Ref. Ares(2015)642466 - 16/02/2015
EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Directorate F - Food and Veterinary Office
DG(SANCO) 2014-7147 - MR FINAL
FINAL REPORT OF AN AUDIT
CARRIED OUT IN
VIET NAM
FROM 09 TO 18 SEPTEMBER 2014
IN ORDER TO EVALUATE THE CONTROL SYSTEMS IN PLACE GOVERNING THE
PRODUCTION OF BIVALVE MOLLUSCS AND FISHERY PRODUCTS DERIVED
THEREFROM INTENDED FOR EXPORT TO THE EUROPEAN UNION
In response to information provided by the Competent Authority, any factual error noted in the
draft report has been corrected; any clarification appears in the form of a footnote.
Executive Summary
This report describes the outcome of a Food and Veterinary Office audit in Vietnam carried out
from 9 to 18 September 2014, as part of its programme of audits in third countries.
The objectives of the audit were to evaluate the official control system in place by the
competent authorities for the production of fishery products derived from live bivalve molluscs
intended for export to the EU, and to verify the extent to which the guarantees and corrective
actions submitted to the Commission services in response to the recommendations of the
previous FVO mission report were implemented and enforced.
The report concludes that the competent authorities have an official control system in place to
control the production of live bivalve molluscs and fishery products derived therefrom.
However, significant deficiencies were identified, mainly related to the classification of
production areas, the monitoring of classified production areas for microbiology, toxinproducing plankton and biotoxins, the decisions after monitoring and official controls of
establishments. There are also significant shortcomings in the system for official certification
that made the official certification unreliable. Because of these deficiencies the competent
authorities cannot provide adequate guarantees with regard to the sanitary conditions of
bivalve molluscs exported to the EU.
Regarding the competent authorities' response to the previous FVO report’s recommendations,
the audit noted that some of the guarantees and corrective actions submitted to the Commission
services in response to the recommendations of that report were not implemented and enforced
by the competent authorities, contrary to what they indicated before the current audit.
The report addresses to the Vietnamese competent authorities a number of recommendations
aimed at rectifying identified shortcomings and enhancing the control system in place.
I
Table of Contents
1 INTRODUCTION........................................................................................................................1
2 OBJECTIVES ...........................................................................................................................1
3 LEGAL BASIS..........................................................................................................................2
4 BACKGROUND..........................................................................................................................2
4.1 GENERAL BACKGROUND..................................................................................................................2
4.2 PRODUCTION AND TRADE INFORMATION.............................................................................................2
4.3 RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS ................................................3
5 FINDINGS AND CONCLUSIONS...................................................................................................3
5.1 LEGISLATION.................................................................................................................................3
5.2 COMPETENT AUTHORITY.................................................................................................................4
5.3 NATIONAL PROVISIONS AND PROCEDURES FOR LISTING LIVE BIVALVE MOLLUSCS PRODUCTION AREAS AND
ESTABLISHMENTS EXPORTING BIVALVE MOLLUSCS TO THE EU.......................................................................5
5.4 OFFICIAL CONTROLS ON LIVE BIVALVE MOLLUSCS FROM CLASSIFIED PRODUCTION AREAS............................6
5.4.1 CLASSIFICATION OF PRODUCTION AND RELAYING AREAS...................................................................6
5.4.2 MONITORING OF CLASSIFIED PRODUCTION AREAS...........................................................................7
5.4.3 DECISIONS AFTER MONITORING................................................................................................10
5.4.4 ADDITIONAL MONITORING REQUIREMENTS...................................................................................11
5.4.5 RECORDING AND EXCHANGE OF INFORMATION.............................................................................11
5.4.6 FOOD BUSINESS OPERATORS' OWN-CHECKS.................................................................................11
5.5 OFFICIAL CONTROLS ON PECTINIDAE, ECHINODERMS, TUNICATES AND MARINE GASTROPODS NOT FILTER
FEEDERS HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS....................................................................12
5.6 OFFICIAL CONTROLS OF FISHERY PRODUCTS DERIVED FROM LIVE BIVALVE MOLLUSCS ..............................12
5.6.1 MOVEMENT OF LIVE BIVALVE MOLLUSCS AND REGISTRATION DOCUMENT ACCOMPANYING BATCHES ..........12
5.6.2 OFFICIAL CONTROL OF ESTABLISHMENTS....................................................................................13
5.6.3 FACILITIES HANDLING BIVALVE MOLLUSCS...................................................................................14
5.6.4 CHECK ON THE EU ELIGIBILITY OF IMPORTED RAW MATERIALS.......................................................15
5.6.5 RASFF NOTIFICATIONS........................................................................................................15
5.7 OFFICIAL CERTIFICATION...............................................................................................................16
5.8 LABORATORIES............................................................................................................................16
5.8.1 LABORATORIES FOR MICROBIOLOGY...........................................................................................17
5.8.2 LABORATORIES FOR TOXIN-PRODUCING PLANKTON........................................................................19
5.8.3 LABORATORIES FOR BIOTOXINS.................................................................................................19
5.8.4 LABORATORIES FOR HEAVY METALS...........................................................................................20
6 OVERALL CONCLUSIONS.........................................................................................................20
7 CLOSING MEETING................................................................................................................21
8 RECOMMENDATIONS...............................................................................................................21
ANNEX 1 - LEGAL REFERENCES.................................................................................................23
II
ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT
Abbreviation
Explanation
ASP
Amnesic shellfish poison
BM
Fishery products derived from live bivalve molluscs (LBM)
CA
Competent Authority
CCA
Central Competent Authority
Cd
Cadmium
EC
European Community
EU
European Union
FVO
Food and Veterinary Office of the European Commission
LBM
Live bivalve molluscs
MPN
Most probable number
NAFIQAD
The National Agro-Forestry-Fishery Quality Assurance Department of
Vietnam which is the Competent Authority within the scope of this audit
ppm
Parts per million
PSP
Paralytic shellfish poison
RASFF
Rapid Alert System for Food and Feed
SANCO
Health and Consumers Directorate General of the European Commission
SANCO list
The list of classified production areas and facilities approved and listed by
the competent authority for participation in the EU bivalve molluscs export
chain, available on the SANCO's website (at
http://ec.europa.eu/food/food/biosafety/establishments/third_country/index_e
n.htm)
VILAS
Vietnam Laboratory Accreditation Scheme
III
1
INTRODUCTION
The audit took place in Vietnam from 9 to 18 September 2014 and was undertaken as part of the
Food and Veterinary Office's (FVO) planned audit programme. The audit team comprised two
auditors from the FVO and two national experts.
An opening meeting was held in Ho Chi Minh City on 9 September with the National AgroForestry-Fishery Quality Assurance Department (NAFIQAD) of Vietnam which is the Competent
Authority (CA) within the scope of this audit. The NAFIQAD Central Competent Authority (CCA),
the Southern Regional Agency of NAFIQAD and the Branch 4 of NAFIQAD participated in the
meeting. At this meeting the team confirmed the objectives of, and the itinerary for the audit, and
requested additional information regarding the specific elements of the control system in place and
further clarification for some of the documents and information that was sent prior to the audit.
Representatives from the CCA accompanied the FVO team during the whole audit.
2
OBJECTIVES
The objectives of the audit were:
•
To evaluate whether the official controls put in place by the CA could guarantee that the
conditions of production of bivalve molluscs1 (BM) in Vietnam destined for export to the
European Union (EU) were in line with the requirements laid down in EU legislation, and in
particular with the health attestations contained in the certificate of Appendix IV to Annex VI
to Regulation (EC) No 2074/2005.
