Source: EURLEX
Language: en
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# 52012DC0122

**REPORT FROM THE COMMISSION on the overall operation of official controls in the Member States on food safety, animal health and animal welfare, and plant health /\* COM/2012/0122 final \*/**

  

TABLE OF CONTENTS

1..... Background. 1

2..... The EU Food Chain. 2

3..... Overview of EU food safety controls. 3

3.1.    Review
of annual reports of Member States. 3

3.2.    Results
of the Commission's control activities in the Member States. 10

3.3.    Other
sources of information on controls in the Member States. 21

3.4.    Commission
follow-up and enforcement 22

4..... Conclusions. 24

1.
Background

Article 44 (1) of Regulation (EC) No
882/2004[1]
(Feed and Food Controls Regulation) requires Member States to submit to the
Commission each year a report on the implementation of their multi-annual
national control plans established in compliance with Article 41 of that
Regulation.  The reports should contain:

(a)
details of amendments to multi-annual national
control plans, to take into account among other factors, changes in
legislation, new diseases or risk factors, new science, the results of past
controls and significant organisational changes;

(b)
the results of controls and audits carried out
in the previous year under the national control plan;

(c)
the type and number of cases of non-compliance
identified through the controls;

(d)
actions to ensure effective implementation of
the national control plan, including enforcement actions and their results.

Article 44 (4) and (6) of the
Regulation require the Commission to establish and submit to the European
Parliament and Council an annual report on the overall operation of controls in
the Member States in the light of:

(a)
the annual reports submitted by the national
authorities;

(b)
EU audits[2]
and inspections carried out in the Member States;

(c)
and any other relevant information.

The Commission submitted its first report
to the European Parliament and the Council in August 2010.[3]  The main purpose of
that report was to provide a first screening of the data and information on
official controls contained in the first annual reports from the Member States.
It also gave a summary of results of EU audits and inspections. It was discussed
by Member States in the Standing Committee of the Food Chain and Animal Health
in September 2010. The Committees on the Environment and on Agriculture and
Rural Affairs of the European Parliament, discussed it in October 2010.

The Commission has begun discussions with
the Member States on the issues raised in the first report, and specifically on
how the collection and handling of data on official controls can be streamlined
and standardised.

This second report takes a somewhat
different approach from the first. It aims to give an overview of EU food
safety controls that is not confined to the latest year for which annual
reports are available from all Member States but draws on the latest
information from all three main sources of information on controls to give as
up to date an account as possible of how the EU control system is functioning.

The main sources this report draws on are:
(a) the annual reports from the Member States for 2008 and 2009, (b) the
results of the Commission’s control activities over the period 2008-2010, and
(c) other relevant information on controls including:

·   recent reports from Member States on controls in specific sectors;

·   the results of EU rapid alert systems (Rapid Alert System for Feed
and Food - RASFF, the Animal Disease Notification System - ADNS and, the alert
system for threats to plant health - Europhyt);

·   discussions and decisions on controls in the Standing Committee on
the Food Chain and Animal Health and the Standing Committee on Plant Health;

·   a review of infringement cases related to weaknesses in control
systems in the Member States.

2.
The EU
Food Chain

To understand how the EU system of official
controls along the food chain (including those necessary to ensure plant
health, and animal health and welfare) operates, it is useful to first get an
idea of the scale and complexity of the EU food chain.  According to the latest
data available from Eurostat, the value of total output from the EU food chain
is around €750 billion. Total employment in the sector, from primary production
through to retail and catering, is over 48 million. There are around 14 million
primary agricultural producers and 3 million food business operators
operating along the EU food chain from food manufacturing to retail and
catering. These global figures give an idea of the scale of the food industry.
It is huge, but it is also highly varied and complex.

In primary production, for example, the
average size of farm ranges from around 90 ha in countries such as the Czech
Republic, to around 50 ha in countries like the UK, France and Germany, and
to less than 8 ha in other countries such as Poland, Bulgaria and Romania.

There is also a great variation in the
types of farming practiced across the EU; to a large degree this is explained
by agro-climatic conditions, but also by longstanding agricultural traditions.

In the EU, there are around 300,000 food
manufacturing businesses. However, for many products - such as wine, olive oil,
eggs and cheese - processing may be done by agricultural holdings rather than
manufacturing enterprises. To focus on the manufacturing sector alone would
understate the total size and complexity of the EU food system. Within the
manufacturing sector specifically, a small number of enterprises operating on a
global scale account for a very large share of output. In the dairy sector for
example, 1% of the enterprises produce over 60% of total EU output. Outside of
primary production, the largest number of food business operators is found
towards the end of the food chain, in the retailing and catering sectors. There
are over one million food retailers in the EU, many of them small family
businesses, although a small number of large supermarket chains dominate the
sector in terms of total sales. There are almost 1.4 million restaurants
and catering establishments.

3.
Overview
of EU food safety controls
3.1.
Review of annual reports of Member States

The EU has developed extensive and
detailed legislation designed to ensure that the food provided to consumers
through this large and complex system of food production is safe and
wholesome.  The basic principles of EU feed and food law are laid down in
Regulation (EC) No 178/2002[4].
Under this Regulation, the primary responsibility for ensuring that food is
safe rests with the food businesses right along the food chain, from primary
production to the point of final sale to the consumer.  Member States are
obliged to monitor and verify that business operators fulfil the requirements
of EU law on food and feed safety (including animal health, animal welfare and
plant health). They are required to operate a system of controls for this
purpose.

Regulation (EC) No 882/2004 sets out how
these controls should be organised and operated. In essence it lays down
general rules for the performance of official controls to verify compliance
with EU rules on the safety of the food chain. In particular, the Regulation
imposes requirements on the Member States: when they verify:

·
compliance by operators with the sectoral legal
requirements, or

·
that goods to be placed on the EU market (either
EU produced or imported from third countries) are in compliance with the
standards and requirements of sectoral legislation.

In addition, Member State authorities
perform other official tasks under Regulation (EC) No 882/2004, such as those
carried out to fight or eradicate animal disease agents (e.g.. animal testing
for certain diseases in the contest of a programme, an epidemiological
investigation following an outbreak, vaccination against animal diseases, or
the killing of animals infected with pathogens.)

Regulation (EC) No 882/2004 also sets out
detailed rules on controls by the Commission services on the Member States to
verify that they comply with the obligations laid down in sectoral legislation
and in Regulation (EC) No 882/2004. Member States must establish and implement multi-annual
national control plans to give effect to the requirements of the Regulation.  These
plans typically cover a three to five-year period and were applied for the
first time from the start of 2007. Member States are required to submit to the
Commission an annual report on the implementation of their multi-annual national
control plans. Annual reports have been received for 2007, 2008 and 2009.

The results of the Commission’s first
analysis of national reports were summarised in its overview report of last
year, COM(2010) 441. In that report it was
very difficult to draw conclusions for the EU as a whole due the large variability
between national reports in both structure and content and the absence of
harmonised data on controls. This is still a feature of the reports for 2008
and 2009 and reflects, in part, the significant differences between Member
States in terms of agri-structures, administrative cultures and size. Nonetheless,
the comparability of reports has improved significantly, as a result of a)
Member States acquiring experience with their production, and b) the
Commission's ongoing and active dialogue with the Member States to further
improve the content, and in particular to enhance their comparability.  Since
information has now been provided by most Member States for a sequence of three
years, some interesting trends and developments over time can be identified.
These are summarised below.

