Circular No. 08/2013/TT-BYT guiding the advertisement of food under the management of the Ministry of Health

Issue nos 09-10/March 2013 49 THE MINISTRY OF HEALTH Circular No. 08/2013/TT-BYT of March 13, 2013, guiding the advertisement of food under the management of the Ministry of Health Pursuant to June 21, 2012 Advertising Law No. 16/2012/QH13; Pursuant to June 17, 2010LawNo. 55/2010/ QH12 on Food Safety and the Government's Decree No. 38/2012/ND-CP of April 2 5, 2012, detailing a number of articles of the Law on Food Safety; Pursuant to the Government's Decree No. 63/2012/ND-CP of August 31, 2012, defining the functions, tasks, powers and organizational structure of the Ministry of Health; At the proposal of the director of the Vzetnam Food Administration; The Minister of Health promulgates the Circular guiding the advertisement of food under the management of the Ministry of Health. e Vietnam Law & Legal Forum 50 Chapter I GENERAL PROVISIONS Article 1. Scope of regulation 1. This Circular provides conditions, competence, dossiers and procedures for certifying contents of adve1tisements of food under the management of the Ministiy of Health. 2. This Circular applies to organizations and individuals engaged in the introduction and advertisement of food under the management of the Minist1y Health in Vietnam's tenito1y. Article 2. Types of foodsubject to registration of adve1tisement contents 1. Functional food; 2. Micronut:1ient-fo1tified food; 3. Natural mineral water; 4. Bottled water; 5. Food additives, food processing aids; 6. Food packaging tools and food packages and containers used during food production, processing and ti·ading; Article 3. Prohibited acts in food adve1tising 1. Advertising food without written ce1tifications of adve1tisement contents granted by competent health agencies. 2. Advertising counte1f eit or poor-quality food. 3. Advertising food as having effects as medicines. 4. Adve1tising food not in confonnity with the contents of the regulation conformity announcement or the announcement of confonnity with food safety regulations or exaggerating the effects of food. Issue nos 09-10/Marcb 2013 (Cong Bao nos 169-170/March 25, 2013) 5. Adve1tising food in the form of a1ticles written by physicians, phannacists or health workers desc1ibing food as having effects of treating diseases. 6. Using images, reputation and mails of health units and health workers or letters of thanks of patients for food adve1tising. 7. Other prohibited acts as prescribed by the adve1tising law. Chapter II CONDITIONS, COMPETENCE, DOSSIERS AND PROCEDURES FOR CERTIFYING CONTENTS OF FOOD ADVERTISEMENTS Article 4. Conditions on contents of food adve1tisements 1. The adve1tisement contents of in the mass media, on leaflets, posters and bills must comply with announced infonnation on the effects of products; other info1mation, if any, must be proved with scientific documents, and the following details must be accurate and trnthful: a/ Name of the product; b/ Origin of goods, names and addresses of the manufacturer and impo1ter; c/ Effects of the product (if any); di Warnings (if any) for using the product; dd/ Inst:111ctions for use and preservation ( for products having special usages and requiring special methods of preservation); el For functional food, the advertisements must read or say: "This product is not medicine and cannot substitute medicine." The adve1tisements must be written in Times New Roman font, size 14 pt, or must be audible in n01mal conditions. © Vietnam Law & Legal Forom Issue nos 09-10/March 2013 (Cong Bao nos 169-170/March 25, 2013) 2. Adve1tisements on signboards, billboards, panels, racks, shelves and other objects, aerial, unde1water or moving objects do not necessarily contain all information on the product (usages, effects, preservation) but must be consistent with the content of the regulation conf onnity announcement or the announcement of confo1mity with food safety regulations. Article 5. Competence to grant written ce1tifications of contents of food adve1tisements, registration for organization of food introduction seminars and conferences 1. The Ministiy of Health assigns the Vietnam FoodAdministi-ation to grant wiitten ce1tifications of contents of adve1tisements of functional food and micronutrient fortified food. 2. Food Safety and Hygiene Depa1tments shall grant w1itten ce1tifications of contents of adve1tisements of food under the management of the health sector, including bottled water, natural 1nineral water; food additives, food processing aids, food packaging tools and food packages and containers dming food production, processing and trading; certify dossiers of registration for organization of seminars and conferences to introduce food under the management of Ministry of Health in their localities; and ce1tify contents of adve1tisements of food under the management of other 