Ministry of Health proposes stricter regulations on cosmetic business

The cosmetics sector in Vietnam is currently governed primarily by Decree No. 93/2016/ND-CP, Circular No. 06/2011/TT-BYT, and related legal documents. However, over time, these regulations have revealed significant gaps with substandard cosmetic products continuing to circulate openly in the market, posing risks to consumer health and undermining fair competition.

In response to these issues, the Ministry of Health is developing the first draft of a new Decree on Cosmetics Management (“Draft”) which seeks to strengthen the regulatory framework. The Draft introduces a range of proposed changes to improve oversight, address existing shortcomings, and promote a more transparent and equitable business environment in the cosmetics industry. 

One of the major focuses of the Draft is the tightening of regulations on cosmetic advertising. To prevent misleading or deceptive cosmetic advertisements, the Draft proposes to prohibit the use of images, uniforms, or names of doctors, pharmacists, healthcare professionals, or medical facilities in cosmetic advertisements. Additionally, the use of certain terms such as “treatment,” “heals immediately,” “eradicates,” “cures,” “permanently cured,” “kills viruses,” “kills fungi,” “fat reduction,” “weight loss,” and similar phrases in cosmetic advertising will be banned. These proposal are aimed at preventing cosmetics from being mistaken for medicinal products and enhancing the clarity and reliability of advertising content. While these stricter rules may initially challenge businesses in revising their promotional strategies, they are expected to support a healthier competitive environment and protect consumer interests.

The Draft also proposes enhanced requirements for cosmetic manufacturing facilities. Specifically, the Draft requires each facility to appoint a full-time quality assurance officer with a university degree in a relevant field, specialized training in cosmetic quality management, and at least two years of relevant experience. In terms of infrastructure, the Draft sets out more detailed and specific standards for ventilation, lighting, water systems, and equipment used in the manufacturing process, aiming to raise safety and quality benchmarks across the industry.

Moreover, in contrast to the current regulations, which only require the appointment of a production supervisor with relevant expertise, the Draft goes further by requiring that all personnel directly involved in the production process must possess appropriate professional knowledge, experience, skills, and competence consistent with the scale of the facility. Furthermore, these personnel must be trained in manufacturing procedures in accordance with CGMP principles. 

Significant changes are also proposed to the cosmetic product notification process. Under the current framework, a receipt number must be issued within three working days from the date a valid dossier is submitted, and remains valid for five years. The Draft, however, proposes to extend this processing period to ten working days and reduce the validity of the receipt number from five years to three. According to the Ministry, this adjustment is consistent with international practice, where the validity period often ranges from one to three years.

Overall, the Draft introduces more specific and detailed regulations compared to the current framework, reflecting the Ministry of Health’s efforts to address existing shortcomings and elevate the regulatory standards for the cosmetics sector. If adopted, the new regulations will likely extend the time required for cosmetic notification procedures and place greater restrictions on advertising activities. However, in the long run, the Draft is expected to help establish a more transparent, equitable, and stable business environment.