1989L0437 — EN — 22.12.1989 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of20June1989
on hygiene and health problems affecting the production and the placing on the market of egg
products
(89/437/EEC)
(OJ L 212, 22.7.1989, p. 87)
Amended by:
Official Journal
No page date
►M1Council Directive 89/662/EEC of 11 December 1989 L 395 13 30.12.1989
▼B
COUNCILDIRECTIVE
of20June1989
on hygiene and health problems affecting the production and the
placingonthemarketofeggproducts
(89/437/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
Whereas, in order to ensure the smooth operation of the common
market and more especially of the common organization of the market
in eggs established by Regulation (EEC) No 2771/75(4), aslas t
amended by Regulation (EEC) No 3907/87(5), and of the common
system of trade for ovalbumin and lactalbumin introduced by Regula-tion (EEC) No 2783/75(
6), asamended by Regulation (EEC) No 4001/
87(7), it is essential that the marketing of egg products should no
longer be hindered by disparities existing between Member States inrespect of health requirements in this area; whereas this will enableproduction to be better harmonized and bring about competition onequal terms while assuring consumers of a quality product;
Whereasthe marketing of certain egg productswhich are not covered
by Annex II to the Treaty isclos ely linked with the marketing of egg
products for which a market organization exists; whereas distortions of
competition should be eliminated for all egg products;
Whereasit appearsappropriate to exclude from the s cope of thisDirec-
tive egg products which are obtained in small scale enterprises, shopsor restaurants and used for the manufacture of foodstuffs intended fordirect sale to the final consumer or to be consumed on the spot;
Whereashealth requirementss hould be laid down for the production,
storage and transport of egg products; whereas, in particular, it is
important that rules be laid down governing the approval of establish-ments;
Whereasit isimportant als o that the health requirementsto be met by
egg productsbe laid down;
Whereas the said rules must apply in an identical manner to intra-
Community trade and to trade within the Member States;
Whereas it is the responsibility primarily of producers to ensure that
egg productsmeet the health requirementslaid down in thisDirective;
whereasthe competent authoritiesof the Member Statesmus t, by
carrying out checks and inspections, see to it that producers complywith the abovementioned requirements; whereas the rules governingthese checks and inspections must take account of the demands of theinternal market;
Whereas a random check must be made to detect the presence of resi-
dues of substances liable to be harmful to human health;1989L0437 — EN — 22.12.1989 — 001.001 — 2
(1) OJ No C 67, 14. 3. 1987, p. 9 and OJ No C 53, 2. 3. 1989, p. 10.
(2) OJ No C 187, 18. 7. 1988, p. 184.
(3) OJ No C 232, 31. 8. 1987, p. 1.
(4) OJ No L 282, 1. 11. 1975, p. 49.
(5) OJ No L 370, 30. 12. 1987, p. 14.
(6) OJ No L 282, 1. 11. 1975, p. 104.
(7) OJ No L 377, 31. 12. 1987, p. 44.
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Whereas Community control measures should be introduced to guar-
antee the uniform application in all Member Statesof the s tandardslaid down in thisDirective;
Whereas, in the context of intra-Community trade, the consignor, the
consignee or their representative must be given the opportunity, wherea dispute arises with the competent authorities of the Member States ofdestination, of seeking an expert's opinion;
Whereasegg productsmanufactured in a third country intended to be
placed on the market on Community territory must not qualify for
more favourable arrangementsthan thos e laid down in thisDirective;
whereas provision should be made for a Community procedure forinspecting establishments in third countries;
Whereas the Commission should be entrusted with the task of adopting
certain measures for implementing this Directive; whereas, to that end,procedures should be laid down introducing close and effective coop-
eration between the Commission and the Member States within the
Standing Veterinary Committee,
HAS ADOPTED THIS DIRECTIVE:
Article 1
ThisDirective laysdown hygiene and health requirementsconcerning
the production and the placing on the market of egg productsfor directhuman consumption or for the manufacture of foodstuffs.
However, thisDirective s hall not apply to:
— finished foodstuffs manufactured from egg products, as defined in
Article 2 and which meet with the provisions of Article 3,
— egg products which are obtained in small scale enterprises and
which, without having undergone any treatment, are used for themanufacture of foodstuffs intended for direct sale, without anyintermediary, to the consumer or consumed on the spot immediately
after having been prepared.
