Proposal for a COUNCIL DIRECTIVE on the hygiene of foodstuffs
Date: 1992-01-10
Institutions: European Commission
Subjects: European standard, food hygiene, foodstuff, foodstuffs legislation, product safety, user guide

COMMISSION  OF  THE  EUBOPEAN  COMMUNITIES 

C0M(91) 525 final - SYN 376 

Brussels, 1U January  1992 

Proposal  for a 

ÇQUNÇII D RECTIVE 

ON THE HYGIENE OF  FOODSTUFFS 

(presented  by the Commission) 

f XPI ANAT™Y  MEMORANDUM 

Council  Directive 89/397/EEC of  14 June 1989 on  the official  control  of 
foodstuffs which deals with  the general  principles  of  food control, allows 
for the adoption of more specific provisions. The present  draft  proposal 
for a Directive on the hygiene of  foodstuffs supplements Directive 89/397 
by general  rules  aimed at  improving  the  level of  food hygiene  In the 
Community  and  the verification of  the compliance with  these rules. It 
contains precautionary measures  to be taken by  the entrepreneurs of food 
businesses  in order  to ensure safe and healthy  foodstuffs. Critical  areas 
such as meat, fish and poulty are already  covered by more specific 
Community  regulations but  this draft  proposal  relates to a framework 
Directive which could serve as a safety  net  to all  foodstuffs concerning 
the whole chain  from production to the sale, to the ultimate consumer. 

These articles contain definitions of  the scope of  the Directive and of 
certain  technical  terms. 

Article 1 and 2 

Article 3 

This article can be considered  as the key article of  the Directive.  It not 
only obliges food business to comply with certain  rules of  hygiene but  it 
explicitly states  that all stages from production untI I I the sale of 
foodstuffs shall  be carried out  in a hygienic way.  It underlines the 
Importance of  the use of HACCP  in all  food businesses. 

Article 4 

This article opens  the possibility, by using a standard  procedure, to adopt 
microbiological  criteria  for  foodstuffs such as the absence of  pathogenic 
bacteria at  levels harmful  to human health. 

Article 5 

Apart  from  the  legal  rules which  apply  to all  food businesses and are 
monitored  by the competent  authorities, these documents of good  hygiene 
practices which may vary  from one branch  to another, are voluntary  and are 
monitored by  the food business  Itself. These documents need  to be 
sufficiently  specific  to ensure  that any entrepreneur  who compiles both 
with  the regulations  from  the Annex  and  the documents of good  hygiene 
practices, applicable  in this branch, works  In a hygienic way within  the 
meaning of article 3, paragraph  1. However, by virtue of  its voluntary 
nature, a document of good hygiene practices  is not enforceable under 
public  law and failure to comply  does not  automatically  imply that 
unhygienic  practices have been carried out. Nor  can a document  of good 
hygiene practices constitute a barrier  to trade within  the meaning of 
Article 30 of  the EEC Treaty. 

-  2 -

The European  standardisation  bodies are  recommended  as the right 
authorities  to adopt  these documents. The article  further  reflects  the 
order of preference which  these documents have. 

Article 6 

The European  standards EN 29000 refer  to the  ISO 9000 series on quality and 
quality systems. They offer  a model  for quality assurance on design/ 
development, production  Installation, surveying,  final  Inspection and test 
and quality management. Application of  the EN 29000 standards may 
facilitate the  Implementation of both general  rules and  the documents of 
good hygiene practices. 

Article II 

The deadlines  laid down  in this art tele take account  of  the  legislative 
procedures which must  be completed  in the various Member States. 

PROPOSAL  FOR  A  COUNCIL  DIRECTIVE 

ON  THE  HYGIENE  OF  FOODSTUFFS. 

