CERTIFICATION PROGRAM PROCEDURES MANUAL SECTION 1. Procedures for the Export and Certification of Fishery Products intended for Export

Transcription

1 CERTIFICATION PROGRAM PROCEDURES MANUAL SECTION 1 Procedures for the Export and Certification of Fishery Products intended for Export FOREIGN TRADE SUBDIRECTION CHILE

2 INDEX INTRODUCTION 4 CHAPTER I. LEGAL BACKGROUND 4 CHAPTER II. DEFINITIONS 5 CHAPTER III. TECHNICAL PROCEDURES AND REQUIREMENTS TO AUTHORIZE SHIPMENT NOTIFICATIONS RELATED TO FISHERY PRODUCTS INTENDED FOR EXPORT 7 1. General Procedures and Requirements 8 CHAPTER IV. PROCEDURES AND REQUIREMENTS RELATED TO THE ISSUANCE OF HEALTH CERTIFICATION Documents to be submitted to Request the Issuance of a Health Certificate Assessment of Sanitary Supporting Documents in accordance to Final Product Control Assessment of Sanitary Supporting Documents in accordance to Quality Assurance Program Procedures and Specific Requirements by Destination Market Issuance of Health Certificates to Japan Issuance of Health Certificates to the European Union Issuance of Health Certificates to Argentina Issuance in Advance of Certificates for Applying to Mexico Import Permit Issuance of Health Certificates for Chilled Refrigerated Products to Peru Procedures and Specific Requirements by Type of Certificate Samples without Commercial Value Special Certificates Sanitary Quality Certificate for Specific Parameters Vibrio cholerae Free Zone Certificate Certificate for Absence of Vibrio cholerae Certificate for Products Free from Vibrio cholerae Certificate for Living Species Food Certificates for Aquatic Animals consumption Special procedures for chilled refrigerated products Partitioning of hake consignments intended to the EU Certification for shipments outside office hours Control of Residue Products covered by Sanitary Certifications Signature and Seal of Sanitary Certificates 244 CHAPTER V. PROCEDURES AND TECHNICAL REQUIREMENTS FOR THE ISSUANCE OF ORIGIN CERTIFICATIONS Instructions to request Certificate of Origin Technical requirements for the issuance of Certificates of Origin Signature and seal of Certificates of Origin 29 CHAPTER VI. BACKUP FILES FOR NOTIFICACTIONS AND CERTIFICATES 29 CHAPTER VII. PRICE OF CERTIFICATES 300 CHAPTER VIII. DELIVERY OF CERTIFICATES FORMATS 300 CHAPTER IX. FISHERIES REGULATIONS ENFORCEMENT 311 CHAPTER X. MODIFICATIONS 311 Page 2 of 57

3 1. Modifications prior to export Modifications following exports Changes of Exports Destinations Return, replacement of certificates 322 CHAPTER XI. ANNEXES 333 Notification of shipment for fisheries products intended for export (NEPPEX) 333 Single model Sworn Declaration of Origin for fisheries and aquaculture products susceptible to marine toxins 333 Model for Sworn Declaration of Origin Mercosur 333 Model for Sworn Declaration of Origin ALADI Peru 333 Sample and Analysis Request for Export (SMAE) 333 Origin Authorization for Sanitary Certification (AOCS) 344 Sanitary Certificates Formats for fisheries products aimed for Export 344 Specific Sanitary Requirements for Authorization of Shipments of bivalve mollusks, echinoderms, tunicates and gastropods 400 Formats for Certificates of Origin for Fisheries Products aimed for Export 455 Special Certificate 47 General Principles related to certificate issuance 48 Features of the notification system for shipments of fisheries products intended for export on the web page 500 Contingency plan in case of impossibility to generate shipment notifications for fisheries products intended for export at Customs 500 Procedure for Sanitary Certification of divided air shipments of chilled refrigerated hake intended for Europe 511 Procedures against alerts of fisheries and aquaculture products intended for export 533 Page 3 of 57

4 INTRODUCTION This Manual is aimed at describing Sernapesca s official procedures to authorize exports and issue certifications for fisheries products aimed for export. CHAPTER I. LEGAL BACKGROUND - DF.L. N 5, 1983 and its modifications, from the Ministry of Economy Development and Reconstruction, current Ministry of Economy Development and Tourism, where is established the organic structure of the National Fisheries and Aquaculture Service. - SD Nº 430, 1992 (restated text of the General Law on Fisheries and Aquaculture) in its Article 122 letter r), empowers the National Fisheries and Aquaculture Service to control the safety of fisheries and aquaculture products aimed for export. - D.F.L. Nº 1, 1992 issued by the Ministry of Economy establishes the functions of the Fish Health Department. - Exempt Resolution Nº 827 dated 1993, issued by the Ministry of Foreign Affairs, sets forth the competent agencies responsible for issuing certificates of origin. - Decree Nº 5 dated 1985 issued by the Ministry of Economy establishes Service Fees. - Regulation (CE) Nº 853/2004 dated 29 April, 2004, sets forth specific health regulations for food of animal origin. - Regulation (CE) Nº 2074/2005 dated 5 December 2005, establishes measures for the application of Regulation 853/ Regulation (CE) Nº 1664/2006 dated 6 November 2006, modifying specific application measures related to Regulation 853/ Memorandum of Understanding between the Government of Chile and the Food and Drug Administration (FDA) of the United States of America, with relation to the Shellfish Health Program in Chile. - Guideline 2006/88 related to zoo-sanitary requirements of animals and aquaculture products and the prevention and control of specific aquatic animal diseases. Page 4 of 57

5 CHAPTER II. DEFINITIONS For the purposes of this manual, the following definitions are established: Authorization at origin for sanitary certification/aocs: document that certifies that the products set forth therein have been manufactured in a facility with an appropriate quality assurance program and therefore can obtain a sanitary certification for specific markets. This document is authorized by the Sernapesca office with jurisdiction over the relevant facility. Road Transportation Document: document used for the transportation of land freight that confirms that a contract exists between the trader and the carrier. Bill of Lading (B/L): document that proves the existence of a maritime transportation contract and confirms that the goods have been shipped aboard a vessel. Certificate of origin: document that certifies the origin of goods, for the purposes of preferential tariffs, non-preferential tariffs, and quota allocations or any other measure set forth by the Law. Self-Certification: is a way to certify origin specifically in accordance with certain trade agreements, where the importer or the producer declares that the goods that are being exported to a specific market comply with the rules of origin set forth in the appropriate Trade Agreement. Sanitary Certificate: official document from the Government of Chile, issued by the National Fisheries and Aquaculture Service that certifies the sanitary conditions of the goods described therein. Control of final product: methodology established to ensure the sanitary condition of a manufactured product that is ready to be marketed, by means of an analysis by a laboratory authorized by Sernapesca, in accordance with the requirements of the product and the destination market. Sworn declaration of origin: Written document that states the origin of the harvested goods under oath. Single Outbound Document/DUS: Document used to submit the goods to the National Customs Service for its subsequent shipment abroad. To be granted authorized to exit Page 5 of 57

6 status (AS, its abbreviation in Spanish) authorization in the form of a Notification for Shipment of Fisheries Products aimed for Export (NEPPEX) is required. Export: Legal exit of national or nationalized goods for its use or consumption abroad. Manufacturing date: Date in which the fisheries product is processed into the product described on the container or label. Air Waybill: Document that serves as a contract of air carriage. Shipment Notification for Fisheries Products aimed for Export/NEPPEX: Form through which a request is made before the National Fisheries and Aquaculture Service for the authorization to export fisheries products. Product fit for Human Consumption: product that has been assessed and that confirms its safety for human consumption. Product not fit for human consumption: product manufactured as food for animals, or the analysis of which does not authorize it as fit for human consumption. Quality assurance program/ PAC: voluntary sanitary control program that, as a result of a hazard analysis and control of critical points, ensures the quality of the final product. Program for the Control of Residues from Pharmaceutical Products, Polluting and Prohibited Substances/ FAR: this program is aimed at ensuring the safety of products manufactured with farmed fish with relation to concentrations or the presence of pharmaceutical products, polluting or prohibited substances. Sampling and analysis request for products aimed for export/ SMAE: form issued by Sernapesca used by the interested party to request the sanitary assessment of a product by means of a final product control to obtain a sanitary certification. Zones susceptible to marine toxins: geographic areas in which the presence of marine biotoxins has been detected historically. Regions: III, IV, X, XI and XII. Zone not susceptible to marine toxins: geographic areas in which the presence of toxins has not been detected historically Regions: I, II, V, VI, VII, VIII, IX, XIV and XV. Page 6 of 57