•
To verify the extent to which the guarantees and corrective actions submitted to the
Commission services in response to the recommendations of the previous FVO mission report
of 20092 have been implemented and enforced by the CA.
In terms of scope the audit focused on the organisation and performance of the CA, the export
certification procedure, the official control system in place covering production, processing and
distribution chains applicable to BM to be exported to the EU. Accordingly, relevant aspects of the
EU legislation referred to in Annex 1 were used as technical basis for the audit.
In pursuit of these objectives, the following sites were visited:
COMPETENT AUTHORITY
Central level
3
Opening meeting, pre-closing meeting and closing
meeting
Regional level
2
South Regional Agency and CCA when acting as
Northern Regional Authority
Branches of NAFIQAD
2
Branches 1 and 4
Local CA
1
Station belonging to the Ho Chi Minh City local CA
Microbiology
2
In Branches 1 and 4
Toxin-producing plankton
2
In Branches 1 and 4
LABORATORY VISITS
1
2
Fishery products derived from live bivalve molluscs (LBM)
ref. DG(SANCO)/2009-8056 – MR – FINAL, published on SANCO's website at http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2289)
1
Biotoxins
2
In Branches 1 and 4
Heavy metals
2
In Branches 1 and 4
1
To observe sample collection of water and live
bivalve molluscs (LBM)
4
All processing clam species, one also processing
scallops and antique ark
CLASSIFIED PRODUCTION AREAS
Classified production areas
FACILITIES HANDLING BM
Processing establishments
3
LEGAL BASIS
The audit was carried out under the general provisions of EU legislation and, in particular, under
Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29
April 2004 on official controls performed to ensure the verification of compliance with feed and
food law, animal health and animal welfare rules.
Full legal references are provided in Annex 1. Legal acts quoted in this report refer, where
applicable, to the last amended version.
4
BACKGROUND
4.1
GENERAL BACKGROUND
At the time of the audit, Vietnam was listed in Annex I to Commission Decision
2006/766/EC establishing the list of third countries from which imports of live, chilled,
frozen or processed BM, echinoderms, tunicates and marine gastropods for human
consumption are permitted. In this list, Vietnam is restricted to exporting frozen or
processed BM, echinoderms, tunicates and marine gastropods.
A previous visit took place in 2009 (ref. DG(SANCO)/2009-8056) which had highlighted
deficiencies in relation to monitoring of production areas, origin of the BM and heat
treatment applied, and the report –published on the Health and Consumers DirectorateGeneral (SANCO) Internet site at http://ec.europa.eu/food/fvo/ir_search_en.cfm – made a
number of recommendations in respect of the action required to the CA. Written
guarantees were received from the CA in relation to the implementation of those
recommendations. After a desk review of these written guarantees, all the
recommendations were considered to be satisfactorily addressed.
4.2
PRODUCTION AND TRADE INFORMATION
According to information provided by NAFIQAD, Vietnam exported around 19 000
tonnes of BM in 2012, 23 000 tonnes in 2013 and 11 500 tonnes in the first six months of
2014. The species of BM exported are clams (baby clam (Meretrix lyrata), yellow clam
(Paphia sp.), bloody clam (Tegillarca granosa)), scallops (Chlamys nobilis) and antique
ark (Anadara antiquate and subcrenata). Since 2011, Vietnam has started to import blue
mussel (Mytilus edulis) and Chilean blue mussel (Mytilus chilensis) for further export to
the EU normally as part of seafood mix products.
2
According to the data provided by NAFIQAD, in 2013 and the first six months of 2012,
around 95% of the BM exported to the EU were clams (both shell-on and off), and 5%
were scallops (only the adductor muscle). The CA indicated that antique ark was harvested
in four production areas but did not provide specific export data for those.
The importing Member States are (by alphabetic order): Belgium, Croatia, Czech
Republic, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain and United
Kingdom.
As per the lists drawn up by the NAFIQAD and available on the SANCO's website (at
http://ec.europa.eu/food/food/biosafety/establishments/third_country/index_en.htm)
(hereafter SANCO list) at the time of the audit there were a total of 18 classified
production areas approved and listed by the CA for participation in the EU BM export
chain; and, 45 out of the 458 establishments approved and listed to export fishery products
were processing and exporting BM.
4.3
RAPID ALERT SYSTEM FOR FOOD AND FEED (RASFF) NOTIFICATIONS
Over the previous two years up to the current audit, 44 RASFF notifications have been
issued for BM. Other than one notification due to a fraudulent certificate, the notifications
were due to the presence of norovirus, in 23 cases, and Salmonella spp, in 20 cases.
Details on how these notifications were handled are presented in section 5.6.5. below.
5
FINDINGS AND CONCLUSIONS
5.1
LEGISLATION
Legal requirements
Article 46(1)(a) of Regulation (EC) No 882/2004 states that Commission experts may
carry out official controls in third countries in order to verify the compliance or
equivalence of third countries legislation with the relevant EU legislation and Article 11(4)
(a) of Regulation (EC) No 854/2004.
Findings
A number of pieces of legislation relevant for the scope of the audit have been adopted
since the previous FVO visit in 2009. NAFIQAD provided a copy of all legislation
requested by the audit team, in English when available.
The audit team did not evaluate in depth the Vietnamese legislation but only checked if
individual relevant EU requirements were equivalent in case of doubts during the audit.
The NAFIQAD informed the audit team that new legislation had been drafted and was
following the normal administrative procedure to establish new legislation. The CA
remarked that some requirements that were not equivalent to EU legislation at the time of
the audit had already been identified and included in that draft.
The audit team noted that:
•
Some requirements that were not equivalent to the EU legislation had been
already detected by the CA, but not others.
•
Examples of requirements that did not provide equivalent guarantees to the EU
ones were: a tolerance of 10% in microbiological results for class "A"
production areas to continue being classified as "A" (see section 5.4.1), the
3
classification of production areas based upon examination of datasets derived
from only six months of E. coli monitoring results (see section 5.4.1), the lack of
specified distance to the defined sampling points where the sample could be
collected (section 5.4.2) and lack of specification that the temperature during
heat treatment should be achieved in the molluscs’ flesh (see section 5.6.3).
•
Limits of cadmium allowed by Vietnamese legislation (2 parts per million
(ppm)) were not equivalent to the EU ones (1 ppm). The CA informed the audit
team of its intention to keep this limit as it was in line with the Codex standard
193-1995. Nevertheless, the CA remarked that in practice the EU limit is the one
applied to BM exported to the EU (see section 5.4.3.).
It has to be noted that this Codex standard is not applicable to scallops and
oysters (one of the new production areas, see section 5.3., was producing
oysters). The CA stated that national legislation had to be reviewed to take this
into account.
Conclusions
From a limited review of the Vietnamese legislation in force applicable to fishery products
derived from LBM, it can be considered that Vietnamese requirements are not fully
equivalent to the relevant EU ones.
5.2
COMPETENT AUTHORITY
Legal requirements
Article 46 of Regulation (EC) No 882/2004 stipulates that EU controls in third countries
shall verify compliance or equivalence of third countries systems with EU food law. These
controls shall have particular regard to points (b) to (e), (g) and (h) of the aforementioned
Article.
Findings
The CCA in Vietnam responsible for the control system for fishery products (including
BM) for export to the EU is NAFIQAD under the Ministry of Agriculture and Rural
Development. The structure and responsibilities of NAFIQAD are as described in the
report DG(SANCO)/2009-8053-MR-FINAL (for fishery products and LBM), and the reorganisation of NAFIQAD that took place 2011 is described in the report DG(SANCO)
2012-6547 - MR FINAL (for fishery products).
