Decree No. 93/2016/ND-CP on conditions for manufacturing cosmetics

DECREE

REGULATIONS ON CONDITIONS FOR PRODUCING COSMETICS

Pursuant to the Law on Government Organization dated June 19, 2015;

Pursuant to the Investment Law on November 26 year 2014;

At the proposal of the Minister of Health;

the Government detailing certain provisionsThe Government issues this Decree on conditions for producing cosmetics.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

This Decree stipulates conditions for cosmetic semi-finished product production facilities, finished product production facilities, and cosmetic packaging facilities (hereinafter collectively referred to as cosmetic production facilities); procedures for issuing, reissuing, amending, and revoking the Certificate of Compliance with Conditions for Producing Cosmetics.

Article 2. Interpretation of Terms

In this Decree, the following terms shall be understood as follows:

1. A cosmetic product is a substance or preparation intended to be applied to external parts of the human body (skin, hair system, nails, lips, and external genital organs) or teeth and oral mucosa with one or more of the following main purposes: cleansing, perfuming, altering appearance, adjusting body odor, maintaining good condition of the body.

2. Semi-finished cosmetic products are products that have not been fully processed and require further production or packaging steps to become finished cosmetic products.

Chapter II

CONDITIONS FOR PRODUCING COSMETICS

Article 3. Conditions for operation of cosmetic production facilities

1. Legally established.

2. Possess the Certificate of Compliance with Conditions for Producing Cosmetics according to Model No. 01 prescribed in the Appendix attached hereto.

Article 4. Conditions for issuing the Certificate of Compliance with Conditions for Producing Cosmetics

Cosmetic production facilities must meet the following conditions:

1. Personnel conditions: The person responsible for production at the facility must have specialized knowledge in one of the following fields: chemistry, biology, pharmacy, or other related fields meeting the requirements of the job.

2. Infrastructure conditions:

a) Must have a location, area, factory, and equipment suitable for the production line and type of cosmetic product that the facility plans to produce as stated in the application for the Certificate of Compliance with Conditions for Producing Cosmetics;

b) Storage areas for raw materials, packaging materials, and finished products must ensure separation between raw materials, packaging materials, and finished products; there must be separate areas for storing flammable and explosive substances, highly toxic substances, and returned, recalled, and rejected raw materials and products.

3. Must have a quality management system meeting the following requirements:

a) Raw materials and auxiliary materials used in the production of cosmetics must meet the manufacturer's quality standards;

b) Water used in the production of cosmetics must at least meet the national technical regulations on drinking water issued by the Minister of Health;

c) Semi-finished products introduced into production must have quality standards and meet the manufacturer's quality standards;

d) Must have a production process for each product;

đ) Must have a quality control department to check the quality of raw materials, semi-finished products, products awaiting packaging, and finished products;

e) Must have a system for retaining documentation.

Chapter III

AUTHORITY, APPLICATIONS, PROCEDURES FOR ISSUING THE CERTIFICATE OF COMPLIANCE WITH CONDITIONS FOR PRODUCING COSMETICS

Article 5. Authority to issue the Certificate of Compliance with Conditions for Producing Cosmetics

The Department of Health shall issue the Certificate of Compliance with Conditions for Producing Cosmetics for cosmetic production facilities within its jurisdiction.

Article 6. Forms of Issuance of the Certificate of Compliance with Conditions for Producing Cosmetics

1. Issuance of the Certificate of Compliance with Conditions for Producing Cosmetics applies to the following cases:

a) A production facility applying for the Certificate of Compliance with Conditions for Producing Cosmetics;

b) A production facility that has already obtained the Certificate of Compliance with Conditions for Producing Cosmetics but has changed its production location;

c) A production facility that has already obtained the Certificate of Compliance with Conditions for Producing Cosmetics but has added production lines compared to those covered by the Certificate of Compliance with Conditions for Producing Cosmetics.

2. Reissuance of the Certificate of Compliance with Conditions for Producing Cosmetics applies to the case where the Certificate of Compliance with Conditions for Producing Cosmetics is lost or damaged.

