VI In the context of an increasingly streamlined business environment, clearly identifying conditional investment and business activities is a top concern for businesses to ensure legal compliance and optimize operational processes. For the cosmetics and personal care sector, especially perfume production, many investors often question the level of government intervention: Does this activity fall under the category of conditional investment and business activities? Accurate identification will determine whether the business needs to meet stringent requirements regarding sub-licenses, facilities, personnel, or product quality standards before officially commencing production. This is a crucial legal basis for businesses to plan their operations and prepare the necessary legal documents. Let’s explore this legal issue with Pham Consult based on current regulations.
1. Is perfume manufacturing a conditional investment and business activity?
According to Clause 1, Article 2 of Government Decree No. 93/2016/ND-CP on the conditions for cosmetic production, a cosmetic product is a substance or preparation used to come into contact with the external parts of the human body (skin, hair, nails, lips, and external genitalia) or teeth and oral mucosa for one or more of the following main purposes: cleaning, perfuming, changing appearance, adjusting body odor, and keeping the body in good condition. Based on the above definition, perfume is considered a cosmetic product.
Furthermore, according to Decision No. 36/2025/QD-TTg of the Prime Minister on the promulgation of the Vietnamese economic sector classification system, perfume manufacturing has an economic sector code specified in Section C, Part II, Appendix II – Content of Vietnamese Economic Sectors; specifically, code 20231, Cosmetics and Perfume Manufacturing. Key products under this code include:
– Perfumes and toiletries;
– Cosmetics and makeup;
– Sunscreen and tanning products;
– Nail care products;
– Shampoos, hairsprays, hair styling and straightening products;
– Toothpaste and oral hygiene products, including denture fixatives;
– Shaving products, including pre- and post-shaving products;
– Deodorants and bath salts;
– Hair removal products.
Combining the above regulations, we can conclude that perfume production is part of the cosmetics industry. This shows that perfume is an important and noteworthy part of this field.
According to the regulations in Appendix IV issued with the 2020 Investment Law, cosmetics production is a conditional investment and business sector. This means that perfume production is a conditional investment and business sector, and to participate in
perfume production, individuals, organizations, or businesses must comply with the regulations and conditions stipulated.
- Conditions for Perfume Production
- Conditions for Perfume Production
According to Article 3 of Decree 93/2016/ND-CP, in order to operate perfume production, a perfume production facility must be granted a Certificate of Eligibility for Cosmetic Production. To be granted this Certificate, a perfume manufacturing facility must meet the following conditions:
– Personnel requirements: The person in charge of production at the facility must have professional knowledge in one of the following fields: Chemistry, Biology, Pharmacy, or other related fields that meet the job requirements.
– Facilities requirements:
+ The facility must have a location, area, factory, and equipment that meet the requirements for the production line and the type of cosmetic products that the facility intends to produce, as stated in the application for the Certificate of Eligibility for Cosmetic Production;
+ The storage area for raw materials, packaging materials, and finished products must ensure separation between raw materials, packaging materials, and finished products; there must be a separate area for storing flammable and explosive substances, highly toxic substances, rejected, recalled, and returned raw materials and products.
– The quality management system must meet the following requirements:
+ Raw materials, auxiliary materials, and semi-finished products used in cosmetic production must meet the manufacturer’s quality standards.
+ Water used in cosmetic production must at least meet the national technical standards for drinking water issued by the Minister of Health;
+ There must be a production process for each product;
+ There must be a quality control department to inspect the quality of raw materials, semi-finished products, products awaiting packaging, and finished products.
2. Application dossier for a Certificate of Eligibility for Cosmetic Production
The application dossier for a Certificate of Eligibility for Cosmetic Production is stipulated in Clause 1, Article 7 of Decree 93/2016/ND-CP, and includes the following documents:
– Application for a Certificate of Eligibility for Cosmetic Production;
– Floor plan and design of the production facility;
– List of existing equipment of the production facility.
Before commencing production, cosmetic manufacturing facilities must submit an application for a Certificate of Eligibility for Cosmetic Production to the Department of Health. The application can be submitted directly or sent by mail to the Department of Health of the province where the manufacturing facility is located.
Within 2 working days of receiving the application for issuance or re-issuance of the Certificate of Eligibility for Cosmetic Production, the Department of Health is responsible for reviewing the application and performing one of the following actions:
– Issuing an acknowledgment slip if the application is complete and valid.
– Notifying in writing of any incomplete or invalid information.
Within 30 days of receiving a complete and valid application and the prescribed assessment fee, the Department of Health is responsible for inspecting the manufacturing facility and issuing the Certificate of Eligibility for Cosmetic Production; if the certificate is not issued or the facility is required to make changes or corrections, a written notification stating the reasons must be provided.
For cases requiring facility changes or corrections:
– The cosmetic manufacturing facility shall make changes or corrections and submit a report to the Department of Health;
– The Department of Health is responsible for reviewing the report, conducting a document-based inspection, or re-inspecting the cosmetic manufacturing facility (if necessary). Within 15 days from the date of receiving the correction report, the inspection agency must provide a written response on the inspection results;
– Within 6 months from the date of issuing the document requiring the cosmetic manufacturing facility to make changes or corrections, if the Department of Health does not receive the correction report from the facility, the application for a Certificate of Eligibility for Cosmetic Production will no longer be valid.
For cosmetic manufacturing facilities that have been granted a “Good Manufacturing Practice for Cosmetics” (CGMP-ASEAN) certificate by the Ministry of Health:
– The Ministry of Health shall send a document to the Department of Health where the cosmetic manufacturing plant is located regarding the issuance of the Certificate of Eligibility for Cosmetic Production; – Within 05 working days from the date of receiving the document from the Ministry of Health, the Department of Health is responsible for issuing the Certificate of Eligibility for Cosmetic Production to these cosmetic production facilities.
