Regulation for Approving Reliability of Certification.Assurance Agency for Labels, Advertisements of Foods and Livestock Products

Regulation for Approving Reliability of Certification.Assurance Agency for Labels, Advertisements of Foods and Livestock Products Ministry of Food and Drug Safety October 2016 Note to reader : If there should be any differences between the original Korean texts and English translation, the original Korean texts shall prevail. Regulation for Approving Reliability of Certification.Assurance Agency for Labels, Advertisements of Foods and Livestock Products Article 1 (Purpose) The purpose of this announcement is to promote the efficiency of labeling and advertisements tasks by prescribing matters necessary for the approval of reliability of labels and advertisements by Certification․Assurance Agency for the permission of labels and advertisements certified and assurance regarding the food defined in Article 13 (2) of the Food Sanitation Act and Article 8 (1) 6 (d) of the Enforcement Rule of the same Act and livestock products defined in Article 32 (2) of the Livestock Products Sanitary Control Act and Article 52 (1) 8 (d) of the same Act. Article 2 (Categories of Labels and Advertisements Certified and Assuranced) The labels and advertisements certified and assuranced are regarding the food defined in the Food Sanitation Act and livestock products defined in the Livestock Products Sanitary Control Act, and are classified into hazard analysis and critical control point (HACCP), ISO 22000, Halal, Kosher, good manufacturing practice (GMP) and Vegan. Article 3 (Establishment and Function of Deliberation Committee) The Chief of the Minister of Food and Drug Safety (hereinafter referred to as the “Minister”) shall establish a Deliberation Committee of labels and advertisements certifying and assurancing agencies for food and livestock products (hereinafter referred to as the “Committee”) under the control of the Minister to deliberate on each of the following; 1. Reliability of agencies or organizations prescribed to fall under each subparagraph of Article 7 (1) 2. Reliability and actual results in the certification and assurance of a Certification․Assurance Agency that has applied for approval pursuant to Article 7 3. Other matters regarding the approval of reliability of a Certification․Assurance Agency Article 4 (Organization of Committee) (1) The Minister shall compose a Committee of at least five deliberative members for each category of labels and advertisements certified and assuranced upon each application for approval. (2) The deliberative member as referred to in paragraph (1) shall be commissioned by the Minister from among persons falling under any of the following subparagraphs: 1. Those who work in relevant government agency and government-funded agencies. 2. Those who are affiliated with relevant industry, academia, or research organizations. (3) The chairperson shall be elected by the Committee from among its deliberative members, and shall represent the Committee and manage all business affairs of the Committee such as presiding over a meeting, etc. Article 5 (Hearing of Opinions of the Interested Persons) The Minister can have a person who is not included in the Committee participate in a meeting, when the person of interest is acknowledged to be needed in the discussion of the matters in question. Article 6 (Operation of the Committee) (1) In order to process affairs of the Committee, the Chairperson shall have one assistant administrator who is the section head in charge of labeling and advertisements. (2) The Minister shall convoke the Committee when he/she deems that the application is suitable after the examination of materials submitted pursuant to Article 7. (3) The decisions of the Committee shall be made by a majority vote of the members present. (4) Where a committee member attends a deliberation, he/she shall submit the secrecy declaration in Form 1 to the Minister. In such case, if a committee member violates the secrecy declaration, only the resolution in which the committee member participated shall be invalid. (5) Should there occur a change in the results of deliberation, such as lack of quorum, deliberation shall be held on the same affair again as prescribed in the latter part of paragraph (4). In such case, the deliberation process shall be in compliance with the said regulation. (6) The Minister may pay allowances and travel expenses to the members present at the deliberation of the Committee within budgetary limits. (7) The expenses necessary for the operation, etc. of the Committee can be spent within the range of the budget. (8) Matters necessary for the operation of the Committee, other than those prescribed by this Act, shall be prescribed by the chairperson. Article 7 (Application for Approval) (1) An agency which desires to obtain approval for its reliability as a labels and advertisements Certification․Assurance Agency for food and livestock products shall fall under any of the following subparagraphs, and the head of the agency concerned shall fill an application form in Form 2 and submit the application form to the Minister. 