Nghị định 38/2012/NĐ-CP hướng dẫn Luật an toàn thực phẩm

DECREE

DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE LAW ON FOOD SAFETY

Pursuant to the Law on Governmental Organization dated December 25, 2001;

Pursuant to the Law on Food Safety dated June 17, 2010;

Pursuant to the Law on standards and technical regulations dated June 29, 2006;

Pursuant to the Law on quality of products, commodities dated November 21, 2007;

At the request of the Minister of Health;

The Government issues a Decree detailing the implementation of some Articles of the Law on Food Safety,

Chapter 1.

GENERAL PROVISIONS

Article 1. Scope of governing

This Decree details the implementation of some Articles of the Law on Food Safety for:

1. Publication of regulation conformity or publication of conformity with the provisions on food safety.

2. Assurance of safety for genetically modified food.

3. Grant and revocation of certificates of eligible facilities for food safety.

4. State inspection on food safety for imported or exported food.

5. Food labeling.

6. Assignment of responsibilities for State management on food safety:

a) Responsibilities of state management on food safety of the Ministry of Health;

b) Responsibilities of state management on food safety of the Ministry of Agriculture and Rural Development;

c) Responsibilities of state management on food safety of the Ministry of Industry and Trade;

d) Responsibilities of state management on food safety of the People's Committees at all levels;

đ) Coordination between the Ministries managing sectors in the performance of state management function on food safety.

7. Specialized inspection on food safety.

Article 2. Subjects of application

This Decree applies to the agencies, organizations, and individuals of Vietnam; the foreign organizations, individuals in Vietnam engaged in production, sales of food; the organizations and individuals engaged in activities related to food safety in Vietnam (hereinafter referred to as organizations and individuals).

Chapter 2.

PUBLICATION OF REGULATION CONFORMITY AND PUBLICATION OF CONFORMITY WITH FOOD SAFETY REGULATIONS

Article 3. Publication of regulation conformity or publication of conformity with food safety regulations

1. Processed food packed availably; food additives; food-processing supporting substances; equipment, packaging materials, food containers (hereinafter referred to as products) that had technical regulations must be publicized regulation conformity and the written publication of regulation conformity must be registered with the competent state agency before products are circulated on the market.

2. The products that have not promulgated technical regulations shall be publicized conformity with food safety regulations and the written publication of conformity with food safety regulations must be registered with the competent state agency before products are circulated on the market until the respective technical regulations are promulgated and take effect.

Article 4. Receipt of written publication of regulation conformity or publication of conformity with food safety regulations

1. The Ministry of Health is responsible for managing the receipt of application for registering the written publication of regulation conformity and publication of conformity with food safety regulations for the organizations and individuals producing and trading products, including: functional foods; food additives; food processing supporting substances; imported products as processed food packed availably, equipment, materials for packaging and food containers.

2. The Departments of Health are responsible for managing the receipt of application for registering the written publication of regulation conformity and publication of conformity with food safety regulations for the products domestically produced of organizations and individuals producing, trading such products located in their respective management areas other than products defined in clause 1 of this Article.

3. Within 7 working days after receiving complete and valid dossiers, the competent State agencies must issue the receipts of the written publication of regulation conformity for dossiers registering for publication of regulation conformity under form specified in Form No.01a issued together with this Decree; in case of refusal, the competent State agencies must issue written replies stating clearly the reasons there for.

4. Within 15 working days after receiving complete and valid dossiers, the competent State agencies must issue the written certification of conformity publication of food safety regulations for dossiers registering for publication of food safety regulations under form specified in Form No.01b issued together with this Decree; in case of refusal, the competent State agencies must issue written replies stating clearly the reasons there for.

5. Within 30 working days after receiving complete and valid dossiers, the competent State agencies must issue the written certification of conformity publication of food safety regulations for dossiers registering for publication of conformity with food safety regulations as functional foods, food fortified with micronutrients in the form prescribed in Form No.01B issued together with this Decree; in case of refusal, the competent State agencies must issue written replies stating clearly the reasons there for.

6. The dossier-receiving agencies of publication of regulation conformity or publication of conformity with food safety regulations shall publicize the products that have been granted the receipts of the written publication of regulation conformity or the written certification of conformity publication of food safety regulations on their electronic information pages (websites) and on the mass media upon request.

Every month, the Health Departments report to the Ministry of Health the reception results of dossiers of publication of regulation conformity or publication of conformity with food safety regulations.

Article 5. Dossier for publication of regulation conformity for the products having been issued technical regulations

1. Publication of regulation conformity based results of certification of regulation conformity of the certification organizations of regulation conformity to be appointed (third party), dossier comprises:

a) A written publication of regulation conformity as prescribed in Form No.02 enclosed with this Decree;

b) A detailed product information, as prescribed in Form No.03a or Form No.03c issued together with this Decree (with joint pages stamp of third party);

c) A certificate of conformity of a third party (notarized copy or copy with the original for comparison);

d) A certificate of conformity with standards of HACCP or ISO 22000 or equivalent in the case the producing organizations and individuals have a quality management system certified as complying with standards of HACCP or ISO 22000 or equivalent (the notarized copy or copy with the original for comparison).

2. Publication of regulation conformity based on results of self-assessment of organizations and individuals producing and trading in food (first party), dossier comprises:

a) Publication of regulation conformity as prescribed in Form No.02 enclosed with this Decree;

b) Detailed information of product, as prescribed in Form No.03a or Form No.03c issued together with this Decree.

c) The product testing results within 12 months, including the criteria required by the respective technical standards; granted by the following entities: the laboratories appointed by competent state agencies or the independent laboratories to be accredited (original or notarized copy); or the laboratories of the origin countries recognized by the competent agencies in Vietnam (original or certified copy or consular legalized);

d) A quality control plan be developed and applied in the form prescribed in Form No.04 enclosed with this Decree (the first-party’s written confirmation);

đ) A periodical monitoring plan (the first-party’s written confirmation);

e) A report on regulation conformity assessment (the first-party’s written confirmation);

g) A certificate of conformity with standards of HACCP or ISO 22000 or equivalent in the case the producing organizations and individuals have a quality management system certified as complying with standards of HACCP or ISO 22000 or equivalent (the notarized copy or copy with the original for comparison).