The audit team noted that:
•
As described in the previously mentioned report from 2011, the CCA had two
regional arms, Central Regional Agency and South Regional Agency. For the
Northern part of Vietnam, the NAFIQAD headquarters acts as a regional agency.
•
The regional agencies took over certain competences from the CCA (for
example the design and implementation of monitoring programmes of classified
production areas, see section 5.4.2) and also from the branch offices, Branches
1-6, (for example the official control of establishments).
Conclusions
The CA responsible for official controls on fishery products derived from LBM is clearly
designated, structured and organised.
4
5.3
NATIONAL PROVISIONS AND PROCEDURES FOR LISTING LIVE BIVALVE MOLLUSCS PRODUCTION AREAS
AND ESTABLISHMENTS EXPORTING BIVALVE MOLLUSCS TO THE EU
Legal requirements
Article 12(1), (2) and (3) and Article 13 of Regulation (EC) No 854/2004; part I.8. I.11.
and I.28. of the model health certificate for imports of fishery products intended for
human consumption established in Appendix IV to Annex VI to Regulation (EC) No
2074/2005.
Findings
The CA has in place national provisions and procedures for listing LBM production areas
and establishments exporting BM to the EU.
Regarding production areas, there have been no additions or modifications to the SANCO
list since the last FVO visit in 2009.
Regarding establishments, national provisions and procedures are described in detail in the
report DG(SANCO) 2012-6547 - MR FINAL (for fishery products).
The audit team noted that:
•
Regarding production areas, out of the 18 production areas on the SANCO list,
only 15 of were included in the national monitoring programme; the other three
areas were not included in the monitoring programme and, according to the
information provided, they had not been monitored in at least the previous five
years.
All production areas contained in the SANCO list were classified as class "B".
However, according to a CA review of the classification, not all production areas
fitted into the "B" category, there were also class "A" and "C" production areas.
A request to update the list according to the SANCO procedures (available at
http://ec.europa.eu/food/food/biosafety/establishments/third_country/proc_intro
_request_en.htm) has not yet been sent by the CA. (see section 4.5.1)
•
Regarding establishments, according to the information provided by the CA at
the time of the audit only 45 out of the 458 establishments that appear on the
SANCO list export BM to the EU (there were only 20 in 2009).
The audit team visited one establishment that was not in operation as the CA had
temporarily suspended it due to non-compliances detected. The CA informed the
audit team that, under national legislation, the temporary suspension of an
establishment for less than one year did not imply its removal from the SANCO
list.
In the same establishment, the authorisation for exporting BM was granted by
the CA although the CA considered as unsatisfactory the heat treatment
parameters that the food business operator applied to the product and requested
the necessary validation to be carried out (see section 5.6.3.).
•
A recommendation regarding the inclusion on the SANCO list only of those
establishments carrying out permitted treatment methods had been made in the
2009 FVO report. The action proposed by the CA, at the time, to address this
recommendation was considered as satisfactory. However, during the audit the
FVO team noted that not all the proposed actions had been adequately
implemented.
5
Conclusions
The national provisions and procedures for listing LBM production areas cannot be
considered as in line with the EU requirements established in Articles 13 of Regulation
(EC) No 854/2004. Furthermore certain aspects of the approval and listing of
establishments exporting BM cannot be considered as meeting the EU requirements
established in Articles 12 of Regulation (EC) No 854/2004, and the corresponding
recommendation of the previous FVO report has not been properly addressed by the CA.
5.4
OFFICIAL CONTROLS ON LIVE BIVALVE MOLLUSCS FROM CLASSIFIED PRODUCTION AREAS
Legal requirements
Article 13, in particular 13.3.(a) of Regulation (EC) No 854/2004 and Part I.8 and II.1 of
the model health certificate for imports of fishery products intended for human
consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005.
5.4.1
Classification of production and relaying areas
Findings
As per the SANCO list, at the time of the audit there were a total of 18 classified
production areas, all of them classified as class "B" based on the level of faecal
contamination.
The CA confirmed that, at the time of the audit, there were no relaying areas in Vietnam.
The audit team noted that:
•
The location of all classified production areas reviewed by the audit team
had been fixed by the CA and there were maps available for each of them.
Also boundaries for some of the classified production areas have been fixed
by the CA but not for other areas for which the boundaries were in practice
defined by fences demarcating the bivalve mollusc farms or by the limits of
the natural bivalve mollusc banks.
•
The CA carried out annual reviews of the classification of production areas;
however, it was based upon examination of datasets derived from only six
months of E. coli monitoring results, which did not allow the determination
of the variability in E. coli levels in potential contaminating sources or
permit proper assessment of the effect of environment or seasonal factors
(to note that Vietnam has a tropical monsoon climate) on microbiological
quality of BM.
•
The CA review of the classification showed that, from 2011, not all
production areas had to be classified as "B", there were also class "A" and
"C". This classification was published on the CA website and it was
considered by them as the actual classification. The CA informed the audit
team that this information was included in the report with the results of the
previous year monitoring programme that was annually sent to DG
SANCO, but a request to update the corresponding list (according to the
SANCO
procedures
available
at
http://ec.europa.eu/food/food/biosafety/establishments/third_country/proc_i
ntro_request_en.htm) was never made.
•
At the time of the audit, the last CA review of the classification resulted in
6
five class "A" production areas, eight "B" production areas and two class
"C". However, for class "A" production areas, the CA considered that these
only had to meet EU health standards for microbiological contamination
(less that 230 most probable number (MPN) of E.coli/100g of flesh and
intra-valvular liquid) in 90% of the cases in order to continue being
classified as "A".
5.4.2
•
In those areas where harvesting was banned during a certain number of
months due to resource protection, (see 5.4.2.), the dataset available should,
in principle, allow adequate classification, as the frequency of sampling for
microbiological monitoring was weekly during the harvesting period.
•
At the time of the audit, the CA had carried out sanitary surveys for the five
new areas that it intended to include on the SANCO list. Reports comprising
summary descriptive characteristics (i.e. size of harvesting area, commercial
species, tidal parameters), together with measurement of physiochemical
parameters (pH, water temperature, turbidity and salinity) were available.
Bacteriological results from single sampling occasions were included but no
evidence of seasonal and/or climatic influences (e.g. rainfall, changes in
population) was made available. No inventory of pollution sources likely to
cause microbiological contamination of the areas was included in the
reports. The outputs of sanitary survey reports were not used to select
sampling points or to define sampling plans.
•
In existing listed production areas, the CA had already carried out a number
of sanitary surveys, but their value was limited in the context of EU
legislation (see above) and there was no systematic programme covering all
areas or formal ongoing review process.
•
Regarding those production areas that have been extended in size since their
boundaries were initially defined, no documented evidence of assessment of
potential changes in the faecal contamination on the extended area or
inclusion of additional sampling points was available.
•
A recommendation regarding the classification of production areas was
already included in the last FVO report from 2009. The actions proposed by
the CA to address this recommendation were considered as satisfactory at
that time. However, during the audit the FVO team noted that not all of
these actions had been implemented.
Monitoring of classified production areas
Findings
Individual monitoring programmes for classified production areas are prepared before the
end of each year by the Regional CA for those areas that are under its control and sent to
the CCA. Once approved by the CCA, the monitoring programme is sent back to the
corresponding Regional CA which forwards it to the local CA for its implementation the
following year.
By reviewing the individual monitoring programmes the CCA ensures the uniformity
between monitoring programmes of different regions.
A total of 20 production areas are included in the national monitoring programme, 15 out
of the 18 included on the SANCO list (see section 5.3) and five new areas (see 5.4.1).
7
Four of the production areas are located off-shore, and the remaining 16 are nearer the
coast in areas with a diurnal tide.