Data collection
and analysis

One feature common to most reports is an
increasing effort to improve the gathering and collection of data on the number
and type of controls completed and on their results. In the drive for
efficiency and effectiveness, good up-to-date data is essential to assess
performance and to identify priorities for future control activities. While
many new and ongoing initiatives in this direction are referred to in the
annual reports, there appears to be limited sharing of know-how and experience
across different control authorities within or between Member States.  In its annual
report last year, the Commission stated its intention to examine, in
cooperation with the Member States, how the potential for the electronic transmission
and analysis of data can be exploited to achieve simplification and standardisation
at EU level. Work has now started on this, and this may in turn assist Member
States in the development of their own information management systems.

Overall statements
of performance

The Commission's guidelines on the
structure and content of reports request each national authority to give an
overall statement on the performance of its control system each year.  These
statements differ in quality. In most reports they are limited to a general
statement that controls were carried out in accordance with planned
arrangements, that overall standards of food safety, animal health and welfare
and plant health are satisfactory, and, where non-compliances have been identified,
they are normally of a minor nature. However, some reports provide a more
comprehensive and substantiated assessment based on a set of indicators of
performance. In some cases these indicators are confined to the number and type
of controls carried out and whether they are in line with initial plans. In
others (France, Finland, Sweden and the Slovak Republic) the indicators go
further and aim to measure performance against the incidence of specific animal
diseases or food borne illnesses. In France there is also an attempt to track
the cost of controls in a number of specific areas.

Progress in the implementation of
multi-annual national control plans

The requirement on Member States to
introduce integrated multi-annual national control plans covering all control
activities across the whole food chain from farm to fork was a major challenge.
National control systems in most countries are highly complex, often with many
different organisations involved in various aspects of control activity in food
and feed, animal health, animal welfare and plant health. In most Member
States, these different organisations would have had little experience in the
past of working together to draw up integrated control plans. Moreover, the
operational responsibility for carrying out controls is devolved to regional
and local authorities in most Member States. Ensuring that their activities are
fully integrated within the national plans in a consistent and coherent manner
required national authorities to reinforce mechanisms for consultation and
communication with their regional and local authorities. The annual reports on
the implementation of the plans indicate that considerable progress has been
made in setting up the structures and procedures for integrating the control plans
of all the actors at national, regional and local level. The main challenge now
for most authorities is to develop information and communication systems that
can provide accurate data on the controls carried out and on their results, so
that performance under the multi-annual national control plans can be
accurately assessed over time, and control objectives and targets adjusted
according to risk-based priorities.

Registration of
food business operators

Effective traceability of food, from
original source to final destination, is a central principle of the EU food
safety control system. The key building blocks of the system are a
comprehensive registration of all operators, an effective system of animal
identification, and traceability of feed and food. There has been significant progress
in the registration of food businesses. However, in the feed area, the
registration of smaller feed establishments is still incomplete. As regards
traceability of animals, some shortcomings are apparent in the identification
of cattle and pigs and in particular, in the systems for sheep, goats and
horses.

Risk assessment
and prioritisation

Regulation (EC) No 882/2004 specifically
requires national authorities to have an explicit risk assessment and control
prioritisation system. As the pressure builds on resources in the years ahead,
this aspect of multi-annual national control plans and related annual reports
needs to be given higher priority. Some Member State reports give a good
description of the systems of risk categorisation of food businesses and how
their controls are organised according to this risk categorisation. The Netherlands, Finland and Slovenia are particularly advanced in this area. In a number of Member
States, however, better risk categorisation of food and feed business operators
is identified by national authorities as an important area needing improvement.
In recent years the Food and Veterinary Office (FVO) of the Directorate General
for Health and Consumers, through its audits, has been placing increased
emphasis on the need for Member States to ensure that official controls in all
sectors are carried out regularly on a risk basis and with appropriate
frequency.

The intensity and scope of controls

Overall, the reports indicate that there
is a high level of control intensity throughout the EU. However, the frequency
of inspections varies greatly according to the nature of the businesses. For
example in sectors regarded as high risk, such as meat and milk production, controls
are much more frequent.

Controls in the areas
of feed and animal by-products are less intensive than for food. Major changes
in EU law over the past decade regarding feed and animal by-products, in
particular the need to have all feed and animal by-product businesses
registered, have imposed a heavy workload on businesses and on control
authorities. It is acknowledged in most reports that there is scope for
improvements and for further intensification of controls based on risk
prioritisation in these sectors.

Controls in the area
of animal health focus on verification of compliance
with requirements concerning animal identification and
testing for animal diseases such as brucellosis, tuberculosis, classical swine
fever and BSE. In addition, Member States are required to have contingency
plans in place to deal with major food and feed safety and animal health
crises.

Coordination
between national, regional and local authorities

In many Member States, the operational
responsibility for conducting official controls rests primarily with regional
and local authorities. This is notable in member states with devolved
competences, such as Germany, Spain, Italy, Greece, the UK, Sweden and Finland, where regional and local authorities may have a strong degree of autonomy.
The challenge these Member States face is how to ensure a sufficiently robust
system of accountability through which regional and local authorities can
provide a proper and consistent account of their control activities to their
national authorities, and through them, to the EU level.

There is also the related issue of
overlapping responsibilities and control activities between different
authorities. This is a long-standing issue in a number of Member States. In Greece, Portugal and Romania, for example, their own internal audit authorities cite overlapping
responsibilities and operational activities as a significant problem. These
Member States are also among those that point to inadequate resources as one of
the reasons why targets for the number of controls cannot be met. In general,
Member States with clearly defined responsibilities and management structures,
which demonstrate accountability at all levels, appear to operate most
effectively.

National audit
systems

Regulation (EC) No 882/2004 requires
Member States to carry out internal audits, or have external audits carried
out, to ensure that their control systems are achieving the objectives of the Regulation.
It also specifies that these audits be subject to independent scrutiny and
carried out in a transparent manner.

Almost all Member States have a system of
audits in place, although in most cases they cover only a limited range of
specific control areas within the overall system. The results of these audits
are presented in the annual reports, but often in very summary form. The main
weaknesses identified in these internal audits and the remedial actions taken,
are generally not reported on in detail. There are, however, some notable
exceptions. For example, Finland and the Czech Republic report on the results
of their audits and the areas of weakness identified.

In addition, there is limited information
in the annual reports on the provisions in place to give effect to the
requirements for audit reports to be subject to independent scrutiny.

The reliability, or otherwise, of Member
States' own audit systems in delivering necessary improvements in controls will
increasingly become a risk criterion taken into account in planning future FVO
audits.

Resources

According to data provided by national
authorities, it is estimated that over 100,000 people are employed directly or
indirectly at national, regional and local level in the carrying out of controls
in food and feed safety, animal health, animal welfare and plant health. This
is a very substantial resource but, in comparing targets for controls with the
actual outturn, some national authorities are pointing to staff shortages as
one of the underlying reasons why control targets are not met. Some Member States,
such as the Netherlands, are quite explicit in stating that their control
systems and operations are being adjusted to take account of the reality of
staff reductions and rationalisation in recent years. Risk assessment and
prioritisation of controls, are essential elements in this adjustment.

