Responsibilities of enterprises when voluntarily requesting the withdrawal of a cosmetic product notification receipt

During the distribution of cosmetic products in the market, there are cases where enterprises voluntarily request the withdrawal of the cosmetic product notification receipt for various reasons. One notable factor is the regulatory changes in the permissible concentration limits of ingredients used in cosmetics, which may require enterprises to withdraw products due to updated legal requirements. 

Regularly reviewing legal regulations and proactively withdrawing cosmetic product notification receipts demonstrates an enterprise’s commitment to compliance with current laws while maintaining and enhancing its reputation. However, when withdrawing products due to changes in legal concentration limits, enterprises must fulfill certain responsibilities to ensure an effective withdrawal process complying with legal requirements while minimizing consumer concerns. 

1. Regulations on the Withdrawal of Cosmetic Products 

Circular No. 06/2011/TT-BYT (“Circular 06”) governs the withdrawal of cosmetic products and the withdrawal of the Notification Receipt Number for cosmetic products, specifically:  

• Product withdrawal: Article 45.1 of Circular 06 states: “Cosmetic products shall be suspended from circulation and withdrawn in the following cases: The organization or individual responsible for bringing the product to market submits a written request for voluntary withdrawal.” 

• Withdrawal of the Notification Receipt Number for cosmetic products: Article 46 of Circular 06 states: “The Notification Receipt Number for cosmetic products shall be withdrawn in the following cases: The organization or individual bringing the product to market submits a written request for the withdrawal of the Notification Receipt Number.” 

Based on the above provisions, it can be understood that: 

• The withdrawal of the Notification Receipt Number for cosmetic products due to changes in the permissible ingredient concentration limits is considered a voluntary withdrawal resulting from regulatory updates. This means that the withdrawal is not due to product quality issues. 

• When evaluating the maximum permissible concentration limits for cosmetic products, enterprises must refer to the legally effective documents at the time of review. Therefore, as long as the enterprise completes the product withdrawal within the timeframe specified by the new regulation, it remains compliant with cosmetic product management laws. 

• However, as of now, Circular 06 does not explicitly define the procedural order for withdrawing products and the Notification Receipt Number whether one should be carried out before the other or if both can be done simultaneously. Meanwhile, enterprises must complete the necessary procedures to obtain approval from the competent authorities for the withdrawal of the Notification Receipt Number. Under optimal conditions, it will take at least 08–10 working days to receive official approval for the product withdrawal from the relevant state authority. 

2. Considerations for product withdrawal reasons 

As analyzed, businesses may voluntarily request the withdrawal of the Receipt Number for the Cosmetic Product Announcement and voluntarily recall products under Articles 45.1(i) and 46.1(i) of Circular 06. This can be interpreted to mean that a product may be suspended from circulation and have its Receipt Number revoked for any reason, at the discretion of the business. 

However, businesses should take note of the following considerations: 

• When submitting a request to revoke the Receipt Number, if the product is subject to mandatory recall due to exceeding the permitted concentration of certain substances, but the business states another reason for the recall, it is uncertain whether the competent authority will approve the recall based on the business’s voluntary request. 

• Additionally, there is a possibility that the competent authority may require compliance with the proper recall procedure and issue a Recall Decision in accordance with the actual nature of the case. This would ensure that consumers receive accurate information and can monitor their skin health for a certain period after using the product. Therefore, in such cases, the decision will also depend on the stance of the competent authority. Furthermore, if the business must wait for the competent authority’s Recall Decision before proceeding with the product recall, it may not meet the expected timeline. 

• Businesses should also be aware of general legal provisions related to the responsibility of providing truthful information as stipulated in the Law on Product and Goods Quality and the 2023 Law on Consumer Rights Protection, specifically: 

Law on Product and Goods Quality 2007: 

Article 16: Obligations of Sellers 

3. Provide truthful information about product and goods quality.

9. Promptly cease sales and notify manufacturers, importers, and buyers upon discovering that a product poses safety risks or does not comply with applicable standards or technical regulations.

Article 17: Consumer Rights 

• Receive truthful information regarding safety levels, quality, transportation, storage, and usage instructions for products and goods. 

• Be informed about product warranties, potential safety risks, and preventive measures upon receiving warnings from manufacturers or importers. 

Law on Consumer Rights Protection 2023: 

Article 10: Prohibited Acts in Consumer Rights Protection 

1. Business organizations and individuals are prohibited from engaging in the following acts: 

a) Deceiving or misleading consumers by providing false, incomplete, or inaccurate information regarding:

• The products, goods, or services they sell or provide; 

• Their reputation, business capability, and ability to supply products, goods, or services; 

• The nature and characteristics of transactions between consumers and businesses; 

• Official certifications, documents, or approvals from competent authorities regarding the products, goods, services, or businesses. 

The above provisions are general regulations concerning product quality. As previously analyzed, if a product is recalled due to a change in legal regulations regarding the allowable concentration of an ingredient, this recall is based on legal compliance rather than a product quality issue that could harm consumer health. Accordingly, when announcing the recall reason, businesses may consider explicitly stating that the recall is due to an adjustment in legal regulations regarding ingredient concentrations. However, there is no absolute approach to handling this issue, as it depends on various external factors. 

3. Obligation to notify the competent authority  

Circular 06 does not require businesses to notify the competent authority when conducting a voluntary recall. Since the law does not impose such an obligation, there is no legal basis for applying sanctions in this case.  

However, regarding the reporting obligation, Article 48.2 of Circular 06 states: 
“Organizations and individuals circulating cosmetic products on the market are responsible for monitoring, detecting, and immediately recalling substandard cosmetics, implementing recall notifications issued by competent regulatory authorities, and reporting the recall to the competent authority…” 

Based on this provision: 

• Businesses are responsible for reporting the recall results to the competent authority. 

• Reporting Deadline: Circular 06 does not specify a deadline for reporting voluntary recalls after completion. To ensure compliance and minimize potential risks, businesses may proactively notify the competent authority of their recall plan and timeline at the time of requesting the withdrawal of the Receipt Number. This allows the authority to acknowledge and document the recall process. After completing the recall, businesses can submit a final consolidated report to the competent authority. 

• If a business determines that it should proceed with a recall notification and reporting process, it may refer to Article 33 of the Law on Consumer Rights Protection 2023 and Articles 18 to 21 of Decree 55/2024/ND-CP for guidance on the procedures. 

See more:

1/ Japanese investors operating in cosmetics retail in Vietnam

2/ Legal framework on cosmetic management activities in Vietnam

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