The Cosmetic Product Information File is a content of great importance in the production, import and distribution of cosmetic products in the Vietnamese market. The reason for this affirmation is that Circular No. 06/2011/TT-BYT has devoted Appendix No. 07-MP to detail the contents and guide the traders to prepare and comply with the making and filling of this information file. Therefore, we would like to provide more detailed regulations related to this content.

In the previous article, we have provided you with legal basic and regulations to take note about the obligation to make, prepare and store the Cosmetic Product Information File for manufacturers, importers, trading in cosmetic products. In order to better understand the relevant regulations, in this article, we present some notes on the parts of the Cosmetic Product Information File as follows:  

Part 1 – Documents on administrative documents and a summary of product

In this part, it mainly archives the documents which have been previously submitted to the competent state agency to be granted the number of receipt of the cosmetic product notification. 

However, there are some documents that are not submitted together with the product notification but are still required to be kept in the Cosmetic Product Information File, including: 

1. Label and information of product; 
2. Manufacturing statement; 
3. Safety Assessment of a Cosmetic Product; 
4. A summary of undesirable effects on human health (if any); 
5. Description of efficacy of cosmetic products (summary); 

Since the above documents are not included in the notification dossier, it should be noted so as not to be lacked.

Part 2 – Documents on material quality  

In this part, the trader must prepare:  

Quality standards and testing methods for ingredients. Regarding fragrance ingredients, name and code number of the composition, name and address of the supplier, certificate of compliance with the IFRA Guidelines are required; 

Data on the safety of the ingredients depending on the data provided by the supplier, published data or reports from Scientific Committees (ACSB, SCCP, CIR). 

Part 3 – Documents on product quality  

1. Regarding the formula of the product: INCI or other approved ACD reference names and corresponding concentrations of the ingredients are required. The formula shall specify the functions of each ingredients. In particular, this formula must be consistent with the list of product ingredients announced in the approved product notification.  
2. As a matter in fact, there are some cases where the information on this document is inconsistent with the information on the approved Notification, at which time, the traders also faces certain legal risks. 
3. About manufacturing: It is required to show the Manufacturer’s contact details; Summary of the manufacturing process; Additional detailed information about the manufacturing process, quality control and relevant documents about manufacturing shall be prepared at the request of the authority. 
4. Relating to the Standards and testing methods used on the finished products: It is required to show the criteria used for microbiological control of cosmetic products; and Analyzing methods corresponding to the quality standards for checking the compliance;   
5. Need to make a brief report on product’s stability (applicable to products whose durability is less than 30 months): The report and the stability testing data/stability assessment data to support product’s durability. 

Part 4 – Documents on safety and efficiency

In this part, the Report on assessment of the safety for human health of the finished product should be made. The latest report on side-effects or undesirable effects (if any) which is updated regularly. Full report of the Efficacy Assessment of the product depending on its compositions and test results

It is significant that these reports must have the name and signature of the auditor accompanied by the auditor’s resume on product safety. 

From the contents mentioned above, the traders need to carefully prepare the points that have been put in highlight to be able to make, prepare and store the Cosmetic Product Information File in accordance with the law. 

Disclaimers:

This article is for general information purposes only and is not intended to provide any legal advice for any particular case. The legal provisions referenced in the content are in effect at the time of publication but may have expired at the time you read the content. We therefore advise that you always consult a professional consultant before applying any content.

For issues related to the content or intellectual property rights of the article, please email cs@apolatlegal.vn.

Apolat Legal is a law firm in Vietnam with experience and capacity to provide consulting services related to Business and Investment and contact our team of lawyers in Vietnam via email info@apolatlegal.com.

NGUYEN THI KIM DUNG, Partner