7 CHAPTER III. TECHNICAL PROCEDURES AND REQUIREMENTS TO AUTHORIZE SHIPMENT NOTIFICATIONS RELATED TO FISHERY PRODUCTS INTENDED FOR EXPORT Any export of fisheries products must be authorized by the National Fisheries and Aquaculture Service (Sernapesca), prior to shipment. To this end, the interested party must submit a notification for Shipment of Fisheries Product aimed for Export at the Sernapesca office located at the Customs port of departure (Annex 1). This form can be downloaded from our web page at: To authorize the Notification, Sernapesca shall assess the administrative and technical requirements, which shall depend on the type of product, the requested certificate, where appropriate, and the destination country. If, in the notification, the exporter declares that he/she shall not require the official certification or shall only require certification of origin, Sernapesca shall authorize export in those cases where the technical, administrative and sanitary requirements detailed in Chapters III, V, IX are complied, in addition to the specific sanitary requirements for the granting of shipment notifications for shellfish, echinoderms, tunicates and gastropods, where appropriate (Annex 7). If the exporter declares having complied with the regulations set forth by Sernapesca in the shipment notification, with relation to salmon injuries, and this is inconsistent with the results of the pre-shipment inspection by Sernapesca, the agency shall impose a sanction against the exporter in accordance with Article 116 of the General Law on Fisheries and Aquaculture. If the exporter requests sanitary certification, he/she must comply with the requirements described in Chapter III, IV, V, IX and in the case of shellfish, gastropods, tunicates and echinoderms, the analysis detailed in Annex VII of Technical Rule CER/NT2. Exports of fisheries products aimed for export to the markets listed in Technical Rule CER/NT3 shall always require the submission of the supporting sanitary documents to comply with the requirements set forth in such rule. Exports of samples without commercial value must comply with the procedures of this chapter and those described in point 5 of Chapter IV of this Manual. Page 7 of 57

8 1. General Procedures and Requirements The interested party, representing shipping agency or Customs agency must notify Sernapesca its intention to export by submitting an original and one copy of a Notification for Shipment of Fisheries Products aimed for Export (Annex 1). The original complete documentation must be submitted at the Sernapesca office located in the area where the customs documentation that processed them and where the goods shall be introduced into the primary export zones, even where the physical exit of the goods is made through another border control point (cabotage). The authorization by NEPPEX shall be granted within 24 hours following its delivery, as long as the complete required documentation is submitted and the sanitary and legal requirements set forth by the Fisheries Service are complied. All data fields on the notification must be completed in accordance with the instructions for completion detailed on the back of the document. Manufacturers involved must be listed under Item B (name and number of the facility) and a clear consistency with the manufacturing dates. Only where the notification area is insufficient for these purposes, a packing list may be attached, following the same format of Item B of the Notification. In this case, the annex shall be identified with the number of the relevant Notification. In the case of air shipments of fresh products, if the information related to date of manufacturing is not available, a Notification for Shipment of Fisheries Products aimed for Export may be submitted exceptionally without this information, which must necessarily be completed prior to its authorization. Products intended for human consumption and not intended for human consumption, must be notified independently. The officer in charge of receiving the Notification must verify that it contains all required information, and the seal and signature by the officer in the Enforcement Department that granted authorization, and a description of the relevant tax documents listed in the relevant notification. The tax documents listed in the Notification must be the same ones submitted by the exporter to the Customs Service at the entrance of the primary zone. With respect to authorizations for facilities: - If the origin certification or export authorization is required, and there is no sanitary certification requirement, this shall be verified in the destination market and that facility is included in the List of Facilities Participating in Sernapesca s Sanitary Control Page 8 of 57

9 Programs. In case it is not listed, the exporter must submit a backup copy of the Resolution issued by the Fisheries Under-Secretariat or the National Fisheries and Aquaculture Service, as appropriate, that authorizes the manufacturer to process. - If the sanitary certification is required, it shall be verified in rule CER/NT3, if the destination market requires the listing of the facility or product, and that the manufacturer and the consignment aimed for export declared by the exporter, is consistent with the information detailed in the List of Facilities Participating in Sernapesca s Sanitary Control Programs. If the manufacturer is not listed in the List of Facilities Participating in Sernapesca s Sanitary Control Programs, it must prove that it has the regulatory approvals to operate, that is, the (s) Resolution(s) issued by the National Fisheries and Aquaculture Service authorizing the processing of the described products, and its inclusion in the list must be requested without delay. This situation must be informed by the port of exit in the Region that has jurisdiction over the manufacturing plant. Upon examining the Notification for Shipment of Fisheries Products aimed for Export, the Sernapesca officer shall assess the type of product, the destination market, and, where appropriate, the requested certificates, and shall request the interested party to ensure the compliance the technical and administrative requirements set forth in this Manual and Technical Rules CER/NT1, CER/NT2 and CER/NT3, as appropriate. The exporter therefore must attach the original sanitary supporting documents that will cover the authorization, that is, the following original documents: - SMAE and Results Report or the Sensory Assessment Records in case of chilled refrigerated products (Control of Final Product) or - AOCS (Quality Assurance Program) or - Sworn Declaration of Origin and/or Toxin Reports issued by the Health Service, as appropriate. If in the SMAE form submitted by the Company to Sernapesca, the exporter is someone other than the manufacturer or the requester, the tax document that supports the transfer of ownership of the product shall be required. In case all required supporting documents are not submitted or in case inconsistencies are detected between the information submitted, the Notification shall be returned to the interested party without being processed. Page 9 of 57

10 Once the compliance of the above requirements is verified, the Sernapesca officer shall access the internet address: and by entering the data related to the notification, the system provides a single number at the national level, which shall be consigned under Item Nº of the Notification for Shipment of Fisheries Products aimed for Export, thereby approving the shipment. Subsequently, the officer shall place the Sernapesca seal (Annex 4), the date and signature on the document. The original Notification shall be returned to the interested party and the copy shall be filed at Sernapesca. The data processing procedures used to generate, modify and annul the Notification are described in Annex 11, and the Contingency Plan in case of the inability to generate Notification for Shipments of Fisheries Products aimed for Export (NEPPEX) for Customs, is described in Annex 12. The original sanitary supporting documents must always be maintained by Sernapesca, along with a copy of the authorized Notification. In case of being required to be used in another notification, the original documents shall be returned to the interested party as long as they are remnants, in such case Sernapesca shall maintain a copy of the sampling request and results Report or Origin Certification for the purposes of the Sanitary Certification. The procedures related to Remnant Control are detailed in Point 7, Chapter IV of this Manual. Once the Notification number is obtained, the interested party, the shipment Company or representative Customs Agent must access Custom s data system in order to link the Notification Nº provided by Sernapesca with the approval of the Single Outbound Document (DUS). The information related to the approval of the Notification shall be communicated internally to the National Customs Service. The Customs Administration shall only authorize the entrance of the fisheries products aimed for export into the primary zone that have been authorized by means of the Notification for Shipments of Fisheries Products aimed for Export. Each Single Outbound Document issued by the National Customs Service shall be associated to a single Notification number, thus the relationship 1 Neppex = 1 DUS shall be respected. Any documents submitted to Sernapesca for the purposes of processing a Notification for Shipments of Fisheries Products aimed for Export, a certification, requested or not, shall be signed by the legal representative designated by the interested company for these purposes. It is important to stress that the export of shellfish, univalves, tunicates and raw echinoderms, must comply with the specific requirements related to marine toxins, Vibrio Page 10 of 57

11 parahaemolyticus, and norovirus controls, as appropriate. These requirements are set forth in Annex 7 of this Manual. CHAPTER IV. PROCEDURES AND REQUIREMENTS RELATED TO THE ISSUANCE OF HEALTH CERTIFICATION Official health certification for fisheries products aimed for export shall be issued following authorization of the export Notification, and as long as the formalities described in Chapter III of the present Manual are fulfilled, apart from the submission of the corresponding sanitary supporting documents, which can be obtained through the following systems: Certification in accordance to the Control of Final Product: Based on sampling and analysis of manufactured products on the basis of date of manufacturing. In order to access this system, the company must be included in the List of plants under Sernapesca s sanitary control program. The sanitary assessment of the consignment intended for export shall be made in accordance with sampling plans and chemical, physical and microbiological determinations detailed in Rule CER/NT2 and CER/NT 3 as appropriate, according to the destination market and type of product. To this end, the sampling and analysis request form must be used (Annex 3) according to the procedures detailed in rule LAB-MP 2 for sampling purposes. Certification in accordance to the Quality Assurance Program (PAC): This system is based on the hazards assessment and critical control points (HACCP) in the productive process. To choose this system, the Company must join Sernapesca s Quality Assurance Program. The manufacturing facility can submit the Origin Authorization form for sanitary certification (Annex 5), which will serve as a sanitary guarantee at the time of export. To support exports of products susceptible to marine toxins (bivalve mollusks, gastropods, tunicates and echinoderms) the results Reports prepared by the Health Service Laboratories may be used. To this end, the original copy of the Report must be submitted simultaneously with the Notification. 1. Documents to be submitted to Request the Issuance of a Health Certificate a) Submit the original Notification for Shipments of Fisheries Products aimed for Export that was returned to the interested party that displays the single number assigned by the officer upon authorizing the export, signed and sealed, prior to Page 11 of 57

