Thông tư 11/2013/TT-BYT hướng dẫn chỉ định tổ chức chứng nhận hợp quy

• Số hiệu: 11/2013/TT-BYT
• Loại văn bản: Thông tư
• Nơi ban hành: Bộ Y tế
• Người ký: Nguyễn Thanh Long
• Ngày ban hành: 08/04/2013

THE MINISTRY OF HEALTH --------	SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------
No. 11/2013/TT-BYT	Hanoi, April 08, 2013

CIRCULAR

GUIDING ON APPOINTMENT OF THE REGULATION CONFORMITY CERTIFICATION ORGANIZATIONS FOR PACKED AND PROCESSED FOODS; FOOD ADDITIVES; FOOD PROCESSING SUPPORTS; PACKAGING MATERIALS, TOOLS IN DIRECT CONTACT WITH FOODS

Pursuant to the Law on Technical regulations and standards, of June 29, 2006 and the Government’s  Decree No. 127/2007/ND-CP, of August 01, 2007, detailing the implementation of a number of articles of the Law on Technical regulations and standards;

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

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

Pursuant to the Government’s Decree No. 63/2012/ND-CP, of August 31, 2012 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 promulgates the Circular guiding on appointment of the regulation conformity certification organizations for packed and processed foods; food additives; food processing supports; packaging materials, tools in direct contact with foods.

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GENERAL PROVISIONS

Article 1.- Scope of regulation

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

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

1. The appointed regulation conformity certification organization mean organization 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

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Article 3.- Requirements for the appointed regulation 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. Regarding assesment experts:

They 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) and satisfy the following requirements:

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/ Posessing 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 of, procedures for registration and appointment of the regulation conformity certification organizations

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2. A registration dossier includes:

a/ Application of appointment of regulation conformity certification organization for products according to form specified in Annex 1 promulgated together with this Circular;

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

c/ Certificate of registration for certification operation issued by Directorate for Standards, Metrology and Quality, the Minister of science and technology (authenticated copy or copy enclosed with original for comparison).

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

dd/ Form of certificate;

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

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

1. The Food Safety Bureau shall manage receipt, handling of 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 for products (hereinafter abbreviated to the receiver).

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

3. Within three months before the decision on appointment of regulation conformity certification organization 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 untill this 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 decision on appointment of the regulation conformity certification organizations shall be updated in the website of the Food Safety Bureau.

Chapter 3

DUTIES OF THE RECEIVER AND THE APPOINTED REGULATION CONFORMITY CERTIFICATION ORGANIZATIONS

Article 6.- Duties 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.

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3. Managing, checking and assessing 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, 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.- Duties of the appointed regulation conformity certification organizations

Apart from duties as prescribed in Article 19 and Article 20 of the Law on product and goods quality, the appointed regulation 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 promulgated together with this Circular to the Food Safety Bureau.

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

Chapter 4

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Article 8.- Effect

This Circular takes effect on May 23, 2013.

Article 9.- Implementation organization

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

2. In necessary case, in order to meet the state management requirement, 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.

In the course of implementation, any arising problems should be reported timely to the Ministry of Health (the Food Safety Bureau) for consideration and settlement.

FOR THE MINISTER OF HEALTH
DEPUTY MINISTER




Nguyen Thanh Long

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