Products derived from terrestrial animals, aquatic animals and plants must satisfy the following requirements a) Their country of origin is a country or territory that has a food safety control system satisfying Vietnam’s regulations and included in the list of registered countries and territories that export foods derived from animals, plans and aquatic animals to Vietnam;

Article 13. General requirements concerning recognition of circulation and self-declaration of circulation of plant varieties 1. Plant varieties belonging to the main plant species may be produced, traded, exported or imported only after being granted the decision on recognition of plant variety circulation as provided for in Article 15 hereof, or granted the Decision on recognition of privileged circulation of plant varieties as provided for in Article 16 hereof, except in the case where plant varieties are intended for research, trial, exhibition, international exchange or production of hybrid seeds for export.

6. An application for import of feeds used for manufacturing and processing of exported products includes: a) An application form, which is made using the Form No. 07.TACN in the Appendix I hereof; b) A contract for manufacturing and processing of feeds for export purposes as conformable to Vietnam’s laws and regulations on import of goods to be used for manufacturing and processing of exported products. 7. Procedures for licensing import of feeds not declared on the web portal of the Ministry of Agriculture and Rural Development: a) The applicant shall submit an application specified in Clauses 2, 3, 4, 5 or 6 of this Article to the Department of Livestock Production. b) Within 15 working days from receipt of the satisfactory application, the Department of Livestock Production shall issue the license to import feeds using the Form No. 09.TACN in the Appendix I hereof; if the application is rejected, respond the applicant and provide explanation in writing.

Article 30. Import of aquafeeds and treatment products 1. Importers of aquafeeds/treatment products imported as prescribed in Clause 2 Article 36 of the Law on Fisheries shall obtain a license from the Directorate of Fisheries. 2. An application for import of aquafeeds/treatment products includes: a) An application form (Form No. 15.NT in the Appendix III hereof); b) A confirmation of the applicant’s participation in a fair or exhibition in Vietnam (if aquafeeds/treatment products are imported for display thereof at a fair or exhibition); c) A research outline approved in accordance with regulations of the law on science and technology (if aquafeeds/treatment products are imported for research purpose).

Licensing or permit import of: - embryo, breed or protected dilute environment need approved by Department of Livestock Production - those are not under the list of animals allowed for production and trade in Vietnam must get the approval from Department of Livestock Production

Licensing or permit import by Administration of Forestry or Department of Cultivation for breeds of plants. All plants must be approved by MARD to be included in the list of breeds of plants allowed for business and trade in Vietnam

Article 12. Applications and procedures for licensing import of plant varieties as prescribed in Clause 2 Article 29 of the Law on Crop Production 1. Composition of an application for licensing import of a plant variety: a) An application form, which is made using the Form No 01.NK in the Appendix IX hereof. b) A technical declaration (required only when following procedures for the first shipment of each variety), which is made using the Form No 02.NK in the Appendix IX hereof. c) A copy of the cooperation agreement in case of import for research, testing and international cooperation purposes. d) A confirmation or invitation to the exhibition or fair sent by the organizer in case of import for exhibition purpose.

The import of crops/plants that are not in the list of plants allowed in production and business in Vietnam must be licensed by the Vietnam Administration of Forestry or Department of Plants, including the import of plants for piloting production, and for the purposes of international cooperation, samples for exhibition, gifts

The import of livestock not in the List of livestock allowed for production and business in Vietnam for research, empirical and other specific purposes need to have license from Department of Livestock

A copy of fumigation certificate issued by Plant Protection Department is required for the first import of fumigation that contain methyl bromide and ingredients of Toxicity Class I or Class II defined by Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

National technical regulation on follow-up formula (for infant from 6th month on and young children up to 36 months of age) (QCVN 11-3:2012/BYT ) related to the minimum and maximum compounds of vitamin, protein, minerals, lipid, etc. to the final products; food additives, etc.

National technical regulation on processed cereal-based foods for infants from 6th month on and young children up to 36 months of age (QCVN 11-4:2012/BYT ), regulating compounds of protein, vitamin, lipid, minerals, food additives, etc. in final products

1. Manufacturers and sellers of foods in Vietnam, in addition to common regulations of law on goods labeling, shall comply with the following regulations: a) The label of medical food shall contain the phrase "Thực phẩm dinh dưỡng y học” (“medical food”) and “Sử dụng cho người bệnh với sự giám sát của nhân viên y tế” (“used under supervision of health workers”); b) The front label of food for special dietary uses shall contain the phrase “Sản phẩm dinh dưỡng (cho đối tượng cụ thể)”. 2. The label of imported products must specify: name and address of the importer, the organization or individual that submits the declaration or registers the self-declaration of products.

Article 46. Animal feed labeling 1. Labeling animal feeds shall comply with law provisions on goods labeling and the following regulations: a) The label or attachment of commercial animal feeds must specify information about name and main ingredients, quality standards, producer, production date, expiry date, maintenance instruction, using instruction of the product; information about the entity responsible for origin of such animal feed product; b) The label or attachment of other animal feeds must specify information used for identification and trace of origin of such animal feed products.

Compulsory contents of product label: - Clear, accurate and easy for consumer to understand - For functional foods and micro-nutrient foods, the label must includes the ingredients, dosage, effects on health, warning,… - For health-nutrient products, vitamin and mineral supplements, there must be announcement on the requirement against nutritious demand, dosage and doctor's prescription - Name of product must be in large font, and at least 3 times bigger than other letters on the label

Article 10. Labeling and advertising of plant varieties 1. A plant variety shall be labeled as prescribed in the Government’s Decree No. 43/2017/ND-CP dated April 14, 2017 as follows: a) Name of the plant variety. b) Varietal grade specified in the national standard. In case a national standard is unavailable, the basic standard shall apply. c) Characteristics of the plant variety: compulsory criteria specified in the national standard or basic standard for value of cultivation and use; criteria for quality of propagating materials specified in the national standard or basic standard in accordance with Article 25 of the Law on Crop Production. If a basic standard applies in the cases of unavailability of a national standard or national technical regulation, it is required to provide sufficient information about the criteria specified in the Form No. 02.CN in the Appendix II hereof; and other voluntary criteria (if any) for the plant variety. d) Instructions for storage and use: storage conditions; scope of use of the plant variety in terms of season and geographical region, brief planting and caring process (in case of special requirements) in accordance with the information provided in the application for issuance of the decision on recognition of plant variety circulation or documents about self-declaration of plant variety circulation. dd) Safety warnings (if any). e) Quantitative data on the plant variety (weight of the plant variety or quantity of plants, potted plants, cuttings). g) Date of manufacture, expiry date; the date of manufacture of grafted plants, which is the date of grafting; the date of manufacture of breeding branches or cuttings, which is the date of cutting; the date of manufacture of seeds or seed tubers, which is the date of harvest; the date of manufacture of the plant variety propagated using tissue culture method, which is the date on which the plant variety is transferred from the tube to the arboretum. h) Name of the organization producing and importing the plant variety. i) Plant variety circulation code if the plant variety is issued with the circulation decision or extended circulation decision. k) Origin of the plant variety: in the case of imported plant variety, write the phrase “sản xuất tại” (“produced in”) and the country’s name or region from which the plant variety is produced. l) Code of the variety batch corresponding to that specified in the documents serving tracing of plant varieties. Batch code shall be specified according to the Appendix VII hereof. m) Information about the genetically modified plant regarding its propagating materials.

