Proposal for a Council Regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption
Date: 2000-07-14
Institutions: European Commission
Subjects: animal product, consumer protection, food inspection, foodstuff, health legislation

19.12.2000

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Official Journal of the European Communities

C 365 E/123

Proposal for a Council Regulation laying down the animal-health rules governing the production,
placing on the market and importation of products of animal origin intended for human
consumption

(2000/C 365 E/05)

(Text with EEA relevance)

COM(2000) 438 final (cid:16) 2000/0181(CNS)

(Submitted by the Commission on 14 July 2000)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of
Committee,

the Economic and Social

Whereas:

(1) In the context of the common agricultural policy, specific
animal health rules have been laid down to govern intra-
Community trade in and imports from third countries of
products of animal origin included in Annex I to the
Treaty.

(2) These rules have ensured the removal of obstacles to trade
in the products concerned, thereby contributing to the
creation of the internal market whilst ensuring a high
level of animal health protection.

(3) These specific rules are contained in the following

Directives:

6 Council Directive 72/461/EEC of 12 December 1972
on health problems affecting intra-Community trade
in fresh meat (1), as last amended by the Act of
Accession of Austria, Finland and Sweden,

6 Council Directive 80/215/EEC of 22 January 1980 on
animal health problems affecting intra-Community
trade in meat products (2), as last amended by the
Act of Accession of Austria, Finland and Sweden,

6 Council Directive 91/67/EEC of 28 January 1991
concerning the animal health conditions governing
the placing on the market of aquaculture animals
and products (3),
amended by Directive
98/45/EC (4),

last

as

trade in and imports from third countries of fresh
poultrymeat (5),
by Directive
93/121/EC (6),

amended

last

as

6 Council Directive 91/495/EEC of 27 November 1990
concerning public health and animal health problems
affecting the production and placing on the market of
rabbit meat and farmed game meat (7), as
last
amended by the Act of Accession of Austria, Finland
and Sweden,

6 Council Directive 92/45/EEC of 16 June 1992 on
public health and animal health problems relating to
the killing of wild game and the placing on the market
of wild-game meat (8), as last amended by Directive
97/79/EC (9),

6 Council Directive 92/46/EEC of 16 June 1992 laying
down the health rules for the production and placing
on the market of raw milk, heat-treated milk and
milk-based
by
Directive 96/23/EC (11),

products (10),

amended

last

as

6 Council Directive 92/118/EEC of 17 December 1992
laying down animal health and public health
requirements governing trade in and imports into
the Community of products not subject to the said
requirements laid down in specific Community rules
referred to in Annex A(I) to Directive 89/662/EEC
Directive
to
as
and,
90/425/EEC (12),
by Directive
97/79/EC.

regards
as

pathogens,

amended

last

(4) The aim of these Directives is to prevent the spread of
animal diseases resulting from the placing on the market
of products of animal origin.

(5) These Directives contain common provisions such as
those restricting the placing on the market of products
coming from a holding or area infected by epizootic
diseases and those requiring products from restricted
areas to undergo treatment to destroy the disease agent.

6 Council Directive 91/494/EEC of 26 June 1991 on
animal health conditions governing intra-Community

(1) OJ L 302, 31.12.1972, p. 24.
(2) OJ L 47, 21.2.1980, p. 4.
(3) OJ L 46, 19.2.1991, p. 1.
(4) OJ L 189, 3.7.1998, p. 12.

(5) OJ L 268, 24.9.1991, p. 35.
(6) OJ L 340, 31.12.1993, p. 39.
(7) OJ L 268, 24.9.1991, p. 41.
(8) OJ L 268, 14.9.1992, p. 35.
(9) OJ L 24, 30.1.1998, p. 31.
(10) OJ L 268, 14.9.1992, p. 1.
(11) OJ L 125, 23.5.1996, p. 10.
(12) OJ L 62, 15.3.1993, p. 49.

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(6) These common provisions can be harmonised, thereby
removing possible inconsistencies introduced when the
specific animal health rules were adopted. Such harmon-
isation will also ensure uniform implementation of the
the Community and
throughout
animal health rules
greater transparency in the structure of Community legis-
lation.

