Report from the Commission to the Council and the European Parliament on the experience gained from the application of the hygiene Regulations (EC) No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 {SEC(2009) 1079}
Date: 2009-07-28
Institutions: European Commission
Subjects: activity report, food contamination, food hygiene, food inspection, food technology, foodstuff, foodstuffs legislation, health control, water

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 28.7.2009 
COM(2009) 403 final 

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

on the experience gained from the application of the hygiene Regulations (EC) 
No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and 
of the Council of 29 April 2004 

{SEC(2009) 1079} 

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TABLE OF CONTENTS 

1. 

2. 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

3.5. 

3.6. 

3.7. 

3.8. 

3.9. 

EXECUTIVE SUMMARY.......................................................................................... 3 

BACKGROUND.......................................................................................................... 4 

EXPERIENCE GAINED SINCE 1 JANUARY 2006................................................. 4 

Overall experience ....................................................................................................... 4 

Scope ............................................................................................................................ 5 

Definitions.................................................................................................................... 5 

Primary production....................................................................................................... 5 

HACCP ........................................................................................................................ 6 

Registration and approval procedures.......................................................................... 7 

Health and identification marking................................................................................ 7 

Guides to good practice................................................................................................ 8 

Flexibility ..................................................................................................................... 8 

3.10. 

Imports ......................................................................................................................... 9 

3.11.  Official controls in relation to products of animal origin ............................................ 9 

3.12.  Microbiological criteria.............................................................................................. 10 

3.13.  Removal of surface contamination............................................................................. 10 

3.14. 

Food Chain Information (FCI) ................................................................................... 10 

3.15. 

Emergency slaughter.................................................................................................. 11 

4. 

CONCLUSIONS........................................................................................................ 11 

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1. 

EXECUTIVE SUMMARY 

Article  16  of  Regulation  (EC)  No  852/20041,  Article  14  of  Regulation  (EC)  No 
853/20042  and  Article  21  of  Regulation  (EC)  No  854/20043  contain  the  legal 
requirement for the Commission to submit a report to the European Parliament and to 
the  Council,  reviewing  the  experience  gained  from  their  application  and,  if 
appropriate, accompanying the report with relevant proposals, not later than 20 May 
2009.  In  addition,  Regulation  (EC)  No  852/2004  requires  the  Commission  to 
consider  if  it  is  desirable  and  practicable  to  extend  the  Hazard  Analysis  Critical 
Control  Point  (HACCP)  requirements  to  food  business  operators  in  the  primary 
production area. 

The  present  report  followed  a  thorough  consultation  process.  It  is  based  on 
information  received  from  the  competent  authorities  in  the  Member  States, 
representatives  of  the  food  business  operator  and  consumer  organisations  at 
European level, and the Commission's Food and Veterinary Office. 

The  report  aims  at  presenting  factually  the  experience  gained,  including  the 
difficulties  encountered,  in  2006,  2007  and  2008  from  the  implementation  of  the 
hygiene package by all interested actors. 

The  report  concludes  that  overall  Member  States  have  taken  the  necessary 
administrative and control steps to ensure compliance but that there is still room for 
improvement in relation to implementation. These conclusions are supported by the 
findings  of  audits  and  inspections  carried  out  by  the  Commission's  Food  and 
Veterinary  Office.  Consulted  stakeholders  consider  that  the  new  principles  and 
requirements introduced by the hygiene package have had a positive impact. It also 
indicates the clear position expressed by the Member States and private stakeholders 
not  to  extend  at  present  the  requirement  for  HACCP-based  procedures  to  food 
business operators carrying out primary production. 

The main difficulties identified are in relation to certain exemptions from the scope 
of the hygiene Regulations, certain definitions laid down in the Regulations and the 
procedure  for  adapting  those  definitions,  certain  practical  aspects  concerning  the 
approval of establishments handling foods of animal origin and the marking of such 
foods,  the  import  regime  for  certain  foods,  the  implementation  of  HACCP-based 
procedures in certain food businesses and the implementation of official controls in 
certain sectors. 

This report does not suggest any detailed solutions to the difficulties reported and is, 
therefore,  not  accompanied  by  proposals.  However,  on  the  basis  of  the  difficulties 
identified, the Commission will consider the need for any proposals to improve the 
food hygiene package. 

