Circular No. 45/2012/TT-BCT providing in ­process inspection of food quality and safety under the state management of the Ministry of Industry and Trade

30 Issue nos 07-08/Januarv 2013 (Cong Bao nos 29-30/January 19, 2013) C ircular No. 45/2012/TT-BCT of December 28, 2012, providing in­ process inspection of food quality and safety under the state management of the Ministry of Industry and Trade Pursuant to the Government's Decre e No. 95/2012/ND-CP of November 12, 2012, defining the functions, tasks, powers and organizational structure of the Ministry of Industry and Trade; Pursuant to June 17, 2010LawNo. 55/2010/ Issue nos 07-08/Januarv 2013 (Cong Bao nos 29-30/January 19, 2013) QHl 2 on Food Safety and the Government's Decree No. 38/2012/ND-CP of April 25, 2012, detailing a number of articles of the Law on Food Safety; Pursuant to November 21, 2007 Law No. 05/2007/QH12 on Product and Goods Quality and the Government's Decree No. 132/2008/ ND-CP of December 31, 2008, detailing a number of articles of the Law on Product and Goods Quality; Pursuant to the Government's Decree No. 94/2012/ND-CP of November 12, 2012, on liquor production and trading; The Minister of Industry and Trade issues the Circular providing in-process inspection of food quality and safety under the state management of the Ministry of Industry and Trade as follows: Chapter I GENERAL PROVISIONS Article l. Scope of regulation This Circular provides the principles, order and procedures for in-process inspection of food quality and safety under the state management of the Ministry of Industry and Trade, including: 1. Beer-liquor-soft drink; 2. Processed milk; 3. Vegetable oil; 4. Processed flour and starch products; 5. Confectionery and jam; 6. Packages and containers of the products 31 specified at Points 1, 2, 3, 4 and 5 of this Alticle. A r ticle 2. Subjects of application This Circular applies to: 1. Organizations and individuals producing food products specified in Article 1 of this Circular and h aving registered relevant production and business lines in accordance with Vietnam's law. 2. Other related agencies, organizations and individuals. Article 3. Interpretation of terms In this Circular, the terms below are constmed as follows: 1. Food production establishment (below referred to as production establishment) means an establishment wh ich conducts one, some or all of the following activities: preliminarily processing, processing, packaging and preservation to tum out food products. 2. Food quality and safety inspection means the inspection of the observance of CUITent laws on assurance of food quality and safety in the production process. 3. Food testing means the implementation of one or some activities of testing and assessing conformity with relevant standards or technical regulations by food, food additives, food processing aids, substances to be added to food, and food packages, containers and packaging materials. 4. Lot of food products means a definite quantity of products of the same name, quality, 32 materials and use duration which are produced at one establishment. Article 4. Inspection principles Food quality and safety inspection must comply with the following principles: 1. Keeping confidential information, documents and inspection results of inspection agencies and production establishments prior to official conclusion. 2. Taking responsibility before law for inspection results and related conclusions. 3. Assuring clear task assignment and decentralization and effective coordination; not causing harassments or troubles which affect operations of inspected production establishments. 4. Assming objectivity, accuracy, publicity, transparency and non-disclimination; members of inspection teams must not have any relations involving direct or indirect economic interests with inspected production establishments. Chapter II ORDER AND PROCEDURES FOR IN­ PROCESS INSPECTION OF FOOD QUALITYAND SAFETY Article 5. Regular inspection 1. Based on the practical situation and requirements for food quality and safety inspection for each production establishment, inspection agencies shall elaborate annual food quality and safety inspection plans (below referred to as plans) and estimate Issue nos 07-08/Januarv 2013 (Cong Bao nos 29-30/January 19, 2013) funds for implementation of such plans before November 1 every year for submission to competent autholities for approval. Inspection plans must clearly identify to-be-inspected products, number of to-be-inspected production establishments and inspection contents. 2. Frequency of inspection: No more than one inspection per year for each production establishment. 3. Inspection agencies shall notify inspection plans to production establishments at least fifteen (15) days before the date of inspection. Article 6. Inegular inspection 1. Inspection agencies shall conduct inegular inspection in one of the following cases: a/ Products in circulation fail to meet food quality and safety requirements or violate or are unconfo1mable with announced applicable standards or relevant technical regulations. b/ There are warnings about food quality and safety from domestic or international organizations. c/ Such inspection is requested by competent state management agencies in charge of food quality and safety. 2. Inspection agencies are not required to notify in advance production establishments of the inspection. Article 7. Inspection contents A food quality and safety inspection covers: 1. Examination of dossiers related to a food Issue nos 07-08/Januarv 2013 (Cong Bao nos 29-30/January 19, 2013) product and its production process. 