Article 6. Dossier for publication of conformity with food safety regulations for products having not yet got technical regulations

1. For imported products (excluding functional food and food fortified with micronutrients), dossier comprises:

a) A written publication of conformity with food safety regulations, as prescribed in Form No.02 enclosed with this Decree;

b) Detailed information of product, as prescribed in Form No.03a or Form No.03c issued together with this Decree;

c) The product testing results within 12 months, including the criteria of major quality, safety criteria granted by the following entities: the laboratories appointed by competent state agencies or the independent laboratories to be accredited (original or notarized copy); or the laboratories of the origin countries recognized  by the competent agencies in Vietnam (original or certified copy or consular legalized).

d) A periodic monitoring plan (certified by organizations and individuals);

đ) Label model of product circulated in the country of origin and auxiliary label in Vietnamese (with certification of organizations and individuals);

e) Samples of complete products for the products imported for first time into Vietnam to compare when filing dossier;

g) A business registration certificate with the food business line or legal entity certificate for organization and individual importing food (copy certified by the organization or individual);

h) A certificate of eligibility of food safety for the importing facilities subject to grant of certificates of eligibility of the food safety according to regulations (copy certified by the organization or individual);

i) A certificate of conformity with standards of HACCP or ISO 22000 or equivalent in the case the producing organizations and individuals have a quality management system certified as complying with standards of HACCP or ISO 22000 or equivalent (the notarized copy or copy with the original for comparison).

2. For domestic produced products (excluding functional food and food fortified with micronutrients), dossier comprises:

a) A written publication of conformity with food safety regulations, as prescribed in Form No.02 enclosed with this Decree;

b) Detailed information of product, as prescribed in Form No.03a or Form No.03c issued together with this Decree;

c) The product testing results within 12 months, including the criteria of major quality, safety criteria granted by the laboratories appointed by competent state agencies or the independent laboratories to be accredited (original or notarized copy);

d) A quality control plan be developed and applied in the form prescribed in Form No.04 enclosed with this Decree (certified by organizations and individuals);

đ) A periodic monitoring plan (certified by organizations and individuals);

e) A model of the product label (certified by organizations and individuals);

g) A business registration certificate with the food business line or legal entity certificate for organization and individual (copy certified by the organization or individual);

h) A certificate of eligibility of food safety for the facilities subject to grant of certificates of eligibility of the food safety according to regulations (copy certified by the organization or individual);

i) A certificate of conformity with standards of HACCP or ISO 22000 or equivalent in the case the producing organizations and individuals have a quality management system certified as complying with standards of HACCP or ISO 22000 or equivalent (the notarized copy or copy with the original for comparison).

3. For functional food and food fortified with micronutrients imported, dossier comprises:

a) A written publication of conformity with food safety regulations, as prescribed in Form No.02 enclosed with this Decree;

b) A detailed product information, as prescribed in Form No.03b issued together with this Decree (with joint-pages stamp of the organization or individual);

c) A certificate for free circulation or health certificate or equivalent certificate issued by competent state authorities of the countries of origin which shows the contents of safe products for the consumer health and in accordance with food law (original or notarized copy or consular legalized);

d) The product testing results within 12 months, including the criteria of major quality, safety criteria granted by the following entities: the laboratories appointed by competent state agencies or the independent laboratories to be accredited (original or notarized copy); or the laboratories of the origin countries recognized  by the competent agencies in Vietnam (original or certified copy or consular legalized);

đ) A periodic monitoring plan (certified by organization and individual);

e) The product label for circulation in the country of origin and auxiliary label in Vietnamese (certified by organizations and individuals);

g) Samples of complete products to compare when filing dossier;

h) A business registration certificate with the food business line or legal entity certificate for organization and individual importing food (copy certified by the organization or individual);

i) A certificate of eligibility of food safety for the importing facilities subject to grant of certificates of eligibility of the food safety according to regulations (copy certified by the organization or individual);

k) A certificate of conformity with standards of HACCP or ISO 22000 or equivalent in the case the producing organizations and individuals have a quality management system certified as complying with standards of HACCP or ISO 22000 or equivalent (the notarized copy or copy with the original for comparison);

l) Information, scientific data to prove the effect of each component constituting function announced (certified by the organization or individual).

4. For functional food and food fortified with micronutrients domestically produced, dossier comprises:

a) A written publication of conformity with food safety regulations, as prescribed in Form No.02 enclosed with this Decree;

b) A detailed product information, as prescribed in Form No.03b issued together with this Decree (with joint-pages stamp of the organization or individual);

c) The product testing results within 12 months, including the criteria of major quality, safety criteria granted by the laboratories appointed by competent state agencies or the independent laboratories to be accredited (original or notarized copy);

d) A model of the product label (certified by organization and individual);

đ) Samples of complete products to compare when filing dossier;

e) A business registration certificate with the food business line or legal entity certificate for organization and individual (copy certified by the organization or individual);

g) A certificate of eligibility of food safety for the facilities subject to grant of certificates of eligibility of the food safety according to regulations (copy certified by the organization or individual);

h) A certificate of conformity with standards of HACCP or ISO 22000 or equivalent in the case the producing organizations and individuals have a quality management system certified as complying with standards of HACCP or ISO 22000 or equivalent (the notarized copy or copy with the original for comparison);

i) Information, scientific data to prove the effect of each component constituting function announced (certified by the organization or individual);

k) A report on effective testing on effect of food products for new products firstly put into circulation on the market (notarized copy or copy with the original for comparison);

l) A quality control plan to be developed and applied in the form prescribed in Form No.04 enclosed with this Decree (certified by organization and individual);

m) A periodic monitoring plan (certified by organization and individual).