1. A foreign government 2. A Certification․Assurance Agency directly managed and supervised by a foreign government 3. A private Certification․Assurance Agency designated by a Certification․Assurance Agency or an association, etc. 4. A private Certification․Assurance Agency equal to an agency as in subparagraphs 1 through 3 (2) An application pursuant to paragraph (1) shall be attached with documents falling under each of the following subparagraphs and be submitted to the Ministry of Food and Drug Safety. 1. Documents that prove the application’s conformity to any of the subparagraphs 1 through 3 of paragraph (1) 2. In cases falling under subparagraph 3 of Article 7 (1), documents regarding designation procedures, designation methods, management methods, etc. of a Certification․Assurance Agency or an association concerned 3. In cases falling under subparagraph 3 of Article 7 (1), a comparative table on human resources and operation standards at the time of the application to be designated as a Certification․Assurance Agency and the designation thereof in relation to performing affairs of certification and assurance 4. In cases falling under subparagraph 4 of Article 7 (1), performance achievements in affairs of certification and assurance for the two recent years as of the application date under paragraph (1) 5. In cases falling under subparagraph 4 of Article 7 (1), human resources and operation standards in relation to performing affairs of certification and assurance as specified in attached Table 1 (3) In cases falling under subparagraph 2 of Article 7 (1), a foreign government that directly manages and supervises the agency concerned, may submit an application form and required documents pursuant to paragraphs (1) and (2). (4) In cases falling under subparagraph 3 of Article 7 (1), a concerned agency or association, etc. may submit an application form and required documents pursuant to paragraphs (1) and (2). Article 8 (Examination of Applications) (1) Upon receipt of an application for approval as a labels and advertisements Certification․Assurance Agency for food and livestock products under Article 7, the Minister shall examine the application form and submitted documents on the format and omission and may, if any supplement is necessary, set a submission deadline and require the applying agency to supplement their application documents. (2) The Minister may, if he/she deems it necessary, conduct an on-site inspection for the applying agency in the examination of documents pursuant to paragraph (1). In such cases, a deliberative member may participate in the on-site inspection. (3) The Minister shall request deliberation by the Committee with the attached results of document examination and on-site inspection pursuant to paragraphs (1) and (2). (4) The Committee shall deliberate on matters in each subparagraph of Article 3 and shall, according to the deliberation results, fill in a report on the results of deliberation in Form 3 and submit the report to the Minister. (5) An agency falling under subparagraphs 1 and 2 of Article 7 (1) may be approved for its reliability by the Minister without going through the deliberation of the Committee. Provided that the same does not apply in cases where the country concerned does not approve the Certification․Assurance Agency accredited by the Republic of Korea. (6) Where the result of deliberation by the Committee is “supplement,” the Minister may set a submission deadline and require the applicant to supplement his/her application documents, and, if necessary, require re-deliberation by the Deliberative Board for the supplementary materials newly submitted. (7) Where the result of deliberation by the Committee is “unsuitable,” or the applying agency has not submitted supplementary materials within the submission deadline for matters that require supplementation pursuant to paragraph (6), the Minister shall inform the applicant that approval is impossible. Article 9 (Approval and Announcement) (1) Where the Minister deems it proper according to the results of deliberation by the Committee or under Article 8 (5), he/she shall issue a certificate of reliability to a labels and advertisements Certification․Assurance Agency for food and livestock products in Form 4. (2) Where the Minister approves the reliability of a labels and advertisements Certification․Assurance Agency for food and livestock products, he/she shall post an announcement that includes the matters provided in the following subparagraph on the website of the Ministry of Food and Drug Safety. 