final report of a mission carried out in china from 05 may

EUROPEAN COMMISSIONHEALTH & CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

DG(SANCO)/ 2009-8108 - MR - FINAL

FINAL REPORT OF A MISSIONCARRIED OUT IN

CHINAFROM 05 MAY TO 15 MAY 2009

IN ORDER TOEVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE

PRODUCTION OF WILD AND FARMED FISHERY PRODUCTS INTENDED FOREXPORT TO THE EUROPEAN UNION

In response to information provided by the Competent Authority, any factual error noted in the draftreport has been corrected;any clarification appears in the form of an endnote.

Executive SummaryThis report describes the outcome of a Food and Veterinary Office mission in Chinacarried out between 5 and 15 May 2009, as part of its programme of inspections inMember States and third countries.

The objective of the mission was to evaluate the public health conditions for theproduction of fishery products intended for export to the European Union. The missioncovered the relevant Community legislation for the public health sector and focusedparticularly on the follow-up to a previous fishery products mission carried out from 25February to 7 March 2005.

The report concludes that the General Administration of Quality Supervision, Inspectionand Quarantine of the People's Republic of China (the Chinese competent authority asfar as public health on exported fishery products is concerned) and its provincialservices, the Entry-Exit Inspection and Quarantine bureaus, have a system for officialcontrols based on written procedures. It is fully implemented by the staff of the provincialservices visited. Overall, the system of official controls and of export certification issatisfactory under many aspects, but, due to shortcomings concerning mainly the EUlisted freezer and factory vessels (their official supervision and the export certification oftheir catches), and the controls of imported raw and semi processed material, it cannothowever be considered yet to fully reach the standards expected by the Communitylegislation concerning third countries from which imports of fishery products arepermitted.

The report addresses to the Chinese Competent Authority a number of recommendationsaimed at rectifying identified shortcomings and enhancing the control system in place.

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TABLE OF CONTENTS

1 INTRODUCTION............................................................................................................ 1

2 OBJECTIVES OF THE MISSION...................................................................................... 1

3 LEGAL BASIS FOR THE MISSION.................................................................................. 2

4 BACKGROUND.............................................................................................................. 3

4.1 Historical background.......................................................................................... 3

4.2 Production and trade information........................................................................ 3

4.3 Rapid Alert System For Food and Feed (RASFF) notifications......................... 4

5 FINDINGS AND CONCLUSIONS...................................................................................... 5

5.1 CONCERNING RECOMMENDATIONS OF THE 2005 MISSION REPORT 65.1.1 Recommendation No 1 (point 6.1) of the 2005 mission report.................... 65.1.2 Recommendation No 2 (point 6.2) of the 2005 mission report.................... 75.1.3 Recommendation No 3 (point 6.3) of the 2005 mission report.................... 85.1.4 Recommendation No 4 (point 6.4) of the 2005 mission report .................... 95.1.5 Recommendation No 5 (point 6.5) of the 2005 mission report .................. 105.1.6 Recommendation No 6 (point 6.6) of the 2005 mission report .................. 10

5.2 OTHER FINDINGS.......................................................................................... 105.2.1 Laboratories............................................................................................... 105.2.2 Water quality supervision.......................................................................... 115.2.3 Monitoring arrangements on contaminants............................................... 125.2.4 List of establishments and vessels which can export to EU member states 125.2.5 Establishments not listed for export to the EU but providing raw material toEU listed establishments....................................................................................... 135.2.6 Export certification – prevention of the fraudulent production ofcertificates..............................................................................................................145.2.7 RASFF notifications................................................................................... 15

6 OVERALL CONCLUSION............................................................................................. 15

7 CLOSING MEETING.................................................................................................... 15

8 RECOMMENDATIONS .................................................................................................. 15

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ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT

Abbreviation Explanation

AQSIQ General Administration of Quality Supervision, Inspection andQuarantine of the People's Republic of China

CA Competent Authority

CIQ Entry-Exit Inspection and Quarantine bureau

CN Combined Nomenclature

CNCA Certification and Accreditation Administration of the People’sRepublic of China

CS Commission Services

EC European Community

EU European Union

EU listed Facilities listed by the competent authority according to Article 12of Regulation (EC) No 854/2004

EUROSTAT Statistical Services of the European Union

FBO Food Business Operator

FP Fishery Products

FRC Free Residual chlorine

FV Factory vessel

FVO Food and Veterinary Office of the European Commission

ISO International Organisation for Standardisation

MoA Ministry of Agriculture

MS Member State/s of the European Union

MT Mission Team

NRCP National Residues Control Programme

OJ Official Journal of the European Communities

PAH Polycyclic Aromatic Hydrocarbons

PCBs Polychlorinated Biphenyls

PP Processing establishment

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Abbreviation Explanation

ppm Parts per million

RASFF Rapid Alert System for Food and Feed

SANCO Health and Consumers Directorate General of the EuropeanCommission

ZV Freezer Vessel

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1 INTRODUCTION

The mission took place in China from 5 to 15 May 2009 and was undertaken as part ofthe Food and Veterinary Office's (FVO) mission programme.