The frequency of sampling is established in the monitoring programme. In production
areas located off-shore, except when harvesting is restricted due to resources protection,
water is sampled weekly to determine the presence and also the level of toxin-producing
plankton. In these off-shore areas LBM are also sampled weekly to determine their
microbiological quality and the presence of biotoxins (lipophilic toxin, amnesic shellfish
poison (ASP) and paralytic shellfish poison (PSP)). In the remaining production areas,
both water and LBM are sampled every second week for the same parameters as in the
off-shore areas. In addition, all production areas are sampled twice per year to determine
the presence of heavy metals (lead, cadmium and mercury) in LBM. Other contaminants
(polycyclic aromatic hydrocarbons-PAH, dioxins and dioxin-like PCBs) are also tested but
not as part of the monitoring programmes.
The location of the sampling points of production areas is defined in the monitoring
programme and points’ positions are included in the production area maps. All species
commercially harvested in each production area are sampled.
The audit team noted that:
•
The audit team assessed the particularities of the areas with diurnal tides
reviewing the tide regime over the year September 2013 to September 2014
for the eight production areas in the Northern region of Vietnam. In those
production areas, clams are harvested by digging from below the surface of
the tidal sand or mud flats where they live. With a diurnal tide pattern, the
level of the sea water varies irregularly over the year, and there are days
when the water level is not low enough to allow harvesting. As a result,
harvesting takes place quite irregularly, but normally in periods of 7-9 days.
The CA confirmed that both harvesting and sample collection may take
place either by day or night. According to the monitoring programme,
official sampling of water and LBM is carried out every second week,
independently of the tides and, consequently, independently of the
harvesting periods. Test results are usually available two or three days after
the sample has been collected, and it is considered valid for two weeks by
the CAs, meaning that LBM harvested more than two weeks after testing is
completed (the audit team saw cases up to 20 days) are still considered by
the CA as meeting the health standards for biotoxins.
•
Sampling points are defined in the monitoring programme; however, their
selection has not been scientifically justified to demonstrate that their
location is representative of the area being monitored except in some
production areas where microbiological results had been to some extent
taken into account.
In addition, for samples of LBM, the CA has not yet determined an
acceptable distance from the sampling point defined for the monitoring
programme, within which a sample may be collected. Sampling points to
determine microbiological quality are exactly the same as those used to
determine the presence of biotoxins.
Regarding toxin-producing plankton, a very limited number of sampling
points cover quite extensive production areas (e.g. one sampling point for an
area of 1,500 hectares or two sampling points for an off-shore area of
8
16,500 hectares).
•
In practice, samples of LBM to determine their microbiological quality and
the presence of biotoxins are collected where harvesters are harvesting
molluscs and not from the designated sampling points. The sampling point
is identified by GPS using a mobile phone but the GPS coordinates are not
recorded on the sample form, therefore no verification that the location of
the sampling point used is within acceptable tolerances of a fixed sampling
point is possible.
•
In 2014 the numbers of sampling points in several areas that had more than
one sampling point were reduced, and the corresponding justification for
this reduction was set out in an official document. For two production areas
for which the audit team requested supporting E. coli monitoring data, the
reduction in the numbers of points was considered to be supported by the
data provided.
The reduction in the number of sampling points for biotoxins was justified
based on historical data showing the absence of ASP and PSP in the country.
Regarding lipophilic toxins, the number of sampling points has not been
reduced in those production areas where the presence of biotoxins above the
limit has been detected.
•
The method used for the collection of LBM samples corresponds to the
methods normally used for commercial harvest and is appropriate.
Sufficient individual animals are sampled to provide a representative
sample. A sample submission form is completed at the time of sampling,
which contains the name of the sampling location, the name of the official
sampling officer, the time of sampling, species and the analyses required for
the sample. Samples are placed in clearly labelled bags and are
accompanied by the sampling form.
Regarding the method used for the collection of water samples, only surface
water is collected from sampling points where the water is over five metres
deep regardless of the instructions from the CCA on how to collect water
samples that can be considered as representative of the water column.
•
Samples of LBM are transported to the laboratory at ambient temperature in
sealed bags to prevent cross-contamination, but there are no formal criteria
for temperature control of samples in transit or time between sample
collection and beginning of analysis. However there is a requirement that
molluscs should be alive when the analysis is begun. Transport time to the
laboratory was reportedly short (within 2-3 hours in the cases checked by
the audit team).
•
The monitoring programme does not include the monitoring of norovirus in
production areas, but the CA informed the audit team of its intention to
systematically monitor norovirus in the future. At the time of the audit,
targeted samples had been taken in five production areas involved in
RASFF notifications and all had tested positive for norovirus (see section
5.8.1.B).
9
5.4.3
Decisions after monitoring
Findings
Monitoring results are sent directly from the laboratories to the regional CAs.
If monitoring results of a production area are satisfactory, regional CAs issue a document
called "notification of harvesting status and post-harvesting treatment" that is sent to the
local CAs and is also published on the CAs’ website. This document establishes the period
when harvesting is permitted in the monitored area, which is normally two weeks.
The audit team noted that:
•
No decisions were taken following a result of E. coli over the corresponding
EU limit for a specific class production area. The CA informed the audit
team that a new procedure for the investigation of the cause of the abnormal
results will be developed.
•
Following test results for water over the limits set by the CA for toxinproducing plankton, sampling of water was intensified and an additional
sample of LBM to determine the level of biotoxins was taken. This new
sample had to be taken close to the sampling point established in the
monitoring programme.
•
Following test results for LBM over the corresponding EU limits for
biotoxins, the CA did not close production areas, contrary to EU legislative
requirements to do so.
According to the CA data, lipophilic toxins over EU limits have been
detected in 15% of the analyses carried out in 2013 and in 17% of the
analyses carried out in 2012; ASP or PSP had not been detected in Vietnam.
In particular, lipophilic toxins over EU limits had been found in three
production areas, where only two species of BM (scallops and antique ark)
are produced. The CCA has a procedure in place to allow harvesting in these
production areas following monitoring results over the corresponding EU
limit for lipophilic toxins. Under this procedure, scallops and antique ark
may be processed by removing the hepatopancreas and gonads and then
exported to the EU. Before export, an analysis to determine the level of
lipophilic toxins in the scallop adductor muscle and in the antique ark flesh
is carried out. The CA uses the limit established in EU legislation as the
level that the final product has to comply with prior to export.
•
Following LBM analyse results over the EU limits for cadmium, the CA did
not close production areas, contrary to EU legislative requirements.
According to the CA data, cadmium over EU limits was detected in 12% of
the analyses carried out in 2013 and in 9% of the analyses carried out in
2012. The CA has in place a procedure similar to the one explained above
for lipophilic toxins.
5.4.4
Additional monitoring requirements
Findings
The audit team noted that:
•
Local CAs routinely carried out active surveillance of production areas, and
10
this includes their monitoring when harvesting is subject to special
conditions for example a harvesting ban to protect resources.
•
5.4.5
Laboratory tests to verify food business operators' compliance with the
requirements for the end product are carried out by CAs to verify the
microbiological quality of the molluscs but not to verify the levels of
biotoxins and contaminants.
Recording and exchange of information
Findings
The audit team noted that:
5.4.6
•
A list of approved production areas including the class of the areas is
available on the CCA's website.
•
All results for the monitoring of toxin-producing plankton, biotoxins and
microbiological quality of LBM are sent directly from laboratories to the
corresponding regional CA (CCA in the case of the northern region of the
country). Regional CAs immediately inform the middlemen, who have the
role of informing harvesters. At the same time, regional CAs publish this
information on their websites, making it available, among others, to food
business operators in the BM sector.