Compulsory contents of label of imported health protection food (quantitative; production date; expiry date; ingredients; warnings if any; usage, storage instructions; risk warning if any; one phrase of "Thuc pham bao ve suc khoe"; one phrase of "Thuc pham nay khong phai la thuoc, khong co tac dung thay the thuoc chua benh")

Compulsory contents of label of imported Veterinary drugs, vaccines and biological products for animal health (Quantitative; production date; expiry date; ingredients; usage, storage instructions; warnings)

Compulsory contents of label of imported Aquatic breeds (Name of breed (including both commercial and scientific names); name of breeding center; number of breeds; quality indicator and standard; sale date; expiry date if any; usage, storage instructions; telephone if any)

Article 4. Labeling of animal feed 1. Details to the displayed on labels of animal feed are specified under Annex II attached to this Circular. 2. Animal feed that is bulk cargo while in circulation is required to have documents attached thereto specified under Annex III attached to this Circular, except for traditional animal feed that is not processed and is sold directly to persons conducting animal husbandry activities. 3. Packaged animal feed by order and animal feed for internal use while in circulation are not required to be labeled as specified in Clause 1 of this Article but the package must be marked to identify and avoid confusion, and attach documents specified under Annex III attach to this Circular. 4. Animal feed containing veterinary drugs with antibiotics to prevent and cure diseases of domestic animals must fully specify name and contents of antibiotics, use instruction and dosing interval on the labels or attached documents while in circulation.

This measure imposes condition on trading animal and aqua feeds to ensure SPS requirements (warehouses and fixtures for feed storage, separated from pesticide, fertilizers and hazardous chemicals. Harmful insect and pest control measures shall be applied)

Requirement on sending registered documents, either in English or Vietnamese, by relevant authority of exporting countries Vietnam's Quality Administration Agency of Agriculture, Forestry and Fishery for registration purpose

Article 2. List of plant quarantine articles subject to the pest risk analysis before being imported into Vietnam 1. Plants and live plant parts. 2. Fresh bulbs and fruits. 3. Weeds and weed seeds. 4. Beneficial organisms used in plant protection industry. 5. Imported plants infected with quarantine plant pests defined as indigenous ones in Vietnam. 6. Other plant quarantine articles likely to carry quarantine plant pests shall be identified by the Plant Protection Department for submission to the Minister of Agriculture and Rural Development for his decision.

Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by an designated laboratory or a laboratory complying with ISO 17025; the data sheet must specify safety indicators prescribed by the Ministry of Health according to risk management principles under international regulations (or standards applied by the supplier if relevant regulations of the Ministry of Health are not available).

Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by an designated laboratory or a laboratory complying with ISO 17025; the data sheet must specify safety indicators prescribed by the Ministry of Health according to risk management principles under international regulations (or standards applied by the supplier if relevant regulations of the Ministry of Health are not available)

Requirement on process and procedures in examining the imported goods Article 13 promulgating the contents of inspection; Article 14 on the method of inspection and sampling; Article 15 on the registration for inspection; Article 16 on the procedure of inspection; Article 17 on the handling of inspection results; and Article 18 on the supervision of imported products circulating in the market

Manufacturers and sellers of food additives shall satisfy the following food safety requirements: 1. Satisfy general food safety requirements specified in specified in Clause 1 Article 19, Clause 1 Article 20 and Clause 1 Article 21 of the Law of Food safety. --------------------------- Article 19. Food safety assurance conditions for food producers and traders 1. Food producers and traders must meet the following conditions: a/ Having suitable venues with appropriate areas and safety distance from toxic and contaminating sources and other harmful factors; b/ Having sufficient technically qualified water for food production and trading: c/ Having adequate appropriate equipment to process materials and process, package, preserve and transport different types of food: having adequate washing and sterilization equipment and tools, disinfecting fluid, and equipment for preventing and controlling insects and harmful animals; d/ Having a waste treatment system which operates regularly under the law on environmental protection: e/ Maintaining food safety assurance conditions and keeping records of source and origin of food materials and other documents on the entire food production and trading process; f/ Complying with regulations on health, knowledge and practices of persons directly engaged in food production and trading. Article 20. Food safety assurance conditions for food preservation 1. Food producers and traders must meet the following conditions for food preservation: a/ Having preservation places and means which are large enough to preserve each type of food separately, allow technically safe and precise loading and unloading and guarantee preservation hygiene: b/ Preventing the effects of temperature, humidity, insects, animals, dust, strange smell and negative environmental effects: guaranteeing sufficient light: having special-use equipment for adjusting temperature, humidity and other climate conditions, ventilation equipment and other special preservation conditions required by each type of food; c/ Complying with preservation regulations of food producers and traders. Article 21. Food safety assurance conditions for food transportation 1. Organizations and individuals transporting food must meet the following conditions: a/ Means for transporting foods are made of materials which do not contaminate food and food packages and are easy to clean; b/ Food preservation conditions as required by food producers and traders are maintained throughout the course of transportation; c/ Food is not transported together with toxic goods or goods which may cause cross-contamination and affect food quality.

3. To grant a certificate on compliance with SPS requirement and food safety for products of plant origin, as per the form in Appendix IIa if the imported batch does not contain objectives under control or giving harm to Viet Nam and meets food safety requirements

Article 8. State inspection of quality of imported plant varieties 1. State inspection of quality of imported plant varieties shall be carried out by assessing and certifying conformity of shipments of imported plant varieties. The conformity assessment and certification shall be carried out the certification body designated by the Department of Crop Production. 2. Importers of plant varieties shall apply for conformity certification by a certification body designated by the Department of Crop Production; submit the Certificate of conformity of shipments of imported plant varieties to the customs authority for customs clearance.

3. The quarantine declaration for imported aquatic animal products for processing of foods for export, aquatic animal products imported directly from foreign fishing vessels or imported indirectly from foreign fishing vessels and transshipped at transfer ports of other countries for processing of foods for export, aquatic animal products used as samples, or exported aquatic animal products that are recalled or returned includes: e) The copy bearing the enterprise’s certification of the Captain’s statement or the Seller’s statement. This document must include the following information: Name and registration number of the fishing vessel, the flag state, catch method, catch dates and area(s) with respect to the aquatic animal products imported directly from foreign fishing vessels;

Method of food safety inspection: - Strict inspection applied to importation from environmental, disease-containing and hazard regions; and if the previous importation was under requirement - Normal inspection applied randomly - Reduced inspection

Article 39. Physical inspection of microorganism sample, biological products, tissues, human body organs 1. Subjects of physical inspection: Any microorganism sample, biological products, tissues, human body organs transported through the border.

Article 29. Inspection of quality of imported aquafeeds and treatment products 1. The inspecting authority is the Ministry of Agriculture and Rural Development or the authorized fishery authority of the province. 2. Contents and procedures for inspection of quality of imported aquafeeds and treatment products shall comply with regulations of the law on product quality.

Article 78. Import of livestock and animal products 1. There must be records of origin of livestock and animal products imported meeting requirements for food quality and safety and disease resistance as per law provisions. 2. Livestock and animal products imported must undergo inspection of food quality and safety and disease resistance as per Vietnamese law provisions before entering the territory of the Socialist Republic of Vietnam through the specified border checkpoint.

Article 7. Inspection of food safety of imported salt 1. The concerned importer shall submit an application for inspection of food safety of imported salt to the inspecting agency at the port of entry of the imported salt shipment.