The mission team (MT) comprised four inspectors from the FVO and four interpretersrecruited by the Commission delegation in Beijing. Team one visited Guangdong andZhejiang provinces, while team two visited Fujian and Liaoning provinces.

2 OBJECTIVES OF THE MISSION

The objectives of the mission were to:

• evaluate whether the official controls put in place by the competent authority (CA)can guarantee that the conditions of production of fishery products (FP) in Chinadestined for export to the European Union (EU) are equivalent to the requirementslaid down in Community legislation, and in particular to the health attestationscontained in the certificate of Appendix IV to Annex VI of Commission Regulation(EC) No 2074/2005;

• verify the extent to which the guarantees and the corrective actions submitted to theCommission services in response to the recommendations of the previous FVOmission report (mission DG(SANCO)/2005-7556, carried out from 25 February to 7March 2005) have been implemented, enforced and controlled by the Chinese CA.

In pursuit of these objectives, the MT proceeded as follows:

• an opening meeting was held on 5 May 2009 with the CA. At this meeting the MTconfirmed the objectives of, and itinerary for the mission, and requested additionalinformation required for the satisfactory completion of the mission;

• the following sites were visited:

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Competent authority

Central level 1 Central CA headquarters inBeijing

Regional level 4 CAs in the followingprovinces: Fujian, Liaoning,Guangdong and Zhejiang

Laboratory visits

Regional laboratories 4 Central provincial laboratoriesof the provincial CA servicesin Fuzhou, Dalian, Guangzhouand Hangzhou

Primary production

Aquaculture farms 2 1 in Guangdong

1 in Zhejiang

Fishing Vessels 5 2 in Dongshan (Fujian)

3 in Zhoushan (Zhejiang)

Food processing facilities

Establishments 13 3 in Zhanjiang, 2 inGuangdong

3 in Fujian, 5 in Dalian

• representatives from the CA (the Chinese competent authority as far as public healthon exported fishery products is concerned is the General Administration of QualitySupervision, Inspection and Quarantine of the People's Republic of China (AQSIQ)at the central level and the Entry-Exit Inspection and Quarantine bureaus (CIQ) atthe provincial level) accompanied the MT during the whole mission.

3 LEGAL BASIS FOR THE MISSION

The mission was carried out in agreement with the Chinese Authorities and under thegeneral provisions of Community legislation and, in particular:

• Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of theCouncil of 29 April 2004 on official controls performed to ensure the verification ofcompliance with feed and food law, animal health and animal welfare rules;

• Commission Decision 98/140/EC of 4 February 1998, laying down certain detailedrules concerning on-the-spot checks carried out in the veterinary field byCommission experts in third countries.

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Full legal references are provided in Annex I. Legal acts quoted in this report refer,where applicable, to the last amended version.

4 BACKGROUND

4.1 HISTORICAL BACKGROUND

China is presently listed in Annex II of Commission Decision 2006/766/EC establishingthe list of third countries and territories from which imports of fishery products in anyform for human consumption are permitted.

China is also listed in the Annex of Commission Decision 2004/432/EC on the approvalof residue monitoring plans submitted by third countries in accordance with CouncilDirective 96/23/EC.

Commission Decision 2002/994/EC of 20 December 2002 concerning certain protectivemeasures with regard to the products of animal origin imported from China is stillapplicable. As far as FP are concerned, each consignment has to be subjected beforedispatch to a chemical test in order to ensure that the products concerned do not present adanger to animal or human health. That chemical test must be carried out in particular, todetect the presence of chloramphenicol and nitrofuran and its metabolites in aquacultureproducts, peeled and/or processed shrimps and crayfish of the species Procambrus clarkiicaught in natural fresh waters by fishing operations. In addition, farmed FP shall betested for the presence of malachite green and crystal violet and their metabolites.

A previous mission took place in 2005 (ref. DG(SANCO)/7556/2005); it highlighteddeficiencies in relation to the official controls on the imported material, those applied tothe fishing vessels, the performance of the additional tests on aquaculture products laiddown in Commission Decision 2002/994/EC, the performance of histamine tests, thecorrection of the deficiencies found in the visited establishments, the registration andcontrol over the aquaculture farms. The report – published on the Health and ConsumersDirectorate-General Internet site at http://ec.europa.eu/food/fvo/ir_search_en.cfm – madea number of recommendations in respect of the action required to the CA. Writtenguarantees were received from the CA in relation to the implementation of thoserecommendations.

4.2 PRODUCTION AND TRADE INFORMATION

Imports of FP from China are authorized from a total of 419 processing establishments(PP), 172 freezer vessels (ZV) and 7 factory vessels (FV) (list published on 13/05/2009).

