Regulations for the Control of Food and Beverages Arsa (Unpublished)

The purpose of this Regulation is to establish the provisions for the regulation, control and health promotion that must be complied with by natural or legal persons under which sanitary authorizations shall be granted for foods and beverages, their raw materials and establishments dedicated to the manufacture, preparation, handling, sale, packaging, preservation, importation, exportation, storage, transportation, distribution, commercialization and others of sanitary interest related thereto, which include hospitality services; as well as the advertising thereof, in order to protect the health of the population. FIELD OF APPLICATION

This Regulation applies to natural or legal persons that manufacture, prepare, handle, sell, package, preserve, import, export, store, transport, distribute, commercialize, advertise foods and beverages, their raw materials, and establishments that intervene in any activity related thereto; which include hospitality services, within the national territory.

The application of this Regulation is the responsibility of the Health Regulatory Agency (ARSA) and its competent delegated authorities.

For the application of this regulation, the following definitions, acronyms and abbreviations are established: Label Depletion: The temporary permission granted by ARSA, so that the interested party exhausts, as its name indicates, the product or labeling or packaging material whose information differs from the current one, due to renewal, modification and current provisions. Health Alert: Any suspicion of a situation of potential risk to the health of the population and of social significance, in the face of which it is necessary to develop urgent and effective Public Health actions. Adulterated Food: That to which deliberately and for fraudulent purposes, a substance has been added or removed. They are modified to vary their composition, weight or volume or to conceal a defect. There may be label falsification to make it appear to be of a known brand or superior quality. Altered Food: When for causes not deliberately caused it has suffered variations in its organoleptic characteristics (taste, smell, texture), chemical composition or nutritional value. Although it remains innocuous (does not constitute a risk to health) it is no longer fit for consumption. Contaminated Food: Food that contains foreign agents and/or substances of any nature in quantities exceeding those permitted in national standards, or in the absence thereof in internationally recognized standards. Falsified Food: That which contains labeling in a deliberately fraudulent manner with respect to the identity, composition and/or origin of a finished product or an ingredient. Falsification can be applied to both branded and generic products. Additionally, they may include products with correct ingredients, incorrect ingredients or technological function or with false packaging or incorrect labeling; they may also contain various impurities and/or in different quantities, both harmful and toxic. Perishable Food: Food that, due to its composition, physical-chemical and biological characteristics, may experience alteration of various kinds within a determined time and which, therefore, requires special conditions of process, preservation, storage, transportation and sale. Example: Dairy products, meats, poultry, fish, cold meats (processed meats), fruits, vegetables and prepared foods. Non-Perishable Food: Food that can be safely stored for long periods of more than 6 months. Example: beans, sugar, flour, pasta, rice, canned goods. Unprocessed Food: Food that has not undergone modifications of physical, chemical or biological origin, except those indicated for hygiene reasons or for the separation of non-edible parts. Processed Food: Food that has been subjected to appropriate technological process for its preservation and subsequent consumption. Semi-Processed Food: Food that has been subjected to appropriate technological process for its preservation and that requires prior treatment before its subsequent consumption. Food: Any substance processed, semi-processed or unprocessed, that is intended for human ingestion including beverages, chewing gum and any other substances used in its elaboration, preparation and treatment, but does not include cosmetics, tobacco or substances used as medicines. Foods Sold on Public Ways: Non-alcoholic foods and beverages ready for consumption, prepared or sold by persons on the street and public places. Food Storage: Consists of the proper accumulation of merchandise, infrastructure conditions and procedures established during the storage of foods, beverages and related products, with the purpose of guaranteeing the quality and safety of said products. Risk Analysis: Consists of the evaluation, management and communication of risks. Regulatory Authority: Body, Agency or public official of the Health Regulatory Agency that by law or delegation has power to ensure compliance with norms, policies, criteria, systems or procedures that, by its own or delegated authority, is competent to regulate, control, monitor and enforce compliance with the current normative framework. Special Authorizations: Process through which the importation, use or consumption of products of sanitary interest are authorized that do not require sanitary registration, but comply with the technical legal requirements established in this regulation and they must not be commercialized. Sanitary Authorization: The act by which the holder of the competent Regulatory Authority approves a natural or legal person, the performance of activities or services related to products and establishments of sanitary interest, complying with the requirements established in the current normative framework. Cancellation of Authorizations: Permanent deprivation of the authorization that had been granted at the request of the interested party or for having incurred in facts or conduct contrary to sanitary provisions. Commercialization: Commercialization is the set of actions and procedures to effectively introduce products into the distribution system. Preservation: Application of technologies responsible for extending the useful life and availability of foods for human consumption, protecting them from pathogenic microorganisms and other agents responsible for their deterioration, and thus allowing their future consumption. Contaminant: Any substance, not intentionally added to food, which is present in said food as a result of production (including operations carried out in agriculture, livestock and veterinary medicine), manufacturing, preparation, treatment, packaging, wrapping, transportation or storage of said food or as a result of environmental contamination. This term does not cover insect fragments, rodent hair and other foreign matter. Quality Control: Planned system of activities whose purpose is to ensure a product of maximum quality. Sanitary Control of Imports: That which allows identification, classification and traceability to facilitate health surveillance of all imported products intended for human consumption and use. Sanitary Control of National Production: That which allows identification, classification and traceability to facilitate health surveillance of all products manufactured in the national territory intended for human consumption and use. Disinfection: The reduction of the number of microorganisms present on the surfaces of buildings, installations, machinery, utensils, equipment, through chemical treatments or appropriate physical methods, until a level that does not