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Document 52013SC0160
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health
/* SWD/2013/0160 final */
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health /* SWD/2013/0160 final */
1. Problems identified Background 1.
Across the EU, the farming sector is the largest
user of animals with at least 2 billion birds (chickens, laying hens,
turkeys, etc.) and 334 million mammals (pigs, sheep, goats, cattle, fur
animals, etc.). There are 13.7 million animal holdings in the EU. The value of
livestock farming output in the EU is €149 billion annually. Animals are
also part of aquaculture, are companion animals, are farmed for fur, and are
used in or form part of various other activities such as experimentation, zoos,
circuses, entertainment and sporting pursuits. 2.
EU intervention is currently focused primarily
on the prevention and control of transmissible diseases that can have
significant health and economic impacts. The impacts of an animal disease
outbreak can vary widely, usually posing a direct risk to animal and often
public health. However, there can also be other negative indirect impacts, such
as economic or social effects, including costs to livestock farmers and related
industries of dealing with disease and of business disruption, public sector
costs of eradication and monitoring, and changes in consumption patterns. Often,
disease outbreaks also have significant impacts on international trade of
animals and animal products. 3.
The current EU animal health legislative
framework involves around 50 basic directives and regulations, some of them
adopted as early as 1964. The veterinary acquis communautaire now covers
more than 400 acts. This set of animal health legislation interacts with the current
legal framework on animal welfare, food safety, public health, animal nutrition,
veterinary medicinal products, environmental protection, official controls and
the Common Agricultural Policy. Consideration
of current policy and problems identified 4.
In 2004, the Commission launched an independent
evaluation to assess the performance of the Community Animal Health Policy
(CAHP) over the previous decade. The EU Animal Health Strategy 2007-2013 (AHS) was
developed as a result of the outcome of this exercise. Stakeholders and
competent authorities of the Member States were asked to identify problems with
current legislation on animal health as part of the Animal Health Law Steering
Group. The CAHP Evaluation and the stakeholders' consultation broadly agreed
that the current system functioned well, however a number of issues were
identified that need improvement. 5.
The main problems identified during the CAHP evaluation
by the stakeholders were: the high complexity of the current CAHP; the lack of
an overall animal health strategy; and an insufficient focus on disease
prevention (with a particular focus on the need for increased biosecurity). A
specific policy issue was also identified related to intra-EU trade in live
animals. Each of these is explained in greater detail below. 6.
Both the need for simplification and the need
for changes in policy proposed in this exercise were identified and emphasised
by the stakeholders. High
complexity of current policy 7.
The current CAHP is highly complex in a number
of ways. First, the large number of pieces of animal health legislation means
that it is difficult for those directly affected (such as farmers and other
stakeholders) to understand their responsibilities without consulting legal
experts. Second, the responsibilities and obligations of animal keepers are not
always clear. Some existing responsibilities are not consistent across
different pieces of legislation, and some are interpreted differently in
different Member States. This could potentially lead to problems if the
legislation does not adequately reflect the roles and needs of animal keepers. In
addition, differences across Member States can lead to an uneven playing field
for animal keepers when it comes to complying with their legal duties. Third,
the rules for commercial farming do not always apply in a proportionate manner
to non-commercial animal keeping. Non-commercial animal keeping (such as that
in hobby or backyard holdings) usually entails a different kind and level of
disease risk compared to industrial farming and the administrative burdens
imposed on non-commercial animal keeping are not always proportionate to the
level of disease risk. Fourth, the definition of the role of the veterinary
services has aspects of legal uncertainty that need to be rectified to ensure
that veterinarians are clear about their legal duties, to avoid conflicts of
interest, and to encourage the development of better veterinary networks.
Fifth, there is currently a lack of rules on the professional qualifications
and training for official and approved veterinarians, which can lead to
differences between levels of health protection across Member States and within
the single market. Sixth, specific animal health conditions relating to imports
are difficult to understand and apply. This creates complexity and
administrative burden for competent authorities, importers and third countries
who may find it difficult to understand their legal duties. Lack of
single overall animal health strategy 8.
