Proposal for a Regulation of the European Parliament and of the Council on official feed and food controls
Date: 2003-02-05
Institutions: European Commission
Subjects: agro-industry, animal nutrition, food inspection, food safety, veterinary inspection

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 5.2.2003
COM(2003) 52 final

2003/0030 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on official feed and food controls

(presented by the Commission)

EXPLANATORY MEMORANDUM

I.

SUMMARY

1.

This proposal is a follow-up of the Commission's announcement in the White
Paper on Food Safety1 that it would submit to the European Parliament and the
Council a proposal for a Regulation on official feed and food safety controls. It
lays down the rules to be respected by the competent authorities responsible for
carrying  out  official  controls  as  well  as  the  tasks  of  the  Commission  with
regard to the organisation of those  controls.  It is  the  result of a  review of the
existing  Community  rules  on  the  subject,  which  were  adopted  separately  for
the animal feed sector, the food sector and the veterinary sector.  It covers the
entire  range  of  activities  covered  by  feed  and  food  law,  which  includes  feed
and food safety but also other aspects that relate to consumer protection, such
as feed and food labelling.

Special  attention  is  paid  to  enforcement  measures  and  in  particular  the
imposition of sanctions at national and Community level. For that purpose, the
proposal contains minimum requirements on criminal sanctions to be imposed
by  the  Member  States  with  regard  to  serious  offences  that  are  committed
intentionally  or  through  serious  negligence.  The  proposal  also  contains  new
tools  for  the  Commission  to  enforce  the  implementation  of  Community  feed
and food law by the Member States.

II.

INTRODUCTION

2.

The motives for the Commission to present this proposal can be summarised as
follows:

●

●

●

The  existing  sectoral  approach  has  lead  to  repetition  or  to  situations
whereby requirements of a similar nature are covered in a different way
for  the  different  sectors  concerned.  For  certain  sectors,  some  control
aspects are lacking, thus leaving loopholes in legislation.

Recent  feed  and  food  emergencies  have  highlighted  deficiencies  in
national  control  systems.  At  the  heart  of  the  problem  is  the  lack  of  a
harmonised  Community  approach  to  the  design  and  development  of
national control systems.

There  is  a  need  to  properly  define  the  role  of  the  Commission's  own
control  services  so  as  to  ensure  the  most  efficient  use  of  available
resources.

1

Document COM (1999) 719.

2

                                                
3.

As stated in the White Paper on Food Safety it follows that:

"There  is  therefore  a  clear  need  for  a  Community  framework  of  national
control systems, which will improve the quality of controls at Community level
and consequently raise food safety standards across the European Union. The
operation of such control systems would remain a national responsibility. This
Community framework would have three core elements.

●

The  first  element  would  be  operational  criteria  set  up  at  Community
level,  which  national  authorities  would  be  expected  to  meet.  These
criteria would form the key reference points against which the competent
authorities would be audited by the FVO, thereby allowing it to develop
a consistent, complete approach to the audit of national systems.

(cid:1) The  second  element  would  be  the  development  of  Community  control
guidelines.  These  would  promote  coherent  national  strategies,  and
identify risk-based priorities and the most effective control procedures. A
Community strategy would take a comprehensive, integrated approach to
the operation of controls. These guidelines would also provide advice on
the  development  of  systems  to  record  the  performance  and  results  of
control actions, as well as setting Community indicators of performance.

(cid:1) The  third  element  of  the  framework  would  be  enhanced  administrative
co-operation in the development and operation of control systems. There
would  be  a  reinforced  Community  dimension  to  the  exchange  of  best
practice between national authorities. This would also include promoting
mutual  assistance  between  the  Member  States  by  integrating  and
completing the existing legal framework."

The  present  proposal  aims  to  create  such  Community  framework  of  national
control  systems  by  merging  and  completing  existing  rules  for  national  and
Community controls within the EU, at the borders and in third countries.

4.

The  proposal  takes  into  account  the  principles  of  food  safety  that  are  spelled
out in the Commission's White Paper on Food Safety, and in particular that:

– 

– 

– 

– 

Food  safety  policy  must  be  based  on  a  comprehensive,  integrated
approach,

Feed and food businesses operators have the prime responsibility for feed
and  food  safety,  whilst  the  competent  authorities  monitor  and  enforce
this  responsibility  through  the  operation  of  national  surveillance  and
control  systems;  the  Commission's  control  services  concentrate  on
evaluating  the  ability  of  competent  authorities  to  deliver  these  systems
through audits and inspections,

Feed and food safety policy must be risk-based,

The  farm  to  table  policy,  covering  all  sectors  of  the  food  chain,
including feed production and animal feeding, primary production, food
processing,  storage  and  distribution,  animal  health  and  animal  welfare,
needs to be systematically implemented.

3

5.

Based  on  the  above  observations,  the  proposal  contains  the  following  main
elements:

– 

– 

– 

– 

The  official  controls  by  Member  States  shall  enable  them  to  verify  and
enforce compliance with national and Community feed and food law; for
that purpose, official controls shall be carried out regularly  and must be
defined on the basis of risk.

The authorities in the Member States that are  competent for  performing
official  controls  shall  meet  operational  criteria  that  guarantee  their
efficiency, effectiveness and impartiality.

Staff performing official controls shall have received adequate training in
order for them to undertake their duties competently.

Specific  control  tasks  may  be  delegated  to  an  independent  body  only
under strict conditions.

–  Methods of sampling and analysis shall be validated in accordance with
internationally accepted protocols, including those based on performance
criteria, and be carried out by laboratories accredited for that purpose.

–  Where non-compliance is identified during official controls,  appropriate
measures shall be taken, including administrative measures and criminal
sanctions.  These  measures  and  sanctions  shall  be  effective,  dissuasive
and proportionate.

– 

Contingency  plans  shall  be  drawn  up  setting  out  measures  to  be
implemented in case of feed and food emergencies.

–  Member  States  shall  proceed  to  regular  controls  of  feed  and  food

imports.

–  Where  official  controls  require  action  by  more  than  one  Member  State,
the  competent  authorities  of  the  Member  States  concerned  shall  afford
each other administrative assistance. This assistance may be extended to
active  co-operation  including  on-the-spot  controls  of  Member  State
experts in another Member State.

– 

– 

In co-operation with the Member States, a Community framework for the
development  and  operation  of  national  control  systems  shall  be
developed taking account of existing best practices and of the experience
of the Commission's control services. It will be based on agreed criteria
for the performance of these systems, and lead to clear guidelines on their
operation. Community guidelines will be developed for that purpose.

Inspections and audits by the Commission's Food and Veterinary Office
(FVO)  shall  be  organised  to  verify  the  effectiveness  of  national  control
systems.

4

6.

– 

– 

– 

Additional  tools  for  the  Commission  to  enforce  implementation  of
Community  feed  and  food  law  by  Member  States  must  be  made
available.

There must be a Community  framework for the training of  control staff
in the Member States in order to ensure a uniform level of decision taken
by such staff.

There  is  a  need  to  take  special  account  of  the  needs  of  developing
countries.

The basic principles related to responsibilities of the Member States authorities
are  already  laid  down  in  the  Regulation  (EC)  No  178/2002  laying  down  the
general  principles  of  food  law,  establishing  the  European  Food  Safety
Authority  and  laying  down  procedures  in  matters  of  food  safety2.  This
Regulation stipulates in particular that "Member States shall enforce food law
and monitor and verify that the relevant requirements of food law are fulfilled
by feed and food business operators at all stages of production, processing and
distribution. For that purpose they shall maintain a system of official controls
and  other  activities  as  appropriate  to  the  circumstances,  including  public
communication  on  feed  and  food  safety  and  risk,  feed  and  food  safety
surveillance and  other monitoring  activities  covering  all stages of production,
processing  and  distribution.  Member  States  shall  also  lay  down  the  rules  on
measures and penalties applicable to infringements of feed and food law. The
measures  and  penalties  provided  for  shall  be  effective,  proportionate  and
dissuasive".

The present proposal describes in more detail how these basic principles must
be interpreted and implemented.

III.

GENERAL ANALYSIS OF EXISTING COMMUNITY LEGISLATION

7.

Community legislation on official controls in the areas of feed and food safety
has been developed over a period of several decades and on a sectoral basis. As
a result, it is contained in several Directives and Decisions.  The  situation  can
be summarised as follows:

Feed

8.

Council Directive 95/53/EC of 25 October 19953 fixes the principles governing
the organisation of official controls in the field of animal nutrition.

The main purpose of this Directive is to harmonise official controls carried out
by the Member States' competent authorities as regards both imports and trade
within the Community.

2

3

OJ L 31, 1.2.2002, p. 1.
OJ L 265, 8.11.1995, p. 17.

5

                                                
The Directive covers all products and substances used in animal nutrition. The
following elements constitute the basic provisions:

(a) Uniform principles for the organisation of checks.

(b) Reinforcement  of  checks  at  source  and  organisation  of  checks  at  the

place of destination in the context of the single market.

(c)

(d)

Systematic documentary checks and random identity and physical checks
on  feed  imports  and  a  procedure  for  improving  the  harmonisation  of
these checks.

Procedures 
infringements are detected.

for 

the  co-operation  between  Member  States  when

(e) A  requirement  for  the  Member  States  to  set  up  national  annual  control

programs.

(f) A  requirement  for  the  Member  States  to  transmit  a  report  on  the
the  Commission

the  national  programs 

to 

implementation  of 
commencing in April 2000.

(g) Based  on  the  above  information,  a  requirement  for  the  Commission  to
present  each  year  an  overall  summary  report  and  a  proposal  for  a
recommendation concerning a co-ordinated Community control program.

(h) A  procedure  for  carrying  out  Commission  on-the-spot  controls  both  in

the Member States and in third countries.

(i)

(j)

The possibility for the Commission, when confronted by a serious risk, to
adopt safeguard measures on products originating in third countries.

Provisions to set up specific control plans when appropriate in addition to
the annual and general control plan.

(k) A requirement for Member States to have adequate contingency plans to

deal with serious feed risks.

(l) A requirement for Member States to inform the Commission as soon as a

serious contamination or risk is detected and has spread.

9.

The  financing  of  official  controls  in  the  animal  feed  sector  is  organised  by
Council Decision 98/728/EC4. This Decision provides for a Community system
for fees to be levied for the examination of dossiers of specified additives and
for  the  approval  of  certain  establishments  and  intermediaries.  The  Decision
fixes an exclusive list of costs that can be taken into account when calculating
control fees. This includes staff costs, administrative costs and technical costs.
Based  on  these  criteria,  Member  States  may  apply  flat-rate  amounts  for
financing expenses for official controls in specific areas. The direct or indirect
refund of the fees to the feed or food business operators is not allowed.

4

OJ L 346 , 22.12.1998, p. 51.

6

                                                
Although  this  Decision  has  only  recently  become  applicable,  it  seems  to
function  properly.  Contrary  to  the  system  that  is  applied  in  the  veterinary
sector, no difficulties in implementing it have been notified to the Commission.

10. Community  methods  of  sampling  and  analysis  for  the  official  control  of
feedingstuffs are laid down in Council Directive 70/373/EEC5. This Directive
empowers  the  Commission  to  establish  such  methods  for  the  purpose  of
checking compliance with quality and compositional requirements, taking into
account current scientific and technical knowledge.

That  has  allowed  to  establish  a  number  of  analytical  methods,  such  as
Commission Directive 98/88/EC of 13 November 1998 establishing guidelines
for  the  microscopic  identification  and  estimation  of  constituents  of  animal
origin  for  the  official  control  of  feedingstuffs6.  Directive  70/373/EEC  does
however not lay down criteria with which methods of analysis shall comply, as
it is the case for foodstuffs (Council Directive 85/591/EEC). There is a need to
harmonise both areas.

Food

11. Two Directives apply to official controls in the food area:

– 

– 

Council Directive 89/397/EEC on the official control of foodstuffs7,

Council  Directive  93/99/EEC  on  the  subject  of  additional  measures
concerning the official controls of foodstuffs8.

The  scope  of  these  Directives  covers  all  food,  without  prejudice  to  the
application of requirements in veterinary legislation described below. They lay
down,  in  a  general  way,  the  general  principles  that  must  be  applied  by  the
control services in the Member States to ensure compliance of foodstuffs, food
additives, vitamins, mineral salts, trace elements and other additives as well as
materials  and  articles  intended  to  come  into  contact  with  foodstuffs.  These
include  in  particular  rules  on  the  organisation  of  the  official  controls  in  the
Member  States,  sampling  and  analysis,  the  right  of  appeal  against  measures
taken  by  the  competent  authority,  the  organisation  of  controls  in  accordance
with in advance  established plans, Community  controls  in the  Member  States
and mutual assistance.

These  Directives  do  not  include  however  common  rules  on  the  control  of
foodstuffs imported into the Community nor on the organisation of Community
controls  in  third  countries.  Neither  do  they  include  procedures  to  be
implemented  in  case  of  food  emergencies  or  on  the  financing  of  official
controls.  They  do  not  specify  the  measures  to  be  taken  when  the  official
controls disclose irregularities.

5

6

7

8

OJ L 170 , 3.8.1970, p. 2.
OJ L 318, 27.11.1998, p. 45.
OJ L 186, 30.6.1989, p. 23.
OJ L 290, 24.11.1993, p. 14.

7

                                                
Veterinary checks

12. There  is  a  comprehensive  set  of  rules  to  be  applied  by  the  controlling
authorities in the Member States to checks on products of animal origin and for
verifying their compliance with Community veterinary rules. These include the
following Directives that are of a general nature and thus applicable to all food
of animal origin:

– 

– 

Council  Directive  89/662/EEC  concerning  veterinary  checks  in  intra-
Community trade with a view to the completion of the internal market9,

Council  Directive  97/78/EC  laying  down  the  principles  governing  the
organisation  of  veterinary  checks  on  products  entering  the  Community
from third countries10.

13. The first  Directive  was  adopted at the  time  of the  establishment  of the  single
market. It aims to ensure that veterinary checks on goods that are intended for
the  EU  market  are  carried  out  at  the  place  of  dispatch  and  no  longer  at  the
internal borders of the Community. It contains elements on the organisation of
the controlling services in the Member States, the measures to be taken in case
of food emergencies and the establishment of control plans.

14. The second Directive fixes in detail all the checks that must be carried out on
goods coming from third countries. It lays down in particular that such  goods
must  be  cleared  in  advance  through  a  border  inspection  post,  which  must  be
included on the list of Commission approved Border Inspection Posts, and that
they  must  be  submitted  to  a  documentary,  identity  and  physical  check.  It
describes  the  procedures  that  must  be  followed  in  case  of  non-compliance  of
the goods with Community veterinary rules.

15.

In  addition  to  these  two  Directives,  a  number  of  product  specific  Directives
exist.  Each  of  these  Directives  contains  obligations  for  the  competent
authorities to perform controls on the products concerned. They include meat,
meat products, egg products, fishery products, milk and dairy products etc.

16. Two  other  Directives  in  the  veterinary  sector  are  of  major  importance  with

regard to the organisation of official controls:

– 

Directive  89/608/EEC  contains  detailed  rules  on  mutual  assistance
between  the  administrative  authorities  of  the  Member  States  and  co-
operation  between  the  latter  and  the  Commission  to  ensure  the  correct
application of legislation on veterinary and zootechnical matters11,

9

10

11

OJ L 395, 30.12.1989, p. 13.
OJ L 24, 30.1.1998, p. 9.
OJ L 351, 2.12.1989, p. 34.

8

                                                
– 

Directive 96/43/EC amending and consolidating Directive 85/73/EEC in
order  to  ensure  financing  of  veterinary  inspections  and  controls  on  live
animals and certain  animal  products12. It  covers, for  products  of  animal
origin and for live animals, the financing of veterinary controls.

17. Finally,  Regulation  (EC)  N°  999/2001  of  the  European  Parliament  and  the
Council laying down rules for the prevention, control and eradication of certain
transmissible  spongiform  encephalopathies  is  of  major  importance  for  the
organisation  of  official  controls  in  veterinary  sector,  as  well  as  the  recently
adopted Regulation (EC) No 1774/2002 of the European Parliament and of the
Council of 3 October 2002 laying down the health rules concerning animal by-
products not intended for human consumption13.

18. The veterinary legislation lays down, for food of animal origin, common rules
on the organisation of official controls, the control of foodstuffs imported into
the  Community,  procedures  to  be  implemented  in  case  of  food  emergencies,
specific measures to be taken when the official controls disclose irregularities,
detailed  rules  on  mutual  assistance  and  on  the  financing  of  veterinary
inspections  and  controls  on  live  animals  and  certain  animal  products.  It  also
covers  the  organisation  of  Community  controls  in  Member  States  and  third
countries.  An  issue  that  is  not  covered  in  a  comprehensive  way  under
veterinary legislation is the question of official sampling and analysis of food.

Other sectors

19.

In the areas of animal health and animal welfare, official control requirements
proper  to  these  sectors  have  been  developed.  However,  bearing  in  mind  its
horizontal character and general nature, the proposal on official feed and food
controls  can  be  fully  applied  to  these  sectors.  This  is  in  line  with  the  White
Paper  on  Food  Safety  stating  that  animal  health  and  animal  welfare  are
important factors that contribute to feed and food safety.

IV.

COMMISSION  CONTROL  RESPONSIBILITIES  UNDER  CURRENT
LEGISLATION

Commission powers and obligations in relation to activities in Member States

20. Controls fall within the wider guardianship role  of  the  Commission to ensure
that  Community  legislation  is  effectively  applied  and  enforced  within  the
Community  as  laid  down  in  Article  211  of  the  EC  Treaty.  There  is  also  the
requirement  in  Article 152  that  “Community  action  …  shall  be  directed
towards  improving  public  health,  preventing  human  illness  and  diseases,  and
obviating sources of danger to human health”. Control obligations contained in
legislative texts are subject to these broader duties to ensure that legislation is
effectively enforced and that dangers to health are obviated.

12

13

OJ L 162, 1.7.1996, p. 1.
OJ L 273, 10.10.2002, p. 1.

9

                                                
21. There  are  only  a  few  instances  where  Community  legislation  requires  the
Commission to carry out controls in the Member States. In the vast majority of
cases the legislation provides  an authorisation to inspect without imposing  an
obligation to do so. Thus the Commission has discretion as to whether to carry
out controls or to use other means of securing  enforcement of  the legislation.
Currently there are two exceptions to this:

(a) Commission  Decision  97/778/EC  requires  the  Commission  to  inspect
border  inspection  posts  normally  on  an  annual  basis  (there  are  about
290 posts in the Community);

(b)

Several  Commission  Decisions  in  recent  years  relating  to  BSE  have
specifically called for controls by the Commission to verify compliance.

The obligation under (a) has never been fully met due to resource constraints.
Moreover, the frequency of inspections currently prescribed is not essential to
ensure  a  high  level  of  protection.  Ensuring  the  proper  functioning  of  these
facilities  should  be  primarily  the  responsibility  of  the  Member  States'
controlling services, whilst the Commission's control services should integrate
their  control  element  into  their  general  audits  of  the  Member  States'  control
systems in line with the ideas expressed in this memorandum. The Commission
considers  that  the  existing  rules  should  therefore  be  reviewed  and  adapted
accordingly. This will be subject of separate proposals.

Commission powers and obligations in relation to third countries

22. As  regards  third  countries,  Community  legislation  generally  imposes  major
obligations to inspect only in the veterinary sector, where the vertical hygiene
Directives provide that Community controls "shall" be carried out with a view
to verifying whether the standards applied by the relevant third country comply
or offer an equivalent level of protection to that applied within the Community.
In  so  far  as  the  hygiene  Directives  include  an  obligation  to  inspect,  a
derogation from this obligation was introduced by Council Decision 95/408 for
all  animals  and  products,  except  cattle,  sheep,  pigs  and  goats  and  their
products.  In  relation  to  the  latter,  Commission  Decision  86/474/EEC  requires
the  Commission  to  carry  out  controls  in  a  large  number  of  countries  and
establishments  annually. Due to resource  constraints,  only  a  small  fraction  of
these countries and establishments are in fact visited each year in relation to the
products  concerned.  It  is  clear  that  the  rules  as  existing  at  present  must  be
adapted so as to take account of these constraints and apply an audit approach
to third countries as soon as practicable.

10

V.

THE ROLE OF THE COMMUNITY

The changing context

23. The context for the Commission’s control activities has changed in a number of

important respects in recent years.

Food safety has moved to and remains at the top of the Community’s agenda.
Part  of  the  present  Commission’s  response  to  the  continuing  concerns  of
European  consumers  about  food  safety  was  to  bring  together  in  1999,  within
the  Directorate  General  for  Health  and  Consumer  Protection,  all  the  services
responsible for feed and food safety issues. In this way it aims to focus all its
available resources, in a concerted and efficient manner, on the main priorities
for ensuring food safety at Community level. Thus, the control and legislative
services  of  the  Commission  work  in  close  co-operation  to  ensure  that  food
safety  legislation  is  up-to-date,  comprehensive  and  practicable,  and  that  it  is
being properly implemented and enforced.

24.

In  Member  States  too,  new  institutional  arrangements  are  being  put  in  place.
Food  safety  agencies  have  been  or  are  being  set  up  in  a  number  of  Member
States  to  help  meet  consumers’  food  safety  concerns.  Some  of  these  new
bodies have major control responsibilities.

25. The range of control  responsibilities  at both national  and Community level is
becoming wider. Community controls have tended in the past to concentrate on
the initial stages of food processing, especially of food of animal origin. Much
of  the  existing  detailed  legislation  on  food  safety  relates  to  controls  in  these
areas.  However,  control  authorities  must  cover  the  whole  food  chain  for  an
ever-expanding number of products and sectors. The food production chain is
also  becoming  more  complex  and  sophisticated,  with 
foods  being
manufactured  by  new  processes  not  foreseen  in  existing  legislation.  Control
systems  need  to  adapt  accordingly.  They  need  to  be  based  upon  an  approach
that is targeted at critical points at each level of control: Community, national,
regional, local and at the level of the individual enterprise.

26. The  Commission  has  also  an  ever  growing  responsibility  to  ensure  that
Community  requirements  are  met  in  relation  to  all  imports  of  food,  animals,
plants  and  their  products  from  third  countries.  The  EU  now  imports  such
products from over 200 countries around the world. These countries range from
the  highly  developed  to  the  poorest  countries  in  the  world.  They  have  very
different control methods and standards. Balancing the demands of Community
legislation on food safety, animal health, animal welfare and plant health issues
against  the  Community’s  trade  and  humanitarian  obligations  concerning  so
many countries is complex and delicate.

The  future  enlargement  of  the  Union  will  also  add  a  new  dimension  to  the
Commission’s responsibilities. It is clear  that many  of the  applicant  countries
face  a  serious  challenge  in  bringing  their  control  systems  up  to  the  standards
required within the Community. The Commission will have to play its part in
helping them to achieve this goal.

11

Community framework for national control systems

27. The  White  Paper  on  Food  Safety  identified  the  need  for  a  more  harmonised
approach  to  the  operation  of  the  systems  in  Member  States  to  monitor  and
enforce  Community  legislation.  It  therefore  proposed  the  development  of  a
Community framework for national control systems in order to raise standards
of food safety across the EU.

28.

In  this  Regulation  the  Commission  proposes  the  introduction  of  a  new
approach  under  which  the  three  aspects  of  control  –  verifying  transposition,
receiving reports from Member States, and carrying out on-the-spot controls –
will be combined into one integrated control process for all feed and food. The
control cycle under this new approach will involve four main stages.

Stage 1:

Broad guidelines will be drawn up by the Commission, in consultation with the
Member  States  and  taking  into  account  the  principle  of  subsidiarity,  on  the
structure  and  organisation  of  integrated  national  control  systems,  and  on  the
scope,  content  and  operation  of  national  control  plans.  These  guidelines  will
aim to promote a harmonised approach to controls, covering the full range of
Community legislation, and embracing all product sectors and all stages of the
feed  and  food  chain.  They  will  encourage  the  adoption  of  best  practices  in
respect of the key principles outlined above at all levels of the control system
in each Member State and will indicate the main performance indicators to be
applied in assessing and auditing national control plans.

Stage 2:

Member States will be required, within six months of the entry into force of the
Regulation,  to  prepare  an  integrated  multi-annual  national  control  plan,  to
maintain this plan and to present it to the Commission upon request. The plans
shall be implemented for the first time one year after the entry into force of the
Regulation.

Stage 3:

On  the  basis  of  the  multi-annual  national  control  plan  the  Commission  will
conduct,  on  a  regular  basis,  a  general  audit  of  the  control  activities  of  each
Member  State  which  may  include  selected  controls  at  regional,  local/district
and  establishment  level  to  verify  aspects  of  the  control  system.  This  general
audit  may  be  supplemented  by  further  audits  of  specific  sectors  or  particular
critical  control  points,  including  the  investigation  of  emergencies  or  new
developments, as considered appropriate.

12

Stage 4:

One year after the implementation of the control plans and annually thereafter,
Member  States  will be required to  present  a  report  to  the  Commission  which
will,  where  necessary,  update  their  initial  plan  in  relation  to (a)  what  new
legislation has been introduced or modified to meet Community requirements,
(b) what important changes have been made to the structure and functioning of
control  systems,  and  (c)  adjustments  made  to  their  control  plans.  Subsequent
Commission audits of the Member States will be based on their updated plans.

A  general  report  on  the  overall  operation  of  national  control  systems  in  the
Member  States,  based  on  the  Member  States  reports,  the  outcome  of
Commission  audits  and  other  relevant  information,  will  be  prepared  by  the
Commission  and  submitted  to  the  European  Parliament  and  Council  and
published.

29. This new approach to controls will have a number of important advantages. For
Member  States  it  will  enable  them  to  plan  and  implement  their  control
activities  with  a  clear  understanding  of  what  is  expected  at  Community  level
and within an overall, integrated Community framework. Existing Community
legislation on food safety, animal nutrition, animal health, animal welfare and
plant health sets out a very broad and diverse range of requirements. Member
States sometimes express concerns that the  criteria  and benchmarks by which
their  control  systems  are  checked  and  assessed  by  the  Commission  are  not
always clear and consistently applied. The new approach will respond to these
concerns.

For  the  Commission,  it  will  be  able  to  apply  its  available  resources  more
effectively by combining its various existing control activities into one overall
integrated  process.  This  approach  will  also  ensure  that  all  the  main
requirements set down in Community legislation are regularly checked and that
no important gaps are left in the control process.

For consumers, the new approach will be more transparent and understandable.
The publication of reports on the overall operation of national control plans in
the Member States and  the  results  of  audits  by  experts  from  the  Commission
will provide a very clear view of how Community legislation on food safety is
being implemented and what the Commission and Member States are doing to
ensure  adequate  consumer  protection  and  to  improve  feed  and  food  safety,
animal health, animal welfare and plant health.

Community controls in third countries

30. The  European  Union  imports  feed,  food,  plants  and  animals  from  over
200 countries around  the world. Under current  legislation,  the  Commission  is
required

(a)

to verify that the competent authorities in these countries are capable of
ensuring that Community requirements are met in respect of all products
exported to the EU,

13

(b)

(c)

in  the  case  of  certain  products,  to  inspect  individual  production
establishments, of which there are currently around 13.500 approved for
export to the Community,

to  monitor  on  a  regular  basis  the  operation  of  around  290 existing
inspection posts that carry out specified checks on all imports of animals,
animal products and food of animal origin at their point of entry into the
EU, and to inspect new inspection posts for their individual approval.

31. This  represents  an  enormous  range  of  responsibilities  for  the  Commission.
Given the limits on its resources, a major effort of prioritisation is needed. It is
considered that adopting a more integrated approach to controls whereby third
countries  would  be  audited  on  the  basis  of  control  plans  similar  to  those
foreseen for the Member States, would facilitate this process. For this purpose,
third countries can be classified into four broad categories:

●

●

●

●

the applicant countries currently negotiating to join the European Union,

the  countries 
that  have  negotiated  veterinary  and  phytosanitary
agreements  with  the  EU  (Canada,  USA,  New  Zealand,  Chile  and
Switzerland).  Under  these  agreements  the  contracting  parties  have
accepted that certain legislative requirements on food safety and  animal
health  provide  an  equivalent  level  of  consumer  and  animal  health
protection,

the  three  countries  that  have  special  agreements  with  the  EU  (Norway,
Iceland  and  the  Faroe  Islands)  which  provide  that  imports  of  all  or
specified products (e.g. fishery products from Iceland) will be treated in
accordance with the relevant agreement,

all other third countries, many of which have only a very small volume of
exports to the EU.

