As a manufacturer, importer and trader of cosmetic products, all of them will not be able to ignore the special regulations related to the obligation to draft, prepare and keep Cosmetic Product Information File.

This content can be affirmed with certainty because Clause 4 Article 48 of Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Minister of Health regulating the management of cosmetics, effective from April 1, 2011 and some related amended documents stipulating the responsibilities of organizations, individuals producing, trading and importing cosmetics for circulation on the Vietnamese market as follows: “Organizations and individuals responsible for bringing products to the market must keep the Product Information File (PIF) for at least 03 years from the time the last production batch is put on the market and presented when the authorities inspect and inspectors requested”.  

Not only that, the responsibility for making Product Information File applies to each cosmetic product as prescribed in Article 11 of Circular No. 06, whereby “each cosmetic product when put on the market must have a Product Information File according to the guidance of ASEAN kept at the address of the organization, individuals are responsible for bringing products to the market”. The parts of Product Information File with 4 sections, including: (i) Part 1: Administrative documents and product summary; (ii) Part 2: Quality of raw materials; (iii) Part 3: Quality of finished products; (iv) Part 4: Safety and efficacy of the product (Clause 1, Article 12 of Circular No. 06).  

The purpose of the storage for the Product Information File is to present to the examining and inspecting agency when requested. Specifically, Part 1 of the Product Information File must be presented immediately. Other parts, if incomplete, shall be presented within 15 – 60 days from the date of inspection at the request of the authorities (Clause 2, Article 12, Circular No. 06).   

In case of not fully complying with the obligation to store Product Information File, the consequences and penalties that traders have to bear will be great. Some penalties can be considered as follows:   

• A fine of between VND 30,000,000 and VND 40,000,000 shall be imposed on organizations and individuals responsible for bringing products to the market when trading in cosmetics without or failing to present the Product Information File within the required time prescribed by law when there is a request for inspection by a competent agency (Point b, Clause 3, Article 71 of Decree No. 117/2020/ND-CP. Amended by Clause 21, Article 2 of Decree No. 124/2021/ND-CP); 
• Forcible recall and destruction of cosmetic products (Point a, Clause 4, Article 71 of Decree No. 117/2020/ND-CP; 
• The receipt number of the cosmetic product notification is revoked when there is no product information file to be presented to the competent authority as prescribed (Point k, Article 46, Circular No. 06);
• Being suspended from receiving dossiers of cosmetic product notificaiton, cosmetic advertising registration dossiers, seminars, and cosmetic introduction events when there is no Product Information File kept at the enterprise as prescribed (Point l, Article 47, Circular 06; 
• In case there are 02 or more cosmetic products that violate the storage of Product Information File and are detected in the same inspection or examination, they are considered aggravating circumstances when sanctioning administrative violations (Clause 5, Article 71 of Decree No. 117/2020/ND-CP; 

With the penaties that are very heavily applied as mentioned above, Units need to review and fully comply with the obligation to store Product Information File to ensure compliance with legal regulations, avoid business interruptions as well as heavy economic losses. In particular, it will be very damaging when the violating cosmetic products are recalled and destroyed. Therefore, the traders need to pay attention to comply in the most complete way.  

NGUYEN THI KIM DUNG, Partner