Article 7. Documents for Application to Obtain and Reissue the Certificate of Compliance for Cosmetic Production

1. The documents for application to obtain the Certificate of Compliance for Cosmetic Production include the following:

a) An application form for obtaining the Certificate of Compliance for Cosmetic Production according to Form No. 02 prescribed in the Appendix attached to this Decree;

b) A floor plan and design of the production facility;

c) A list of existing equipment at the production facility;

d) A list of products currently being produced or planned to be produced and quality standards for each product.

2. The documents for application to reissue the Certificate of Compliance for Cosmetic Production include the following:

a) An application form for reissuing the Certificate of Compliance for Cosmetic Production according to Form No. 03 prescribed in the Appendix attached to this Decree;

b) The original Certificate of Compliance for Cosmetic Production (if available).

3. The documents for application to obtain and reissue the Certificate of Compliance for Cosmetic Production shall be compiled into one set, with a stamp affixed across the pages of the production facility.

Article 8. Acceptance of Documents for Application to Obtain and Reissue the Certificate of Compliance for Cosmetic Production

1. The documents may be submitted directly or sent via postal service to the Department of Health of the province where the production facility is located.

2. Within two working days from the date of receipt of the documents for application to obtain and reissue the Certificate of Compliance for Cosmetic Production, the Department of Health shall have the responsibility to check the documents and perform one of the following actions:

a) Issue a document acceptance receipt according to Form No. 05 prescribed in the Appendix attached to this Decree if the documents are complete and valid as stipulated in Article 7 of this Decree;

b) Notify in writing the contents that are incomplete or invalid.

Article 9. Procedure for Issuance of the Certificate of Compliance for Cosmetic Production

1. Prior to commencing production, the cosmetic production facility shall submit the documents for application to obtain the Certificate of Compliance for Cosmetic Production to the Department of Health.

2. Within thirty days from the date of receipt of the valid documents and the assessment fee as prescribed, the Department of Health shall have the responsibility to inspect the production facility and issue the Certificate of Compliance for Cosmetic Production; in cases where the certificate is not issued or the facility is required to make changes or corrections, a written notification must be provided with the reasons stated.

3. In cases requiring the facility to make changes or corrections:

a) The cosmetic production facility shall implement the changes or corrections and submit a report to the Department of Health;

b) The Department of Health shall have the responsibility to review the report, check the documents or inspect the cosmetic production facility again (if necessary). Within fifteen days from the date of receipt of the correction report, the inspection authority must respond in writing about the inspection results;

c) Within six months from the date of issuance of the document requesting the cosmetic production facility to make changes or corrections, if the Department of Health does not receive a correction report from the facility, the application documents for obtaining the Certificate of Compliance for Cosmetic Production of the facility will lose their validity.

4. For cosmetic production facilities granted the "Good Manufacturing Practice for Cosmetics" (CGMP-ASEAN) Certificate by the Ministry of Health:

a) The Ministry of Health shall send a letter to the Department of Health where the cosmetic production facility is located regarding the issuance of the Certificate of Compliance for Cosmetic Production;

b) Within five working days from the date of receipt of the letter from the Ministry of Health, the Department of Health shall have the responsibility to issue the Certificate of Compliance for Cosmetic Production to these cosmetic production facilities.

Article 10. Procedure for Reissuing the Certificate of Compliance for Cosmetic Production

Within five working days from the date the Department of Health receives the application for reissuance of the Certificate of Compliance for Cosmetic Production from the cosmetic production facility, the Department of Health shall reissue the Certificate of Compliance for Cosmetic Production according to Form No. 01 stipulated in the Appendix issued together with this Decree.

Article 11. Amendment of the Certificate of Compliance for Cosmetic Production

1. The amendment of the Certificate of Compliance for Cosmetic Production applies to cases where the cosmetic production facility has been issued the Certificate of Compliance for Cosmetic Production but there is a change in the name of the production facility or a change in address due to administrative boundary adjustment (the place of production does not change).

2. The application dossier for amending the Certificate of Compliance for Cosmetic Production consists of one set of documents including the following:

a) Application for Amending the Certificate of Compliance for Cosmetic Production according to Form No. 04 stipulated in the Appendix issued together with this Decree;

b) Documents proving the changes.