Article 2
For the purposes of this Directive, the definition given in Article 1 (2)
of Regulation (EEC) No 2772/75(
1) shall apply. The following defini-
tions shall also apply:
1. egg products: products obtained from eggs, their various compo-
nentsor mixturesthereof, after removal of the s hell andmembranes, intended for human consumption; they may be
partially supplemented by other foodstuffs or additives; they may
be liquid, concentrated, dried, crystallized, frozen, quick-frozen orcoagulated;
2. farm of production: without prejudice to Regulation (EEC)
No 2782/75(
2), farm for the production of eggsintended for human
consumption;
3. establishment: establishment approved for the manufacture and/or
treatment of egg products;
4. cracked eggs: eggs with a damaged but unbroken shell, with intact
membranes;
5. batch: a quantity of egg productswhich have been prepared under
the same conditions and in particular treated in a single continuousoperation:
6. consignment: a quantity of egg products for a single delivery to
one destination for further processing by the food industry orintended for direct human consumption;1989L0437 — EN — 22.12.1989 — 001.001 — 3
(1) OJ No L 282, 1. 11. 1975, p. 56.
(2) OJ No L 282, 1. 11. 1975, p. 100.
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7. country of dispatch: the Member State or third country from which
egg productsare dis patched to another Member State;
8. country of destination: the Member State to which egg products are
dispatched from another Member State or from a third country;
9. packing: the placing of egg productsin any form of package;
10. competent authority: the veterinary department or any other
equivalent department designated by the Member State concerned
to monitor compliance with the provisions of this Directive;
11. placing on the market: the marketing of egg products, as defined in
point 5 of Article 1 of Regulation (EEC) No 2772/75.
Article 3
Member States shall ensure that only egg products which meet the
following general requirements are produced as foodstuffs or used in
the manufacture of foodstuffs:
(a) they must have been obtained from hens', ducks', geese's, turkeys's,
guinea fowl'sor quail'seggs , but not a mixture of eggsof differentspecies;
(b) they must bear an indication of the percentage of egg ingredients
they contain when they are partially supplemented by other food-stuffs or, provided they fulfil the requirements of Article 12, byadditives;
(c) they must have been treated and prepared in an establishment
approved in accordance with Article 6 which complieswith Chap-ters I and II of the Annex, and satisfy the requirements of thisDirective;
(d) they must have been prepared under hygiene conditions complying
with ChaptersIII and V of the Annex, from eggsmeeting therequirementslaid down in Chapter IV of the Annex;
(e) they must have undergone a treatment process authorized under the
procedure laid down in Article 14 which enablesthem to meet inter
aliathe analytical specifications laid down in Chapter VI of the
Annex.
However, where it is necessary for technological reasons associated
with the preparation of certain foodstuffs obtained from eggproducts, the competent authority shall decide, on the basis of
criteria to be determined in accordance with the procedure laid
down in Article 14, that certain egg productsneed not undergotreatment; in such a case, the egg products must be used withoutdelay in the establishment where they are intended for the manu-facture of other foodstuffs;
(f) they must comply with the analytical specifications set out in
Chapter VI of the Annex;
(g) they must have undergone a health check in accordance with
Chapter VII of the Annex;
(h) they must have been packed in accordance with Chapter VIII of the
Annex;
(i) they must be stored and transported in accordance with Chapters
IX and X of the Annex;
(j) they must bear the mark of wholesomeness provided for in Chapter
XI of the Annex and, where intended for direct human consump-tion, must meet the requirements of Council Directive 79/112/EECof 18 December 1978 on the approximation of the lawsof the
Member Statesrelating to the labelling, pres entation and adver-
tising of foodstuffs for sale to the ultimate consumer(
1), aslas t
amended by Directive 86/197/EEC(2).1989L0437 — EN — 22.12.1989 — 001.001 — 4
(1) OJ No L 33, 8. 2. 1979, p. 1.
(2) OJ No L 144, 29. 5. 1986, p. 38.
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Article 4
The competent authorities shall ensure that the manufacturers of egg
products adopt all measures necessary to comply with this Directive,
and in particular that:
— samples for laboratory examination are taken in order to check that
the analytical specifications set out in Chapter VI of the Annex
have been observed,
— egg productsthat may not be kept at the ambient temperature are
transported or stored at the temperatures stipulated in Chapters IXand X of the Annex,
— the period during which the conservation of egg products is assured
islaid down,
— the results of the various checks and tests are recorded and kept for
presentation to them for a period of two years,
— each batch marked in such a way that its date of treatment can be
identified; thisbatch mark mus t appear on the treatment record and
on the mark of wholesomeness provided for in Chapter XI.
Article 5
1. Member States shall ensure that checks are effected to detect any
residues of substances having a pharmacological or hormonal action,and of antibiotics, pesticides, detergents and other substances which
are harmful or which might alter the organoleptic characteristics of
egg productsor make their cons umption dangerousor harmful tohuman health.
2. If the egg products examined show traces of residues in excess of
the permitted levelsfixed in accordance with paragraph 4, they mus t
not be allowed to be used in food for human consumption or placed
on the market, either for the manufacture of foodstuffs or for directhuman consumption.
