EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2019-6695

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

COLOMBIA

FROM 18 MARCH 2019 TO 05 APRIL 2019

IN ORDER TO

FOLLOW UP THE AUDIT DG(SANTE) 2016-8690 TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE PRODUCTION OF FISHERY PRODUCTS DERIVED FROM TUNA SPECIES INTENDED FOR EXPORT TO THE EUROPEAN

UNION

Ref. Ares(2019)5536693 - 03/09/2019

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Executive Summary

This report describes the outcome of an audit in Colombia carried out from 18 to 20 March and 5 April 2019, as part of the published Directorate-General for Health and Food Safety audit programme.

The objective of the audit was to verify the extent to which the guarantees and the corrective actions submitted to the Commission services in response to the recommendations of the previous DG(SANTE) tuna fishery products audit report of 2016 have been implemented and enforced by the competent authority.

This follow-up audit found that the majority of the recommendations of the 2016 audit report have been largely or partially addressed. As a result, the overall situation improved when compared with the 2016 audit. However, the implementation of the controls is incomplete to date, which is a critical point given that the introduction of a "split system" for EU-eligible and non-eligible products by its very nature requires additional and very reliable controls along the production chain (fishery products obtained from "dual use" fish holds are not permitted in the EU). This, together with the less than robust assurances regarding the permanent separation of the brine systems in such "split" production, implies that Colombia is not yet in a position to provide full guarantees that fishery products intended for export to the EU meet all the required standards, in particular in respect of the absence of contamination with fuel.

The audit also found that fish oil produced from by-products which may have been contaminated with fuel – and which, for that reason, is not eligible for export to the EU, either as food- or feed grade oil – was exported to the EU.

The report contains recommendations to the competent authority to address the shortcomings identified.

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Table of Contents

1 Introduction ....................................................................................................................................1

2 Objective and scope .......................................................................................................................1

3 Legal Basis .....................................................................................................................................2

4 Background ....................................................................................................................................2

4.1 General Background ................................................................................................................2

4.2 Production and Trade Information ..........................................................................................2

4.3 Rapid Alert System for Food and Feed (RASFF) Notifications ...............................................3

5 Findings and Conclusions ..............................................................................................................3

5.1 Recommendation No 1 of the audit report DG(SANTE) 2016-8690: National provisions and procedures for listing EU approved establishments ................................................................3

5.2 Recommendations No 2-4 of the audit report DG(SANTE) 2016-8690: Official controls ......7

6 Overall Conclusions .....................................................................................................................16

7 Closing Meeting ...........................................................................................................................17

8 Recommendations ........................................................................................................................17

ANNEX 1 – Legal references

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ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation

EC European Community

EU European Union

EU export certificateModel health certificate for imports of fishery products intended for human consumption as defined in Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005

EU listed establishments

Establishments included in lists made in accordance with Article 12 of Regulation (EC) No 854/2004 and available at http://ec.europa.eu/food/safety/international_affairs/trade/non-eu-countries_en, from which imports into the EU are permitted.

Eurostat The statistical office of the European Union

FBO(s) Food business operator(s)

HACCP Hazard Analysis and Critical Control Points

INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

RASFF Rapid Alert System for Food and Feed

TRACES Trade Control and Expert System

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1 INTRODUCTION

The audit took place in Colombia from 18 to 20 March and 5 April 2019, as a follow-up to an audit carried out in 2016 on the same subject (1). The audit team comprised two auditors from the Directorate-General for Health and Food Safety.

An opening meeting was held in Bogotá on 18 March 2019 with the competent authority, the INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) within the Ministry of Health and Social Protection. At this meeting the audit team confirmed the objective of, and the itinerary for the audit, and requested additional information on specific elements of the control system in place. Representatives from the competent authority accompanied the audit team throughout the audit.

2 OBJECTIVE AND SCOPE

The objective of the audit was to verify the extent to which the guarantees and the corrective actions submitted to the Commission services in response to the recommendations of the previous DG(SANTE) tuna fishery products audit report of 2016 have been implemented and enforced by the competent authority.

Specifically in this context, the audit team assessed whether the official controls in place can provide assurance that the conditions of production of fishery products from tuna species and destined for export to the European Union (EU) meet the relevant requirements laid down in EU legislation, and specifically with the health attestations contained in the model health certificate of Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005 (2) (hereafter referred to as: “the EU export certificate”).

Given the intrinsic nature of a follow-up audit, and in terms of scope, the audit focused on the measures put in place to address the 2016 audit report recommendations.

Relevant EU legislation referred to in Annex 1 served as a technical basis for this audit. The EU legal acts quoted in this report refer where applicable, to the last amended version (3).

In pursuit of the audit objectives, the audit team visited the following sites:

Competent Authority

INVIMA 3 Headquarters (2) and local office (1).

Processing Facilities

Freezer Vessels 3 1 in Colombia and 2 outside Colombia

(1) Report reference DG(SANTE)/2016-8690 – available at http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3800.

(2) Model health certificate for imports of fishery products intended for human consumption as defined in Appendix IV to Annex VI to Regulation (EC) No 2074/2005.

(3) The EU legislation can be found in the Internet at http://eur-lex.europa.eu/en/index.htm.