(7) The veterinary checks on products of animal origin
intended for trade must be carried out
in accordance
with Council Directive 89/662/EEC of 11 December
1989 concerning veterinary checks in intra-Community
trade with a view to the completion of
the internal
market (1), as last amended by Directive 92/118/EEC.
Directive 89/662/EEC contains safeguard measures that
may be implemented in case of a serious hazard to
animal health.

(8) Products imported from third countries must not present

an animal health hazard for Community livestock.

(15) Provision must be made

the organisation of
Community audits and inspections in order to ensure
the uniform application of the animal health provisions.

for

(16) The products covered by this Regulation are listed in

Annex I of the Treaty.

(17) Since the measures necessary for the implementation of
this Regulation are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of
28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission (4),
they should be adopted by use of
the regulatory
procedure provided for in Article 5 of that Decision,

HAS ADOPTED THIS REGULATION:

Article 1

(9) To that end, procedures must be introduced to prevent
the introduction of epizootic diseases. Such procedures
include an evaluation of the animal health situation in
the third countries concerned.

This Regulation lays down the animal-health rules governing
the placing on the market of and imports from third countries
of products of animal origin.

(10) Procedures must be introduced for establishing general or
specific rules or criteria to be applied to imports of
products of animal origin.

(11) Rules concerning the importation of meat of domestic
ungulates and meat products prepared from or with
such meat are already contained in Council Directive
72/462/EEC of 12 December 1972 on health and
veterinary inspection problems upon importation of
bovine, ovine and caprine animals and swine,
fresh
meat or meat products from third countries (2), as last
amended by Directive 97/79/EC.

Article 2

For the purposes of this Regulation, the definitions laid down
in the Directives referred to in Annex I and, where applicable,
in Council Regulation . . ./. . . on the hygiene of foodstuffs, shall
apply.

CHAPTER I

ANIMAL HEALTH REQUIREMENTS FOR THE PRODUCTION
AND MARKETING OF COMMUNITY PRODUCTS

Article 3

(12) The procedures applicable to the importation of meat and
meat products can be used as a model for the importation
of other products of animal origin.

The marketing of products of animal origin must not result in
the spreading of diseases transferable to animals. To that effect,
the following rules shall be complied with:

(13) Veterinary checks on products of animal origin imported
into the Community from third countries must be carried
out in accordance with Council Directive 97/78/EC of
principles
laying
18 December
governing the organisation of veterinary checks on
products entering the Community from third countries (3);
Directive 97/78/EEC contains safeguard measures that
may be implemented in case of a serious hazard to
animal health.

down

1997

the

(14) Account must be taken of the rules laid down by the
@Office International des EpizootiesA (OIE) when adopting
rules for international trade.

(1) OJ L 395, 30.12.1989, p. 13.
(2) OJ L 302, 31.12.1972, p. 28.
(3) OJ L 24, 30.1.1998, p. 9.

1. Products of animal origin shall be obtained from animals
which fulfil the animal health conditions laid down by the
relevant Community legislation.

2. Products of animal origin shall be obtained from animals:

(a) which come from a holding,

territory or part of a
territory or, in the case of aquaculture products, from
a farm, zone or part of a zone, not subject to animal
health restrictions
and
restrictions
products
under the rules referred to in Annex I or other disease-
control measures imposed by Community legislation,

and in particular

concerned,

applicable

animals

to the

(4) OJ L 184, 17.7.1999, p. 23.

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(b) which were not slaughtered in an establishment

in
which animals infected, or suspected of being infected
with one of the diseases covered by the rules referred to
at (a) above, or carcases of such animals, were present at
the time of slaughter.

3. Notwithstanding part 2 and subject to compliance with the

disease-control measures referred to in Annex I:

(a) the marketing of products of animal origin coming from
a territory or part of a territory subject to animal health
restrictions but which are not coming from a holding
which is infected or suspected of being infected shall be
permitted provided, as the case may be, that:

6 the products, before being

referred to hereunder,

submitted to the
are obtained,
treatment
handled, transported and stored separately from or
at different
the
animal-health conditions,

times than products fulfilling all

5. Where:

6 provisions adopted for animal health reasons under
Article 9 of Directive 89/662/EEC require products of
animal origin from a Member State to be accompanied
by a health certificate, or

6 products must be accompanied by a certificate on
the animal health situation in a Member

account of
State or part of a Member State,

in the language of

the specimen for such certificates must conform to the
model
established in accordance with the procedure
referred to in Article 11. Certificates must be drawn up at
least
the certifying official and the
language of the place of destination. The products must
be accompanied by the original certificate, which must
consist of a single sheet of paper and be made out for a
single consignee.