32. Applicant countries

The Commission has intensified its control activities in applicant countries in
anticipation of enlargement. At present its control responsibilities relate only to
those  sectors  and  establishments  approved  for  export  to  the  EU,  which  are
generally small relative to the national sectors as a whole. However, agreement
has been reached with most applicant countries that controls of the FVO should
now  extend  to  all  areas  of  feed,  food,  animal  and  plant  production.  The
Commission's  role  in  relation  to  the  applicant  countries  has  therefore  already
changed substantially in recent  years,  requiring  it  to  take  on  major  additional
responsibilities, and to extend its controls to cover the whole production chain
in these countries in the same way as in Member States.

The applicant countries already account for a large proportion of the feed, food,
plants  and  animals  currently  imported  from  outside  the  Community,  in
particular the higher risk products of animal origin and live animals.

14

33. Countries with a bilateral agreement

Veterinary  agreements  have  been  concluded  with  the  USA,  Canada,  New
Zealand, Chile and Switzerland. These agreements provide a framework under
which  the  parties  to  each  agreement  may  agree  that  for  certain  animals  and
products their respective legislation offers an equivalent level of protection for
trade purposes.

With  respect  to  Mercosur,  it  was  agreed  at  the  recent  EU-Mercosur  Summit
held  in  Madrid  on  17  May  2002,  to  start  negotiations  on  sanitary  and
phytosanitary  measures  between  the  EU  and  the  Mercosur  countries.  These
negotiations  will  be  part  of  the  single  undertaking  of  the  future  bi-regional
association agreement.

At  present,  each  agreement  covers  sanitary  measures  applied  to  most  live
animals  and  commodities  containing  products  of  animal  origin,  with  the
exception  of  certain  issues  specified  in  the  agreements  (e.g.  certain  residues,
additives,  labelling).  Currently  limitations  exist  with  regard  to  the  number  of
items  for  which  full  equivalency  has  been  agreed.  Thus  the  Commission  is
required  to  apply  two  different  standards  when  verifying  the  operation  of
control systems  in  relation  to  trade  with  these  countries.  For  the  products  for
which full equivalence has been  agreed, the  Commission must  verify  that the
control systems in these countries are operated in accordance with and deliver
the standards laid down in their own domestic legislation. For other products, it
carries  out  inspections  to  verify  whether  control  systems  in  place  can  ensure
that  the  requirements  of  Community  legislation  are  met  in  relation  to  those
aspects  where  equivalency  has  not  yet  been  agreed.  The  increasing  demands
arising from this dual system of control needs to be addressed.

It seems appropriate therefore to conduct one general, comprehensive audit of
each  of  these  countries  which  would  cover  all  the  main  sectors  which  export
products to the EU. As with the Member States, the authorities in countries that
are  party  to  the  agreements  would  have  available  a  plan  setting  out  the
structure,  organisation  and  functioning  of  control  systems  in  relation  to  the
main  products  they  export  to  the  EU.  The  audits  would  then  be  carried  out
against this background. If particular issues emerge from these general audits,
they  may  subsequently  be  the  subject  of  additional  more  specific  audits  as
appropriate.

Broadly the same approach will apply to the three other countries with which
the Community has special agreements.

34. Other Third Countries

Around  190  other  third  countries  export  feed,  food,  plants  or  animals  to  the
EU.  With  the  limits  on  its  resources,  the  Commission  cannot  meet  all  its
current  obligations  in  relation  to  the  evaluation  of  competent  authorities  and
the checking of establishments in these countries.

15

It seems appropriate therefore to organise audits in these countries on the basis
of control plans similar to those foreseen for Member States, in respect of the
products they export to the EU.

Currently  the  Commission  verifies  the  guarantees  given  by  third  countries
through  exchanges  of  correspondence,  questionnaires,  reports  on 
the
implementation  of  controls  and  on-the-spot  inspections  in  respect  of  each
commodity  sector  for  which  the  third  country  is  approved  to  export  to  the
Community.  This  exchange  of  information  corresponds  with  the  actions
provided for in Articles 4 and 7 and point 3 of Annex B of the Agreement on
the Application of Sanitary and Phytosanitary Measures (SPS Code) adopted in
the framework of the World Trade Organisation.

Under  the  new  arrangement,  exporting  third  countries  shall  be  required  to
maintain a control plan which provides accurate and up-to–date information on
the general organisation and management of the relevant control systems, and
to maintain  up-to-date  records on  the  implementation  of  these  systems,  all  of
which shall be made available to the Commission on request. The control plan
and  records  will  replace  the  system  of  pre-mission  questionnaires  except  in
specific  instances  where  supplementary  information,  not  covered  by  the
standard  plan  or  records,  is  required.  The  control  plan  shall  be  proportionate
and technically and economically  feasible taking  account of specific  situation
of the third country and the nature of the products exported to the Community.
Guidelines will be established specifying how these control plans and records
should  be  drawn  up  and  presented  to  facilitate  third  countries  in  complying
with this requirement. Commission audits will then be carried out against these
plans  by  a  multidisciplinary  team  covering  the  main  sectors  exporting  to  the
EU. The frequency of these controls should be determined on the basis of risk:
where, on the basis of an assessment involving the nature of the products, the
guarantees  given  by  a  third  country  and  possible  records  on  compliance
history, a higher risk is perceived, the frequency of the audits shall be higher. If
particular issues emerge from these general audits, they may be the subject of
subsequent more specific audits as appropriate.

Experience has shown that competent authorities in some of the less developed
countries  can  have  major  difficulties  in  organising  their  control  systems  in  a
manner  that  is  required  to  meet  Community  standards.  The  Commission  is
often presented with a dilemma in these circumstances. To follow the letter of
the law requires the Commission to propose closing down imports from these
countries  in  accordance  with  the  precautionary  approach.  But  the  products  in
question may often be one of the few  sources of foreign revenue  available to
them and an import ban often has very serious economic consequences, not just
for the establishments in question, but for the whole country.

The  Commission  will  seek  to  identify  means  of  helping  countries  in  these
circumstances  while  ensuring  that  consumer  health  protection  will  not  be
compromised.  For  example,  additional  assistance  could  be  given  through
Community aid and training programmes to third countries in order to provide
guidance  on  the  best  methods  of  achieving  Community  standards  and  to
identify particular control solutions that more precisely reflect the level of risk
posed by particular products.

16

VI.

ANALYSIS OF THE PROPOSAL

35. The  proposal attached herewith  aims  to  review  the  existing  Community  rules
on  official  controls.  Such  a  review  will  eliminate  discrepancies  between  the
different parts of existing Community legislation and to fill loopholes in feed
and food law in certain areas. The resulting harmonisation across all sectors of
feed and food law will increase transparency.

36. With  the  adoption  of  Regulation  (EC)  No  178/2002  laying  down  the  general
principles  of  food  law,  establishing  the  European  Food  Safety  Authority  and
laying down procedures in matters of food safety, a number of issues have now
been resolved for all areas of feed and  food law. These do not therefore need
further attention in the present proposal. This is the case for:

– 

– 

– 

– 

The basic definitions of feed and food law.

The basic responsibility of the Member States with regard to official feed
and food controls.

Procedures for the implementation of emergency measures.

Information  to  be  made  available  to  the  Commission  and  the  other
Member  States  in  the  event  of  feed  and  food  posing  a  serious  threat  to
health.

Official controls by the Member States

37. Objectives and general obligations

The objective of official controls carried out by the Member States shall be to
enforce  feed  and  food  law  and  to  reveal  whether  feed  and  food  business
operators  at  all  stages  of  production,  processing  and  distribution  fulfil  the
relevant  requirements  of  such  law.  For  these  purposes,  the  different  control
techniques  that  are  available  such  as  inspections,  monitoring,  verification,
audits,  sampling  and  the  analysis  of  samples  must  be  implemented.  The
intensity  of  these  controls  depends  on  many  factors:  in  addition  to  a  basic
routine  monitoring  programme,  account  must  be  taken  of  identified  risks
associated  with  particular  feed  and  food  commodities  or  businesses,  the
performance of feed and food businesses with regard to in-house controls, the
suspicion of non-compliance and possible fraudulent practices.

17

38. Competent authorities

Member  States  shall  designate  the  authorities  that  are  competent  for  carrying
out  official  controls.  These  competent  authorities  shall  meet  a  number  of
operational  criteria  that  must  guarantee  their  efficiency,  effectiveness  and
impartiality. They shall in particular have or have access to a sufficient number
of  suitably  qualified  staff.  It  must  be  ensured  that  these  staff  can  function
properly  also  in  extreme  conditions  of  possible  feed  and  food  emergencies.
This  requires  contingency  plans  to  be  established  and  staff  to  be  properly
trained to implement these plans. Audits subject to independent scrutiny shall
be carried out to ensure that competent authorities achieve the objective of this
regulation.

Suitable  co-ordination  procedures  shall  also  be  established  in  order  to  ensure
that  different  departments  involved  in  official  controls  are  acting  effectively
together. This is particularly important in Member States with a decentralised
structure, where it is essential that there is effective and efficient co-ordination
between  the  central  competent  authority  and  the  authority  or  authorities  to
which the competence for performing official controls has been delegated.

39. The delegation of control tasks to non-governmental control bodies

Several  Member  States  have  delegated  certain  control  tasks 
to  non-
governmental  bodies.  This  is  in  particular  the  case  for  the  laboratory
examination of official samples.  It  does  not  exclude  however  that  other  tasks
are delegated to such bodies. Where Member States practice such delegation of
competence,  it  must  be  ensured  that  a  high  level  of  consumer  protection  is
maintained.  For  that  purpose,  the  proposal  lays  down  that  bodies  to  which
competence  for  performing  official  controls  is  delegated  must  operate  in
accordance  with  strictly  defined  conditions  and 
in  accordance  with
internationally  recognised  rules  that  must  ensure  their  competence  and
independence.

It must also be envisaged that certain control tasks cannot be delegated to non-
governmental  bodies.  A  procedure  is  therefore  provided  to  define  at
Community level the tasks that can (or cannot) be delegated to such bodies.

18

40. Sampling and analysis

There is an urgent need to ensure that results  following official sampling  and
sample  analysis  are  obtained  on  the  basis  of  common  principles.  This  is  not
always  ensured  in  the  Community  legislation  in  force.  Although  ideally  all
methods  of  sampling  and  analysis  should  be  harmonised,  it  is  not  feasible  to
reach this goal in the short term. The proposal instead introduces requirements
for  laboratories  to  implement,  where  they  are  available,  methods  of  analysis
that  are  validated  in  accordance  with  international  protocols,  including  those
based  on  performance  criteria,  such  as  those  accepted  by  the  European
Committee  for  Standardisation  (CEN),  the  International  Organisation  for
Standardisation  (ISO)  and  the  International  Union  of  Pure  and  Applied
Chemistry  (IUPAC).  There  should  also  be  a  procedure  that  allows  the
Commission  to  establish  methods  of  sampling  and  analysis.  The  laboratories
that are designated to analyse official samples shall be accredited in accordance
with the relevant international standards established for that purpose.

In developing, harmonising and validating methods of sampling and analysis or
for  establishing  performance  criteria  for  such  methods,  the  Commission’s
Framework  programme  and  Joint  Research  Centre  (JRC)  play  already  a
prominent role and their capacities could even better be exploited in the future,
whether or not in co-operation with the international bodies referred to above.

For ensuring a high standard of sampling and analysis, the proposal relies to a
certain  extent  on  the  work  of  the  CEN.  This  standardisation  body  has
developed  activities  in  the  food  sector.  This  involvement  has  so  far  been
restricted  to  the  development  of  analytical  methods,  a  number  of  which
emanate from ISO. A number of EN Standards developed by CEN relate to the
organisation  of  controls.  This  is  in  particular  the  case  for  the  validation  of
methods  of  analysis  and  to  the  operation  and  accreditation  of  control  bodies.
These standards have a recognised international status fully justifying their use
in this context.

41. Contingency plans

Experience has shown that the prompt handling and management of emergency
situations  requires  the  availability  of  infrastructures,  material  and  human
resources that can be mobilised in the short term and for a certain period in time.
It also requires a high degree of co-ordination where responsibilities are shared
between  different  services  or  departments.  The  present  proposal  introduces  an
obligation  to  ensure  effective  emergency  management  of  feed  and  food
emergencies through the establishment of contingency plans.

19

42. Feed and food imports

Certain  sectors,  and  in  particular  the  veterinary  sector,  already  implement
detailed rules to ensure that imported products  are  effectively controlled. The
products covered by that sector (products of animal origin) must be presented
at an approved EU border inspection post and be submitted to a documentary
check as well as to an identity and physical check in accordance with a scheme
the principles of which are laid down at EU level. There are also requirements
for  products  in  transit  and  for  products  that  are  temporarily  stored  on  the
territory  of  the  Community.  It  functions  properly,  and  there  is  no  reason  to
amend the system.

For  feed  and  food  other  than  that  of  animal  origin,  there  is  no  harmonised
Community  approach  towards  import  controls.  The  present  proposal  aims  to
introduce a control system for these products based on the following principles:

(a)

(b)

The  Member  States  shall  proceed  to  regular  controls  of  feed  and  food
that  will  be  released  for  free  circulation  in  the  Community.  These
controls  shall  be  organised  using  a  statistically  based  sampling  plan.
They can take place at any point of the distribution of the goods: before
release for free circulation or afterwards, e.g. at the importer’s premises,
during processing or at the point of retail sale. There shall in any way be
a close co-operation between the customs services and the authority that
is competent for controlling feed and food imports.

In addition it is proposed to establish at Community level a list of priority
feed  and  foodstuffs  for  which  experience  has  shown  that  hazards  may
occur  (e.g.  aflatoxins  in  certain  foods).  Such  feed  and  food  shall  be
presented  at  specially  designated  and  equipped  inspection  posts  for  the
carrying out of the necessary checks. These controls must be carried out
before the goods are released for free circulation.

Additionally and in order to allow for the possibility of controls on feed
and  food  from  third  countries  that  enters  into  free  zones  and  free
warehouses  or  is  placed  in  transit,  customs  warehousing,  inward
processing,  processing  under  customs  control  or  temporary  admission,
the proposal foresees a possibility for performing official controls of feed
and food kept under these different customs approved treatments or uses.

The present proposal aims also to better define the essential controls that
are  needed  to  ensure  feed  safety  along  the  same  lines  as  those  that  are
developed for food.

20

43. Financing of official controls

A  system  of  control  fees  is  applied  at  present  in  two  sectors:  the  veterinary
sector and the feed sector. The system in the veterinary sector relies on a flat
rate  from  which  departures  can  be  made  in  order  to  take  account  of  local
differences  with  regard  to  the  elements  that  have  been  taken  into  account  to
calculate  the  flat  rate  (wages,  transport  costs  etc.)  Although  the  fees  in  the
veterinary  sector  have  been  introduced  to  avoid  differences  between  Member
States  that  may  lead  to  distortions,  experience  has  shown  that  important
differences  between  and  in  certain  cases  within  Member  States  continue  to
exist. The system has not always attained the desired objective.

In the feed sector, fees can be levied for particular well-specified control tasks.
The Directive that governs this sector does not fix a Community flat rate, but
leaves this to the Member States who must observe certain criteria in fixing flat
rates. The rules that fix these principles have been adopted relatively recently
(Council  Decision  98/728  of  14  December  1998  concerning  a  Community
system of fees in the animal feed sector).

Taking into account the experience gained so far, it is proposed to lay down the
principles that underlie the financing of official controls and in particular that:

–  Member  States  must  ensure  that  adequate  financial  resources  are

available for organising official controls;

– 

– 

– 

if  inspection  fees  are  imposed  to  feed  and  food  business  operators,
common principles must be observed for setting the level of such fees,

where  official  controls  reveal  non-compliance  with  feed  and  food  law,
the extra costs that result from more intensive controls possibly linked to
such  non-compliance  be  borne  by  the  feed  and  food  business  operator
concerned,

there is a need for flexibility in order to take into account the interests of
small businesses.

44. Official certification

Within  the  EU,  where  there  is  free  circulation  of  goods,  there  is  no  need  to
provide  for  consignments  of  feed  and  food  to  be  systematically  accompanied
by official certificates issued by the competent authority.

Two  areas  can  be  identified  however  where  official  certification  can  be
envisaged:  (a)  in  exceptional  circumstances  when  a  feed  or  food  emergency
occurs  within  the  EU,  and  (b)  in  order  to  obtain  confirmation  from  the
authorities  in  exporting  third  countries  that  the  goods  comply  with  the  EU
standards or with standards equivalent thereto.

In  order  to  cover  these  areas  the  proposal  provides  for  a  procedure  for
specifying the cases and conditions under  which  official  certification must be
ensured.

21

Reference laboratories

45. A  number  of  Community  Reference  Laboratories  (CRLs)  have  been
established  under  Community  legislation  in  force.  They  are  operating  with
Community  financial  support.  These  laboratories  have  an  important  role  in
ensuring a high level of  consumer protection. They must provide the national
reference laboratories, for example, with details of analytical methods, organise
comparative  testing, co-ordinate  within  their  area of competence the practical
and  scientific  activities  needed  to  obtain  new  analytical  methods,  conduct
training  courses  and  provide  technical  assistance  to  the  Commission.  CRLs
exist  at  present  for  residue  testing  (four laboratories),  milk  testing,  the
quantification of biotoxins  in molluscs,  for  testing  molluscan shellfish  for  the
absence  of  harmful  viruses,  for  the  control  of  zoonoses  (salmonella)  and  for
transmissible spongiform encephalopathies (TSEs).

The  present  proposals  lays  down  procedures  to  ensure  that  these  laboratories
can continue their work and for establishing new laboratories should the need
arise.

For  each  CRL,  a  national  reference  laboratory  must  be  established  in  each
Member  State.  Such  laboratories  function  as  the  point  of  communication
between  the  CRL  and  all  the  official  laboratories  in  the  Member  States.  The
national reference laboratories play therefore an important role in ensuring that
a uniform level with regard to analytical results of official samples is achieved.

Mutual assistance

46. Mutual assistance between the controlling authorities of the Member States is
an  essential  element  of  Community  legislation.  It  must  ensure  effective  co-
ordination where action is required by more than one Member State (e.g. feed
and  food  emergencies  or  non-compliance  that  affect  two  or  more  Member
States).

Although this aspect is covered in the legislation affecting the different sectors
concerned,  it  is  conceived  in  different  ways  resulting  in  unnecessary
differences.  The  present  proposal  fixes  a  uniform  system  based  on  the
following principles:

(a) Member States shall designate a liaison body the role of which shall be to
assist  and  co-ordinate  communication,  transmission  and  reception  of
requests for assistance.

(b) Upon  receiving  a  reasoned  request,  the  liaison  body  shall  contact  the
relevant authorities who shall ensure that the requesting party is provided
with  all  necessary  information  and  documents  enabling  it  to  verify
compliance with feed and food law.

(c)

If necessary, the different parties shall seek together ways and means of
remedying the situation.

The  procedure  applies  to  the  exchange  of  all  information,  except  that  which
cannot be released because of it being the subject of legal proceedings.

22

National control plans

47. As  set  out  above,  the  proposal  provides  for  the  establishment  of  national
control plans that set out the national control system and activities in a global
and comprehensive way. These plans will have to be developed along the lines
that  are  contained  in  guidelines  to  be  established  by  the  Commission  in
consultation with the Member States.

48. The  Member  States  are  requested  to  report  annually  on  the  results  of  the
controls that have been carried out the previous year. If necessary, the control
plans must be adapted in function of these results. The Commission will then,
on a regular basis, audit the Member States on the basis of their updated plans.

Community activities

49. Community controls in the Member States

Until  now,  Community  controls  in  the  Member  States  were  organised  in
function  of  the  mandates  the  Commission  has  in  the  different  sectoral
Directives.  This  system  has  not  always  permitted  to  evaluate  Member  State
control systems in a global way.

The  creation  of  a  single  legal  basis  with  the  present  proposal  and  the
establishment  of  control  plans  will  allow  the  Community  control  services  to
perform a general audit of the Member States' control systems globally. These
audits  will  be  carried  out  globally  in  order  to  verify  the  continuous
achievement  of  the required level of control by  the  competent  services  in  the
Member States. If needed, these can be supplemented by more specific audits
and inspections for a particular sector or problem.

50. Community controls in third countries

The  volume  of  imported  feed  and  food  is  substantial.  Given  the  available
resources, it is excluded that all of the operators in third countries involved in
feed and food exports are individually controlled in a systematic way by FVO
inspectors.  The  proposal  therefore  establishes  a  system  that  obliges  the
controlling authorities in third countries to guarantee that feed and food that is
exported to the EU complies with EU feed and food law or with requirements
that are judged equivalent to those.

For  that  purpose,  the  proposal  requires  third  countries  to  have  a  control  plan
available,  similar  to  those  foreseen  for  Member  States,  in  respect  of  the
products they export to the EU. These plans will form the basis for subsequent
Commission  audits  and  inspections  that  will  be  carried  out  within  a
multidisciplinary  framework  covering  the  main  sectors  exporting  to  the  EU.
Where necessary more specific inspections and audits of particular sectors can
be carried by the Community control teams. The same principles shall apply to
live animals and plants.

23

51. Third country controls in the Community

In the same way as the FVO is entitled to perform controls in third countries to
verify compliance  or  equivalence of the third  requirements with EU  feed  and
food  law,  third  country  authorities  are  entitled  to  organise  controls  in  the
Member  States.  Experience  has  shown  that  it  is  beneficial  in  some  cases  to
ensure that representatives of the FVO accompany the third country teams that
visit  Member  States.  These  representatives  can  assist  Member  States  by
providing information and data that are available at Community level and that
may  be  useful  in  the  context  of  the  third  country  control  carried  out.  The
present proposal provides for a procedure to ensure such assistance.

The training of control officials

52. The integrated and global approach towards feed and food safety requires high
levels of competence and expertise from the controlling authorities: they need
to  have  a  broad  knowledge  of  different  hazards  (chemical,  biological  and
physical)  that  can  occur  along  the  feed  and  food  chain.  They  must  also
understand the  mechanisms  of  the  market  in  which  ingredients  for  composite
products can be obtained from different sources. At the same time, they need to
be  informed  about  very  specific  problems  that  are  inherent  to  specific
production methods. They must  be able to identify  non-compliance with feed
and food safety requirements and to detect fraudulent practices.

Modern control techniques require feed and food control officials to be highly
skilled  so  that  controls  are  efficient,  objective  and  adequate.  This  is  in
particular  the  case  where  the  performance  of  hazard  analysis  and  control
techniques applied by food operators must be assessed.

Control  of  feed  and  food  production  and  marketing  requires  therefore  a
multidisciplinary  approach.  Feed  and  food  inspectors  will  need  continuing
training and updating of their knowledge. It is essential that the necessary legal
provisions are made to facilitate such training. The present proposal therefore
requires the establishment of proper training programmes both at national and
Community level.

In this  context,  special  attention  has  been  paid  to  the  organisation  of  training
programmes  at  Community  level  and  provision  is  made  for  organising  such
training.  It  must  be  ensured  for  example  that  the  assessment  of  the
implementation  of  the  HACCP  principles  and  the  decisions  that  are
subsequently  taken  by  the  assessor  reflect  an  approach  that  is  based  on  a
standard  procedure  that  applies  in  a  uniform  way  in  all  Member  States.  The
organisation  of  training  courses  is  left  to  a  future  decision,  but  a  possibility
could  be  the  establishment  of  a  training  centre  under  the  aegis  of  the
Commission, within the limits of the human and financial  resources available
to  it.  Leading  experts  in  the  area  of  feed  and  food  controls  and  the  different
control techniques could be invited. Control officials from the Member States,
but also from third countries and in particular from developing countries could
be invited to follow the courses.

24

Enforcement of feed and food law

53. National enforcement measures

In order to guarantee and maintain a high level of public health and consumer
protection, adequate enforcement measures must be available to the competent
authorities and effectively used by them in order to tackle non-compliance with
feed and food law.

The responsibility for implementing and  enforcing community legislation lies
primarily with the Member States. According  to  Article  10 of the EC Treaty,
Member States  must take  all  measures  necessary  to  guarantee  the  application
and  effectiveness  of  Community  law.  Such  measures  include,  in  any  event,
effective  proportionate  and  dissuasive  penalties  (judgement  of  the  Court  of
10 July 1990 in case C-326/88). Such measures may consist of administrative
measures or criminal sanctions to be imposed by  the  competent  authorities in
the Member States.

54. Administrative enforcement measures

Administrative enforcement measures are  to  a  greater  or  lesser  extent  spelled
out  in  certain  Community  acts  such  as  the  veterinary  legislation  (Directives
89/662/EEC  and  97/78/EEC),  the  feedingstuffs  legislation  (Article  13  of
Directive  95/53/EEC)  and  the  food  legislation  (Article  10  of  Directive
89/397/EEC). In these Community acts, these measures extend from a simple
requirement  “to  take  the  requisite  measures”  (Article  10  of  Directive
89/397/EEC)  to  take  action  at  the  level  of  the  products  (withdrawal  from  the
market, destruction, product sanitation etc.) or of the food business concerned
(taking  of  corrective  action,  temporary  or  permanent  closure  of  a  food
business).  National  legislation  may  also,  of  course,  provide  for  further,
different administrative sanctions.

Such administrative measures, having direct effect on operators, are a powerful
tool and, if properly used, also have an important dissuasive effect. The present
proposal  therefore  re-confirms  the  need  for  the  Member  States  to  take
administrative enforcement measures. It also aims to ensure that a requirement
to that effect applies to all feed and food businesses at all levels of the feed and
food chain.

55. Criminal sanctions

There  is  a  lack  of  certainty  in  Community  law  with  regard  to  the  Member
States’  obligation  to  provide  criminal  penalties.  In  addition,  there  is  no
minimum  standard  with  regard  to  the  constituent  elements  of  offences  to  the
detriment of feed and food safety.

In many cases, only criminal penalties will provide a strong dissuasive effect.
The  provision  for  such  sanctions  demonstrates  social  disapproval  of  a
qualitatively  different  nature  compared 
to  administrative  enforcement
measures. There is also an additional guarantee of impartiality of investigating
authorities, because other authorities than those who have granted exploitation
licences will be involved in a criminal investigation.

25

Therefore, a common minimum set of serious offences under EU feed and food
law, or under rules adopted by the Member States in order to comply with such
law, for which Member States are required to impose criminal penalties, must
be  established.  This  takes  the  form  of  a  list  of  serious  offences  against
Community  feed  and  food  law  committed  intentionally  or  through  serious
negligence,  for  which  Member  States  must  provide  for  criminal  sanctions.
These  are  the  offences  that  could  threaten  most  feed  and  food  safety  and
therefore public health.

The  proposal  aims  to  set  a  minimum  standard  of  feed  and  food  safety
protection, including animal health and animals welfare, through criminal law.
It does not cover all activities regulated by Community feed and food law, but
only important offences that may lead to the placing on the market of feed or
food  that  are  unsafe  in  the  sense  of  Articles 14  and  15  of  Regulation  (EC)
No 178/2002.

The  offences  listed  in  the  present  proposal  are  offences  that  may  eventually
lead  to  the  placing  on  the  market  of  unsafe  feed  or  food.  Considering  the
seriousness  of  the  threat  they  pose  to  public  health,  it  is  important  that  these
offences are made punishable "per se", whether they eventually lead or not to
the placing on the market of unsafe feed or food.

Member States may, of course, establish additional offences and/or provide for
different additional types of enforcement measures and penalties. For instance,
they  may  consider  to  provide  for  disqualification  of  natural  persons  from
engaging  in  an  activity  of  founding  or  directing  a  company  or  other  form  of
enterprise.

The nature of the sanctions can only be determined under national law by the
Member  States.  For  the  same  reason,  the  Regulation  does  not  regulate
questions of criminal investigations and prosecutions, nor questions of criminal
procedure. It is up to the authorities in the Member States to decide whether the
offences listed in the Regulation must be prosecuted in any case or whether the
competent authority may refrain from providing for criminal penalties in minor
cases where the impact on feed and food safety is insignificant.

As to natural persons, the proposal would oblige Member States to provide for
effective,  dissuasive  and  proportionate  criminal  penalties  against  the  defined
breaches of Community law.  In order to ensure a high level of feed  and food
safety, it is important also to include sanctions against complicity (participation
and instigation) in the offences that are listed. In serious cases, Member States
would  have  to  provide  for  the  possibility  of  imprisonment  but  would  have  a
broad discretion in defining such serious cases.