There is a lack of a single overall animal
health strategy. The final report of the CAHP
evaluation highlighted the lack of a single general approach behind the CAHP.
Instead, the CAHP is perceived to be a patchwork of specific measures and actions,
with inconsistent objectives and an unclear overall direction. Resources, personnel
and management attention have tended to follow animal health crises with a
subsequent tendency to reduce focus on the definition and achievement of
longer-term strategic objectives. There are four main problems here. First, the
lack of categorisation and prioritisation of animal disease policy measures.
This has often led to a tactical rather than strategic, and therefore (in the
long term) sub-optimal allocation of resources for disease control. Second,
there is still poor co-ordination of animal disease surveillance with various
surveillance systems and actors not working together in the most effective ways
possible. A better co-ordination effort could reduce the risk and impact of
disease outbreaks. Third, there is insufficient harmonisation of EU legislation
with agreed international (OIE, the World Organisation for Animal Health)
standards. Greater convergence would lead to improved competitiveness in
international markets and would avoid trade disputes (whilst respecting the
need to retain the high health standards expected in the EU). Fourth, a long-term
view of emerging, re-emerging and exotic diseases is not sufficiently taken in
current EU legislation. There is a need to promote a more strategic outlook in
order to respond to, control and monitor future disease threats. Prevention
rather than cure 9.
Lastly, there is an insufficient focus in the
current EU framework on disease prevention rather than cure. Freedom from
animal diseases is widely considered to be a global public good, as it
protects the health of animals and public health, as highlighted in the 'One
World – One Health' concept developed by the WHO (World Health Organisation),
OIE (World Organisation for Animal Health) and FAO (Food and Agriculture
Organisation). Its importance is not limited to the rural economy but has an
impact on the whole of society. While animal health crises will always occur,
the CAHP evaluation highlighted the need to focus more on disease prevention
and rapid and effective risk management in order to reduce the incidence and
scale of animal disease outbreaks. This deficit manifests itself in poor
co-ordination of animal disease surveillance and monitoring, as noted above;
the lack of EU level promotion of biosecurity measures on-farm to prevent
disease outbreaks; the absence of a vaccination strategy to better prevent and
control animal diseases; and the inconsistent provisions on training in animal
health for those dealing with animals. Intra-EU
trade in live animals 10. Whilst the previously described problems fit under the thematic
headings, the CAHP evaluation steering group and the wide public consultation
both highlighted problems with intra-EU trade that fell under several of these
different categories. First, the current animal health rules for intra-EU trade
are not always proportionate to the animal health risks posed by movements. In
particular, some low-risk movements are required to comply with stricter
requirements than necessary. Second, in many cases, there is replication of
procedures which adds to the administrative burden associated with movements.
Third, the concept of compartmentalisation has been used successfully in some
areas, but not yet extended to other appropriate parts of EU animal health law,
and could be in the future. 2. Analysis of Subsidiarity: is EU
action justified on grounds of subsidiarity? 11. Articles 43, 114 and 168 of the Treaty on the Functioning of the
European Union provide the legal basis for the EU legislative measures on
animal health, as they are an essential part of EU agricultural, public health
and consumer protection, trade and single market policy. 12. The need for action passes the 'necessity test' and the 'added value
test'. The objectives of animal health policy cannot be achieved by Member
States acting alone, and can be better achieved by the EU acting in harmony. In
very general terms, good animal health gives not only private benefits for the
particular animal keepers and owners concerned with individual animals, but is
a public good with wider societal benefits. The transmissible and
trans-boundary nature of many animal diseases means that a common approach,
rather than a series of individual actions, is likely to have the greatest
overall benefits. Therefore, both in 'peace time' and in the case of an
outbreak, the cost of not having action at an EU level is potentially much
greater than working together. 13. The benefits of harmonised rules for the prevention, notification,
