EUROPEAN COMMISSION

HEALTH & CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

DG(SANCO)/ 2009-8205 - MR - FINAL

FINAL REPORT OF A MISSION

CARRIED OUT IN
THE NETHERLANDS ANTILLES
FROM 20 JANUARY TO 29 JANUARY 2009
IN ORDER TO
EVALUATE THE OPERATION OF CONTROLS OVER THE PRODUCTION OF
MILK, HEAT TREATED MILK AND MILK BASED PRODUCTS FOR HUMAN
CONSUMPTION DESTINED FOR EXPORT TO THE EUROPEAN UNION, AS
WELL AS THEIR CERTIFICATION PROCEDURES
 Executive Summary
A mission to the Netherlands Antilles (AN) was carried out from 20 to 29 January 2009
in order to evaluate the adequacy of guarantees given by the CA of the AN for export
milk and milk-based products to the EU.
Dairy establishments in AN, which are on the list of establishments, from which Member
States (MS) are permitted to import milk and milk based products, are restricted to using
only raw materials which originate from other approved third countries or MS for
production of food destined for export to the European Community (EC). The mission
team visited 4 establishments on the above-mentioned list and 1 which had been recently
de-listed. The 4 establishments on the list produced premixes for the food industry. Only
2 of the establishments visited had produced composite milk and milk based products,
which had more than 50% of milk and milk based products in the final product in
2007-2008.
The Competent Authorities (CAs) responsible for the controls of establishments, from
which the MS are permitted to import milk and milk based products to the EU had
sufficient legal and enforcement powers and staff. However, no procedures had been
established to ensure effective co-ordination between the different CAs responsible for
control of the whole production chain for milk and milk products destined for EU export.
The laboratory visited had some shortcomings in relation to its facilities, equipment and
quality control. These shortcomings could endanger the validity of the results.
A procedure was in place for the approval of the establishments. Although a control
system for dairy establishments producing for the EU export market was in place it did
not verify that all relevant EU requirements had been taken into account. Shortcomings
were noted as the CA had failed to identify some relevant deficiencies in relation to the
general and specific hygiene requirements in the establishments in relation to exports to
the EU.
Deficiencies were noted in relation to import controls of raw materials of dairy origin.
The system currently in place for import controls does not ensure that all raw materials
of dairy origin are EU eligible.
The procedure in place for certification does not take into account all the relevant
requirements as specified in Council Directive 96/93/EC and Commission Decision
2004/438/EC. Some export certificates had been issued without having sufficient
guarantees to ensure that the exported milk based products fulfilled all animal health
requirements of the EU export certificate.
Some shortcomings were noted in the establishments visited in relation to maintenance,
pest control and Hazard Analysis Critical Control Points (HACCP). A number of
recommendations were made to address the deficiencies in relation to the export of milk
and milk based products to the EU.

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TABLE OF CONTENTS

1 INTRODUCTION............................................................................................................ 1
2 OBJECTIVES OF THE MISSION...................................................................................... 1
3 LEGAL BASIS FOR THE MISSION.................................................................................. 2
4 BACKGROUND.............................................................................................................. 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

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8 RECOMMENDATIONS .................................................................................................. 14

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 ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT

Abbreviation Explanation

AN Netherlands Antilles

CA Competent authority(ies)

CCA Central Competent Authority(ies)

CO Certificate of Origin

DPH Directorate of Public Health

EC European Community

EU European Union

FBO Food Business Operator(s)

FVO Food and Veterinary Office

HACCP Hazard Analysis and Critical Control Points

IPH Inspectorate of Public Health

LHD Local Hygiene Department(s)

MPHSD Ministry of Public Health and Social Development

MS Member State(s)

OCT Overseas Countries and Territories

OV Official veterinarian(s)

TC Third Country(ies)

VS Veterinary Services

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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.

2 OBJECTIVES OF THE MISSION

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:

Central competent 1 IPH, Opening and closing

authorities meeting

Local competent authorities 1 Veterinary Services (VS) of

Curaçao

Dairy establishments 5 The CCA had

communicated the
de-listing of them by a
letter to the Commission
Services dated January
2009

Customs 1 The central customs office

in Curaçao

Laboratories 1 Private laboratory analysing

public health and clinical
samples

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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.

4.1 EXPORT OF MILK AND MILK BASED PRODUCTS FROM EU TO THE AN

The main exports of milk and products from the EU to the AN in 2007 comprised the
following products and amounts (in tonnes):
(source: Eurostat)
Milk 2 206
Cream 1 129
Buttermilk and whey 517
Butter 163
Cheese 2 159
Ice cream 137

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The major trade partners for the above exports from the EU to the AN comprised the
Netherlands, Belgium, Germany, United Kingdom and France.