Food business operators' own-checks
Findings
The audit team noted that food business operators' own checks are not used by the CAs to
decide on classification, opening or closure of production areas.
Conclusions
The classification of production areas is not carried out in line with the EU requirements
established in Chapter II. A of Annex II to Regulation (EC) No 854/2004, as i) annual
classification of production areas is based upon examination of datasets derived from only
6 months of E. coli monitoring results, ii) for class "A" production areas, as the CA
considers that these only have to meet EU health standards for microbiological
contamination in 90% of the cases in order to continue being classified as "A", and iii) the
boundaries of production areas have not always been fixed by the CA. The value of
sanitary surveys is limited, as they are incomplete and the data gathered are not used to
define sampling points. The corresponding recommendation of the previous FVO report
has not been properly addressed by the CA.
The monitoring of production areas is not carried in line with the EU requirements
established in Chapter II. B of Annex II to Regulation (EC) No 854/2004 as the
geographical distribution of the sampling points (for microbiological quality, toxinproducing plankton and biotoxins) and the sampling frequency except in off-shore
production areas (for toxin-producing plankton and biotoxins) cannot ensure that the
results of the analysis are as representative as possible of the area considered. Sampling
plans to check the microbiological quality of LBM are not based on adequate sanitary
surveys and, therefore, there is no scientific justification for the selection of their location.
The low number of sampling points and frequency of sampling to checks for the presence
of toxin-producing plankton and the fact that samples are not representative of the water
column mean that this monitoring plan cannot be considered as an adequate early warning
11
system for the appearance of biotoxins. The inadequate frequency of sampling to check for
the presence of biotoxins does not guarantee that BM exported to the EU meet the
required health standards.
Decisions after monitoring are not taken in line with the EU requirements established in
Chapter II. C of Annex II to Regulation (EC) No 854/2004. The CAs do not either close
production areas when results of sampling show that the health standards for molluscs are
not met, or when there may be a risk to human health, nor do they reclassify a production
area when the relevant microbiological criteria are no met.
The CA system based on laboratory tests to verify food business operators' compliance
with the requirements established in Chapter II. D of Annex II to Regulation (EC) No
854/2004 for the end products is not fully in line with EU requirements as the verification
of biotoxins and contaminants is not included.
5.5
OFFICIAL CONTROLS ON PECTINIDAE, ECHINODERMS, TUNICATES AND MARINE GASTROPODS NOT
FILTER FEEDERS HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS
Legal requirements
Article 13.2. of Regulation (EC) No 854/2004 and Part II.1 of the model health certificate
for imports of fishery products intended for human consumption established in Appendix
IV to Annex VI to Regulation (EC) No 2074/2005.
Findings
According to the information provided by the CA, only BM (and not echinoderms,
tunicates and non-filter feeding marine gastropods) are exported to the EU and they are
only harvested in classified production areas.
5.6
OFFICIAL CONTROLS OF FISHERY PRODUCTS DERIVED FROM LIVE BIVALVE MOLLUSCS
Legal requirements
Part II.1 of the model health certificate for imports of fishery products intended for human
consumption established in Appendix IV to Annex VI to Regulation (EC) No 2074/2005.
5.6.1
Movement of live bivalve molluscs and registration document accompanying batches
Findings
According to the CA procedures, every time a batch of LBM is moved from a production
area to an establishment it has to be accompanied by a document. There are two types of
documents that may accompany LBM to establishments:
1. "Note of Harvesting", which is a document issued by authorised persons in
associations of harvesters or by the offices (stations) that in some cases the local
CAs have close to the production areas. Once LBM arrive at an establishment,
the food business operators must send this document back to the local CA
where the production area is located, and the local CA replaces it by a
"Certificate of Origin". This new document is sent to the corresponding food
business operator who has to keep it and to present it when requesting a
certificate for export to the EU from the CA.
2. The "Certificate of Origin", issued by the local CAs, may also accompany LBM.
In this case, prior to transporting LBM, middlemen directly request the local
CA to replace the “Note of Harvesting” by the “Certificate of Origin”.
12
As in some cases LBM are transported great distances in the country (e.g. from production
areas in the north to establishments in the south), the CA has also defined the conditions
for such movement. These conditions include the ambient temperature inside the truck
(20-25ºC) and the maximum length of the trip (40 hours).
The audit team noted that:
•
5.6.2
In all the cases checked by the audit team, the CA had verified the existence
of the “Certificate of Origin” and the information contained in it prior to
issuing an export certificate.
Official control of establishments
Findings
There have been no major changes since the 2009 FVO visit as regards the design and
implementation of official controls in fishery product establishments, including
establishments handling BM, except for the frequency of inspections.
Since December 2013, Circular No. 48/2013/TT-BNNPTNT has replaced Circular No.
55/2011/ TT-BNNPTNT, and it establishes the categorisation of establishments according
to their level of compliance with food safety criteria requirements. Establishments are
classified from Class 1 (very good) to Class 4 (not acceptable) and there are specific
frequencies of official controls established for each class (e.g. once per year for Class 1
establishments).
The audit team noted that:
•
A specific checklist for BM establishments was prepared by the CCA and its
use is compulsory for inspectors during official controls. The checklist
includes the model of the report that had to be drafted following official
controls. A copy of the checklist/report has to be provided to the food
business operator.
•
In addition, the CCA has also prepared a manual for inspectors of fishery
product establishments, with a specific chapter for BM, and specific
provisions for the controls of procedures based on HACCP, traceability, etc.
•
Frequencies of official controls were met in all establishments visited, both
according to the previous and the new Circulars.
•
Circular No. 48 also prescribes the additional control regime to be carried
out in exporting establishments. Exporting establishments are divided into
two “regimes”. Those meeting the highest criteria are treated under a
"priority regime" with the remained being treated under a “regular regime”.
To be considered under the “priority regime” establishments must have a
good hygiene record and have been graded as Class 1 or 2 for at least the
previous 12 months and must have had no recorded non-compliances in
exporting consignments over the preceding 3 months. At the time of the
audit, out of the 45 establishments exporting BM to the EU, 31 were under
the "priority regime" and 14 under "regular regime".
In establishments under "priority regime" official samples of final product
13
of 15-25%3 of the production lots are taken while in establishments under
"regular regime" 100% of the export consignments (which can include more
than one lot) are officially sampled. Samples are tested for microbiological
criteria according to national legislation, in particular for total plate count,
E. coli, Salmonella and S. aureus.
5.6.3
Facilities handling bivalve molluscs
Findings
Although all establishments visited during the audit had been officially controlled in line
with established frequencies and reports were in all cases available, the following
deficiencies, noted by the audit team, had not been reported:
•
Although all SANCO listed production areas in Vietnam are classified as
class "B", none of the establishments visited by the audit team applied the
heat treatment parameters in line with EU requirements.
For clams, the heat treatments applied in the different establishments varied
(immersion in boiling water, steaming under pressure, etc.) and in all cases
checked by the audit team food business operators had carried out the
validation of the heat treatments being applied; however, the validated
parameters were not the ones to be used when producing BM for EU export.
For scallops, only blanching (light heat treatment involving immersion in
boiling water for 8-10 seconds) was applied.
•
In all the cases checked by the audit team, food business operator owncheck testing for Salmonella and S. aureus were carried out using the EU
reference methods. However, in some cases testing for E. coli was not
carried using the EU reference method or an alternative validated method.
•
Although, in all the establishments visited, the only source of water used
during processing of BM was the public network there were different
potential sources of contamination. For example, the limited amount of
water used for conditioning of high quantities of LBM or the high
percentage of vacuum packed bags with broken vacuum during immersion
in boiling water.