Article 9a. Animal quarantine and inspection of quality of imported animal source feeds before customs clearance 1. Imported animal source feeds on the List of imports subject to inspection by a specialized agency before customs clearance under the management of the Ministry of Agriculture and Rural Development have to undergo both quarantine and quality inspection.

Requirement on process and procedures in examining the imported goods Article 13 promulgating the contents of inspection; Article 14 on the method of inspection and sampling; Article 15 on the registration for inspection; Article 16 on the procedure of inspection; Article 17 on the handling of inspection results; and Article 18 on the supervision of imported products circulating in the market

1. Food manufacturers and sellers shall retain information about manufacturers or suppliers of products and buyers (if any) in the form of contracts, logbooks or other methods to serve origin tracing. Information serving origin tracing includes: a) Names and categories of the products sold; d) Dates, quantities, batch numbers of the products sold.

Article 5. Requirements regarding information of traceability database of food-related products applicable to food-related product business establishments When establishing a database of traceability of food-related products, a food-related product business establishment must organize, keep record, archive, be ready to extract and report the following information: 1. Name and address of facilities providing food-related products for the business establishment. 2. Information on kind of food-related products, amount of products of batches received, sold and in inventory of the business establishment. 3. List of name and address of clients, agents distributing food-related products (if any); amount of products in batches received, sold and in inventory.

1. Livestock breeds and products thereof imported must be confirmed in writing by the competent authority or the organization authorized by the competent authority of the exporting country in terms of their sources, origin, quality and purpose for breed multiplication or production.

Article 78. Import of livestock and animal products 1. There must be records of origin of livestock and animal products imported meeting requirements for food quality and safety and disease resistance as per law provisions. 2. Livestock and animal products imported must undergo inspection of food quality and safety and disease resistance as per Vietnamese law provisions before entering the territory of the Socialist Republic of Vietnam through the specified border checkpoint.

2. The organization or individual producing and selling plant varieties shall have documents serving tracing of the plant variety batch, including information about plant variety sales contract and invoices; documents about quality of the plant variety batch and appropriate label according to Article 10 of this Decree.

Article 1. List of plant quarantine articles 1. Vegetation Plants and living parts of plants. 2. Plant products a) Various types of tubers, bulbs, fruits, seeds, flowers, leaves, plant bodies, stems, roots, barks; b) Various types of grains, broken seeds, oil cakes, raw natural fibers and botanic fibers; c) Flour and starch extracted from plants (except for dough and modified starch); d) Tobacco stems, fibers, pipe tobacco fibers, yeast used in animal feeds, raw cotton, waste cotton, straw, thatch and aquatic plants; dd) Round wood, timber, wood pallets, sawdust, coconut sawdust; e) Animal feed materials extracted from plants; g) Plant rack made from plants. 3. Various types of mushrooms (except for salted, pickled, frozen, canned mushrooms and yeasts). 4. Cocoons, silk wastes and lac. 5. Various types of insects, spiders, pathogenic fungus, nematodes, germs, viruses, phytoplasmas, viroids and noxious weeds used for testing, training, biological control and scientific research. 6. Means of conveyance and storage of plant quarantine articles. 7. Other articles likely to carry quarantine plant pests shall be identified by the Plant Protection Department for submission to the Minister of Agriculture and Rural Development for his decision. 8. Where the exportation of articles that are not specified in the List in accordance with this Article, the plant inspection shall be carried out at the request of importing countries and International Agreements of which Vietnam is the signatory.

Article 4. Application for issuance of the certificate of food safety 1. Application for a new certificate of food safety: a) The application form made according to the Form No. 01a provided in the Appendix enclosed herewith; b) The description of facilities, equipment and devices meeting food safety requirements made according to the Form No. 02a (for food manufacturers), Form No. 02b (for food sellers) or both the Form No. 02a and the Form No. 02b (for an establishment both manufacturing and selling foods) provided in the Appendix enclosed herewith; c) The certificate of good health or the written certification of health, granted by the health facility of district level or higher, of the establishment owner and persons directly engaging in the production or trading of foods (the copy certified by the food establishment); d) The certificate of completion of training course in food safety or the certificate of qualification in food safety of the establishment owner and persons directly engaging in the production or trading of foods (the copy certified by the food establishment).

Article 8. Inspection after issuance of the certificate of food safety 1. Regulatory authorities that have the power to issue the certificate of food safety prescribed in Article 6 hereof and other competent authorities shall conduct inspections after the issuance of the certificate of food safety. 2. A regulatory authority is entitled to conduct inspection of the food establishment whose certificate of food safety is issued by its inferior authority. 3. The inspection after the issuance of the certificate of food safety shall be conducted once a year.

Article 13. General requirements concerning recognition of circulation and self-declaration of circulation of plant varieties 2. Plant varieties not belonging to the main plant species may be produced, traded, exported or imported only if breeding organizations or individuals are granted permission for self-declaration of circulation of plant varieties as provided for in Article 17 hereof, except in the case where plant varieties are intended for research, trial, advertisement, exhibition, international exchange or production of hybrid seeds for export. In case where organizations and individuals wish to apply for the decision on recognition of circulation of plant varieties, they must comply with the provisions of Article 15 of this Law; or if they wish to apply for the decisions on recognition of the privileged circulation of plant varieties, they must comply with the provisions of Article 16 of this Law.

Article 32. Requirements applied for commercial animal feeds before put into circulation 1. Applied standards and conformity declaration shall be made as per law provisions on technical standards and regulations and product and goods quality.

2. Animal feeds that are firstly imported from countries or territories whose testing process or animal feeds are not accredited by Vietnam or animal feeds produced in Vietnam containing new substances which are not tested in Vietnam must undergo testing before declaration, except for animal feeds created as a result of national or ministerial scientific and technological tasks accredited or approved by competent authorities.

Requirement on conformity announcement prior to circulation applied to processed food, food additives, manufacturing-supportive substances for prepackaged food; packaging tools and materials, containing materials for food

Article 8. Elaborating eligibility requirements for production and sale of plant varieties An organization or individual producing and selling plant varieties shall comply with the eligibility requirements specified in Article 22 of the Law on Crop Production and some of the following regulations: 1. Before selling plant varieties, the organization or individual shall send a notification via an email or in person or by post to the Department of Agriculture and Rural Development of the province where plant varieties are sold, which contains the following information: business location, name of the organization or individual or legal representative and contact telephone so that the notification is posted on the web portal of the provincial Department of Agriculture and Rural Development;

A certified copy of Certificate of Free Sales (CFS) is required for the first importation of plant protection products that are not included in the list of permitted plant protection products to use in Viet Nam

Self-declaration procedures: a) The self-declaration shall be posted through mass media or the producer’s website or premises; 01 copy of the self-declaration shall be submitted, directly or by post, to regulatory authority designated by the People’s Committee of the province (hereinafter referred to as “receiving authority”); b) Right after the self-declaration is submitted, the supplier is entitled to manufacture and sell the product and assume full responsibility for the safety of such product; c) The receiving authority shall post the self-declaration and the product names therein on its website. If the supplier has more than one factory that produces the same product, self-declaration documents shall be submitted to the regulatory authority of one of the provinces of the supplier’s choice. Once selected, self-declaration documents shall be submitted to the same authority. 3. Self-declaration documents must be written in Vietnamese language; documents in other languages must be translated into Vietnamese language and notarized. The documents must be unexpired when the self-declaration is submitted.

Food suppliers must register the declarations of the following products: 1. Dietary supplements, medical foods, food for special dietary uses. 2. Dietary products for children up to 36 months. 3. Mixed food additives with new uses, food additives that are not on the list of permitted food additives compiled by the Ministry of Health (hereinafter referred to as “unregistered food additives”).