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Establishments on land (EU listed)

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3 LEGAL BASIS

The audit was carried out under the general provisions of the Trade Agreement between and European Union and its Member States, of the one part, and Colombia and Peru, of the other part, annexed to Council Decision 2012/735/EU as amended, and, in particular, Article 93 (Verifications).

In addition, general provisions of the EU legislation were taken into account, in particular, Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

4 BACKGROUND

4.1 GENERAL BACKGROUND

Colombia is included in Annex II to Commission Decision 2006/766/EC which sets out the list of third countries and territories from which imports of fishery products are permitted.

EU Member States are currently authorised to import fishery products from Colombia from fourteen establishments on land, one reefer vessel, and thirty freezer vessels. Of these, the following are relevant for tuna fishery products: three establishments on land; the reefer vessel; and, twelve freezer vessels. Member States are also authorised to import animal by-products from two processing facilities. The lists of these authorised facilities (hereafter: EU listed establishments) are available on the European Commission website: (http://ec.europa.eu/food/safety/international_affairs/trade/non-eu-countries_en)

The last audit by the Commission services in Colombia covering fishery products (and focusing on tuna) took place in October 2016. The 2016 audit report made four recommendations to the competent authority, which, in response, provided three subsequent action plans with corrective actions to address those recommendations, between March 2017 and March 2018. The recommendations, and the proposed corrective actions, are presented in section 5 of this report.

4.2 PRODUCTION AND TRADE INFORMATION

According to Eurostat data, in 2017 and 2018, the EU imported from Colombia approximately 33 650 tonnes of fishery products. Around 73 % of those imports were tuna fishery products (92 % processed tuna (cooked and canned) and 8 % frozen (whole round and loins). The figures obtained from TRACES are comparable to the ones of Eurostat.

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During this period the EU also imported from Colombia 61.4 tonnes of fish oil as animal by-products, for feed purposes (TRACES data).

4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS

There was one RASFF notification related to Colombian tuna products since the 2016 audit. This notification concerned an erroneous indication of the approval number of the production facility on the label.

5 FINDINGS AND CONCLUSIONS

5.1 RECOMMENDATION NO 1 OF THE AUDIT REPORT DG(SANTE) 2016-8690: NATIONAL PROVISIONS AND PROCEDURES FOR LISTING EU APPROVED ESTABLISHMENTS

1. Recommendation No 1 required the competent authority to ensure that the official control system guarantees that freezer vessels are only EU listed if adequate guarantees are provided with regard to the requirements of Article 12 of Regulation (EC) No 854/2004 and, throughout the duration of their approval period (two years), with the requirements at least equivalent to the EU rules, namely, the requirements of Chapter I, Section VII of Annex III to Regulation (EC) No 853/2004.

2. The recommendation was made because the 2016 audit found that the competent authority could not demonstrate that freezer vessels would maintain the conditions that allowed them to be approved, and included in the EU list.

Actions proposed by the competent authority

3. The competent authority proposed the following corrective actions (text combined from the 1st and 2nd action plans):

The INVIMA, through the inspection, surveillance and control actions will carry out sanitary controls, HACCP certifications and their renewal for the fishing vessels that provide raw material located in Manta (Ecuador) destined to the EU, within the time frames established, to the effect of the administrative formality in order to authorize the commission and movement of the officials which shall be carried out in a time period of no more than five days; this will guarantee that the officials arrive at the port before or during the unloading process, or transfer of the product, thus allowing to carry out the control of the process, evaluate the sanitary conditions of the fishing vessel and undertake the verification and audit of the HACCP plan. It is necessary to make clear the Guideline No. 52 (copy provided) requests a time period of two working days for the notification of the arrival of the fishing vessel on the part of the operators (vessel owners) since the fishing vessels arrive in Cartagena (Colombia), where no extra time is required for scheduling the corresponding activity, which is limited just to controlling the unloading process and the sanitary conditions of the fishing vessel.

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In the event that the certifications expire during the fishing trips (so, therefore, the fishing vessel is at sea fishing), it shall be guaranteed that the visit for the renewal of the certification is carried out before the fishing vessel sets sail, something that was notified to the operators pursuant to official letter No. 400-3775-2017 (copy attached). For this purpose, the operators of the fishing vessel shall make the HACCP certification request, or its renewal, no less than two months before the expiry date of the certification, as well as the request for the certification visit before it expires. Likewise, the operators are committed to report the arrival of the fishing vessel at the port no less than five days in advance. In the event that the fishing vessel does not request the renewal of the HACCP certification of the fishing vessel in a timely manner, and if the certification is not carried out before its expiry, it is understood that the certification indeed expires and, therefore, the fishing vessel is removed from the EU list. With the purpose of facilitating and fulfilling the process in an effective manner, though official letter 400-2846-2017, attached hereto, the operators are notified about the decisions adopted, the terms and deadlines for their execution, as well as the responsibilities and commitments of each one of the parties. Likewise, the National Government enacted Resolution 0179 of March 14, 2017, through which the process for secondments is simplified, with the purpose of being able to fulfil all the actions required within the time periods established (copy provided). Therefore, the INVIMA commits itself to carry out the HACCP certification visits of the fishing vessel every two years, and their follow-up and control every year. INVIMA is committed to complying with the demands posed by the European Union, and it has already carried out actions and has informed the operators. This is supported by the official letters attached hereto. In twelve months to comply with the entire measure. Starting in the month of June 2018, it shall be guaranteed that the sanitary and unloading controls of the fishing vessel, as well as the HACCP certifications of the fishing vessels shall be carried out within the time periods established before their expiry.

