Decree 78/2018/ND-CP amending Decree 127/2007/ND-CP guiding the Law on Standards and Technical Regulations

DECREE

AMENDING A NUMBER OF ARTICLES OF THE GOVERNMENT'S DECREE NO. 127/2007/ND-CP DATED AUGUST 01, 2007, DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE LAW ON STANDARDS AND TECHNICAL REGULATIONS

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

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

At the request of the Minister of Science and Technology;

The Government promulgates the Decree amending a number of Articles of the Government's Decree No. 127/2007/ND-CP dated August 01, 2007, detailing the implementation of a number of Articles of the Law on Standards and Technical Regulations.

Article 1. To amend a number of Articles of the Government's Decree No. 127/2007/ND-CP dated August 01, 2007 detailing the implementation of a number of Articles of the Law on Standards and Technical Regulations as follows:

1. Article 2a is added after Article 2 as follows:

 “Article 2a. General requirements on development of standards, technical regulations

1. Development of standards must

a) Include representatives of relevant scientific and technological organizations, regulatory bodies, associations, enterprises, consumers and experts. 

b) Comply with the principle of consensus operation on the basis of public and democratic discussion and commenting.  

2. Development of technical regulations shall

a) Ensure that national technical regulations and local technical regulations are consolidated, consistent and appropriate to international conventions to which Vietnam is a signatory.

After acquiring permission from the Ministry of Science and Technology, other Ministries, Ministry-level agencies, People’s Committees of provinces and central-affiliated cities shall grant ex officio approval for plans for development of national technical regulations and local technical regulations as prescribed in Articles 29, 60 and 61 of the Law on Standards and Technical Regulations to ensure consolidation, consistence and appropriation of the regulations.

The Ministry of Science and Technology shall be responsible for giving comments on plans for development of national technical regulations and local technical regulations within 10 business days starting from the date of receipt of the written request from the authorities responsible for developing the plans.

b) Prioritize developing amendments to technical regulations for each group of subjects with similar technical characteristics and management requirements.

c) Stipulate management measures and limits for technical characteristics of products, commodities, services, processes and environments for the purpose of state management, ensuring safety, hygiene, health and environment; protection of plants and animals; protection of national interests and security, legitimate rights and interests of consumers; the rights to freedom of business operation for organizations and individuals.

d) Contents of national technical regulations may be invoked in other national technical regulations, national standards, international standards, regional standards and foreign standards.

dd) In case a technical regulation is invoked in international standards, regional standards and foreign standards, the authority issuing such regulation shall ensure provision of the Vietnamese copy of the invoked document to individuals/organizations for their reference upon request.

e) During development of technical regulations, regulations on recognition of equivalence must be inspected to ensure compliance with international conventions to which Vietnam is a signatory.

In case a technical regulation is likely to create a technical barrier in international trade, the authority issuing such regulation must send a draft regulation to the Ministry of Science and Technology for international opinions as prescribed in international conventions to which Vietnam is a signatory.”

2. Clause 5 of Article 3 is amended as follows:

 “5. When using funding from funding sources for annual scientific and technological services for development of draft national standards, Ministries and regulatory bodies shall prioritize scientific and technological organizations, associations and enterprises in charge of such development. Organizations and individuals using their own funding for research and development of national standards and/or assistance in  research and development of technical regulations shall be entitled to incentive policies for fulfillment of scientific and technological duties as prescribed by the Law on Science and Technology.”

3. Article 4a is added after Article 4 as follows:

 “Article 4a. Development, evaluation and publication of national standards

Procedures for development, evaluation and publication of national standards shall be carried out according to Article 17 of the Law on Standards and Technical Regulations. In case Ministries and/or Ministry-level agencies organize the development of national standards, development, evaluation and publication of national standards shall be carried out according to Article 17 of the Law on Standards and Technical Regulations as follows:

1. Ministries, Ministry-level agencies or authorities assigned the duties of development of national standards shall establish a writing board or writing team (hereinafter referred to as “writing team”) to carry out the development of a draft national standard;

2. The writing team shall organize the evaluation of the realities, research of technical materials; sampling, experiment and testing (if any) to determine technical requirements and criteria of the draft;

3. After the draft is completed, the writing team shall submit it to Ministries and/or Ministry-level agencies for comments from relevant regulatory bodies, organizations and individuals and members of the corresponding technical board for national standards; and for announcement of the gathering of such comments on the websites of relevant Ministries, Ministry-level agencies and organizations.

