Professional Documents
Culture Documents
i
TABLE OF CONTENTS
1 INTRODUCTION............................................................................................................ 1
2 OBJECTIVES OF THE MISSION...................................................................................... 1
3 LEGAL BASIS FOR THE MISSION.................................................................................. 2
4 BACKGROUND.............................................................................................................. 2
4.1 Export of milk and milk based products from EU to the AN.............................. 2
4.2 Exports of milk and milk products from the AN to the EU................................ 3
5 MAIN FINDINGS........................................................................................................... 3
5.1 Competent Authorities......................................................................................... 3
5.1.1 Legislation.................................................................................................... 3
5.1.2 Organisation and co-ordination of Competent Authorities ......................... 4
5.1.3 Legal/enforcement powers........................................................................... 5
5.1.4 Audits........................................................................................................... 5
5.1.5 Staff performing official controls................................................................. 5
5.1.6 Resources..................................................................................................... 5
5.1.7 Organisation of official controls.................................................................. 5
5.1.8 Control and verification procedures............................................................ 6
5.2 Laboratory Service.............................................................................................. 7
5.3 Application of hygiene rules at establishment level............................................ 7
5.3.1 Approval of establishments.......................................................................... 7
5.3.2 General and specific hygiene requirements................................................. 8
5.3.3 HACCP-based systems................................................................................. 9
5.3.4 Heat treatment.............................................................................................. 9
5.3.5 Traceability systems..................................................................................... 9
5.3.6 Identification marking and labelling.......................................................... 10
5.4 Official controls at establishment level............................................................. 10
5.4.1 Traceability systems................................................................................... 10
5.5 Import controls.................................................................................................. 10
5.6 Official certification.......................................................................................... 11
6 CONCLUSIONS............................................................................................................ 12
6.1 Competent authorities........................................................................................ 12
6.2 Laboratory service............................................................................................. 13
6.3 Application of hygiene rules at establishment level.......................................... 13
6.4 Official controls at establishment level............................................................. 13
6.5 Import controls.................................................................................................. 13
6.6 Official certification.......................................................................................... 13
7 CLOSING MEETING.................................................................................................... 13
ii
8 RECOMMENDATIONS .................................................................................................. 14
iii
ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT
Abbreviation Explanation
AN Netherlands Antilles
CA Competent authority(ies)
CO Certificate of Origin
EC European Community
EU European Union
MS Member State(s)
OV Official veterinarian(s)
TC Third Country(ies)
VS Veterinary Services
iv
1 INTRODUCTION
The mission took place on the Netherlands Antilles (AN) from 20 to 29 January 2009.
The mission was undertaken as part of the Food and Veterinary Office's (FVO) planned
mission programme.
The mission team comprised 2 inspectors from the FVO. The mission team was
accompanied during the mission by 2 representatives of the central competent authorities
(CCA), the Inspectorate of Public Health (IPH) within the Ministry of Public Health and
Social Development (MPHSD). An opening meeting was held on 20 January 2009 with
the CCA. At this meeting the inspection team confirmed the objectives and itinerary of
the mission and additional information required for the satisfactory completion of the
mission was requested.
The objectives of the mission were to assess the adequacy of guarantees given by the CA
of the AN for export of milk and milk based products to the EU.
The mission team did, in particular:
• Assess the controls in place over the production of milk and milk-based products
intended for export to the EU; and
• Review the systems for certification of milk and milk based products in relation to
the requirements of Council Directive 96/93/EC.
In pursuit of these objectives, the following sites were visited:
1
3 LEGAL BASIS FOR THE MISSION
The mission was carried out under the general provisions of Community legislation and,
in particular Article 46 of Regulation (EC) No 882/2004 of the European Parliament and
of the Council.
Full legal references are provided in Annex 1. Legal acts quoted in this report refer,
where applicable, to the last amended version.
4 BACKGROUND
The AN belong to the overseas countries and territories (OCT) to which the provisions of
Council Decision 2001/822/EEC on association of the OCT with the European
Community apply. It comprises 5 islands, Curaçao, Bonaire, Saint Maarten, Saint
Eustatius and Saba. The last FVO mission to the AN (ref DG(SANCO)/1146/2000) was
carried out in March 2000. No previous FVO mission has taken place to the AN to
evaluate the dairy sector.
