Common Position (EC) No 12/2002 of 20 November 2001 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Regulation of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption
Date: 2001-11-20
Institutions: Council of the European Union
Subjects: EU control, animal disease, animal product, foodstuffs legislation, health legislation, veterinary inspection

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COMMON POSITION (EC) No 12/2002

adopted by the Council on 20 November 2001

with a view to adopting Regulation (EC) No . . ./2002 of the European Parliament and of the
Council of . . . laying down health rules concerning animal by-products not intended for human
consumption

(2002/C 45 E/06)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

animal by-products other
disposal.

than in feed and for their

Having regard to the Treaty establishing the European
Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of
Committee (2),

the Economic and Social

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

(1) Council Directive 90/667/EEC of 27 November 1990
laying down the veterinary rules for the disposal and
processing of animal waste,
its placing on the
market and for the prevention of pathogens in feed-
ingstuffs of
fish origin and amending
Directive 90/425/EEC (4) established the principle that all
animal waste, regardless of its source, may be used for the
appropriate
production of
treatment.

feed material

animal or

following

for

(2) The Scientific Steering Committee has adopted a number
of opinions since the adoption of that Directive. Their
main conclusion is
that animal by-products derived
from animals not fit for human consumption following
health inspection should not enter the feed chain.

(3) In the light of

those scientific opinions, a distinction
should be drawn between the measures to be imple-
mented, depending on the nature of animal by-products
used. The possible uses of certain animal materials should
be limited. Rules should be laid down for the use of

(1) OJ C 96 E, 27.3.2001, p. 40.
(2) OJ C 193, 10.7.2001, p. 32.
(3) Opinion of the European Parliament of 12 June 2001 (not yet
published in the Official
Journal), Council Common Position of
20 November 2001 and Decision of the European Parliament of
. . . (not yet published in the Official Journal).

(4) OJ L 363, 27.12.1990, p. 51. Directive as last amended by the 1994

Act of Accession.

(4) In the light of the experience gained in recent years, it is
appropriate to clarify the relationship between Directive
90/667/EEC and Community environmental
legislation.
This Regulation should not affect
the application of
legislation or hinder the devel-
existing environmental
opment of new rules on environmental protection,
particularly as regards biodegradable waste.

(5) The International Scientific Conference on Meat-and-Bone
Meal organised by the Commission and the European
Parliament, held in Brussels on 1 and 2 July 1997,
initiated a debate concerning the production and feeding
of meat-and-bone meal. The Conference called for further
reflection on the future policy in this area. In November
1997, to launch the widest possible public debate about
the future of
the
Commission finalised a consultation paper on meat-
it appears
and-bone meal. Following that consultation,
that there is a general recognition of the need to amend
Directive 90/667/EEC to bring it in line with the new
scientific information.

the Community’s

feed legislation,

(6) The European Parliament, in its resolution of 16 November
2000 on BSE and safety of animal feed (5), called for a ban
on the use of animal protein in feed until the present
Regulation enters into force.

(7) Scientific advice suggests that the practice of feeding an
animal species with proteins derived from the bodies, or
parts of bodies, of the same species presents a risk of
this
spreading disease. As a precautionary measure,
practice should therefore be prohibited.
Implementing
rules should be adopted to ensure the necessary sepa-
ration of animal by-products destined for use in feed at
every stage of processing, storage and transport. However,
there should be scope to establish derogations from this
general prohibition in relation to fish and fur animals if
justified by scientific advice.

(8) Catering waste containing products of animal origin can
also be a vector for the spread of disease. All catering
waste generated from means of transport operating inter-
nationally should be disposed of safely. Catering waste
produced within the Community should not be used for
the feeding of farmed animals other than fur animals.

(5) OJ C 223, 8.8.2001, p. 281.

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(9) From October 1996, the Food and Veterinary Office of
the Commission (FVO) carried out a number of rounds of
inspections in Member States, to assess the presence and
management of main risk factors
and surveillance
procedures with regard to BSE. Part of the assessment
covered the systems of commercial rendering and other
methods of animal waste disposal. General conclusions
and a number of
recommendations were drawn up
following those inspections, with particular reference to
the traceability of animal by-products.

the
information necessary to enable it
situation and to lay down implementing rules if appro-
priate.

to monitor

(15) Community inspections should be carried out

in the
Member States to ensure uniform implementation of the
health requirements. Such inspections should also include
audit procedures.

(10) To avoid any risk of dispersal of pathogens and/or
residues, animal by-products should be processed, stored
and kept separated in an approved and supervised plant
designated by the Member State concerned or be disposed
In certain circumstances,
of
especially when it
time of
transport,
designated
processing, incineration or coincineration plant could be
located in another Member State.

in a suitable manner.

justified by distance,

is
capacity

problems,

the

or

up

the

relevant

end,
by

Commission

(16) The basis for Community legislation on health issues is
scientific
sound science. To this
Decisions
committees
set
97/404/EC (2) and 97/579/EC (3)
should be consulted
scientific
wherever necessary.
advice is required on the use of products of animal
improvers. Pending
origin in organic fertilisers and soil
the adoption of Community rules in the light of
this
advice, Member States may maintain or adopt national
rules that are stricter than those envisaged in this Regu-
lation, provided that
such rules comply with other
applicable Community legislation.

In particular,

further

(11) Directive 2000/76/EC of the European Parliament and of
the Council of 4 December 2000 on the incineration of
waste (1) does not apply to incineration plants if the waste
treated consists solely of animal carcases. It is necessary to
lay down minimum requirements for such incineration
plants to protect animal and public health. Pending the
adoption of Community requirements, Member States
may adopt environmental
legislation for such plants.
Less strict requirements should apply to low-capacity
incineration plants, such as those located on farms and
at pet crematoria, to reflect the lower risk posed by the
material treated and to avoid unnecessary transport of
animal by-products.

(17) A wide variety of approaches exists in Member States as
regards the financial support for processing, collection,
storage and disposal of animal by-products. To ensure
that the conditions of competition between agricultural
products are not affected, it is necessary to carry out an
analysis and, if necessary, to take appropriate measures at
Community level.

(18) In the light of the above, a fundamental revision of the
to animal by-products
applicable

Community
appears to be necessary.

rules

(12) Specific rules

should be laid down on controls

for
processing plants, with particular reference to detailed
procedures for the validation of processing methods and
for self-supervision of production.

(13) Derogations

from the rules on the use of animal
by-products may be appropriate to facilitate the feeding
of animals not destined for human consumption. The
competent authorities should control such uses.

(14) Derogations may also be appropriate to permit

the
disposal of animal by-products on site in controlled
the
circumstances. The Commission should receive

(19) Animal by-products not destined for human consumption
(in particular processed animal protein, rendered fats,
petfood, hides and skins and wool) are included in the
list of products in Annex I to the Treaty. The placing on
the market of such products constitutes an important
source of income for part of the farming population. To
ensure rational development in this sector and increase
productivity, animal health and public health rules for
in question should be laid down at
the products
the
Community level. Given the significant
spread of diseases
exposed,
to which animals
particular requirements should apply to the placing on
the market of certain animal by-products, particularly in
regions with a high health status.

risks of
are

(2) OJ L 169, 27.6.1997, p. 85. Decision as amended by Decision

2000/443/EC (OJ L 179, 18.7.2000, p. 13).

(3) OJ L 237, 28.8.1997, p. 18. Decision as amended by Decision

(1) OJ L 332, 28.12.2000, p. 91.

2000/443/EC.

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a

the
The

approval

importation

that
observed.

(20) To ensure that products imported from non-member
countries are of a hygiene standard which is at
least
equal or equivalent to the hygiene standard applied by
the Community,
should be
system of
introduced for non-member countries and their estab-
inspection
together with a Community
lishments,
such
to ensure
procedure
for
conditions
approval
from
are
non-member countries of petfood and raw material for
to conditions different
petfood can take place subject
from those applicable to such material produced in the
Community,
the guarantees
required concerning the residues of substances prohibited
in accordance with Council Directive 96/22/EC of 29 April
1996 concerning the prohibition on the use in stock
farming of certain substances having a hormonal or
thyrostatic action and of beta-agonists, and repealing
Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (1).
To ensure that such petfood and raw material are used
only for their intended purpose,
it is necessary to lay
down appropriate control measures on importation of
material covered by such derogations.

in particular as

regards

(21) Animal by-products that pass through the Community in
transit, and those originating in the Community and
destined for export, can create a risk for animal and
Certain
public
requirements
laid down by this Regulation should
therefore apply to such movements.

Community.

within

health

the

(22) The accompanying document

the best way of

for products of animal
origin is
satisfying the competent
authority of the place of destination that a consignment
this Regulation. The
complies with the provisions of
health certificate should be maintained for the purposes
of verifying the destination of certain imported products.

(23) Council Directive 92/118/EEC of 17 December 1992
laying down animal health and public health requirements
governing trade 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 and, as
to
Directive 90/425/EEC (2) pursues
the abovementioned
objectives.

regards pathogens,

(24) The Council and the Commission have adopted several
implementing Directives 90/667/EEC and
Decisions
92/118/EEC.
Furthermore, Directive 92/118/EEC has
been substantially amended and further amendments are
to be made. Consequently, a great number of Community
acts currently regulate the animal by-products sector and
there is a need for simplification.