26

As to legal persons, it is essential for effective enforcement of Community feed
and  food  law  that  they  can  be  held  liable  and  that  sanctions  against  legal
persons  are  taken.  However,  for  some  Member  States  it  might  be  difficult  to
provide  for  criminal  sanctions  against  legal  persons  without  changing
fundamental  principles  of  their  national  legal  systems.  Therefore,  Member
States would be able to foresee sanctions other than those of a criminal nature
as long  as they  are  effective,  proportionate  and  dissuasive.  For  instance,  they
could provide for non-criminal fines, judicial supervision, judicial winding-up
orders or exclusion from entitlement to public benefits or aid.

The  Commission  believes  that  such  a  measure  is  justified  in  order  to  ensure
that feed and food safety rules are respected throughout the EU by means of a
harmonised approach in all Member States. This objective is best achieved by a
Community  approach  in  accordance  with  Article  5,  paragraph  2  of  the  EC
Treaty.

56. Community safeguard measures

The  procedure  referred  to  in  Article  226  of  the  Treaty  (infraction  procedure)
offers a tool for the Commission to proceed against Member States that fail to
implement Community law.

Although this procedure is a powerful instrument, the time constraints imposed
on  it  render  it  impractical  where  a  failure  to  implement  Community  law
requires  prompt  action  to  safeguard  feed  and  food  safety.  The  safeguard
measure  adopted  under  Regulation  (EC)  No  178/2002  allows  the  taking  of
measures only where there is evidence that feed or food that  is placed on the
market is likely  to constitute a serious risk to  human  health, animal health or
the environment, and that such risk cannot be contained satisfactorily by means
of measures  taken  by the  Member  State(s)  concerned.  This  measure  does  not
allow  the  Commission  to  take  action  when  there  is  clear  evidence  that  a
Member State’s control system shows serious shortcomings and is inadequate
to  implement  Community  law  properly  thus  possibly  compromising  feed  and
food safety in a more general way.

The present proposal adds a new dimension to the existing safeguard measure
in  Regulation  (EC)  No  178/2002.  It  introduces  a  tool  that  would  allow  the
Commission  to  take  measures  when  there  is  proof  that  a  Member  State’s
control  system  is  inadequate.  These  may  include  the  suspension,  for  the
Member  State  in  question,  of  the  placing  on  the  market  of  certain  feed  or
foodstuffs, laying down special conditions for certain feed or foodstuffs or the
taking  of  any  other  interim  measure  required  to  ensure  protection  of  human
health, animal health and animal welfare.

Special and Differential treatment

57. Article 10  of  the  agreement  on  the  application  of  Sanitary  and  Phytosanitary
Measures  (SPS  Code)  adopted  by  the  World  Trade  Organisation  lays  down
that,  in  the  preparation  of  sanitary  or  phytosanitary  measures,  Members  shall
take  account  of  the  special  needs  of  developing  country  Members,  and  in
particular of the least-developed country Members.

27

The  EU imports large quantities  of  feed  and  food  from  developing  countries.
These  countries  fall  within  the  same  general  requirements  laid  down  in
Regulation (EC) No 178/2002 that third countries must ensure that feed or food
exported towards the EU complies with the relevant requirements of feed and
food  law,  or  with  conditions  recognised  by  the  Community  to  be  at  least
equivalent  thereto  or,  where  a  specific  agreement  exists  between  the
Community  and  the  exporting  country,  with  the  requirements  contained
therein.

Whilst it  is  not  possible  to  grant  derogations  on  the  health  standards  that  are
established  under  Community  feed  and  food  law,  it  is  possible  to  consider  a
number  of  activities  to  assist  developing  countries  to  provide  the  requisite
guarantees. The proposal therefore introduces procedures to that effect. These
concern,  for  example,  a  phased  introduction  of  the  requirement  to  present  a
control programme, assistance with the establishment of a control programme,
the  promotion of twining  projects between developing countries  and  Member
States,  sending  Community  experts  on  the  spot  so  as  to  assist  in  the
organisation of official controls.

Financial support

58. The proposal includes a number of activities that require a financial input from

the Community. These are in particular:

●

●

●

●

●

●

●

the designation of new reference laboratories;

the creation of a database on country profiles;

the participation of national experts in FVO missions;

the standardisation of methods of analysis and sampling, in particular by
the establishment of criteria based performance standards;

the support for developing countries;

the creation of training facilities for control staff of the Member State and
third countries;

feed and food safety studies, conferences and publications.

At the moment, feed and food safety controls account for about € 3 Mio in the
annual Community budget. Implementing all of the above proposed measures
would increase this amount to approximately € 16 Mio  annually or  €  95 Mio
over  six  years.  €  7.5  Mio  out  of  those  €  16  Mio  are  foreseen  for  training  of
control officials from Member States, Candidate Countries and third countries
on the (new) EU feed and food control measures.

This action must be considered as the completion of action 79 of the White
Paper  on  Food  Safety  which  aims  to  provide  for  a  legal  basis  to  ensure
adequate  Community  financial  support  of  actions  necessary  to  enhance  food
safety.

28

Implementing measures

59. The  proposed  rules  cover  an  extensive  area  including  official  controls  of  all
feed  and  food  at  all  stages  of  the  food  chain  within  the  Community  or
presented at the Community border for import. These rules cannot cover all the
details that characterise official controls. They must therefore be considered as
a framework containing the essential requirements on the basis of which more
detailed rules to ensure uniform implementation by the Member States can be
developed  if  necessary.  It  is  for  that  reason  that  provision  is  made  for  the
development  of  such  implementing  rules  in  accordance  with  the  procedure
provided for in Article 5 of Council Decision 1999/468/EC.

Scope of the proposed Regulation

60. The principles set out in this proposal are generally applicable to all feed  and
food  law,  and  to  animal  health  and  animal  welfare  legislation.  However,
bearing  in  mind  that  for  certain  areas  of  food  law  there  are  already
comprehensive and specific control measures in place, the proposed Regulation
should therefore take account of this acquis.

The  scope  of  the  proposal  does  therefore  not  extend  to  the  verification  of
compliance  with  the  rules  on  the  common  organisation  of  the  markets  of
agricultural products (arable crops, wine, olive oil, fruit and vegetables, hops,
milk and milk products, beef and veal, sheepmeat and goatmeat and honey) for
which  a  well  established  and  specific  control  system  is  already  in  place.  In
addition,  the  purpose  and  objectives  of  the  proposal  are  different  from  the
purpose and objectives of the controls that  apply to  the  common  organisation
of the agricultural markets.

The  following  contain  specific  measures  for  the  verification  of  compliance
with the requirements contained therein:

– 

– 

– 

– 

Council  Directive  2000/29/EC  of  8  May  2000  on  protective  measures
against  the  introduction  into  the  Community  of  organisms  harmful  to
plants or plant products and against their spread within the Community14,

Council  Regulation  (EEC)  No  2092/91  of  24  June  1991  on  organic
production  of  agricultural  products  and  indications  referring  thereto  on
agricultural products and foodstuffs15,

Council Regulation (EC) No 2081/92 of 14 July 1992 on the protection
of  geographical  indications  and  designations  of  origin  for  agricultural
products and foodstuffs16, and

Council Regulation (EC) No 2082/92 of 14 July 1992 on  certificates of
specific character for agricultural products and foodstuffs17.

14

15

16

17

OJ L 169, 10.7.2000, p. 1.
OJ L 198, 22.7.1991, p. 1.
OJ L 208, 24.7.1992, p. 1.
OJ L 208, 24.7.0992, p. 9.

29

                                                
This proposal should be flexible enough so as to take account of the specificity
of these areas.

The structure of future Community rules on feed and food controls

61. The  proposal  joined  herewith  provides  for  the  general  rules  applicable  to  the
official controls of all feed and food at any stage of production, processing and
distribution,  whether  produced  within  the  EU,  exported  to  or  imported  from
third  countries.  In  addition  to  these  general  rules,  it  must  be  envisaged  that
particular problems need particular solutions. There must therefore be room for
more specific control measures in order to maintain a high level of protection.
Within this context it is clear that existing more specific control rules must be
kept in place. These are for example:

– 

– 

– 

– 

– 

– 

Council Directive 96/22/EC of 29 April 1996 concerning the prohibition
on  the  use  in  stockfarming  of  certain  substances  having  a  hormonal  or
thyrostatic  action  and  of  beta-agonists,  and  repealing  Directives
81/602/EEC, 88/146/EEC and 88/299/EEC18,

Council  Directive  96/23/EC  of  29  April  1996  on  measures  to  monitor
certain  substances  and  residues  thereof  in  live  animals  and  animal
products  and  repealing  Directives  85/358/EEC  and  86/469/EEC  and
Decisions 89/187/EEC and 91/664/EEC19,

Regulation (EC) N° …/… of the European Parliament and of the Council
laying  down  specific  rules  for  the  organisation  of  official  controls  on
products of animal origin intended for human consumption20,

Regulation  (EC)  N°  999/2001  of  the  European  Parliament  and  of  the
Council  of  22  May  2001  laying  down  rules  for  the  prevention,  control
and eradication of certain transmissible spongiform encephalopathies21,

Regulation (EC) N°…/… of the European Parliament and of the Council
on  the  control  of  salmonella  and  other  food-borne  zoonotic  agents  and
and
amending  Council  Directives 
90/539/EEC22,

64/432/EEC, 

72/462/EEC 

Council  Directives  86/362/EEC  of  24  July  1986  on  the  fixing  of
maximum  levels  for  pesticide  residues  in  and  on  cereals23  and
90/642/EEC of 27 November 1990 on the fixing of maximum levels for
pesticide  residues  in  and  on  certain  products  of  plant  origin,  including
fruit and vegetables24 and the implementing rules resulting therefrom,

18

19

20

21

22

23

24

OJ L 125, 23.5.1996, p. 3.
OJ L 125, 23.5.1996, p. 10.
COM (2000) 438, doc. 2000/0180 (COD).
OJ L 147, 31.5.2001, p. 1.
COM (2001).
OJ L 221, 7.8.1986, p. 37.
OJ L 350, 14.12.1990, p. 71.

30

                                                
– 

Commission  Directives  92/1  of  13  January  1992  on  the  monitoring  of
temperatures  in  the  means  of  transport,  warehousing  and  storage  of
quick-frozen  foodstuffs  intended  for  human  consumption25  and  92/2  of
the
13 January  1992 
the
Community  method  of  analysis  for 
temperatures of quick-frozen foods intended for human consumption26.

the  sampling  procedure  and 
the  official  control  of 

laying  down 

Likewise, it is not excluded that in future new rules must be developed where
special problems arise. In that event, proposals will be made to that effect.

25

26

OJ L 34, 11.2.1992, p. 29.
OJ L 34, 11.2.1992, p. 30.

31

                                                
2003/0030 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of

on official feed and food controls

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Articles 37, 95 and 152(4)(b) thereof,

Having regard to the proposal from the Commission1,

Having regard to the opinion of the Economic and Social Committee2,

Having regard to the opinion of the Committee of the Regions3

Acting in accordance with the procedure laid down in Article 251 of the Treaty,

Whereas:

(1) 

(2) 

(3) 

Feed and Food should be safe and wholesome. Community legislation comprises a set
of rules to ensure that this objective is attained. These rules extend to the production
and the placing on the market of both feed and food.

The  basic  rules  with  regard  to  feed  and  food  law  are  laid  down  in  Regulation  (EC)
No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying
down the general principles and requirements of food law, establishing the European
Food Safety Authority, and laying down procedures in matters of food safety4.

In addition to those  basic  rules,  more  specific  feed  law  and  food  law  cover  different
areas  such  as  animal  nutrition  including  medicated  feedingstuffs,  feed  and  food
hygiene,  zoonoses,  animal  by-products,  residues  and  contaminants,  control  and
eradication  of  animal  diseases  with  a  public  health  impact,  feed  and  food  labelling,
pesticides,  feed  and  food  additives,  vitamins,  mineral  salts,  trace  elements  and  other
additives,  materials  in  contact  with  food,  quality  and  compositional  requirements,
drinking water, ionisation, novel foods and genetically modified organisms (GMOs).

1

2

3

4

OJ C , , p. .
OJ C , , p. .
OJ C […], […], p. […].
OJ L 31, 1.2.2002, p. 1.

32

                                                
(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Animal  health  and  animal  welfare  are  also  important  factors  that  contribute  to  the
quality and safety of food.

Community feed and  food  law  is  based  on  the  principle  that  feed  and  food  business
operators at all stages of production, processing and distribution within the businesses
under  their  control  are  responsible  for  ensuring  that  feed  and  food  satisfy  the
requirements of feed and food law which are relevant to their activities.

The Member States should enforce feed and food law and monitor and verify that the
relevant requirements of food law are fulfilled by feed and food business operators at
all  stages  of  production,  processing  and  distribution.  Official  controls  should  be
organised for that purpose.

A  Community  framework  should  be  established  for  the  organisation  of  official
controls  covering  all  the  areas  of  feed  and  food  law,  including  animal  health  and
welfare.

As a general rule this Community framework should not include official controls with
regard  to  organisms  harmful  to  plants  and  plant  products  since  these  controls  are
already  adequately  covered  by  Council  Directive  2000/29/EC  of  8  May  2000  on
protective measures against the introduction into the Community of organisms harmful
to  plants  or  plant  products  and  against  their  spread  within  the  Community5.  Certain
aspects of this Regulation should however also apply to the plant health sector and in
particular those concerning the establishment of national control plans and Community
inspections within the Member States and in third countries. It is therefore appropriate
to amend Directive 2000/29/EC accordingly.

Council  Regulations  (EEC)  No  2092/91  of  24  June  1991  on  organic  production  of
agricultural  products  and  indications  referring  thereto  on  agricultural  products  and
foodstuffs6,  (EEC)  No  2081/92  of  14  July  1992  on  the  protection  of  geographical
indications  and  designations  of  origin  for  agricultural  products  and  foodstuffs7,  and
(EEC) No 2082/92 of 14 July 1992 on certificates of specific character for agricultural
products and foodstuffs8 contain specific measures for the verification of compliance
with the requirements contained therein. These requirements of this Regulation should
be flexible enough so as to take account of the specificity of these areas.

(10)  For the verification of  compliance with  the  rules  on  the common  organisation of the
markets  of  agricultural  products  (arable  crops,  wine,  olive  oil,  fruit  and  vegetables,
hops,  milk  and  milk  products,  beef  and  veal,  sheepmeat  and  goatmeat  and  honey)  a
well  established  and  specific  control  system  is  already  in  place.  This  Regulation
should  therefore  not  apply  to  these  areas,  all  the  more  since  the  objectives  of  this
Regulation  differ  from  the  objectives  pursued  by  the  control  mechanisms  for  the
common organisation of the markets of agricultural products.

5

6

7

8

OJ L 169, 10.7.2000, p. 1. Directive as last amended by Commission Directive 2002/36/EC (OJ L 116,
3.5.2002, p. 16).
OJ, L 198, 22.7.1991, p. 1. Regulation as last amended by Commission Regulation (EC) No 436/2001
(OJ L 63, 3.3.2001, p. 16).
OJ L 208, 24.7.1992, p. 1. Regulation as last amended by Commission Regulation (EC) No 2796/2000
(OJ L 324, 21.12.2000, p. 26).
OJ L 208, 24.7.1992, p. 9. Regulation as last amended by the Act of accession of Austria, Finland and
Sweden.

33

                                                
(11)  The  competent  authorities  for  performing  official  controls  should  meet  a  number  of
operational  criteria  so  as  to  ensure  their  impartiality  and  effectiveness.  They  should
have  a  sufficient  number  of  suitably  qualified  and  experienced  staff  and  possess
adequate facilities and equipment to carry out their duties properly.

(12)  The official controls should be carried out using appropriate techniques developed for
that purpose, including routine surveillance checks and more intensive controls such as
inspections,  verifications,  audits,  sampling  and  the  testing  of  samples.  The  correct
implementation  of  those  techniques  requires  appropriate  training  of  the  staff
performing  official  controls.  Training  is  also  required  in  order  to  ensure  that  the
competent authorities take decisions in a uniform way, in particular with regard to the
implementation  of  the  Hazard  Analysis  and  Critical  Control  Points  (HACCP)
principles.

(13)  The  frequency  of  official  controls  should  be  regular  and  proportionate  to  the  risk,
taking  into  account  the  results  of  the  checks  carried  out  by  feed  and  food  business
operators  under  HACCP  based  control  programmes  or  Quality  Assurance
Programmes,  where  these  are  designed  to  meet  requirements  of  feed  and  food  law.
Where  necessary,  ad  hoc  controls  must  be  carried  out  in  case  of  suspicion  of  non-
compliance with feed and food law.

(14)  Official  controls  should  take  place  on  the  basis  of  documented  procedures  so  as  to

ensure that these controls are carried out uniformly and are of consistent high quality.

(15)  The  competent  authorities  should  ensure  that  where  different  control  units  are
involved in carrying out official controls, appropriate co-ordination procedures are in
place and effectively implemented.

(16)  The competent authorities should also ensure that, where the competence to carry out
official controls has been delegated from the central level to a regional or local level,
there is effective and efficient co-ordination between the central level and that regional
or local level.

(17)  Laboratories  involved  in  the  analysis  of  official  samples  should  work  in  accordance
with internationally approved procedures or criteria based performance standards and
use methods of analysis that have as far as possible been validated.

(18)  The  designation  of  Community  and  national  reference  laboratories  should  contribute
to a high quality and uniformity of  analytical results. This objective can  be achieved
by  activities  such  as  the  application  of  validated  analytical  methods,  ensuring  that
reference  materials  are  available,  the  organisation  of  comparative  testing  and  the
training of staff from laboratories.

(19)  The activities of reference laboratories should cover all the areas of feed and food law,
in  particular  those  areas  where  there  is  a  need  for  precise  analytical  and  diagnostic
results. This includes animal health given the importance of this sector with regard to
feed and food law.

34

(20)  For  a  number  of  activities  related  to  official  controls,  the  European  Committee  for
Standardisation (CEN) has developed European Standards (EN Standards) appropriate
for  the  purpose  of  this  Regulation.  These  EN  Standards  relate  in  particular  to  the
operation and assessment of testing laboratories and to the operation and accreditation
of  control  bodies.  International  standards  have  also  been  elaborated  by  the
International  Organisation  for  Standardisation  (ISO)  and  the  International  Union  of
Pure and Applied Chemistry (IUPAC). These Standards might, in certain well defined
cases,  be  appropriate  for  the  purposes  of  this  Regulation,  taking  into  account  that
performance criteria are laid down in feed and food law in order to ensure flexibility
and cost effectiveness.

(21)  Provision  should be made for delegating  competence for performing  specific  control
tasks from the competent authority to a non-governmental body, and for the conditions
under which such delegation can take place.

(22)  Appropriate  procedures  should  be  available  for  the  co-operation  of  the  competent
authorities  in  and  between  the  Member  States,  in  particular  when  official  controls
reveal that feed and food problems extend to more than one Member State. In order to
facilitate  such  co-operation,  Member  States  should  designate  one  or  more  liaison
bodies  with  the  role  of  co-ordinating  the  transmission  and  reception  of  requests  for
assistance.

(23) 

(24) 

In accordance with Article 50 of Regulation 178/2002, the Member States shall inform
the  Commission  where  information  relating  to  the  existence  of  a  serious  direct  or
indirect risk to human health deriving from food or feed is available.

It is important to create uniform procedures for the control of feed and food from third
countries  introduced  into  the  territory  of  the  Community,  taking  into  account  that
harmonised import procedures are already established for:

– 

– 

food of animal origin by virtue of Council Directive 97/78/EC of 18 December
1997  laying  down  the  principles  governing  the  organisation  of  veterinary
checks on products entering the Community from third countries9;

for  live  animals  by  virtue  of  Council  Directive  91/496/EEC  of  15 July 1991
laying down the principles governing the organisation of veterinary checks on
animals entering the Community from third countries and amending Directives
89/662/EEC, 90/425/EEC and 90/67510.

These procedures function properly and should be maintained.

(25)  The checks on feed and food from third countries referred to in Directive 97/78/EEC
are  limited  to  veterinary  aspects.  It  is  necessary  to  supplement  these  checks  with
official controls on aspects that are not covered by veterinary checks, such as those on
additives, labelling, traceability, irradiation of food and materials in contact with food.

9

10

OJ L 24, 30.1.1998, p. 9.
OJ L 268, 24.9.1991, p. 56. Directive as last amended by Directive 96/43/EC (OJ L 162, 1.7.1996, p. 1).

35

                                                
(26)  Community  legislation also provides  for  procedures  for  the  control  of  imported  feed
by  virtue  of  Council  Directive  95/53/EC  of  25  October  1995  fixing  the  principles
governing  the  organisation  of  official  inspections  in  the  field  of  animal  nutrition11.
That Directive contains principles and procedures that must be applied by the Member
States when releasing imported feed for free circulation.

(27) 

It  is  appropriate  to  establish  Community  rules  in  order  to  ensure  that  feed  and  food
from third countries is submitted to official controls before release for free circulation
in the Community. Special attention should be paid to import controls of feed and food
for which there may be an increased risk of contamination.

(28)  Provision should also be made for the organisation of official controls of feed and food
that is introduced into the territory of the Community under customs procedures other
than free circulation, and in particular those introduced under the customs procedures
referred  to  in  points  (b)  to  (f)  of  article  4(16)  of  Regulation  (EC)  No  2913/92  of  12
October 1992 establishing the Community Customs Code12, as well as their entry into
a  free  zone  or  free  warehouse.  This  includes  the  introduction  of  feed  and  food  from
third countries by passengers of international means of transport and through parcels
sent by mail.

(29)  For  the  purpose  of  official  controls  on  feed  and  food,  it  is  necessary  to  define  the
territory of the Community in which the  rules apply  in order  to  ensure  that feed and
food that is introduced in this territory is submitted to the controls prescribed by this
Regulation. This territory is not necessarily the same as provided for in Article 299 of
the Treaty, or as defined in Article 3 of Council Regulation (EEC) No 2913/92.

(30) 

(31) 

In  order  to  ensure  a  more  efficient  organisation  of  the  official  controls  on  feed  and
food  from  third  countries  and  in  order  to  facilitate  commercial  flows,  it  may  be
necessary to designate specific points of entry for feed and food from third countries
into the territory of the Community. Likewise, it may be necessary to require advance
notice of the arrival of goods at the territory of the Community.

In establishing rules on the official controls of feed and  food  from third countries, it
should be ensured  that  that  the  competent  authorities  and  the  customs  services  work
together,  taking  into  account  that  rules  to  that  effect  already  exist  in  Council
Regulation (EEC) No 339/93 of 18 February 1993 on checks for conformity with the
rules on product safety in the case of products from third countries13.

(32)  Adequate  financial  resources  should  be  available  for  organising  official  controls.
Where for that purpose fees are imposed on feed and food business operators, common
principles should apply. It is appropriate therefore to lay down the criteria for setting
the  level  of  inspection  fees.  With  regard  to  fees  applicable  for  import  controls,  it  is
appropriate to establish directly the rates for main import items with a view to ensure
their uniform application and to avoid trade distortions.

11

12

13

OJ L 265, 8.11.1995, p. 17. Directive as last amended by Directive 2001/46/EC (OJ L 234, 1.9.2001,
p. 55).
OJ L 311, 12.12.2000, p. 17.
OJ L 40, 17.2.1993, p. 1.

36

                                                
(33)  Community food law and feed law provide for the registration or approval of certain

feed and food businesses by the competent authority. This is in particular the case in:

– 

– 

– 

Regulation (EC) No …/… of  the European Parliament  and  of the Council on
the hygiene of foodstuffs14;

Regulation (EC) No …/…  of the  European Parliament  and  of the Council on
the laying down specific hygiene rules for food of animal origin15;

Council Directive 95/69/EC of 22 December 1995 laying down the conditions
and  arrangements  for  approving  and  registering  certain  establishments  and
intermediaries  operating  in  the  animal  feed  sector  and  amending  Directives
70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC16.

Procedures should be put in place in order to ensure that registration and approval of
feed and food businesses are carried out in an efficient and transparent way.

(34) 

In order to have a global and uniform approach with regard to official feed and food
controls,  Member  States  should  establish  and  implement  national  control  plans  in
accordance  with  broad  guidelines  elaborated  at  Community  level.  These  guidelines
should promote coherent national strategies, and identify risk-based priorities and the
most  effective  control  procedures.  A  Community  strategy  should 
take  a
comprehensive, integrated approach to the operation of controls.

(35)  The national control plans should cover food law and feed law, and the legislation on

animal health and animal welfare.

(36)  The national control plans should establish a solid basis for the Commission inspection
services to carry out controls in  the Member States. The  control plans should enable
the  Commission  inspection  services  to  verify  whether  the  official  controls  in  the
Member  States  are  organised  in  accordance  with  the  criteria  laid  down  in  the  this
Regulation. Where appropriate and in particular where the audit of the Member States
against  the  national  control  plans  shows  weaknesses  or  failures,  detailed  inspections
and audits should be carried out.

(37)  Member States should be required to present an annual report to the Commission with
information  on  the  implementation  of  the  national  control  plans.  This  report  should
provide the results of the official  controls  and  audits  carried  out  during  the  previous
year  and,  where  necessary,  an  update  of  the  initial  control  plan  in  response  to  these
results.

(38)  Community  controls  in  the  Member  States  should  allow  the  Commission  control
services to verify whether feed and food law, and the legislation on animal health and
animal  welfare  are  implemented  in  a  uniform  and  correct  way  throughout  the
Community.

14

15

16

OJ L
OJ L
OJ L 332, 30.12.1995, p. 5. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999,
p. 20).

37

                                                
(39)  Community  controls  in  third  countries  are  required  in  order  to  verify  compliance  or
equivalence  with  Community  feed  and  food  law  as  well  as  with  the  legislation  on
animal health. Third countries may also be requested to establish control plans similar
to those intended for Member States, in respect of the feed and food exported by them.
These  plans,  which  should  be  established  on  the  basis  of  Community  guidelines,
should  form  the  basis  for  subsequent  Commission  controls,  which  should  be  carried
out  within  a  multidisciplinary  framework  covering  the  main  sectors  exporting  to  the
Community.  This  evolution  should  allow  a  simplification  of  the  current  regime,
enhance effective control co-operation, and consequently facilitate trade flows.

(40) 

In  order  to  ensure  that  imported  feed  and  food  comply  with  or  are  equivalent  to
Community food law and feed law, it is necessary to establish procedures that allow
the definition of import conditions and certification requirements as appropriate.

(41)  Breaches of feed and food law may constitute a threat to human health, animal health,
and animal welfare. Such breaches should therefore be subject to effective, dissuasive
and proportionate measures at national level throughout the Community.

(42)  Such  measures  should  include  administrative  action  by  the  competent  authorities  in
the  Member  States  who  should  have  procedures  in  place  for  that  purpose.  The
advantage of such procedures is that quick action can be undertaken in order to restore
the situation.

(43)  Experience  has  shown  that  the  existing  systems  of  sanctions  have  not  always  been
sufficient  to  achieve  compliance  with  Community  law.  Such  compliance  can  and
should be strengthened by the application of criminal penalties, which demonstrate a
social  disapproval  of  a  qualitatively  different  nature  compared  to  administrative
measures or a compensation mechanism under civil law.

(44)  Entrusting  to  judicial  authorities,  rather  than  to  administrative  authorities  the  task  of
imposing  penalties,  entails  giving  responsibility  for  investigating  and  enforcing  the
respect  of  animal  health  rules  and  feed  and  food  law  to  authorities  which  are
independent of those which grant exploitation licences.

(45)  Certain  offences  should  therefore  be  considered  criminal  offences  when  they  are
committed  intentionally  or  through  negligence,  and  should  be  subject  to  criminal
penalties, involving in serious cases deprivation of liberty.

(46)  Legal  persons  should  also  be  subject  to  effective,  dissuasive  and  proportionate
penalties, because breaches of Community law to a large extent are committed in the
interest of legal persons or for their benefit.

(47)  Feed and food business operators should have a right to appeal  against the decisions
taken by the competent authority as a result of the official controls, and be informed
about such right.

(48) 

It is appropriate to take account  of the  special needs of  developing  countries,  and  in
particular of the least-developed countries, and to introduce measures to that effect.