The AN are included in the Annex to Decision 2004/432/EC listing TC complying with
Directive 96/23/EC on residue monitoring, with the restriction that they can only use raw
material from other approved TC for food production as the AN are authorised to export
milk products to the EU without having to submit an annual residue monitoring plan for
milk as requested by Directive 96/23/EC.
The AN is currently included in Column A of Annex I to Commission Decision
2004/438/EC. This permits the MS to import milk and milk products which have
undergone heat-treatments as specified in Article 2, point 3 of the above Decision.
Dairy establishments in AN, which are on the list of establishments, from which MS are
permitted to import milk and milk based products are restricted to using only raw
materials which originate from other approved TC or MS for production of food destined
for export to the EC.
2
The major trade partners for the above exports from the EU to the AN comprised the
Netherlands, Belgium, Germany, United Kingdom and France.
5 MAIN FINDINGS
5.1.1 Legislation
The main legislation regulating the production of milk and milk based products
comprises the following:
3
• National Decision 72 of 12 September 2006 (National Decision on Quality of
Drinking Water).
National legislation was also received on additives (National Decision 62 of 11 February
2005) and on labelling (Ministerial Decision 53 of 9 June 2004).
The National Decision on production and export of milk and milk-based products
comprises rules in relation to approval procedure of dairy establishments and their listing.
It comprises relevant provisions of Annex B and C of the repealed Council Directive
92/46/EC.
In addition, the above Decision prohibits the use of raw milk and heat-treated milk and
milk products originating from TCs and establishments which are not on the list of
countries and establishments from which MS are permitted to import raw milk,
heat-treated milk and milk based products to the EU, in case these materials are used for
processing of milk-based products which are destined for export to the EU. The national
legislation also prohibits the EU export of milk and milk based products which are
derived from domestic cows.
4
food business operators (FBO) producing for the local market, including restaurants and
retail shops. In addition, the LHDs are also responsible for controls on imported foods
intended for the domestic market.
5.1.4 Audits
The inspector of the IPH is also responsible for the supervision of the LHD of the AN
and carries out annual audits over their activities. The last audit report for Curaçao was
received. The report revealed some deficiencies in relation to resources (for example,
insufficient availability of transport vehicles).
5.1.6 Resources
Sufficient resources were available at the IPH for carrying out the controls of the dairy
establishments approved for EU export.
5
inspection before the export approval, followed by at least 1 annual routine inspection.
The inspector was carrying out the pre-approval inspections and the assistant inspector
was carrying out annual routine inspections of the establishments.
6
5.2 LABORATORY SERVICE
The CCA stated that the public health laboratory services have been privatised. The
laboratory visited was in the process of obtaining ISO 17025 accreditation, starting with
its water analyses. The laboratory had nominated a quality control manager and a quality
control manual as well as standard operational procedures were available. An annual staff
training programme had been established. The laboratory participated annually in
external proficiency testing for water analysis. Documented procedures were available
for testing of the culture media, and for the maintenance and quality controls of reference
strains.
However, the following deficiencies were noted:
• The quality control manual did not yet cover all areas of activity. For example, the
SOP for analyses of milk product was still at draft stage.
• The results of the water proficiency testing were not always satisfactory.
• The laboratory had not established external quality controls (for example,
participation in proficiency testing) for analysis of foodstuffs.
• The same laboratory was used for analysing clinical microbiology samples and food
samples, which could lead to cross-contamination.
• The laboratory had some deficiencies in relation to housekeeping and equipment.
(Some of the media used were expired, a pipette designated to the PCR laboratory
was found in the general microbiology department, the contents of the only -70°C
deep freezer were in disorder and there was no alarm in case of its breakdown).
• Not all pipettes had yet been included in the calibration scheme.
• The laboratory analysing both clinical and food microbiology was not equipped with
a laminar flow safety cabinet, although it was handling samples containing
potentially pathogenic microbes.
• There were no indications of restricted access for certain laboratories for the staff.
• The results of the analyses did not mention the methods used.
• The laboratory results were sometimes delivered to the FBO with a significant delay
and after the consignments had already left the harbour.
