The Draft Decree regulating the management of cosmetics in Vietnam (Draft) is currently being developed with the goal of enhancing the efficiency of state management, protecting consumer rights and ensuring the quality of cosmetic products circulating on the market. The draft Decree is expected to create a transparent, synchronous and feasible legal corridor. However, through the process of consultation and research, we realized that many contents in the Draft still have inadequacies that need to be adjusted to suit international practices and practices. This article will analyze the points that need to be amended in the Draft Decree, and at the same time make specific recommendations to complete this document.
1. There is still a burden of administrative procedures in cosmetic announcement
One of the important contents of the Draft Decree is the regulation on cosmetic declaration procedures, which is a mandatory step for products to be allowed to circulate in the Vietnamese market. However, some provisions in the Draft are placing unnecessary administrative burdens on businesses, reducing feasibility in practice.
1.1. Regulations on re-disclosure when changing information
According to Point b, Clause 1, Article 7 of the Draft, enterprises must re-carry out all cosmetic declaration procedures if there is a change in information according to Appendix No. 04. However, the Draft has not yet published the details of the content of Appendix 04, making it difficult for businesses to assess the reasonableness and ability to apply this regulation. Requiring re-disclosure of any changes without clear criteria can lead to how machines are applied, which is time-consuming and costly.
For example, administrative changes such as trademarks or information on labels usually do not affect product quality. Requiring enterprises to re-carry out all disclosure procedures in these cases is unnecessary and contrary to the spirit of administrative reform of the Government. Instead, there should be a clear classification mechanism between technical and administrative changes and changes that affect product quality. For immaterial changes, businesses should be allowed to carry out information update procedures according to a simplified process, instead of having to re-publish from scratch.
1.2. Shortening the validity period of cosmetic declaration certificates
The Draft Decree proposes to shorten the validity period of cosmetic declaration slips from 05 years (according to Circular 06/2011/TT-BYT) to 03 years (Clause 3, Article 7). Although the goal of this regulation is to strengthen state management and consumer protection, the shortening of the time limit poses many practical problems.
Firstly, requiring enterprises to carry out re-announcement procedures every 03 years, even if there is no change in product quality or nature, increases the frequency of carrying out administrative procedures, leading to unnecessary costs and time. Second, this regulation can negatively affect the legitimate business activities of enterprises, especially small and medium-sized enterprises that already have difficulty complying with complex legal regulations.
To solve this problem, the Drafting Committee should consider keeping the 5-year term as currently prescribed. In case you still want to shorten the time limit, it is necessary to design a simple reconfirmation or renewal mechanism for products that have not changed substantially, instead of forcing businesses to repeat the entire announcement process.
1.3. Limitation on modification of the disclosure dossier
According to Point d, Clause 1, Article 10, the Draft limits enterprises to only amend the cosmetic declaration dossier 01 time within 03 months. If the dossier is still unsatisfactory after this amendment, the enterprise must resubmit the entire dossier from the beginning. This regulation is kept the same from Circular 06/2011/TT-BYT, but does not ensure flexibility, especially in the context that the system for processing published documents still has many inadequacies.
Currently, the process of processing documents at some authorities is still mainly done manually, the online system often encounters errors, and in some localities, businesses have to submit documents both online and in person. These factors increase the risk of the application being returned because of technical or administrative errors that are not related to the quality of the product. Limiting the revision of records only once is unreasonable and causes difficulties for businesses.
A feasible solution is to allow businesses to modify the dossier up to 03 times during the processing period, or at least allow the modification until it meets the requirements without having to resubmit it from the beginning. In case the number of amendments is exceeded, the enterprise can submit an explanation to be considered for further processing of the dossier, instead of having to start the whole process again. At the same time, it is necessary to build a mechanism for classifying errors (handled by enterprises, systems or agencies) to ensure fairness and transparency.
2. Request for adjustment of the certificate of production establishment due to change of administrative boundaries
Clause 3, Article 15 of the Draft requires enterprises to adjust the Certificate of eligibility for cosmetic production when the address changes due to adjustment of administrative boundaries. This regulation is not in line with the principle of reforming administrative procedures and reducing compliance costs for businesses.
Changes in administrative boundaries are objective factors, decided by state agencies, and do not change the reality of production conditions, personnel, infrastructure or operating positions of establishments. Requiring businesses to resubmit all documents, including personnel declarations, floor plans, and equipment lists, just because of the change of administrative address names is unnecessary, wasting time and money.
Instead, the Drafting Committee should amend the regulations in the direction of only requiring enterprises to send a notice with a written confirmation from the competent authority on the change of administrative boundaries. If the other contents of the certificate remain unchanged, there is no need to re-issue the certificate.
3. Stipulating the composition of cosmetic declaration dossiers that are not in accordance with international practices
The composition of cosmetic declaration dossiers in the Draft Decree, especially the requirements related to imported products, also needs to be adjusted to ensure feasibility and conformity with international practices.
3.1. Requirements for verification of the owner of imported products
According to Point b, Clause 1, Article 9, for imported products whose owners are not production establishments, enterprises must submit a written certification of the product owner enclosed with the signature of the representative of the production establishment. This regulation is difficult because in many countries, owners and manufacturers are not homogeneous, and signature authentication is not common or does not have a suitable mechanism.
For example, in Singapore, the Health Sciences Authority (HSA) only requires disclosure by a "responsible person" and does not require confirmation of ownership or certification of signatures from the manufacturer. The provisions in the Draft are contrary to international practice and may increase the cost and processing time for importers, especially in the context that the model of processing cosmetics on order or transfer of trademarks is very popular in the global market.
