DG(SANCO)/ MR

Transcription

1 1 The CA should ensure that standards applied to The INVIMA shall issue a technical regulation that will fishery products exported to the EU are fully equivalent modify Resolution 776 of 2008 through the Ministry for to EU requirements in particular, regarding histamine, Social Protection, Through which the technical PAH and freezer vessels. regulation on physical-chemical and microbiological requirements will be established, which fish products should meet, to wit, fish, mollusks, and crustaceans for human consumption so that the parameters for polycyclic aromatic hydrocarbons (PHA) shall be included for all fish products as well as establishment of the parameters for histamines in fish products coming from fish species associated with a high histidine content, placing particular emphasis on the following families: Coryphaenidae, Pomatomidae and Scombresocidae. Date of last edit: 12 April

2 Products belonging to the Scombridae, Clupeidae and Engraulidae are currently regulated under Resolutions 776 of 2008 (Reason why the technical regulation has been established on the physical-chemical and microbiological prerequisites that fish products should meet particularly fish, mollusks, and crustaceans for human consumption), 148 of 2007 (Through the technical regulation is established on the prerequisites that tuna should meet under preserves along with tuna preparations that are manufactured, imported or exported for human consumption and 337 of 2006, (Through which the Technical regulation is issued on the prerequisites that sardines in preserves should Date of last edit: 12 April

3 meet that are manufactured, imported or exported for human consumption). The INVIMA shall likewise issue a technical regulation, through the Ministry for Social Protection, under which the prerequisites and conditions are set forth that fishing vessels with freezer containers should meet for implementing the HACCP System along with the procedure for its verification, certification, and inclusion, by the INVIMA as the Competent Authority, on the official freezer-container fishing vessels authorized to provide raw materials to fish-product processing establishments that export to the European Union. Date of last edit: 12 April

4 Considering that this process also requires the drafting, assessment, review, and debugging of the respective documentation, the corresponding consultations, at the national as well as the international levels, to the World Trade Organization (WTO), will take one (1) year for compliance and execution, in other words by May The CA should ensure that freezer vessels providing raw material are EU-listed and that they meet the conditions laid down in the relevant EU legislation. In particular freezer vessels should be equipped with temperature-recording devices and have a HACCP plan as required in Chapter I, Section VIII, of Annex III to Regulation (EC) No 853/2004 and in Article 5 of The INVIMA shall issue a technical regulation through the Ministry for Social Protection which shall establish the prerequisites and conditions (including temperaturemeasurement devices) that should be meet by the freezer-container fishing vessels in order to implement the HACCP System along with the procedure for its verification, certification, and inclusion, by the INVIMA Date of last edit: 12 April

5 Regulation (EC) No 852/2004. as the Competent Authority, on the official freezercontainer fishing vessels authorized to provide raw materials to fish-product processing establishments that export to the European Union. Once the compliance-verification process has taken place, related to the prerequisites established in the technical regulation (including visits to the freezercontainer vessels and the drafting of the respective act), a certification shall be issued in which will be stated the name and identification of the vessel, the products handled or provided, the term in force, and shall assign a code to the same. As a result, the list of authorized vessels shall be drafted which shall be submitted to the Date of last edit: 12 April

6 European Union by May While the specific regulation is issued, the procedure that has been carried out shall continue to be utilized for the sanitary inspection of the freezer-container fishing vessels with the objective of verifying compliance with the sanitary requirements, formulation of the requirements that may be deemed necessary, and the drafting of the respective acts, currently in force within the INVIMA quality performance system. As of said date, the INVIMA shall likewise guarantee the periodic presence of an INVIMA inspector within the unloading processes to verify compliance with the sanitary Date of last edit: 12 April

7 conditions and conduct the organoleptic assessment of the product or raw materials. 3 The CA should ensure that unloading of fish and fishery products are carried out in line with point 1, Chapter II, Section VIII of Annex III to Regulation (EC) No 853/2004. As of said date, the INVIMA shall guarantee the periodic presence of an inspector during unloading operations of tuna fish at the plants in order to conduct organoleptic control over the product and verify that these operations are carried out according to that s et forth within European Union legislation. Conduct visits to authorized fish-production plants that export to the European Union with the objective of verifying compliance with the sanitary requirements stipulated within the European sanitary legislation, placing emphasis on the deficiencies pointed out in the Date of last edit: 12 April

8 report of the EU official mission from which the respective act shall be drafted bearing the requirements deemed necessary and thereafter the respective follow up shall be conducted. These activities shall be carried out during the second half of The CA should ensure that only establishments that meet the conditions laid down in the relevant EU legislation (considering the requirements of Chapter I of Annex III to Regulation (EC) No 854/2004, Regulation (EC) No 853/2004 and Regulation (EC) No 852/2004 are EU listed (taking into account the requirements of Article 12 of Regulation (EC) No 854/2004). Conduct visits to all authorized fish-production plants that export to the European Union with the objective of verifying compliance with the sanitary requirements stipulated under European sanitary legislation, placing emphasis on the deficiencies pointed out in the report of the EU official mission from which the respective act shall be drafted bearing the requirements deemed necessary and thereafter the corresponding follow up shall be conducted. Date of last edit: 12 April

