Ministerial Regulation No. 518/MoH on the basic principles in the application of sanitary and technical measures for food safety management

1 Lao People’s Democratic Republic Peace Independence Democracy Unity Prosperity  Ministry of Health No. 518 /MoH Vientiane Capital, date 18 March 2009 MINISTERIAL REGULATION ON THE BASIC PRINCIPLES IN THE APPLICATION OF SANITARY AND TECHNICAL MEASURES FOR THE FOOD SAFETY MANAGEMENT Pursuant to the Food Law No. 04/NA, dated 15 May 2004 Pursuant to the Prime Minister Decree on the Structure and Activities of Ministry of Public Health, No. 114/PM, dated 4 July 2008 Pursuant to the Proposal of Food and Drugs Department The Minister of Public Health issued the Regulation as follows: Chapter I General Provisions Article 1: Objective This Ministerial Regulation stipulates the basic principles and methodologies for the application of Sanitary and Technical Measures to conduct management, inspection and monitoring of food activities and business aiming to promote and ensure the food quality, standard and safety in order to protect consumers’ health and life, facilitate fair practices and food trade; additionally, to promote the development and growth of food businesses; and to comply with the requirements of international economic integration framework. Article 2: Scope of Application This Ministerial Regulation is applied to any sanitary and technical measure to protect human health and life of food businesses. Article 3: Interpretation of Terms Basic Principles: refers to the basic principles which are specified in Article 4 of this Ministerial Regulation and derived from the Agreement of Application of Sanitary and Phytosanitary Measures of the World Trade Organization. Measure: refers to legal documents stipulating the principles, rules and standards including sanitary and technical measures which are applied in management and inspection 2 of the production, processing, import-export of products, service, transportation and distribution of food. Sanitary Measure: refers to any measure which is applied to protect human health or life from risks that may occur from food additives, contaminants, poisons or diseases that cause food illness or other adverse health effects. Technical Measure: refers to any technical measure which is applied in management and inspection of the production, processing, import, packaging and food labeling, including control, inspection and the procedures to certify and distribute food in Lao PDR. Creation of unnecessary barriers to food business: refers to the application of any measure intended to protect consumer health and life which deviate from basic scientific principles and international standards and create unnecessary barriers to food businesses and trade. Risk Assessment: refers to the assessment to the potential of adverse effect on human health or life arising from consuming or using a specific food product within the certain time period. Food Business: refers to the business of food processing, food production, food service, food import-export, food storage, food transportation and food distribution. Food Production Business: refers to industrial food and home-made production, including household production for domestic use in Lao PDR or export to foreign countries Food Service: refers to food service in restaurants or other places to eat (Article 20 of the Food Law). Integrated Food Chain Approach: refers to any approach to control the safety of food throughout the food chain from farm to table and which engages all relevant stakeholders. Chapter II The Basic Principles in the Application of Sanitary and Technical Measures Article 4: Basic Principles The application of sanitary and technical measures for this administration in relation to food safety shall follow these principles: 1) Necessity to protect consumer health; 2) Standards determined in Lao PDR; 3) Ensure transparency; and 4) Non- discrimination Article 5: Necessity to protect consumer health 3 The protection of consumer health or life shall be ensured by the sanitation and safety of food as stipulated in Article 14 and 15 of the Food Law while avoiding unnecessary barriers to food business activities or without in adherence to scientific principles. Article 6: Food standards in Lao PDR Foods which are produced, imported and distributed in Lao PDR shall comply with the food standards of Lao PDR, based on the Codex Alimentarius standards, guidelines and recommendations. In the case that the standards of Lao PDR are higher than Codex Alimentarius standards, guidelines and recommendations or where Codex standard do not exist, the scientific justification shall be made by the relevant competent authorities. Article 7: Transparency 1. Any measure which has been adopted or changed shall be promptly published and notification provided in writing, through available media in such a manner as to enable related government agencies, businesses, citizens and trading partners to be informed. There should be a reasonable interval between the publication of such measures and it is entry into force in order to allow time for related stakeholders to prepare themselves, except in urgent circumstances. 2. Related agencies have the obligation to provide SPS enquiry points and notification points regarding SPS related information. 