Chapter IV
REGULATORY REQUIREMENTS FOR TRADE AND INVESTMENT IN THE ENVIRONMENT PROTECTION SECTOR
Section 1. ELIGIBILITY REQUIREMENTS FOR TRADE IN BIOLOGICAL PRODUCTS USED FOR WASTE TREATMENT
Article 17. Eligibility requirements for trade in biological products used for waste treatment
1. Organizations or individuals trading and importing biological products used for waste treatment (hereinafter referred to as bioproducts) must obtain the certificate of marketing authorization of bioproducts, issued by the Vietnam Environment Administration, the Ministry of Natural Resources and Environment under the provisions of this Decree.
2. Bioproducts which have been accredited by the certificate of marketing authorization, but being subject to any change to ingredients or contents of active ingredients which affects treatment efficiency and health safety of human beings and living organisms, require re-issuance of the certificate of marketing authorization in accordance with Article 20 hereof.
Article 18. Certificate of marketing authorization
The certificate of marketing authorization of bioproducts used for waste treatment must provide the following information:
1. Name of bioproduct in question.
2. Quantity of bioproducts qualifying for marketing authorization.
3. Composition of active ingredients, microorganisms (scientific nomenclature, concentration, density) in the bioproduct in question.
4. Manufacturer's name, address and telephone.
5. Applicant's name, address and telephone.
6. Administration method and expiry date of bioproduct in question.
7. Packaging details of bioproduct.
Article 19. Application dossier for registration of marketing authorization
1. Application form for registration of marketing authorization of bioproducts completed by using the form stipulated in the Appendix I of this Decree.
2. Copy of enterprise registration certificate (where appropriate).
3. Bioproduct manufacturing process.
4. The certified copy or the copy with attachment of the original copy for verification purpose (if an organization or individual submits registration dossier in person) of test result report or analysis of quality of bioproduct, issued by local or foreign accredited testing bodies.
5. The description of bioproduct according to the template provided in the Appendix II of this Decree.
6. The certified copy or the copy with attachment of the original copy for verification purpose (if an organization or individual submits registration dossier in person) of evaluation report made by managerial-level Science Council with respect to bioproducts which are results of scientific research projects (where appropriate).
7. Testing results of bioproduct (where appropriate).
8. Official label and packaging form that require authorization with attachment of storage and use instruction leaflets and warnings of health risks to human beings and living organisms.
9. The certified copy or the copy with attachment of the original copy for verification purpose (if an organization or individual submits registration dossier in person) of patents on inventions or commitments to compliance with regulations on intellectual property rights for locally-manufactured bioproducts in question.
10. The certified copy or the copy with attachment of the original copy for verification purpose (if an organization or individual submits registration dossier in person) of the certificate of marketing authorization of bioproducts, issued by a manufacturing country’s competent regulatory authority with respect to imported bioproducts.
11. Detailed testing schedule, including important information such as testing contents, time, location and agency of testing with respect to bioproducts which have not had recognized test results.
Article 20. Application procedure for the certificate of marketing authorization of bioproducts
1. Organizations or individuals referred to in Article 17 hereof shall submit 7 sets of application dossiers for registration of marketing authorization of bioproducts referred to in Article 19 hereof, whether directly or by post, to the Vietnam Environment Administration for consideration, assessment and grant of the certificate of marketing authorization of bioproducts.
2. Within a permitted period of 05 working days of receipt of submitted application dossier, the Vietnam Environment Administration shall be responsible for verifying sufficiency and validity of such application dossier. Where application dossier is not sufficient or valid, submitting organizations or individuals must be notified in writing for any modification and supplementation.
3. Within a maximum period of 10 working days after the deadline for consideration of sufficiency and validity of application dossier, with regard to bioproducts which have not had testing results, the Vietnam Environment Administration shall give the written notification of inspection or monitoring programs in line with the detailed testing schedule of organizations or individuals applying for registration of marketing authorization of bioproducts.