38

(49)  The rules contained in this Regulation underpin the integrated and horizontal approach
necessary to implement a coherent control policy on feed and food safety. There must
be  room  however  to  develop  specific  control  rules  where  required.  Likewise,  more
specific  rules  existing  in  the  area  of  feed  and  food  controls  should  be  kept  in  place.
These include in particular the following acts:

– 

– 

– 

– 

– 

– 

– 

– 

Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the
use  in  stockfarming  of  certain  substances  having  a  hormonal  or  thyrostatic
action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC
and 88/299/EEC17,

Council Directive  96/23/EC of  29  April  1996 on measures to monitor certain
substances  and  residues  thereof  in  live  animals  and  animal  products  and
repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC
and 91/664/EEC18,

Regulation  (EC)  No  …/…  of  the  European  Parliament  and  of  the  Council  of
[…]  laying  down  specific  rules  for  the  organisation  of  official  controls  on
products of animal origin intended for human consumption19,

Regulation (EC) No 999/2001 of the European Parliament and of the Council
of 22 May 2001 laying down rules for the prevention, control and eradication
of certain transmissible spongiform encephalopathies20,

Regulation  (EC)  No…/…  of  the  European  Parliament  and  of  the  Council  of
[…]  on  the  control  of  salmonella  and  other  food-borne  zoonotic  agents  and
amending Council Directives 64/432/EEC, 72/462/EEC and 90/539/EEC21,

Council  Directive  86/362/EEC  of  24  July  1986  on  the  fixing  of  maximum
levels for pesticide residues in and on cereals22,

Council  Directive  90/642/EEC  of  27 November  1990  on  the  fixing  of
maximum  levels  for  pesticide  residues  in  and  on  certain  products  of  plant
origin,  including  fruit  and  vegetables23  and  the  implementing  rules  resulting
therefrom,

Commission  Directive  92/1/EEC  of  13  January  1992  on  the  monitoring  of
temperatures  in  the  means  of  transport,  warehousing  and  storage  of  quick-
frozen foodstuffs intended for human consumption24,

17

18

19

20

21

22

23

24

OJ L 125, 23.5.1996, p. 3.
OJ L 125, 23.5.1996, p. 10.
COM (2000) 438, doc. 2000/0180 (COD).
OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 270/2002
(OJ L 45, 15.2.2002, p. 24).
COM (2001)452 final-2001/0177 (COD).
OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2002/42/EC (OJ L 134,
22.3.2002, p. 29).
OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2002/42/EC.
OJ L 34, 11.2.1992, p. 28.

39

                                                
– 

Commission Directive 92/2/EEC of 13 January 1992 laying down the sampling
procedure and the Community method of analysis for the official control of the
temperatures of quick-frozen foods intended for human consumption25.

(50)  This Regulation covers areas that are already covered in certain Directives in force at
present. It is appropriate therefore to repeal in particular the following acts on feed and
food controls and to replace them by the rules of this Regulation:

– 

– 

– 

– 

– 

– 

– 

Council  Directive  70/373/EEC  of  20  July  1970  on  the  introduction  of
Community  methods  of  sampling  and  analysis  for  the  official  control  of
feedingstuffs26;

the
Council  Directive  85/591/EEC  of  20  December  1985  concerning 
introduction  of  Community  methods  of  sampling  and  analysis  for  the
monitoring of foodstuffs intended for human consumption27;

Council  Directive  89/397/EEC  of  14  June  1989  on  the  official  control  of
foodstuffs28;

Council Directive 93/99/EEC of 29 October 1993 on the subject of additional
measures concerning the official control of foodstuffs29;

Council Directive 95/53/EC of 25 October 1995 fixing the principles governing
the organisation of official inspections in the field of animal nutrition30;

Council  Directive  96/43/EC  of  26  June  1996  amending  and  consolidating
Directive 85/73/EEC in order to ensure financing of veterinary inspections and
controls on live animals and certain animal products and amending Directives
90/675/EEC and 91/496/EEC31;

Council  Decision  98/728/EC  of  14  December  1998  concerning  a  Community
system for fees in the animal feed sector32;

25

26

27

28

29

30

31

32

OJ L 34, 11.2.1992, p. 30.
OJ  L  170,  3.8.1970,  p.  2.  Directive  as  last  amended  by  Regulation  (EEC)  No  3768/85  (OJ  L  362,
31.12.1985, p. 8).
OJ L 372, 31.12.1985, p. 50.
OJ L 186, 30.6.1989, p. 23.
OJ L 290, 24.11.1993, p. 14.
OJ  L  265,  8.11.1995,  p.  17.  Directive  as  last  amended  by  Directive  2001/46/EC  of  the  European
Parliament and of the Council (OJ L 234, 1.9.2001, p. 55).
OJ L 162, 1.7.1996, p. 1.
OJ L 346, 22.12.1998, p. 51.

40

                                                
(51)  The following rules should be amended in the light of this Regulation:

– 

– 

– 

Council  Directive  89/662/EEC  of  11  December  1989  concerning  veterinary
checks in intra-Community trade with a view to the completion of the internal
market33;

Directive 96/23/EC;

Council Directive 97/78/EC of 18 December 1997 laying down the principles
governing  the  organisation  of  veterinary  checks  on  products  entering  the
Community from third countries34;

– 

Directive 2000/29/EC.

(52) 

In  accordance  with  the  principles  of  subsidiarity  and  proportionality  as  set  out  in
Article 5 of the Treaty, the objectives of the proposed action to ensure a harmonised
approach  with  regard  to  official  feed  and  food  controls,  cannot  be  sufficiently
achieved  by  the  Member  States  since  such  harmonisation  requires  a  Community
approach,  and  can  therefore,  by  reason  of  its  complexity,  its  trans-border  character
and,  with  regard  to  feed  and  food  imports,  its  international  character,  be  better
achieved by the Community. This Regulation confines itself to the minimum required
in order to achieve those objectives and does not go beyond what is necessary for that
purpose.

(53)  The measures necessary for the implementation of this Regulation should be adopted
in accordance  with  Council Decision 1999/468/EC of 28 June  1999  laying  down  the
procedures for the exercise of implementing powers conferred on the Commission35,

HAVE ADOPTED THIS REGULATION:

TITLE I
SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1
Subject matter and scope

1.

The purpose of this Regulation is to lay down the general rules for the performance
of official controls as defined in Article 2(1). This Regulation aims to:

(a)

(b)

prevent  risks  to  humans  and  animals,  either  directly  or  through  the
environment;

protect  consumer 
information.

interests, 

including 

those  with  regard 

to  consumer

33

34

35

OJ  L  395,  30.12.1989, p.  13.  Directive  as  last  amended  by  Directive  96/23/EC  (OJ  L  13,  16.1.1997,
p. 28).
OJ L 24, 30.1.1998, p. 9.
OJ L 184, 17.7.1999, p. 23.

41

                                                
2.

This Regulation shall not apply to official controls for the verification of compliance
with the rules on common market organisations of agricultural products.

Article 2
Definitions

For  the  purposes  of  this  Regulation,  the  definitions  laid  down  in  Articles 2  and 3  of
Regulation (EC) No 178/2002 shall apply.

The following definitions shall also apply:

1.

2.

3.

4.

5.

6.

7.

8.

9.

"official control" means any form of control performed by the competent authority or
by  the  Community  for  the  verification  of  compliance  with  feed  and  food  law,
including animal health and animal welfare rules;

"verification"  means  the  confirmation  by  examination  and  provision  of  objective
evidence that specified requirements have been fulfilled;

"feed law" means the laws, regulations and administrative provisions governing feed
in general and feed safety in particular; it covers any stage of production, processing,
distribution and use of feed;

"competent  authority"  means  the  authority  of  a  Member  State  or  a  third  country
designated to carry out official controls;

"control  body"  means  a  non-governmental  body  to  which  the  competent  authority
has delegated certain control tasks;

"audit"  means  a  systematic  and  independent  examination  to  determine  whether
activities  and  related  results  comply  with  planned  arrangements  and  whether  these
arrangements are implemented effectively and are suitable to achieve objectives;

"inspection"  means  the  examination  of  plants,  animals,  feed  and  food,  of  their
processing,  of  feed  and  food  businesses,  of  their  management  and  production
systems  including  finished  product  testing  and  feeding  practices,  and  of  the  origin
and  destination  of  production  inputs  and  outputs,  in  order  to  verify  that  all  these
items conform to legal requirements;

"official  certification"  means  the  procedure  by  which  the  competent  authority  or
control bodies provide written or equivalent assurance that feed and food or feed and
food businesses conform to requirements;

"import" means the release for free circulation of feed and food and the intention to
release  feed  or  food  for  free  circulation  within  the  meaning  of  Article 79  of
Regulation (EEC) No 2913/92 in one of the territories referred to in Annex I;

10.

"introduction"  means  import  as  defined  in  point  9  above,  and  the  placing  of  goods
under  the  customs  procedures  referred  to  in  points  (b)  to  (f)  of  article  4(16)  of
Regulation  (EEC)  No  2913/92,  as  well  as  their  entry  into  a  free  zone  or  free
warehouse;

42

11.

12.

13.

14.

"documentary  check"  means  the  examination  of  the  commercial  documents  and
where  appropriate  the  documents  required  under  feed  and  food  law  that  are
accompanying the consignment;

"identity  check"  means  a  check  by  visual  inspection  to  ensure  that  the  documents
accompanying  the  consignment  tally  with  the  labelling  and  the  content  of  the
consignment;

"physical check" means a check on the feed or food itself;

"control  plan"  means  a  plan  established  by  the  competent  authority  containing
general  information  on  the  structure  and  organisation  of  the  feed  and  food  control
systems operated by it.

TITLE II
OFFICIAL CONTROLS BY MEMBER STATES

Chapter I: General obligations

Article 3
General obligations with regard to the organisation of official controls

1.

Member  States  shall  organise  official  controls  on  a  regular  basis  and  with  a
frequency appropriate to achieve the objectives of the present Regulation, taking into
account:

(a)

identified risks associated with feed and food, feed and food businesses, the use
of  feed  or  food  or  any  process,  material,  substance,  activity  or  operation  that
may influence feed and food safety;

(b)

the experience and knowledge gained from previous controls;

(c)

the  reliability  of  the  controls  already  carried  out  by  feed  and  food  business
operators;

(d)

suspicion of possible non-compliance.

2.

3.

4.

As a general rule, official controls shall be carried out without prior warning.

Official  controls  shall  be  carried  out  at  any  stage  of  production,  processing  and
distribution  of  feed  and  food.  They  shall  include  controls  on  feed  and  food
businesses, on the use of feed or food, on any process, material, substance, activity or
operation applied to feed and  food and, where relevant for achieving the objectives
of this Regulation, on live animals and plants.

Feed  and food intended  for  export  outside  the  Community  shall  be  controlled  with
the same care as feed and food intended for the Community market.

43

Chapter II: The competent authorities

Article 4
Designation of competent authorities and operational criteria

Member States shall designate the competent authorities responsible for the purposes
and official controls set out in this Regulation.

The competent authorities shall meet the following criteria:

(a)

they must be impartial and free from any conflict of interest;

(b)

(c)

(d)

(e)

(f)

they must ensure the effectiveness and appropriateness of the official controls
at all stages of feed and food production, processing and distribution;

they must have, or have access to, an adequate laboratory  capacity for testing
and  to  a  sufficient  number  of  suitably  qualified  and  experienced  staff  so  that
the  official  controls  and  control  duties  can  be  carried  out  efficiently  and
effectively;

they must have appropriate and properly maintained facilities and equipment to
ensure that staff can perform their control duties efficiently and effectively;

they  must  have  the  legal  powers to carry out official  controls  and  to  take  the
measures prescribed by this Regulation;

they  must  have  contingency  plans  in  place  and  be  prepared  to  operate  such
plans in case of emergencies.

Where  a  central  competent  authority  has  conferred  the  competence  to  carry  out
official controls to another authority or authorities, in particular those at regional or
local level, there shall be effective and efficient co-ordination between or among the
central competent authority and the authority or authorities to which that competence
has been conferred.

The quality and uniformity of the controls shall be ensured at all levels at which the
competent authorities are operating.

Where  within  a  competent  authority  official  control  duties  are  given  to  different
control units, efficient co-ordination and  co-operation  between  these  different  units
shall be ensured.

Audits  shall  be  carried  out  to  ensure  that  the  competent  authorities  achieve  the
objectives  of this  Regulation.  These  audits  shall  be  subject  to  independent  scrutiny
and shall be carried out in a transparent manner.

Detailed rules for the implementation of this Article may be adopted in accordance
with the procedure referred to in Article 62(3), including for the accreditation of the
competent authorities referred to in paragraph 1.

1.

2.

3.

4.

5.

6.

44

Article 5
Delegation of specific control tasks

1.

2.

The competent authority may delegate specific control tasks to one or more control
bodies.  However,  the  activities  referred  to  in  Article  54  shall  not  be  the  subject  of
such a delegation.

A list of tasks that  may  or may  not be delegated may be  established  in  accordance
with the procedure referred to in Article 62(3).

The  competence for performing specific  control tasks  shall not be delegated unless
the following criteria are met:

(a)

there must be an accurate description of the tasks that can be carried out by the
control body and of the conditions under which the delegated competence can
be exercised;

(b)

there must be proof that the control bodies :

(i)

have  the  expertise,  equipment  and  infrastructures  required  to  carry  out
the tasks that have been assigned to them;

(ii)

have a sufficient number of suitably qualified and experienced staff;

(iii) are impartial and free from any conflict of interest;

(c)

(d)

(e)

(f)

it  must  be  ensured  that  the  control  bodies  work  and  are  accredited  in
accordance  with  the  European  Standard  EN  45004  "General  criteria  for  the
operation of various types of bodies performing inspection";

the results of the controls carried out by control bodies shall be communicated
to  the  competent  authority  on  a  regular  basis  and  upon  request  of  the  latter;
where the results of the controls show non-compliance or a suspicion thereof,
the competent authority shall be informed immediately by the control bodies;

the  control  bodies  must  regularly  carry  out  internal  audits  in  order  to  ensure
their capacity to perform efficiently the tasks that have been assigned to them;

there  must  be  efficient  co-ordination  between  the  delegating  competent
authority and the control bodies;

3.

The control bodies shall be subject to audits as necessary organised by the delegating
competent  authority.  If  as  a  result  of  an  audit  it  appears  that  such  bodies  fail  to
perform  the  tasks  that  have  been  delegated  to  them,  the  delegation  of  competence
may  be  withdrawn,  and  shall  be  withdrawn  without  delay  in  the  absence  of
appropriate and timely remedies.

45

4.

Any Member State wishing to delegate a specific control task to a control body shall
notify the Commission and the other Member States. This notification shall provide
detailed description of:

(a)

the task to be delegated;

(b)

the body to which the task will be delegated.

Member  States  shall  have  three  months  from  the  receipt  of  a  notification  to  send
written comments to the Commission. The Commission may – and, when it receives
written comments from one or more Member States, shall – consult Member States
within  the  committee  referred  to  in  Article  62(1).  The  Commission  may  decide,  in
accordance with the procedure referred to in Article 62(3), whether the measure may
be implemented subject to, if necessary, appropriate amendments.

Article 6
Staff performing official controls

1.

2.

Staff of the competent authority performing official controls shall have, for their area
of  competence,  received  appropriate  training  in  order  to  undertake  their  duties
competently  and  to  ensure  that  official  controls  are  carried  out  in  a  uniform  way.
This training shall cover as appropriate the areas referred to in Annex II, Chapter I.

Staff performing  official  controls  shall  be regularly  kept up-to-date  on  all  issues  in
their area of competence and shall receive additional training as necessary.

Article 7
Confidentiality

Without prejudice to the need to protect public health, staff of the competent authority shall
respect  rules  of  confidentiality  on  information  acquired  when  undertaking  their  duties  and
shall be bound by rules on professional secrecy laid down in national legislation.

Article 8
Control procedures and guidelines

1.

2.

Official controls by the competent authority shall be carried out in accordance with
documented  procedures.  This  documentation  shall  contain 
information  and
instructions  for  staff  performing  official  controls  including  inter  alia  the  areas
referred to in Annex II, Chapter II.

Specific  control  procedures  and  guidelines  for  controls  may  be  determined  in
accordance  with  the  procedure  referred  to  in  Article  62(2).  These  may  include
procedures for official controls on the implementation of the HACCP principles or of
management systems operated by the feed and food businesses where these systems
are designed to meet feed and food law requirements.

46

Article 9
Verification procedures and reports

1.

2.

The  competent  authority  shall  have  procedures  in  place  for  the  verification  of  the
efficiency  and  efficacy  of  its  control  system  and  for  taking  corrective  action  when
needed.

The competent authority shall establish reports of the official controls that have been
carried  out.  These  reports  shall  at  least  include  a  description  of  the  purpose  of  the
official control, the control methods that have been applied, the results of the official
controls and where appropriate the corrective action to be taken by the feed or food
business  concerned.  These  reports  shall  be  submitted  to  those  who  have  been  the
subject of the controls.

Article 10
Control activities, methods and techniques

Official controls shall include the following activities:

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(h)

(i)

(j)

The verification of the efficacy of the control systems put in place by feed and food
business operators.

Inspection  of  feed  and  food  businesses  and  their  surroundings,  premises,  offices,
equipment, installations, machinery as well as of feed and food.

Checks on the hygiene conditions in feed and food businesses.

Assessment  of  the  procedures  on  good  manufacturing  practices  (GMP),  good
hygiene  practices  (GHP)  and  HACCP,  taking  into  account  the  use  of  guides
established for that purpose.

Examination  of  written,  documentary  material  and  other  records  which  may  be
relevant to the assessment of compliance with feed or food law.

Examination of any control and verification system set up by the undertaking and of
the results obtained.

Interviews with the feed and food business operators and with the staff employed by
feed and food businesses.

The  reading  of  values  recorded  by  measuring  instruments  installed  by  the
undertaking.

Controls  carried  out  with  the  competent  authority's  own  instruments  in  order  to
verify the measurements made by the feed or food business.

Any other activity used to verify compliance with feed and food law.

Official controls shall be carried out using appropriate control methods and techniques such
as monitoring, surveillance, verification, audit, inspection, sampling and analysis.

47

1.

2.

3.

4.

5.

1.

2.

Chapter III: Sampling and analysis

Article 11
Methods of sampling and analysis

In  the  context  of  official  controls  methods  of  sampling  recognised  by  international
organisations shall be used, where available.

The  methods  of  analysis  used  within  the  context  of  official  controls  shall  be  fully
validated in accordance with Community legislation or with internationally accepted
protocols,  in  particular  those  methods  that  have  been  accepted  by  the  European
Committee  for  standardisation  (CEN).  If  these  are  not  available,  methods  accepted
by other international organisations or by national bodies may be used.

Where such methods of analysis are not available, other methods fit for the intended
purpose or developed in accordance with scientific protocols may be used.

When justified by the circumstances the methods of analysis may be validated within
a single laboratory according to an internationally accepted protocol.

The  methods  of  analysis  shall  comply  whenever  possible  with  all  or  with  the
appropriate criteria set out in Annex III.

The  methods  of  sampling  and  analysis  to  be  applied  for  ensuring  compliance  with
feed and food law, including the reference methods to be used in the case of dispute
and the acceptance criteria for such methods, may be laid down in accordance with
the procedure referred to in Article 62(3).

Feed  and  food  business  operators,  whose  products  are  subject  to  sampling  and
analysis,  may  apply  for  a  second  opinion.  This  implies  that  a  sufficient  number  of
samples, taken under identical  conditions, are  taken so  as to  provide feed and food
business operators with a counter sample. However, this right shall not prejudice the
obligation of the competent authorities to take prompt action in case of emergencies.

Article12
Official laboratories

The  analysis  of  samples  taken  during  official  controls  shall  be  carried  out  by
laboratories designated for that purpose by the competent authority. Any laboratory
that fulfils the criteria laid down in paragraph 2 shall be eligible for designation as an
official laboratory.

The  laboratories  referred  to  in  paragraph  1  shall  operate,  be  assessed  and  be
accredited in accordance with the following European Standards developed by CEN:

(a)

EN  ISO/IEC  17025  on  "General  requirements  for  the  competence  of  testing
and calibration laboratories";

(b) EN 45002 on "General criteria for the assessment of testing laboratories";

48

3.

4.

1.

2.

(c)

EN 45003 on "Calibration and testing laboratory accreditation system-General
requirements for operation and recognition",

taking  into  account  criteria  for  different  testing  methods  laid  down  in  Community
feed and food law.

The  accreditation  and  assessment  of  testing  laboratories  referred  to  in  paragraph  2
may relate to individual tests or groups of tests.

Any  deviation  in  the  way  in  which  the  standards  referred  to  in  paragraph 2  are
applied  shall  be  adopted  in  accordance  with  the  procedure  referred  to  in
Article 62(3).

Chapter IV: Crisis management

Article 13
Contingency plans

For  the  implementation  of  the  general  plan  for  crisis  management  referred  to  in
Article  55  of  Regulation  (EC)  No  178/2002,  Member  States  shall  draw  up
contingency operational plans setting out measures to be implemented without delay
where  feed  or  food  have  been  found  to  pose  a  serious  risk  to  humans  or  animals
either  directly  or  through  the  environment,  and  specifying  the  administrative
authorities to be engaged together with their powers and responsibilities, as well as
channels and procedures for transmitting information among the relevant actors.

Member  States  shall  review  these  contingency  plans  as  appropriate,  particularly  in
the  light  of  changes  in  the  organisation  of  the  control  services  and  of  experience,
including experience gained in simulation exercises.

Where necessary, guidelines may be issued to harmonise those contingency plans in
accordance  with  the  procedure  referred  to  in  Article  62(3),  ensuring  that  such
contingency  plans  are  compatible  with  the  general  plan  for  crisis  management
referred to in Article 55 of Regulation (EC) No 178/2002. These guidelines shall also
indicate  the  role  of  stakeholders  in  the  establishment  and  operation  of  the
contingency plans.

Chapter V: Controls on the introduction of feed and food from
third countries

Article 14
Controls on feed and food of animal origin

The  checks  on  feed  and  food  of  animal  origin  provided  for  in  Council  Directive  97/78/EC
shall, as appropriate, be supplemented with official controls on the verification of compliance
with aspects of feed law and food law that are not covered by that Directive, including those
aspects referred to in Articles 47 to 49 of this Regulation.

49

Article 15
Controls on feed and food of non-animal origin

1.

The competent authorities shall proceed to regular official controls of feed and food
of non-animal origin not covered by Directive 97/78/EC, imported into the territories
referred to in Annex I. These controls shall be organised using a plan established on
the basis of potential risks and shall include any aspect of feed and food law.

These controls shall take place at an appropriate place, including the point of entry of
the  goods  into  one  of  the  territories  referred to in Annex  I,  the  point  of  release  for
free  circulation,  warehouses,  the  premises  of  the  importing  feed  and  food  business
operator, or other points of the feed and food chain.

These  controls  may  also  include  checks  on  goods  that  are  placed  under  one  of  the
customs  procedures  referred  to  in  points  (b)  to  (f)  of  Article  4(16)  of  Regulation
(EEC) No 2913/92, or to be handled  in free zones or  free warehouses. Satisfactory
results of these checks do not preclude feed and food from compliance with feed and
food law at the moment of release for free circulation, and from renewed controls.

2.

The  controls  referred  to  in  paragraph  1  shall  include  at  least  a  documentary  check
and, as appropriate, an identity check and a physical check.

Physical  checks  shall  be  conducted  in  accordance  with  a  frequency  taking  into
account:

(a)

(b)

possible  risks  that  may  be  associated  with  the  different  feed  and  food
commodities;

the history of compliance with the requirements of a product, establishment of
origin,  importing  feed  or  food  business  operator,  exporting  feed  or  food
business operator, or third country;

(c)

the controls carried out by the importer;

(d)

the guarantees given by the exporting third country’s competent authority.

Physical checks may include:

(a)

checks of the means of transport;

(b)

checks on the packaging;

(c)

checks of the temperature of the products;

(d)

sampling and laboratory testing; or

(e)

any other check necessary to check compliance with feed or food law.

Physical  checks  shall  be  carried  out  under  satisfactory  conditions  and  at  a  place,
which allows investigations to be conducted  correctly, representative samples  to be
taken, and the feed and food to be handled hygienically. Samples must be handled in
such a way as to avoid altering the validity of the sample.

50

3.

In accordance with the procedure referred to in Article 62(3), a list shall be drawn up
of  feed  and  food  of  non-animal  origin,  that  on  the  basis  of  known  risks  shall  be
subject to an increased level of official controls at the point of entry into territories
referred to in Annex I. The frequency and the nature of these controls shall also be
laid down in accordance with the procedure referred to in Article 62(3).

Article 16
Points of entry and in-advance information

To the extent strictly necessary for the organisation of the controls referred to in Article 15(3)
and  for  the  controls  of  feedingstuffs,  the  Member  States  may  designate  particular  points  of
entry in their territory for the various types of feed and food products. They shall inform the
Commission and the other Member States thereof. These measures shall be designed in such a
way as to avoid unnecessary disruption of trade.

For  the  same  purpose  and  subject  to  the  same  conditions,  Member  States  may  require  feed
and food business operators responsible for the consignments to forward to them in-advance
information concerning the arrival and the nature of a consignment.

Article 17
Action in case of suspicion

Where it is suspected that feed law or food law have not been complied with or where there is
doubt as to the identity or the actual destination of the consignment, the competent authority
shall  carry  out  any  control  that  it  deems  appropriate  in  order  to  confirm  or  rule  out  the
suspicion.

The products checked shall then remain under supervision of the competent authority until the
results of the checks are obtained.

Article 18
Action following controls of feed and food from third countries

Feed  or  food  from  third  countries  not  complying  with  feed  and  food  law  may  be  seized  or
confiscated,  and  shall  be  destroyed,  submitted  to  a  special  treatment  in  accordance  with
Article  20,  or  re-dispatched  outside  the  Community  in  accordance  with  Article  21.  Where
necessary, products shall be recalled following importation.

Feed  and food  to be  destroyed, submitted  to a  special  treatment,  or  used  for  other  purposes
shall  not  give  rise  to  any  adverse  effects  on  human  and  animal  health  either  directly  or
through the environment.

Article 19
Decisions on consignments

Where a consignment of feed or food is not complying with feed or food law, the competent
authority  in  consultation  with  the  feed  or  food  business  operators  responsible  for  the
consignment  shall  take  a  decision  on  its  destination.  Such  decisions  shall  be  taken  without
unnecessary delay.

51

If the official controls provided for in Articles 14 and 15 indicate that a consignment is likely
to  have  adverse  effects  on  human  or  animal  health,  the  competent  authority  shall  seize  and
destroy  the  consignment  in  question,  or  take  any  other  appropriate  measure  necessary  to
protect human and animal health.

Feed  or  food  of  non-animal  origin  which  is  subject  to  an  increased  level  of  controls  in
accordance with Article 15(3) without being presented for official controls, shall be recalled
and seized without delay, and the competent authority shall decide either to destroy the feed
or food or to re-dispatch it in accordance with Article 21.

Where feed and food are denied introduction, the competent authority shall inform the other
Member States and the Commission of the findings and of the identification of the products
and notify its decisions to the customs services. Such decision shall be subject to the right of
appeal referred to in Article 54(3).

Article 20
Special treatments

The special treatment provided for in Article 18 may include:

(a)

(b)

bringing the products into line with the requirements of Community law, or with the
requirements  of  a  third  country  of  re-dispatch,  including  decontamination  where
appropriate;

processing  in  any  other  suitable  manner  for  purposes  other  than  animal  or  human
consumption.

The  competent  authority  shall  ensure  that  the  special  treatments  are  carried  out  under  its
control and in accordance with the procedures prescribed by it.

Article 21
Re-dispatch of consignments

In  the  case  of  re-dispatch  of  consignments  of  feed  and  food  outside  the  territories  of  the
Community, the destination of the consignments shall be agreed with the person responsible
for the load. However, a consignment shall not be re-dispatched to the third country of origin
or to another third country unless the competent authorities of the third country of destination
have  expressly  agreed  to  receive  the  consignment,  after  having  been  fully  informed  of  the
reasons for which and the circumstances under which the feed or food concerned could not be
placed on the market in the Community.

Re-dispatch  shall  take  place  within  a  maximum  time  limit  of  60 days  from  the  day  the
decision has been submitted to the feed or food business operator, where this is not precluded
by  the  results  of  the  control.  If  and  when  the  person  responsible  for  the  load  gives  his
agreement,  or  if  re-dispatch  is  found  impossible  after  60  days  on  the  basis  of  the  control
results, the consignment shall be destroyed.

Pending  re-dispatch  of  consignments  or  confirmation  of  the  reasons  for  rejection,  the
competent authorities shall keep the consignments in question under their supervision.

52

The controlling competent authority shall activate the notification procedure provided  for in
Article 50(3) of Regulation (EC) 178/2002, and further measures shall be taken as necessary
by the competent authorities co-operating in accordance with Title IV, so as to ensure that it is
not possible to reintroduce the rejected consignments into the Community.