1. Approval number 2. Date of approval 3. Name of the Certification․Assurance Agency, representative, corporate registration number, and the place of facility 4. Categories of labels and advertisements that are certified and assuranced (3) Where there is a change to the qualifications of an agency that has been approved by the Minister for its reliability as a labels and advertisements Certification․Assurance Agency at the time of its application, the head of the agency shall immediately report it to the Minister. Provided that in cases falling under paragraphs (3) and (4) of Article 7, a foreign government that directly manages and supervises the agency concerned or a private agency or association that has designated the agency concerned may report changed matters. (4) Where the Minister receives a report on any changed matter pursuant to paragraph (3), he/she shall examine the report and decide on whether to continue to approve the reliability of the labels and advertisements Certification․Assurance Agency concerned. In such cases, the Minister shall give a notice regarding the facts decided to the head of the Certification․Assurance Agency and post an announcement that includes changed matters on the Ministry’s website. (5) Where an agency does not observe the duty to report any change pursuant to paragraph (3), the Minister may withdraw the approval of reliability of the Certification․Assurance Agency concerned. Article 10 (Time Limit for Reexamination) The Minister shall review the validity every three years from Jan. 1, 2016 in accordance with the “Regulation on the Issuance and Management of Instructions, Regulations, etc.” (Presidential Instruction No. 334) and take measures, such as improvement, etc. Supplementary Provision <No. 2016-119, 2016.10.27.> Article 1 (Enforcement Date) This Rule shall enter into force on January 1, 2017. Article 2 (Preparation Actions for Enforcement) Notwithstanding Article 1, an agency that falls under any of the subparagraphs of Article 7 (1) and desires to obtain approval for its reliability as a labeling and advertisements Certification․Assurance Agency for food and livestock products according to this announcement may apply to the Minister for approval pursuant to the revised Article 7 before this announcement enters into force. (2) The Minister who received an application for approval pursuant to Article 7 (1) may establish a Deliberation Committee pursuant to the revised Article 4, and examine the application pursuant to the revised Article 8, and give a notice regarding the examination results to the applying agency before this announcement enters into force. [Annex 1] Certification․Assurance Agency Operational Standards (related to Article 7) 1. General Matters A. The head of the Certification․Assurance Agency shall establish policies and procedures for certification․assurance tasks in order to secure the fairness of certification․assurance tasks. B. The head of the Certification․Assurance Agency and the personnel that conduct certification․assurance tasks shall have no economic interest with regard to clients and corresponding companies. C. The personnel that conduct certification․assurance tasks cannot conduct the corresponding tasks in the following cases: 1) When the personnel that conduct certification․assurance tasks might affect the tasks due to personal connections, such as blood relationships, or economic interests with the clients and the people concerned. 2) When the personnel that conduct certification․assurance tasks have conducted consultations regarding certification․assurance tasks. 3) When the personnel that conduct certification․assurance tasks worked at a client’s company within the previous 24 months. 2. Securing Resources A. The head of the Certification․Assurance Agency shall secure the personnel required for conducting certification․assurance tasks. B. The head of the Certification․Assurance Agency shall establish and implement plans to provide education and training for the personnel that conduct certification․assurance tasks so that they can acquire professional knowledge and skills related to certification․assurance tasks. C. The head of the Certification․Assurance Agency shall maintain and manage up-to-date records on the competency, educational training, experience, appointment, and dismissal, etc. of the personnel that conduct certification․assurance tasks. D. The head of the Certification․Assurance Agency shall designate the categories of certification․assurance tasks in accordance with the knowledge, experience, etc. of the personnel that conduct certification․assurance tasks. 3. Procedure for Certification․Assurance tasks A. Certification․Assurance The Certification․Assurance Agency shall include the matters in the following paragraphs regarding certification․assurance tasks: 1) The head of the Certification․Assurance Agency shall have a staff appropriate for conducting certification․assurance tasks upon the request regarding certification․assurance. 2) After reviewing the related data, etc, the head of the Certification․Assurance Agency might request the client to submit supplementary data if they are not found to be sufficient and can reject the application form when the client does not supplement the data. B. Record Maintenance 1) The head of the Certification․Assurance Agency shall have policies and procedures for managing the data, etc. related to certification․assurance. 