3. Any necessary information regarding SPS measures, forms, procedures, time periods and other information shall be published properly. Additionally information shall be announced at the places of administrative services in order to facilitate access to food business entrepreneurs. Article 8: Non discrimination The application of sanitary measures shall be consistent with the non discrimination principle, de jure and de facto between country and country or between supplier and supplier. Chapter III Food safety framework Article 9: A framework to ensure food safety A framework to ensure food safety of Lao PDR consists of administration, legislation, risk assessment, integrated food chain approach, national human resource capacity, national data collection and scientific research, international standards and trade, national and international cooperation. Article 10: The implementation of the food safety framework The implementation operation of the food safety framework in Lao PDR complies with the Food Law and the National Food Safety Policy as well as other food related regulations which have already been implemented and enforced. In case where the food safety framework may contradict or is not covered by the basic principles which are stipulated under Ministerial Regulations, the Ministerial Regulations and principles shall prevail. Article 11: Risk assessment 4 The measures applied for food safety shall be based on reasonable risk assessment framework and comply with international or regional standards as well as transparent and non discriminating principles. Article 12: Recognition of foreign standards. Lao PDR recognizes the standards of countries that have adopted the standards of Codex Alimentarius. The SPS certification of those countries will be accepted by Lao PDR. In case the product fails to meet such standards, it can also be rejected. Chapter IV Rights and Obligations of Public Health Agencies Article 13: Rights and obligations of Ministry of Public Health In addition to regular rights and obligations according to their roles, additional rights and obligations are as follows: 1) To extend the basic principles of Article 4 in this Ministerial Regulation to the food safety framework in Lao PDR. 2) To monitor, summarize, evaluate and assess the results of the application of basic principles under Article 4 of this Ministerial Regulation and also entitled to improve and amend any food related legislation which is inconsistent with this Ministerial Regulation. 3) To coordinate with other related government agencies in order to ensure the basic principles of this Ministerial Regulation are further applied to the food safety framework of Lao PDR (Annex 1 of National Food Safety Policy). 4) To participate in liaising, coordinating and negotiating in the fields of sanitary and technical activities which are related to food businesses at both the national and international levels. 5) To disseminate the basic principles of this Ministerial Regulation to health agencies, related organizations and the business sector, in order that they be informed and understand this Ministerial Regulation throughout the country. Article 14: Rights and Obligations of Provincial and Vientiane Public Health Offices In addition to regular rights and obligations according to their roles, additional rights and obligations are as follows: 1) To implement, monitor, inspect and summarize the results of the application of the basic principles as provided for in Article 4 of this Ministerial Regulation and report to Ministry of Public Health regularly; 2) To disseminate the basic principles of this Ministerial Regulation to related stakeholders, government agencies and the business sector, in order that they to understand and implement it; 3) To coordinate with other government agencies to ensure the basic principles of this Ministerial Regulation are applied to the food safety framework of Lao PDR (as provided for in the Annex 1 of National Food Safety Policy); and 4) To implement the instructions of the Ministry of Health in order to apply the sanitary and technical measures to the food safety framework. Article 15: Rights and Obligations of District Health Offices 5 In addition to regular rights and obligations according to their roles, additional rights and obligations are to implement the application of basic principles as provided for in Article 4 of this Ministerial Regulation and regularly report to provincial health offices. Chapter V Dispute Settlements Article 16: the procedures of dispute settlements The dispute settlements consist of the following procedures: 1. Consultation 2. Administrative appeal 3. Court appeal Article 17: Consultation Any party can request a consultation on a dispute related to the implementation of this Ministerial Regulation to understand reasons and to create mutual understanding. Each party should allow reasonable time and provide the necessary information to facilitate such consultation. Article 18: Administrative appeal If the dispute can not be settled through consultation. the complainant can submit an appeal to a higher authority than the public health agency or other relevant agencies. The health and other relevant agencies shall ensure impartiality for both parties, and such dispute shall be settled within 90 days. Article 19: Court appeal If any party is not satisfied with the decision made under Article 18 of this regulation, such party can appeal to the court as provided for in related laws and regulations. Chapter VI Final Provisions Article 20: The implementation The Department of Food and Drugs, Ministry of Public Health shall undertake the responsibility to extend and coordinate with provincial, Vientiane Health Offices and other related agencies throughout the country in order to implement this Ministerial Regulation. Article 21: Entry into force The Ministerial Regulation shall be entered into force 30 days after signature. If there are any contradictions between this Ministerial Regulation and other related regulations, the solution paragraph 2 of Article 10 of this Ministerial Regulation shall prevail. The Minister of Ministry of Health Dr. Phonemek DALALOY