Article 22
Costs

The  feed  or  food  business  operator  responsible  for  the  consignments  or  his  representative,
shall  be  liable  for  the  costs  incurred  in  the  process  of  a  special  treatment,  re-dispatch,
destruction or storage under supervision of the competent authority of the consignment.

Article 23
Approval of pre-export checks by third countries

1.

Specific  pre-export  checks  performed  by  a  third  country  on  feed  and  food
immediately prior to export to the Community with a view to verify that the exported
products satisfy the requirements of the Community may be approved in accordance
with the procedure referred to in Article 62(3). The approval may only apply to feed
and food originating in the third country concerned, and may be  granted for one or
more products.

Where such approval has been granted the frequency of import controls for  feed or
food  established  under  the  plan  provided  for  in  Article  15(1),  or  under  Directive
97/78/EC  for  feed  and  food  of  animal  origin,  may  be  adapted.  However,  Member
States  shall  conduct  controls  of  feed  and  food  imported  in  accordance  with  the
approval  referred  to  in  the  first  subparagraph  on  a  significant  proportion  of  the
consignments.  Such  proportions  shall  be  sufficient  to  ensure  that  the  pre-export
checks conducted by the competent authority or  control bodies of  the third country
remain effective and efficient.

2.

The approval referred to in paragraph 1 may only be granted to third countries if:

(a)

(b)

it has been shown after a Community audit that the Community requirements,
or requirements that are at least equivalent, are met;

the  controls  carried  out  by  the  third  country  prior  to  dispatch  are  considered
effective and efficient so as to replace or reduce the documentary, identity and
physical checks prescribed in Community law.

3.

The approval referred to in paragraph 1 shall specify the competent authority in the
third country under whose responsibility the pre-export checks are performed and as
necessary the control body to which such controls may have been delegated by the
central competent authority. Such delegation may only be approved when the criteria
referred to in Article 5, or equivalent conditions, are fulfilled.

The  competent  authority  and  control  body  specified  in  the  approval  shall  be
responsible for contacts with the Community.

53

4.

5.

6.

The  competent  authority  or  control  bodies  of  the  third  country  shall  draw  up,  for
each consignment checked prior to its entry into one of the territories referred to in
Annex I, an official certificate the model of which shall be specified in the approval
referred to in paragraph 1.

Where  border  controls  reveal  significant  irregularities,  Member  States  shall
immediately  inform  the  Commission  and  the  other  Member  States,  increase  the
number  of  consignments  checked  in  accordance  with  this  Article  and  where
necessary  to  allow  a  proper  analytical  examination  of  the  situation,  keep  an
appropriate number of samples under appropriate storage conditions.

In accordance with the procedure referred to in Article 62(3), the approval referred to
in paragraph 1 shall be either suspended or revoked if it is found that, in a significant
number  of  consignments,  the  goods  do  not  correspond  to  the  information  in  the
certificates issued by the competent authority or control bodies of the third country.

Article 24
Competent authorities and customs services

For the organisation of the controls referred to in this Chapter, the competent authorities and
the customs services shall work together.

With regard to consignments of feed and food of animal origin and of feed and food referred
to in Article 15(3), the customs authorities shall not allow the introduction or the handling in
free zones or free warehouses, unless proof has been supplied that controls have been carried
out with satisfactory results.

Where  samples  are  taken,  the  competent  authority  shall  inform  the  customs  services  and
indicate  whether  or  not  the  goods  can  be  released  prior  to  the  results  of  the  analysis  of  the
samples being available.

In  the  case  of  release  for  free  circulation  they  shall  work  together  in  accordance  with  the
requirements laid down in Articles 2 to 6 of Regulation (EEC) No 339/93.

Article 25
Implementing measures

1.

2.

Where  necessary  to  ensure  the  uniform  implementation  of  controls  on  the
introduction  of  feed  and  food,  measures  to  that  effect  shall  be  laid  down  in
accordance with the procedure referred to in Article 62(3).

In particular, detailed rules may be laid down for:

(a)

feed and food imported or placed under one of the customs procedures referred
to in Article 4(16)(b) to (f) of Regulation (EEC) No 2913/92 or that are to be
handled in free zones or free warehouses;

(b)

food  for  the  supply  of  the  crew  and  passengers  of  international  means  of
transport where such food does not comply with food law;

54

(c)

(d)

food  ordered  and  sent  by  mail  or  carried  by  passengers  and  crew  of
international means of transport;

specific  conditions  or  exemptions  concerning  certain  territories  referred  to  in
Article 3 of Regulation (EEC) No 2913/92, so as to take account of the natural
constraints specific to these territories;

(e)

ensuring  uniformity  of  the  decisions  taken  by  the  competent  authority  as
referred to in Article 19.

Chapter VI: Financing of official controls

Article 26
General principle

Member States shall ensure that adequate financial resources  are made available for official
controls.

Article 27
Activities subject to fees

Where the detection of non-compliance with feed and food law leads to control activities that
exceed  the  normal  monitoring  activity  of  the  competent  authority,  the  expenses  caused  by
these activities shall be charged to the  feed  and food business operators concerned by  these
additional controls. The normal monitoring activity is that required by Community or national
law  and  in  particular  that  described  in  the  plan  provided  for  in  Article  42.  Activities  that
exceed the normal monitoring activities include the taking and analysis of samples as well as
other  controls  that  are  required  to  check  the  extent  of  the  problem  and  to  verify  whether
corrective action has been taken.

In  setting  the  level  of  these  expenses,  account  shall  be  taken  of  the  principles  set  out  in
Article 28.  In  addition  to  the  publication  of  the  method  and  data  used  for  calculating  the
expenses, Member States shall adopt and publish in advance the criteria for defining control
activities  that  exceed  normal  monitoring  and  for  identifying  the  operators  concerned  by  the
expenses linked thereto.

Article 28
Level of fees

Where for the purpose of Article 26 fees are imposed to feed and food business operators, the
following principles shall apply:

(a)

the following expenses are eligible for calculating the fees:

(i)

staff salaries;

(ii)

travel and associated costs;

(iii)

laboratory and sampling costs;

55

(b)

account shall be taken of:

(i)

the interests of feed and food businesses with a small turnover;

(ii)

the level of official controls required, in relation to the quality and intensity of
the own checks already carried out by feed and food businesses;

where  in  an  establishment  several  official  control  activities  are  carried  out,  these
activities must be considered as a single activity and shall not therefore account for
multiple fees;

the  methods  and  data  used  for  the  calculation  of  the  fees  shall  be  published  or
otherwise made available to the public;

the  direct  or  indirect  refund  of  fees  regularly  collected  by  Member  States  shall  be
prohibited;  however,  the  application  of  average  fees  shall  not  be  regarded  as  an
indirect refund.

without  prejudice  to  charging  the  expenses  referred  to  in  Article  27,  the  fees  shall
replace  all  other  charges  or  fees  levied  by  the  competent  authorities  of  Member
States for the controls covered by this Regulation;

(c)

(d)

(e)

(f)

(g)

feed and food business operators shall receive proof of payment of the fees.

1.

2.

3.

4.

1.

Article 29
Fees for import controls

Member States shall collect fees for the costs incurred by the competent authority for
performing controls on imported feed, food and animals.

The  fees  are  to  be  paid  by  the  importer  or  his  customs  agent  and  charged  at  the
customs  office  responsible  for  the  border  inspection  post,  directly  at  the  border
inspection post or at the competent authority in charge of the import controls.

The  amount  of  the  fees  for  the  activities  covered  by  Directive  97/78/EC,  and
Directive 91/496/EEC is set out in Annex IV.

Other  activities  for  which  fees  shall  be  levied  and  the  amount  thereof  may  be
established in accordance with the procedure referred to in Article 62(3).

Chapter VII: Other provisions

Article 30
Official certification

Without  prejudice  to  certification  requirements  adopted  for  animal  health  or
phytosanitary  purposes,  certification  requirements  may  be  adopted  in  accordance
with the procedure referred to in Article 62(3), concerning:

(a)

the models of the certificates;

56

(b)

the qualifications of the certifying officers;

(c)

(d)

(e)

(f)

the  principles  that  are  to  be  respected  for  ensuring  reliable  certification,
including electronic certification;

the procedures to be followed in case of the withdrawal of certificates and for
replacement certificates;

consignments  that  are  split  into  smaller  consignments  or  that  are  mixed  with
other consignments.

the documents that must follow the goods after the official controls have been
carried out.

2.

Where official certification is required, it shall be ensured that:

(a)

a link exists between the certificate and the consignment;

(b)

the information in the certificate is accurate and authentic.

3.

1.

2.

Feed and food  certification requirements shall be combined where  appropriate with
other certification requirements in a single model of certificate.

Article 31
Registration/approval of feed and food business establishments

The competent authorities shall establish the procedures to be followed by feed and
food  business  operators  who  apply  for  the  registration  of  their  establishments  in
accordance  with  Regulation  (EC)  No  …/…  (on  the  hygiene  of  foodstuffs),
Regulation  (EC)  No  …/…  (laying  down  specific  hygiene  rules  for  food  of  animal
origin), or Directive 95/69/EC.

The  competent  authorities  shall  keep  up-to-date  the  list  of  the  establishments  that
have applied for registration. Where such a list already exists for  other  purposes, it
may also be used for the purposes of this Regulation.

The competent authorities shall establish procedures to be followed by feed and food
business operators who apply for the approval of their establishments in accordance
with  Regulation  (EC)  No  …/…  (on  the  hygiene  of  foodstuffs),  Regulation  (EC)
No …/… (laying down specific hygiene rules for food of animal origin, or Directive
95/69/EC.

When  receiving  an  application  for  approval  from  a  feed  or  food  business  operator,
the competent authorities shall make an on-the-spot control.

The  competent  authority  shall  approve  establishments  only  if  it  has  been
demonstrated  that  they  meet  the  relevant  requirements  of  feed  or  food  law.  The
approval shall be withdrawn if the approval conditions are no longer fulfilled. In that
event, it must be ensured that feed and food business operators cease their operations.

57

In  establishments  starting  up  their  activities,  the  competent  authority  shall  grant  an
initial approval if it appears from an on-the-spot control that all of the infrastructure
and equipment requirements are adhered to and that operational procedures such as
the HACCP system are in place.

A  final  approval  can  only  be  granted  if  it  appears  from  a  new  on-the-spot  control
carried  out  within  three  months  after  the  initial  approval  has  been  given  that  all
requirements of relevant feed and food law are complied with.

The competent authorities shall keep up-to-date the list of the establishments that are
approved and make it available for the other Member States.

TITLE III
REFERENCE LABORATORIES

Article 32
Community reference laboratories

1.

The  Community  reference  laboratories  referred  to  in  Annex  V  shall  be  responsible
for:

(a)

(b)

(c)

(d)

(e)

(f)

providing  national  reference  laboratories  with  details  of  analytical  methods,
including reference methods;

co-ordinating  the  application,  by  national  reference  laboratories,  of  the
methods referred to in (a), in particular by organising comparative testing and
by assuring an appropriate follow-up of such comparative testing in accordance
with internationally accepted protocols, when available;

co-ordinating  within  their  area  of  competence,  the  practical  arrangements
needed  to  apply  new  analytical  methods  and  informing  national  reference
laboratories of advances in this field;

conducting  initial  and  further  training  courses  for  the  benefit  of  staff  from
national reference laboratories and of experts from developing countries;

providing  scientific  and technical assistance  to  the  Commission,  especially  in
cases where the results of analyses are contested between Member States;

collaborating with laboratories responsible for analysing feed and food in third
countries.

2.

3.

Article 12(2) and (3) shall apply to the Community reference laboratories.

The Community reference laboratories shall comply with the following conditions:

(a)

they must have suitably qualified staff with adequate training in the techniques
applied to the analysis and testing of feed and food;

58

(b)

they must possess the equipment and substances needed to carry out the tasks
assigned to them;

(c)

they must have an appropriate administrative infrastructure;

(d)

they must ensure that its staff respect the confidential nature of certain subjects,
results or communications;

(e)

they must have sufficient knowledge of international standards and practices;

(f)

they must have available, if appropriate, an updated list of available reference
substances and reagents and an updated list of the manufacturers and suppliers
of such substances and reagents;

(g)

they must take into account the research activities at national and Community
level.

Other Community reference laboratories relevant to the areas referred to in Article 1
may  be  included  in  Annex  V  in  accordance  with  the  procedure  referred  to  in
Article 62(3);

Additional  responsibilities  and  tasks  for  Community  reference  laboratories  may  be
laid down in accordance with the procedure referred to in Article 62(3).

The  Community  reference  laboratories  may  be  granted  a  Community  financial
contribution in accordance with Article 28 of Council Decision 90/424/EEC36.

The Community reference laboratories may be subject to Community inspections in
order  to  verify  whether  the  requirements  laid  down  in  this  Regulation  are  being
complied with.

Paragraphs  1  to  7  shall  apply  without  prejudice  to  more  specific  rules,  and  in
particular Chapter VI of Regulation (EC) No 999/2001 and  Article  14  of  Directive
96/23/EC.

Article 33
National reference laboratories

Member  States  shall  ensure  that  one  or  more  national  reference  laboratories  are
designated for each Community reference laboratory referred to in Article 32.

These national reference laboratories shall:

(a)

(b)

collaborate  with  the  Community  reference  laboratory  in  their  area  of
competence;

co-ordinate,  within  their  area  of  competence,  the  activities  of  the  official
laboratories  responsible  for  the  analysis  of  samples  in  accordance  with
Article 11;

4.

5.

6.

7.

8.

1.

36

OJ L 224, 18.8.1990, p. 19.

59

                                                
(c) where  appropriate  organise  comparative  tests  between  the  official  national

laboratories;

(d)

(e)

(f)

ensure that the information supplied by the Community reference laboratory is
the  official  national
disseminated 
laboratories;

the  competent  authority  and 

to 

to 

assist  with  the  implementation  of  the  co-ordinated  control  plans  adopted  in
accordance with Article 53;

be responsible for carrying out other specific duties provided for in accordance
with the procedure referred to in Article 62(3).

2.

3.

4.

5.

6.

1.

2.

3.

Article 12(2) and (3) shall apply to the national reference laboratories.

Member States shall communicate the name and address of each national  reference
laboratory to the Commission, the relevant Community reference laboratory and the
other Member States.

Where  more  than  one  national  reference  laboratory  is  designated  per  Community
reference laboratory, it must be ensured that these laboratories work closely together
so  as  to  ensure  efficient  co-ordination  between  them,  with  the  other  national
laboratories and with the Community reference laboratory.

Additional responsibilities and tasks for national reference  laboratories  may  be  laid
down in accordance with the procedure referred to in Article 62(3).

Paragraphs  1  to  4  shall  apply  without  prejudice  to  more  specific  rules  and  in
particular Chapter VI of Regulation  (EC) No 999/2001 and  Article  14  of  Directive
96/23/EC.

TITLE IV
ADMINISTRATIVE ASSISTANCE AND CO-OPERATION

Article 34
General principles

Where  the  outcome  of  official  controls  requires  action  by  more  than  one  Member
State,  the  competent  authorities  of  Member  States  shall  afford  each  other
administrative assistance.

The administrative assistance shall be granted upon request, or spontaneously where
required  by  the  course  of  investigations.  Administrative  assistance  may  include,
where appropriate, participation to on-the-spot controls carried out by the competent
authority of another member State.

Articles  35  to  41  shall  not  prejudice  national  rules  applicable  to  the  release  of
documents  which  are  the  object  of,  or  are  related  to,  court  proceedings,  nor  rules
aimed at the protection of commercial interests of natural or legal persons.

60

1.

2.

3.

4.

1.

2.

3.

Article 35
Liaison body

Each Member State shall designate a single liaison body to liase as appropriate with
the liaison bodies of other Member States. The role of the liaison bodies shall be to
assist  and  co-ordinate  communication  and,  in  particular,  the  transmission  and
reception of requests for assistance.

Member States shall inform the Commission and the other Member States of all the
relevant details of their designated liaison body, and of any change that are made to
it.

The  designation  of  liaison  bodies  shall  not  preclude  direct  contacts,  exchange  of
information or co-operation between Member States' officials. Where an official of a
Member  State  contacts  an  official  of  another  Member  State  on  one  of  the  matters
referred  to  in  this  title,  he  shall  inform  at  the  same  time  the  liaison  bodies  of  both
Member  States concerned about the nature of the  contact.  He  shall  also  forward  to
the liaison bodies concerned all information that is the subject of the contact.

Where  a  liaison  body  receives  information  on  the  existence  of  a  serious  direct  or
indirect  risk  to  human  health  deriving  from  feed  or  food,  this  information  shall  be
immediately notified to the national contact point for the rapid alert system referred
to in Article 50 of Regulation (EC) No 178/2002.

Article 36
Assistance on request

Upon  receiving  a  reasoned  request,  the  requested  competent  authority  shall  ensure
that  the  requesting  competent  authority  is  provided  with  all  necessary  information
and  documents  enabling  the  latter  to  verify  compliance  with  feed  and  food  law
within its jurisdiction.

For  that  purpose,  the  competent  authority  of  the  requested  Member  State  shall
arrange  for  the  conduct  of  any  administrative  enquiries  necessary  to  obtain  such
information and documents.

The information and documents provided pursuant to paragraph 1 shall be forwarded
without delay. Documents may be transmitted in their original form or copies may be
provided.

By agreement between the requesting authority and the requested authority, officials
designated  by  the  requesting  authority  may  be  present  during  administrative
enquiries.

Such  enquiries  shall  at  all  times  be  carried  out  by  the  officials  of  the  requested
authority.  The  requesting  authority's  officials  may  not,  on  their  own  initiative,
exercise the powers of enquiry conferred on officials of the requested authority.

61

4.

1.

2.

1.

2.

3.

1.

They shall, however, have access to the same premises and documents as the latter,
through  their  intermediary,  and  for  the  sole  purpose  of  the  administrative  enquiry
being carried out.

The  officials  of  the  requesting  authority  present  in  another  Member  State  in
accordance  with paragraph  3  shall  at  all  times  be  able  to  produce  written  authority
stating their identity and their official capacity.

Article 37
Assistance without request

Where  a  competent  authority  becomes  aware  of  non-compliance  with  feed  or  food
law, and  such  non-compliance may have  implications for  another  Member  State  or
Member States, it shall pass such information to the other Member State(s) without
prior request and without delay.

The  Member  States  receiving  such  information  shall  investigate  the  matter  and
inform  the  first  Member  State  of  the  results  of  this  investigation  and  where
appropriate of the measures taken.

Article 38
Assistance in case of risks and non-compliance

If  during  an  official  control  carried  out  at  the  place  of  destination  of  the  goods  or
during  their  transport  the  competent  authority  of  the  Member  State  of  destination
establishes that the goods do not meet feed or food law requirements in such a way
as to create a risk to human or animal health or constitute a serious infringement of
feed or  food law, it shall contact the competent authorities  of  the  Member  State  of
dispatch without delay.

The  competent  authorities  of  the  Member  State  of  dispatch  shall  investigate  the
matter,  take  all  necessary  measures  and  notify  the  competent  authority  of  the
member State of destination of the nature of the investigations and official controls
carried out, the decisions taken and the reasons for such decisions.

If the competent authority of the Member State of destination has reason to believe
that  such  measures  are  inadequate,  the  competent  authorities  of  the  two  Member
States  shall  together  seek  ways  and  means  of  remedying  the  situation  including,  if
appropriate, an on-the-spot joint inspection.

Article 39
Relations with third countries

When the competent authority of a Member State receives information from a third
country, that authority shall pass that information on to the competent authorities of
the  Member  States  which  might  be  interested  in  it  and  in  any  event  to  all  those
Member States which request it.

Such  information  shall  also be communicated to  the  Commission whenever it is of
relevance at Community level.

62

2.

1.

Provided  the  third  country  has  given  a  legal  undertaking  to  provide  the  assistance
required to gather evidence of the irregular nature of transactions that are or appear
to  be  contrary  to  the  relevant  feed  and  food  law,  information  obtained  under  this
Regulation  may  be  communicated  to  that  third  country,  with  the  consent  of  the
competent  authorities  which  supplied  the  information,  in  accordance  with  laws
applying to the communication of personal data to third countries.

Article 40
Co-ordinated assistance and follow up by the Commission

The  Commission  shall  as  quickly  as  possible  co-ordinate  the  action  undertaken  by
the Member States when it, further to information received from the Member States
or  from  other  sources,  becomes  aware  of  activities  which  are,  or  appear  to  be,
contrary  to  the  food  law  or  feed  law  and  which  are  of  particular  interest  at
Community level, and in particular:

(a) where  such  activities  have,  or  might  have,  ramifications  in  several  Member

States, or

(b) where it appears that similar activities have been carried out in several Member

States.

Where official controls at destination show repeated non-compliance or other risks to
2.
humans  or  animals  from  feed  or  food,  either  directly  or  through  the  environment,  the
competent authority of the Member State of destination shall inform the Commission and the
competent authorities of the other Member States without delay.

3.

The Commission may:

(a)

send an inspection team for making an on-the-spot control:

(b)

request the competent authority of the Member State of dispatch to intensify its
official controls on the matter and to report on the action and measures taken.

Where  the  measures  provided  for  in  paragraphs  2  and  3  are  taken  to  deal  with
repeated  irregularities  by  a  feed  or  food  business,  the  competent  authority  shall
charge any expenses due by such measures to the business in question, including the
costs established by the Commission for its inspection. In the latter case, the amounts
collected  by  the  Member  State  shall  be  remitted  to  the  Commission  following  a
procedure  to  be  established  in  accordance  with  the  procedure  provided  for  in
Article 62(3).

Article 41
Disclosure of information

In  criminal proceedings, the  information forwarded under this  Chapter  can  be  used
only  with  the  prior  consent  of  the  sending  Member  State  in  accordance  with,  for
those  Member  States  who  are  parties  to  them,  the  international  conventions  and
agreements in force on mutual assistance in criminal affairs.

4.

1.

63

2.

3.

1.

2.

If  the  sending  Member  State  indicates  that  the  information  contains  data  whose
disclosure  could  undermine  the  protection  of  commercial  interests  of  a  natural  or
legal  person,  the  receiving  Member  State  shall  undertake  not  to  disclose  the
information  without  the  prior  consent  of  the  sending  Member  State.  If  it  is  not
possible  for  the  receiving  Member  State  to  give  such  undertaking,  it  shall  not  be
contrary to the terms of this Regulation for the sending Member State to withhold it.

Any  refusal to  provide information according  to the provisions  of  this  Article shall
give reasons.

TITLE V
CONTROL PLANS

Article 42
Multi-annual national control plans

For  the  implementation  of  Article  17(2)  of  Regulation  (EC)  No  178/2002  and  of
Article 45 of this Regulation, Member States shall within six months after the entry
into force of this Regulation prepare an integrated multi-annual national control plan.
National control plans shall:

(a)

(b)

be  maintained  by  the  Member  States  and  presented  to  the  Commission  upon
request; and

be  implemented  for  the  first  time  one  year  after  the  entry  into  force  of  this
Regulation at the latest.

National  control  plans  shall  contain  general  information  on  the  structure  and
organisation of the feed and food control, animal health and animal welfare systems
in the Member States and in particular on:

(a)

(b)

(c)

(d)

the  strategic  objectives  of  the  plan  and  how  these  are  reflected  in  the
prioritisation of controls and allocation of resources;

the designation of competent authorities and their tasks at central, regional and
local level, and on the resources available to these authorities;

the  general  organisation  and  management  of  official  control  systems  at
national,  regional  and  local  level,  including  official  controls  in  individual
establishments;

the  control  systems  applied  to  the  different  sectors  and  the  co-ordination
between  the  different  services  of  the  competent  authorities  in  charge  of
controlling these sectors;

(e) where appropriate, the delegation of competence to control bodies;

(f)

the  methods  to  ensure  that  operational  criteria  referred  to  in  Article 4(2)  are
met;

64

(g)

the training of control officials referred to in Article 6;

(h)

the documented procedures referred to in Articles 8 and 9;

(i)

the  organisation  and  operation  of  contingency  plans  for  disease  emergencies,
food contamination incidents and other human health risks;

(j)

the organisation of co-operation and mutual assistance.

3.

National  control  plans  may  be  adjusted  during  their  implementation.  Amendments
may be made in the light of, or in order to take account of, factors including:

(a)

new legislation;

(b)

the emergence of new diseases or other health risks;

(c)

significant changes to the structure, management or operation of the competent
national authorities;

(d)

the results of controls carried out by the Member States;

(e)

the  results  of  controls  carried  out  by  the  Commission  in  accordance  with
Article 45;

(f)

an amendment of the guidelines referred to in Article 43;

(g)

scientific findings;

(h)

the outcome of audits carried out by a third country.

Article 43
Guidelines for multi-annual national control plans

1.

The  national  control  plans  referred  to  in  Article  42(1)  shall  be  drawn  up  in
accordance with broad guidelines to be established in accordance with the procedure
referred to in Article 62(2). They shall in particular:

(a)

promote a uniform, comprehensive and integrated approach to official controls
of feed and food, animal health and animal welfare legislation, and embrace all
sectors and all stages of the food chain;

(b)

identify risk based priorities and the most effective control procedures;

(c)

identify other priorities and the most effective control procedures;

(d)

identify  the  points  in  the  production,  processing  and  distribution  of  feed  and
food  which  will  provide  the  most  reliable  and  indicative  information  about
compliance with feed and food law;

(e)

encourage the adoption of best practices at all levels of the control system;

(f)

encourage the development of effective traceability systems;

65

2.

1.

(g)

(h)

(i)

(j)

(k)

provide advice on the development of systems to record the  performance  and
results of control actions;

reflect  standards  and  recommendations  made  by  the  relevant  international
bodies regarding the organisation and operation of official services;

lay down criteria for the conduct of the audits referred to in Article 4(5);

lay down the structure of, and information to be included in, the annual reports
required in Article 44;

indicate  the  main  performance  indicators  to  be  applied  in  assessing  national
control plans.

Where  necessary,  the  guidelines shall be  adapted  in  the  light  of  the  analysis  of  the
annual  reports  submitted  by  the  Member  States  as  referred  to  in  Article 44,  or  the
audits and controls carried out by the Commission.

Article 44
Annual reports

One  year  after  starting  the  implementation  of  the  national  control  plans,  and
subsequently every year, the Member States shall submit to the Commission a report
indicating:

(a)

(b)

an update of the initial national control plan in relation to the factors referred to
in Article 42(3);

results  of  controls  and  audits  conducted  in  the  previous  year  under  the
provisions of the national control plan;

(c)

the type and number of infringements that have been established;

(d)

the  actions  to  ensure  the  effective  operation  of  the  national  control  plans,
including enforcement actions and their results.

In order to ensure a uniform presentation of this report and in particular of the results
of official controls, this information shall be drawn up in accordance with guidelines
to be adopted in accordance with the procedure referred to in Article 62(2).

This report shall be established within four months of the end of the  year to which
the report relates and shall be sent to the Commission.

2.

In  the  light  of  the  reports  referred  to  in  paragraph  1,  the  outcome  of  Commission
controls in the Member States and  any  other relevant  information,  the  Commission
shall establish a report on the overall operation of the official control systems in the
Member States. It may, where appropriate, include recommendations on:

(a)

possible improvements to the official control and audit systems in the Member
States, including their scope, management and implementation,

66

(b)

specific  control  actions  concerning  sectors  or  activities  either  covered  or  not
covered by the national control plan,

(c)

co-ordinated plans aiming at addressing issues of particular interest.

On  the  basis  of  the  conclusions  and  recommendations  contained  in  this  report,  the
national control plans and the guidelines shall, where appropriate, be adapted.

This report shall be submitted to the European Parliament and the Council.

TITLE VI
COMMUNITY ACTIVITIES

Chapter I: Community controls

Article 45
Community controls in the Member States

1.

2.

3.

Experts of  the Commission, who may  be assisted by  experts  of  the  Member  States
appointed  by  the  Commission,  shall  carry  out  general  and  specific  audits  in  the
Member  States.  The  general  audits  shall  be  organised  on  a  regular  basis  in  co-
operation with the competent  authorities in the Member States. Their main purpose
shall be to verify that the overall official control activities in the Member States are
in  accordance  with  the  national  control  plans  referred  to  in  Article  42  and  in
compliance  with  Community  law.  For  this  purpose  Member  States  shall,  upon
request, immediately make available up-to-date copies of the national  control plans
to the Commission.

