Draft Laws

Food and Medicine Administration Proclamation /Draft/

PART THREE
FOOD SAFETY ADMINISTRATION

6. General
1) Every person who provides food for use by the public shall ensure its safety.
2) The rigor of safety assessment of food shall be based on its type and potential risk to human health.
3) Every food and packing material shall comply with the national standard adopted by the appropriate body.
4) Notwithstanding sub-article (3) of this article, the executive organ may use acceptable standards adopted by international organizations to regulate the safety of food for which national standard is not issued.
5) The executive organ or regional health regulator may request third party conformity assessment regarding the safety of food provided by food institution.
6) Every food prepared for the purpose of exporting shall be safe and promote the country’s sustainable trade interest.
7) Every locally produced food for which mandatory standard is issued shall bear the applicable mark and shall possess a certificate issued for this purpose.
7. Registration of food and food trade establishment
1) Every person shall be registered by the executive organ or regional health regulator before commencing a food trade activity.
2) Unless authorized by the executive organ or regional health regulator, no food trade establishment may provide a pre-packed food for use by the public.
3) Registration of food and food trade establishment shall be renewed within the time frame required by the executive organ or regional health regulator.
4) Details about registration of food and food trade establishment shall be determined by a directive issued to implement this proclamation.
8. Food manufacturing, preparation, storage, transport or selling place
1) Every food establishment shall have the responsibility to ensure that equipment or material used in food manufacturing, storage, or transport is clean and free from contaminants, and ensures that it complies with safety requirements issued by the executive organ.
2) In addition to the responsibilities provided under sub-article (1) of this article, every food trade establishment shall have the responsibility to ensure that places for food manufacturing, preparation, storage, or sell are clean and far from contaminants.
3) Every food establishment may use equipment or materials with direct contact in the food only if it fulfills safety requirements and shall ensure that devices are periodically calibrated by an appropriate organ.
4) It shall be the responsibility of every food establishment to ensure that food is stored, transported, or placed for sale in such a way that its safety is preserved and, if necessary, a proper cold chain is maintained.
5) Any food product may not have chemical residue including pesticide, fertilizer, animal medicine, food additive chemical, cleaning chemical, a radioactive substance, and other contaminants above the maximum level issued or adopted by the appropriate organ.
6) Every food establishment, depending on the nature of the food, has the obligation to give adequate information about handling and use of foods it offers to sell.
9. Personnel working in food establishments
1) Every food establishment shall ensure that its employees who are engaged in the manufacturing, preparation, or service
a) has appropriate education or related training in food safety;
b) and who have a direct contact with the food to be free from food-borne illness and take appropriate measure to prevent food-borne illnesses; and
c) wore an appropriate safety clothing.
2) Every person who participates in the manufacturing of food and has knowledge of or reason to believe that a significant risk to the public’s health exists shall immediately report, as appropriate, to the executive organ or regional health regulator.
3) Implementation of this provision shall be determined by a directive.
10. Food manufacturing
1) Every food establishment has obligation to install the required quality control system to ensure the safety of foods it produces.
2) It shall be the responsibility of every food manufacturer, importer or preparer to ensure the safety of raw materials used for food manufacturing.
3) Every packaged food manufacturer shall report to the executive organ if it introduces change in the type, content, and manufacturing process of the food it produces.
11. Food import and export
1) Food may be imported only when it complies with applicable safety standards, and a permit is granted by the executive organ.
2) Without prejudice to sub-article (1) of this article, if the executive organ has reason to suspect the safety of the food it may perform a laboratory test, or order laboratory test to be performed by a third party and its cost covered by the importer.
3) If any imported food has established safety problem, the executive organ may determine to evaluate good manufacturing practices of the manufacturer.
4) Food found to be unsafe under this proclamation may be returned to its country of origin or be locally disposed at the expense of its importer.
5) A food exporter, as necessary, may get health certificate of food it intends to export from the executive organ.