3. Tests for residues must be carried out in accordance with proven
and scientifically recognized methods, in particular those prescribed inCommunity Directives or other international standards.
It must be possible to assess the tests for residues using reference
methodslaid down in accordance with the procedure s et out in Article14 after the Scientific Veterinary Committee has expressed its opinion.
In accordance with the same procedure, at least one reference labora-
tory must be designated in each Member State to carry out the
examination for residues in the event of application of Articles 7 and 8.
The Commission shall publish the reference methods and the list of
reference laboratoriesin the Official Journal of the European Commu-
nities.
4. Acting by a qualified majority on a proposal from the Commis-
sion, the Council shall adopt:
— the detailed arrangementsfor monitoring,
— the tolerances for the substances referred to in paragraph 2,— the frequency of sampling.
Article 6
1. Member States shall draw up lists of their approved establish-
ments, each of which shall have an approval number. Member Statesshall forward this list to the other Member States and to the Commis-sion.
No Member State shall approve an establishment unless compliance
with this Directive is assured. A Member State shall withdraw approval
if the conditionsfor granting it ceas e to be fulfilled. The other Member
States and the Commission shall be informed of the withdrawal ofapproval.
2. The inspection and monitoring of establishments and packaging
centres shall be carried out regularly on the responsibility of the1989L0437 — EN — 22.12.1989 — 001.001 — 5
▼B
competent authority, which shall at all times have free access to all
parts of the establishments, in order to ensure that this Directive isbeing observed.
If such inspections reveal that not all the requirements of this Directive
are being met, the competent authority shall take the appropriate action
to remedy the situation.
Article 7
1. Expertsfrom the Commis s ion may, in cooperaton with the
competent authorities, make on-the-spot checks insofar as that is indis-
pensable for ensuring uniform application of the Directive; they may inparticular verify whether establishments and packing centres approvedin accordance with Article 5 (3) of Regulation (EEC) No 2772/75 areactually complying with the Directive.
A Member State within the territory of which a check isbeing carried
out shall give all necessary assistance to the experts in carrying out
their duties. The Commission shall inform the Member State concerned
of the results of the checks.
The Member State concerned shall take any measures required to take
account of the results of the check. If the Member State does not takethose measures, the Commission may, in accordance with the proce-dure laid down in Article 13, decide that the Member State inquestion must suspend the placing on the market of egg products from
the establishment which fails to comply with this Directive.
2. Before the checksreferred to in paragraph 1 are carried out, in
accordance with the procedure laid down in Article 14, the generalprovisions for applying this Article shall be determined and a Commis-sion recommendation shall be established, containing the rules to befollowed for the purpose of the checks provided for in paragraph 1.
Article 10
The Annex to thisDirective s hall be amended by the Council acting by
a qualified majority on a proposal from the Commission.
Article 11
1. Pending the application of the provisions of this Directive,
national provisions governing imports of egg products from third coun-tries shall continue to apply and must not be more favourable than
those governing intra-Community trade.
2. On-the-spot inspections shall be carried out by experts from the
Member States and the Commission. Member States' experts instructedto carry out these inspections shall be appointed by the Commission onproposals from the Member States. Inspections shall be carried out onbehalf of the Community, which shall bear the costs relating thereto.
3. A list of the establishments which meet the requirements set out
in the Annex shall be drawn up in accordance with the procedure laid
down in Article 14.
4. The health certificate accompanying the productson importation
and the form and nature of the mark of wholesomeness applied to theproducts shall correspond to a model to be determined in accordancewith the procedure laid down in Article 14.
Article 12
The Council, acting by a qualified majority on a proposal from the
Commission, shall decide which additives contained in the list of addi-tivesauthorized by the Community rulesin force on additiveswhichmay be used in foodstuffs may be used for the egg products definedin Article 3 (a) and the detailed rules on such use.1989L0437 — EN — 22.12.1989 — 001.001 — 6
▼M1
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Pending such decision, national rules governing such use shall continue
to apply.
Article 13
1. Where the procedure laid down in thisArticle isto be applied,
the matter shall be referred forthwith to the Standing VeterinaryCommittee set up by the Council Decision of 15 October 1968 (herein-
after referred to as‘the committee’) by itschairman on hisinitiative or
at the request of a Member State.
2. The respresentative of the Commission shall submit to the
committee a draft of the measures to be taken. The committee shall
deliver itsopinion on the draft within a time limit which the chairman
may lay down according to the urgency of the matter. The opinionshall be delivered by the majority laid down in Article 148 (2) of theTreaty in the case of decisions which the Council is required to adopton a proposal from the Commission. The votes of the representatives ofthe Member Stateswithin the committee s hall be weighted in the
manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the committee.
4. If the measures envisaged are not in accordance with the opinion
of the committee, or if no opinion is delivered, the Commission shall,without delay, submit to the Council a proposal relating to themeasures to be taken. The Council shall act by a qualified majority.
