UAE Healthcare / Pharma LawCabinet Resolution No. (26) of 2017 Concerning the Executive Regulations of Federal Law No. (10) of 2015 Concerning Food Safety

Article (1) Definitions For applying the provisions hereof, the following words and phrases shall have the meanings assigned thereto respectively, unless otherwise required by the context: State : The United Arab Emirates. Emirate : Any Emirate of the State. Ministry : The Ministry of Climate Change and Environment. Minister : The Minister of Climate Change and Environment. Competent Authority : The local authority in charge of food and fodder safety in each emirate. Concerned Bodies : The ministries, government bodies, federal public authorities and departments in charge of food and fodder safety. Law : Federal Law No. (10) of 2015 Concerning Food Safety. Food : Any substance or a part thereof, in the unprocessed form, primary, manufactured or semi-manufactured form, that is intended for human consumption as either food or drink,

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 2 including the beverages, bottled drinking water, pickles, spices and chewing gum, along with any substance used for manufacturing, preparing and processing food, but not including cosmetics, tobacco or substances used only as drugs. Fodder : Any substance or a part thereof intended to be used as animal food through the mouth, whether in its unprocessed form, manufactured, processed and prepared form in whole or in part, including the additives of fodder and substances used as animal food for the purposes of improving the quality of foodstuff made of an animal origin. Food Chain : All phases through which food passes, starting from fodder, primary production until it reaches the consumer, including the phases of manufacturing, preparation, processing, packaging, packaging, transportation, storage, distribution, service, offering and sale thereof. Circulation : The process of production, manufacturing, preparation, processing, packing, repacking, packaging, making ready, transportation, importation, possession, storage, distribution, service, offering, sale, exportation or re-exportation of food or fodder at any of the food chain phases. Organization : It is the organization duly licensed to trade in food or fodder through a fixed or mobile premises, permanent or temporary. Organization’s Officer : The natural or legal person authorized and in charge of compliance with the provisions of the law as well as the regulations, bylaws and resolutions issued in implementation thereof at the Organization under his liability. Fodder Safety : Ensuring that the fodder does not cause harm to the food made of an animal origin or any harm to the health of humans or animals as per the intended use. Fodder : All circumstances and measures required to ensure safety and

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 3 Healthiness health of the fodder used for consumption by animals as per the intended use. Consignment : A specified quantity of food and/fodder that includes one or more batches typically covered in the same health certificate and other documentation. Primary Production : The phases preceding the manufacturing and processing of food, which include the cultivation and harvesting thereof, breeding farm animals and milking, hunting wild animals, fishing and seafood catching, collecting and harvesting wild animals. Consumer : Each person who uses food to fulfill personal needs or others' needs. Technical Regulations : A document which sets out the characteristics of the service, product, means of production and management systems, the symbols, codes, data, packaging, labeling, label requirements that apply to the product or its means of production or limited to any of them, and conformity to which is mandatory according to the specifications and standards applicable in the State. Food Safety : Ensuring that the food does not cause harm to the consumer upon circulation or consumption as per the intended use. Food Fitness : Ensuring that the food does not cause harm to the consumer upon circulation or consumption as per the intended use. Misleading Food : Food that is untruly prescribed for commercial promotion purposes, including any inaccurate information Adulterated Food : Food to the original ingredients of which other substances are added to minimize its quality or nutritional value, or some of its ingredients rich in the nutritional value are removed, or any of its original information is changed without disclosing the same in the nutrition facts label. Spoiled Food : Food that undergoes unintended changes in its apparent or taste characteristics; e.g. appearance, stature, odor, taste or flavor,

