1
NEW LEGISLATIVE FRAMEWORK OF FOOD HYGIENE IN THE
EUROPEAN UNION
FORMER SITUATION
Historically, the regulation of food hygiene has been a basic part
of European Community’s legislation from the very beginings.
According to that time development of the Community, the
legislations were sectorial, related to products, product groups
resulting in a mainly vertical regulatory pattern of directives with
consequent inhomogeneity on Community level (Directives are
not legally bound in their entirely, National laws must only
comply with Directives).
In order to regulate the hygiene condition and control of food
production and trade in the European Union during the last four
decades, 1 horisontal and 17 vertical Directives were released.
WHY REMODELLING IS NECESSARY
The vertical character carries several overlappings in legislation
and this is further complicated by countless modifications
generating growing inhomogeneity on EU level.
In contrast, there is a principally free movement of products in
the EU internal market against a inhomogenously complex
legislation. The food-chain has also been getting more complex
and its elements are changing. The food borne hazards,
therefore, are also changing and new risk types are emerging.
Consumers are reacting with leaking confidence.
Evaluating the situation, European Commitee decided (1999) to
reform food safety regulation making it bound homogenously
along the entire food chain, food sectors and member states.
The necessary basic principles and detailed executive plan were
summarized
in
the
„White
Book
on
Food-Safety”
(COM(1999)719-Final).
2
CONSTRUCTION AND IMPLEMENTATION OF THE NEW FOOD
HYGIENE REGULATION (NEW HYGIENE PACKAGE)
Following the law making plan laid down in the White Book, the
European Committee lanced the new food hygiene regulations
(so called Hygiene package) for discussion and finally, those
were entered into force. The package involved 5 regulations and
directives as follows:
1. General food hygiene rules: 852/2004/EU (Members’
implementation: 2006)
2. Special hygiene prescriptions for food of animal origin:
853/2004/EU (Members’ implementation: 2006)
3. Official control of food of animal origin intended for
human
consumption:
854/2004/EU
(Members’
implementation: 2006)
4. Animal health rules related to food of animal origin
intended
for
human
consumption:
2002/99/EU
(Members’s implementation: 2005l)
5. List of Directives overruled by the new rules: 2004/41/EU
(Members’ adoption: 2006)
Ad 1-3 are are regulations, 4 and 5 are Directives.
In 2002, the European Parlament and the Committee accepted
the regulation (178/2002/EC) on
 The general principles and requirements of food-law
 The procedures corresponding to food-safety and
 The establishment of European Food Safety Office
This is not part of the New hygiene package but the rules of the
package closely connected to this basic regulation that may be
considered as the Food Law of EU.
Further regulations and directives:
 The 882/2004/EU regulation is dealing with the official food
and feed control (It is in close relationship with 854/2004/EU)
 The regulation of 2160/2003/EU and the directive of
2003/99/EU on protection against, monitoring of salmonellas
and other zoonotic causatives, respectively.
3
SHORT DISCUSSION OF THE RELEASED REGULATIONS AND
DIRECTIVES
General regulation of food hygiene
The 852/2004/EU Regulation replaced the 93/43/EEC Directive. It
covers all food commodities and food undertakings. Concerning
traditional product manufacturing methods and distribution and
geographically hardly approachable production sites, the
Regulation is flexible and allows their regulation on the National
level without violating basic hygiene principles.
Exempts are primary production for own use, low volume
products sold directly to final consumer by a local trader.
In contrast to 93/43/EEC, 852/2004/EU regulate also the primary
production, thereby the whole food-chain is involved („field to
table”). It declares that it is the producer/distributor who is
responsible for food safety and safety can be ensured in
framework of HACCP by applying all the 7 principles.
In respect of small undertakings, it is flexible and in case of
production without identifiable CCP, GHP might substitute CCPrelated safety assurance and the administrative work is also
suggested to be kept on reasonable measure.
In primary production, the application of all principles of HACCP
is not mandatory but compulsory the introduction of GHP and
the elaboration of related hygiene guidelines are suggested.
In order to facilitate the appropriate practical application of
HACCP principles in other segments of food chain, the
regulation suggests the elaboration of GHP guidelines both on
EU and National levels.
The general part of the Regulation contains 2 attachments. The
first one summarizes the the hygiene requirements of the
primary production, the second one (similarily to Directive
93/43/ECC) regulates the general hygiene conditions of
production and distribution.
