UAE Healthcare / Pharma LawFederal Law No. (10) of 2015 Concerning the Food Safety

Article (1) Definitions In implementation of the provisions hereof, and unless otherwise required by the context, the following words and expressions shall have the meanings assigned thereto: The State : United Arab Emirates. The Ministry : Ministry of Environment and Water. The Authority : Emirates Authority for Standardization & Metrology (ESMA). The Minister : Minister of Environment and Water The Competent Authority : The local authority in charge of the safety of food and fodder in every Emirate. The Concerned Bodies : The Federal Ministries, government departments and public institutions concerned with the safety of food and fodder. Organization : The organization licensed to trade in food or fodder whether through a fixed or mobile, permanent or temporary facility. Organization Officer : The licensed natural or juridical person in charge of compliance with the provisions hereof as well as the regulations and resolutions issued hereunder in the Organization under his responsibility. Trading : The production, manufacturing, preparation, processing, packing, repacking, packaging, preparation, transportation, importation, possession,

-- 2 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 3 storage, distribution, serving, offering, sale, exportation or re-exportation of food or fodder in any of the food chain phases. The Licensee : A natural or juridical person holding a valid license to practice any activity related to the trading of food or fodder. Food : Any raw or primitive material or part thereof which is manufactured or semi-manufactured and edible for human consumption, whether by eating or drinking, including the bottled drinks and drinking water, pickles, spices, gum and any material used in the manufacturing, elaboration and processing of food. However, the food does not include the cosmetics, tobacco or materials which are only used as drugs. Fodder : Any material or part thereof assigned for feeding animals by mouth whether raw, manufactured, processed or prepared in whole or part including the fodder additives and the products used for feeding animals for the purposes of improvement of food material produced from animal origin. Fodder Safety : To ensure that the fodder does not affect the foods produced from animal origin or causes any damage to the human or animal health depending on the intended use. Fodder Health : All the necessary actions and measures taken to ensure the safety and validity of used fodder for consumption by the animal depending on the intended use. Primary Production : The phases preceding the manufacturing and preparation of food, including its cultivation and harvesting, breeding and milking farm animals, hunting wild animals, fish and marine food fishing and collection and harvesting of land products. Consignment : A specified quantity of food, fodder or both containing one or more batch usually in the same health certificate and other documents. Consumer : Whoever uses food to satisfy his personal needs and those of others. Technical : The document setting the properties of service or product, the production

-- 3 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 4 Regulations methods, the management systems, terms, codes, data, packaging, labeling as well as the requirements of the statement label applicable to the product or its production methods or limited to any of them and where the conformity is obligatory according to the specifications and standards applicable in the State. Food Chain : All the phases of the food starting from the fodder through the primary production till the consumption, including the manufacturing, elaboration, processing, packing, packaging, preparation, transport, import, possession, storage, distribution, serving, offering and sale. Food Safety : To ensure that the food does not cause any harm to the consumer when circulated or consumed depending on the intended use. Food Health : All the necessary actions and measures taken to ensure the safety and validity of used food through all food chain stages. Food Edibility : To ensure that the food is valid for human consumption depending on the intended use. Misleading Food : The food wrongly described for the purpose of commercial promotion including any inaccurate information about such food. Adulterated Food : A type of food, to the original components of which other substances are added to reduce its quality or nutrition value or some of the contents of which, rich in nutrition, are removed or the food the original information of which is changed without indicating the same on the food label. Spoiled Food : Food to the apparent or taste properties of which unintended changes were made including to its appearance, consistency, smell, taste or flavor making it inedible for human consumption or reducing the quality of its edibility. Harmful Food : Food containing hazards by its nature or hazards that have been mixed to it during any of the circulation phases, making it non-compliant with the technical regulations and legislation applicable in the State and adversely affecting the consumer's health.