According to Eurostat, total imports of fishery products (FP) in 2008 from China into EUwere about 482,000 tonnes, mainly fish fillets (69%, combined nomenclature (CN)code=0304 – fish fillets and other fish meat, whether or not minced, fresh, chilled orfrozen), crustaceans (8%, CN code=0306), and cephalopods (6.3%, CN code=0307).

These products were imported mainly into Germany, Spain, United Kingdom, France and

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http://ec.europa.eu/food/fvo/ir_search_en.cfm

Netherlands.

According to the Chinese authorities, about 30,000 tons are landed directly inCommunity ports (with or without transhipment).

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

122 RASFF notifications were recorded for FP originating in China since the 2005mission took place.

Year Number ofRASFF notifications

2005 (from April) 12

2006 23

2007 50

2008 26

2009 (until April) 11

TOTAL 122

For 2008 and 2009:

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Product Number ofRASFF

Main reasons

Cephalopods 2 2 high level of additives

Fish and FP(except crustaceans andmolluscs)

26 7 parasites infestation

5 unauthorisedestablishments

4 with certificationproblems

4 bad hygienic state

2 rupture of cold chain

1 fraud (fake labels)

1 high content ofmercury

1 high content ofadditive

1 presence of residuesof

veterinary medicinalproducts

Crustaceans 9 6 presence of residuesof veterinary medicinalproducts

1 with unauthorizedadditive

1 rupture of cold chain

1 bad hygienicconditions

5 FINDINGS AND CONCLUSIONS

The previous mission report (DG(SANCO)/2005-7556) included six recommendationsaddressed to the CA. A corrective action plan dealing with these was submitted to theCommission services.

NB: Council Directives 91/493/EEC and 92/48/EEC have been repealed by Directive2004/41/EC of 21 April 2004 repealing certain Directives concerning food hygiene andhealth conditions for the production and placing on the market of certain products ofanimal origin intended for human consumption and amending Council Directives89/662/EEC and 92/118/EEC and Council Decision 95/408/EC. Communityrequirements are now described in Regulations (EC) No 852/2004 and No 853/2004.

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5.1 CONCERNING RECOMMENDATIONS OF THE 2005 MISSIONREPORT

5.1.1 Recommendation No 1 (point 6.1) of the 2005 mission reportRecommendation 6.1 of the 2005 mission report

The central CA should improve the supervision on imported FP (destined for re-export tothe EU) to ensure that there is no commingling of eligible and ineligible product.

Findings

For imported raw or semi processed material, the consignments are always controlled byCIQ against Chinese standards but the EU eligibility is not controlled i.e.:

• the EU listing of the country of origin (is it authorised by EU to export fisheryproducts to its territory?) is not ascertained (see Article 11.1 of Regulation (EC) No854/2004 and Article 2 and Annex II of Commission Decision 2006/766/EC),

• the listing of the establishment or the ZV/FV of origin on the EU list of theexporting country is not ascertained (see Article 12 of Regulation (EC) No854/2004). In several cases, the MT found that the establishments or ZV/FV oforigin were not on the lists described above;

• the export certificate required by the Chinese authorities from the exporting countrydoes not certify that the products satisfy the requirements laid down for suchproducts according to Regulation (EC) No 852/2004 and Regulation (EC) No853/2004 or provisions that are equivalent to those requirements.

In one province visited, the MT was informed by the local CIQ official that this EUeligibility check was performed via a search on the web site of the list of EU approvedestablishments(http://ec.europa.eu/food/food/biosafety/establishments/third_country/index_en.htm).This was not done in the three other provinces visited.

In one establishment visited, large quantity of imported raw material (frozen squid) wasfound in the cold storage; no indication was mentioned on the packaging concerning theorigin of the products.

In one case, imported raw material was accepted at the Chinese border with an invalidhealth certificate:

• instead of indicating the name and approval number of the establishment or thefishing vessel of origin, the name of the broker was mentioned, and

• the certifying officer was located 1,300 km away from the place where the fish waslanded from the fishing vessels and then exported to China.

As a consequence, he/she did not know from which establishment or fishing vessels theFPs were originating in and could not make any check on the fish exported.

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Conclusions

The recommendation of the previous mission report is not properly addressed.Concerning raw or semi processed material imported in China for being processed in EUlisted establishments and being exported to EU the system in place cannot allow the CAto certify some of the statements contained in the health certificate (Appendix IV toAnnex VI of Regulation (EC) No 2074/2005) since the EU eligibility of the raw and/orsemi-processed material is not checked.


The central CA should ensure that all consignments of aquaculture products are tested forantibiotic residues in accordance with Commission Decision 2002/994/EC (as amended)and that the system of traceability allows this to be demonstrated. The central CA shouldensure that official histamine tests are conducted in accordance with the protocoldescribed in Chapter 5 of Council Directive 91/493/EC.

Findings

The certification procedure is clear and correctly implemented, including the additionalcertification for aquaculture products, peeled and/or processed shrimps and crayfish asrequired in Commission Decision 2002/994/EC.