6 the products have undergone a treatment sufficient
to eliminate the animal-health problem concerned,

Article 4

Official controls

6 the

treatment

an establishment
applied at
approved for that purpose by the Member State
where the animal-health problem occurred,

is

Official controls shall be carried out by the competent auth-
orities of the Member States to ensure compliance with this
Regulation, its implementing rules and any safeguard measures
applied to products of animal origin, pursuant hereto.

6 the products which must be
treatment are properly identified.

submitted to a

Detailed rules on these controls, their results and the decisions
to be taken on the basis of those results shall be adopted in
accordance with the procedure referred to in Article 11.

This paragraph shall be applied in accordance with
Annexes II and III(1) and (2) hereto, or with detailed
rules to be adopted in accordance with the procedure
referred to in Article 11;

(b) the marketing of aquaculture products not complying
with the conditions laid down in paragraph 2 shall be
permitted subject to the conditions laid down in Annex
III(3) hereto and where necessary in accordance with
further conditions to be laid down in accordance with
the procedure referred to in Article 11.

4. Derogations from paragraph 2 may be granted in specific
situations, in accordance with the procedure referred to in
Article 11. In such cases, particular account shall be taken
of:

Article 5

Follow-up of official controls and right of appeal

Where infringements of
action shall be taken to remedy the situation.

the animal-health rules are found,

Where the legal or natural person or persons involved in the
infraction fail to remedy the situation within the time fixed by
the competent authority, or if a serious animal-health risk is
found, restrictions shall be placed on the production and
marketing of the products concerned. Such restrictions may
entail a ban on the production and marketing of products of
animal origin and the withdrawal and, if necessary, destruction
of products already placed on the market.

(a) any measure or test to be carried out on the animals;

(b) the specific characteristics of the disease in the species

concerned.

Infringements of this Regulation, its implementing rules or any
safeguard health measures applied to products of animal origin,
as well as any failure to cooperate with the competent
authority shall result
the appropriate
criminal and/or administrative penalties by the competent
national authorities.

in the imposition of

Where such derogations are granted, any measures needed
to ensure the protection of animal health in the Community
shall be adopted in accordance with the same procedure.

In taking corrective action or imposing criminal and/or admin-
istrative penalties, Member States shall take account of
the
findings of Community checks.

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Rights of appeal against decisions taken by the competent auth-
orities as provided for by the national legislation in force in the
Member States shall not be affected by this Regulation.

CHAPTER II

IMPORTS FROM THIRD COUNTRIES

Article 6

Community audits and inspections

inspections at all

Experts from the Commission may, in cooperation with
1.
the competent authorities of the Member States, make audits
and/or
in the production and
stages
marketing of products of animal origin as well as on the
organisation and functioning of the competent authorities in
the Member States, in order to ensure the uniform application
of this Regulation, its implementing rules and any safeguard
measures pursuant hereto. Commission experts may be accom-
panied by the competent authority of the Member State and
any expert appointed by the Commission for the purpose of an
audit and/or inspection.

The

Commission

general
shall
2.
programme of audits and/or
to the Member
States on a regular basis and shall inform them of the results.

communicate

inspections

its

3.
The procedure for inspections and/or audits referred to in
paragraph 1 may be determined or amended in accordance
with the procedure referred to in Article 11.

4.
To enable audits and/or inspections to be carried out
efficiently,
the Member State in whose territory an audit
inspection is undertaken shall give all necessary
and/or
assistance and provide all documentation requested by the
Commission experts for the purpose of the audit.

5.
The Commission shall ensure that the experts referred to
in paragraph 1 received adequate training in food hygiene and
safety, auditing techniques and where relevant to their duties
the principles of the hazard analysis and critical control points
system,
their duties
competently,

them to undertake

in order

for

6. Member States shall ensure that the experts referred to in
paragraph 1 have access to all premises or parts of premises
and information relevant to the execution of their duties under
this Regulation.

If during a Commission audit or inspection a serious risk to
animal health is identified, the Member State concerned shall
immediately take all measures necessary to safeguard animal
health. If such measures are not taken, or if they are considered
to be insufficient,
take the measures
the Commission shall
necessary to safeguard animal health and inform the Member
States thereof.