4. With the 3rd action plan, the competent authority informed the commission services of the state of implementation of the proposed corrective actions, as follows:

During 2017, the following activities were carried out: 2) Visits to renew HACCP certifications and registration with the European Union, as follows: - Two vessels in June, three in September and one in December. The visits were carried out before the expiry of the certifications, which were thus renewed; the approval for EU export was therefore maintained.During the visits, the requirements and observations recorded in the audit report made during the year 2016.3) HACCP certification inspection visits:

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- Two vessels in December 4) Unloading inspections: - One vessel in July, two in September and one in November 5) Withdrawal of establishments from the list of establishments authorised for EU export. On the basis of the official communication No 17079966 of 2017/07/28 INVIMA requested to DG SANTE, the withdrawal from the list of establishments authorised for EU export one vessel for failure to renew the HACCP certification in a timely manner. By the official communication No 17104610 of 2017/10/03 INVIMA requested the inclusion again in the list of establishments authorised for EU export. The mentioned vessel was eventually included in that list, which entered into force from 3 December 2017.

Findings

5. During the audit the competent authority provided further information/clarification with regard to the announced corrective actions, as follows:

a. The demonstration that an EU listed facility complies with the requirements of the approval is achieved through the renewal of the HACCP (Hazard Analysis and Critical Control Points) "certification" (which is valid for two years) together with at least one inspection visit carried out to assess the implementation of that HACCP plan. This inspection visit should be carried out during the two years of validity of the HACCP certification (ideally, approximately one year after the visit for that certification).

b. The Guideline No 52 of 2016 was replaced by Guideline No 32 of 2017.

c. The proposed advanced period of five days established for the food business operators (FBO) to communicate the arrival of the fishing vessels to port (outside Colombia - in Manta, Ecuador) was adhered to for the HACCP certification, but not for the remaining official control visits.

d. As a consequence, the competent authority could not ensure compliance with point 4.2 of Guideline No 32, which stipulates that the competent authority should carry out sanitary and unloading controls (inspections) for every fishing vessel at least twice per year.

e. The competent authority also indicated that, in their understanding, an inspection visit with a view of HACCP certification would count as a sanitary control.

f. The competent authority confirmed that the administrative procedures to authorise the displacement of official staff outside Colombia (for the purposes of controls in Manta) are working well and in a timely manner after the publication in March 2017 of Resolution No 0179.

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6. The audit team noted that the request for re-inclusion of the freezer vessel in the EU list occurred after an on-the-spot visit of the vessel with a view to HACPP certification. That on-the-spot visit had a satisfactory result and recommended the inclusion of the freezer vessel in the EU list.

7. The audit team visited three EU-listed freezer vessels and assessed the files of all EU listed vessels relevant for tuna fishery products (see section 4.1). The audit team noted that the vessels visited had a valid approval based on an HACCP certification visit done within less than 2 years. The audit team also noted that since the 2016 audit the competent authority inspected all vessels with a view to certifying their HACCPs, in line with the actions proposed to address recommendation No1 of the 2016 audit report.

8. However, the audit team also confirmed that the planned sanitary and unloading controls had not been carried out in seven out of the twelve freezer vessels within the defined frequency of twice per year. This is mainly due to the fact that although those vessels unload many times in Manta, the FBO concerned does not communicate the arrival in port within a reasonable time frame to allow control personnel to make the necessary travel arrangements. This non-communication constitutes a failure on the part of the FBO to comply with the instruction contained in INVIMA's official letter No 0400-2915-2017 of 13/06/2017. The competent authority did not take further actions to remedy this issue.

9. These sanitary and unloading controls together with the HACCP certification would allow the competent authority to demonstrate that the EU listed facilities comply with the conditions that allowed their inclusion on the EU list, as required by Article 12(2)(a) of Regulation (EC) No 854/2004. However, the non-adherence to the frequencies defined by the competent authorities and which they consider the prerequisite to demonstrate full compliance with Article 12(2)(b) of Regulation (EC) No 854/2004 and with Chapter I(1)(b) of Annex III to the same Regulation, calls the reliability of such guarantees in question.

Conclusion on national provisions and procedures for listing establishments exporting fishery products to the EU

10. The competent authority adequately implemented the measures proposed to address recommendation No 1 of the 2016 report.

11. Nevertheless, the non-respect on the part of the FBOs of freezer vessels of the competent authority's instruction to communicate to it the call into port in such a way that it can organise the foreseen controls, does not allow the competent authority to respect its fixed deadlines for the sanitary and unloading controls. This, in turn, affects the ability of the competent authority to demonstrate full compliance with Article 12(2)(b) of Regulation (EC) No 854/2004.

