Decree No. 78/2018/ND-CP dated May 16, 2018 of the Government on amending and supplementing a number of articles of the Government’s Decree No. 127/2007/ND-CP of August 01, 2007, detailing the implementation of a number of articles of the Law on Standards and Technical Regulations

DECREE

Amending and supplementing a number of articles of the Government’s Decree No. 127/2007/ND-CP of August 1, 2007, detailing the implementation of a number of articles of the Law on Standards and Technical Regulations^[1]

Pursuant to the June 19, 2015 Law on Organization of the Government;

Pursuant to the June 29, 2006 Law on Standards and Technical Regulations;

At the proposal of the Minister of Science and Technology;

The Government promulgates the Decree amending and supplementing a number of articles of the Government’s Decree No. 127/2007/ND-CP of August 1, 2007, detailing the implementation of a number of articles of the Law on Standards and Technical Regulations.

Article 1.To amend and supplement a number of articles of the Government’s Decree No. 127/2007/ND-CP of August 1, 2007, detailing the implementation of a number of articles of the Law on Standards and Technical Regulations, as follows:

1. To add the following Article 2a:

“Article 2a. General requirements for elaboration of standards and technical regulations

1. Elaboration of standards

a/ To be participated by representatives of related management agencies, associations, unions, science and technology enterprises and organizations, consumers and experts;

b/ To comply with the principle of consensus on the basis of public and democratic discussions and opinion contribution.

2. Elaboration of technical regulations

a/ The national technical regulation (QCVN) and local technical regulation (QCDP) system must be uniform, consistent and conformable with treaties which Vietnam has signed or acceded to.

Ministries, ministerial-level agencies and provincial-level People’s Committees shall approve plans on elaboration of national and local technical regulations under their scope of management as defined in Articles 29, 60 and 61 of the Law on Standards and Technical Regulations after obtaining opinions of the Ministry of Science and Technology to ensure the uniformity and consistency of the system.

The Ministry of Science and Technology shall contribute opinions on a plan on elaboration of national and local technical regulations within 10 working days after receiving an official written request of the concerned plan-formulating agency.

b/ To prioritize the elaboration of technical regulations regulating groups of subjects which are similar in terms of technical characteristics and management requirements;

c/ To prescribe management measures and limitation levels of technical characteristics of products, goods, services, processes and the environment to directly serve the state management requirements in order to ensure safety, sanitation and health and protect the environment; protect flora and fauna; protect national interests and security and legitimate rights and interests of consumers; and respect the right to freedom of production and trading of organizations and individuals;

d/ A national technical regulation may cite other national technical regulations and national, international, regional and foreign standards;

dd/ In case of citing international, regional or foreign standards for technical requirements, promulgating agencies shall ensure the availability of Vietnamese versions of the cited documents upon requests of organizations and individuals for reference;

e/ When elaborating technical regulations, it is necessary to review regulations on recognition of equivalence and ensure compliance with treaties which Vietnam has signed or acceded to.

In case a technical regulation may lead to a technical barrier in international trade, the promulgating agency shall send its draft to the Ministry of Science and Technology for submission to collect international opinions in accordance with the treaties which Vietnam has signed or acceded to.”

2. To amend and supplement Clause 5, Article 3 as follows:

“5. Ministries and sectors shall, upon using annual scientific and technological non-business funds to elaborate draft national standards, consider prioritizing science and technology organizations, associations, unions and enterprises to assume the prime responsibility for the elaboration. In case organizations and individuals use their own funds to research and elaborate national standards or support the research and elaboration of technical regulations, they may enjoy incentives for the performance of scientific and technological tasks in accordance with the Law on Science and Technology.”

3. To add the following Article 4a:

“Article 4a. Elaboration, appraisal and announcement of national standards

The order and procedures for elaboration, appraisal and announcement of national standards must comply with Article 17 of the Law on Standards and Technical Regulations. In case a ministry or ministerial-level agency organizes the elaboration of a national standard, the elaboration, appraisal and announcement of such national standard must comply with Article 17 of the Law on Standards and Technical Regulations with the following steps:

1. The ministry, ministerial-level agency or agency assigned to elaborate the national standard shall establish an elaboration board or team (below referred to as elaboration team) to draft the national standard.

2. The elaboration team shall assess the reality and study of technical documents; and take samples for analysis, testing and assay (if any) to identify technical criteria and requirements of the draft standard.