Article 7. Application for publication of regulation conformity or publication of conformity with food safety regulations

1. Dossier for publication of regulation conformity or publication of conformity with food safety regulations is bound as follows:

a) General legal documents are made in 01 book, including:

- A business registration certificate with the food business line or legal entity certificate for organization and individual (copy certified by the organization or individual);

- A certificate of eligibility of food safety for the facilities subject to grant of certificates of eligibility of the food safety according to regulations (copy certified by the organization or individual);

- A certificate of conformity with standards of HACCP or ISO 22000 or equivalent in the case the organizations and individuals have a quality management system certified as complying with standards of HACCP or ISO 22000 or equivalent (the notarized copy or copy with the original for comparison).

b) Dossier for publication of regulation conformity or publication of conformity with food safety regulations for products is made in 02 books, including the documents as specified in Article 5, Article 6 of this Decree, unless the documents specified in point a, clause 1 of this Article.

2. Organizations and individuals producing and trading products may directly submit dossier for publication of regulation conformity or publication of conformity with food safety regulations for products to the competent state agencies of the Ministry of Health and the Departments of Health or submit them by mail.

3. For organizations and individuals producing and trading products conducting publication of regulation conformity or publication of conformity with food safety regulations for products from the second times onward shall submit only 01 set of general legal documents.

Article 8. Re-issuance of receipt of written publication of regulation conformity and written certification of publication of conformity with food safety regulations

1. Where there is no change in processes of producing, processing food affecting the quality criteria and violations of limits of food safety compared with the publication, the organizations and individuals producing, trading food must re-register periodically the written publications of regulation conformity or publications of conformity with food safety regulations:

a) 05 years for the products of the trading, manufacturing facilities having one of the certificates of advanced quality management system: HACCP, ISO 22000 or equivalent;

b) 03 years for the products of the trading, manufacturing facilities having no the certificates mentioned above.

2. The re-registration of the written publication of regulation conformity or publication of conformity with food safety regulations is made in the competent state agencies that issued receipt of written publication of regulation conformity and written certification of publication of conformity with food safety regulations of the first time for such products.

3. Dossier applying for re-issuance of receipt of written publication of regulation conformity and written certification of publication of conformity with food safety regulations includes:

a) An application for re-issuance of receipt of written publication of regulation conformity and written certification of publication of conformity with food safety regulations by the form prescribed in Form No.05 issued together with this Decree (certified by the organization or individual);

b) A latest receipt of written publication of regulation conformity or written certification of publication of conformity with food safety regulations (copy);

c) Results of periodic tests of products made by the accredited laboratories to be appointed by the competent state agencies (a notarized copy or copy with the original for comparison):

- 1 time/year for the facilities having one of the certificates of advanced quality management system: GMP, HACCP, ISO 22000, or equivalent.

- 2 times/year for the facilities having no the certificates mentioned above.

d) A certificate of conformity with standards of HACCP or ISO 22000 or equivalent in the case the organizations or individuals have the quality management system certified as complying with HACCP or ISO 22000 or equivalent (copy notarized or copy with the original for comparison);

4. Within 7 working days from the date of receiving the request, the competent state agencies shall re-issue receipt of written publication of regulation conformity or written certification of publication of conformity with food safety regulations; in case of refusal, the competent State management agencies must issue written replies stating clearly the reasons.

5. Where there is any change in processes of producing, processing food affecting the quality criteria and violations of limits of food safety compared with the publication, the organizations and individuals producing, trading food must re-register the publications of regulation conformity or publications of conformity with food safety regulations with the competent State management agencies under the provisions of Article 4, 5 and 6 of this Decree.

Article 9. Regulation conformity marks for products

The products specified in clause 1 of Article 3 of this Decree shall be marked regulation conformity under the provisions of law on standards and technical regulations after being received the written publications of regulation conformity by the competent state agencies.

The use of regulation conformity mark shall comply with Point c, Clause 1 of Article 49 Law on standards and technical regulations and Article 15 of Decree No.127/2007/ND-CP dated August 01, 2007 detailing the implementation of a number of Articles of the Law on standards and technical regulations.

Chapter 3.

SAFETY ASSURANCE FOR GENETICALLY MODIFIED FOOD

Article 10. Safety assurance for food with ingredients from genetically modified organisms and products of genetically modified organisms

1. The regulations on conditions for granting written certification of genetically modified organisms which are eligible for use as food; the order and procedures for granting and revoking written certification of genetically modified organisms which are eligible for use as food; list of genetically modified organisms which are granted written certification of genetically modified organisms which are eligible for use as food shall comply with the provisions of Section 1 of Chapter VI of the Decree No.69/2010/ND-CP dated June 21, 2010 on Biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms.

2. Minister of Agriculture and Rural Development is responsible for issuing and revoking written certification of genetically modified organisms which are eligible for use as food; preparing and publishing a list of genetically modified organisms which are granted written certification of genetically modified organisms which are eligible for use as food; and setting up, defining on the functions, tasks and mechanisms of operation of the Safety Council of genetically modified organisms and products of genetically modified organisms used as food.

Article 11. Labeling for goods containing genetically modified organisms and products of genetically modified organisms for use as food

1. The organizations and individuals circulating foods containing genetically modified organisms and products of genetically modified organisms on the market at a rate greater than 5% of each component, in addition to complying with the provisions of law on labeling, it must also demonstrate the information related to genetically modified organisms on the labels.

2. The Ministry of Agriculture and Rural Development presides over and coordinates with the Ministry of Science and Technology to make detailed instructions for the labeling of foods containing genetically modified organisms and products of genetically modified organisms.

Chapter 4.

GRANT AND REVOCATION OF CERTIFICATES OF ELIGIBLE FACILITIES FOR FOOD SAFETY

Article 12. Grant of certificates of eligible facilities for food safety

1. The grant of certificates of eligible facilities for food safety is done for each trading, manufacturing facility; each independently manufacturing plant in a location (hereinafter referred to as facility), except for the following cases:

a) Small initial production;

b) Retail food business;

c) Street venders;

d) Sales of availably packaged food without requirement on special storage conditions as prescribed.