The general audits may be supplemented by specific audits and inspections covering
one or more specific  areas.  These  specific  audits and inspections shall in particular
serve to:

(a)

verify the implementation of the national control plan, feed and food law and
the  animal  health  and  animal  welfare  legislation  and  may  include,  as
appropriate, on the spot inspections of the official services and of the facilities
associated with the sector being audited;

(b)

verify the functioning and organisation of the competent authorities;

(c)

investigate important or recurring problems in the Member States;

(d)

investigate emergency situations, emerging problems or  new developments in
the Member States.

The Commission shall establish, for each control carried out, a report on its findings.
This report shall, if appropriate, contain recommendations for the Member States on
the improvement of compliance with feed and food law. These reports shall be made
publicly available.

67

4.

The Commission shall establish an annual control programme, communicate it to the
Member States in advance, and report on the results thereof. This programme may be
amended to take account of developments in the feed and food safety, animal health
and plant health situation.

5.

Member States shall:

6.

1.

(a)

(b)

(c)

ensure  an  appropriate  follow-up  of  the  recommendations  resulting  from  the
Community controls;

give all necessary assistance and provide all documentation and other technical
support requested by Commission experts to enable controls to be carried out
efficiently;

ensure that the experts of the Commission have access to all premises or parts
of  premises  and  information,  including  informatics  systems,  relevant  to  the
execution of their duties.

Detailed  rules  concerning  Community  controls  in  the  Member  States  may  be
determined or amended in accordance with the procedure referred to in Article 62(3).

Article 46
Community controls in third countries

Experts of  the Commission, who may be assisted by  experts  of  the  Member  States
appointed by the Commission, may carry out  controls in third countries  in  order to
verify, on the basis of the control plans referred to in Article 47(1), either compliance
or  equivalence  of  third  country  legislation  and  systems  with  Community  feed  law
and food law, and Community animal health legislation. In doing so, account shall in
particular be taken of:

(a)

the legislation of the third country;

(b)

the organisation of the competent authority/authorities of the third country and
of  its  control  services,  of  the  powers  and  independence  of  these  services  and
the  supervision  to  which  they  are  subject,  as  well  as  the  authority  that  these
services have to enforce effectively their legislation;

(c)

the training of staff in the performance of control functions;

(d)

the resources including diagnostic facilities available to the control services;

(e)

the  existence  and  operation  of  documented  control  procedures  and  control
systems based on priorities;

(f) where  applicable,  the  situation  regarding  animal  health,  zoonoses  and  plant
health,  and  the  procedures  for  notification  to  the  Commission  services  and
relevant international bodies of outbreaks of animal and plant diseases;

(g)

the extent and  operation of controls over  imports  of  animals,  plants  and  their
products;

68

2.

3.

4.

5.

(h)

the  assurances  which  the  third  country  can  give  regarding  compliance  or
equivalence with Community requirements.

In  order  to  facilitate  the  efficiency  and  effectiveness  of  the  controls  in  a  third
country, the Commission may, in advance of carrying out such controls, request that
third  country  to  submit  a  control  plan  referred  to  in  Article  47(1)  and  where
appropriate written records on its implementation referred to in Article 47(3).

The frequency of the controls carried out by the Commission in third countries shall
be determined on the basis of:

(a)

a risk assessment of the products exported to the Community;

(b)

the provisions of Community legislation;

(c)

the volume and nature of imports from the country concerned;

(d)

(e)

(f)

(g)

(h)

(i)

the results of controls already carried out by the Commission services or other
inspection bodies;

the  results  of  import  controls  and  of  any  other  controls  performed  by  the
Member States;

information  received  from  the  European  Food  Safety  Authority  or  similar
bodies;

information  received  from  internationally  recognised  bodies  such  as  WHO,
Codex Alimentarius and the Office International des Epizooties (OIE), or from
other sources;

evidence  of  emerging  disease  situations  or  other  health  risks  that  might  have
consequences for imports of live animals, live plants or their products;

the need to  investigate  or  respond  to  emergency  situations  in  individual  third
countries.

The criteria for determining the risk for the purpose of the risk assessment referred to
in  point  (a)  shall  be  decided  in  accordance  with  the  procedure  referred  to  in
Article 62(3).

The  procedure  and  guidelines  for  controls  in  third  countries  may  be  determined  or
amended in accordance with the procedure referred to in Article 62(3).

These shall include, in particular, procedures for and guidelines on:

(a)

controls in third countries in the context of a bilateral agreement;

(b)

controls in other third countries.

If during a Community control a serious risk to humans or animals is identified, the
Commission shall immediately take the emergency measures deemed necessary and
inform the Member States thereof.

69

6.

1.

2.

3.

The Commission shall communicate its programme of controls in third countries to
the Member States in advance and report on the results thereof. This programme may
be  amended  to  take  account  of  developments  in  the  feed  and  food  safety,  animal
health and plant health situation.

Chapter II
Import conditions

Article 47
General import conditions

Imports of feed and food, animals or animal products from a third country into one of
the  territories  referred  to  in  Annex  I  shall  be  subject  to  the  notification  to  the
Commission by the third country that it has in place a control plan accessible upon
request,  which  provides  the  following  accurate  and  up-to-date  information  on  the
general  organisation  and  management  of  sanitary  control  systems  operated  by  the
competent authority of the third country:

(a)

(b)

any  sanitary  or  phyto-sanitary  regulations  adopted  or  proposed  within  its
territory;

any  control  and  inspection  procedures,  production  and  quarantine  treatment,
pesticide tolerance and food additive approval procedures, which are operated
within its territory;

(c)

risk  assessment  procedures,  factors  taken  into  consideration,  as  well  as  the
determination of the appropriate level of sanitary or phytosanitary protection;

(d) where appropriate, the follow-up given to the recommendations made pursuant

to controls referred to in Article 46.

A control plan referred to in paragraph 1 shall be proportionate and technically and
economically  feasible taking into account the  specific situation  and structure  in the
third country  and the nature of the products exported.  Its scope shall  cover  at  least
the products intended to be exported to the Community.

Imports of feed and food, animals or animal products from a  third country  into the
Community  shall  be  subject  to  the  maintenance  by  the  third  country  of  written
records on the implementation of the control plan referred to in paragraph 1.

The records on the implementation of the control plan shall indicate:

(a)

results of the domestic controls carried out under the control plan;

(b)

important  changes  which  have  been  made  to  the  original  plan  or  to  the
structure and functioning of the relevant control systems, in particular to meet
Community requirements or recommendations;

70

4.

1.

2.

3.

Guidelines specifying how the control plan and the records referred to in paragraph 3
shall be drawn up and presented to the Commission, as well as transitional measures
to  allow  third  countries  time  to  prepare  and  implement  the  control  plan  shall  be
established in accordance with the procedure referred to in Article 62(2).

Article 48
Specific import conditions

The  conditions  and  detailed  procedures  to  be  respected  when  importing  feed  and
food from third countries or regions thereof shall be established where necessary in
accordance with the procedure referred to in Article 62(3).

The conditions and detailed procedures referred to in paragraph 1 may include:

(a)

the establishment of a list of third countries from which feed and food may be
imported in one of the territories referred to in Annex I;

(b)

the establishment of models of certificates accompanying consignments;

(c)

special  import  conditions,  depending  on  the  type  of  product  and  the  possible
risks associated therewith.

Third countries shall appear on  a list referred to in point (a) of paragraph  2  only if
their competent authorities provide appropriate guarantees as regards compliance or
equivalence with Community feed and food law.

When drawing up or updating lists particular account shall be taken of:

(a)

the third country’s legislation in the sector concerned;

(b)

the structure  and  organisation  of  the  competent  authority  of  the  third  country
and  its  control  services,  as  well  as  the  powers  available  to  it/them  and  the
guarantees  that  can  be  provided  with  regard  to  the  implementation  of  the
legislation concerned;

(c)

the existence of adequate feed and food controls;

(d)

the regularity and rapidity of information supplied by the third country on the
presence of hazards in feed and food;

(e)

the guarantees given by a third country that:

(i)

conditions applied to the establishments from which feed and food  may
be  imported  in  the  Community  comply  with  or  are  equivalent  to  the
requirements in Community feed and food law;

(ii)

a list of such establishments is established and kept up-to-date;

(iii)

the  list  of  establishments  and  its  updated  versions  are  communicated  to
the Commission without delay;

71

4.

1.

2.

3.

(iv)

the establishments are the subject of regular and effective controls by the
competent authority of the third country.

In  deciding  the  import  conditions  referred  to  in  point  (c)  of  paragraph  1,  account
shall be taken of the information  submitted by  third  countries  and where necessary
the results of Community controls carried out in third countries.

These  import  conditions  may  be  established  for  each  commodity  or  group  of
commodities  and  per  third  country  or  regions  thereof,  or  for  a  group  of  third
countries.

Article 49
Equivalence

Pursuant  to  the  implementation  of  an  equivalence  agreement,  or  to  a  satisfactory
audit,  a  decision  may  be  taken,  in  accordance  with  the  procedure  referred  to  in
Article 62(3), recognising that measures in areas of feed and food law applied by a
third country or a region thereof, offer guarantees equivalent to those applied in the
Community, if the third country supplies objective proof in this respect.

The  decision  referred  to  in  paragraph  1  shall  set  out  the  conditions  governing  the
importation of feed and food from that third country or region of a third country.

Those conditions may include:

(a)

the nature and content of the certificates that must accompany the products;

(b)

specific requirements applicable to importation into the Community;

(c) where  necessary, procedures for drawing  up  and  amending lists  of  regions  or

establishments from which imports are permitted.

The decision referred to in paragraph 1 shall be repealed in accordance with the same
procedure  and  without  delay  where  any  of  the  conditions  for  recognition  of
equivalence established at the time of its adoption cease to be fulfilled.

Article 50
Support for developing countries

In accordance with the procedure referred to in Article 62(3) the following measures may be
adopted for ensuring that developing countries are able to comply with the provisions of this
Regulation:

(a)

(b)

a  phased  introduction  of  the  requirement  to  present  a  control  plan  for  the  products
that are exported to the Community, and a report on the results of such plan;

assistance  on  the  establishment  of  a  control  plan,  if  necessary  by  Community
experts;

(c)

the promotion of twin projects between a developing country and a Member State;

72

(d)

(e)

(f)

1.

2.

3.

1.

the  development  of  guidelines  to  assist  developing  countries  in  organising  official
controls on the products exported to the Community;

the  sending  of  Community  experts  to  developing  countries  so  as  to  assist  in  the
organisation of official controls;

the  participation  by  control  staff  of  developing  countries  in  the  training  courses
referred to in Article 51.

Chapter III
Training of control staff

Article 51
Training of control staff

The  Commission  may  organise  training  courses  for  the  staff  of  the  competent
authorities  in  the  Member  States  responsible  for  the  controls  referred  to  in  this
Regulation.  These  training  courses  shall  serve  to  develop  a  harmonised  approach
towards  official  controls  in  the  Member  States.  They  may  include  in  particular
training on:

(a) Community feed and food law;

(b)

control  methods  and  techniques  such  as  the  auditing  of  systems  designed  by
feed and food business operators to meet feed and food law requirements;

(c)

controls to be carried out on feed and food imported into the Community;

(d)

feed and food production, processing and marketing methods and techniques.

The  training  courses  referred  to  in  paragraph  1  may  be  open  to  participants  from
third countries, in particular from developing countries.

Detailed  rules  for  the  organisation  of  training  courses  may  be  laid  down  in
accordance with the procedure referred to in Article 62(3).

Chapter IV
Other Community activities

Article 52
Third country controls in the Member States

Experts from the Commission may assist the Member States during controls carried
out  by  third  countries,  upon  request  and  in  co-operation  with  the  authorities  of  the
Member States.

73

2.

Member  States  in  whose  territory  a  control  as  referred  to  in  paragraph 1  is
undertaken  by  a  third  country  shall  inform  the  Commission  about  the  planning,
scope, documentation and  any other  relevant information  enabling the  Commission
to take part efficiently in the control.

3.

The assistance by the Commission shall serve in particular to:

(a)

clarify Community feed and food law;

(b)

provide information and data available at Community level that may be useful
for the control carried out by the third country;

(c)

ensure uniformity with regard to controls carried out by third countries.

Article 53
Co-ordinated control activities

Community co-ordinated plans may be established in accordance with the procedure referred
to in Article 62(2). These plans shall be:

(a)

(b)

1.

2.

organised annually in accordance with a programme; and

where considered necessary, organised on an ad-hoc basis in particular with a view
to establish the prevalence of hazards in feed or food.

TITLE VII
ENFORCEMENT MEASURES

Chapter I: National enforcement measures

Article 54
Action in case of non-compliance

Where non-compliance with feed law or food law is identified and depending on the
nature of the non-compliance, the competent authority shall take action to ensure that
the feed or food business operator remedies the situation.

Such action shall include, where appropriate, the following measures:

(a)

the imposition of sanitation procedures or any other corrective action deemed
necessary  to  ensure  the  safety  of  feed  and  food  or  compliance  with  feed  law
and food law;

(b)

the  restriction  or  prohibition  of  the  placing  on  the  market,  importation  or
exportation of feed and food;

(c)

the recall, withdrawal and/or destruction of feed and food;

74

(d)

the authorisation to use feed or food for other purposes;

(e)

the suspension of operation or closure of all or part of the business concerned
for an appropriate period of time;

(f)

the suspension or withdrawal of the approved status of establishments;

(g)

the measures referred to in Article 19 on consignments from third countries;

(h)

other measures deemed appropriate by the competent authority.

In deciding which action to take in accordance with the first subparagraph, account
shall be taken of the record of the feed or food business operator with regard to non-
compliance with feed or food law.

The decisions concerning the action taken by the competent authority in accordance
with paragraph 1 together with the reasons thereof, shall be notified in writing to the
feed or food business operator concerned or his representative and where appropriate
to  the  competent  authority  of  the  Member  State  of  dispatch.  The  feed  or  food
business operator shall be informed of his rights of appeal against such decisions and
of the procedure and time limits applicable.

Article 55
Penalties

Member States shall lay down the rules on  penalties  applicable to infringements of
feed  and  food  law  and  shall  take  all  measures  necessary  to  ensure  that  they  are
implemented.  The  penalties  provided  for  must  be  effective,  proportionate  and
dissuasive.  The  Member  States  shall  notify  those  provisions  and  any  subsequent
amendment to the Commission without delay.

For  the  purpose  of  paragraph  1,  the  activities  referred  to  in  Annex  VI  shall  be
criminal  offences  when  committed  intentionally  or  through  serious  negligence,
insofar as they breach rules of Community feed and food law or rules adopted by the
Member States in order to comply with such Community law.

The offences referred to in paragraph 2 and the instigation to or participation in such
offences shall, as for natural persons, be punishable by sanctions of criminal nature,
including as appropriate deprivation of liberty, and, as for legal persons, by penalties
which  shall  include  criminal  or  non-criminal  fines  and  may  include  other  penalties
such as exclusion from entitlement to public benefits or aid, temporary or permanent
disqualification  from  engaging  in  business  activities,  placing  under  judicial
supervision or a judicial winding-up order.

3.

1.

2.

3.

75

Chapter II: Community enforcement measures

Article 56
Safeguard measures

Where the Commission has evidence that there is a serious failure in the control systems of a
Member  State  and  where  such  failures  may  constitute  a  possible  and  widespread  risk  for
human  health,  animal  health  or  the  welfare  of  the  animals,  either  directly  or  through  the
environment,  the  emergency  measures  referred  to  in  Article  53  of  Regulation  (EC)
No 178/2002 may be applied.

These measures shall only be adopted after:

(a)

(b)

Community  controls  have  shown  and  reported  non–compliance  with  Community
legislation; and

the  Member  State  concerned  has  failed  to  correct  the  situation  upon  request  and
within the time limit set by the Commission.

TITLE VIII
ADAPTATION OF COMMUNITY LEGISLATION

Article 57
Amendment of Directive 89/662/EEC

In Annex A of Council Directive 89/662/EEC, Chapter I is replaced by the following:

"ANNEX A

CHAPTER I

Council  Regulation  (EC)  No  …/…  laying  down  the  animal  health  rules  governing  the
production, placing on the market and importation of products of animal origin intended for
human consumption.

Article 58
Amendment of Directive 96/23/EC

In Article 30 of Directive 96/23/EC, the part of paragraph 1 beginning "Where such additional
checks  demonstrate…"  and  ending  "…or  to  use  it  for  other  purposes  authorised  by
Community  legislation,  without  indemnity  or  compensation",  is  replaced  by  the  following
text:

"Where  checks  demonstrate  the  presence  of  unauthorised  substances  or  products  or  when
maximum  limits  have  been  exceeded,  the  provisions  of  Articles  18  to  22  of  Regulation
(EC) No …/… (on official feed and food controls) shall apply. "

76

Article 59
Amendment of Directive 97/78/EC

1.

Article 1 of Directive 97/78/EC is replaced by the following text:

"Veterinary  checks  on  products  from  third  countries  introduced  into  one  of  the
territories listed in Annex I shall be carried out by Member States in accordance with
this  Directive  and  with  Regulation  (EC)  No  …./….  on  official  feed  and  food
controls".

2.

Article 2, paragraph 2(a) is replaced by the following text:

"(a)

"products"  means  the  products  of  animal  origin  referred  to  in  Directives
89/662/EEC  and  90/425/EEC,  and  in  Regulation  (EC)  No  1774/2002  laying
down  health  rules  concerning  animal  by-products  not  intended  for  human
consumption37; it also includes the plant products referred to in Article 19;"

In Article 7, the words "inspection fees referred to in Council Directive 85/73/EEC
of 29 January 1985 on the financing of veterinary inspections and  controls covered
by Directives 89/662/EEC, 90/425/EEC, 90/675/EEC and 91/496/EEC (amended and
consolidated)"  are  replaced  by:  "inspection  fees  referred  to  in  Regulation  (EC)
No …/… on official feed and food controls".

In Article 10, paragraph 1 point (b), the following words are deleted : "or, in the case
of  establishments  approved  in  accordance  with  Council  Decision  95/408/EC  of
22 June  1995  on  the  conditions  for  drawing  up,  for  an  interim  period,  provisional
lists  of  third  country  establishments  from  which  Member  States  are  authorised  to
import  certain  products  of  animal  origin, fishery  products  or  live  bivalve  molluscs,
from  an  establishment  which  has  undergone  either  a  Community  or  a  national
inspection".

In Article 12, paragraph 9 is deleted.

In Article 15, paragraph 5 is deleted.

Article 16 is replaced by the following text:

3.

4.

5.

6.

7.

"Detailed  rules  for  the  introduction  of  products  of  animal  origin  sent  by  post  or
carried by passengers and crew of international means of transport shall be laid down
in accordance with Article 25 of Regulation (EC) No …/… on official feed and food
controls".

8.

Article 17 is replaced by the following text:

"Consignments  which  have  been  introduced  into  one  of  the  territories  of  the
Community  without  being  presented  for  veterinary  checks  in  accordance  with  the
requirements  of  Articles  3  and  4  shall  be  seized  or  confiscated,  and  handled  in
accordance with Articles 18 to 22 of Regulation (EC) No …/… on official feed and
food controls".

37

OJ L 273, 10.10.2002, p. 1.

77

                                                
9.

10.

11.

Article 21 is deleted.

Article 23 is deleted.

In  Article  24,  paragraph  1,  second  indent,  the  words  "in  accordance  with  Article
17(2) (a) and (b)" are replaced by the words "in accordance with Article 17".

Article 60
Amendment of Directive 2000/29/EC

In Directive 2000/29/EC, the following Article 27(a) is added:

"Article 27(a)

For the purpose of this Directive, Articles 42 to 46 of Regulation (EC) No …/… (on official
feed and food controls) shall apply"

Article 61
Repeal of Community acts

Directives 70/373/EEC, 85/591/EEC, 89/397/EEC, 93/99/EEC,  95/53/EC  and  96/43/EC  and
Decision 98/728/EC are repealed with effect from 1 January 2005.

However,  the  implementing  rules  adopted  on  the  basis  of  these  acts  as  listed  in  Annex  VII
shall remain in force insofar as they are not in contradiction with this Regulation, until they
are repealed or where necessary replaced by rules having the same effect adopted on the basis
of this Regulation.

Reference to the repealed acts shall be construed as references to this Regulation.

TITLE IX
GENERAL PROVISIONS

Article 62
Standing Committee procedure

1.

2.

The Commission shall be assisted by the Standing Committee on the Food Chain and
Animal  Health  instituted  by  Article  58  of  Regulation  (EC)  No  178/2002,  or  where
necessary  for  the  purpose  of  this  Regulation,  by  the  Standing  Committee  on  plant
health set up by Council Decision 76/894/EEC38.

Where reference is made to this paragraph Articles 3 and 7 of Decision 1999/468/EC
shall apply, having regard to the provisions of Article 8 thereof.

38

OJ L 340, 9.12.1976, p. 25.

78

                                                
3.

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months.

4.

The Committee shall adopt its rules of procedure.

Article 63
Implementing and transitional measures

1.

2.

Implementing and transitional measures necessary to ensure a uniform application of
this  Regulation  may  be  laid  down  in  accordance  with  the  procedure  referred  to  in
Article 62(3).

In order to take account of the specificity of Regulations (EEC) No 2092/91, (EEC)
No 2081/92 and (EEC) No 2082/92, the rules  laid down in  this Regulation  may be
adapted in accordance with the procedure referred to in Article 62(3).

Article 64
Amendment of Annexes and references to European standards

In accordance with the procedure referred to in Article 62(3), amendments may be made to:

(a)

(b)

the  Annexes  to  this  Regulation,  except  for  Annex  VI,  in  order  to  take  account  of
scientific and technological progress;

the references to the European Standards referred to in this Regulation in the event
that these references are amended by CEN.

Article 65
Community financial support

1.

The appropriations required for:

(a)

the  travel  and  subsistence  expenses  incurred  by  the  Member  State  experts
appointed by the Commission as referred to in Articles 45(1) and 46(1);

(b)

the training of control staff referred in Article 51;

(c)

the  financing  of  other  measures  necessary  to  ensure  the  application  of  this
Regulation,

shall be decided each year as a part of the budgetary procedure.

2.

The measures referred to in paragraph 1(c) shall include in particular the organisation
of  conferences,  the  establishment  of  databases,  the  publication  of  information,  the
organisation of studies, the organisation of meetings in order to prepare the sessions
of the Standing Committee on the Food Chain and Animal Health.

79

3.

A Community technical support and financial contribution for the organisation of the
activities referred to in Article 50 may be granted within the limits of the human and
financial resources available to the Commission.

TITLE X
FINAL PROVISION

Article 66
Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Communities.

It shall apply from 1 January 2005.

However, Article 55 paragraphs 2 and 3 shall apply from 1 July 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at,

For the European Parliament
The President

For the Council
The President

80

ANNEX I

TERRITORIES REFERRED TO IN ARTICLE 2(9)

The territory of the Kingdom of Belgium.

The territory of the Kingdom of Denmark with the exception of the Faroe Islands and
Greenland.

The territory of the Federal Republic of Germany.

The territory of the Kingdom of Spain with the exception of Ceuta and Melilla.

The territory of the Hellenic Republic.

The territory of the French Republic.

The territory of Ireland.

The territory of the Italian Republic.

The territory of the Grand Duchy of Luxembourg.

The territory of the Kingdom of the Netherlands in Europe.

The territory of the Portuguese Republic.

The territory of the United Kingdom of Great Britain and Northern Ireland.

The territory of the Republic of Austria.

The territory of the Republic of Finland.

The territory of the Kingdom of Sweden.

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

81

ANNEX II

THE COMPETENT AUTHORITIES

Chapter I: subject matters for the training of staff performing
official controls

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

The different control techniques such as auditing, sampling and inspection.

The control procedures.

Feed law and food law.

The different stages of production, processing and distribution, and the possible risks
for human health, and where appropriate for the health of the animals and plants and
for the environment.

Assessment of non-compliance with feed law and food law.

Hazards in animal, feed and food production.

The  Hazard  Analysis  and  Critical  Control  Point  (HACCP)  procedures  and  the
techniques for the assessment of the HACCP procedures.

Management  systems  such  as  quality  assurance  programmes  operated  by  the  feed
and food businesses and the assessment thereof in so far as these are relevant for feed
law and food law requirements.

Official certification systems.

Contingency arrangements in case of emergencies.

Legal proceedings and implications of official controls.

Examination  of  written,  documentary  material  and  other  records,  including  those
related  to  proficiency  testing,  accreditation  and  risk  assessment,  which  may  be
relevant to the assessment of compliance with feed law or food law; this may include
financial and commercial aspects.

Any other area, including animal health and animal welfare, that is deemed necessary
to ensure that official controls are carried out in accordance with this Regulation.

Chapter II: subject matters for control procedures and guidelines

1.

2.

The organisation of the competent authority and the relationship between the central
competent  authorities  and  the  authorities  to  which  the  competence  for  performing
official controls has been conferred to.

The relationship between the competent authorities and the non-governmental bodies
to which the competence for performing official controls has been delegated.

82

3.

4.

5.

6.

7.

8.

9.

10.

11.

A statement on the objectives to be achieved.

The tasks, responsibilities and duties of staff.

The control methods and techniques.

Monitoring and surveillance programmes.

Mutual assistance in case the controls require action by more than one Member State.

Action to be taken following official controls.

The co-operation with other services or departments that may have responsibilities in
the matter.

Verification of appropriateness of methods of analysis and detection tests.

Any other activity or information required for the proper functioning of the official
controls.

83

ANNEX III

CRITERIA FOR METHODS OF ANALYSIS

1.

Methods of analysis should take into account the following criteria:

(a)

accuracy;

(b)

applicability (matrix and concentration range);

(c)

limit of detection;

(d)

limit of determination;

(e)

precision;  repeatability  intra-laboratory  (within  laboratory),  reproducibility
inter-laboratory (within and between laboratories) generated from collaborative
trial  data  and  where  performance  criteria  for  analytical  methods  have  been
established,  criteria  compliance  tests,  rather  than  measurement  uncertainty
considerations;

(f)

recovery;

(g)

selectivity;

(h)

sensitivity;

(i)

(j)

linearity;

other criteria that may be selected as required.

2.

3.

4.

5.

The precision values referred to in 1(e) shall either be obtained from a collaborative
trial  which  has  been  conducted  in  accordance  with  an  internationally  recognised
protocol  on  collaborative  trials  (e.g.  ISO  5725:1994  or  the  IUPAC  International
Harmonised  Protocol)  or,  where  performance  criteria  for  analytical  methods  have
been  established,  be  based  on  criteria  compliance  tests.  The  repeatability  and
reproducibility values shall be expressed in an internationally recognised form (e.g.
the 95% confidence intervals as defined by ISO 5725:1994 or IUPAC). The results
from the collaborative trial shall be published or freely available.

Methods  of  analysis  which  are  applicable  uniformly  to  various  groups  of
commodities  should  be  given  preference  over  methods  which  apply  only  to
individual commodities.

In  situations  where  methods  of  analysis  can  only  be  validated  within  a  single
laboratory  then  they  should  be  validated  in  accordance  with  IUPAC  Harmonised
Guidelines,  or  where  performance  criteria  for  analytical  methods  have  been
established, be based on criteria compliance tests.

Methods of analysis adopted under this Regulation should be edited in the standard
layout  for  methods  of  analysis  recommended  by  the  International  Organisation  for
Standardisation.

84

ANNEX IV

FEES RELATED TO THE CONTROL OF GOODS IMPORTED INTO THE
COMMUNITY

Chapter I
Fees applicable to imported meat

The fee for  the official control  of imported meat is fixed  at a level  of € 5  per tonne,  with a
minimum amount of € 30 per consignment.

Chapter II
Fees applicable to imported fishery products

The fee for the official control of imported fishery products is fixed at a level of €5 per tonne,
with a minimum amount of € 30 per consignment. Above 100 tonnes, the minimum standard
amount of € 5 shall be reduced to:

– 

– 

€ 1,5 per additional tonne for fishery products which have undergone no preparation
other than gutting;

€ 2,5 per additional tonne of other fishery products.

Chapter III
Fees applicable to imported live animals covered by Directive
91/496/EEC

With  regard  to  animals  covered  by  Council  Directive  91/496/EEC  of  15 July  1991  laying
down the principles governing the organisation of veterinary checks on animals entering the
Community  from  third  countries  and  amending  Directives  89/662/EEC,  90/425/EEC  and
90/675/EEC1, the following applies:

1.