1ninist:1ies or sectors stating health effects. Article 6. Dossiers of registration for certification of food adve1tisement contents Before advertising food, organizations and individuals shall send 1 set of dossier of registration of advertisement contents to a competent state agency. A dossier set comprises: 51 1. A written registration for certification of contents of the adve1tisement (made according to Appendix 1 to this Circular); 2. The business registration certificate, for enterprises, or the establishment license, for representative offices of foreign traders ( copy bearing the registering organization's or individual's seal); 3. Thewiitten ce1tification of the announcement of confonnity with food safety regulations (for products for which relevant technical regulations are not available) or receipt of the technical regulation confonnity announcement issued by a competent state agency ( copy bearing the registeling organization's or individual's seal); 4. The product info1mation sheet ce1tified by a competent agency ( copy beaiing the registe1ing organization's or individual's seal). 5. The food adve1tisement: a/ One video, audio or computer disc recorded with the advertisement contents, enclosed with two copies of the script (bearing the registering organization's or individual's seal), for television, cinema or radio adve1tisements. b/ Two copies of the adve1tisement layout (bearing the registering organization's or individual's seal) enclosed with an elecu·onic file of the adve1tisement contents applied for registration, for advertisements on printed newspapers, leaflets, posters and bills or on other objects, adve1tisements on e-newspapers, e-po1tals of enterprises or adve1tising agencies and on the Internet. 6. Reference documents and scientific documents evidencing information not yet included in the ce1tified product inf onnation sheet. In case these documents are written in © Vietnam Law & Legal Fornm 52 a foreign language, their Vietnamese versions are required. These documents must bear the registering organization's or individual's seal affixed on every two adjoining pages. 7. The specimen label of the product approved by a competent health agency ( copy bearing the registering organization's or individual's seal). Article 7. Procedures for grant of written ce1tifications of food adve1tisement contents 1. Within 10 working days after receiving a valid and complete dossier, a competent state agency shall grant a written ce1tification of adve1tisement contents (made according to Appendix 2 to this Circular); in case of refusal, it shall issue a written reply clearly stating the reason. 2. Within 3 months after the dossier­ receiving agency issues a written request for dossier supplementation and modification, if the registering agency, organization or individual fails to modify and supplement the dossier or reply in writing the dossier-receiving agency, it/he/she will be considered no longer wishing to adve1tise food as registered. Article 8. Food introduction seminars and conferences 1. Seminars to introduce food with domestic sale pe11nits or without domestic sale pe11nits but having pe1mits for sale in the countiy of manufacture may be organized as follows: a/ Domestic organizations or individuals with relevant business registration ce1tificates may organize food inti·oduction seminars; b/ Foreign organizations and individuals Issue nos 09-10/Marcb 2013 (Cong Bao nos 169-170/March 25, 2013) wishing to organize a seminar on food products not yet permitted for sale in Vietnam but already permitted for sale in the countly of manufacture shall coordinate with a domestic organization or individual possessing a relevant business registration ce1tificate in organizing the seminar. 2. Speakers at a seminar must possess professional qualifications in medicine, pharmacy or nutrition or a university or higher-level degree in relevant disciplines and shall take responsibility before law for the trnthfulness and accuracy of their speeches at the seminar or conference. 3. Contents of food inti·oduction documents used at seminars and conferences must comply with the advertising law and other relevant laws. 4. Before organizing a food introduction seminar or conference, an organization or individual shall send a dossier of request for certification of contents of the seminar or conference to a competent state agency in the locality where the seminar or conference will be organized and may organize the seminar or conference only after obtaining the written certification of the dossier of registration of a food inti·oduction seminar or conference. 