2. The Minister of Health, Minister of Agriculture and Rural Development, Minister of Industry and Trade defines competence to issue, revoke certificates of eligible facilities for food safety under the field assigned to manage in Article 62, 63, 64 of the Law on food safety and this Decree and provides for the management methods for different types of production, business at Point a, b, c and d, Clause 1 of this Article.

Article 13. Revocation of certificates of eligible facilities for food safety

The facilities manufacturing, trading food are revoked certificates of eligible facilities for food safety in the cases:

1. The trading, producing organizations and individuals do not operate the food business line registered.

2. There are decisions of the competent state agencies on transformation of business line at the old facilities.

3. The facilities producing and trading food are stripped the right to use the certificates in accordance with provisions of the law on sanction of administrative violations in the field of food safety.

Chapter 5.

STATE INSPECTION ON SAFETY OF IMPORTED, EXPORTED FOOD

Article 14. Inspection of imported food

1. All foods, food materials, food additives, processing supporting substances, tools, materials for packaging, food containers imported into Vietnam must be inspected at the competent state inspection agency appointed by the ministry managing sectors, except for the cases specified in clause 2 of this Article.

2. The following cases are exempted from state inspection on food safety for imported food:

a) Food brought along with upon entry for private consumption within the norms is exempted from import duties;

b) Food in diplomatic bags, consular bags;

c) Food in transit and transshipment;

d) Food sent in bonded warehouses;

đ) Food as the prototype or research sample;

e) Food as samples displayed in the fairs, exhibitions.

3. The Ministry of Health is responsible for inspection and issue of notices of inspection results for imported lot of foods under its management jurisdiction of from 2 Ministries or more.

The Ministry of Agriculture and Rural Development is responsible for inspection and issue of notices of inspection results for imported lot of foods under its management jurisdiction of from 2 Ministries or more, including fresh food.

Article 15. State inspection on food safety at the exporting countries

1. In case of assessment for mutual recognition, the competent State management agencies of Vietnam develop the plan of inspection, notification and coordination with the competent authorities of the exporting countries to implement the inspection of the food safety control systems of the exporting countries and the facilities manufacturing, trading exported food into Vietnam under international treaties which the Socialist Republic of Vietnam is a member:

a) The competent authorities of the exporting countries send registration dossier to the ministries managing sectors;

b) Within 30 working days from the date of receiving complete registration dossiers of list of the trading, manufacturing facilities of the competent authorities of the exporting countries, the competent authorities of the ministries managing sectors shall appraise them and inform the competent authorities of the exporting countries the results of appraisal and the inspection plan in case of the inspection necessity for the exporting countries into Vietnam.

2. The competent authorities of the exporting countries send 01 set of registration dossier to the competent authorities of Vietnam: Ministry of Health or Ministry of Agriculture and Rural Development or the Ministry of Industry and Trade, including:

a) A list of the facilities manufacturing, trading food registering for export into Vietnam by the form prescribed in Form No.06 issued together with this Decree;

b) A  written information on the management systems and capacity for food safety control of the competent authorities of exporting countries by the form prescribed in Form No.07 issued together with this Decree;

c) A summary of information on conditions to ensure food safety the facilities manufacturing, trading food by the form prescribed in Form No.08 issued together with this Decree.

Article 16. State inspection on food safety for exported food

1. The Health Minister, Minister of Agriculture and Rural Development, Minister of Industry and Trade shall define the state inspection competence on food safety for exported food under their management assigned sectors at Articles 62, 63, 64 of the Law on food safety.

2. The Ministry of Agriculture and Rural Development is responsible for inspection for the exported lot of foods including many food items under the management jurisdiction of 2 ministries or more.

Chapter 6.

LABELING

Article 17. Recording expiry date on food labels

1. Safety shelf life is required to be recorded as "Expiry date" or "Use date" for functional foods, food supplements, health protecting foods, medical nutritional food, food fortified nutrients and foods likely to be damaged by microorganisms. Safety shelf life for other foods could be recorded as "best use before date" suitable to food products.

2. For food recorded "Expiry date" or "Use date" shall not be sold to market when its time limit is expired.

3. For food recorded "best use before date", after this time foods are still allowed to be be sold to market if the manufacturers demonstrate that such foods are still safe with the competent state agencies and required to be written clearly its shelf life in one of two forms of "Expiry date" or "Use date". Only the food manufacturers are allowed prolonging shelf life for their food products and shelf life only is permitted to be prolonged for a maximum period equal to shelf life provided for at the first time.

Article 18. Mandatory contents for labeling

1. The availably packaged foods are required to be labeled under the provisions of the law on food labeling.

2. Depending on each type of availably packaged food, in addition to the provisions in clause 1 of this Article, the mandatory contents for labeling must also meet some following provisions:

a) Information on the label must match the nature of the product, be honest, accurate, clear and not misleading to the users;

b) For functional foods, food fortified with micronutrients, it must be shown on the label the following main contents: Announcement of nutrients; active ingredient of biological effects; the health effects; specification of objects, the dosage, usage, warnings, if any;

c) For medical nutritional food, supplements of vitamins, minerals, micronutrients not for community popularization such as formula food for pregnant mothers, children under 36 months of age and food through the catheter for patients must be publicized the respone rate compared with nutritional needs, the use dosage of each object and instruction of doctors;

d) Functional foods, food fortified with micronutrients, food additives, some genetically modified food (subject to labeling in accordance with provisions of the law on the labeling for genetically modified food) must be specified the composition and concentration in food;

đ) When taking a certain ingredient in a product to be the product’s name, it must be clearly recorded such ingredient beside product’s name;

e) Product’s name must be the clearest, largest font size and at least threefold of other font size on the label;

g) When moving the label, it must make sure that the contents shall not be erroneous compared with the original label content.

3. Ministry of Health shall preside over and coordinate with the Ministry of Agriculture and Rural Development, Ministry of Industry and Trade to detail the food labeling.

Chapter 7.