• One consignment, containing milk based components, destined for EU export had
tested positive for Escherichia coli but instead of excluding it from export it had
been retested with negative result and exported.
• No procedure has been established for the sampling of the consignments which are
destined for export to the EU. This sampling was carried out by the FBO.
1. Written request of the FBO to the Head of the IPH for the establishment to be
approved for export to the EU.
2. Inspection of the establishment by the inspector of the IPH.
3. Approval was issued by the IPH, together with a letter stating the rules and
restrictions to be followed, if the establishment was found to be in line with EC
requirements.
Documentation seen in relation to the approvals was available for all establishments
visited, and comprised the details as described above.
• The HACCP manuals seen contained some errors (for example, 1 HACCP referred
to legislation on slaughter animals).
• The HACCP manuals of the establishments visited which were undergoing changes
in their production were not yet finalised (for example, the recall procedure and
rework had not been included).
• In another establishment, the list of CCP in the HACCP manual also contained
control points, but on the other hand the heat-treatment was not considered as a
CCP.
• No procedure had been established by the FBO for sampling of the final products.
• Although the CCA met stated that they were checking the inventory lists at the
establishments, the data available on these inventories was insufficient to guarantee
full traceability.
• There was no documented evidence that the CCA had checked other traceability
elements established by the FBO.
• The CA responsible for the controls at establishment level had not noted that the
documentation in relation to some export consignments was incomplete.
10
that the products would be EU eligible) and were produced in EU listed establishments
under hygienic conditions.
The following deficiencies were noted in relation to the import controls:
• There was no procedure in place for veterinary import controls of milk and milk
based products destined to be used as raw materials for milk and milk based
products destined for export to the EU.
• Both CCAs (VS and IPH) stated that no physical controls or sampling are carried
out in relation to the imported dairy products to be used for products destined for
EU export.
• For 1 consignment which had arrived from the EU to be used as raw material for a
milk and milk based product destined for export to the EU, no health certificate or a
copy of it could be found in the files of the IPH.
• One consignment of full cream milk powder had arrived in 2008 from Northern
Ireland without guarantees that the product was fit for human consumption.
• The system in place does not guarantee that products imported for local
consumption are not used as raw materials for dairy products destined for export to
the EU. For example, 1 of the establishments visited had also used a milk product as
a raw material for a composite product destined for EU export, whereas the raw
material had initially been imported by a trader as a product to be used on the local
market. No copies of the health certificates were available for this imported product
in the files of the IPH (however, the product was fit for human consumption,
originated from a MS and was correctly labelled).
1. Notification by the FBO to the IPH of the intended export and filling out the EU
health certificate with the necessary details (the head of the VS has provided the
establishments with the blank certificate model by e-mail). The FBO should inform
the IPH about the inventory, origin and destination of the raw materials used for
production of milk and milk based products destined for EU export when requesting
a health certificate for these export consignments.
2. The IPH receives and checks the following documentation in relation to the export
batch:
- EU health certificate
- Loading list
- Results from the PH laboratory on microbiology for each container to be exported
- EU heath certificates of the raw materials of dairy origin used for the product
- Inventory list from the establishment in relation to imported and used raw material
of dairy origin.
3. If the above file is correct the inspector sends the EU export certificate to the VS,
11
where usually the Head of the VS signs the animal health section of the certificate
(but both OVs can sign).
4. The Head of the IPH then signs the public health part of the certificate.
5. The files are sent to the customs, including the CO and the invoice for the customer.
The staff at the customs check that all the necessary documentation is correct and
complete and stamps and signs the CO of origin, after which the consignment can be
dispatched (after being sealed by the shipping company).
The customs staff met had a procedure and checklist in place for the export of milk and
milk based products to the EU. However, the customs staff met stated that their priority
was to check the procedure in relation to the CO linked to Decision 2001/822/EC.
The following shortcomings were noted in relation to the official certification:
• The CCA had in most cases not checked the health certificates of the milk and milk
based products imported and used as raw material for production of the milk based
products destined for export to the EU. Thus the guarantees on the export certificate
for the exported milk composite products had been ascertained without checking
that all supporting documentation was correct.
• Sometimes the certificates for imported milk and milk based products had arrived
with significant delay (especially for products from New Zealand). In some cases
the date of the import certificate was later than the date on the AN export certificate.
