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                                                                       SCOPING PAPER


  PURPOSE       The "Scoping Paper" is one tool that could help the AH Advisory
   WHY?         Committee and DG SANCO to better understand varied proposal for action
                that are suggested by one or several stakeholders. Specifically:
                   By integrating all relevant elements in a single document, it seeks to
                    introduce a degree of consistency to the way proposal for actions are
                    submitted to DG SANCO.
                   It would present the initiative to a wider audience within the Animal
                    Health Advisory Committee,
                   It could be modified and/or improved by the AH Advisory Committee. It
                    could also promote ownership and support from the AH Advisory
                   It could reach a wide support of the AH Advisory Committee providing
                    DG SANCO with all relevant information to facilitate SANCO
                    management decision-making on policy,

 DEFINITION     The purpose of a Scoping Paper is to provide information. The type and
 WHAT IS IT?    extent of this will be dependent on the initiative proposed, but at its basic
                level, it should be sufficient to allow the reader (who may only have a
                minimal knowledge of the subject) to get an overview of the issue.

 STRUCTURE      The Scoping Paper template is attached in Annex.
WHAT DOES IT    The best way of describing it is that it should be a “quick and simple”
 LOOK LIKE?     impact assessment. It should allow for a first informed debate on policy
                options and possible impacts within the AH advisory Group, and later on
                enable DG SANCO management to take a decision on the way forward. It
                should be emphasised that, although it broadly follows the format of the
                impact assessment guidelines, the Scoping Paper is not a formal impact
                assessment – not least as it will be produced near the start of an initiative.

LENGTH & TIME    The length of a Scoping Paper will be dependent on the initiative, but
 HOW LONG?      should be between 2 and 8 pages long. The stakeholder will need to
                consider carefully how best to describe the initiative, the objectives, the
                options and possible impacts. It should be seen as a discussion document
                that provides an initial broad overview of how DG SANCO/stakeholders
                might take the proposed initiative forward. Therefore, it does not have to be
                too detailed.

PRESENTATION   Scoping papers must be sent well in advance to the Director of the Animal
  WHEN, BY     Health and Welfare Directorate (SANCO Directorate D, Bernard Van
               Goethem). It must be of general interest for the AH advisory Committee.
  WHOM ?       The scoping paper will be circulated to all stakeholders at least six weeks
               before an eventual discussion during the next committee. The Director
               might invite the stakeholder to present its proposal to the AH Advisory
               Committee. The AH Advisory Committee would be invited to give its views
               on the proposal.
                                Scoping Paper Template

               SCOPING PAPER


              TEMPLATE FOR

                  Please complete in accordance with the
        “Guidelines for the preparation of a Scoping Paper”
The intention is that this is a 'quick and simple' explanation. Therefore, it does not need to be detailed,
but rather give a broad overview of the issue. Simply put - what is the problem/issue, what are our
objectives, what are our options and what kind of impacts could be expected.
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Keep short, no more than 25 words, but ensure that it provides enough information to be broadly

STAKEHOLDER proposing the action

Keep short and in simple languiage but ensure that it provides enough information to get an overview
of what the initiative is about and why it is needed.

In defining the problem, do not forget to consider, if relevant, subsidiarity.


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Without going into detail, set out the current status and timing foreseen for the initiative (start date,
likely adoption date, etc., set out data availability and identify needs for additional data to be in a
position to analyse the impacts and provide any detail as regards past, current and planned
stakeholder consultations.

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                    ANNEX 1

Indicate the title of the proposed initiative. Remember that the title is the most
"visible" part of the initiative. Therefore, it is important to be concise and use clear
language (no more than 25 words), but also to ensure that it provides enough
information to be broadly understandable.


Indicate the name of your association.


The purpose of this section is to give an overview of the origin of the initiative. You
should explain, concisely and in a simple language, where the initiative comes from,
why it is needed and what it is about. For instance, it could be required for the
following reasons:

          stakeholders' input/expectations,
          new data,
          a scientific development,
          a newly arisen problem,
          an identifiable risk,
          emerging international trends,
          a recommendation from an evaluation/audit of a previous initiative,

You have to be able to describe and explain the issue, in a very short piece of text.

Make it understandable.

You should be thinking about several key questions:

       Is the issue multifaceted (includes separate issues) or one single issue?
       You should be clear about who says it is an issue.

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            If available, give indication about how big of an issue it is/the scale of the
             issue – how many industry sectors are concerned? Is it an issue in all
             Member States (MS) or some MS only? Etc.

Focus on the issue, a good problem definition will clearly explain what the problem is.

You should consider whether the issue is appropriate for action by the EU and, if yes,
whether it is within the union’s remit to act (the subsidiarity factor)?


What objectives should be pursued?

When defining your objectives, you should have in mind the 4 main objectives of the
EU Animal Health Strategy:

           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.

Objectives should correspond with the issue at stake and its root causes should be
clear and should address key elements.

Ideally, objectives should be SMART (Specific, Measurable1, Accepted, Realistic and

What are the policy options available? Describe all the alternatives that could
conceivably operate to achieve the objectives defined in the previous section.

When identifying the policy options available, you should also consider availability of
legal basis, existing/planned EU and Member State legislation, international
agreements and whether MS are likely to support the initiative.

    Measurable means assessable and not necessarily quantifiable.

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In considering policy options, you should take into account the following points:

      Be clear about what the effect of doing nothing is. The do-nothing scenario
       (i.e. no change) should always be among the options identified, for more
       detailed study.
      Do not assume legislation is the only option. Remember that the fact to
       consider different options do not necessarily lead to adopting them. It may well
       be that legislation will be deemed necessary.
      Consider alternatives to regulation (e.g. guidelines, self-regulation, etc…) as
       potential options.

At this point in time, you should identify the likely major economic, environmental
and social impacts and briefly set out how they might be affected by each identified
policy-option. If there are no expected impacts in one or other area, the reason should
be briefly explained. To have an overview of possible impacts, you can refer to
Annex 3.

Assessment of impacts will necessarily be preliminary and will not provide detailed
quantitative data.

Attention should be focused on impacts which are likely to be the most significant
and should clearly identify affected populations (including, if necessary, population
sub-groups: e.g. farmers, food industry, hobby farmers, zoos).

Where positive impacts could be increased and negative impacts reduced or offset by
refinement of the option, or by flanking measures, then you might wish to indicate your
idea for possible enhancing and mitigation measures (e.g. transition periods,
exemptions for certain groups, etc.) to make it more effective and efficient.

Impacts on 3rd countries, their populations, their businesses and on particular regions
should also be considered.

What are the respective advantages and disadvantages of each policy option? For
tabulation, see example 1 in Annex 2.1. Weigh up the strengths, weaknesses,
opportunities and threats (SWOT analysis) of each policy-option. For tabulation, see
example 2 in Annex 2.1.

In comparing policy options, please summarise in a table all the costs and benefits
linked to the various policy options (see example 3 in Annex 2.1). You can also
compare the various policy options using the criteria of effectiveness (achievement of
results), efficiency (resource use) and consistency (balance of impacts across the
three pillars). For tabulation, see example 4 in Annex 2.1. Finally, you can also assess

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impacts across the 3 pillars, namely economic, environmental and social impacts. For
tabulation, see example 5 in Annex 2.1.


The objective of this section is to give brief information on the current status of the
proposed initiative, as well as the next steps foreseen. This section provides the
opportunity to present any additional information of interest for the AH advisory
Committee and DG SANCO.

It should be used to expand some of the points but can be used to add any further
details you feel will be relevant in relation to the initiative. The most obvious areas are
data needs and consultations (see below) but there might be other issues with
which you feel are worth mentioning.

   1. Data availability and further data needs. If you believe it is likely that they will be
      a need to carry out the future Impact Assessment, then you should highlight
      what are the essential data needs and how much of this you already have or
      what still needs to be collected.

   2. Consultations expected or foreseen Consultation Plan (Whom? On what? How?
      And When?). It is important to understand who else has been or will be involved
      in the work around the initiative. It is important to identify, at an early stage,
      what implications the initiative might or will have on other stakeholders.

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               Annex 2 – Tabulation of Options

Example 1 – Comparing advantages and disadvantages

         OPTIONS:                        Advantages                          Disadvantages

         Option A

         Option B

         Option C

         Option D

Example 2 – Comparing Strengths, Weaknesses, Opportunities and Threats (SWOT

    OPTIONS:         Strengths           Weaknesses             Opportunities              Threats
    Option A
    Option B
    Option C
    Option D

Example 3 – Comparing and quantifying costs and benefits. For all of the options
considered, you need to identify a set of costs and benefits. You should then express
costs and benefits in quantitative terms, using  (very negative),  (negative) and 
(neutral) for costs and  (very positive)  (positive)  (neutral) for benefits.

 COSTS              Identified Cost A     Identified Cost B      Identified Cost C      Identified Cost D

    Option A                                                                              
    Option B                                                                               
    Option C                                                                              
    Option D                                                                              
 BENEFITS         Identified Benefit A   Identified Benefit B   Identified Benefit C   Identified Benefit D

    Option A                                                                              
    Option B                                                                               
    Option C                                                                              
    Option D                                                                               

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Example 4 – Comparing effectiveness, efficiency and consistency

                                   Effectiveness          Efficiency             Consistency

        Option A
        Option B
        Option C
        Option D

Example 5 – Comparing economic, environmental and social impacts (3 Pillars
Analysis). You should then express costs and benefits in quantitative terms, using 
(very negative),  (negative) and  (neutral) for costs and  (very positive) 
(positive)  (neutral) for benefits.

                           Option 1            Option 2          Option 3            Option 4

                        Benefits   Costs   Benefits   Costs   Benefits   Costs    Benefits   Costs

    Social, including
     Public Health

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                          Annex 3 – List of Impacts
                               Economic Impacts

     Impacts on :                                  Key questions

Competitiveness, trade     Does the option have an impact on the competitive position of
and investment flows       EU firms in comparison with their non-EU rivals?
                           Does it provoke cross-border investment flows (including
                           relocation of economic activity)?
                           Are the proposed actions necessary to correct undesirable
                           outcomes of market processes in European markets?

Competition in the         Does the option affect EU competition policy and the
internal market            functioning of the internal market? For example, will it lead to a
                           reduction in consumer choice, higher prices due to less
                           competition, the creation of barriers for new suppliers and
                           service providers, the facilitation of anti-competitive behaviour
                           or emergence of monopolies, etc?

Business costs: impact     Will it impose additional adjustment, compliance or transaction
on conduct of business     costs on businesses?
                           Does the option affect the cost or availability of essential inputs
                           (raw materials, machinery, labour, energy, etc.)?
                           Does it affect access to finance?
                           Does it have an impact on the investment cycle?
                           Will it entail the withdrawal of certain products from the market?
                           Is the marketing of products limited or prohibited?
                           Will it entail stricter regulation of the conduct of a particular
                           business? Will it directly lead to the closing down of
                           Are some products or businesses treated differently from others
                           in a comparable situation?

Administrative costs on    Does the option impose additional administrative requirements
businesses                 on businesses or increase administrative complexity?
                           Do these costs weigh relatively heavily on SMEs?

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Property rights            Are property rights affected (land, movable property,
                           tangible/intangible assets)? Is acquisition, sale or use of
                           property rights limited? Or will there be a complete loss of

Innovation, research and   Does the option stimulate research and development?
                           Does it facilitate the introduction and dissemination of new
                           production methods, technologies and products?
                           Does it affect intellectual property rights (patents, trademarks,
                           copyright, other know-how rights)?
                           Does it promote or limit academic or industrial research?
                           Does it promote greater resource efficiency?

Consumers, households      Does the option affect the prices consumers pay?
and families
                           Does it impact on consumers’ ability to benefit from the internal
                           Does it have an impact on the quality and availability of the
                           goods they buy, and on consumer choice?
                           Does it affect consumer information and protection?
                           Does it have significant consequences for the financial situation
                           of individuals or families, both immediately and in the long run?
                           Does it affect the economic protection of the family and of

Specific regions or        Does the option have significant effects on certain sectors?
                           Will it have a specific impact on certain regions, for instance in
                           terms of jobs created or lost?
                           Does it have specific negative consequences for SMEs?

Third countries and        Is the option consistent with EU trade policy and our
international relations    international obligations, including in the WTO?
                           Is it consistent with the objectives of EU foreign policy and
                           EU/EC development policy?
                           Does the option affect third countries with which we have
                           preferential trade arrangements?
                           Does the option affect developing, least developed and middle
                           income countries?

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Public authorities   Does the option have budgetary consequences for public
                     authorities at different levels of government, both immediately
                     and in the long run?
                     Does the option require significant establishing new or
                     restructuring existing public authorities?

The macroeconomic    What are the overall consequences of the option for economic
environment          growth and employment?
                     Does it contribute to improve the conditions for investment and
                     for the proper functioning of markets?
                     Does the option have direct or indirect inflationary

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                               Environmental Impacts

   Impacts on:                                      Key questions

Air quality            Does the option have an effect on emissions of acidifying, eutrophying,
                       photochemical or harmful air pollutants that might affect human health,
                       damage crops or buildings or lead to deterioration in the environment
                       (polluted soil or rivers etc)?

Water quality and      Does the option decrease or increase the quality or quantity of
resources              freshwater and groundwater?
                       Does it raise or lower the quality of waters in coastal and marine areas
                       (e.g. through discharges of sewage, nutrients, oil, heavy metals, and
                       other pollutants)?
                       Does it affect drinking water resources?

Soil quality or        Does the option affect the acidification, contamination or salinity of soil,
resources              and soil erosion rates?
                       Does it lead to loss of available soil (e.g. through building or
                       construction works) or increase the amount of usable soil (e.g. through
                       land decontamination)?

The climate            Does the option affect the emission of ozone-depleting substances
                       (CFCs, HCFCs, etc.) and greenhouse gases (e.g. carbon dioxide,
                       methane etc) into the atmosphere?

Renewable or non-      Does the option affect the use renewable resources (freshwater, fish)
renewable              more quickly than they can regenerate?
                       Does it reduce or increase use of non-renewable resources
                       (groundwater, minerals etc)?

Biodiversity, flora,   Does the option reduce the number of species in any area (i.e. reduce
fauna and              biological diversity) or increase the range of species (e.g. by promoting
landscapes             conservation)?
                       Does it affect protected or endangered species or their habitats or
                       ecologically sensitive areas?
                       Does it split the landscape into smaller areas or in other ways affect
                       migration routes, ecological corridors, or buffer zones?
                       Does the option affect the scenic value of protected landscape?

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Land use              Does the option have the effect of bringing new areas of land
                      (‘greenfields’) into use for the first time?
                      Does it affect land designated as sensitive for ecological reasons?
                      Does it lead to a change land use (for example split between rural and
                      urban, or change in type of agriculture)?

Waste production /    Does the option affect waste production (solid, urban, agricultural,
generation /          industrial, mining, radioactive or toxic waste) or how waste is treated,
recycling             disposed of, or recycled?

The likelihood or     Does the option affect the likelihood or prevention of fire, explosions,
scale of              breakdowns, accidents and accidental emissions?
                      Does it affect the risk of unauthorised or unintentional dissemination of
                      environmentally alien or genetically modified organisms?
                      Does it increase or decrease the likelihood of natural disasters?

Mobility (transport   Does the option increase or decrease consumption of energy and
modes) and the        production of heat?
use of energy
                      Will it increase or decrease the demand for transport (passenger or
                      freight), or influence its modal split?
                      Does it increase or decrease vehicle emissions?

The environmental     Does the option lead to changes in natural resource inputs required
consequences of       per output? Will it lead to production becoming more or less energy
firms’ activities     intensive?
                      Does the option make environmentally un/friendly goods and services
                      cheaper or more expensive through changes in taxation, certification,
                      product, design rules, procurement rules etc?
                      Does the option promote or restrict environmentally un/friendly goods
                      and services through changes in rules for capital investments, loans,
                      insurance services etc cheaper?
                      Will it lead to businesses becoming more or less polluting through
                      changes in the way in which they operate?

Animal and plant      Does the option have an impact on health of animals and plants?
health, food and
                      Does the option affect animal welfare (i.e. humane treatment of
feed safety
                      Does the option affect the safety of food and feed?

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                                   Social Impacts

   Impacts on:                                      Key questions

Employment and      Does the option facilitate new job creation?
labour markets
                    Does it lead directly to a loss of jobs?
                    Does it have specific negative consequences for particular professions,
                    groups of workers, or self-employed persons?
                    Does it affect the demand for labour?
                    Does it have an impact on the functioning of the labour market?

Standards and       Does the option impact on job quality?
rights related to
                    Does the option affect the access of workers or job-seekers to vocational or
job quality
                    continuous training?
                    Will it affect workers' health, safety and dignity?
                    Does the option directly or indirectly affect workers' existing rights and
                    obligations, in particular as regards information and consultation within their
                    undertaking and protection against dismissal?
                    Does it affect the protection of young people at work?
                    Does it directly or indirectly affect employers' existing rights and obligations?
                    Does it bring about minimum employment standards across the EU?
                    Does the option facilitate or restrict restructuring, adaptation to change and
                    the use of technological innovations in the workplace?

Social inclusion    Does the option affect access to the labour market or transitions in/out of the
and protection of   labour market?
particular groups
                    Does it lead directly or indirectly to greater in/equality?
                    Does it affect equal access to services and goods?
                    Does it affect access to placement services or to services of general
                    economic interest?
                    Does the option make the public better informed about a particular issue?
                    Does the option affect specific groups of individuals, firms, localities, the
                    most vulnerable, the most at risk of poverty, more than others?
                    Does the option significantly affect third country nationals, children, women,
                    disabled people, unemployed, the elderly, political parties or civic
                    organisations, churches, religious and non-confessional organisations, or
                    ethnic, linguistic and religious minorities, asylum seekers?

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Equality of      Does the option affect equal opportunities and equal treatment for all?
treatment and
                 Does the option affect gender equality?
non -            Does the option entail any different treatment of groups or individuals directly
discrimination   on grounds such as sex, race, colour, ethnic or social origin, genetic
                 features, language, religion or belief, political or any other opinion,
                 membership of a national minority, property, birth, disability, age or sexual
                 orientation? Or could it lead to indirect discrimination?

Private and      Does the option affect the privacy of individuals (including their home and
family life,     communications) or their right to move freely within the EU?
personal data
                 Does it affect family life or the legal, economic or social protection of the
                 Does the option involve the processing of personal data or the concerned
                 individual’s right of access to personal data?

Governance,      Does the option affect the involvement of stakeholders in issues of
participation,   governance as provided for in the Treaty and the new governance
good             approach?
                 Are all actors and stakeholders treated on an equal footing, with due respect
and access to
                 for their diversity? Does the option impact on cultural and linguistic diversity?
                 Does the option affect the autonomy of the social partners in the areas for
                 which they are competent? Does it, for example, affect the right of collective
                 bargaining at any level or the right to take collective action?
                 Does the implementation of the proposed measures affect public institutions
                 and administrations, for example in regard to their responsibilities?
                 Does the option make the public better informed about a particular issue?
                 Will the option affect the individual’s rights and relations with the public
                 Does it affect the individual’s access to justice?
                 Does the option make the public better informed about a particular issue?
                 Does it affect the public’s access to information?
                 Does the option affect the media, media pluralism and freedom of
                 Does the option raise (bio)ethical issues (cloning, use of human body or its
                 parts for financial gain, genetic research/testing; use of genetic information)?

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Public health and    Does the option affect the health and safety of individuals/populations,
safety               including life expectancy, mortality, and morbidity, through impacts on the
                     socio-economic environment (e.g. working environment, income, education,
                     occupation, nutrition)?
                     Does the option affect the potential for bioterrorism?
                     Does the option increase or decrease the likelihood of health risks due to
                     substances harmful to the natural environment?
                     Does it lead to health damage due to changes in the amount of noise or air,
                     water or soil quality in populated areas?
                     Will it lead to health damage due to changes energy use and/or waste
                     Does the option affect lifestyle-related determinants of health such as use of
                     tobacco, alcohol, or physical activity?
                     Are there specific effects on particular risk groups (determined by age,
                     gender, disability, social group, mobility, region, etc.)?

Crime, Terrorism     Does the option improve or hinder security, crime or terrorism?
and Security
                     Does the option help or hinder crime or terrorism?
                     Does the option affect the detection risks of the criminal or his/her potential
                     gain from the crime?
                     Is the option likely to increase the number of criminal acts?
                     Does it affect law enforcement capacity?
                     Will it have an impact on the balance between security interests and the
                     rights of suspects?
                     Does it affect the rights of victims of crime and witnesses?

Access to and        Does the option have an impact on services in terms of their quality and
effects on social    access to them?
protection, health
                     Does it have an effect on the education and mobility of workers (health,
and educational
                     education, etc.)?
                     Does the option affect the access of individuals to public/private education or
                     vocational and continuing training?
                     Does it affect the cross-border provision of services, referrals across borders
                     and co-operation in border regions?
                     Does the option affect the financing / organisation / access to social, health
                     and education systems (including vocational training)?
                     Does it affect universities and academic freedom or self-governance?


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