ASSIGNMENT OF STATE MANAGEMENT RESPONSIBILITIES ON FOOD SAFETY

Article 19. The principles of assignment of state management responsibilities on food safety

1. On the basis of the provisions of the Law on food safety and assurance in accordance with current legal documents.

2. On the basis of the unification of state management on food safety.

3. Ensuring the management throughout the entire process of production, trade of food.

4. Close coordination between ministries, branches.

5. Ensuring the principle of a door, a product, a trading, producing facility is just under the management of a state management agency.

6. Ensuring the science, completion, and feasibility.

7. State management decentralization between central and local government at all levels in the state management on food safety.

8. In the management process, if any problems arise, any interferences arise that can not be clearly defined, the Ministry of Health shall preside over and coordinate with the Ministry of Agriculture and Rural Development, Ministry of Industry and Trade to compile a Joint Circular for specific instructions.

Article 20. Responsibilities of state management on food safety of the Ministry of Health

1. Ministry of Health is responsible before the Government for performing the unified state management on food safety.

2. Within its scope of duties and powers, the Ministry of Health is responsible for:

a) Implementing the regulations on joint responsibility of State management on food safety as provided for in clause 1 of Article 62 of the Law on food safety;

b) Reporting periodically, irregularly with Government on the food safety management based on monitoring and synthesis of reports of the sector managing ministries;

c) Evaluating, developing plan and schedule for compilation, control of national technical standards for all food products, food additives, processing supporting substances, tools and materials for packaging and food containers to meet the requirements on management and in accordance with social - economic development in each period;

d) Presiding over to compile the national technical regulations for products under the jurisdiction specified in Article 62 of the Law on food safety; promulgating the national technical regulations or providing for norms and the safety limit for all food products, food additives, processing supporting substances, tools, packaging materials, food containers;

đ) Appointing the regulation conformity certification organizations for food products, food additives, processing supporting substances, tools, materials for packaging, food containers that have been issued technical regulations on the basis of consultation with the ministries managing branches when necessary;

e) Managing food safety during the process of production, preliminarily processing, food processing, preservation, transportation, export, import and trade for: Food additives, processing supporting substances, bottled water, natural mineral water, functional food, food fortified with micronutrients, tools, materials for packaging, food containers;

g) Specifically providing for the management of functional foods, food additives and food fortified with micronutrients;

h) Organizing the grant of receipt of written publication of regulation conformity, written certification of publication of conformity with food safety regulations, written certification of food advertising content for the foods of their management assigned areas;

i) Organizing and decentralizing the grant of certificates of eligible facilities for food safety to the organizations and individuals producing and trading the products of their assigned areas at Point e, Clause 2 of this Article;

k) Conducting medical certification for food; food additives; food processing supporting substances; tools, packaging materials, food containers when organizations and individuals have requested;

l) Providing for conditions of testing facilities, appointing the units to participate in testing food for State administration under its jurisdiction; appointing the units to perform testing as arbitration and to make final conclusions when having the difference in testing results of the food testing units within and outside the health sector;

m) Providing for food safety conditions for collective kitchens, hotels, resorts, restaurants, establishments trading catering services;

n) Appointing the state inspection agency on imported food safety for the products under their assigned areas at Point e, Clause 2 of this Article and clause 3 of Article 14 of this Decree.

Article 21. Responsibilities of state management on food safety of the Ministry of Agriculture and Rural Development

1. To coordinate in compilation of national technical regulations for food products.

2. To manage food safety for primary production of agricultural, forestry, fisheries and salt products including: The process of planting, breeding, harvesting, fishing, mining agriculture, forestry, fishery products, production of salt.

3. To manage food safety during the production, collection, slaughter, preliminarily processing, processing, storage, transport, export, import and trade of cereals; meat and products from meat; seafood and aqua products; vegetables, fruits and vegetable products, roots and fruits; eggs and egg products; raw milk; honey and honey products; genetically modified food; salt, spice, sugar; tea, coffee; cocoa; pepper; cashew and agricultural products; tools, packaging materials, food containers in its areas assigned for management.

4. To organize the grant of written certification of contents of food advertisements for foods in the areas assigned for management. In case of certifying food advertising content with publication of the health effects, it must be approved by the Ministry of Health.

5. To organize and decentralize the grant of certificates of eligible facilities for food safety to the organizations and individuals producing and trading the products under its assigned areas in clauses 2, 3 and 7 of this Article.

6. To develop and promulgate the regulations on conditions to ensure food safety for the facilities producing, preliminarily processing, processing and trading the products under its assigned areas at clause 3 of this Article on the basis of providing for general conditions to ensure food safety for the facilities producing, trading food issued by the Health Ministry.

7. To manage food safety for wholesale markets, markets of agricultural auction.

8. To provide for conditions of the testing establishments; appoint the testing units and the proofing testing units; announce the testing results for food under the areas assigned for management.

9. To appoint the State inspection agency on imported food safety for the products under the areas assigned for management in clause 3 of this Article and clause 3 of Article 14 of this Decree.

Article 22. Responsibilities of state management on food safety of the Ministry of Industry and Trade

1. To coordinate in compilation of national technical regulations for food products.

2. To manage food safety during the production, processing, storage, transport, export, import and trade for wine, beer, soft drinks, processed milk, vegetable oil, flour making products, starch, bread, jams, candies, containing packages under its management.

3. To organize the grant of written certification of contents of food advertisements for foods in the areas assigned for management. In case of certifying food advertising content with publication of the health effects, it must be approved by the Ministry of Health.

4. To organize and decentralize the grant of certificates of eligible facilities for food safety to the organizations and individuals producing and trading the products in the areas assigned for management in clauses 2, 5 of this Article.

5. To manage food safety for the markets, supermarkets, and the establishments under the system of reservation, distribution of food commodities.

6. To inspect for prevention and combat of fake foods, commercial fraud on the market for all kinds of food, food additives, food processing supporting substances, tools, packaging materials and food containers.

7. To provide for conditions of the testing establishments; appoint the testing units and the proofing testing units; announce the testing results for food under the areas assigned for management.