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5.2 RECOMMENDATIONS NO 2-4 OF THE AUDIT REPORT DG(SANTE) 2016-8690: OFFICIAL CONTROLS COVERING THE PRODUCTION CHAIN AND PLACING ON THE MARKET

12. The 2016 audit report made three recommendations in respect of official controls covering the production chain and placing on the market:

a. Recommendation No 2 required the competent authority to ensure that all freezer vessels involved in the production chain for tuna fishery products for EU export (or the parts of those vessels assigned to that production chain) comply with standards at least equivalent to EU rules, in particular, with point of Chapter I(I)(A)(1), Section VIII of Annex III to Regulation (EC) No 853/2004 and Chapter IV(2) of Annex II to Regulation (EC) No 852/2004.

b. Recommendation No 3 required the competent authority to ensure the existence HACCP systems established by FBOs for freezer vessels and that those systems properly identify any hazards that must be prevented or eliminated and establish procedures to verify that the measures of control implemented work effectively, in line with Article 5 (2) (a) and (f) of Regulation (EC) 852/2004.

c. Recommendation No 4 required the competent authority to ensure that all import consignments undergo adequate controls to guarantee that imported raw materials used for the manufacture of products to be exported to the EU have been caught, handled, landed, prepared and processed (as applicable) in accordance with the EU rules.

13. These recommendations were made as the 2016 audit established that: EU listed Colombian freezer vessels did not comply with the EU rules with regard to the correct use of fish holds ("dual use" fish holds, i.e. fish holds used to initially store fuel and, later on, to freeze and store frozen products); HACCP based procedures implemented by the FBOs of those freezer vessels did not comply with the EU rules (generic HACCP plans not reflecting the real operations); and, the competent authority could not demonstrate the EU eligibility of raw materials imported and used in the manufacture of products for EU export.

Actions proposed by the competent authority

14. In reply, the competent authorities presented the following actions:

a. For recommendation No 2: In its 1st action plan the competent authority informed that the practice of "dual use" of fish holds would continue and that thorough and adequate cleaning of the holds before being used to freeze and store frozen fishery products would ensure that fishery products were not contaminated with fuel (residues). Moreover, it indicated that fish originating from "dual use" fish holds would be tested for indicators of fuel contamination before being used for EU exports.

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This reply was not accepted by the Commission services because the EU rules do not allow to freeze and store frozen fishery products in holds previously used to store diesel.

In its 2nd action plan the competent authority informed that the use of fish holds for storage of fuel had been prohibited and that it will verify compliance with this requirement during the official control visits (the sanitary and unloading controls and the HACCP certification). This prohibition was communicated to the relevant FBOs by an official letter of 30/06/2017 (ref. 400-3775-2017). The competent authority stated that three scenarios would be possible: (1) some fish holds permanently and exclusively dedicated to store fuel; (2) no fish holds dedicated to store fuel; and, other possibilities indicated by the FBOs and subject to the assessment and authorisation by the competent authority. The competent authority also stated that it was in contact with the authorities of Ecuador to discuss the possibility of the latter to carry out, on its behalf, sanitary and unloading controls on the Colombian vessels. The deadline suggested to implement this measure was June 2018.

In the 3rd action plan, submitted following a request for an update from the Commission services, the competent authority informed:

The FBO (having reviewed different alternatives to comply with the requirements formulated by European Union, particularly in relation to dual-use tanks) informed INVIMA by letter that it considers ending the practice unfeasible and that is has decided to continue using multi-purpose tanks; in the interest of complying with EU rules it will use a segregated system to ensure product stored in these tanks is not used in the preparation of products destined for EU member states. To this end, the operator is in the process of implementing the following actions: (1) Designating and marking a number of specific tanks as holds that will be used to

store fuel on each vessel (identification of multi-purpose tanks). (2) Putting in place a check on the separation of product which was stored in multi-

purpose tanks in order to prevent product from these tanks being used as raw material in the preparation of product which will be exported to the EU.

(3) Putting in place a separation system for fishing vessels and storage tanks on steamers or cargo freezer vessels in order to ensure traceability of the raw material.

Through inspection, monitoring and control activities (“HACCP certification”, certification inspections, health and unloading inspections and on-going inspections in processing establishments) INVIMA will carry out the following actions:

(1) Verifying, with the information provided by the operator, that the designated tanks are clearly identified for dual-purpose use.

(2) Verifying the storage and separation conditions of the product (raw material) at every stage from catching, transport, unloading, storage and processing until the finished product is exported.

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(3) Ensuring at all times through traceability, fishing vessel capacity, capacity of tanks identified as multi-purpose, storage and separation in the cargo vessel, that raw material stored in multi-purpose tanks is never used in the preparation of products destined for the EU.

(4) During the process of issuing health certificates a traceability review will be carried out to ensure that product to be exported to the EU does not come from raw material stored in multi-purpose tanks.

In addition, INVIMA is working on an agreement with the competent authority in Ecuador (the Ministry of Aquaculture and Fisheries) for that authority to carry out the required health inspections (docking, unloading and setting sail of tuna fishing vessels) and to ensure full compliance with EU health standards, in particular the explicit prohibition of the use of multi-purpose tanks.

b. For recommendation No 3 (summary of the responses given in the 1st and 2nd action plans): INVIMA requested the adjustment of the HACCP plans of the vessels inspected in the previous certification audit in November 2016, and will be require the adjustment to the HACCPs to the remaining vessels this year. The FBO responsible for the vessels inspected in November 2016 drew up an action plan addressing the shortcomings identified:

1) Establishing an individual and specific HACCP plan for each vessel taking all hazards into consideration.