-- 4 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 5 Food Label : Any statement, mark or any descriptive or image item whether written, printed, drawn, marked, engraved, stamped or pasted on the food container in addition to any document or information that is attached to, included in, associated with, or accompanying the food. Identification card: Any statement, mark or any descriptive or image item whether written, printed, drawn, marked, engraved, stamped or pasted on the fodder package in addition to any document or information that is attached, included, associated or accompanying thereof containing the explanation information related to the fodder description, composition, nature, preparation or guidelines on its use and storage. Health Measures : Measures applied for the purpose of protection of the consumer's health in the State from the hazards resulting from food additives, pollutants, pollutants, poisons or pathogens in the foods, from the hazards resulting from the diseases transported by plants, animals, vegetable or animal products or from the risks resulting from any other hazards in the food. Control : An obligatory activity aimed at protecting the consumer's health and to ensure the safety of food and fodder throughout their circulation phases in any stage of the food chain, their compliance with the requirements of health and quality and their accurate and clear description according to the provisions hereof and the issued rules, regulations and resolutions. Food Safety Systems : Organized, systematic scientific methods and ways aimed at early identification and assessment of risk sources and adoption of control measures to ensure the food safety. Seizure : Actions or measures taken by the competent or concerned authorities to keep the food or fodder under custody in the place they set until they verify its compliance with the provisions hereof. Tracking : A set of actions and measures aimed at tracking and tracing the movement of food and fodder throughout all the phases of circulation in the food chain.

-- 5 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 6 Recovery : Actions and measures to be taken to recover the food or fodder in case they do not comply with the provisions hereof. Such actions and measures include communicating with the consumer or traders of fodder once they receive it. Withdrawal : Actions and measures to be taken to recover the food or fodder in case they do not comply with the provisions hereof in any phase of the food chain and before they reach the end user. Risks : The potential the occurrence of detrimental impacts to the human health as a result of exposure to the risk source in the food or fodder in any phase of the food chain. Risk Analysis : Identifying the potential risks in the food or fodder based on scientific bases and the adoption of necessary measures for their management. Such analysis includes three elements: risk assessment, management and reporting. Risk Assessment : Assessment of the portability of occurrence of negative impacts and their effect on the consumer's health based on scientific bases. Such assessment comprises the identification and description of the risk source and the exposure to the risk source and source description. Risk Management : Estimation of the suitable alternatives in view of the risk assessment and other relevant factors to protect the consumer's health and encourage the fair commercial practices and adoption of preventive and regulatory options when necessary. Food Additives : Any substance that is not food or part of its components itself whether or not having nutrition value. Such substance is added to the food for technical purposes and its addition makes, or is expected to make, directly or indirectly in such substance or its side product a part of the food components or affects its properties. Packet : Any form of containers through which the food or fodder is kept or packed for sale as one unit including cans, rolls and bundles.

-- 6 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 7

Article (4) Competencies and Powers Subject to the provisions of the applicable legislation, the competent authorities shall be responsible for verifying the food throughout food chain stages. The Ministry shall be in charge of standardizing the procedures and supervising thereof in coordination with the competent authorities and concerned bodies in a way that achieves the following: 1. Setting the necessary policies, strategies and legislation to ensure the safety of foods in all stages of the food chain and to regulate the trade of food to enhance the food security and support the national economy. 2. To regulate the activities of trade of food and fodder including import, export and

-- 7 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 8 re-export. 3. To regulate the advertisement of the circulated food. 4. To contribute in the creation of awareness of the consumer on the food safety. The Ministry shall be in charge of creating awareness about the nature of any risk in the food, if any. 5. Management of crises, accidents, risks and notices related to the safety of food and fodder.

Article (6) Health and Precautionary Measures 1. In coordination with the competent authorities and concerned bodies, the Ministry shall set the health measures. The following shall be considered when such measures are set and implemented: A. To be based on scientific evidences and principles based on the risk analysis for all food chain stages aimed at the protection of the consumer's health and to implement such principles with transparency, objectivity and independency. B. To be based on the international standards, guidelines and recommendations in case

-- 8 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 9 the sufficient scientific proofs are unavailable. C. Not to discriminate between local and imported food and fodder. 2. The Ministry and the competent authority must take the precautionary measures towards any food or any related substances or activities that may cause harm to the consumer's health and must review such measures within a proper time period based on the risk analysis.

