EUROPEAN COMMISSIONHEALTH AND CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

PERU

FROM 04 TO 13 APRIL 2011

IN ORDER TO ASSESS THE CONTROLS OF MYCOTOXIN CONTAMINATION IN SPICES INTENDED FOR EXPORT INTO THE EUROPEAN UNION

DG(SANCO) 2011-6030 - MR FINAL

Ref. Ares(2011)873469 - 11/08/2011

Executive Summary

This report describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Peru, from 4 to 13 April 2011.

The objective was to assess the control systems in place to control mycotoxin contamination in spices (paprika) intended for export into the European Union (EU). Specifically, the audit team followed up on action taken by the competent authorities (CAs) in response to the recommendations made by the FVO in the report by Health and Consumers Directorate-General (DG (SANCO))/2009-8175).

Some progress has been made since the previous mission in 2009. Two guidelines on good agricultural practice (GAP)/good manufacturing practice (GMP) have been drafted and made available to the stakeholders, training sessions have been organised on the issue of mycotoxins in paprika and improvements have been made in the drying process of paprika. Nevertheless, procedures followed for the drying and storage of paprika at the processors visited did not fully follow the Codex Alimentarius Code of Hygienic Practice for Spices and Dried Aromatic Plants (CAC/RCP 42-1995). Procedures have been established for following up Rapid Alert System for Food and Feed (RASFF) notifications.

The lack of a formal legal basis impedes the registration of establishments and official controls of implementation of food hygiene requirements and Hazard Analysis Critical Control Points (HACCP). As a result, official controls on mycotoxins in paprika exported to the EU have not yet been implemented.

Regarding the follow up to mission DG(SANCO)/2009-8175, out of ten recommendations made in the report, only two have been fully addressed. The other recommendations are either partly addressed or action is still pending, mainly due to the lack of legal basis.

The report makes a number of recommendations to CAs aimed at rectifying the shortcomings identified and improving implementation of control measures.

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Table of Contents 1 INTRODUCTION ........................................................................................................................1 2 OBJECTIVES ...........................................................................................................................1 3 LEGAL BASIS ..........................................................................................................................2

3.1 THE LEGAL BASIS FOR THE AUDIT .....................................................................................................2 3.2 STANDARDS ..................................................................................................................................2

4 BACKGROUND ..........................................................................................................................2 5 FINDINGS AND CONCLUSIONS ...................................................................................................3

5.1 RELEVANT NATIONAL LEGISLATION ..................................................................................................3 5.2 COMPETENT AUTHORITIES ...............................................................................................................4 5.3 OFFICIAL CONTROLS ON PRODUCTION AND PROCESSING .....................................................................6 5.4 PROCEDURES FOR EXPORTING TO THE EU ........................................................................................8 5.5 METHOD OF SAMPLING CONSIGNMENTS ...........................................................................................9 5.6 LABORATORY SERVICES .................................................................................................................9 5.7 PRIVATE CONTROLS ON PAPRIKA .....................................................................................................12 5.8 RESPONSE TO RASFF NOTIFICATIONS ...........................................................................................12

6 OVERALL CONCLUSIONS .........................................................................................................13 7 CLOSING MEETING ................................................................................................................13 8 RECOMMENDATIONS ...............................................................................................................13ANNEX 1 - LEGAL REFERENCES .................................................................................................15ANNEX 2 – STANDARDS QUOTED IN THE REPORT ...........................................................................16

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ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation ExplanationADEX Peruvian Exporters Association

ASTA American Spice Trade Association

CA(s) Competent Authority(ies)

CAC/RCP Codex Alimentarius Commission/Recommended Code of Practice

CAC/GL Codex Alimentarius Commission/Guideline

CCA(s) Central Competent Authority(ies)

CN Combined Nomenclature

CODEX Codex Alimentarius Commission of the Food and Agriculture Organisation of the United Nations and World Health Organisation

DG (SANCO) Health and Consumers Directorate-General

EU European Union

FAPAS Food Analysis Performance Assessment Scheme, UK

FVO Food and Veterinary Office

GAP Good Agricultural Practice

GMP Good Manufacturing Practice

HACCP Hazard Analysis Critical Control Points

HPLC-FD High Performance Liquid Chromatography-Fluorescence Detector

ILAC International Laboratory Accreditation Cooperation

INDECOPI Peruvian National Accreditation Body

IPM Integrated Pest Management

ISO/IEC International Organisation for Standardisation/International Electrotechnical Commission

LC/MS/MS Liquid Chromatograph — Tandem Mass Spectrometry

LOD Limit of Detection

LOQ Limit of Quantification

MS(s) Member State(s)

III

OTA Ochratoxin A

PROMPERU Commission for the Promotion of Peru Export and Tourism

PT Proficiency test

QM Quality manual

RASFF Rapid Alert System for Food and Feed

SENASA Plant Health National Service

SOP Standard Operation Procedure

TC(s) Third Country(ies)

USD United States of America Dollars

IV

1 INTRODUCTION

This audit took place in Peru from 4 to 13 April 2011 in order to assess controls on mycotoxin contamination in spices (paprika) intended for export to the European Union (EU). The audit team comprised two auditors from the Food and Veterinary Office (FVO) and one Member State (MS) expert.