12 shipment. b) Number of Single Outbound Document processed by the National Customs Service, which shall be examined by the inspector that issues the certification in the consultation web page. In the case of air or land shipments, the DUS must have Accepted for Processing status. c) Relevant Export Invoice, photocopy. d) Requested Certificates, 1 original and two copies, previously printed, numbered and delivered by the Fisheries Service. Certificates are identified by the same number of the Notification for Shipment of Fisheries Products aimed for Export. e) B/L or non-negotiable copy (original or photocopy) issued by the shipping Company, Air Waybill, or Land Waybill. f) Sanitary supporting documents shall not be requested at this time, since they were already requested upon authorization of shipment, in accordance with point 1 of Chapter III of this manual. If the exporter requires specific certificates in addition to those required by destination markets, they must be clearly indicated in the notification and therefore, the supporting sanitary certificates must include the new certification requirements. 2. Assessment of Sanitary Supporting Documents in accordance to Final Product Control The interested party must submit the original SMAE, Sampling and Results Report, including the required analysis, according to type of manufacturing, facility category, destination and type of certificate required, according to the Technical Rules CER-NT2 and CER-NT3, as appropriate. The results Reports must be valid, dated and signed by the Head of Laboratory or another authorized signature. In the case of the Results Reports with electronic signature, the interested party may submit a copy, the original of which must be confirmed by the Sernapesca Inspector, as follows: a) Go to the list of Analysis Entities available on Sernapesca s Web page. b) Under the Electronic Signature column, open the link related to Analysis Entities to examine the report. Page 12 of 57

13 c) Complete the fields, Nº Audit and Nº Document with the codes in the Results Report before you. d) Verify that the information contained on the copy is consistent with the original copy displayed on the screen. e) Under the personnel authorized for electronic signature column, verify the officers authorized for electronic signatures. f) Additionally, the signature can be validated by accessing the icon Signatures: verify signatures added to this document, located on the left hand side of the document displayed on the screen. The way to validate signatures is described in the Signature Validation Manual, available under the same column, in the list of Analysis Entities. It is important to recall that, in the case of bivalve mollusks, gastropods, tunicates and echinoderms, the analysis detailed in Annex VI of Technical Rule CER/NT 2 shall be necessary. When the information related to the packing of the product in the Notification for Shipment of Fisheries Products aimed for Export is inconsistent with the information contained in the Sampling and Analysis Request for Export, the existence of a re-packaging authorization must be verified, and the compliance of the provisions set forth in document LAB/MP 2. In such case, the certificate shall be issued if: - The Sampling and Analysis for Export Request and the relevant sampling report display the sentence authorized re-packaging with the abbreviated signature and the Sernapesca Seal (Annex 4) that authorized the procedure. - The re-packaging report for packaged products (primary packaging) that must have the Sernapesca seal when the re-packaging has been performed in a place that is different to the port of shipment. 3. Assessment of Sanitary Supporting Documents in accordance to Quality Assurance Program The interested party must submit an original AOCS (Annex 5), authorized by Sernapesca at the office that has jurisdiction over the area in which the manufacturing facility is located, which must be issued to the export s destination market. Page 13 of 57

14 The officer shall confirm that the original AOCS is appropriately signed and sealed, and that the products described are valid. In addition, he/she must confirm that the information declared in the AOCS with relation to the description of the product and destination market is consistent with the notification submitted initially and with the requested certificate. For frozen products, the Origin Authorization for Sanitary Certification shall only be valid if the product has been stored in the facilities of the manufacturing plant or in cold storage plants authorized by Sernapesca. For this purpose, the interested party must declare in the AOCS and in the Notification for Shipment of Fisheries Products aimed for Export, if the product has been stored in a refrigerator other than the cold storage in the plant. If so, its name and location must be stated, and this data must be supported by clearance documents related to the conveyance of the product. The Sernapesca officer shall verify that the cold storage facility is listed in the List of Companies enrolled in Sernapesca s Sanitary Control Programs. If the products are stored in a refrigerator that is not authorized by Sernapesca, certification may only be granted for markets that do not require a PAC, with a final product analysis of the consignment, by means of a Sampling and Analysis Request for Export, with a sample number n = 5, c=0, by consignment. The following determinations shall be made: - Determination of Total Recount of Mesophilic Aerobic Micro-organisms 35ºC - Organoleptic Physical Analysis If the manufacturer states having complied with Sernapesca rules related to salmon injuries in the AOCS, and this data is inconsistent with the results of the pre-shipment inspection carried out by Sernapesca, in the case of manufacturing facilities, exports to the corresponding market shall be restricted. 4. Procedures and Specific Requirements by Destination Market 4.1. Issuance of Health Certificates to Japan Sanitary certification granted for products intended for Japan must contain the complete information related to the recipient, and may not display the indication "to the order of " since the product may be rejected by the competent authority in the point of destination. Page 14 of 57

15 4.2. Issuance of Health Certificates to the European Union Sanitary certification granted for products intended for the UE must contain the complete information related to the recipient, and may not display the indication "to the order of " since the product may be rejected by the competent authority in the point of destination. In the case of bivalve mollusks, tunicates and echinoderms intended for the EU, the interested party must certify that the resource originates from natural Banks or farms, as appropriate, included in the List of Harvesting Areas under the SPBM by submitting a Single model Sworn Declaration of Origin for fisheries and aquaculture products susceptible to marine toxins, Model 1 (Annex 2) upon submitting an AOCS or a provisional AOCS, if the application is sent for processing. The officer must verify that the manufacturing process is consistent with the classification of the declared harvesting area (type A, B, C) and that the detailed information is in line with such list. The sanitary guarantees that support the certification of products intended for the European Union must be presented prior or on the same day of shipment, according to the requirements of that market. For this purpose, the interested party must submit the Authorization of Origin for Sanitary Certificate, prior to, or on the same day of shipment, jointly with the Notification for Shipment of Fisheries Products intended for Export. Compliance with consumer information requirements set forth in Regulation 2065/2001 CE must be verified in the commercial documents accompanying the consignment, which includes: - For extractive fishing products: commercial name, scientific name, harvest zone (established by FAO) - For fresh water or farmed extractive fishing products: commercial name, scientific name and the word Chile. These requirements are not valid for fisheries products not intended for human consumption. Page 15 of 57

16 4.3. Issuance of Health Certificates to Argentina Process monographs The exporter that wishes to send his/her production to Argentina must submit a process monograph for each product, importer and brand name intended for this market at SENASA (Annex 6). For these purposes, the interested party shall submit a Notification for Shipment of Fisheries Products intended for Export at the Sernapesca office that has jurisdiction over the area in which the manufacturing plant is located and attach a pre-printed monograph certificate and the description of the process, including the qualitative and quantitative formulation of the product (with percentages), on paper or their own numbered sheets. The information shall be authorized if it is consistent with the processes supervised by Sernapesca through the Program for Authorization of fisheries plants and factory vessels or Quality Assurance Program. In case of being required, Results reports from regular verifications and heat treatment studies may be attached to the monograph, as appropriate, as well as the details of the material that enters into contact with the product, and the material used to pack and wrap. The Sernapesca officer shall check the above document in order to verify that is consistent with the process carried out by the plant and that the Company is authorized to export to such market in the List of Companies enrolled in Sernapesca Sanitary Control Programs. In case of being authorized, the process description provided by the plant shall be validated with the Sernapesca seal (Annex 4), the veterinarian s seal and the signature of Sernapesca s Veterinary Doctor on every sheet. This document shall be attached to the Process Monograph Certificate, which shall be signed and sealed by the Veterinary Doctor. The issuance procedure must comply with the provisions set forth in Annex 10. The issuance of process monographs for markets other than Argentina shall be assessed by the Fisheries Health Department at headquarters, upon submission of the relevant request submitted at a regional office by the interested party Land Exports This procedure applies for the export or transit of fisheries products by land to the territory of Argentina. These consignments must be accompanied by a sanitary certificate or certificate of origin, (Annex 6), as appropriate, and must be protected by a security seal. Page 16 of 57

17 In order to comply with this requirements, a cooperation agreement was subscribed between Sernapesca and the Livestock and Agriculture Service (SAG) that sets forth that the officers of the Agriculture Service located in the appropriate border controls, shall be tasked with placing the security seals provided by Sernapesca. The carrier must submit the export invoice and the Sanitary Certificate or Origin Certificate, as appropriate, to the Agriculture and Livestock Service official at the border, who shall place the protection seal and indicate the number of seals placed on the relevant certificate, and the vehicle license number, if not indicated. Every three months, the Agriculture and Livestock Service shall send copies of the certificates issued by Sernapesca with the number of seals placed, to the particular regional Sernapesca office Certificate of Origin The Certificate of Origin for Fisheries Products (Annex 6) is requested to convey Chilean fisheries products from one place of the country to another, through Argentinean territory. To obtain this certificate, the interested party must submit the following documentation: - Notification for Shipment of Fisheries Products aimed for Export. - Certificate of Origin of Fisheries Products, with clearance documents related to the consignment. - Tax document that certifies the origin and destination of the product. This certificate must be signed and sealed by a Veterinarian Doctor. The document must display a Sernapesca seal for issuance purposes. This certificate shall be free of charge for the requesting Company, since the related commercial operation does not consist in an export. The numbering of the Notification shall be made through the business Window application accessed through the Neppex Advanced Manual tab Issuance in Advance of Certificates for Applying to Mexico Import Permit This procedure may be applied to exports intended for Mexico, and consists in the issuance of the sanitary certificate prior to shipment. This procedure is applied on the basis of a Page 17 of 57