5. Activities of inti·oducing and adve1tising donors' products at seminars or conferences must comply with advertising regulations of this Circular and other relevant laws. Article 9. Dossiers and procedures for certifying the registi·ation for organization of food inti·oduction seminars and conferences 1. A dossier of registration for organization of a food introduction seminar or conference comprises: © Vietnam Law & Legal Forom Issue nos 09-10/March 2013 (Cong Bao nos 169-170/March 25, 2013) a/ Tue wlitten registration of the agenda of the food introduction seminar or conference (made according to Appendix 3 to this Circular). b/ A copy of the business registration ce1tificate, for enterprises, or the establishment license, for representative offices ( copy beaiing the registe1ing organization's or individual's seal); c/ The ce1tificate of the standard applicable to the product or the receipt of the registration of the regulation confonnity announcement, certified by a health agency. For food not yet pem1itted for sale in Vietnam but having a certificate of free sale in the country of manufacture, such certificate is required ( copy bearing the registe1ing organization's or individual's seal); di A copy of the product info1mation sheet certified by a competent agency ( copy bearing the registering organization's and individual's seal); dd/ Specimen labels of the product (copies bearing the registering organization's and individual's seal); el Two copies of the layout or script or a set of documents to be used in the seminar or conference bearing the registering organization's or individual's ce1tification and seal on eve1y two adjoining pages ( enclosed with 1 video or audio disc or electronic file); g/ A list of speakers (with infonnation on their professional diplomas or academic titles); h/ Reference or scientific documents proving advertising information not yet mentioned in the ce1tified product info1mation sheet. In case these documents are made in a foreign language, their Vietnamese versions are required. These documents must have the registering organization' or individual' seal 53 affixed on eve1y two adjoining pages. 2. Procedures for ce1tifying the contents of advertisements of food products at food introduction seminars or conferences Before organizing a food introduction seminar or conference, an organization or individual shall send a registration dossier to the Food Safety and Hygiene Department of the locality where the seminar or conference will be organized. Within 10 working days after receiving a complete and valid dossier, the Food Safety and Hygiene Department shall issue a written ce1tification of the dossier of registration for a food introduction seminar or conference (made according to Appendix 4 to this Circular); in case of refusal, it shall issue a written reply clearly stating the reason. Article 10. Method of numbering written ce1tifications of food adve1tisement contents 1. Written certifications of advertisement contents granted by the Ministry of Health (the Vietnam Food Administration) shall be numbered in the following order: serial number/ year of grant/XNQC-ATTP (for example: 123/2008/XNCQ-ATTP). 2. Written certifications of advertisement contents granted by provincial-level Food Safety and Hygiene Sub-Departments shall be numbered similarly as those granted by the Vietnam Food Administration, followed by the abbreviated name of the province or centrally run city after two capital letters YT. The abbreviated names of provinces and centrally rnn cities are provided in Appendix 5 to this Circular. For example: 123/2013/ XNQC-YTHN. © Vietnam Law & Legal Fornm 54 AI·ticle 11. Validity of w1itten certifications of food adve1tisement contents A wiitten ce1tification of food adve1tisement contents will be invalidated in the following cases: Issue nos 09-10/Marcb 2013 (Cong Bao nos 169-170/March 25, 2013) the Ministry of Health (the Vietnam Food Administration) for study and settlement. Minister of Health NGUYEN THI KIM TIEN I. The receipt of the regulation confo1mity * All appendices to this Circular are not announcement or the wiitten ce1tification of the translated. announcement of confo1mity with food safety regulations is no longer valid. 2. The enterprise has its certificate of satisfaction of food hygiene and safety conditions revoked. 3. There are changes in product compositions or uses. Chapter III IMPLEMENTATION PROVISIONS Article 12. Effect This Circular takes effect onAp1il 26, 2013. Article 13. Transitional provisions Agencies, organizations and individuals that have registered food adve1tisement dossiers and received the receipts of dossiers ofregistration for adve1tisement of food or food additives from a competent state agency before the effective date of this Circular may continue the advertisements until these advertising documents are no longer valid. Article 14. Organization of implementation The d irectors of the Vietnam Food Administration and provincial-level Health Departments shall organize the implementation of this Circular. Any problems arising in the process of implementation should be reported to © Vietnam Law & Legal Forom