THE  COUNCIL  OF  THE  EUROPEAN  COMMUNITIES 

Having  regard  to  the  Treaty  establishing  the  European  Economic  Community 
and  in particular  Article  100a  thereof, 

Having  regard  to  the  proposal  from  the  Commission, 

In cooperation  with  the  European  Parliament, 

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

Whereas  the  free  movement  of  foodstuffs  is an  essential  pre-condition  for 
the  completion  of  the  internal  market;  whereas  the  principle  of  mutual 
recognition  on  which  It  is based  implies  confidence  in  the  standard  of 
safety  for  human  consumption  of  foodstuffs  in  free  circulation,  and  in 
particular  their  standard  of  hygiene;  throughout  all  stages  from  production 
and  sale  to  the  ultimate  consumer; 

Whereas  It  Is essential  to  protect  human  health;  whereas  this  protection 
has  already  been  the  subject  of  Council  Directive  89/397/EEC(1) on  the 
official  control  of  foodstuffs  as  well  as  of  more  specific  rules  in  this 
field;  whereas  an  Important  objective  of  such  controls  Is  food  hygiene; 
whereas  Council  Directive  89/397/EEC  concentrates  on  Inspection,  sampling 
and  analysis  and  should  be  supplemented  by  provisions  aimed  at  Improving 
the  level  of  food  hygiene  and  Increasing  confidence  In  the  standard  of 
hygiene  of  foodstuffs  in  free  circulation; 

Whereas  the  general  rules  of  hygiene  for  foodstuffs  to  be  respected  at  the 
time  of  production,  processing,  manufacturing,  packaging,  storing, 
transportation,  distribution,  handling  and  sale  to  the  ultimate  consumer  of 
foodstuffs  should  be  harmonised  In order  to  protect  human  health; 

Whereas  the  use  of  HACCP  (Hazard  Analyses  and  Critical  Control  Points)  Is 
recognized  to  Identify  the  critical  control  points  and  their  control  and 
monitoring  requirements. 

Whereas  microbiological  criteria  for  certain  foodstuffs  should  be  adopted 
in accordance  with  scientifically  accepted  general  principles,  In order  to 
protect  human  health; 

Whereas  the  use  of  documents  of  good  hygiene  practices  within  the  Community 
based  on  the  relevant  codes  of  practice  of  the  Codex  Alimentarius  should  be 
recommended; 

Whereas,  however,  as  an  entrepreneur  Is  responsible  for  the  hygiene  in  his 
food  business,  the  use  of  these  documents  which  are  not  part  of 
legislation,  should  be  voluntary; 

(1) OJ  r\r  L  186,  30.6.1989,  p.  23 

H 

Whereas,  In order  to have  the general  rules of  hygiene  for  foodstuffs and 
the documents of good  hygiene practices  implemented  the application of 
standards of  the EN 29000 series should  be  recommended; 

Whereas  the respect  of  the general  rules of hygiene  for  foodstuffs should 
be controlled  In accordance with  Directive  89/397/EEC  by  the competent 
authorities  in the Member  States, with  the aim of preventing  the ultimate 
consumer  from being  harmed by  foodstuffs unfit  for  human consumption or 
potentially dangerous  to human  health; 

Whereas  It  Is necessary  to ensure  that only  safe  foodstuffs are placed on 
the market  and appropriate powers should  be granted  to the competent 
authorities,  in order  to protect  human health; 

Whereas, however, the  legitimate rights of  food businesses should  also be 
preserved; 

Whereas  the Commission  should  be aware of  the competent  authorities  in the 
Member  States  responsible  for  the official  control  of  food  hygiene; 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

1.  This Directive  lays down  the general  rules of hygiene  for  foodstuffs 

and  the verification of  the compliance with  these rules. 

2.  This Directive shall  apply without  prejudice  to the provisions adopted 

In the context  of more specific Community  rules. 

For  the purpose of  this Directive: 

Article 2 

-  "food hygiene" means all measures necessary  to ensure  the safety, 

soundness and wholesomeness of  food  at all  stages  from  its production, 
processing, manufacturing, packaging, storing, transportation, 
distribution, handling  and sale  to the  final  consumer; 

-  "food business" means any undertaking  carrying out  production, 
processing, manufacturing, packaging,  storing,  transportation, 
distribution, handling  and sale of  foodstuffs;* 

-  "entrepreneur" means the owner or  the operator  of  the foodbuslness or his 

représentâtIve; 

* The definition  Includes establishments such  as hospitals, old  peoples 

homes, canteens etc., whether  state-owned  or  private. 

Article 3 

1.  The production, processing, manufacturing, packaging, storing, 

transportation, distribution, handling and sale of  foodstuffs shall  be 
carried out  In an hygienic way. 