However in one case the MT found that the additional certificate was signed on the basisof the test results of the raw material which was tested seven months before. There wasno clear link between the raw material tested and the consignment exported andmoreover, during this time many things could have occurred in the establishment(batches mixed up, inappropriate antimicrobial treatment, etc). Article 3 of CommissionDecision 2002/994/EC indicates that each consignment has to be subject before dispatchto a chemical test in order to ensure that the products concerned do not present a dangerto animal or human health. This implies that the end products before dispatch have to betested, not the raw material from which they originate.

Histamine tests are performed on samples taken during the CIQ pre-export inspectionvisits when fish associated with high level of histidine are concerned. Several officialhistamine test results were examined by the MT; nine samples are tested with the methoddescribed in the Chinese National Standard (GBT 5009-45.2003: Analytical method ofhygienic standard for fish and other aquatic products) which is based on the histamineextraction and the use of a spectrophotometer.

Conclusions

Provisions of Article 3 of Commission Decision 2002/994/EC are not entirelyimplemented.

For each tested consignment, the number of samples tested for histamine is nine, asindicated in Regulation (EC) No 2073/2005 (Annex I, Chapter 1, 1.26 and 1.27).

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The central CA should apply the specific Community requirements laid down in theAnnexes of Council Directives 91/493/EEC and 92/48/EEC with regard to theregistration, control/supervision and standards of fishing vessels which intend to exportFP and aquaculture products to the EU.

Findings

Fishing vessels providing raw material to EU listed establishments are specifically listedby CIQ and are also regularly inspected by CIQ staff. Several parameters are checkedincluding the medical condition of the crew. The conditions of the vessels visited by theMT were satisfactory. The list of this category of fishing vessels is available on theAQSIQ intranet site and therefore available to the provincial and local CIQs which canforward it to the food business operators (FBOs) interested. No specific document isgiven to the fishing vessels captains or owners to indicate that they are approved by CIQto provide raw material to EU listed PP.

EU listed FV and ZV: according to the information provided to the MT, they areinvolved in direct landing into EU ports: they need to get a special licence delivered bythe Ministry of Agriculture and they shall be equipped with the vessel monitoringsystem. They have a sanitary inspection by CIQ staff at the port of call when they arrivein China. Being in general quite far away, they come rarely to China: as a consequencethey tend to be inspected only every three years, if they want to remain on the EU list.

A discrepancy of 35 fishing vessels was found between the EU list and the list of fishingvessels which received a licence from the Ministry of Agriculture to land directly theircatches in Community ports. According to the statement of the Ministry of Agriculturerepresentative during the initial meeting on 5 May 2009, those vessels have "no legalstatus in China". The Certification and Accreditation Administration of the People’sRepublic of China (CNCA) informed the MT that they launched an investigation to findout the origin of this discrepancy and that its outcome will be communicated to the MT.During the final meeting held in Beijing on 15 May 2009, the CNCA representativeinformed the MT that 28 EU listed fishing vessels would be delisted in the near futureand further information will be provided for the seven others (see Endnote).

Concerning the EU listed fishing vessels landing indirectly their catches in EU ports (i.e.after transhipment), AQSIQ (Custom Clearance Department) informed the MT during thefinal meeting that for some of them transhipment is carried out in a third country on theArabian Sea and from there, the FP are sent to EU in containers. A specific agreementwas signed between AQSIQ and the Authorities of the Member State where thesecontainers are sent: the certification of these FPs is ensured by a company which receiveddelegation from AQSIQ, with the approval of the member state authority. No furtherinformation was available at that time (background information on the company itself,description of its activities as far as exports to EU are concerned, the links made betweenthis company and AQSIQ, quantity of fishery products exported to EU under thesupervision of this company, physical description of the way the FP are exported (fishing

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grounds, fishing vessels, transhipment or landing locations, ports of imports in EU...),involvement of the company in the official certification of the FP exported to EU,agreement signed with the member state authorities (summary of the agreement, detailsof the member state authorities concerned), official supervision by the Chineseauthorities of the activities of this company...).

If reefer vessels are used to deliver the FPs to EU ports, the Chinese CA representativesmet could not provide any information on this issue.

Conclusions

Sanitary supervision of the fishing vessels providing raw material to EU listedestablishments is satisfactory but insufficient for EU listed fishing vessels (ZV andFV)(Annex III, Chapter I, 1.(b) of Regulation (EC) No 854/2004).

Information available to the MT concerning the conditions of direct or indirect landingand certification of the FP concerned is not sufficient (see Article 47(1) of Regulation(EC) No 882/2004).


The CCA should take measures to correct the non-compliances and deficiencies observedduring the mission, in particular in the establishments/vessels visited and in all similarestablishments/vessels not visited.