(1) OJ L 125, 23.5.1996, p. 3.
(2) OJ L 62, 15.3.1993, p. 49. Directive as

last amended by

Commission Decision 2001/7/EC (OJ L 2, 5.1.2001, p. 27).

(25) Such simplification will

lead to more transparency with
regard to specific health rules for products of animal
origin not destined for human consumption. Simplifi-
cation of the specific health legislation must not lead to
deregulation. It is therefore necessary to maintain and, to
ensure public and animal health protection, to tighten the
detailed health rules for products of animal origin not
destined for human consumption.

(26) The products concerned should be subject to the rules for
veterinary checks, including checks by experts from the
Commission, and any protective measures laid down by
Council Directive 90/425/EEC of 26 June 1990
concerning veterinary and zootechnical checks applicable
in intra-Community trade in certain live animals and
products with a view to the completion of the internal
market (3).

(27) Effective checks

should be carried out on products
imported into the Community. This can be achieved by
implementing the controls laid down in Council Directive
97/78/EC of 18 December 1997 laying down the prin-
ciples governing the organisation of veterinary checks
on products entering the Community from non-member
countries (4).

(28) Directive 90/667/EEC, Council Decision 95/348/EC of
22 June 1995 laying down the veterinary and animal
health rules applicable in the United Kingdom and
Ireland to the treatment of certain types of waste
intended to be marketed locally as feedstuffs for certain
animal categories (5) and Council Decision 1999/534/EC
of 19 July 1999 on measures applying to the processing
of certain animal waste to protect against transmissible
spongiform encephalopathies and amending Commission
Decision 97/735/EC (6) should therefore be repealed.

(29) To take account of technical and scientific progress, close
and effective cooperation should be ensured between the
Commission and the Member States within the Standing
Veterinary Committee
set up by Council Decision
68/361/EEC (7).

(30) The measures necessary for the implementation of this
Regulation should be
adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (8),

(3) OJ L 224, 18.8.1990, p. 29. Directive as last amended by Directive

92/118/EEC.

(4) OJ L 24, 30.1.1998, p. 9.
(5) OJ L 202, 26.8.1995, p. 8.
(6) OJ L 204, 4.8.1999, p. 37.
(7) OJ L 255, 18.10.1968, p. 23.
(8) OJ L 184, 17.7.1999, p. 23.

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HAVE ADOPTED THIS REGULATION:

This Regulation shall not affect veterinary legislation
3.
having as its objective the eradication and control of certain
diseases.

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

This Regulation lays down animal and public health rules

1.
for:

(a) the collection, transport, storage, handling, processing and
use or disposal of animal by-products, to prevent these
products from presenting a risk to animal or public health;

(b) the placing on the market and, in certain specific cases, the
export and transit of animal by-products and those
products derived therefrom referred to in Annexes VII
and VIII.

Article 2

Definitions

For the purpose of this Regulation, the following defi-

1.
nitions shall apply:

(a)

animal by-products: entire bodies or parts of animals or
products of animal origin referred to in Articles 4, 5 and 6
not
including ova,
embryos and semen;

intended for human consumption,

(b) Category 1 material: animal by-products referred to in

Article 4;

(c) Category 2 material: animal by-products referred to in

Article 5;

2.

This Regulation shall not apply to:

(d) Category 3 material: animal by-products referred to in

Article 6;

(a) raw petfood originating from retail shops or in premises
adjacent to sale points, where the cutting and storage are
performed solely for
supplying the
consumer directly on the spot;

the purpose of

(b) liquid milk and colostrum disposed of or used on the farm

of origin;

(c) entire bodies or parts of wild animals not suspected of
being infected with diseases communicable to humans or
animals, except for fish landed for commercial purposes
and bodies or parts of wild animals used to produce
game trophies;

(d) raw petfood for use on site derived from animals
slaughtered on the farm of origin for use as foodstuffs by
the farmer and his family only, in accordance with national
legislation;

(e) catering waste, unless:

(i) from means of transport operating internationally,

(ii) destined for animal consumption, or

(iii) destined for use in a biogas plant or for composting;

(f) ova, embryos and semen intended for breeding purposes;

and

(g) transit by sea or by air.

(e)

(f)

animal: any vertebrate or invertebrate animal
fish, reptiles and amphibians);

(including

farmed animal: any animal that is kept, fattened or bred by
humans and used for the production of food (including
meat, milk and eggs), wool, fur, feathers, skins or any
other product of animal origin;

(g) wild animal: any animal not kept by humans;

(h) pet animal: any animal belonging to species normally
nourished and kept, but not consumed, by humans for
purposes other than farming;

(i)

(j)

to

competent authority: the central authority of a Member
State
the
ensure
competent
this Regulation or any authority to
requirements of
which
that
has
authority
competence, in particular for the control of feedingstuffs;
it shall also include, where appropriate, the corresponding
authority of a non-member country;

compliance with

delegated

central

that

placing on the market: any operation the purpose of
which is to sell animal by-products, or products derived
therefrom covered by this Regulation, to a third party in
the Community or any other form of supply against
payment or free of charge to such a third party or
storage with a view to supply to such a third party;

(k)

trade: trade between Member States in goods within the
meaning of Article 23(2) of the Treaty;

(l)

transit: a movement through the Community from one
non-member country to another;

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(m) producer: any person whose activity produces animal

(ii) animals killed in the context of TSE eradication

by-products;

measures,

(n) TSEs:

all

transmissible
except those occurring in humans;

spongiform encephalopathies,

(o)

specified risk material: material referred to in Annex V to
Regulation (EC) No 999/2001 of the European Parliament
and of the Council of 22 May 2001 laying down rules for
the prevention, control and eradication of certain trans-
missible spongiform encephalopathies (1).

The specific definitions set out

2.
apply.

in Annex I shall also

Article 3

General obligations

Animal by-products, and products derived therefrom,
1.
shall be collected,
stored, handled, processed,
disposed of, placed on the market, exported, carried in
transit and used in accordance with this Regulation.

transported,

2.
However, Member States may regulate under national law
the importation and placing on the market of products not
referred to in Annexes VII and VIII, pending the adoption of
a decision in accordance with the procedure referred to in
Article 33(2). They shall immediately inform the Commission
of the use that they make of this possibility.

3. Member States shall, either individually or cooperatively,
ensure that adequate arrangements are in place, and that a
sufficient infrastructure exists, to ensure compliance with the
requirement of paragraph 1.

CHAPTER II

CATEGORISATION, COLLECTION, TRANSPORTATION,
DISPOSAL, PROCESSING, USE AND INTERMEDIATE STORAGE
OF ANIMAL BY-PRODUCTS

Article 4

Category 1 material

1.
Category 1 material shall comprise animal by-products of
the following description, or any material containing such
by-products:

(a) all body parts, including hides and skins, of the following

animals:

(i) animals

suspected of being infected by a TSE in
accordance with Regulation (EC) No 999/2001 or in
which the presence of a TSE has been officially
confirmed,

(iii) animals other than farmed animals and wild animals,
including in particular pet animals, zoo animals and
circus animals,

(iv) experimental animals as defined by Article 2 of
Council Directive 86/609/EEC of 24 November 1986
on the approximation of laws, regulations and admin-
istrative provisions of the Member States regarding the
protection of animals used for experimental and other
scientific purposes (2), and

(v) wild animals, when suspected of being infected with

diseases communicable to humans or animals;

(b) (i) specified risk material, and

(ii) where, at the time of disposal, specified risk material has
not been removed, entire bodies of dead animals
containing specified risk material;

(c) products derived from animals

to which substances
prohibited under Directive 96/22/EC have been admin-
istered and products of animal origin containing residues
of environmental contaminants and other substances listed
in Group B(3) of Annex I to Council Directive 96/23/EC of
29 April 1996 on measures to monitor certain substances
and residues thereof in live animals and animal products
and repealing Directives 85/358/EEC and 86/469/EEC and
Decisions 89/187/EEC and 91/664/EEC (3), if such residues
exceed the permitted level laid down by Community legis-
lation or, in the absence thereof, by national legislation;

(d) all animal material collected when treating waste water
from Category 1 processing plants and other premises in
which specified risk material
including
screenings, materials
from desanding, grease and oil
mixtures, sludge and materials removed from drains from
those premises;

removed,

is

(e) catering waste from means of transport operating inter-

nationally; and

(f) mixtures of Category 1 material with either Category 2
material or Category 3 material or both,
including any
material destined for processing in a Category 1 processing
plant.

2.
Category 1 material shall be collected, transported and
identified without undue delay in accordance with Article 7
and, except as otherwise provided in Articles 23 and 24,
shall be:

(1) OJ L 147, 31.5.2001, p. 1. Regulation as

last amended by
Commission Regulation (EC) No 1326/2001 (OJ L 177, 30.6.2001,
p. 60).

(2) OJ L 358, 18.12.1986, p. 1.
(3) OJ L 125, 23.5.1996, p. 10.