The audit was undertaken as part of the FVO’s annual audit programme in the context of a series of audits in third countries (TCs) to evaluate control systems and operational standards in this sector.

The team was accompanied during the audit by a representative of the central competent authority (CCA), the Plant Health National Service (SENASA).

An opening meeting was held on 4 April 2011 with the CCA, SENASA. At this meeting, the objectives of and itinerary for the audit were confirmed and additional information required for the satisfactory completion of the audit was requested.

2 OBJECTIVES

The objectives of the audit were to:

• Verify whether control systems are in place to control mycotoxin contamination in spices (paprika) intended for export to the EU within specified EU contaminant limits, complying with or at least equivalent to Commission Regulation (EC) No 1881/2006;

• Follow-up recommendations of the report by Health and Consumers Directorate-General (DG (SANCO))/2009-8175.

In terms of scope, the audit reviewed the controls on production and export, including national legislation, competent authority (CA) organisation, their controls and enforcement capability.

To meet this objective, the following sites were visited:

COMPETENT AUTHORITY/IES Comments Competent authorities

Central 1 SENASARegional/local

2 SENASA Regional Offices in Arequipa and Ica

LABORATORY/IES Public laboratories 1 SENASA laboratory in Lima Private approved laboratories 1 Private laboratory in LimaPRODUCERS

4 2 major growers of paprika in Arequipa region2 major growers of paprika in Ica region

PROCESSORS 4 2 paprika processors/exporters in Arequipa

1 paprika processors/exporter in Ica1 paprika processor/exporter from Lima (meeting with the representatives of the company in the paprika grower visited in Ica)

POINTS OF EXPORT

1

1 Main port of export of paprika in Callao-Lima OTHER SITES (E.G. RESEARCH CENTRE)

1 Peruvian Exporters Association (ADEX)

3 LEGAL BASIS

3.1 THE LEGAL BASIS FOR THE AUDIT

The audit was carried out under EU legislation, specifically Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council, which stipulates that EU controls in TCs may verify compliance or equivalence of TC legislation and systems with EU feed and food law and EU animal health legislation. These controls must have particular regard to the assurances which the TC can give regarding compliance with, or equivalence to, EU requirements.

A full list of EU legal instruments cited in this report is provided in Annex 1. EU legal acts cited in this report refer, where applicable, to the last amended version.

3.2 STANDARDS

The Guidelines and Codes of Practice of the Codex Alimentarius Commission of the Food and Agriculture Organisation of the United Nations and World Health Organisation (CODEX) were also taken into account during the audit.

A full list of the standards cited in this report is provided in Annex 2. References to specific provisions of these texts are provided at the beginning of each section.

4 BACKGROUND

The FVO has carried out missions to the main exporting countries to evaluate their official control systems for preventing aflatoxin contamination in foodstuffs. The reports on these missions are available on DG SANCO’s internet site at http://ec.europa.eu/food/fvo/ir_search_en.cfm.

The report of the mission DG(SANCO)/2009-8175 contained recommendations to the CAs of Peru, and action plans were received, which were considered satisfactory to address the recommendations of the reports.

According to Article 15(1) of Regulation (EC) No 882/2004, the CAs of the MSs regularly check paprika imported into the EU. According to Regulation (EC) No 669/2009, paprika from Peru is subject for increased level of physical checks at EU border prior to its import to the EU (10% of the consignments are subject for sampling for mycotoxins).

Information on foodstuffs found to have public health implications is disseminated as alert notifications through the Rapid Alert System for Food and Feed (RASFF) to all MSs and to the exporting country. For paprika, notifications concern the mycotoxin content of goods exceeding the EU limits of 30 ppb Ochratoxin A (OTA), 5 ppb Aflatoxin B1 and 10 ppb total aflatoxins. From March 2009 (since previous mission DG(SANCO)/2009-8175) to the time of the audit, 16 notifications relating to mycotoxins in paprika from Peru were notified through the RASFF. Table 1 gives the breakdown of these notifications and the volume of imports into the EU.

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Table 1

TC Imports to EU(metric tonnes)

Number of RASFF notifications

2009 2010 2009 2010 2011Paprika (Capsicum annuum),whole (CN code ex 0904 20 10)

andcrushed or ground (CN code ex 0904 20 90)

24 178(ES, UK,BE, DE)

18 764(ES, UK, BE,DE, NL)

9 6 1

Source: Peruvian Customs

In view of the continuous number of RASFF notifications since the previous mission DG(SANCO)/2009-8175, the FVO decided to undertake this audit.

5 FINDINGS AND CONCLUSIONS

5.1 RELEVANT NATIONAL LEGISLATION

Legal requirementsArticle 46(1)(a) of Regulation (EC) No 882/2004 stipulates that EU controls shall have, inter alia particular regard to the legislation of the TC.