18 requirement of the Mexican market that provides for an authorization to import fisheries products. In this case, the certificate may be issued without the complete official information required for certification set forth in point 1 of Chapter 4. The interested party shall submit a Notification for Shipment of Fisheries Products aimed for Export directly at the Fish Health Department at the shipment port with the original certificate form and two copies. The Sernapesca official shall issue the certificate, keep the original document and provide the Notification and a photocopy of the certificate that displays the sentence: "the present certificate is issued with the single purpose to advance customs formalities before the relevant Mexican authorities. The Notification shall be numbered through the business Window application, by accessing the Neppex Advanced Manual tab. At the time of export, upon processing the final certificate, the official shall access the Authorized Advanced Neppex tab and may access the FIP number for export through the number of the issued advanced notification. Both the advanced copy and the final certificate shall keep the same format, content, folio number, seals, signatures and reference numbers, and the date of issuance shall be the only difference. To withdraw the original copy, the interested party must submit the sanitary and tax supporting documents. The issuance of advanced certificates for markets other than Mexico shall be assessed by the Fish Health Department at headquarters, on the basis of a request made at a regional office by the interested party Issuance of Health Certificates for Chilled Refrigerated Products to Peru The sanitary certificates for exports of fisheries products intended for Peru must follow the procedures set forth in point 1, Chapter III and IV of this Manual. For chilled refrigerated products, the sensorial assessment in original form and one copy must be submitted at the Sernapesca regional office, jointly with the NEPPEX, and Sernapesca Sanitary Certificate, at the latest, on the working day following the date of the sensorial assessment, in accordance with the service hours of the regional office. The Sernapesca inspector shall number the NEPPEX and issue the Sanitary Certificate indicating the date and time displayed on the records. 5. Procedures and Specific Requirements by Type of Certificate Page 18 of 57

19 5.1. Samples without Commercial Value Human Consumption Samples without commercial values refer to those consignments of up to 20 kilograms of products exported in order to open new markets, exhibit Chilean products in international fairs, tastings, scientific research or household consumption. The interested party must comply with the Notification procedures detailed in Chapter III of this manual and the market requirements set forth in technical rule CER/NT3. In order to issue the sanitary certification in accordance with Final Product Controls, only samples and analysis of products susceptible to marine toxins, vibrio parahaemolyticus or norovirus shall be required, in accordance with Annex 7. If the destination market requires the issuance of a certificate ensuring manufacturing practices under HACCP, an Origin Authorization for Sanitary Certification shall be submitted. Such markets are detailed in technical rule 3 of the present manual (CER/NT3). It is noted that in the issue of sanitary certificates that cover samples without commercial value may be used a Pro forma invoices. For the specific case of Brazil, samples without commercial value intended for exhibitions or fairs must be accompanied by a Sanitary Certificate issued by the Argentina, Brazil, Chile and Uruguay Committee, that may be issued in accordance with the compliance of Technical Rule CER/NT3 Brazil item. Exceptionally, the above mentioned certificate may be issued when the fish products have been manufactured in plants authorized to export to such market, but that do not have labelling authorization from DIPOA. To this end, DIPOA must grant a special permit that must be directly requested before this Agency by the importer through a letter indicating: company name and authorization number of the manufacturing facility, point of entry to Brazil, date of entry, description and quantity of the product. Such letter must be authorized with the official signature and seal at the Sernapesca office with jurisdiction over the area in which the facility is located. Not Intended for Human Consumption When the sample is intended for purposes other than for human consumption (research, Page 19 of 57

20 laboratory, universities, etc.), the interested party shall contact the nearest Sernapesca office and inform its interest in exporting these products. Sernapesca shall assess the use of a Special Certificate format depending on the product and destination market. The issued certificate must always indicate its use at the point of destination. Once the export and issuance of the certificate is approved, the product must be duly labelled and must indicate product not fit for human consumption, and the address and contact information of the consignee at the point of destination Special Certificates These certificates confirm special sanitary conditions that are not envisaged in the official certificates. To issue a Special Certificate, the requested text must be submitted for assessment at the Sernapesca office at the shipment port of the product or at the Sernapesca office at the point of origin. If the issuance of the Certificate is authorized, the Notification for Shipment of Fisheries Products aimed for Export must be presented, attaching the original copy of the special certificate (Annex 9) with the printed text, and the supporting documents. Special certificates must always provide a description of the required data and clearly establish the scope Sanitary Quality Certificate for Specific Parameters Sanitary quality certification for specific parameters is provided with the use of a Quality Certificate for Export (Annex 6), upon request by the destination country or the consignee. To this end, the interested party must previously submit a Notification for Shipment of Fisheries Products aimed for Export at the Sernapesca office that belongs to the shipping place of the product. The above certificate shall be issued as long as the parameters or conditions required for certification, such as microbiological, physical, chemical, organoleptic, toxicological determinations and other sanitary quality characteristics are presented prior to numbering the Notification for Shipment of Fisheries Products aimed for Export. In these cases, the certificate shall clearly indicate the type of quality that is being certified. To issue this certificate the product must be fit for human or animal consumption, as appropriate. Page 20 of 57

21 5.4. Vibrio cholerae Free Zone Certificate The interested party must submit a Notification for Shipment of Fisheries Products aimed for Export at the Sernapesca office corresponding to the shipment place of the product. The Certificate for free zones may be issued to fisheries products, without requiring analyses Certificate for Absence ofvibrio cholerae The interested party must submit a Notification for Shipment of Fisheries Products aimed for Export and supporting documents at the Sernapesca office corresponding to the shipment place of the product Bivalve Mollusks from Region VI to the North Certification for absence of Vibrio cholerae may be provided for bivalve mollusks from the VI Region northward. To this end, a Vibrio cholerae analysis shall be made in five (5) samples taken from the consignment for export, regardless of its size, the number of keys, and category of the manufacturing facility. Bivalve mollusks from delimited areas aimed for the European Union or the United States are exempt from this requirement, and shall be subject to the following paragraph Fisheries products from all parts of the country, including bivalve mollusks from the VII region southward and from delimited areas countrywide A certificate ensuring the absence of Vibrio cholerae may be granted without requiring analyses Certificate for Products free from Vibrio cholerae The interested party must submit a Notification for Shipment of Fisheries Products aimed for Export and supporting documents at the Sernapesca office corresponding to the shipment place of the product. Facilities that are in conformity with the Final Product Control may be granted certification for products free fromvibrio cholerae for all fisheries products regardless of their origin. Page 21 of 57

22 For this purpose, analyses shall be made from five (5) samples taken from the consignment for export, regardless of their size and the category of the facility. In the case of chilled refrigerated products, the manufacturing facility must carry out an analysis every fortnight if the product originates from Regions I to VI, or on a monthly basis, if they originate from Region VII and southward. The result of the analyses shall determine the issuance of the certificate. Facilities that are in conformity with the Quality Assurance Program, must include the determination of Vibrio cholerae in the program verifications, in accordance with the origin of the raw material, and the following frequency: - Originating in the VI region to the north: monthly verifications - Originating in the VII region to the south: quarterly verifications A photocopy of the analysis report of this verification shall be submitted with the Origin Authorization for Sanitary Certification, which supports the certifications that the facility requires, up to the following verification. To issue the certificate for Products free from Vibrio cholerae, the name of the laboratory responsible for the analysis shall be indicated under the Inspection Station field of the certificate, and the date of shipment in the Date of Inspection field Certificates for Living Species To obtain a certification for living aquatic animals, the interested parties must request it at the Department of Aquaculture of the Regional Sernapesca Office with jurisdiction over the area in which the farm is located, by presenting a notification and indicating the type of certification needed, the species and the destination market. This information must be sent to the Aquaculture Unit at National Headquarters for its evaluation and to establish the certification procedures. The procedures shall be informed to the interested party and copied to the Fish Health inspectors at the port of exit and the Fish Health Department at National Headquarters Certificates for Food for Aquatic Animals consumption To obtain a certification for food for aquatic animals, the interested parties must request it at the Department of Aquaculture of the Regional Sernapesca Office with jurisdiction over the Page 22 of 57