8. To appoint the State inspection agency on imported food safety for the products under the areas assigned for management in clause 2 of this Article.

Article 23. Responsibilities of state management on food safety of the People's Committees at all levels

1. People's Committees of provinces and cities under central authority implement state management on food safety within the localities, to take responsibility before the government on food safety within their respective localities.

a) To organize and administer the interdisciplinary Steering Committee on hygiene and food safety in the provinces or cities under central authority;

b) To direct the implementation of the provisions of the Government, the ministries, branches on food safety.

2. To promulgate local technical regulations on food safety for local particular food products.

3. The Health Departments take responsibilities before the People's Committees of provinces and cities under central authority for implementing state management on food safety within their respective localities; are the standing contact points of interdisciplinary Steering Committee on food safety at the localities.

a) To be a synthetic contact point to report on food safety situation at the localities for the People's Committees of provinces and cities directly under the Central Government, Ministry of Health;

b) Annually inspect food safety situation in the province; to be a contact point to monitor the risk of food contamination in the area;

c) To inspect, examine products and the facilities manufacturing, trading food additives, processing supporting substances, bottled water, natural mineral water, functional foods, micronutrient fortified foods in the area as decentralized by the Ministry of Health; establishments trading catering services, street food;

d) To preside over and coordinate with the specialized departments to implement the irregular inspection and examination for the entire process of production, trade of food under the management scope of other sectors when having a direction of People's Committee, head of interdisciplinary Steering Committee of hygiene and food safety of provinces and cities directly under the Central Government, Ministry of Health; when detecting food, food additives, processing supporting substances, tools, materials for packaging, containers of food circulated  in the area commit acts of violations likely to cause serious effects on the health of consumers; when having a difference in the conclusions of the inspection of the specialized departments; at the proposals of specialized departments;

đ) To organize the reception of written publication of regulation conformity or written certification of publication of conformity with food safety regulations; to certify food advertising content as assigned in clause 2 of Article 4 of this Decree; to issue certificates of edigible facilities for food safety for the facilities producing, trading types of products as assigned by the Ministry of Health;

e) To be responsible for managing food safety in the area, management of safety ensuring conditions for the retail facilities producing, trading food, street food, facilities producing, trading catering services, food safety in the market in the area and the objects as assigned for management.

4. Departments of Agriculture and Rural Development are responsible for:

a) Inspecting, examining products and the facilities producing, trading food as assigned by the Ministry of Agriculture and Rural Development;

b) Organizing to grant certificates of edigible facilities for food safety for the facilities producing, trading types of products as assigned by the Ministry of Agriculture and Rural Development;

c) Organizing the issuance of written certification of food advertising content as assigned by the Ministry of Agriculture and Rural Development;

d) Periodically, irregularly reporting to Standing interdisciplinary Steering Committee (Health Departments) to aggregate, report to the People's Committees of provinces and cities directly under the Central Government, Ministry of Health, Ministry managing branches.

5. Departments of Industry and Trade are responsible for:

a) Inspecting, examining products and the facilities producing, trading food as assigned by the Ministry of Industry and Trade;

b) Organizing to grant certificates of edigible facilities for food safety for the facilities producing, trading types of products as assigned by the Ministry of Industry and Trade;

c) Organizing the issuance of written certification of food advertising content as assigned by the Ministry of Industry and Trade;

d) Inspecting for prevention and combat of fake foods, commercial fraud on the market for all kinds of food, food additives, food processing supporting substances, tools, packaging materials and food containers;

đ) Periodically, irregularly reporting to Standing interdisciplinary Steering Committee (Health Departments) to aggregate, report to the People's Committees of provinces and cities directly under the Central Government, Ministry of Health, Ministry managing branches.

6. People's Committees of districts are responsible before the People's Committees of provinces and cities directly under the Central Government on food safety in the respective areas for.

a) Organizing and administering interdisciplinary Steering Committee on hygiene and food safety in the respective districts;

b) Directing and implementing the provisions of the Government, ministries, branches and People's Committees of provinces and cities directly under the Central Government on food safety;

c) Managing the business of street food, restaurants, and hotels in the area of ​​districts under decentralization.

7. People's Committees of communes, wards are responsible before the People's Committees of districts on food safety in the respective areas for.

a) Organizing and administering interdisciplinary Steering Committee on hygiene and food safety in the communes and wards;

b) Implementing the provisions of the Government, ministries, branches and superior People's Committees of on food safety;

c) Being responsible before the People's Committees of districts on the management of the business activities of street food, restaurants and hotels in the communes, wards under decentralization.

Article 24. Coordination among the ministries managing branches in state management on food safety

The ministries managing branches within their respective State management scope shall coordinate with the Ministry of Health in implementing the state management activities to ensure unified state management of food safety effectively.

1. Ministry of Health, Ministry of Agriculture and Rural Development, Ministry of Industry and Trade organize to implement the programs of monitoring, prevention of food safety incidents as prescribed in Article 52 of the Law on food safety under the area assigned.

2. When food poisoning occurs, the Ministry of Health is responsible for organizing emergency, timely treatment for patients got food poisoning. Branches managing ministries shall provide for complete documents of information relating to the origin of food suspected causing poisoning under its management scope; coordinate with the Ministry of Health to investigate the cause and monitor the root cause investigation, conduct the origin access, and handling of food causing poisoning.

Chapter 8.

SPECIALIZED INSPECTION OF FOOD SAFETY

Article 25. Agencies assigned function of food safety inspection

Inspection of food safety is the specialized inspection conducted by the health sector, sectors of agriculture and rural development, industry and trade. The assignment of the agencies to perform the function of specialized inspection of food safety is made under the provisions of the Government on the agencies assigned to perform the function of specialized inspection.

Article 26. Coordination among ministries, branches and other forces in food safety inspection

1. The Ministries of: Health, Agriculture and Rural Development, Industry and Trade are responsible for inspection of food safety during production, processing, storage, transportation, export and import, trade of food under the sector assigned management in accordance with provisions in Articles 62, 63, 64, 65, 67 of the Food Safety Law.