If, within 15 daysof the date of referral to the Council, the Council has
not acted, the proposed measures shall be adopted by the Commission,save where the Council has decided against the said measures by asimple majority.
Article 14
1. Where the procedure laid down in thisArticle isto be applied,
the chairman shall refer the matter without delay to the committee onhisown initiative or at the reques t of a Member State.
2. The representative of the Commission shall submit to the
committee a draft of the measures to be taken. The committee shalldeliver itsopinion on the draft within a time limit which the chairmanmay lay down according to the urgency of the matter. The opinionshall be delivered by the majority laid down in Article 148 (2) of the
Treaty in the case of decisions which the Council is required to adopt
on a proposal from the Commission. The votes of the representatives ofthe Member State within the committee shall be weighted in themanner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the committee.
4. If the measures envisaged are not in accordance with the opinion
of the committee, or if no opinion is delivered, the Commission shall,without delay, submit to the Council a proposal relating to the
measures to be taken. The Council shall act by a qualified majority.
If, within three monthsof the date of referral to the Council, the
Council has not acted, the proposed measures shall be adopted by theCommission, save where the Council has decided against the said
measures by a simple majority.
Article 15
Member States shall bring into force the laws, regulations and admin-
istrative provisions necessary to comply with this Directive by 31
December 1991. They shall inform the Commission thereof forthwith.
The Commission shall, no later than 31 December 1994, submit a
report to the Council on the experience acquired on the subject, accom-panied, where appropriate, by proposals aimed at adapting the Annex1989L0437 — EN — 22.12.1989 — 001.001 — 7
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to this Directive taking special account of scientific and technological
developments.
Article 16
This Directive is addressed to the Member States.
Article 17
The Ruleslaid down in Directive 89/662/EEC(1) concerning veterinary
checksapplicable in intra-Community trade, with a view to the
completion of the internal market, shall apply in particular to checks
at origin, to the organization of and follow-up to the checksto becarried out by the Member State of destination, and to the protectivemeasures to be implemented.1989L0437 — EN — 22.12.1989 — 001.001 — 8
(1) OJ No L 395, 30. 12. 1989, p. 13▼M1
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ANNEX
CHAPTER I
GENERALCONDITIONSOFAPPROVALANDOPERATION
Establishments must possess at least:1. in areaswhere eggsare s tored and where egg productsare manufactured or
stored:
(a) waterproof flooring which is easy to clean and disinfect, rotproof and
laid in such a way as to facilitate the draining of water; the water must
be channelled towardsdrainsfitted with gratingsand trapsto prevent
odours;
(b) smooth, durable, impermeable walls, with a light-coloured, washable
coating up to a height of at least two metres and up to at least storage
height in chilling or refrigeration rooms and in stores. Wall to floor junc-
tions must be rounded or similarly finished in such a way as to facilitate
cleaning;
(c) doorsin material that doesnot deteriorate and, if of wood, with a s mooth
and impermeable covering on both sides;
(d) ceilings which are easy to clean and which have been built and finished
in such a way as to prevent the accumulation of dirt and the formation of
mould, the possible peeling of paint-work and the condensation of water
vapour;
(e) adequate ventilation and, if necessary, good steam extraction;
(f) adequate natural or artificial lighting;
(g) as near as possible to the work stations:
— an adequate number of facilitiesfor the cleaning and dis infecting of
handsand the cleaning of equipment with hot water. Tapsmus t not
be operable by hand or the arms. For the cleaning of hands, these
facilitiesmus t be provided with hot and cold running water or water
premixed to a suitable temperature, cleaning and disinfecting
productsand hand towelswhich can be us ed once only,
— facilities for the disinfecting of tools;
2. an appropriate number of changing rooms, with smooth, impermeable and
washable walls and floors, wash basins and flush lavatories. The latter must
not give directly on to the work area. Wash basins must have hot and cold
running water or water premixed to a suitable temperature, materials for
cleaning and disinfecting the hands, and hand towels which can be used
once only. Wash basin taps must not be hand-operable. There must be a
sufficient number of wash basin close to the lavatories;
3. a separate area and adequate facilities for cleaning and disinfecting fixed and
mobile containers and tanks. However, this area and these facilities shall not
be required if there are provisions for the cleaning and disinfecting of
containersand tanksat other centres ;
4. facilities for the supply of exclusively potable water within the meaning of
Council Directive 80/778/EEC of 15 July 1980 relating to the quality of
water intended for human consumption(
1);
However, facilities supplying non-potable water are authorized for steam-
production, fire-fighting and the cooling of refrigeration equipment, provided
that the pipes installed for this purpose preclude the use of such water for
other purposes and present no risk of contamination to the egg products.