12. Food additive

1) Use of maximum level of a food additive shall be in accordance with standards issued by the appropriate body.
2) The executive organ shall determine the list of allowable food additives.
3) The executive organ may, where appropriate, prohibit the use of food additives in a certain category of foods.
4) For the purpose of this article, “food additive” means any substance prepared in accordance with applicable requirements and added to food in order to give flavor, impart color, preserve, and enhance its appearance or other related functional purposes.
13. Infant formula and follow-up formula
1) Every infant formula and follow-up formula shall comply with applicable national quality and safety standards; its component shall not be genetically modified and exposed to any radiation during manufacturing, and its packaging is made from anon-plastic material, and contains a label bearing the source of its protein.
2) The safety and quality regulation of infant formula, follow-up formula, and complimentary food shall be determined by a directive issued to implement this proclamation.
3) For the purpose of this article, “infant formula” means industrially formulated food to satisfy the normal nutritional requirements of infants up to six months of age.
4) For the purpose of this article, “follow-up formula” means a food product of animal or vegetable origin and industrially formulated in accordance with the appropriate standard for feeding infants and young children from the sixth month on up to three years of age.
5) For the purpose of this article, “complementary food” means a food product industrially formulated for infants and young children from the sixth month on up to two years of age to be used in addition to breast milk and follow-up formula.
14. Food supplement
1) Food supplement may not be imported or placed on the market without registration.
2) The rigor of safety assessment of food supplements shall be commensurate based on its type, potential risk to human health, and its health claim.
3) For the purpose of this article, “food supplement” means a concentrated source of vitamin, mineral, amino acid, or other substance with nutritional or physiological effect, alone or in combination prepared in a dosage form and intended to supplement the normal diet.
4) Detail implementation of this article shall be determined by a directive.
15. Food fortification
1) Every food identified for fortification shall fulfill applicable standards adopted by the appropriate body.
2) Vitamins, minerals, or other essential nutrients permitted for fortification purpose may only be used if it fulfills requirements set by the appropriate body.
3) Every food manufacturer that fortifies food in accordance with sub-article (1) and (2) of this article shall accordingly label the food as fortified.
4) For the purpose of this article, “fortification” means the addition of one or more nutrient to a food for the purpose of preventing or correcting a demonstrated deficiency of nutrients and preventing related health problem, or increase nutrients in a manufactured food.
16. Food irradiation
1) Irradiation of food shall be carried out in such a way that it is designed to meet the requirement of food safety and using the appropriate type and limit of radiation.
2) Regulation of irradiation requirement shall be implemented in cooperation with appropriate bodies.
3) Detail implementation of this article shall be determined by a directive.

17. Water safety
1) Any pipe or bottled water or other potable water supplier or producer shall ensure compliance with the national safety standard.
2) The safety and effectiveness of every water treatment chemical or device shall be regulated by the executive organ.
3) Detail implementation of this article shall be determined by a directive.
18. Post-market safety monitoring
1) Every food manufacturer or importer shall have a system to enable it to continuously monitor the safety of the food it produces or imported.
2) If the public’s health is in danger due to a confirmed safety problem relating to food manufacturing, storage, transport or handling, the executive organ or regional health regulator may notify the public through the appropriate mass-media not to use the food and order recall of the product.
3) The executive organ shall periodically undertake safety monitoring of food products placed onto the market; and may order the cost be covered by its manufacturer or importer.
4) Detail implementation of this article shall be determined by a directive.
19. Alcoholic drinks
1) Every industrially prepared alcoholic drink shall comply with applicable national or other standard accepted by the country issued with regard to its content.
2) It shall be illegal to sell any alcoholic drink to anyone under the age of 18.
3) No person may sale alcoholic drink Health institutions, education facilities, kindergartens, universities and colleges, government institutions, places of worship, sporting places, cinema houses and other places determined by a regulation issued to implement this proclamation.
4) Additional restrictions with regard to the time and manner of sale of alcoholic drink may be determined in accordance with a regulation issued to implement this proclamation.
5) For the purpose of this article, “alcohol” means any drink with 2% or more alcohol volume.

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