2) Ensuring that a copy of the temperature records for fishing vessels is kept in the Manta office.

3) Improving training for all crew, especially the chief engineer and his team, particularly on verifying both manual and automatic temperature records, in order to ensure that the temperatures of the tanks and products are monitored and inspected and that corrective action is taken when discrepancies are identified.

4) Providing all vessels with a calibrated probe thermometer for verifying the internal temperature of the product at the top of the tank, to be tested against the readings of the automatic device.

5) Investigating the possible causes for the thawing of fish at the surface, and verifying whether or not the sensors are appropriately located in the tanks and may be kept in their current position. Taking any corrective action required.

6) Rectifying minor shortcomings identified by INVIMA as a result of the health inspections and HACCP certification audit.

Furthermore, INVIMA will monitor compliance with the action plan presented by the operator, verifying its effectiveness and smooth functioning through health inspections and HACCP certification audits. Deadline for completion: (1st action plan) - Nine months.

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Vessel operators will be notified that compliance with the established requirements is mandatory. In 2017, in compliance with health control operations and HACCP certification audits on fishing vessels, specific requirements will be set out and monitored in follow-up inspections. The requirement has already been met in [three] vessels, in compliance with the certification audit carried out in November 2016, which set out the corresponding requirements. (2nd action plan) - Twelve months The operators were of fishing vessels notified about the obligatory nature of the compliance with the requirements set out (evidence attached hereto). During 2017 and the first half of 2018, in compliance with the sanitary control activities and the HACCP certification audits of the fishing motor ships, the specific requirements shall be formulated. They shall be subject to follow-up and surveillance in the future controls or certifications visits. To date, the requirement has already been carried out for the fishing vessels in compliance with the certification executed in the month of November 2016, in which the corresponding requirements were formulated.

c. For recommendation No 4: Pursuant to the Colombian regulation and the procedures established, INVIMA carries out the necessary sanitary and unloading controls to all foreign flag fishing vessels, affiliated to tuna processing companies, which are providers of raw material destined to the EU. The foregoing, taking into account that said raw material is considered an import and, therefore, it receives the sanitary controls established. To that end, through official letters 400-2914-2017 and 400- 2915-2017, the operators were requested to comply with these requirements due to its mandatory nature. Likewise, it shall be verified and ensured that said motor ships are on the list of the EU. Guideline No. 52 is attached hereto; it was issued by the Directorate for Food and Beverages, addressed to the Directorate for Sanitary Operations, including the Official Inspectors located at Controls sites, First Barrier, And GTTs (Ports, airports and border crossings), in relation to the Inspection, Surveillance and controls activities in fishing vessels and/or cargo ships including Colombian and foreign flag vessels. Deadline for completion: INVIMA has Guideline No 52 through which precise instructions ate given to the officials of the ports, stating the specific controls to carry out in the fishing motor ships that unload raw materials in those places destined to establishments that produce products for the EU (attached hereto). The procedure for Colombian and foreign flag motor ships is specified. The obligatory nature of the sanitary requirements established is stated

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- Sanitary control upon unloading. - Issuance of the sanitary inspection certificate. The process has already been implemented. Notification shall be made to authorities of third countries during the next six months. The purpose is that they take into account the requirements of the EU for imported raw material.

15. The competent authority informed in the 3rd action plan the level of implementation of the proposed corrective actions, as follows:

a. For recommendation No 3: During the HACCP certification and inspection visits to vessels in 2017, particular emphasis was placed on the requirements set out in the audit report by the EU; including the following in particular: (1) Establishing an individual and specific HACCP plan for each vessel taking all

hazards into consideration. (2) Improving training for all crew, especially the chief engineer and his team,

particularly on verifying both manual and automatic temperature records, in order to ensure that the temperatures of the tanks and products are monitored and followed up and that corrective action is taken when discrepancies are identified.

(3) Providing all vessels with a calibrated probe thermometer for verifying the internal temperature of the product at the top of the tank, to be compared with the readings of the automatic device.

(4) Ensuring the continual monitoring and recording of the temperature of the tanks and taking corrective action as appropriate.

b. For recommendation No 4: In 2017 only one [identified] vessel, docked in a Colombian port, where a health and unloading inspection was carried out on 22 November. The product (frozen tuna), was destined for [a named company]. It was verified that the [identified] vessel was duly registered on the official list of establishments approved for export to the EU. In accordance with Colombian standards and established procedures, INVIMA will carry out the necessary health and unloading inspections on all vessels with foreign flags belonging to tuna processing companies supplying raw material for export to the EU, bearing in mind that such raw material is considered an import and therefore subject to the established health inspections.

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Findings

Facilities, including vessels, handling fishery products

Freezer and reefer vessels (relevant for recommendations No 2 and 3)

16. The audit team clarified with the competent authority and the FBO the reasons why stopping the practice of "dual use" of fish holds was considered unfeasible. These reasons are exclusively economic: the FBO stated that the fishing operation would not be economically viable if using different strategies than the "dual use" of fish holds (e.g. fuel transfer at sea from tanker is more expensive). Moreover, the FBO informed that reducing to two the number of "dual use fish holds" would be sufficient for their fishing operations.