The fee for the control of the following species shall be at the standard rate of € 5 per
tonne live weight with a minimum amount of € 30 per consignment: bovine, porcine
and  ovine  animals,  solipeds,  poultry,  rabbits.  These  include  domestic  and  wild
species.

1

OJ L 268, 24.9.1991, p. 56.

85

                                                
2.

The  fee  for  the  control  of  other  species  is  fixed  at  the  actual  cost  of  inspection
expressed  per  animal  or  per  tonne  imported,  with  a  minimum  of  € 30  per
consignment,  it  being  understood  that  this  minimum  does  not  apply  to  imports  of
species  covered  by  Commission  Decision  97/794/EC  of  12  November  1997  laying
down certain detailed rules  for  the application of  Council  Directive  91/496/EEC as
regards veterinary checks on live animals to be imported from third countries2.

2

OJ L 323, 26.11.1997, p. 31.

86

                                                
ANNEX V

COMMUNITY REFERENCE LABORATORIES

1.

Community reference laboratory for milk and milk products

AFSSA-LERHQA
41, rue du 11 Novembre 1918
94700 Maison Alfort
France

2.

Community reference laboratories for the analysis and testing of zoonoses

The laboratories designated in accordance with

– 

– 

Directive …/… on the monitoring of zoonoses and zoonotic agents, amending
Council  Decision  90/424/EEC  and  repealing  Council  Directive  92/117/EEC1,
and

Regulation  …/…  on  the  control  of  salmonella  and  other  food-borne  zoonotic
agents  and  amending  Council  Directives  64/432/EEC,  72/462/EEC  and
90/539/EEC2.

3.

Community reference laboratory for the monitoring of marine biotoxines

The  laboratory  referred  to  in  Council  Decision  93/383/EEC  of  14 June  1993  on
reference  laboratories  for  the  monitoring  of  marine  biotoxines3,  as  amended  by
Decision 1999/312/EC4.

4.

Community reference laboratory for viruses in molluscs

The  laboratory  referred  to  in  Council  Decision  1999/313/EC  of  29 April  1999  on
reference  laboratories  for  monitoring  bacteriological  and  viral  contamination  of
bivalve molluscs5.

5.

Community reference laboratories for residues

The laboratories referred to in Annex V, Chapter 1 of Council Directive 96/23/EC of
29 April 1996 on measures to monitor certain substances and residues thereof in live
animals and  animal  products and  repealing directives  85/358/EEC and  86/469/EEC
and Decisions 89/187/EEC and 91/664/EEC6.

Community  reference  laboratory  for  transmissible  spongiform  encephalopaties
(TSEs)

The laboratory referred to in Annex X, Chapter B of Regulation (EC) No 999/2001.

COM (2001) 452, document 2001/0176 (COD).
COM (2001) 452, document 2001/0177 (COD).
OJ L 166, 8.7.1993, p. 31.
OJ L 120, 8.5.1999, p. 37.
OJ L 120, 8.5.1999, p. 40.
OJ L 125, 23.5.1996, p. 10.

87

6.

1

2

3

4

5

6

                                                
ANNEX VI

CRIMINAL OFFENCES

1.

Feedingstuffs

(a)

The use of materials whose circulation or use for animal nutrition purposes is
restricted  or  prohibited,  in  breach  of  Article  1  of  Commission  Decision
91/516/EEC of 9 September 1991 establishing a list of ingredients whose use is
prohibited  in  compound  feedingstuffs1  and  Articles  3  and  11(b)  of  Council
Directive 96/25/EC of 29  April 1996 on  the  circulation  of  feed  materials,2  or
the  use  of  which  as  feed  materials  for  the  preparation  of  compound
feedingstuffs  is  prohibited  in  breach  of  Articles  3  and  10a(3)  of  Council
Directive  79/373/EEC  of  2  April  1979  on  the  marketing  of  compound
feedingstuffs3.

(b) The  contamination  of  feedingstuffs  with  undesirable  substances  and  products
in breach of Articles 3 and 4 of Council Directive 1999/29/EC of 22 April 1999
on  the  undesirable  substances  and  products  in  animal  nutrition4  and/or  of  the
rules adopted by the Member States in order to comply with it.

(c)

The  use  of  unauthorised  or  prohibited  additives  in  feedingstuffs  in  breach  of
Article 3 of Council Directive 70/524/EEC  of  23  November  1970  concerning
additives in feedingstuffs5 and/or of the rules adopted by the Member States in
order to comply with it.

2.

BSE/TSE

(a)

The illegal handling and the placing on the market of specified risk materials in
breach of Article 8 of Regulation (EC) No 999/2001.

(b) The  feeding  to  animals  of  prohibited  products,  in  breach  of  the  prohibition

referred to in Article 7 of Regulation (EC) No 999/2001.

(c)

The use of ruminant material for the production of certain products of animal
origin, in breach of Article 9(1) and (2) of Regulation (EC) No 999/2001.

(d) The placing on the market of an animal suspect of being infected with TSE or

any product thereof in breach of Article 12 of Regulation (EC) No 999/2001.

(e)

The placing on the market of any product of an animal confirmed to be infected
with TSE in breach of Article 13 of Regulation (EC) No 999/2001.

1

2

3

4

5

OJ L 281, 9.10.1991, p. 23.
OJ L 125, 23.5.1996, p. 35.
OJ L 86, 6.4.1979, p. 30.
OJ L 4.5.1999, p. 32.
OJ L 14.12.1970, p. 1.

88

                                                
3.

Food

(a)

The contamination and placing on the market of food with substances that may
seriously  affect  human  health,  in  breach  of  the  provisions  of  Council
Regulation  (EEC)  No  315/93  of  8  February  1993  laying  down  Community
procedures for contaminants in food6.

(b) The illegal handling, illegal placing on the market and illegal use in animals of
prohibited substances in breach of the provisions of Directive 96/22/EC and/or
of the rules adopted by the Member States in order to comply with it.

(c)

The use of unauthorised or prohibited additives in food in breach of Article 2
of  European  Parliament  and  Council  Directive  No  95/2/EC  of  20  February
1995 on food additives other than colours and sweeteners7 and/or of the rules
adopted by the Member States in order to comply with it.

(d) The placing on the market of meat that has not been submitted to  the  official
controls, in breach of Regulation (EC) No …/… (laying down specific rules for
the organisation of official controls on products of animal  origin  intended  for
human consumption).

(e)

(f)

The  placing  on  the  market  of  meat  that  has  been  declared  unfit  for  human
consumption  at  post-mortem  inspection,  in  breach  of  Regulation  (EC)
No …/… (laying down specific rules for the organisation of official controls on
products of animal origin intended for human consumption.

The slaughter for human consumption of animals that have been found unfit for
human consumption at ante mortem inspection,  in  breach  of  Regulation  (EC)
No …/… (laying down specific rules for the organisation of official controls on
products of animal origin intended for human consumption).

4.

Pesticides

(a)

The  use  of  prohibited  pesticides  in  breach  of  Article  3  of  Council  Directive
79/117/EEC of  21  December  1978  prohibiting  the  placing  on  the  market  and
use of plant protection products containing certain active substances8.

(b) The  use  of  unauthorised  pesticides  in  breach  of  Articles  3  and 4  of  Council
Directive  91/414/EEC  of  15  July  1991  concerning  the  placing  of  plant
protection products on the market9.

(c)

The improper  use  of  authorised  pesticides  in  breach  of  Articles  3,  4  and 9  of
Directive 91/414/EEC.

6

7

8

9

OJ L 37, 13.2.1993, p. 1.
OJ L 91, 18.3.1995, p. 1.
OJ L 33, 8.2.1979, p. 36.
OJ L 230, 19.8.1991, p. 1.

89

                                                
(d) The improper use of materials containing pesticides in feed and food, in breach
of  Articles  3, 4, 3, and 3 of Council Directives  76/895/EEC  of  23  November
1976 relating to the fixing of maximum levels for pesticide residues in and on
fruit and vegetables10, 86/362/EEC of 24 July 1986 on the fixing of maximum
levels for pesticide  residues  in  and on  cereals11, 86/363/EEC  of  24 July  1986
on the fixing of maximum levels for pesticide residues in and on foodstuffs of
animal  origin12  and  90/642/EEC  of  27  November  1990  on  the  fixing  of
maximum  levels  for  pesticide  residues  in  and  on  certain  products  of  plant
origin, including fruit and vegetables13 respectively.

5.

Safeguard restrictions

– 

– 

Violation of a prohibition to import, export, place on the market, use or move
animals,  feed  or  foodstuff  adopted  according  to  the  provisions  laid  down  in
Article 53 of Regulation (EC) n° 178/2002.

Violation of a prohibition to import, export, place on the market, use or move
animals, feed or foodstuff adopted according to the provisions of the relevant
community feed and food legislation.

6.

Animal by-products

The illegal placing on the market, the export or the use as feed material of processed
animal protein and other processed products, in breach of the provisions laid down in
Article 19 of Regulation (EC) N° 1774/2002 of the European Parliament and of the
Council  laying  down  health  rules  concerning  animal  by-products  not  intended  for
human consumption.

7.

Animal health

(a)

The failure to notify the suspected presence of epizootic diseases in breach of:

(i) Article  3  of  Council  Directive  85/511/EEC  of  18  November  1985
introducing  Community  measures  for  the  control  of  food-and-mouth
disease14  and/or  of  the  rules  adopted  by  the  Member  States  in  order  to
comply with it;

(ii) Article  3(1)  of  Council  Directive  2001/89/EC  of  23 October  2001  on
Community measures for the control of classical swine fever15 and/or of
the rules adopted by the Member States in order to comply with it;

(iii) Article  3  of  Council  Directive  92/40/EEC  of  19  May  1992  introducing
Community  measures  for  the  control  of  avian  influenza16  and/or  of  the
rules adopted by the Member States in order to comply with it;

10

11

12

13

14

15

16

OJ L 340, 9.12.1976, p. 26.
OJ L 221, 7.8.1986, p. 37.
OJ L 221, 7.8.1986, p. 43.
OJ L 350, 14.12.1990, p. 71.
OJ L 315, 26.11.1985, p. 11.
OJ L 316, 1.12.2001, p. 5.
OJ L 167, 22.6.1992, p. 1.

90

                                                
(iv) Article  3  of  Council  Directive  92/66/EEC  of  14  July  1992  introducing
Community  measures  for  the  control  of  Newcastle  disease17,  and/or  of
the rules adopted by the Member States in order to comply with it;

(v) Article  3  of  Council  Directive  92/119/EEC  of  17  December  1992
introducing  general  Community  measures  for  the  control  of  certain
animal  diseases  and  specific  measures  relating  to  swine  vesicular
disease18,  and/or  of  the  rules  adopted  by  the  Member  States  in  order  to
comply with it;

(vi) Article  4  of  Council  Directive  93/53/EEC  of  24  June  1993  introducing
minimum Community measures for the control of fish diseases19, and/or
of the rules adopted by the Member States in order to comply with it;

(vii) Article  5(1)  of  Council  Directive  95/70/EC  of  22 December  1995
introducing  minimum  Community  measures  for  the  control  of  certain
diseases affecting bivalve molluscs20, and/or of the rules adopted by the
Member States in order to comply with it;

(viii) Article 3 of Council Directive 2000/75/EC of 20 November 2000 laying
down specific provisions for the control and eradication of bluetongue21
and/or of the rules adopted by the Member States in order to comply with
it;

(ix) Article  3(1)  of  Council  Directive  2002/60  on  African  swine  fever22,
and/or the rules adopted by the Member States in order to comply with it;

(x) Article 3 of Council Directive 92/35/EEC of 29 April 1992 laying down
control rules and measures to combat African horse sickness23, and/or the
rules adopted by the Member States in order to comply with it.

(b) The non respect of the instructions given by the competent authority in case of
a suspected or confirmed outbreak of one of the diseases referred to in Council
Directive  82/894/EEC  on  the  notification  of  animal  diseases  within  the
Community24  and/or  of  the  rules  adopted  by  the  Member  States  in  order  to
comply with it.

17

18

19

20

21

22

23

24

OJ L 260, 5.9.1992, p. 1.
OJ L 62, 15.3.1969, p. 69.
OJ L 175, 19.7.1993, p. 23.
OJ L 332, 30.12.1995, p. 33.
OJ L 327, 22.12.2000, p. 74.
OJ L 192, 20.7.2002, p. 27.
OJ L 157, 10.6.1992, p. 19.
OJ L 378, 31.12.1982, p. 58.

91

                                                
8.

Animal welfare

The causing of unnecessary and severe pain, suffering or injury to animals in breach
of

(a) Article  3 or 4 of  Council Directive 98/58/EC  of  20 July  1998  concerning  the

protection of animals kept for farming purposes25;

(b) Article 3 or 4 of Council Directive 91/629/EEC of 19 November 1991 laying
down  minimum  standards  for  the  protection  of  calves26,  as  last  amended  by
Commission Decision 97/182/EC27;

(c) Article  3  or  4  (1)  of  Council  Directive  91/630/EEC  of  19  November  1991
laying down minimum standards for  the  protection  of pigs28, as last amended
by Commission Directive 2001/93/EC29;

(d) Article  3  of  Council  Directive  1999/74/EC  of  19  July  1999  laying  down

minimum standards for the protection of laying hens30;

(e) Article  3  (1)  of  Council  Directive  91/628/EEC  of  19  November  1991  on  the
protection  of  animals  during  transport  and  amending  Directives  90/425/EEC
and 91/496/EEC31, last amended by Council Directive 95/29/EC32;

(f) Article 3 or 5 (1) of Council Directive 93/119/EC of 22 December 1993 on the

protection of animals at the time of slaughter or killing33.

9.

Feed and food from third countries

The illegal introduction into the territory of the Community of feed and food in
breach of Articles 14, 15 and 16 of this Regulation.

25

26

27

28

29

30

31

32

33

OJ L 221, 8.8.1998, p. 23.
OJ L 340, 11.12.1991, p. 28.
OJ L 76, 24.02.1997, p. 30.
OJ L 340, 11.12.1991, p. 33.
OJ L 316, 1.12.2001, p. 36.
OJ L 203, 3.8.1999, p. 53.
OJ L 340, 11.12.1991, p. 17.
OJ L 148, 30.6.1995, p. 52.
OJ L 340, 31.12.1993, p. 21.

92

                                                
ANNEX VII

INVENTORY OF THE IMPLEMENTING RULES THAT HAVE BEEN TAKEN ON
THE BASIS OF THE DIRECTIVES REPEALED

1.

Implementing  rules  based  on  Directive  70/373/EEC  on  the  introduction  of
Community  methods  of  sampling  and  analysis  for  the  official  control  of
feedingstuffs.

(a)

(b)

(c)

(d)

(e)

(f)

First  Commission  Directive  71/250/EEC  of  15  June  1971  establishing
Community methods of analysis for the official control of feedingstuffs1.

Second Commission Directive 71/393/EEC of 18 November 1971 establishing
Community methods of analysis for the official control of feedingstuffs2.

Third  Commission  Directive  72/199/EEC  of  27  April  1972  establishing
Community methods of analysis for the official control of feedingstuffs3.

Fourth  Commission  Directive  73/46/EEC  of  5  December  1972  establishing
Community methods of analysis for the official control of feedingstuffs4.

First  Commission  Directive  76/371/EEC  of  1  March  1976  establishing
Community methods of sampling for the official control of feedingstuffs5.

Seventh  Commission  Directive  76/372/EEC  of  1  March  1976  establishing
Community methods of analysis for the official control of feedingstuffs6.

(g) Eight  Commission  Directive  78/633/EEC  of  15  June  1978  establishing
Community methods of analysis for the official control of feedingstuffs7.

(h) Ninth  Commission  Directive  81/715/EEC  of  31  July  1981  establishing
Community methods of analysis for the official control of feedingstuffs8.

(i)

(j)

Tenth  Commission  Directive  84/425/EEC  of  25  July  1984  establishing
Community methods of analysis for the official control of feedingstuffs9.

Eleventh  Commission  Directive  93/70/EEC  of  28  July  1993  establishing
Community methods of analysis for the official control of feedingstuffs10.

1

2

3

4

5

6

7

8

9

10

OJ L 155, 12.7.1971, p. 13; Directive as last amended by Directive 1999/27/EC (OJ L 118, 6.5.1999,
p. 36).
OJ  L  279,  20.12.1971, p.  7.  Directive  as  last  amended  by  Directive  98/64/EC  (OJ  L  257,  19.9.1998,
p. 14).
OJ L 123, 29.05.1972, p. 6. Directive as last amended by Directive 1999/79/EC (OJ L 209, 7.8.1999,
p. 23).
OJ  L  83,  30.3.1973,  p. 21.  Directive  as  last  amended  by  Directive  1999/27/EC  (OJ  L  118,  6.5.1999,
p. 36).
OJ L 102, 15.4.1976, p. 1. Directive  as  amended  by  the  Agreement  on  the  European  Economic  Area
(OJ L 1, 3.1.1994, p. 220).
OJ L 102, 15.4.1976. Directive as last amended by Directive 94/14/EC (OJ L 94, 13.4.1994, p. 30).
OJ L 206, 29.7.1978. Directive as last amended by Directive 84/4/EEC (OJ L 15, 18.1.1984, p. 28).
OJ L 257, 10.9.1981, p. 38. Directive as amended by the Agreement on the European Economic Area.
OJ L 238, 6.9.1984, p. 34.
OJ L 234, 17.9.1993, p. 17.

93

                                                
(k) Twelfth  Commission  Directive  93/117/EC  of  17  December  1993  establishing
Community methods of analysis for the official control of feedingstuffs11.

(l)

Commission Directive 98/64/EC of 3 September 1998 establishing Community
methods of analysis for the determination of amino-acids, crude oils and fats,
and olaquindox in feedingstuffs and amending Directive 71/39312.

(m) Commission Directive 98/88/EC of 13 November 1998 establishing guidelines
for  the  microscopic  identification  and  estimation  of  constituents  of  animal
origin for the official control of feedingstuffs13.

(n) Commission Directive 1999/27/EC of 20 April 1999 establishing Community
methods  of  analysis  for  the  determination  of  amprolium,  diclazuril  and
carbadox  in  feedingstuffs  and  amending  Directives  71/250/EEC,  73/46/EEC
and repealing Directive 74/203/EEC14.

(o) Commission Directive 1999/76/EC of 23 July 1999 establishing a Community
method of analysis for the determination of lasalocid sodium in feedingstuffs15.

(p) Commission  Directive  2000/45/EC  of  6  July  2000  establishing  Community
methods  of  analysis  for  the  determination  of  vitamin  A,  vitamin  E  and
tryptophan in feedingstuffs16.

(q) Directive  2002/70/EC  of  26  July  2002  establishing  requirements  for  the
determination of levels of dioxins and dioxine-like PCBs in feedingstuffs17.

2.

Implementing rules based on Directive 95/53/EC of 25 October 1995  fixing the
principles  governing  the  organisation  of  official  inspections  in  the  field  of
animal nutrition

(a) Commission  Directive  98/68/EC  of  10  September  1998  laying  down  the
standard  document  referred  to  in  Article  9(1)  of  Council  Directive  95/53/EC
and  certain  rules  for  checks  at  the  introduction  into  the  Community  of
feedingstuffs from third countries18.

(b) Commission  Recommendation  2002/214/EC  of  12  March  2002  on  the
coordinated inspection programmes in the field of animal nutrition for the year
2002 in accordance with Council Directive 95/53/EC19.

11

12

13

14

15

16

17

18

19

OJ L 329, 30.12.1993, p. 54.
OJ L 257, 19.9.1998, p. 14.
OJ L 318, 27.11.1998, p. 45.
OJ L 118, 6.5.1999, p. 36.
OJ L 207, 6.8.1999, p. 13.
OJ L 174, 13.7.2000, p. 32.
OJ L 209, 6.8.2002, p. 15.
OJ L 261, 24.9.1998, p. 32.
OJ L 70, 13.3.2002, p. 20.

94

                                                
LEGISLATIVE FINANCIAL STATEMENT

Policy area(s): Health and Consumer Protection

Activit(y/ies): Food safety, animal health, animal welfare and plant health

TITLE OF ACTION: PROPOSAL FOR REGULATION  OF THE  EUROPEAN  PARLIAMENT  AND  OF  THE

COUNCIL ON OFFICIAL FEED AND FOOD CONTROLS

1.

BUDGET LINE(S) + HEADING(S)

(cid:1)  B1-331: Other measures in the veterinary, animal welfare and public health field

(ABB code: 170402)

(cid:1)  B1-334  (new):  Feed  and  food  safety  and  related  activities  (new  ABB  code:

170407)

(cid:1)  B1-334A  (new):  Feed  and  food  safety  and  related  activities  –  administrative

expenditures (ABB code: 17010404)

(cid:1)  B5-3130B: Standardisation and approximation of legislation(ENTR) (ABB code:

020403)

(cid:1)  Support  for  developing  countries  in  the  framework  of  existing  geographical

programmes (DEV/AIDCO)

2.

OVERALL FIGURES

2.1. Total allocation for action (Part B): € 94.736 million for commitment

2.2. Period of application: the duration of the action is unlimited

2.3. Overall multiannual estimate of expenditure:

(a)

Schedule  of 
(financial intervention) (see point 6.1.1)

commitment 

appropriations/payment 

appropriations

€ million (to three decimal places)

Year
[n]

[n+1]

[n+2]

[n+3]

[n+4]

Commitments

7.236

Payments

7.236

7.736

7.786

8.061

8.061

8.061

8.061

8.061

8.061

[n+5
and
subs.
Years]
8.061

Total

47.216

8.061

47.216

95

(b) Technical  and  administrative  assistance  and  support  expenditure(see

point 6.1.2)

Commitments

7.920

7.920

7.920

7.920

7.920

7.920

47.520

Payments

7.920

7.920

7.920

7.920

7.920

7.20

47.520

Subtotal a+b

Commitments

15.156

15.156

15.981

15.981

15.981

15.981

94.736

Payments

15.156

15.156

15.981

15.981

15.981

15.981

94.736

(c) Overall  financial  impact  of  human  resources  and  other  administrative

expenditure
(see points 7.2 and 7.3)

18.844

18.844

18.844

18.844

18.844

18.844

113.064

Commitments/
payments

TOTAL a+b+c

Commitments

34.000

34.000

34.825

34.825

34.825

34.825

Payments

34.000

34.000

34.825

34.825

34.825

34.825

207.800
*

207.800
*

*

out of which an indicative amount of € 16.2 Mio is linked to external aid
programmes

2.4. Compatibility with financial programming and financial perspective

[X] Proposal is compatible with existing financial programming.
[…] Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the

financial perspective.

[…] Proposal  may 

require  application  of 

the  provisions  of 

the

Interinstitutional Agreement.

2.5. Financial impact on revenue:1

[X] Proposal  has  no  financial  implications  (involves  technical  aspects

regarding implementation of a measure)**

** where appropriate, the financial impact on revenue could be subject to a
further analysis, in particular as far as the training centre is concerned.
OR

[…] Proposal has financial impact – the effect on revenue is as follows:

(NB  All  details  and  observations  relating  to  the  method  of  calculating  the
effect on revenue should be shown in a separate annex.)

1

For further information, see separate explanatory note.

96

                                                
Budget
line

Revenue

(€ million to one decimal place)

Situation following action

[n+1]

[n+2]

[n+3]

[n+4]

[n+5]

Prior to
action
[Year
n-1]

[Year
n]

(a) Revenue in absolute terms

(b) Change in revenue

(cid:1)

(Please specify each budget line involved, adding the appropriate number of rows
to the table if there is an effect on more than one budget line.)

3.

BUDGET CHARACTERISTICS

Budget line : B1-331 (ABB 170402)

Type of
expenditure

New

EFTA
contri-
bution

Contri-
butions
from
applicant
countries

Heading in
financial
perspective

Comp

Non-diff

NO

NO

NO

No [1A]

Budget line : B1-334 (ABB 170407)

Type of
expenditure

New

EFTA
contri-
bution

Contri-
butions
from
applicant
countries

Heading in
financial
perspective

Comp

Non-diff

YES

NO

NO

No [1A]

Budget line : B1-334A (ABB 17010404)

Type of
expenditure

New

EFTA
contri-
bution

Contri-
butions
from
applicant
countries

Heading in
financial
perspective

Comp

Non-diff

YES

NO

NO

No [1A]

97

Budget line : B5-313 (ABB 020403)

Type of
expenditure

New

EFTA
contri-
bution

Contri-
butions
from
applicant
countries

Heading in
financial
perspective

Non-
comp

Diff

NO

NO

NO

No [3]

4.

5.

LEGAL BASIS

Articles 37, 95 and 152, par. 4 of the Treaty

DESCRIPTION AND GROUNDS

5.1. Need for Community intervention2

5.1.1. Objectives pursued

Recent  feed  and  food  emergencies  have  highlighted  deficiencies  in  national
control  systems.  At  the  heart  of  the  problem  is  the  lack  of  a  harmonised
Community  approach  to  the  design  and  developments  of  national  control
systems.  The  White  Paper  on  Food  Safety  places  particular  emphasis  on  this
problem and clearly indicates this proposal to address the issues as one of the
most  important  actions  to  achieve  a  high  standard  of  consumer  protection
across the EU.

The present proposal is the result of a review of the existing Community rules
on  the subject, which  were  adopted  separately  for  the  animal  feed  sector,  the
food  sector  and  the  veterinary  sector.  It  lays  down  uniform  procedures  to  be
respected  by  the  competent  authorities  responsible  for  carrying  out  official
controls as well as the tasks of the Commission with regards to the monitoring
of  these  control  activities.  In  accordance  with  the  holistic  approach,  the
proposal applies to the entire range of activities covered by feed and food law,
which includes feed and food safety and other aspects that relate in general to
consumer  protection.  Uniform  and,  in  certain  areas,  strengthened  procedures
are also proposed for the control of feed and food imports from third countries.

In order to achieve the best results from this action, the proposal also contains
enforcement  measures,  which  include  the  imposition  of  sanctions  at  national
and  Community  level  in  accordance  with  national  and  Community  law
respectively.

2

For further information, see separate explanatory note.

98

                                                
5.1.2. Measures taken in connection with ex ante evaluation

On 12 January 2000, the Commission adopted the White Paper on Food Safety
(COM  (1999)  719  final).  This  paper  constitutes  a  360°  degrees  perspective
evaluation of the Community Food Safety Policy.

The White Paper stresses, in particular, the need for a comprehensive piece of
legislation  in  order  to  replace  the  different  control  requirements,  taking  into
account  the  general  principle  that  all  parts  of  the  feed  and  food  production
chain  must  be  subject  to  official  controls.  It  also  indicates  a  clear  need  for  a
Community  framework  of  national  control  systems,  aimed  at  improving  the
quality of feed and food controls in the European Union. In response to these
issues  the  White  Paper  sets  out  a  plan  for  a  radical  reform  of  the  food  law
based  on  a  comprehensive,  integrated  approach  ("farm  to  fork"  approach)  as
well as the establishment of a European Food Authority.

5.1.3. Measures taken following ex post evaluation

Not applicable, because it is a new action.

5.2. Action envisaged and budget intervention arrangements

Implementation of the Feed and Food Control regulation will involve seven (7)
principal  actions,  as  detailed  below.  These  concern,  in  particular,  a  new
approach  by  the  Commission  to  monitoring  the  implementation  of  relevant
Community  legislation,  and  actions  to  support  this  new  approach.  There  is  a
clear  need  for  these  actions,  which  will  improve  the  quality  of  controls  at
Community level and, consequently, raise food safety standards and provide a
high level of consumer protection across the European Union. In addition, the
implementation  of  these  actions  will  enable  food  safety  to  be  organised  in  a
more co-ordinated and integrated manner with a view to a better functioning of
the internal market.

1.

At present, Community controls in Member States and in third countries
are organised largely on a sectoral basis and are related to the mandates
the  Commission  has  in  different  sectoral  or  thematic  legislation.  The
draft  Regulation  proposes  a  new  approach  to  the  way  in  which  the
Commission,  and  in  particular  the  Food  and  Veterinary  Office  (FVO),
monitors  the  implementation  of  feed  and  food  law,  including  animal
health  and  plant  health,  by  Member  States,  and  by  third  countries
exporting feed, food, plants or animals to the EU.

