The FAIRS Report is based on Peruvian regulations for importing food products. This report intends to help U.S. exporters understand and meet local import requirements and, consequently, facilitate trade between the U.S. and Peru.
THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Date: 7/1/2011 GAIN Report Number: Peru Food and Agricultural Import Regulations and Standards - Narrative FAIRS Country Report 2011 Approved By: Emiko Purdy Prepared By: Alvaro Loza Report Highlights: Sections updated: Pesticide and other contaminants; Biotechnology products and Agency Contacts. The FAIRS Report is based on Peruvian regulations for importing food products. This report intends to help U.S. exporters understand and meet local import requirements and, consequently, facilitate trade between the U.S. and Peru. Section I. Food Laws: DISCLAIMER: This report was prepared by the Office of Agricultural Affairs of the USDA/Foreign Agricultural Service in Lima, Peru, for U.S. exporters of domestic food and agricultural products. While every possible care was taken in the preparation of this report, information provided may not be completely accurate either because policies have changed since its preparation, or because clear and consistent information about these policies was not available. It is highly recommended that U.S. exporters verify the full set of import requirements with their foreign customers, who are normally best equipped to research such matters with local authorities, before any goods are shipped. FINAL IMPORT APPROVAL OF ANY PRODUCT IS SUBJECT TO THE IMPORTING COUNTRY?S RULES AND REGULATIONS AS INTERPRETED BY BORDER OFFICIALS AT THE TIME OF PRODUCT ENTRY. Peru has a well developed food safety and regulatory system. Regulations are generally based on sound science but the risk assessment and rule-making process can be slow and burdensome. The Ministry of Health?s Office of Environmental Health (DIGESA) is the Peruvian counterpart to the Food and Drug Administration (FDA) regarding sanitary supervision and registration for processed food and beverages. The National Agricultural Sanitary and Phytosanitary Service (SENASA), part of the Ministry of Agriculture, is responsible for developing and implementing Peru?s sanitary and phytosanitary regulations and is the counterpart to APHIS and FSIS. Peruvian standards and input requirements pose no major problems for U.S. exports. Most market access issues relate to customs procedures, including HS classifications, and inadequate or improperly completed documentation. 1.1 The General Health Law (Law No. 26842 of July 20, 1997) This law contains the framework for food regulations on sanitary supervision and control of food and beverages in Peru. This type of law is implemented by various rules, supreme decrees and supreme resolutions which must be published in the official newspaper "El Peruano" before being implemented. DIGESA, within the Ministry of Health, is responsible for implementing most regulations regarding processed food products. The present regulations establish that: Production and trade of food and beverages for human consumption are subject to supervision based on food sanitary standards. It is prohibited to import, manufacture, trade, distribute or store food and beverages that have been adulterated, contaminated, altered or declared unfit for human consumption. Food and beverages manufactured locally or in a foreign country can only be traded with the corresponding certificate of sanitary registration. It is prohibited to import food and beverages from countries where distribution or consumption of the same product is not allowed due to health risk. Personnel involved in production, handling, transportation, conservation, storage, outlay and supply of food and beverages must comply with sanitary standards to avoid contamination. Facilities manufacturing, processing and supplying food and beverages must control the sanitary quality and food safety in accordance with the requirements of the Ministry of Health nationwide. 1.2 Regulations of Sanitary Inspection and Control for Food and Beverages (Supreme Decree No. 007- 98-SA of September 25, 1998) According to the provisions of the General Health Law and the General Principles of Food Safety included in the Codex Alimentarius, the present regulation establishes the general hygiene standards, health conditions and requirements for the production, transportation, manufacturing, storage, marketing, preparation and sale of food and beverages for human consumption in Peru, including: The conditions, requirements and procedures for the registration, modification and cancellation of food and beverage sanitary registration. The regulations concerning inspection of the activities and services related to the production and distribution of food products. The applicable measures and sanctions for food safety. The organoleptic characteristics, chemical composition and microbiological conditions that apply to food and beverages. The food quality and safety standards, to which food and beverage manufacturers are subject, based on the Hazard Analysis and Critical Control Points (HACCP) system. Sanitary Supervision Agencies (Title II, Supreme Decree No. 007-98-SA) Ministry of Health?DIGESA: Responsible for sanitary supervision of food and beverage manufacturing, distributing and marketing. Ministry of Agriculture-SENASA: Responsible for sanitary supervision of fresh fruits and vegetables and animal products