The steam and water concerned may not come into contact with the egg
products or be used for cleaning or disinfecting containers, plant or equip-
ment which come into contact with the egg products. Pipes carrying non-
potable water must be clearly distinguished from those carrying potable
water;
5. appropriate equipment for protection against pests such as insects and
rodents;
6. equipment, couplings and instruments or their surfaces which are intended to
come into contact with egg products must be made of smooth material which
is easy to wash, clean and disinfect, resists corrosion and does not transfer
substances to the egg products in such quantities as to endanger human
health, cause deterioration in the composition of the egg products or
adversely affect their organoleptic characteristics.1989L0437 — EN — 22.12.1989 — 001.001 — 9
(1) OJ No L 229, 30. 8. 1980, p. 11.
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CHAPTER II
SPECIALCONDITIONSFORTHEAPPROVALOFESTABLISHMENTSIn addition to the general conditions laid down in Chapter I, establishments must
have at least:
1. suitable rooms large enough for the separate storage of the eggs and the
finished egg products, where necessary, with refrigeration equipment to
keep the egg products at the appropriate temperatures; cold stores must be
equipped with a thermometer or a remote recording thermometer;
2. where dirty eggs are used, facilities for washing and disinfecting the eggs; a
list of products authorized for performing this disinfection shall be drawn up
in accordance with the procedure laid down in Article 14;
3. (a) a special room with appropriate facilities for breaking eggs and
collecting their contentsand removing the partsof s hell and membrane;
(b) a separate room for operations other than those referred to in (a).
Where egg products are pasteurized, pasteurization may be carried out
in the room referred to in (a), when the establishment has a closed
pasteurization system; in other cases pasteurization must be carried out
in the room referred to in (b). In the latter case, every step must be
taken to prevent the contamination of egg productsafter their pas teuri-
zation;
4. suitable facilities for in-plant conveying of egg contents;5. in the cases provided for in this Directive, equipment approved by the
competent authority for the treatment of egg products, fitted at least with:
(a) in the case of pasteurization:
— automatic temperature control,
— a recording thermometer,— an automatic safety device preventing insufficient heating;
(b) in the case of a continuous pasteurization system, the equipment must
also be fitted with:
— an adequate safety system preventing the mixture of pasteurized egg
products with incompletely pasteurized egg products, and
— an automatic safety recording device preventing the aforementioned
mixture;
6. a room for the storage of other foodstuffs and additives;7. where the products are packed in disposable containers, an appropriate and,
if necessary, separate area for the storage of such containers and the raw
materialsintended for their manufacture;
8. facilities for the immediate removal and separate storage of empty shells,
and of eggsand egg productswhich are unfit for human cons umption;
9. suitable equipment for the hygienic packaging of egg products;
10. to carry out analyses and examinations in accordance with the requirements
of this Directive on raw materials and egg products, an establishment must
have an appropriate laboratory. If it does not, it must secure the services of
a laboratory that fulfils those requirements. In the latter case it shall inform
the competent authority accordingly;
11. where required, suitable equipment for the thawing of frozen egg products
which must undergo treatment and further handling in an approved estab-
lishment;
12. a separate room for the storage of cleaning and disinfection products.
CHAPTER III
HYGIENE REQUIREMENTS RELATING TO THE PREMISES, EQUIP-
MENTANDSTAFFOFESTABLISHMENTS
The highest degree of cleanliness must be required of staff, premises and equip-
ment:
1. staff who treat or handle eggs and egg products must, in particular, wear
clean working clothes and headgear. They must wash and disinfect their
hands several times in the course of each working day and on each resump-
tion of work.
It must be forbidden to smoke, eat, spit or chew in areas where eggs and egg
productsare handled and s tored;
2. no animals may enter the establishments. Any rodents, insects or other
vermin found must be systematically destroyed;1989L0437 — EN — 22.12.1989 — 001.001 — 10
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3. premises, equipment and instruments used for working on egg products must
be kept clean and in a good state of repair. Equipment and instruments must
be carefully cleaned and disinfected several times if necessary during the
working day, at the end of the day'swork and before being re-us ed where
they have been soiled. Closed pipe-line systems for conveying egg products
must be provided with an appropriate cleaning system which ensures their
cleaning and disinfection in all parts. After having been cleaned and disin-
fected, pipes must be rinsed out with potable water;
4. premises, instruments and equipment must not be used for purposes other
than the processing of egg products except the processing of other foodstuffs
either simultaneously or at different times after the authorization of the
competent authority hasbeen obtained, provided that all appropriate
measures are taken to prevent contamination of or adverse changes in the
productscovered by thisDirective;
5. potable water must be used for all purposes: however, non-potable water may
be used in exceptional cases for steam production provided that the pipes
installed for this purpose preclude the use of this water for other purposes
and present no danger of contamination of eggs or egg products. In addition,
the use of non-potable water may be authorized in exceptional cases for the
cooling of refrigeration equipment. Non-potable water pipesmus t be clearly
distinguished from pipes used for potable water;
6. detergents, disinfectants and similar substances must be used and stored in
such a way that instruments, equipment and egg products are not adversely
affected. Their use must be followed by thorough rinsing of such instruments
and equipment with potable water;
7. persons who are possible sources of contamination must be prohibited from
working with or handling eggsor egg products ;
8. any person employed to work with or handle eggs or egg products must be
required to produce a medical certificate to show that there is no reason why
he or she should not engage in such work. The medical certificate must be
renewed yearly unless another staff medical check-up scheme offering
similar guarantees is recognized in accordance with the procedure laid down
in Article 14.