2) The head of the Certification․Assurance Agency shall submit the documents related to certification․assurance upon the request of the Minister of Food and Drug Safety. C. Secrecy Maintenance 1) The head of the Certification․Assurance Agency, the personnel that conduct certification․assurance tasks, or any person that has held that position shall not disclose the information they acquired during their position to others or use that information for other purposes. 2) The head of the Certification․Assurance Agency shall establish written policies and procedures in order to maintain the secrets of data related to certification․assurance submitted by clients. [Form 1] Secrecy Declaration I hereby vow that I will respect the following matters in reviewing the examination results for the approval of reliability of the labels and advertisements Certification․Assurance Agency concerned for the permission of labels and advertisements certified and assuranced on food and livestock products. 1. I shall respect the related regulations, conduct fair tasks, and maintain dignity as a deliberative member. 2. I shall maintain independence from any commercial relations of interest with a Certification․Assurance Agency subject to the examination for approval or other suppressions. 3. I shall not disclose the information acquired in the process of work without the consent of the interest parties and the Minister of Food and Drug Safety. Date: / / Affiliation Name: (seal) To the Minister of Food and Drug Safety 210㎜×297㎜ [common paper 60g/㎡(recyclable materials)] [Form 2] Application for Approval of Certification․Assurance Agency for a Labels and Advertisements of Food and Livestock Products Processing Period 90 days Category of Certification and assurance Applying agency Name of agency Corporation registration number Representative Date of birth Place Phone number Qualifications (in relation to Article 7 (1) ) □ subparagraph 1, □ subparagraph 2, □ subparagraph 3, □ subparagraph 4 Applicable Act for Establishment Establishment Date (year/month/day) I apply for the approval of reliability of Certification․Assurance Agency for labels and advertisements of food and livestock products pursuant to Article 13 (2) of the Food Sanitation Act and Article 8 (1) 6 (d) of the Enforcement Rule of the same Act, along with Article 32 (2) of the Livestock Products Sanitation Control Act and Article 52 (1) 8 (d) of the Enforcement Rule of the same Act. Date: / / Applicant (seal or sign) To the Minister of Food and Drug Safety Required Documents 1. In cases falling under subparagraph 1 through 3 of Article 7(1), documents that prove the fact 2. In cases falling under subparagraph 3 of Article 7 (1), documents regarding designation procedures, designation methods, management methods, etc. of the private Certification․Assurance Agency or organization concerned 3. In cases falling under subparagraph 3 of Article 7 (1), a comparative table on human resources and operation standards at the time of the application to be designated as a Certification․Assurance Agency and the designation thereof in relation to performing affairs of certification and assurance 4. In cases falling under subparagraph 4 of Article 7 (1), performance achievements in affairs of certification and assurance for the two recent years as of the application date under paragraph (1) 5. In cases falling under subparagraph 4 of Article 7 (1), human resources and operation standards in relation to performing affairs of certification and assurance as specified in attached Table 1 210㎜×297㎜[common paper 60g/㎡(recyclable materials)] [Form 3] Report on the Deliberation Results Agenda Items for Deliberation: □ Approval of the reliability of a labels and advertisements Certification․Assurance Agency □ A change to the reliability of a labels and advertisements Certification․Assurance Agency □ Others ( ) Name of applying agency: Category of approval and assurance: Deliberation Results: With respect to the agenda items for deliberation, I report the results of deliberation as above. Date: / / Chairperson: (Signature) 210㎜×297㎜[common paper 60g/㎡(recyclable materials)] [Form 4] (front) Certificate of Reliability of Certification․Assurance Agency for Labels and Advertisements of Food and Livestock Products Name of Agency: Representative: Place: Corporation Registration Number: Category of Certification and assurance: I approve the reliability of the labels and advertisements Certification․Assurance Agency concerned for the permission of labels and advertisements certified and assuranced on food and livestock products pursuant to Article 13 (2) of the Food Sanitation Act and Article 8 (1) 6 (d) of the Enforcement Rule of the same Act, along with Article 32 (2) of the Livestock Products Sanitation Control Act and Article 52 (1) 8 (d) of the Enforcement Rule of the same Act. Date: / / Minister of Food and Drug Safety official seal 210㎜×297㎜[common paper 60g/㎡(recyclable materials)] (back) Changed Matters Date Contents