such as dairy and meats for human consumption. Vice-Ministry of Fisheries: Responsible for sanitary supervision for capture, transportation and processing of seafood products, as well as sanitary conditions at shipment ports. Municipalities: Responsible for sanitary supervision of the establishments trading and manufacturing food and beverages. They work closely with DIGESA. Sanitary Registration of Processed Food and Beverages (Title VIII, Supreme Decree No. 007-98-SA) DIGESA is in charge of registering, re-registering, modifying, suspending and canceling the sanitary registration of food and beverages nationwide and also: Makes mandatory the sanitary registration for processed food and beverages sold in Peru. Defines industrial food and beverages as those finished products for human consumption that result from physical, chemical or biological processing of animal, plant or mineral inputs and which contain food additives. Establishes which food and beverages are not subject to health registration, including: a) those in natural conditions, packed or not, such as grains, fruits, vegetables, meats, and eggs; b) free samples; and c) products donated by foreign charitable entities. Establishes that a product?s sanitary registration permits its manufacture, import or sale by the registration holder who will be responsible for the sanitary quality and safety of the food or beverage being sold. Establishes product groups for sanitary registration purposes using a qualitatively similar mix of basic ingredients and food additives that identify the group as such. 1.3 Food Safety Law (Legislative Decree 1062 of June 28, 2008) This regulation establishes the legal regime in order to guarantee food safety standards application along the food chain. Animal feed is also included within law?s range. Food suppliers must comply with sanitary and quality regulations approved by the sanitary authority. All agricultural products (fresh or processed) imported to Peru must carry an official certificate issued by the competent health authority from the country of origin. The law creates The Sectorial Food Safety Commission (COMPIAL Spanish abbreviation) and its purpose is the coordination between the government and the private sector of any activity that guarantees the accomplishment of this law throughout the country. The ministries of Health, Agriculture, and Production form this commission. The law indicates specific functions for each agency involved. The Ministry of Health, through DIGESA, is the primary food safety authority in the country. Its main function is to establish general hygiene standards throughout the food and beverage chain for human consumption. The national agricultural sanitary and phytosanitary service (SENASA) has complete authority on monitoring and supervising food safety standards application for agricultural products (primary and animal feed). The Technological Fishing Institute (ITP) is the sanitary authority on fishery sector. They are in charge of the capture, extraction, transport and processing surveillance of hydrobiological products as well as to assure the hygiene standards application on disembarkation areas. ITP issues the sanitary certificate for fish products. The Food Safety regulation proposed by SENASA was approved through the Supreme Decree 004- 2011-AG on April 27, 2011. The Ministries of Agriculture and Health endorsed this document and its main objective is to establish guidelines to assure food safety practices on primary food products and feed produced within and outside the country. 1.5 The Ministry of Agriculture (Legislative Decree No. 997 of March 13, 2008) The MOA is responsible for promoting and developing the agricultural sector. It is divided into three major organizations: The National Agricultural Sanitary and Phytosanitary Service (SENASA): responsible for developing and promoting the participation of the private sector in the implementation, prevention, control, and eradication of plant pests and animal diseases. The National Institute for Agricultural Innovation (INIA): modified by Legislative Decree No. 997 of March 13, 2008, is responsible for designing and executing the national strategy for agricultural innovation. 1.6 The National Agricultural Sanitary and Phytosanitary Service (SENASA) SENASA is responsible for enforcing regulations that govern domestic and imported plants and animals and their respective products and by-products and for preventing the introduction of foreign and exotic animal and plant diseases. It is composed of three major offices: Plant Health Office: responsible for protecting the health of plants and preventing the introduction and spread of foreign pests within Peru. It is similar to APHIS? Plant Protection and Quarantine unit in the United States. All U.S. unprocessed products of plant origin like bulk grains, fresh fruits and vegetables, nuts, or seeds can only be exported to Peru if accompanied by an APHIS phytosanitary certificate, complying with SENASA?s import permit requirements. To clear customs, these products are subject to inspection by SENASA. Animal Health Office: responsible for enforcing regulations governing the import and the export of live animals, semen, embryos and by-products of animal origin, as well as the registration of veterinary products. In cooperation with Peru?s State governments, SENASA enforces federal laws and regulations to protect and improve animal health, control and eradicate animal diseases such as Food-and-Mouth Disease. It defends borders against foreign and exotic animal diseases. SENASA?s regulatory responsibilities for live animals and animal genetics are similar to those assisgned to APHIS? veterinary services in the United States. Farming, Livestock and Food Safety Inputs Office: responsible for supervising seed quality, control, and registration for agricultural chemical pesticides, pharmaceuticals, food and biological products for animals as well as registration and supervision of organics certification and agricultural production safety. Port and Airport Callao Inspection Stations: functionally depend on the Animal and Plant Health Offices. These stations enforce regulations according to the agricultural health for trading domestic and imported agricultural products. 