CHAPTER IV
REQUIREMENTSCONCERNINGEGGS INTENDEDFOR THEMANU-
FACTUREOFEGGPRODUCTS
1. Eggs used for the manufacture of egg products must be put up in packaging
which complies with Commission Regulation (EEC) No 95/69 of 17 January
1969 implementing Regulation (EEC) No 1619/68 on marketing standards
for eggs(1), aslas t amended by Regulation (EEC) No 3906/86(2).
2. (a) For the manufacture of egg products, only non-incubated eggs which are
fit for human consumption may be used; their shells must be fully devel-
oped or contain no breaks;
(b) by way of derogation from (a), cracked eggsmay be us ed for the manu-
facture of egg productsprovided they are delivered directly from the
packing centres and the farm of production to an approved establishment,
where they shall be broken as quickly as possible.
3. Eggs and egg products which are unfit for human consumption must be
removed and denatured in such a way that they cannot be re-used for human
consumption. They must immediately be placed in the room provided for inpoint 8 of Chapter II.
CHAPTER V
SPECIALHYGIENE REQUIREMENTSFOR THE MANUFACTUREOF
EGGPRODUCTS
All operations must be carried out in such a way as to avoid all contamination
during the production, handling and storage of egg products, and in particular;
1. eggs and egg products presented for subsequent treatment at an approved
establishment must be stored immediately on arrival in the rooms provided
for in Chapter II point 1 until they are processed. The temperature of these
rooms must be such as to ensure that they are not contaminated. Trays of
shell eggs must not be placed directly on the floor;1989L0437 — EN — 22.12.1989 — 001.001 — 11
(1) OJ No L 13, 18. 1. 1969, p. 13
(2) OJ No L 364, 23. 12. 1986, p. 20.
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2. eggs must be unpacked, and, if necessary, washed and disinfected, in a
room which is separate from the breaking room; packaging material must
not be taken into the breaking room;
3. eggsmus t be broken in the room provided for in Chapter II, point 3 (a);
cracked eggs as mentioned in Chapter IV, point 2 (b) must be processed
without delay;
4. dirty eggs must be cleaned before being broken; this must be carried out in
a room which iss eparate from the breaking room or from any room where
exposed egg contents are handled. Cleaning procedures must be such as to
prevent contamination or adulteration of the egg contents. Shells must be
sufficiently dry at the time of breaking to prevent adulteration of the egg
contentsby the remainsof the cleaning water;
5. eggs other than hen eggs or those of turkeys or guinea fowl must be handled
and processed separately. All equipment must be cleaned and disinfected
when processing of hen eggs and those of turkeys and guinea fowl is
resumed;
6. breaking, whatever procedure is used, must be carried out in such a way as
to avoid as far as possible contamination of the egg contents. To that end,
the contentsof eggsmay not be obtained by the centrifugation or crus hing
of eggs, nor may centrifugation be used to obtain the remains of egg whites
from empty shells. The remains of shells or membranes must be kept out of
the egg product as far as possible and must not exceed the quantity speci-
fied in point 2 (c) of Chapter VI;
7. after breaking, each particle of egg product must undergo treatment as
quickly as possible; heat treatment consists of treating the egg product at
an appropriate temperature for an appropriate period in order to eliminateany pathogenic organisms present. During heat treatment, temperatures
must be registered continuously. The records of each batch having under-
gone treatment must be kept at the disposal of the competent authority for
two years. A batch which has been insufficiently treated may immediately
undergo treatment again in the same establishment provided that the new
treatment renders it fit for human consumption; should it be found to be
unfit for human consumption, it must be denatured in accordance with point
3 of Chapter IV;
8. if treatment isnot carried out immediately after breaking, the egg contents
must be stored under satisfactory hygiene conditions, either frozen or at a
temperature of not more than 4 ºC. The storage period at 4 ºC must not
exceed 48 hours, except in the case of ingredients to be desugared;
9. where certain production practices so require, the Commission shall deter-
mine, pursuant to Article 14 and by 31 December 1991, the existence of
special cases and shall lay down specific conditions according to which
egg products coming from an approved establishment may be treated in
another approved establishment, on the unterstanding that the following
general conditionsare complied with:
(a) ass oon asthe egg productshave been obtained, they mus t be either
deep frozen or chilled to a temperature of not more than 4 ºC in the
latter case, they must be treated at their place of destination during the
48 hoursfollowing the day of the breaking of the eggsfrom which they
