CELEX: 51991PC0525
Language: en
Date: 1992-01-10
Title: Proposal for a COUNCIL DIRECTIVE on the hygiene of foodstuffs

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)
 ---pagebreak---                              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.
 ---pagebreak---                                     - 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.
 ---pagebreak---                           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
 ---pagebreak---                                       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.
 ---pagebreak---                                    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
 ---pagebreak--- 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
 ---pagebreak---  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.
                                    A N N E X
                                         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;
 ---pagebreak--- 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. A N 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.
 ---pagebreak---      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
 ---pagebreak---                                     »
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.
 ---pagebreak---                                     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
 ---pagebreak---                                     -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.
 ---pagebreak---                                     -/«-
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.
 ---pagebreak---                                                                     ISSN 0254-1475
                                                              COM(91) 525 final
                                                     DOCUMENTS
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                                Catalogue number : CB-CO-91-574-EN-C
                                                             ISBN 92-77-78575-6
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