1.8 The Ministry of Health (Law Decree No. 584 of April 18, 1990) The Ministry of Health rules, guides, and promotes the National Health System to achieve a healthier environment. Concerning food products, it is composed of two major organizations: Office of Environmental Health (DIGESA): supervises, creates regulations and controls other agencies of the Ministry of Health and Municipalities within its three offices: basic services for health (water and drainage quality), ecology and environmental protection, and food safety and animal disease control. The last is the Peruvian counterpart to the Food and Drug Administration (FDA) regarding food sanitary quality and safety supervision and the registration of processed food and beverages. General Direction of Pharmaceutical Products and Drugs (DIGEMID): is responsible for registering, modifying, discontinuing and canceling the sanitary registration of natural products for health use, dietetic products and sweeteners. 1.9 National Fish Health Service (SANIPES) (Law No 28559 of June 27, 2005) SANIPES is under Ministry of Production and its main goal is to establish procedures in order to promote and certify the quality of fish products. The technological Fishing Institute (ITP) is the competent authority of the service. They are in charge of the capture, extraction, transport and processing surveillance of hydrobiological products as well as to assure the hygiene standards application on disembarkation areas. ITP issues the sanitary certificate for fish products and technical protocols related to sanitary regulations. 1.10 Peru?s Customs - SUNAT (Law No. 24829 of June 8, 1998) On July 12, 2002, ADUANAS merged with the Tax Agency (SUNAT), Ministry of Economy and Finances, by Supreme Decree No. 061-2002-PCM changing its name to SUNAT. SUNAT-Customs controls the international traffic of merchandise, collects tariffs and prevents and sanctions customs offenses. It is divided into six offices, four of which are related to import procedures and regulations: management and tariff collection, sanction supervision, smuggling prevention and boundary control, and technical customs, which regulates tariffs. SUNAT has offices in each port and airport nationwide that work in conjunction with private customs agencies. 1.11 Ministry of Foreign Trade and Tourism - MINCETUR (Law No. 27790 of July 23, 2002) MINCETUR is responsible for defining, leading, carrying out, coordinating, regulating and supervising foreign trade and tourism. It also has the leading responsibility of negotiating trade agreements in coordination with other Ministries, principally the Ministry of Foreign Affairs and the Ministry of Economy and Finance. 1.12 National Institute for the Defense of Competition and for the Protection of the Intellectual Property - INDECOPI (Law Decree No. 25868 of November 24, 1992) Within the Ministry?s Presidential Council (PCM), INDECOPI promotes loyal competence, protects all forms of intellectual property and encourages applied knowledge of quality. Most important offices related to trade include: Office of Consumer Protection: protects consumer rights, especially the right to be properly informed about goods and services offered in the Peruvian market. Office of Repression of Unfair Competition: enforces regulations regarding publicity to protect consumers and sanctions practices against trade in good faith. Office of Dumping and Subsidies: regulates market distortions due to imports that enter Peru with subsidies or below market prices. Office of Market Access: supervises public administration behavior in order to avoid market access barriers affecting economic agents. Office of Technical and Trade Regulations: is the national standards agency. Prepares, approves, and advertises Peruvian Technical Standards which are adopted voluntarily by the industry. 1.13 Ministry of Environment (Legislative Decree No 1013 of May 13, 2008) This Ministry is responsible for designing, establishing, executing, and supervising national and sectorial environmental policies. It seeks to further a sustainable use of natural resources and promotes the compliance of conservation in order to prevent degradation of the natural resources and reverse negative processes that may affect them. The law provides for the merger with CONAM and the Natural Protected Areas office of INRENA. Section II. Labeling Requirements: The Consumer Protection Office within INDECOPI is responsible for food and beverage labeling inspection and advertising (Supreme Decree No. 007-98-SA). Penalties depend on criteria such as the seriousness of the offense or the intention and behavior of the offender. 