There is a basic argument that food safety regulations and compliance must improve. The Government is in the process to amend several laws that relate to food safety. The key legislation is the Law on Food Safety and Decree 15/2018/ND-CP ("Decree 15"). There are others, but these are the most important. The proposed amendments have received much attention from the food industry. The focus is on self declaration and registration of product declaration. The Vietnam Food Administration under the Ministry of Health has organized many seminars and direct dialogues with the business community to find the optimal way to update the rules.
We look at three significant areas:
- Improvements in administrative procedures are necessary but must be practical and effective
Decree 15 has three important groups of administrative procedures with which food and beverage enterprises must comply: Product self-declaration; Registration of the product declaration statement; and Re-Declaration and Re-Registration of Products. The draft amendments to Decree 15 ("Amended Draft") requests additional documents/information for all of these procedures: product explanations, product formulas, and testing methodologies. The Amended Draft also fundamentally adjusts performance timelines for product self-declaration and registration. Producers' great fear is that these steps will increase the time to self-declare--a process that has succeeded in streamlining registration.
For example, for products subject to self-declaration, the Amended Draft stipulates that within 7 days, the competent authority must post the self-declaration dossier on its electronic information platform. Additionally, it also requires that "Within 03 (three) months from the date of receipt of the self-declaration dossier, the receiving authority is responsible to review the legality of the dossier. In case it detects that the dossier does not comply with regulations, the receiving authority must notify and request enterprises to withdraw the dossier". This means that the management authority will review the dossiers, and if the authorities determine that a dossier is not compliant, it will require withdrawal of the self-declaration dossier. Under the current regime, after the competent authority posts self-declaration dossiers on the electronic information page, enterprises are entitled immediately to manufacture and circulate the products in the market. Then, the authorities are entitled to post-inspect products (not the self-declaration dossier) to clarify whether the products meet standards as declared in the self-declaration dossier. This post-inspection is a strong advantage of Decree 15 in which the authorities inspect the products directly to prevent enterprises from providing false information in the self-declaration dossier. After self-declaration dossiers are posted, normally, enterprises will start to manufacture and deliver the products, but now, under the Amended Decree, they face the risk that if their self-declaration dossiers are seen not to be compliant, authorities will require their withdrawal, and products circulating in the market may also be recalled. As a result, enterprises may not manufacture and circulate their products in the market at the time the dossiers are posted. Instead, they must wait until the 3-month review period expires to ensure smooth circulation. We believe that the new requirement for a three-month review of self-declaration dossier is not practical, is a step backward, and needs to be re-considered.
With respect to products subject to registration, now, after enterprises submit their registration dossiers, the authorities will review and may request supplementation/revisions. The Amended Draft only allows enterprises to supplement/revise each dossier three times, and the period allowed is 30 days for each supplementation/revision. That means that after three unsuccessful attempts, the registration dossier will be deemed invalid. Enterprises must then re-submit new registration dossiers, and the registration process will begin again. The time limit and the complication to file under the Amended Draft make registration more difficult. In fact, due to the characteristics of products subject to registration, the registration dossier may be supplemented more than three times and the time to supplement certain documents may exceed 30 days [eg, documents issued abroad, such as CFS (Certificate of Free Sale) or similar documents]. The fear is that enterprises cannot complete the registration process with only three supplementations/revisions with a limit of 30-days each. Many products can take +/- 10 supplementations/revisions to complete. Therefore, many believe that there should be no limit to supplementation.
- Must retroactive application be made for products that are already legally circulating in the market?
In addition, the Amended Draft requires that all self-declared/registered products in the market must be re-declared and re-registered as soon as the amended decree takes effect. Products that have been manufactured and imported under previous rules can continue to circulate only until their existing expiration date. This means that after the expiration date, products now in the market will have to be re-declared and re-registered. This means that products which can now legally circulate will be required to be re-declared/re-registered. Are these re-declarations/re-registrations practical? If all products now circulating have complied with current laws, is re-declaration/re-registration necessary? A new regulation should not be applied retroactively as the Amended Draft would do. We strongly suggest removing the need for re-declaration and re-registration.
- Concerns about the possibility of revealing confidential business information
For products subject to registration, the Amended Draft requires that when registering for declaration, enterprises must provide explanatory information on product ingredients and product formulas. This requirement is completely new, and it carries the high risk of disclosure of confidential information. Explanatory information must be posted on a mandated electronic information page available to the public. Any organization/individual can easily access this privileged information. This will obviously and clearly create an unfair business environment. We strongly recommend that this provision be dropped.
Decree 15 has long been considered an outstanding achievement in reducing administrative procedures, creating conditions for products to quickly access the market and to ensure safety. The amendment of certain regulations of Decree 15 is necessary to meet management and business objectives after seven years of application. However, the business community hopes that the amendments will be carried out fairly and effectively to protect the interests of consumers, to continue to ensure the Government's food safety management, and to guarantee stable and smooth operations of food and beverage companies. Naturally, adjustment of the Decree needs to be consistent with the Law on Food Safety.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