• Although the FBOs were required to keep a register of the arriving raw material, the
storage in stock and the products exported, there was not always a clear link
between the imported raw materials and the exported products and there was no
evidence that the CCA had checked the traceability.
• The files of the certificates were not always complete and 1 certificate with the same
number had been issued twice on 2 different dates.
• There was no procedure in place in relation to cancelled and replaced certificates.
6 CONCLUSIONS
12
No training programme in relation to special EU requirements has been provided for the
CA involved in the above controls.
The staff met were not aware of all relevant requirements in relation to certification, as
required in Directive 96/93/EC and Decision 2004/438/EC.
7 CLOSING MEETING
A closing meeting was held on 29 January 2009 with the representatives of the IPH and
the VS. At this meeting, the main findings and conclusions were presented by the
mission team. The CA took note of these findings and conclusions.
13
8 RECOMMENDATIONS
14
The competent authority's response to the recommendations can be found at:
http://ec.europa.eu/food/fvo/ap/ap_the_netherlands_antilles_8205_2009.pdf
15
ANNEX 1 - LIST OF LEGISLATION REFERENCED IN THE REPORT
16
Reference OJ Ref. Detail
27.5.2004, p.
33
Decision OJ L 154,
2004/438/EC 30.4.2004, p. Commission Decision 2004/438/EC of 29 April
72–92, 2004 laying down animal and public health and
corrected and veterinary certifications conditions for introduction
re-published in in the Community of heat-treated milk, milk-based
OJ L 92, products and raw milk intended for human
12.4.2005, p. consumption
47
Decision OJ L 116, 2007/275/EC: Commission Decision of 17 April
2007/275/EC 4.5.2007, p. 2007 concerning lists of animals and products to be
9–33 subject to controls at border inspection posts under
Council Directives 91/496/EEC and 97/78/EC
Regulation OJ L 31, Regulation (EC) No 178/2002 of the European
(EC) No 1.2.2002, p. Parliament and of the Council of 28 January 2002
178/2002 1–24 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
Regulation OJ L 139,
(EC) No 30.4.2004, p.
852/2004 1, Corrected Regulation (EC) No 852/2004 of the European
and Parliament and of the Council of 29 April 2004 on
re-published in the hygiene of foodstuffs
OJ L 226,
25.6.2004, p. 3
Regulation OJ L 139,
(EC) No 30.4.2004, p.
853/2004 55, Corrected Regulation (EC) No 853/2004 of the European
and Parliament and of the Council of 29 April 2004
re-published in laying down specific hygiene rules for food of
OJ L 226, animal origin
25.6.2004, p.
22
Regulation OJ L 139,
(EC) No 30.4.2004, p.
Regulation (EC) No 854/2004 of the European
854/2004 206, Corrected
Parliament and of the Council of 29 April 2004
and
laying down specific rules for the organisation of
re-published in
official controls on products of animal origin
OJ L 226,
intended for human consumption
25.6.2004, p.
83
17
Reference OJ Ref. Detail
Regulation OJ L 165,
(EC) No 30.4.2004, p. Regulation (EC) No 882/2004 of the European
882/2004 1, Corrected Parliament and of the Council of 29 April 2004 on
and official controls performed to ensure the verification
re-published in of compliance with feed and food law, animal
OJ L 191, health and animal welfare rules
28.5.2004, p. 1
Regulation OJ L 338, Commission Regulation (EC) No 2073/2005 of 15
(EC) No 22.12.2005, p. November 2005 on microbiological criteria for
2073/2005 1–26 foodstuffs
Regulation OJ L 338, Commission Regulation (EC) No 2074/2005 of 5
(EC) No 22.12.2005, p. December 2005 laying down implementing
2074/2005 27–59 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
Regulation OJ L 338, Commission Regulation (EC) No 2076/2005 of 5
(EC) No 22.12.2005, p. December 2005 laying down transitional
2076/2005 83–88 arrangements for the implementation of Regulations
(EC) No 853/2004, (EC) No 854/2004 and (EC) No
882/2004 of the European Parliament and of the
Council and amending Regulations (EC) No
853/2004 and (EC) No 854/2004
18