3. After finalizing the draft standard, the elaboration team shall report such to the ministry or ministerial-level agency for sending it to related agencies, organizations and individuals and members of the relevant technical board(s) for national standards for collection of their opinions; and notify the collection of opinions on portals of related ministries, ministerial-level agencies and organizations.

The Ministry of Science and Technology shall publicize on its portal the list and contact addresses of members of technical boards for national standards.

The time limit for collection of opinions on a draft is 60 days from the date of draft sending; in case of urgency involving a health, safety and environmental issue, the time limit for collection of opinions may be shorter but must be at least 30 days.

To organize seminars with participation of related parties to discuss and contribute opinions on the draft;

4. The elaboration team shall synthesize and assimilate contributed opinions; finalize the draft and make a dossier of draft national standard for submission to the ministry or ministerial-level agency for examination of the dossier and contents of the draft standard according to assigned tasks before submitting them to the Ministry of Science and Technology for appraisal.

5. The Directorate for Standards, Metrology and Quality shall assist the Minister of Science and Technology in organizing the appraisal of the draft national standard under Article 18 of the Law on Standards and Technical Regulations.

6. The ministry or ministerial-level agency assuming the prime responsibility for elaborating the national standard shall accept and assimilate opinions and finalize the draft national standard and related dossier based on appraisal opinions and submit them to the Ministry of Science and Technology within 120 days from the date of appraisal notification.

Past that time limit, the draft national standard must be re-appraised;

7. The Ministry of Science and Technology shall consider and announce the national standard based on results of appraisal and post-appraisal finalization of the draft national standard and related dossier.”

4. To amend Points d and dd, Clause 1 of Article 5 as follows:

“d/ A list of agencies, organizations and individuals to which copies of the draft national standard have been sent for collection of opinions; the document on summing and assimilation of contributed opinions enclosed with documents containing opinions. The document on assimilation of contributed opinions must clearly explain scientific and practical grounds for each unaccepted or disagreed opinion;

dd/ An official request for appraisal of the draft national standard and announcement of national standard of a ministry or ministerial-level agency with contents certifying the completeness of the dossier of draft national standard.”

5. To amend Clause 2 of Article 9 as follows:

“2. The Minister of Science and Technology shall organize the appraisal of draft national technical regulations under Article 33 of the Law on Standards and Technical Regulations.

In case a national technical regulation is elaborated to manage group-II products and goods, the concerned minister or the head of the concerned ministerial-level agency shall promulgate such national technical regulation after reaching agreement with the Minister of Science and Technology on measures to manage products and goods in the technical regulation in order to ensure that no unnecessary technical barrier to production, trading and commercial activities is created.”

6. To amend Points d and dd, Clause 1 of Article 10 as follows:

“d/ A list of agencies to which the draft has been sent for collection of opinions; the document on the summing and assimilation of contributed opinions enclosed with documents containing such opinions, including opinions of related ministries and sectors;

dd/ An official request for appraisal made by the ministry or ministerial-level agency, certifying the completeness of the dossier of the draft national regulation.”

7. To amend and supplement Clause 1 of Article 23 as follows:

“1. Ministries and ministerial-level agencies shall elaborate and promulgate national technical regulations for the sectors under state their management functions and tasks as assigned by the Government, specifically as follows:

a/ The Ministry of Health

- Community well-being; safety of foods, food additives, food processing aids and functional foods, drinking water, residential water, vaccines and medical biologicals, working environment; household chemicals, insecticides and germicides;

- Medical examination and treatment, healthcare, convalescence and functional rehabilitation, plastic surgery and appraisal in the health sector;

- Drugs, drug materials, pharmaceutical materials, traditional drugs and cosmetics;

- Medical instruments and devices;

- Occupational safety and health regarding occupational health factors in the working environment, except radioactive and radiation factors;

- Occupational safety regarding medical instruments and devices subject to strict occupational safety requirements;

- Services in the health sector.

b/ The Ministry of Agriculture and Rural Development

- Production, cultivation, culture, processing, harvest, preservation and transportation of agro-forestry-fishery products, salt, and cattle and poultry slaughtering;

- Plant varieties, livestock breeds and aquatic animal breeds;

- Agricultural and forestry supplies, animal feed; aquatic animal feed; environmental treatment products for use in husbandry and rearing of aquatic animals; fertilizers;

- Plant protection and veterinary drugs, plant and animal quarantine;

- Hydraulic works, rural hygienic water, dikes, natural disaster prevention and control;