4. Within a maximum period of 20 days of receipt of all required application dossier, subject to regulations set forth in Clause 2 of this Article or bioproduct testing results referred to in Clause 3 of this Article, the Vietnam Environment Administration shall establish and convene a meeting of the sectoral Science Council on verification of application dossier for registration of marketing authorization of bioproducts (hereinafter referred to as Council).
5. Issuance of the certificate of marketing authorization of bioproducts
a) Within a maximum period of 07 working days after the Council approves and does not amend or modify such test results, the Vietnam Environment Administration shall consider and make its decision on granting the certificate of marketing authorization of bioproducts;
b) Where the Council’s approval of test results includes any amendment or supplementation, the Vietnam Environment Administration must notify submitting organizations or individuals of further improvement of submitted application dossiers. Within a permitted period of 07 working days of receipt of completely amended or modified dossiers, the Vietnam Environment Administration shall consider and make its decision on granting the certificate of marketing authorization of bioproducts;
c) Where the Council refuses such approval, within a maximum period of 02 working days after the end of the Council’s meeting, the Vietnam Environment Administration shall notify organizations or individuals applying for registration of marketing authorization of bioproducts of this in which reasons for such refusal should be expressly stated.
6. With respect to bioproducts assigned the certificate of marketing authorization, organizations or individuals having the demand for extension of permission for trade in and importation of these bioproducts shall be responsible for notifying the Vietnam Environment Administration, the Ministry of Natural Resources and Environment of their name and quantity with within a minimum of 15 business days before the marketing authorization takes effect. Within a permitted period of 05 working days of receipt of this notification, the Vietnam Environment Administration shall be responsible for responding to these organizations and individuals in writing. Organizations or individuals shall be authorized to launch bioproducts into the market after receiving the Vietnam Environment Administration’s approval.
Article 21. Withdrawal and revocation of certificate of marketing authorization
1. Certificate of marketing authorization of bioproducts shall be withdrawn or revoked in the following circumstances:
a) Certificate of marketing authorization of bioproducts is issued in contravention of applicable regulations;
b) There is any change to ingredients of bioproducts;
c) Competent regulatory authorities have verified that those bioproducts which have been registered for marketing authorization have been found in violation of industrial property rights.
2. Organizations or individuals subject to withdrawal or revocation of the certificate of marketing authorization of bioproducts shall be responsible for withdrawing and treating bioproducts which have been manufactured, imported and currently launched into the market in accordance with laws and regulations.
3. When the certificate of marketing authorization of bioproducts is subject to withdrawal or revocation, the Vietnam Environment Administration shall bear a burden of displacing these bioproducts from the approved list of bioproducts used in waste treatment in Vietnam and posting information about this action on the official website of Vietnam Environment Administration and the Ministry of Natural Resources and Environment.
Article 22. Accredited bioproduct testing facilities
1. Accredited bioproduct testing facility refers to an organization performing its designated functions in conducting researches, biological or environmental technology transfers (in compliance with the establishment decision or the certificate of registration of scientific and technological operations, issued by competent regulatory authorities) which have sufficient equipment, materials and human resource required to apply bioproducts in every project site under their use instructions.
2. Organizations or individuals applying for registration of marketing authorization of bioproducts may decide on accredited testing bodies or facilities, and shall be liable for any cost incurred from conduct of any test as agreed upon in any contract.
3. Accredited testing bodies or facilities may, at their own discretion, decide on cooperation with any relevant agencies during the testing process, and shall be responsible for keeping custody of testing result reports within a minimum of 60 months after the end of a test.
Article 23. Contents, method and reporting of results of bioproduct tests
1. Contents of tests on bioproducts include:
a) Ingredients, quality of bioproducts specified in specified statutory standards;
b) Efficacy of bioproducts, if used according to instructions;
c) Evaluation of health safety of bioproducts for human beings and living organism.
2. Testing method must conform to relevant technical standards and regulations, or otherwise ensure objectivity and scientificity.
