Regulatory documents
The decision of the chief state sanitary inspector of the Russian Federation from 20th of May, 2009. N 36, Moscow, from “On the biological active food suppliers audit (BAFS)”
• Published on 5th of August, 2009.
• Comes into effect on 16th of August, 2009.
Registered in the Ministry of Justice of the Russian Federation on 10th of July, 2009.
Registered N 14312.
I am the chief state sanitary inspector of the Russian Federation - G.G. Onishchenko, having analyzed the implementation of the decision of the Chief state sanitary inspector of the Russian Federation from 06.03.2007 N 8 "On the increase of manufacturing and circulation supervision of BAFS"1, and the materials of the state supervision for obligatory requirements on manufacturing and circulation of biological active food suppliers (later - BAFS) established by the normative legal enactments of the Russian Federation, note that:
At the consumers market of the Russian Federation there are more than 7500 BAFS in the circulation. In 2008, the Federal service for supervision in the sphere of protection of consumers' rights and welfare of a person registered 1675 BAFS (2004 - 884, 2005 - 1949, 2006 - 1855, 2007 - 1621) of domestic and foreign manufacturing.
By the end of 2008 in the Russian Federation had worked 182 organizations engaged in the BAFS manufacturing, 63% out of which were located in the Central and Siberian federal districts.
In the BAFS manufacturing there are engaged 38 860 projects: 3506 trade organizations, 783 storing warehouses, and 34 385 projects of pharmaceutical network.
Among the observed organizations in 2008 engaged in the BAFS manufacturing, the irregularities of the sanitary-and-epidemiologic requirements was found in 39 out of 87 that made up 44,7%.
In the BAFS manufacturing the following irregularities are found more often:
- unsatisfactory sanitary-and-technical condition of working areas;
- lack of documents validated the safety of incoming raw materials;
- the BAFS manufacturing without the governmental registration certificate;
- lack of control of released products;
- the BAFS retail trade is executed out of the adopted paragraph 7.4.1. of The Sanitary Regulations and Normatives 2.3.2.1290-03 "The hygienic requirements to the biological active food suppliers (BAFS)2 manufacturing and circulation organization", alongside by means of distant and distributor trade;
- nonobservance of the storing terms of BAFS;
- BAFS sales without documents approved their governmental registration;
- discrepancy of the information contained on the label with the requirements established by the legislative acts of the Russian Federation.
There are cases of lacking the information of the ingredients composition of BAFS in the label, lacking the information about the biological active substances the source of which is a BAFS, contraindications to the use of BAFS, information that BAFS is not a medicine.
The institutions of the Russian Trade and Sanitary Inspection carry out laboratory BAFS researches on the hygienic indicators and on the composition of the biological active substances. Thus, in 2008:
- on the chemical indicators there were studied 13 032 of BAFS tests, 1,16% out of which did not correspond to the hygienic regulations, 4,92% on the same indicator of import BAFS;
- on the microbiological indicators there were studied 17 953 of BAFS tests, 3,63% out of which did not correspond to the hygienic regulations, 5,48% on the same indicator of import BAFS;
- on the testing of biological active substances there were studied 2185 of BAFS tests, из них не соответствовали установленным требованиям 4,5% out of which did not correspond to the established requirements.
According to the results of the revealed irregulations there were issued the orders of removal from sales 772 batches of BAFS with the volume of 857 kg, 1426 - fined to the sum of 2793545 rubles, 8 projects were suspended from the operation which were engaged in BAFS manufacturing and circulation (Rostov Oblast, Krasnodar Region, Adygei Republic, Tatarstan Republic, St. Petersburg). The materials on 12 issues of infraction of the legislation connected with BAFS manufacturing and circulation were forwarded to the law-enforcement authorities by the Department of the Russian Trade and Sanitary Inspection to the Tatarstan Republic, Altai, Primorye, Krasnodar, Krasnoyarsk Territories, Penza, Sverdlovsk, Kurgan, Rostov Oblasts, and Khanty-Mansi Autonomous Okrug.
By the Federal Supervision Service in the sphere of protection of consumers' rights and welfare of a person there have been received numerous complaints from the citizens of the Russian Federation about the malpractice of BAFS distribution that has evident signs of fraud.
The mentioned is expressed, in particular, in informing the consumers with deliberately false information about different non-existing clinics, medical centres, and other false information that mislead people.
At the same time, a wrong stable mistrust and evidently negative consumers' attitude are formed even in spite of the fact that in the citizens' complaints in the overwhelming majority of cases figure the food products of the mentioned group given in a legal circulation and underwent the governmental registration procedure.
As it is often occur, in the capacity of BAFS consumers there are figured people of an advanced age, including disabled persons inclined to submit to the influence of insistent persuasions, this kind of appellations indicates the purposeful and obviously intentional illegal actions in relation to the citizen-applicants from the side of the persons identification of which is complicated in some cases by the use of fake names and addresses, the evaluation to whom must be given by the law-enforcement authorities
A special anxiety is provoked by the sufferers' described cases of buying BAFS in the network that has nothing in common with the purchase contract, that causing harm to their health that can testify the penal act indication from the side of persons who sold BAFS.
To the Federal service for supervision in the sphere of protection of consumers' rights and welfare of a person there were sent the appropriate applications concerning the Prosecutor General's Office of the Russian Federation and the Chief Directorate of Home Affairs of Moscow to solve the issue on the taking required measures of registration on the basis of received materials.