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 4 which renders it unfit for human consumption or minimizes the quality of its fitness as food. Harmful Food : Food that contains hazards in its origin or that are mixed with it during any phase of its circulation, which render it non- conforming to the legislation and technical regulations applicable in the State and adversely affects the consumer's health. Nutrition Facts Label : Any statement, mark, descriptive or illustrative sign, whether written, printed, drawn, marked, engraved, stamped or attached to the food packet, in addition to any document or information attached to, accompanying or ancillary to the food. Label : Any statement, mark, descriptive or illustrative sign, whether written, printed, drawn, marked, engraved, stamped or attached to the fodder packet, in addition to any document or information attached to, accompanying or ancillary thereto, which contains illustrative information about characteristics of the fodder, composition, nature, preparation, use or storage instructions. Control : A regulatory activity intended to protect consumer's health, ensure safety of the food and fodder during their circulation phases at any of the food chain phases and conformity with the requirements of health and quality, and marking the same with accurately and clearly in accordance with the law as well as regulations, rules and resolutions issued in implementation thereof. Seizure : Actions or measures taken by the competent authorities or by the concerned body to seize food or fodder at a designated place, until they verify that that food or fodder is conforming to the provisions of law and this Resolution. Source of Danger : A biological, chemical or physical factor of the food or fodder, or a condition that may make any of them harmful or negatively

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 5 affect consumer health. Risks : The likelihood of negative effects that may affect human health as a result of being exposed to a source of danger in food or fodder at any stage of the food chain. Risk Assessment : The assessment of the likelihood of negative effects and the severity thereof on consumer health based on scientific grounds, including the identification and description of the source of danger as well as the assessment of exposure to the source of danger and risks description. Food with a source of danger : Food that shall be stored at specific temperatures aiming to minimize the growth of pathogenic microorganisms that are likely to be present, or to prevent the creation of toxins therein. Food Additives : Any substance that is not considered a food or a part thereof, whether nutritional or not, which is intentionally added to the food for technical purposes. That substance or the by-product thereof become or expected to become, after being added, whether directly or indirectly, a part of the food ingredients or affecting its properties. Package : Any form of containers used to reserve or package food or fodder in order to be sold as a unit including cans, rolls and packages Health Claim : Any statement, declaration, suggestion, indication or intimation of the existence of a relationship between the food, one of its ingredients or its health or quality conditions and its impact on human health. this shall include the following types of claims: 1. Nutritional (functional) role claim: a nutritional claim that describes the physiological role of the nutrient in the growth, development and functionality of human body natural functions. 2. Other functional nutritional claims: claims related to the side effects of the consumption of certain foods or their

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 6 ingredients, within the overall diet, on natural functions or vital activities of the body. Such claims are related to their positive participation in health, improvement of a specific function of the body or to maintain health. 3. Claims to reduce the risk of disease: claims linking the consumption of certain food or food ingredients within the overall diet, to reducing the risk of a relevant illness or health condition. Good Agricultural Practices : Standards applied to agricultural production procedures and phases to ensure the safety and security of food, fodder and industry personnel according to sustainable foundations for agricultural practices. Good Manufacturing Practices : Standards applied to the processes related to the manufacture of food and fodder that are necessary for producing high quality and healthy food or fodder, that comply with health and quality measures and related legislation.

Article (3) Food Registration and Accreditation Requirements The manufacturers, producers and importers of food through all state ports shall register the same before being put into circulation, in accordance with National Accreditation & Registration System announced by the Ministry, however, the following shall be excluded

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 7 from the provisions of this article: 1. Food circulated for non-commercial purposes under the relevant legislation, including the following: a. Food imported for personal use. b. Food samples Imported for scientific studies and research that are not intended for human consumption. c. Food samples intended for advertising and marketing study, that are not intended for sale, including free samples distributed to consumers, samples intended for compliance requirements, and any foods whose indication card is marked with "Free Sample" phrase. d. Food samples used in exhibitions and festivals that are not intended for sale. 2. Any food in respect of which a Resolution is issued by the Minister in coordination with the competent authority and the concerned bodies.