- Food safety and hygiene for products, processes and services in the initial production (crop cultivation, animal husbandry, harvest culture, exploitation, aquaculture and salt making), collection, preliminary processing, slaughtering, processing, preservation, transportation, import and trading of agro-forestry-fishery products and salt under the management by the Ministry of Agriculture and Rural Development;

- Fishing gears and equipment subject to strict safety requirements in fisheries;

- Occupational safety and health (excluding machinery, equipment and materials subject to strict occupational safety requirements) for agro-forestry-fishery products and salt; cattle, poultry and domestic animals; agro-forestry-fishery materials; fertilizers; products in the culture, rearing, harvest, processing, preservation and transportation of agro-forestry-fishery products and salt; additives and chemicals used in agriculture, forestry and fisheries; plant and animal protection drugs; hydraulic works and dikes;

- Occupational safety regarding machinery, equipment and materials subject to strict occupational safety requirements in the group of agricultural, forestry, salt-making and fishery machinery, equipment and materials;

- Services in agriculture and rural development.

c/ The Ministry of Transport

- Means of transport; special-use loading and unloading and construction vehicles and equipment, containers used in road, railway, inland waterway and maritime transportation, and vessels and equipment for offshore exploration, exploitation and transportation;

- Traffic infrastructure works;

- Transportation business;

- Traffic safety;

- Occupational safety and health (excluding machinery, equipment and materials subject to strict occupational safety requirements), for means of transport and special-use loading and unloading and construction vehicles and equipment in the transport sector (excluding vehicles used for national defense and security purposes and fishing vessels); special-use technical equipment and devices in the transport sector; and vessels and equipment for offshore exploration and exploitation;

- Occupational safety regarding machinery, equipment and materials subject to strict occupational safety requirements in the following group of machinery and equipment: means of transport subject to registration in accordance with the regulations in transport sector; special-use loading and unloading and construction vehicles and equipment in the transport sector; and vessels and equipment for offshore exploration and exploitation;

- Services in the sector of transport.

d/ The Ministry of Construction

- Civil construction works, houses and office buildings;

- Construction materials;

- Architecture, urban construction planning and rural construction planning;

- Urban technical infrastructure works;

- Urban traffic works;

- Industrial works;

- Occupational safety and health in the formulation of technical measures and organization of work construction;

- Occupational safety regarding machinery, equipment and materials subject to strict occupational safety requirements for use in construction;

- Construction services.

dd/ The Ministry of Industry and Trade

- Industrial technical safety (safety of pressure-bearing and lifting equipment, special-use industrial equipment subject to safety requirements); electricity safety in the management and operation of electric instruments and equipment; mining and oil and gas exploitation (excluding equipment and facilities for oil and gas offshore exploration and exploitation);

- Safety of chemicals, industrial explosives and industrial environment;

- Safety in mechanical engineering, metallurgy, electricity, energy, oil and gas exploitation, mineral exploitation and chemicals (including pharmaceutical chemicals);

- Safety of the consumer goods industry;

- Safety of the food industry and other processing industries;

- Occupational safety and health (excluding machinery, equipment and materials subject to strict occupational safety requirements) for mechanical engineering and metallurgy; electricity production, transmission and distribution; new energy and regenerated energy; coal exploitation; exploitation, processing, transportation, distribution and storage of oil and gas and their products, except for vessels and equipment for offshore exploration and exploitation;

- Occupational safety regarding machinery, equipment and materials subject to strict occupational safety requirements in the following group of machinery, equipment and materials: industrial explosion materials; pressure equipment and special-use industrial lifting equipment; mining and oil and gas exploitation devices and equipment, except for vessels and equipment for offshore exploration and exploitation;

- Occupational safety and health regarding chemicals (including pharmaceutical chemicals), except for chemicals in vocational training establishments specified at Point e of this Clause and occupational health factors regarding chemicals in the working environment prescribed at Point a of this Clause;

- E-commerce;

- Services in the industrial and trade sectors.

e/ The Ministry of Labor, War Invalids and Social Affairs

- Occupational safety and health regarding personal protection devices for laborers; tools and technical equipment in vocational training establishments; and environmental process products, goods and services not specified at Points a, b, c, d, dd, g, n, o and q of this Clause;

- Occupational safety regarding machinery, equipment and materials subject to strict occupational safety requirements, except for machinery, equipment and materials specified at Points a, b, c, d, dd, g, n, o and q of this Clause;