17. For the Colombian fleet (i.e. 12 freezer vessels) the "dual use" of two fish holds represents, approximately, an increase by 55% of the capacity to store fuel at the beginning of a fishing trip (thus roughly extending the current maximum stay at sea of 70 days up to 108 days). These two "dual use fish holds" also would represent roughly 15% of fish that could not be used for export to EU. This fish would be used in the production of fishery products for domestic consumption and other international markets.

18. Based on the information obtained, the audit team established that the competent authority allows the FBOs concerned to implement a "split system" for the production of fishery products, in order to guarantee that fishery products obtained from "dual use fish holds" are not exported to the EU. The measures adopted for that "split system" include: a. Interruption of the system for brine circulation between the different types of fish

holds. b. Identification of the "dual use" fish holds. c. Development of written procedures covering the handling of the brine and fish on-

board to ensure their effective separation. d. Development of a procedure to ensure traceability of fish placed in "dual use" fish

holds throughout the complete production chain (special tags/labels, use of unique numbered bins and specific batch code).

e. Development of procedures for the unloading and transfer of fish from "dual use" fish holds from the freezer vessels (and also reefer vessel).

f. Development of procedures at the establishment on land for the receiving, storage and processing of fish from "dual use" fish holds.

19. The audit team noted that the HACCP plans of all freezer vessels have been updated since the 2016 audit and in April/May 2018 specific procedures (see paragraph 18) for the practice of "dual use" of fish holds were incorporated in the HACCP of all freezer vessels. Freezer vessels were subject to changes to separate the brine circuit of the "dual use" fish holds from the brine circuit of the other fish holds. These changes took place while the vessels were at port. The vessels were modified between January and

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December 2018 (one in January, two in April, one in July, two in August, five in September, and, one in December).

20. The competent authority made available the records of the official controls of the vessels and the audit team compared the dates when the controls took place with the dates when the FBO made the changes in the HACCP and brine system. From those records the audit team established that the competent authority assessed the conformity with the proposed measures of four freezer vessels. Based on the dates of the inspections, the audit team accepts that the competent authority also assessed the conformity in two other freezer vessels, but that assessment and its outcome was not recorded. The competent authority did not assess the conformity with the proposed measures in the remaining six freezer vessels.

21. The reefer vessel was also assessed by the competent authority to verify the correct implementation of the procedures related to the transfer, identification, separation and landing of fish originated from "dual use" fish holds.

22. Despite the above assessments, the audit team noted that it is left to the discretion of the official staff performing the inspection which aspects are evaluated, and what to record of that evaluation (with the exception of traceability); the check-lists currently in use by the competent authority do not have a specific indication/field that would cover the existence of this "split system" and that would indicate the specific points to be assessed.

23. The absence at this stage of an assessment of six freezer vessels (half of the EU listed vessels dedicated to tuna) on their level of conformity with the measures proposed to implement a "split system" represents a critical weakness in the system implemented to guarantee that no fish originated from "dual use" fish holds is exported to the EU, in particular considering that the maintenance of such a "split system" throughout the production chain in itself already requires an additional control effort to be reliable. Moreover, the reliability of the guarantees is further affected by the failure to fully implement the official control system of freezer vessels (mainly the ones transhipping in Manta, Ecuador) as planned, as described in paragraphs 5.c, 8 and 9 above.

24. In the three freezer vessels visited (one of the vessels assessed, one of the vessels not assessed and one of the vessels assessed but with no written evidence of that assessment (see paragraph 20), the audit team noted that the FBOs implemented the proposed procedures.

25. The audit team has strong reservations about the solution found to separate the brine circulation systems between the "dual use" fish holds, and the remaining fish holds: this solution does not seem to be permanent and it can be easily reverted – this reversion could be used with the intention to have a single brine circuit during the fishing trip, as this has obvious logistical and economic benefits.

26. The remaining procedures (see paragraph 18) adopted at the freezer vessels, the reefer vessel and the establishment can, if correctly and consistently applied by the relevant

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FBOs, minimise the risk of accidentally use fish from "dual use" fish holds in the manufacture of products for EU exports.

27. The audit team notes that globally, the measures proposed to address recommendation No 2 have been implemented by the FBOs, but that these measures still present weak points, and that the competent authority has not yet verified in all freezer vessels if the measures adopted are in conformity with the ones announced. This "split system" relies on full and continued compliance by all the relevant operators with specific and dedicated arrangements to ensure that no products originating in "dual use" fish holds are exported to the EU. Against this background, the audit team notes that the control system implemented by the competent authority is the same as the previous one in terms of frequency, and that the higher risk/probability to export to the EU fishery products which do not comply with the EU rules associated with the operation of a "split system" was not taken into account to adjust the frequency for the official controls.

28. With regard to recommendation No 3 of the 2016 audit report, the audit team noted in that HACCP plans were available, updated and specific for each of the vessels visited. This represents a significant improvement compared to the previous audit even if the audit team identified individual points that would require further refining and improvement, and which were pointed out during the visits.