Article (4) Food Registration Procedures Food shall be registered in the National Accreditation & Registration System announced by the Ministry, in accordance with the following procedures: 1. The food organization's officer shall submit the registration application online. The application shall meet all data and documents specified by the Ministry. 2. The competent authority shall: a. Look into the registration application referred to in clause 1 of this Article and audit the data contained therein. b. Complete the necessary procedures for the registration of food according to the food group, main and subcategories, manufacturing processes and food additives. c. Dispatch samples to the approved laboratories for being tested, identify the required tests, based on the risk assessment, and ensure that the tests results are registered with National Accreditation & Registration System by the concerned laboratory. d. The Ministry shall approve the registration of food after ensuring that all

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 8 procedures have been completed and that the required documents and records are attached. e. The competent authority shall control the circulated and imported food and inspect the same to verify its registration and compliance with the database in National Accreditation & Registration System.

Article (5) Fodder Registration Requirements The manufacturers, producers and importers of fodder through all state ports shall register the same in accordance with National Accreditation & Registration System announced by the Ministry before being circulated. The fodder traded for non-commercial purposes under the relevant legislation shall be excluded from the provision of clause 1 of this article, including: a. Fodder imported for personal use. b. Samples Imported for scientific studies and research. c. Samples intended for advertising and marketing study, that are not intended for sale, including free samples distributed to consumers, samples intended for compliance requirements, and any samples whose indication card is marked with "Free Sample" phrase. d. Samples used in exhibitions and festivals, that are not intended for sale.

Article (6) Fodder Registration Procedures Fodder shall be registered in the National Accreditation & Registration System announced by the Ministry, in accordance with the following procedures: 1. The fodder organization's officer shall submit the registration application online. The application shall meet all data and documents specified by the Ministry. 2. The competent authority shall: a. Look into the registration application referred to in clause 1 of this Article and audit the data contained therein.

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 9 b. Complete registration procedures by fodder group, main and sub categories, manufacturing processes and fodder additives. c. Dispatch samples to the approved laboratories for being tested, identify the required tests, based on the risk assessment, and ensure that the tests results are registered with National Accreditation & Registration System by the concerned laboratory. 3. The Ministry shall approve the registration of fodder after ensuring that all the procedures have been completed and that the required documents and records are attached. 4. The competent authority shall control the traded and imported fodder, and inspect the same o as to verify its registration and compliance with the database in National Accreditation & Registration System.

Article (9) Circulation of Food & Fodder 1. For circulation of Food and fodder, the following shall be observed: a. Domestic and imported food and fodder shall meet the relevant legislation

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 10 requirements and technical regulations. They shall also conform to the mandatory standards and any other conditions or standards contained in any agreement in force in the exporting state. b. Fodder or food contact materials, such as packaging materials, shall not constitute a source of danger or contamination to food or fodder accorded to the intended use. c. The nutrition facts label of the food and label of fodder, whether packaged or non- packaged, shall be available and their explanatory data requirements shall be met. The information contained in the card shall clear, true and in Arabic. d. Indicating the country of origin for the locally manufactured and imported food and fodder on their respective package clearly and without misleading. e. Indicating the country of packing for the imported food and fodder, clearly and without misleading, in case the country of packing is not the country of origin. 2. The organization shall not: a. Trade in food that is violating the technical regulations or provisions hereof, including damaged, harmful to health, adulterated, misleading or unfit food. b. Trade in food or fodder that is not registered or expired without obtaining a written permission from the competent authority. c. Trade in food contains, within its ingredients, pork, its derivatives, any alcoholic substances or any other substances that are contrary to the provisions of Islamic Sharia without obtaining the necessary permission according to the technical regulations and mandatory standards. d. Trade in any food for special uses or food with health claims or trading of any food additives without a prior written approval of the competent authority or concerned bodies. Such food shall not be harmful to health or in breach of the provisions of Islamic Sharia and shall meet all the conditions and specifications under the relevant legislation. e. Import any food or fodder for the first time without being accredited by National Accreditation & Registration System announced by the Ministry. f. Trade in the fodder that constitute an inevitable danger to human and animal

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 11 health, or the fodder violating the technical regulations and the provisions hereof.