The problem connected with illegal sales of BAFS that contains in its composition potent agents, narcotic substances, and psychotropic substance, is still actual. In connection with it there were expanded the list of forbidden BAFS and products for manufacturing that can cause harm for health of a person (the Sanitary Regulations and Normatives 2.3.2.2351-08 "The add-ins and alterations N7to the Sanitary Regulations and Normatives 2.3.2.1078-01" adopted by the Chief state sanitary inspector of the Russian Federation from05.03.2008 N 173). There are registered numerous facts of the disregard of advertising legislation.
The raw of the managing subjects with a help of the Mass Media means gives to the population the deliberately false information about the consumers features of BAFS indicating the application sphere that does not correspond to the recording in the governmental registration certificate.
In concordance with the Federal law from 30.03.1999 N 52-FL "On the sanitary-epidemiological well-being of the population" (The Legislation Meeting of the Russian Federation, 1999, N 14, art. 1650; 2002, N 1 (part 1), art. 2; 2003, N 2, art. 167; 2003, N 27 (part 1), art. 2700; 2004, N 35, art. 3607; 2005, N 19, art. 1752; 2006, N 1, art. 10; 2006, N 52 (part 1), art. 5498; 2007, N 1 (part 1), art. 21; 2007, N 1 (part 1), art. 29; 2007, N 27, art. 3213; 2007, N 46, art. 5554; 2007, N 49, art. 6070; 2008, N 24, art. 2801; 2008, N 29 (part 1), art. 3418; 2008, N 44, art. 4984; 2008, N 52 (part 1), art. 6223; 2008, N 30 (part 2), art. 3616; 2009, N 1, art. 17), and by the Law of the Russian Federationи from 07.02.1992 N 2300-1 "On the protection of consumers' rights" (The Legislation Meeting of the Russian Federation, 15.01.1996, N 3, art. 140, 20.12.1999, N 51, art. 6287, 07.01.2002, N 1 (part 1), art. 2, 30.08.2004, N 35, art. 3607, 08.11.2004, N 45, art. 4377, 27.12.2004, N 52 (part 1), art. 5275, 31.07.2006, N 31 (1 part), art. 3439, 23.10.2006, N 43, art. 4412, 27.11.2006, N 48, art. 4943, 29.10.2007, N 44, art. 5282, 28.07.2008, N 30 (part 2), art. 3616) decree:
1. To the juridical persons and individual entrepreneurs who implement an import on the territory of the Russian Federation, BAFS manufacturing and circulation:
1.1. To supply with quality and safety of BAFS in concordance with the legislation of the Russian Federation;
1.2. To implement the sales of BAFS strictly in concordance with the Sanitary Regulations and Normatives 2.3.2.1290-03 "The hygienic requirements to the manufacturing organization and circulation of the biological active food suppliers (BAFS)" in the pharmaceutical institutions and specialized stores, or in the grocery stores, in the dietary products departments;
1.3. To observe the requirements on the information entering on the label that is coordinated with the governmental registration certificate of BAFS;
1.4. Do not allow use the terms in the names of BAFS and in the drawings that lead astray and indicate the supposed efficiency of BAFS;
1.5. To take measures on securing the legislation implement when preparing an advertisement material about BAFS;
2. To ask the Ministry of Home Affairs of the Russian Federation with a view to nonadmission of illegal BAFS spreading - to enforce the measures on suppression within its competence;
3. To recommend to the means of mass media:
3.1. To ensure the implement of obligatory requirements when spreading the BAFS advertisement;
3.2. To recommend assisting the bodies of the Russian Trade and Sanitary Inspection in the execution of work on the information of the population on the issues of BAFS sales.
4. To the managers of the Administration bodies of the Public Health of the subjects of the Russian Federation - to take measures on nonadmission for medical workers to prescribe BAFS in the capacity of agents which have a medicinal effect.
5. To the Institution of the Russian Academy of Medical Sciences to the Scientific-research Institute of Nutrition - to finalize the project of methodical directions "The guide on the methods of the quality control and safety of BAFS for food" with a glance of notes of the experts of the state sanitary-hygienic standardization at the Russian Trade and Sanitary Inspection, and to represent it to the Russian Trade and Sanitary Inspection till 15.06.2009.
6. To the chief doctors of the Federal State Institution of Health of the hygienic-and- epidemiology centre in the subjects of the Russian Federation - to take measures on providing the experimental laboratories with the modern equipment and training courses for the specialists on the control methods of BAFS.
7. To the administration managers of the Russian Trade and Sanitary Inspection on the subjects of the Russian Federation:
7.1. To enforce the governmental BAFS manufacturing and circulation inspection paying attention to the correspondence of information on the product with the established requirements;
7.2. To meet the requirement in the cooperation with the bodies of the public prosecutor's office and home affairs on the issues of illegal circulation of BAFS;
7.3. To hold events jointly with the law-enforcement authorities on control and inspection in relation to the juridical persons and individual entrepreneurs who implement the BAFS sales;
7.4. To carry out an explanatory work in the means of mass media on the issues of the BAFS sales;
7.5. To report about the carried out work till 01.01.2010.
8. To entrust the control over the implementation of the given decision to the deputy of the Chief state sanitary doctor of the Russian Federation - L.P. Gulchenko.
1 Registered in the Ministry of Justice of Russia 09.04.2007, registration number 9267
2 Registered in the Ministry of Justice of Russia 15.05.2003, registration number 4536
3 Registered in the Ministry of Justice of Russia 03.04.2008, registration number 11465