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OJ  L  139,  30.4.2004,  p.  1.  Regulation  as  last  amended  by  Regulation  (EC)  1019/2008  (OJ  L  277, 
18.10.2008, p. 7). 
OJ  L  226,  25.6.2004,  p.  22.  Regulation  as  last  amended  by  Regulation  (EC)  1020/2008  (OJ  L  277, 
18.10.2008, p. 8). 
OJ  L  226,  25.6.2004,  p.  83.  Regulation  as  last  amended  by  Regulation  (EC)  1021/2008  (OJ  L  277, 
18.10.2008, p. 15). 

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The  report  is  accompanied  by  a  staff  working  document  (SWD)  where  Annexes 
referred to in the report can be found. Annex I of this accompanying document sets 
down the abbreviations and technical terms used in the report. 

2. 

BACKGROUND 

On  29  April  2004,  the  European  Parliament  and  the  Council  adopted  the  "food 
hygiene package". It comprises three basic Acts, Regulations (EC) No 852/2004 and 
853/2004,  addressed  to  food  business  operators  (FBO)  and  Regulation  (EC)  No 
854/2004,  along  with  Regulation  (EC)  No  882/2004  on  official  controls,  to 
competent  authorities  (CA)4.  The  basic  Acts  are  further  specified  in  three 
Commission  Regulations  laying  down  implementing  measures  (see  SWD  – 
Annex III).  In  addition,  guidance  documents  have  been  established  by  the 
Commission and the MS (see SWD - Annex IV).  

These  new  Regulations  introduced  a  shift  in  approach  to  food  hygiene  policy.  The 
clear  objective  of  this  package  was  to  simplify  the  existing  legal  corpus  on  food 
hygiene  (see  SWD  -  Annex  V),  make  it  more  coherent  by  separating  the  different 
disciplines  (public  health,  animal  health  and  official  controls)  and  concentrate  on 
objectives to be reached by FBO rather than maintaining very detailed requirements. 
The  Regulations  provide  ample  possibilities  to  adapt  the  technical  requirements  of 
the food hygiene package in function of the nature of the food business concerned. 

Because of its innovative nature, the European Parliament and the Council requested 
the Commission to submit a report already after only three years of implementation 
(see SWD - Annex VI). The report shall, in particular, review the experience gained 
from  the  application  of  the  new  Regulations  and  consider  whether  it  would  be 
desirable and practicable to extend the implementation of the HACCP principles to 
the level of primary production.  

In  order  to  establish  the  report,  the  Commission  consulted  all  major  stakeholders 
bilaterally or collectively (see SWD - Annex VII). 

The purpose of the report is to present factually the experience gained in 2006, 2007 
and 2008 from the implementation of the hygiene package by the CA and by private 
stakeholders'  organisations,  and  to  identify  the  difficulties  that  arose  from  this 
implementation.  

3. 

EXPERIENCE GAINED SINCE 1 JANUARY 2006 

3.1. 

Overall experience 

The  overall  experience  of  applying  the  hygiene  Regulations  may  be  regarded  as 
positive. The MS are, in general, satisfied with the structure and the principles of the 
hygiene legislation. They are clearly not of the opinion that the legislation requires a 
fundamental  overhaul.  For  most  MS  it  is  too  early  to  give  a  balanced  and  detailed 
evaluation of the experiences encountered when implementing the hygiene package.  

4 

See diagram on the current legal framework in SWD - Annex II. 

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FVO inspection missions confirmed this finding, as in general, the application of the 
hygiene  package  did  not  lead  to  major  difficulties  for  FBO  and  CA.  The  problems 
identified  during  the  missions  were,  to  a  variable  extent,  more  important  in  small 
establishments. 

The MS also regard the establishment of guidance documents, where appropriate, to 
help FBO and the CA to implement the hygiene Regulations, as positive. 

3.2. 

Scope 

MS are, in some instances, required to lay down under national law specific rules to 
cover certain activities excluded from the scope of the hygiene package. 

MS noted difficulties in relation to the local supply of small quantities of foods when 
applied to cross-border trade into a MS of destination having a different approach to 
these  activities.  Some  MS  identified  other  difficulties  in  relation  to  the  notion  of 
"undertakings",  which  are  characterised  by  a  certain  continuity  of  activities  and  a 
certain  degree  of  organisation,  and  its  application  to  private  persons  occasionally 
handling, preparing or serving foods. 

The  non-applicability  of  Regulation  (EC)  No  853/2004  to  retail  activities  has  also 
generated  difficulties.  For  a  majority  of  MS,  there  is  an  inconsistency  in  that  cold 
stores  carrying  out  similar  activities  are  subject  to  different  rules  and  approval 
regimes, this being dependent on whether the cold store falls under the definition of 
retail or not. In the same way, the interpretation of the terms "marginal, localised and 
restricted"  in  relation  to  the  exemption  from  approval  of  retail  establishments  have 
also been the source of difficulties. 