Article (12) Spoiled Food Food shall be considered spoiled if the unintended changes in its apparent properties, taste, texture, odor, taste, flavor, or color lead to any of the following: 1. Become unfit for human consumption, as in the cases of the growth of bacteria and fungi. 2. Its fitness for of human consumption is reduced, in a manner that does not cause harm to consumer health and safety, including any of the following: a. Increased fractions of wheat-processed foods or reduced odor of substances containing aromatic oils. b. Become rotten or contaminated with bacteria, viruses, fungus or toxins resulting therefrom, parasites, worms or insects in all its phases or Xenobiotics at a rate

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 12 which is higher than the rate permitted under the technical regulations and mandatory standard. 3. Any other case determined by the minister or the competent authority and in a manner not inconsistent with the provisions hereof.

Article (13) Harmful Food 1. Upon evaluating food as harmful to health, the following factors shall be considered: a. Its impact on consumer health or future generations, whether directly after being eaten or in the short or long run. b. Potential impacts of its cumulative toxicity. c. Causing allergy to a particular segment of consumers. 2. Food shall be considered harmful to health in any of the following cases: a. In case it contains any toxic substance or source of danger that have been proven to have a negative effect on consumer health. b. In case it contains a hazardous source, contaminants or toxins at a rate that is higher than the rate permitted under the relevant technical regulations and mandatory standards. c. In case it contains a food additive, that is prohibited under the technical regulations and mandatory standard. d. In case it contains a permitted food additive at a rate that is higher than the rate permitted under the technical regulations and mandatory standards. e. In case the food is hazardous and is traded after its expiration date stated on the nutrition facts label. f. In case the food is rotten or contaminated to an extent that negatively affects consumer health. g. In case the food is traded in an environment or conditions that make it harmful to health or vulnerable to cross-contamination, including food-borne diseases. h. In case the food is made, in whole or in part, from decayed or corrupted plant or animal raw material, or from the output of an animal which is sick or carrier of an

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 13 illness whose output is not permitted for human consumption or from a dead animal. i. In case food contact materials or tools that are , under the technical regulations and mandatory standards, not intended for food use purposes are used in the circulation thereof. j. In case it is contaminated with radioactive material, whose radioactivity rate is higher than the rate permitted under the technical regulations and mandatory standards. k. In case it contains hormones, chemicals, or medicines, including veterinary medicines or any residues thereof, at a rate that is higher than the rate permitted under the technical regulations and mandatory standards or in the absence of technical regulations or other food standards that allow the use of such substances or the residues thereof in food. l. In case it contains allergens or any other causes that negatively, affect the consumer health and was traded without the nutrition facts label or without indicating that fact on the nutrition facts label according to the technical regulations and mandatory standard. m. In case it is traded in the direct sale outlets of the consumer without meeting trading requirement if required by the relevant legislation. n. Any other case determined by the Ministry or the competent authority and in a manner not inconsistent with the provisions hereof. The Ministry may take temporary precautionary measures under which food is deemed to be harmful to health in case a risk assessment is conducted on that food, even if that assessment is incomplete, and a set of scientifically proven assumptions that support the probability of occurrence of such risks are available until new scientific data that require reconsideration of such measures are obtained.

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 14

Article (14) Adulterated Food Food shall be considered adulterated in any of the following cases: 1. In case it contains a permitted food additive, which is not permitted to be used in that food according to the technical regulations and mandatory standards. 2. In case its actual contents do not match the information contained in the nutrition facts label. 3. In case any of its ingredients have been removed, altered, or re-prepared without indicating this on the nutrition facts label, even if such procedures are permitted under the relevant regulations, instructions, and decisions. 4. In case a substance that may reduce its nutritional value is added thereto, whether for the purpose of profit or to hide a defect or deficiency therein or to increase the size or weight or any other reason as per the definition of the adulterated food. 5. In case it contains pork or any of its derivatives or products or any alcoholic substances without obtaining a prior permission, and without indicating this on the nutrition facts label in accordance with the technical regulations and mandatory standards. 6. In case any modification is made to its shelf life contrary to what is indicated in the original nutrition facts label without obtaining the prior written approval of the competent authority. 7. In case it is traded without a nutrition facts label. 8. In case it is traded before being registered with the competent authorities under the relevant legislation and Resolutions. 9. Any other cases determined by the Ministry or the competent authority and in a manner not inconsistent with the provisions hereof.