29. For the remaining nine freezer vessels, the audit team noted that all have been visited by the competent authority for the HACCP-certification and although the visit reports contained requests for certain corrections, overall the conclusions were satisfactory.

30. The audit team considers that the measures proposed to address recommendation No 3 of the 2016 audit report have been largely and satisfactorily implemented.

Checks on the EU eligibility of imported raw materials (relevant for recommendation No 4)

31. The competent authority informed the audit team that Guideline No 52 of 2016 was replaced by Guideline No 32 of 2017 to address this issue. However, during the discussion it became clear that INVIMA has an understanding of the term "sanitary inspection certificate" which differed from that of the audit team: while INVIMA intended to inform that this certificate is issued by them once certain import conditions are met (country of origin approved to export to the EU; facility included in the EU list; and, imported product inspection with a favourable result), the audit team had understood that this certificate was issued by the exporting country and accompanied the consignment upon arrival in Colombia.

32. In practice, the only change made since the 2016 audit was the implementation of controls of products landed in Colombia directly from fishing vessels flying the flag of another third country that Colombia did not consider, under fishery policy rules, as an import (see paragraph 73 of the 2016 audit report). However, those controls do not require that the imported consignments are accompanied with an attestation that demonstrates that those imported products have been obtained/produced in accordance

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with the EU rules. Since the 2016 audit, only one such case occurred but the audit team was informed by the FBO that those products were not used for EU exports.

33. In the case of products imported via refrigerated containers, the audit team noted that all consignments imported and used for the manufacture of products for EU export, originated from facilities of EU Member States.

34. Guideline No 32 of 2017 still does not require that consignments imported into Colombia of fishery products that will be used in the manufacture of products for EU exports are accompanied of an attestation (e.g. export certificate issued by the relevant authorities of the exporting country) that demonstrate that those imported products have been obtained/produced in accordance with the EU rules (i.e. they are EU eligible for the production of products for EU exports).

35. As such, the audit team found that recommendation No 4 of the 2016 audit report was, effectively, not addressed (see recommendation No 3 of current report). However, there were no negative consequences for the consignments exported to the EU.

Additional findings

36. During the visits to the establishments the audit team found significant shortcomings in the floors (in storage rooms of two establishments out of three) and the walls (in storage rooms of one establishment out of three) of the cold stores used to store frozen raw materials. In another establishment the audit team noted that the cold stores were not equipped with a temperature recording device, as required by the EU rules.

37. The audit team checked records for consignments of products exported to the EU and noted that the raw materials used did not originate from "dual use" fish holds. The audit team also noted that the competent authority carries out traceability checks on consignments exported to the EU during the official control visits of the EU listed establishments.

38. The audit team noted that products discarded from the production (e.g. scraps, left-overs, bones, skin, viscera, etc. – hereinafter "by-products") are used for the manufacture of fish oil and fish meal. During production there is no separation of these by-products according to the status of the originating fish, which means that those products are a mixture of by-products obtained from EU eligible fishery products (which could potentially be considered animal by-products EU category 3) and from fishery products which are not EU eligible as they originate from "dual use" fish holds.

39. The operator informed the audit team that the fish meal is not exported to the EU and that the fish oil produced is supplied to another Colombian operator. However, from TRACES, the audit team noted that part of the fish oil produced was shipped to the EU as feed and that the establishment is listed as an establishment for animal by-products of category 3. When the audit team raised this issue with INVIMA, the latter indicated that the competency for feed is with another authority, the Instituto Colombiano Agropecuario (ICA).

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40. As animal by-products produced from fishery products originating from "dual use" fish holds qualify under EU rules as animal by-products Category 2, the audit team concludes that the resulting fish oil –which is in any event not eligible for food in the EU - cannot be exported to the EU as a feed material (only Category 3 material is eligible), and not certified as such.

Conclusions on official controls of production and placing on the market

41. The audit team concludes that FBOs have undertaken the implementation of the measures proposed to address the recommendation No 2 of the 2016 audit report in respect of the "dual use" of fish holds. However, the verification of the correct and reliable implementation of these measures by the competent authority is to date incomplete as only part of the vessels have been covered. Moreover, the implementation of the regular official controls over freezer vessels announced in the action plan (and which are a constituent part of the guarantees offered in respect of EU requirements) is hindered by the fact that FBO landing outside Colombia do not announce their arrival in a timely fashion as required, which in turn prevents the competent authorities to organise and carry out the requisite controls at the established frequency which, in the view of the audit team, should already be reviewed given the introduction of the "split system". Lastly, the audit team has reservations about the reliability of the solution implemented to separate the brine circulation systems, which can easily be reversed.

42. The competent authority implemented adequately the measures proposed to address recommendation No 3 of the 2016 audit report related to HACCP, and these measures were found to be largely effective.

43. The competent authority implemented the measures proposed to address recommendation No 4 but those measures do not effectively address that recommendation as they did not result in obtaining the required assurances as to the eligibility of the raw materials (see recommendation No 3 of current report).

44. Currently three EU listed facilities visited do not comply with all the requirements of Regulation (EU) No 853/2004, namely with regard to the structural and equipment requirements applicable to cold stores.

45. Colombia exported to the EU consignments of feed-grade fish oil produced from raw materials that, according to the EU rules, cannot be used for the manufacture of those products if intended for the EU.