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(a) directly disposed of as waste by incineration in an incin-
eration plant approved in accordance with Article 12;

(b) processed in a processing plant approved under Article 13
using any of processing methods 1 to 5 or, where the
competent authority so requires, processing method 1, in
which case the resulting material shall be permanently
marked, where
in
and finally
accordance with Annex VI, Chapter
disposed of as waste by incineration or by coincineration
in an incineration or coincineration plant approved in
accordance with Article 12;

technically possible with smell,

I,

(c) with the exclusion of material referred to in paragraph
1(a)(i) and (ii), processed in a processing plant approved
in accordance with Article 13 using processing method 1,
in which case the resulting material shall be permanently
in
marked, where
accordance with Annex VI, Chapter
and finally
disposed of as waste by burial
in a landfill approved
under Council Directive 1999/31/EC of 26 April 1999 on
the landfill of waste (1);

technically possible with smell,

I,

(d) in the case of catering waste referred to in paragraph 1(e),
disposed of as waste by burial in a landfill approved under
Directive 1999/31/EC; or

(e)

in scientific knowledge,
in the light of developments
disposed of by other means
approved in
that
accordance with the procedure referred to in Article
the appropriate scientific
33(2), after consultation of
committee. These means may either
supplement or
replace those provided for in subparagraphs (a) to (d).

are

by Article 4(1)(d) or from Category 2 processing plants,
including screenings, materials
from desanding, grease
and oil mixtures, sludge and materials removed from
drains from those premises;

(c) products of animal origin containing residues of veterinary
drugs and contaminants listed in Group B(1) and (2) of
Annex I to Directive 96/23/EC,
if such residues exceed
laid down by Community legislation;
the permitted level

(d) products of animal origin, other than Category 1 material,
that are imported from non-member countries and, in the
course of the inspections provided for in Community legis-
lation, fail to comply with the veterinary requirements for
their importation into the Community, unless they are
returned or their importation is accepted under restrictions
laid down under Community legislation;

(e) animals and parts of animals, other than those referred to
in Article 4, that die other than by being slaughtered for
human consumption, including animals killed to eradicate
an epizootic disease;

(f) mixtures of Category 2 material with Category 3 material,
including any material destined for processing in a
Category 2 processing plant; and

(g) animal by-products other than Category 1 material or

Category 3 material.

Intermediate handling or storage of Category 1 material
take place only in Category 1 intermediate plants

3.
shall
approved in accordance with Article 10.

Category 2 material shall be collected, transported and
2.
identified without undue delay in accordance with Article 7
and, except as otherwise provided in Articles 23 and 24,
shall be:

Category 1 material shall not be imported or exported
4.
except in accordance with this Regulation or with rules laid
down under
the procedure referred to in Article 33(2).
However, the import or export of specified risk material shall
take place only in accordance with Article 8(1) of Regulation
(EC) No 999/2001.

Article 5

Category 2 material

(a) directly disposed of as waste by incineration in an incin-
eration plant approved in accordance with Article 12;

(b) processed in a processing plant approved in accordance
with Article 13 using any of processing methods 1 to 5
or, where the competent authority so requires, processing
in which case the resulting material shall be
method 1,
technically possible with
permanently marked, where
smell, in accordance with Annex VI, Chapter I, and:

1.
Category 2 material shall comprise animal by-products of
the following description, or any material containing such
by-products:

(i) disposed of as waste either by incineration or by coinci-
neration in an incineration or coincineration plant
approved in accordance with Article 12, or

(a) manure and digestive tract content;

(b) all animal materials collected when treating waste water
from slaughterhouses other than slaughterhouses covered

(1) OJ L 182, 16.7.1999, p. 1.

for use

(ii) in the case of rendered fats, further processed into fat
derivatives
soil
in organic
improvers or for other technical uses, other than in
cosmetics, pharmaceuticals and medical devices,
in a
Category 2 oleochemical plant approved in accordance
with Article 14;

fertilisers or

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(c) processed in a processing plant approved in accordance
with Article 13 using processing method 1, in which case
the resulting material shall be permanently marked, where
technically possible with smell, in accordance with Annex
VI, Chapter I, and:

(i) in the case of resulting proteinaceous material, used as
improver in compliance
an organic fertiliser or soil
laid down in accordance
with requirements,
with the procedure referred to in Article 33(2), after
consultation of the appropriate scientific committee,

if any,

(ii) transformed in a biogas plant or in a composting plant

approved in accordance with Article 15, or

(iii) disposed of as waste by burial in a landfill approved

under Directive 1999/31/EC;

(d) in the case of material of fish origin, ensiled or composted
in compliance with rules adopted in accordance with the
procedure referred to in Article 33(2);

(e)

in the case of manure, digestive tract content separated
from the digestive tract, milk and colostrum,
the
competent authority does not consider them to present a
risk of spreading any serious transmissible disease:

if

(i) used without processing as raw material in a biogas
plant or in a composting plant approved in accordance
with Article 15 or treated in a technical plant approved
for this purpose in accordance with Article 18,

(ii) applied to land in accordance with this Regulation, or

(iii) transformed in a biogas plant or composted in
accordance with rules laid down under the procedure
referred to in Article 33(2);

(f)

in the case of entire bodies or parts of wild animals not
suspected of being infected with diseases communicable to
humans or animals, used to produce game trophies in a
technical plant approved for this purpose in accordance
with Article 18; or

(g) disposed of by other means, or used in other ways,

in
accordance with rules laid down under
the procedure
referred to in Article 33(2), after consultation of the appro-
priate scientific committee. These means or ways may
in
replace
supplement or
either
subparagraphs (a) to (f).

those provided for

3.
Intermediate handling or storage of Category 2 material,
other than manure, shall take place only in Category 2 inter-
mediate plants approved in accordance with Article 10.

4.
Category 2 material shall not be placed on the market or
exported except in accordance with this Regulation or with

rules laid down under the procedure referred to in Article
33(2).

Article 6

Category 3 material

1.
Category 3 material shall comprise animal by-products of
the following description, or any material containing such
by-products:

(a) parts of slaughtered animals, which are fit

for human
consumption in accordance with Community legislation,
but
intended for human consumption for
are not
commercial reasons;

(b) parts of slaughtered animals, which are rejected as unfit for
human consumption but are not affected by any signs of
diseases communicable to humans or animals and derive
from carcases that are fit
for human consumption in
accordance with Community legislation;

(c) hides and skins, hooves and horns, pig bristles and feathers
originating from animals that are slaughtered in a slaught-
erhouse, after undergoing ante-mortem inspection, and
were fit, as a result of such inspection, for slaughter for
human consumption in accordance with Community legis-
lation;

(d) blood obtained from animals other than ruminants that are
slaughtered in a slaughterhouse, after undergoing ante-
mortem inspection, and were fit, as a result of such
inspection,
for human consumption in
accordance with Community legislation;

slaughter

for

(e) animal by-products derived from the production of
including

intended for human consumption,

products
degreased bones and greaves;

(f)

former foodstuffs of animal origin, or former foodstuffs
containing products of animal origin, other than catering
waste, which are no longer
for human
consumption for commercial reasons or due to problems
of manufacturing or packaging defects or other defects
which do not present any risk to humans or animals;

intended

(g) raw milk originating from animals that do not show
clinical signs of any disease communicable through that
product to humans or animals;

(h) fish or other sea animals, except sea mammals, caught in
the open sea for the purposes of fishmeal production;

(i)

(j)

fresh by-products from fish from plants manufacturing fish
products for human consumption;

shells, hatchery by-products and cracked egg by-products
originating from animals which did not show clinical signs
of any disease communicable through that product
to
humans or animals;

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(k) blood, hides and skins, hooves, feathers, wool, horns, hair
and fur originating from animals that did not show clinical
signs of any disease communicable through that product to
humans or animals; and

Intermediate handling or storage of Category 3 material
take place only in Category 3 intermediate plants

3.
shall
approved in accordance with Article 10.

(l) catering waste other than as referred to in Article 4(1)(e).

Article 7

Category 3 material shall be collected, transported and
2.
identified without undue delay in accordance with Article 7
and, except as otherwise provided in Articles 23 and 24,
shall be:

(a) directly disposed of as waste by incineration in an incin-
eration plant approved in accordance with Article 12;

(b) processed in a processing plant approved in accordance
with Article 13 using any of processing methods 1 to 5,
in which case the resulting material shall be permanently
in
marked, where
accordance with Annex VI, Chapter I, and disposed of as
waste either by incineration or by coincineration in an
incineration
in
coincineration
or
accordance with Article 12 or
in a landfill approved
under Directive 1999/31/EC;

technically possible with smell,

approved

plant

(c) processed in a processing plant approved in accordance

with Article 17;

(d) transformed in a technical plant approved in accordance

with Article 18;

(e) used as raw material

in a petfood plant approved in

accordance with Article 18;

(f)

transformed in a biogas plant or in a composting plant
approved in accordance with Article 15;

(g)

in the case of catering waste referred to in paragraph 1(l),
transformed in a biogas plant or composted in accordance
with rules laid down under the procedure referred to in
in
Article 33(2) or, pending the adoption of such rules,
accordance with national law;

Collection, transportation and storage

Animal by-products and processed products shall be
transported and identified in accordance with

1.
collected,
Annex II.

this Regulation,
animal by-products

During transportation, a commercial document or, when
2.
shall
required by
accompany
and processed products.
Commercial documents and health certificates shall satisfy
for the period, specified in
the requirements, and be kept
Annex II.

a health certificate,

3. Member States shall ensure that adequate arrangements
exist to guarantee the collection and transportation of Category
1 and Category 2 material in accordance with Annex II.