2.1 General Requirements Every food and beverage packed for marketing must be labeled in accordance with the provisions included in these regulations. The label contents must comply with the provisions established in INDECOPI?s Peruvian Metrological Standards NMP 001:1995, Packed products. Labeling, and Article No. 117 of Supreme Decree No. 007-98-SA. An adhesive Spanish label needs to be applied before the product reaches the point of sale. The information should include: Name of the product. Food additives and ingredients. Manufacturer?s name and address. Importer?s name, commercial name and address, phone, taxpayer?s identification (RUC). This information may appear on a separate adhesive label. Number of sanitary registration. Expiration Date (shelf life, established by the manufacturer) as provided in the Codex Alimentarius or the applicable Peruvian sanitary standard. Lot code or key. Special conservation conditions, if any. Net weight or volume of the content. Country of origin. Instructions for use. Law 28405 of November 30, 2004 was passed concerning the labeling of value-added products. This law declares labeling mandatory for value-added products that are consumed, imported or manufactured and sold nationwide in order to develop a national labeling system. The ruling (Supreme Decree 020- 2005-PRODUCE) lists the products to which this law is applied, but may be subject to changes such as including food products in the future. Depending on the type of product regarding composition, dimension and other characteristics, labels must have: name of product, country of manufacture and product validation (date of expiration, conditions for storage and observations). In case imported products do not meet these requirements, importers will be allowed to properly label them in private storage before customs clearance. INDECOPI will monitor labeling requirements at the retail/wholesale level. Section III. Packaging and Container Regulations: 3.1 Packaging (Title VIII, Supreme Decree No. 007-98-SA) The package containing the product must be made of a harmless material, free from substances that could affect its food safety. Likewise, packages must be manufactured to preserve the product?s sanitary quality and composition throughout its useful life. Packing made of metals, alloys or plastic should not: Contain impurities consisting of lead, antimony, copper, zinc, chromium, iron, tin, mercury, cadmium, arsenic or other metals or metalloids that can be hazardous to human health in quantities or at levels above the maximum allowed limits. Contain residual styrene, vinyl chloride, achrynolitryl monomers or any other residual monomers or substances that can be considered hazardous to human health in quantities or at levels above the maximum allowed limits. The maximum levels allowed will be determined by the Ministry of Health?s sanitary standards. This provision also applies to any lamination, varnish, film, coating or part of the package in contact with the foods and beverages. Packages manufactured from previously used recycled paper, cardboard or plastic are forbidden. Section IV. Food Additives Regulations: 4.1 Food additives (Title VII, Supreme Decree No. 007-98-SA) Sanitary quality of inputs and food additives: inputs and food additives for food and beverage manufacturing must meet the health quality requirements established in the sanitary standards issued by DIGESA. The Consumer Protection Office of INDECOPI is responsible for sanctions on the subject. Allowed Additives: food additives not permitted by the Codex Alimentarius are forbidden and they cannot be kept within food and beverage facilities. A complete list of approved food additives can be found at www.codexalimentarius.net. Flavorings accepted by the United States Food and Drug Administration (FDA), and the Flavor and Extractive Manufacturing Association (FEMA) are also allowed. For example, on October 10, 2002, potassium bromate, formerly very popular in Peru as bakery ingredient, was declared unfit for human consumption. 4.2 Sanitary Authorization for food additives (Directorial Resolution No. 0775/2003/DIGESA/SA of July 16, 2004) The importer should adjust to the following procedure to request the sanitary authorization or its renewal in DIGESA (http://www.digesa.minsa.gob.pe/formularios/aditivos.asp): Sign the application form that includes the name, address, RUC of the importer, contact information of the manufacturer, and the list of products for which the sanitary authorization is being requested. For each additive the importer needs to include the composition (in mg/kg and the numbering system -SIN- according to Codex Alimentarius), type of package, storage conditions, useful life, code system for the lot of production and physical-chemical and microbiological quality analysis issued by the manufacturer laboratory or other authorized laboratory in Peru. Present the certificate of free trade and use issued by the health authority of the country of origin within the past year. Payment for administrative procedures and inspection. The sanitary authorization lasts six months from the date of issue. Issuing procedures will take approximately fifteen working days. Section V. Pesticides and Other Contaminants: SENASA is the agency responsible for the regulation of pesticides, herbicides and fungicides used in fumigation of agricultural products. Peru adopts Decision No. 436 and Resolution No. 630 of the Andean Community (CAN) regarding registration