Documents about scientific evidence of the effects of the product or ingredients (original or authenticated copy). If scientific evidence of effects of the ingredients is used, the daily dose must be greater or equal to 15% of the content of such ingredients mentioned in the document;

Products for treatment or improvement of aquaculture environment not yet mentioned in Appendix 4 to this Circular or not on the list of those permitted for circulation in Vietnam (not yet permitted or to have a certificate of circulation in Vietnam (imported for testing, research, introduction at fairs, exhibitions, analysis samples in laboratories), must be applied for imported permission.

Article 37. Application for Certificate of Eligibility for LPG/LNG/CNG importer/exporter 1. An application form for Certificate of Eligibility for LPG/LNG/CNG importer/exporter according to Form No.1 provided in Appendix issued thereto.

Article 16. Requirements to be satisfied to import used ships for breaking 1. An importer of the used ship for breaking is required to meet the following requirements: a) It must be a Vietnamese enterprise 100% of charter capital of which is held by Vietnamese organization(s) or individual(s); b) It must own or manage the ship-breaking facility which has been put into operation in accordance with law regulations.

Article 2. Regulated entities This Circular applies to holders of the license for sale and provision of cyberinformation security products and services that import cyberinformation security products on the List.

1. A ship dismantlement enterprise shall be issued with a license for import of used ships for dismantlement by the Ministry of Transport if it: a) is established as prescribed by law; b) has a division in charge of occupational safety and environmental protection; c) has a legal capital of VND 50 (fifty) billion.

3. Entities to be granted import permits: Entrepreneurs that have already granted Investment certificate, Investment license, Certificate of enterprise registration, Certificate of business registration or similar legal papers, Certificate of satisfaction of business conditions for non-table electronic games intended for foreigners, and Certificate of casino business.

Article 8. Import Procedures 1. Traders importing used cars are enterprises which have been granted a car import business license by the Ministry of Industry and Trade according to the provisions of law.

Article 44. Fertilizer import 1. Organizations and individuals that have fertilizers already obtaining the decision on recognition of fertilizer in circulation in Vietnam may import or authorize other organizations and individuals to import fertilizers in such decision without having to hold fertilizer import permits.

2. Any organization/individual importing medical devices with the registration number must satisfy the following conditions: a) Being the registration number holder or having the power of attorney made by the holder of the registration number. The registration number holder that authorizes an importer to import medical devices shall send the power of attorney the Ministry of Health and the customs authority as well; b) Having storage facilities conformable to the requirements specified in clause 3 Article 13 of this Decree and having vehicles for delivering medical devices conformable to requirements specified in clause 4 Article 13 of this Decree or having the contract with the establishment capable of storing and transporting medical devices.

26. Clause 2 of Article 41 is amended as follows: “2. An organization or individual that wishes to import medical devices that already have a registration number shall: a) be the registration number holder or authorized in writing by the registration number holder. When authorizing import of medical devices, the registration number holder shall send a copy of the authorization letter to the registration number issuer and the customs authority; b) has a warehouse and vehicles satisfying the requirements specified in Clause 2 Article 37 of this Article or has a medical device storage and transport contract with a capable service provider; c) has a warehouse and an inventory monitoring system for medical devices containing narcotic substances and precursors that satisfy the requirements in Clause 3 Article 37 of this Decree.”

Article 2. Principles of management of the import, export and temporary import for re-export of ozone layer-depleting substances 3a/ Traders that import or export ozone layer-depleting substances shall register with the Ministry of Natural Resources and Environment and obtain the Ministry's certification thereof. The Ministry of Natural Resources and Environment shall certify the volume of HCFCs registered for import by a trader based on the import quotas for HCFCs provided in Article 3 and the average volume of HCFCs actually imported by that trader in three (3) consecutive years preceding the year of import registration by the trader.

Article 3. Importing tobacco ingredients and cigarette rolling paper 1. Based on the annual tariff quota, the enterprise’s production, the domestic capacity to supply raw materials and the enterprise's registration of import of tobacco ingredients and cigarette rolling paper serving its production of tobacco products for domestic sale, the Ministry of Industry and Trade shall consider giving approval to the enterprise for use of tobacco ingredients/ cigarette rolling paper for prescribed purposes other than exchange or trading in any forms. The enterprise shall submit an application for registration of import of tobacco ingredients/ cigarette rolling paper using the form provided in the Appendix 1 enclosed herewith. 2. The enterprise that imports tobacco ingredients/ cigarette rolling paper serving its production of tobacco products for export or processing of tobacco products for export shall submit an application for registration of import of tobacco ingredients/ cigarette rolling paper using the form provided in the Appendix 2 enclosed herewith to the Ministry of Industry and Trade. 3. The enterprise that imports tobacco ingredients serving its manufacturing of tobacco ingredients for export or processing of tobacco ingredients for export shall submit an application for registration of import of tobacco ingredients using the form provided in the Appendix 3 enclosed herewith to the Ministry of Industry and Trade.

Article 15. Application for certificate of eligibility for fertilizer trade 1. An application for certificate of eligibility for fertilizer trade, which is made using Form No. 08 of Appendix I enclosed with this Decree. 2. A photocopy of the certificate of completion of training or refresher course on fertilizers or diploma of vocational secondary school or higher of the person directly trading fertilizers as prescribed in Point c Clause 2 Article 42 of the Crop Production Law.

Unrecognized or prohibited fertilizer products containing harmful residues exceeding the limit prescribed in national technical regulations and national standards or Appendix V of this Decree if there are no national technical regulations or national standards and other relevant regulations

Compulsory contents of label of imported Diapers, sanitary napkins, facial masks, cotton removers, cotton buds, toilet paper (composition; technical specification; usage; warnings if any; production month; expiry date)

Compulsory contents of label of imported Helmets for motorcycle, moped, electric bicycle riders (hereinafter referred to as helmets) (size; production month, year; model; quantitative; usage; one phrase "Mu bao hiem dung cho nguoi di moto, xe may"; warnings (if any))

Compulsory contents of label of imported health protection food (quantitative; production date; expiry date; ingredients; warnings if any; usage, storage instructions; risk warning if any; one phrase of "Thuc pham bao ve suc khoe"; one phrase of "Thuc pham nay khong phai la thuoc, khong co tac dung thay the thuoc chua benh")

Compulsory contents of label of imported Veterinary drugs, vaccines and biological products for animal health (Quantitative; production date; expiry date; ingredients; usage, storage instructions; warnings)

Compulsory contents of label of imported Aquatic breeds (Name of breed (including both commercial and scientific names); name of breeding center; number of breeds; quality indicator and standard; sale date; expiry date if any; usage, storage instructions; telephone if any)

Requirements of labelling: The height of letters on the label is not less than 1.2mm. In case the label is on one side of the cover, it should not be less than 0.9mm. The color of text must be in contrast with the background of label. It is recommended that nutritious information should be labelled under guidance of CODEX Way of labelling:Chapter II comprises of 10 articles, promulgating the way of labelling, including name of products; ingredients of products; quantity, manufacturing date, validation and preservation; usage guidance; recommendations and safety warnings; name and address of responsible organization/individuals; origin of product; receipt of conformity notification or certification of conformity assessment ; and exemption of some compulsory labelling requirements

Article 16. In addition to the regulation stated in Chapter II, food additives should be label as follows: - Name of group and name of additives, their international codes - If there are two or more additives, their names should be listed on descending order of quantity - Clearly state "For foods" under the name of additives with minimum text of 2mm and in bold Article 17. For irradiated techniques used in produced, processed and preserved foodstuffs, there should be "Irradiated foodstuff" on the label or the symbol of irradiation in compliance with international regulation that Vietnam has adopted

Article 46. Animal feed labeling 1. Labeling animal feeds shall comply with law provisions on goods labeling and the following regulations: a) The label or attachment of commercial animal feeds must specify information about name and main ingredients, quality standards, producer, production date, expiry date, maintenance instruction, using instruction of the product; information about the entity responsible for origin of such animal feed product; b) The label or attachment of other animal feeds must specify information used for identification and trace of origin of such animal feed products.