3. A bioproduct testing report must include the followings:
a) Name of the testing body or facility or individual applying for a test;
b) Name of bioproduct in question with attachment of dossier stating ingredients, efficacy, storage and administration method, label and packaging;
c) Pre-testing conditions of bioproducts;
d) Testing subject matters;
dd) Testing location, time, scale and method;
e) Testing results, conclusions and recommendations.
Article 24. Monitoring and inspection of bioproduct tests
1. The Vietnam Environment Administration shall be responsible for monitoring and inspecting, or authorizing the Department of Environmental Protection within each local government, to carry out monitoring or inspection of tests on application of bioproducts according to the written notification stated in Clause 3 Article 20 hereof.
2. Monitoring and auditing commission shall be composed of representatives of the Vietnam Environment Administration or the local Department of Environmental Protection and biotechnological experts.
3. Results produced from monitoring and inspection activities shall be documented, inclusive of consulting opinions and recommendations, with the presence and agreement of members of the monitoring and auditing commission, and representatives of bioproduct testing bodies or facilities.
Article 25. Approved list of biological products used for waste treatment in Vietnam
1. Bioproducts with certificates of marketing authorizations must be emplaced in the approved list of bioproducts used in waste treatment in Vietnam which must be posted on the official website of Vietnam Environment Administration and the Ministry of Natural Resources and Environment.
2. The Vietnam Environment Administration shall be responsible for conducting a regular review and modification of the approved list of bioproducts used in waste treatment in Vietnam every 6 months.
Section 2. REGULATORY REQUIREMENTS FOR TRANSPORTATION OF DANGEROUS GOODS WHICH ARE HAZARDOUS AND INFECTIOUS SUBSTANCES
Article 26. Licensing requirements for transportation of dangerous goods which are hazardous and infectious substances
1. Organizations or individuals must obtain a license to transport dangerous goods which are hazardous and infectious substances on condition that:
a) the weight of dangerous goods which are hazardous or infectious substances transported on road vehicles equals or exceeds the statutory weight limit beyond which the certificate of transportation is required in accordance with column 6 Appendix III as annexed to this Decree;
b) the weight of dangerous goods of a single class or division does not exceed the statutory weight limit listed in column 6 Appendix III hereof beyond which the certificate of transportation is required, but the total weight of a mixed load of hazardous or infectious substances transported on the same road vehicle is greater than 01 tonne/shipment (excluding the weight of the packaging).
2. Organizations or individuals must conform to requirements referred to in this Decree, and may be exempt from applying for a license to transport dangerous goods which are hazardous and infectious substances on condition that:
a) the weight of dangerous goods which are hazardous or infectious substances transported on road vehicles is within the statutory weight limit beyond which the certificate of transportation is required in accordance with column 6 Appendix II hereof, but a environmental incident response and contingency plan is available for transportation of dangerous goods (using the form given in the Appendix IV hereof) and transportation requirements referred to in Article 27, 28 and 29 hereof are met;
b) dangerous goods which are hazardous or infectious substances are transported by inland waterways or railroad, but such transportation meets respective regulations set out in the Decree No. 29/2005/ND-CP or the Decree No. 14/2015/ND-CP and conforms to requirements referred to in Article 27, 28 and 29 hereof.
Article 27. Requirements for packing, packaging, containing objects, labeling, and hazard placarding and marking, of hazardous and infectious substances
1. Statutory requirements for packing, packaging and containing objects of dangerous goods which are hazardous and infectious substances:
a) Packing dangerous goods and using various materials as packaging and containing objects of dangerous goods must meet regulations specified in the National Standard TCVN 5507:2002 – Dangerous chemicals - Safety regulations in production, trading, use, handling and transportation practices (hereinafter referred to as TCVN 5507:2002), or substitute documents, and conform to technical requirements or standards respectively applied to such dangerous goods (where appropriate);
b) Packaging and containing objects of dangerous goods must be anti-corrosive, stainless and non-reactive with inner substances, and watertight, airtight and rigid, to prevent any leakage or spillage during transportation under normal conditions, and maximally restrict any spillage or leakage of dangerous goods into the surrounding environment in case of emergency;
c) Shipping organizations or individuals using packaging materials or containing objects for dangerous goods must conduct relevant tests and take responsibility for results of these tests on such packaging materials and containing objects to be used in order to prevent any spill or leakage during transportation;
b) Packaging materials and containing objects of dangerous goods when in use must be stored in a separate place in conformity with regulations laid down in the National Standard TCVN 5507:2002.