•
Temperature records in cold stores registered above -18ºC during some
hours almost every day.
•
Food business operators had all supporting documentation for the
consignments of BM exported available; however, when requested by the
audit team they were not able to provide data on all LBM received and
processed in their establishments4 of some exporting lots.
A recommendation regarding the adequate heat treatment of BM from class "B"
3 In their response to the draft report the CA indicated that the percentage of official samples of final product in
establishments under “priority regime” is, as regulated in Annex 10 of Circular No 48/2013/TT/BNNPTNT, 15% of
the production lots for 1-classified establishments and 25% of the production lots for 2-classified establishments.
4 In their response to the draft report the CA stated that during routine inspection of food safety conditions of food
business operators or inspection and sampling of BM, NAFIQAD has verified the eligibility of the raw materials and
traceability. The Certificate of Origin should be checked for every BM lot. However, NAFIQAD confirmed that this
check has not been effectively carried out in all cases and some ineligible lots which entered the EU export chain
were noted by the FVO audit team in September 2014. In addition, they acknowledged that the record keeping
systems of these establishments are not fully appropriate and do not always easily facilitate these checks.
14
production areas was included in the last FVO report from 2009. The actions proposed by
the CA to address this recommendation were considered as satisfactory. However, during
the audit the FVO team noted that not all of these proposed actions had been implemented.
5.6.4
Check on the EU eligibility of imported raw materials
Findings
Since 2011, Vietnam has started to import frozen mussels from Denmark (Mytilus edulis)
and from Chile (Mytiles chilensis) for further processing and export to the EU. According
to the information provided by the CA, these BM are used in establishments as one of the
ingredients of seafood mix products.
The audit team noted that:
•
5.6.5
The CA had checked that every consignment of mussels from Chile had
been harvested in an EU listed production area and had been processed in an
EU listed processing establishment. However, the Vietnamese CA did not
request that Chilean certificates to guarantee the eligibility of the BM to be
further exported to the EU.
RASFF notifications
Findings
The CA has a procedure in place to undertake an investigation on the causes of each
notification.
The audit team noted that:
•
Most of the RASFF notifications, both for Salmonella spp and for
norovirus, were linked to one establishment. The corresponding follow-up
documentation for this establishment was presented to the audit team.
Regarding Salmonella spp, although it took several months, the
investigations made, at the request of the CA, by the food business operator
identified the cause of the contamination. In this case, the corrective actions
proposed and implemented by the food business operator were considered
as satisfactory by the CA. Regarding norovirus, at the time of the audit the
CA together with the food business operator was in the process of
investigating the cause of the contamination. The ongoing investigations
linked the contamination to one single middleman who collected LBM from
five production areas. The CA was carrying out further testing of LBM from
these production areas as well as from final product, as described in section
5.8.1.B below.
Conclusions
Despite of the fact that establishments are officially controlled according to the procedures
and frequencies established by the CA and that there is a specific sampling regime for
exporting establishments, the CA is not in a position to ensure that these establishments
comply with EU requirements and, in particular, with the parameters to be applied for heat
treatment of BM from class "B" production areas in order to eliminate pathogenic microorganisms (set out in Chapter II. A.5 of Section VII of Annex III to Regulation (EC) No
853/2004). The corresponding recommendation of the previous FVO report has not been
properly addressed by the CA.
15
The CA's import controls of BM for further export to the EU do not include the control of
the eligibility of the BM for the EU market. (see conclusion of section 5.7)
The procedure in place to follow-up RASFF notifications provides guarantees that official
measures are taken when required, although sometimes with certain delay.
5.7
OFFICIAL CERTIFICATION
Legal requirements
Article 14 and Annex VI to Regulation (EC) No 854/2004; Article 6 and Appendix IV to
Annex VI to Regulation (EC) No 2074/2005; and, Article 6 of Directive 96/93/EC.
Findings
The CA has a certification system in place. Certificates for BM (fishery products derived
from LBM) are issued by the corresponding Branch where the establishment that has
processed the BM is located. Exported consignments are officially sampled for
microbiological criteria (total plate count, E. coli, Salmonella and S. aureus) in
establishments under "regular regime" (see section 5.6.2.) and certificates are only issued
following satisfactory testing results.
The audit team noted that:
•
The CA uses the export certificate model set out in Regulation (EC) No
2074/2005, and the corresponding supporting documentation provided by the
food business operator is available to the certifying officer who issues the export
certificate.
•
The CA informed the audit team that export certificates are consciously issued
for scallops that had only been blanched (light heat treatment involving
immersion in boiling water for 8-10 seconds) as if they had been heat treated in
line with the EU requirements (all scallops were harvested in class "B"
production areas).
•
Export certificates for clams are issued by the CA although these BM are not
heat treated in line with the EU requirements (all clams harvested in class "B"
production areas). The audit team confirmed this fact in all four establishments
visited (see section5.6.3.).
•
Export certificates for seafood mix products containing Chilean mussels are
issued by the CA although the eligibility of mussels cannot be demonstrated.
•
At the time of the audit the CA had already taken measures to address a noncompliance detected in the EU related to the commodity code (HS code)
included in the box reference I.19 of the export certificate model set out in
Regulation (EC) No 2074/2005.
Conclusions
The system in place for the issuance of EU export certificates for BM cannot be
considered as in line with EU requirements: the CA does not ensure the integrity of the
information contained in the certificate contrary to Article 4 of Directive 96/93/EC, the
CA cannot ensure that products exported satisfy the relevant requirements contrary to
Article 14. 2 of Regulation (EC) No 854/2004 and the certifying officers certify data
which has not be ascertained by them contrary to Article 3 of Directive 96/93/EC.
16
5.8
LABORATORIES
Legal requirements
Article 46(1)(d) of Regulation (EC) No 882/2004; Chapter 1 of Annex I to Regulation
(EC) No 2073/2005; Article 3 and Annex III to Regulation (EC) No 2074/2005;
Regulations (EC) Nos 1883/2006 and 333/2007; and Regulation (EU) No 252/2012.
Points 41 and 42 of Guidelines of Codex Alimentarius CAC/GL 26-1997 on the Design,
Operation, Assessment and Accreditation of Food Import and Export Inspection and
Certification Systems.
Findings
All official samples taken in the context of official controls (for monitoring of production
areas and verifying food business operators' compliance) were analysed by the CA
laboratories. The audit team visited two CA laboratories, in Branches 1 and 4. Both
laboratories had departments for microbiology, toxin-producing plankton, biotoxins and
heavy metals.
5.8.1
Laboratories for microbiology
A. Bacteriology
The audit team noted that:
•
Both laboratories visited were adequately equipped and staff were trained and
competent in their corresponding fields of expertise. Training requirements for
staff were formalised and documented training records were available.
•
Both laboratories are accredited to ISO IEC 17025 by the Vietnam Laboratory
Accreditation Scheme (VILAS), which is a member of International
Laboratory Accreditation Cooperation-ILAC.
The scope of accreditation includes the EU reference methods for E. coli (ISO
TS 16649-3) and Salmonella spp (ISO 6579) in LBM, and for E. coli (ISO TS
16649-3) and coagulase-positive staphylococci (ISO 6888-1 or 2) in cooked
molluscan shellfish.
•
Analysis of microbiology are carried out according to the methods accredited:
Ø Regarding E. coli in LBM, standard operating procedures are
appropriate and records associated with the sample at each stage of the
procedure were well defined and demonstrated that critical steps were
well controlled. Although the number of dilutions used did not allow
the enumeration of results above 18,000 MPN E. coli/100 ml, staff are
aware of the need to use an increased number of decimal dilutions for
more contaminated areas. A table according to the ISO 7218:2007
standards is used for interpretation of data for MPN, however the Amd
1:2013 was not taken into account.