and control of chemical pesticides for agricultural use and Peru?s Supreme Decree No. 016-2000-AG of May 8, 2000 and its amendment (Ministerial Resolution No. 0476-2000-AG of July 16, 2000) regulate the registration and control of pesticides. Registration procedures are included in: http://www.senasa.gob.pe/RepositorioAPS/0/0/JER/NORMASANDINASSOBREPLAGUICIDAS/Decisión%20436%20 norma%20andina%20para%20el%20regsitro%20y%20control%20de%20plaguicidas.pdf 5.1 Registration for Biological Pesticides SENASA requires that new importers and new pesticides be registered following SENASA?s Text of Administrative Procedures (TUPA). The procedure for registering new pesticides is as follows: Signed application by the legal representative and the technical advisor including technical information on the active ingredient and on the product such as type of container, product waste, toxicity, and environmental effects. Certificate of free trade and use. Physical/chemical analysis, endorsed by the Peruvian Consulate and the Foreign Affairs Ministry, no older than one year. Biological test results of research centers or specialized professionals. Section VI. Other Regulations and Requirements: DIGESA is responsible for sanitary regulations that apply to most processed food products, including their manufacture, in accordance with the Codex Alimentarius. 6.1 Food and Beverage Sanitary Registration (RSA) (Law No. 26842 of July 20, 1997, Supreme Decree No. 001-2002-SA of March 2, 2002) The importer is responsible for sanitary registration of food and beverages or its renewal. The registration procedure is available at: http://www.digesa.minsa.gob.pe/expedientes/detalles.aspx?id=28. The application form should contain the following information: Name or commercial name, address, and RUC of the importer. Manufacturer?s name or commercial name, address and country of origin. Product or group of products for which the Sanitary Registration is being requested. Each product must include: The physical/chemical and microbiological quality analysis from the Plant quality control laboratory. Only the physical/chemical analysis could be performed by an authorized laboratory in Peru. For a list of authorized laboratories, please check: www.indecopi.gob.pe or www.digesa.sld.pe/formularios/laboratorios.htm. The list of ingredients and quantitative composition of additives, identified by their generic name and international reference number or commercial name. Preservation and storage conditions. Information about the packing used, including types and materials. Useful life under normal preservation and storage conditions. DIGESA does not require expiration date for alcoholic beverages others than beer. Lot code system. Nutritional properties for special diet food and beverages. Along with the application form signed, the exporter needs to submit the certificate of free trade, the future label (see Section II Labeling requirements), and the registration receipt. If the certificate of free trade and use is not available, the importer should present a document issued by the Peruvian Consulate in the country of origin. All documents must not be older than one year from their date of issue. The corresponding translation into Spanish must be enclosed. DIGESA authorizes the following U.S. agencies to issue the certificate of free trade and use: Agency Location Address Certificate Contact Telephone Fax 5600 Fishers Lane, R N/A 463- N/A 1-888- N/A ockville, 6332 Maryland 20875 L- Irma W (202)418-ashington Food Products Moran or (202)418-3069 or FDA and Additives Keisha 3428 C 5100 Paint - Houston 418-3358 Mi Branch ami Parkway Dr Quynh-inks and College Da Anh (301)436- (301)436- iry Products Ng 2028 2651 uyen Park, MD Hydrobiological Rochelle (301)436- (301)436- 20740 Products King 1416 2601 Nutraceutic Vincent (301)436- (301)436- Products Keys 1431 2636 P.O. Box TDH Houston 12008 (512)719- Austi /A n, TX Food N/A N 0246 78711 Alcoholic ATF Houston N/A beverages and N/A N/A N/A tobacco FDA: Food and Drug Administration, web site: www.fda.gov TDH: Texas Department of Health - licensing and enforcement, web site: www.tdh.state.tx.us/bfds TABC: Texas Alcoholic Beverage Commission, web site: www.tabc.state.tx.us ATF: Bureau of Alcohol, Tobacco, Firearms and Explosives, web site: www.atf.gov The sanitary registration is issued per product or group of products, and per manufacturer. A group of products consist of those products elaborated by the same manufacturer and with the same qualitative composition of basic ingredients and food additives. Current code numbering of the sanitary registration is included in the certificate. Using an example, codification for imported and local foods is as follows: Classification of Food and Beverage Groups for the Sanitary Registration Food and Beverage Category Food and Beverage Category J. Meat and meat products. A. Milk and Dairy Products. K. Hydro biological products (seafood). B. Ice cream and Ice cream mixtures. L. Eggs and egg products. C. Oil and fats. M. Salt, species, condiments and sauces. D. Freeze-dried, dehydrated or concentrated A. N. Fruits and other vegetables products. (including E. Cereals, pulses and by-products. tubers and mushrooms). F. Sugars, honey and by-products. O. Prepared food. G. Confectionery. P. Beverages. H. Bakery and pastries. Q. Stimulant and spirit beverages. I. Special diet food. R. Canned food. S. Food additives. Registration or renewal of registration of products in