99

Central  to  this  new  approach  will  be  the  requirement  that  all  Member
States and third countries (for the products they export to the EU) present
to  the  Commission  a  general  multi-annual  control  plan  that  describes
how the national authorities ensure that the requirements of Community
legislation  on  feed  and  food  safety  from  "farm  to  fork"  are  met.  In  the
case of third countries the general control plan shall form the basis of the
guarantees that produce exported to the Community meets the prescribed
requirements.  Some  of  these  third  country  plans  will  be  quite  modest
since the range of products they export to the EU is limited. On the basis
of these general multi-annual control plans the Commission will conduct,
on  a  regular  basis,  general  audits  of  the  control  activities  of  Member
States and third countries. These general audits of overall control systems
supplemented  by  inspections  of  specific  sectors  or  particular  control
points  as  considered  appropriate  will  largely  replace  the  existing
sectoral/thematic approach in both Member States and third countries.

At  present,  because  of  resource  constraints,  many  of  the  control
obligations placed on the Commission  in  the  existing  legislation  cannot
be  completely  met  following  the  current  sectoral/thematic  control
practices.  However,  the  new  approach  does  not  request  any  additional
staff  because  it  is  intended  to  enable  the  Commission  to  deploy  its
existing  resources  more  efficiently  and  effectively  by  combining  its
various control activities into one overall integrated process. It also aims
at  ensuring  that  compliance  by  national  authorities  with  all  the  main
requirements of Community legislation is regularly checked and that no
important gaps are left in the control process.

The  existing  practice  of  using  national  experts 
to  supplement
Commission expertise will be continued under the new approach. As the
scope  of  general  audits  will  be  more  far  ranging  and  will  involve  a
review  of  a wider  range of Community  legislation  it  is  likely  that  there
will  be  an  increase  in  the  number  of  national  experts  involved  on  an
annual basis.

2.

In order to achieve the objective pursued by this proposal, it will be also
necessary  to  extend  the  existing  network  of  Community  References
Laboratories  (CRLs)  operating  with  the  Community  financial  support
(see the list in Annex V of the proposal).  The experience clearly shows
that  these  laboratories  have  an  important  role  in  ensuring  scientific  and
technical support in the area of food safety and in ensuring a high level of
consumer  protection.  They  must  provide 
the  national  reference
laboratories,  for  example,  with  details  of  analytical  methods,  organise
comparative  testing,  co-ordinate  research  into  new  analytical  methods,
conduct  specialised  training  and  provide  technical  assistance  to  the
Commission.

The designation of a number (6) of new CRLs  is particularly needed in
the  sectors  of  microbiological  risks  (in  relation  to  some  emergent
problems  with  pathogenic  agents  such  as  Listeria,  E.  coli  and
Campylobacyer), feed, food contaminants, materials and articles intended
to come into contact with foodstuffs, food additives.

100

Listeria,  E.  coli  (verotoxigenic)  and  Campylobacter  are  responsible  of
important food-borne diseases with a relatively high mortality in humans
and  should  be  considered  as  a  priority  for  new  CRLs.  The  analytical
methods are quite difficult and ring tests would be necessary, especially
when there  are  problems  in  the  intracommunity  trade.  It  should  be  also
considered  that  these  zoonotic  agents  have  been  included  in  the  list  of
pathogens  and  diseases  to  be  monitored  according  to  the  new  proposal
for a Directive on the monitoring of zoonoses and zoonotic agents (COM
(2001)  452  final).  For  food  contaminants,  food  additives  and
material/articles intended to come into contact with foodstuffs, it is also
considered important to establish CRLs. In these sectors, which are very
complex, there is still a lack of methods to analyse all the substances for
which  regulations  exist.  The  CRL  will  be  requested,  in  particular,  to
provide  national 
information  on
analytical  methods,  to  assist  in  the  validation  of  analytical  methods,  to
train  the  staff  of  the  national  laboratories  in  new  methodologies,  to
ensure  a  harmonised  application  of  methods  of  analysis,  to  provide
reference materials and co-ordinate new research in the field.

laboratories  with 

the  up-to-date 

As  concerns  the  feed  sector,  and  in  particular  in  the  field  of  feed
additives  and  feed  contaminants,  there  is  also  a  need  for  a  specialised
expertise  at  Community  level  and  the  establishment  of  a  CRL  is
considered necessary as for the other sectors above indicated.

3.

Harmonisation  of  feed  and  food  controls  lead  to  an  increased  need  for
standardization  activities,  in  particular  as  concerns  the  development  of:
common  validated  analytical  methods  in  order  to  ensure  necessary
comparison of best results; sampling methods; methods for confirmation
of  test  results  and  guidance  documents  based  on  new  feed  and  food
safety  rules,  in  particular  the  HACCP  (Hazard  Analysis  and  Critical
Control Points).

The involvement of standardization bodies such as CEN should therefore
be  considered  as  another  important  point  in  the  framework  of  this  draft
proposal. European standards already today contribute to the quality and
the  safety  of  food  by  reinforcing  European  food  policy  and  legislation
(e.g.  irradiated  food  materials,  article  in  contact  with  food,  aflatoxins,
genetically  modified  organisms,  Listeria  monocytogenes,  etc.).  More
than 100 European standards have already been produced by CEN in the
food  sector  with  the  financial  contribution  of  the  Community.  For  this
work, CEN has established  several  technical  committees  which  have an
trade  federations  and  professional
active 
institutions.

liaison  with  European 

101

4.

5.

A  Country  Profile  database,  in  which  all  Community  control  activities,
including  control  plans,  reports  on  implementation,  outcome  of  general
audits, other inspections and follow up procedures, should be recorded, is
needed.  This  would  facilitate  the  integration  of  Community  control
activities  and  enable  a  comprehensive  overview  of  the  state  of
implementation  of  EU  legislation.  The  development  of  this  instrument
will also  enable  the  Commission  to  monitor  the  performance  of  control
actions as well as setting prioritisation of activities.

Training  is  a  strategic  issue  in  the  context  of  this  proposal.  The
establishment  of  a  Community  training  centre  and  the  organisation  of
training  programmes  for  officials  from  Member  States  are  particularly
needed with a view to ensuring that controls are carried out in a uniform
way  and  to  promoting  a  harmonised  approach  to  feed  and  food  safety
across  the  EU.  Community  training  programmes  will  also  make  an
important  contribution  to  improve  uniform  judgements  in  case  of
infringements. The  new Commission facilities  in  Grange/Ireland,  which
is  equipped  for  this  purpose,  as  well  as  other  facilities  available  in
Brussels  are  suitable  venues  for  the  co-ordination  and  delivery  of  the
training programmes.

However,  the  development  and  management  of  the  training  programme
would  be  a  separate  and  distinct  task  and  not  an  integral  part  of
Commission activities. It is envisaged that the provision and management
of the overall training activity will be contracted from the private sector.

The  costing  of  this  training  centre  is  provisionally  based  on  a  total
number of 300 participants annually from Member States and from third
countries  (in  particular  developing  countries).  For  the  purpose  of  this
estimate, around 15 courses of 2 weeks duration each should be provided
annually.

Moreover,  as  the  programme  develops,  it  should  be  possible  to  provide
additional  training  days  or  some  lecture  format  courses  with  larger
classes keeping within budget or at relatively little additional costs.

It  is  proposed  that  the  contracted  training  provider  develops  the
programme,  in  accordance  with  Commission  directions.  In  this  respect,
the type of training foreseen, which is of high-specialised nature, will be
directed  at  the  operation  of  official  controls  in  the  context  of
implementation  of  EU  legislation.  In  the  case  of  developing  third
countries,  specific  training  formats  will  be  developed  to  meet  specific
training requirements.

Depending  on  the  range  of  training,  it  is  foreseen  that  this  would  be
developed by a core group of 6 to 8 full-time staff who would also act as
trainers, supplemented by expert input from specialists in all fields. The
training  contractors  should  provide  the  support  services  for  language
services, administration and management of the programme.

102

The global estimated expenditures for participation, training courses and
training  materials,  language  services  (including  interpretation  and
translation  services)  as  well  as  administration  and  management  of  the
programme would amount to around € 7.5 Mio each year. It is foreseen
that  the  programme  will  be  developed  in  incremental  steps  over  a  six
year-period  on  the  supposition  that  training  will  cover  the  full  scope  of
the  feed  and  food,  animal  health  and  animal  welfare  and  plant-health
legislation.

As  programmes  will  also  require  updating  and  adjustment  following
evaluation, development is foreseen as a continuous process.

6.

The draft Regulation also foresees the possibility to deliver assistance to
developing  countries  through,  in  particular,  technical  assistance  in  the
countries  themselves,  the  promotion  of  twinning  projects  and  the
provision of training courses in the EU for officials from third countries
(this  training  could  be  combined  in  part  with  that  for  officials  from
Member States).

Moreover the draft Regulation is in line with the objectives indicated in
the  Communication  from  the  Commission  to  the  Council  and  the
European  Parliament  on  Trade  and  Development,  Assisting  developing
countries benefit from trade (COM (2002) 513 final) which put emphasis
on the international dimension of Feed and Food Safety Standards. This
Communication,  as  it  is  clearly  stated  on  page  25,  reveals  the  need  “to
reinforce  current  efforts  to  improve  developing  countries’  capacity  in
sanitary  and  phytosanitary  field,  as  compliance  with  sanitary  and
phytosanitary standards  has  emerged as one  of the  major  constraints  on
the increase of exports by developing countries to industrialised markets.
In  particular,  pursue  the  development  of  a  programme  of  action  in  the
sanitary and phytosanitary field, including a standard approach to country
assessment,  a  menu  of  possible  technical  assistance  measures  for
common  problems,  including  relevant  training  programmes,  and  the
identification of sources of additional funding and relevant expertise”.

These  activities  will  therefore  be  decided  in  the  framework  of  external
aid  programmes  and  will  focus  on  the  countries  listed  by  the
Development Aid Committee of OECD.

The  amounts  indicated  hereafter  are  only  indicative  as  they  refer  to
external aid appropriations.

7.

The  technical  and  legislative  process  (in  particular  because  of  the  large
number  of  implementation  measures  to  be  prepared  and  adopted
following  the  adoption  of  the  proposal)  will  be  largely  based  upon  the
existing staff.

However,  the  cost  of  meetings  with  relevant  experts  of  Member  States
and, where necessary, of external expertise should be taken into account.
Travelling  costs  for  such  meetings  are  reimbursed  for  one  expert  per
Member State.

103

A  total  of  five  meetings  per  year  of  the  Standing  Committee  for  Food
Chain and Animal Health (already financed under Part A of the budget)
is planned.

Twenty  meetings  of  expert  working  groups  per  year  (sectors:  feed
control,  food  control,  co-ordinated  control  programmes,  control  of
residues and contaminants, control on imports and list of third countries)
are  planned.  These  meetings  are  already  financed  under  part  A  and
should  be,  after  the  entry  into  force  of  this  draft  Regulation,  financed
under 
line,  administrative
expenditures).

the  budget  (B1-334A 

the  Part  B  of 

The  global  number  of  estimated  meetings  for  this  activity  should,
however, not increase significantly in relation to the current situation.

A number of meetings will be required to review the outcome of general
audits, the guidelines for the general control plans and the annual report
on  the  outcome  of  controls.  It  is  also  intended  to  have  more  active
dialogue  between  the  Commission  and  Member  States  and  third
countries on the results of control activities generally. It is estimated that
additional six meetings per year will be necessary for this purpose (to be
financed under the administrative expenditure under the B1-334A line ).

Some  additional  expenditure  will  be  also  required  for  certain
accompanying measures which include, in particular, the organisation of
conferences,  the  establishment  of  the  necessary  databases  and  the
publication  of  information  relating  to  feed  and  food,  animal  health,
animal welfare and plant health.

5.3. Methods of implementation

Direct  management  i.e.  technical  and  financial  approval  of  the  action  by
Commission staff.

104

6.

FINANCIAL IMPACT

6.1. Total financial impact on Part B - (over the entire programming period)

(The method of calculating the total amounts set out in the table below must be
explained by the breakdown in Table 6.2.)

6.1.1. Financial intervention

Commitments (in € million to three decimal places)

Breakdown

[Year
n]

[n+1]

[n+2]

[n+3]

[n+4]

[n+5
and
subs.
Years]

Total

Existing Community
Ref. Lab. (currently
financed under B1-331,
to be financed under B1-
334, 170407)
(Art. 34)
New Community Ref.
Laboratories (new to be
financed under B1-334,
170407) (Art. 34)
Country profile database
to current FVO database
(MIS 24 – system) (part
of the costs are currently
financed under B5-100,
to be financed under
budget line B1-334,
170407)
Expenses for national
experts participating in
FVO missions (currently
financed under B5-100,
to be financed under
budget line B1-334,
170407)
(Art. 48, 49 and 69)
Standardisation of
methods of analysis
(currently financed by
ENTR under budget line
B5-3130B, 020403)
Support for developing
countries – twin
projects* (Art. 54)
Support for developing
countries – technical
assistance on-the-spot*
Art. 54

2.661

2.661

2.661

2.661

2.661

2.661

15.966

0.500

1.000

1.500

1.500

1.500

1.500

7.500

0.375

0.375

0.200

0.200

0.200

0.200

1.550

0.500

0.500

0.500

0.500

0.500

0.500

3.000

0.500

0.500

0.500

0.500

0.500

0.500

3.000

2.500

2.500

2.500

2.500

2.500

2.500

15.000

0.200

0.200

0.200

0.200

0.200

0.200

1.200

TOTAL

7.236

7.736

8.061

8.061

8.061

8.061

47.216

*

these  amounts  are  only  indicative  as  they  refer  to  external  aid  actions  within  the
geographical programmes

105

6.1.2.

Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure
(commitment appropriations)

New – to be financed
under B1-334A

[Year
n]

[n+1]

[n+2]

[n+3]

[n+4]

[n+5
and
subs.
Years]

Total

1) Technical and
administrative assistance
a) Technical assistance
offices – Training Centre
(Art. 53 et 54) budget
line
B1-334A, 17010404)

b) Other technical and
administrative assistance:
- intra muros:
- extra muros
of which for construction
and maintenance of
computerised
management systems

Subtotal 1

2) Support expenditure
a) Studies/Conferences
b) Meetings of experts
c) Information and
publications

Subtotal 2
TOTAL

7.500

7.500

7.500

7.500

7.500

7.500

45.000

0.100
0.270

0.050

0.420
7.920

0.100
0.270

0.050

0.420
7.920

0.100
0.270

0.050

0.420
7.920

0.100
0.270

0.050

0.420
7.920

0.100
0.270

0.050

0.420
7.920

0.100
0.270

0.050

0.420
7.920

0.600
1.620

0.300

2.520
47.520

106

6.2. Calculation 

of 

costs 

by  measure 

envisaged 

in 

Part  B

(over the entire programming period)1

(Where  there  is  more  than  one  action  give  sufficient  detail  of  the  specific
measures to be taken for each one to allow the volume and costs of the outputs
to be estimated.)

Commitments (in € million to three decimal places)

Type
of outputs
(projects, files )

1

Laboratories

Number of
outputs

(total for years
1…. n)

Average unit
cost

Total cost

(total for years
1…n)

2

60

3

0.266

4=(2X3)

15.966

Laboratories

30

0.250

7.500

Participants

1800

0.025

7.500

Country

Analysis

Experts

Projects

Missions

UE +200 third
countries

30

30

0.500

0.040

1.550

3.000

3.000

15.000

1.200

Breakdown

Existing Community
Reference Laboratories
(currently financed under
B1-331, to be financed
under B1-334, 170407)

(See annex V of Feed and
Food Regulation : CRL
milk, zoonoses,
salmonella, marine
biotoxins, bivalve
molluscs, TSE, 4 CRL on
residues)

Community Reference
Laboratories (new to be
financed under B1-334,
170407)

(micro-biological risks
such Listeria and E.Coli ,
food contaminants, food
additives, feed, contact
material, …)

Training programmes
(budget line : B1-334A,
17010404)

Country Profile database
(B1-334, 170407)

Standardisation of methods
of analysis (B5-3130B,
020403)

Expenses for national
experts participating in
FVO missions (budget line
B1-334, 170407)
(Art. 48, 49 and 69)

Support for developing
countries – twin projects

Support for developing
countries – technical
assistance on-the-spot

1

For further information, see separate explanatory note.

107

                                                
7.

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

7.1.

Impact on human resources

Types of post

Officials or
temporary
staff

A

B

C

Other human
resources

Total

Staff to be assigned to
management of the action using
existing additional resources

Number of
permanent
posts

107

6

36

149

Number of
temporary
posts

11

11

Total

118*

6*

36*

0

160*

*

out of which staff for FVO : 107A , 6B, 36C (in total 149)

7.2. Overall financial impact of human resources

Description of tasks
deriving from the action

If necessary, a fuller
description of the tasks
may be annexed.

Type of human resources

Officials

Temporary staff

Other human resources

(specify budget line)

Amount (€)

16.092.000

1.188.000

Method of calculation *

149 x 108.000

11 x 108.000

Total

17.280.000

The amounts are total expenditure for twelve months.

The needs for human and administrative resources shall be covered within the
allocation  granted  to  the  managing  DG  in  the  framework  of  the  annual
allocation procedure.

108

7.3. Other administrative expenditure deriving from the action

Amount €

Method of calculation

1.512.000

52.000

Equivalent  of  225  missions  per
year (new approach may involve
some  consolidation  of  missions
per
using  more 
mission)

inspectors 

5  meetings/year  x  10.400€  =
52.000

Budget line

(number and heading)

Overall allocation (Title A7)

A0701 – Missions

A07030 – Meetings

A07031 – Compulsory
committees1
A07032 – Non-compulsory
committees1
A07040 – Conferences

A0705 – Studies and
consultations

Other expenditure (specify)

Information systems
(A-5001/A-4300)

Other expenditure - Part A
(specify)

Total

1.564.000

The amounts are total expenditure for twelve months.

1 Regulatory Committee (Standing Committee Food Chain and Animal Health)

I.

II.

III.

Annual total (7.2 + 7.3)

Duration of action

Total cost of action (I x II)

8.

FOLLOW-UP AND EVALUATION

8.1. Follow-up arrangements

18.844.000 €

illimited

€

The  Commission  will  constantly  monitor  the  implementation  of  this  action.
According to Article 46 of the proposal, Member States are requested to submit
every  year  a  report  with  the  main  information  on  the  implementation  of
national control plans. The Commission shall assess the information provided
by  member  States  as  well  as  the  outcome  of  Commission  controls  in  the
Member States and establish a report on the overall operation of official control
systems  in the Member  States.  This report will  be  submitted  to  the  European
Parliament and the Council.

The  Commission  will  also  evaluate  the  outcome  of  Community  controls  in
third countries and report on the results thereof (Article 49).

Appropriate procedures are already in place for evaluating the yearly technical
work-programmes  of 
the  existing  Community  Reference  Laboratories.
Estimated costs are normally evaluated between the Commission services and
the relevant CRL; they are revised if necessary, before a Commission decision
is adopted each year. The same procedures will be followed for new designed
CRLs.

109

Appropriate  procedures  will  be  also  established  for  evaluating  Community
programmes concerning  training  and  assistance for developing  countries.  The
FVO will have an important role in ensuring the organisation, the management
and adequate follow-up information on the inputs, outputs and results of these
programmes.

8.2. Arrangements and schedule for the planned evaluation

The Commission has to consider yearly the effectiveness of the feed and food
control system through wide sources of information, in particular from reports
and documentary evaluations indicated above in point 8.1.

9.

ANTI-FRAUD MEASURES

DG  SANCO  currently  enforces  appropriate  measures,  including  controls  and
inspection, in order to prevent risk of fraud or irregularities concerning Community
expenditures.

In  this  context,  also  OLAF  may  intervene  on  its  own  initiative  or  following
information from different sources.

110

IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE
TO SMALL AND MEDIUM-SIZED ENTERPRISES( SMEs)

TITLE OF PROPOSAL

Regulation of the European Parliament and of the Council on official feed and food controls

DOCUMENT REFERENCE NUMBER

SANCO/ 1420/2002 REV 1 - COM (2003) 52 Final

THE PROPOSAL

1.

Taking  account  of  the  principle  of  subsidiarity,  why  is  Community  legislation
necessary in this area and what are its main aims?

The  proposal  is  contained  in  the  action  programme  in  the  Annex  to  the
Commission’s  White  Paper  on  Food  Safety.  The  proposal  aims  to  establish  a
Community framework of national and Community control systems by merging and
completing  the  existing  Community  rules  for  national  controls  and  Community
controls within the European Union, at the borders and in third countries.

This proposal lays down at Community  level  the  general  principles  to be respected
by  the  competent  authorities  in  the  Member  States  for  the  performance  of  official
feed and  food controls and their follow up as well as the  tasks of  the  Commission.
The  new  system  of  official  control,  according  to  the  stable  to  table  approach,  will
cover  all  sectors  of  the  food  chain,  including  feed  production  and  animal  feeding,
primary production, food processing, storage and distribution. Feed and food from a
third  country  to  be  introduced  in  the  territory  of  the  European  Union  shall  be
submitted to official control prior to the release of feed and food for free circulation.

The harmonisation of control systems at Community level will guarantee a better and
equal protection of consumers all around Europe and, besides, a smooth functioning
of  the  internal  market.  All  the  interested  parties  agrees  that  this  harmonisation  is
needed.

THE IMPACT ON BUSINESS

2.

Who will be affected by the proposal?

– 

which sectors of business

All feed and food businesses along the entire food chain - including businesses
involved  in  feed  production  and  animal  feeding,  primary  production,  food
processing, storage, transport, distribution, retail level, importers and exporters
-  will  be  affected  by  this  proposal  due  to  the  fact  that  they  are  the  targets  of
official controls.

111

– 

– 

which sizes of business (what is the concentration of small and medium-sized
firms)

All sizes of businesses are affected, including a large proportion of small and
medium-sized firms.

are  there  particular  geographical  areas  of  the  Community  where  these
businesses are found

Businesses in the feed and food sectors are broadly distributed in all Member
States, therefore the proposal has a similar impact over the entire Community
and it is not aimed at any particular geographical area.

3.

What will business have to do to comply with the proposal?

The proposal is mainly addressed to competent authorities in the Member States. It is
their  task  to  organise  official  controls  in  order  to  verify  whether  feed  and  food
businesses uphold their responsibilities and to monitor the correct application of feed
and food legislation by these businesses at all stages of the feed and food chain.

As a consequence of this, feed and food businesses will be subject to regular controls
by  the  competent  authorities  in  the  Member  States.  This  creates  a  situation  where
feed  and  food  business  operators  have  to  assume  their  responsibility  in  the
implementation and enforcement of the requirements of food law and have to ensure
the safety and wholesomeness of products for which they are responsible.

Where  non-compliance,  including  frauds,  infringements,  irregularities  or  any  other
failure,  is  identified  and  depending  on  the  nature  there-of,  food  business  operators
shall be requested by the competent authorities in the Member States to remedy the
situation.  Depending  on  the  results  of  control  activities,  where  necessary,  food
businesses shall be subjected to appropriate measures and sanctions.

The  competent  authorities  in  the  Member  States  may  subject  feed  and  food
businesses to the levying of fees for costs incurring for certain control activities. This
is  to  ensure  that  adequate  financial  resources  are  made  available  for  organising
national  official feed and  food controls.  As a matter of subsidiarity,  it  is left to  the
Member States to define what activities are subject to fees.

4.

What economic effects is the proposal likely to have?

– 

on employment

The  effect  of  the  proposal  on  employment  is  expected  to  be  more  or  less
neutral.

112

– 

on investment and the creation of new businesses

Rules  for  the  organisation  of  official  feed  and  food  controls  already  apply  at
present.  This  proposal  aims  to  a  better  harmonisation  and  to  establish  an
effective  and  consistent  Community  framework  of  national  official  control
systems  for  ensuring  protection  of  consumer  health  and  safety  and  equal
requirements of feed and food businesses. It is not expected that the proposed
rules will create extra investments or the creation of new businesses.

– 

on the competitiveness of businesses

Beside  a  higher  level  of consumer protection, quality  official  control  systems
will  make  an  effective  contribution  to  the  functioning  of  the  internal  market
and  to  the  improvement  of  business  competitiveness.  At  present,  businesses
that  do  not  respect  the  same  standards  for  the  protection  of  consumer  health
and safety might have an unfair advantage over those that do.

An  effective  implementation  of  official  control  systems  at  national  and
Community level will reduce such unfair competition between businesses both
within the internal market and in the context of international trade. The whole
business sector could also gain a marketing advantage in terms of the increased
confidence  by  consumers  as  a  result  of  the  improvement  in  official  control
activities.

5.

Does the proposal contain measures to take account of the specific situation of small
and medium-sized firms (reduced or different requirements etc)?

This  proposal  follows  a  horizontal  approach  and  its  provisions  are  of  general
application. Therefore, it does not contain measures specifically aimed at or adapted
for small and medium-sized firms.

It  is  mainly  addressed  to  the  Member  States  which  have  the  task  of  organising
official  controls  in  order  to  verify  and  monitor  the  correct  application  of  feed  and
food legislation by businesses at all stages of the feed and food chain.

CONSULTATION

6.

List the organisations which have been consulted about the proposal and outline their
main views.

A  broad  consultation  with  Member  States  and 
the  relevant  organisations
representative  of  social  and  economic  parties  has  been  carried  out.  Most  of  the
comments received as a result of this consultation have been taken into consideration
in the framework of this proposal.

An ad-hoc meeting of the Advisory Committee  has been  held  to  discuss  the mayor
issues  in  relation  with  the  new  official  feed  and  food  control  system.  Many  of  the
organisations  consulted  within  the  Advisory  Committee  have  confirmed  their
position on written.

113

List of organisation that participated at the meeting:

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

Bureau Européen des Unions des Consommateurs (BEUC)

European Community of Consumer Co-operatives (EUROCOOP);

Federation of Veterinarians in Europe (FVE)

Committee  of  Agricultural  Co-operation 
(COPE/COGECA)

in 

the  European  Union

EUROCOMMERCE

European Livestock and Meat Trading Union (UECBV)

Association of Poultry Processors and Poultry Import and Export Trade in the
European Union (AVEC)

Confédération Internationale de la Boucherie et de la Charcuterie (CIBS)

European  Association  of  Craft,  Small  and  Medium  Sized  Enterprises
(EUAPME)

European Dairy Association (EDA)

Confédération des Industries Agroalimentaires de la CEE (CIAA)

Fédération Européenne des Fabricants d’Aliments Composés (FEFAC)

Union  Européenne  du  Commerce  de  Gros  des  Produits  Laitiers  et  Dérivés
(EUCOLAIT)

Fédération  Européenne  de  l’Industrie  des  Aliments  pour  Animaux  Familiers
(FEDIAF)

Fédération Européenne de l’Industrie de la Santé Animale (FEDESA)

Fédération Européenne des Fabricants d’Adjuvants pour la Nutrition Animale
(FEFANA)

Liaison Centre for the Meat Processing Industry in the EU (CLITRAVI)

Comité du Commerce des Céréales et des Aliments du Bétail auprès de la CEE
(COCERAL)

Eurogroup for animal welfare.

The main conclusions of this consultation are as follow:

– 

General  endorsement  of  all  organisation  for  the  proposal  and  for  most  of  the
principles  underlying  it.  The  new  concept  of  national  control  plans  was
particularly welcomed.

114

– 

– 

– 

– 

– 

– 

– 

Representatives  of  the  feed  and  food  production,  processing  and  distribution
sectors stressed that in carrying  out official controls, account should be  taken
of  the  results  of  the  own  checks  already  carried  out  by  the  feed  and  food
businesses.

Concerning  imports,  representatives  of  the  feed  and  food  production,
processing  and  distribution  sectors  expressed  concern  about 
the  cost
implications for the destruction,  re-dispatch  or  storage  of  consignments  when
non-compliance is found at import.

Concerning the laboratory tests, certain organisations requested to have access
to  the  same  laboratory,  testing  methods  and  reference  materials  as  the
competent authorities. They also request that a counter sample should be made
available to them in order to safeguard their interests.

Concerning inspection fees, certain groups stressed that official controls should
be financed from national budget and not from fees imposed on feed and food
businesses.  Other  groups  insisted  that  the  fees  imposed  to  them  should  be
balanced  so  as  not  to  create  excessive  burdens  on  small  businesses.  One
consumer  organisation  cautions  against  consumers  ending  up  paying  higher
food prices when a system of fees is imposed.

Some  organisation  expressed  concern  about  possible  consequences  for  third
countries,  in  particular  on  the  need  to  present  control  plan.  From  their  part,
consumers  welcomed  the  proposal  on  the  issue  of  assistance  for  developing
countries.

Certain  organisations  stressed  the  need  to  create  a  transparent  situation  with
regard to standards to be respected by third countries when exporting feed and
food to the Community.

Representatives  of  the  feed  and  food  production,  processing  and  distribution
sectors stressed the need to be kept informed about the results of national and
Community controls.

115