constitute a risk of contamination for foods to be prepared. Distribution: The set of activities, which are performed from the moment the product is manufactured by the manufacturer until it is purchased by the final consumer. Distributor: Natural or legal person who is responsible for distributing and commercializing a product at the national level. Preparation: Have as their object the initial transformation of raw food to obtain another different product, generally more suitable for its ingestion. Some of the preparation processes are based on food preservation. Food Packaging: Any container that contains food for its delivery as a single product, which covers them from external agents of alteration and contamination, as well as from adulteration. Food Establishment: It is the place where foods and beverages are manufactured, distributed, handled, stored, packaged, sold and dispensed; vehicles that transport food; food sales points on public ways and hospitality services. Sale: Place where food products of prime necessity are sold, at retail. Manufacturer: Natural or legal person responsible for the production of foods and beverages suitable for human consumption, through preparation, preservation and packaging processes. Health Promotion: Set of actions oriented to promote continuous improvement of sanitary conditions of processes, products, methods, installations, services or activities that may cause a risk to the health of the population through communication schemes, training, coordination and agreement with public, private and social sectors, as well as other non-regulatory measures. Hospitality: Establishments that provide accommodation and food services among others. Sanitary License: The authorization granted by ARSA so that an establishment can manufacture, import, export, transport, distribute, handle, store, package, sell and dispense foods and beverages, once it complies with all technical and legal requirements. Cleaning: The elimination of soil, food residues, dirt, grease or other objectionable matter. Handling: Any business activity in which persons intervene in aspects such as the preparation, manufacture, transformation, preparation, packaging, storage, transportation, distribution, handling, sale, supply or services of food products intended for consumers. Sanitary Measure: Set of actions applied by ARSA to prevent, mitigate, control or eliminate an event that originates risks that affect the health of the population. Microenterprise: That company with a minimum of one remunerated person working in it, which is almost always the result of an entrepreneurial project, who will even be in charge of managing and operating the same. It has a fairly limited impact on the market in which it operates, does not sell large volumes, nor does it need a large amount of capital to function, but on the other hand, manual labor will predominate. Sampling: Taking units of a product that are representative of the total of the same. Temporary Sanitary Permit: The temporary authorization granted by ARSA for the commercialization of foods and beverages in the national territory, which does not have sanitary registration. Sanitary Permit for Microenterprise: The Sanitary authorization granted to those entrepreneurial persons who are starting a business and who do not yet have an establishment independent of their home, through this authorization they are allowed to develop for one year until obtaining their sanitary license. Products of Sanitary Interest: Foods and beverages, medicines, biologics, biotechnological, homeopathic, natural, food supplements, cosmetics, hygienic, medical device for human use, pesticides for domestic and professional use, laboratory reagents, controlled chemical substances and others that are thus considered by the competent Regulatory Authority. Advertising: All promotion of informational and persuasive activities deployed with the objective of inducing the supply, acquisition or use of foods and beverages, regardless of the strategies, means and communication vehicles employed is considered advertising. For purposes of this regulation, advertising and propaganda are included in promotion activities. Sanitary Registration for Microenterprise: The sanitary authorization granted to foods and beverages of those entrepreneurial persons who have a sanitary permit for microenterprise, with the limitation that this product can only be commercialized in the national territory. Sanitary Registration: The authorization granted by ARSA, so that a product of sanitary interest can be manufactured, prepared, packaged, stored, imported, exported, distributed and promoted, once it complies with all technical and legal requirements. Honduran Technical Regulation: Document that establishes technical provisions that safeguard legitimate national objectives regarding goods, services and their processes, whose observance is mandatory. Technical Manager of the Establishment: The person with professional or technical training in the area, who assumes the technical and scientific direction of the establishment together with the owner; according to the needs of the establishment, are responsible for services, the implementation of Good Manufacturing Practices, the good condition and supply of raw materials, products, as well as infractions to legal and regulatory provisions that derive from their operation. Risk: Function of the probability of a harmful effect on health and the severity of that effect, as a consequence of a hazard. Applicant: That which is legally responsible for managing the procedure before ARSA, which may be the principal, attorney or legal representative or anyone they designate. Suspension of Authorizations: Sanction consisting of the temporary cessation of the right conferred by sanitary authorization for having incurred in non-compliance with the current sanitary regulations. Sample Taking: Constitutes the act of selecting a determined portion, number of containers or units of measure of the product that are representative of the batch of food from which it is obtained. Food Transportation: The operation in which fresh or processed products are mobilized whether in raw or processed form, for direct consumption or to be used as raw materials or ingredients in manufacturing or food preparation processes. Traceability: Ability to identify the origin of a product and its destination. Health Surveillance: Set of actions to carry out physical verification or inspection of products, processes or services throughout the production and commercialization chain, and their comparison against the requirements established in the corresponding regulations to evaluate their compliance. Acronyms and Abbreviations: ARSA: Health Regulatory Agency BPA/D: Good Storage Practices and Good Distribution Practices BPL: Good Laboratory Practices BPM: Good Manufacturing Practices CLV: Certificate of Free Sale FDA: Food and Drugs Administration WHO: World Health Organization RTCA: Central American Technical Regulation CHAPTER II SANITARY REGULATIONS APPLICABLE TO PRODUCTS, SERVICES AND ESTABLISHMENTS OF SANITARY INTEREST

In the case of establishments related to foods and beverages and others of sanitary interest in which hospitality services are included, this Regulation provides for mandatory compliance with current sanitary regulations that must be applied in the following order of precedence:

• a)

  Constitution of the Republic,

• b)

  Central American Technical Regulations,

• c)

  The Health Code;

• d)

  This Regulation;

• e)

  Honduran Technical Regulations, and f) other normative documents that ARSA approves and adopts.