2. 

Food business operators shall  identify  any process undertaken which  is 
critical  to ensuring  food safety  and ensure  that adequate  safety 
procedures are  Identified,  Implemented, maintained  and  reviewed. 
(Hazard Analyses and Critical  Control  Points or  HACCP). 

3.  Food businesses shall  comply with  the rules of hygiene  for  foodstuffs 

as  listed  In the Annex  to this Directive. 

Article 4 

Microbiological  criteria  for foodstuffs may be adopted  In accordance with 
the procedure  laid down  In article  10 and after  consulting  the Scientific 
Committee  for Foodstuffs as  Installed by Decision 74/234/EEC^1^, or any 
other  procedure provided  for  In more specific Community rules. 

Article 5 

1.  Member  States shall  recommend entrepreneurs  from  the various food 

business sectors to develop and  implement  documents of good  hygiene 
practices which supplement  the provisions of  the Annex  and are based 
on the Recommended  International  Code of Practice, General  Principles 
of Food Hygiene^2) and/or  the relevant  parts from  the more  specific 
Commodity  Standards derived  from  it. 

2. 

In order of preference documents of good  hygiene practices shall  be in 
the form of 

a) European standards adopted by a European standardization body as 
mentioned  In  list 1 of  the Annex of Council  Directive 83/189/EEC 
laying down a procedure  for  the provision of  information  In the 
field of  technical  standards and  régulâtlons^3^ 

b) National  standards adopted  by a national  standardization body 
as mentioned  In list 2 of  the Annex of Directive 83/189/EEC 

c) Professional  codes of good  hygiene practices. 

(1) 0J nr L 136 of  20.5.1974, p.1 

(2) Codex Alimentarius Volume A. Recommended  international  Code of 

Practice. General  Principles of Food Hygiene. Second Revision  (1985). 

Food and Agricultural Organization of  the United Nations World Health 

Organization. Rome, 1988. 

(3) 0J nr L 109 of  26.4.1983, p. 75 

3.  Member  States shall  notify  the Comisslon of  the professional  codes of 
good  hygiene practices as refered  to  in paragraph  2 c, adopted within 
their  Jurisdiction. They shall  accompany  these codes by their 
comments. 

4.  Member  States and  the Commission  assess documents of good  hygiene 

practices with  a view to determining  to what  extent  they  can be 
presumed  to comply with article 3.  In case of dispute a decision shal 
be taken  In accordance with  the procedure  laid down  In article 10. 

5.  This article shall  apply without  prejudice  to Directive 83/189/EEC. 

Article 6 

Member  States shall  recommend  entrepreneurs of  the food businesses  to apply 
the European Standards of  the EN 29000 series  In order  to  Implement  the 
general  rules of hygiene  for  foodstuffs and  the documents of good  hygiene 
pract ices. 

Article 7 

The competent  authorities shall  carry out  controls  In conformity with 
Directive 89/397/EEC  In order  to ensure  that  the provisions of article 3 
paragraphs  1 and 3 are being complied  with by the food businesses.  In doing 
so due consideration shall  be given  to the documents of good  hygiene 
practices as referred  to  In article 5 where  they exist. 

Article 8 

If while carrying out  the controls  referred  to  In article 7, the 
competent  authorities ascertain  that  failure to respect  these 
provisions might  result  In risks to the wholesomeness of  foodstuffs or 
to human health, they shall  take appropriate measures, which may 
extend  to the withdrawal  and/or  the destruction of  the foodstuff or to 
the closure of  the undertaking  for an appropriate  period of time. 

The undertaking  concerned  shall  be granted  the right of  appeal  to the 
appropriate authorities. 

The Member  States shall  designate  the competent  authorities and shall 
notify  these  to the Commission. 

Article 9 

Article  10 

The Commission  shall  be assisted  by  the Standing Committee  on  Foodstuffs 
set up by Council  Decision  69/414/EEC*1). 

(1) OJ  N° L 291, 19.11.1969, p. 9 

The Commission  representative shall  submit  to the Committee a draft of  the 
measures to be taken. The Committee shall  deliver  its opinion on  the draft 
within a time  limit which  the chairman may  lay down according  to the 
urgency of  the matter,  if necessary  by means of vote. 