Regulation (EC) No 1881/2006 lays down the specific standards for the admissible levels of aflatoxins and sets maximum levels for certain contaminants (including mycotoxins) in foodstuffs.

Regulation (EC) No 401/2006 lays down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs.

FindingsSince the mission DG(SANCO)/2009-8175, no changes have been made to the national legislation in the context of this audit.

The audit team noted that there is still no national legislation governing the following:

• registration of primary producers of paprika;• requirements for registering food establishments processing paprika for export to the EU;• requirements to implement the procedures based on Hazard Analysis Critical Control Points

(HACCP) principles;• general food hygiene requirements applicable to these establishments;• official control of primary producers and processors of paprika that export their produce to

the EU.SENASA informed the audit team that a Draft Agrifood Safety Regulation was pending approval by the President of the Country. Once adopted, the Regulation would provide the legal basis for registering primary producers and processors of paprika, for implementing procedures based on HACCP principles and for primary producers to implement Good Agricultural Practices (GAP). The legislation would also cover food hygiene requirements applicable to the above-mentioned establishments. The audit team was informed that an 18-month transitional period was planned for

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implementing the regulation and thus the deadline for full implementation of the Regulation was the beginning of 2013. According to SENASA, 18 months is the period allocated to food establishments to upgrade to meet the criteria set by the Regulation.

There are no official sampling requirements established for the official control of mycotoxins in paprika. The audit team was informed that a draft guideline was available and would be implemented once the Agrifood Safety Regulation was adopted. According to the CA, the draft guideline follows the principles of Regulation (EC) No 401/2006.

The audit team observed that a set of Standard Operating Procedures (SOPs) had been drafted on the implementation of the Agrifood Safety Regulation, such as SOPs for registering food establishments, the authorisation of private laboratories to perform official control analysis, the official control of primary producers and processors of paprika and implementation of a national monitoring programme of residues and pollutants, including mycotoxins in paprika. Implementation of the SOPs was pending the adoption of the Agrifood Safety Regulation.

The audit team was informed that, since the previous mission DG(SANCO)/2009-8175, SENASA had drafted GAP and Good Manufacturing Practices (GMP) guides (namely ‘Guidelines for good practices for the prevention of mycotoxin contamination in Capsicum’) in June 2010, which had been made available to the stakeholders. ADEX had drafted another GAP/GMP guide since the previous mission, which had been made available to its members. In the establishments visited by the audit team, staff was aware of the existence of each of these guides and a hard copy of the SENASA guide was shown to be available.

The audit team observed that there was no national maximum level of mycotoxins in paprika. According to the CA, responsibility lies with the Ministry of Health. However, the CA had no information as to when this limit would be established. The audit team was informed that the Draft Agrifood Regulation stipulates that products intended for export must comply with the food safety requirements of the country of destination, such as maximum limits of mycotoxins in spices exported to EU countries.

ConclusionsThere is no national legislation governing the registration of paprika producers and processors, food hygiene applicable to paprika producers and processors and governing the implementation of procedures based on HACCP principles in these establishments equivalent to the requirements of Articles 3-6 Regulation (EC) No 852/2004 in conjunction with Article 10 of the same Regulation.

There is no national legislation governing the official control of primary producers and processors of paprika for export to EU, including official sampling. Therefore the recommendations made in mission report DG(SANCO)/2009-8175 regarding the development of an official control system for mycotoxins control and providing guarantees that processing activities and facilities processing paprika for EU export comply with relevant CODEX guideline have not yet been addressed.

Good progress has been made in drafting GAP and GMP guidelines for controlling mycotoxins contamination in paprika. Therefore the recommendation made in the mission report DG(SANCO)/2009-8175 regarding the promotion of GAP standards has been addressed.

5.2 COMPETENT AUTHORITIES

Legal requirementsArticle 46(1)(b) and (c) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, inter alia, particular regard to the organisation of the TC’s CAs, their powers and independence, the

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authority they have to enforce the applicable legislation effectively, and the training of staff in the performance of official controls.

FindingsCompetent authorities

SENASA is the main CA for this audit. It is a CA for the official control of primary producers and producers of agri-food (fruit and vegetables), but its controls on paprika are limited to plant health issues and do not include food safety issues such as food hygiene, implementation of HACCP and control of mycotoxin contamination, due to the lack of a legal basis.

No changes have been made to the structure of SENASA since the previous mission DG(SANCO)/2009-8175. Controls are carried out by the 24 regional and local offices. There are four local offices in the Arequipa region and five in the Ica region. There are approximately 100 members of staff available in both regions for official controls of primary producers and processors of all agri-food, including paprika.

The Ministry of Health is responsible for adopting maximum levels for contaminants in foodstuffs, including mycotoxins in paprika. However, as already mentioned, there is no information available as to when maximum levels for paprika will be established under national legislation.

SENASA usually informs stakeholders via official letters and publication on its website. Evidence of such communication was demonstrated to the audit team, such as the Directorate Resolution taken in January 2010 No 194-2009-AG-SE-ASA-DIAIA on the EU requirements for Paprika and Directorate Resolution No 073-2010-AGSE-ASA-DIAIA approving the ‘Guidelines for good practices for the prevention of mycotoxin contamination in Capsicum’ in June 2010.