Compulsory contents of product label: - Clear, accurate and easy for consumer to understand - For functional foods and micro-nutrient foods, the label must includes the ingredients, dosage, effects on health, warning,… - For health-nutrient products, vitamin and mineral supplements, there must be announcement on the requirement against nutritious demand, dosage and doctor's prescription - Name of product must be in large font, and at least 3 times bigger than other letters on the label

Imported cigarettes for sale at duty free shops must have their labelling printed with health warnings in Vietnamese or English in accordance with the law on prevention and control of tobacco harms and the Framework Convention on Tobacco Control (FCTC)

Article 2, item 1a) Energy labels are mandatory for home and industrial equipment and appliances that follow: straight fluorescent tubes, compact fluorescent bulbs, magnetic and electronic ballasts for fluorescent lights, air conditioners, electric cookers, refrigerators, electric fans, horizontal-axis and vertical-axis washing machines, video cameras, three-phase distribution transformers, and electric engines. Article 2, item 2a) Energy labels are mandatory for commercial freezers; Article 2, item 3a) Energy labels are mandatory for automobiles for the transport of up to 7 persons;

Article 2, item 1c) From January 1, 2020, energy labels are mandatory for: LED light bulbs, electric kettles. Article 2, item 2d) Energy labels are mandatory for laptop computers from January 1, 2020; Article 2, item 3c) Energy labels are mandatory for motorcycles and mopeds from January 1, 2020;

Requirement on profile of application and authorized agency involving in the granting of import license of fertilizer (one foreign-language copy containing information on ingredients, usage instruction, etc.)

Compulsory contents of label of imported genetically modified food (quantitative; production date; expiry date; ingredients; warnings if any; one phrase of "Thuc pham bien doi gen" or "Bien doi gen" next to the name of GMO ingredient alongside content)

Compulsory contents of label of imported Medicines, medicinal materials for human use (Quantitative, content, intensity or weight; production date; expiry date; form; packaging, product quality; Registration number or import licence, batch production number; Information, warnings related to safety and health; usage, storage instructions)

Compulsory contents of label of imported medical equipment (Number of circulation or registration number; Batch or serial number; Production or expiry dates (must have expiry dates for medical equipment for anti-bacteria, once-use, tester, controlling materials); warnings, usage and storage instructions

Compulsory contents of label of imported cosmetics (Quantitative; ingredients; production batch number; production date or expiry date; with products having stability degree of less than 30 months, expiry date is compulsory; usage instructions; information, warnings)

Compulsory contents of label of imported household chemicals (Quantitative; production date; expiry date; ingredients or content of active substances; production batch number; circulation number in Vietnam; usage, storage instructions; information, warnings)

Compulsory contents of label of imported Biological products, microorganisms, chemicals, environmental remediation substances (Quantitative; production date; expiry date; ingredients; usage, storage instructions; warnings (if any); telephone (if any))

Compulsory contents of label of imported Political, economic, cultural, scientific, educational and art publications (Name of Press, publishing house; name of author, translator; publication licence; technical specification; warnings if any)

Compulsory contents of label of imported Personal protective equipment, fire safety equipment (quantitative; production date; expiry date; technical specification; warning; usage, storage instructions)

Compulsory contents of label of imported Informatics, communication, post and telecommunications equipment; refurbished IT products (production year; technical specification; warning; usage, storage instruction; with refurbished products, there must be one phrase "san pham tan trang lam moi" or in English equivalent)

Compulsory contents of label of imported cars (name of carmaker; trademarks, commercial name, model code; Frame or VIN number; body weight; number of seats (for passenger motor vehicle; total weight; production year; warnings if any)

Compulsory contents of label of imported Trailer, semi-trailer (name of carmaker; trademarks, commercial name, model code; Frame or VIN number; body weight; total weight; production year; warnings if any)

Compulsory contents of label of imported motorcycles for specific use (name of maker; trademarks, commercial name, model code; Frame number; particular technical specification; production year; warnings if any)

Compulsory contents of label of imported four-wheeled Passenger motor vehicles (name of maker; trademarks, commercial name, model code; body weight; number of persons that are permitted to carry; total weight; frame or VIN number; production year; warnings if any)

Compulsory contents of label of imported Spare parts of transportation vehicles (trademarks, commercial name, model code; part number; technical specification if any; production year if any; warnings if any)

Manufacturers and sellers of foods the content of GM ingredients in which exceeds 5% of total ingredients, in addition to compliance with common regulations of law on goods labeling, the goods label must contain information about the GMOs, except for the cases specified in Clause 2 of this Article.

Compulsory contents of label of imported chemicals (quantitative; production date; expiry date if any; recognition code if any; information, warnings if any; preventive measures if any; usage, storage instruction)

1. Importers and exporters of medicinal products and materials and providers of medicinal product and medicinal material storage services (except for importers and exporters of herbal medicinal materials and traditional ingredients and providers of medicinal product and traditional ingredient storage services) shall apply GSP requirements specified in Appendix I hereof and updated documents specified in Clause 5 Article 3 hereof.

Article 6. Requirements applied to gas importers and exporters 1. Every gas importer or exporter must: a) be an enterprise founded in accordance with provisions of laws; b) own wharves or enter into a contract for leasing wharves of Vietnam port system for at least 5 years which have been permitted to be put in use by competent authorities. c) own gas tanks or enter into a contract of gas tank lease which meets all safety regulations; d) satisfy all requirements for fire preventing and fire extinguishing in accordance with provisions of laws; dd) own LPG bottles or enter into a contract of leasing LPG bottles eligible to be put on the market (applied to bottled LPG importers and exporters)

Amends: 561004/Clause 2 of Article 41 is amended as follows: “2. An organization or individual that wishes to import medical devices that already have a registration number shall: c) has a warehouse and an inventory monitoring system for medical devices containing narcotic substances and precursors that satisfy the requirements in Clause 3 Article 37 of this Decree.”.

2. Any organization/individual importing medical devices with the registration number must satisfy the following conditions: a) Being the registration number holder or having the power of attorney made by the holder of the registration number. The registration number holder that authorizes an importer to import medical devices shall send the power of attorney the Ministry of Health and the customs authority as well; b) Having storage facilities conformable to the requirements specified in clause 3 Article 13 of this Decree and having vehicles for delivering medical devices conformable to requirements specified in clause 4 Article 13 of this Decree or having the contract with the establishment capable of storing and transporting medical devices.