3. The acceptance of the application dossier for amending the Certificate of Compliance for Cosmetic Production shall be carried out in accordance with Article 8 of this Decree.

4. Within five working days from the date the Department of Health receives the application for amending the Certificate of Compliance for Cosmetic Production from the cosmetic production facility, the Department of Health shall issue the Certificate of Compliance for Cosmetic Production according to Form No. 01 stipulated in the Appendix issued together with this Decree, retaining the original certificate number, clearly indicating the amendment number, the date of amendment, and the reason for amendment.

Article 12. Revocation of the Certificate of Compliance for Cosmetic Production

The issuing authority of the Certificate of Compliance for Cosmetic Production shall revoke the Certificate of Compliance for Cosmetic Production in the following cases:

1. The cosmetic production facility does not meet all the conditions prescribed in Article 4 of this Decree;

2. The Certificate of Compliance for Cosmetic Production was issued beyond the authority or contains content contrary to the law;

3. The cosmetic production facility conducts cosmetic production at an address different from that stated on the Certificate of Compliance for Cosmetic Production;

4. Falsifying documents in the application dossier to obtain issuance, reissuance, or amendment of the Certificate of Compliance for Cosmetic Production;

5. The cosmetic production facility voluntarily requests the revocation of the Certificate of Compliance for Cosmetic Production.

Article 13. Fee for Assessment of Standards and Conditions for Cosmetic Production

A cosmetic production facility submitting an application for issuance of the Certificate of Compliance for Cosmetic Production must pay the fee for assessment of standards and conditions for cosmetic production in accordance with the laws on fees and charges.

Chapter IV

IMPLEMENTING PROVISIONS

Article 14. Effective Date

This Decree takes effect from July 1, 2016.

Article 15. Transitional Provisions

1. A cosmetic production facility operating before the effective date of this Decree may continue producing types of cosmetics that have already been granted registration numbers for product declaration forms still valid but must complete the procedures for applying for the Certificate of Compliance for Cosmetic Production in accordance with this Decree before December 31, 2018.

2. If a cosmetic production facility operating before the effective date of this Decree produces additional types of cosmetics other than those already granted registration numbers for product declaration forms, it must complete the procedures for applying for the Certificate of Compliance for Cosmetic Production in accordance with this Decree before commencing production of new cosmetic products.

3. For cosmetic production facilities that have been issued the "Good Manufacturing Practice for Cosmetics" (CGMP-ASEAN) certificate by the Ministry of Health before the effective date of this Decree, the Ministry of Health shall notify the list of such cosmetic production facilities to the Department of Health to issue the Certificate of Compliance for Cosmetic Production for these facilities before December 31, 2016.

4. During operation, cosmetic production facilities must apply a quality management system based on the principles and standards of "Good Manufacturing Practice for Cosmetics" (CGMP-ASEAN).

Article 16. Implementation Organization

1. The Minister of Health is responsible for organizing and guiding the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial People's Committees, and municipal People's Committees directly under the central government are responsible for implementing this Decree./.

 

ANNEX

(Accompanied pursuant to Decree No. 93/201177 July 1, 2016 of the Government)

 

Form No. 01

 

 

CERTIFICATE OF COMPLIANCE FOR COSMETIC PRODUCTION
(*)

First Issuance Date:

Article adjustment number: ..., date: ..., reason for adjustment: ...

- Based on Decree No. ... of the Government stipulating conditions for manufacturing cosmetics;

- Based on ... stipulating functions and tasks of ...

- Pursuant to the proposal of...

(AUTHORITY) CERTIFICATION

(**) …………………………………………………………………………………………….

Address: …

Meets Conditions for Manufacturing Cosmetics

The production line includes: ....(***)

 

 

Mobile phone…

                                                                                                                                   DIRECTOR
                                                                                                                                            (Signature, stamp, full name)signature, stamp, full name name)

 

(*) In case of reissue, the Certificate shall clearly state "REISSUED VERSION".

(**) Clearly state the name of the cosmetic manufacturing facility mentioned in the Application for Issuance of the Certificate of Compliance with Conditions for Manufacturing Cosmetics.

