Circular No. 08/2004/TT-BYT guiding the management of functional foodstuff products

OFr!C!t\L CAlLl ft THE IVl{NJSIJ3.Y.0F HEALTH CIRCULAR No:' ()8/2004/TT~BYT OF AUGUST ,23, 2004 GUIDING THE MANAGEMENT OF FUNCTIONAL FOODSTUFF PRODUCTS In order to uniformly manage the trading of functional foodstuff products on the market, ensure safety for consumers' health and create favorable conditions for enterprises in their business activities, the Ministry of Health hereby guides the management of functional foodstuff products (hereinafter called functlona\ ~oodstuff~, for short) as follows: I. DEFINITION AND APPELLATIONS OF FUNCTIONAL FOODSTUFFS 1. Fu nctlonaJ foodstuffs mean tlloso u sod to m1pport human organs' functiom", ~1avo nutrient 2. FH11ctional foodstuffs, depending on their effects, contents of micro~substanccs and l1se lnstruclions, also have other appellations below: a/ Food~,tuf1s complemented with micro nutrients; b/ Complementary foodstuffs; c/ Health protection foodstuffs; d/ Medical nutritious products. II. CONDITIONS FOR DETERMINATION OF FUNCTIONAL FOODSTUFFS Foodstuff products complemented wfth such nutrients as vitamins, mineral salts and biological active agent-containing substances, wllich are announced as functional foodstuffs by producers or are certified by competent State bodies of the producing countries or the circulation~permitting countries that they comply with the foodstuff legislation, and fully meeuhe following conditions, shall be regarded as functional foodstuffs: "I . For foodstuffs comp1etnented with micro-nutrients: If the daily volume of micro .. nutrient intakes under the use instructions inscribed in the products' labels consists of at least one vitamin or mineral salt witt1 its content tJeing 3 times higher than that in the Recommended Nutr-ient Intakes (RNI 2002) issued together with this Circular (not printed ~10rein), the certificates of products' safety issued by the competent State bodies of the producing countries or the circulation--permitting countries are required, and the RNI levels of added micro nutrients must be clearly inscribed in the products' labels or auxiliary labels (for import products}; effects, put !luman body at ease, incroa:H-J 2. For biological activH agent••cont,1ining resistance and roch1ce pathoqenic dw1qnrf; functional foodstuffs: If Hie products am OFFICl/\1. GAZl-~lTt announced -\o t,avo eHects 01 suppnrtino tiurn,;rn organs' functions, increasing the rosistn.nce oi· reducing pan1ogenic dangers, the clinical testing rnports on the products' effects or docurnenh, proving tho effects of the product:,' components with suct1 functions or the certificates of the products' effects inscribed on t11e labels, issued by competent State bodies of the producing countries or the circulation~permitting countries, are required. 3. The contents inscribed in functional foodstuffs' labels must meet the conditions >1.ccording to law provisions on labels and the following conditions: a/ The contents of use instructions for special purpose products rnust include appellations of pmducfgroups { comp!emen~iy foodstuffs, health protection foodstuffs, functional foodstuffs, diet foodstuffs, medical nutritious foodstuffs); users, products' effects, dosages, contraindications, special notes, or side-effects of products (if any): bl For biological active agent-containing foodstuffs, the following words "These products are not medicines, having no eifects of substituting curative medicines" must be inscribed on tfleir labels or auxiliary labels; c/ Functional foodstuff products' labels must not be inscribed with treatment indications for any specific diseases or with their effect of substituting curative medicines. 4. For vitamin- and mineral salt-containing products which are not listed in the RNI mentioned in Clause 1 of this Section, products which are produced at home but not yet identifiod as 1oods1uffs or medicines, or products containin[l biologically active substances, without adequate rJocurnentB to provo the safety and effects of 1.,uc1·1 active substances, the Foodstuff Safety and l-lygiunc Oopa1lmunt shall have to assu111G ti prime (esponsibflity tor, and coordinate Vi.Ii Vietnam f)harmacy Management Depal'tme and tho Traditional Medir.ine Department of tt Health Ministry in, considering for cfassificEJit and uniform management. Ill. MANAGEMENT OF FUNCTIONAL. FOODSTUFFS 1. Functional foodstuffs which fully meet thl conditions prescribed in Section II of this Circuit shall be managed and compliant with !a1 pro'.1isions on. foodstuffs. These products :<1.r subject to the announcertientotfoodstuff hygicn and sa1ety standards at the Foodstuff Safety a11 Hygiene Department, the ·Health Ministry, strict!· according to law provisions·oh·foodstuffs befon they are put into circulation on the market. 2. The•information on, advertisement for am labeling of products which are regarded a: functional foodstuffs shall comply with lav provisions on Information, advertisement anc labeling, and must ensure the truthfulness accuracy and clarity, arid must not causE damage to producers, traders or consumers lV. IMPLEMENTATION ORGANIZATION 1. The Foodstuff Safety and Hygiene Department of the Health Ministry shall have ta organize, d(rect, examine, inspect and supervL:;8 the implementation of this Circular. 2.. The provinc\al/munic\pa\ Health Services a1 ;d Health Sections of the branches shall have to organize, di roct, inspect, exam i ntrana · s upervi: :(::, t\1e imp\ement:1.tion of this Circular by the functiorFtl foodstuff-producing and --tradinq units. 3. Tho functional foodBtuff-producing and trndinn units sliall lwvo to irnpl:-,rn:'r!f J1·1p pmvisions of thi:~ Circular. V. IMPLEMENTI\T!ON PROVISIONS 1. This Circular takes (➔ ffE-,ct ·1 b days aftor· its publication in the Official Gazette. To annul the Health Ministry's Circular No. 20/2001/TT-BYT of September 11, 2001 guiding the mana~1ement of medicinal foodstuff products. 2. In the course of implementation of this , Circular, if any difficulties or problems arise, the unit;, 8hould rop0rtthemto the Ministry of Health (the Foodstuff Safety and Hygiene Departrnentj tor consideration and settlement. For the Health Minister Vice Minister TRAN CHI LIEM No. 0/ (Gii D 20(Jll)