2. Examination of the compliance with food quality and safety requirements in the production process at the production establishment. Article 8. Grounds for food quality and safety inspection 1. Relevant standards, national technical regulations and in-house standards announced for application to food products under the management of the Ministiy of Industry and Trade. 2. Cunent laws on food quality and safety in the production process. 3. Clment laws on goods labeling. Article 9. Examination of dossiers related to food and food production processes 1. Certificate of registration of relevant business lines in accordance with Vietnam's law. 2. Certificate of establishment's eligibility for food safety. 3. Liquor production license, for liquor production establishments. 4. Receipt of the regulation conformity statement or written ce1tification of announcement of confonnity with food safety regulations or ce1tificate of product standards. 5. Regulation conformity statement or product information sheet and control sample. 33 6. Product testing results released within 12 months by an accredited or a Minister of Industiy and Trade-designated laboratory. 7. Water quality testing slip. 8. Sample storage dossier for each lot of food products produced at the establishment. 9. Sale and purchase contracts, invoices and documents related to food materials, food additives, food processing aids and food preservatives. 10. Ce1tificates of food safety training of the establishment's owner and persons directly engaged in food production. 11. Health ce1tificates of the establishment's owner and persons directly engaged in food production or list of the establishment's employees directly engaged in production, issued by a district- or higher-level medial establishment according to regulations. 12. Contents of the product's label, which must be conf 01mable with those registered with competent agencies. 13. Ce1ti:ficate of confo1mity with HACCP or ISO 22000 or equivalent standard and food quality and safety management dossiers (if any), for establishments applying HACCP or ISO 22000 quality conti·ol systems. 14. Record of the latest inspection or examination conducted by a competent state agency (if any). Article 10. Inspection of a production establishment's cm-rent state 34 1. An inspection of a food production establishment's current state covers: a/ Physical foundations: Location and the environment; designs, strnctures and layouts of workshops; ventilation systems; lighting systems; water, steam and compressed air supply systems; waste and garbage treatment systems; restrooms and locker rooms; garbage collection and treatment systems; and wastewater drainage and treatment systems. b/ Food production and processing equipment and devices: Food production and processing equipment and devices; food-packaging equipment and devices; cleaning equipment and devices; control and measuring equipment; hand washing and sterilizing devices; sample storage and preservation; devices for preventing and controlling insects and hannful animals; use of detergent chemicals. c/ Persons directly engaged in food production and processing: Personal protective clothes; personal hygiene. d/ Preservation of food in production: Storehouses for preservation of food matedals, packages, food additives, food processing aids and food products; stands and shelves of matedals and finished products; temperan1re and humidity control equipment; and vehicles for canying materials and finished products. 2. Inspection results shall be made according to Appendix I to this Circular, not translated. 3. Tue sampling of food suspected to violate quality and safety requirements for testing complies with Appendix II to this Circular, not translated. Issue nos 07-08/Januarv 2013 (Cong Bao nos 29-30/January 19, 2013) Article 11. Handling of inspection results 1. Inspection teams shall make inspection records according to the fo1m provided in Appendix I to this Circular and notify inspection results to competent management agencies in charge of food quality and safety and inspected production establishments. 2. In case a food product does not satisfy food quality and safety requirements as prescribed, the inspection team shall require the production establishment to remedy the product's inconfonnities within the time limit stated in the inspection record. 3. In case a production establishment fails to remedy the inconfonnities stated in the record of the previous inspection, the inspection team shall notify such to the provincial-level Industiy and Trade Department of the locality in which the establishment is based and the competent food safety management agency for supe1vision and handling. 4. In case a production establishment again violates regulations on assurance of food safety in the production process or fails to remedy its violations as required in the inspection record, the inspection team shall propose in wdting the competent food safety management agency to handle the establishment in accordance with law. Article 12. Funds for inspection and testing 1. Funds for food quality and safety inspection of production establishments come from: Issue nos 07-08/Januarv 2013 (Cong Bao nos 29-30/January 19, 2013) a/ Annual state budget expenditures according to cunent law; b/ Other lawful funding sources. 2. Fm1ds for talcing and testing food samples complies withArticles 41 and 58 of the Law on Product and Goods Quality, Article 48 of the Law on Food Safety and other laws. Chapter III RESPONSIBILI TIES AND POWERS OF INSPECTION AGENCIES, INSPECTION TEAMS AND RELATED ORGANIZATIONS AND INDIVIDUALS Article 13. Responsibilities and powers of inspection agencies Food quality and safety inspection agencies have the following responsibilities and powers: 1. To elaborate annual plans on food quality and safety inspection for submission to competent agencies for approval. 