Article 7

General provisions

The provisions applicable to the importation of products of
animal origin from third countries shall comply with or be
to the production and
to those
equivalent
marketing of Community products.

applicable

Article 8

Compliance with Community rules

In order to ensure the respect of the general obligation laid
down in Article 7,
the following shall be established in
accordance with the procedure referred to in Article 11:

1. Lists of the third countries or parts of third countries from
which imports of specified products of animal origin are
permitted.

When establishing these lists, particular account shall be
taken of:

6 the legislation of the third country,

6 the organisation of

the competent authority and its
inspection services in the third country, the powers of
these services, the supervision to which they are subject,
and their authority to monitor effectively the application
of their legislation,

6 the actual animal health conditions applied to the
and
production, manufacture,
dispatch of products of animal origin intended for the
Community,

handling,

storage

6 the assurances the third country can give regarding
compliance with the relevant animal health conditions,

6 experience of marketing the product

from the third
country and the results of import checks carried out,

6 the results of Community inspections

in the third

country,

6 the health status of the livestock, other domestic animals
and wildlife in the third country, having particular
regard to exotic animal diseases and any aspects of the
general health situation in the country, which might
pose
animal health in the
a
Community,

risk to public or

6 the regularity and speed with which the third country
supplies information about the existence of infectious or
contagious animal diseases in its territory, in particular
the diseases mentioned in Lists A and B of the Inter-
national Office of Epizootic Diseases (OIE) or,
in the
case of diseases of aquaculture animals, the notifiable
diseases as listed in the Aquatic Animal Health Code
of the OIE,

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6 the rules on the prevention and control of infectious or
contagious animal diseases in force in the third country
and their implementation,
including rules on imports
from other countries.

The list drawn up under this paragraph may be combined
with other lists drawn up for public health purposes.

amended in accordance with the procedure referred to in
Article 11.

If during a Community audit and/or inspection a serious
4.
the Commission shall
risk to animal health is identified,
immediately take the measures necessary to safeguard animal
health and shall immediately inform the Member States thereof.

2. Special import conditions for each third country or group
of third countries, having regard to the health situation of
the third country or countries concerned. Such conditions
shall include details of the health certificate to accompany
consignments bound for the Community. Such certificates
must:

6 be drawn up in the language or languages of

the
Member State of destination and those of the Member
State in which the border inspection takes place; the
Member
inspection or destination may
to the use of a Community language other
consent
than its own,

State of

6 accompany the products in the original,

6 consist of a single sheet of paper,

6 be made out for a single consignee.

The certificate must be issued on the day the products are
loaded for dispatch to the country of destination and be
signed by a representative of the competent authority. It
may be combined with the certificate to be provided for
under the public health rules.

3. Where necessary,

6 the detailed rules for the application of this Article, and

6 criteria for classifying third countries and parts thereof

with regard to animal diseases.

Article 9

Community inspections and audits

Audits and/or inspections at all stages covered by this
1.
Regulation may be
from the
carried out by
Commission in third countries in order to verify compliance
or
rules.
Commission experts may be accompanied by any other
expert appointed by the Commission for the purposes of the
audit and/or inspection.

equivalence with Community

experts

animal

health

The audits and/or inspections in third countries referred
the

2.
to in paragraph 1 shall be carried out on behalf of
Commission and the latter shall meet the costs incurred.

5.
The Commission shall ensure that its experts and other
experts referred to in paragraph 1 have received adequate
training in animal health and auditing techniques in order
for them to undertake their duties competently.

CHAPTER III

FINAL PROVISIONS

Article 10

The Annexes hereto may be amended or supplemented in
accordance with the procedure referred to in Article 11. This
procedure shall
in particular be followed to lay down the
criteria for classifying third countries and parts thereof with
regard to particular diseases.

Article 11

Standing Veterinary Committee procedure

The Commission shall be assisted by the Standing
by Council Decision

instituted

1.
Veterinary Committee,
68/361/EEC (1).

2. Where reference is made to this paragraph, the Regu-
laid down in Article 5 of Decision
latory procedure
1999/468/EC shall apply, in compliance with Article 7(3) and
Article 8 thereof.

