Proposed new regulations for managing cosmetics.

(Chinhphu.vn) - The Ministry of Health is seeking public opinion on the draft Decree regulating the management of cosmetics, replacing Decree No. 93/2016/ND-CP, in order to overcome the shortcomings and limitations of current regulations and address issues arising in practice.

Improving the quality of domestically produced cosmetic products and integrating them with international standards.

Some shortcomings and obstacles need to be amended and supplemented.

The Ministry of Health stated that, based on 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 its implementing guidelines, many current regulations have gradually revealed shortcomings and obstacles, failing to meet practical requirements.

The legal regulations on cosmetic management are still too general and need to be more clearly defined, such as the conditions for cosmetic production, the authority to take cosmetic samples, and the procedures for testing cosmetic products.

The legal regulations governing cosmetics management are overlapping, inadequate, or no longer relevant to current practices and need to be amended or abolished. For example, current laws stipulate a declaration procedure but still require pre-declaration of documents; labeling regulations haven't kept pace with technological advancements; and the current procedures for verifying cosmetic advertising content are an administrative barrier, increasing the burden on businesses and incompatible with the trend towards post-inspection management.

In addition, 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.

Furthermore, there are some shortcomings and obstacles related to the Law on Product Quality, the Law on Standards and Technical Regulations, the Law on International Treaties, and Vietnam's commitments in the ASEAN Cosmetics Agreement. Currently, cosmetics do not have a separate law to manage them but are governed by multiple laws such as the Investment Law, the Law on Product Quality, the Law on Standards and Technical Regulations, etc. Therefore, regulating quality management measures for cosmetics can only be done by applying existing laws to guide implementation.

Therefore, drafting a Decree regulating the management of cosmetics to replace Decree No. 93/2016/ND-CP is necessary to overcome the shortcomings and limitations of current regulations 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.

Cosmetic products circulating in the market must ensure safety for human health.

The draft Decree stipulates that cosmetic products circulating in the market must ensure safety for human health when used under normal conditions; the formula must comply with the Annexes of the ASEAN Cosmetics Agreement; the product must meet the declared applicable standards and regulations on heavy metal limits, microbial limits, and impurity limits as prescribed.

The draft also clarifies the responsibilities of the publishing entity in establishing, maintaining, and updating the Product Information File (PIF), being responsible for the accuracy and integrity of scientific data proving the quality, safety, and efficacy of the product; and adds the responsibility to monitor and report adverse effects of cosmetic products after they are put on the market.

Unify the conditions for granting Certificates of Eligibility for Cosmetic Production and CGMP Certificates.

Regarding cosmetic production in Vietnam , the draft proposes a unified condition for granting both a Certificate of Eligibility for Cosmetic Production and a Certificate of Good Manufacturing Practice (CGMP) for Cosmetics, aiming to improve the quality of domestically produced cosmetic products and facilitate international integration. Businesses can apply for both simultaneously, reducing cumbersome administrative procedures and business conditions.

The draft also clearly stipulates the cases for granting, re-issuing, adjusting, and revoking the Certificate; it defines that the Certificate has unlimited legal validity, but the facility must maintain compliance with CGMP principles and standards throughout its operation, and is subject to periodic or unscheduled inspections based on risk management principles; the inspection to maintain compliance with CGMP is conducted periodically every 3 to 5 years or unscheduled based on risk management principles, serving as the basis for updating the facility's legal status on the National Cosmetics Database System.

In addition, the draft also specifies the cases for revoking the Certificate of Eligibility for Cosmetic Production and the responsibility for updating the status of maintaining compliance with CGMP standards on the National Cosmetics Database System.

Readers are invited to view the full draft and provide feedback here.

Minh Hien

Source: https://baochinhphu.vn/de-xuat-quy-dinh-moi-quan-ly-my-pham-10226052717012974.htm