2. Ministry of Health, the central standing interdisciplinary steering committee on hygiene and food safety preside over and coordinate with the ministries managing branches, other relevant forces to organize and assign the implementation of interdisciplinary inspection.

3. The Ministry of Health inspects, examines irregularly for the entire process of production, export, import, trade of food under the jurisdiction of other ministries in the following cases:

a) Under the direction of the Prime Minister or Head of the central interdisciplinary steering committee on hygiene and food safety;

b) Upon detection of violations of food, food additives, food processing supporting substances, tools, packaging materials, food containers that may cause serious affect to the health of consumers;

c) When there is a difference in the conclusions of the inspection of the ministries managing branches;

d) At the request of the ministries managing branches, sectors.

Chapter 9.

IMPLEMENTATION PROVISIONS

Article 27. Effect

This Decree takes effect as from June 11, 2012.

Article 28. Responsibility for implementation

The ministers, heads of ministerial-level agencies, heads of Governmental agencies, Presidents of the People’s Committees of provinces and cities directly under the Central Government and other concerned organizations and individuals are responsible for the implementation of this Decree.

APPENDIX

(Issued together Decree No.38/2012/ND-CP dated April 25, 2012 of the Government)

Form No.01a

RECEIPT OF WRITTEN PUBLICATION OF REGULATION CONFORMITY

……. (Name of agency receiving publication) ...... confirm receipt of the written publication of regulation conformity of: .......... ............ (Name of organization or individual) …………………………………… phone,………….. Fax………………… Email ……………………. For product: ………………………………………… produced by ……………………….. (name and address of producer and country of origin) …………… produced suitable to technical regulations (sign number of technical regulations) …………………………………………………..

This notice acknowledges the commitment of enterprise, is not valid for certification for the product in compliance with the respective technical regulations. Enterprise must bear full responsibility for the conformity of the product announced.

Periodically ... (5 years or 3 years) ... organization, individual must re-conduct the registration of written publication of regulation conformity.

Form No.01b

WRITTEN CERTIFICATION OF PUBLICATION OF CONFORMITY WITH FOOD SAFETY REGULATIONS

……. (Name of agency certifying publication) ...... confirm publication of conformity with of food safety regulations of: .......... ............ (Name of organization or individual) address …………………………………… tel,………….. Fax………………… Email ……………………. For product: …………………………………………………………..…… produced by ……………………….. (Name and address of producer and country of origin) …………… produced suitable to food safety regulations.

Organization, individual shall implement the regime of inspection and periodical testing in accordance with current regulations and shall be fully responsible for the conformity of the product announced.

Periodically ... (5 years or 3 years) ... organization, individual must re-conduct the registration of written publication of conformity with food safety regulations.

Form No.02

Form No.03a

DETAILED WRITTEN INFORMATION OF PRODUCTS

1. Technical requirements:

1.1. Organoleptic criteria:

- Status: (specify solid, liquid, solid, and uniformity as not lumpy ...)

- Color: (describe color range from the finished product until expiration

- Odour: (describe the taste of products)

- Other specific status if any

1.2. The principal quality criteria (as the technical requirements of the manufacturer):

For example:

* Instruction:

- Major quality criteria and quality indicators are the criteria of stability, easy to control, nutritional value.

- Humidity or free water content for mixed or solid, dried product,; pH for the thick, liquid products.

- Solid content on the total real weight for the mixture product.

- Ash content for product mixed much composition in the different state upon mixed.

- Criteria indicates the decomposition of products for products high in fat, protein (eg NH3 content for meat products; the burnt content, Kreiss reaction to oil, grease, ...)

1.3. The microbiological criteria (applied in accordance with technical regulations or food safety regulations):

For example:

* Instruction:

- The maximum rate is the rate that enterprises publicize in the allowed limit during the distribution of products and not exceeding the prescribed rate of hygiene for the product or product group which is defined as mandatory application accordance with technical regulations or food safety regulations.

1.4. Content of heavy metals (applicable to technical regulations or food safety regulations):

For example:

1.5. Content of unwanted chemicals (plant protection chemicals, other chemicals).

* Instructions: clearly stating application to technical regulations or regulations for a certain food group.

2. Composition:

* Instructions: list all ingredients and food additives used in food production, to be listed in descending order of volume. If the main material is taken as the product name, it can write proportion % unless it stated in the main components near the product name.

3. The expiry date (clearly stating its written location on the packaging of retail product).

4. Manuals and maintenance: full declaration of methods of processing, usage, objects of use, warning if any, and method of preservation.

5. Packaging material and packaging specifications.

6. The production process (with detailed explanation of the production process): Add into appendix of the detailed written information of product.

7. Measures to distinguish true, fake (if any).

8. Labeling contents: required to conform to the law regulations on food labeling.

9. Origin and traders taking responsibility for the quality of goods

* Instructions: Origin is the place where products are packaged and labeled completely.

- For imported food:

+ Origin: manufacturer's name and country of origin.

+ Name and address of organization or individual of publication, import, exclusive distribution.

- For domestic products:

+ Name and address of organization or individual of publication, import, exclusive distribution.

Form No.03b

DETAILED WRITTEN INFORMATION OF PRODUCTS FOR FUNCTIONAL FOOD, FOOD FORTIFIED WITH NUTRIENTS

1. Technical requirements:

1.1. Organoleptic criteria:

- Status: (specify solid, liquid, solid, and uniformity as not lumpy, tablet ...)

- Color: (describe color range from the finished product until expiration

- Odour: (describe the taste of products)

- Other specific status if any

1.2. The principal quality criteria (as the technical requirements of the manufacturer):

For example:

* Instructions:

- Humidity or free water content for solid or mixed, dried product; pH for the thick, liquid products.

- Contents of the active substance making utility of the products (vitamins, minerals, herbs, nutrients …).

1.3. The microbiological criteria (applied in accordance with technical regulations or food safety regulations):

For example:

* Instruction:

- The maximum rate is the rate that enterprises publicize in the allowed limit during the distribution of products and not exceeding the prescribed rate of hygiene for the product or product group which is defined as mandatory application accordance with technical regulations or food safety regulations.