The period provided for in Article 5(6) of Decision

3.
1999/468/EC shall be 3 months.

Article 12

Member States shall notify the Commission of any provisions
they adopt specifically to implement this Regulation and all the
legal instruments used and measures taken for its implemen-
tation and enforcement.

Article 13

This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

It shall apply from 1 January 2004.

3.
The procedure for the audits and/or inspections in third
countries referred to in paragraph 1 may be determined or

This Regulation shall be binding in its entirety and directly
applicable in all Member States.

(1) OJ L 225, 18.10.1968, p. 23.

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DISEASES OF CONCERN IN TRADE WITH PRODUCTS OF ANIMAL ORIGIN

I. Diseases for which control measures have been introduced under Community legislation

ANNEX I

Disease

Directive

Classical swine fever

Foot-and-mouth disease

Avian influenza

Newcastle disease

Rinderpest
Peste des petits ruminants
Swine vesicular disease

Council Directive 80/217/EEC introducing Community
measures for the control of classical swine fever

Council Directive 85/511/EEC introducing Community
measures for the control of foot-and-mouth disease

Council Directive 92/40/EEC introducing Community
measures for the control of avian influenza

Council Directive 92/66/EEC introducing Community
measures for the control of Newcastle disease

92/119/EEC introducing

Council Directive
general
Community measures for the control of certain animal
diseases
swine
vesicular disease

specific measures

relating

and

to

Infectious Salmon Anaemia (ISA)
Infectious haematopoietic necrosis (IHN)
Viral haemorrhagic septicaemia (VHS)

Molluscs diseases

Council Directive 93/53/EEC introducing minimum
the control of certain fish
Community measures for
diseases

Council Directive
95/70/EC introducing minimum
Community measures for the control of certain diseases
affecting bivalve molluscs

II. Measures relating to African swine fever

Pending the adoption of specific control measures for African swine fever, Directive 80/217/EEC shall apply, mutatis
in the event of outbreaks of African swine fever. Notwithstanding that Directive, decisions to lift the
mutandis,
restrictions applied under this point shall be taken in accordance with the procedure referred to in Article 11.

1. Meat

impose an immediate ban on
A Member State in whose territory African swine fever has been recorded shall
movements of fresh pigmeat from the part of its territory in which the outbreak occurred to the rest of the
Community.

For the purpose of defining parts of the territory as referred to above, particular account shall be taken of:

6 the methods used to combat the disease, in particular the elimination of pigs from holdings which are infected,

contaminated or suspected of infection or contamination,

6 the surface area of the parts of the territory concerned and their administrative and geographical boundaries,

6 the incidence of the disease and its tendency to spread,

6 the measures taken to prevent the disease from spreading,

6 the measures taken to restrict and control the movement of pigs both inside and outside the part of the territory

concerned.

2. Meat products

A Member State in whose territory African swine fever has been recorded shall
impose an immediate ban on
movements of meat products from the part of its territory in which the outbreak occurred to the rest of the
Community. However,
the derogation provided for in Article 3(3) shall apply to meat products that have
undergone one of the treatments referred to in Annex III points 1(a) and (e).

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ANNEX II

Special identification mark for fresh meat coming from a territory or a part of a territory not fulfilling all
relevant animal health requirements

Fresh meat obtained from animals coming from a holding situated in an area under animal health restrictions for one of
the diseases referred to in Annex I and to be submitted to a treatment to eliminate the animal health problem concerned
must be identified as follows:

1. The health mark for fresh meat must be covered by a cross consisting of two straight lines crossing at right angles

with the point of intersection in the centre of the stamp and the information thereon remaining legible.

2. The mark may also be made with a single stamp; the following information must appear on the mark in perfectly

legible characters:

6 on the upper part, the name of the exporting country in capitals,

6 in the centre, the veterinary approval number of the slaughterhouse,

6 on the lower part, one of the following abbreviations: CE 6 EF 6 EK 6 EC 6 EY 6 EG,

6 two straight lines crossing the stamp, intersecting at right angles at the centre of the stamp in such a way that

the information is not obscured,

6 information whereby the veterinarian who inspected the meat may be identified.

The mark must be applied by or under the responsibility of the official veterinarian responsible for controlling the
implementation of the animal health requirements.