the Sanitary Registry will be accepted if the file complies with all the established requirements. This procedure will take no more than seven working days. Observations will be forwarded to the importer for accomplishment. Verification of the product?s sanitary quality will take place after the registration or renewal thereof in the Sanitary Registry. The sanitary registration of food and beverage will be valid for five years from the date of issue. It may be renewed after an application is filled by the registration holder between seven and sixty working days before the registration?s expiration date. 6.2 Sanitary Authorization for Importing Samples of Food and Beverages (less than 100 Kg. or equivalent) In order to import food and beverage samples, the importer or the interested party should follow these steps: Submit to DIGESA a sworn application (http://www.digesa.sld.pe/formularios/18.pdf) detailing the product name, country of origin, weight and use. Copy of the commercial invoice. Copy of the airway bill or bill of lading or postal advice letter. Registration receipt. 6.3 Certificate for Sanitary Registration of Current Registered Food and Beverages Once registered, food and beverages can be imported and sold by anyone. If applicable, DIGESA will issue a sanitary registration certificate for the imported product on behalf of the interested party. The importer and seller of a product under a sanitary registration certificate for imported product have the same responsibilities as the registration holder, concerning the sanitary quality and food safety of the product. In this case, the name or commercial name, the address and RUC of the importer must be printed or labeled on each package sold to consumers. The sworn application includes the contact information of the requesting company and the registration holder, the name or commercial name of the product, its sanitary registration number and the payment receipt. Section VII. Other Specific Standards: 7.1 Endangered Species The Natural Resources Service (INRENA) is responsible for promoting the rational use and conservation of natural resources and endangered species. INRENA regulates the import and export of endangered species animals and plants under the Convention of the International Trade in Endangered Species of Wild Flora and Fauna (CITES). INRENA services can be found in www.inrena.gob.pe/serusu/varios/tupa2006.pdf. 7.2 Marine Products The Vice-Ministry of Fisheries / PRODUCE (www.produce.gob.pe) is responsible for sanitary supervision for fish captures, transportation and processing of hydro biological products, as well as for ensuring sanitary conditions of shipment ports. In addition, PRODUCE issues import permits for hydro biological research species and aquaculture. The major laws and regulations applied to fishery inspection programs for canned, frozen and cured fish are issued in the Resolution No. 409-98-PE of August 25, 1998. DIGESA is responsible for issuing the sanitary registration certificate for imported seafood products. 7.3 Biotechnology Products Peru is a member of the Biosafety Protocol. The Biosafety Law No. 27104, Law of Risk Prevention for Products Derived from Biotechnology, issued in 1999, along with its Regulation (Supreme Decree No. 108-2002-PCM), establishes CONAM as the authority for overseeing safety issues concerning biotechnology products. This law also establishes a counseling body, the National Committee of Biological Diversity (CONABID), which advises sector institutions (INIA, DIGESA and Vice Ministry of Fisheries) and proposes regulations to CONAM. CONABID is formed by a variety of government agencies such as SENASA, the private sector, international organizations and universities. In addition, the regulation provides guidelines to protect human health, the environment and biological diversity as well as to promote research and development of biotechnology, with regard to its applications for production, handling, research and servicing and intentional release of Genetically Modified Organisms (GMOs). Peru approves the Agricultural Biosafety Regulation: On April 15, 2011, the government of Peru (GOP) published Supreme Decree 003-2011-AG which regulates research, production and trade of genetically modified (GM) products. The Agricultural Biosafety Regulation appoints the National Institute for Agricultural Innovation (INIA) as the lead agency for regulating agricultural biotechnology issues. It also establishes a technical working group that includes members from INIA, the Ministry of Environment, Ministry of Agriculture, the Peruvian SPS agency (SENASA) and academia. The technical working group will be responsible for conducting the risk assessment prior to approving a GM application. For further information on Biotechnology please refer to our current Biotechnology report. Section VIII. Copyright and/or Trademark Laws: INDECOPI ensures trademarks, copyrights and intellectual property through three offices: distinctive marks, new technologies and inventions (patents), and copyright. 