were obtained, except in the case of ingredients to be desugared;
(b) they must be packaged, checked, transported and handled in accordance
with the requirementsof the Directive;
(c) they must be labelled in accordance with the requirements laid down in
Chapter XI. The nature of the goods must be indicated as follows: ‘non-
pasteurized egg products — to be treated at place of destination — date
and time of breaking —’;
10. further processing operations after treatment must ensure that there is no
recontamination of the egg product; liquid productsor concentrated
products which have not been stabilized so as to keep at room temperature
must be either dried or cooled to a temperature not exceeding 4 ºC immedi-
ately, or after undergoing a fermentation process; products for freezing must
be frozen immediately after treatment;
11. egg productsmus t be kept at the temperaturesrequired by thisDirective
until they are used for the manufacture of other foodstuffs;
12. in approved establishments, the preparation of egg products from raw mate-
rials which are not suitable for the manufacture of foodstuffs is prohibited,
even for non-food purposes.1989L0437 — EN — 22.12.1989 — 001.001 — 12
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CHAPTER VI
ANALYTICALSPECIFICATIONS
1.Microbiological criteria
All batchesof egg productsmus t, after treatment, undergo microbiological
checks by sampling in treatment establishments in order to guarantee that
they meet the following criteria:
(a) salmonellae: absence in 25 g or ml of egg product;
(b) other criteria:
— mesophilic aerobic bacteria: M = 105in 1 g or 1 ml,
— enterobacteriaceae: M = 102in 1 g or 1 ml,
— staphylococci: absence in 1 g of egg product,
M = maximum value for the number of bacteria; the result is
considered unsatisfactory if the number of bacteria in one or
more sample units is M or more.
2.Othercriteria
All batches of egg products must undergo checks by sampling in treatment
establishments in order to guarantee that they meet the following criteria:
(a) the concentration of 3 OH-butyric acid must not exceed 10 mg/kg in the
dry matter of the unmodified egg product;
(b) in order to ensure the hygienic handling of eggs and egg products before
treatment, the following standards shall apply:
— the lactic acid content must not exceed 1 000 mg/kg of egg product
dry matter (applicable only to the untreated product),
— the succinic acid content must not exceed 25 mg/kg of egg product
dry matter.
In the case of fermented products, however, these values are those
recorded before the fermentation process;
(c) the quantity of eggshell remains, egg membrane and any other particles
in the egg product must not exceed 100 mg/kg of egg product;
(d) the residual quantities of the substances mentioned in Article 5 (1) may
not exceed the tolerancesmentioned in Article 5 (4);
3. before 31 December 1991, the Commission will, in accordance with the
procedure laid down in Article 14, determine:
— the analysis and test methods,
— the sampling plans,— the number of samples to be taken,
— the analytical tolerances.
Pending those decisions the Member States will recognize as reference
methods all analysis and test methods recognized internationally.
CHAPTER VII
HEALTHCONTROLANDSUPERVISIONOFPRODUCTION
1. Establishments will be subject to supervision by the competent authority.
Supervision by the competent authority will include any supervision
measures considered necessary to ensure that manufacturers of egg products
meet the requirementsof thisDirective, and in particular:
— checkson the origin of eggsand the des tination of egg productsand of
the recordsreferred to in the fourth indent of Article 4,
— inspection of eggs intended for the manufacture of egg products,
— inspection of egg products on dispatch from the establishment,
— verification of the cleanliness of the premises, facilities and instruments
and of staff hygiene,
— taking of any samples required for laboratory tests to ensure that eggs and
egg productscomply with the requirementsof thisDirective; the res ults
of such tests must be entered in a register and notified to the egg products
manufacturer.
2. At the request of the competent authority, manufacturers of egg products
must increase the frequency of the laboratory tests referred to in the first
indent of Article 4 where this is considered necessary to ensure hygienic
production of the egg products.1989L0437 — EN — 22.12.1989 — 001.001 — 13
▼B
CHAPTER VIII
PACKAGINGOFEGGPRODUCTS
1. Egg products must be packaged in satisfactory hygiene conditions so as to
ensure that they are not contaminated.
Containersmus t comply with all rulesof hygiene, including the following:
— they must not be such as to impair the organoleptic characteristics of the
egg products,
— they must not be capable of transmitting to the egg products substances
harmful to human health,
— they must be strong enough to protect the egg products adequately.