Foods and beverages referred to in this Regulation shall be obligated to comply with current sanitary regulations that must be applied in the following order of precedence: a) Constitution of the Republic b) Central American Technical Regulations, c) The Health Code; d) This Regulation; and, e) Honduran Technical Regulations, f) Codex Alimentarius Standards, g) Standards of the Federal Code of Regulations of the Food and Drug Administration Office (FDA) of the United States of America or European Union Directives, and other regulations that ARSA approves and adopts. To determine the precedence of what is stipulated in subsection f) of this article, the order shall follow the regulations that indicate the most current and complete specifications to verify product quality.

To exercise sanitary control of foods and beverages and of establishments dedicated to the manufacture, preparation, handling, sale, packaging, preservation, importation, exportation, storage, transportation, distribution, commercialization and advertising of foods and beverages, their raw materials and others of sanitary interest related thereto which include hospitality services, ARSA establishes as control mechanisms: Sanitary License, Sanitary Registration, Sanitary Inscription, Temporary Sanitary Permit, Sanitary Inspection, Laboratory Analysis and other mechanisms that, according to the needs, ARSA establishes.

Products foods and beverages and others of sanitary interest shall be commercialized only if they have sanitary authorization issued by ARSA, to natural or legal persons who are properly authorized by this Agency. Every natural or legal person who commercializes products Foods and Beverages and others of sanitary interest prior to their entry to the market must notify ARSA, each batch to be commercialized. Foods and Beverages Products for personal use or consumption that do not have sanitary registration, shall be regulated in accordance with the special regulations that ARSA issues for such purposes.

All food and beverage establishments, their raw materials and others of sanitary interest related thereto which include hospitality services, shall be subject to this Regulation, for which they must comply with the essential requirements, established in the regulations issued for such purpose.

According to the activity or service they provide, all establishments subject to this regulation must be located in independent premises and must be separated from any other commercial or residential establishment. From the foregoing paragraph, establishments of sanitary interest are included that according to the activity or service they provide, at the reasoned discretion of ARSA, may be installed in shopping centers, supermarkets, department stores and other similar establishments, the same may be located in common areas, provided that the services are related, in this case the recovery fee for services provided shall be accumulated and only one single sanitary license shall be issued, and they must comply with the minimum requirements established in current sanitary regulations. In cases where the establishment has different services, for different products regulated by ARSA, the sanitary license shall obtain the nomenclature of the service or product that presents the highest risk.

ARSA must prepare, and make official the classification lists of food and beverage establishments, and others of sanitary interest related thereto which include hospitality services, which must be updated according to the needs that are determined.

Food sales points on public ways must comply with what is established in current regulations.

Food and beverage factories and warehouses must comply with what is established in the legal regulations described in Article 5 of this Regulation.

Food and beverage production establishments must have a technical manager of the establishment who performs the technical direction and supervision in accordance with the complexity of the establishment and the criteria that ARSA establishes for such purpose.

Establishments where foods and beverages are handled, sold and served must comply with the hygiene and sanitary conditions established in the regulations that ARSA issues for such purpose.

For establishments where foods and beverages are handled, sold, and served, the following prohibitions are established:

• a)

  The entry of persons without adequate uniforms to the processing or handling section, as well as the presence of unauthorized persons.

• b)

  Eating, drinking, sleeping, smoking, or spitting in areas related to the process, packaging, storage, and service of foods.

• c)

  Using the premises, facilities, furniture, equipment, and utensils for purposes other than those of the activity itself.

• d)

  Selling or transferring gratuitously foods that are unfit for human consumption.

• e)

  The presence of persons suffering from infectious contagious diseases.

• f)

  The entry and presence of domestic animals.

• g)

  The storage of dangerous substances. OF THE REQUIREMENTS FOR FOOD AND BEVERAGE HANDLERS

Every person who handles and sells foods must submit to medical evaluations and controls: general medical examination, stool examination, urine examination, investigation of infectious hepatitis and other infectious-contagious pathologies, in public or private health facilities, of which a record must be kept in the employee's personal files of the company. Said controls must be performed every six (6) months.

Every food handler must comply with the following requirements:

• a)

  Be in good health.

• b)

  Personal hygiene and good appearance.

• c)

  Practice hygiene habits.

The following are prohibited:

• a)

  Handling foods if presenting symptoms that could cause direct contamination to the foods.

• b)

  Cleaning hands and utensils with one's work coat or apron.

• c)

  Inserting fingers into utensils and touching prepared foods or foods being prepared without gloves.

• d)

  Unauthorized persons intervening in the preparation and service of foods. OF THE STORAGE OF FOODS

The storage of foods and beverages and their raw materials must comply with the following conditions:

• a)

  Stack foods by lots that maintain proper distance between them and from the walls, floors, and ceilings.

• b)

  Have spaces that facilitate the cleaning of facilities, movement, receipt, handling, and sale of foods.

• c)

  Rotate inventory and make periodic removals based on the storage time and conservation conditions required by each product following the rule of first to expire, first to exit.

• d)

  Maintain the conditions of the premises and the good state of the foods.

• e)

  Remove deteriorated, expired, altered, infected, or contaminated foods, as well as those whose containers appear broken or dented; these shall be processed accordingly through denaturalization and destruction.

• f)

  Foods that require special temperature conditions must be conserved at the appropriate temperature without interruption so that foods do not suffer alterations or changes in their initial characteristics.

• g)

  Foods and beverages and their raw materials must be conserved taking into account their nature and characteristics in order to maintain the useful life thereof.