The Ministry of Science and Technology shall organize the publication of the list of members of the technical board for national standards and their contacts on the board’s information portal.

Duration of comment gathering shall last at least 60 days, starting from the date of submission of the draft; in case of emergency related to health, safety and/or environment, such duration may be shortened but it shall not be shorter than 30 days.

Symposia shall be organized for relevant parties to discuss and give comments on the draft;

4. The writing team shall compile and process comments; finalize the draft and prepare a dossier of draft national standard as prescribed by law. The dossier shall be submitted to Ministries and/or Ministry-level agencies for ex officio consideration before being submitted to the Ministry of Science and Technology for organization of evaluation;

5. The Directorate for Standards, Metrology and Quality shall assist the Minister of Science and Technology with organization of evaluation of the draft national standard as prescribed in Article 18 of the Law on Standards and Technical Regulations;

6. Ministries and/or Ministry-level agencies in charge of development of national standards shall be responsible for receiving and handling comments and finalizing the draft national standard and relevant dossier on the basis of evaluation comments. The evaluation results shall be submitted to the Ministry of Science and Technology within 120 days starting from the date of notice of evaluation.

In case such deadline is missed, the draft national standard must be reevaluated;

7. The Ministry of Science and Technology shall consider and publish the national standard on the basis of the evaluation results and results of completion of the draft national standard and relevant dossier after the evaluation.

4. Points d and dd of clause 1 of Article 5 are amended as follows:

 "d) A list of regulatory bodies, organizations and individuals sent a draft for comments; compilation of accepted comments attached to comment papers. Contents of the compilation must provide scientific and practical bases for each accepted or rejected content;

dd) A written request for evaluation of the draft and national standard publication of Ministries and/or ministerial-level agencies, which must include confirmation of completion of the draft dossier;

5. Clause 2 of Article 9 is amended as follows:

 “2. Minister of Science and Technology shall organize the evaluation of drafts of national standards as prescribed in Article 33 of the Law on Standards and Technical Regulations.

In case a national technical regulation is developed for the management of category 2 commodities, Ministries and Ministry-level agencies shall promulgate such regulation after reaching an agreement with the Minister of Science and Technology on measures for management of commodities provided for by such regulation, preventing unnecessary technical barriers for business operation and trade.”

6. Points d and dd of clause 1 of Article 10 are amended as follows:

"d) A list of regulatory bodies sent a draft for comments; compilation of accepted comments attached to comment papers, which must include comments of relevant regulatory bodies;

dd) A written request for evaluation of Ministries and/or Ministry-level agencies, which must include confirmation of completion of the draft dossier.”

7. Clause 1 of Article 23 is amended as follows:

“1. Ministries and Ministry-level agencies shall develop and promulgate national technical regulations for the fields under state management assigned by the Government, to be specific:

The Ministry of Health shall be in charge of:

- Community health; food safety, food additives, food processing aids, functional foods, drinking water, water for daily activities, vaccines and biologicals and the occupational environment; household chemicals, insecticidal and germicidal preparations;

- Medical examination and treatment, care, nursing, rehabilitation, aesthetics, appraisal in the health sector;

- Drugs, medicinal ingredients, pharmaceuticals, traditional drugs, cosmetics;

- Medical equipment;

- Occupational safety and hygiene for factors related to occupational hygiene in the occupational environment, excluding factors related to radioactivity and radiation;

- Occupational safety for medical equipment subject to strict occupational safety requirements;

- Health services.

b) The Ministry of Agriculture and Rural Development shall be in charge of:

- Production, cultivation, processing, harvesting, storage and transportation of agricultural products, forest products, aquatic products and salt and slaughtering of livestock and poultry;

- Plant varieties, animal breeds and aquatic breeds;

- Materials for agriculture and forestry, animal feeds; aquatic feeds; environmental remediation products used in livestock production and aquaculture; fertilizers;

- Agrochemicals, veterinary drug, quarantine of plants and animals;

- Irrigation works, rural clean water supply, dykes, natural disaster prevention and control;

