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The chemical management in Vietnam now attracts many stakeholders’ attention. Significant changes are scheduled to be made to the predominant chemical law of Vietnam, namely the Law on Chemicals. In September of 2020, the Vietnam Chemical Agency under Ministry of Industry and Trade (MOIT) held a seminar at Hanoi to collect comments from companies and organizations for the purpose of review and evaluation of domestic chemical regulations (ChemLinked News [1]).
Besides the amendments of regulations on hazardous chemicals, Vietnam has also drafted a control act on the new chemical substances. By now, the draft has been completed, which is expected to be published in the second quarter of 2021 and finally enter into effect by this year. Followings are the main contents in the draft:
Scope and procedure of exemption,
Responsibilities and obligations of domestic and foreign enterprises,
Registration of new chemicals and foreign chemicals,
Registration of polymers,
Approval of foreign chemical inventories, and
Protection of chemical substance information.
Among them, new chemicals refer to chemicals not yet listed in the national chemical inventory (NCI) or foreign chemical inventories recognized by Vietnamese competent state agencies, and foreign chemicals refer to chemicals not yet listed in the nation chemical inventory (NCI) but already listed in foreign chemical inventories recognized by Vietnamese competent state agencies. Reduction of date requirements will be provided for the foreign chemicals to simplify the registration procedure. After the submission of the new chemical substance registration dossier, there will be a 90-day data review period. For the foreign chemicals, the review period will be shortened accordingly. After completing the registration for the first time, new chemical substances or foreign chemical substances need to submit an annual report before January 31 of each year. After 5 years of registration of a new chemical substance, the authority will conduct a risk assessment and decide whether to list the substance in the NCI based on the assessment results. For a foreign chemical, the listing process could be conducted 2 years after the registration.
As the basis of the implementation of differentiated management for new chemicals and existing chemicals, Vietnam has opened the NCI nomination window 5 times since the September of 2016 to solicit information of chemicals that have circulated in the country. For the first 3 times nomination, the application shall be submitted to the authority via e-mail. In April of 2020, the nomination takes the form of online submission on Vietnam National Chemical Database (VNCD) for the first time. The 2020 supplementation attracted widespread attention from the industry, but due to the short window period, a large number of existing substances have not been submitted for nomination in time. Therefore, the Vietnamese authorities opened the fifth window for list additions on October 16th, 2020, which will end on April 15th, 2021, and there is almost only 1 month left.
Figure 1. VNCD Page
Vietnam domestic manufacturers and importers of chemical substances can register an account of VNCD and sign in the system to inquire about the status of chemical substances or nominate chemicals. In addition, this system can be used for submitting annual report as well. By February 24th, the draft NCI contains 48,857 chemical substances, while only 9,618 substances have been approved, 9,578 substances are now under examination, and the rest 29,661 substances are lack of evidence.
Figure 2. Statuses of substances
(Green: Approved; Yellow: Under examination; Red: Lack of evidence)
Enterprises may find public substance information search is available on VNCD without signing in, which shows the listing information of the chemical substance in the United States, the European Union, Japan’s, and Vietnam's chemical inventories, and the control requirements of the Vietnamese authorities for the substance. It shall be noted that the public database search result can only reflect whether a substance has been nominated to NCI but cannot accurately show the status of the substance. If the substance keeps the status of lacking evidence, it will not be listed in NCI.
For now, supplementation of evidence and nomination of substances are both available. According to the practical experience of REACH24H, for substance lack evidence or has not been nominated, the following materials shall be submitted to help the substance be listed:
Chemical name (shall meet the requirements of IUPAC or CAS nomenclatures),
CAS number,
Material Safety Data Sheet (MSDS, shall meet the GHS requirements of Vietnam, in English or Vietnamese), and
Documents proving the chemical has been used in Vietnam (e.g., purchase contract or invoice, etc., the date shall be earlier than April 15th, 2021, in English or Vietnamese)
For more guidelines to the nomination operation, please refer to this article: Vietnam Reopens the Substance Nomination Window for the National Chemical Inventory [2].
The submitted substance names must be accurate, and it is best to provide the authoritative databases search results. Chemicals with incorrect substance names will not pass the review. The circulation proving documents need to match the product name in the SDS, and the SDS of the product is required to reflect the substance information that to be nominated. For substances that are of low hazard or that are not reflected in the SDS due to information protection, a formal statement and the description of the substance in the product are required.
Chemicals without CAS number can also be nominated. For such chemicals, submitting from the VNCD system and being listed in draft NCI are infeasible for now, but enterprises can submit the above-mentioned nomination materials to the authority via e-mail. It is certain that the Vietnam authority is considering formulating a special list to manage substances without CAS numbers.
For most foreign enterprises, it is difficult to protect confidential business information because the nomination materials must be submitted by Vietnam domestic importers. Relying on reliable global resources, REACH24H can help enterprises solve the problems of information protection and complete materials submission. So far, REACH24H has completed the nomination of almost 1,000 substances. As the window period is about to end, we suggest enterprises prepare relevant materials as soon as possible to avoid missing the opportunity.
