Circular No. 11/2013/TT-BYT guides the designation of organizations to certify compliance for processed packaged foods, food additives, food processing aids, and food packaging materials.

CIRCULAR

Guidelines for designating organizations to certify conformity for processed packaged foods; food additives;

processing aids; packaging materials, utensils that come into direct contact with food.

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Pursuant to the Law on Technical Standards and Regulations dated June 29, 2006, Decree No. 127/2007/ND-CP dated August 1, 2007 of the Government detailing implementation of certain provisions of the Law on Technical Standards and Regulations;

Pursuant to the Law on Product Quality dated November 21, 2007, Decree No. 132/2008/ND-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of the Law on Product Quality;

Pursuant to the Food Safety Law dated June 17, 2010, Decree No. 38/2012/ND-CP dated April 25, 2012 of the Government detailing implementation of certain provisions of the Food Safety Law;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Food Safety Administration;

The Minister of Health issues this Circular guiding the designation of organizations to certify conformity for processed packaged foods, food additives, processing aids, packaging materials, and utensils that come into direct contact with food.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 1. This Circular guides requirements, procedures, and processes for designating organizations to certify conformity for processed packaged foods, food additives, processing aids, packaging materials, and utensils that come into direct contact with food (hereinafter referred to as products), as well as the responsibilities of agencies receiving and organizing certification of conformity for designated organizations.

Article 2. In cases where international treaties, agreements, or mutual recognition arrangements between Vietnam and other countries or territories concerning the recognition of conformity assessment results from designated conformity assessment bodies have different provisions than those set forth in this Circular, the provisions of such international treaties, agreements, or arrangements shall apply.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

Clause 1. A designated conformity assessment organization is an organization meeting the requirements stipulated in Article 3 of this Circular and designated by the Ministry of Health to conduct conformity assessment of products in accordance with corresponding technical regulations to meet state management needs.

Clause 2. Recognition of conformity assessment results refers to the acceptance by competent state authorities, organizations, and individuals operating in Vietnam of conformity assessment results conducted by conformity assessment bodies of other countries or territories.

Chapter II

REQUIREMENTS, PROCEDURES, AND PROCESSES FOR REGISTRATION AND DESIGNATION OF CONFORMITY ASSESSMENT ORGANIZATIONS

Article 3. Requirements for designated conformity assessment organizations

Clause 1. Legally established, having functions to operate in the field of certification.

Clause 2. Registered and granted a certificate of registration for certification activities by the General Department of Standardization, Metrology, and Quality Control under the Ministry of Science and Technology in accordance with laws on product quality.

Clause 3. Assessment experts:

Must have at least five full-time staff members (civil servants or employees under fixed-term contracts of twelve months or more, or indefinite-term contracts) who meet the following criteria:

Point a. Hold a bachelor's degree or higher, with expertise relevant to the assessment and certification fields, including at least three experts with over three years of work experience.

Point b. Hold certificates of completion from annual training courses on food safety organized by the Food Safety Agency.

Clause 4. Possess sufficient technical documentation, applicable documents, and certification procedures consistent with mandatory regulations for corresponding products and technical regulations.

Article 4. Procedures and formalities for registering the designation of conformity assessment certification organizations

1. Organizations that meet the requirements set out in Article 3 of this Circular, when they wish to participate in conformity assessment certification activities for products, shall prepare and submit one (1) set of registration files to the Food Safety Administration, Ministry of Health.

2. The registration dossier includes:

a) A request form for designating a conformity assessment certification organization for products according to the model prescribed in Appendix 1 attached to this Circular;

b) Decision on establishment or Business Registration Certificate (copy);

c) Certificate of registration for the field of certification activities issued by the Standardization, Measurement and Quality Control Agency, Ministry of Science and Technology (certified copy or copy with original for verification);

d) List of assessors according to the model prescribed in Appendix 2 attached to this Circular, accompanied by certificates of specialized training;

đ) Sample Certificate;

e) List of technical documents, standards, and technical regulations corresponding to the registered product according to the model prescribed in Appendix 3 attached to this Circular.