23 area in which the food processing plant is located, by presenting a Shipment Notification for Fisheries Products aimed for Export and indicating the type of certification needed, the species and the destination market. This information must be sent to the Aquaculture Unit at National Headquarters for its evaluation and to establish the certification procedures. The procedures shall be informed to the interested party and copied to the Fish Health inspectors at the port of exit and the Fish Health Department at National Headquarters. 6. Special procedures for chilled refrigerated products In case of broken packages that contain products with primary packaging, Sernapesca shall allow the issuance of a certificate, but may not issue a certificate to markets that require HACCP statements. For these products, the addition of ice or gel pack shall be authorized at the port of shipment, only when the product is appropriately protected (primary packing), in such a way to avoid direct contact between the product with ice or gel pack. Ice or gel packs shall be added under appropriate sanitary conditions, in a closed facility, protected from possible contamination and an appropriate temperature, in such a way that it does not affect the product cold chain. In both cases, assurance can be provided through the application of procedures similar to the ones followed to store frozen products in freezers not authorized by Sernapesca, set forth in point 3 of chapter IV of this manual. These procedures shall always be informed by the exporter or shipping agency, to the Sernapesca office at the port of shipment of the product in order to inspect the conditions under which they are performed. Sernapesca shall not issue sanitary certificates in case of broken packages that contain bulk packaged products Partitioning of hake consignments intended to the E.U. In case of air consignments of chilled refrigerated hake intended for Europe, that arrive out of office hours at Santiago Arturo Merino Benitez Airport, and the cargo of which may suffer partition thus leading to inconsistencies between the sanitary certificate and the consignments actually loaded, the exporter shall apply the procedure described in Annex 13 Page 23 of 57

24 of this manual to obtain sanitary certifications Certification for shipments outside office hours In case of air consignments that arrive outside office hours at any Sernapesca office, official certificates may be obtained in advance, prior to the arrival of the product at the port of shipment where is going to be exported. Advanced certification may be granted 72 hours before the shipping of the product, upon submission of all required documents in original form. 7. Control of Residue Products covered by Sanitary Certifications Where the sanitary certificate includes more products than the actual number of products intended for export, the difference shall be balanced. To record these residues, an official from the Fisheries Health Department in the Region in charge of issuing the certificate, shall indicate on the back of the Sampling and Analysis Request for Export or the Origin Authorization for Sanitary Certification, the number of products by date of manufacturing and the balance in favor of the exporter, his/her abbreviated signature and place the Sernapesca Seal (Annex 4), date and number of the relevant Notification. 8. Signature and Seal of Sanitary Certificates Once the requirements to obtain the certificate are met, the authorized Sernapesca officer, whose signature must be registered before the relevant agencies, shall sign and seal the original document and 2 copies, including the copy maintained by Sernapesca, with the use of red ink. The total number of sealed copies shall display a seal or inscription on the top part of the page, indicating the word COPY. To this end, the Sernapesca seal (Annex 4) and the officer s signature shall be placed in the relevant field on the certificate, as well as the seal that identifies the officer as Official Inspector or Veterinarian Doctor in accordance with the requirements of the sanitary certificate being issued, described in Annex 6 of this manual. Page 24 of 57

25 CHAPTER V. PROCEDURES AND TECHNICAL REQUIREMENTS FOR THE ISSUANCE OF ORIGIN CERTIFICATION This procedure is aimed at certifying that the origin of the exported product is Chile. Markets such as the United States, Canada, Mexico, Costa Rica, El Salvador, Guatemala, Honduras, South Korea, P4 (Singapore, New Zealand and Brunei), Panama and Australia have selfcertification, and therefore do not require a certification of origin issued by the National Fisheries and Aquaculture Service. For markets in the European Union, Colombia, EFTA, China and Turkey, the certification of origin is issued by the Ministry of Foreign Affairs, supported by the Chamber of Commerce and Sofofa. 1. Instructions to request Certificate of Origin The interested party or their shipping or customs agency must follow the provisions of Chapter IV of this rule in order to obtain a certificate of origin. If a company requests a certificate of origin and the product is intended for markets that have entered into a sanitary certification agreement, the List of Companies Participating in Sernapesca s Sanitary Control Programs must indicate that the manufacturing company is authorized to export to the intended market and that the agreed sanitary certificate is being requested. To obtain a certificate of origin, the interested party must submit to the Sernapesca office related to the place of shipment of the product the following information: - Notification for Shipment of Fisheries Products intended for Export authorized by Sernapesca in its original form. - B/L in original form or non-negotiable copy (original or photocopy). This document shall be replaced by the Air Waybill, in the case of air consignments, or the International Land Consignment Note in case of land consignments. - Export Invoice, copy in original form. A pro forma invoice shall only be accepted for shipping of chilled refrigerated products and in specific situations prior to the assessment and authorization by the Ministry of Foreign Affairs. In these cases, the exporter must commit to promptly submitting a copy of the export invoice in original form. - Original and copy of requested Certificates of Origin, which must have been printed, numbered and issued by the National Fisheries and Aquaculture Service. Page 25 of 57

26 The Sernapesca officer shall verify that the data displayed on the certificates are consistent with those indicated on the DUS and Export Invoice, and that they support all background information requested in the certificates. The number of the Notification for Shipment of Fisheries Products intended for Export must be displayed on the top right hand side of certificates. The commercial name and the complete scientific name of the product must always be indicated. The consistency between the exporter identified in the certificate of origin and the invoicing party must always be verified. The issuance of certificates of origin for products with specific requirements such as: marine toxins, vibrio parahaemolyticus or norovirus, must comply with the commercial requirements and also with sanitary requirements described in Chapter 2 of this manual. 2. Technical requirements for issuance of Certificates of Origin Specific technical requirements for different certificates of origin formats issued by Sernapesca are described below. These formats are available in Annex 8. a) For the issuance of Certificates of Origin Chile (Sernapesca format), Certificates of Origin ALADI Venezuela and Certificates of Origin ALADI Peru, only the documents and supporting documents described above shall be required. In the case of Certificates of Origin ALADI Peru, a Specific Sworn Declaration (Annex 2) from the exporter with the information that demonstrates that the goods comply with the specific requirements shall also be attached. ALADI certificates shall be issued within 7 days following the submission of the relevant application and shall be valid during 180 days from the date of issuance. Certificates shall be issued on the same date as the commercial invoice, or during the following 60 days, but in no case shall they be issued in advance. Certificate of Origin ALADI: This certificate ensures that the product originates in Chile and as such, may qualify for tariff preferences granted by the ALADI market, according to Technical Rule CER/NT1. It must be signed by the exporter or his/her representative (by means of a power of attorney) in a designated site. The following must also be verified: b) The name of the country exporting the goods in the field Importing country. Page 26 of 57

27 c) Under the NALADISA column, the product for export, expressed in NALADISA code and in the Chilean Harmonization Code, according to the ALADI Agreement, and the name of the product in the column Denomination of Goods. d) Under the column Declaration of Origin the exporter must indicate the number of the relevant commercial invoice and the agreement that covers the product. e) The export invoice must have been extended for a maximum of 60 days prior to the issuance of the certificate. If extended otherwise, in field Rule (3) it must be indicated that the product has an invalid export invoice. f) Field (3) must indicate the rule relevant to the agreement that covers the product. g) There is no need to indicate the FOB value. An ALADI Certification of Origin is not required for Mexico, in accordance to the Chile- Mexico free trade agreement. In the specific case of Ecuador, Peru and Venezuela, it is required the issuance of certificates of origin ACE Nº65, ACE Nº38 and ACE Nº23, respectively. In case that the invoice of the exchanged goods is issued by an operator in a third country, that is a member or non-member of the Association, the exporting company shall have the options detailed in Article 9 of Chapter II, Point 4.5 Rules of Origin ALADI of technical rule CER/NT 1. Exceptionally, if the third operator invoice is not available at the time of issuance, the column FOB value can be left blank, and rather indicate the expression Operation by a third operator in the column Observations of the certificate, clarifying the participation of a third commercial operator. Mercosur Certificate of Origin: This certificate is issued for markets that are part of Mercosur based on the Chile-Mercosur Economic Complementation Agreement, ACE Nº35, according to Technical Rule CER/NT1. The following must be indicated: a) The description of the goods must be consistent with the NALADISA code and with the commercial invoice. b) A Simple Sworn Declaration (Annex 2) of the exporter with the background information that demonstrates that the goods comply with the requirements. Page 27 of 57

28 c) The declaration must entirely comply with the origin provisions of the agreement. This declaration shall be valid for 180 days and may be submitted during such period for every shipment with the same characteristics. d) The FOB value of the goods for export must be indicated. e) Duly complete all fields in the certificate, otherwise the certificate shall be considered invalid. Field 3 shall only be crossed out when the importer and the consignee are the same person, as well as field 14, where appropriate. The certificate of origin shall be issued, at the latest, within five (5) working days following the submission of the relevant Notification for Shipment of Fisheries Products aimed for Export and shall be valid during 180 days from the date of issuance. The Certificates of Origin Mercosur shall not be issued in advance to the date of issuance of the commercial invoice related to the relevant operation, but rather on the same date or within the following 60 days. Certificates may be issued at the latest 10 working days following the final shipment of the certified goods. Those products intended for fairs or promotional events sponsored by competent agencies, must comply with the above paragraph. If tariff codes other than those declared in the relevant agreements are required for this certification of origin, this information may be stated in the observations field of the certificate, on the understanding that the agreed codes are declared in the tariff code field. Certificate of Origin Form A: Used to certify that the product is from Chile and thus qualify for duty-free treatments in certain developed countries within the framework of the Generalized Preferential System (S.G.P.), refer to document Technical Rule CER/NT1. It must be signed by the exporter or its representative (authorized by a power of attorney) at an authorized location. The following must be verified: a) The number and date of the export invoice. b) The complete data required related to the weight of the product, order number and markings, where appropriate. c) The indication signed or issued must be made in field Nº 4. Page 28 of 57