4.2 EXPORTS OF MILK AND MILK PRODUCTS FROM THE AN TO THE EU

In 2007 and 2008, the AN was not exporting milk and milk based products (except for 2
consignments in 2008).
However, some food preparations (CN codes 1901 and 2106 9098), containing milk
based components, were exported in 2007 (2 068 and 3 307 tonnes respectively). In
2008, the exports also included sugar mixed with caseinates (CN code 2106 1000).
The major trading partners for the export of the above products from the AN to EU
comprised the Netherlands and Belgium.
The only information available in relation to exports of milk and milk based products
from the AN to the EU in European Commission's integrated computerised veterinary
system were 2 consignments exported in 2008, namely 1 consignment of 4005 kg
(anhydrous butter fat mixed with sugar) and another of 1 kg (concentrated milk).

5 MAIN FINDINGS

5.1 COMPETENT AUTHORITIES

5.1.1 Legislation
The main legislation regulating the production of milk and milk based products
comprises the following:

• National Ordinance 334 of 29 December 1997 containing rules on goods (Goods

Ordinance); and
• National Decision 56 on general rules on foodstuffs based on Article 3 of Goods
Ordinance) of 29 April 2005 (National Decision on production and export of milk
and milk based products).
Legislation regulating the powers and tasks of the CA involved in controls/certification
of milk and milk based products comprise the following:

• The Veterinary Regulation No 17 of 22 February 1933 (powers of the VS - the Head

of the VS stated that new legislation is being drafted to replace this regulation).
• National Ordinance 8 of 18 December 2003 (powers and tasks of IPH) about rules
on public health inspections).
National legislation in relation to drinking water comprises the following:

• National Ordinance 37 of 7 April 2006 on Quality of Water Destined for Human

Consumption (National Ordinance on Drinking Water) ; and

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 • 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.

5.1.2 Organisation and co-ordination of Competent Authorities

5.1.2.1 Veterinary Services

The VS are part of the Insular Governments and are responsible for the animal health
controls. The VS comprise the Director and 2 departments, of which 1 is dealing with
meat inspection, the other with planning, surveys and contingency plans in relation to
animal health. The VS has 2 official veterinarians (OVs) who can sign the animal health
part of the export certificate (the third OV post of the VS was vacant).
The director of the VS has the power to decide and set conditions for imports of live
animals and meat and the OVs are also responsible for checking the arriving
consignments in relation to the above goods. However, the OVs are not involved in the
controls of imported milk, heat-treated milk and milk based products.

5.1.2.2 Public Health Services

The Public Health Services comprise different units with different responsibilities. The
IPH within the MPHSD is the CCA responsible for the approval and control of the dairy
establishments, from which the MS are permitted to import milk and milk based
products. The director of the IPH reports directly to the Minister of the MPHSD. The
Head of the IPH stated that imported products intended for further processing of which
the final dairy products are destined to be exported to the EU are in principle the
responsibility of the IPH. However, the IPH staff met stated that they had not carried out
controls on the imported milk and milk based products at their entry to AN. (See also
Chapter 5.5 Import Controls).
The 5 islands also have local hygiene departments (LHD) which are, amongst other tasks,
responsible for vector control, and inspection and sampling of food products and water at

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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.

5.1.3 Legal/enforcement powers

The VS of Curaçao are empowered by Veterinary Regulation No 17 of 22 February 1933
to establish the rules for imports of live animals and of meat and implement animal
health controls on these imports and slaughter of livestock.
The powers of the CCA responsible for the supervision of the processing of milk and
milk based products and their production for export to the EU are given in the National
Ordinance No 8 of 18 December 2003 on Public Health Inspections (Ordinance on Public
Health).
The Ordinance on Public Health provides the CCA with enforcement powers, including
sanctions, to ensure that animal products comply with the sanitary rules. Sanctions
include fines, with a maximum fine of 1 million guilder. The CCA met stated that so far
no fines had been given for FBO of dairy establishments approved for EU exports.
However, some warning letters had been issued in the past.

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).

5.1.5 Staff performing official controls

The number of staff responsible for official controls in relation to EU export dairy
establishment was 3, namely 1 inspector who had also other responsibilities (supervision
of the LHD of whole AN, including annual audits), 1 adjunct inspector dealing with the
dairy sector, pesticides and irradiation and 1 assistant inspector (food controller). The
assistant inspector was also responsible for other areas, for example, fishery products and
recalls of different food products, drinks and other commodities.
The adjunct inspector had been recruited in 2008 and has since then accompanied the
assistant inspector on inspections.