The storage of processed products shall take place only in

4.
storage plants approved in accordance with Article 11.

5.
However, Member States may decide not to apply the
provisions of this Article to manure transported between two
points located on the same farm or between farms and users
located in the same Member State.

Article 8

Dispatch of animal by-products and processed products to
other Member States

1.
Animal by-products and processed products shall be sent
to other Member States only subject to the conditions laid
down in paragraphs 2 to 6.

2.
The Member State of destination must have authorised
the receipt of Category 1 material, Category 2 material,
processed products derived from Category 1 or Category 2
material and processed animal protein. Member States may
make the application of processing method 1 prior
to
dispatch a condition of authorisation.

(h) in the case of material of fish origin, ensiled or composted
in accordance with rules laid down under the procedure
referred to in Article 33(2); or

Animal by-products, and processed products referred to

3.
in paragraph 2, shall be:

(i) disposed of by other means, or used in other ways,

in
accordance with rules laid down under the procedure
referred to in Article 33(2), after consultation of the appro-
priate scientific committee. These means or ways may
either
in
replace
subparagraphs (a) to (h).

those provided for

supplement or

(a) accompanied by a commercial document or, when required

by this Regulation, a health certificate, and

(b) conveyed directly to the plant of destination, which must
have been approved in accordance with this Regulation.

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4. When Member States send Category 1 material, Category
2 material, processed products derived from Category 1 or
Category 2 material and processed animal protein to other
Member States,
the place of
the competent authority of
inform the competent authority of the place of
origin shall
destination of each consignment by means of
the ANIMO
system, or by another method by mutual agreement. The
message shall contain the information specified in Annex II,
Chapter I, paragraph 2.

(c) undergo the plant’s own checks provided for in Article 25;

and

(d) be checked by the competent authority in accordance with

Article 26.

3.

To be approved, Category 3 intermediate plants must:

5. When informed of
its dispatch in accordance with
paragraph 4, the competent authority of the place of desti-
nation shall
inform the competent authority of the place of
origin of the arrival of each consignment by means of the
ANIMO system, or by another method by mutual agreement.

through
6. Member States of destination shall ensure,
regular checks, that the designated plants on their territory
use consignments only for authorised purposes and keep full
records demonstrating compliance with this Regulation.

(a) meet the requirements of Annex III, Chapter I;

(b) handle and store Category 3 material in accordance with

Annex III, Chapter II, Part A;

(c) undergo the plant’s own checks provided for in Article 25;

and

(d) be checked by the competent authority in accordance with

Article 26.

Article 9

Records

Article 11

Approval of storage plants

1.
Any person consigning, transporting or receiving animal
by-products shall keep a record of consignments. Records shall
contain the information, and be kept for the period, specified
in Annex II.

2.
However, this Article shall not apply to manure trans-
ported between two points located on the same farm or
locally between farms and users located in the same Member
State.

1.
Storage plants
competent authority.

shall be subject

to approval by the

2.

To be approved, storage plants must:

(a) meet the requirements of Annex III, Chapter III; and

(b) be checked by the competent authority in accordance with

Article 26.

CHAPTER III

Article 12

APPROVAL OF INTERMEDIATE, STORAGE, INCINERATION
AND COINCINCERATION, CATEGORY 1 AND 2 PROCESSING,
CATEGORY 2 AND CATEGORY 3 OLEOCHEMICAL, BIOGAS
AND COMPOSTING PLANTS

Article 10

Approval of intermediate plants

Category 1, 2 and 3 intermediate plants shall be subject

1.
to approval by the competent authority.

To be approved, Category 1 or Category 2 intermediate

2.
plants must:

(a) meet the requirements of Annex III, Chapter I;

Approval of incineration and coincineration plants

of

and

The

incineration

coincineration

processed
1.
products shall take place in accordance with the provisions
of Directive 2000/76/EC. The incineration and coincineration
of animal by-products shall take place either in accordance
with the provisions of Directive 2000/76/EC or, when that
in accordance with the provisions
Directive does not apply,
of
Incineration and coincineration plants
this Regulation.
shall be approved under that Directive or in accordance with
paragraph 2 or 3.

2.
To be approved by the competent authority for the
purpose of disposing of animal by-products, a high capacity
incineration or
to which Directive
coincineration plant
2000/76/EC does not apply must fulfil:

(a) the general conditions laid down in Annex IV, Chapter I;

(b) handle and store Category 1 or Category 2 material

in

accordance with Annex III, Chapter II, Part B;

(b) the operating conditions laid down in Annex IV, Chapter II;

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(c)

the requirements laid down in Annex IV, Chapter III,
concerning water discharges;

To be approved, Category 1 and Category 2 processing

2.
plants must:

(d) the requirements laid down in Annex IV, Chapter IV,

(a) meet the requirements of Annex V, Chapter I;

concerning residues;

(e)

the temperature measurement requirements laid down in
Annex IV, Chapter V; and

(b) handle, process and store Category 1 or Category 2
in accordance with Annex V, Chapter II and

material
Annex VI, Chapter I;

(f)

the conditions concerning abnormal operating laid down in
Annex IV, Chapter VI.

(c) be validated by the competent authority in accordance with

Annex V, Chapter V;

3.
To be approved by the competent authority for the
purpose of disposing of animal by-products, a low-capacity
incineration or
to which Directive
2000/76/EC does not apply must:

coincineration plant

(d) undergo the plant’s own checks provided for in Article 25;

(e) be checked by the competent authority in accordance with

Article 26; and

(a) be used only for the disposal of dead pet animals and/or

Category 2 and Category 3 material;

(f) ensure that, after processing,

the products

satisfy the

requirements of Annex VI, Chapter I.

(b) when located on a holding, be used only for the disposal of

material from that particular holding;

(c)

fulfil the general conditions laid down in Annex IV, Chapter
I;

(d) fulfil

the applicable operating conditions laid down in

Annex IV, Chapter II;

(e)

fulfil the requirements laid down in Annex IV, Chapter IV,
concerning residues;

(f)

fulfil the applicable temperature measurement requirements
laid down in Annex IV, Chapter V; and

(g) fulfil the conditions concerning abnormal operating laid

down in Annex IV, Chapter VI.

Approval

4.
the
conditions under which it was granted are no longer fulfilled.

immediately

suspended

shall

be

if

The requirements of paragraphs 2 and 3 may be modified
5.
in the light of developments
in scientific knowledge in
accordance with the procedure referred to in Article 33(2),
after consultation of the appropriate scientific committee.

Approval

3.
the
conditions under which it was granted are no longer fulfilled.

immediately

suspended

shall

be

if

Article 14

Approval of Category 2 and Category 3 oleochemical
plants

Oleochemical plants shall be subject to approval by the

1.
competent authority.

2.

To be approved, Category 2 oleochemical plants must:

(a) process rendered fats derived from Category 2 material in
accordance with the standards laid down in Annex VI,
Chapter III;

(b) establish and implement methods of monitoring and
checking the critical control points on the basis of the
process used;

(c) keep a record of

to
point (b) for presentation to the competent authority; and

the information obtained pursuant

(d) be checked by the competent authority in accordance with

Article 26.

Article 13

3.
To be approved, Category 3 oleochemical plants must
process rendered fats derived only from Category 3 material
and meet the relevant requirements referred to in paragraph 2.

Approval of Category 1 and Category 2 processing plants

Category 1 and Category 2 processing plants shall be

1.
subject to approval by the competent authority.

Approval

4.
the
conditions under which it was granted are no longer fulfilled.

immediately

suspended

shall

be

if

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Article 15

Approval of biogas plants and composting plants

Biogas plants and composting plants shall be subject to

1.
approval by the competent authority.

To be approved, biogas plants and composting plants

2.
must:

(a) meet the requirements of Annex VI, Chapter II, Part A;

(b) handle and transform animal by-products in accordance

with Annex VI, Chapter II, Parts B and C;

The measures referred to in paragraph 1 shall guarantee

2.
that the products are obtained from animals that:

subject

restrictions under disease

(a) 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
to animal health restrictions
applicable to the animals and products concerned, and in
control measures
particular
imposed by Community legislation or by virtue of a
serious transmissible disease listed in Council Directive
92/119/EEC of 17 December 1992 introducing general
Community measures for the control of certain animal
diseases and specific measures relating to swine vesicular
disease (1);

(c) be checked by the competent authority in accordance with

Article 26;

(b) were not slaughtered in a plant in which animals infected,
or suspected of being infected, with one of the diseases
covered by the rules referred to in (a) were present at the
time of slaughter.

(d) establish and implement methods of monitoring and

checking the critical control points; and

(e) ensure that digestion residues and compost, as appropriate,
comply with the microbiological standards laid down in
Annex VI, Chapter II, Part D.