To solve the problem, the Drafting Committee should replace the requirement for certification of the owner with a document proving the legal distribution right of the unit in the name of the publisher, helping to simplify the procedure while still ensuring legality.
3.2. Unclear about free flow certification (CFS)
The draft does not specify whether Free Flow Certificates (CFS) issued by non-state organizations, such as trade associations, will be accepted. Meanwhile, in some countries such as South Korea, Japan or Thailand, associations or trade organizations are also allowed to issue CFS for export purposes. The lack of specific regulations can cause difficulties for businesses, especially those that export cosmetics to the global market.
The drafting committee needs to add specific criteria for accepting CFS from non-state organizations, ensuring transparency and creating favorable conditions for businesses.
3.3. Request for authentication of signatures in authorization documents
Point g, Clause 1, Article 11 requires that the power of attorney in the announcement dossier must be certified by the signature of the representative of the authorizing party (the owner or overseas production establishment). This regulation is not feasible because in many countries, the authorization to carry out administrative procedures such as announcing cosmetics only requires a civil contract or a normal letter of authorization, and does not require signature authentication.
Requiring signature authentication incurs the cost of consular legalization or international notarization, while Power of Attorney is only of a domestic administrative nature and does not involve product ownership. Moreover, the legal responsibility has been transferred to the unit in the name of the announcing, so it is not necessary to require signature authentication.
The solution is to abolish the requirement for signature authentication, only require the Power of Attorney to have full information about the parties, the scope of authorization, the validity period, and be clearly signed in accordance with the provisions of the law of the host country.
Deputy Minister of Health Do Xuan Tuyen speaks at the workshop “Current Situation of Cosmetics Management and Future Directions”. Source: Ministry of Health
4. Many terms in the Draft are unclear as well as lack of quantitative criteria
Terms and concepts in the Draft Decree, especially in Article 2, need to be supplemented with detailed guidance to avoid inconsistent application and cause legal risks to enterprises.
4.1. Unwanted effects
Clause 8, Article 2 defines "unwanted effects" related to the adverse effects of cosmetics, but does not provide specific technical standards or quantitative criteria. This can lead to subjective interpretation, causing inconsistency in application among local management agencies. Businesses may face the risk of being sanctioned due to different interpretations of the severity of the violation.
The draft should add specific guidance on the threshold for assessing adverse effects, such as the frequency of occurrence, the extent of the impact on user health, or the post-audit assessment mechanism. This will ensure fairness and transparency in management.
4.2. Distinguishing cosmetics from similar products
Although the Draft refers to the ASEAN Cosmetic Harmonization Agreement to classify cosmetics, there is no domestic legal document detailing how to distinguish cosmetics from drugs, functional foods, or personal care products. Products such as toothpaste, acne products with mild antibacterial active ingredients often fall into the intersection zone between cosmetics and pharmaceuticals, leading to difficulties in classification.
The lack of clear guidance makes businesses vulnerable to administrative sanctions due to subjective interpretation from the management agency. The drafting committee needs to supplement classification criteria based on the type of use, ingredients, purpose of use, and use limits, and build a reference list to support businesses.
5. Cosmetics management should focus on post-inspection and transparency
To achieve the goal of effective management, the Draft Decree needs to be designed in the direction of strengthening post-inspection, transparency of evaluation criteria, and encouraging the responsibility of enterprises, instead of expanding administrative procedures in a formal way.
5.1. Strengthening selective post-inspection
Instead of tightening the announcement procedure, the Drafting Committee should focus on the post-inspection mechanism, prioritizing the inspection of products that are at high risk, have feedback from consumers, or have a history of violations. This will reduce the administrative burden on genuine businesses and improve management efficiency.
5.2. Transparency of evaluation criteria
The criteria for evaluating dossiers of disclosure, product quality inspection, and handling violations should be public and clear to avoid arbitrary application. Businesses need to be provided with detailed guidance to comply with regulations and reduce legal risks.
5.3. Encouraging the responsibility of each enterprise
The draft should require enterprises to self-disclose accurate information, keep complete records, and take legal responsibility for the truthfulness of the submitted documents. This will promote a sense of compliance of businesses without imposing complex administrative procedures.
6. Conclusions and recommendations
The Draft Decree regulating cosmetics management is an important step towards completing the legal framework for the cosmetics industry in Vietnam. However, there are still many inadequacies in the regulations on disclosure procedures, dossier components, and terminology, which can cause difficulties for businesses and reduce the efficiency of state management. To ensure transparency, synchronization and feasibility, the Drafting Committee needs to consider the following recommendations:
Firstly, keep the validity period of the cosmetic declaration certificate unchanged at 05 years, or design a simple extension mechanism for products that do not change substantially.
Secondly, it is allowed to amend the publication dossier up to 03 times during the processing period, with an explanation mechanism to avoid resubmission from the beginning.
Thirdly, simplify the procedure for updating information when changing the address due to adjustment of administrative boundaries.
Fourth, abolish the requirement to authenticate signatures in documents certifying the owner and Power of Attorney, replacing them with documents proving the legal right to distribute.
Fifth, supplementing the criteria for accepting CFS from organizations not belonging to state agencies.
Sixth, provide detailed guidance on cosmetic classification criteria and evaluate "unwanted effects" to ensure uniform application.
With appropriate adjustments, the Draft Decree will become a solid legal foundation, supporting businesses to develop sustainably, while protecting consumer rights and improving the efficiency of state management in the field of cosmetics.
Lawyer Nguyen Ngoc Tra My - Lawyer Cao Nguyen Bao Lien
HM&P Law Firm
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hmplaw.vn