Article (15) Misleading Food Food shall be considered misleading in the following cases: 1. In case it is misleadingly packaged or prepared, falsely descripted or the nutrition facts label is misleading to the consumer for the purpose of commercial promotion.

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 15 2. In case it contains any permitted food additive that has a function or role in the production process such as thickeners without indicating this on the nutrition facts label. 3. In case the nutrition facts label is in violation of the terms and conditions specified in the technical regulations and mandatory standards. 4. In case the nutrition facts label does not include all the required information in Arabic. 5. In case the nutrition facts label contains any health claim conforming to the technical regulations and the mandatory standard without obtaining the prior written approval of the competent authority or the concerned bodies. 6. In case the nutrition facts label contains any nutritional claim, health claim or any other claim that is contrary to the technical regulations and mandatory standards. 7. In case the nutrition facts label contains unclear or illegible words, phrases, information, images, drawings, or logos. 8. In case the food is treated with radiation for preservation purpose without indicating this on the nutrition facts label. 9. In case it contains, within its ingredients, genetically altered or modified substances without indicting this on the nutrition facts label according to the technical regulations and mandatory standards. 10. Any other cases determined by the Ministry or the competent authority and in a manner not inconsistent with the provisions hereof.

Article (16) Food in Breach of Technical Regulations Food shall be considered in violation of the technical regulations in any of the following cases: 1. In case it violates the mandatory document applicable in the state that specifies its characteristics or methods of production. 2. In case it violates the terms, codes, data, packaging conditions, labeling and indication card requirements which are mandatory in the State. 3. In case the nutrition facts label includes words, phrases, information, pictures,

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 16 drawings or logos that are contrary to the public morals and laws applicable in the state. 4. In case it is packaged or prepared in inappropriate manner that is inconsistent with the public morals and laws applicable in the State.

Article (18) Records & Data The organization's officer shall: 1. Keep records of suppliers' data and food supplied by them, including the supplier's name, address, date of receipt, nature and quantity of food, batch number and any other relevant data to be determined by the Ministry or the competent authority. 2. Keep records of the customers' data and the food supplied to them, including the customer's name, address, date of supply, the nature and quantity of food, batch number and any other relevant data required by the Ministry or the competent authority, excluding food establishments that sell their products directly to the consumer. 3. Maintain the records and data referred to in this Article for a period not less than the following: a. 180 days after the expiration date of the food whose shelf life is more than five years. b. 180 days from the date on which the supplier supplies short shelf life food with definite consumption date, and for food with a shelf life of less than three months

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 17 and any food distributed directly to the consumer c. Five years for all other cases 4. Provide copies of the records and data referred to in this article and any other data requested by the Ministry or the competent authority during the periods specified in clause 3 of this Article. 5. Ensure that the tracking procedures are efficient, periodically reviewed and updated if necessary.

Article (19) General Rules for Fodder Healthiness For the purpose of ensuring the healthiness of fodder, the producing organization shall conform to the following: 1. Application of the basic rules of good agricultural practices to the production and trading procedures of the raw materials used within its ingredients. 2. Application of the basic rules of good manufacturing practices to the production and trading procedures of the used raw materials and its ingredients. 3. Meeting the general requirements during manufacturing and trading thereof, including the following: a. The site shall be far from the potential sources of contamination, and shall be kept clean in all cases, so that its nature does not allow the gathering of wastewater. b. The design and construction of the organization shall generally allow the completion of the production and processing of fodder in a manner that does not lead to contamination and gathering of wastewater. c. The design, construction, and maintenance of the internal areas of the organization shall allow for the control of risks that threaten the safety of fodder. The contamination during the circulation of materials and products shall be minimized and adequate ventilation and lighting shall be provided. d. The equipment and water used in manufacturing shall be in conformity with the technical regulations and mandatory standard and shall be stored so as not to be contaminated by any means.

