Circular No. 11/2013/TT-BYT guiding the designation of regulation conformity certification organizations for prepackaged processed foods; food additives; food processing aids; and packaging and utensils in direct contact with food

24 THE MINIST RY OF HEALTH Circular No. 11/2013/TT-BYT of April 8, 2013, guiding the designation of regulation conformity certification organizations for prep ackaged processed foods; food additives; food processing aids; and packagings and utensils in direct contact with foods Issue nos 11-12/April 2013 (Cong Bao nos 231-232/May 4, 2013) food processing aids; and packagings and utensils in direct contact with foods. Chapter I GENERAL PROVISIONS Article 1. Scope of regulation 1. This Circular guides the requirements, order and procedures for designation of regulation conformity certification organizations for prepackaged processed foods; food additives; Pursuant to the June 29, 2006 Law on food processing aids; and packagings and Standards and Technical Regulations, and the utensils in direct contact with foods subject to Government's Decree No. 12712007 IND-CP of relevant technical regulations (below refened August 1, 2007, detailing the implementation of to as products); responsibilities of receiving a number of articles of the Law on Standards and Technical Regulations; Pursuant to the November 21, 2007 Law on Product and Goods Quality, 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 June 17, 2010 Law on Food Safety, 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 on 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 the Head of the Food Safety Department; T he Minister of Health promulgates the Circular to guide the designation of regulation conformity certification organizations for prepackaged processed foods; food additives; agencies and designated regulation confo1mity certification organizations. 2. In case treaties, conventions and agreements on mutual recognition between Vietnam and countries and tenitories concerning the recognition of conformity assessment results by designated confo1mity assessment organizations have provisions different from those of this Circular, provisions of such treaties, conventions and agreements prevail. Article 2. Interpretation of te1ms In this Circular, the terms below are construed as follows: 1 . Designated regulation conformity certification organization is an organization meeting the requirements prescribed in Article 3 of this Circular and designated by the Ministry of Health to ce1tify products confo1mable with respective technical regulations in order to serve state management. 2. The recognition of regulation confo1mity certification results means acceptance by competent state agencies, organizations and © 'V;etnarn Law & Legal Forom Issue nos 11-12/April 2013 (Cong Bao nos 231-232/May 4, 2013) individuals operating in Vietnam of results of regulation conformity ce1tification perfo1med by confo1mity assessement organizations of other countiies or tenitories. Chapter II REQUIREMENTS, ORDER, PROCEDURES FOR REGISTRATION AND DESIGNATION OF REGULATION CONFORMITY CERTIFICATION ORGANIZATIONS Article 3. Requirements for a designated regu la t ion conformity ce r ti f ica t ion organization 1. Having been establised in accordance with law and having functions in the ce1tification area. 2. Having registered and been granted a certificate of registration of certification activities by the Directorate for Standards, Metrology and Quality of the Ministry of Science and Technology in accordance with the law on product and goods quality. 3. Having at least five state payroll assessment experts (public employees or employees under conti·acts of a te1m of at least 12 months or labor contracts of an indefinite te1m) and satisfying the following requirements: al Possessing a university or higher degree and having professional qualifications relevant to assessment and cerficiation fields, of whom at least three have at least three years' work experience; bl Possessing certificates of annual ti·aining courses on food safety organized by the Food Safety Depaitment. 25 4. Having sufficient technical materials and documents compliant with regulations applicable to to-be-certified products and a certification process relevant to applicable technical regulations. Article 4. Order and procedures for registration of designation of regulation confo1mity ce1tification organizations 1. When wishing to conduct regulation conformity certification for products, an organization meeting the requirements presclibed in Article 3 of this Circular shall compile a registration dossier and send 1 (one) set of dossier to the Food Safety Depa1tment of the Ministiy of Health. 2. The registi·ation dossier includes: al A witten request for designation of regulation conf 01mity ce1tification organization for products, made according to the form provided in Appendix 1 to this Circular; bl A copy of the establishment decision or the business registi·ation certificate; cl A ce1tificate of registi·ation of ce1tification field granted by the Directorate for Standards, Metro logy and Quality of the Ministiy of Science and Technology (a certified copy or a copy enclosed with the original for comparison); di A list of assessment experts made according to the provided fo1m in Appendix 2 to this Circular and their professional training ce1tificates; dd/ A ce1tificate fonn; el A list of technical materials, standards and technical regulations to products registered for designation, made according to the fo1m provided in Appendix 3 to this Circular. © Vietnam Law & Legal Fornm 26 Article 5. Designation, redesignation, temporaiy suspension or revocation of decisions on the designation of regulation conformity certification organizations 1. The Food Safety Department shall manage the receipt and processing of dossiers of registration for designation of regulation conformity certification organizations, designate, redesignate, temporarily suspend and revoke decisions to designate organizations to make regulation confonnity ce1ti:fication for products (below refe1Ted to as the receiving agency). 