Training

The
national reports give a detailed account of the training programmes organised
each year for control staff and for food business operators. Overall, the
training effort is very substantial. It focuses on three main priorities.
First, the hygiene package Regulations introduced in 2006 required an increased
focus on good hygiene practice and the application of HACCP[5] principles by all food business
operators. Considerable work has been done over recent years to familiarise food
business operators and control staff at all levels with the requirements of the
new Regulations. Second, developments in science and technology, especially in
relatively new areas of food and feed production (e.g. novel foods, GMO, food
contact materials, food and feed additives) require constant updating of
know-how by staff. Third, increased focus on animal feed and animal by-products
controls has called for a special effort to familiarise businesses and control officials
with the new requirements of EU law in these sectors.

Training
at national level is supported and complemented by training organised by the
Commission under the Better Training for Safer Food programme which started in
2006 and is provided for under Article 51 of Regulation (EC) No 882/2004.  This
programme, covering a wide range of topics, aims to make official controls more
effective in ensuring that operators at all levels respect EU legislation
safeguarding public, animal and plant health, and animal welfare. This in turn
contributes to providing safer food and feed, advancing animal and plant health
standards, and raising levels of consumer and animal protection.

The
results of Commission control activities, such as in the area of General
Hygiene as described in Part 3.2 of this report, confirm that further training
is necessary in certain areas.

Laboratories

All Member States
must designate laboratories to carry out the analysis of samples taken during
official controls. These laboratories are obliged to operate, and be assessed
and accredited, according to defined EU or international standards to ensure
uniform and high standards. There is a large network of official laboratories
across the EU. Many of these operate at national level, but regional and local
authorities may also designate their own official laboratories, in particular
in Member States with autonomous regions or local authorities. This can lead to
a considerable proliferation of official laboratories. The process of
accreditation is complex and often relatively expensive, especially for smaller
regional or local laboratories. As a result, some Member Sates continue to
report delays in reaching full accreditation of all their official laboratories
involved in testing in the context of official controls. In 2010, the
Commission initiated discussions with Member States on accreditation
requirements.

FVO audits
confirm that the level of compliance of laboratories with EU law varies between
sectors. For example in relation to fish and fishery products, in general, laboratories
performing analyses in the context of official controls, seem to be well
equipped and able to carry out the analyses required; most are accredited. The
situation is different, for instance, in relation to laboratories operating
under Salmonella national control plans. FVO audits also report laboratory
shortcomings in relation to pesticides controls in some Member States.

Outcome of
official controls and monitoring

a) Main areas of non-compliance

In food production, there are two main
recurring themes in Member States' reports on non-compliance in food
production: hygiene controls in establishments; and labelling. The requirements
of the hygiene package Regulations took effect from 2006. The national reports on
controls for 2007 recorded widespread deficiencies in the application of these Regulations,
probably due, in part, to the fact that they had only come into force the
previous year. Steady progress in this area is recorded in 2008 and 2009 but
most reports point to continuing problems for small operators in the retail and
catering end of the food chain. The main weaknesses include: outdated buildings
and equipment; absence or weak systems of own-checks by businesses; poor
application of HACCP; and inadequate record-keeping. Some authorities point to
problems in the retail and catering sectors caused by high staff turnover,
especially of seasonal workers, thus making it difficult to have staff well
trained on good hygiene practices. On labelling, the main difficulty seems to
arise from the complexity of requirements arising from different areas of
legislation (e.g. additives, nutrition, place of origin, etc).

On feed, the main non-compliances relate
to: delays in the registration of business operators; inadequate application of
HACCP principles; hygiene in feed manufacturers; and contraventions of the
rules on additives in feed.

On animal health, the main weaknesses
reported relate to animal identification and movement controls.

In relation to animal welfare on farms, many of the weaknesses found
were attributed to lack of knowledge of farmers, particularly smaller farmers.
Some Member States recorded a reduction in the level of non-compliances on
farms following the provision of training and information to farmers.

Outcome of
official controls and monitoring

b) Overall trends in food borne illness

Salmonella and Campylobacter are
the two main causes of food borne illness in the EU. EFSA’s analysis of the
zoonoses reports of each Member State confirms a decreasing
trend in the European Union of salmonellosis cases in humans. In total 108,614 confirmed
human cases were reported in 2009 (data published in 2011) and in particular,
human cases caused by S. Enteritidis decreased markedly. The EFSA
report points to the application of Salmonella control programmes in MS as a cause for this reduction.

The annual reports of Member States on
controls indicate that sampling and testing of samples for these two
microbiological hazards account for a very large share of sampling and testing
related to food production in the Member States.

National
enforcement measures

Regulation (EC) No 882/2004 lays down that
competent authorities shall ensure that business operators take remedial action
when non-compliance is identified. It also requires Member States to have
clearly defined rules on the sanctions applicable when EU law is infringed. The
sanctions must be effective, proportionate and dissuasive. Almost all reports
give a brief summary of the actions taken to deal with non-compliances. The
most common actions are warning notices, fines, temporary or, in serious cases,
permanent business closures, and, in rare cases, criminal proceedings in the
case of fraud and serious breaches of legal requirements. In general,
information on the systems of sanctions and how they are operated is limited
and the level of detail varies from one Member State to another. In the absence
of more specific and harmonised data in annual reports, it is not possible to
judge how consistent the overall system of enforcement is across the Member
States. In certain Member States, such as the Czech Republic, there is a trend
towards moving from court based procedures to less onerous and more effective
administrative procedures for certain less serious non-compliances.

Official
controls following the emergence of specific health threats - food, animals and
plants

In recent years, the main health
emergencies arising within the EU in the area of food and feed safety had their
origin in the manufacturing of feed. In 2008 high levels of dioxin
contamination were detected in pig meat in Ireland. The problem was traced to
problems in the feed manufacturing process arising from the use of highly
contaminated waste oils in the drying process. In 2010, dioxin contamination
was discovered in products originating in Germany. This was traced to fats,
specifically for industrial use only, being added to animal feed. The
Commission is in the process of adopting specific measures to deal with this
particular risk.

In the animal health area, Member States
have had to focus additional control efforts on Bluetongue, and avian
influenza. The recent outbreak of Foot and Mouth Disease in Bulgaria underlines the importance of continued vigilance, but also demonstrates that the EU control
measures are, when properly applied, effective in preventing the spread of the
disease.

In the area of plant health, the
containment of the pinewood nematode threat in Portugal and the implementation
of measures aimed at eradicating the outbreak in Spain, have been assigned a
high priority.  Similarly, the rapid spread of the red palm weevil in
Mediterranean countries and repeated outbreaks of Asian and citrus long horned
beetles, required strengthened control and containment action by Member States.
 The measures at EU level and the control efforts made by the Member States
concerned are described in section 3.2 of this report.

Interesting developments as possible
examples of good practice

Classification of establishments and
publication of the results (Denmark, the Czech Republic, UK, and Belgium): The requirement that all food business operators be
registered, combined with the publication of inspection results of these
businesses by official authorities, makes it easier to offer consumers a useful
indication of compliance standards in restaurants and shops. A number of
examples are already available, the oldest one being the Danish ‘smiley’ scheme
(http://www.findsmiley.dk/en-US/Forside.htm).
Similar ideas are being pursued in the UK and Belgium.

