Conditions for issuance of Certificate of eligibility for cosmetic manufacturing in Vietnam

Conditions for issuance of Certificate of eligibility for cosmetic manufacturing in Vietnam (Internet image)

1. What is cosmetic product?

According to Clause 1, Article 2 of Decree 93/2016/ND-CP, cosmetic product is a substance or a preparation intended to be placed in contact with the various external parts of the human body (skin, hair system, finger nails, toenails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, correcting body odours or keeping the human body in good condition.

2. Conditions for issuance of Certificate of eligibility for cosmetic manufacturing in Vietnam

According to Article 4 of Decree 93/2016/ND-CP (amended in Decree 155/2018/ND-CP), a cosmetic manufacturer may be qualified to apply for a Certificate of eligibility for cosmetic manufacturing if it satisfies all of the following conditions:

- Personnel requirement: The production manager must have professional knowledge about one of the following majors: Chemistry, Biology, Pharmacy or other relevant majors in order to meet job requirements.

- Infrastructure requirement:

+ Its location, area, workshop and equipment must meet requirements on the production line and types of cosmetic products which will be produced by that manufacturer as described in the application dossier for Certificate of eligibility for cosmetic manufacturing;

+ Raw materials, packaging materials and finished products stores must ensure the separation between raw materials, and packaging materials, and finished products, and have separate areas for storing flammable and explosive matters, highly toxic substances, discharged or recalled or returned materials or products.    

- Its quality management system must satisfy the following requirements:

+ Raw materials, auxiliary materials and semi-finished products which are used to manufacture cosmetic products must satisfy the quality standards adopted by the manufacturer

+ The water used in the production of cosmetic products must comply with the national technical regulations on drinking water quality promulgated by Minister of Health;

+ The production process must be available for each type of cosmetic products;

+ The quality of raw materials, semi-finished products, bulk products and finished products must be monitored by quality control divisions;

3. Forms of issuance of Certificates of eligibility for cosmetic manufacturing in Vietnam

According to Article 6, Decree 93/2016/ND-CP, a Certificate of eligibility for cosmetic manufacturing shall be issued in the following cases:

- A cosmetic manufacturer applies for Certificate of eligibility for cosmetic manufacturing;

- A cosmetic manufacturer that has Certificate of eligibility for cosmetic manufacturing issued moves its production location;

- A cosmetic manufacturer that has Certificate of eligibility for cosmetic manufacturing issued supplements its production line other than that stated in the issued Certificate of eligibility for cosmetic manufacturing.

4. Cases of revocation of Certificate of eligibility for cosmetic manufacturing in Vietnam

According to Article 12 of Decree 93/2016/ND-CP, the certificates of eligibility for cosmetic manufacturing shall be revoked by the issuing authorities in the following cases:

- A cosmetic manufacturer fails to meet all of conditions set forth in Article 4 of Decree 93/2016/ND-CP;

- A Certificate of eligibility for cosmetic manufacturing has been issued by an incompetent authority or includes unlawful contents;

- A cosmetic manufacturer runs its operations at a location other than that stated in the issued Certificate of eligibility for cosmetic manufacturing;

- The application for issuance/re-issuance/amendment of Certificate of eligibility for cosmetic manufacturing has been forged;

- A cosmetic manufacturer voluntarily applies for the revocation of Certificate of eligibility for cosmetic manufacturing.

Thanh Rin

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