Ø Regarding Salmonella spp in LBM, standard operating procedures are
appropriate and records seen for each stage of the analysis were clear
and well controlled.
Ø Regarding E. coli in final product, the EU reference method for E. coli
was used in Branch 1 but not in Branch 4, where ISO 16649-2 was used
17
(this method does not enable the microbiological limits required by the
EU to be met as the limit of detection is not sufficient). In Branch 4, all
results for E. coli were <0.2 MPN E. coli/100g (below the limit of
detection of the assay), and the audit team was informed that it was
very unusual to see a result >0.2. The audit team noted that all products
are tested after freezing at -20°C, which reduces the viability of E. coli
and, therefore causes a decrease in detectable MPN (to be noted that
freezing would not inactivate viable viruses). The CA stated that official
samples of BM for E. coli enumeration are also taken following heat
treatment but prior to freezing at establishments, but did not provide
data to the audit team although the team requested them.
Ø Regarding coagulase-positive Staphylococci in final product, the audit
team did not examine details of the analysis but the standard operating
procedure provided at Branch 4 was in line with ISO 6888-1.
•
Even though sample submission forms completed by the official sampling
officer are not held in the laboratory and the system relies upon manual
(written) transfer of information, sample receipting is well controlled in both
laboratories. Samples are assigned a unique sample identification number
which enables traceability throughout each stage of the process. Sample
rejection criteria, specific for BM, are not documented but staff are aware of
the minimum number of animals required for analysis and the requirement that
molluscs are alive before the onset of analysis.
•
Both laboratories participated in an external proficiency testing scheme
specifically for enumeration of E. coli in BM offered by AsureQuality Limited
(New Zealand) with satisfactory results but the most recent results for ISO TS
16649-3 in this matrix specific scheme were in 2010.
In October 2013, Branch 4 also participated with satisfactory results in external
proficiency testing provided by Ianz for ISO 16649-2 and ISO 7251, which
was designed for meat and meat products but not for BM.
Nevertheless, the quality of test results was assured by robust internal quality
assurance including annual repeatability and reproducibility assessments (for
enumeration of E. coli) and the use of appropriate reference strains as positive
and negative controls for all assays.
B. Virology
The audit team noted that:
•
Norovirus analyses in BM were carried out in Branch 4 and 6 (this latter
laboratory was not visited by the audit team). The methodology for
norovirus determination was different between the two laboratories;
conventional two step reverse transcription PCR (04.2-CL4/ST, 3.51 ky
thuat PCR) without confirmation of the product was carried out at Branch 4
(this was verified during the laboratory visit) whereas at Branch 6 viral
RNA was extracted using High Pure Viral RNA Kit (Roche) followed by
application of a proprietary real time norovirus detection kit (NKNORO
Realtime RT-PCR, ky thuat Real time PCR). Neither method is consistent
with ISO TS 15216 parts 1 or 2 (the putative reference method for
determination of norovirus in foodstuffs including bivalve shellfish).
Equivalent performance of the two methods between the two laboratories
18
had not been demonstrated and it was not clear that either would generate
equivalent results to ISO TS 15216.
5.8.2
•
Analyses were carried out on final products and on LBM from five
production areas that were involved in the RASFF notifications mentioned
in section 5.6.5. (the latter were all tested in Branch 4, as part of
investigations triggered following these RASFF notifications). Samples
from the five production areas tested positive for norovirus.
•
Methods were not accredited to ISO IEC 17025. Limits of detection for the
conventional assay were given as 50 copies per reaction (reaction volume 23µl) and 20 copies/µl for GI and GII for the real time assay. A validation
report including data on specificity, sensitivity and relative accuracy was
available at Branch 4 for the conventional PCR method, but the
performance characteristics of the method including the limit of detection
could not be verified from the information provided. No verification data
was provided for the real time method. It was noted that the methods had
detected norovirus in a number of samples, and therefore had the capability
to generate positive results in real samples. No independent quality
assurance (e.g. participation in proficiency testing, analysis of quantitative
reference materials) was undertaken. On the basis of the information
provided it was not possible to assess the quality of the data generated by
either method.
Laboratories for toxin-producing plankton
The audit team noted that:
5.8.3
•
Both laboratories carried out qualitative and quantitative determination of
toxin-producing plankton, and the list of toxin-producing plankton species was
available for the staff carrying out the counting.
•
In Branch 1, a wide range of toxin-producing plankton species relevant to
lipophilic toxin, ASP and PSP was determined using the Utermöhl method for
quantitative analyses.
•
In Branch 4, the range of species determined was more limited. In particular
for lipophilic toxin only Donophisis caudata was determined as, according to
the CA, this was the only species present in these Vietnamese waters. The
determination method used in this laboratory was a Manual of the
Intergovernmental Oceanographic Commission (IOC) from 2004.
Laboratories for biotoxins
The audit team noted that:
•
Both laboratories visited were adequately equipped and staff were trained and
competent in their corresponding fields of expertise.
•
Both laboratories were accredited to ISO IEC 17025 by VILAS, and the scope
of accreditation included the analysis of:
Ø PSP in shellfish by mouse bioassay based on the AOAC official
method 959.08, Edition 2007;
Ø ASP in shellfish by high-performance liquid chromatography with
19
ultraviolet detection method; and,
Ø lipophilic toxins in shellfish by mouse bioassay using the entire body
of the LBM as test portion. The bioassay involved acetone extraction
and it was supplemented with liquid/liquid partition steps with
dichloromethane/water to remove potential interferences as foreseen in
Chapter III B of Annex III to Regulation (EC) No 2074/2005.
5.8.4
•
Analysis of biotoxins were carried out according to the methods accredited.
•
The procedure for LBM sample receipting for biotoxin testing was the same as
that for microbiological testing (see section 5.8.1.).
•
Both laboratories participated in proficiency tests for ASP but not for PSP and
lipophilic toxins as, according to the CA, they did not find an organiser for
them.
•
In both laboratories lipophilic toxins were reported as diarrheic shellfish poison
which may lead to result interpretation errors.
•
In the laboratories’ standard operational procedures, reference to repealed
legislation (Commission Decision 225/2002/EC) is still made.
•
According to the information provided by the CA, both laboratories will
implement the LC-MS/MS method for lipophilic toxins from 1 January 2015.
The CA informed the audit team that although the equipment was in place, the
delay in the validation and implementation of the method was due to the
difficulties to find reference material for all compounds included in the
lipophilic toxins group and its cost. The audit team observed that Branch 4 had
in place all necessary equipment and trained staff to carry out this method but
Branch 1 had only one piece of equipment which would be used for other
purposes also.
Laboratories for heavy metals
The audit team noted that:
•
Both laboratories visited were adequately equipped and staff were trained and
competent in their corresponding fields of expertise.
•
Both laboratories were accredited to ISO IEC 17025 by VILAS, and the scope
of accreditation included the analysis of heavy metals.
•
Both laboratories used the same method of analysis, which met the
performance criteria established in EU legislation.
•
Both laboratories participated in proficiency tests with satisfactory results.
Conclusions
The general performance of the laboratories carrying out official testing, except for
norovirus analyses, allows the CA to provide the required guarantees regarding the
reliability of the testing results, although their participation in proficiency testing is
limited. Certain methods and performance criteria require revision.