 Self-reporting of remedial actions by
business operators (Netherlands): As part of the effort to improve
efficiency of control services and to lighten the burden of control activities
on food business operators, the Netherlands has introduced an electronic system
of self-reporting by food business operators. Using this system, a food
business operator can report to the control authority, through a web-based
reporting tool, on actions taken in response to recommendations arising from
previous control visits. In the case of more routine non-compliances, these
reports are generally accepted without the need for follow-up visits by the
authorities, although occasional spot checks are done on random basis.

Quality management systems (Belgium, the Czech Republic, Germany, Lithuania and Slovenia): A number
of Member States have introduced quality management systems (QMS) within their
control services and have had them accredited to international standards. For
example, in the Czech Republic, the quality management systems of most control
bodies are audited by external bodies against the ISO 9001 standard. They
regard these systems as important instruments for improving the overall
effectiveness and efficiency of controls, and ongoing independent performance reviews
encourage continuous improvement.  In Germany, a special Länder Working Group on
Quality Management has developed a harmonised framework for the preparation of
QMS in each of the 16 Länder.

3.2.
Results of the Commission's control activities
in the Member States

Regulation (EC)
No 882/2004 requires the Commission to carry out controls in the Member States
to verify that, overall, official controls take place in accordance with the
respective multi-annual national control plans and in accordance with EU law.

To meet the
Commission’s obligations, the FVO undertakes, each year, a programme of audits
and inspections to verify compliance with feed and food law, animal health and
welfare and plant health legislation, and to verify that official controls in
these areas are carried out in line with EU law.  This programme is published
on the Commission’s web site at the beginning of each year.

The findings of
each audit are set out in a report addressed to the relevant national
authority, together with conclusions and recommendations to address identified
shortcomings. How recommendations are dealt with is set out in section 3.4 of
this report.

Information from
FVO audits may trigger the adoption of emergency or safeguard measures by the
Commission (in the form of Commission Decisions) in case of a serious threat to
food safety, animal or plant health, or where risks cannot be contained by
action taken by the affected Member States alone. These legal instruments may
impose  additional controls, but also measures to prevent trade in, or imports
of, feed, food, animals, and plants or any of their products, depending on the
situation.

Information from
FVO audits may also be used, where relevant, as evidence of violations of EU
law, in the context of infringement proceedings (see section 3.4).

Through the
publication of the audit reports and the Member State action plans, as well as
regularly updated country profiles, the Commission provides stakeholders and
citizens with a factual account of how control authorities in each Member State deliver on their duty to ensure the correct implementation of the EU law.

In recent years
the FVO has carried out around 250 audits each year, covering the whole food
chain as well as animal health and welfare and plant health.

Audits in the
food safety area make up the main part of the programme. Over the period under
review, at least 70% of all audits were concerned with food safety with some of
these also covering related aspects of animal health. Around 12% of audits
related specifically to animal health only. Animal welfare and plant health
accounted for the balance, with roughly 8% of audits focused on each of these
areas each year.

FVO reports provide meaningful information
on how Member States' control systems have been performing in the areas covered
by its audits during the reporting period. The following section sets out the
issues of interest covered by the programme over the past three years in the
Member States on food safety, animal health, animal welfare and plant health.
It provides also a brief summary of the main findings and conclusions arising
from the different series of audits.

The reports of FVO audits, as well as competent authority responses
to FVO report recommendations, can be found at: http://ec.europa.eu/food/fvo/index\_en.cfm

Food Safety

Official
controls on milk and meat production

During the period under review, the FVO
carried out a series of audits on hygiene controls related to red meat and milk
production in almost all Member States. These confirmed that all Member States
have introduced robust control systems largely in line with the provisions of
Regulation (EC) No 882/2004 and that the necessary upgrading of meat/milk
producing and processing establishments to EU standards in the context of
accession, has largely been successfully completed in the ten Member States
that joined the EU in 2004. The food business operators have made the
transition to the requirements of the hygiene package Regulations. Where
deficiencies were seen, they could usually be attributed to individual failures
of control staff, which usually points to a weak system of supervision. The
other main reason for persisting deficiencies is related to poor enforcement of
legislation by control authorities.

Moreover the series identified a tendency,
primarily in some of the ‘old’ Member States, not to comply strictly with
current meat inspection requirements, for example, regarding: (a) the use of
technical staff instead of official veterinarians to carry out ante-mortem inspection,
and (b) the absence of official veterinarians at slaughter, especially in smaller
slaughterhouses, with post-mortem inspection carried out at a later stage.

Official
controls on baby food

Audits were carried out in 11 Member
States and in Switzerland to evaluate controls on the production of baby food.
No major shortcomings with regard to the systems of hygiene control and
traceability were found at food businesses operating in the sector. However,
HACCP programmes in these businesses were generally not designed to take into
account the specific risks associated with baby foods. Shortcomings were also
noted in relation to composition and labelling requirements, as well as
own-checks of residues of pesticides and contaminants.

Official controls on infant formulae and
baby food were not always satisfactory in relation to ingredients,
compositional criteria and nutritional substances, labelling, as well as
pesticide residues. These shortcomings in official controls were frequently
connected to limited training of official staff in relation to specific
requirements of the legislation, inadequately designed sampling and testing
programmes and limited capacities for pesticide residue analyses.  As is the
case with other sectors, the shortcomings identified are being systematically
addressed through various follow-up activities.

Transitional
arrangements for compliance with the ‘Hygiene Package’ Regulations

Under the hygiene package Regulations that
apply since 2006, food businesses, whose approvals were then restricted to
supplying their domestic markets, were allowed a transitional period until the
end of 2009 to meet the full requirements of the Regulations. The businesses
were typically small capacity establishments processing limited volumes of food
of animal origin. By the end of the transitional period, these establishments
had either to adjust the scope of their activities or to comply with hygiene
requirements, although the Regulations allow for flexibility in relation to
certain provisions.

Six Member States were recently visited to
review progress in this area. It was found that, where national authorities had
introduced flexibility arrangements in accordance with EU Regulations, this
provided solutions for many of the small food business operators, in particular
in the red meat and milk sectors. In Member States with less flexible
arrangements, non-compliance was more prevalent. However, because Member States
do not fully respect the requirement to notify national flexibility
arrangements to the Commission, full verification at EU level of compliance
with these arrangements is not possible.

Traceability of
beef and beef products

A series of audits on traceability of beef
and beef products is due to be completed by the end of 2011. In comparison with
the situation in 2002, when the last review was undertaken, controls of
traceability of beef and beef products and mandatory labelling have improved in
the Member States visited. In relation to the traceability of live animals, there
were some shortcomings, mainly related to the management of databases, controls
on holdings, and notification of movements by livestock markets or dealers.

Official
controls on fish and fishery products

Audits were carried out in nine Member
States to assess compliance with EU requirements on fish.  Overall it was found
that comprehensive official control systems for fishery products were in place
in all the countries visited, including registration and approval of
establishments and fishing vessels. In some countries significant variations in
the implementation of official controls were found between different regions.
In general, laboratories performing official analyses were well equipped and
able to carry out the necessary analyses. Most laboratories were accredited.

While the overall systems were well
designed and managed, three specific areas of weakness were identified in
relation to controls over: (a) primary production sites, such as fishing
vessels and fish farms; (b) some factory and freezer vessels; and (c) specific
parameters related to fishery products, such as organoleptic checks, freshness
indicators, histamine, parasites and microbiological checks.

Official
controls on poultry

There were 12 audits of Member State control systems for poultry meat and poultry meat products. Generally the overall
level of compliance was good. The entire poultry production chain was covered,
although in some cases the number of controls at farm level was limited. The
main areas identified for improvement were in relation to: the application of
specific hygiene requirements, such as the sampling frequency of carcasses and the
implementation of HACCP plans in establishments; and non-notification to the
Commission of national legislation allowing flexibility for small capacity
slaughterhouses. The latter point mirrors the situation on flexibility
arrangements in the red meat and milk sectors described earlier in this report.

Salmonella
control plans

Seven audits of Salmonella national
control plans in the poultry sector were carried out. In all Member States visited,
control plans had been introduced, but in some cases implementation had been
delayed for certain categories.  In all Member States, the plans for monitoring
and official sampling for Salmonella in different poultry categories did not
fully comply with EU legislation, largely due to deficiencies in sampling,
actions taken following positive test results, and laboratories.

Import controls for food of non-animal origin

On the
implementation of Commission Decisions relating to mycotoxin and Sudan dye adulteration, official controls have improved significantly, in particular for
sampling, sample preparation and dealing with non-compliant consignments.
However, weaknesses were found in: commodities where the frequency of controls
is subject to risk assessment by Member States; Rapid Alert notifications;
laboratories; and reporting of analytical results.

More recently,
FVO audits in Member States have been paying particular attention to the
implementation of Regulation (EC) No 669/2009 on official controls on imports
of certain feed and food of non-animal origin[6].
The first results indicate that, overall, Member States have implemented the
key obligations of the Regulation, in particular by creating Designated Points
of Entry (DPEs) for documentary, identity and physical checks. Areas requiring
further development include: improved networking between competent authorities;
and the facilitation of onward transportation of consignments between different
Member States while results of physical checks are pending.

Pesticide
residues

The FVO carried
out 10 audits on controls of pesticide residues in the Member States. The
results indicate that responsibilities for competent authorities are clearly identified
and overall pesticide residue control programmes were being implemented
satisfactorily, and were risk-based.

However official
controls in several Member States suffer from a lack of laboratory equipment
capable of performing effective analyses within the broad analytical scope
required by EU legislation. Recommendations for corrective action have been
addressed to these Member States and are being actively followed up.

FVO audits noted
that, while own-controls are a general requirement under EU food law,   food
business operators (notably the large retail chains) have implemented particularly
comprehensive auto-control systems targeted at pesticide residues. They also
noted that these systems, which operate in parallel with official controls, had
not been subject to an assessment by competent authorities. Therefore, and in
line with Regulation (EC) No 882/2004, FVO recommended that Member States evaluate the reliability of
these own-control systems, and take account of the results in establishing the
frequency of official controls (the Regulation specifically requires Member
States' official controls shall take account of the reliability of own-checks
carried out by FBO).

Official controls on
the application of Regulation (EC) 852/2004 ("General Hygiene")

Twenty two audits took
place to Member States to assess the official control systems in place to
verify compliance with: food hygiene rules established under Regulation (EC) No
852/2004; traceability and labelling provisions; and rules applicable to the
placing on the market of bottled water. Official controls were in place in all
the Member States visited and the inspections observed by FVO audit teams confirmed
that national inspectors were confident in assessing hygiene requirements.
However, in relation to the assessment of HACCP by competent authorities,
weaknesses were encountered in most Member States, with a corresponding low level
of implementation of HACCP principles by food business operators themselves.  A
lack of training was also observed.

Official controls on
food additives

Sixteen audits were
carried out to assess the official control systems in place for food additives
in certain Member States. The results showed that well established legal
frameworks and organisational structures were in place for official controls in
all the Member States visited, including good laboratory networks. There is
generally a sufficient number of control staff, although the level of
qualifications and training could be improved. Control procedures are generally
well documented, the risk-based approach in controls is broadly followed, and
measures are undertaken in cases of non-compliance. However, some deficiencies
were identified in controls on the purity and labelling of food additives. In
general, there is no control at the point of import, except for the
unauthorised colours explicitly referred to in EU legislation. EU legislation
on monitoring the consumption and use of food additives was not implemented in a
number of Member States.  This is being actively addressed through the
follow-up process.

Official controls on
materials intended to come into contact with food

A series of sixteen
audits was undertaken to assess official controls on food contact materials
(FCM). While legal frameworks are established for official controls on FCM,
implementation has only started recently in a number of Member States and
further efforts are needed to develop the control systems, including specific
control guidelines, laboratory upgrading, and sector-specific training. The
designation of competent authorities for official controls is often unclear,
resulting in the lack, or overlap, of controls. As the registration of FCM
operators is not mandatory under EU law, there is no guarantee that they are
covered by official controls. There were, generally, well established
risk-based controls at FCM manufacturing level, but further efforts are needed
on controls at FCM user level, such as on food processors. Competent authority
staff often had been insufficiently trained on specific issues related to FCM,
such as traceability systems, good manufacturing practice, and assessing the
declaration of compliance.

Official
controls on genetically modified organisms (GMO)

FVO audits
focused on official controls carried out to verify compliance with traceability
and labelling requirements related to the placing on the market of GMO food,
feed and seed, and on the performance of specific controls required under emergency
decisions aimed at preventing the import of non-authorised GMO. While controls
are in general carried out according to EU requirements, some shortcomings were
noted in relation to: import controls of Chinese rice; laboratory accreditation;
and insufficient sampling for laboratory analysis.

Animal Health

Animal disease
eradication programmes: task force activities

In addition to FVO activities on disease eradication, as described
below, a task force for monitoring EU co-financed disease eradication
programmes was created in 2000, with the objective of increasing the
effectiveness of these programmes.  For some diseases, such as bovine tuberculosis, brucellosis, rabies and classical swine fever, specific subgroups have been created to provide technical support to
Member States and to monitor implementation.

Bovine
tuberculosis and brucellosis eradication

The eradication of bovine tuberculosis and
brucellosis in cattle, sheep and goats is a high priority in Member States not
officially free from these diseases. The FVO carried out 10 audits of
tuberculosis and/or brucellosis eradication programmes. In general the programmes,
approved and co-financed by the EU, were well implemented. Nonetheless, in some
of the Member States visited, shortcomings (in some cases serious) were
detected in respect of movement restrictions, testing and sampling frequencies,
and/or the performance of epidemiological investigations.

As a result of FVO and task force
activities, the Commission is paying particular attention to ensuring that
shortcomings in these Member States are addressed through enhanced design,
implementation and monitoring of eradication programmes.

Rabies

Due to the implementation of the EU-funded
rabies eradication programmes, significant progress in the eradication of
rabies has been reported in the course of FVO audits to the Baltic Member
States.  However, in some Member States, the implementation of vaccination
programmes showed deficiencies. The results of FVO audits indicate that the
incidence of rabies in domestic and wild animals is still of concern.

Classical swine
fever

Due to the increased application of bio-safety
measures and improved vaccination campaigns for wild boars in the context of an
EU funded eradication programme, only sporadic outbreaks of Classical swine fever
(CSF) in domestic pigs have occurred in recent years in the EU. These were well
contained by the Member States by means of enforcement of the relevant EU
legislation and contingency plans (see below). In spite of these improvements,
CSF persists in the wild boar population in some regions in a few Member States
in central and southeast Europe, thus posing a risk of reintroduction of the
virus into the domestic pig population. The FVO monitors the disease situation
and the authorities are assisted, inter alia through the activities of
the task force, particularly in Bulgaria and Romania, in tackling the disease
in the special circumstances prevailing in each of those Member States.

Contingency plans

Member States
have a legal requirement to develop contingency plans in order to be prepared
for possible outbreaks on their territory of major epizootic diseases, such as
Foot and Mouth Disease, and Classical Swine Fever. The FVO conducted audits of
these contingency plans in eight Member States. These audits concluded that
competent authorities have generally demonstrated their ability to respond promptly
to notifications of suspect epizootic diseases and to take measures required.
Recommendations were made to further improve some aspects, such as the state of
preparedness of laboratories, local arrangements, and regular reviews and
updates of the plans.

Official
controls on Foot and Mouth Disease (FMD) laboratories

There is a legal
requirement for the Commission to inspect EU laboratories that handle live
foot-and-mouth disease virus, because of the risks to animal health of the
virus escaping from a controlled environment. There are 16 National diagnostic laboratories
and three laboratories authorised to handle the virus for vaccine production.
In recent years, eight laboratories were inspected, with mixed results. Serious
problems were found in three laboratories, which could have presented a risk of
escape of the virus. In two of these the problems, involving waste disposal
systems, were resolved quickly, but in the third, the level of biosecurity was
inadequate and approval to handle live FMD virus was withdrawn. Given the risks
involved and the significant resources necessary to oversee the operation of these
laboratories at both Member State and EU level, these findings confirm that FMD
laboratories should only be approved in those Member States that are in a
position to guarantee compliance with Article 65 of Directive 2003/85/EC, and
in particular to ensure the necessary resources for that purpose.

BSE

On BSE, there has been a sharp fall in the
incidence of the disease, and this has allowed a substantial raising of the age
for testing.  The frequency of FVO audits in this area has been correspondingly
reduced.

Bluetongue

Following the
availability of vaccines against the bluetongue serotype 8, FVO audits were
conducted in four Member States to evaluate the implementation of co-financed
emergency vaccination against bluetongue. Although some shortcomings were
identified, mainly regarding the exclusion from vaccination of specific
sub-populations such as fattening cattle and replacement lambs, the vaccination
campaigns were, in general, carried out as required by the approved programmes.

Animal Welfare

The FVO carried out 39 audits of animal
welfare controls covering welfare on-farm, during transport and at slaughter.
This intensive programme, which covered all Member States, threw up important
findings in three main areas.

FVO audits have been monitoring progress
by Member States on the phasing out of un-enriched cages for laying hens by the
deadline of 1 January 2012. There are concerns that a substantial
number of producers in several Member States will fail to meet the deadline.
The Commission is working with experts in the Member States with the aim of
accelerating the phasing out process and achieving compliance during 2011.

On the welfare of pigs, Member States are
at various stages in preparation for the deadline of 1 January 2013 for the obligatory group housing of pregnant sows. FVO monitoring of progress on this
issue indicates that in the majority of Member States, significant efforts will
be needed to meet the deadline.  Not enough progress has been made in regard to
more long-standing requirements such as the need to use other environmental or
management practices instead of tail-docking piglets, with the exception of Sweden and Finland, where there is already a ban on tail-docking.

Regarding transport, although only a small
number of Member States were well organised in 2007 to meet the requirements
for approval of means of transport, there has been steady progress in getting
better levels of compliance in recent years. Notably, the new requirement, for
the installation of temperature monitoring equipment and a warning device, has
generally been successfully implemented. However, in a majority of Member
States the process of vehicle approval has not adequately addressed certain
requirements in relation to watering devices and satellite navigation systems.

Plant Health

Import control
of regulated articles

Eleven audits have been carried out on Member State import control systems for plant health, as part of an audit series of the
revised EU plant health import regime applied since 2005. Significant improvements were noted in control systems. However,
there are points, which still need to be addressed, especially with regards to
controls at places other than points of entry. Problems were noted in relation
to regulated goods in transit, since it was not possible to identify all such
goods at the first point of entry. As a result, some goods were thus not
subjected to the necessary plant health controls. Resource allocations and
deficiencies in infrastructure are at the root of such shortcomings in some
Member States.

Harmful
organism outbreaks

Twenty three audits covered a range of
harmful organisms. As far as the most important pests are concerned, the
Pinewood nematode (Bursaphelenchus xylophilus) occurs in Portugal and an outbreak appeared in Spain. A series of legislative adaptations and Commission
enforcement initiatives aimed at strengthening controls, including several FVO
audits, has contributed to keeping the pest from spreading to the rest of the
EU. In the case of the red palm weevil, (Rhynchophorus ferrugineus), FVO
audits showed that Member States have been struggling to control this pest. Its
biology makes early detection and control difficult, and there have been
substantial problems with implementing the required eradication measures in
private gardens and cities where the host plants (palms) are typically located.
Red palm weevil is now widespread in many of the areas in the EU where palms
are grown.

The Chinese Longhorn Beetle and the Asian
Longhorn beetles (Anoplophora spp.) are pests of a wide range of woody
plants.  FVO audits have shown that in practice, Member States do not
systematically apply the measures necessary for timely eradication.
Nevertheless, with the exception of a large outbreak in Northern Italy,
outbreaks have generally been at least contained in small areas and some have
been eradicated.

Internal plant
health controls

Sixteen audits were carried out on internal
plant health controls, including protected zone maintenance, implementation of
the plant passport system and controls in the potato sector. Most of the audits
confirmed proper controls in the protected zones, but there were cases where
Member States were requested to improve controls substantially in order to
avoid withdrawal of protected zone status. The plant passport audits showed
mixed results. They indicated that numerous non-compliances identified during
the previous audit series had not been addressed. The results also showed that
with adequate prioritisation of tasks and allocation of resources, a proper
control system can be established. Progress was recorded in most audits in the
potato sector.

Animal feed and
animal by-products (ABP)

Thirty nine audits have been undertaken in
this area by the FVO. The main conclusions arising from these audits are set
out below.

While the approval process is complete in
all Member States for the larger feed establishments requiring approval, the
registration of smaller establishments was still very incomplete.  EU legislation requires registration of all operators
active at any of the stages of production, processing, storage, transport or
distribution of feed.

There were frequent flaws in the design
and implementation of HACCP-based procedures, coupled with a lack of expertise
within the competent authorities on how to assess them.

On import controls, a risk-based approach
was lacking in many cases, and there was a low frequency of physical checks for
some commodities.

There is a potential risk that processed
animal protein, contained in organic fertilisers and soil improvers might find
its way into feed.  FVO audits have identified the need
to strengthen official controls on organic fertilisers and soil improvers,
which were largely satisfactory at production
plants, but weak in the rest of the marketing and use chain. The next round of
FVO audits is placing particular emphasis on controls on this part of the feed
chain.

There has been significant improvement in
the use of ABP commercial documents, as well as in their accuracy and
reliability. The same applies to the collection, transport, identification and
disposal of ABP which, aside from the retail sector, are largely in line with
the relevant requirements.

Import controls
on food of animal origin and animals

There have been 30 FVO audits on import
and transit controls. All Member States have
comprehensive official systems for import controls in place and in the main,
they work properly.

In particular, the development
and implementation of a common computerised system for imports in TRACES has
facilitated and simplified many procedures for border inspection posts and
improved the communication between Member States related to import and transit.
It has also facilitated an overview of the pattern of imports into the EU.
However, the fact that some of the main importing Member States do not yet
fully use TRACES remains a weakness.

The audits identified
a number of issues to be addressed:

The current rules
regarding controls on transhipments of consignments, originating in one third
country en route to another, are complex and difficult to enforce, in
particular in relation to notification to the relevant border inspections
posts, and follow-up and verification of exit within the required time limits.  While
these difficulties apply in all ports, they are most common in the larger ports
where the majority of such transhipments take place.  Pending a reassessment of
the current rules, some amendments have been made to the applicable time
limits, and guidelines have been issued to render the rules both more effective
and easier to enforce.

There is great
variability in the monitoring plans for imported consignments in Member States.
The monitoring strategy, the levels of sampling and the range of products and
origins tested differ widely.

Competent authorities
do not systematically use enforcement measures and sanctions to improve
compliance in areas such as the notification of consignments before their
physical arrival, and the correct completion of official documentation.

Residues of
veterinary medicines and contaminants

The FVO has conducted
20 audits on residues of veterinary medicines and contaminants in the Member
States. The main conclusions from these are set down below.

The analysing
laboratories in most Member States are now accredited to ISO 17025:2005 but
there is a great variation as to the number of residue methods included in the
scope of accreditation. The conditions and procedures for such method accreditation
depend on the policy of the national accreditation bodies. If they accept
"flexible scope", after initial accreditation criteria have been
fulfilled, the laboratory can add substance/matrix/species combinations to an
already accredited method, without seeking the approval of the accreditation
body each time. If the national accreditation bodies require each such additional
method to be submitted for approval, which usually takes place in connection
with the annual audits, the procedure is much slower and often more costly for
laboratories.

Commission Decision
2002/657/EC provides official residue laboratories with binding instructions on
the validation of residue methods. Although time-consuming and somewhat
complicated, this has harmonised the approach to validation in Member States,
increased the reliability of results and provided guidance for residue
laboratories in third countries.

Horses treated with
certain medicines need to be safely excluded from the food chain for six months
(for certain medicines) or for life. This is done in Section IX of the
equine passport, which every horse in the EU should have from about six months
of age. Although the deadline for registration of all horses has passed, implementation
is still ongoing in several Member States. In most Member States equine
passports are required and checked at slaughter but very few, if any, Member
States have carried out controls on the link between certain treatments and the
entries in Section IX of the passport.

Food chain information
(FCI) at slaughter is being provided for all species in most Member States.
However, the interpretation of the legislation varies considerably. Some Member
States require owners/keepers to declare on the FCI all treatments given to an
animal during its lifetime. Others only require a declaration that the animals
are not slaughtered before the end of a withdrawal period for a medication.

3.3.
Other sources of information on controls in the
Member States

Sector-specific reporting

Provisions in EU
legislation on different aspects of food safety, animal health and welfare and
plant health require Member States to submit regular reports on certain
specific requirements. On the basis of these national reports, the Commission
in turn produces a number of sectoral reports, which provide an account of the
state of implementation of certain aspects of EU legislation applicable to the
food chain, including in some cases specific data on official controls and of
results thereof in the areas concerned.

Among the most
relevant such reports, are those on: monitoring and testing of ruminants for
the presence of Transmissible Spongiform Encephalopathy (TSEs); trends and
sources of zoonoses; zoonotic agents and food-borne outbreaks in the European
Union (mandated to EFSA); notifiable diseases of bovine animals and swine (in the
context of the intra-EU trade); annual EU-wide pesticide residues monitoring report;
and reports on animal disease eradication task force
meetings.

A table, listing
the main Commission reports published in the past year and their websites, is
included in the Annex to this Report.

Rapid alert
systems and other reporting tools

The existing rapid
alert systems for food and feed safety (RASFF), animal disease outbreaks (ADNS)
and plant disease outbreaks (Europhyt) represent important tools for managing
the rapid response to emergencies and emerging risks and a source of
information on the pattern of hazards and diseases as they develop along the
food chain. The data they provide may be an important indicator of compliance
shortcomings in relation to established safety standards. Detailed results from
these food safety and animal disease alert systems are summarised each year in
annual reports on RASFF and ADNS published on the Commission's web site:

http://ec.europa.eu/food/food/rapidalert/index\_en.htm
http://ec.europa.eu/food/animal/diseases/adns/index\_en.htm
.

For Europhyt, the notification tool for interceptions
of consignments for plant health
reasons, the Commission is in the process of launching a website with monthly
interception reports.

TRACES, the
system which allows the exchange of information between the Commission and the
Member States on controls carried out on animals and animal products (on
domestic products and imports from third countries) is another important source
of data, not only on volume of movements of the commodities covered, but also
on official veterinary controls carried out: http://ec.europa.eu/food/animal/diseases/traces/index\_en.htm.

Reporting at
SCOFCAH meetings

Reports on the
operation of controls are also presented by Member States regularly at meetings
of the Standing Committee of the Food Chain and Animal Health. These may be
either routine reports on the incidence and control of food borne illness,
animal diseases or plant diseases; or they may be related to recent outbreaks
and emergency actions taken in response. They represent another important
source of information for the Commission to assess how controls are operating
in the Member States. In recent years, the Commission has adopted the practice
of publishing these presentations on the Commission’s website along with the
minutes of the respective meetings.

Also, in some areas, the Commission prepares a compilation of such
reports as received from the Member States and makes them available through the
proceedings of the Standing Committee (available at the following web site:

http://ec.europa.eu/food/committees/regulatory/index\_en.htm).

3.4.
Commission follow-up and enforcement

Sustained attention to and co-ordination
of enforcement action remains a priority in all areas covered by this report.
The recommendations contained in FVO audit reports are an important input to
this. They are systematically followed up, through a range of activities.

Member State competent authorities are requested
to present an "action plan" describing how they have addressed or
intend to address the recommendations. In turn, the Commission evaluates the
action plan and systematically monitors the implementation of all these actions
through a number of follow-up activities including:  (a) general follow-up
audits during which the FVO and Member State authorities meet to review
progress made on all recommendations made to that Member State; (b) on-the-spot
follow-up audits on specific issues, or requests for written reports on
specific issues; and (c) high-level bilateral meetings in the event of
over-arching, or persistent problems.

Another source of
information which may point to non-compliance or enforcement problems are
complaints from members of the public or NGOs, and the Commission is careful to
ensure that these are pursued with the Member States concerned as well, with a
view to achieving a positive outcome.

In terms of other tools, and during the course of 2009-2010, the
Commission found the EU Pilot Project, which has been operating in 15 volunteer Member States since
April 2008 with the aim of providing quicker and fuller answers to questions arising
from the application of EU laws, to be a useful tool as
it has enhanced communication between the Commission and Member States, and
contributed to the resolution of enforcement problems, without the need to
resort to formal infringement proceedings. .

However, there where competent authorities fail to take to take
satisfactory corrective action to address persistent problems, and where the
mechanisms described above do not lead to a satisfactory resolution or
insufficient progress, the Commission may have to launch infringement
proceedings, to achieve compliance by the Member State.

This occurred in three cases against Greece because it persistently
failed to comply with a range of important components of EU food safety
legislation. The Court delivered three judgments condemning Greece for failures in the application of EU law.  Specifically:

- FVO audits found long-standing, fundamental and systemic
shortcomings in the official controls carried out by Greece which were mainly
attributable to a shortage of human resources in the Greek veterinary services.
As a result, both the central administration and the decentralised authorities,
failed to carry out official controls in an effective and substantial way.  The
Court concluded that the results of the efforts made by the Greek authorities
to solve these problems were unsatisfactory[7].

- the Court also concluded that Greece had failed to correctly apply
key provisions of EU law on animal by-products not intended for human
consumption[8]
and on protection of animals during transport and in slaughterhouses[9].

In addition, the Commission issued reasoned opinions in 2010 against
Italy and Spain.

- In the case of Italy, FVO audits found that the ability of the
Italian authorities to meet their obligations under EU plant health legislation
was impeded by a lack of staff. As a result Italy failed in many instances to
comply with notification requirements. In addition, the problem identified by
the FVO resulted in a chronic failure on behalf of the Italian authorities to
ensure a close, rapid, immediate and effective co-operation with the
Commission.

- In the case of Spain, FVO audits found that Spain was not correctly applying EU animal welfare requirements in relation to: authorisation of
transporters; approval of means of transport; control of journey logs; checks on
fitness of animals for transport; inspections; and penalties.

More information on infringements is available in the annual reports
on monitoring the application of EU law published on the Commission's website: http://ec.europa.eu/eu\_law/infringements/infringements\_annual\_report\_en.htm

4.
Conclusions

On the whole, Member States ensure a good level of implementation of
official controls across the food chain, and respect for food safety, plant and
animal health, and animal welfare issues. While there is scope for improvement,
there has been progress in the efficient use of control instruments and
resources, and in planning, implementation, and co-ordination of controls
across all sectors.

Official controls, and legislative instruments to optimise their
effectiveness, are key features of the EU food chain. They allow competent
authorities to perform controls on a risk basis, and to identify shortcomings
and address them in a timely manner. They also provide competent authorities
with a meaningful overview of the food safety and health situations.

Member State reports provide reassurance that
national competent authorities take their role seriously and with increasing
levels of competence, as confirmed by reports from
audits carried out by Commission experts.

On-the-spot specific audits by the Commission, as well as general
follow-up audits covering all sectors, are of particular importance in
identifying weaknesses to be addressed, and in ensuring that corrective actions
are taken.

These Commission audit reports, complementing Member State control activities, provide a robust system for assessing the effectiveness of Member State control systems.

In order to give reasonable assurances of compliance
with EU legislation, the Commission, whenever necessary, takes the appropriate
measures to achieve improvements in official control and audit systems in the
Member States.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

ANNEX

LIST OF PUBLISHED COMMISSION SECTORIAL REPORTS ON THE
IMPLEMENTATION OF EU LEGISLATION ON FOOD

SAFETY, ANIMAL HEALTH, ANIMAL WELFARE AND PLANT
HEALTH

Report || Legal basis || Publication

Annual Report on the monitoring and testing of ruminants for the presence of transmissible spongiform  encephalopathy (TSE) in the EU || Article 6 (4) of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies || http://ec.europa.eu/food/food/biosafety/tse\_bse/monitoring\_annual\_reports\_en.htm

The EU Summary Report on trends and sources of zoonoses, zoonotic agents and food-borne  outbreaks in the European Union || Article 9 (2) of Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (Mandated to EFSA, elaborated by EFSA in cooperation with ECDC) || http://www.efsa.europa.eu/en/efsajournal/doc/2090.pdf

The Rapid Alert System for Food and Feed (RASFF) annual report || Article 50 of Regulation (EC) No 178/2002 of the European 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 || http://ec.europa.eu/food/food/rapidalert/rasff\_publications\_en.htm

Report || Legal basis || Publication

Annual EU-wide Pesticide Residues Monitoring Report || Article 32 of Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (Mandated to EFSA) || http://ec.europa.eu/food/fvo/specialreports/pesticides\_index\_en.htm http://www.efsa.europa.eu/en/efsajournal/pub/1646.htm

Annual report on food irradiation || Article 7(3) of Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation || http://ec.europa.eu/food/food/biosafety/irradiation/index\_en.htm

Commission Staff Working Paper on the Implementation  of National Residue Monitoring Plans in the Member States || Article 8 of Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues 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 || http://ec.europa.eu/food/food/chemicalsafety/residues/control\_en.htm

Report || Legal basis || Publication

Commission annual reports on surveillance of avian influenza in poultry and wild birds, by Member States || Article 19.1 of Commission Decision 2006/875/EC and article 9.1 of Commission Decision 2006/876/EC approving programmes for the eradication and monitoring of animal diseases of certain TSEs and for the prevention of zoonoses presented by the Member States and by Bulgaria and Romania for the year 2007. || http://ec.europa.eu/food/animal/diseases/controlmeasures/avian/eu\_resp\_surveillance\_en.htm

Reports of the meetings of the experts sub-groups (Bovine brucellosis, sheep&   goats brucellosis, bovine    tuberculosis and rabies) of the Task Force (TF) for monitoring disease eradication in the Member States. || The Task Force was created in 2000 as an action foreseen in the Commission White Paper on Food Safety. || http://ec.europa.eu/food/animal/diseases/eradication/taskforce\_en.htm

Report || Legal basis || Publication

Annual  summary  of submissions from Member States concerning imports of    products  of  animal origin        for   personal consumption, summarising the relevant information on the    measures  taken  to advertise and enforce the rules   laid   down  in  the Regulation,   and on the results thereof || Art. 7 (1) of Commission Regulation (EC) No. 206/2009/EC (repealing Art. 5 (1) of Commission Regulation (EC) No. 745/2004) on the introduction into  the  EU of personal consignments of products of animal origin || http://ec.europa.eu/food/animal/animalproducts/personal\_imports/sum\_personal\_imports\_2005\_2007\_final.pdf

Animal welfare: transport Regulation || Article 27(2) of Council Regulation (EC) No 1/2005 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 || http://ec.europa.eu/food/animal/welfare/transpor t/inspections\_reports\_reg\_1\_2005\_en.htm

[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 (OJ L 165, 30.4.2004, p1).

[2]       Since 2010, the term "inspection" has been replaced
by "audit", to reflect the broader scope of FVO activities.
"Audit" is generally used in this report, for ease of reference.

[3]       COM(2010) 441 final of 25.8.2010.

[4]     Regulation
(EC) No 178/2002 of the
European 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.

[5]       Hazard Analysis and Critical Control Points.

[6]       Commission
Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No
882/2004 of the European Parliament and of the Council as regards the increased
level of official controls on imports of certain feed and food of non-animal
origin and amending Decision 2006/504/EC.

[7]       Judgment of the Court of Justice of 23.4.2009 in case
C-331/07.

[8]       Judgment of the Court of Justice of 17.12.2009 in case
C-248/08.

[9]       Judgment of the Court of Justice of 10.9.2009 in case
C-416/07.

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