2. To decide on the fo1mation of inspection teams to conduct planned regular inspection or inegular inspection. 3. To issue a handling decision within 3 working days after receiving an inspection team's report on suspension of production or business activities, sealing of food or suspension of advertising of unsafe food. 4. To handle violations detected through food quality and safety inspection according to Alticle 30 of the Law on Product and Goods Quality and related laws. 35 5. To notify production establishments of inspection results and relevant conclusions. 6. To settle complaints and denunciations about decisions of inspection teams or acts committed by inspection team members in accordance with the law on complaints and denunciations. Article 14. Responsibilities and powers of inspection teams When conducting food quality and safety inspection, an inspection team has the following responsibilities and powers: 1. To conduct food quality and safety inspection of production establishments in accordance with its fo1mation decision approved by a competent authority. 2. To comply with law and adhere to the inspection principles specified in Article 4 of this Circulai-. 3. To summa1ize and repo1t on food quality and safety inspection and inspection results to the provincial-level People's Committee, the Ministry of Industry and Trade and the competent food quality and safety management agency. 4. When necessary, to request the inspected production establishment to produce relevant documents. 5. To request the establishment producing food ineligible for food quality and safety to take remedies. 6 . To take samples for testing when necessa1y. 36 A1·ticle 15. Responsibilities and powers of production establishments 1. To coordinate with inspection teams and inspection agencies in the course of food quality and safety inspection at the establishments. 2. To open and manage books to monitor and fully record matters related to food quality and safety at the establishments. 3. To preserve at the establishments and provide documents, technological processes and equipment related to inspected products in accordance with Articles 9 and 10 of this Circular. Issue nos 07-08/Januarv 2013 (Cong Bao nos 29-30/January 19, 2013) 7. To remedy the inconfo1mities stated in inspection records as required by inspection agencies and inspection teams. 8. To complain about inspection teams' conclusions in accordance with law. Chapter IV IMPLEMENTATION PROVISIONS Article 16. Effect 1. This Circular takes effect on Februaiy 20, 2013. 2. The Ministry of Industry and Trade's Circulai· No. 47/2010/TT-BCT of December 4. To abide by food quality and safety 31, 2010, providing in-process inspection of inspection activities of inspection agencies food quality, hygiene and safety under the and violation handling decisions of competent management of the Ministiy of Indust1y and agencies. Trade, ceases to be effective on the effective 5. To repo1t on: a/ The remedy of the ineligibility for food quality and safety in the production process to food quality and safety inspection agencies and provincial-level Industry and Trade Depaitments of the localities in which they are based according to Appendix V to t h is Circulai·, not translated: b/ The obse1vance of the law on assurance of food quality and safety upon request of competent agencies according to Appendix VI to this Circular, not translated. 6. To maintain food quality and safety assurance conditions in accordance with law. date of this Circular. Article 17. Organization of implementation 1. The Light Indust1y Department of the Ministiy of Indust1y and Trade shall assume the prime responsibility for, and coordinate with related units in, inspecting production establishments referred to in Appendix VII to this Circular. 2. Provincial-level Indust1y and Trade Departments shall inspect production establishments other than those refe1Ted to in Appendix VII to this Circular in their localities and production establishments referred to in Clause 1 of this Circular as authorized by the Ministiy of Indust1y and Trade. Issue nos 07-08/Januat'V 2013 37 (Cong Bao nos 29-30/January 19, 2013) 3. The Light Industry Department consideration and amendment.­ and provincial-level Industry and Trade Departments shall receive and summarize repmts on problems arising in the course of implementation of this Circular for repmting to the Minister of Industry and Trade for For the Minister of Industry and Trade Deputy Minister NGUYEN NAM HAI Appendix VII LIST OF PRODUCTION ESTABLISHMENTS SUBJECT TO FOOD QUALITY AND SAFETY INSPECTION BY THE MINISTRY OF INDUSTRY AND TRADE (To the Minister of Industry and Trade's Circular No. 4512012/IT-BCT of December 28, 2012) No. Product Scope 1 2 3 4 5 6 7 8 Liquor Designed capacity of 3,000,000 liters of product/year or higher Beer Designed capacity of 50,000,000 liters of product/year or higher Soft drink Designed capacity of 20,000,000 liters of product/year or higher Processed milk Designed capacity of 20,000,000 liters of product/year or higher Vegetable oil Designed capacity of 50,000 tons of product/year or higher Confectione1y and Designed capacity of 20,000 tons of product/year or higher jam Processed flour and Designed capacity of 100,000 tons of product/year or higher starch products Packaging tools and packages and containers of above-mentioned products