Article 5. Designation, re-designation, temporary suspension, revocation of the decision on designation of conformity assessment certification organizations

1. The Food Safety Administration is responsible for organizing the management of the work of receiving, processing registration files for the designation of conformity assessment certification organizations, designation, re-designation, temporary suspension, and revocation of decisions on the designation of conformity assessment certification organizations for products (hereinafter referred to as the receiving agency).

2. Within no more than thirty working days from the date of receipt of complete and valid files, the receiving agency will examine the files, conduct an actual capability assessment at the facility (if necessary), and issue a decision on the designation of a conformity assessment certification organization according to the model prescribed in Appendix 4 attached to this Circular. The validity period of the designation decision shall not exceed three (03) years.

In cases where the designation is refused, the receiving agency must notify the reasons for refusal in writing to the organization that submitted the registration file.

3. Three months before the decision on the designation of a conformity assessment certification organization expires, if there is a need, the conformity assessment certification organization must re-register according to the provisions of Article 4 of this Circular.

4. During the course of operation, the designation agency will periodically and randomly inspect and supervise the activities of the certification organization. When the certification organization violates the law, the designation agency will issue a decision temporarily suspending the activities of the certification organization until the certification organization takes corrective actions. Within three months from the date of temporary suspension, if the certification organization fails to correct the violations discovered, the designation agency will revoke the designation decision already issued.

5. Six months after being revoked, the certification organization may re-register its activities if needed.

Information on designation, re-designation, temporary suspension, and revocation of the decision on the designation of product certification organizations will be updated and made public on the Food Safety Administration's website.

Chapter III

RESPONSIBILITIES OF THE RECEIVING AGENCY AND DESIGNATED CONFORMITY ASSESSMENT CERTIFICATION ORGANIZATIONS

Article 6. Responsibilities of the Receiving Agency

1. Receive and process registration files for the designation of conformity assessment certification organizations, designation, re-designation, temporary suspension, and revocation of decisions on the designation of conformity assessment certification organizations.

2. Announce the list of designated conformity assessment certification organizations on the agency’s website within three (3) days from the date of signing the designation decision so that organizations and individuals can be informed.

3. Manage, inspect, and evaluate the activities of designated conformity assessment certification organizations. Apply measures prescribed in Clause 4 and Clause 5 of Article 5 of this Circular when the conformity assessment certification organization violates the provisions of this Circular or those stipulated in Article 20 of the Product Quality Law.

4. Announce on the Food Safety Administration's website the name of the designated, re-designated, temporarily suspended, and revoked conformity assessment certification organizations, and simultaneously inform the Standardization, Measurement and Quality Control Agency (Ministry of Science and Technology) for coordinated management.

5. Quarterly and randomly when required, the receiving agency is responsible for compiling the situation and results of the activities of designated conformity assessment certification organizations, reporting to the Minister of Health, and informing the Standardization, Measurement and Quality Control Agency (Ministry of Science and Technology) for coordinated management.

Article 7. Responsibilities of designated conformity assessment organizations

In addition to the responsibilities stipulated in Articles 19 and 20 of the Law on Product Quality and Safety, the designated conformity assessment organization shall have the following responsibilities:

1. Timely report to the Food Safety Administration on the reduction of scope or suspension, revocation of certificates of conformity and the right to use the conformity mark.

2. Regularly every quarter or at any time upon request, the designated conformity assessment organization shall report to the Food Safety Administration the results of conformity assessment activities for products according to the form specified in Appendix 5 issued together with this Circular.

3. Report to the Food Safety Administration all changes affecting the capacity for conformity assessment activities in the registered fields within fifteen days (15) from the date of change.

Chapter IV

IMPLEMENTATION

Article 8. Effective Date

This Circular takes effect from May 23, 2013.

Article 9. Implementation Organization

1. The Ministry of Health assigns the Food Safety Administration to organize guidance and implementation of this Circular.

2. In cases where it is necessary to meet management requirements, the Food Safety Administration shall report to the Minister of Health for consideration and temporary designation of a conformity assessment organization that has not yet met the requirements stipulated in Article 3 of this Circular.

During the implementation process, if there are any difficulties, agencies and organizations shall promptly reflect them to the Ministry of Health (Food Safety Administration) for consideration and resolution./.