Article (8) Import 1. No food or fodder may be imported for the first time unless approved by the Ministry within a national system for approval and registration to be announced by the Ministry and to come in force as of the date of enforcement hereof. 2. No food or fodder may be imported through the State ports unless accompanied by the documents and certificates required under the provisions hereof as well as the rules and regulations issued by virtue thereof. 3. The risk analysis system for control of the food and fodder imported through all the borders of the State shall be approved under the provisions hereof as well as the rules and regulations issued by virtue thereof, the obligatory standards and technical regulations.

-- 9 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 10

Article (9) Obligations of the Person in Charge of the Food Organization Subject to the provisions of the Consumer's Protection Law, the Person in charge of the food organization shall: 1. Implement the regulations of food safety based on the risk source analysis approved by the State; 2. Ensure the food health, safety and edibility for human consumption; 3. Facilitate the duties of the officer in charge during the performance of the control, inspection and audit duties; 4. Provide the requested documented registers reflecting his compliance with this Law as well as the rules and regulations issued by virtue thereof; 5. Train and qualify his personnel in the field of the food health and safety according to the approved standards; 6. Ensure the medical fitness of his staff; 7. Notify the Ministry and the competent authorities about any food under his supervision which poses risks to the consumer's health; 8. Track the food traded in his organization under the regulation issued in this regard, identify the places of its distribution and storage and provide the relevant registers; 9. Ensure the accuracy and correctness of the data of the identification card of the food under his supervision to facilitate the tracking of the food; 10. Withdraw and recover the food if proved to be invalid for human consumption or in breach of the provisions hereof as well as the rules and regulations issued by virtue thereof, the obligatory standards and technical regulations and notify the competent authority and the Ministry of the same; 11. Provide any detailed information to the Ministry, the competent authorities or the concerned bodies related to the food traded in such organization and 12. Any other obligations set by the executive regulations.

-- 10 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 11

Article (10) Obligations of the Fodder Organization The officer in charge of the fodder organization shall: 1. Ensure the safety of fodder under his supervision; 2. Ensure the implementation of the general rules of fodder health as set by the Executive Regulations hereof; 3. Implement the good manufacturing practices and methods based on the risk analysis system and critical point control system approved by the State; 4. Provide the requested documented registers reflecting his compliance with this Law as well as the rules and regulations issued by virtue thereof; 5. Provide qualified persons to deal with the fodder; 6. Notify the Ministry and the competent authorities of any fodder under his supervision which may threaten the animal or human health; 7. Track the fodder traded in his organization under the regulations issued in this regard, identify the places of its distribution and storage and provide the relevant registers; 8. Ensure the accuracy and correctness of the data of the identification card of the fodder under his supervision to facilitate the tracking of the fodder; 9. Withdraw and recover the fodder if proved to be invalid or in breach of the provisions hereof as well as the rules and regulations issued by virtue thereof, the obligatory standards and technical regulations and notify the competent authority and the Ministry of the same; 10. Provide any detailed information to the Ministry, the competent authorities or the concerned bodies related to any fodder traded in such organization.

Article (11) Control and Inspection The Ministry and the competent authorities shall control the food and fodder in food chain stages and in the organizations through the following: 1. Obliging the organization to submit copies of its documents and certificates before the inspection process.

-- 11 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 12 2. Taking samples from the food and fodder according to the accredited system of risk analysis of the imported or locally manufactured foods or fodders or those existing in the markets and analyzing them, if necessary, in the accredited laboratories to verify their validity and conformity to the obligatory standard specifications, technical regulations and the provisions hereof. 3. To keep under custody any food or fodder from which samples have been taken for laboratory test until the results are declared. 4. If the results of the apparent test or laboratory test of the sample prove that it does not comply with the obligatory standard specifications, technical regulations and the provisions hereof, the competent authorities must take all the necessary actions in this regard. 5. Any other actions that the Ministry or the competent authorities deem necessary for the control and inspection process.