- Occupational safety and health for laborers engaged in chemical activities; and the management of chemicals used in vocational training establishments;

- Safety of public recreation facilities;

- Services in the sector of labor, war invalids and social affairs.

g/ The Ministry of Information and Communications

- Networks, works, products and services in post and telecommunications, electronics, information technology and television broadcasting;

- Radio frequency and equipment for emitting or receiving radio waves;

- Publications, printing and press products;

- Occupational safety and health (excluding machinery and equipment subject to strict occupational safety requirements) for telecommunications works; and the network of telecommunications, electronics and information technology;

- Occupational safety regarding machinery and equipment subject to strict occupational safety requirements in the group of telecommunications machinery and equipment; and equipment for emitting or receiving radio waves;

- Occupational safety and health for radio frequency in working environment, except for occupational health factors regarding frequency in the working environment specified at Point a of this Clause;

- Services in the sector of information and communications.

h/ The Ministry of Natural Resources and Environment

- The environment: quality of the surrounding environment; environmental observation, assessment of the environmental status; strategic environment assessment; environmental impact assessment; pollution control; waste management and environmental and imported waste management;

- Exploration, survey, evaluation and inventory of natural resources: land, water, geology, minerals, climate, seas and islands;

- Survey and evaluation of quality and deposits of water and mineral resources;

- Hydrometeorology and climate change;

- Metrology, cartography and geographical information;

- Remote sensing;

- Services in natural resources and environment.

i/ The Ministry of Education and Training

- Teaching materials and technical equipment used in schools;

- Education and training services.

k/ The Ministry of Finance:

- Financial services (insurance, audit, tax, customs, etc.);

- National reserves.

l/ The Ministry of Culture, Sports and Tourism

- Protection and promotion of cultural heritage value: conservation, maintenance and restoration of historical-cultural relics and scenic places; archaeological survey and excavation; management and protection of underwater cultural relics; registration of national relics, antiques and treasures;

- Materials for assorted cinematographic products;

- Fine arts, photography and advertisement;

- Equipment and tools for sports training and competition and tourism;

- Services in culture, entertainment, physical training, sports and tourism.

m/ The Ministry of Home Affairs

- Clerical and archival activities and professional operations;

- Process of preservation of archived documents;

- Clerical and archival services.

n/ The Ministry of National Defense

- Military devices and equipment, weapons, ammunitions and products for national defense and national defense facilities which are not classified as national secrets;

- Occupational safety and health regarding military devices and equipment, weapons, ammunitions and products for national defense and national defense facilities which are not classified as national secrets;

- Occupational safety regarding machinery, equipment and materials subject to strict occupational safety requirements for exclusive use for national defense and military purposes.

- Safety and security in the military and national defense sector.

o/ The Ministry of Public Security

- Fire prevention and fighting, technical equipment and devices, weapons, ammunitions, explosive materials, supportive tools and other products used in the people’s public security force which are not classified as national secrets;

- Occupational safety and health regarding technical equipment and devices, weapons, ammunitions, explosive materials, supportive tools and other products used in the people’s public security force which are not classified as national secrets;

- Occupational safety regarding fire prevention and fighting machinery and equipment subject to strict occupational safety requirements;

- Security services.

p/ The Government Cipher Commission shall formulate and submit to the Minister of National Defense for promulgation

- Civil code products and services.

q/ The Ministry of Science and Technology: atomic energy, radiation and nuclear safety; codes and barcodes and origin traceability; children’s toys; crash helmets for motorcycle riders; household electric and electronic appliances; fuels; steel; other products, goods and services not specified at Points a, b, c, d, dd, e, g, h, i, k, l, m, n, o and p of this Clause and products, goods and services in the sector of national defense and security, and state secrets;

- Occupational safety and health regarding nuclear reactors, nuclear materials, source nuclear materials, radioactive substances and radiation devices.”

8. To add the following Clause 3 to Article 24:

“3. Contents of standards announced for application must ensure environmental safety and hygiene, human health and property and must not contravene the relevant technical regulations.”

9. To annul the regulations on organization of conformity assessment provided in Articles 16, 17 and 18 of this Decree.

Article 2.Effect

This Decree takes effect on July 1, 2018.

Article 3.Organization of implementation

Ministers, heads of ministerial-level agencies, heads of government-attached agencies and chairpersons of provincial-level People’s Committees shall implement this Decree.-

On behalf of the Government
Prime Minister
NGUYEN XUAN PHUC