Many  private  stakeholder  organisations  have,  for  competitiveness  reasons,  also 
raised  concerns  on  the  exclusion  of  retail,  some  requesting  a  full  extension  of  the 
scope of Regulation (EC) No 853/2004 to retail, others pleading for a review of the 
legislation  as  regards  certain  activities  carried  out  at  retail  level  (e.g.  mincing, 
slicing) with a view to applying the same rules to the same activities throughout the 
Community. 

3.3. 

Definitions 

The concept of 'composite product' remains difficult to implement and gives rise to 
uncertainties for both FBO and CA.  

The definition of retail as provided for in Regulation (EC) No 178/2002 is perceived 
as  a  continued  source  of  difficulties  as  it  appears  not  to  be  totally  adapted  for  the 
purpose of the hygiene package (see also point 3.2.). 

MS  and  many  private  stakeholders'  organisations  have  questioned  other  definitions 
(e.g.  dwelling-houses,  lagomorphs,  invertebrates,  blood,  casings).  They  have  also 
questioned the procedure for establishing or amending such definitions. 

3.4. 

Primary production 

The  current  food  hygiene  rules  for  primary  production  are  generally  considered 
the  protection  of  primary  products  against 
appropriate  and  adequate  for 

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contamination. However, certain MS considered it premature to assess the impact of 
the  hygiene  package  requirements  on  primary  production.  Other  MS  reported 
difficulties  with  regard  to  the  vague  nature  of  certain  objectives  set  down  in 
Regulation (EC) No 852/2004 and the lack of clear guidance for primary producers. 
Guides  to  good  practice,  where  available,  have  proven  to  be  crucial  tools  to  help 
primary producers to fulfil their obligations (see points 3.5.and 3.8.). 

Record-keeping was perceived as a source of difficulties in some MS, but to varying 
extents. 

3.5. 

HACCP 

• 

In  general,  the  implementation  of  HACCP  principles  is  not  called  into 
question,  as  it  is  perceived  as  relevant  to  allow  FBO  to  achieve  their  food 
safety objectives and as sufficiently flexible to be adapted even to small food 
businesses. 

Most  industrial  food  businesses  have  HACCP-based  procedures  in  place. 
Delays  in  implementation  were  noted  in  former  small  capacity  abattoirs 
benefiting from a transitional arrangement. 

However,  in  most  MS,  difficulties  with  such  procedures  were  identified  in 
small  food  businesses  and  more  particularly,  in  micro  and  small  catering  and 
retail  establishments.  Provision  of  generic  systems  from  outside  consultants 
have been reported in some cases not to reflect the reality of the establishment 
and to impose more documentation and records than are mandatory. They seem 
therefore to be less than efficient and overly expensive for small businesses. In 
some MS, the CA have alleviated the issues, either by conducting risk analyses 
for  certain  types  of  activities  or  by  participating  in  the  creation  of  simplified 
and practical material for the attention of small businesses. In other MS, food 
sectors  were  encouraged  to  develop  guides  to  good  practices,  which  have 
proven to be very useful tools. 

Record-keeping  is  sometimes  perceived  as  an  administrative  burden  by  small 
food businesses. MS have taken initiatives to simplify this step and minimise 
the documentation to be kept. 

Some private stakeholder organisations claimed that MS differed regarding the 
assessment of HACCP-based procedures by CA. Some organisations indicated 
a  tendency  of  CA  to  have  high  expectations  of  small  businesses  and  to 
exaggerate documentary requirements in some instances. Others indicated that 
the size and nature of the business was taken into account and that the majority 
of  CA  makes  use  of  flexibility  in  the  implementation  of  HACCP-based 
procedures. 

Difficulties were also identified during FVO inspection missions regarding CA 
capability  in  adequately  assessing  HACCP-based  procedures.  Progress  has 
been  noted  since  the  first  inspection  round  in  2006  but  there  is  still  room  for 
improvement. 

•  MS  and  private  stakeholders  consider  it  impracticable  to  extend  the 
requirement  for  HACCP-based  procedures  to  FBO  carrying  out  primary 

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production. Guides to good practices are generally considered to be better and 
more practical tools for primary producers than HACCP-based procedures. 

3.6. 