Findings

AQSIQ and provincial CIQs have drafted and implemented in the relevant provinces ofthe country a comprehensive system of sanitary supervision of the fishery productsexported to the EU with check lists and inspection reports templates.

This includes the regular supervision of the EU listed establishments with routineinspection almost every month, inspection at regular interval every six months, audit forthe renewal of the sanitary registration of exporting processing establishments everythree years. Moreover, at the time of the procedure for listing the PP for export to EU,CNCA may organise an additional audit by CIQ staff who are not those that haveprepared the file for listing.

During the visits in the establishments, the MT found that these inspection visits areeffectively implemented, and when deficiencies are found, an action plan has to beprovided within a limited time frame by the FBO, and a follow up visit is alwaysperformed by the CIQ staff to ascertain the correction of all deficiencies.

Some deficiencies were however found during the visits of the MT and were allpresented at the end of each visit in all but one establishment; they were not severe buthave to be taken into account and corrected (e.g. unhygienic filleting operations,unsatisfactory general maintenance, …).

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Conclusions

The recommendation of the previous mission report is properly addressed.


The registration by the central CA of farms supplying raw materials to establishmentsexporting aquaculture products to the EU should be consistent with provisions of Article9, Council Directive 96/23/EC.

Findings

Farms are also regularly visited by Ministry of Agriculture (MoA) and CIQ. During thevisits to PP processing aquaculture products, the MT could in all but one case find thefarm of origin on the list of farms which can provide aquaculture products to EU listedPP. It turned out that the registration number of the farm changed in 2006 but this wasnot reflected in the list provided to the Commission services.

Conclusions

The recommendation of the previous mission report is properly addressed.


The CA should take measures that ensure their local CIQ inspectors are aware of theproducts (e.g. antibiotics) in use on aquaculture farms under their supervision. Inparticular, so that the farm register provides an accurate record of the treatmentsadministered, the identification of the animals and the withdrawal period, as foreseen inArticle 10 of Council Directive 96/23/EC.

Findings

According to the information provided, training has been provided to the relevant staff.

Conclusions

According to the information provided by the Chinese Authority, in the absence of directfinding on the subject, the recommendation of the previous mission report can beconsidered as addressed.

5.2 OTHER FINDINGS

5.2.1 Laboratories

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Legal requirement

Article 11 of Regulation (EC) No 178/2002


Findings

All laboratories visited in the provinces are accredited to International Organisation forStandardisation (ISO) 17025 standard for all the relevant tests performed on fisheryproducts. These laboratories participate in general to proficiency tests concerning testsperformed on fishery products.

During the visits in the provincial CIQ central laboratories, the MT found that CIQbranches laboratories ("Local Technology Centres") are also involved in the testing of FPexported to the EU. This was not mentioned in the information provided by the Chineseauthorities before the mission.

According to the information collected in the provincial CIQs, these CIQ brancheslaboratories are also accredited to ISO 17025 but do not participate regularly in relevantproficiency tests.

Proficiency tests on histamine were not performed in the CIQ laboratories visited.

Conclusions

Despite the accreditation to "ISO 17025" standard of all official laboratories visited, thequality control procedures for monitoring the validity of tests are not complete for thebranches laboratories, and, for histamine, for all CIQs laboratories concerned.

Deficiencies found in the official laboratories regarding the absence of proficiency testscast doubt on the reliability of the assessment and accreditation process.

5.2.2 Water quality supervisionLegal requirement

Directive 98/83/EC of 3 November 1998 on the quality of water intended for humanconsumption,

Annex II, Chapter VII of Regulation (EC) No 852/2004,

Article 3(2) of Regulation (EC) No 853/2004.

Findings

Concerning the water testing, the Ministry of Health services are the CA in charge.Samples are taken regularly and several parameters of the Directive 98/83/EC are tested.However, according to the test results found in the establishments visited, severalparameters of the Directive 98/83/EC are not tested for (e.g. heavy metals, enterococci).

In the PP visited, if the water is chlorinated, it is correctly supervised by the FBO and themaximum level used is quite low and always below 1ppm of free residual chlorine

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(FRC).

However in one PP visited, the testing method used by the quality control managerduring the MT visit was not sensitive enough as the strips could only detect FRC valueabove 20ppm (parts per million).

Conclusions

Official water testing is regularly performed by the Ministry of Health services. For theChinese CA, in EU listed facilities, potable water test results must be in compliance withcriteria set up in Directive 98/83/EC.

5.2.3 Monitoring arrangements on contaminantsLegal requirement

Chapter II.D of the Annex III to Regulation (EC) No 854/2004.

Regulation (EC) No 1881/2006 (points 3.1, 3.2, 3.3, 3.4, 5 and 6 of the Annex)

Findings

Concerning the monitoring arrangements on contaminants on FP exported to the EU, itwas explained to the MT that many tests on heavy metals (lead, cadmium, mercury andinorganic arsenic) and polychlorinated biphenyls (PCBs) are performed on imported andexported products (pre-export testing).