3.
Subject to compliance with the disease control measures
referred to in paragraph 2(a), the placing on the market of
animal by-products, and products derived therefrom referred
to in Annexes VII and VIII, that come from a territory or
part of a territory subject to animal health restrictions but
are not
suspected of being infected shall be
permitted provided that, as appropriate, the products:

infected or

Approval

3.
the
conditions under which it was granted are no longer fulfilled.

immediately

suspended

shall

be

if

CHAPTER IV

PLACING ON THE MARKET AND USE OF PROCESSED ANIMAL
PROTEINS AND OTHER PROCESSED PRODUCTS THAT
COULD BE USED AS FEED MATERIAL, PETFOOD, DOGCHEWS
AND TECHNICAL PRODUCTS AND APPROVAL OF RELATED
PLANTS

Article 16

General animal health provisions

shall

take all necessary measures

1. Member States
to
guarantee that animal by-products, and products derived
therefrom referred to in Annexes VII and VIII, are not
to
dispatched from any holding situated in a zone subject
restrictions because of the occurrence of a disease to which
the species from which the product is derived is susceptible, or
from any plant or zone from which movements or trade would
constitute a risk to the animal health status of the Member
States or areas of Member States, except where products are
treated in accordance with this Regulation.

(1) OJ L 62, 15.3.1993, p. 69. Directive as last amended by the 1994

Act of Accession.

(a) are obtained, handled, transported and stored separately
times from products fulfilling all

from or at different
animal health conditions;

(b) have undergone a treatment sufficient

to eliminate the
animal health problem concerned in accordance with this
Regulation at a plant approved for that purpose by the
Member State where the animal health problem occurred;

(c) are properly identified;

(d) comply with the requirements laid down in Annexes VII
and VIII, or with detailed rules
to be laid down in
accordance with the procedure referred to in Article 33(2).

Conditions alternative to those set out in the first subparagraph
may be laid down in specific situations by decisions adopted in
accordance with the procedure referred to in Article 33(2).
Such decisions shall take account of any measures concerning
the animals or tests to be carried out on them and the specific
characteristics of the disease in the species concerned and shall
specify any measures needed to ensure the protection of animal
health in the Community.

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Article 17

Approval of Category 3 processing plants

Category 3 processing plants shall be subject to approval

1.
by the competent authority.

2.

To be approved, Category 3 processing plants must:

authority for the purposes of checking compliance
with the standards established by this Regulation;

(iv) to keep a record of the information obtained pursuant
to points (ii) and (iii) for presentation to the competent
authority. The results of the checks and tests shall be
kept for at least two years;

(a) meet the requirements of Annex V, Chapter I, and Annex

VII, Chapter I;

(b) handle, process and store only Category 3 material
accordance with Annex V, Chapter II, and Annex VII;

in

(v) to inform the competent authority, should the result of
the laboratory examination referred to in point (iii) or
any other information available to them reveal
the
existence of a serious animal health or public health
hazard; and

(c) be validated by the competent authority in accordance with

Annex V, Chapter V;

(b) to be checked by the competent authority in accordance

with Article 26.

(d) undergo the plant’s own checks provided for in Article 25;

(e) be checked by the competent authority in accordance with

Article 26; and

(f) ensure that, after processing,

the products

satisfy the

requirements of Annex VII, Chapter I.

Approval

3.
the
conditions under which it was granted are no longer fulfilled.

immediately

suspended

shall

be

if

Approval

the
3.
conditions under which it was granted are no longer fulfilled.

immediately

suspended

shall

be

if

Article 19

Placing on the market and export of processed animal
protein and other processed products that could be used
as feed material

Member States shall ensure that processed animal protein and
other processed products that could be used as feed material
are placed on the market or exported only if they:

Article 18

(a) have been prepared in a Category 3 processing plant
approved and supervised in accordance with Article 17;

Approval of petfood plants and technical plants

Petfood plants and technical plants shall be subject to

1.
approval by the competent authority.

To be approved, the petfood plant or the technical plant

2.
must:

(a) undertake,

in the light of the specific requirements laid
down in Annex VIII for the products the plant produces:

(i) to comply with the specific production requirements

set out in this Regulation;

(ii) to establish and implement methods of monitoring and
checking the critical control points on the basis of the
process used;

(iii) depending on the products,

for
analyses in a laboratory recognised by the competent

to take samples

(b) have been prepared exclusively with Category 3 material, as

specified in Annex VII;

(c) have been handled, processed, stored and transported in
accordance with Annex VII and in such a manner as to
ensure compliance with Article 22; and

(d) meet the specific requirements laid down in Annex VII.

Article 20

Placing on the market and export of petfood, dogchews
and technical products

1. Member States
shall ensure that petfood, dogchews,
technical products, other than those referred to in paragraphs
2 and 3, and those animal by-products referred to in Annex
VIII are placed on the market or exported only if they:

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(a) meet either:

(i) the specific requirements laid down in Annex VIII, or

(ii) when a product could be used both as a technical
product and as feed material, and Annex VIII contains
no specific requirements, the specific requirements laid
down by the relevant Chapter of Annex VII; and

(b) come from plants approved and supervised in accordance
with Article 18 or,
in the case of animal by-products
referred to in Annex VIII, from other plants approved in
accordance with Community veterinary legislation.

2. Member States shall ensure that organic fertilisers and soil
improvers produced from processed products, other than those
produced from manure and digestive tract content, are placed
on the market or exported only if they meet requirements, if
any, laid down in accordance with the procedure referred to in
Article 33(2), after consultation of the appropriate scientific
committee.

3. Member States shall ensure that fat derivatives produced
from Category 2 material are placed on the market or exported
only if they:

(a) have been prepared in a Category 2 oleochemical plant
approved in accordance with Article 14 from rendered
fats resulting from the processing of Category 2 material
in a Category 2 processing plant approved in accordance
with Article 13 following the application of any of
processing methods 1 to 5;

(b) have been handled, processed, stored and transported in

accordance with Annex VI; and

(c) meet any specific requirements laid down in Annex VIII.

Article 21

Safeguard measures

(c)

the application to pasture land of organic fertilisers and soil
improvers, other than manure.

Rules for the implementation of this Article,

2.
including
shall be adopted in
rules concerning control measures,
accordance with the procedure referred to in Article 33(2).
Derogations from paragraph 1(a) may be granted in relation
to fish and fur animals by the same procedure, after consul-
tation of the appropriate scientific committee.

CHAPTER V

DEROGATIONS

Article 23

Derogations regarding the use of animal by-products

1. Member States may authorise, under the supervision of
the competent authorities:

(a) the use of animal by-products for diagnostic, educational

and research purposes; and

(b) the use of animal by-products for taxidermy purposes in
technical plants approved for this purpose in accordance
with Article 18.

2. (a) Member States may also authorise the use of the animal
by-products specified in subparagraph (b) for the feeding
of the animals specified in subparagraph (c), under the
supervision of
and in
competent
accordance with the rules laid down in Annex IX.

authorities

the

(b) The animal by-products referred to in subparagraph (a)

are:

(i) Category 2 material, provided that it comes from
animals which were not killed or did not die as a
result of the presence or suspected presence of a
disease communicable to humans or animals, and

Article 10 of Directive 90/425/EEC shall apply to the products
covered by Annexes VII and VIII to this Regulation.

(ii) Category 3 material referred to in Article 6(1)(a) to
(j) and, subject to Article 22, in Article 6(1)(l);

Article 22

Restrictions on use

The following uses of animal by-products and processed

1.
products are prohibited:

(a) the feeding of a species with processed animal protein
derived from the bodies or parts of bodies of animals of
the same species;

(c) The animals referred to in subparagraph (a) are:

(i) zoo animals,

(ii) circus animals,

(iii) reptiles and birds of prey other than zoo or circus

animals,

(iv) fur animals,

(b) the feeding of farmed animals other than fur animals with
catering waste or feed material containing or derived from
catering waste; and

(v) wild animals the meat of which is not destined for

human consumption,

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(vi) dogs from recognised kennels or packs of hounds,

and

(vii) maggots for fishing bait.

(d) In addition, Member States may authorise the use of
Category 1 material referred to in Article 4(1)(b)(ii) for
the feeding of endangered species of necrophagous birds
in accordance with rules laid down under the procedure
referred to in Article 33(2).

3. Member States shall inform the Commission of:

(a) the use made of the derogations referred to in paragraph 2;

and

(b) the verification arrangements introduced to ensure that the
animal by-products concerned are used only for authorised
purposes.

authorised and registered pursuant

4.
Each Member State shall draw up a list of users and
to
collection centres
paragraph 2(c)(iv), (vi) and (vii) within its territory. Each user
and collection centre shall be assigned an official number for
inspection purposes and to be able to trace the origin of the
products concerned.

The competent authority shall supervise the premises of users
and collection centres referred to in the previous subparagraph
and have free access at all time to all parts of such premises, to
referred to in
ensure compliance with the requirements
paragraph 2.

If such inspection reveal that those requirements are not being
complied with, the competent authority shall take appropriate
action.

5.
Detailed rules concerning verification measures may be
adopted in accordance with the procedure referred to in Article
33(2).

Article 24

Derogations regarding the disposal of animal by-products

The competent authority may, where necessary, decide

1.
that:

(a) dead pet animals may be directly disposed of as waste by

burial;

(b) the following animal by-products originating in remote
areas may be disposed of as waste by burning or burial
on site:

(i) Category 1 material referred to in Article 4(1)(b)(ii),

(ii) Category 2 material, and

(iii) Category 3 material; and

(c) animal by-products may be disposed of as waste by
burning or burial on site in the event of an outbreak of
a disease mentioned in List A of the International Office of
Epizootic Diseases (OIE), if the competent authority rejects
transport to the nearest incineration or processing plant
because of the danger of propagation of health risks or
because a widespread outbreak of an epizootic disease
leads to a lack of capacity at such plants.