Clause 2 of Article 41 is amended as follows: “2. An organization or individual that wishes to import medical devices that already have a registration number shall: b) has a warehouse and vehicles satisfying the requirements specified in Clause 2 Article 37 of this Article or has a medical device storage and transport contract with a capable service provider;

Article 4.- Management and preservation of weapons, military explosives and support tools 2. The regime of management and preservation of weapons, military explosives and support tools a) Agencies, organizations and enterprises equipped with and using military weapons, explosives and combat gears must compile records and monitoring books; When using it, it must be permitted by the head of the agency, organization or enterprise and recorded in the records and books for monitoring; After use, it must be handed over to the person assigned to manage the warehouse, storage place for maintenance, preservation and sign and receive in the monitoring book; b) Every year, agencies, organizations and enterprises must have a plan to conduct technical inspection, evaluate the quality and classify weapons, military explosives, equipped and used support tools. . For weapons, military explosives and support tools that are no longer usable or have expired, they must report to the equipment and license-granting agency of registration confirmation for recall and liquidation. , destruction; c) Every 6 months, every year, agencies, organizations and enterprises must send written reports to the licensing agency for use of the certificate of registration on the situation and results of the management and use of weapons. military explosives and supporting tools; d) In case of loss of weapons, military explosives or supporting tools or an incident at the warehouse or storage of military weapons, explosives and combat gears, a written report must be made immediately. agencies that have issued permits, certificates to take handling measures according to regulations; dd) Persons assigned to manage warehouses and places where weapons, military explosives and combat gears are kept must make full statistics and record in the monitoring book of issuance, receipt, recall, transfer, transfer, upgrade, damage, loss or repair of weapons, military explosives and support tools; Regularly inspect and maintain, take measures to prevent rust, rust, termites, termites, moisture, mold, loss, fire, explosion and other dangerous cases for military weapons, explosives tools; Carry out cleaning in and out of warehouses, where weapons, military explosives and support tools are stored.

Importers must own or rent storage facilities for preservation of animal and fishery feeds which conform to storage requirements in order to ensure quality standards, environmental protection and recommendations given by manufacturers

This measure sets out requirement on places of warehouses and harbors, loading and unloading places shall satisfy conditions for security and order and ensure the safe distances between those places and works and objects to be protected

18. Send a report of distribution system, goods label, gas export, import and trading activities to the Ministry of Industry and Trade before March 30 each year. 19. make a following-up book or develop an electronic data system applying information technology to supervise bottled LPG sold to other LPG traders or customers Such following-up book or electronic data system must specify the following information on bottled LPG: the owner, bottle type, series number, testing expiry, name and address of the purchaser or customer and delivery date.

2. The used ship to be imported for breaking must meet the following requirements: a) It is a type of ships prescribed in Article 5 hereof; b) The ship is not under any mortgage or maritime claim according to the written certification of the shipowner who shall also assume responsibility for such certification; c) The imported ship shall not be modified, upgraded, repurposed, transferred or sold to another party.

30. Article 56b shall be added as follows: "Article 56a. Power and procedures to issue, reissue, and revoke certificates of eligibility for environment protection in import of scrap 1. The Ministry of Natural Resources and Environment shall issue, reissue, and revoke certificates of eligibility for environment protection in import of scrap used as production materials (hereinafter referred to as Certificate). 2. Required documents in an application for issuance of Certificate: a) An application form using form No. 01 Appendix VI Section III issued herewith; b) A report on eligibility for environment protection in import of scrap used as production materials using form No. 02 Appendix VI Section III issued herewith; c) A copy of business registration certificate or enterprise registration certificate; TIN registration certificate; d) A copy of decision on approval for EIA report; dd) A copy of inspection result of waste treatment works for the project owner to carry out commissioning issued by the provincial environment protection authority as prescribed in Point a Clause 6 Article 16b of Government’s Decree No. 18/2015/ND-CP (applies solely to projects which have been undergoing commissioning phase); e) A copy of inspection result of commissioning of waste treatment works issued by the provincial environment protection authority as prescribed in Point d Clause 6 Article 16b of Government’s Decree No. 18/2015/ND-CP (applies solely to projects which have just completed commissioning phase); g) A copy of one of the following documents: confirmation of completion of environment protection works or license for hazardous waste treatment or certificate of eligibility for environment protection in import of scrap of the applicant for reissuance of Certificate; h) A copy of contract for transfer of treatment of impurities and waste with a qualified organization (if the facility has no technology or equipment to treat impurities accompanying imported scrap and waste); i) A commitment to re-export, treat, or dispose of violating imported scrap using form No. 03 Appendix VI Section III issued herewith. 3. Procedures for verification, time limit, issuance of Certificate a) The importer of scrap used as production materials shall prepare e-documents (application for issuance of Certificate prescribed in Clause 2 of this Article) and send them to the Ministry of Natural Resources and Environment via national single-window system. Procedures for initiation, receipt, exchange, response, and giving of administrative procedure processing result in this Clause shall be done via national single-window system and specialized system of the Ministry of Natural Resources and Environment in accordance with regulations on administrative procedures via National Single Window, ASEAN Single Window and specialized inspection of exported goods and imported goods; b) Within 5 working days from the day on which the valid and complete application is received, the receiving body or the authorized body shall set up an inspectorate to inspect eligibility for environment protection in import and use of imported scrap used as production materials as prescribed in Article 56 hereof. If the application is insufficient, the receiving body or the authorized body shall notify the applicant of completion and provide explanation. The inspectorate shall conduct an inspection visit, take and analyze waste sources generating from the project, facility for assessment (take and analyze composite samples for assessment in case of necessity). The cost incurred in taking and analysis of samples shall be covered by the fee for issuance of Certificate; if the composite sample is taken, cost incurred shall be covered by the applicant. The inspection result shall be expressed in a report; c) If the importer meets the conditions for environment protection as prescribed, the competent authority shall consider issuing a Certificate; if not, the competent authority shall notify the applicant of completion of the application and fulfill the eligibility conditions for environment protection. The applicant shall complete the application and send the completed application to the competent authority for consideration; in case of necessity, the competent authority shall re-verify conditions for environment protection and consider issuing the Certificate; d) Time limit for issuance of Certificate is 25 working days from the day on which the valid and complete application is received; time limit for issuance of Certificate is 20 working days from the day on which the valid and complete application is received. The above time limit does not include the time limit for completion of application and analysis of waste samples; dd) The Certificate is valid for 5 years using Form No. 04 Appendix VI Section III issued herewith. Regarding new projects, the procedure for issuance of Certificate shall replace the procedure for inspection and certification of completion of environment protection works. The Certificate shall replace confirmation of completion of environment protection works. Regarding hazardous waste treatment facilities and projects having the phase of production, recycling, reuse of scrap as production materials, the procedure for issuance of the Certificate shall be combined with the procedure for issuance of the license for hazardous waste treatment. The licensing agency shall issue both Certificate and license for hazardous waste treatment. 4. Procedures for inspection, time limit for issuance of Certificate in case of projects of commissioning of waste treatment works a) The importer of scrap used as production materials shall prepare e-documents (application for issuance of Certificate prescribed in Points a, b, c, d, dd, h, and I Clause 2 of this Article) and send them to the Ministry of Natural Resources and Environment via national single-window system. Procedures for initiation, receipt, exchange, response, and giving of processing administrative procedure results in this Clause shall be carried out in accordance with Point a Clause 3 of this Article; b) Within 15 working days, from the day on which the valid and complete application is received, the competent authority shall consider issuing a Certificate; if the application is unsatisfactory, the receiving body shall notify the applicant of completion and fulfill the eligibility conditions for environment protection; in case of necessity, the competent authority shall conduct an inspection visit to waste treatment works before issuing the Certificate; c) The Certificate is valid for 1 year in order for the project of commission of waste treatment works using Form No. 04 Appendix VI Section III issued herewith. 5. 90 days before the expiry date of the Certificate, the applicant must submit the application prescribed in Points a, b, c, d, g, h and I Clause 2 hereof for reissuance of the Certificate. Procedures for inspection, reissuance of Certificate shall be carried out as prescribed in Clause 3 of this Article. 6. If the Certificate is lost or damaged, the applicant shall request the issuing authority in writing to issue a copy of Certificate. 7. Certificate shall be revoked in the following cases: a) A violation against regulations on environment protection is so serious that the Certificate may be suspended or the operation may be mandatorily suspended as prescribed by the Government on penalties for administrative violations in environment protection and has not completed the rectification of violation consequences; b) The importer of scrap must terminate the import of scrap as production materials or goes bankrupt and is dissolved. 8. The licensing agency of a Certificate shall issue a decision on revocation of such Certificate, specifying the name of importer whose Certificate is revoked, bases and reasons for revocation and remedial measures enclosed if the importer has not fulfilled responsibilities as prescribed in Article 63 hereof. 9. The agency which issues, reissues or revokes a Certificate and the competent person who impose a decision on penalty for administrative violation on the importer of scrap in form of suspension of the Certificate or mandatory suspension of operation shall publish such information on their website, and send the original of Certificate, revocation decision and penalty decision to: a) National single-window system; b) The Ministry of Finance (the General Department of Customs); c) The environmental protection authority of province where the manufacturer using imported scrap as production materials is located; d) The licensing agency of Certificate in case of penalty for violation; dd) The holder of Certificate. 10. The Ministry of Natural Resources and Environment shall provide guidelines for inspection and issuance of Certificates; regulations on environment monitoring techniques prescribed in this Article.”