Registration and approval procedures 

• 

• 

In  general,  no  major  difficulties  were  noted  as  regards  registration  of  food 
businesses.  Specific  systems  or  existing  databases  were  used  to  register  food 
businesses (e.g. primary producers). Efforts were also made to harmonise and 
minimise  the  information  which  businesses  are  required  to  supply  to  CA  to 
reduce the administrative burden. 

However, ensuring that all FBO meet their obligation to register is sometimes 
difficult, e.g. FBO who do not contact their authorities before opening a food 
business, food brokers and Internet traders who are not easily targetable. Other 
problems  arose  from  the  need  for  private  persons  occasionally  handling, 
preparing or serving foods to be registered. 

No charge is generally levied by CA for processing registration. 

No  particular  problems  were  noted  concerning  the  supply  of  approval 
information to the CA. However, difficulties have been identified in relation to 
the  type  of  establishment  requiring  approval,  in  particular  for  those  carrying 
out  general  activities,  such  as  cold  storage  (see  point  3.2.)  and  repacking 
establishments. 

Approval  of  former  small  capacity  establishments  was  raised  by  a  few  MS. 
Solutions can be found through flexibility provisions contained in the hygiene 
package.  However,  such  provisions  have  to  be  promoted  at  national  level, 
which may have created difficulties in certain MS (see point 3.9.). 

Two  MS  indicated  that  all  food  businesses  had  to  be  approved  on  their 
territory. 

•  While  access  from  the  Commission  website  to  every  national  site  containing 
lists  of  approved  food  establishments  is  now  possible,  certain  MS  have  not 
used  the  agreed  specifications  aiming  at  harmonising  and  codifying  the 
presentation  of  the  lists  to  draw  up  or  update  their  lists.  The  maintenance  of 
active links to national sites has also to be improved. 

3.7. 

Health and identification marking 

No  major  difficulties  have  arisen  in  relation  to  health  or  identification  marking 
principles. However, difficulties were reported in relation to certain practical aspects, 
e.g. situations where a new mark should be applied to wrapped/consumer-packaged 
products  and  food  is  repacked.  In  such  cases,  some  MS  are  of  the  opinion  that 
marking must also meet the needs of official control and traceability objectives. 

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3.8. 

Guides to good practice5 

• 

The  MS  have  greatly  promoted  the  development  of  national  guides.  The 
participation of CA differs from one MS to another, but in general, guidelines 
for developing such guides, practical advice and guidance have been given by 
CA to food sectors. CA are involved in the assessment process of these guides 
and sometimes financially support their diffusion. 

Most  private  stakeholders'  organisations  have  expressed  a  positive  attitude  to 
national guides to good practice and to the encouragement given by the CA. No 
figure as to the extent of their use can be given. 

The  use  of  guides  is  taken  into  account  in  a  variable  way  by  CA  when 
performing  official  controls.  Some  MS  have  developed  an  award  system  to 
deserving  FBO  who  apply  validated  guides,  resulting  in  reduction  of  the 
control frequency and of the level of fees charged by CA for official controls. 
In other MS, the inspection bears on the correct use of the guide when claimed 
to be applied. Some further MS do not require FBO to prove the adequacy of 
their  control  measures  if  they  follow  the  guide.  Guides  may  also  offer  useful 
guidance  to  CA  and  indicate  what  is  best  practice  when  the  terms  'where 
appropriate',  where  necessary',  'adequate'  and  'sufficient'  are  used  in  the 
legislation. 

• 

Five Community guides have already been developed and are under evaluation. 
Two  more  guides  are  under  preparation  and  will  be  submitted  to  evaluation 
once  ready.  However,  about  half  of  the  organisations  at  EU  level  were 
considering, or were in consultation with their members, if they should develop 
draft documents and follow the procedure to obtain recognition. The other half 
of  the  organisations  indicated  that  they  had  no  plans  to  develop  Community 
guides. 

3.9. 

Flexibility 

In order to protect food diversity and to serve consumers and the needs of small-scale 
producers,  provisions  were  included  in  the  legislation  for  flexibility.  In  accordance 
with  the  principle  of  subsidiarity,  MS  are  best  placed  to  find  appropriate  solutions 
based  on  local  situations  and  on  appropriate  levels  of  hygiene  in  these  businesses, 
without compromising the objective of food safety. 