The audit team saw evidence that, since the previous mission DG(SANCO)/2009-8175, training has been organised for stakeholders in all the major paprika cultivating areas on good practices in paprika cultivation and processing. In total, three workshops were held in Ica, Arequipa and Lambayeque regions in 2009 (attended by 180 participants). Five workshops in Ica, Arequipa, Tacna, Ancash and Lambayeque regions were organised in 2010 (390 stakeholders attended these training sessions). They were opened to all and did not specifically focus on paprika growers and processors exporting produce to EU. The audit team noted in the Arequipa region visited that approximately 10 % of stakeholders had access to this training (in total 200 participants out of approximately 1700 potential paprika growers and processors). In Ica, the level of trained paprika growers is possibly higher as there are 150 paprika growers and processors in the region and in total some 130 participants attended training sessions in 2009 and 2010. The audit team was informed that the number of training sessions in the regions was limited due to budgetary limitations, but further training was scheduled as part of special projects in 2011, for which the budgets had already been allocated (for example 25 000 USD in the Ica region).

There has been no specific training organised for SENASA staff for the official control of mycotoxins in paprika. The audit team was informed that training on sampling was tentatively scheduled for the second half of April 2011.

Customs authorities

In the context of this audit, customs authorities are responsible for customs clearance of consignments for EU export.

Other authorities/bodies

ADEX has taken the initiative to promote GAP and GMP amongst its members. Around 30 of its members are involved in exporting paprika. According to ADEX, out of the total paprika export, some 45 % are exported by members of ADEX.

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ADEX has developed GAP and GMP guidelines for paprika cultivation and they actively participate in training stakeholders in cooperation with SENASA and the Commission for the Promotion of Peru Export and Tourism (PROMPERU).

ConclusionsThere are no changes in the responsibilities of CAs since the previous mission DG(SANCO)/2009-8175.

The means of communication between CAs and stakeholders have been established, however as there is neither registration nor official control over producers and processors of paprika for EU export, there is no evidence that all stakeholders receive the same level of information.

Good progress has been made on training, but not all stakeholders have had access to training on good practices in paprika cultivation and processing.

Training for SENASA staff on the official control of mycotoxins in paprika is still pending and was due to start in April 2011. Therefore, the recommendation in the mission report DG(SANCO)/2009-8175 regarding training is not yet addressed.

Additional activities to promote good practices in paprika cultivation and processing have been undertaken by non-governmental organisations.

5.3 OFFICIAL CONTROLS ON PRODUCTION AND PROCESSING

Legal requirementsArticle 46 (1) (e) and (b) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, inter alia, particular regard to the existence and operation of documented control procedures and control systems based on priorities, and the CA’s capability to enforce applicable legislation.

The CODEX Code of Hygienic Practice for Spices and Dried Aromatic Plants (CAC/RCP 42-1995) contains recommended practices based on GAP, GMP and HACCP.

EU aflatoxin levels are specified in the Annex of Commission Regulation (EC) No 1881/2006.

FindingsCultivation (GAP)

There is no registration system of paprika growers implemented by SENASA, due to the lack of a legal basis (as mentioned under the chapter on legislation). However, some information on the number of growers can be extracted from other registers, such as the register of farmers who apply for irrigation permission under the Water Users Board or registers under pest management projects.

There are no official controls of implementation by paprika growers of the ‘Guidelines for good practices for the prevention of mycotoxin contamination in Capsicum’ by SENASA due to the lack of a legal basis.

In the Arequipa region, paprika is cultivated in approximately 6000 ha by approximately 1700 farmers (approximately 850 growers cultivated paprika in 2010). In Ica, paprika is cultivated in approximately 1700 ha by approximately 150 farmers. The average size of the farms differs between regions. In Arequipa, 5 % of farms are bigger than 10 ha, 30 % are considered as medium size farms (3-4 ha) and 65 % are considered as small farms (less than 1 ha). In Ica, medium and large farms predominate.

The audit team visited four paprika growers: two in Arequipa and two in Ica. All growers were large-scale growers with paprika cultivated in areas over 100 ha. According to SENASA regional

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offices, small growers do not produce paprika for export but only for the domestic market. However, no clear evidence was provided to the audit team to corroborate this statement.

The audit team noted that the paprika growers they visited had joined private certification schemes and were aware of the GAP guidelines drafted by SENASA.

All paprika growers had log books available for their farming activities, which also included information on implementation of Integrated Pest Management (IPM).

All farmers visited were aware of the risks of mould growth and considered quick drying of the product as a critical step to reduce mould growth. Fumigation of the fields was also practiced.

In the report of previous mission DG(SANCO)/2009-8175, a recommendation was made regarding the drying of paprika on the fields, specifying that paprika should be sun dried in a way that there is no direct contact with the sand or soil. In the two farms visited in Arequipa, plastic sheets were used, while in Ica drying still took place directly on the sand. However, according to the growers visited, additional precautionary measures are followed in this case, such as sand/soil analysis before its use as a drying area or treatment of the sand with chlorinated water. In addition, due to differences in climate, the drying process in Ica is significantly faster, ranging between 3-7 days. As there is no research as yet conducted on this, options are not included in the national GAP/GMP guide ‘Guidelines for good practices for the prevention of mycotoxin contamination in Capsicum’.

Processing and storage

SENASA does not have a registration system for paprika processors and therefore the overall number of paprika processors in Peru is unknown. Since there is no official control by SENASA of paprika processors (due to the lack of a legal basis), information on the level of implementation of procedures based on HACCP principles is not available.

The audit team visited two processing plants in the Arequipa region and one processing plant in the Ica region. In addition, representatives from one processing plant in Lima were present at the paprika grower visited in Ica.

One of the three establishments visited had developed a HACCP system and the other two had started the process of developing a HACCP system.

The processors visited kept on file all information related to the products received, including the name of the seller, analytical data at reception and files for export documentation. All processors visited had traceability systems which traced produce back to individual farmers or plots.

All the plants visited generally followed CODEX Standard CAC/RCP 42-1995 on Hygiene Practice for Spices and Dried Aromatic Plants. They had in-house mycotoxin control measures in place for the final product and in two establishments incoming raw materials were also analysed. Manual sorting to remove mouldy pods was also practiced in all the establishments visited. However, the storage conditions of paprika pods in some establishments did not always comply with the requirements of the above-mentioned standard as it was not possible to control the humidity and temperature to reduce the risk of mould growth.

Regarding research, SENASA in cooperation with other bodies such as ADEX and The International Potato Center, are currently in the process of drafting new research projects on mycotoxin contamination in paprika, with the main focus on the first processing stage such as drying and the use of plastic tunnels for temperature and humidity control during initial processing. However, the timeline for implementing these projects is yet to be defined.

The audit team obtained information on research into mycotoxin contamination in paprika conducted by a private company. According to SENASA, this information was also sent to them for evaluation and will be presented to stakeholders at the forthcoming ‘International Capsicum Forum’

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in Lambayeque, in July 2011.

Non-compliant products

SENASA has established procedures for controlling rejected consignments in line with the Regulation on the Plant Quarantine No 032-2006-A6, concerning plant health issues. There are no procedures yet for supervising consignments rejected at EU borders and returned to Peru due to mycotoxin contamination to ensure that the same products are not re-exported to EU. The audit team was informed that the Draft Agri Food Safety Regulation provides for such procedures, but they are still to be developed.

Representatives of the food industry stated that when produce is rejected at EU borders, it is generally destroyed in the EU. Only in very exceptional cases would the product be sold to another country.

According to SENASA, only one consignment rejected at the EU border was returned to Peru. In that case, due to the very poor phytosanitary conditions of the paprika, the whole consignment was destroyed under customs supervision.

ConclusionsThere is sufficient information on GAP and GMP available to paprika growers and processors and in the farms visited, GAPs were generally implemented and documented.

There is no official control of implementation of GAP and GMP for paprika cultivation and processing and therefore compliance with the national GAP guides is not guaranteed

The level of HACCP implementation in the establishments processing paprika for export to the EU is not known and therefore the recommendation made in mission report DG(SANCO)/2009-8175 on HACCP has not yet been addressed.

In the spice processors visited, the GMP principles laid down in the CODEX Standard CAC/RCP 42-1995 on Hygiene Practice for Spices and Dried Aromatic Plants were followed. However, the storage conditions in some establishments did not fully comply with the requirements set out in the points 7.1.4 and 7.6 of the above-mentioned standard.

Progress has been made to address the recommendation made in mission report DG(SANCO)/2009-8175 on the drying of paprika. However, drying directly on the ground was still practiced, which is neither in line with the requirements of CODEX Standard CAC/RCP 42 -1995 nor with the national GAP/GMP guide ‘Guidelines for good practices for the prevention of mycotoxin contamination in Capsicum’. Therefore, further research is needed to ensure that alternative methods used for drying are sufficient to avoid mycotoxin contamination of paprika.

SENASA has made little progress since the previous mission DG(SANCO)/2009-8175 on research into mycotoxin contamination in paprika. To date, research on mycotoxin has been mainly undertaken by the private sector.

There are no procedures in place to ensure that spices rejected at EU borders due to mycotoxin contamination are not re-exported to EU.

5.4 PROCEDURES FOR EXPORTING TO THE EU

Legal requirementsArticle 46(1)(h) of Regulation (EC) No 882/2004 stipulates that EU controls shall have, inter alia, particular regard to the assurances which the TC can give regarding compliance with, or equivalent to, EU legislation.

8

FindingsNo changes have been made to the export procedure since the previous mission DG(SANCO)/2009-8175.

There is no mycotoxin control procedure established for paprika exported to the EU.

According to the information provided by the spice processors visited, containerisation and customs clearance of paprika intended for EU export does not take place in the facilities of the paprika processors. Produce ready for export is generally transported to the main port of export in Callao in by lorry, where the product is put in containers. According to the processors, the timeline between the departure of the paprika consignment from the processors’ facilities and arrival at EU borders is generally not more than 25 calendar days.

ConclusionsThere is a clear export procedure for paprika exported to the EU, but it does not include mycotoxin controls. As a result, there is no official mycotoxin control of paprika intended for EU export at any stage of its production, processing or export.

5.5 METHOD OF SAMPLING CONSIGNMENTS

Legal requirementsArticle 1 of Regulation (EC) No 401/2006 requires that sampling for the official control of mycotoxin levels in foodstuffs be carried out in accordance with the methods set out in its Annex I. Concerning spices, the method of sampling is laid down in Annex I.E.

FindingsNo sampling for mycotoxin analysis has been undertaken to date and there are no official sampling requirements established for the official control of mycotoxins in paprika (see 5.1).

The audit team was informed that a National Monitoring Program on Residues and Pollutants, including mycotoxins in paprika, was due to start in 2011. Funds to implement the program had been allocated to SENASA regional offices, but training of staff responsible for sampling was still pending. The program was scheduled to run for four years. Each year, a total of 50 samples for mycotoxin analysis of paprika would be taken from the farm to the processor in the agri-food chain.

The audit team noted that the methods of sampling conducted by the paprika processors for mycotoxins analysis in the establishments visited differed significantly. In one establishment visited, a reference was made to Regulation (EC) No 401/2006. Nonetheless, none of the sampling procedures were equivalent to the procedure established by that Regulation.

ConclusionsNo sampling for mycotoxin analysis has been undertaken to date.

The sampling procedures followed in the establishments visited were not equivalent to the requirements of Regulation (EC) No 401/2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs.

5.6 LABORATORY SERVICES

Legal requirements

9

Article 46(1)(d) and (c) of Regulation (EC) No 882/2004 stipulate that EU controls shall have, inter alia, particular regard to the resources including diagnostic facilities available to CAs, and the training of staff in the performance of official controls.

Article 2 of Regulation (EC) No 401/2006 requires that sample preparation and methods of analysis used for the official control of mycotoxin levels in foodstuffs comply with the criteria set out in its Annex II.

Points 41 and 42 of CODEX Guidelines CAC/GL 26-1997 on the Design, Operation, Assessment and Accreditation of Food Import and Export Inspection and Certification Systems lays down that inspection services should utilise laboratories that are evaluated and/or accredited under officially recognised programmes to ensure that adequate quality controls are in place to provide for the reliability of test results. In accordance with Guidelines of CODEX CAC/GL 27-1997, point 3, the laboratories should comply with ISO/IEC 17025 standard.

FindingsThere is currently one official laboratory under SENASA designated for mycotoxin analysis of paprika.

As mentioned in 5.1, it will be possible to designate private laboratories for official analysis under the Agrifood Safety Regulation, once it is adopted.

Official laboratory

The SENASA laboratory visited is not accredited and the budget for the accreditation has yet to be allocated. The accreditation process is expected to begin in 2011 but no evidence of the date of first visit was given. The chosen accreditation body is from the United States of America, a full member of the International Laboratory Accreditation Cooperation (ILAC).

The laboratory started to perform mycotoxin analyses of paprika in 2010 (two analyses for a third party). It has LC/MS/MS equipment available for mycotoxin analysis and the laboratory is also working on another method: HPLC-FD.

In 2010, laboratory staff started working on the Quality Manual (QM), but it still needs revision before finalisation. To date, the laboratory started the validation process for OTA in paprika and participated in the proficiency test (PT) organised by the EU Reference Laboratory for mycotoxins in Geel, with a good result. In addition, in 2011 the laboratory participated in FAPAS (Food Analysis Performance Assessment Scheme, UK) PT for OTA in coffee with a z-score of 1.5, but with an unacceptable recovery factor (62 %). The validation report gave a recovery value of 67 %, which differs from the one reported in the FAPAS report. Another PT is in progress on aflatoxins in rice but the FAPAS report is not yet available.

The laboratory has five chemical analysts, of which one is a manager supervisor available for mycotoxin analysis. The audit team noted that the draft QM does not give a detailed description of the role and functions of staff. In particular, when assessing the competence of mycotoxin analysts, no correlation with people involved in the performance of PT was found.

Since the previous mission the laboratory has received new grinding equipment which is suitable for grinding large quantities (more than 10 kg) of paprika in one run.

The audit team found some shortcomings regarding the calculation of recovery. The procedure for calculating recovery factors uses two replicate analyses per day over four days for a total number of trials, equal to 8 replicates. The recovery factors were calculated for three spiked concentration levels (5, 10 and 20 ppb) but not at the level of legal maximum limit (30 ppb).

The limit of repeatability was not calculated. Analyses are repeated only twice instead of at least six times and the standard deviation of repeatability and the relative standard deviation were not

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correctly reported. The same applies to the reproducibility parameters.