3. Traders shall submit quarterly and annual reports on export and import of HFCs in the same forms and within the same time limits as those for HCFCs prescribed in Clause1 and Clause 2 Article 8 of the Joint Circular No. 47 and the provisions in Appendix V enclosed herewith.”

Traders shall make reports on the import, export and temporary import for re-export of HCFCs and import of HCFC- 141b pre-blended polyol according to the form provided in Appendix VII to this Circular (not printed herein) and send them to the Ministry of Industry and Trade and the Ministry of Natural Resources and Environment as follows: Quarterly reports on the import and temporary import for re-export of HCFCs under licenses granted by the Ministry of Industry and Trade must be sent prior to the 5th of the first month of the subsequent quarter. Annual reports (enclosed with copies of customs declarations) on the import and temporary import for re-export of HCFCs under licenses granted by the Ministry of Industry and Trade; and on the import of HFCF-141b pre-blended polyol, and the export of HCFCs under certifications of the Ministry of Natural Resources and Environment must be sent prior to December 31.

In producing and trading facilities, liquid and solid waste treatment measures shall be applied to protect the environment under the Law on Environment ( Wastewater shall be treated to meet standards in QCVN 62 - MT: 2016/BTNMT on farming effluents)

4. Producing and importing establishments shall make periodical reports and send them to quality management agencies before January 15 every year according to the form provided in Form No. 04 of the Appendix enclosed herewith.

This measure replaces potentially unsafe products under the management of the Ministry of Industry and Trade in Circular 41/2015/TT-BCT, complied with related quality standard in column 3 of the Appendix

Article 6. Requirements for measurement in gas import, import, manufacture, process, blending and trade; provision of ports for gas import, export, gas tanks and warehouses to store LPG bottles; provision of gas transportation services; gas refueling and filing; LPG bottle retail Gas traders must: 1. Use measuring instruments satisfactory to requirements specified in Article 5 of this Circular; 2. Comply with regulations on use of measuring instruments and measuring systems of manufacturers and imports, and specialized requirements for metrology operation of competent metrology regulatory agencies. During use or period examination, if measuring instruments or measurement systems are discovered to be flawed or unsatisfactory to regulations on measurement deviations, traders who own measuring instruments and measurement systems must stop using such instruments and systems to adopt rectification measures; 3. Results of gas measurement in trading between organizations and individuals must fulfill following requirements: a) In case measuring instruments or measurement systems are used to determine volume or mass of gas a1) Measurement results of LPG/LNG/CNG in volume shall be converted to base units (base temperature is 15oC and base pressure is 101325 Pa). In case LPG is provided for households, LPG measurement results shall be determined by actual measurement; a2) Deviations of measurement results of LPG/LNG at base conditions must not exceed 1.5 times of the permissible deviations of measuring instruments or measurement systems; a3) Deviations of CNG measurement results must not exceed 2 times of the permissible deviations of measuring instruments or measurement systems; b) In case measuring instruments and calculation methods are used to determine heat of specific LNG/CNG amount, the LNG/CNG amount must satisfy following requirements: b1) Measurement results of LNG/CNG must satisfy requirements specified in Point a of this Clause; b2) Calculation methods conform to guidance of competent metrology agencies; c) In case of pre-bottled LPG: amount of LPG in bottles must conform to metrology technical requirements applied to amount of pre-packed commodities according to regulations and law on metrology; 4. In case of using true quantity markings on labels of pre-bottled LPG, comply with requirements for publicizing true quantity markings on labels of pre-packed commodities according to regulations and law on metrology; 5. Develop plans and conduct self-inspection regarding measuring instruments, measurement systems and measurement conditions by performing following tasks: a) Prepare plans to specify details and period of self-inspection; b) Conduct at least 1 inspection during the period of self-inspection according to plans; c) Store results of periodic self-inspection at location that is convenient for examination of competent agencies and individuals.

Requirement of safety, energy savings and environmental protection regarding the importation of used machinery, equipment and technical lines (in line with Viet Nam's standards and/or technical regulations)

Article 1. The following three national technical regulations on environment are promulgated together with this Circular, including: 1. QCVN 31:2018/BTNMT - National technical regulation on environment for imported steel scraps for production; 2. QCVN 32:2018/BTNMT - National technical regulation on environment for imported plastic scraps for production; 3. QCVN 33:2018/BTNMT - National technical regulation on environment for imported paper scraps for production. Article 2. Steel, plastic and paper scraps on the List of imported scraps for production enclosed with the Prime Minister’s Decision No. 73/2014/QD-TTg dated December 19, 2014 are potentially unsafe commodities (group-2 imports) under the management of the Ministry of Natural Resources and Environment.

Article 1. The following three national technical regulations on environment are promulgated together with this Circular, including: 1. QCVN 65:2018/BTNMT - National technical regulation on environment for imported glass scrap for production. 2. QCVN 66:2018/BTNMT - National technical regulation on environment for imported non-ferrous metal scraps for production. 3. QCVN 67:2018/BTNMT - National technical regulation on environment for imported slag from iron or steel industry for production. Article 2. Glass scraps, non-ferrous metal scraps and granulated slag from iron or steel industry specified on the List of imported scraps for production enclosed with the Prime Minister’s Decision No. 73/2014/QD-TTg dated December 19, 2014 are potentially unsafe commodities (group-2 imports) under the management of the Ministry of Natural Resources and Environment.