MS and private stakeholders have indicated that they were in general very satisfied 
with the flexibility provided for in the hygiene package, which is considered as well 
designed to give appropriate responses to local problems. However, based on the few 
notifications  of  national  measures  to  this  effect  received  so  far  and  criticisms 
emanating from certain food businesses (see point 3.6.), MS may not have availed of 
all flexibility possibilities offered in the legislation. 

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See overview of guides to good practice in SWD - Annex VIII. 

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3.10. 

Imports 

•  MS considered it necessary to further harmonise the import rules for products 
of  animal  origin  for  which  Regulation  (EC)  No  853/2004  lays  down  specific 
requirements  (e.g.  frogs'  legs,  snails,  rendered  animal  fats).  They  also  face 
difficulties with the listing and controls of third country vessels for which the 
responsibility for inspection has been delegated to a country or to a MS other 
than the flag state. 

• 

• 

Experience  shows  that  clarification  of  situations  where  national  import  rules 
apply in the absence of harmonised Community rules is necessary. 

Recent crises due to imported composite products have confirmed the need for 
greater  control  of  such  products.  This  may  require  implementation  of  more 
detailed  legislation  and  checks  upon  importation  (e.g.  importers  role,  specific 
health certificate). 

Experience  has  shown  that  the  current  listing  procedure  for  third  country 
establishments presents difficulties (e.g. listing period). With the development 
of  new  Community  IT  tools,  consideration  may  be  given  to  reviewing  this 
procedure. 

3.11.  Official controls in relation to products of animal origin 

•  Many  MS  have  developed  specific  control  tools,  including  check-lists  and 
standard  operating  procedures.  They  also  put  their  efforts  into  training  as 
auditing  activities  imply  an  important  conceptual  change  for  inspectors.  MS 
expressed satisfaction with the Commission training initiative, "Better training 
for safer food", which complemented their own training activities and offered 
specific training on key-aspects of the hygiene package (e.g. HACCP). 

However, difficulties persist in many MS with regard to audits as demonstrated 
by FVO inspection missions. Even if significant progress has been made since 
2006, there is still room for improvement. 

• 

Although  elements  of  modernisation  have  already  been  incorporated  in  the 
hygiene package since its entry into application in January 2006, many MS and 
interested  private  stakeholders'  organisations  consider  that  meat  inspection 
should  be  reviewed.  This  position  is  driven  by  human  resources  problems 
encountered  by  certain  MS  in  appointing  official  veterinarians  (OV)  to 
slaughterhouses and by the increasing public health importance of hazards that 
cannot be easily detected by conventional meat inspection. It was pointed out 
that  the  role  of  official  auxiliaries  should  be  enhanced,  the  division  of 
responsibilities  between  FBO  running  slaughterhouses  and  CA  should  be 
further clarified and additional inspection tasks be delegated to slaughterhouse 
staff. 

Certain  MS  and  private  stakeholders'  organisations  consider  that  the  use  of 
slaughterhouse  staff  should  be  extended  to  slaughterhouses  slaughtering 
species other than poultry and lagomorphs. 

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• 

• 

FVO missions have shown that in a few MS Trichinella testing is not properly 
implemented. In addition, difficulties exist in relation to the accreditation of in-
house slaughterhouses laboratories in some MS. However, one MS claimed to 
use only accredited laboratories. 

Denmark  has  been  recognised  as  a  region  presenting  a  negligible  Trichinella 
risk  and  can  derogate  from  the  testing  regime  in  domestic  swine.  Requests 
from two other MS have also been received. This derogation is today limited to 
EU MS and consideration may be given to extending it to third countries. Two 
MS expressed interest in recognising holdings as Trichinella-free. 

Varied  fraudulent  practices  have  been  disclosed  since  2006  in  cold  stores 
located  in  a  number  of  Member  States.  As  also  discussed  in  the  frame  of  the 
animal  by-products  legislation,  most  of  the  MS  considered  it  necessary  to 
reinforce the control instruments at their disposal. 

Other specific difficulties arose from the use, in certain MS for animal welfare 
reasons, of non-fully validated chemical methods instead of mouse bio-assays 
in routine analyses. The European Food  Safety Authority (EFSA) is expected 
to  deliver  a  scientific  opinion  on  the  current  limits  for  marine  biotoxins  and 
their detection methods by December 2009. 

3.12.  Microbiological criteria 

Based  on  FVO  reports,  it  appears  that  food  business  operators'  procedures  only 
occasionally  ensured,  in  the  first  year  of  application  of  Regulation  (EC)  No 
2073/2005,  that  process  hygiene  criteria  and  food  safety  criteria  were  met  or  even 
taken  into  consideration.  This  was,  in  addition,  quite  often  not  addressed  by  CA 
official supervision. Although the situation has improved in 2007/2008, there are still 
some MS where this Regulation is not implemented satisfactorily. 

