Simplify administrative procedures and decentralize and delegate authority in the management of cosmetics.

(Chinhphu.vn) - The Ministry of Health is seeking public opinion on the draft Decree regulating the management of cosmetics in order to simplify administrative procedures, decentralize power, and enhance the effectiveness, efficiency, order, and discipline of state management of cosmetics.

Simplify administrative procedures, decentralize power and authority, and enhance the effectiveness, efficiency, order, and discipline of state management in the field of cosmetics management.

Some shortcomings and obstacles

According to the Ministry of Health , a review of the practical implementation of Government Decree No. 93/2016/ND-CP dated July 1, 2016, regulating the conditions for cosmetic production and related guiding documents shows that many current regulations have gradually revealed shortcomings and obstacles, failing to meet practical requirements:

Some legal regulations regarding cosmetic management are still too general and need to be clarified, such as the conditions for cosmetic production, the authority to take cosmetic samples, and the procedures for testing cosmetics...

Furthermore, some legal regulations on cosmetic management are overlapping, inadequate, not highly feasible, or no longer suitable for current practices and need to be amended or repealed. For example, current laws stipulate a declaration procedure but still require pre-declaration of documents; regulations on labeling have not kept pace with technological development trends; and the current procedure for confirming the content of cosmetic advertisements is an administrative barrier, increasing the burden on businesses and not in line with the trend towards post-inspection management...

Furthermore, several practical issues need to be added to the Decree, such as regulations on the authority to develop, issue, and update the list of prohibited, restricted, or permitted substances under the ASEAN Cosmetics Agreement; regulations on periodic or unscheduled inspections of facilities that have been granted Certificates of Eligibility for Production or Certificates of "Good Manufacturing Practice for Cosmetics" (CGMP); regulations on inspection and monitoring of the safety and quality of cosmetics after declaration, on recalling violating cosmetic products, and on temporarily suspending the acceptance of cosmetic product declaration applications...

Therefore, drafting a Decree regulating the management of cosmetics is necessary to overcome the shortcomings and limitations of Decree 93/2016/ND-CP and address issues arising in practice; simplify administrative procedures, decentralize power and authority, and enhance the effectiveness, efficiency, order, and discipline of state management of cosmetics.

Revised and improved content

In line with the policy of shifting from pre-inspection to post-inspection, coupled with enhanced inspection and supervision, the transition of business condition management from licensing and certification to the disclosure of business conditions and post-inspection, the reduction of administrative procedures, and the implementation of the ASEAN Cosmetics Agreement, the draft Decree amends and refines the requirements for safety and quality of cosmetic products:

To ensure the safety and quality of cosmetic products, the draft regulations stipulate that cosmetic products must meet ASEAN requirements regarding limits on heavy metals, microorganisms, and trace impurities. The cosmetic formulations must comply with the Annexes of the ASEAN Cosmetics Agreement according to the latest updated version from the ASEAN Cosmetics Council and must be assessed for safety according to the ASEAN Guidelines for Cosmetic Safety Assessment. The internal standards developed by cosmetic manufacturers for their products must be maintained and published in accordance with the Law on Standards and Technical Regulations.

Regarding the declaration of cosmetic products: The new declaration mechanism operates on the principle of "Businesses take responsibility first - Regulatory agencies inspect later" (a complete shift from pre-inspection to post-inspection), in accordance with the regulations of the ASEAN Cosmetics Agreement: Before being put into circulation, products must be self-inspected by the establishment and the information publicly disclosed on the centralized electronic cosmetic management system (and related information portals).

This forces businesses to take full responsibility for the safety and legality of their products from the outset; the Provincial People's Committee only receives and publicly announces the information. This public announcement confirms that the application has been submitted to the system, not that it constitutes content approval.

After a product is announced and put into circulation, the state agency will conduct a document review. If the documents are found to be incomplete, the regulatory agency will revoke the previously issued product announcement number, conduct a surprise inspection, recall the product, and handle the violation.

Product registration dossiers must include "Quality Standards for Cosmetic Products" to control product safety and quality, and to serve as a basis for post-registration quality inspection and testing (applicable in cases where it is a basic standard and has not yet been published in the National Database on Standards, Measurement, and Quality).

Cosmetic manufacturing in Vietnam

The draft Decree stipulates a unified condition for granting both a Certificate of Eligibility for Cosmetic Production and a CGMP Certificate to improve the quality of domestically produced cosmetic products and integrate them with international standards; businesses can apply for both simultaneously, reducing cumbersome administrative procedures and business conditions.

Manufacturing facilities must be assessed periodically every three years, in accordance with international practice, or on an ad hoc basis to ensure that they consistently maintain all conditions and comply with the principles and standards of "Good Manufacturing Practice for Cosmetics" (CGMP) throughout their operation.

The Ministry of Health is currently seeking feedback on this draft on the Ministry's online portal.

Minh Hien

Source: https://baochinhphu.vn/don-gian-hoa-thu-tuc-hanh-chinh-phan-cap-phan-quyen-quan-ly-my-pham-102260224155242917.htm