2. Within 30 working days after receiving a complete and valid dossier, the receiving agency shall examine the dossier and evaluate the real capability at site (if necessaiy) and issue a decision to designate a regulation confonnity certification organization, made according to the fonn provided in Appendix 4 to this Circular. In case of refusing the designation, the receiving agency shall notify in writing the the reason for refusal to the dossier-submitting organization. 3. Three months before the expiration of the decision on designation of a regulation conformity certification organization, the regulation conf 01mity ce1ti:fication organization shall cany out procedures for re-registration prescribed in Alticle 4 of this Circular if it needs to be fu1ther designated. 4. In the course of operation, the designating agency shall periodically and irregularly inspect and supervise the ce1ti:fication agency's activities. When the ce1ti:fication organization violates the law, the designating agency shall Issue nos 11-12/April 2013 (Cong Bao nos 231-232/May 4, 2013) issue a decision to temporarily suspend the certification organization's activities until the certification organization remedies its violations. Within three months from the date of being temporarily suspended, if the certification organization fails to remedy its violations, the designating agency shall issue a decision to revoke the granted designation decision. 5. Six months after the designation decision is revoked, the ce1ti:fication organization may re-register its operation if it so wishes. 6. Information on the designation, re­ designation, temporary suspension and revocation of decisions on the designation of regulation confonnity ce1tification organizations must be updated on the website of the Food Safety Department. Chapter III RESPONSIBILITIES OF THE RECEIVING AGENCY AND DESIGNATED REGULATION CONFORMITY CERTIFICATION ORGANIZATIONS Article 6. Responsibilities of the receiving agency 1. To receive and process dossiers of registration for designation of regulation conformity certification organizations, designate, redesignate, temporarily suspend and revoke decisions to designate regulation confo1mity ce1tification organizations. 2. To notify organizations and individuals of the list of designated regulation confonnity certification organizations on its website within 3 (three) days from the date of signing designation decisions. © 'V;etnarn Law & Legal Forom Issue nos 11-12/April 2013 (Cong Bao nos 231-232/May 4, 2013) 3. To manage, inspect and assess activities of designated regulation conformity certification organizations. To apply the methods prescribed in Clauses 4 and 5 of this Circular when a regulation conf 01mity certification organization violates the provisions of this Circular or Article 20 of the Law on Product and Goods Quality. 4. To publicize the names of regulation conformity certification organizations designated, redesignated, temporarily suspended, or having their designation decisions revoked on its website and report to the Directorate for Standar·ds, Metro logy and Quality (the Ministry of Science and Technology) for coordinated management. 5. To review the situation and results of activities of designated regulation conformity certification organizations on a quarterly basis or at requests and report them to the Minister of Health and notify them to the Directorate for Standards, Metrology and Quality (the Ministry of Science and Technology) for coordinated management. Article 7. Responsibilities of designated regula t ion conformity cer ti fica t ion organizations Apart from the responsibilities prescribed in Articles 19 and 20 of the Law on Product and Goods Quality, designated regulation confonnity certification organizations shall: 1. Promptly report to the Food Safety Department on the naITowing of the scope or temporary suspension or revocation of their conformity certificates and the right to use regulation conformity seals. 27 2. Make quarterly or iITegular reports when requested, to the Food Safety Department on results of their regulation conformity certification activities for products, according to the form provided in Appendix 5 to this Circular. 3. Report all changes affecting their regulation conformity certification capacity in the registered fields to the Food Security Department within fifteen (15) days after such changes occur. Chapter IV ORGANIZATION OF IMPLEMENTATION Article 8. Effect This Circular takes effect on May 23, 2013. Article 9. Organization of implementation 1. The Ministry of Health assigns the Food Safety Department to guide and implement this Circular. 2. In necessary cases to meet the state management requirements, the Food Safety Department shall report to the Minister ofHealth for consideration and temporary designation of regulation conformity certification organizations that are not up to the requirements prescribed in Article 3 of this Circular. Any problems arising in the course of implementation should be promptly reported to the Ministry of Health (the Food Safety Department) for consideration and settlement. For the Minister of Health Deputy Minister NGUYEN THANH LONG © Vietnam Law & Legal Fornm