8.1 Trademarks The Office for Distinctive Marks is the agency in charge of the registration of trademarks, brands, commercial names, slogans and appellation d?origine and works accordingly to the Decision 486 of the Andean Community about Industrial Property for Andean Countries and Peruvian Law Decree 823 for the Industrial Property. Also, Peru is a signatory to the Paris Convention for the Protection of Industrial Property in compliance with the WTO agreements on trade-related aspects of Intellectual Property Rights. Registering brands and trademarks to ensure brand property is highly recommended. Requirements are found on INDECOPI?s text of administrative procedures (TUPA) at www.indecopi.gob.pe. Section IX. Import Procedures: 9.1 Import Procedures in Peru?s Customs - SUNAT (Supreme Decree No. 011-2005-EF of January 26, 2005) For customs clearance the importer or local agent must present the following documentation: Customs Unique Declaration (DUA) paid, and issued in SUNAT and filed by a customs agent. Authenticated photocopy or carbon copy of the Airway bill or bill of lading. Authenticated photocopy of the Commercial invoice. Packing list. Authenticated photocopy of the insurance document. Authenticated photocopy of the Food sanitary registry (RSA) for processed food products issued by DIGESA, or the sanitary certificate for animals, plants or their by-products issued by SENASA. Ticket or authorization for dispatch if requested. Once the customs agent submits the DUA electronically, SUNAT will determine the type of control for the merchandise within the following channels: green, orange and red. Channel green permits delivery of the product once duties are paid; channel orange requires review of the documentation and channel red requires the review of the documentation and physical inspection. The U.S. ? Peru Trade Promotion Agreement (PTPA) provided duty free access for two-thirds of U.S. food and agricultural products. For more information on the TPA, please check the U.S. Trade Representative (USTR) website at: www.ustr.gov/Trade_Agreements/Bilateral/Peru_TPA/Final_Texts/Section_Index.html. 9.2 Customs Procedures for Anticipated Dispatch (Anticipated Dispatch System) The procedure begins before the arrival of the merchandise to Customs and only if it is submitted to only one importer through one type of customs systems. The importer should provide customs with the same documents mentioned above: an available RUC and a record of at least 10 DUAs in the customs systems of importation, temporary admission, temporary importation or customs warehouse within the previous 12 months of the current DUA transmitted. In addition, the importer must not owe Customs debts for above $3,300 in fines. 9.3 Customs Procedures for Importing Samples (Simplified Import Procedure) This procedure is used in order to import samples with no commercial value (gifts that do not exceed $1,000 FOB or products less than $2,000 FOB) and samples with commercial value (that do not exceed $2,000 FOB). Alcoholic beverages are always considered samples of commercial value, which must pay import taxes and tariffs. Samples should be made unusable for sale, by means of cuts, perforations, inscriptions, unsealing, or others. Once the Simple Declaration (DS) is processed, the merchandise is always subject to inspection. The owner of the merchandise, the consignee or the customs agent must comply with these requirements to receive clearance from SUNAT: Simple Declaration (DS) issued by SUNAT and filled by the interested part. Airway bill, bill of lading, or postal advice letter. Commercial invoice. Identification card, passport, or RUC of the importer. Insurance letter. Sanitary authorization for food processed products or sanitary certificate for animals, plants or their by-products. 9.4 Import Procedures for Products of Animal and Plant Origin Before the product is shipped, the importer must request an import permit from SENASA and forward it to the exporter, including all the specific certification requirements. The exporter will provide to the importer the corresponding official health certificate of the country of origin. SENASA?s inspector at the port or airport of entry verifies the accomplishment of the import permit requirements. For new products, both of animal or plant origin, SENASA requires that a risk assessment be carried out according to the Andean Community, the World Trade Organization (WTO) and the recommendations of the Animal Health World Organization (OIE) and the Codex Alimentarius as well as the sanitary conditions of the exporter country. All certificates for animals, plants, or their by-products must be error free, no pen or ink changes, or have any other type of amendments. If applicable the product must be packed in a material authorized for human consumption, and labeled according to U.S. regulations. Also, the product must identify its content, net weight and the facility where it was produced, following SENASA?s import requirements. The application for the import permit and SENASA?s import procedures (TUPA) are is available at: www.senasa.gob.pe. 9.4.1 Fresh, Chilled and Frozen Products or By-products of Animal Origin The list of tariff codes for animals and their by-products subject to import requirements from SENASA (Supreme Decree No. 051-2000-AG and Chief Resolution No. 191-2000) is summarized in the following table: Chapter/Tariff Code Description Chapter 1 Live Animals Chapter 2 Meat and Edible Meat Offals Chapter 4 Milk, Dairy and Egg Products 0504 Sausage Casings 0511 Bovine Semen and Embryos Chapter 41 Raw Hides, Skins and Leathers Chapter 51 Wool and Animal Hair 9.4.2 Fruits and Vegetables, Commodities and Raw Agricultural Products On January 4, 2003, SENASA issued plant health requirements for seeds and vegetables of phytosanitary risk. Vegetable quarantine procedures and phytosanitary risk categories