What are the regulations on the manner to establish the cosmetic product proclamation report and the proclamation data in Vietnam? - Thanh Truc (Phu Tho)
Article table of contents
Instructions on establishing the cosmetic product proclamation report in Vietnam
The manner to establish the cosmetic product proclamation report in Vietnam specified in Clause 1, Article 5 of Circular 06/2011/TT-BYT, is as follows:
(1) The cosmetic product report is set up in accordance with the form in appendix No 01-MP. The proclamation report must be signed by the representative under laws and with the seal of the organizations or individuals who are responsible for sale products in the market at the positions of report’s paper margins. The manner to write contents in the cosmetic product report shall followed the instruction in the appendix No 02-MP
(2) Every cosmetic product proclaimed in a proclamation report.
Cosmetic product which perfect produced in every different enterprises shall be proclaimed separately. In case there are more than one company, taking part in the manufacturing process in order to product a complete product, may joint make a proclamation report and clear state each companies’ name and full address.
Products have the same owners in one of the following situations is permitted to proclaim in one proclamation report:
- Products are packed with a joint name and sold out in form of a product set.
- Products have same name, same product line with similar formulas but different in color or smell. For products of hair dye, perfume, must be separate proclaimed with each color, each smell.
- Other kinds will be decided by the department of Medicine management – the Health Ministry based on the ASEAN Cosmetic Association’s decision.
(3) The manner to write component of formula which are composed in the cosmetic product:
- Components in the product formula must be efficiently listed in descending order of content. Components of perfume, aroma causing substances and their materials can be written in word “flavoring” (perfume, fragrance, flavor, and aroma). Components with less than 1% content can be listed in whatever order after components with more than 1%. Color causing substances can be listed in whatever order after other components in accordance with the color index (CI) or by names mentioned in the Appendix 4 (Annex IV) of the ASEAN Cosmetic Treaty. The cosmetic products for making up under different colors, the producer can list all color causing substances in “containable” section or “+/-”.
- Having full percentages of components provided of limit of concentration and content according to the Appendix (Annexes) of the ASEAN Cosmetic Treaty. Between the unit position and decimal position shall be marked with a comma (”,”).
- Ingredient’s name must be written in the International law name Nomenclature of Cosmetic Ingredients - INCI is regulated in the latest publications: The International Cosmetic Ingredient Dictionary, the British Pharmacopoeia, the United States Pharmacopoeia, the Chemical Abstract Services, the Japanese Standard Cosmetic Ingredient, and the Japanese Cosmetic Ingredients Codex. Plant title and the fluid is extracted from plant must be written in the scientific title which involves the limb and species (the limb title can be shortened). Ingredients from the animal need accurately writing in the scientific name of that animal.
The following substances are not subject to be considered as the cosmetic Ingredient:
- Impurities in materials used.
- Auxiliary materials used for the technology purpose but absent from the end-product.
- Exerted materials used with a necessary mount such as solvent or the bearer of scent-causing ingredients.
(4) The language in the proclamation report may be in Vietnamese or English. Contents which are mentioned in section 3 (the usage purpose), section 7 (the information of organization, individual who are responsible for putting products on the market), section 8 (information of enterprise’s representative under the law), section 9 (information of import company) in the proclamation report must be written in Vietnamese or in Vietnamese and English.
Instructions on establishing the cosmetic product proclamation report in Vietnam (Internet image)
Manner to submit the proclamation data in Vietnam
Pursuant to Clause 2, Article 5 of Circular 06/2011/TT-BYT, the proclamation data (the soft version of the proclamation report): Organizations, individuals can submit the proclamation data according to clause 1, article 4 of this Circular by one of two following ways:
- Direct declaration: Organizations or individuals, who signed on the cosmetic product proclamation, must send the text to the Medicine Management department under the Ministry of Health to be issued an entry account to access the cosmetic management database, and fill in forms in the database directly.
The proclamation report which is submitted to the competent state management agency must be printed out from that database.
- Access the Medicine Management department’s electronic information page (website), download the database of the cosmetic product report (Appendix 01-MP), fill all the information into the database according to the law regulation, save to the electronic device (USB, CD-ROM, etc.).
The proclamation report which is to be submitted to the Government’s Management Office must be printed from that database.
The organization or the individual, whose name is on the cosmetic proclamation, must completely be responsible for the propriety of content of the cosmetics product proclamation report (signed and sealed version) compare with the proclamation data (soft version) declared or submitted to the Management Office.
Mai Thanh Loi