The opinion shall  be recorded  In the minutes  -, In addition, each Member 
State shall  have the right  to ask  for  its position  to be recorded  in the 
minutes. 

The Commission shall  take the utmost  account  of  the opinion delivered by 
the Committee.  It shall  Inform  the Committee of  the manner  In which  Its 
opinion has been  taken  Into account. 

Article 11 

Member  States shall  bring  Into force  the Laws, regulations and 
administrative provisions necessary  to comply with  this Directive before 
(-). They shall  forthwith  Inform  the Commission  thereof. 

When Member  States adopt  these provisions, these shall  contain a reference 
to this Directive or shall  be accompanied  by such  reference at  the time of 
their official  publication. The procedure  for  such  reference shall  be 
adopted by Member States. 

This Directive  Is addressed  to the Member States. 

Article  12 

A N N EX 

I 

BUILDING REQUIREMENTS 

1.  The building  layout, design and construction of premises and equipment 

shal I : 

a)  permit  adequate cleaning and/or  disinfection; 

b)  prevent  the accumulation of dirt, the contact with  toxic materials, 

the shedding of particles  into food, and, as far as practicable, the 
formation of condensation or mould on surfaces; 

c)  permit good  food hygiene practices,  including  the avoidance of cross 

contamination between operations by equipment, air  supply or personnel 
and  the exclusion of external  sources of contamination such as pests, 
Insects or animals; 

d)  provide suitable  temperature conditions  for  the hygienic  processing 

and storage of products; 

2. 

3. 

4. 

5. 

6. 

All  food  premises  must  have  an adequate  number  of washbasins for 
cleaning  hands  and of  flush  lavatories  connected  to an  effective 
draining  system.  Lavatories  must  not  lead  directly  Into  rooms  in which 
food  Is handled. 

Washbasins  for cleaning  hands must  be provided  with  hot and cold 
running  water, materials  for cleaning  hands and for hygienic  drying. 

There  must  be suitable  and sufficient  means of ventilation  In all 
parts of the food  business  premises. Mechanical  air  flow  from a 
contaminated  area  to a clean  area  must  be avoided.  Ventilation  systems 
must  be so constructed  as to enable  filters  and other  parts  requiring 
cleaning  or  replacement  to be readily  accessible. 

AN  sanitary  conveniences  within  food  premises  shall  be provided  with 
adequate  natural  or mechanical  extract  ventilation. 

There  must  be adequate  natural  or  artificial  lighting  In all parts of 
the  food  business  premises. 

I I 

ROOM  REQUIREMENTS 

1. 

In areas  where  food  is prepared,  treated  or processed  (excluding 
dining  areas): 

a) Floors must  be kept  clean  and must  be made of  impervious, non-
absorbent,  washable, and non-toxic  materials;  they  must  be 
maintained  in a sound  condition  and they  must  be easy  to clean and 
disinfect. 

b) Walls must  be constructed  of  Impervious, non-absorbent, washable, 

non-toxic  materials;  their  surface  must  be smooth  and crack  free up 
to a height  appropriate  for the operations. 

c) Ceilings  must  be designed,  constructed  and finished  to prevent  the 
accumulation  of dirt  and to reduce  condensation,  the growth of 
moulds and the shedding of  particles. 

d) Windows and other openings must  be constructed  to avoid  the 

accumulation of dirt, and  those which  are opened  to the outside 
environment  must where necessary  be fitted with  Insect proof 
screens able to be easily  removed  for cleaning. 

e) Doors must  have smooth  and non-absorbent  surfaces. 

f) Working  surfaces must  be smooth, crack  free, without  Joints, 

washable and made of non-toxic materials. 

2. 

Where  necessary,  adequate  provisions  must  be provided  for the cleaning 
and  disinfecting of work  tools  and equipment.  These  provisions  must be 
constructed  of a material  resistant  to corrosion  and must  be easy to 
clean  and have  an adequate  supply  of hot and cold  water. 

When appropriate, adequate provisions must  be provided  for any 
necessary washing of  the food. Every  sink or other  such  facility must 
have an adequate supply of  hot  and/or  cold water  as required  and be 
kept  clean. 