were issued on August 24 and on October 3, 2003. On July 18, 2005, SENASA established specific plant health requirements for imported botanical seeds. On October 26, 2005, SENASA published the list of quarantine pests not present in Peru. On February 28, 2005 by Directorial Resolution N. 0105-2005, SENASA approved the Manual of Phytosanitary Procedures (harmonized from International Regulation for Phytosanitary Measures - NIMF 15) for the entry and exit of wood packaging used for International Trade enforced on September 1, 2005. The list of tariff codes for plants and their products subject to import requirements from SENASA (Supreme Decree No. 032-2003-AG and Chief Resolution No. 299-2003) is shown below: Chapter/HS Code Description Chapter 6 Live Trees and Plants, Bulbs, Roots and Flowers Chapter 7 Edible Vegetables and Tubers Chapter 8 Edible Fruits and Nuts Chapter 9 Coffee, Tea and Spices Chapter 10 Cereals Chapter 11 Products of the Milling Industry, Malt and Starches Chapter 12 Oilseeds, Miscellaneous, Grains, Hay and Straw Chapter 14 Other Vegetable Products 1701 - 1702 Sugars and Syrups 1801 - 1802 Cocoa, Grains and Waste 2101 - 2103 Miscellaneous and Edible Preparations 2302 ? 2306 Food Industry Waste, Prepared Animal Feed 2308 - 2309 2401 Tobacco, No manufactured 4401, 4403 ? 4409 Woods 4411 ? 4413 4415 5201 ? 5203 Cotton and Cotton Waste U.S. counterparts of SENASA for Products of Animal and Plant Origin U.S. Agency Health Certificate for U.S. product Animal Health Inspection Fresh fruits and vegetables; live animals and animal by-products Service (APHIS) (including biological genetic material) Food Safety Inspection Meats and by-products, for human consumption Service (FSIS) Agricultural Marketing Milk and dairy products Service (AMS) 9.4.3 Processed Food Products In order to import processed food products, including alcoholic and non-alcoholic beverages, documentation must be accompanied with the corresponding food sanitary registry (RSA) granted by DIGESA. 9.4.4 Appeals System for Disputed or Rejected Product The infringement of SUNAT procedures and sanctions are issued in the Customs General Law Regulations (Supreme Decree No. 129-2004-EF) of September 12, 2004. SUNAT notifies in Appendix I. Government Regulatory Agency Contacts: Ministry of Agriculture (MINAG) Minister: Jorge Villasante Address: Av. La Universidad No 200, La Molina Phone: (511) 613-5800 Fax: (511) Web site: www.minag.gob.pe The National Agricultural Sanitary and Phytosanitary Service (SENASA) Director: Dr. Oscar Dominguez Address: Av. La Molina 1915 Phone: (511) 313-3300 Fax: (511) 313-1486 Web site: www.senasa.gob.pe Plant Health: Contact: Eng. Jorge Barrenechea Phone: (511) 313-3300 Animal Health: Contact: Dr. Glen Halze Phone: (511) 313-3300 Food Safety Contact: Eng. Carlos Caballero Phone: (511) 313-3300 Port Callao: Contact: Eng. Nelson Guerrero Phone: (511) 429-0367 Airport Callao: Contact: Eng. Aemar Quiñonez Phone: (511) 575-1599 Ministry of Health (MINSA) Minister: M.D. Oscar Ugarte Address: Av. Salaverry 801, Jesus Maria, Lima 11 Phone: (511) 315-6600 Fax: (511) 431-0093 Web site: www.minsa.gob.pe General Environmental Health Bureau (DIGESA) General Director: M.D. Edward Cruz Address: Las Amapolas 350, Urbanizacion San Eugenio, Lince, Lima 14 Phone: (511) 442-8353 / 442-8356 Fax: (511) 422-6404 Web site: www.digesa.minsa.gob.pe Food safety and Sanitary Registration Director: Eng. Rosa Maria Cerna Phone: (511) 442-8353 General Direction of Pharmaceutical Products and Drugs (DIGEMID) General Director: M.D. Victor Alejandro Dongo Address: Calle Coronel Odriozola 111, San Isidro, Lima 27 Phone: (511) 422-8456 Fax: (511) 422-8456 Web site: www.digemid.minsa.gob.pe Ministry of Foreign Trade and Tourism (MINCETUR) Minister: Ms. Eduardo Ferreyros Address: Calle Uno Oeste 50-60, Urb. Corpac, San Isidro, Lima 27 Phone: (511) 513-6100 Fax: (511) 224-3362 Web site: www.mincetur.gob.pe Ministry of Environment Minister: Mr. Antonio Brack Address: Av. Guardia Civil 205, San Borja Phone: (511) 225-5370 Fax: (511) 255-1202 National Institute for the Defense of Competition and for the Protection of the Intellectual Property (INDECOPI) President: Eduardo de la Piedra Higueras Address: Calle de la Prosa 138, San Borja Phone: (511) 224-7800 Fax: (511) 224-0348 Web page: www.indecopi.gob.pe Vice Ministry of Fisheries (Ministry of Production) Viceminister: Mr. Alfonso Miranda Address: Calle Uno Oeste No. 060, Urbanizacion Corpac, San Isidro Phone: (511) 616-2222 / 415-1111 Fax: (511) 224-2950 Web site: www.produce.gob.pe Appendix II. Other Import Specialist Contacts: For a list of authorized laboratories in Peru, please refer to www.indecopi.gob.pe If you have any question or comments regarding this report or need assistance exporting to Peru, please contact the Foreign Agricultural Service in Lima at the following address: U.S. Embassy Lima, Foreign Agricultural Service (FAS) Mailing Address: Office of Agricultural Affairs, Unit 3785, APO AA 34031 Address: Av. La Encalada cdra. 17, Monterrico, Lima 33 Phone: (511) 434-3042 Fax: (511) 434-3043 E-mail: Aglima@usda.gov For further information, check the FAS web site www.fas.usda.gov or FAS Lima web site www.usdaperu.org.pe. Please, also refer to our other current food market and import regulations related reports: FAIRS Export Certificate; Exporter Guide; Food Processing Ingredients Sector; Retail Food Sector and Hotel, Restaurant and Institutional Sector. Author Defined: