In response to information provided by the competent authority, any factual error noted in the draft report has been corrected.

EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2019-6738

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

MALAYSIA

FROM 05 MARCH 2019 TO 13 MARCH 2019

IN ORDER TO

EVALUATE THE SYSTEM OF OFFICIAL CONTROLS FOR THE EXPORT OF PLANTS AND PLANT PRODUCTS TO THE EUROPEAN UNION

Ref. Ares(2019)5488705 - 30/08/2019

I

Executive Summary

This report describes the outcome of an audit carried out by the Directorate-General for Health and Food Safety of the European Commission in Malaysia from 5 to 13 March 2019 as part of the published audit programme. The objective of the audit was to evaluate the system of official plant health controls for the export of plants, plant products and plants intended for planting to the European Union (EU).

The measures implemented by the competent authorities following the 2013 audit have improved the system of plant health controls of goods exported to the EU. The main elements which contributed to the improvement of the level of compliance with EU rules include the implementation of a web-based system supporting export consignment inspections and issuance of the phytosanitary certificates, the revision of the system of official inspection with updated guidelines and standard operating procedures (SOPs) and the application of the provisions of International Standards for Phytosanitary Measures No 31 for export inspections.

A number of control measures were still insufficient, in particular ensuring that the places of production of aquatic plants are free from Bemisia tabaci and Radopholus sp., the relevant SOPs and guidelines are implemented for all the inspections of EU export and the sampling rates of export controls are adjusted according to the specific plant health risk.

Despite the significant positive developments, imports of regulated products from Malaysia still represent a medium level of plant health risk for the EU.

The report contains recommendations to the National Plant Protection Organisation of Malaysia to address the shortcomings identified.

II

Table of Contents1 Introduction ....................................................................................................................................1

2 Objectives and scope......................................................................................................................1

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

3.1 Relevant EU Legislation..........................................................................................................2

3.2 International standards.............................................................................................................2

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

4.1 Audit series ..............................................................................................................................2

4.2 Notifications of interceptions ..................................................................................................3

4.3 Production and trade statistics .................................................................................................5

5 Findings and Conclusions ..............................................................................................................6

5.1 Production system of plants and plant products for EU export...............................................6

5.2 Organisational aspects of the plant health controls .................................................................8

5.3 Phytosanitary status of harmful organisms relevant for EU export ......................................12

5.4 System of export inspections.................................................................................................14

5.5 Phytosanitary certificates.......................................................................................................19

5.6 Actions taken in response to internal findings and EU notifications ....................................21

5.7 Wood packaging material and ISPM 15 certification ...........................................................23

5.8 Follow-up of recommendations of audit report.....................................................................24

6 Overall Conclusions .....................................................................................................................25

7 Closing Meeting ...........................................................................................................................26

8 Recommendations ........................................................................................................................26

III

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation

2013 auditAudit carried out by Commission in Malaysia in November 2013 on the system of official plant health controls on the exports of plants and plant products to the EU. Ref: DG(SANCO)/2013-6816

ADAdditional declaration to the phytosanitary certificate as defined by ISPM 12 and requested by the provisions of Annex IV of Council Directive 2000/29/EC

ConsignmentAs defined by ISPM 5: a quantity of plants, plant products and/or other articles being moved from one country to another and covered, when required, by a single phytosanitary certificate.

DG Health and Food Safety

European Commission's Directorate-General for Health and Food Safety

DoA Department of Agriculture

EU European Union

EUROPHYT-Interceptions European Union Notification System for Plant Health Interceptions

HOOrganism, harmful to plants or plant products (harmful organism) as defined by Article 2(1)(e) of Council Directive 2000/29/EC and listed in Annex I and II of that Directive

HT Heat Treatment as defined by ISPM 15

IPPC International Plant Protection Convention

ISPM International Standards for Phytosanitary Measures

KLIA Kuala Lumpur International Airport

MAQIS Malaysian Quarantine and Inspection Service

MB Methyl bromide

MoA Ministry of Agriculture and Agro-Based Industry

MyPhytoWeb-based system operated by the DoA for registration of export consignment inspections and issuance of the export PC

NPPO National Plant Protection Organisation

PBD Plant Biosecurity Division of the Department of Agriculture

PC Phytosanitary certificate, as defined by ISPM 7 and ISPM 12

PFA Pest free area as defined by ISPM 4

PFPP Pest free place of production as defined by ISPM 10

IV

Abbreviation Explanation

Plants for plantingPlants, intended for planting, as defined in Article 2(1)(d) of Council Directive 2000/29/EC - plants which are already planted or which are not planted but are intended to be planted.

Regulated plant/plant product

As listed in Annex IV and Annex V to Council Directive 2000/29/EC.

SOPs Standard Operating Procedures

WPM Wood packaging material as defined by ISPM 15

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1 INTRODUCTION

This audit took place in Malaysia from 5 to 13 March 2019 and was undertaken as part of the planned audit programme of the Directorate General for Health and Food Safety of the European Commission (DG Health and Food Safety).

The audit team consisted of two auditors of the DG Health and Food Safety and one expert from an EU Member State. Representatives of the Department of Agriculture (DoA) of the Ministry of Agriculture and Agro-Based Industry (MoA), which is the National Plant Protection Organisation (NPPO) in Malaysia, accompanied the audit team during the audit.

An opening meeting was held on 5 March 2019 at the headquarters of the DoA in Kuala Lumpur, during which the objectives were confirmed.

Unless specified otherwise, the data quoted in the following sections and elsewhere in the report, were provided by the NPPO.

2 OBJECTIVES AND SCOPE

The objectives of the audit were to evaluate: The system of official controls for the export of plants and plant products regulated by

Directive 2000/29/EC to the European Union (EU) including wood packaging material (WPM) attached to consignments and

The implementation of actions by the Malaysian authorities to address the recommendations of the audit carried out by the Commission services in November 2013 (ref: DG(SANCO)/2013-6816 – 'the 2013 audit').

To meet these objectives the following meetings and visits were carried out:

Meetings/visits No. Comments

Central 1 Department of Agriculture of the Ministry of Agriculture and Agro-Based Industry

Regional 2 Biosecurity Offices of the Department of Agriculture in Cameron Highlands and Johor

Competent Authorities

Laboratories 1 Plant Health Laboratory of the Biosecurity Office, Johor Bahru

Production sites 5

of aquatic plants, vegetables, herbs, cut flowers and cut leaves in the regions Cameron Highlands and Johor; wood pallet producer in Kuala Lumpur region

Packing houses 4of aquatic plants, fruit, vegetables, herbs, cut flowers and cut leaves in the regions Cameron Highlands and Johor

Plant health control sites

Point of exit 1 Plant health inspection point at Kuala Lumpur International Airport

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The audit team assessed in particular the: Legal and organisational aspects of phytosanitary controls related to export of plants

and plant products to the EU subject to EU import requirements (regulated plants/plant products);

Pest status in Malaysia of the organisms harmful to plants or plant products, regulated by the EU (HO);

Plant health aspects of the production of plants for EU export; System of official inspections carried out at production sites and on consignments

before export to the EU; System of issuance of phytosanitary certificates (PC) including the applications of

additional declarations (AD).

3 LEGAL BASIS

The audit was carried out under the general provisions of EU legislation, in particular Articles 21 and 27(a) of Council Directive 2000/29/EC, and in agreement with the NPPO.

3.1 RELEVANT EU LEGISLATION

Council Directive 2000/29/EC provides for protective measures against the introduction into and spread within the EU of Harmful Organisms (HO)s. The legal references for this Directive and other relevant EU legislation are listed in Annex 1. References to EU legislation are to the latest amended version, where applicable.

3.2 INTERNATIONAL STANDARDS

Article X(4) of the International Plant Protection Convention (IPPC) establishes that contracting parties should take into account, as appropriate, international standards when undertaking activities related to the Convention. The International Standards for Phytosanitary Measures (ISPMs) issued by the IPPC provide a basis, in addition to the EU import requirements, for evaluating official export controls in contracting parties.

The full text of the IPPC and of all adopted ISPMs is available on the IPPC website (www.ippc.int). The ISPMs of particular relevance to this audit are listed in Annex 2.

4 BACKGROUND

4.1 AUDIT SERIES

4.1.1 Export controls in non-EU countries

The DG Health and Food Safety carries out continuous assessment of the plant health risk related to the import of plants, plant products and other objects to the EU. The interceptions reported by EU Member States and Switzerland into the EU Notification System for Plant Health Interceptions (EUROPHYT-Interceptions) are analysed together with other available

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relevant information (e.g. trade statistics). Since 2014 a monthly Alert List has been published on the website of the DG Health and Food Safety (https://ec.europa.eu/food/plant/plant_health_biosecurity/non_eu_trade/alert_list_en), which indicates countries with the total number of HO interceptions of commodities above a defined level in an annual period preceding the date of publication. Audits are planned to those countries, where the interception figures raise doubts whether the official export controls ensure conformity with EU import requirements. Malaysia has been continuously on the Alert List since 2014 due to the total number of interceptions with HOs and in particular due to HO presence in consignments of fruit, vegetables, cut flowers and herbs. In 2018, Malaysia ranked between 5th and 8th place with the total number of consignments intercepted with HOs (see chapter 4.2).

4.1.2 Plants for planting

In 2015 DG Health and Food Safety launched an audit series in non-EU countries, which export the largest volumes of plants intended for planting (plants for planting) to the EU, on the plant health controls of these commodities.

Plants for planting are generally considered as high-risk products from a plant health perspective. They provide a viable pathway for HOs, since they are grown on after entry into the EU or serve as propagating material rather than being consumed shortly after importation. Council Directive 2000/29/EC requires that each consignment of plants for planting must be accompanied by a PC. The EU legislation sets specific conditions, usually in the form of options, which depend on the plant genus or species and the plant health status of the specific HO(s) of concern in the country, area or place of production. The NPPO of the exporting country shall certify on the PC the chosen option in the form of an AD and also certify that the required conditions are met.

4.1.3 Plant health audit by Commission services in Malaysia

The Commission services carried out an audit in Malaysia in November 2013 and assessed the system of official plant health controls on the exports of plants and plant products to the EU. The report of the 2013 audit and information about the actions by the NPPO to address the recommendations of the report are available on the website of the DG Health and Food Safety (http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3221).

4.2 NOTIFICATIONS OF INTERCEPTIONS

In the period from 1 January 2014 to 31 December 2018, EU Member States and Switzerland notified to EUROPHYT-Interceptions a total of 268 consignments of plants and plant products from Malaysia, which were intercepted due to the presence of HOs. The majority of the interceptions were with herbs (Corchorus sp., Eryngium sp., Ocimum sp.), orchids (Dendrobium sp.), fruits (Averrhoa sp. and Psidium sp.) and aquatic plants (Vallisneria sp).

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The most commonly intercepted HOs were white flies (Bemisia tabaci), Thrips palmi, fruit flies (Tephritidae). Aquatic plants were mainly intercepted due to the presence of harmful nematodes (Hirschmanniella sp., Meloidogyne sp. and Radopholus sp.)

In 2014 the Commission services wrote to the NPPO of Malaysia, highlighting the main issues and requesting action to address ongoing interceptions.

Since 2014, 412 consignments were intercepted for plant health reasons other than the presence of HOs. The main issue was the missing PC, in particular in 2018, followed by missing or inadequate ISPM 15 marks on WPM and by inadequate or missing ADs.

Table I summarises the number of interceptions of plants and plant products from Malaysia due to plant health reasons, reported to EUROPHYT-Interceptions1.

Table I. Number of interceptions from Malaysia

Number of intercepted consignmentsReason

2014 2015 2016 2017 2018Presence of HOs (total)* 40 38 55 68 67

Type of product (from the total) Fruit, vegetables and herbs 29 20 34 46 42 Aquatic plants 4 3 10 5 20 Cut flowers 4 11 11 11 5 Wood Packaging Material 3 4 - 6 -

Harmful organism (from the total) Bemisia tabaci 15 9 16 34 29 Thrips palmi 3 11 11 12 2 Xanthomonas axonopodis pv. citri 1 2 - - 1 Fruit flies (Tephritidae) 11 8 18 10 12 Nematodes (Hirschmanniella sp., Meloidogyne sp. and Radopholus sp. - - 4 1 17

Leaf miners (Liriomyza spp.) - 2 5 5 2

Other than HO presence (total) 29 36 43 53 251 PC absent 4 10 8 25 231 Additional declaration inadequate, missing 6 4 8 5 9 Incomplete or false information on PC 8 3 3 7 5 Prohibited plants - 4 12 7 2 WPM - missing , inadequate ISPM15 mark 9 11 11 12 5

Source: EUROPHYT-Interceptions* There can be more than one product in each consignment; hence the sum of the figures can be more

than the total

1 Further information on EUROPHYT-Interceptions and summaries of interceptions, are available on the DG Health and Food Safety website: http://ec.europa.eu/food/plant/plant_health_biosafety/europhyt/index_en.htm

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4.3 PRODUCTION AND TRADE STATISTICS

Malaysia exports relatively limited quantities of a wide range of plants for planting, regulated cut flowers, fruit, vegetables and herbs. The DoA provided information about the export volumes of plants for planting, cut flowers, cut foliage, fruit, vegetables and herbs in 2017 – 2018.

Table II. Malaysian exports to the EU (2017-2018)

Common name Botanical name 2017 2018

Plants for planting, cut flowers, cut foliageAquatic plants different species 45,391,218 pcs 27,087,312 pcsOther plants for planting different species 398,529 pcs 784,444 pcsCut Flowers/ Cut Foliage different species 971,731 pcs 997,318 pcsOrchid plants different species 12,853 pcs 25,737 pcsFruitsDurian Durio zibethinus 5,249 kg 11,445 kgJackfruit Artocarpus heterophyllus 923,105 kg 640,310 kgMango Mangifera indica 9,373 kg 488 kgPapaya Carica papaya 6,387 kg 1,182 kgPassion fruit Passiflora edulis 1,756 kg 1,405 kgPineapple Ananas comosus 366 kg 160 kgStarfruit Averrhoa carambola 440,027 kg 495,239 kgRambutan Nephelium lappaceum 5,168 kg 4,012 kgGuava Psidium guajava 6,754 kg 9,594 kgVegetablesBitter melon Momordica charantia 1,907 kg 13,755 kgEggplants Solanum spp. 44,618 kg 18,327 kgKaffir lime Citrus hystrix 4,557 kg 8,200 kgBasil Ocimum basilicum 59,397 kg 59,876 kgHoly basil Ocimum tenuiflorum 11,204 kg 4,581 kgCowpea Vigna sinensis 288,411 kg 260,836 kgCulantro (Mexican coriander) Eryngium foetidum 30,239 kg 19,062 kgHyacinth bean Dolichos lablab 131,858 kg 47,272 kgChilli Capsicum sp. 85,454 kg 75,506 kgBetel leaves Piper betle - kg 35,230 kgBlack pepper Piper nigrum 110,755 kg 33,096 kg

Source: DoA

The audit team learned that from the Cameron Highlands area Trichosanthes cucumerina and Corchorus olitorius are also exported to the EU.

A limited number of companies (about 30 annually) produce and/or export plants and plant products to the EU. The Johor Bahru and KLIA offices of the DoA are responsible for the vast majority of the export inspections.

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The EU destinations of the regulated products are the Netherlands, United Kingdom, Germany, Belgium, Spain, France, Italy, Greece, Hungary, Denmark, the Czech Republic and Romania. Products from the northern and central parts of the peninsula are mainly exported via the Kuala Lumpur International Airport (KLIA), while products from the southern regions (aquatic plants, cut flowers and foliage) are transited with Malaysian PC via the Singapore International Airport.

The DoA and the exporters met by the audit team stated that basil, Mexican coriander and chillies are partly sourced from Thailand or Indonesia due to the shortage in domestic supply (see chapter 5.4.3).

5 FINDINGS AND CONCLUSIONS

5.1 PRODUCTION SYSTEM OF PLANTS AND PLANT PRODUCTS FOR EU EXPORT

Legal requirements

Annex IV, Part A Section I to Directive 2000/29/EC. Points which are relevant to the products currently exported by Malaysia are 16.2, 16.6, 18.1, 32.1, 32.2, 32.3, 34, 36.1, 36.2, 44, 45.1, 45.2 and 46.

ISPM 36.

Findings

5.1.1 Growers

1. The audit team visited growers of aquatic plants, vegetables, cut flowers and cut leaves for EU export and noted that: The growing technologies enable the production of quality products. The presence of

any pest or disease symptom is considered as a quality issue as the importers force growers to ensure that the exported goods are free from any pest;

Many HOs are widespread in the production areas (see chapter 5.3). The growers are generally aware of the pests of EU concerns. In each farm visited the crops are treated with pesticides according to a treatment schedule depending on the phenology. Measures for integrated pest management are also applied. Sticky yellow and blue traps are commonly placed in greenhouses, but usually not checked or replaced frequently. Some growers regularly scout the crop for the presence of white flies and thrips and apply additional chemical treatments based on the findings;

In most of the farms the pest management technology cannot ensure that the place of production is free from HOs. Despite the use of pesticides and application of other measures the audit team observed prevalence of HOs (in particular white flies, thrips and leaf miners) in the open air and greenhouse crops;

The NPPO requests the production of aquatic plant species, which are known hosts of Bemisia tabaci), in insect proof greenhouses (see chapter 5.4.2). However, a grower visited produced for EU export in a greenhouse which did not provide sufficient

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protection against the introduction of insects. The mesh size and the double door system were insufficient and the mechanical damages of the net were not immediately repaired. Therefore the greenhouse is not considered as a place of production free from this pest;

The growers cooperate with the NPPO, observe the biosecurity guidelines required by the DoA and recommendations they receive from the plant health inspectors;

The DOA requires growers with packing houses for the EU export to apply good agricultural practice to produce quality products compliant with the phytosanitary requirements of the importing countries. In particular, effective cropping, systems approach for pest management with surveys for the determination of the pest status and farm records for the traceability of the products are required.

5.1.2 Packing houses

2. Practically each grower exporting to the EU has its own packing house. There are packing houses without own production facilities as well. The audit team visited packing houses of herbs, vegetables, cut flowers and cut leaves and noted that the establishments: Are registered by the DoA, observe the rules and follow the requirements set by the

registration document (see chapter 5.4.1); Generally use post-harvest treatment. The herbs and sometimes fruit and vegetables

are washed which helps decreasing the possible presence of insects. One company submerged cut orchids in a pesticide solution for five minutes. Aquatic plant packing houses wash-off completely the growing medium after the plants are harvested;

Operate an internal quality control system with inspections at least at two stages of the process (at the reception and at end point after packaging) for the presence of any visible symptoms of insects and diseases;

Ensure that the quality control staff are trained for the identification of the most evident occurrence of HOs. Their work is assisted by posters and basic morphological keys provided by the DoA. The controllers met by the audit team had sufficient knowledge and experience in checking for the presence of the most relevant insects with bare eyes or with magnifying glasses. In general they did not apply destructive sampling, however, one packing house visited used a destructive inspection method for checking the presence of thrips in orchid flowers;

Cooperate well with the DoA inspectors and provide sufficient facilities (separate area, inspection tables, lighting) for the consignment inspections (see chapter 5.4.2).

3. Packing houses without production facilities purchase goods from various different Malaysian producers or import articles mainly from Thailand for EU export. The packing house staffs usually do not check the Malaysian production sites in the vegetation period and do not provide advice to the growers about plant health requirements. They have limited possibilities to trace back non-compliant products to the grower.

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4. The packing houses can only import goods for EU export with a DoA permit. The goods arrive to Malaysia with a PC of the exporting country and are subject to official import phytosanitary controls.

Conclusions on production of plants and plant products for export to the EU

5. HOs are widespread in the areas of Malaysia with production for EU export. Growing technologies mitigate the risk of the presence of HOs in the crops, but complete freedom cannot be achieved.

6. EU legislation requires for a range of plants for planting that the place of production is free from certain HOs. With the production technology, applied by the growers visited by the audit team, those requirements cannot be met (see conclusion in paragraph No 63).

5.2 ORGANISATIONAL ASPECTS OF THE PLANT HEALTH CONTROLS

Legal requirements

Article 2(1)(i) of Directive 2000/29/EC.

Article IV of the IPPC. ISPM 7, in particular provisions on resources, infrastructure and communication.

Findings

5.2.1 National plant protection organisation

7. There were no organisational changes since the 2013 audit. The DoA, as part of the MoA, is the NPPO in Malaysia. The Plant Biosecurity Division (PBD) of the DoA is responsible for phytosanitary certification of plants and plant products exported to the EU. The PBD supervises the operation of the Malaysian Phytosanitary Certification Assurance Scheme and the certification schemes for the application of ISPM 15 (see chapter 5.7.) The PBD is responsible for multilateral and bilateral relations in plant health and also operates the secretariat of the National Pest Management Committee.

8. The PBD is sub-divided into sections. The Accreditation and Export Facilitation section is responsible for the co-ordination of export inspections and issuance of the PC. It also conducts studies and trials on quarantine treatment of exported goods according to the requirements of the importing countries. The Pest Management Section deals with surveillance, the Diagnostic and Expertise Section coordinates laboratory services and the Import and Enforcement Section deals with the pest risk analysis.

9. There are 11 PBD offices, one in each state of Malaysia, responsible for export related phytosanitary controls. In particular the PBD offices at KLIA, in Johor Bahru and for Cameron Highlands (to a lesser extent) are involved in EU export related activities.

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10. The Malaysian Quarantine and Inspection Service (MAQIS), which is another department of the MoA, inspect the imported plants and plant products. MAQIS issues import permits and export licences for plants and plant products. Border offices of MAQIS check documents of each consignment of plants and plant products presented to Customs, including whether the required PC is present or not.

5.2.2 National legislation

11. There were no changes since the 2013 audit. The basic legislation for plant health are the Plant Quarantine Act of 1976 and the Plant Quarantine Regulations of 1981 which deal with the export phytosanitary certification, including the general powers of officers, access to documents and records, official checks, inspections and the issuance of the PC. A new Biosecurity Act has been drafted and the PBD expects that it will be submitted to the Parliament in 2020. The DoA stated that the new Act will provide enhanced legal powers for the NPPO.

5.2.3 Revision of the export certification system

12. Since 2015, the export phytosanitary certification activities of Malaysia are assisted by a centralised, web-based system and database, called MyPhyto, which is currently operational in the DoA offices of the peninsular Malaysia. The regions of the Malaysian islands (Sabah and Sarabak) use a manual system.

13. Registered exporters apply for export inspections online in MyPhyto. The outcome of the consignment inspections is recorded in the database and the system issues the PC (see chapters 5.4.3, and 5.5).

14. Recommendation No 9 of the 2013 audit report required action to be taken to review the effectiveness of the certification and inspection system (system review). The audit team checked the detailed operation of MyPhyto and considers that the system significantly improves the Malaysian export phytosanitary certification, in particular through its enhanced function for documentation and traceability, the information provided to inspectors and exporters and the standardised and centrally controlled application of ADs.

5.2.4 Standards, guidelines

15. The activities related to the phytosanitary certification of plants and plant products exported to the EU are regulated by a series of DoA Standard Operating Procedures (SOPs) including rules for inspections of the places of production and consignments, requirements for sampling and laboratory tests and for administrative procedures

16. The NPPO stated that the SOPs are based on the relevant ISPMs and take into consideration the available scientific information and the general rules of the Malaysian public administration. They are regularly updated.

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17. Following the 2013 audit, biosecurity guidelines were elaborated for the production of aquatic plants for export with the aim to establish pest free places of production (PFPPs) in line with EU import requirements.

18. The DoA updated the written requirements for inspectors related to site inspection for aquatic farms, consignment inspection at the point of exit and at packing houses, including procedures for rejection.

19. MyPhyto contains detailed information about the phytosanitary requirements of importing countries per plant and type of consignment and it is accessible on-line for the inspectors.

20. Recommendation No 2 of the 2013 audit report requested the NPPO to provide inspectors with appropriate instructions for export checks and about EU import requirements. The audit team noted that the DoA addressed the recommendation with updated guidelines and instructions and with information uploaded into MyPhyto.

5.2.5 Resources, training

21. Inspectors are appointed by the Director General of the DoA. The required minimum qualification is a diploma or equivalent in agriculture or related field (minimum two years in third level education). A newly appointed inspector must complete a DoA introduction course before commencing any certification activity.

22. The DoA stated that since the 2013 audit the following courses were organised for inspectors: Introduction course to the plant biosecurity inspection officer; Workshop on the identification of whiteflies; Plant health laboratory training; Workshop on fruit flies; Workshop on leaf-miners in general and on the taxonomy of leaf-miners of

agricultural importance; Hands-on training on the establishment of pest status of ornamental plant pests.

23. The audit team learned that in addition to the events listed in the paragraph above, the Plant Biosecurity Office in Johor Bahru organised training courses for inspectors and exporters about phytosanitary inspections at the point of exit, identification of pests and diseases of aquatic plants, SOPs on the production of aquatic plants and hands-on training of new EU requirements.

24. The audit team noted that: The courses organised by the DoA are not mandatory for the inspectors (except the

introduction course); The inspectors met by the audit team in Cameron Highlands and KLIA biosecurity

offices have not attended any training course on EU export related issues since the 2013 audit;

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Some of the inspectors met by the audit team at different inspection sites were not fully aware of EU import requirements and did not have sufficient knowledge about the scientific and technical information necessary for the inspections (see chapters 5.4.2 and 5.4.3).

5.2.6 Laboratories and technical support

25. The competent authority stated that in general it is verified by visual inspections whether the places of production and products are in conformity with EU requirements. In the majority of cases, samples are not taken for laboratory analysis. Since the 2013 audit some new methods were implemented for the detection of HOs (e.g. the Kuala Lumpur laboratory uses an immunostrip detection kit for the identification of citrus canker).

26. The audit team visited the laboratory of the Biosecurity Station in Johor Bahru which checks samples of aquatic plants for the presence of harmful nematodes and noted that: The laboratory was well equipped and the staff was experienced in the identification

of soil nematode species with morphological keys (in particular regarding Radopholus sp. and Hirschmanniella sp.);

The method used by the laboratory, however, could not ensure the proper extraction of nematodes which are possibly present in the plant samples. The extraction time in the ultrasonic machine was insufficient and the sediment was not sufficiently concentrated (e.g. a 'funnel' method could be used);

The test results cannot be considered official as the samples are taken and sent to the laboratory by the growers (see chapter 5.4.2).

5.2.7Communication and collaboration within the NPPO and with stakeholders

27. The audit team noted that: There is continuous communication and information exchange between the DoA, and

the regional offices, using various means. Communication efforts concentrate on the regional offices which are responsible for inspecting the largest volumes of exports;

Due to the small volume of exports to the EU from Cameron Highlands, there was limited communication with this office on EU requirements. As a consequence their inspectors met by the audit team, were not sufficiently familiar with EU import requirements;

MyPhyto is a powerful tool for informing inspectors and exporters about the phytosanitary import requirements per product and destinations and for obtaining real-time information about phytosanitary inspections and PC issuance;

Local managers were professional in the supervision of the export certification activity in the KLIA and Johor Bahru offices;

28. The audit team noted that a range of initiatives were taken to raise awareness and improve knowledge of the growers and packing houses of EU import requirements. The main elements are:

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In 2019, the DoA published a guideline of phytosanitary requirements for export of horticulture products from Malaysia. The document is printed in English and contains detailed information per product about the import requirements of Malaysia's main trade partners, including the EU. It also explains the phytosanitary certification procedure and lists the PBD offices, where PCs are issued;

MyPhyto contains detailed information about phytosanitary requirements related to products and export destinations, which can be accessed by registered exporters;

The DoA and the regional PBD offices organised training courses and information events for the interested growers and exporters;

Inspectors met by the audit team in Cameron Highland and Johor regions explained that they maintain close working relations with growers and packing houses, organise hands-on training and provide all relevant information about EU requirements for the growers and packing house staff.

Conclusions on the organisational aspects of the plant health controls

29. The plant health system of Malaysia provides a sufficient basis for phytosanitary controls of plants and plant products to be exported to the EU.

30. Although there were improvements in the laboratory capacities and in the relevant knowledge and experience of the laboratory staff, the methods applied cannot sufficiently ensure the detection of HOs present in the samples.

31. The training and awareness raising activities introduced since the 2013 audit contributed to the improvement of EU export related knowledge of the inspectors, exporters, packing houses and growers. However, it is still not ensured that inspectors involved in export controls possesses sufficient knowledge about EU import requirements and technical aspects necessary for the work.

32. The introduction of MyPhyto enhanced the effectiveness of export inspections and the PC issuance. Its database is of significant assistance to the inspectors and exporters. The introduction of MyPhyto is considered as a significant revision of the export certification system.

5.3 PHYTOSANITARY STATUS OF HARMFUL ORGANISMS RELEVANT FOR EU EXPORT

Legal requirements

Part A of Annex I, Part A of Annex II and Part A Section I of Annex IV of Directive 2000/29/EC.

ISPM 4, ISPM 6, ISPM 8, ISPM 10 and ISPM 17.

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Findings

33. The DoA confirmed that Bemisia tabaci, Liriomyza huidobrensis, Liriomyza sativae, Thrips palmi, and numerous fruit fly species are widespread in Malaysia.

34. Citrus canker (Xanthomonas citri pv. citri and pv. aurantifolii) has recently been introduced into the northern production areas of the country. Recommendation No 5 of the 2013 audit report requested to ensure that citrus fruit exported from Malaysia meet EU import requirements related to the citrus canker with controls at the field of production and traceability of the consignments. In response to this recommendation, in 2015-2019 official surveys were carried out in the Cameron Highlands production area with the aim of establishing a pest free area (PFA). The results indicated that the bacterium was present in each surveyed orchard in each year; however, the number of positive plants and the severity of the symptoms varied.

35. Based on the survey results there is no possibility to establish and maintain any PFA or even a PFPP for citrus canker in Malaysia. Based on the survey results and following EU interceptions of citrus canker in 2018, since January 2019, the DoA does not issue PC for citrus fruit produced in Malaysia for EU export.

36. Pomacea species are present in Malaysia and damage 7 to 8% of rice farms. The NPPO takes control measures for the purposes of containment and eradication.

37. In order to reduce the number of EU interceptions, the DoA carried out surveys in the period from 2015 to 2019 in six aquatic plant nurseries of the region Johor to determine the status of Bemisia tabaci, soil nematodes and snail populations. Growing sites of Anternanthera, Hygrophyla, Cryptocoryne, Echinodorus and Lobelia species were surveyed for white flies and sites with Vallisneria, Anubias, Echinodorus, Hygrophila and Alternanthera plants for nematodes and snails with a specific method was developed by the DoA.

38. Based on the survey results the DoA considers that: The sites covered by insect protection nets, can achieve PFPP status for Bemisia

tabaci, provided that appropriate monitoring and chemical control is applied. Although soil nematodes, in particular Hirschmanniella sp. were commonly found in

Vallisneria and Hygrophyla crops, with the current system of sampling and laboratory tests the EU requirements can be met.

Snails and their eggs can easily be removed from plant parts using pressurised water after harvesting. Therefore no snail infestation was found in consignments prepared for export.

The audit team noted that in particular for Bemisia tabaci and Radopholus sp. the current practice does not justify the DoA approach (see chapters 5.2.6 and 5.4.2).

39. In order to meet EU requirements the DoA developed biosecurity guidelines, which became mandatory for growers intending to export to the EU. Training sessions were

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also conducted for interested parties on pest identification and control (see chapter 5.4.1).

40. The DoA confirmed that Amauromyza maculosa, Cercospora angloensis, Keiferiella lycopersici, Spodoptera frugiperda, Phyllosticta citricarpa and Thaumatotibia leucotreta are not present in the country and have never been reported or found during official inspections. Official surveys were recently started in the border area with Thailand for Spodoptera frugiperda as the pest might be present in that neighbouring country.

Conclusions on phytosanitary status of HOs relevant for EU export

41. Numerous HOs including white flies, soil nematodes, fruit flies and citrus canker are present and widespread in the production areas of Malaysia. The establishment of PFAs for those organisms is not possible. Ensuring that the EU export requirements are met, in particular that the place of production is free from Bemisia tabaci and Radopholus sp., necessitates specific efforts from the growers such as establishing isolated places of production and during plant health inspections concerning the sampling regime and the meticulousness of the checks.

5.4 SYSTEM OF EXPORT INSPECTIONS

Legal requirements

Annex IV, Part A Section I to Directive 2000/29/EC. Points which are most relevant to the products currently exported by Malaysia are 16.2, 16.6, 18.1, 25.7.2, 32.1, 32.2, 32.3, 34. 36.1, 36.2, 44, 45.1, 45.2, 46 and Annex V, Part B to Directive 2000/29/EC.

ISPM 7, ISPM 23, in particular its chapter 1.4, ISPM 27, ISPM 31 and ISPM 36.

Findings

5.4.1Registration of producers

42. The DoA informed the audit team that each producer of aquatic plants and each packing house which prepares consignments of fruit, vegetables, herbs, cut flowers and cut leaves for EU export is registered by the regional biosecurity offices. The farms with their own packing houses are also registered.

43. The registered farms are obliged to: Have a packaging house; Apply good agricultural practice; Use a systems approach for pest management, including periodic surveys; Apply a cropping system which reduces pest risk and outbreaks; Use pesticides which are authorised in Malaysia; Operate a traceability system for their products;

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Operate a quality control system during harvest.

44. Registered packing houses are obliged to: Establish facilities in which the goods are protected from HO infection/infestation

during processing; Apply internal quality controls at least at the reception of goods and on the packed

product; Apply product traceability and record-keeping systems; Be capable of applying post-harvest treatments according to the requirements of the

importing country; Process and store the products to different destinations (exporting countries, domestic)

separately.

45. The NPPO stated that the fulfilment of these requirements is checked by official inspections before the registration and continuously during export activities.

5.4.2 Inspections of places of production for EU export

46. Recommendation No 4 of the 2013 audit report requested to ensure that the places of production of aquatic plants are free from Bemisia tabaci and Radopholus sp. in line with the relevant provisions of Directive 2000/29/EC.

47. The DoA stated that in order to address this recommendation biosecurity guidelines were developed for the production of aquatic plants. The growers are obliged to: Cover the place of production (greenhouse) of the species which are considered as

hosts of Bemisia tabaci with an inspect-proof net (minimum mesh number of 32); Use sticky traps and crop scouting for the detection of the presence of insects, in

particular for white flies; Carry out crop scouting for snails and use snail repellents in the greenhouses; Collect samples per plant species to be exported and to send them to the DoA

Biosecurity Office laboratory for nematode test.

48. The NPPO stated that the place of production of aquatic plants is officially inspected at least once every three weeks as required by point 45.1.b, Annex IV Part A, Section I. of Directive 2000/29/EC. The outcome of each inspection is duly recorded.

49. The audit team noted that if Bemisia tabaci is detected during an inspection at the place of production of aquatic plants, EU export from the site is suspended and a pesticide treatment is requested. A follow-up inspection takes place two days after the chemical treatment is completed. If no infestation is detected, the possibility to export is re-established. Thereafter, the inspection frequency of once every three weeks is applied. This practice is not in line with point 45.1.c, Annex IV Part A. Section I. of Directive 2000/29/EC, which requires weekly inspections for nine weeks to ensure that the place of production is free from the pest after an infestation was detected.

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50. The audit team observed an inspection at a place of production of aquatic plants for EU export and noted that: The inspectors possessed the necessary tools (magnifying glass, knives etc.) for visual

checks; The inspectors randomly selected a sufficient number of plants in the crop for visual

inspection. The inspection procedure included the tapping of the plants, inspecting the leaves and checking the catches of sticky traps for the presence of adults in the greenhouse. However, the plants and especially the backside of the leaves and shoots were not meticulously inspected with a magnifying glass to check the possible presence of eggs and juvenile forms of the pest. Therefore the inspection was not suitable to verify that the place of production was free from Bemisia tabaci although it is required by Point 45.1.b, Annex IV, Part A, Section I of Council Directive 2000/29/EC;

The presence of snails was also checked. As only a few plants were selected randomly, the method was not sufficient to detect a low level infestation in the crop;

No official samples were taken for laboratory analysis to verify that the place of production was free from Radopholus sp. and other harmful nematodes;

An inspection report was prepared which contained all necessary information for the export certification.

51. The audit team noted that: Growers take samples from aquatic crops shortly before the plants are harvested and

send them to the regional NPPO laboratory for nematode analysis. The samples contain rooted plants, the growing medium is washed off;

As the samples are not taken by NPPO inspectors they cannot be considered official. The representativeness is not ensured either, as the NPPO does not have information about the sampling method and exact origin of the plants;

The currently used analytical method (see paragraph 26 in chapter 5.2.6) does not provide sufficient guarantees for the detection of harmful nematodes in the samples.

Point 18(b), Annex IV, Part A, Section I of Council Directive 2000/29/EC requires that for a range of plant species representative samples of soil and roots from the place of production have been subjected since the last complete cycle of vegetation to official nematological testing. The applied sampling and test regime does not meet this requirement.

5.4.3 Pre-export inspection of consignments

52. Pre-export consignment inspections take place in the packing houses or in the inspection station of the plant health office at KLIA. Registered exporters must apply for the inspections two days in advance on-line in MyPhyto. The relevant data boxes in the database interface must be completed and all supporting documents must also be uploaded in scanned format. Hard copies are requested during the inspection.

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53. The system allocates the inspection file to the inspector who first verifies the completeness and appropriateness of the uploaded information. Specific attention is paid to products and destinations (MyPhyto flags those to the inspector) where export licence, laboratory analysis or field inspection report is required. A non-compliant request is rejected. The exporter must lodge a new application for the same goods. The inspector schedules the checks and determines the sample size according to the data (consignment, lots, units) in the application.

54. The DoA stated that for EU exports inspectors are requested to sample the export lot according to the hypergeometric table of ISPM 31 which ensures the detection of a 5% infection/infestation in the lot at 95% confidence level. For the application of ISPM 31 the same product for export to the same destination is considered as a lot and the boxes in which the plants and plant products are exported are considered as units. After the selection of the appropriate number of the boxes the entire content must be checked.

55. It was also stated that during sampling the inspector cross-checks the appropriateness of information about the products and quantities. After the inspection is completed the inspector enters the results into MyPhyto. The completed file is sent for approval to a supervisor. After the file is approved the PC is printed (see chapter 5.5.1).

56. The audit team noted that a DoA SOP in force lists the minimum number of boxes/units to be sampled for export inspection product-by-product. The figures indicated in that SOP were not always in line with the ISPM 31 values, referred to by the NPPO.

57. Certain export consignments presented for inspection contain goods imported from Thailand (see chapter 5.1.3). Herbs, fruit and vegetables arrive to Malaysia with a Thai PC and are subject to import phytosanitary controls by MAQIS. The packing houses repack the imported items and may mix them with locally produced goods. The DoA usually cannot trace-back the origin of the goods. The term 'Peninsular Malaysia and Thailand' is indicated as the place of origin on the PC.

58. The audit team observed several demonstrations of consignment inspections of various products to be exported to the EU and noted that: The inspectors applied sampling rates according to the tables of ISPM 31 ensuring the

detection of a 5% infection/infestation at 95% confidence level; However, in the Cameron Highlands region the inspectors used a sample rate which

ensured 90% confidence level for detecting a 5% level infection/infestation; At the inspection sites the conditions (stainless steel tables, light, magnifying glasses)

were appropriate for visual inspections. The staff of the packing houses provided assistance for sampling. The boxes were

randomly selected from the entire lot. The full content of the selected boxes was visually checked using magnifying glass and cutting tools;

The inspectors aimed to detect the presence of any live insect or other disease symptoms;

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The majority of the inspections were carried out adequately. Inspectors were fully aware of the ISPM 31 rules and symptoms of the main HOs.

However, the lack of meticulousness of some inspections, in particular in the Cameron Highlands region, did not ensure the detection of a barely visible infection/infestation;

In addition, some inspectors did not have a satisfactory knowledge about EU requirements and about the HOs.

59. Recommendation No 1 of the 2013 audit report requested that official checks are performed only by staff, which has appropriate level of expertise and technical information. Recommendation No 3 of the 2013 audit report requested that the sample size used for consignment inspections is in line with requirements of ISPM 31. The audit team noted that since the 2013 audit, thanks to the DoA efforts there were positive developments, however, due to the reasons described in the paragraph above and in the relevant paragraphs of chapter 5.4.2, it is considered that the recommendations were only partly addressed.

60. Recommendation No 7 of the 2013 report requested official pre-export inspections of orchid cut flowers exported to the EU. Based on the information obtained during a visit to an orchid grower and during the demonstrated inspections the audit team considers that this recommendation was addressed.

61. The audit team noted that for sampling, the DoA guidelines require the mechanical application of ISPM 31 tables at the rates mentioned above. The confidence level or level of detection is not adjusted taking into consideration the existing risk (e.g. seasonal patterns in pest prevalence, EU notifications and findings during consignment inspections). The measures applied when a HO is found in the lot or consignment during the pre-export inspections is described in chapter 5.6.1.

Conclusions on the system of export inspections

62. The changes implemented by the NPPO improved the phytosanitary controls of plants and plant products to be exported to the EU and in general enhanced the level of conformity with the EU requirements.

63. However, the measures are not sufficient to ensure full conformity with EU requirements that the place of production of aquatic plants is free from Radopholus sp. and Bemisia tabaci.

64. Although provisions of ISPM 31 are applied for determining sampling rates, the confidence level or the level of detection is not adjusted according to the specific risk of HO presence. This can explain why HOs remain undetected during export checks and the respective consignments are intercepted at EU import controls.

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5.5 PHYTOSANITARY CERTIFICATES

Legal requirements

Article 2(1)(i) and Article 13a(3) and (4) and Annex IV, Part A Section I of Directive 2000/29/EC.

ISPM 5, ISPM 7 and ISPM 12.

Findings

5.5.1 Issuance of the phytosanitary certificate

65. Since 2015, PCs are issued by MyPhyto in the Peninsular territory of Malaysia. The non-peninsular regions (Sabah and Sarawak) use the same PC format which is issued outside the web-based system.

66. The format and content of the Malaysian PC are in line with IPPC and EU requirements. In addition to that each PC contains a QR code which enables readers to access the electronic version of the document stored in MyPhyto. This feature minimises the possibility of falsification.

67. The inspector checks the application for the completeness of information and adds the results of the inspection to the file (see also chapter 5.4.2). The system then prepares the PC with the AD if relevant. The PC may be printed after the inspection file is completed by the inspector and verified by a supervisor. Exporters may collect the PC in one of the 17 offices of the DoA.

5.5.2 Additional declarations

68. MyPhyto automatically adds to the PC the country and product specific AD in the form as it is stored in the central database. The DoA stated that the central database is regularly updated, based on the information the NPPO receives from the importing countries. Feedback from the exporters may also be taken into consideration and added to the system.

69. The audit team checked some ADs issued for the main types of plants and plant products exported to Malaysia to the EU and noted that: In general, the declarations dealt with each point of Annex IV, Part A, Section I of

Directive 2000/29/EC, which was relevant to the exported plant species/product; In general the declarations reflected correctly the plant health status of the place of

production and/or of the consignment in relation to each relevant HO; However, some declarations contained incorrect or irrelevant statements, the main

examples are summarised in Table III.

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Table III. Examples of incorrect ADs applied by Malaysia on PCs for plants and plant products destined for the EU

ProductAdditional declaration in relation to the relevant points of Annex IV, Part A, Section I of Directive 2000/29/EC

Audit team comments

Basil (Ocimum sp.)

Consignment complies with Annex IV.A.I 32.2a of Directive 2000/29/EC, originated in a country free from Amauromyza maculosa and Liriomyza sativae

Not correct as Liriomyza sativae is widespread in Malaysia.Point 32.2 first indent (freedom of the country) is valid for Amauromyza maculosa, while 32.2 second indent (statement about inspected immediately prior to exports and found free) must be used for Liriomyza sativae

Growing medium Consignment complies with Annex IV.A.I 34.a second indent of Directive 2000/29/EC

Not completePoint 34.a refers to the status of the growing medium at the time of planting only. In addition fulfilment of one of the options of point 34.b (status since the planting) must be also declared.

Consignment complies with Annex IV.A.I 45.1b (or 45.1.c) of Directive 2000/29/EC

Not correctThe site visited by the audit team could not be considered as PFPP for Bemisia tabaci.The system of official inspections is not in line with the requirements of point 45.1.c.See findings of chapter 5.4.2 and the related conclusions.

Aquatic plants

Consignment complies with Annex IV.A.I 18b of Directive 2000/29/EC based on field samples

Not correctThe current Malaysian sampling system does not make this certification possible (see findings of chapter 5.4.2).

Consignment complies with Annex IV.A.I 36.1b and 45.1.b of Directive 2000/29/EC (The place of production is free from Thrips palmi).

Not correctConsidering the pest status of Thrips palmi in Malaysia only greenhouses with appropriate insect isolation can be declared as PFPP. The audit team received no evidence that herbaceous plants (except aquatic plants) and Ficus sp. are produced in insect-proof houses.Conformity with point 36.1c should be certified instead.

Herbaceous plants and Ficus sp.

Consignment complies with Annex IV.A.I 32.1 and 32.3 of Directive 2000/29/EC

Not completePoint 32.1 – the point applies for Liriomyza sativae, conformity with one of the options must be declared.Point 32.3 - the point applies for Liriomyza huidobrensis, conformity with one of the options must be declared.

The plants meet requirements of Regulation 2007/365

Not correctThe regulation has been repealed.

Plants of Palmae intended for planting Not complete

The declaration of conformity with one of the options of points 37 and 37.1 is missing.

70. Recommendation No 6 of the 2013 report requested the NPPO to ensure that on the PC the relevant ADs are issued when it has been ascertained that the specific requirements have been complied with. The audit team concluded that this recommendation was partially addressed (see also the relevant parts of chapters 5.4.2 and 5.4.3.)

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Conclusions on phytosanitary certificates

71. The Malaysian PC is in line with IPPC and EU requirements. The MyPhyto system significantly reduces the possibility of administrative errors during certification. The QR code with MyPhyto web link provides for additional security.

72. The information provided on the PCs is in many cases not reliable as the AD does not reflect correctly the plant health status of the consignment in line with requirements referred to by the annexes of Directive 2000/29/EC do.

5.6 ACTIONS TAKEN IN RESPONSE TO INTERNAL FINDINGS AND EU NOTIFICATIONS

Legal requirements

ISPM 7, ISPM 13, ISPM 17 and Section 2.6 of ISPM 23.

Findings

5.6.1 Internal findings

73. As it was stated in chapter 5.4.2 the measures applied when Bemisia tabaci is detected during inspections at the places of production of aquatic plant are not in line with EU requirements.

74. Inspectors met by the audit team at the packing houses stated that they reject the entire lot after any HO finding in any of the inspected boxes. However, if a HO is identified during inspections at the KLIA the affected box is rejected but the inspection continues. The entire lot is only rejected if a second positive case is found in the next five boxes. If the export consignment is composed of different lots, the export of the other lots with negative inspection results is allowed (see also chapter 5.4.3).

75. The practice in KLIA is not in line with ISPM 5 According to the provisions of the standard in the case of any finding the entire lot (i.e. which is composed of the same plant species) must be considered as infested/infected.

76. Recommendation No 8 of the 2013 audit report requested that when a HO is detected during pre-export inspections, the whole lot should be considered as not being free from that HO in line with provisions of ISPM 5 and should not be certified for EU export. Due to the practice applied at KLIA the recommendation is not addressed.

77. The audit team was informed that plants and plant products of a rejected lot may be presented again for export inspection after re-sorting or after an appropriate treatment. In any case the goods must be re-packed. The goods to be exported after re-packing are not subject to intensified inspections.

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5.6.2 EU notifications

78. The DoA headquarters receive e-mail notifications from the EUROPHYT-Interceptions system. Thereafter the relevant regional office is informed.

79. For EU notifications with HOs the responsible inspector visits the place of production or the packing house. After the case is investigated a report with recommendations for actions to avoid repeated occurrence is prepared. The implementation of the recommended measures is checked by follow-up inspections as appropriate.

80. The audit team noted that: The NPPO presented detailed information in writing about the follow-up of many

individual notifications; In one region visited, the competent authorities followed-up each EU notification

without delays; However, in the Cameron Highland region there were delays in the follow-up and in

particular concerning the notification of a consignment with citrus canker.

The NPPO stated that it is particularly difficult to follow-up HO interceptions of consignments without Malaysian PC, as the EUROPHYT-Interceptions notification usually does not contain sufficient information about the origin of the goods and means of transport.

81. If the consignment is intercepted due to missing or inadequate AD the issue is usually rectified with a replacement PC.

82. The NPPO stated that initial measures were taken to reduce the number of EU notifications due to the absence of a PC. Awareness-raising for air passengers was initiated in the form of leaflets distributed at KLIA. Discussions started with the postal services and Customs about how to identify regulated articles in postal packages. Although packages are currently scanned by X-ray before export, the used technology is not sufficient for the identification of plants.

Conclusions on actions taken in response to internal findings and EU notifications

83. The measures implemented after infestation of Bemisia tabaci is detected at the place of production of aquatic plants and after a HO is found during consignment inspections at KLIA, are not in line with EU requirements and ISPM provisions and therefore cannot prevent the recurrence of the issues which lead to repeated EU interceptions.

84. EU notifications with HOs are followed up and the implemented measures reduce the risk of repeated occurrences. However, the actions were implemented with delays in some cases.

85. Due to the lack of checks of postal packages and personal luggage considerable volumes of regulated articles are exported from Malaysia to the EU without inspection and PC.

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5.7 WOOD PACKAGING MATERIAL AND ISPM 15 CERTIFICATION

Legal requirements

Point 2 of Part A, Section I of Annex IV of Directive 2000/29/EC.

ISPM No. 15.

Findings

86. The vast majority of WPM used by Malaysian exporters are pallets, produced from locally sourced tropical wood. The approval and the controls of the heat treatment (HT) and methyl bromide (MB) treatment facilities are carried out in the framework of accreditation schemes established by the DoA. The application of the Malaysian Heat Treatment Accreditation Scheme started in 2004. At the time of the audit 96 companies were accredited and registered. The Malaysian Fumigation and Accreditation Scheme started in 2006. At the time of the audit 107 companies were registered and accredited for MB treatment.

87. The 2013 audit had identified shortcomings in the implementation of ISPM 15 related to the official supervision of HT facilities and the repair of pallets.

88. The DoA stated that since the 2013 audit the control system of WPM treatment companies was improved. In particular: Homogeneity studies are now part of the authorisation process as requested by

recommendation No 10 of the 2013 audit report; Each facility is subject to at least annual inspections as requested by recommendation

No 11 of the 2013 audit report; During the inspection of the HT chambers particular attention is paid to the

distribution of temperature probes and whether there is an appropriate separation of treated and untreated WPM;

The inspection system now ensures, as requested by recommendation No 12 of the 2013 audit report, that pallets are repaired only with treated WPM in line with provisions of ISPM 15.

89. To achieve better traceability companies are obliged to stamp or burn in addition to the ISPM 15 mark a so called 'WPM control Number' issued by the regional DoA office. This is a unique number for each treated lot with the treatment date, series number and code of the relevant DoA office, in the form ddmmyy/000/XX.

90. The audit team visited a pallet producer with approved HT facility in the Kuala Lumpur area and noted that:

The accreditation for HT and application of the ISPM 15 mark was valid for two years. The authorisation may be extended after a new inspection of the treatment site. DoA inspectors visit the plant at least twice a year;

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The company carried out the HT in line with the provisions of ISPM 15. The temperature probes were officially calibrated annually. Wood probes were applied taking into consideration the cold spot of the chamber. Recorded temperature readings of each treatment were available for inspection. The stacking of the pallets enabled free circulation of the air. The company applied a large safety margin for the treatment. The wood temperature was kept above 56oC at least for eight hours. The treated and untreated pallets were stored separately;

On the treated pallets the WPM control number, issued by the regional DoA office, was applied correctly;

However, some of the ISPM 15 marks were not fully in line with the requirements of the standard as the IPPC logo and information about the country, treatment provider and treatment type was not surrounded by a frame;

In addition, some ISPM 15 marks presented to the audit team by the DoA contained the sign 'DB' referring to the debarked status of the WPM, which must not be part of the ISPM 15 mark any more.

5.8 FOLLOW-UP OF RECOMMENDATIONS OF AUDIT REPORT

The table below summarises the follow-up of recommendations made in report DG SANCO 2013/6813:

No DG(SANCO)2013/6813 Assessment1 Ensure that official checks are performed only by

staff, who have the appropriate level of expertise and technical information, in line with section 3 of ISPM 7, and Article 2(1)(i) of Council Directive 2000/29/EC.

Partially addressed as some shortcomings were identified at Cameron Highlands and KLIASee findings Nos 24, 50 and 58; conclusion No 31 and recommendation No. 1.

2 Ensure that staff performing inspections are provided with the appropriate instructions for performing the export checks and with the import requirements of the importing countries, in line with section 2.2 and 4.2 of ISPM 7.

Addressed by the implementation of MyPhyto and the DOA guidelinesSee chapters 5.2.3 and 5.2.4; conclusion No 32.

3 Ensure that appropriate checks are carried out of plants and plant produce; in particular, that the sample size used is in line with the requirements of ISPM 31.

Addressed with the implementation of the DoA guidelines, however in one region the guidelines were not followedSee findings Nos 54, 55, 58; conclusion No 64 and recommendation No. 3.

4 Ensure that for aquatic plants exported to the EU, meet the requirements in points 18(b) and 45.1(c), Annex IV, Part A, Section I of Council Directive 2000/29/EC, for place of production freedom from Radopholus sp. and Bemisia tabaci are fulfilled.

Not addressedSee findings Nos 49, 50, 51; conclusion No 63 and recommendation No. 2.

5 Ensure that for Citrus fruit exported to the EU, the Official surveys confirmed that no PFA can be established

Conclusions on wood packaging material and ISPM 15 certification

91. The system of authorisation of the WPM treatment and of the application of the ISPM mark is in line with the requirements of ISPM 15. In line with recommendations of the 2013 audit report the effectiveness of the related official controls improved. However, the information content of an observed mark was not fully in line with ISPM requirements, which can lead to rejections in the EU.

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No DG(SANCO)2013/6813 Assessmentrequirements in the first indent of point 16.2(c), Annex IV, Part A, Section I of Council Directive 2000/29/EC, for field of production controls and traceability relating to Xanthomonas axonopodis pv. citri, are fulfilled.

for Xanthomonas axonopodis pv. citri in the production regions of Malaysia. As the NPPO suspended the export of citrus fruit to the EU the recommendation became obsolete.See findings Nos 33, 34, 35; conclusion No 41.

6 Ensure that for exports to the EU, phytosanitary certificates and the relevant additional declarations are issued only when it has been ascertained that the specific requirements as specified in Annex IV, Part A, Section I to Council Directive 2000/29/EC have been complied with, in particular, for aquatic plants and Citrus fruit.

Partially addressed. Some additional declaration do not reflect correctly the status of the harmful organism in the place of production or in the consignmentSee findings Nos 69 and 70; conclusion No 72 and recommendation No. 4.

7 Ensure that for orchid cut flowers exported to the EU, the requirements in point 36.2 second indent, Annex IV, Part A, Section I of Council Directive 2000/29/EC are fulfilled. In particular, that the pre-export inspections are official.

AddressedSee finding No 60;

8 Ensure that when a harmful organism is detected during the pre-export inspection, the whole lot should be considered as not being free from the harmful organisms, in line with ISPM 5, and should not be exported to the EU, since it does not comply with EU requirements.

Partially addressed – different practices are applied at the packing stations and at the KLIA inspection pointSee findings Nos 74, 75 and 76; conclusion No 84 and recommendation No. 5.

9 Ensure that action is taken to review the effectiveness of the export certification system and to review the export inspection system, in particular, in light of the ongoing interceptions of harmful organisms by the EU, in line with sections 6 of ISPM 7 (System review) and 2.6 of ISPM 23.

AddressedSee chapter 5.2.3; conclusion No 32.

10 Ensure that WPM treatment providers monitor the treatment temperature at a location likely to be the coldest as required in Annex 1 of ISPM 15. Proper homogeneity studies should be included as part of the authorisation process.

AddressedSee finding No 91; conclusion No 92.

11 Ensure that the official supervision referred to in ISPM 15, section 4.1 is adequate to verify that all authorised establishments are implementing this standard correctly.

Partially addressedSee findings Nos 89, 90 and 91; conclusion No 92 and recommendation No. 7.

12 Ensure that repair of WPM marked as treated to ISPM 15 standard is done in accordance with section 4.3.2 of the ISPM 15 standard.

AddressedSee finding No 89; conclusion No 92.

6 OVERALL CONCLUSIONS

The measures implemented by the competent authorities following the 2013 audit have improved the system of plant health controls of goods exported to the EU. The main elements which contributed to the improvement of the level of compliance with EU rules include the implementation of a web-based system supporting export consignment inspections and the issuance of the PC, the revision of the system of official inspection with updated guidelines and SOPs and the application of the provisions of ISPM 31 for export inspections.

A number of control measures were still insufficient, in particular ensuring that the places of production of aquatic plants are free from Bemisia tabaci and Radopholus sp., the relevant SOPs and guidelines are implemented for all the inspections of EU export and the sampling rates of export controls are adjusted according to the specific plant health risk.

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Despite the significant positive developments, imports of regulated products from Malaysia still represent a medium level of plant health risk for the EU.

7 CLOSING MEETING

A closing meeting was held on 13 March 2019 at the NPPO headquarters in Kuala Lumpur, during which the main findings and preliminary conclusions of the audit team were presented. The competent authorities of Malaysia accepted the information provided by the audit team.

8 RECOMMENDATIONS

The NPPO of Malaysia is recommended to:

No. Recommendation

1. Ensure that official checks are performed only by staff who have the appropriate level of expertise and technical information, in line with section 3 of ISPM 7 and Article 2(1)(i) of Council Directive 2000/29/EC.

The recommendation is based on conclusion No. 31.Associated findings Nos. 24, 50 and 58.

2. Ensure that aquatic plants exported to the EU meet the requirements in points 18(b) 45.1(b) and 45.1(c), Annex IV, Part A, Section I of Council Directive 2000/29/EC that the place of production is free from Radopholus sp. and Bemisia tabaci.

The recommendation is based on conclusion No. 63.Associated findings Nos. 49, 50 and 51.

3. Ensure that inspection and sampling rates of consignments, applied prior to EU exports, provide for an appropriate level of confidence that the commodities are free from harmful organisms as required by Council Directive 2000/29/EC.

The recommendation is based on conclusion No. 64.Associated findings Nos. 54, 55, 57, 58 and 61.

4. Ensure that additional declarations on the phytosanitary certificates refer correctly to EU requirements, listed in Annex IV, Part A, Section I, of Directive 2000/29/EC, which are relevant to the commodity in question and also refer to the option chosen by the National Plant Protection Organisation.

The recommendation is based on conclusion No. 72.Associated findings No. 69 and 70.

5. Ensure that when a harmful organism is detected during a pre-export inspection of a consignment, the whole lot is considered as not being free from the harmful organism, in line with provisions of ISPM 5.

27

No. Recommendation

The recommendation is based on conclusion No. 83.Associated findings Nos. 74, 75 and 76.

6. Ensure that appropriate measures are implemented following EU interceptions for reasons other than presence of harmful organisms, in order to reduce the repeated occurrence, in particular concerning postal parcels and personal luggage.

The recommendation is based on conclusion No. 85.Associated finding No. 82.

7. Ensure that the mark applied on wood packaging material, treated by approved establishments in Malaysia, is in line with requirements of ISPM 15.

The recommendation is based on conclusion No. 91.Associated finding No. 90.

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=2019-6738

ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal TitleDir. 2000/29/EC OJ L 169, 10.7.2000,

p. 1-112 Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

ANNEX 2 STANDARDS QUOTED IN THE REPORT

International Standard

Title

ISPM No. 4 International Standard on Phytosanitary Measures Publication No 4, Requirements for the establishment of pest free areas, Food and Agriculture Organisation, Rome, Adopted 1995; published 2017, https://www.ippc.int/en/publications/614/

ISPM No. 5 International Standard on Phytosanitary Measures Publication No 5, Glossary of phytosanitary terms, Food and Agriculture Organisation, Rome, Adopted 2018; published 2018; https://www.ippc.int/en/publications/622/

ISPM No. 6 International Standard on Phytosanitary Measures Publication No 6, Surveillance, Food and Agriculture Organisation, Rome, Adopted 1997; published 2018, https://www.ippc.int/en/publications/615/

ISPM No. 7 International Standard on Phytosanitary Measures Publication No 7, Phytosanitary certification system, Food and Agriculture Organisation, Rome; Adopted 2011; published 2016, https://www.ippc.int/en/publications/613/

ISPM No. 8 International Standard on Phytosanitary Measures Publication No 8, Determination of pest status in an area, Food and Agriculture Organisation, Rome; Adopted 1998; published 2017, https://www.ippc.int/en/publications/612/

ISPM No 10. International Standard on Phytosanitary Measures Publication No 10, Requirements for the establishment of pest free places of production and pest free production sites, Food and Agriculture Organisation, Rome; Adopted 1999; published 2016,https://www.ippc.int/en/publications/610/

ISPM No. 12 International Standard on Phytosanitary Measures Publication No 12, Phytosanitary certificates, Food and Agriculture Organisation, Rome; Adopted 2014; published 2017, https://www.ippc.int/en/publications/609/

ISPM No 13 International Standard on Phytosanitary Measures Publication No 13, Guidelines for the notification of non-compliance and emergency action, Food and Agriculture Organisation, Rome; Adopted 2001; published 2016, https://www.ippc.int/en/publications/608/

ISPM No. 14 International Standard on Phytosanitary Measures Publication No 14, The

International Standard

Title

use of integrated measures in a systems approach for pest risk management, Food and Agriculture Organisation, Rome, Adopted 2002; published 2017, https://www.ippc.int/en/publications/607/

ISPM No. 15 International Standard on Phytosanitary Measures Publication No 15, Regulation of wood packaging material in international trade, Food and Agriculture Organisation, Rome, Adopted 2013; published 2018, https://www.ippc.int/en/publications/640/

ISPM No. 17 International Standard on Phytosanitary Measures Publication No 17, Pest reporting, Food and Agriculture Organisation, Rome, Adopted 2002; published 2017, https://www.ippc.int/en/publications/606/

ISPM No. 23 International Standard on Phytosanitary Measures Publication No 23, Guidelines for Inspection, Food and Agriculture Organisation, Rome, Adopted 2005; published 2016, https://www.ippc.int/en/publications/598/

ISPM No 27 International Standard on Phytosanitary Measures Publication No 27, Diagnostic protocols for regulated pests, Food and Agriculture Organisation, Rome, Adopted 2006; published 2016, https://www.ippc.int/en/publications/593/

ISPM No. 31 International Standard on Phytosanitary Measures Publication No 31, Methodologies for sampling of consignments, Food and Agriculture Organisation, Rome, Adopted 2008; published 2016, https://www.ippc.int/en/publications/588/

ISPM No. 36 International Standard on Phytosanitary Measures Publication No 36, Integrated measures for plants for planting, Food and Agriculture Organisation, Rome, Adopted 2012; published 2016, https://www.ippc.int/en/publications/636/