5.1.6 Resources
Sufficient resources were available at the IPH for carrying out the controls of the dairy
establishments approved for EU export.

5.1.7 Organisation of official controls

The official controls of EU export dairy establishments by the IPH comprised the initial

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.

5.1.8 Control and verification procedures

The IPH had established a standard checklist for the inspection of establishments
approved for EU export, taking into account the Community specific requirements for
milk and milk products. Reports and checklists of pre-approval inspections and most
annual inspections were available. The reports comprised findings and conclusions and
an overall assessment of the compliance with the Community requirements.
No additional verification procedures had been established.
The following shortcomings were noted in relation to the performance of the CA:

• There was no evidence of any documented procedure or guidelines for controls by

the IPH on imported milk and milk-based products intended for further processing
into final dairy products destined for export to the EU.
• There was no documented evidence of any checks by the IPH on imported milk and
milk-based products intended for further processing into final dairy products
destined for export to the EU.
• There was no documented evidence of effective co-operation between the LHD and
IPH, although the LHD is indirectly involved in the import controls as the customs
staff met stated they would in form the LHD, not the IPH, if they would detect
irregularities or problems with the imported raw materials of dairy origin.
• No special training programme in relation to special EU requirements has been
provided for CA involved in the above controls.
• The IPH was not aware of all EU requirements in relation to certification of the
products destined for export to the EU (see also Chapter 5.6 Certification)
• Although the establishments visited had been approved for EU export none of them
was in line with all the relevant EC requirements as specified in Regulations (EC)
No. 852/2004 and No. 853/2004.
• Additional visits by the CCA to the establishments before approval were not always
documented.
• Some deficiencies identified by the mission team had not been included in reports
by the IPH staff (for example, access and presence of birds and insects in the
production area, lack of full traceability between the imported raw materials and
exported dairy products, housekeeping deficiencies).
• Sometimes the annual inspection reports were issued to the FBO with a delay of 1-2
months after the inspection.
• The inspection reports often did not include deadlines for corrective actions.
• No written documentation was provided to the mission team in relation to the
de-listing procedure of the 2 establishments in January 2009.

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 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.

5.3 APPLICATION OF HYGIENE RULES AT ESTABLISHMENT LEVEL

5.3.1 Approval of establishments

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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 TCs or MS for the production of food destined for
export to the EC. The AN had 6 dairy establishments on the above-mentioned list
(published 18 July 2008), but the CCA had de-listed 2 of them shortly before the mission
in January 2009. The CS were requested to delete these establishments from the list by a
fax dated 8 January 2009.
Of the 5 establishments visited 4 produced composite milk products. The
fifth establishment visited had recently been de-listed and was considered by the mission
team not to be a dairy establishment, as it produced alcoholic beverages (liquors), of
which one was milk based (however, the end product contained more than 50% of
milk). Three of the establishments visited were producing dry premixes for the dairy
industry (sugar based), whereas 1 was planning to produce “wet products” based on
anhydrous milk fat mixed with cocoa or sugar.
Only 2 of the establishments visited had produced composite milk and milk based
product, which had more than 50% of milk and milk based products in the final product
in 2007-2008.
None of the 5 establishments visited was producing milk and milk based products for EU
export during the visit of the mission team.
The approval procedure comprised the following steps:

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.

5.3.2 General and specific hygiene requirements

The establishment visited planning to produce “wet products” had in general satisfactory
equipment for the intended type of production. The mixing equipment for production of
dry products was in general adequate.
The following deficiencies were noted:

• In all establishments visited some maintenance problems were noted in relation to

the ceilings, walls, doors, and floors (for example broken roof panels, flaking paint,
walls not easy to clean, in 1 establishment stagnating water in a narrow corridor
behind the maintenance department).
• The production area for milk and milk based products in all establishments visited
was not pest proof (doors were either not available or they were kept open, or they
8
 did not close tightly, insect screens were broken) and insects and birds were flying
in an area where exposed products were handled.
• In 1 establishment producing dry products a metal filter had a partly broken mesh.
• Deficiencies were also noted in relation to cleanliness and housekeeping in the
production and storage areas.
• The own control laboratory visited in 1 establishment lacked essential equipment to
carry out the analysis planned (for example, no refrigerator, gas or exhaust cabinet
for organic solvents).
• In general, at all the establishments visited, requirements concerning hygiene were
not met in the production areas for products which were destined for export to the
EU. For example, birds flying over production line which was partly exposed as
well as dirty and dusty storage area for raw materials.

5.3.3 HACCP-based systems

All the establishments visited had established HACCP principles and HACCP manuals
were available. In all establishments visited the FBO had procedures in place or under
development based on the HACCP principles. Results of sampling of final products and
water were available and in general satisfactory. The establishments visited had in
general adequate documentation in relation to their own control programme.
The following deficiencies were noted in relation to the HACCP and own control
programmes:

• 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.

5.3.4 Heat treatment

Three of the establishments visited used as raw material milk powder or caseinates,
which had already been subject to heat treatment. One establishment visited was planning
to commence production of unhydrous butter fat mixed with sugar and/or cocoa which
would be further subjected to pasteurisation. The pasteurisation equipment was adequate.

5.3.5 Traceability systems

The establishments visited had established traceability systems. The FBO visited kept
inventories of the milk and milk based products imported and exported and kept in store
9
(including composite products). However, the raw materials destined for EU export
production were not always well separated from other materials in the storage area.

5.3.6 Identification marking and labelling

The products imported from the EU and from TCs seen by the mission team, destined to
be used for production of milk products for the EU market, were correctly labelled.

5.4 OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL

5.4.1 Traceability systems

The establishments visited did not produce any milk and milk based products for the
local market and the FBO met stated that all milk based raw materials used would be
purchased from the MS or TC and establishments which are on the lists of countries and
establishments, from which the MS are permitted to import milk and milk based
products.
The following deficiencies were noted by the mission team:

• 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.

5.5 IMPORT CONTROLS

The staff of the IPH had so far not carried out controls on imported milk and milk-based
products intended to be used as raw material for dairy products destined for export to the
EU.
According to the officials met at the Customs Office in Curaçao, when milk and
milk-based products arrive on AN the customs staff verify that these products arrive with
the certificate of origin (CO) as defined in Appendix 3 of Annex III to Decision
2001/822/EC and that the products match with the CO. The customs officials met stated
that they would inform the LHD, if they detect or suspect irregularities or a public health
problem in relation to the imported milk and milk based products (this has, however, not
happened) and that it would then be the responsibility of the LHD to inform the IPH
about the situation. The customs officials also stated that all dairy products from the EU
or TC, would be accompanied by a health certificate.
The raw materials of dairy origin seen by the mission team to be used for products
destined for export to the EU derived either from a MS or from EU export-approved
establishments in TC (mainly from New Zealand or Australia). The certificates from the
TCs stated that the products were fit for human consumption (but did not always mention

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).

5.6 OFFICIAL CERTIFICATION

According to the CCA met the certification procedure for milk products for export to the
EU comprises in principle the following steps:

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

6.1 COMPETENT AUTHORITIES

The CA responsible for the controls of establishments, from which the MS are permitted
to import milk and milk based products to the EU have sufficient legal and enforcement
powers and staff.
However, no procedures had been established for the effective co-ordination between
different CA responsible for control of the whole production chain for milk and milk
based products destined for EU export.
Implementation of the control system in place for veterinary import controls on milk and
milk based products imported to be used as raw material for milk and milk based
products destined for export to the EU was insufficient.

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.

6.2 LABORATORY SERVICE

The laboratory visited had some shortcomings in relation to its facilities, equipment and
quality control. These shortcomings could endanger the validity of the results.

6.3 APPLICATION OF HYGIENE RULES AT ESTABLISHMENT LEVEL

Some shortcomings were noted in the establishments visited in relation to maintenance,
pest control and HACCP. These shortcomings could be rectified with some effort.
Traceability systems had been established and the documentation in relation to own
controls was in general adequate.

6.4 OFFICIAL CONTROLS AT ESTABLISHMENT LEVEL

Although a control system for dairy establishments producing for the EU export market
was in place it did not verify that all the relevant EU requirements had been taken into
account. Shortcomings were noted as the CA had not included checks on traceability in
their controls and had not identified some relevant deficiencies in relation to the general
and specific hygiene requirements in the establishments in relation to export to the EU.

6.5 IMPORT CONTROLS

Deficiencies were noted in relation to import controls of raw materials of dairy origin.
The system currently in place for import controls does not ensure that all raw materials of
dairy origin, used for dairy products destined for EU export, are EU eligible.

6.6 OFFICIAL CERTIFICATION

The procedure in place for certification does not take into account all relevant
requirements as specified in Directive 96/93/EC and Decision 2004/438/EC. Some export
certificates had been issued without having sufficient guarantees to ensure that the
exported milk based products fulfilled all the animal health requirements of the EU
export certificate.

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.

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8 RECOMMENDATIONS

An action plan describing the action taken or planned in response to the

recommendations of this report and setting out a time table, and a description of the
actions taken to correct the deficiencies found should be presented to the
Commission within 25 working days of the receipt of the report.
No. Recommendation
To ensure that controls of dairy products destined for exports to the EU cover the
1 whole production chain to enable certification according to the requirements of
Council Directive 96/93/EC and Commission Decision 2004/438/EC.
To provide appropriate training on the relevant EU requirements as given in
Regulations (EC) No 852/2004, No 853/2004, No 854/2004 and Council
Directive 96/93/EC for the competent authorities involved in official controls of
2 dairy establishments from which imports to the Community are permitted to
ensure that they are aware of the legal provisions, as required in points 9.2. and
11.2. of the model health certificate MILK-HTC of Annex II, Part 2 of
Commission Decision 2004/438/EC.
To ensure that the laboratory, analysing samples derived from dairy
establishments, from which Member States are permitted to import milk and milk
based products, has adequate facilities and equipment and establishes quality
3
control schemes to guarantee the validity of the results, in order to be in line with
the requirements of Article 12 of Regulation (EC) No 882/2004 taking into
consideration the derogation of Article 18 of Regulation (EC) No 2076/2005.
To ensure that the imported raw materials of dairy origin to be used for milk
based products destined for exports to the EU are accompanied by health
4 certificates containing all the necessary details to enable correct certification of
the final products destined for export to the EU in line with the provisions of
Article 3 of Council Directive 96/93/EC.
To ensure that the traceability between the imported raw materials of dairy origin
to be used as raw material for milk based products destined for exports to the EU
5 and the final milk based products destined for exports to the EU is established so
that certifying officers can ascertain data required for export certification in line
with Article 3 of Council Directive 96/93/EC.
To ensure that the certification of dairy products destined for export to the EU is
6 carried out according to the requirements of Council Directive 96/93/EC and
Commission Decision 2004/438/EC.
To urgently correct deficiencies in the dairy establishments from which Member
States are permitted to import milk and milk-based products, to guarantee that
7
establishments are in line with EU standards, as required by Article 12 of
Regulation (EC) No 854/2004.

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

Reference OJ Ref. Detail

Directive OJ L 125, Council Directive 96/22/EC of 29 April 1996
96/22/EC 23.5.1996, p. concerning the prohibition on the use in
3–9 stockfarming of certain substances having a
hormonal or thyrostatic action and of ß-agonists,
and repealing Directives 81/602/EEC, 88/146/EEC
and 88/299/EEC
Directive OJ L 125, Council Directive 96/23/EC of 29 April 1996 on
96/23/EC 23.5.1996, p. measures to monitor certain substances and residues
10–32 thereof in live animals and animal products and
repealing Directives 85/358/EEC and 86/469/EEC
and Decisions 89/187/EEC and 91/664/EEC
Directive OJ L 330, Council Directive 98/83/EC of 3 November 1998
98/83/EC 5.12.1998, p. on the quality of water intended for human
32–54 consumption
Directive OJ L 13,
Council Directive 96/93/EC of 17 December 1996
96/93/EC 16.1.1997, p.
on the certification of animals and animal products
28–30
Directive OJ L 18, Council Directive 2002/99/EC of 16 December
2002/99/EC 23.1.2003, p. 2002 laying down the animal health rules governing
11–20 the production, processing, distribution and
introduction of products of animal origin for human
consumption
Directive OJ L 157, Directive 2004/41/EC of the European Parliament
2004/41/EC 30.04.2004, and of the Council of 21 April 2004 repealing
p.33 corrected certain Directives concerning food hygiene and
and health conditions for the production and placing on
re-published in the market of certain products of animal origin
OJ L 195, intended for human consumption and amending
02.06.2004, p. Council Directives 89/662/EEC and 92/118/EEC
12 and Council Decision 95/408/EC
Decision OJ L 314, 2001/822/EC: Council Decision of 27 November
2001/822/EC 30.11.2001, p. 2001 on the association of the overseas countries
1–77 and territories with the European Community
("Overseas Association Decision")
Decision OJ L 154,
2004/432/EC 30.4.2004, p. 2004/432/EC: Commission Decision of 29 April
44–50, 2004 on the approval of residue monitoring plans
corrected and submitted by third countries in accordance with
re-published in Council Directive 96/23/EC
OJ L 189,

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