2. Labeling requirements:
Labeling and marking of dangerous goods shall comply with regulations on goods labels and labeling of chemicals.
3. Requirements for hazard marking and placarding shall be provided as follows:
a) They must be displayed on the packaging and containing objects of dangerous goods;
b) A vehicle transporting dangerous goods must be marked with a placard of a hazard according to the class or division of transported goods. If a mixed load of dangerous goods of different classes or divisions are transported on the same vehicle, placards or markings of hazards of these dangerous goods must be fully displayed. Hazard placards or markings shall be placed on two opposing sides and at the back of a cargo transport unit, be of resilience to protect against adverse weather effects and other common physical effects from handling, stowage and transportation activities. Hazard placards and markings shall not be displayed on a cargo transport unit if it does not carry any dangerous goods;
c) Hazard placards and markings signaling a hazard of a cargo class or division must conform to regulations laid down in Article 6 of the Decree No. 29/2005/ND-CP, Article 24 of the Decree No. 14/2015/ND-CP or Article 9 of the Decree No. 104/2009/ND-CP;
d) With respect to road or rail vehicles transporting bulk cargos that have quantities equaling or exceeding the statutory limits beyond which the certificate of transportation is required as referred to in Column 6 Appendix III to this Decree, in addition to placement of hazard placards or markings, emergency information panel must be displayed at the rear with its bottom edge which is at a height of at least 450mm above ground level.
4. Requirements for handling and storage of dangerous goods:
a) Organizations or individuals involved must comply with instructions on storage, handling and warehousing of specific classes of dangerous goods as referred to in the National Standard TCVN 5507:2002, or notifications of dangerous goods consignors or carriers or operators;
b) Loading, unloading and warehousing dangerous goods shall conform to Article 9 of the Decree No. 29/2005/ND-CP, Article 29 of the Decree No. 14/2015/ND-CP or Article 12 of the Decree No. 104/2009/ND-CP.
5. Chemical safety datasheets must be provided for transportation of dangerous goods which are hazardous and infectious substances in accordance with prevailing regulations.
Article 28. Licensing requirements for vehicles transporting dangerous goods which are hazardous and infectious substances
Road, rail or inland waterways transport units carrying dangerous goods which are hazardous or infectious substances must meet conformity requirements for specific transport units as referred to in Article 13 of the Decree No. 104/2009/ND-CP, Article 30 of the Decree No. 14/2015/ND-CP, and Article 10 of the Decree No. 29/2005/ND-CP, and the following conditions:
1. Do not carry dangerous goods on the same transport unit with passengers, livestock, food items or drinks, or carry dangerous goods likely to react with others to cause fire, explosions or generate any new substance hazardous for the environment and human health on the same transport unit.
2. Have equipment used for partially or completely covering cargo compartments. Cover accessories or equipment must meet waterproofing and fire protection requirements, and cannot be damaged when in contact with classes of goods in transit, and must remain safe in case of violent shocks, impacts or frictions, and prevent any discharge of contaminants and pollutants into environment in case of incidents or emergency situations.
3. Ensure that equipment or materials are fully provided to respond to any emergency situation during transportation as described in the plan for response to any environmental incidents or emergency situations that may arise during transportation of dangerous goods as provided for in the form given in the Appendix IV annexed hereto.
4. Meet rules, regulations and standards concerning transportation of dangerous chemicals or goods, and fire safety conditions in accordance with lawsoft, and comply with regulatory policies on compulsory fire and explosion insurance.
