaceutical and pharmaceutical analysis, Republican control and analytical laboratory).
Requirements for BAA All the requirements for biologically active additives and their production processes are set out in the Technical Regulations TC (EAEC) "On food safety (TR CU 021/2011 adopted by the CU Commission Decision of December 9, 2011 N 880".
Steps for registration of dietary supplements
1) testing of samples;
2) examination of documents;
3) design of certificate registration.
Security During registration trials BAA is checking following security:
• Microbiological;
• The content of toxic elements;
• Pesticides (for dietary supplements with plant components);
• Acceptable levels of radionuclides.
If you want to make sure in advance that your product by its properties can actually be registered as a dietary supplement, please contact us (
info@regpharmpat.by), we will hold a pre-registration test, the results of which you can adjust the recipe, technology or simply gain confidence that your supplements may be successfully registered without modification.
We provide pre-registration conducting tests only in accredited laboratories and, in the case of positive results obtained protocols can be used in the registration process.
Approved components List of prohibited ingredients can be found in Annex 7 of the Technical Regulations of the Customs Union.
Each BAA - its certificate
If you register several, even very similar in composition dietary supplements, you will need to obtain a separate certificate for each BAA.
The exception is register supplements in various forms (e.g., powders, capsules, tablets).
In Republic of Belarus registration of BAA even contrast in tastes should be essential, and you issue certificates of state registration of dietary supplements, as much as you represent.
Documents required for registration of dietary supplements (in accordance with Annex 3 to the number of Unified form of a document confirming safety of products approved Resolution Customs Union Commission dated May 28, 2010 N 299.
For the purposes of issuing a document confirming safety of products (goods), you should have following documents: 1. Quality Certificate issued by authorities, confirming that the product is not a medicine, but an biologically active additive (dietary supplement) (
should be legalized);
2. The hygienic certificate, which indicates that the manufacturing process corresponds to the national and/or international requirements for biologically active food additives. (for example, ISO certificate) (
should be legalized);
3. Documents confirming legal registration of the manufacture in the country of origin (
should be legalized);
4. Specification; The document shold contain the following: safety data and parameters;
composition of ingred ients and its characteristics, expiration date, storage conditions. In case of biologically active food additives are presented, which contain the parts of the plant, their botanical name in the Latinuage and form (extract, infusion, etc.) (
should be indicated);
5. Manufacturer’s quality and safety certificates, protocols of analysis;
6. Brief information about the manufacturing technology, enterprise standard of this biologically active food additive production;
7. Explanatory note, which describes this biologically active food additive, including scientific basis for the effectiveness of the supplement, its application scope, application recommendation, contraindications, application limitation if they presence;
8. Declaration confirming presence or absence of the genetically modified organisms;
9. Declaration confirming absence of psychotropic and drastic components;
10. Declaration confirming not using of nanotechnologies;
11. Certificate of origin for raw materials;
12. Manufacturer’s power of attorney to performance the registration of the biologically active food additives registration with indication of the recipient of registration certificate both its owner and with indication of the right to sign the contracts*. (
should be legalized);
13. Samples (totally 450-500 g.)
Translations of documents the manufacturer (manufacturer) in foreign languages must be certified in accordance with the legislation of the Party, where state registration is conducted.
Parties may further request other documents provided for, legislation of the Party where state registration is conducted.
In the design of the document confirming safety of products (goods) could be refused in the following cases:
inconsistency of controlled goods Uniform sanitary requirements;
if presented documents and (or) information that is not complying with the legislation of the Party where state registration is conducted, as well as co-holding false information;
If there are no parties provided by the legislation, where state registration is conducted, the reasons for processing and issuing a document confirming safety of products (goods);
if in respect of controlled goods and the conditions of their production and trafficking can not be at the present level of development of science set safety requirements, and there are no methods for determining and measuring in production and habitat brow-century hazards of such products;
the availability of information about cases of adverse effects of controlled goods on human health and its habitat in the production, trafficking and consumption (use of either) production.
The decision on refusal by post or by e-mail within three working days to the applicant, Director (manager) of the authorized bodies of the Parties and entered into information system of the Eurasian Economic Community in the field of technical regulation, sanitary and phytosanitary measures, and an integrated information system of foreign and mutual trade of the Customs Union.
All documents for registration in Republic of Belarus are available in a single copy.
Represented foreign applicants should have a document, accompanied by a Russian translation, notarized or signed by interpreter with a copy of the diploma of interpreter.
The presence of foreign test reports, certificates of analysis and reporting-when taken into account, but does not eliminate the need for testing in the laboratory, L-bath in Republic of Belarus.
We recommend to pay attention to the labeling of dietary supplements: Do not order the printing of labels to confirm the layout experts, so you do not have to make additional labels and / or pay fines.
One of the documents required for registration of dietary supplements is an explanatory memorandum justifying the properties of dietary supplements by the presence of certain components in the composition. Our experts will help it make, if necessary. But our team and can also organize and conduct clinical studies of dietary supplements to both you and your customers can really be sure of the effectiveness of dietary supplements. Then, in addition to the certificate of state registration of products you can get a report on research and voluntary certificate.
To register, BAA also need to provide samples for testing - 6-8 pcs. (Depending on the standard packaging, ~ 450-500 g).
Pricing and registration of dietary supplements
Price examination and testing of dietary supplements depend on the number of components of dietary supplements.
Approximate prices of tests and examination for 1 complexity group BAA - BAA-component ~ 600 US dollars; BAA Group 5 difficulty - BAA, in which 11 or more components ~ 950 US dollars.
Standard term test / examination BAA is 60 days, the registration - up to 30 days in the absence of comments from the experts to apply for. If necessary, we can help to optimize the timing.
Data on dietary supplements that have passed the procedure of state registration, shall be entered into a single-Register of certificates of state registration or national of the Unified Register of the Russian Federation, Republic of Belarus, Republic of Kazakhstan.
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