11 I 

EQUIPMENT  REQUIREMENTS 

Without  prejudice  to Council  Directive 89/392/EEC on  the approximation of 
the  laws of  the Member  States relating  to machinery^1) all  articles, 
fittings, equipment  and accessories with which  food comes  Into contact, or 
might  cause contamination,  in the course of a food business shall  be kept 
clean and, 

a)  be so constructed, be of such materials and be kept  In such good 

order, repair  and condition  as to prevent, so far  as  Is reasonably 
practical, any  risk of contamination of  the  food; 

b)  with  the exception of non-returnable containers  and packaging, be so 

constructed, be of such materials and be kept  in such good order, 
repair  and condition as to enable  them  to be kept  thoroughly  cleaned; 

c)  be  Installed  In such a manner  to allow adequate cleaning of  the 

surrounding area. 

IV 

FOOD WASTE 

1.  Food waste and other  refuse must  not  be deposited or  allowed to 

accumulate  In a food  room except  so far  as may be unavoidable  for the 
proper  carrying on of  the business. 

2.  Adequate provision must  be made  for  the removal  and  storage of  food 

waste and other  refuse. Refuse stores must  be designed  and managed  in 
such a way  as to enable  them  to be kept  clean  and prevent  pests from 
gaining  access to them and avoid  contamination of  food, drinking 
water, equipment  or premises. 

WATER  SUPPLY 

There must  be an adequate  supply of  potable water  as specified  In 
Council  Directive 80/778/EEC  relating  to the quality of water  intended 
for human  comsumptlon^2) 

(1)  OJ L183 of 29.6.1989, p.9 

(2) OJ. L 229 Of 30.8.1980, p.11 

» 

2. 

3. 

4. 

1. 

2. 

1. 

2. 

3. 

Ice used  directly  in contact  with  food  must  be  made  from  water  which 
meets  the  specifications  referred  to  in Directive  80/778/EEC.  It  must 
be made,  handled  and  stored  under  conditions  which  proctect  it  from 
a 11  contaminât Ion. 

Steam  used  directly  In contact  with  food  must  not  contain  any 
substance  which  presents  a  hazard  to  health  or  Is  likely  to 
contaminate  the  product. 

Water  unfit  for  drinking  used  for  the  generation  of  steam, 
refrigeration,  fire  control  and  other  similar  purposes  not  relating  to 
food,  must  be  conducted  in separate  systems,  readily  Identifiable  and 
having  no  connection  with  nor  any  possibility  of  reflux  Into  the 
potable  water  systems. 

VI 

PERSONAL  HYGIENE 

Every  person,  engaged  in a  food  handling  area,  shall  maintain  a  high 
degree  of  personal  cleanliness. 

No  person,  known  or  suspected  to  be  suffering  from  or  to  be  a  carrier 
of  a  disease  likely  to  be  transmitted  through  food  or  while  afflicted 
with  Infected  wounds,  skin  infections,  sores  or  with  diarrhoea  shall 
be  permitted  to work  in any  food  handling  area  in any  capacity  In 
which  there  is any  likelihood  of  directly  or  indirectly  contaminating 
food  with  pathogenic  micro-organisms. 

PRODUCTION  HYGIENE 

No  raw  materials  or  ingredients  shall  be  accepted  by  a  food  business 
if  they  are  known  to  be  so  contaminated  with  parasites,  pathogenic 
micro-organisms  or  toxic,  decomposed  or  foreign  substances  that,  after 
normal  sorting  and/or  preparatory  or  processing  procedures  applied  by 
food  businesses,  they  would  still  be  unfit  for  human  consumption. 

Raw  materials  and  Ingredients  stored  in  the  establishment  shall  be 
kept  in appropriate  conditions  designed  to  prevent  harmful 
deterioration  and  to  protect  them  from  contamination. 

All  food  shall  be  handled,  stored,  packaged  and  transported  in such  a 
way  that  it  is protected  against  any  contamination  likely  to  render 
the  food  unfit  for  human  consumption,  injurious  to  health  or 
contaminated  in such  a way  that  it  would  be  unreasonable  to  expect  It 
to  be  consumed  In  that  state. 
In particular,  food  must  not  be  so  placed  as  to  involve  any  risk  of 
cross  contamination. 

