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. 
Article 1 and 2 
These articles contain definitions of the scope of the Directive and of 
certain technical terms. 
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. 
Article 2 
For the purpose of this Directive: 
- "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. 
Article 9 
The Member States shall designate the competent authorities and shall 
notify these to the Commission. 
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. 
Article 12 
This Directive Is addressed to the Member States. 
ANNEX 
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. 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. 
3. Washbasins for cleaning hands must be provided with hot and cold 
running water, materials for cleaning hands and for hygienic drying. 
4. 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. 
5. AN sanitary conveniences within food premises shall be provided with 
adequate natural or mechanical extract ventilation. 
6. 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. 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. 
3. 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. 
4. 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 
1. Every person, engaged in a food handling area, shall maintain a high 
degree of personal cleanliness. 
2. 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 
1. 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. 
2. 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. 
3. 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 
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