Moreover it was also explained to the MT that specific monitoring arrangements forcontaminants are included in the National Residue control programme (NRCP) sent tothe Commission services. The approval of this NRCP enables China to be listed in theCommission Decision 2004/432/EC on the approval of residue monitoring planssubmitted by third countries in accordance with Council Directive 96/23/EC: as aconsequence China can export aquaculture products to the EU.

However in the NRCP almost all the samples are taken from aquaculture products;concerning the wild fishery products only crawfish are covered.

Conclusions

Monitoring arrangements to control the levels of contaminants in wild fishery productsintended to be exported to the EU are not set up by the CA.

5.2.4 List of establishments and vessels which can export to EU memberstates

Legal requirement


Findings

EU listed establishments are establishments which have been approved for export by the

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CA and which have requested specifically the possibility to export to the EU. In theapproval for export to the EU, there is no clear definition of the activities or of theproducts authorised to export to these countries. As a consequence, in several PPexporting also to other countries, processing procedures forbidden for the EU market areimplemented (cleaning of the product with hyper chlorinated water, treatment of fishfillets with carbon monoxide): there was no official document available to the MTshowing that such products could not be exported to the EU.

Concerning the list of PP provided to the Commission services (CS), it appeared that thedescription of the location of the PP in term of city and region is not consistent within thesame province and also throughout China. Apparently, the list provided by the local CIQsto CNCA does not match with the template which shall be sent to the CS. As aconsequence, there is a lack of consistency on the final list sent to the CS. For example,in the column “region”, in some cases the province (e.g. Liaoning) is indicated, in othercases the city is indicated (e.g. Dalian).

Conclusions

In the EU listed establishments, practices not compliant with Community provisions arepermitted (see in particular Article 3(2) of Regulation (EC) No 853/2004). The productsobtained are supposed to be for other markets but there is no document provided by theCA to the FBO explicitly excluding the products so obtained from export to the EU.

The list of facilities drawn up by the CA in accordance with Article 12 of Regulation(EC) No 854/2004 is not consistent as far as the location of the facilities is concerned.

5.2.5 Establishments not listed for export to the EU but providing rawmaterial to EU listed establishments

Legal requirement


Findings

According to the information provided to the MT:

• EU listed establishments can buy raw material from Chinese establishments whichare not EU listed (i.e. not-EU listed Chinese establishment): a list of 1228 facilitieshas been provided to the MT,

• these establishments are under the same sanitary supervision as the EU listed ones.The MT could not organise any visits in these establishments: in two provinces, theprovincial CAs could not tell the MT which of these 1228 facilities are actually providingraw material to EU listed facilities, and which EU listed PPs are buying raw materialfrom such establishments; in another province, the provincial CA indicated that onenot-EU listed Chinese establishment was providing raw material to a EU listed PP, but itwas not in operation at the time of the MT visit.

In one province visited, the provincial CA told the MT that no EU listed PPs buy any

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material from not-EU listed Chinese establishments. However, during the visit of an EUlisted PP, it turned out that it buys regularly dried shrimps from a not-EU listedestablishment (see Endnote).

Conclusions

The provisions of Article 12.2(b) of Regulation (EC) No 854/2004 are not entirelyimplemented.

5.2.6 Export certification – prevention of the fraudulent production ofcertificates

Legal requirement

Article 14 and Annex VI of Regulation (EC) No 854/2004

Appendix IV to Annex VI to Regulation (EC) No 2074/2005 includes the model healthcertificate for imports of FP intended for human consumption.

Article 5 of Directive 96/93/EC

Findings

No consignments can be exported without a pre export inspection performed by the localCIQ concerned. This includes the analysis of samples taken on the consignment; theanalyses carried out are adapted to the type of FP concerned (e.g. fish associated withhigh level of histidine are always tested for histamine before export). The pre exportanalysis carried out take also into account the official tests already done on the rawmaterial. For example, if the raw material was tested for heavy metals, the test is notrepeated on the end product. This can also be the case for veterinary drug residues.

If the outcome of the pre-export inspection is favourable, CIQ issues a certificate("Certificate of custom declaration for export cargo") which is required by the customs tocontinue the exporting procedure, and signs also the export health certificate (oneoriginal and two duplicates). However, as explained to the MT in the provinces visited,there is no regular communication between the CIQ services producing the official exportdocuments (export health certificates and the "Certificate of custom declaration forexport cargo") and the relevant custom services to compare what CIQs sent to the customservices, and what the customs received; this could lead to the acceptance by the customservices of certificates which are not authentic (see Endnote).

Loopholes in the current system exist as several RASFF notifications to China concernedexports to EU from unauthorised establishments (two in 2008, two in 2009).

Conclusions

Systematic pre-export checks are carried out by CIQs for each consignment to beexported. However, checks and controls measures necessary to prevent the use offraudulent certificates at least equivalent to the provisions of Article 5 of Directive96/93/EC are not entirely implemented.