6 OVERALL CONCLUSIONS

This follow-up audit found that the majority of the recommendations of the 2016 audit report have been largely or partially addressed. As a result, the overall situation improved when compared with the 2016 audit. However, the implementation of the controls is incomplete to

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date which is a critical point, given that the introduction of a "split system" for eligible and non-eligible products (i.e. fishery products obtained from "dual use" fish holds, and which is not permitted in the EU) by its very nature requires additional and very reliable controls along the production chain. This, together with the less than robust assurances regarding the permanent separation of the brine systems in such "split" production, implies that Colombia is not yet in a position to provide full guarantees that fishery products intended for export to the EU meet all the required standards, in particular in respect of the absence of contamination with fuel.

The audit also found that fish oil produced from by-products which may have been contaminated with fuel – and which, for that reason, is not eligible for export to the EU, either as food- or feed grade oil – was exported to the EU.

7 CLOSING MEETING

At the closing meeting held in Bogota on 5 April 2018, the audit team presented the main findings and preliminary conclusions of the audit. The competent authority acknowledged the findings and preliminary conclusions and committed to correcting the deficiencies found. The competent authority also committed to inspect the remainder freezer vessels (see paragraph 20) with a view to assess their conformity with the proposed measures.

8 RECOMMENDATIONS

In order to be able to provide the guarantees set out in the public health attestations of the health certificate for imports (model defined in Appendix IV to Annex VI to Regulation (EC) No 2074/2005) the competent authority should provide Commission services with an action plan, including a timetable for its completion, within one month of receipt of the report, in order to address the following recommendations:

No. Recommendation

1. The competent authority should ensure the adherence to the established frequencies for the supervision of freezer vessels included in the list of establishments authorised for EU exports in order to provide guarantees that those vessels comply with all relevant EU requirements, as set out in Article 12 (2.) (b) of Regulation (EC) No 854/2004.

Recommendation based on conclusion No 11. Associated findings Nos 5.c, 5.d, 8 and 9.

2. The competent authority should ensure the correct and complete implementation of the official control system covering the additional requirements imposed to guarantee that fishery products from "dual use" fish holds is not exported to the EU. In particular, the controls should be carried out with the frequency defined in the adopted procedures and with a view to unequivocally assess the conformity of the FBOs and products with the "split system" requirements. Moreover, the competent authority should consider

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No. Recommendation

reviewing the frequencies for the controls bearing in mind the increased risk of exporting non-EU compliant products associated with the operation of a "split system".

Recommendation based on conclusions No 11 and 41. Associated findings Nos 8, 9, 20, 23, 25 to 27.

3. The competent authority should ensure that that imported raw materials used for the manufacture of products to be exported to the EU have been caught, handled, landed, prepared and processed (as applicable) in accordance with the EU rules, i.e. that the imported consignments are accompanied with an attestation (e.g. export certificate issued by the relevant authorities of the exporting country) confirming adherence to the applicable EU rules.

Recommendation based on conclusion No 43. Associated findings Nos 31 to 35.

4. The competent authority should take measures aimed at rectifying the deficiencies detected in the EU establishments in order to be able to provide assurance that these establishments comply with the EU rules as required by Article 12 (2.) (a) of Regulation (EC) No 854/2004.

Recommendation based on conclusion No 44. Associated finding No 36.

5. The competent authority should take measures to ensure that fish oil obtained from or containing raw materials which are not eligible for export to the EU, are not certified for export to the EU either as food, or feed grade fish oil.

Recommendation based on conclusion No 45. Associated findings Nos 38 to 40.

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The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2019-6695

ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal TitleDec. 2006/766/EC OJ L 320,

18.11.2006, p. 53-57 2006/766/EC: Commission Decision of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted

Dir. 96/93/EC OJ L 13, 16.1.1997, p. 28-30

Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products

Reg. 2406/96 OJ L 334, 23.12.1996, p. 1-15

Council Regulation (EC) No 2406/96 of 26 November 1996 laying down common marketing standards for certain fishery products

Reg. 852/2004 OJ L 139, 30.4.2004, p. 1, Corrected and re-published in OJ L 226, 25.6.2004, p. 3

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs

Reg. 853/2004 OJ L 139, 30.4.2004, p. 55, Corrected and re-published in OJ L 226, 25.6.2004, p. 22

Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin

Reg. 854/2004 OJ L 139, 30.4.2004, p. 206, Corrected and re-published in OJ L 226, 25.6.2004, p. 83

Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Reg. 2073/2005 OJ L 338, 22.12.2005, p. 1-26

Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs

Reg. 2074/2005 OJ L 338, 22.12.2005, p. 27-59

Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004

Reg. 1881/2006 OJ L 364, 20.12.2006, p. 5-24

Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs

Reg. 333/2007 OJ L 88, 29.3.2007, p. 29-38

Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs

Reg. 589/2014 OJ L 164, 3.6.2014, p. 18-40

Commission Regulation (EU) No 589/2014 of 2 June 2014 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) No 252/2012

Reg. 2017/644 OJ L 92, 6.4.2017, p. 9–34

Commission Regulation (EU) 2017/644 of 5 April 2017 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) No 589/2014