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1. Treatments in order to eliminate animal health risks from meat

ANNEX III

Treatment (*)

Foot-
and-mouth
disease

Classical
swine fever

Swine
vesicular
disease

African swine
fever

Rinderpest

Newcastle
disease

Avian
influenza

Peste des
petits
ruminants

Disease

(a) Heat treatment in a hermetically sealed
container with a F0 value of 3,00 or
more

(b) Heat

treatment

a minimum
temperature of 70 IC, which must be
reached throughout the meat

at

(c) Heat

treatment

a minimum
temperature of 80 IC which must be
reached throughout the meat

at

to at

(d) Heat treatment in a hermetically sealed
container
a
minimum of 4 hours, during which
time the core temperature must be at
least 70 IC for 30 minutes

least 60 IC for

(e) Natural fermentation and maturation of
not
less than 9 months for boneless
meat, resulting in the following charac-
teristics: aw value of not more than
0,93 or a pH value of not more than
6,0

(f) As (e) above but meat may contain
bone. All the necessary measures must
be taken to avoid cross contamination

(g) Salami processing in accordance with
criteria to be laid down in accordance
Veterinary
Standing
with
the
following
procedure,
Committee
Scientific
the
opinion
Committee

relevant

of

(h) Ham and loins which have undergone
natural fermentation and maturation, of
least 190 days for hams and 140
at
days for loins

(i) Heat

ensuring

treatment

core
temperature of at least 65 IC is reached
the time necessary to achieve a
for
to or
pasteurisation value (pv) equal
more than 40

a

+

+

+

+

+

+

+

6

+

+

+

+

+

+

6

+

6

6

+

+

+

+

6

6

6

6

6

+

6

+

+

+

6

+

+

6

+

+

+

+

+

6

+

6

6

+

+

+

+

+

6

6

6

6

+

+

+

+

+

+

+

+

6

6

6

6

6

6

6

6

6

+

@+A: Effectiveness recognised.

(*) All the necessary measures must be taken to avoid cross contamination.

2. Treatment to eliminate animal health risks from milk

Milk of species susceptible to foot-and-mouth disease and milk products manufactured entirely or partly with such milk,
may not come from a surveillance area as provided for by Directive 85/811/EEC unless the milk or milk product has
undergone one of the following treatments, under the supervision of the competent authority:

(a) sterilisation to an Fo value of 3 or above; or

(b) a single UHT treatment at 130 IC for 2-3 sec.;

(c) an initial heat treatment having a heating effect at least equivalent to that obtained by pasteurisation at a temperature
of at least 72 IC for at least 15 seconds and sufficient to result in a negative reaction to the phosphatase test,
followed by:

(i) a second heat treatment, resulting in a negative reaction to the peroxidase test, or

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(ii) in the case of milk powder or a product containing milk powder, a second heat treatment having an effect at
least equivalent to that obtained by the first heat treatment and sufficient to result in a negative reaction to the
phosphatase test, followed by a drying procedure, or

(iii) an acidification procedure whereby the pH is reduced to below 6 and maintained at that level for at least one

hour,

(iv) a second heat treatment having an effect at least equivalent to that obtained by the first heat treatment; both
heat treatments shall be applied to milk with a pH above 7,0 (this treatment is not allowed for milk from a
protection and surveillance zone);

(d) the initial heat treatment referred to under (c), applied to milk with a pH of less than 7,0 (this treatment is not

allowed for milk from a protection and surveillance zone).

3. Treatment to reduce animal health risks in aquaculture products

(a) Aquaculture fish susceptible to infectious haematopoietic necrosis and viral haemorrhagic septicaemia originating in
a zone not approved for those diseases may be introduced into an approved zone only if such fish are killed, headed
and eviscerated prior to dispatch. This requirement shall be waived for fish from an approved farm in a
non-approved zone.

(b) Live molluscs susceptible to bonamiosis and marteiliosis originating in a zone not approved for those diseases may
be introduced into an approved zone only where they are either intended for direct human consumption or
delivered to the canning industry. They shall not be relayed unless:

6 they originate in an approved farm in a non-approved zone, or

6 they are temporarily immersed in storage ponds or purification centres specially equipped and approved for that
purpose by the competent authority, and having, in particular, a system for the treatment and disinfection of
waste water.

Any detailed rules needed for the implementation of these requirements shall be adopted in accordance with the
procedure referred to in Article 11.