• h)

  Maintain relative humidity according to the nature of the product.

• i)

  Adequate air circulation.

• j)

  Protect against the direct action of sunlight, when harmful to the product.

• k)

  Separate substances or products that emit odors from those others that could absorb them.

• l)

  Control of insects and rodents.

The following are prohibited: a) Storing and transporting foods and beverages and their raw materials together with dangerous substances. b) Storing and transporting foods and beverages and their raw materials that are altered, contaminated, adulterated, falsified, or expired together with others that are suitable for human consumption.

The provisions established in Articles 20 and 21 shall not apply to factories and warehouses thereof, as these shall be subject to the provisions of the Central American Technical Regulation Industries of Processed Foods and Beverages Good Manufacturing Practices.

The transport of foods and beverages and their raw materials must be carried out in such a manner as to guarantee sanitary conditions; therefore, they must comply with the following conditions:

• a)

  Designed and constructed in such a way as to ensure the correct conservation of foods and beverages and their raw materials, as well as protection from contaminants.

• b)

  Closed and internally lined with sanitary, impermeable, corrosion-resistant material that is easy to clean, which allows them to be kept in adequate hygiene conditions, as well as the containers and utensils used in any activity related to transport.

• c)

  Have independent sections for each product when transporting more than one variety of foods and beverages and their raw materials.

The following are prohibited:

• a)

  Being used for purposes other than their own function.

• b)

  Placing raw materials and foods directly on the surface of vehicles.

• c)

  Transporting foods in the same vehicle with contaminating objects or substances.

• d)

  Transporting foods and animals in the same vehicle.

• e)

  Transporting raw materials and foods in vehicles that do not have their respective Sanitary License authorization. OF THE STANDS OR PREMISES WHERE NON-ALCOHOLIC FOODS AND BEVERAGES ARE SOLD ON PUBLIC ROADS

The stands or premises where non-alcoholic foods and beverages are sold on public roads must comply with the hygienic-sanitary conditions established in the regulations that ARSA issues for such purpose.

Other establishments are considered those that, according to their activity, provide services different from those described in this regulation; they shall be equally subject to the provisions established in this regulatory body and other applicable current regulations. CHAPTER III OF THE SANITARY LICENSE AND ITS RENEWAL GENERAL PROVISIONS

Prior to its installation and operation, every food and beverage establishment and others of sanitary interest requires a Sanitary License issued by ARSA. The modification and renewal of the Sanitary License granted to a food and beverage establishment and others of sanitary interest requires prior authorization from ARSA.

The Sanitary License for food and beverage establishments and others of sanitary interest shall, at the option of the interested party, have a validity of two (2), four (4), or six (6) years, counted from the date of its issuance.

ARSA shall grant the Sanitary License in accordance with the procedures established in its quality management system.

A single Sanitary License may cover various activities or services, provided that these are related to each other and are located within the same physical facilities and under the same business name or denomination. In that case, the recovery fee for services provided for each activity shall be accumulated.

When an establishment is unable to directly provide a particular activity or service and such activity or service is mandatory for its operation, it may provide such activities or services through the service purchase mechanism, provided that the establishment offering the activity or service possesses its corresponding current Sanitary License.

It is strictly prohibited for all food and beverage establishments and other establishments of sanitary interest to engage in activities or provide services different from those approved by ARSA and to operate open to the public without possessing a current Sanitary License.

The owners or legal representatives of establishments must inform within a period not exceeding thirty (30) business days, when they decide to cease providing their services temporarily or permanently, and must notify of the reopening. REQUIREMENTS TO OBTAIN THE SANITARY LICENSE

To obtain the Sanitary License for food and beverage establishments, the following requirements must be met: 1. Submit a request addressed to the Sanitary Regulation Agency whose title states, ''SANITARY LICENSE IS REQUESTED'' and includes the following information: a. Body to which it is directed: Sanitary Regulation Agency (ARSA). b. Name and general information of the owner or legal representative. c. Corporate name or company designation (when applicable). d. Name of the establishment. e. Exact address of the establishment, including telephone and email. f. Activity or Activities to which it will be dedicated. g. Requested validity period. (2, 4 or 6 years). h. Place and date of the request. i. Signature of the applicant. 2. Photocopy of the articles of incorporation of the company or individual merchant properly registered (when applicable). 3. Location sketch of the establishment. 4. Sketch of the distribution of internal and external areas according to the type of establishment and photographs of the same. 5. Sworn Statement, duly authenticated/legalized (when applicable). 6. Recovery fee for services rendered.

In the case of vehicles and means of transport of food products and services of sanitary interest, items (1, 5 and 6) of the previous article must be met and also the following specific requirements: a) Copy of the proof of annual single rate for vehicle registration. b) Lateral, frontal and rear photographs of the vehicle, showing the conditions in which the product will be transported.

In the case of food and non-alcoholic beverages sold on public roads, the following requirements must be met: 1. Submit a request addressed to the Sanitary Regulation Agency whose title states, ''SANITARY LICENSE IS REQUESTED'' and includes the following information: a. Name and general information of the owner or holder. b. Address. c. Name of the food handler(s) at the sales point. d. Exact address of the sales point, its route or path (when applicable). e. Type of sale (mobile or stationary). f. Foods that it manufactures, prepares, handles or sells. g. Name or business designation of the establishment (when applicable). h. Place and date of the request. i. Signature of the applicant. 2. Food Handler Health Card for persons involved in the activity (current). 3. Sworn Statement, duly authenticated/legalized. 4. Recovery fee for services rendered. The validity of the sanitary license for food sales on public roads shall be for a duration of 2 (two) years from the date of issue. REQUIREMENTS TO OBTAIN THE SANITARY LICENSE FOR FOOD FACTORIES AND WAREHOUSES

To obtain the sanitary license for food and beverage factories and warehouses, it shall be regulated in accordance with what is established in the Central American Technical Regulation, Processed Foods. Procedure to grant the Sanitary License to Factories and Warehouses in effect.

