Sunday, February 1, 2015

Regulatory framework on food safety testing

i.          General regulatory framework on food safety
The Law on the Quality of Products and Goods No. 05/2007/QH12 dated 21 November 2007 (“QPG Law”) and Law on Food Safety 55/2010/QH12 dated 17 June 2010 (“FS Law”), together with their guiding regulations, are the legal documents primarily regulating food safety matters in Vietnam.
The QPG Law (effective as of 1 July 2008) regulates the responsibilities of manufacturers/ traders for the quality of their products and provides for the Ministry of Science and Technology’s overall responsibility for State management of the quality of goods, including foods. The FS Law (effective as of 1 July 2011), specifies the responsibilities to the Ministry of Health (MOH), Ministry of Agriculture and Rural Development (MARD) and Ministry of Industry and Trade (MOIT) for the safety of food; and describes the rights and obligations of organizations and individuals in respect of food safety, conditions to ensure food safety and doing business in food, advertising, labeling food etc.
In general, to produce and/or trade in foods, entities must satisfy certain conditions on health and safety in order to be licensed and, with respect to high-risk foods, must obtain a certificate on satisfaction of standards on food hygiene and safety. Items that relate to food, safety, hygiene, human health and the environment must meet Vietnamese standards for the hygiene and safety of food products set by the MOH. However, applicable food regulations allow in principle, for higher food safety and better food control system for the purpose of protecting public health, preventing fraud and deception, reducing food adulteration and facilitate trade.
Moreover, the FS Law requires publication of conformity with food safety regulations of products/goods before they are circulated on the market.  There are slightly different regimes and requirements for producers of items such as processed food, food additives, food-processing support substances, equipment, packaging materials, food containers for which there are specific technical regulations and those of other items[1].
According to the Circular No. 19/2012/TT-BYT[2], to comply with such obligations, organizations may use appointed testing laboratories, recognized independent testing laboratories, accepted testing laboratories or use a certifying organization appointed by the MOH in order to conduct product tests.
The Circular No. 19/2012/TT-BYT[3] defines such laboratories as follows: (i) appointed testing laboratories are testing laboratories appointed by competent agencies in Vietnam; (ii) recognized independent testing laboratories are testing laboratories which have been recognized by a recognizing organization and organized independently of the producers; and (iii) accepted testing laboratories are testing laboratories of organizations producing product which have been recognized by a recognizing organization and testing laboratory appointed by overseas competent agencies.
ii.         Regulatory framework on food safety testing services
With respect to activities of food testing, the FS Law provides that food testing means the conduct of one or several tests and assessments of the conformity with relevant technical regulations and standards of food, food additives, food processing aids, food fortifiers, packages, tools and food containers. The FS Law has one chapter regulating activities of food testing, analysis of food safety risks, prevention and remedy of food safety incidents.
Under the FS Law, food testing establishments must satisfy certain conditions to operate legally.  Specifically, under Article 46 of the FS Law, food testing establishments must: (i) have organizational apparatus and technical capacity qualified for the requirements of national or international standards applicable to the testing establishments; (ii) establish and maintain a managerial system qualified for the requirements of national or international standards; (iii) register the operation of assessment of conformity with standards or technical regulations with a competent State agency when engaging in the certification activities of standard or regulation conformity.
Under the FS Law, Food testing establishments may provide testing services, collect testing charges and take responsibility before law for the results of their tests[4].
Joint Circular No. 20/2013/TTLT-BYT-BCT-BNNPTNT dated 01 August 2013 regulating the conditions, orders, procedures for appointing Food testing establishments for the purpose of State management (“Joint Circular No. 20”) provides further guidance on the conditions for food testing establishments.  Specifically, that food testing establishments must be established in accordance with laws, and have registered function of food testing. Meanwhile, with respect to the capacity, food testing establishments must meet certain requirements including: (i) having quality management system meeting National Standard No. TCVN ISO/IEC 17025: 2007 or International Standard ISO/IEC 17025:2005; (ii) having equipment and facilities suitable for conducting tests within the entity’s registered scope of operations; (iii) having at least two testers who have university-level training qualifications in the registered field and at least three years testing experience in the same field.
Joint Circular No. 20 also provides that food testing establishments may submit registration dossier to be appointed as food testing establishments for the purpose of State management (and/or for non-State private purposes).
iii.        Business line of Food safety testing
In Vietnam, business lines are classified under the Vietnam’ Economic Branch System which is defined similarly to the International Standard Industrial Classification of All Economic Activities of the United Nations. With respect to food testing and analysis, this activity broadly falls under Biz Code No. 7120 (technical testing and analysis) which includes testing activities in the field of food hygiene, including veterinary testing and control in relation to food production
Under Vietnam’s WTO Service Sector Commitments, technical testing and analysis is classified under the United Nation’s CPC provision code Class: 8676 - Technical testing and analysis services with the subclass: 86761 - Composition and purity testing and analysis services which include the activities of “testing and analysis services of the chemical and biological properties of materials such as air, water, waste (municipal and industrial), fuels, metal, soil, minerals, food and chemicals. Included are testing and analysis services in related scientific fields such as microbiology, biochemistry, bacteriology, etc. Excluded are medical and dental testing services.” 
Under the WTO Commitments, foreign investors are allowed in principle to directly iunvest in Vietnam to establish entities engaged in technical testing and analysis activities (CPC 8676, excluding conformity testing of transport vehicles and certification of transport vehicles).  Though certain exceptions were included in the WTO Commitments where joint ventures would be required, these were limited and, at present, foreign investors are freely allowed to invest in this sector subject to general foreign investment licensing rules.



[1] Article 3 of Decree No. 38/2012/ND-CP of the Government dated 25 April 2012 Detailing the implementation of a number of articles of the Law on Food Safety (“Decree No. 38/2012/ND-CP”)
[2] Circular No. 19/2012/TT-BYT of the Ministry of Health dated 09 November 2012 Guiding the announcement of regulation conformity and announcement on conformity with regulation on food safety (“Circular No. 19/2012/TT-BYT”)
[3] Article 2 of Circular No. 19/2012/TT-BYT
[4] Article 46.2 of FS Law