Special hygiene prescriptions for food of animal origin
In order to ensure a higher safety of food of animal origin that
carry more severe microbiological and chemical hazard for
health of consumer than other food, the EU elaborated special
hygiene rules in form of Regulation of 853/2004/EU.
The regulation describes (similarily to the 852/2004/EU):
 The tasks of food-enterpreneurs
 The special hygiene prescriptions for production and
distribution of fresh and processed food of animal origin
(excluded products containing of food of plant origin)
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 It is valid only for whole-sale distribution. In retail
distribution, the application of general hygiene rules are
sufficient (852/2004/EU)
 The flexibility in enforcement and fields of National
regulations are the same as listed in 852/2004/EU, the latter
is supplemented with possible National regulation of low
quantity game-meat intended for selling to final consumer
or retailer by hunters, as well as the prohibition or
restriction of direct marketing for human consumption of
fresh milk and cream.
Most important food-enterpreneur and miscellenous product
related prescriptions are
 Approval and record keeping of production and distributor
establishments
 Mandatory identification or approval for human
consumption (meat stamp) of food of animal origin
 Requirements for importing products originated from third
countries
 Availability of so called food-chain information
 Only
approved
food
production
or
distributor
establishment may operate (if they produce/distribute food
of animal origin which are listed in Attachment III).
Exempts are those establishments which perform only
primary production, only transportation, only storage
without need of temperature control or retail distributor
units supplying direct/final consumers, this latter must,
however, be registered
 For ensuring tracebility, only food of animal origin having
identifier marking is allowed to be marketed. Two permitted
forms of marking are existing, namely identification
marking and the meat-stamp. How meat stamp must be
applied coupled with meat inspection, is regulated by
854/2004/EU. If this regulation actualy does not order the
use of stamp, the food must be labelled by identfication
mark. This mark is oval in European Union establishments
and shows the abbreviated (according to ISO standard)
name of the member state, the approval number of the
establishment and the abbreviation of the European Union
(EU). The site of marking is the product itself, or its
individual or collective package. The label might be printed
on sticking-tape or on plastic or metal plate.
 An important new element is the food-chain information. It
indicates the animal health status of flock/herd of the
slaughter animals and health status of the actually
slaughtered animals. According to the regulation, the
slaughterhouse may accept of entering slaughter animals if
the related food-chain information from the farm is in hand
24 hours before arrival of animals and if it is made
available for the official veterinarian.
5
 The farm must describe/declare the animal-health-status of
the herd/flock in question (with special regard to the
possible presence of zoonotic carriers that clinically nondetectable and might lead to cross-contamination at
slaughter and with special regard to the absence of
veterinary drug residue over the corresponding MRL:
observing withdrawal time). Further demand is the
description of possible diseases and treatment occurred,
results of earlier ante mortem inspections, production
indices of the herd/flock, name and availability of the
responsible veterinarian. The official veterinarian must be
informed before the ante mortem inspection on any data
that indicate public health risk or if the slaughter animals
are without this food chain information (or if it is not
complete). In this case the official veterinarian will make
the appropriate decision.
 The animal health authority may give permission of
giving/accepting the the food chain information at time of
arrival of the slaughter animals in case of pig, poultry and
farmed game if the ante mortem inspection was carried out
at the farm and the animals proved to be healthy,
furthermore in case of solipeds or emergency slaughter.
 Attachment III of the regulation contains description of
special hygiene requirements for the production and
marketing of the following products: meat of slaughter
animals (solipeds), poultry meat, meat of farmed game and
game meat, ground meat, meat-products, mechanically
recovered meat, live bivalve molluscs, fish, fishery
products, fresh milk, milk products, egg and egg products,
thigh of frog, snail, animal fat, gastric and intestinal
preparations, gelatin, collagen.
 Actualy, these items are regulated by 14 EU Directives
which will be overruled by Directive 2004/41/EU from 01
January 2006.
The third important Regulation of the „Hygiene package” is the
854/2004/EU dealing with the official control of food of animal
origin. The official control has 3 main aspects:
 Public health
 Animal health
 Animal welfare
This regulation is coupled to regulation of 882/2004/EU on
official control of food and animal feed(ingstuff). One of the
most important part of the regulation is the description of the
official control of fresh meat. It discusses in detail the tasks of
official veterinarian and technician and requirements of their
professional education/knowledge. Declared important tasks are
the meat-stamping at slaughterhouses and meat plants that
reflects meat inspection judgement, furthermore the survaillance
of control of establishment hygiene and corresponding HACCP
system including verification in framework of self-control.