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5.2.7 RASFF notificationsLegal requirement

The Community provisions concerning the Rapid Alert System are the Articles 50, 51and 52 of Regulation (EC) No 178/2002.

Findigs

When RASFF notification is sent from EU, the MT could see in one PP thatinvestigations are duly carried out. Based on Article 18 of the Administrative Regulationof sanitary registration for food processing establishments for export (AQSIQannouncement No 20, adopted on 27 March 2002, coming into effect from 20 May2002), the production of the concerned PP is suspended until the outcome of the CIQinvestigation.

Conclusions

In case of RASFF notifications reviewed by the MT, the CA implemented appropriateactions and measures.

6 OVERALL CONCLUSION

The Chinese system of official controls and export certification is satisfactory in manyrespects. However it cannot be considered fully in line with Community requirementssince there are some deficiencies regarding in particular control of eligibility of importedraw material, and supervision and certification procedures for EU listed FV and ZV.

7 CLOSING MEETING

During the closing meeting held in Beijing on 15 May 2009, the MT presented thefindings and preliminary conclusions of the mission to the CA.

The representatives of the Chinese authorities took note of the findings and conclusionspresented; they requested some clarifications and made comments in relation to thedeficiencies presented by the MT.

8 RECOMMENDATIONS

The CA should provide Commission services with an action plan, including atimetable for its completion, within one month of receipt of the report, in order toaddress the following recommendations for FP exported to the EU.

No. Recommendation

1 In order to allow the CA to certify some of the statements contained in the health

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No. Recommendation

certificate (Appendix IV to Annex VI of Regulation (EC) No 2074/2005), the CAshould improve the supervision on imported FP (destined for re-export to theEU).

2

The CA should ensure that provisions of Article 3 of Commission Decision2002/994/EC are entirely implemented: "each consignment of products (listed inPart II of the Annex) has to be subject before dispatch to a chemical test in orderto ensure that the products concerned do not present a danger to animal or humanhealth".

3The CA should ensure that the sanitary supervision of the EU listed fishingvessels (ZV and FV) is in line with provision of Annex III, Chapter I, point 1.(b)of Regulation (EC) No 854/2004.

4

The CA should provide the Commission services with the relevant informationconcerning the conditions of direct landing (after transshipment or not) andcertification of the FP originating in the EU listed ZV and FV, in accordance withArticle 47(1) of Regulation (EC) No 882/2004.

5

The CA should ensure that the assessment and accreditation of officiallaboratories is carried out in accordance with the standards at least equivalent tothose specified in Art 12.2 of Regulation (EC) No 882/2004 i.e. (a) EN ISO/IEC17025 on ‘General requirements for the competence of testing and calibrationlaboratories’ and (b) EN ISO/IEC 17011 on “General requirements foraccreditation bodies accrediting conformity assessment bodies’. Inter alia,participation of the official laboratories in inter laboratory comparison orproficiency-testing programmes for the relevant analytical methods should beensured.

6

The CA should ensure that potable water used in the establishments complies atleast with all parameters (audit monitoring of potable water) of Directive98/83/EC of 3 November 1998 on the quality of water intended for humanconsumption.

7

The Chinese CA should set up monitoring arrangements to control the level ofcontaminants in wild fishery products in accordance with provisions at leastequivalent with the Community legislation (Annex III, Chapter II, D ofRegulation (EC) No 854/2004 and points 3.1, 3.2, 3.3, 3.4, 5 and 6 of the Annexto Regulation (EC) No 1881/2006).

8

In the EU listed establishments, the CA should ensure that all productionpractices are in compliance with provisions equivalent to the Community ones (inparticular Article 3(2) of Regulation (EC) No 853/2004) when FP are destined tothe EU market. When practices not compliant with Community ones arepermitted for other markets, this could be reflected in the CA certificate providedby the CA to the FBO, and specifying the activities authorised for EU exports andthe practices required for the EU market.

9 The CA should ensure that the provisions of Article 12.2(b) of Regulation (EC)No 854/2004 are entirely implemented.

16

No. Recommendation

10The CA should ensure that checks and controls measures necessary to prevent theuse of fraudulent certificates at least equivalent to the provisions of Article 5 ofDirective 96/93/EC are implemented.

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

http://ec.europa.eu/food/fvo/ap/ap_china_8108_2009.pdf

9 ENDNOTES

Concerning Detail

Section 5.1.3In their response to the draft report the CA noted that the 28 EU listedvessels have been delisted in July 2009 and that the 7 others areauthorised by MOA for far ocean fishing operations.

Section 5.2.5 In their response to the draft report the CA indicated that the driedshrimps are not used to manufacture products exported to the EU.

Section 5.2.6

In their response to the draft report the CA considered that there is aninteractive custom clearance certificate verification system between CIQand the Custom Services; moreover the CA indicated that an agreementon cooperation in preventing illegal imports and exports was signed withthe EU in 2006 and that they are willing to reinforce the cooperationwith the EU on this matter.

