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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II EVALUATION OF EDIBILITY SAFETY AND NUTRITION QUALITY CHAPTER III APPLICATION AND APPROVAL CHAPTER IV LABELING CHAPTER V MONITORING CHAPTER VI SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. Based on the Food Hygiene Law of the PR China (hereinafter referred to Food Hygiene Law) and Ag GMO Safety Administration Regulations, these regulations are established to strengthen the monitoring and administration of genetically modified (GM) food and protect consumers' rights of health and awareness. Article 2. GM food mentioned in these measures refers to food and food additives that are made from animals, plants and microorganisms whose genome structures have been modified through genetic engineering technology. These include: (1) genetically modified animals, plants, or microorganism products; (2) products directly processed from genetically modified animals, plants, or microorganisms; and (3) Food and food additives made from raw materials of genetically modified animals, plants, or microorganisms or their directly processed products. Article 3. Being a new source of food, GM food shall be produced or imported after it has been reviewed and approved by the Ministry of Health. GM food shall not be produced or imported without the review and approval of the Ministry of Health , nor shall it be used as food or food raw material. Article 4. GM foods shall be compliant with relevant rules, regulations, or standards and shall not pose any acute, chronic or potential health hazard to the human body. Article 5. The edibility, safety and nutrition quality of GM food shall not be lower than that of the corresponding original food. Article 6. The manufacturer of GM food shall meet the requirements of the state regulations with regard to food manufacturers. The manufacturer of GM food shall ensure the edibility, safety and nutrition quality of the GM food being manufactured or operated. The manufacturer of GM food shall keep a record on purchase (sale) of GM food, including purchasing (sale) unit name, address, and quantity. The related records shall be kept for at least two year. CHAPTER II EVALUATION OF EDIBILITY SAFETY AND NUTRITION QUALITY Article 7. The Ministry of Health shall set up an evaluation system for GM food safety, and nutrition quality. MOH shall promulgate and publicize the procedures and related standards with regard to the evaluation of GM food edibility safety and nutrition quality. Article 8. The evaluation of GM food safety and nutrition quality will be conducted on a case by case basis in accordance with the principles of risk assessment, and substantial equivalence. Article 9. MOH will form a GM food expert committee composed of experts of food safety, nutrition, and genetic engineering to take charge of the evaluation of food edibility safety and nutrition quality. Article 10. As required for the evaluation of GM food edibility safety and nutrition quality, MOH will accredit qualified testing agencies to undertake verification of evaluation of GM food edibility safety and nutrition quality. CHAPTER III APPLICATION AND APPROVAL Article 11. The manufacturer or importer of GM food shall apply to MOH with the following materials: (1) application form; (2) approval documents issued by relevant government departments; (3) enterprise standards; (4) safeguard measures for edibility safety; (5) packaging design and labeling sample; (6) technical documents that relate to the evaluation of GM food edibility safety and nutrition quality; (7) evaluation report of applicant on GM food edibility safety and nutrition quality and verification report on GM food edibility safety and nutrition quality produced by a MOH accredited testing agency; and (8) Other materials conducive to the evaluation of GM food edibility safety and nutrition quality. Article 12. Technical documents that relate to the evaluation of GM food edibility safety and nutrition quality mentioned in Item 6 of Article 11 include: (1) name of GM food (specie); (2) Physical/chemical features, usage and special functions of GM food; (3) Possible processing method(s) of GM food, category of final product(s) and main ingredients( including nutritious and harmful ingredients); (4) The purpose of gene modification and expected technical effects, and the expected impact on food product features; (5) The name, features and edibility history of gene provider; the source, features, functions and edibility history of carrier material, and gene features and insert position; (6) name, features, functions, and content of the derivative of the introduced gene; (7) Known or suspected allergic and toxic features of the derivative, and evidence of edibility safety of the derivative; and (8) Possible unexpected effects( including the evaluation of metabolite) Article 13. In addition to the required materials listed in Article 11 and 12, the applicant for GM food imports shall also supply certification documents from the government of the exporting country (region) showing the product has been approved for production, operation, and use in the country (region). Article 14. The Ministry of Health shall decide weather to approve it within 6 months following receipt of an application for GM food. Article 15. MOH will list the approved GM food into the GM food catalogue that are eligible for food production and operation. CHAPTER IV LABELING Article 16. The food product (including raw material and its processed food) that contains GM organism and/or its derivative(s) shall be labeled "GM XX product" or " with GM XX as raw material". GM food that derives from potential allergic food shall also be labeled "this product is modified from XX food gene, those who are allergic to XX food should be careful". Article 17. GM food shall be labeled in the following manners: (1) products in package: indicated at marked position on the label; (2) product in bulk: indicated on the label or separately arranged sign board; (3) product in transshipment: indicated on the bill of lading; (4) Imported product: indicated in the business contract and customs clearance form. Article 18. The labeling of GM food shall be authentic and objective, and must be free from the following content: (1) explicit or implicit indication of disease cure; (2) falsification or fabrication of product function; (3) other contents that MOH has banned for labeling. CHAPTER V MONITORING Article 19. MOH will re-evaluate the GM food that has been approved for production or importation if one of the following situations has been found: (1) Scientific knowledge about the GM food edibility safety and nutrition quality has changed; (2) The GM food edibility safety and nutrition quality has been questioned; or (3) Other reasons that require a re-evaluation. Article 20. MOH will arrange periodic or random monitoring inspections on GM food production and operation. Article 21. The MOH accredited testing agencies responsible for the evaluation of GM food edibility safety and nutrition quality shall conduct the evaluation in accordance with the procedures and related standards stipulated by MOH. In case a testing agency produces false inspection report or fails to ensure the inspection quality due to negligent management, MOH will order a correction to its act, criticize it publicly, and, in severe cases, have its accreditation revoked. Article 22. The personnel engaged in GM food inspection, review, and monitoring shall be equipped with professionalism and morale. Article 23. The regular hygiene monitoring management for GM food production and operation shall be executed based on the Food Hygiene Law and relevant regulations. CHAPTER VI SUPPLEMENTARY PROVISIONS Article 24. Violators of these measures will be penalized by the health executive department based on the related provisions of the Food Hygiene Law. Article 25. MOH shall be responsible for interpretation of these measures. Article 26. These measures will take effect as of July 1, 2002. |
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