Article 4. Roadmap for application of QCVN 1. From June 1, 2020, domestically produced and imported steel for the reinforcement of concrete under the HS codes specified in the Appendix issued together with QCVN 07: 2019 / BKHCN issued by this Circular shall satisfy Requirements specified in QCVN

The import of treatment and improvement products for sea-product raising environment must be licensed by Department of Fisheries if they are not included in the List of treatment and improvement products for raising environment allowed for circulation in Vietnam (different additional requirement on different products, eg. contents of chemical, etc. --> effectively a quality requirement)

Article 9. Kid toys 1. Kid toys must be ensured 100% new; 2. Quality of kid toys must be ensured to conform to National technical regulation on kid toy safety as prescribed in the Circular No. 18/2009/TT-BKHCN dated June 26, 2009 of the Ministry of Science and Technology on National technical regulation on kid toy safety – QCVN 3:2009/BKHCN. 3. Content, form, design and function of kid toys must be ensured not to harm education and development of kids’ personalities, not to impose danger or negative effects on their health and not to violate the provisions set out in Article 6 hereof. Kid toys that meet conditions mentioned above shall qualify for import into Vietnam. Import procedures are carried out at the customs authority;

4. Conditions for import: - Machines, equipment must be 100% new. Contents, images, sounds and forms must meet requirements for quality and be suitable for Vietnamese people and do not violate the provisions on prohibition against dissemination and circulation in Vietnam; - Must have a location for installation and doing business for imported machines and equipment in accordance with the business registration issued by the competent agency; - Travellodge establishment recognition that is still unexpired at the time of importation as regulated. - Must comply with other requirements as prescribed in the Investment certificate or the Business registration certificate and Certificate of satisfaction of business conditions for non-table electronic games intended for foreigners, and Certificate of casino business.

Weapons, explosives, explosives precursors and combat gears shall be inspected, assessed and registered in accordance with regulations of law on managing quality of products and goods before they are produced, traded and used in Vietnam

Food trading establishments that are required to have Certificates of conformity with food safety regulations under the management of MOIT must have Certificate of enterprise registration, Certificate of household business registration or other papers of equivalent legal effect

This measure sets out the sample-based testing for each batch of imports of motorcycles and engines. The sample is on a random basis; the sample size is 1,2 or 3 depending on the number of items in the batch (under 100, between 100-500, over 500, respectively)

33. Article 59 shall be replaced as follows: “Article 59. Conformity assessment of technical regulations on environment associated with imported scrap used as production materials 1. Conformity assessment bodies of technical regulations on environment associated with imported scrap used as production materials include: a) Appointed appraisal bodies as per the law; b) Accredited foreign appraisal bodies as per the law in case of the case prescribed in Clause 6 Article 60 hereof. 2. The conformity assessment body of technical regulations on environment is entitled to provide services within Vietnam’s territory upon its eligibility as prescribed in Clause 5 Article 25 of the Law on Quality of Products and Goods, Government's Decree No. 74/2018/ND-CP dated May 15, 2018 on amendments to the Government's Decree No. 132/2008/ND-CP dated December 31, 2008, detailing the implementation of a number of articles of the Law on Quality of Products and Goods, the Government's Decree No. 107/2016/ND-CP July 1, 2016 on conditions for provision of conformity assessment services and Government's Decree No. 154/2018/ND-CP dated November 9, 2018 on amendments and annulment of certain regulations on investment and business conditions in state management of the Ministry of Science and Technology and certain regulations on specialized inspection. 3. The Ministry of Natural Resources and Environment shall provide guidelines for conformity assessment practices and certification, accreditation of conformity assessment bodies of technical regulations on environment associated with imported scrap used as production materials as prescribed in this Article.”

3. Testing, checking and acceptance of industrial explosives of new types shall be carried out in accordance with the QCVN 01:2012/BCT – National technical regulations on safety in the process of producing, testing and performing check and acceptance of Industrial explosive materials.

3. Requirements for fuel consumption test a) Two-wheeled motorbikes comply with the cycle of the Type I exhaust test specified in QCVN 77: 2014 / BGTVT; b) Motorcycles (except 2-wheel motorbikes) and mopeds shall follow the cycle of Type I emission test specified in QCVN 04: 2009 / BGTVT; c) If the vehicle has a new structure or technology that does not have regulations on testing according to QCVN 77: 2014 / BGTVT and QCVN 04: 2009 / BGTVT, the fuel consumption shall be tested according to the standards. , corresponding UNECE, EC, EEC regulations.

This measure sets out the testing and sampling requirement for imported helmet. Sample size is 20, 32, 50 and 80 for the batch of up to 500, between 500 and 1200, between 1200 and 3200, and over 3200 units

This measure sets out the sample-based testing for each batch of imports of electric bikes. The method is inline with National Standard QCVN 68:2013/BGTVT. The sample is on a random basis; the sample size is 1,2 or 3 depending on the number of items in the batch (under 100, between 100-500, over 500, respectively)

+ Regarding imported motor vehicles manufactured by a country applying the type approval method, the quality management authority shall carry out type assessment according to the results of safety and environmental protection inspection and testing of representative samples and results of Conformity of Production assessment; + Regarding imported motor vehicles manufactured by a country applying the self-certification method, the quality management authority shall carry out type assessment according to the results of safety and environmental protection inspection and testing of representative samples and by testing samples collected from market.

The import of treatment and improvement products for sea-product raising environment must be licensed by Department of Fisheries if they are not included in the List of treatment and improvement products for raising environment allowed for circulation in Vietnam (risk analysis report is required)

Requirement on testing of quick testing set on foodstuffs. Prior to being circulated into Vietnam, all quick testing set on food stuffs must be tested in Vietnam, except those being recognized by WHO, FAO, JECFA, AOAC, ISO and other parties involved in MRA with Vietnam.

1. Apply quality standards to pharmaceutical product and pharmaceutical starting material tests: a) The test must be carried out in accordance with the approved and updated pharmaceutical product/pharmaceutical starting material quality standards.

Documents used as basis for inspection of compliance with GDP principles by a pharmacy business establishment are those included in its application for certificate of eligibility for pharmacy business (the distributor is not required to submit these documents because they have been submitted when it applies for the certificate of eligibility for pharmacy business) prescribed in Article 38 of the Law on Pharmacy and Article 32 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for the implementation of the Law on Pharmacy (hereinafter referred to as “the Decree No. 54/2017/ND-CP”). In the case of a distributor of controlled pharmaceutical products, the documents prescribed in Article 38 of the Law on Pharmacy and Article 49 of the Decree No. 54/2017/ND-CP are required to be submitted.

Documents used as basis for inspection of GSP compliance by a storage facility are those included in its application for certificate of eligibility for pharmacy business (the establishment is not required to submit these documents because they have been submitted when it applies for the certificate of eligibility for pharmacy business) prescribed in Article 38 of the Law on Pharmacy and Article 32 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for the implementation of the Law on Pharmacy (hereinafter referred to as “the Decree No. 54/2017/ND-CP”). Storage facilities for storage of special-controlled medicinal products must have the documents prescribed in Article 38 of the Law on Pharmacy and Clause 31 Article 5 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to some Articles related to business conditions under state management of the Ministry of Health (hereinafter referred to as “the Decree No. 155/2018/ND-CP”).

Requirement of evidence of certification (if foreign producers have GMP, just own testing result for each import batch; if foreign producers have no GMP, need additional testing result by authority in exporting countries)

Requirement of a certified true copy of the manufacturing license issued by a competent authority of the exporting country in oder to import specially controlled drug ingredients with certificate of registration of sale in Vietnam

Products for treatment and improvement of aquaculture environment already on the list of those permitted for circulation in Vietnam (already permitted for circulation) or having certificates of circulation in Vietnam, when being imported, conducting the quality inspection according to current regulations of the Ministry of Agriculture and Rural Development