29 d) Table Nº8 related to origin criteria must indicate the correct code that differ depending on the country involved. e) The format must be yellow. Certificate of Origin ACE 65: Document used to certify that the product is originating from Chile, and as such, can qualify for tariff treatments in Ecuador, on the basis of the Economic Complementation Agreement N 65 signed between Chile and Ecuador, according to the technical specifications described in Technical Rule CER/NT1. It must be signed by the exporter in a duly authorized location. 3. Signature and seal of Certificates of Origin To certify origin, the authorized Sernapesca officer with registered signature, shall place the Sernapesca stamp (Annex 4) and his/her signature in the relevant table. The name of the officer and the official inspector seal must be placed to obtain ALADI certification of origin. CHAPTER VI. BACKUP FILES FOR NOTIFICATIONS AND CERTIFICATES The Fish Health officer that issues the certification must keep a filed copy of all required documentation. The Notification must be filed attaching the sanitary documents in original form or copy (Request for Sampling and Analysis for Export, with its corresponding sampling and analysis reports or Origin Authorization for Sanitary Certification, as appropriate), the export invoice, the bill of loading, transport document or Air Waybill, as appropriate, and an identical copy of the issued certificate(s). The information filing system must be arranged in such a way to allow easy access to the documentation. Page 29 of 57

30 CHAPTER VII. PRICE OF CERTIFICATES In accordance to Decree Nº 5 dated 1985, MINECON, the following tariffs are set for certifications, which shall be subject to a 50% surcharge on holidays and weekends: - Sanitary and Quality Certificates: 1 UF if the shipment is under or equal to net kilograms and 2 UF for shipments over net kilos. - Certificates of Origin: 0,5 UF independent of the number shipped. - Sanitary Certificates for samples without commercial value: 0,5 UF - Special Certificates: 1,5 UF Certificates must be charged in accordance with the format used, classifying them in one of the 4 categories established in the Decree. CHAPTER VIII. DELIVERY OF CERTIFICATE FORMATS Each Sernapesca office that delivers certificate formats to interested parties must maintain a record of the type of certificate and certificate number in the Logbook for Delivery of Export Certificates or in another registry to ensure traceability, by certificate format, and blank official certificate forms available in each office and delivered to users. The amount of certificate formats to give away must be enough to allow fluency to the certifications formalities. The Sernapesca officer shall record in such logboook, the name, signature and identification number (RUT in Chile) of the person that withdraws the documents, the company or customs agency he/she represents, numbering of certificates and date of delivery. The officer shall also show the requesting party the note on the first page of the logbook, in order to inform him/her about the management of public documents. Note Logbook for Delivery of Export Certificates The party that commits negligent actions with relation to such certificates, set forth in Art. 193 of the Penal Code, may be sentenced to ordinary imprisonment within minor to maximum range. (Art. 194, Penal Code). The information related to the types of formats delivered to the user and the numbering must be included in section D of the Neppex form. Page 30 of 57

31 CHAPTER IX. FISHERIES REGULATIONS ENFORCEMENT CER/MP1/September 2014 In case the Enforcement Department requests the Fish Health Department to verify the compliance of a fisheries rule, prior to the issuance of a sanitary or origin certificate, the office responsible for certifications must verify its compliance in accordance with the instructions provided by the Enforcement Department. These instructions, in a reasonable period, must be available in writing, including the aim of the action, the start and end date of the procedure and any other detail necessary for its correct application. CHAPTER X. MODIFICATIONS 1. Modifications prior to export In case of a request to modify the data used to complete the Neppex, the interested exporter shall submit the application at the Sernapesca office where the Notification was processed, attaching the document in original form and the sanitary documents, where appropriate. If the requested modification is related to the information in the sanitary documents SMAE or AOCS, the modification of such documents must be requested previously at the Sernapesca office in which they were authorized. The process of the modification request of the Neppex can only continue with the authorized sanitary documents. 2. Modifications following exports 2.1 Changes of Exports Destinations A requirement to modify the destination country of the goods shall be assessed on a case by case basis, and the request shall be evaluated only if the product has not reached the destination point originally declared. The interested exporter shall submit the request at the Sernapesca office in which the Neppex was processed, attaching a letter from the Manager of the exporting company detailing the following: - Neppex number involved - New destination country - Reasons for making the request - Attach the supporting documents, that is, SMDA (Request to modify the customs destination point), tracking of the vessel, new export invoice, new transport document (Land transportation document, Airway bill or B/L) and updated sanitary documents Page 31 of 57

32 related to the new market, if appropriate. - Certificates previously issued by Sernapesca in original and copy form. CER/MP1/September 2014 The regional officer shall perform a technical assessment of the submitted information and the request to change the destination country submitted by the exporter, and where appropriate, the request and issues shall be authorized. No charge shall be applied in case of a change of certificate. 2.2 Return, replacement of certificates In case of the cancellation of a shipment, in respect of which Sernapesca has issued and delivered the relevant certificate, the interested party shall return the original certificate and the copies issued, without the right to reimbursement of its charge. Certificate amendments shall not be accepted. In case of corrections, new certificates must be issued prior delivery of the original certificate, and certifying the change in the relevant documents. If certificates that contain information that differs from the Notification that was processed initially were requested, the interested party shall submit a formal request by the Manager of the exporting company indicating the reasons for such request, addressed to the Regional Sernapesca office that has jurisdiction over the shipping office. This request must be accompanied by an authorization of the manufacturing facilities involved and the complete set of documents that support the change. If the modification refers to the consignee in a sanitary certificate, the exporter must submit a letter of responsibility clearly indicating the information related to the new consignee and his/her responsibility with relation to the requested change. If the modification involves the consignee in a certificate of origin, a new export invoice must be presented clearly indicating the information related to the new consignee. Once the documents required to request the modification have been submitted, Sernapesca shall perform a technical assessment of the related sanitary aspects and shall provide a response to the requirement within the deadline set forth by Law. Page 32 of 57

33 CHAPTER XI. ANNEXES ANNEX Nº 1 Notification of shipment for fisheries products intended for export (NEPPEX) ANNEX Nº 2 Single model Sworn Declaration of Origin for fisheries and aquaculture products susceptible to marine toxins Model Sworn Declaration for Certificate of Origin Mercosur Model Sworn Declaration for Certificate of Origin ALADI Peru ANNEX Nº 3 Sampling and Analysis Request for Export (SMAE) Stamp format Fish Health Department: ANNEX Nº 4 Sernapesca stamp Page 33 of 57

34 ANNEX Nº 5 Origin Authorization for Sanitary Certification (AOCS) ANNEX Nº 6 Sanitary Certificate Formats for Fisheries Products aimed for Export 1.- Health Certificate for fisheries and aquaculture products: This certificate demonstrates that fisheries products aimed for export are fit for human consumption except for algae and by-products thereof. Its issuance must comply with the requirements detailed in technical rule CER/NT2. The format is available in PDF file, and must be printed under special format with the logo. 2.- Sanitary certificates for imports of fisheries products aimed for human consumption EU (different languages): This certificate qualifies products for export to the EU and intended for human consumption. The issuance requires compliance of requirements set forth in Technical Rule CER/NT3. The format is available in PDF file and must be printed in a special format with logo. 3.- HACCP Certificate: This certificate is issued at the request of manufacturing facility and demonstrates that, at the time of issuance, the company has implemented HACCP for a specific processing line. The manufacturing plant must have PAC certification. This document is available in bilingual English/Spanish format. The format is available in PDF file and must be printed in a special format with logo. 4.- Process Monograph Certificate: This certificate indicates that the manufacturing facility took the operational steps described in the attached monograph. This document is available in bilingual English/Spanish format. The format is available in PDF file and must be printed in a special format with logo. Page 34 of 57

35 5.- Certificate for Absence of Vibrio cholerae: This certificate is issued to any market that requests the specific certification in absence of Vibrio cholerae. This document is available in bilingual English/Spanish format. The format is available in PDF file and must be printed in a special format with logo. 6.- Certificate for Product Free from Vibrio cholerae: specific certification for products free of Vibrio cholerae. This document is available in bilingual English/Spanish format. The format is available in PDF file and must be printed in a special format with logo. 7.- Certificate for Zone free from Vibrio cholerae: specific certification for products from a Free Zone of Vibrio cholerae. This document is available in bilingual English/Spanish format. The format is available in PDF file and must be printed in a special format with logo. 8.- Quality Certificate for Export: sanitary quality certification for specific parameters such as microbiological, physical, chemical, sensorial, toxicological and others. This document is available in bilingual English/Spanish format. The format is available in PDF file and must be printed in a special format with logo. 9.- Not intended for human consumption Committee Certificate: Sanitary certificate for fish and fish by-products (harvested/farmed) not intended for human consumption, traded between Argentina, Brazil, Chile and Uruguay. Its issuance requires the compliance of Technical Rule CER-NT3. This certificate can only be signed and sealed by a Veterinarian Doctor, replacing the Official Inspector with the Veterinarian Doctor seal. This document is available in bilingual Portuguese/Spanish format. The format is available in PDF file and must be printed in a special format with logo Health Certificate for fish and fishery products intended for export from Republic of Chile to the People s Republic of China: certifies products intended for human consumption in China. Its issuance requires the compliance of the requirements set forth in documents CER/NT2 and CER/NT3. This certificate may only be sealed and signed by a Veterinarian Doctor, replacing the Official Inspector with the Veterinarian Doctor seal. The Chinese/English Format available in Word file and must be printed in a special format with logo Sanitary certificate for fisheries and aquaculture products intended for the Republic of Croatia: certifies exports of fisheries products intended for human consumption. This certificate may only be sealed and signed by a Veterinarian Doctor, replacing the Official Inspector with the Veterinarian Doctor seal. For its issue, the Page 35 of 57