2. The room in which containers are stored must be dust and vermin free; mate-
rials for making disposable containers must not be stored on the floor.
3. Containers used for egg products must be clean prior to being filled; re-
usable containers must be cleaned, disinfected and rinsed before being filled.
4. Containersmus t be brought into the work room in a hygienic manner and
must be used without undue delay.
5. Immediately after packaging, the containers must be closed and placed in the
storage rooms referred to in Chapter II, point 1.
6. Containers intended for egg products may be used for other foodstuffs if
required, provided they are cleaned and disinfected so as not to contaminate
the egg products.
7. Containers which are to be used for the transport of egg products in bulk
must comply with all the rules of hygiene, and in particular the following:
— their inside surfaces and any other part which may come into contact with
the egg product must be made of a smooth material which is easy to
wash, clean and disinfect, resists corrosion and does not transfer
substances to the egg product in such quantities as to endanger human
health, cause deterioration in the composition of the egg product or
adversely affect its organoleptic characteristics,
— they must be designed so that the egg product can be removed comple-
tely; if they are fitted with taps, these must be easy to remove, dismantle,
wash, clean and disinfect,
— they must be washed, cleaned, disinfected and rinsed immediately after
each use and, if necessary, before re-use,
— they must be appropriately sealed after being filled and remain sealed
during transportation until they are used,
— they must be reserved for the transport of egg products.
However, without prejudice to the provisions of this Chapter, for the first
time and in this case by 31 December 1990, the Commission, according to
the procedure provided for in Article 14 and to the extent that the egg
products and the other foodstuffs concerned suffer no adverse effects as a
result, shall fix, if necessary, the specific conditions with which such
containers must comply in order to be used to transport other foodstuffs, in
particular, conditionsrelating to:
— the washing, cleaning and disinfection of containers before they are re-
used,
— transport conditions,— the length of time during which the may be used.
Until the decisions provided for in the second subparagraph are brought into
force and not later than 31 December 1991:
— the national rules authorizing the use of containers for transport on the
national territory of foods tuffsother than egg productsaswell asbilateral
agreements concluded by the Member States in this respect shall remain
applicable, whilst complying with the general provisions of the Treaty,
— Member States, whose national rules make provision for such an author-
ization, may neither restrict nor prohibit the entry into their territory of
transport from other Member States which provide for the same authori-
zation,
— Member Stateswhich forbid the trans port on their territory of other food-
stuffs in containers designed for the transport of egg products may make
the transport of egg products coming from other Member States to the
same requirements.1989L0437 — EN — 22.12.1989 — 001.001 — 14
▼B
CHAPTER IX
STORAGE
1. Egg products must be stored in the storage rooms referred to in point 1 of
Chapter II.
2. Egg products for which certain storage temperatures are required must be
maintained at those temperatures. The storage temperatures must be recorded
continuously, the cooling rate must be such that the product reaches the
required temperatures as quickly as possible and the containers must be
stored in such a way that air can freely circulate round them.
3. The temperature in storage must not exceed the following values:
— deep frozen products: −18º C,
— frozen products: −12º C,
— chilled products: + 4º C,— dehydrated products(excluding egg whites ): + 15º C.
CHAPTER X
TRANSPORT
1. Vehicles and containers for the transport of egg products must be designed
and equipped in such a way that the temperatures required by this Directive
can be maintained continuously throughout the period of transport.
2. Egg products must be dispatched in such a way that they are adequately
protected during transportation from anything which may be detrimental to
them.
3. The temperatures prescribed in point 3 of Chapter IX, must be maintained
during transport.
CHAPTER XI
MARKINGOFEGGPRODUCTS
1. Without prejudice to the provisions of Directive 79/112/EEC, every
consignment of egg products that leaves an establishment must have a label
bearing the following particulars:
(i) either:
— on the upper part, the initial letter or lettersof the cons igning
country in capitals, i.e. B/D/DK/EL/ESP/F/IRL/I/L/NL/P/UK,
followed by the approval number of the establishment,
— on the lower part, one of the following sets of initials: CEE — EEC
— EEG — EOK — EWG — EØF;
(ii) or:
— on the upper part, the name of the consigning country in capitals,
— in the centre, the approval number of the establishment,— on the lower part, one of the following sets of initials: CEE — EEC
— EEG — EOK — EWG — EØF;
(iii) the temperature at which the egg productsmus t be maintained and the
period during which their conservation may thus be assured.
The label must be legible, indelible and in easily decipherable charac-
ters.
2. The transport documents must in particular include:
(a) the nature of the productswith an indication of the s peciesof origin;
(b) the batch numbers;(c) the place of destination and the name and address of the first addressee.
3. This information, and that contained in the mark of wholesomeness, must be
given in the official language or languagesof the country of des tination.1989L0437 — EN — 22.12.1989 — 001.001 — 15