- Food safety and hygiene for products, processes and services of initial manufacturing (cultivation, harvesting, commercial fishing, aquaculture, salt production), collection, preliminary treatment, slaughtering, processing, preservation, transportation, import and sale of agricultural, forest, aquatic and salt products under the management of the Ministry of Agriculture and Rural development;

- Fishing equipment and other equipment subject to strict safety requirements in fishery;

- Occupational safety and hygiene (excluding machines, equipment and materials subject to strict occupational safety requirements) for: agriculture, forestry, fishery and salt production; livestock, poultry and domesticated animals; agricultural, forestry and fishery materials; fertilizers; products of agricultural, forestry, fishery and salt production, harvesting, processing, preservation and transportation; agricultural, forestry and fishery additives and chemicals; agrochemicals and veterinary drug; irrigation works and dykes;

- Occupational safety for agriculture, forestry, salt production and fishery machines, equipment and materials that are subject to strict occupational safety requirements;

- Services related to agriculture and rural development.

c) The Ministry of Transport shall be in charge of:

- Means of transportation; specialized loading and construction equipment, containers for land, railroad, inland waterway and sea transportation and equipment for survey, operation and transportation on sea;

- Transport infrastructure works;

- Transport operation;

- Traffic safety;

- Occupational safety and hygiene (excluding machines, equipment and materials subject to strict occupational safety requirements) for: means of transportation; specialized loading and construction equipment for transportation (excluding equipment for national defense and security and for commercial fishing vessels); specialized technical equipment for transportation; and equipment for survey and operation on sea;

- Occupational safety for machines and equipment that are subject to strict occupational safety requirements of the following types: means of transportation subject to registration according to transportation regulations; specialized loading and construction equipment for transportation; equipment for survey and operation on sea;   

- Transportation services.

d) The Ministry of Construction shall be in charge of:

- Civil construction works, housing and offices;

- Construction materials;

- Architecture and planning for urban and rural construction;

- Urban technical infrastructure works;

- Urban transport works;

- Industrial works;

- Occupational safety and hygiene for formulation of technical measures and organization of execution of construction works;

- Occupational safety for machines, equipment and materials subject to strict occupational safety requirements that are used in the execution of construction works;

- Construction services.

dd) The Ministry of Industry and Trade shall be in charge of:

- Industrial technical safety (safety of pressure vessels, lifting equipment and equipment with specific industrial safety requirements); electrical safety in management and operation of electrical equipment; extraction of oil, gas and oil and gas fields (excluding equipment for survey and extraction of oil and gas on sea);

- Safety of chemicals, industrial explosives and the industrial environment;

- Safety in metallurgy, electricity, energy and mechanical production, oil and gas extraction, mining and chemicals (including pharmaceutical chemistry);

- Safety of consumer goods industry;

- Safety of food industry and other processing industries;

- Occupational safety and hygiene (excluding machines, equipment and materials subject to strict occupational safety requirements) for: mechanical production and metallurgy industries; production, transmission and distribution of electricity; new energy and renewable energy; coal mining; extraction, processing, transportation, distribution and storage of oil, gas and oil and gas products, excluding equipment for survey and extraction on sea;

- Occupational safety for machines, equipment and materials subject to strict occupational safety requirements of the following types: industrial explosives; specific industrial lifting equipment and pressure vessels; equipment for extraction of oil, gas and oil and gas fields, excluding equipment for survey and extraction on sea;

- Occupational safety and hygiene for chemicals (including pharmaceutical chemistry), excluding chemicals in vocational establishments prescribed in point e herein and occupational hygiene factors  related to chemicals in the occupational environment prescribed in point a herein;

- Electronic commerce;

- Industrial and commercial services.

e) The Ministry of Labor - War Invalids and Social Affairs shall be in charge of:

- Occupational safety and hygiene for personal protection equipment for workers; technical equipment and tools in vocational establishments; products, commodities, services, processes and environments not prescribed in points a, b, c, d, dd, g, n, o and q herein;

- Occupational safety for machines, equipment and materials subject to strict occupational safety requirements, excluding the machines, equipment and materials prescribed in points a, b, c, d, dd, g, n, o and q herein;

- Occupational safety and hygiene for workers involved in chemical-related activities; management of use of chemicals in vocational establishments;

- Safety of public recreational facilities;

- Services related to labor, war invalids and social affairs.

g) The Ministry of Information and Communications shall be in charge of:

- Networks, construction works, products and services of post, telecommunications, electronics, information technology and broadcasting;

- Radio frequencies, transmitters and transceivers of radio frequencies;

- Published and printed materials, journalistic products;

- Occupational safety and hygiene (excluding machines and equipment subject to strict occupational safety requirements) for telecommunications construction works; networks of telecommunications, electronics and information technology.

- Occupational safety for telecommunications machines and equipment and radio frequency transmitters and transceivers that are subject to strict occupational safety requirements;

- Occupational safety and hygiene for radio frequencies present in the occupational environment, excluding occupational hygiene factors related to frequencies in the occupational environment prescribed in point a herein;

- Information and telecommunications services.

h) The Ministry of Natural Resources and Environment shall be in charge of:

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

- Survey, investigation, assessment and stocktaking of natural resources including land, water, geology, minerals, climate, sea and islands;

- Exploration and assessment of quality and deposits of water and mineral resources;

- Hydrometeorology and climate change;

- Formulation of maps and geographical information;

- Remote sensing;

- Services related to natural resources and the environment.

The Ministry of Education and Training shall be in charge of:

- Teaching and technical equipment and tools in schools;

- Education and training services.

k) The Ministry of Finance shall be in charge of:

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

- National reserve.

l) The Ministry of Culture, Sports and Tourism shall be in charge of:

- Protection and promotion of cultural heritage values: preservation, renovation and restoration of historical - cultural relics and famous landscapes and beauty spots; archaeological exploration and excavation; management and protection of underwater cultural heritages; registration of vestiges, antiques and national precious objects;

- Materials for cinematographic products;

- Fine arts, photography and advertisements;

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

- Cultural, recreational, gymnastics, sports and tourist services.

m) The Ministry of Home Affairs shall be in charge of:

- Archiving activities and operation;

- Procedures for preservation of archived documents;

- Archiving services.

n) The Ministry of National Defense shall be in charge of:

- Military equipment, weapons and ammunition, products in service of national defense and national defense construction works that are not national secrets;

- Occupational safety and hygiene for military equipment, weapons and ammunition, products in service of national defense and national defense construction works that are not national secrets;

- Occupational safety for machines, equipment and materials subject to strict occupational safety requirements that are employed for specialized military and national defense purposes;

- Safety and security in national defense.

o) The Ministry of Public Security shall be in charge of:

- Firefighting, technical equipment, weapons, military equipment, explosives, assisting tools and other products in service of the people’s public security force that are not national secrets;

- Occupational safety and hygiene for technical equipment, weapons and ammunition, military equipment, assisting tools, explosives and other products in service of the people’s public security force that are not national secrets;

- Occupational safety for firefighting machines and equipment subject to strict occupational safety requirements;

- Security services.

p) The Government Cipher Commission shall formulate and submit to the Ministry of National Defense for promulgation:

- Civil code products and services.

q) The Ministry of Science and Technology shall be in charge of: atomic energy, radiation and nuclear safety; codes, barcodes and tracing; children’s toys; helmets for two-wheel motorcycle users; household electrical - electronic appliances; fuels; steel; other products, commodities and services, excluding the subjects prescribed in points a, b, c, d, dd, e, g, h, i, k, l, m, n, o and p herein and products, commodities and services related to national defense and security or national secrets;

- Occupational safety and hygiene for nuclear reactors, nuclear materials, nuclear material sources, radioactive materials and radioactive devices.”

8. Clause 3 of Article 24 is amended as follows:

“3. Contents of published applicable standards must ensure safety, hygiene, environment, human health and property and must not be contrary to corresponding technical regulations.”

9. Provisions on organization of suitability evaluation prescribed in Article 16, Article 17 and Article 18 of this Decree are hereby annulled.

Article 2. Effect

This Decree takes effect from July 01, 2018.

Article 3. Implementation

Ministers, heads of Ministry-level agencies, heads of Governmental agencies, Chairpersons of People’s Committees of provinces and central-affiliated cities are responsible for the implementation of this Decree

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