36 requirements in CER/NT2 must be complied. The format is available in English/Croatian format and is not found in pre-printed format Sanitary certificate for fisheries and aquaculture products intended for the Republic of Tunisia: certifies the export of fisheries products intended for human consumption. Its issuance requires the compliance of the requirements described in documents CER/NT2 and CER-NT3. The format is in English and is not available in preprinted form. 13.-Sanitary certificates for farmed oysters with raw gonads intended for Canada: Certifies the export of farmed oysters with gonads, raw intended for human consumption. Its issuance requires the compliance of requirements described in documents CER/NT2 and CER/NT3. The format is available in trilingual format English/French/Spanish and is not available in pre-printed form Official Veterinary Certificate for fisheries products intended for Costa Rica: Certifies the export of products intended for human consumption. Its issuance requires the compliance of the requirements described in documents CER/NT2 and CER/NT3. The format is available in Spanish and is not pre-printed Sanitary Certificate for Marine Algae and their by-products intended for human consumption: certifies the export of algae and its by-products intended for human consumption. Its issuance requires the compliance of requirements described in document CER/NT2. Bilingual format available in English/Spanish available in Word file, and must be printed in a special format with logo Sanitary certificate for fisheries and aquaculture products intended for Tahiti: certifies fisheries products intended for human consumption. Its issuance requires the compliance of requirements described in documents CER/NT3 y CER/NT2. Trilingual format available in French/Spanish, available in Word file, and must be printed in special format with logo Veterinary Certificate for Fish and Seafood (fishery products) and products of their processing intended for human consumption, exported from the Republic of Chile into the Russian Federation: certifies the export of products intended for human consumption. Its issuance requires the compliance of requirements described in documents CER/NT2 y CER/NT3. Format available in Russian/English available in PDF format, and must be printed in special format with logo. Page 36 of 57

37 18.-Certificate of Origin for Fisheries Products: used for Chilean fisheries products conveyed from one part of the country to another, having to transit through Argentina. This certificate must be signed and sealed by a Veterinarian Doctor, replacing the Official Inspector stamp by the Veterinary Doctor stamp. Available in PDF format, and must be printed in special format with logo. 19.-Sanitary certificate for fisheries and aquaculture products not intended for human consumption: for exclusive use in products not intended for human consumption such as fishmeal and fish oil. Its issuance requires the compliance of requirements described in document CER/NT2. Bilingual format available in English/Spanish available in Word file, and must be printed in a special format with logo. 20. Sanitary certificate for fisheries and aquaculture products not intended for human consumption in Australia: used for fishmeal and fish oil. Its issuance requires the compliance of requirements described in documents CER/NT2 and CER/NT3. Format available in English/Spanish, and not available in pre-printed form. 21.-Sanitary certificate for processed animal proteins not intended for human consumption, including mixtures and products other than animal feed that contain them, intended for the European Union or for transit through the EU: exports of fishmeal intended to the EU. This certificate can only be signed and sealed by a Veterinarian Doctor, replacing the Official Inspector stamp by the Veterinary Doctor stamp. Its issuance requires the compliance of requirements described in document CER/NT3. Available in PDF format in the following languages: Spanish, English, French, Italian, German, Dutch, Danish, Portuguese, Greek, Finish, Swedish, and Polish. 22.-Sanitary certificate for fish oil not intended for human consumption, for its use as an ingredient for animal feed or technical purposes exported to the EU or that transit through the EU: Exports of fish oil intended to the EU or other markets. This certificate can only be signed and sealed by a Veterinarian Doctor, replacing the Official Inspector stamp by the Veterinary Doctor stamp. Its issuance requires the compliance of requirements described in document CER/NT3. Available in PDF format in the following languages: Spanish, English, French, Italian, German, Dutch, Danish, Portuguese, Greek, Finish, Swedish, and Polish. 23. Sanitary certificate for fisheries and aquaculture products not intended for human consumption intended for export to Canada. For its use in fishmeal and fish oil. Its issuance requires the compliance of requirements described in documents CER/NT2 and Page 37 of 57

38 CER/NT3. Format in English/Spanish not available in pre-printed form. CER/MP1/September Sanitary certificate for marine algae and by-products of marine algae not intended for human consumption: exports of dry algae and by-products thereof not intended for human consumption. Its issuance requires the compliance of requirements described in document CER/NT2. Available in bilingual format in English/Spanish, in PDF file and must be printed in special format with logo. 25.-Committee certificate for human consumption: Sanitary certificate for fisheries products and by-products (harvest/farming) intended exclusively for human consumption and marketed between Argentina, Brazil, Chile and Uruguay. Its issuance requires the compliance of requirements described in document CER/NT3. Available in bilingual format in Portuguese/Spanish, in PDF file and must be printed in special format with logo. 26.-Certificate for fish meal and fish oil for animal feed for products destined to Japan: certifies fishmeal and fish oil intended for Japan. Its issuance requires the compliance of requirements described in documents CER/NT2 and CER/NT3. Available in the English version, in PDF file and must be printed in special format with logo Veterinary certificate regarding food for aquatic animal exported to New Caledonia: Issued for fishmeal intended for New Caledonia. Its issuance requires the compliance of requirements described in document CER/NT2. Available in bilingual format in English/French, not available in pre-printed form Health certificate for fisheries products not intended for human consumption exported to the People`s Republic of China: certification for fishmeal and fish oil not intended for human consumption. Its issuance requires the compliance of requirements described in documents CER/NT2 and CER/NT3. This certificate can only be signed and sealed by a Veterinarian Doctor, replacing the Official Inspector stamp by the Veterinary Doctor stamp. Available in bilingual format in Spanish/Chinese in PDF file and must be printed in special format with logo. 29.-Veterinary Certificate for fodder fish meal exported from the Republic of Chile into the Russian Federation: Used to certify the export of fishmeal and fish oil not intended for human consumption. Its issuance requires the compliance of requirements described in documents CER/NT2 and CER/NT3. Format available in Russian/English, in PDF file and must be printed in special format with logo. Page 38 of 57

39 30.- Sanitary certificate for hydrolized protein not intended for human consumption in the European Union: certifies exports of fish peptones intended for the EU and other markets that have adopted regulation (CE) 1774/2002, in accordance with the requirements detailed in Technical Rule CER/NT3. Its issuance requires the compliance of requirements described in document CER/NT3. Not available in pre-printed format Phytosanitary certificate: certifies that the declared export product, at the time of loading, complies with the phytosanitary requirements set forth by the National Fisheries and Aquaculture Service. This certificate is intended for products not fit for human consumption. Available in English/Spanish format, in PDF file and must be printed in special format with logo Special Certificate: format blank certificate used to issue official documents, available in pre-printed form Sanitary certificate for imports of compound products intended for the EU (different languages): This certificate demonstrates the fitness of compound products containing 50% or more of fisheries products intended for export to the UE. Its issuance requires the compliance of requirements described in document CER/NT3. Formats available in PDF file, must be printed in special format with logo Sanitary certificate for imports of bivalve mollusks, echinoderms, tunicates and living marine gastropods resources intended for human consumption. This certificate demonstrates that living fisheries resources qualify for export to the EU and are fit for human consumption. Its issuance requires the compliance of requirements described in document CER/NT3. Format available in Word file, must be printed in special format Veterinary Health Certificate for export of fish and fisheries products to Israel: This certificate demonstrates that fisheries products qualify for export to Israel and are fit for human consumption. Its issuance requires the compliance of requirements described in document CER/NT3. Format available in Word file, must be printed in special format Veterinary Health Certificate for the export of fisheries products intended for human consumption to the Republic of Turkey: This certificates demonstrates that fisheries products qualify for export to Turkey and are fit for human consumption. Its issuance requires the compliance of requirements detailed in technical rules CER/NT2 and CER/NT3. Available in English/Turkish format at the web page of Sernapesca and must be printed in special format with logo. Page 39 of 57