control and eradication of animal diseases at EU level have been demonstrated
during animal disease outbreaks in recent times. These crises showed the EU's
capability to react quickly, limiting the spread of diseases and minimising
their impacts. This was largely due to the harmonised approach to disease
control. The current system also enables the development of sustainable
surveillance and monitoring programmes by providing co-financing at the EU
level. In the past, the EU harmonised approach to disease control has enabled
the EU to defend the interests of its Member States on the international scene. 14. Trans-boundary spread of animal diseases is a permanent threat for
livestock keepers and Member States as it can have major economic implications
for both the private and public sectors. Many diseases can easily spread from
one country to another and can reach pandemic proportions. Wild animals can play
an important epidemiological role in the transmission of animal diseases and
their movements are extremely difficult to control or restrict between Member
States (for example, classical swine fever in wild boar posing a potential
threat to farmed pigs). For this reason control measures and harmonised
surveillance systems are needed at EU level. 15. Given the above, the future legislation should confirm the high
degree of competence already attributed to the EU in this area during the last
decades, which is well accepted by the Member States and stakeholders alike. 3. Objectives of EU initiative: What
are the main policy objectives? 16. The EU as a whole is working towards the objectives of the Europe
2020[1]
strategy. Animal health objectives should uphold these crucial overarching
objectives by reducing the risk of the negative economic, social (including
public health) and environmental impacts of poor animal health or animal
disease outbreaks; and consequently by supporting the economic security and
success of animal keepers, particularly farmers and thus contributing to smart,
inclusive and sustainable growth. 17. It is worth reiterating here that animal health objectives do not
stand in isolation. Good animal health is a critical factor in ensuring the
viability and sustainability of the internal market; and particularly of the
food sector, which is the largest single economic sector in the EU. There is
inevitably overlap and interaction with other areas of policy, such as animal
welfare, food safety, animal nutrition, veterinary medicines, and official
controls, but also wider agricultural and environmental issues such as invasive
alien species. 18. The general objectives of EU animal health
policy are as outlined in the EU Animal Health Strategy 2007-2013, and are: Goal 1 -
to ensure a high level of public health and food
safety by minimising the incidence of biological and chemical risks to humans. -
to promote animal health by preventing/reducing
the incidence of animal diseases, and in this way to support farming and the
rural economy. -
to improve economic
growth/cohesion/competitiveness assuring free circulation of goods and
proportionate animal movements. -
to promote farming practices and animal welfare
which prevent animal health related threats and minimise environmental impacts in
support of the EU Sustainable Development Strategy. 19. Animal welfare in particular has close links with animal health and
any objectives for animal health need to pay full regard to the welfare
requirements of animals, in accordance with Article 13 of the Treaty on the
Functioning of the European Union (TFEU). 20. These general objectives demonstrate that the basis for EU action is
wider than simply preventing public or animal health problems from arising or
ensuring the economic security of farmers. The scope of any new measures will
need to encompass not just kept animals (including production animals, animals
used for work, sport, recreation or display, companion animals and animals used
in research); but also, to an extent, wild animals, where their poor health has
the potential to jeopardise any of these objectives. 21. The scope of this exercise is to build a simplified and more
coherent legislative framework for animal health, based on good governance and
compliant with international (e.g. OIE) standards. 22. The report outlines the specific and operational objectives of the
Animal Health Law in more detail. 4. Policy Options 23. In order to solve the problems identified and achieve the
above-mentioned operational objectives, we have considered the 5 policy options
below. 24. Option 1: Do nothing (i.e.: continue with current policy). Current
animal health rules would remain, with technical updates and adaptations made
as necessary but without a horizontal framework establishing overall strategic
objectives. Where possible, existing regulatory tools would be used to tackle
problems identified. 25.
Option 2: Simplification
of existing legislation with no major content or policy changes. This option
would enable the bringing together of all the existing Animal Health
legislation into one large piece of legislation, but would not make any
significant changes to the content of the legislation itself. Changes would
only be made as circumstances required, and in order to comply with the Lisbon
Treaty. 26. Option 3: Existing legal framework with more self-regulation. This
option would complement the current animal health policy and existing
legislation with additional initiatives of a non-regulatory nature (self-regulation
is defined by the Commission as "voluntary agreements between private
bodies to solve problems by taking commitments between themselves"). 27. Option 4: A new simplified flexible general legislative framework on
animal health issues, based on achieving certain animal health outcomes. Under
this option, a new simplified legal framework would set out the principles and
objectives for animal health policy required to achieve desired outcomes. The
outcomes, such as certain animal health and linked public health standards,
would be agreed at EU level. However, the framework would be flexible to allow
Member States to apply EU rules as appropriate in accordance with local
circumstances to achieve the desired outcomes. 28. Option 5: A new prescriptive legislative framework on animal health
issues, based on setting specific processes and standards for animal health
policy. Under this option, a new comprehensive legal framework would set out
the principles and objectives of animal health. This framework would set
specific standards for animal health rules and procedures which would be
required across Member States, with little flexibility for Member States to
adapt the rules to their differing circumstances. 5. Assessment of impacts Option 1 – No
Change 29. To allow for a proper comparison of the options, Option 1,
continuing with current animal health policy, is being used as the policy
baseline and the impacts of the other options will be assessed in relation to it.
30. The no change option has already been rejected by both the impact
assessment for the Animal Health Strategy and the CAHP assessment, and would
therefore be extremely difficult to justify. No change will mean a continuation
of the current EU level approach to tackling animal health issues and the
problems identified in the report. Option 2 –
Simplification of existing legal framework with no significant policy change 31. This option assumes there would be a simplification of the existing
legal framework, by bringing together the several pieces of existing
legislation into one overall piece of legislation but without addressing policy
objectives and developments set out in the AHS. 32. Animal health policy would not change materially; the benefits
associated with this option are solely those from the simplification of the
legislation. By bringing together all the existing legislation into one place,
there would be some improved simplicity and duplications avoided. 33. However, the existing legislation has no set of principles of
overarching coherence and so to put everything in one piece of legislation
would lead to a long list of the existing aquis, really achieving very
little in the way of genuine simplification, so the objectives set out in the
AHS will not be met. Option 3 –
Existing legal framework with more self-regulation 34. This option is composed mainly of non-regulatory actions that will
be carried out with the resources currently available and will not create
additional administrative burdens. These actions would include the Commission
and/or Member States either developing guidance and best practice to improve
animal health measures or encouraging stakeholders to do so. These would
complement the existing animal health legal framework and would aim to achieve
better prevention of animal diseases. Legislation
would be updated individually as necessary to comply with new requirements
(such as the new decision-making processes following the introduction of the
Lisbon Treaty), or with technological developments. 35. In general terms, offering guidance and promoting best practices for
animal health measures will make animal keepers and other actors in the food
chain better informed about animal health measures and the animal disease risks
and responsibilities of their actions. If animal keepers are more aware of best
practices for preventing diseases, they are more likely to implement measures,
such as biosecurity and surveillance, which would be worthwhile for them in
terms of reducing the frequency and impact of animal diseases. 36. However, these actions will not be mandated. They rely on the
willingness of stakeholders to develop guidance in the first place; and the
co-operation of animal keepers in voluntarily following this guidance, under
circumstances where it may not always be in their direct interest to do so.
Therefore the actual effects of this option being put into practice are very
uncertain, ranging from no change at all at one end to a potentially fairly
positive impact at the other. Option 4 –
flexible general legislative framework for animal health issues 37. The economic and public health impacts of option 4 are expected to
be largely positive. First, there are the benefits expected from reduced
disease instance. Overall, resources will be better targeted according to risk,
saving time and money. A strategy to make the best possible use of vaccines
will be developed and may have positive economic impacts in the reduction of
the instance of animal disease and all the associated positive impacts. 38. Undoubtedly there would be some initial impact from the need for
familiarisation with the new legislative framework for farmers and other animal
keepers as well as competent authorities. Nevertheless this initiative aims to simplify existing
legislation, so it is considered that any burden will actually be very limited,
and derogations introduced where appropriate. Where new measures might be
introduced, such as for biosecurity, they will be based on giving possibilities
and incentives to improve rather than introducing compulsory measures. This
means e.g. that the additional familiarisation and implementation will be the
farmer's or operator's choice to create positive (economic and animal health)
benefits. As due to the very nature of animal diseases,
regular updates of valid rules are already a standard procedure; one-off familiarisation costs are likely
to be integrated into business-as-usual costs. In the long term, the simplified, more coherent strategic framework
should benefit all, and in particular, make more sense to those learning about
their obligations for the first time (for example, for new entrants to
farming). 39. Overall and in the long term, it is fair to assume that a
simplified, flexible and outcome-based framework will impose a lower
administrative burden on farming and related industries and animal keepers than
the prescriptive framework of option 5. This is because its inherent
flexibility means obligations and requirements could be tailored to national or
regional circumstances, introducing derogations for low-risk situations where
appropriate, and enabling Member States to tailor any administrative
obligations to that which is only strictly necessary according to a reasonable
assessment of risk. 40. There are three examples that were felt particularly important to
analyse in more detail: biosecurity, trade and vaccination, which are set out
in the report text and in some detail in the accompanying annexes to this
report. An example of the potential impact on administrative burden is
summarised in Table 5.2 of the main report. 41. As noted above, there should be a slightly positive social effect
with respect to the flexibility of the veterinary labour market and in
particular, some benefits from achieving the same standard of safety of animals
and animal products. 42. Assuming that there is a reduced instance of animal disease
outbreaks, we can extrapolate several other positive environmental impacts.
Animal diseases found in kept animals can have negative impacts on wildlife
(for example, avian flu, as wild birds may not only actively spread this
disease to domestic poultry but also be infected by domestic poultry). Thus
reducing their incidence should have an overall positive impact on wildlife. Option 5 –
prescriptive general legislative framework for animal health issues 43. Option 5 is likely to lead to a significant reduction in the
instance of animal disease in the EU, with all the associated economic, social
and environmental benefits analysed in some detail in the report. However,
option 5 is likely to have a significant administrative burden. In addition,
more prescriptive rules are likely to become obsolete much more quickly with
environmental and technological changes. 44. Option 5 should entail a reduction in animal disease, but it is
difficult to assert with any confidence that requiring the same standards
across the board, as in option 5, will have a better or worse effect than a
well-executed risk-based approach, as that in option 4. It depends at what
level resources are applied and standards are set. One could assert that
(assuming the same level of resources applied to each option) a good risk-based
application of resources will have a more beneficial effect than a uniform
standard applied across the board. 45. The administrative burden for Member States is potentially very
large with this option. The size of the burden would depend on exactly how it
was implemented, but if there were requirements for Member States to provide
training for animal keepers; as well as developing, administering and enforcing
new animal health measures in biosecurity and surveillance; the burdens would
be very significant. 46. The prescriptive legislative framework will set the knowledge and
skills which much be attained in the professional qualifications and training
for official and approved veterinarians at EU level. Ensuring that
veterinarians have the same knowledge and skills throughout the EU will make it
is easier for official and approved veterinarians to work in other Member
States without compromising health standards. 47. There should largely be positive environmental impacts from the
implementation of option 5, very similar to those outlined in option 4. On the
one hand, more mandated actions might be expected to produce more positive
environmental impacts of the kind outlined in relation to option 4. However,
the increased rigidity of option 5 may mean that measures are less adaptable to
particular environmental circumstances, perhaps leading to some negative
environmental, including welfare impacts. It is very difficult to assess even
the relative direction of travel here, let alone to quantify the expected
impacts. 6. Comparison of Options 48. Overall, option 4 seems to be the option most likely to deliver a
good level of effectiveness, efficiency and coherence with EU objectives. It
should achieve the main objectives of delivering the clarity and coherence of
an overall strategy and framework, but leaving flexibility to allow for
particular circumstances in particular Member States or areas, and to adapt to
rapidly changing circumstances. Therefore, it is also the option which best
respects the principles of subsidiarity and proportionality. Options 2 or 3,
while offering more continuity with the present context, simply lack any
guarantee of positive outcomes, and retain the existing confusing myriad of
legislation. Option 5 would deliver the objective of simplicity with an
overarching strategy and framework, but is likely to be too rigid to adapt
successfully to differing circumstances across the Union, so potentially
undermining its own objectives. 49. The main benefit of option 4 is in its flexibility. As noted
previously, the nature of the overarching enabling framework means that it is
possible for certain specific policy measures to use the tools outlined in
general terms in options 3 or 5. The tools of option 3 (some self-regulatory
schemes or elements) could be introduced or encouraged if it was felt to be
unnecessary or inappropriate to cover a specific issue in legislation. The more
prescriptive legislative framework described in option 5 could be introduced
for particular issues, species or diseases under delegated or implementing
legislation under the flexible legislative framework if more detailed measures
were necessary or appropriate. Table 6.1:
Comparison of Options 3-5 Objectives || Option 3 || Option 4 || Option 5 Effectiveness || Option 3 has a range of outcomes from no change compared to the baseline, to a relatively significant self-regulatory system. Its effectiveness in relation to achieving the objectives is therefore more likely to be positive than negative. + || Option 4 is likely to be effective in achieving or working towards these objectives. + || Option 5 is likely to be effective in achieving or working towards these objectives, but may be less likely to maintain this effectiveness in the long term because of its lack of flexibility. + Efficiency || Its efficiency depends on the amount of resources devoted to getting a self-regulatory system up and running. However, it will not require time consuming regulatory change. +/- || The flexible framework will require limited familiarisation costs; because this will mainly be undertaken within already existing training networks (e.g. BTSF, etc).It is likely to be more understandable and efficient in the longer term for stakeholders, both animal keepers and MS. ++ || Option 5 is likely to require more administrative burden to familiarise and implement. While it will allow for more coherence in the legislation and may lead to an overall benefit, the lack of flexibility means that as circumstances change, more resource will be required to change the legislation. + Coherence with EU objectives || It would not achieve the objectives set out in the EU AHS of bringing together all AH legislation under one framework. - || Would achieve the EU AH strategy goal of bringing together all AH legislation into a coherent and flexible framework. Is in line with flexible approach taken elsewhere and is most likely to achieve the operational objectives in section 3. ++ || Would achieve the EU AH strategy goal of a single legislative framework but the lack of flexibility means it is less likely to achieve some of the operational objectives as it is less able to be adapted to changing circumstances in the future. + 7. Monitoring and Evaluation 50. Simple and reliable performance indicators will help to measure progress. They should cover both hard
indicators of animal health and softer indicators tracking the confidence,
expectations and perceptions of European citizens. 51. It is very difficult to prescribe a set of precise indicators here
that will definitively show that such a wide-ranging initiative such as the
Animal Health Law has succeeded in its objectives. Nevertheless, a series of
measurements over a fairly generous timeframe should give an indication of the
general direction of travel. 52. Examples of what the hard indicators of success are: -
the proportion of EU veterinary expenditure for
eradication and monitoring measures vs. emergency measures; -
restrictions (number of areas x length of
restrictions) due to outbreaks of regulated notifiable diseases; -
the number of large scale disease outbreaks and
of animals culled due to eradication measures; -
overall costs and losses for the EU, MS and
farmers and other stakeholders due to animal disease outbreaks; -
animal consignments moved across borders under
the simplified regime; -
the number of training sessions taken up by
animal keepers, especially farmers. 53. As noted above, this impact assessment is necessarily a wide-ranging
overview. When specific secondary legislative measures are introduced, more
specific impact assessments will likely need to be completed, and as part of
this, much more specific indicators for each measure. It is envisaged that an
evaluation should take place around five years after the implementation of the
AHL, and the results will be made available for future decision-making. [1] http://ec.europa.eu/europe2020/index_en.htm