17

http://ec.europa.eu/food/fvo/ap/ap_china_8108_2009.pdf

ANNEX 1 - LIST OF LEGISLATION REFERENCED IN THE REPORT

Reference OJ Ref. Detail

Directive91/493/EEC

OJ L 268,24.9.1991, p.15–34

Council Directive 91/493/EEC of 22 July 1991laying down the health conditions for theproduction and the placing on the market of fisheryproducts

Directive95/2/EC

OJ L 61,18.3.1995, p.1–40

European Parliament and Council Directive No95/2/EC of 20 February 1995 on food additivesother than colours and sweeteners

Directive96/23/EC

OJ L 125,23.5.1996, p.10–32

Council Directive 96/23/EC of 29 April 1996 onmeasures to monitor certain substances and residuesthereof in live animals and animal products andrepealing Directives 85/358/EEC and 86/469/EECand Decisions 89/187/EEC and 91/664/EEC

Directive98/83/EC

OJ L 330,5.12.1998, p.32–54

Council Directive 98/83/EC of 3 November 1998on the quality of water intended for humanconsumption

Directive2000/13/EC

OJ L 109,6.5.2000, p.29–42

Directive 2000/13/EC of the European Parliamentand of the Council of 20 March 2000 on theapproximation of the laws of the Member Statesrelating to the labelling, presentation andadvertising of foodstuffs

Directive2004/41/EC

OJ L 157,30.04.2004,p.33 correctedandre-published inOJ L 195,02.06.2004, p.12

Directive 2004/41/EC of the European Parliamentand of the Council of 21 April 2004 repealingcertain Directives concerning food hygiene andhealth conditions for the production and placing onthe market of certain products of animal originintended for human consumption and amendingCouncil Directives 89/662/EEC and 92/118/EECand Council Decision 95/408/EC

Regulation(EC) No2406/96

OJ L 334,23.12.1996, p.1–15

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


OJ L 31,1.2.2002, p.1–24

Regulation (EC) No 178/2002 of the EuropeanParliament and of the Council of 28 January 2002laying down the general principles and requirementsof food law, establishing the European Food SafetyAuthority and laying down procedures in matters offood safety


OJ L 139,30.4.2004, p.1, Corrected

Regulation (EC) No 852/2004 of the EuropeanParliament and of the Council of 29 April 2004 onthe hygiene of foodstuffs

18


andre-published inOJ L 226,25.6.2004, p. 3


OJ L 139,30.4.2004, p.55, Correctedandre-published inOJ L 226,25.6.2004, p.22

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


OJ L 139,30.4.2004, p.206, Correctedandre-published inOJ L 226,25.6.2004, p.83

Regulation (EC) No 854/2004 of the EuropeanParliament and of the Council of 29 April 2004laying down specific rules for the organisation ofofficial controls on products of animal originintended for human consumption


OJ L 165,30.4.2004, p.1, Correctedandre-published inOJ L 191,28.5.2004, p. 1

Regulation (EC) No 882/2004 of the EuropeanParliament and of the Council of 29 April 2004 onofficial controls performed to ensure the verificationof compliance with feed and food law, animalhealth and animal welfare rules


OJ L 338,22.12.2005, p.1–26

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


OJ L 338,22.12.2005, p.27–59

Commission Regulation (EC) No 2074/2005 of 5December 2005 laying down implementingmeasures for certain products under Regulation(EC) No 853/2004 of the European Parliament andof the Council and for the organisation of officialcontrols under Regulation (EC) No 854/2004 of theEuropean Parliament and of the Council andRegulation (EC) No 882/2004 of the EuropeanParliament and of the Council, derogating fromRegulation (EC) No 852/2004 of the EuropeanParliament and of the Council and amendingRegulations (EC) No 853/2004 and (EC) No854/2004

19



OJ L 338,22.12.2005, p.83–88

Commission Regulation (EC) No 2076/2005 of 5December 2005 laying down transitionalarrangements for the implementation of Regulations(EC) No 853/2004, (EC) No 854/2004 and (EC) No882/2004 of the European Parliament and of theCouncil and amending Regulations (EC) No853/2004 and (EC) No 854/2004


OJ L 364,20.12.2006, p.5–24

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


OJ L 364,20.12.2006, p.32–43

Commission Regulation (EC) No 1883/2006 of 19December 2006 laying down methods of samplingand analysis for the official control of levels ofdioxins and dioxin-like PCBs in certain foodstuffs


OJ L 88,29.3.2007, p.29–38

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

Decision2006/766/EC

OJ L 320,18.11.2006, p.53–57

2006/766/EC: Commission Decision of 6November 2006 establishing the lists of thirdcountries and territories from which imports ofbivalve molluscs, echinoderms, tunicates, marinegastropods and fishery products are permitted

20

final report of a mission carried out in china from 05 may

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