Changing the language on cosmetic product labels after the issuance of the Product Notification Number and Advertisement Content Approval

In the process of distributing and marketing cosmetic products in the Vietnamese market, businesses often seek to adjust product packaging to better align with their business strategies, target customer segments, or specific markets. However, under Vietnamese law, cosmetic products must obtain a Product Notification Number in order to be legally circulated on the market. Furthermore, throughout the course of doing business, companies are also required to obtain approval for the content of any cosmetic product advertisements. 

While the product label sample is not a mandatory document in either the product notification or advertisement content approval procedures, any subsequent change to the label, such as a change in the language used, may give rise to legal issues concerning the continued validity of the issued Product Notification Number and the compliance of the advertisement content with the approved version. 

This article aims to analyze the current legal regulations governing changes to the language used on cosmetic product labels, clarify the scope within which such modifications are permissible, and outline the procedures that businesses must follow to ensure regulatory compliance. 

1. Issues related to the issued product notification number (“Product Notification”): 

According to Article 9 of Circular No. 06/2011/TT-BYT on the management of cosmetics (“Circular 06”), once a cosmetic product has been granted a Product Notification, the enterprise is responsible for carrying out either a new product notification or a supplementary notification, depending on the nature of the changes made. The applicable procedure is specified in Appendix 05-MP attached to Circular 06. 

Under Appendix 05, depending on the nature of the change made after the product has been notified, there are two applicable procedures: (i) a new product notification or (ii) a supplementary notification. Specifically: 

• A new product notification must be carried out in cases where there are changes to the brand name, product name, the responsible company placing the product on the market, product form, intended use, product formulation, or manufacturer/packager (name and/or address). 

• A supplementary notification applies in cases of changes to the product presentation form, name and/or address of the responsible company placing the product on the market (provided that the enterprise registration certificate or investment certificate number remains unchanged), name and/or address of the importer, change in the company’s legal representative, packaging size, packaging material, or product label (in which case the supplementary notification is required only if the updated information is included in the Product Notification). 

Changing the language on the product label does not fall under the categories requiring a new Product Notification or a supplementary notification. Therefore, the enterprise is not required to apply for a new Product Notification nor carry out procedures to update the product label when changing the language used on the packaging. 

Furthermore, as mentioned in the introduction of this article, at the time of submission of the product notification dossier for imported cosmetics, the product label is not a mandatory document in the dossier. Accordingly, when there is a change to the label or packaging of a cosmetic product, the enterprise is not required to conduct a new or repeated product notification, nor to notify authorities of changes to the packaging for such product. 

2. Issues related to the issued advertisement content approval certificate for cosmetic products

For advertisement registration dossiers that have already been granted an Advertisement Content Approval Certificate, if any changes fall under the cases specified in Clause 1, Article 30 of Circular No. 06/2011/TT-BYT (“Circular 06”), the law requires that a supplementary registration dossier be submitted. Specifically, these cases include: 

• Changes to the name or address of the organization or individual responsible for placing the product on the market, provided there is no change in the enterprise registration certificate number or investment certificate number; 

• Changes to the name or address of the entity registering the advertisement, or organizing the seminar or event to introduce the cosmetic product, provided there is no change in the enterprise registration certificate number or investment certificate number; 

• Changes to the official location or time of the seminar or product introduction event compared to what was previously registered. 

For any changes not falling under the above categories, the enterprise must carry out a new registration for the issuance of an Advertisement Content Approval Certificate, as stipulated in Clause 3, Article 30 of Circular 06. 

However, with regard to the Advertisement Content Approval Certificate, businesses should pay attention to the following scenarios: 

• No changes to the advertisement content: Although the product label may have changed, if the advertisement content previously approved under the existing Advertisement Content Approval Certificate remains unchanged, the enterprise is not required to carry out either a supplementary or new registration procedure under the above regulations. 

• Changes to the product image in the advertisement: If the product image used in the approved advertisement content is modified to match the new label/packaging that features a different language, this change does not fall under the category of changes permitted for supplementary registration as per Clause 1, Article 30 of Circular 06. In this case, the enterprise is required to carry out a new registration for the Advertisement Content Approval Certificate. 

If the advertisement content is changed as described above, but the enterprise does not register for a new Advertisement Content Approval Certificate and continues to advertise the product based on the previously issued certificate, the enterprise may be deemed to have committed a violation and may be subject to administrative penalties. This act may be sanctioned under Clause 5, Article 4 and Clause 2, Article 69 of Decree No. 117/2020/NĐ-CP on administrative penalties in the health sector (“Decree 117”). Specifically, organizing seminars, conferences, or cosmetic product introduction events that are inconsistent with the information previously notified to the competent authority may result in a fine ranging from VND 60,000,000 to VND 80,000,000. 

In addition to the points analyzed above, it is important to note that the product label is one of the required components of the Cosmetic Product Information File (PIF). Therefore, the enterprise must ensure that all versions of the packaging are properly stored and updated in the PIF to be readily available for submission to state authorities upon request. To minimize potential risks for the company placing the product on the market, it is advisable to request that the manufacturer provide an official written notice of the packaging change along with a sample of the new packaging. This documentation should be stored as part of the PIF and can serve as supporting evidence in case clarification is required by the competent authorities. 

Related posts

1. Details of cosmetic product information file
2. Product information file of cosmetic products
3. Issues To Take Notice Of Before Advertising Cosmetics

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