40 ANNEX Nº 7 Specific Sanitary Requirements for Authorization of Shipments of bivalve mollusks, echinoderms, tunicates and gastropods To authorize shipment notifications, the sanitary certificates detailed in points I, II and III of this Annex which are complimentary, must be considered. I. CONTROL OF Vibrio parahaemolyticus. Export of raw bivalve mollusks, equinoderms, tunicates and gasteropods must comply with specific requirements related to control of Vibrio parahaemolyticus in accordance with the details described herein. 1. Control of Vibrio parahaemolyticus in living, fresh chilled resources. To authorize Notifications for shipments of living, fresh chilled bivalve mollusks, echinoderms, tunicates and gasterpods, they must originate from areas classified as type A (PSMB/EU) or Approved (PSMB/USA), in accordance to the List of Harvesting Areas of the PSMB, except for those products harvested and processed in the Magallanes Region. If the origin of the resources is not a PSMB area, the Company interested in exporting must notify its intention to export before Sernapesca in advance, in order to establish a special sampling program in the harvesting area, which should apply prior to export. This monitoring activity shall consist in 2 daily samples during three consecutive days (6 samples in total). 2. Control of Vibrio parahaemolyticus in processed resources. To authorize Notifications for shipments of processed bivalve mollusks, echinoderms, tunicates and gastropods, they must comply with the requirements described in the Quality Assurance Program or perform the analysis of finished product in accordance to the sampling plans set forth in Technical Rule CER/NT2. Page 40 of 57

41 II. CONTROL OF MARINE TOXINS General considerations - As long as a consignment has a biotoxin analysis, performed by the Health Service, they shall be considered as part of the analysis required by Sernapesca and they shall be deducted from the number of samples described in each sampling plan. If the number of analysis issued by the Health Services is equal or higher than the samples required by Sernapesca, additional samples shall not be necessary. - For biotoxin determinations, samples shall be extracted from each consignment by applying the table in accordance with the total net weight. Canned products shall be excluded from this measure, in which case the sampling tables shall be applied in accordance with the total drained weight of the product. - Simple Sworn Declaration, Model 1 must be submitted to obtain an AOCS, SMAE or Neppex for products susceptible to marine toxins. 1. Authorization of Notification for Shipments of living and chilled refrigerated living resources. Shipment Notifications shall only be authorized for fresh or living resources susceptible to marine toxins, when they originate from areas not affected by red tides, otherwise, these resources must originate from areas classified as type A (PSMB/UE) or Approved (PSMB/USA), in accordance with the List of Extraction Areas PSMB, which must be proven by means of a Simple Sworn Declaration, Model 1. In this case, biotoxin analysis shall be not required. Bivalve mollusks, tunicates and gastropods are defined as products susceptible to marine toxins. 2. Authorization of Notifications for Shipment of echinoderms. To obtain authorization of Notifications for shipment of sea urchins and sea cucumber, without prejudice of their origin and presentation, sampling and analysis of biotoxins shall not be required. Proof of origin shall only be required when the product is intended for the European Union, in which case an AOCS shall be submitted. Page 41 of 57

42 3. Authorization of Notifications for Shipment of abalone from PSMB extraction areas To obtain authorization of Notifications for shipment of abalone from areas included in the Sanitary Program for Bivalve Molluscs, proof of origin must be made by submitting a Simple Sworn Declaration, Model 1. Sampling and analysis of biotoxins shall not be required without prejudice of the region of origin. 4. Authorization of Notifications for Shipment supported by a Quality Assurance Program. For products manufactured in facilities with validated Quality Assurance Programs, Authorization of Notifications for Shipment shall be granted upon submission of an Origin Authorization for Sanitary Certification (AOCS) for the relevant consignment, except in case of raw material originating from natural banks of Region X, in which case VPM analysis shall be made for each export consignment, in accordance with Chapter 4 of Annex VI of Technical Rule CER/NT 2. Upon requesting Shipment Notification at the port of exit, the interested party shall submit the following documents in original form: - Shipment Notification for Fisheries Products intended for Export. - Origin Authorization for Sanitary Certification (AOCS) 5. Authorization of Notifications for Shipment supported by Final Product Control In case of products not manufactured under the Quality Assurance Program the following shall apply Processed Resources From the Magallanes Region. To obtain Authorization of Notifications for Shipment, products from the Magallanes Region shall require biotoxin analysis in accordance with the provisions of Chapter 2 of Annex VI of Technical Rule CER/NT 2. Upon requesting Authorization of Notifications for Shipment at the port of exit, the following documents shall be submitted in original form: Page 42 of 57

43 - Shipment Notification for Fisheries Products aimed for Export. - Sampling and Analysis Request for Export. - Relevant Analysis Report. - Results from the Health Labs, when they are used to support authorizations for notifications and/or sanitary Certification Processed Resources from General Carlos Ibáñez del Campo Region. To obtain Authorization of Notifications for Shipment, products from this Region shall require biotoxin analysis in accordance with the provisions of Chapter 3 of Annex VI of Technical Rule CER/NT 2. To process the Request for sampling of products susceptible to marine toxins originating from the XI Region, Sernapesca shall require the submission of the Resolution from the Sanitary Authority of Region XI that authorizes them for human consumption, which is always supported by Laboratory analysis results. In case the product accounts for raw material intended for processing in another Region, the Resolution that authorizes the transportation of raw material shall be responsibility of the sanitary authority of the region of destination, shall be submitted to clear such products for final consumption. Upon requesting Authorization of Notifications for Shipment at the port of exit, the following documents shall be submitted in original form: - Shipment Notification for Fisheries Products aimed for Export. - Sampling and Analysis Request for Export. - Relevant Analysis Report. - Results from the Health Labs, when they are used to support authorizations for notifications and/or sanitary Certification Processed resources from the Regions of Atacama, Coquimbo and Los Lagos. To obtain Authorization of Notifications for Shipment, products manufactured with resources from this Region shall require PSP, ASP, and DSP analysis in accordance with the sampling plans set forth in Chapter 5 of Annex VI of Technical Rule CER/NT 2. Upon requesting Authorization of Notifications for Shipment at the port of exit, the Page 43 of 57

44 following documents shall be submitted in original form: - Shipment Notification for Fisheries Products aimed for Export. - Sampling and Analysis Request for Export. - Relevant Analysis Report. - Results from the Health Labs, when they are used to support authorizations for notifications and/or sanitary Certification Processed Resources from Regions of Arica and Parinacota, Tarapacá, Antofagasta, Valparaíso, del Libertador Bernardo O Higgins, del Maule, del Bío Bío, La Araucanía, and los Ríos. To obtain authorization of Notifications for shipment proof of origin must be made by only submitting a Simple Sworn Declaration, Model 1 in accordance to Annex 2. Upon requesting Authorization of Notifications for Shipment at the port of exit, the following documents shall be submitted in original form: - Shipment Notification for Fisheries Products aimed for Export. - Origin Sworn Declaration. III. Control of Norovirus in raw Oysters Notifications for shipment for raw oysters (living, fresh or frozen), shall be authorized only if they originate from an area under the Bivalve Molluscs Sanitary Program with Category A and if the facility ensures that the lots intended for export are free from Norovirus by taking samples that consider n = 3 for each harvesting area of origin and each week of processing. Page 44 of 57

45 ANNEX Nº 8 Formats for Certificates of Origin for Fisheries Products aimed for Export Certificate of Origin Chile: ensures that the product originates from Chile, it is printed in 2 languages simultaneously: English and Spanish. It is not eligible for tariff reductions and a Notification for Shipment of Fisheries Products aimed for Export is previously required (Neppex), Single Exit Document (Dus) and original export invoice. Certificate of Origin ALADI: ensures that the product originates from Chile and allows eligibility for preferential tariffs of the destination market, member of ALADI. It must be signed by the exporter and indicate the importing country, NALADISA codes and Chilean harmonized code, number of export invoice and Economic Agreement subscribed between Chile and the destination country. Certificate of Origin Mercosur: ensures that the product originates from Chile for markets members of Mercosur. The certificate must include: a description of the goods with NALADISA code, the FOB value and Simple Sworn Declaration (Annex 2) by the exporter with the background information ensuring compliance with the relevant requirements. The certificate may be issued within 5 working days following submission of Neppex and up to 10 days subsequent to shipment. The date of certification may not be prior to the date of issuance of the invoice. Certificate of Origin ALADI Venezuela: ensures that the product originates from Chile for fisheries products intended for export to Venezuela. Only requires submission of: Neppex, Dus and export invoice. Certificate of Origin ALADI Peru: ensures that the product originates from Chile for products intended for export to Peru. To obtain this certificate, the following documents must be submitted: Neppex, Dus, export invoice and simple sworn declaration (Annex 2) by the exporter with the documents ensuring compliance with the relevant requirements. Must be issued within 7 days from the time of request, the certification date must not be prior to the date of issuance of the invoice, and is valid during 180 days. Certificate of Origin Form A: ensures that the product originates from Chile and allows eligibility to preferential tariffs in developing countries within the framework Page 45 of 57

46 of the Generalised System of Preferences (G.S.P). Must include: exporter s signature, invoice number and date, and the format is yellow. Certificate of Origin ACE 65: ensures that the product originates from Chile and allows eligibility to tariff preferences in Ecuador in accordance with the Economic Complementary Agreement N 65 signed between Chile and Ecuador, according with the technical specifications in Technical Rule CER/NT1. Must be signed by the exporter in the location designated for this purpose. Page 46 of 57

47 ANNEX 9 Special Certificate Page 47 of 57