No derogation may be granted in respect of Category 1

2.
material referred to in Article 4(1)(a)(i).

In the case of Category 1 material referred to in Article
3.
4(1)(b)(ii), burning or burial may take place in accordance with
paragraph 1(b) or (c) only if the competent authority auth-
orises and supervises the method used and is satisfied that it
precludes all risk of transmission of TSEs.

4. Member States shall inform the Commission of:

(a) the use they make of

the possibilities provided for in
paragraph 1(b) in respect of Category 1 and Category 2
material; and

(b) the areas that

they categorise as remote areas for the
purpose of applying paragraph 1(b) and the reasons for
that categorisation.

5.
The
necessary:

competent

authority

shall

take

the measures

(a) to ensure that the burning or burial of animal by-products

does not endanger animal or human health; and

(b) to prevent

the abandonment, dumping or uncontrolled

disposal of animal by-products.

6.
Detailed arrangements for implementing this Article may
be laid down under the procedure referred to in Article 33(2).

CHAPTER VI

CONTROLS AND INSPECTIONS

Article 25

Plants’ own-checks

their

Operators and owners of
representatives

intermediate and processing
1.
shall adopt all measures
plants or
necessary to comply with the requirements of this Regulation.
They shall put in place, implement and maintain a permanent
procedure developed in accordance with the principles of the
system of hazard analysis and critical control points (HACCP).
They shall in particular:

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(a)

identify and control the critical control points in the plants;

(g)

instigate
procedures within the plant.

appropriate

decontamination

and

cleaning

(b) establish and implement methods
checking such critical control points;

for monitoring and

(c)

in the case of processing plants, take representative samples
to check compliance:

(i) of each processed batch with the standards for the

products established by this Regulation, and

(ii) with the maximum permitted levels of physicochemical

residues laid down in Community legislation;

(d) record the results of the checks and tests referred to in
points (b) and (c) and keep them for a period of at least
two years for presentation to the competent authorities;

(e)

introduce a system ensuring the traceablility of each batch
dispatched.

2. Where the results of a test on samples taken pursuant to
this
paragraph 1(c) do not comply with the provisions of
Regulation, the operator of the processing plant must:

(a) notify the competent authority immediately of

the full
details of the nature of the sample and the batch from
which it was derived;

(b) establish the causes of failures of compliance;

(c) reprocess or dispose of the contaminated batch under the

supervision of the competent authority;

(d) ensure that no material

suspected or known to be
contaminated is moved from the plant before being repro-
cessed under the supervision of the competent authority
and re-sampled officially in order to comply with the
standards laid down in this Regulation, unless destined
for disposal;

(e)

increase
production;

the

frequency of

sampling and testing of

(f)

investigate animal by-products records appropriate to the
finished sample; and

Detailed arrangements

implementing this Article,
for
3.
including rules concerning the frequency of checks and
reference methods for microbiological analyses, may be laid
down under the procedure referred to in Article 33(2).

Article 26

Official controls and lists of approved plants

The competent authority shall at regular intervals carry
1.
out
approved in
and supervision at plants
inspections
accordance with this Regulation. Inspections and supervision
of processing plants shall take place in accordance with Annex
V, Chapter IV.

The frequency of

2.
inspections and supervision shall
depend on the size of the plant, the type of products manu-
factured, risk assessment and guarantees offered in accordance
with the principles of the system of hazard analysis and critical
control points (HACCP).

3.
If the inspection carried out by the competent authority
reveals that one or more of the requirements of this Regulation
are not being met, the competent authority shall take appro-
priate action.

4.
Each Member State shall draw up a list of plants
approved in accordance with this Regulation within its
It shall assign an official number to each plant,
territory.
which identifies the plant with respect to the nature of its
activities. Member States shall send copies of
the list and
updated versions to the Commission and other Member States.

Detailed arrangements

5.
implementing this Article,
for
including rules concerning the frequency of checks and
reference methods for microbiological analyses, may be laid
down under the procedure referred to in Article 33(2).

CHAPTER VII

COMMUNITY CONTROLS

Article 27

Community controls in Member States

Experts from the Commission may make on-the-spot
1.
in cooperation with the competent authorities of
checks,
in so far as is necessary for the uniform
Member States,
application of this Regulation. The Member State on whose
territory checks are made shall provide the experts with all
their duties. The
the assistance necessary for carrying out
Commission shall
the
results of the checks made.

inform the competent authority of

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Rules for the implementation of this Article, in particular
2.
those governing the procedure for cooperation with national
competent authorities, shall be laid down under the procedure
referred to in Article 33(2).

CHAPTER VIII

PROVISIONS APPLICABLE TO THE IMPORTATION AND
TRANSIT OF CERTAIN ANIMAL BY-PRODUCTS AND
PRODUCTS DERIVED THEREFROM

Article 28

General provisions

The provisions applicable to the importation of products
from non-member
referred to in Annexes VII and VIII
countries shall be no more favourable or less favourable that
those applicable to the production and marketing of
those
products in the Community.

the importation from non-member countries of
However,
petfood and raw material
for petfood production, derived
from animals which have been treated with certain substances
prohibited in accordance with Directive 96/22/EC, shall be
is marked and
permitted provided that such raw material
under specific conditions laid down under
the procedure
referred to in Article 33(2).

Article 29

Prohibitions and compliance with Community rules

1.
The importation and transit of animal by-products and
processed products shall be prohibited, except in accordance
with this Regulation.

The importation into, and the transit

2.
the
Community of the products referred to in Annexes VII and
satisfy the
VIII may take place only if
requirements set out in paragraphs 3 to 6.

such products

through,

specified

3.
Products referred to in Annexes VII and VIII shall, save as
from a
otherwise
in those Annexes,
non-member country or parts of non-member countries on a
list
to be drawn up and updated in accordance with the
procedure referred to in Article 33(2).

come

The list may be combined with other lists drawn up for public
and animal health purposes.

When the list is drawn up, particular account shall be taken of:

(a)

the legislation of the non-member country;

(b) the organisation of

the competent authority and its
inspection services
the
in the non-member
powers of those services, the supervision to which they
are subject, and their authority to monitor effectively the
application of their legislation;

country,

(c)

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

(d) the assurances the non-member country can give regarding

compliance with the relevant health conditions;

(e) experience of marketing the product from the non-member
country and the results of import checks carried out;

(f)

the
result of
non-member country;

any Community

inspections

in the

(g) the health status of the livestock, other domestic animals
and wildlife in the non-member country, having particular
regard to exotic animal diseases and any aspects of the
general health situation in the country which might pose
a risk to public or animal health in the Community;

(h) the regularity and speed with which the non-member
country supplies
existence of
information about
infectious or contagious animal diseases in its territory, in
particular the diseases mentioned in Lists A and B of the
OIE or, in the case of diseases of aquaculture animals, the
notifiable diseases as listed in the Aquatic Animal Health
Code of the OIE;

the

(i)

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

4.
Products referred to in Annexes VII and VIII, except for
technical products, must come from plants on a Community
list drawn up under the procedure referred to in Article 33(2)
on the basis of a communication from the competent auth-
the non-member country to the Commission
orities of
the plant complies with the Community
declaring that
requirements and is subject
to supervision by an official
inspection service in the non-member country.

Approved lists shall be amended as follows:

(a) the Commission shall

inform the Member States of the
modifications proposed by the non-member
country
concerned to the lists of plants within five working days
of the receipt of the proposed modifications;

(b) the Member States shall have seven working days, from
receipt of the modifications to the lists of plants referred
to in point
to send any written comments to the
Commission;

(a)

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(c) when at least one Member State makes written comments,
the Commission shall inform the Member States within five
working days and include the point on the agenda of the
next meeting of the Standing Veterinary Committee for
decision under the procedure referred to in Article 33(2);

(d) when the Commission receives no comments from the
Member States within the time limit
referred to in
subparagraph (b), Member States shall be considered to
list. The
to
have
Commission shall
inform the Member States within five
working days, and imports shall be authorised from such
plants five working days after receipt of this information by
the Member States.

the modifications

accepted

the

Detailed rules for the application of this Article shall be

3.
laid down under the procedure referred to in Article 33(2).

Article 31

Community inspections and audits

1.
Experts from the Commission, where appropriate accom-
panied by experts from the Member States, may carry out
on-the-spot checks with a view to:

(a) drawing up the list of non-member countries or parts
importation

and determining

conditions

for

thereof
and/or transit;

5.
Technical products referred to in Annex VIII must come
from plants that the competent authorities of the non-member
countries have approved and registered.

(b) verifying compliance with:

Save as otherwise specified in Annexes VII and VIII, a
6.
laid down in
health certificate corresponding to the model
Annex X, certifying that
the conditions
the products meet
referred to in those Annexes and come from plants offering
such conditions, must accompany consignments of products
referred to in those Annexes.