Article (12) Trade of Food and Fodder 1. The traded and imported food and fodder must comply with the technical regulations and legislation applicable in the State as well as the obligatory standard specifications and any conditions or standards set in any bilateral agreement with the exporting company. 2. The organization may not trade in any harmful, adulterated, misleading, spoiled, inedible food or that in breach of the technical regulations as set forth in the Executive Regulations hereof and the regulations issued in implementation thereof. 3. The fodder posing confirmed risk to the heath of humans or animals or that in breach of the technical regulations and the provisions hereof as set forth in the Executive Regulations hereof may not be traded. 4. It shall be prohibited to dispose of or change the data or components of the food or fodder kept under custody unless with a written permission from the competent authority as set forth in the Executive Regulations hereof and the regulations issued in implementation thereof.

-- 12 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 13

Article (14) Penalties Without prejudice to any more severe penalty in any other law: 1. Whoever trades any adulterated, harmful or spoiled food in any stage of the food chain shall be punished by imprisonment for not less than three months and a fine of not less than AED (100,000) one hundred thousand dirhams and not more than AED (2,000,000) two million dirhams or with either penalty. 2. Whoever trades without license, any food containing pork meat, derivatives or products, any alcoholic substances or any material against the provisions of the Islamic Sharia shall be punished by imprisonment for not less than one month and a fine of not less than AED (50,000) fifty thousand dirhams and not more than AED (500,000) five hundred thousand dirhams or with either penalty. 3. Whoever trades, circulates or publishes false description of a food for the purpose of misleading the consumer shall be punished by a fine of not less than AED (10,000) ten thousand dirhams and not more than AED (100,000) one hundred thousand dirhams. 4. Whoever disposes of any food or fodder kept under custody under the provisions hereof and the regulations and rules issued in implementation thereof shall be punished by imprisonment for not less than three months and not more than two years and a fine of not less than AED (100,000) one hundred thousand dirhams and not more than AED (300,000) three hundred thousand dirhams or with either penalty.

-- 13 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 14 5. Subject to the provision of item (1) of this article, whoever trades food or fodder against the technical regulations issued in implementation of the provisions hereof shall be punished by a fine of not less than AED (10,000) ten thousand dirhams and not more than AED (100,000) one hundred thousand dirhams. 6. Any person attempting to commit any of the offenses punishable under this Law shall be punished by the penalty of the full offense. 7. Whoever breaches any provision other than the provisions for which above mentioned penalties are assigned shall be punished by a fine of not less than AED (10,000) ten thousand dirhams. 8. The penalty shall be doubled in all cases in case of repetition of the offense.

Article (17) Regulation of Administrative Measures 1. The Ministry and the competent authority may take any of the following measures and penalties: A. Warning;

-- 14 of 16 --

Federal Law No. (10) of 2015 Concerning the Food Safety 15 B. Administrative closure of the organization in breach of the provisions hereof for a period of not more than three months. The Ministry and the competent authority shall have the right to issue the resolutions allowing such establishment to resume its business before the expiration of the administrative closure period in case of removal of the breach subject and C. Final closure of the organization and requesting the concerned body to withdraw its license in case of failure to remove the reasons of such breach after the period of administrative closure. 2. The organization may submit a grievance against the temporary or permanent closure resolution within thirty days from the date of being notified of such resolution as set by the Executive Regulations hereof. 3. The penal action may not be filed in respect of the offenses set forth in the items (2), (5) and (7) of the article (14) unless with a written request from the Ministry or the competent authority. 4. Conciliation may be concluded in respect of the offenses set forth in the items (2), (5) and (7) of the article (14) before the referral of the action to the competent court against the payment of an amount of not more than AED (100,000) one hundred thousand dirhams for every offense. 5. The Cabinet shall issue a resolution setting the regulations of conciliation and the amount of such conciliation in respect of each of the offenses referred to in the item (4) of this article.