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 18 e. Waste disposal systems shall ensure the identification and sorting of their types and that they are collected and removed in a safe manner that prevent contamination of products or production areas. f. The equipment and devices used shall be smooth, easy to clean and resistant to rust and scratch. g. Measuring devices shall be calibrated, calibratable, adjustable and reusable. h. fodder ingredients shall be ensured that they do not affect the safety thereof and that they are in conformity with the technical regulations and mandatory standards. i. Contamination and pest prevention and monitoring programs shall be applied based on risk assessment, and measures shall be taken in order to prevent any physical, chemical, biological or radiological contaminants. j. Cleaning and sterilization programs shall be in place to maintain full health conditions that prevent contamination and all causes affecting public health. k. Meeting the hygiene, personal and behavioral requirements of the employees shall be ensured in proportion to the risks to which the production is exposed. l. The materials and products shall be stored in clean, dry and well-ventilated places and protected from dust, vapors and other sources of contamination according to their intended use. Programs ensuring the effective control of storage and transport stages, storage temperature, humidity and other environmental conditions shall be developed in accordance with the product specifications.

Article (20) Fodder Inevitably Detrimental to Human or Animal Health Fodder shall be considered inevitably detrimental to human or animal health in any of the following cases: 1. In case it contains any toxic substance that causes damage in the short or long run. 2. In case it contains pesticide residues or contaminants at a rate that are higher than the rate permitted under the technical regulations and mandatory standards. 3. In case it contains additives or contaminants that are banned in the State.

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Cabinet Resolution of 2017 Concerning the Executive Regulations of Federal Law of 2015 Concerning Food Safety 19 4. In case it contains a permitted substance at a rate that is higher than the rate permitted under the technical regulations and mandatory standards. 5. In case it has expired in accordance with the expiration date contained in the label. 6. In case it is damaged, decayed or contaminated with bacteria, viruses, fungus, or the toxins resulted therefrom, or parasites, worms or insects in all its phases or Xenobiotics that can cause inevitable harm. 7. In case it is traded in an environment or conditions that have made it harmful to health or subject to cross-contamination, including food-borne diseases. 8. In case it is made from the output of an animal, which is sick or carrier of an illness whose output is not permitted for animal consumption or from an animal that has died before being hunted or slaughtered. 9. In case the containing package is made from materials that are not conforming to the fodder containers requirements under the technical regulations and mandatory standards. 10. In case it is contaminated with radioactive material and the rate of radioactivity is higher than the rate permitted under the technical regulations and mandatory standards. 11. In case it contains hormones or medicines, including veterinary medicines or any residues thereof, at a rate that is higher than the rate permitted under the technical regulations and mandatory standards or in the absence of Standard specifications that allow the use of these substances or their residues in feed. 12. In case the label does not include the precautions necessary in accordance with the technical regulations and mandatory standards.

Article (22) Administrative Measures 1. In the event of any violation of the provisions hereof and without prejudice to any administrative measure or any penalty provided for in the relevant legislation, the Ministry or the competent authority may, as the case may be, take any of the measures provided for in this Article, which are as follows: a. Notice. b. Administrative closure of the organization that violates the provisions hereof for a period not exceeding three months. The Ministry or the competent authority may order to allow the violating organization to re-operate before the end of the administrative closure period in case that organization removes the subject matter of violation. c. Final closure of the organization and requesting the licensing authority to withdraw its license in case of failure to remove the reasons for the violation after the end of the administrative closure period. 2. The organization may appeal against the decision of final or administrative closure before the issuing entity within thirty days from the date of being notified of such decision, however the entity's decision in this regard shall be final.