From a MS perspective, the main difficulty reported relates to the implementation of 
the Listeria monocytogenes criterion for ready-to-eat foods which are able to support 
the growth of such a pathogen. 

3.13.  Removal of surface contamination 

The use of substances to remove surface contamination from foods of animal origin 
is  subject  to  approval  by  Comitology  procedure.  Based  on  EFSA  opinions,  an 
attempt to authorise the use of four substances to remove surface contamination from 
poultry  carcases  was  proposed  by  the  Commission  in  2008.  The  European 
Parliament, the MS and a great majority of private stakeholders' organisations clearly 
indicated their opposition to such an authorisation, even under strict conditions. 

The  possible  use  of  other  decontamination  techniques,  including  steam,  hot  water 
and other physical treatments, are under discussion with the MS. 

3.14. 

Food Chain Information (FCI) 

Provisions  were  made  for  FCI  to  be  progressively  introduced  until  the  end  of  the 
transitional period (31.12.2009). Two MS indicated having not used these provisions. 

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• 

• 

• 

FCI was to be implemented on 1 January 2006 in the poultry sector. No major 
difficulties  were  reported  since  similar  provisions  applied  in  previous 
legislation. 

FCI is compulsory in the pig sector since 1 January 2008 and in the veal calf 
and horse sectors since 1 January 2009. Few difficulties were identified in the 
pig  sector  (see  below).  Reports  on  the  veal  calf  and  horse  sectors  are  not  yet 
available. 

FCI is to be available for the other species (sheep, goats and adult bovines) by 
1  January  2010.  Some  MS  anticipate  difficulties,  in  particular,  with 
individually identified animals. 

The delay for supplying FCI before the arrival of the animals has been considered as 
difficult  to  comply  with  in  all  instances  in  the  pig  sector.  Similar  difficulties  are 
expected  in  future  for  other  animal  sectors.  MS  and  certain  private  stakeholders' 
organisations are in favour of greater flexibility in this regard. 

As  the  responsibility  for  organising  FCI  and  its  practical  arrangements  (e.g. 
documents, way for exchanging information) was left to MS, difficulties were noted 
in intra-Community trade of animals and are also expected with imports. A first step 
to ease the access to the information required by the different MS is in operation at 
Commission  level.  However,  some  MS  indicated that it may also  be  appropriate to 
develop at EU level a specific form for intra-Community trade and possibly imports. 

Experience has also shown that clarification on the relation between FCI and animal 
health certificates required when trading live animals is necessary. 

3.15.  Emergency slaughter 

MS did not report particular difficulties regarding the practical rules for emergency 
slaughter,  but  questioned  the  special  mark  and  the  marketing  limitation  for  such 
meat.  Some  MS  stressed  the  need  for  applying  the  special  mark  also  to  derived 
products. Other MS consider that there are no food safety reasons that can justify a 
restriction  on  the  placing  on  the  market  of  such  meat  if  recognised  fit  for  human 
consumption after ante- and post-mortem inspection. 

4. 

CONCLUSIONS 

Member  States  and  food  business  operators  have  indicated  that  they  are  generally 
satisfied  with  the  hygiene  Regulations  and  that  they  have  made  good  progress  in 
adjusting  to  them.  There  is  broad  support  for  the  principles  introduced  by  the 
Regulations. Member States consider that the legislation requires slight adjustments 
but not a fundamental overhaul. 

According  to  the  MS  and  private  stakeholders'  organisations,  the  application  of  the 
hygiene  package  did  not  lead  in  general  to  major  difficulties  for  food  business 
operators  and  competent  authorities.  However,  the  inspections  carried  out  by  the 
Food  and  Veterinary  Office  since  early  2006  have  revealed  that  on-going  control 
problems  and  hygienic  production  standards  require  further  improvement  in  a 
number of Member States. As a first step, better enforcement by all involved actors, 

EN 

11 

   EN 

FBO and CA, is therefore necessary to address the most outstanding issues identified 
in the report. 

On  that  basis,  the  Commission  will  consider  how  to  address  the  identified 
difficulties. In submitting its proposals, the Commission will pay particular attention 
to  the  fact  that  the  benefits  of  the  simplification  achieved  with  this  new  legal 
framework are, as far as possible, maintained. 

EN 

12 

   EN