The Renewal of the Sanitary License for food and beverage establishments and other establishments of sanitary interest is the extension of its validity, at the option of the interested party, and shall have a validity of two (2), four (4) or six (6) years. Once the sanitary license expires, it shall be in an inactive state, which may be reactivated by making effective the recovery fee for services rendered for reactivation of the sanitary license and the recovery fee for renewal, which shall be counted from the date of the previous expiration. REQUIREMENTS TO OBTAIN THE RENEWAL OF THE SANITARY LICENSE FOR FOOD AND BEVERAGE ESTABLISHMENTS

To obtain the Renewal of the Sanitary License for food and beverage establishments, the following requirements must be met: 1. Submit a request addressed to the Sanitary Regulation Agency whose title states, ''SANITARY LICENSE RENEWAL IS REQUESTED'' and includes the following information: a. Name and identification number of the owner or legal representative of the establishment. b. Corporate name or company designation (when applicable). c. Name of the establishment. d. Exact address of the establishment, including telephone and email. e. Activity or Activities to which it will be dedicated. f. Requested validity (2, 4 or 6 years). g. Number of the previous sanitary license. h. Place and date of the request. i. Signature of the applicant. 2. Submit a sworn statement, duly authenticated/legalized, stating that it maintains the original conditions under which the sanitary license was granted. 3. Recovery fee for services rendered.

In the case of vehicles and means of transport of food products, they must comply with items 1 (a, e, f, g, h, i), 2) and 3) of the preceding article and the copy of the proof of annual single rate for vehicle registration.

In the case of food and non-alcoholic beverages sold on public roads, the following requirements must be met: 1. Submit a request addressed to the Sanitary Regulation Agency whose title states, ''SANITARY LICENSE RENEWAL IS REQUESTED'' including the requirements established in article 36 of this Regulation, and if appropriate, it shall be granted for the same validity period as the article referred to.

To obtain the renewal of the sanitary license for food and beverage factories and warehouses, it shall be regulated in accordance with what is established in the Central American Technical Regulation, Processed Foods. Procedure to grant the Sanitary License to Factories and Warehouses in effect. MODIFICATION OF THE SANITARY LICENSE

The Sanitary License may be modified if any one or several of the following changes occur: transfer of ownership, change of name or corporate designation of the establishment, change of location, expansion or reduction of activities, services and business hours when applicable, and others at the discretion of ARSA.

ARSA shall grant the modification of the sanitary license, preserving the nomenclature and validity of the Sanitary License initially granted. If the modification results in a change in the category of the establishment, the adjustment shall be applied according to the recovery fee for services rendered. REQUIREMENTS TO OBTAIN THE MODIFICATION OF THE SANITARY LICENSE

To obtain the Modification of the Sanitary License, the following requirements must be met: 1. Submit a request addressed to the Sanitary Regulation Agency whose title states, ''MODIFICATION OF THE SANITARY LICENSE IS REQUESTED'' and includes the following information:

• a)

  Name and identification number of the owner or legal representative of the establishment.

• b)

  Corporate name or company designation (when applicable).

• c)

  Name of the establishment.

• d)

  Exact address of the establishment, including telephone and email.

• e)

  Description and justification of the modification requested.

• f)

  Place and date of the request.

• g)

  Signature and seal of the applicant. 2. Original License. 3. Document that supports the change (when applicable). 4. Recovery fee for services rendered. NOMENCLATURE OF THE SANITARY LICENSE

The Sanitary License shall have the following nomenclature:

• a)

  The capital letters HN, followed by a hyphen (-): Which means Honduras.

• b)

  The capital letters LEA, followed by a hyphen (-): Which means license for food and beverage establishment. In the case of means of transport, the capital letters LTA shall be used and for stalls or premises on public roads, the capital letters LVPA shall be used.

• c)

  Four (4) digits: Two (2) numbers that identify the month and two (2) numbers that identify the year, followed by a hyphen (-).

• d)

  Sequential numbering of four (4) digits, beginning with the number 0001. OF FOOD AND BEVERAGES GENERAL PROVISIONS

The importation and commercialization of food and beverages shall be carried out exclusively by natural or legal persons authorized by ARSA. The Competent Authority in customs, through its departments, shall only permit the entry into the country of food and beverages if it demonstrates possession of valid authorization issued by ARSA.

All food and beverages, whether national or imported, that are intended to be donated, must comply with what is established in the present regulations.

ARSA shall prepare and officially communicate the classification by types of food and beverages, considering the risks that these represent for the health of the population, which shall be updated periodically.

In accordance with the Sanitary Risk that food and beverages represent, they are classified as follows: a) Risk "A" High Risk b) Risk "B" Medium Risk c) Risk "C" Low Risk OF SANITARY REGISTRATION GENERAL PROVISIONS

Food and beverages, prior to their manufacture and elaboration, that are sold under a brand name and determined name to be commercialized, as well as their storage, importation, packaging, distribution, advertising and commercialization in the national territory, as well as those that, before being placed for sale, undergo some process of elaboration, transformation and division, require Sanitary Registration or sanitary authorization issued by ARSA.