M 

4. 

Notwithstanding  the  need  for  more  stringent  requirements  in certain 
circumstances  In the  Interests of  food  safety,  raw  materials, 
Ingredients,  intermediate  products  and  finished  products  likely  to 
support  the multiplication  of  pathogenic  and  toxigenic  micro-organisms 
must  be  kept  at  temperatures  which  inhibit  the growth  of  such  micro 
organisms  to  levels  that  are  harmful  to health  except  where  the 
practicalities of  handling  during  preparation,  transport,  storage, 
display  and  service of  food  require  time  limited  exemptions  consistent 
with  food  safety. 

5. 

Foodstuffs  to be  held  or  served  at  chilled  temperatures  must  be  cooled 
as quickly  as possible  following  the  final  heat  processing  stage, or 
final  preparation  stage  if no  heat  process  Is applied,  to a 
temperature  necessary  to ensure  the  safety  of  the  foodstuff. 

6. 

Inedible  substances  shall  be  adequately  labelled  and  stored  in 
separate  and  secure  containers. 

VI 11 

TRAINING 

Food  business operators  shall  ensure  that  food  handlers  are 
Instructed/trained  and  supervised  commensurate  with  their  work  activity 

-4îr 

Impact  assessment  form 

The  Impact of  the proposal  on business with special  reference  to small  and 
medium  sized enterprises  (SMEs). 

Title of  the proposal 

Draft  proposal  for  a Council  Directive on  the hygiene of  foodstuffs. 

Reference Number  (Répertoire) 

The proposal 
1. 

The control  of  foodstuffs  is already  the subject  of  Community 
harmonization  (Dir. 89/397/EEC and others) 

The present  draft  lays down  the general  rules of  hygiene  for  foodstuffs and 
the verification of  the compliance with  these rules. 
The varying  situation  In the Member  States regarding  the hygiene of 
foodstuffs  (the absence of  rules or  differing  rules) forms a barrier  to the 
free circulation of  foodstuffs and consequently  Justifies the adoption of 
common  rules. 

The  Impact  on business 

2. 

Who will  be affected  by  the proposal 

-  which  sectors of  business 

-  which  sizes of  business  (what  Is the concentration of  small  and 

medium  sized  firms) 

-  are  there particular  geographlclal  areas of  the Community  where 

these businesses are  found. 

The  regulation on  food  hygiene  concerns all  food businesses whether  they 
are multinational  or  SME and equally  the producers as well  as the  transport 
and business untertaklngs. These undertakings  are found  In all  areas of  the 
EEC. 

- / «-

3.  What will  business have  to do to comply with  the proposal. 

It consists  for  the undertaking  to  identify  the critical  points  regarding 
hygiene and  to  lay down and  respect  rules which will  guarantee good  hygiene 
practIce. 

4.  What  economic effects  is the proposal  likely  to have 

-  on employment 

-  on  Investment  and  the creation of new businesses 

-  on  the competetlve position of businesses. 

The adoption of  these new rules should enable  the quality of  the food to 
Improve both  for  Intra-Community  business and  for exports outside  the 
Community.  This would consequently have a favourable  impact  on 
International  competition. 

5.  Does the proposal  contain measures  to take  Into account  of  the 
specific situation of small  and medium  sized  firms  (reduced or 
different  requirements etc.) 

No, the measures proposed  apply  Just as much  to  large undertakings  as to 
SMEs. 

Consultât Ion 

6. 

List  the organizations which  have been consulted about  the proposal 
and outline  their main views. 

The Advisory  Committee  for Foodstuffs which  Includes business,  Industry, 
agriculture, consumers and  trade unions was consulted on  this draft. On the 
whole  this Committee  was  favourable  to the draft with a slight  reserve from 
agriculture and business. 
The abovementioned sector  feared  the  Introduction of new codes of good 
hygiene practice  in the different  Member  States. Consequently  the draft  has 
been modified. 

ISSN 0254-1475 

COM(91) 525 final 

DOCUMENTS 

EN 

10 

Catalogue number : CB-CO-91-574-EN-C 

ISBN 92-77-78575-6 

Office for Official Publications of the European Communities 
L-2985 Luxembourg