Circular No. 11/2013/TT-BYT dated April 08, 2013 of the Ministry of Health guiding the appointment for conformity certification organization for packed and processed foods; addictives; processing support addictives; packaging materials and equipments for having direct contact with foods

 THE MINISTRY OF HEALTH

Circular No. 11/2013/TT-BYT dated April 08, 2013 of the Ministry of Health guiding the appointment for conformity certification organization for packed and processed foods; addictives; processing support addictives; packaging materials and equipments for having direct contact with foods

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006 and the Decree No. 127/2007/ND-CP of August 01, 2007, detailing the implementation of a number of articles of the Law on Standards and Technical Regulations;

Pursuant to the Law on product and goods quality dated November 21, 2007 and the Decree No. 132/2008/ND-CP dated December 31, 2008 of the Government detailing the implementation of a number of articles of the Law on product and goods quality

Pursuant to the Law on food safety  dated June 17, 2010 and the Decree No. 38/2012/ND-CP dated April 25, 2012 of the Government detailing the implementation of a number of articles of the Law on food safety;

Pursuant to Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health

At the proposal of Director of Food Safety Bureau;

The Minister of Health issues the Circular guiding the appointment for conformity certification organization for packed and processed foods; addictives; processing support addictives; packaging materials and equipments for having direct contact with foods.

Chapter 1

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Circular guides on requirement, order, procedures for appointment of the regulation conformity certification organizations for packed and processed foods; additives; food processing supports; packaging materials, tools in direct contact with foods which have respective technical regulations (hereinafter called products); responsibilities of the receiver and appointed regulation conformity certification organizations.

2. In case international treaties, conventions, agreements on mutual recognition between Vietnam and countries, areas, territories relating to recognition of conformity assessment results by the appointed conformity assessment organizations otherwise provides, such international treaties, conventions, agreements will prevail.

Article 2. Term interpretations

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

1. Conformity certification organization are organizations that meets requirements specified in Article 3 of this Circular and is appointed by the Ministry of Health in order to perform certification for products in conformity with respective technical regulations in service of state management requirement.

2. Recognition of regulation conformity certification result means acceptance of competent state agency, organization, individual operating in Vietnam, with respect to the regulation conformity certification result which is performed by a organization of conformity assessment of other country or territory.

Chapter 2

REQUIREMENTS, ORDER, PROCEDURES FOR REGISTRATING AND APPOINTING THE CONFORMITY CERTIFICATION ORGANIZATIONS

Article 3. Requirements for the appointed conformity certification organizations

1. They are established as prescribed by law, with activity function in the certification field.

2. They have registered and granted certificate of registration for certification operation by The Directorate for Standards, Metrology and Quality – The Ministry of Science and Technology as prescribed by law on product and goods quality.

3. Assessment experts:

There must have at least 05 assessment experts in official payroll (public employees or laborers who have signed contract with term of 12 months or more or non-term contract) satisfying requirements as follows:

a/ Graduated from university or higher, specialized in conformity with the assessment and certification, of which at least 03 experts with working experience from 03 years or more;

b/ Possessing certificates of annual training courses on food safety organized by the Food Safety Bureau.

4. Having sufficient technical documents, documents in conformity with regulations compulsorily apply to respective products and certification process in conformity with the respective technical regulations.

Article 4. Order, procedures for registration and appointment of the conformity certification organizations

1. When organizations meeting requirements specified in Article 3 of this Circular wish to participate in conformity certification activities for products, they may make registration dossiers and send 01 (one) set of dossier to the Food Safety Bureau, the Ministry of Health.

2. A registration dossier includes:

a/ Application for appointing the conformity certification organization for products according to form specified in Annex 1 issued with this Circular;

b/ The establishment decision of Business Registration Certificate (copy);

c/ Registration certificate for operation issued by Directorate for Standards, Metrology and Quality, the Minister of Science and Technology (certified copy or copy enclosed with original for comparison).

d/ List of assessment experts according to form specified in Annex 2 issued together with this Circular and enclosed with certificates of training in professional skills and operations;

dd/ Certificate forms;

e/ List of technical documents, standards and technical regulations with respective to products registered for appointment according to form specified in Annex 3 issued with this Circular.