It is not permitted to manufacture, elaborate, package, store, import, export, distribute and promote wholesale or retail or make any advertising of all food and beverages that do not possess Sanitary Registration or valid sanitary authorization. Raw materials, food and beverages that do not have sanitary registration and that are not commercialized in the country may be exported prior to authorization from ARSA, before each exportation.

Raw materials and food that are not subjected to any process of transformation or packaging do not require Sanitary Registration, but shall be under surveillance and sanitary inspection by ARSA. OF THE REQUIREMENTS TO OBTAIN OR RENEW SANITARY REGISTRATION

To obtain the Sanitary Registration of food and beverages, it shall be regulated in accordance with the conventions or international treaties ratified by Honduras and the other provisions established by ARSA.

ARSA shall authorize the Sanitary Registration, assigning a unique nomenclature to it.

To obtain the renewal of sanitary registration of food and beverages, it shall be regulated in accordance with the conventions or international treaties ratified by Honduras and the other provisions established by ARSA. OF THE REQUIREMENTS TO OBTAIN THE RECOGNITION OF SANITARY REGISTRATION

To obtain the Recognition of Sanitary Registration of food and beverages, it shall be regulated in accordance with the conventions or international treaties ratified by Honduras and the other provisions established by ARSA. Without prejudice to ARSA conducting a posteriori sanitary surveillance and inspection. OF THE MODIFICATION OF SANITARY REGISTRATION.

To obtain the modification of the Sanitary Registration of food and beverages, it shall be regulated in accordance with the conventions or international treaties ratified by Honduras and the other provisions established by ARSA.

Furthermore, every holder of Sanitary Registration must request from ARSA the modification of the Sanitary Registration when changes occur in any condition existing at the moment of its initial grant, such as: name of the manufacturer or distributor of the product, name of the registered product, of the container, label and packaging, of the commercial presentation, of the excipients of the product that do not modify the nature thereof.

When food products, beverages or other related items undergo modification of the active principle, chemical formula, concentration of active principle, excipients that modify the nature of the product, country of origin of the manufacturer, a new sanitary registration shall be processed.

ARSA shall authorize the modification of the Health Registration, Recognition of the registration, health registration, preserving the same nomenclature and validity of that originally granted. OF THE NOMENCLATURE OF THE HEALTH REGISTRATION

The Health Registration shall have the following nomenclature:

• a)

  The capital letters HN, followed by a hyphen (-): Which means Honduras.

• b)

  The capital letter A, followed by a hyphen (-): Which means food and beverage.

• c)

  Four (4) digits: Two (2) numbers identifying the month and two (2) numbers identifying the year, followed by a hyphen (-).

• d)

  Sequential numbering of four (4) digits, beginning with the number 0001.

  OF THE CAUSES FOR NON-ISSUANCE OF HEALTH AUTHORIZATIONS

Health authorizations shall not be granted when: 1. There exists an international alert issued by a regulatory authority. 2. The documentation presented according to current regulations is incomplete, incorrect, or not current. OF THE CANCELLATION OF HEALTH AUTHORIZATIONS

Health registrations shall be immediately cancelled when it is demonstrated:

• a)

  That the product proves to be harmful or unsafe for the consumer under normal conditions of use.

• b)

  When there exist national or international alerts regarding the consumption of a particular product where it is demonstrated that the product presents a risk to the health of the population.

• c)

  When it is demonstrated that the data and information contained in the authorization file are erroneous or false.

• d)

  When falsity is proven in the sworn statement.

• e)

  As a result of a process of health surveillance and inspection by ARSA it is demonstrated that the product is not suitable for human consumption.

• f)

  That for any other justified cause constitutes a foreseeable risk to the health or safety of persons.

• g)

  When the holder of the health registration requests it.

• h)

  In the event that the result of the food safety control analysis is found outside specifications, and once the administrative procedure is concluded, ARSA shall cancel the health authorization, and may not submit a new application until three (3) years after the cancellation of the health authorization. Once this time has elapsed, he may request the health authorization through a new application, prior to its issuance, the food safety control analysis shall be conducted by the official laboratory.

  CHAPTER IV OF THE HEALTH AUTHORIZATIONS PRIOR AND SUBSEQUENT TO THE COMMERCIALIZATION OF FOODS AND BEVERAGES GENERAL PROVISIONS

To obtain the Health Authorization of the Free Sale Certificate, Importation and Exportation, Donations, Special Authorizations, Notification of importation, Notification of national production, and other authorizations of foods and beverages and their raw materials; which in the future are determined by ARSA, they must comply with the requirements established in this Regulation. ARSA shall determine when it is necessary to obtain a Health Authorization not contemplated in this section and shall establish the requirements that must be met, prior to issuing the corresponding Health Authorization to the applicant. FREE SALE CERTIFICATE FOR FOODS AND BEVERAGES

To obtain the Authorization of the Free Sale Certificate the following requirements must be presented: 1. Submit an application addressed to the Health Regulatory Agency whose title states: FREE SALE CERTIFICATE IS REQUESTED, and includes the following data:

• a)

  Product name.

• b)

  Legal name of the holder and manufacturer of the product.

• c)

  General data of the applicant.

• d)

  Address of the holder and manufacturer.

• e)

  Health Registration number.

• f)

  Health License number.

• g)

  Place and date of the application.

• h)

  Destination country of the product.

• i)

  Signature of the applicant. 2. Service recovery fee. The Free Sale Certificate for foods and beverages shall have a validity of two (2) years counted from the date of its issuance. In the case of the health registration that expires before this period, the validity of this certificate shall be the same as that of the health registration.