1.4. Content of heavy metals (applicable to technical regulations or food safety regulations):

For example:

1.5. Content of unwanted chemicals (plant protection chemicals, other chemicals).

* Instructions: clearly stating application to technical regulations or regulations for a certain food group.

2. Composition:

* Instructions: list all ingredients and food additives used in food production, to be listed in descending order of volume. If the main material is taken as the product name, it can write proportion % unless it stated in the main components near the product name.

- For raw materials of special features, it must clearly explain the origin, material resource, technology, documentation for proving its features ... to create function.

- For rare raw materials derived from native plants and animals, which are strictly protected by law, it must declare and demonstrate clearly the origin, source and use rights (eg, tiger bone, white horses or other products of wildlife protected by laws).

3. Expiry date (stating clearly the location to write on the packaging of the retail products).

4. Manuals (fully declaring by order: mechanism of action, utility, objects of use, usage, dosage, recommendations if any and method of preservation).

- Mechanism of action of the products included in the appendix of the detailed written information on the product.

Explaining the mechanism that create the usage of products scientifically, obviously (based on uniform of usage, the dose of the major constituents, types of products and processing technologies for diseases and functions that the products work). The recommendations, warnings, and advertisement out of its usage recorded on the label must also be explained.

For the products for infants under 2 years with micronutrient supplements, it must explain the nutritional formula to replace the explanation for mechanism of action.

- Usage of the product: it must focus and often not as the sum of all usages of the all compositions. It must always have the words "WARNING: This product is not a medicine and not effective as a substitute for medicine" right after the part of usage publication; other recommendations, if having mandatory provisions for application or if necessary to protect the users and brand name.

5. Packaging materials and packaging specifications.

6. The production process (with detailed explanation of the production process): Added into appendix of the detailed written information of the product.

7. Measures to distinguish true, fake (if any).

8. Labeling contents (labels being circulated): required to conform to the mandatory regulations on food labeling.

9. Origin and traders taking responsibility for the quality of goods

* Instructions: Origin is the place where products are packaged and labeled completely.

- For imported food:

+ Origin: manufacturer's name and country of origin.

+ Name and address of organization or individual of publication, import, exclusive distribution.

- For domestic products:

+ Name and address of organization or individual of publication, import, exclusive distribution

Form No.03c

DETAILED WRITTEN INFORMATION OF PRODUCTS FOR TOOLS, MATERIALS FOR PACKACKING, FOOD CONTAINERS

1. Technical requirements:

1.1. Organoleptic criteria:

- Status:

- Color:

- Odour:

- Other characteristics:

1.2. The criteria on the contaminated rate:

For example:

2. Composition (including all raw materials and additives used in processing, are listed in descending order of volume).

3. Manuals.

4. Packaging materials and packaging specifications.

5. The production process (with detailed explanation of the production process): Added into appendix of the detailed written information of the product.

6. Measures to distinguish true, fake (if any).

7. Labeling contents (labels being circulated): required to conform to the law regulations on food labeling.

8. Origin and traders taking responsibility for the quality of goods

* Instructions:

- For imported food:

+ Origin: manufacturer's name and country of origin.

+ Name and address of organization or individual of publication, import, exclusive distribution.

- For domestic products:

+ Name and address of organization or individual of publication, import, exclusive distribution.

Form No.04

Name of organization, individual: …………………………………………………………………………

Address: …………………………………………………………………………………………..

PLAN OF QUALITY CONTROL

Product:………………………………………………………………………………………

Form No.05

APPLICATION FOR REISSUANCE OF RECEIPT OF WRITTEN PUBLICATION OF REGULATION CONFORMITY OR WRITTEN CERTIFICATION OF PUBLICATION OF CONFORMITY WITH FOOD SAFETY REGULATIONS

To: (Name of agency granting Receipt or Written certification)

… "Name of organization or individual" .... granted Receipt of written publication of regulation conformity or Written certification of publication of conformity with food safety regulations No. ........... on ....... month ........ year ........ granted by ........... "Name of the agency certifying publication of conformity with food safety regulations or receiving written publication of regulation conformity".

Now, we make application for re-granting Receipt of written publication of regulation conformity or written certification of publication of conformity with food safety regulations.

Dossier applying for re-granting includes:

1. An application for re-granting Receipt of written publication of regulation conformity or written certification of publication of conformity with food safety regulations.

2. Slips of results of periodical tests for products.

3. Certificate of conformity with standards of HACCP or ISO 22000 or equivalent in the case of producing organization or individual having a quality management system certified as complying with HACCP or ISO 22000 or equivalent.

4. Written certification of publication of conformity with food safety regulations or Receipt of written publication of regulation conformity that has been issued previously.

We make this application respectfully request for re-granting Receipt of written publication of regulation conformity or written certification of publication of conformity with food safety regulations.

We commit to ensure the conformity of the product as published.

Form No.06

LIST OF THE FACILITIES PRODUCING, TRADING FOOD REGISTERING FOR EXPORT INTO VIETNAM

Form No.07

INFORMATION ON MANAGEMENT SYSTEM AND CAPACITY OF CONTROLLING FOOD SAFETY OF THE COMPETENT AGENCIES OF THE EXPORTING COUNTRIES

1. Organizational system and managerial apparatus:

…………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

2. Officials executing duties (number, qualifications, Technical training courses …):

…………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

3. Systems of documents, standards, procedures of control and certification of food safety:

…………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

4. System of inspection, supervision of residues, microorganisms causing diseases … for the trading, producing facilities:

…………………………………………………………………………………………………………………

…………………………………………………………………………………………………………...

5. Program of inspection, supervision on food safety:

Form No.08

SUMMARY OF INFORMATION ON THE CONDITIONS TO ENSURE FOOD SAFETY OF THE PRODUCING, TRADING FACILITIES

1. Name of the trading, producing facilities:

2. Address:

3. Product:

4. Description of production process:

5. Quality management system applied: