COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Healthier Animals and Plants and a Safer Agri-Food Chain A modernised legal framework for a more competitive EU
Date: 2013-05-06
Institutions: European Commission
Subjects: animal health, consumer protection, food safety, marketing standard, plant health control, plant propagation

EUROPEAN 
COMMISSION 

Brussels, 6.5.2013  
COM(2013) 264 final 

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE 
EUROPEAN PARLIAMENT 

Healthier Animals and Plants and a Safer Agri-Food Chain 

A modernised legal framework for a more competitive EU 

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CONTENTS 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

1.5. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

2.5. 

3. 

4. 

The current context ...................................................................................................... 4 

Animal Health .............................................................................................................. 4 

Plant health................................................................................................................... 4 

Plant reproductive material .......................................................................................... 5 

Official controls ........................................................................................................... 5 

Management of expenditure......................................................................................... 6 

The need to modernise the EU legal framework for animals, plants and the food 
chain ............................................................................................................................. 6 

Animal health ............................................................................................................... 6 

Plant health................................................................................................................... 7 

Plant reproductive material .......................................................................................... 7 

Official controls ........................................................................................................... 8 

Management of expenditure......................................................................................... 8 

The ‘Review Package’ ................................................................................................. 8 

The content of the ‘Review Package’ .......................................................................... 9 

4.1. 

The Animal Health Law............................................................................................... 9 

4.1.1.  Main changes ............................................................................................................... 9 

4.2. 

The Plant Health Law................................................................................................. 10 

4.2.1.  Main changes ............................................................................................................. 11 

4.3. 

The Plant Reproductive Material Law ....................................................................... 12 

4.3.1.  Main changes ............................................................................................................. 12 

4.4. 

The Regulation on Official Controls.......................................................................... 14 

4.4.1.  Main changes ............................................................................................................. 14 

4.5. 

Management of expenditure....................................................................................... 16 

5. 

Conclusion.................................................................................................................. 16 

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COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE 
EUROPEAN PARLIAMENT 

Healthier Animals and Plants and a Safer Agri-Food Chain 

A modernised legal framework for a more competitive EU 

Introduction 

Ensuring a high level of health for humans, animals, and plants  is a Treaty objective  of the 
EU.  Over  time,  the  EU  has  built  up  a  comprehensive  body  of  law  designed  to  prevent  and 
manage risks to animal and plant health and the safety of the food chain at EU and national 
level. The law in these policy areas is enforced by means of a common set of rules on official 
controls to be carried out by the competent authorities in the EU Member States. 

The legal framework which the EU has developed so far has proven, overall, to be effective in 
preventing and countering risks. However, the modern global market increasingly exposes the 
EU  to  new  risks  and  constantly  calls  for  innovation  and  competitiveness.  This  and  the 
experience  gained  with  EU  law  in  this  area,  points  to  the  need  to  simplify  and  update 
available instruments and to further integrate the approach across the different areas. 

The  Commission  therefore  conducted  a  revision  of  the  current  legal  framework  for  animal 
health,  plant  health,  plant  reproductive  material  and  official  controls  aimed  mainly  at 
increasing  effectiveness,  consistency  and  legal  clarity  in  those  areas.  In  doing  so,  it  was 
seeking to foster the productivity, smooth functioning and accessibility of the internal market 
and  to  reinforce  the  EU’s  competitiveness  on  a  global  scale.  Thus,  the  review  is  ultimately 
contributing  to  delivering  smart,  sustainable  and  inclusive  growth  in  line  with  the  EU  2020 
goals. 

This  Communication  presents  the  resulting  four  legislative  proposals  in  the  four  areas  of 
animal  health,  plant  health,  plant  reproductive  material  and  official  controls  (the  ‘review 
package’) and explains, for each of them, the current context, the rationale behind the package 
and the main improvements introduced. 

The review package also includes a fifth proposal establishing a multiannual programme for 
EU  financing  of  actions  aimed  at  ensuring  a  high  level  of  health  for  humans,  animals  and 
plants along the agri-food chain and in related areas while allowing businesses to operate in 
an environment that favours competitiveness and job creation. 

Food production and consumption is central to any society, and has economic, social and, in 
many  cases,  environmental  consequences.  The  agri-food  industry  is  the  second  largest 
segment of EU industry. The total output of the food chain is worth some €
 750 billion a year. 
The  sector  employs  over  48  million  people,  from  primary  production  through  to  retail  and 
catering.  There  are  around  14  million  primary  agricultural  producers  and  25  million  food 
businesses operating along the EU agri-food chain. 

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1. 

THE CURRENT CONTEXT 

In  order  to  afford  citizens  a  high  level  of  human,  animal  and  plant  health  while 
encouraging the efficient functioning of the internal market, EU legislation provides 
a  set  of  harmonised  rules  to  prevent,  eliminate  or  reduce  health  risks  to  humans 
which may arise along the agri-food chain and in the two areas most closely related 
to  it,  i.e.  plant  and  animal  health.  Overall,  EU  rules  aim  at  addressing  health  risks 
proper — i.e. risks to the integrity of humans, animals and plants from microbial and 
chemical  contamination,  diseases  and  pests  —  but  they  may  also  include  measures 
ensuring  productivity and diversity  in plant production (for food security purposes) 
and  regulating  specific  production  methods  (e.g.  animal  welfare  and  geographical 
indications). 

1.1. 

Animal health 

Animal  health  is  a  concern  for  all.  Currently,  EU  intervention  is  focused  on 
preventing  and  controlling  transmissible  diseases  that  may  have  significant  health 
and  economic  impacts.  The  impact  of  an animal  disease  outbreak  can  vary  widely, 
but  it  usually  poses  a  direct  risk  to  animal  and  often  public  health,  partly  through 
food of animal origin. However, there can also be indirect negative effects (possibly 
economic or social), including the cost to livestock farmers and related industries of 
dealing  with  disease  and  of  business  disruption,  the  cost  to  the  public  sector  of 
eradicating and monitoring the disease, and changes in consumption patterns. Often, 
disease outbreaks also have significant effects on international trade in animals and 
animal products. 

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 €

 156 billion a year. 

1.2. 

Plant health 

Plant  health  is  a  key  factor  in  sustainable  and  competitive  agriculture,  horticulture 
and forestry. A large proportion of the food we consume, and of the feed fed to food-
producing animals, comes from plants. The first objective of plant health rules is to 
protect  the  living  products  (i.e.  trees,  shrubs  and  plants)  of  EU  agriculture, 
horticulture  and  forestry,  public  and  private  green  (for  example  street  trees,  plants 
within  public  /  private  gardens)  and  the  environment  by  preventing  the  entry  and 
spread  of  non-native  pests.  Plant  health  rules  secure  safe  trade  by  imposing  EU 
import  requirements  and  conditions  for  the  movement  of  plants  and  plant  products 
within  the  EU.  Outbreaks  of  listed  pests  have  to  be  eradicated  or,  if  that  is 
impossible,  contained  to  protect  the  rest  of  EU  territory.  A  second  objective  is  to 
ensure  that  healthy  plant  material  is  used  at  the  beginning  of  the  chain  of  plant 
production, by preventing the spread of pests in seeds and planting material. 

The value of crops grown in the EU is €
 205 billion annually. Without the protection 
afforded by plant health rules, EU agriculture, horticulture and forestry would suffer 
severe  economic  damage.  A  range  of  internationally  regulated  pests  threatens  the 
 9  billion),  potatoes  (EU 
cultivation  of  crops  such  as  wheat  (value  of  EU  exports:  €
production value: €

 9 billion) and tomatoes (production value: €

 9-12 billion). 

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1.3. 

Plant reproductive material 

Plant reproductive material is the cornerstone of agricultural, horticultural and forest 
production.  It  is  the  first  link  in  the  agri-food  chain,  affecting  the  diversity,  health 
and quality of plants and food. Plant reproductive material is controlled to ensure the 
identity,  health  and  quality  of  the  material for  the  benefit  of  its  users,  e.g.  farmers, 
gardeners  or  foresters.  The  objectives  of  EU  legislation  on  plant  reproductive 
material are to improve agricultural, horticultural and forest productivity, ensure the 
smooth operation of the EU market for those products and the competitiveness of the 
sector on a global scale. 

Today, the EU commercial seed market is worth approximately €
 6.8 billion, which 
represents more than 20 % of total worldwide sales of commercial seed. The EU is a 
net exporter of seeds. 

The  EU  sector  is  also  highly  competitive  in  world  trade:  it  is  the  world’s  largest 
 4.4  billion,  representing 
exporter  of  seeds,  with  an  estimated  export  value  of  €
roughly 60% of the total worldwide seed export value of €7.7 billion. 

1.4. 

Official controls 

A high level of health along the agri-food chain depends on consistent, effective and 
timely enforcement of EU standards by the Member States. The correct application 
of  agri-food  chain  rules  and  of  the  rules  on  animal  health  and  animal  welfare,  on 
plant health, on plant reproductive material and on plant protection products must be 
ensured  across  the  EU  for  humans,  plants  and  animals  to  be  healthier  and  for  the 
internal  market  to  thrive  and  work  smoothly.  For  this  to  be  possible,  the  relevant 
authorities in the Member States must be given a clear, reliable and consistent legal 
environment in which to make effective and efficient use of enforcement tools, and 
of  official  controls  in  particular.  They  also  need  appropriate  resources  to  ensure 
continuity and consistency in their work, on the basis of needs linked to enforcement 
objectives. 

More than 100 000 full-time staff are assigned to performing official controls in the 
EU, which involve inspections and other control-related activities. To give but a few 
examples:  some  70 000  samples  a  year  on  average  are  analysed  by  over  270 
accredited  laboratories  checking  for  pesticide  residues.  In  2010  alone,  736 806 
samples  were  taken  to  check  veterinary  residues.  Some  320 000  samples  from 
domestic  poultry  and  wild  birds  were  analysed  in  2011  purely  in  relation  to  avian 
influenza. 

The  efficient  operation  of  an  EU-wide  system  of  official  controls  is  of  paramount 
importance  both  for  exports  and  imports.  The  EU’s  capacity  to  export  to  non-EU 
countries relies on the added value that its products can be shown to have compared 
to those of competitors from outside the EU. This can be only be achieved by having 
an efficient official controls system which ensures that high standards of safety and 
quality are consistently enforced and the corresponding expectations of trade partners 
are met. In the other direction, the EU is the world’s largest importer of live animals, 
food  and  feed.  Checks  carried  out  by  the  Member  States’ competent  authorities  on 
products  arriving  from  non-EU  countries  ensure  that  the  latter  comply  with  EU 
standards or with standards which offer an equivalent level of protection. 

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In  2010  EU  food  and  beverage  imports  were  worth  €
 78  billion,  and  exports 
 73 billion.  The  EU  imported  79.3  million  tonnes  of  food  and  live  animals  and 
3.4 million tonnes of beverages in 2010, with a trade deficit of 14 million tonnes for 
food and live animals, and a surplus of 6 million tonnes for beverages. 

1.5.  Management of expenditure 

The  current  legal  basis  for  EU  funding  is:  Council  Decision  2009/470/EC  for 
veterinary  eradication  programmes  and  veterinary  emergency  measures;  Council 
Directive 2000/29/EC for plant health measures; and Regulation (EC) No 882/2004 
of the  European Parliament  and  of the Council  for  funding  measures  regarding  EU 
reference  laboratories,  Better  Training  for  Safer  Food  (BTSF)  and  other  measures 
deployed to implement official control rules. 

In  2011  €
 314.6 m  was  mainly  allocated  to  animal  disease  eradication  programmes. 
Expenditure on laboratories, BTSF and other measures represented 9 % of the total. 
7 %  was  allocated  to  plant  health  operational  measures,  while  3 %  was  allocated  to 
the emergency fund for veterinary and other diseases. 

2. 

THE NEED TO MODERNISE THE EU LEGAL FRAMEWORK FOR ANIMALS, PLANTS AND 
THE AGRI-FOOD CHAIN 

2.1. 

Animal health 

The  current  EU  animal  health  legislative  framework  consists  of  around  50  basic 
directives  and  regulations,  some  of  which  were  adopted  in  the  early  1960s.  Since 
then a body of over 400 veterinary acts — most of them drawn up between 1988 and 
1995 for a Community of only 12 Member States — has been built up. Meanwhile, 
new  challenges  have  emerged:  diseases  have  sprung  up  which  were  unknown  a 
decade  ago,  while  others  (e.g.  foot  and  mouth  disease,  bluetongue  and  avian  flu) 
have  recently  reappeared,  reminding  us  of  the  serious  risks  they  pose.  Trading 
conditions have also changed radically, with the volume of trade in animal products 
increasing significantly both within the EU and worldwide. 

In  2004  the  Commission  launched  an  independent  evaluation  to  assess  the 
performance  of  the  Community  Animal  Health  Policy  (CAHP)  over  the  previous 
decade.  Although  both  this  evaluation  and  the  later  consultations  concluded  that, 
overall, the current system was functioning properly, it also revealed the need for a 
revision of the current rules to address the following issues: 

– 

– 

– 

– 

the complexity of the policy framework; 

the lack of an overall animal health strategy; 

insufficient focus on disease prevention; 

the possibility of improving intra-EU trade in live animals. 

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2.2. 

Plant health 

Since their introduction in 1977, plant health rules have protected the EU against the 
introduction  and  spread  of  many  pests.  Currently,  Council  Directive  2000/29/EC  is 
the  main  instrument  in  this  area.  However,  with  trade  globalisation  and  climate 
change the EU is facing a higher risk of entry of new pests, increased opportunities 
for  their  establishment  and  spread  as  well  as  increased  vulnerability  of  agricultural 
and natural ecosystems. 

An  evaluation  of  plant  health  rules  carried  out  in  2010  showed  that  the  current 
regime  must  adapt  in  order  to  address  new  risks  effectively.  Indeed,  in  the  last  ten 
years major outbreaks of dangerous import-related pests affecting forestry (e.g. pine 
wood nematode, citrus longhorn beetle, and red palm weevil) have raised awareness 
among policy makers and the public of the cost and impact of inadequate protection. 
The main problems identified by the 2010 evaluation related to: 

– 

– 

– 

– 

insufficient focus on prevention in relation to imports presenting high risks; 

the  need  to  focus  on  pests  which  spread  across  Member  States  and  so  are  a 
priority for the EU; 

the need for more effective instruments for controlling the presence and natural 
spread of pests; 

the  need  to  modernise  existing  instruments  for  intra-EU  movement  (i.e.  plant 
passports and protected zones). 

2.3. 

Plant reproductive material 

The  EU  legal  framework  for  plant  reproductive  material  has  developed  since  the 
1960s.  It  consists  of  12  basic  Council  directives  and  nearly  90  secondary  acts 
covering  variety  listing  for  the  purpose  of  authorisation  for  marketing  and  specific 
marketing requirements for different species. 

While  EU  legislation  has  achieved  the  initial  objectives  of  guaranteeing  free 
marketing  and  ensuring  the  safety  and  quality  of  plant  reproductive  material,  the 
following issues require further attention: 

– 

– 

– 

– 

the complexity and the fragmentation of the current legislation; 

the considerable administrative burden for authorities, as most of the tasks on 
registration and certification need to be carried out by official authorities; 

the lack of consistency with other EU policies (e.g. sustainable agriculture and 
forestry, biodiversity protection, climate change, the bio-economy); 

the lack of a consistent approach to recovering the costs of registering varieties 
and certifying plant reproductive material. 

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2.4. 

Official controls 

Official  controls  are  governed  by  Regulation  (EC)  No  882/2004.  Evidence  of  its 
implementation has been collected primarily through on-the-spot auditing by experts 
of  the  European  Commission,  but  also  through  feedback  from  Member  States  and 
stakeholders regarding the actual day-to-day implementation. This evidence confirms 
that  the  main  changes  introduced  by  the  2004  Regulation  to  the  way  competent 
authorities organise and carry out official controls along the agri-food chain has laid 
the basis for a more integrated and horizontal, and thus more efficient, approach to 
enforcement.  At  the  same  time,  it  points  to  a  set  of  shortcomings  which  call  for 
further improvements, in particular: 

– 

– 

– 

– 

simplification of the overall legal framework, which currently suffers from the 
remaining  fragmentation,  overlaps  and  gaps,  and  therefore  differences  in 
interpretation and implementation at national level; 

more consistent use of the ‘risk-based controls’ principle; 

more systematic and consistent use of administrative cooperation tools and of 
computerised information systems; 

the repeal of unnecessary administrative requirements. 

As  regards  the  financing  of  official  controls  and  the  need  to  ensure  steady  and 
consistent funding of the work of the competent authorities, the evidence also points 
to  current  uncertainties  about  the  long-term  sustainability  of  official  controls.  An 
external  study  carried  out  in  2011  found  that  the  Regulation’s  provisions  on 
financing  official  controls  from  fees  are  not  fully  delivering  on  the  objective  of 
ensuring an adequate level of resources to conduct official controls. 

There is also evidence that the current rules are failing to ensure a fair and consistent 
approach across sectors: only some sectors are charged, and fees are not calculated in 
a uniform and transparent manner across Member States, or in a manner that rewards 
operators’ compliance. 

2.5.  Management of expenditure 

The current legal framework has to be adjusted in line with the proposed changes in 
the  different  policy  areas  to  ensure  their  objectives  are  met.  Furthermore, 
management  of  expenditure  is  currently  complex  and  needs  aligning  with  the 
Multiannual Financial Framework (MFF). A new legal basis is therefore needed. 

3. 

THE ‘REVIEW PACKAGE’ 

To  pursue  the  objective  of  strengthening,  modernising  and  streamlining  the  current 
legal environment in order to ensure a high level of protection of human, animal and 
plant health, the Commission is putting forward a package of five proposals to revise 
EU rules: 

– 

laying down animal health requirements (the Animal Health Law); 

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– 

– 

– 

– 

laying  down  protective  measures  against  pests  of  plants  (the  Plant  Health 
Law); 

governing  the  production  and  placing  on  the  market  of  plant  reproductive 
material (the Plant Reproductive Material Law);  

governing  official  controls  and  other  official  activities  performed  to  ensure 
compliance  with  the  entire  set  of  agri-food  chain  rules  (including  the  above) 
(the Regulation on Official Controls); and 

governing  the  management  of  EU  expenditure  in  the  main  areas  of  the  agri-
food chain. 

All  five  legislative  proposals  covered  by  the  package  are  to  be  submitted  to  the 
European  Parliament  and  Council  for  adoption  under  the  ordinary  legislative 
procedure  (under  Articles  289(1)  and  294  of  the  Treaty  on  the  Functioning  of  the 
European  Union).  The  European  Economic  and  Social  Committee  and  the 
Committee of the Regions will be asked for an opinion. 

4. 

THE CONTENT OF THE ‘REVIEW PACKAGE’ 

4.1. 

The Animal Health Law 

The EU Animal Health Strategy 2007-2013 was adopted in 20071. At its heart is the 
notion that ‘prevention is better than cure’ and its goals are to ensure a high level of 
public health and food safety; to support farming and the rural economy; to improve 
economic  growth,  cohesion  and  competitiveness;  and  to  promote  farming  practices 
and  animal  welfare  which  minimise  environmental  impacts.  Later  on,  the  Action 
Plan  for  the  implementation  of  the  strategy2  referred  to  the  development  of  an  EU 
Regulation on animal health, referred to here as the Animal Health Law (AHL), as 
one  of  the  main  deliverables  of  the  strategy  for  a  modern  and  innovative  legal 
framework  supporting  the  achievements  of  the  above  goals.  The  Commission’s 
proposal for the AHL is the result of extensive consultations of interested parties. 

4.1.1.  Main changes 

Simplification, modernisation and increased consistency across EU animal health 
legislation have been major driving principles of the revision process in this area. 

In  line  with  this  approach,  the  AHL  lays  down  the  foundations  for  a  wide  and 
comprehensive  legislative  framework  for  EU  animal  health  policy.  It  clearly  sets 
out  the  overarching  principles  and  objectives  necessary  to  reduce  animal  disease 
further  while  maintaining  the  EU’s  economic  competitiveness.  Detailed  provisions 
— such as specific disease control measures, identification and registration rules for 
certain  species,  and  specific  measures  on intra-EU  movement  for  particular  species 
— are to be dealt with by means of delegated or implementing acts. Using these acts 

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http://ec.europa.eu/food/animal/diseases/strategy/index_en.htm. 
COM(2008) 545 final, http://ec.europa.eu/food/animal/diseases/strategy/documents_en.htm. 

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to  introduce  more  specific  rules  or  requirements  allows  the  flexibility  and  speed 
needed to react to rapidly changing scenarios and veterinary emergencies. 

Enhancement  of  disease  surveillance,  disease  notification  and  reporting 
networks  will  better  support  early  detection  and  control  of  diseases,  including 
emerging  diseases  such  as  those  linked  to  climate  change,  and  ensure  greater 
convergence with international standards. 

Simplification and clarification 

A  simpler legislative framework will help authorities and operators to understand 
and use it, ensure their actions are more consistent and objective-focused, and set out 
general principles to be followed to promote disease prevention and control. This has 
the  potential  to  reduce  the  administrative  burden  on  them  by  cutting  down  the 
time taken to familiarise themselves with the legislation and by introducing scope for 
simplifying  certain  administrative  requirements  and  making  them  more  coherent 
including a more coherent and consistent legal framework for vaccination. 

The  new  AHL  will  clarify  the  animal  health  responsibilities  of  operators, 
veterinarians and others, partly by requiring a basic level of knowledge for the first 
time. 

Introducing new technologies 

The  AHL  will  allow  more  scope  for  using  new  technologies  for  animal  health 
activities such as monitoring pathogens, electronic  identification and registration of 
animals and electronic certificates. Use of new technologies and systems will tend to 
reduce the administrative burden on both veterinary authorities and operators in their 
day-to-day work. 

Increased flexibility through the use of a risk-based approach 

Criteria  for  listing  animal  diseases,  categorised  systematically  and  on  a  scientific 
and evidential basis will be introduced. This will allow the EU to better prioritise the 
use of its resources, giving less priority to diseases which pose less risk. 

Wider use of ‘compartmentalisation’ will be permitted (i.e. where some farms are 
considered safe even during disease outbreaks), allowing a more risk-based approach 
to animal disease control and potentially fewer trade restrictions. 

4.2. 

The Plant Health Law 

The Commission’s proposal for a Regulation on protective measures against pests of 
plants, referred to here as the Plant Health Law, meets the request of the Council of 
21  November  2008  for  an  evaluation  of  the  EU  plant  health  rules,  considering  the 
need  to  amend  the  existing  legal  framework  and  the  impact  of  such  amendments. 
Stakeholders  and  Member  States  authorities  were  extensively  consulted  throughout 
the revision process. 

Against  this  background,  the  proposed  Regulation  aims  to  overcome  the  flaws 
identified  following  the  evaluation  of  the  plant  health  rules  in  2010  and  to  put  in 
place  a  robust,  transparent  and  sustainable  regulatory  framework  that  is  ‘fit  for 

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purpose’.  Overall,  synergies  with  the  plant  reproductive  material  regime  are 
reinforced,  while  avoidable  duplications  and  unnecessary  burdens  are  removed. 
Official controls by Member States’ competent authorities on operators’ compliance 
with  EU  plant  health  requirements  are  covered  in  the  proposal  for  a  Regulation  on 
Official Controls. 

4.2.1.  Main changes 

Scope 

The geographical scope of the proposed Regulation is limited to the territories of 
the  Member  States  in  Europe,  excluding  overseas  countries  and  territories  and 
outermost  regions,  where  the  pests  against  which  the  EU  needs  to  be  protected  are 
indigenous. 

The proposed Regulation covers all organisms directly harmful to plants, i.e. insects, 
mites,  nematodes,  pathogenic  micro-organisms  and  parasitic  plants  (now  called 
pests).  It  covers  both  quarantine  pests  and  quality  pests,  as  currently  regulated 
under the ‘Marketing Directives’ for seed and plant propagating material. Criteria for 
deciding on the appropriate assignment of pests (quarantine or quality) are provided 
in the Annexes to the Regulation. The Annexes also set out principles and measures 
for the management of phytosanitary risks. 

Exports of plants, plant products and other objects to third countries are also covered 
by  the  proposed  Regulation.  Exports  are  governed  either  in  accordance  with  the 
relevant EU requirements, or, if the non-EU country’s rules so allow or that country 
so  agrees,  in  accordance  with  the  requirements  of  that  country.  The  proposal  also 
provides  for  the  introduction  of  a  pre-export  certificate,  for  cases  where  plant 
material is exported from a Member State which is not the Member State of origin. 
The  pre-export  certificate  is  meant  to  replace  the  informal  guidance  document 
currently in use. 

Enhanced prevention on import and reinforced early action against outbreaks 

Prevention  is  enhanced  by  empowering  the  Commission  to  adopt  precautionary 
measures  concerning  new,  high-risk  planting  material  imported  from  non-EU 
countries, based on a preliminary risk assessment, for a time limit of four years. This 
time span is considered necessary to perform a full risk assessment and rule on the 
appropriateness  of  permanent  measures.  The  proposed  Regulation  provides  that 
when  passengers  bring  regulated  plants  into  the  EU  territory  in  their  luggage 
they must now comply fully with the relevant requirements and prohibitions. 

Furthermore,  the  proposed  Regulation  obliges  Member  States  to  carry  out 
surveillance in their territory for the presence of pests in areas where they were 
not previously known to occur. If pests are detected, Member States will be expected 
to  carry  out  eradication  measures,  including  the  demarcation  of  a  restricted  area 
consisting  of  an  infested  zone  surrounded  by  a  buffer  zone.  In  addition,  enhanced 
levels of preparedness and surveillance are required for quarantine pests identified as 
priority  pests.  Surveillance  and  eradication  obligations  will  not  apply  to  quality 
pests. 

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The proposed Regulation empowers the Commission to adopt implementing acts to 
contain (control) quarantine pests that cannot be eradicated from the EU territory. 

Reinforcement and modernisation of the internal market provisions 

Where  plant  material  is  to  be  moved  within  the  EU,  the  proposed  Regulation 
provides  for  the  mandatory  use  of  a  plant  passport,  attesting  compliance  with  the 
legislation  on  quarantine  and  quality  pests.  The  passport,  simplified  and 
standardised under the Commission’s proposal, is to be issued by operators, under 
the  supervision  of  the  competent  authorities.  Operators  will  have  to  store  the 
information  necessary  to  trace  infested  consignments,  but  the  passport  can  contain 
data  carriers  (barcodes,  etc.)  instead  of  the  current  lot  number.  Where  planting 
material  requires  both,  a  plant  passport  and  a  certification  label  under  EU  law  on 
plant  reproductive  material,  the  two  labels  can  now  be  combined  in  a  single 
document, thus reducing the administrative burden on operators. Plant passports will 
be required for all nursery stock, but not for sales to final non-professional users. 

4.3. 

The Plant Reproductive Material Law 

In  2007,  Member  States  in  the  Council  asked  that  the  existing  legislation  on 
marketing  plant  reproductive  material  be  made  simpler.  Following  an  external 
evaluation3 in 2007-2008, an Action Plan4 was adopted in 2009. The Commission’s 
proposal for a Regulation on the marketing of plant reproductive material (referred to 
here  as  the  Plant  Reproductive  Material  Law,  builds  on  extensive  consultations  of 
Member States, stakeholders and the Community Plant Variety Office (CPVO). 

4.3.1.  Main changes 

The  major  principles  behind  the  revision  were  simplification,  modernisation,  cost 
reduction,  greater  efficiency  and  increased  flexibility  for  operators,  ensuring  an 
appropriate  level  of  harmonisation  across  the  EU  and  horizontal  coordination  with 
other, mostly environmental EU policy objectives. 

Simplification and modernisation 

These objectives have been achieved by replacing the 12 directives currently dealing 
with  specific  types  of  plant  reproductive  material,  such  as  agricultural  crops,  fruit 
plants,  ornamental  plants,  vegetables  and  forest  reproductive  material,  with  one 
regulation. It introduces harmonised basic rules to all types of plant reproductive 
material  (such  as  freedom  from  harmful  organisms  and  defects)  while  maintaining 
stricter  rules  for  important  plants  marketed  throughout  the  EU,  e.g.  listed  plant 
species, the varieties of which have to undergo tests for distinctness, uniformity and 
stability and certification and inspections for marketing. In addition, the scope of the 
law is extended to exports and to supply for industrial processes. 

3 

4 

FCEC  (2008),  Evaluation  of  the  Community  acquis  on  the  marketing  of  seed  and  plant  propagating 
material (S&PM). Final Report. 
SEC(2009) 1272 final. 

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Flexibility, cost reduction and efficiency gains 

The aim of significantly reducing the overall administrative burden and cost has been 
achieved  by  giving  operators  and  competent  authorities  considerable  freedom  in 
completing registration and certification tasks and by introducing the principle of 
cost  recovery  for  variety  registration  (and  for  certification  via  the  Regulation  on 
Official  Controls).  However,  micro-enterprises  will  be  exempted  and  fees  could  be 
reduced for varieties with an officially recognised description and for registration of 
heterogenous  material,  in  the  interest  of  conserving  genetic  resources  and 
biodiversity. 

The  new  legislation  fosters  flexibility  in  variety  registration  by  allowing  most 
registration  tasks  for  new  varieties  to  be  performed  by  operators  under  official 
supervision if the operator requests this. 

The  current  obligation  to  notify  the  Commission  of  a  variety  and  include  it  in  the 
Common Catalogues before marketing throughout the EU will be abolished to speed 
up  innovation,  i.e.  market  access  for  new  plant  varieties.  Registering  a  plant 
variety in one Member State will be sufficient. 

The CPVO will have a greater role in variety registration. The CPVO will manage 
the  EU  Plant  Variety  Database  instead  of  the  Commission  and  the  option  of 
registering a variety directly with the CPVO will be introduced. To ensure the quality 
of  the  registration  process,  national  variety  examination  centres  will  be  audited  by 
the  CPVO.  The  CPVO  will  also  continue  to  harmonise  testing  protocols  for  new 
varieties. In addition, a ‘one-key, several doors’ approach will enable a new variety 
to  be  registered  for  marketing  purposes  and  granted  plant  variety  rights  under  a 
single procedure. 

The  process  of  certifying  plant  reproductive  material  lots  before  marketing  will 
also  be  made  more  flexible.  The  option  of  certification  by  the  operator  under  the 
official  supervision  of  a  Member  State  competent  authority  will  be  extended  to  all 
listed species and to all marketing categories of plant reproductive material. 

Horizontal coordination with other EU policy objectives 

In order to improve biodiversity and conservation of plant genetic resources on farm, 
the requirements for traditional and conservation varieties and other material, e.g. 
heterogenous and niche market material, have been considerably reduced. No variety 
testing and certification are required. This will considerably improve market access 
for such material. Traditional and conservation varieties can be registered at low cost 
on  the  basis  of  historical  data  by  using  a  variety  description  recognised  by  the 
competent  authority.  In  addition,  the  rules  have  been  amended  to  cater  for  the 
possibility to authorise for marketing of heterogenous material (e.g. populations) and 
niche market material in small quantities by micro-enterprises. 

Testing  protocols  for  the  agricultural  sustainability  criteria  (e.g.  for  disease  and 
drought  resistance)  for  variety  registration  will  be  harmonised  for  the  first  time  to 
steer plant breeding in a more sustainable direction. However, the Member States 
may  continue  to  manage  testing  of  new  varieties  for  value  for  cultivation  and  use, 
based on their agro-ecological conditions. 

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4.4. 

The Regulation on Official Controls 

The  proposal  to  amend  the  general  framework  for  official  controls  laid  down  in 
Regulation (EC) No 882/2004 incorporates the outcome of a number of evaluations 
which have dealt with the different aspects of that framework. 

Options  for  revision  were  extensively  discussed  with  Member  States  within  the 
Working  Group  on  the  General  Application  of  Regulation  882/2004  and  at  the 
preparatory  stages  of  two  studies  (in  2009  and  2011)  carried  out  on  the  state  of 
application  of  the  rules  governing  the  financing  of  official  controls.  Stakeholders 
were consulted in the Advisory Group on Food Chain and Animal Health and Plant 
Health. 

4.4.1.  Main changes 

Consolidation of the integrated approach, with sector-specific flexibility 

One  major  novelty  is  the  broadening  of  the  scope  of  the  rules  on  official  controls, 
and  in  particular,  their  extension  to  relevant  controls  on  plant  health,  plant 
reproductive materials and animal by-products, which until now have been governed 
by  sectorial  provisions  not  fully  consistent  with  the  approach  laid  down  in 
Regulation (EC) No 882/2004. The current detailed set of rules applicable to official 
controls on residues of veterinary medicines will be repealed to allow this area to be 
regulated  in  a  more  risk-based,  but  still  health-protective  way,  under  the  same 
legislative framework. 

This  revision  will  have  a  significant  impact  on  the  legal  framework  governing 
official  controls  on  products  from  non-EU  countries.  It  provides  a  set  of  common 
rules for all control activities to be performed at EU borders on animals and goods 
from non-EU countries which require increased attention for health reasons. In this 
context,  it  introduces  Border  Control  Posts  (BCPs)  designed  to  replace  the  current 
Border  Inspection  Posts  (BIPs  —  for  animals  and  derived  products),  Designated 
Points of Entry (DPEs — for feed and food products of plant origin) and Points of 
Entry  (plants  and  plant  products).  A  uniform  set  of  rules  will  apply  to  controls 
carried out at the BCPs and a Common Health Entry Document (CHED) will be used 
for  prior  notification  of  the  arrival  of  consignments  and  to  record  official  controls 
and  decisions  (replacing  the  standard  documents  currently  in  use  in  each  sector)5. 
While  documentary  controls  will  remain  systematic  for  all  regulated  goods  and  for 
animals,  common  criteria  will  ensure  that  identity  and  physical  controls  do  not 
exceed  what  is  required  having  regard  to  the  risk  posed  by  different  categories  of 
products. 

Provision  is  made  for  adopting  further  rules  for  specific  sectors  by  means  of 
delegated and implementing acts. 

5 

I.e. the Common Veterinary Entry Document (CVED) in the area of veterinary controls, the Common 
Entry Document (CED) for non-veterinary controls, and the phytosanitary certificate currently in use in 
the plant health sector. 

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More effective enforcement mechanisms 

A  number  of  changes  will  ensure  that  the  toolkit  offered  by  Regulation  (EC)  No 
882/2004 to national enforcers is made simpler to use and more effective: 

– 

– 

– 

for  each  of  the  sectors  covered  by  the  package,  each  Member  State  will  be 
asked  to  designate  a  single  authority  responsible  for  coordinating  preparation 
and  ensuring  the  coherence  of  a  multi-annual  control  plan  and  to  act  as  a 
contact  point  for  the  Commission  and  other  Member  States  in  relation  to 
official controls; 

electronic  handling  and  processing  of  the  CHED  for  all  animals  and  goods 
subject to controls at the border will be introduced; 

while the requirement for all official laboratories to be accredited against ISO 
standard  17025  is  reaffirmed,  transitional  measures  and  temporary  or 
permanent derogations are provided for as appropriate. 

The  proposal  also  aims  at  improving  the  usability  of  the  rules  on  ‘administrative 
assistance’,  i.e.  the  mechanisms  which  allow  cooperation  between  national  control 
authorities on cross-border enforcement issues, where violations of EU rules need to 
be pursued not only in the Member State in which the violation was detected but also 
in  the  Member  State  where  it  originates.  A  new  EU  wide  mechanism  for  the  rapid 
exchange  of  information  related  to  serious  and  widespread  violations  will  enable 
Member States to address fraudulent practices more effectively. 

Financing of official controls 

Allocating  appropriate  resources  to  official  controls  is  essential  to  prevent  major 
disruptions  to  the  EU’s  system  of  official  controls  in  the  agri-food  chain  and  to 
guarantee its capacity to anticipate and respond to health emergencies as effectively 
as possible. 

The proposal builds on the current system of mandatory fees (at present only charged 
to certain operators and/or for certain controls). It strengthens the principle according 
to  which  competent  authorities  should  be  able  to  charge  businesses  in  order  to 
recover the costs they incur in carrying out their official control duties along the agri-
food  chain  and  in  certain  related  areas  (e.g.  veterinary  and  phytosanitary  controls, 
controls on plant reproductive material). 

A  number  of  improvements  to  the  current  set  of  rules  are  proposed  with  a  view  to 
ensuring a consistent and steady stream of resources to the competent authorities and 
to eliminating the known shortcomings of the existing system: 

– 

– 

mandatory fees will be charged to all registered food and feed businesses and 
to operators in the plant and plant reproductive material sectors so as to spread 
the cost of controls across the entire chain; 

fees will enable the competent authorities to fully recover the costs incurred, so 
as  to  make  their  revenues  less  dependent  on  national  budgetary  policies  and 
reduce  the  risk  of  under-resourcing  as  a  result  of  funds  being  reallocated  to 
competing priorities; 

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– 

more equity and fairness will be achieved by ensuring that the methods used to 
calculate  the  fees  and  the  list  of  costs  covered  are  fully  transparent,  and  by 
requiring  Member  States  to  reward  consistent  compliance  by  operators  (e.g. 
with reduced fee rates); 

– 

as a rule, micro-enterprises will be exempted from the payment of the fees. 

4.5.  Management of expenditure 

The main objective of the Commission’s proposal on management of expenditure is 
to  accompany  proposed  changes  in  the  relevant  policy  areas  and  to  seek  alignment 
with the EU’s Multiannual Financial Framework, while allowing the use of reserves 
in  the  agricultural  sector  under  certain  circumstances,  for  example  in  response  to 
crises. 

Regarding plant health, in order to protect the EU against the introduction and spread 
of  pests,  survey  programmes  for  the  presence  of  pests  will  be  funded  as  well  as 
phytosanitary  support  measures  for  the  outermost  regions  of  Member  States.  The 
new framework will also allow funding of initiatives designed to update legislation 
in  order  to  keep  up  with  technological  and  scientific  development  and  to  ensure 
efficient  and  effective  enforcement.  In  case  of  emergency  measures,  Union  co-
financing  will  be  possible  as  of  the  entry  into  force  of  the  Plant  Health  Law  for 
compensation to growers for the lost value of plant material subject to destruction. 

5. 

CONCLUSION 

The  proposed  legislative  package  is  the  result  of  a  major  revision  of  the  most 
relevant components of EU legislation governing the production and placing on the 
market  of  food,  the  safety  of  the  food  and  feed  chain,  and  the  health  of  plants  and 
animals. 

The  revision  in  question  has  involved  experts  from  the  Member  States,  and  all 
concerned  stakeholders,  since  2004  in  the  case  of  the  animal  health  legislation  and 
for more than three years in the other areas. It was carried out to assess the fitness for 
purpose of the vast range of rules which the EU has produced over time to deliver the 
Treaty objectives of ensuring a high level of health for humans, animals and plants 
during  the  various  processes  along  the  path  from  farm  to  fork  (from  primary 
production  to  the  consumption  and  disposal  of  food).  Production  methods  and 
techniques  have  changed,  globalisation  and  increased  exchanges  are  having  an 
impact  on  the  spread  of  hazards  and  risks,  new  hazards  and  risks  have  arisen,  and 
consumers’ expectations and education have evolved with all that. 

This  comprehensive  revision  has  resulted  in  the  proposed  changes  to  the  animal 
health  legislation,  to  the  legislation  governing  plant  health  and  plant  reproductive 
material  and  to  the  rules  on  official  controls  and  other  official  activities  along  the 
agri-food  chain.  These  changes  aim  to  deliver  a  more  effective  and  modern  legal 
framework  for  those  issues,  to  increase  the  flexibility  and  proportionality  of  rules 
established  in  some  cases  more  than  40  years  ago  and,  overall,  to  better  meet  the 
needs of citizens and businesses. 

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