  IMPORTATION OF RAW MATERIALS FOR FOODS AND BEVERAGES

To obtain the Health Authorization for the importation of raw materials for foods and beverages, the following requirements must be presented for each shipment to import: 1. Submit an application addressed to the Health Regulatory Agency, whose title states IMPORTATION OF RAW MATERIAL / FOODS AND BEVERAGES IS REQUESTED, which includes the following data: a. Name and address of the importer. b. Name of the raw material / food and beverage to be imported. c. Date of arrival of the shipment. d. Port of entry and name of the customs office. e. Name of the customs office through which the customs clearance will be processed. f. Class, type, and quantity of raw material / food and beverage. g. Identification of the means of transport. h. Country of origin of the raw material / food and beverage to be imported. i. Health Registration number of the food and beverage to be imported when applicable. j. Batch number of the raw material / food and beverage to be imported. k. Expiration date of the raw material / food and beverage to be imported. l. Other information that in the judgment of the importer may serve the Regulatory Authority. m. Signature of the applicant. 2. Pro forma invoice. 3. Service recovery fee. OF THE SPECIAL HEALTH AUTHORIZATIONS FOR IMPORTATION

In the case of Donations, prior to its entry into the national territory, a Special Health Authorization for Importation must be obtained, and must comply with the requirements established in this Regulation.

In the case of Importation of Foods for Exhibition and Tasting purposes, it shall be regulated in accordance with the conventions or international treaties ratified by Honduras and the other provisions established by ARSA.

In the event that circumstances of disasters and national emergencies and public necessity arise, declared official by Decree issued by the Executive Branch, prior to its entry into the national territory, a Special Health Authorization for Importation must be obtained.

Foods and beverages whose importation authorization is found within the parameters stated in Articles 67, 68, and 69 may not

be commercialized under any modality and shall be subject to health surveillance and inspection by ARSA.

The Special Health Authorizations referred to in this Section shall have a validity of ninety (90) days counted from the date of issuance. OF THE REQUIREMENTS TO OBTAIN SPECIAL HEALTH AUTHORIZATIONS FOR IMPORTATION

To obtain the Special Health Authorization for Importation of Donations, the following requirements must be complied with: 1. Submit an application addressed to the Health Regulatory Agency with the following information:

• a)

  Name and address of the importer.

• b)

  Name and address of the exporter.

• c)

  Name of the product to be imported.

• d)

  Date of arrival of the shipment.

• e)

  Name of the customs office through which the customs clearance will be processed.

• f)

  Class, type, and quantity of food to be imported.

• g)

  Expiration dates.

• h)

  Identification of the means of transport.

• i)

  Country of origin of the food or beverage.

• j)

  Beneficiaries.

• k)

  Other information that in the judgment of the importer may serve the Regulatory Authority.

• l)

  Signature of the applicant. 2. Invoice or pro forma invoice. 3. Letter of acceptance from the beneficiary. 4. Service recovery fee. OF THE SPECIAL HEALTH AUTHORIZATIONS FOR EXPORTATION OF FOODS AND BEVERAGES

Within the special authorizations, the authorization for exportation of raw materials, foods, and beverages produced in the national territory and not consumed in the country is established, and shall be subject to health regulations for manufacturing, storage, and transport. The authorization shall contain the requirement to establish on the product label the following legend: "PRODUCT EXCLUSIVELY FOR EXPORTATION"

TRACEABILITY MECHANISM FOR FOODS AND BEVERAGES

ARSA shall establish a traceability system for Foods and Beverages products and others of Health Interest for which it shall develop the necessary regulations to establish traceability controls to identify the origin and destination, which will allow timely attention to any risk that could affect the health and life of the population.

As part of the traceability system, sanitary control of imports, sanitary control of national production, and others that ARSA deems convenient shall be established. TEMPORARY SANITARY PERMIT

The Temporary Sanitary Permit shall be issued for foods and beverages that request to commercialize the product in the national territory prior to requesting the sanitary registration and shall have a validity of six (6) months from its date of issuance and being renewable only once for 6 months, presenting the same requirements.

To request the authorization of said permit, the following requirements must be fulfilled: 1. Submit an application addressed to the Sanitary Regulation Agency whose title indicates TEMPORARY SANITARY PERMIT IS REQUESTED, and include the following data: 1. Submit an application addressed to ARSA, indicating at least the names of 5 principal recipients of the products that will be commercialized according to their purchase volume. 2. Copy of the invoice or proforma invoice of the products that will be commercialized with their respective lot number and expiration date. 3. Present a document from a competent authority (foreign authority) that certifies that the imported products are suitable for human consumption. (Certificate of Free Sale, Sanitary Registration, Export Certificate, Good Manufacturing Practices Certificate or other Sanitary Certificate). In case of not having these, a Sworn Statement (Signed by the legal representative) duly authenticated/legalized (when applicable) must be presented. 4. Copy of the product label. 5. Recovery fee for services rendered.

The Sanitary Permit for microentrepreneurs shall have a validity of two (2) years from its date of issuance. After this time, the citizen must request the respective sanitary license.

To request the sanitary permit for microenterprises for food and beverage products, the following requirements must be met: 1. Submit an application addressed to the Sanitary Regulation Agency whose title indicates SANITARY PERMIT IS REQUESTED, and include the following data:

• a)

  Name and particulars of the owner or legal representative.

• b)

  Name of the establishment when applicable.

• c)

  Exact address of the establishment.

• d)

  List of products to be elaborated or services to be offered.

• e)

  Place and date of the application.