6
OVERALL CONCLUSIONS
The CAs have an official control system in place to control the production of LBM and fishery
20
products derived therefrom. However, significant deficiencies were identified, mainly related to the
classification of production areas, the monitoring of classified production areas for microbiology,
toxin-producing plankton and biotoxins, the decisions after monitoring and official controls of
establishments. There were also significant shortcomings in the system for official certification that
made official certification unreliable. Because of these deficiencies the CAs cannot provide
adequate guarantees with regard to the sanitary conditions of BM exported to the EU.
Regarding the CAs’ response to the previous FVO report’s recommendations, the audit team noted
that some of the guarantees and corrective actions submitted to the Commission services in
response to the recommendations of that report had not been implemented and enforced by the CAs,
contrary to what the CCA had indicated before the current audit.
7
CLOSING MEETING
During the closing meeting held in Hanoi on 18 September 2014, the audit team presented the
findings and preliminary conclusions of the audit to the CCA.
During this meeting, the CCA acknowledged all the findings and preliminary conclusions presented
by the audit team, provided a commitment to correct the deficiencies and presented a document
with certain corrective actions already implemented or ready to be implemented.
8
RECOMMENDATIONS
The CCA should provide Commission services with an action plan, including a timetable for its
completion, within one month of receipt of the report, in order to address the following
recommendations for BM intended for export to the EU.
N°.
Recommendation
1.
The CA should ensure that national legislation includes requirements at least
equivalent to those established in EU legislation, in order to provide all guarantees
required by the health certificate for imports of fishery products defined in Appendix
IV of Annex VI to Regulation (EC) No 2074/2005.
2.
The CA should ensure that the SANCO lists of production areas and establishments
only include those that comply with the requirements of Articles 12 and 13 of
Regulation (EC) No 854/2004, in order to provide all guarantees required by the health
certificate for imports of fishery products defined in Appendix IV of Annex VI to
Regulation (EC) No 2074/2005.
3.
The CA should ensure that the classification of production areas, including sanitary
surveys, is carried out in line with Chapter II. A of Annex II to Regulation (EC) No
854/2004, in order to provide all guarantees required by the health certificate for
imports of fishery products defined in Appendix IV of Annex VI to Regulation (EC)
No 2074/2005.
4.
The CA should ensure that the monitoring of production areas is carried out in line
with Chapter II. B of Annex II to Regulation (EC) No 854/2004, in order to provide all
guarantees required by the health certificate for imports of fishery products defined in
21
N°.
Recommendation
Appendix IV of Annex VI to Regulation (EC) No 2074/2005.
5.
The CA should ensure that decisions after monitoring are taken in line with Chapter II.
C of Annex II to Regulation (EC) No 854/2004, in order to provide all guarantees
required by the health certificate for imports of fishery products defined in Appendix
IV of Annex VI to Regulation (EC) No 2074/2005.
6.
The CA should ensure that additional monitoring requirements include biotoxins and
contaminants as required in Chapter II. D of Annex II to Regulation (EC) No
854/2004, in order to provide all guarantees required by the health certificate for
imports of fishery products defined in Appendix IV of Annex VI to Regulation (EC)
No 2074/2005.
7.
The CA should ensure that BM from class "B" areas exported to the EU have
undergone adequate treatment to eliminate pathogenic micro-organisms as required in
Chapter II. A.5 of Section VII of Annex III to Regulation (EC) No 853/2004, in order
to provide all guarantees required by the health certificate for imports of fishery
products defined in Appendix IV of Annex VI to Regulation (EC) No 2074/2005.
8.
The CA should ensure that the certification system is in line with the EU requirements
and in particular with Articles 3 and 4 of Directive 96/93/EC and with Article 14.2 of
Regulation (EC) No 854/2004.
The competent authority's response to the recommendations can be found at:
http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_inspection_ref=2014-7147
22
ANNEX 1 - LEGAL REFERENCES
Legal Reference
Official Journal
Title
Dec. 2006/766/EC
OJ L 320, 18.11.2006, 2006/766/EC: Commission Decision of 6
p. 53-57
November 2006 establishing the lists of third
countries and territories from which imports of
bivalve molluscs, echinoderms, tunicates, marine
gastropods and fishery products are permitted
Dir. 96/93/EC
OJ L 13, 16.1.1997, p. Council Directive 96/93/EC of 17 December 1996
28-30
on the certification of animals and animal products
Dir. 98/83/EC
OJ L 330, 5.12.1998, Council Directive 98/83/EC of 3 November 1998
p. 32-54
on the quality of water intended for human
consumption
Reg. 178/2002
OJ L 31, 1.2.2002, p. Regulation (EC) No 178/2002 of the European
1-24
Parliament and of the Council of 28 January 2002
laying down the general principles and
requirements of food law, establishing the
European Food Safety Authority and laying down
procedures in matters of food safety
Reg. 852/2004
OJ L 139, 30.4.2004, Regulation (EC) No 852/2004 of the European
p. 1, Corrected and Parliament and of the Council of 29 April 2004 on
re-published in OJ L the hygiene of foodstuffs
226, 25.6.2004, p. 3
Reg. 853/2004
OJ L 139, 30.4.2004,
p. 55, Corrected and
re-published in OJ L
226, 25.6.2004, p. 22
Regulation (EC) No 853/2004 of the European
Parliament and of the Council of 29 April 2004
laying down specific hygiene rules for food of
animal origin
Reg. 854/2004
OJ L 139, 30.4.2004,
p. 206, Corrected and
re-published in OJ L
226, 25.6.2004, p. 83
Regulation (EC) No 854/2004 of the European
Parliament and of the Council of 29 April 2004
laying down specific rules for the organisation of
official controls on products of animal origin
intended for human consumption
23
Legal Reference
Official Journal
Title
Reg. 882/2004
OJ L 165, 30.4.2004,
p. 1, Corrected and
re-published in OJ L
191, 28.5.2004, p. 1
Regulation (EC) No 882/2004 of the European
Parliament and of the Council of 29 April 2004 on
official controls performed to ensure the
verification of compliance with feed and food law,
animal health and animal welfare rules
Reg. 2073/2005
OJ L 338, 22.12.2005, Commission Regulation (EC) No 2073/2005 of 15
p. 1-26
November 2005 on microbiological criteria for
foodstuffs
Reg. 2074/2005
OJ L 338, 22.12.2005, Commission Regulation (EC) No 2074/2005 of 5
p. 27-59
December 2005 laying down implementing
measures for certain products under Regulation
(EC) No 853/2004 of the European Parliament and
of the Council and for the organisation of official
controls under Regulation (EC) No 854/2004 of the
European Parliament and of the Council and
Regulation (EC) No 882/2004 of the European
Parliament and of the Council, derogating from
Regulation (EC) No 852/2004 of the European
Parliament and of the Council and amending
Regulations (EC) No 853/2004 and (EC) No
854/2004
Reg. 1881/2006
OJ L 364, 20.12.2006, Commission Regulation (EC) No 1881/2006 of 19
p. 5-24
December 2006 setting maximum levels for certain
contaminants in foodstuffs
Reg. 333/2007
OJ L 88, 29.3.2007, p. Commission Regulation (EC) No 333/2007 of 28
29-38
March 2007 laying down the methods of sampling
and analysis for the official control of the levels of
lead, cadmium, mercury, inorganic tin, 3-MCPD
and benzo(a)pyrene in foodstuffs
Reg. 252/2012
OJ L 84, 23.3.2012, p. Commission Regulation (EU) No 252/2012 of
1-22
21 March 2012 laying down methods of sampling
and analysis for the official control of levels of
dioxins, dioxin-like PCBs and non-dioxin-like
PCBs in certain foodstuffs and repealing
Regulation (EC) No 1883/2006
24