Article 5. Appointment, reappointment, temporary suspension, withdrawal of appointment decision for the conformity certification organizations

1. The Food Safety Bureau shall manage receipt, handling of registration dossiers for appointing conformity certification organizations, appointment, reappointment, temporary suspension, withdrawal of appointment decision for the conformity certification organizations for products (hereinafter called the receiver).

2. Within 30 working days, after receiving a full and valid dossier, the receiver shall consider dossier, perform assessment on actual capability at facility (if necessary) and issue a appointment decision for the conformity certification organizations according to the form specified in Annex 4 issued with this Circular.  The effective time limit of decision on appointment does not exceed three (03) year.

In case of refusal, it should have a written notice on the reason thereof to applicants.

3. Within three months before the appointment decision for the conformity certification organizations is expired, if has demand, the regulation conformity certification organization must perform procedures for re-registration as prescribed in Article 4 of this Circular.

4. During operation, the appointing agency shall periodically and irregularly inspect, supervise activities of the certification organizations.   When a certification organization violates law, the appointing agency shall issue decision on temporarily suspending activities of the certification organization until these certification organization remedies violations. Within three months, after being temporarily suspended, if the certification organization fails to remedy the detected violation, the appointing agency shall issue decision on withdrawal of the issued appointment decision.

5. A certification organization which has been withdrawn the appointment decision, past six months, may be entitled to register for re-operation if it has demand.

6. Information of appointment, re-appointment, temporary suspension, withdrawal of appointment decision for the conformity certification organizations shall be updated in the website of the Food Safety Bureau.

Chapter 3

RESPONSIBILITIES OF THE RECEIVER AND THE APPOINTED CONFORMITY CERTIFICATION ORGANIZATIONS

Article 6. Responsibilities of the receiver

1. Receiving, handling the registration dossiers of appointment of the regulation conformity certification organizations, appointment, reappointment, temporary suspension, withdrawal of decision on appointment of the regulation conformity certification organizations.

2. Notifying list of the appointed regulation conformity certification organizations in the website of agency 03 (three) days after signing the appointment decision for information.

3. Managing, checking and assigning activities of regulation conformity certification which are performed by the appointed regulation conformity certification organizations Applying measures specified in clause 4 and clause 5 Article 5 of this Circular when the regulation conformity certification organizations violating provisions of this Circular or Article 20 of Law on product and goods quality.

4. Notifying name of the regulation conformity certification organizations which are appointed, re-appointed, and temporarily-suspended and revoked for appointment decision in the website of the Food Safety Bureau, and notifying Directorate for Standards, Metrology and Quality (the Ministry of science and technology) for coordination in management. 

5. Quarterly, irregularly, as requested, the receiver shall summarize situations, operation results of the appointed regulation conformity certification organizations, report them to the Minister of Health and notify to Directorate for Standards, Metrology and Quality (the Ministry of science and technology) for coordination in management. 

Article 7. Responsibilities of the appointed regulation conformity certification organizations

Apart from responsibilities as prescribed in Article 19 and Article 20 of the Law on product and goods quality, the appointed conformity certification organizations shall:

1. Timely report to the Food Safety Bureau for narrowing scope or temporary suspension, withdrawal of the conformity certificates and the use right of regulation conformity seal.  

2. Quarterly or irregularly as requested, the appointed regulation conformity certification organizations shall report result of regulation conformity certification activities for product according to form specified in Annex 5 issued with this Circular to the Food Safety Bureau.

3. Report all changes affecting capability of registered conformity certification activities to the Food Safety Bureau, within fifteen (15) days, after change arises.

Chapter 4

IMPLEMENTATION ORGANIZATION

Article 8. Effect

This Circular takes effect on May 20, 2013.

Article 9. Implementation organization

1. The Ministry of Health shall assign the Food Safety Bureau in organizing the guidance and implementing this Circular.

2. In the necessary case to meet the state management requirements, the Food Safety Bureau shall report to the Minister of Health for consideration and temporary appointment for regulation conformity certification organizations that have not yet met requirement as prescribed in Article 3 of this Circular.

Any arising problems in the course of implementation should be reported promptly to the Ministry of Health (the Food Safety Bureau) for consideration and settlement.

For the Ministry of Health

Deputy Minister

Nguyen Thanh Long

* All appendices are not translated herein.