Pending the compilation of

in
7.
paragraph 4 and the adoption of model certificates as
referred to in paragraph 6, Member States may maintain the
controls provided for in Directive 97/78/EC and certificates
provided for under existing national rules.

the list provided for

Article 30

Equivalence

1.
In accordance with the procedure referred to in Article
33(2), a decision may be taken recognising that the health
measures applied by a non-member country, a group of
non-member countries or a region of a non-member country
to the production, manufacture, handling,
and
transport of one or more categories of products referred to
in Annexes VII and VIII offer guarantees equivalent to those
applied in the Community, if the non-member country supplies
objective proof in this respect.

storage

The decision shall
the conditions governing the
importation and/or transit of animal by-products from that
region, country or group of countries.

set out

2.

The conditions referred to in paragraph 1 shall include:

(a) the nature and content of the health certificate that must

accompany the product;

(b) specific health requirements applicable to importation into,

and/or transit through, the Community; and

(c) where necessary, procedures for drawing up and amending
lists of regions or plants from which imports and/or transit
are permitted.

(i) the conditions for inclusion in a Community list of

non-member countries,

(ii) import and/or transit conditions,

(iii) the conditions for recognising equivalence of measures,

(iv) any emergency measures applied under Community

legislation.

The Commission shall appoint experts from the Member States
responsible for these checks.

The checks referred to in paragraph 1 shall be carried out
the costs
the Community, which shall meet

2.
on behalf of
incurred.

The frequency of and the procedure for

3.
the checks
referred to in paragraph 1 may be specified in accordance
with the procedure referred to in Article 33(2).

If a check referred to in paragraph 1 reveals a serious
4.
the Commission shall
infringement of
immediately ask the non-member country to take appropriate
measures or shall suspend consignments of products and
immediately inform the Member States.

the health rules,

CHAPTER IX

FINAL PROVISIONS

Article 32

Amendments to Annexes and transitional measures

After consultation of the appropriate scientific committee on
any question that could have an impact on animal or public
health, the Annexes may be amended or supplemented and any
appropriate
in
accordance with the procedure referred to in Article 33(2).

transitional measures may

adopted

be

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Article 33

Regulatory procedure

The Commission shall be assisted by the Standing
(cid:145)the

hereinafter

referred

to

as

1.
Veterinary Committee,
Committee(cid:146).

2. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at 15 days.

3.

The Committee shall adopt its rules of procedure.

Article 34

Consultation of scientific committees

The appropriate scientific committees shall be consulted on any
matter within the scope of this Regulation that could have an
effect on animal or public health.

than envisaged in this Regulation pending the
further
adoption of Community rules for their use in accordance
with Article 20(2). Member States may adopt or maintain
national rules restricting the use of fat derivatives produced
from Category 2 material further than envisaged in this Regu-
lation pending the addition to Annex VIII of Community rules
for their use in accordance with Article 32.

Article 36

Financial arrangements

The Commission shall prepare a report on the financial
arrangements in Member States for the processing, collection,
storage and disposal of animal by-products accompanied by
appropriate proposals.

Article 37

Repeal

90/667/EEC

and
Directive
1999/534/EC shall be repealed with effect from six months
after the entry into force of this Regulation.

and Decisions

95/348/EC

Article 35

National provisions

References to Directive 90/667/EEC shall be construed from
that date as references to this Regulation.

1. Member States shall communicate to the Commission the
text of the provisions of any national law that they adopt in the
field covered by this Regulation.

2.
In particular, Member States shall inform the Commission
of the measures taken to ensure compliance with this Regu-
lation within one year of its entry into force. On the basis of
the information received, the Commission shall submit a report
to the European Parliament and the Council accompanied, if
appropriate, by legislative proposals.

3. Member States may adopt or maintain national rules
improvers
restricting the use of organic fertilisers and soil

Article 38

Entry into force

This Regulation shall enter
into force on the 20th day
following its publication in the Official Journal of the European
Communities.

It shall apply six months after the date of its entry into force.
However, Article 12(2) shall apply as specified in Article 20 of
Directive 2000/76/EC.

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

Done at . . .

For the European Parliament

The President

For the Council

The President

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ANNEX I

SPECIFIC DEFINITIONS

For the purpose of this Regulation:

1.

(cid:145)apiculture products(cid:146) means honey, beeswax, royal jelly, propolis or pollen used in bee-keeping;

2.

(cid:145)batch(cid:146) means a unit of production produced in a single plant using uniform production parameters (cid:151) or a number
of such units, when stored together (cid:151) and that can be identified for the purposes of recall and re-treatment or
disposal should tests show that to be necessary;

3.

(cid:145)biogas plant(cid:146) means a plant in which biological degradation of products of animal origin is undertaken under
anaerobic conditions for the production and collection of biogas;

4.

(cid:145)blood products(cid:146) means products derived from blood or fractions of blood, excluding blood meal; they include
dried/frozen/liquid plasma, dried whole blood, dried/frozen/liquid red cells or fractions thereof and mixtures;

5.

(cid:145)blood(cid:146) means fresh whole blood;

6.

(cid:145)bloodmeal(cid:146) means products derived from the heat-treatment of blood in accordance with Annex VII, Chapter II, and
intended for animal consumption or organic fertilisers;

7.

(cid:145)canned petfood(cid:146) means heat-processed petfood contained within a hermetically sealed container;

8.

(cid:145)Category 1 or Category 2 intermediate plant(cid:146) means a plant in which unprocessed Category 1 or Category 2
material is handled and/or temporarily stored for the purpose of further transportation to its final destination and
where certain preliminary activities, such as removal of hides and skins and performing post-mortem examinations,
may take place;

9.

(cid:145)Category 1 processing plant(cid:146) means a plant in which Category 1 material is processed before its final disposal;

10.

(cid:145)Category 2 oleochemical plant(cid:146) means a plant processing rendered fats derived from Category 2 material under
conditions set out in Annex VI, Chapter III;

11.

(cid:145)Category 2 processing plant(cid:146) means a plant in which Category 2 material is processed before its final disposal,
further transformation or use;

12.

(cid:145)Category 3 intermediate plant(cid:146) means a plant in which unprocessed Category 3 material is sorted and/or cut and/or
chilled or deep-frozen into blocks and/or temporarily stored for the purpose of further transporting to its final
destination;

13.

(cid:145)Category 3 oleochemical plant(cid:146) means a plant processing rendered fats derived from Category 3 material;

14.

(cid:145)Category 3 processing plant(cid:146) means a plant in which Category 3 material is processed into processed animal protein
and other processed products that could be used as feed material;

15.

(cid:145)catering waste(cid:146) means all waste food originating in restaurants, catering facilities and kitchens, including central
kitchens and household kitchens;

16.

(cid:145)coincineration plant(cid:146) means a disposal site as defined in Article 3(5) of Directive 2000/76/EC;

17.

(cid:145)coincineration(cid:146) means the disposal of animal by-products or products derived therefrom in a coincineration plant;

18.

(cid:145)collection centres(cid:146) means premises collecting and treating certain animal by-products intended to be used for the
feeding of the animals specified in Article 23(2)(c);

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19.

(cid:145)composting plant(cid:146) means a plant in which biological degradation of products of animal origin is undertaken under
aerobic conditions;

20.

(cid:145)digestion residues(cid:146) means residues resulting from the transformation of animal by-products in a biogas plant;

21.

(cid:145)digestive tract content(cid:146) means the content of the digestive tract of mammals and ratites, whether or not separated
from the digestive tract;

22.

(cid:145)dogchews(cid:146) means untanned products for pet animals to chew, produced from hides and skins of ungulates or other
animal material;

23.

(cid:145)feed material(cid:146) means those feed materials, as defined in Directive 96/25/EC (1), that are of animal origin including
processed animal proteins, blood products, rendered fats, fish oil, fat derivatives, gelatin and hydrolysed proteins,
dicalcium phosphate, milk, milk-based products and colostrum;

24.

(cid:145)fishmeal(cid:146) means processed animal protein derived from sea animals, except sea mammals;

25.

(cid:145)fur animals(cid:146) means animals kept or reared for the production of fur and not used for human consumption;

26.

(cid:145)gelatin(cid:146) means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen
produced from bones, hides and skins, tendons and sinews of animals (including fish and poultry);

27.

(cid:145)greaves(cid:146) means the protein-containing residue of rendering, after partial separation of fat and water;

28.

(cid:145)hermetically sealed container(cid:146) means a container that is designed and intended to be secure against the entry of
micro-organisms;

29.

(cid:145)hides and skins(cid:146) means all cutaneous and subcutaneous tissues;

30.

(cid:145)high-capacity incineration plant(cid:146) means an incineration plant other than a low-capacity incineration plant;

31.

(cid:145)hydrolysed proteins(cid:146) means polypeptides, peptides and aminoacids, and mixtures thereof, obtained by the hydrolysis
of animal by-products;

32.

(cid:145)incineration plant(cid:146) means a disposal site as defined in Article 3(4) of Directive 2000/76/EC;

33.

(cid:145)incineration(cid:146) means the disposal of animal by-products or products derived therefrom in an incineration plant;

34.

(cid:145)laboratory reagent(cid:146) means a packaged product, ready for use by the end user, containing a blood product, and
intended for laboratory use as reagent or reagent product, whether used alone or in combination;

35.