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Minimum 1 official vet must be present during both ante and
post mortem meat inspection at slaughterhouses, and at post
mortem inspection in game-depots.
The regulation is flexible in the following specified cases:
A) Not obligatory the presence of official
slaughterhouse-site ante mortem inspection if
vet
during
 The ante mortem inspection was carried out at the farm by
official (or charged offical) vet, the offcial vet checked the
food chain information and then, the results of these were
given to the official slaughterhouse technicians
 Having the information, the official technicians decide if
the slaughter of animals is without food safety risk and the
body and health condition of the animals are appropriate or
not
 The official vet regularly controls if the above described
duties of official technicians are properly-done
B) Not obligatory the presence of official vet during post mortem
inspection if
 The post mortem inspection is carried out by official
technicians and the abnormal organs (parts) altogether
with the belonging carcase are detained
 The detained meat is inspected by the official vet (not
obligatory in case of poultry)
 The official technician documents his work according to
the directions of the official vet
The above described flexible procedure must not be applied in
case of emergency slaughter or at slaughters when potential
public health risk case emerged, or if the slaughter of cattle,
sheep or goat is intended from herd/flocks that are noneradicated of tuberculosis or brucellosis, furthermore in case of
(other) notifiable diseases.
Member states may permit that at poultry or hare slaughter the
work of official technicians are carried out by professional
technicians of the slaughterhouse, supposing that the
slaughterhouse run a HACCP system for 12 months altogether
with the application of GHP, the salughterhouse professionel
technicians must have education comparable to the official
technicians, and the work of official technicians must be done
under the control of official vet. If a member state wants apply
this possibility, it has to be reported to the European Committee.
7
Beside task determination, the regulation defines the necessary
personnel professional requirements.
Official vet must have a wide-range of theoretical knowledge
(exam is demanded but based on graduate or postgraduate
education authority may give escape) and at least 200 hours
practice under the control of an official vet. Requirements of
part-time official vets are determined by the member states.
Official technicians must have at least 500 hours theoretical and
400 hours practical education and must have exam on topics
determined in the regulation.
The Regulation details the meat inspection. The new aspect is
that member states may permit of carrying out the ante mortem
inspection of pig by official or charged official vet at the farm
and this is followed by a simplified inspection (identification and
observation) of animals.
Also in national regulatory framework, the simplified (only
observation) post mortem inspection of pigs, which are coming
from well controlled integrated production systems, may be
permitted.
Following this, the regulation describes the official control of
production and distribution of live bivalve molluscs, fishery
products and in brief, fresh milk and milk products.
8
SUMMARY OF THE NEW FOOD HYGIENE SAFETY REGULATION
IN THE EUROPEAN UNION
178/2002/EU
Regulation
HYGIENE
852/2004/EU
Regulation
CONTROL
853/2004/EU
Regulation
FeedHygieneRegulation
854/2004/EU
Regulation
882/2004/EU
Regulation
ZOONOSES
ANIMAL HEALTH
2160/2003/EU
Regulation
2002/99/EU
Directive
2003/99/EU
Directive
(under preparation)
IMPLEMENTATIVE RULES (COMMITTEE DECISIONS)
NATIONAL REGULATION
9
FORMER FOOD HYGIENE DIRECTIVES OF THE EUROPEAN
UNION AND THEIR HARMONISED HUNGARIAN EQUIVALENTS
(Reflects the sectorial, vertical structure of the former food related
legislation)
Regulated field
General hygiene
EU Directive*
93/43/EEC
Fresh meat
Fresh poultry meat
Game-meat, hare
64/433/ EEC
71/118/ EEC
91/495/ EEC,
92/45/ EEC
91/493/ EEC
91/492/ EEC
89/437/ EEC
92/46/ EEC
77/99/ EEC
94/65/EU
Fishery products
Sea molluscs
Egg products
Milk, milk products
Meat products
Cut, ground meat
Meat and
distribution
meat
product
Hungarian Rules
90/2003. FVMESzCsM
100/2002. FVM
70/2002. FVM
9/2002. FVM
40/2002. FVM
80/2004. FVM
23/2002. FVM
1/2003. FVM
20/2003. FVM
77/2002. FVMESzCsM
79/2003. FVM
80/215/ EEC
72/461/ EEC
91/494/ EEC
Trichinella examination
77/96/ EEC
69/2002. FVM
 * = Number of the original directive
 FVM = Ministry of Agriculture and Country-Development
 ESzCsM = Ministry of Health