To measure uncertainty, the metrological approach was followed, but the calculation was made only for the level of contamination of 15 ppb. No uncertainty was calculated for the EU legal limit of OTA — 30 ppb.

As for the quantification limit (LOQ), the laboratory calculated only the instrumental value and not the experimental value. In addition, no control charts and no control samples were available.

The validation process is not complete, with only few levels of performance criteria available. No information on the field of application of the OTA method in paprika was given in the validation report.

The audit team was informed that, after adoption of Agrifood Safety Regulation, the SENASA laboratory would act as coordinator of a network of designated official laboratories by organising ad hoc PT.

Private laboratory

The audit team visited one private laboratory located in Lima. The laboratory was certified to operate according to ISO/IEC 17025 standard by an internationally recognised certification body to implement services and analysis of food for physical, chemical and microbiological parameters. This certification covers the analysis of various parameters, including aflatoxins and OTA in paprika. As far as laboratory accreditation to ISO/IEC 17025 standard is concerned, the laboratory is in the process of accreditation by the National Accreditation Body INDECOPI and it is expected to be completed by mid-May 2011. The audit team noted that neither INDECOPI nor the certification body that conducted the laboratory certification against ISO/IEC 17025 standard are full members of ILAC. INDECOPI is only an ILAC Associate Member and the certification body is not included in the list of ILAC accreditation bodies.

From July 2010 onwards, the laboratory analysed 692 samples for aflatoxins and 590 samples for OTA with 12 % of non-compliant samples reported. The laboratory uses validated methods, for OTA it uses an in-house method and for aflatoxin an American Spice Trade Association (ASTA) method. The laboratory has already implemented the basic requirements for analysing mycotoxins in paprika according to the ISO/IEC 17025 standard requirements. All documents are in electronic form and backup is available. More specifically, the QM, staff training, internal and external quality control, limit of detection (LOD) and LOQ calculation, uncertainty measurements are in place or are due to be implemented within a month.

However, some shortcomings were observed. A discrepancy was noted between the work carried out to validate the methods and the work established during the performance of routine analysis, as there was no evidence for follow-up to monitor performance. The analytical report does not mention a recovery factor nor the method for reporting it, nor does it mention an uncertainty measurement. No replicate analyses are performed and therefore no assessment is made of precision in terms of repeatability and reproducibility. No alternative instrumentation is available in the event of failure of the sole method (HPLC-FD). There was no participation in proficiency testing in 2010, apart from inter-laboratory comparison trials carried out in collaboration with foreign laboratories in Spain and the USA. Lastly, performance criteria (repeatability, reproducibility, standard deviation of repeatability and reproducibility) have not been established even though the methods were deemed to be validated.

ConclusionsThe official laboratory for mycotoxin analysis under SENASA in Lima is not yet evaluated and/or accredited under officially recognised programmes (in line with the CODEX - point 41 of CAC/GL 26-1997 and point 3 of CAC/GL 27-1997) and therefore the recommendation made in the mission

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report DG(SANCO)/2009-8175 regarding accreditation of official laboratories has not yet been addressed.

The official laboratory has received proper grinding equipment and therefore the recommendation made in the mission report DG(SANCO)/2009-8175 regarding grinding equipment has been addressed.

The current quality control measures in place, the validation study and staff training do not ensure the reliability of analytical results.

The private laboratory visited is more experienced in the analysis of OTA in paprika and is in more advanced stage in method validation than SENASA laboratory. However, the method currently used for analysis of OTA in paprika does not fully follow to the criteria equivalent to the criteria established in the Annex II of Regulation (EC) 401/2006.

5.7 PRIVATE CONTROLS ON PAPRIKA

FindingsThe audit team noted that the paprika growers/processors visited had joined private certification schemes. All growers/processors had their farming activities well documented and included mycotoxin controls in final products, with some growers/processors also controlling raw materials. According to the growers/processors visited, participation in the private certification schemes was requested by their trade partners in the EU.

ConclusionsAll paprika growers/processors visited were subject to additional private controls, which provide some guarantees on compliance of paprika with EU mycotoxin requirements.

5.8 RESPONSE TO RASFF NOTIFICATIONS

Legal requirementsPoint 6 of CODEX Guidelines CAC/GL 25-1997 requires exchange of information between countries on rejections of imported food. In particular the food control authorities in the exporting country should undertake the necessary investigation to determine the cause of any problem that has led to the rejection of the consignment. The food control authority in the exporting country, if requested, should provide the authorities in the importing country with information on the outcome of the necessary investigation, if available. Bilateral discussions should take place as necessary.

FindingsSince September 2009, SENASA has had direct access to the RASFF database and is able to download all RASFF notifications, including those related to mycotoxins in paprika from Peru.

There are no penalties set for the companies involved in RASFF notifications on mycotoxins in paprika. According to SENASA, the draft Agrifood Safety Regulation provides for penalties (fines) in the event of companies involved in notifications.

There are good procedures established for following up RASFF and all investigations are well documented. However, due to the lack of a clear legal basis, SENASA’s work to follow up each notification is limited as companies are not obliged to provide SENASA with information on their export activities. According to SENASA, full follow up of RASFF notifications was achieved in approximately 50 % of investigations.