(***) Clearly state the production line as: Packaging production line; semi-finished product production line (dry); semi-finished product production line (wet); finished product production line (dry) or (wet) or other types.

 

Form No. 02

 

APPLICATION FOR ISSUANCE OF THE
CERTIFICATE OF COMPLIANCE WITH CONDITIONS FOR MANUFACTURING COSMETICS

Respectfully submitted to: ...

Establishment name:

Fax:

Business registration certificate number, issue date, issuing authority.

Telephone:                                       Fax:                                    Email:

Based on Decree No. ……. dated … month … year … of the Government stipulating conditions for manufacturing cosmetics, the facility ... requests the Department of Health ... to issue the Certificate of Compliance with Conditions for Manufacturing Cosmetics (the production line includes: ...(*)), the dossier includes the following documents:

1. Floor plan and design of the factory;

2. List of existing equipment at the factory;

3. List of products currently manufactured and/or planned to be manufactured; quality standards for each product.

The facility ... commits that the contents stated in this Application are true and fully assumes responsibility for the stated contents.

 

 

                                                                                                          DIRECTOR OF THE FACILITY
                                                                                                            (Signature name, full name, stamp)

 

(*) Clearly state the production line as: Packaging production line; semi-finished product production line (dry); semi-finished product production line (wet); finished product production line (dry) or (wet) or other types.

 

Implementation Report of Production Projects of Supporting Industry Products Confirmed with Incentives

 

APPLICATION FOR REISSUANCE OF THE
CERTIFICATE OF COMPLIANCE WITH CONDITIONS FOR MANUFACTURING COSMETICS

Respectfully submitted to: ...

Establishment name:

Fax:

Business registration certificate number, issue date, issuing authority.

Telephone:                                       Fax:                                    Email:

CERTIFICATE OF COMPLIANCE WITH CONDITIONS FOR MANUFACTURING COSMETICS

Based on Decree No. ……. dated … month … year … of the Government stipulating conditions for manufacturing cosmetics, the facility ... requests the Department of Health ... to reissue the Certificate of Compliance with Conditions for Manufacturing Cosmetics according to the Certificate of Compliance with Conditions for Manufacturing Cosmetics previously issued number …, date …

The facility ... commits that the contents stated in this Application are true and fully assumes responsibility for the stated contents.

 

 

Reason for requesting reissue: ……… (*)
                                                                                                                                DIRECTOR OF THE FACILITY name, full name, stamp)

 

                                                                                                                      (Signature

 

Form number 04

 

(*) Clearly state the reason for requesting reissue as: Lost or damaged.
CERTIFICATE OF COMPLIANCE WITH CONDITIONS FOR MANUFACTURING COSMETICS

Respectfully submitted to: ...

Establishment name:

Fax:

Business registration certificate number, issue date, issuing authority.

Telephone:                                       Fax:                                    Email:

APPLICATION FOR AMENDMENT OF THE

CERTIFICATE OF COMPLIANCE WITH CONDITIONS FOR MANUFACTURING COSMETICS

The facility ... commits that the contents stated in this Application are true and fully assumes responsibility for the stated contents.

 

 

Based on Decree No. ……. dated … month … year … of the Government stipulating conditions for manufacturing cosmetics, the facility ... requests the Department of Health ... to amend the Certificate of Compliance with Conditions for Manufacturing Cosmetics according to the Certificate of Compliance with Conditions for Manufacturing Cosmetics previously issued number …, date …
                                                                                                                          (Signature name, full name, stamp)

 

(*) State clearly the reason for requesting adjustment as: Change in the name of the cosmetic production facility or change in address due to administrative boundary adjustments.

 

Form number 05

 

RECEIPT FOR ACCEPTANCE OF APPLICATION FILE

Name of recipient:

Position, working unit:

Has accepted the application file (*) of the cosmetic production facility: …

The application file includes the following documents:

1...

2...

3...

 

 

                                                                                                                                                  ACCEPTING PERSON
                                                                                                                                          (Signature name, full name, stamp)

 

(*) Clearly state the application for issuance, reissuance, or adjustment of the Certificate of Compliance with Conditions for Cosmetic Production.