5. Have cabins providing enough space for at least two persons, including 01 driver and 01 driver's mate on a road vehicle.
Article 29. Qualification requirements for drivers and driver’s mates of vehicles transporting dangerous goods which are hazardous and infectious substances
1. Drivers must obtain driver's licenses that remain valid and relate to the type of vehicle printed in the license for transportation of dangerous goods.
2. Drivers and driver’s mates of vehicles transporting dangerous goods must meet one of the following requirements:
a) Complete training programs and certificates in transportation of dangerous goods which are hazardous or infectious substances conferred by the Ministry of Natural Resources and Environment;
b) Complete training programs and certificates in chemical safety or other certificates in transportation of dangerous goods conferred by competent regulatory authorities;
c) Complete at least vocational or professional associate degrees in the chemical sector.
Article 30. Transportation of dangerous goods which are hazardous and infectious substances for hire
Where the consignor of dangerous goods hires the operator of a transport unit licensed to transport dangerous goods, the following regulations must be obeyed:
1. With regard to road vehicles:
a) The consignor of dangerous goods must enter into an economic agreement or written arrangement, including transportation-related terms and provisions, with the operator of a transport unit licensed to carry dangerous goods, which is appropriate to specific classes of goods to be transported;
b) Where the consignor of dangerous goods does not hold a license for transportation of dangerous goods which is appropriate to the class of dangerous goods to be transported, (s)he must fully meet transportation requirements under the provisions of Article 27, 28 and 29 hereof and submit the application dossier for a license for transportation of dangerous goods by road vehicles for each shipment in accordance with laws.
2. With regard to inland waterways or rail transport units:
The consignor of dangerous goods must enter into an economic agreement or written arrangement, including transportation-related terms and provisions, with the operator of a transport unit licensed to carry dangerous goods under which the consignor is bound to meet requirements concerning safe transport and environmental protection relevant to the class of dangerous goods to be transported under the provisions of Article 27, Clause 1, 2, 3 and 4 Article 28 and Article 29 hereof.
3. Hiring of transport units carrying dangerous goods must conform to regulations of prevailing laws.
Section 3. LICENSING REQUIREMENTS FOR HAZARDOUS WASTE TREATMENT
Article 31. Licensing requirements for hazardous waste treatment
Organizations or individuals submitting the registration application for a license for hazardous waste disposal and treatment must meet requirements referred to in Article 9 of the Government’s Decree No. 38/2015/ND-CP dated April 24, 2015 regarding management of waste and scrap materials, and technical requirements and management procedures concerning licensing requirements for hazardous waste treatment, including:
1. Equipment or appliances used for storage, transport and treatment of hazardous wastes (including primary treatment, recycling, co-processing of, recovery of energy from hazardous wastes) must conform to technical requirements and management procedures referred to in the Appendix V of this Decree.
2. Transport units carrying hazardous wastes must be equipped with internet-connected GPS devices to identify their positions and record their trips.
3. Each piece of equipment or device shall only be allowed to get one license for hazardous waste treatment, except sea, rail and air transport units.
4. Environmental protection facilities associated with hazardous waste treatment premises and hazardous waste transit stations (where appropriate) must conform to technical requirements and management procedures referred to in the Appendix V of this Decree.
5. Organizations or individuals submitting the registration application for a license for hazardous waste treatment must fully prepare and develop contents relating to safe operation processes for facilities, equipment or devices; and plans for pollution control and environmental protection, labor safety and health protection, emergency prevention and response, annual training and drilling programs, environmental treatment and environmental protection upon termination of their operations; and environmental monitoring, operational monitoring and effectiveness assessment of hazardous waste treatment.
6. Organizations or individuals submitting the registration application for a license for hazardous waste treatment practices must design safe operation instruction boards in the simplified or flowchart form which have proportionate size and are installed at visible places on transport units, inside dangerous waste treatment premises and transit stations (if any).
Tìm kiếm
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