• f)

  Signature of the applicant. 2. Have received training from ARSA (Certified by diploma). 3. Location sketch. 4. Layout sketch of the premises. 5. Sworn Statement, ARSA format. 6. Copy of the Identity Card. 7. The recovery fee for services rendered

The Sanitary Permit for microentrepreneurs shall have the following nomenclature:

• a)

  The capital letters HN, followed by a hyphen (-): Which means Honduras.

• b)

  The capital letters PSAM, followed by a hyphen (-): Which mean Sanitary Permit for Foods and Beverages for Microentrepreneurs.

• c)

  Four (4) Numbers, Two (2) numbers that identify the month and two numbers that identify the year, followed by a hyphen (-).

• d)

  Sequential numbering of four (4) digits, with which the product is identified, beginning with the number 0001

To request the Sanitary Registration for microenterprise food and beverage products, the following requirements must be met: 1. Submit an application addressed to the Sanitary Regulation Agency whose title indicates SANITARY REGISTRATION OF MICROENTERPRISE PRODUCT IS REQUESTED, with the following data: a) Name and particulars of the legal representative. b) Name of the product c) Name of the Product Holder. d) Name and address of the Manufacturer. e) Commercial form or presentation. f) Place and date of the application. g) Signature of the applicant. 2 Have received training from ARSA. 3 Sworn Statement, ARSA format. 4 Copy of the Identity Card. 5 Number of the microentrepreneur sanitary permit 6 Label or project with which it is commercialized. 7 Recovery fee for services rendered

The Sanitary Registration for microentrepreneurs shall have a validity of two (5) years from its date of issuance.

The product with Sanitary Registration for microentrepreneurs may only be commercialized in the national territory.

The Sanitary Registration for microentrepreneurs shall have the following nomenclature: e) The capital letters HN, followed by a hyphen (-): Which means Honduras. f) The capital letter AM, followed by a hyphen (-): Which means Foods and Beverages for Microentrepreneurs. g) Four (4) Numbers, Two (2) numbers that identify the month and two numbers that identify the year, followed by a hyphen (-). h) Sequential numbering of four (4) digits, with which the product is identified, beginning with the number 0001

Everything related to the advertising of foods and beverages and their establishments shall be regulated in accordance with its specific regulations.

Laboratory analyses of foods and beverages shall be performed by ARSA Laboratories, and when other external laboratories, national or foreign, are required, these must comply with GLP and be recognized by the competent Authority.

Laboratory analyses of foods and beverages shall be performed post-registration by sanitary surveillance and inspection, once the products are commercialized, for which purpose the necessary samples shall be taken to allow a complete analysis of the product.

The recovery fee for services rendered for laboratory analyses shall be assumed by the registration holder or legal representative at the time of requesting the sanitary registration, renewal, and in the corresponding modifications.

The labeling of foods and beverages that are distributed or commercialized in the national territory shall be regulated in accordance with the conventions or international treaties ratified by Honduras and the provisions established by ARSA.

Requests must be submitted in accordance with Article 61 of the Administrative Procedure Law, Chapter on Initiation of Proceedings. Once the request is submitted, it shall be verified whether it complies with all requirements established by law. If it does not comply, the petitioner shall be required to complete their request within the corresponding timeframe, with the warning that failure to do so will result in the dismissal of the proceedings without further action. In the event that all requirements are met, the request shall be admitted and notified, and it shall be forwarded to the corresponding Office so that, in accordance with its complexity, sanitary risk, or other aspects inherent to its nature, the corresponding evaluation and subsequent resolution shall be issued. However, the timeframes may be extended if so determined by the competent authority by virtue of its complexity, sanitary risk, or other aspects inherent to its nature for the evaluation and resolution of requests. This article shall be applicable without prejudice to the provisions of procedures that are resolved through the regulation of cost recovery for services rendered, thereby respecting the principles of transparency, promptness, economy, and efficiency. When the request is submitted by a third party, such party must demonstrate the capacity in which they are acting. The proceedings arising from appeals filed against resolutions issued by ARSA shall be governed by the provisions set forth in the Administrative Procedure Law. INSPECTION, SURVEILLANCE, AND SANITARY INSPECTION

ARSA shall establish inspection, surveillance, and sanitary inspection actions for food and beverages through the regulations established for this purpose. CHAPTER XI ON SANITARY PROMOTION

ARSA shall establish actions to promote continuous improvement of sanitary conditions, processes, products, methods, installations, services, or activities through its communication, training, coordination, and concertation schemes with public, private, and social sectors, as well as other non-regulatory measures. CHAPTER XII ON COST RECOVERY FEES FOR SERVICES RENDERED

ARSA shall establish cost recovery fees for services rendered for each of the sanitary authorizations and services mentioned in this Regulation. CHAPTER XIII FINAL PROVISIONS

In order to fulfill the objectives of this Regulation, ARSA, through its respective offices, shall establish mechanisms for organization, operation, and coordination.

This Regulation establishes the requirements and provisions to which all food and beverages and other matters of sanitary interest shall be subject, and does not contravene what is established in the current Central American Technical Regulations, agreements, or international treaties ratified by Honduras.

For the resolution of matters not expressly provided for in this Regulation, the provisions of the Health Code, Administrative Procedure Law, Civil Procedural Code, General Principles of Administrative Law, and the technical standards issued by ARSA shall be applied as subsidiary law.

All articles relating to food and beverages contained in the Regulation for the Sanitary Control of Products, Services, and Establishments of Sanitary Interest (Executive Agreement 06-2005) dated November 4, 2005, are hereby repealed; furthermore, all related legal regulations that oppose it are hereby repealed.

This Regulation shall enter into force twenty days (20) after its publication in the Official Gazette "La Gaceta".