9 These activities shall be carried out during the second half of The CA should provide guarantees that fishery products for export to the EU have satisfactorily undergone all the official controls laid down in Chapter II of Annex III to Regulation (EC) No 854/2004, in particular, monitoring of certain contaminants histamine testing and organoleptic checks should be carried out in line with EU requirements. In addition to conducting the visits alluded to in the above numeral, under prior review and adjustment, the sampling plan shall be strictly executed for the official control which shall include the determination of all of the sanitary parameters as well as for contaminants stipulated under European and Colombian sanitary legislation. (See attachment on sampling plan for official control). Control over unloading shall likewise be intensified which shall include the sanitary conditions of the same as well as organoleptic controls over raw materials or products. Date of last edit: 12 April

10 The INVIMA National Reference Laboratory shall implement the methodology for determining Polycyclic Aromatic Hydrocarbons (PAH) (Benzopyrenes) and dioxins in fish products in The implementation for determining tin in the matrixes of interest will be implemented during the second half of 2011, process which will be included in In the event of discovering any hardship in carrying out his process, the determination for PAH and tin shall be contracted out to an accredited private laboratory. Nonetheless, it is noteworthy to clarify that the tin-plated Date of last edit: 12 April

11 cans utilized in tuna production in Colombia are two-level cans that do not have any welded joints in their design, which could transfer this element to the product. Likewise the varnish and sealers utilized in the manufacture of tinplated cans do not contain tin within their components. 6 The CA should ensure that imported fishery products to be used as raw material in the fishery products EU export production chain comply with applicable EU requirements. Decree 3075 of 1997 establishes the following with regard to the importation of foodstuffs and raw materials: Article 56. Sanitary Inspection Certificate: Every lot or shipment of foodstuffs or raw materials object of importation requires a sanitary inspection certificate for this process issued by the sanitary authority at the port-of-entry of the products. Date of last edit: 12 April

12 Article 57. Documentation for the issuance of the Sanitary Inspection Certificate for legalization: the following are required for the issuance of the sanitary inspection certificate for legalizing foodstuffs and raw materials for foodstuffs: a. Sanitary certificate form the country of origin or its equivalent. b. Copy of the sanitary registration for those products that are subject to this prerequisite as established under the present decree. c. Inspection Act for the merchandise. d. Results of the laboratory analysis conducted upon product samples. Date of last edit: 12 April

13 PARAGRAPH. The sanitary authority at the port-of-entry may exempt products from a laboratory analysis that, in conformity with the present decree, are not found within those considered of major risk to public health as well as other foodstuffs that, as a result of the surveillance and control activities conducted on the imports, repeatedly evidence behavior of an acceptable level of sanitary quality. Based on the above-cited regulation, the INVIMA, as the entity responsible for the sanitary control over the importation and exportation of foodstuffs and raw materials, at ports, airports, and border crossings, shall require importers to expressly manifest, within the Sanitary Date of last edit: 12 April

14 Certificate that should accompany each shipment or merchandise imported, that the same complies with European Union sanitary legislation when its destination are fish-product processing plants for exportation to the European Union. 7 The CA should ensure that laboratories involved in official control apply the principles of internationally recognised quality assurance techniques and are evaluated and/or accredited under officially recognised quality management and assurance programmes equivalent to international standards, such as ISO/IEC 17025, to ensure the reliability of analytical results. The INVIMA, through the National Reference Laboratory for Foodstuffs and Alcoholic Beverages, set up a technicalassistance schedule that will be carried out throughout 2011 with the objective of strengthening the technical capability of the Official Laboratories of the National Network. During the second half of 2011, an introduction seminar shall be conducted on the implementation of the quality Date of last edit: 12 April

15 performance system under ISO 17025, and shall hand down the corresponding directives to continue with the compliance in the implementation of the qualityperformance system applicable to testing and calibration official laboratories. The INVIMA shall verify the progress made regarding the implementation and development of the methodologies within the validation process as well as of ISO IEC/2005. Laboratories participating in the official control over fish products, by 2015, shall be accredited and their scope shall cover the analytical methodologies of interest for these products. Date of last edit: 12 April

16 Complementary to the action plan technical tutors were assigned in April 2011 as well as from the Quality Group to guarantee technical assistance and continuous support to the Official Network Laboratories. The INVIMA National Reference Laboratory will have included all of the analytical techniques by 2013, within its scope of accreditation that comprise the official control over fish products destined for the European Union. 8 The CA should ensure that laboratories involved in official control take into account in particular, the analytical method for histamine and the performance criteria for heavy metals as is laid down in Regulation The National Reference Laboratory shall implement the methodology for determining histamines via the HPLC method during the second half of Date of last edit: 12 April

17 (EC) No 2073/2005 and Regulation (EC) No 333/2007 respectively. Validation of the analytical methodology for determining heavy metals in root products for fishery shall be conducted during the second half of [The present page pertains to an Official Translation of the Report of a Plan of Action for the EU 2011 and is null and void if used for any other purpose(s) or with any other document(s).] TRUE AND COMPLETE OFFICIAL TRANSLATION TO ENGLISH OF A DOCUMENT WRITTEN IN SPANISH BY THE OFFICIAL TRANSLATOR FOR THE REPUBLIC OF COLOMBIA, NILSEN ARINGHARD, AT YOUR SERVICE. NILSEN ARINGHARD Official Translator Date of last edit: 12 April