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The audit team was also informed by the CA that follow up is not always possible also due to lack of traceability in the sampling records which are sumbitted to the EU by MSs and attached to the RASFF notification.

ConclusionsThere are clear procedures established for RASFF, however due to the lack of a legal basis for follow-up, investigations are limited and to date no penalties have been issued (point 6 of C Guidelines CAC/GL 25-1997).

6 OVERALL CONCLUSIONS

Some progress has been made since the previous mission in 2009. Two guidelines on good agricultural practice (GAP)/good manufacturing practice (GMP) have been drafted and made available to the stakeholders, training sessions have been organised on the issue of mycotoxins in paprika and improvements have been made in the drying process of paprika. Nevertheless, procedures followed for the drying and storage of paprika at the processors visited did not fully follow the Codex Alimentarius Code of Hygienic Practice for Spices and Dried Aromatic Plants (CAC/RCP 42-1995). Procedures have been established for following up Rapid Alert System for Food and Feed (RASFF) notifications.

However, the lack of a formal legal basis impedes the registration of establishments and official controls of implementation of food hygiene requirements and Hazard Analysis Critical Control Points (HACCP). As a result, official controls on mycotoxins in paprika exported to the EU have not yet been implemented.

Regarding the follow up to mission DG(SANCO)/2009-8175, out of ten recommendations made in the report, only two have been fully addressed. The other recommendations are either partly addressed or action is still pending, mainly due to the lack of legal basis.

7 CLOSING MEETING

A closing meeting was held on 13 April 2011 with representatives of the CCA. At this meeting, the audit team presented the main findings and preliminary conclusions of the audit. The CAs made initial comments and provided some additional information.

8 RECOMMENDATIONS

The CAs are invited to provide details of the actions taken and planned, including for deadlines for their completion (‘action plan’), aimed at addressing the recommendations set out below, within 25 working days of receipt of this report. The CA should: N°. Recommendation

1. Ensure that all establishments where paprika for export to the EU is produced and processed are registered, equivalent to the requirements of Articles 6 of Regulation (EC) No 852/2004 in conjunction to Article 10 of the same Regulation.

2. Ensure that food business operators exporting spices to the EU implement standards at

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N°. Recommendation

least equivalent to those required by Article 5 of Regulation (EC) No 852/2004 on food safety procedures based on HACCP principles n conjunction to Article 10 of the same Regulation.

3. Ensure that adequate training has been provided to officials responsible for the control of mycotoxins contamination in paprika exported to the EU.

4. Ensure that storage conditions in paprika processing and storage facilities comply with the requirements set out in CODEX Code of Hygienic Practice CAC/RCP 42-1995 for Spices and Dried Aromatic Plants.

5. Ensure that all laboratories performing official controls are evaluated and/or accredited under officially recognised programmes (ISO/IEC 17025 standard) to make sure that adequate quality controls are in place to confirm the reliability of test results (point 41 of CAC/GL 26-1997 and point 3 of CAC/GL 27-1997).

6. Ensure that the RASFF follow-up procedure developed provides for effective enforcement measures taken against all exporters involved in notifications (point 6 of CODEX Guidelines CAC/GL 25-1997).

7. Consider establishing a legal basis for the official control of mycotoxin contamination in paprika intended for export to the EU.

8. Consider implementation of GAP/GMP principles by all paprika growers and processors that produce paprika for export to the EU.

9. Consider putting procedures in place to provide guarantees that paprika rejected at EU borders and returned to Peru due to mycotoxin contamination is not re-exported back to the EU.

10. Consider undertaking research into alternative methods of drying paprika to ensure that methods used by paprika growers are suitable to avoid mycotoxin contamination during the drying process.

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

http://ec.europa.eu/food/fvo/ap/ap_pe_2011-6030.pdf

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ANNEX 1 - LEGAL REFERENCES

Legal Reference Official Journal Title

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. 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. 178/2002 OJ L 31, 1.2.2002, p. 1-24

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

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. 401/2006 OJ L 70, 9.3.2006, p. 12-34

Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs

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Annex 2 – Standards quoted in the reportReference number Full title Publication detailsCAC/RCP 42-1995 Code of hygiene practice for spices

and dried aromatic plants (CAC/RCP 42-1995)

http://www.codexalimentarius.net/web/standard_list.jsp

CAC/GL 25-1997 Guidelines for the exchange of information between countries on rejections of imported food (CAC/GL 25-1997).

http://www.codexalimentarius.net/web/standard_list.jsp

CAC/GL 26-1997 Guidelines on the design, operation, assessment and accreditation of food import and export inspection and certification systems (CAC/GL 26-1997).

http://www.codexalimentarius.net/web/standard_list.jsp

CAC/GL 27-1997 Guidelines for the Assessment of the competence of testing laboratories involved in the import and export control of food (CAC/GL 27-1997).

http://www.codexalimentarius.net/web/standard_list.jsp