(cid:145)landfill(cid:146) means a disposal site as defined by Directive 1999/31/EC;

36.

(cid:145)low-capacity incineration plant(cid:146) means an incineration plant with a throughput of
by-products per hour;

less than 50 kg of animal

37.

(cid:145)manure(cid:146) means any excrement and/or urine of farmed animals, with or without litter, and guano;

38.

(cid:145)organic fertilisers(cid:146) and (cid:145)soil improvers(cid:146) mean materials of animal origin used to maintain or improve plant nutrition
and the physical and chemical properties and biological activity of soils, either separately or together; they may
include manure, digestive tract content, compost and digestion residues;

39.

(cid:145)pasture land(cid:146) means land covered with grass or other herbage and grazed by farmed animals;

40.

(cid:145)petfood plant(cid:146) means a plant producing petfood or dogchews and in which certain animal by-products are used in
the preparation of such petfood or dogchews;

(1) Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC,
82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC (OJ L 125, 23.5.1996, p. 35). Directive as last amended by Directive
2001/46/EC (OJ L 234, 1.9.2001, p. 55).

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41.

(cid:145)petfood(cid:146) means food for pet animals containing Category 3 material;

42.

(cid:145)processed animal protein(cid:146) means animal proteins derived entirely from Category 3 material, which have been
treated in accordance with this Regulation so as to render them suitable for direct use as feed material or other
use in feedingstuffs, including petfood, or use in organic fertilisers or soil improvers; it does not include blood
products, milk, milk-based products, colostrum, gelatin, hydrolysed proteins and dicalcium phosphate;

43.

(cid:145)processed petfood(cid:146) means petfood, other than raw petfood, that has undergone treatment in accordance with the
requirements of Annex VIII;

44.

(cid:145)processed products(cid:146) means animal by-products that have undergone one of the processing methods or another
treatment required by Annex VII or VIII;

45.

(cid:145)processing methods(cid:146) means the methods listed in Annex V, Chapter III;

46.

(cid:145)processing plant(cid:146) means an animal by-products processing plant;

47.

(cid:145)product used for in vitro diagnosis(cid:146) means a packaged product, ready for use by the end user, containing a blood
product, and used as a reagent, reagent product, calibrator, kit or any other system, whether used alone or in
combination, intended to be used in vitro for the examination of samples of human or animal origin, with the
exception of donated organs or blood, solely or principally with a view to the diagnosis of a physiological state,
state of health, disease or genetic abnormality or to determine safety and compatibility with reagents;

48.

(cid:145)raw petfood(cid:146) means petfood which has not undergone any preserving process other than chilling, freezing or quick
freezing to ensure preservation;

49.

(cid:145)remote areas(cid:146) means areas where the animal population is so small, and where facilities are so far away, that the
arrangements necessary for collection and transport would be unacceptably onerous compared to local disposal;

50.

(cid:145)rendered fats(cid:146) means fats derived from processing of Category 2 material or Category 3 material;

51.

(cid:145)storage plant(cid:146) means a plant, other than establishments and intermediaries covered by Directive 95/69/EC (1), in
which processed products are temporarily stored before their final use or disposal;

52.

(cid:145)tanning(cid:146) means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as
aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents;

53.

(cid:145)technical plant(cid:146) means a plant in which animal by-products are used to produce technical products;

54.

(cid:145)technical products(cid:146) means products directly derived from certain animal by-products, intended for purposes other
than human or animal consumption, including tanned and treated hides and skins, game trophies, processed wool,
hair, bristles, feathers and part of feathers, serum of equidae, blood products, pharmaceuticals, medical devices,
cosmetics, bone products for china, gelatin and glue, organic fertilisers, soil improvers, rendered fats, fat derivatives,
processed manure and milk and milk-based products;

55.

(cid:145)unprocessed feathers and parts of feathers(cid:146) means feathers and parts of feathers that have not been treated with a
steam current or by some other method ensuring that no pathogens are transmitted;

56.

(cid:145)unprocessed wool(cid:146) means sheep’s wool that has neither undergone factory washing nor been obtained from
tanning;

57.

(cid:145)unprocessed hair(cid:146) means ruminant hair that has neither undergone factory washing nor been obtained from
tanning;

58.

(cid:145)unprocessed pig bristles(cid:146) means pig bristles that have neither undergone factory washing nor been obtained from
tanning.

(1) Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain
establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC
and 82/471/EEC (OJ L 332, 30.12.1995, p. 15). Directive as last amended by Directive 1999/29/EC (OJ L 115, 4.5.1999, p. 32).

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HYGIENE REQUIREMENTS FOR THE COLLECTION AND TRANSPORT OF ANIMAL BY-PRODUCTS AND
PROCESSED PRODUCTS

ANNEX II

CHAPTER I

Identification

1. All necessary measures must be taken to ensure that:

(a) Category 1, Category 2 and Category 3 materials are identifiable and kept separate and identifiable during

collection and transportation; and

(b) processed products are identifiable and kept separate and identifiable during transportation.

2. During transport, a label attached to the vehicle, container, carton or other packaging material must clearly indicate:

(a) the category of the animal by-products or, in the case of processed products, the category of animal by-products

from which the processed products were derived; and

(b) (i) in the case of Category 3 material, the words (cid:145)not for human consumption(cid:146),

ii) in the case of Category 2 material, other than manure and digestive tract content, and processed products

derived therefrom, the words (cid:145)not for animal consumption(cid:146), or

iii) in the case of Category 1 material and processed products derived therefrom, the words (cid:145)for disposal only(cid:146).

CHAPTER II

Vehicles and containers

1. Animal by-products and processed products must be collected and transported in sealed new packaging or covered

leak-proof containers or vehicles.

2. Vehicles and reusable containers, and all reusable items of equipment or appliances that come into contact with

animal by-products or processed products, must be:

(a) cleaned, washed and disinfected after each use;

(b) maintained in a clean condition; and

(c) clean and dry before use.

3. Reusable containers must be dedicated to the carriage of a particular product to the extent necessary to avoid

cross-contamination.

CHAPTER III

Commercial documents and health certificates

1. During transportation, a commercial document or, when required by this Regulation, a health certificate must

accompany animal by-products and processed products.

2. Commercial documents must specify:

(a) the date on which the material was taken from the premises;

(b) the description of the material, including the information referred to in Chapter I, the animal species for Category
3 material and processed products derived therefrom destined for use as feed material and, if applicable, the
ear-tag number;

(c)

the quantity of the material;

(d) the place of origin of the material;

(e)

the name and the address of the carrier;

(f)

the name and the address of the receiver and, if applicable, its approval number; and

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(g)

if appropriate:

(i) the approval number of the plant of origin, and

ii) the nature and the methods of the treatment.

3. The commercial document must be produced at least in triplicate (one original and two copies). The original must
accompany the consignment to its final destination. The receiver must retain it. The producer must retain one of the
copies and the carrier the other.

4. A model for the commercial document may be laid down under the procedure referred to in Article 33(2).

5. Health certificates must be issued and signed by the competent authority.

CHAPTER IV

Records

The records referred to in Article 9 must contain the information referred to in Chapter III, paragraph 2, as follows.
They must contain:

(a) the information referred to in subparagraphs (b) and (c); and

(b) in the case of records kept by any person consigning animal by-products,

the information referred to in

subparagraphs (a), (e) and, if known, (f); or

(c)

in the case of records kept by any person transporting animal by-products,
subparagraphs (a), (d) and (f); or

the information referred to in

(d) in the case of records kept by any person receiving animal by-products, the date of reception and the information

referred to in subparagraphs (d) and (e).

CHAPTER V

Retention of documents

The commercial document and the health certificate referred to in Chapter III, and the records referred to in Chapter IV,
must be kept for a period of at least two years for presentation to the competent authority.

CHAPTER VI

Temperature conditions

1. The transport of animal by-products must take place at an appropriate temperature, to avoid any risk to animal or

public health.

2. Unprocessed Category 3 material destined for the production of feed material or pet food must be transported chilled

or frozen, unless processed within 24 hours of departure.

3. The design of vehicles used for refrigerated transport must ensure the maintenance of an appropriate temperature

throughout transport.

CHAPTER VII

Specific rules for transit

The carriage of animal by-products and processed products in transit must meet the requirements of Chapters I, II, III
and VI.

CHAPTER VIII

Control measures

The competent authority must take the necessary measures to control the collection, transport, use and disposal of
animal by-products and processed products, including by checking the keeping of required records and documents and,
when this Regulation requires it or the competent authority considers it necessary, by sealing.

When the competent authority applies a seal to a consignment of animal by-products or processed products, it must
inform the competent authority of the place of destination.

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HYGIENE REQUIREMENTS FOR INTERMEDIATE AND STORAGE PLANTS

ANNEX III

CHAPTER I

Requirements for the approval of intermediate plants

1. Premises and facilities must meet at least the following requirements.

(a) The premises must be adequately separated from the public highway and other premises such as slaughterhouses.
The layout of plants must ensure the total separation of Category 1 and Category 2 material from Category 3
material from reception until dispatch.

(b) The plant must have a covered space to receive animal by-products.

(c) The plant must be constructed in such a way that it is easy to clean and disinfect. Floors must be laid down in

such a way as to facilitate the draining of liquids.

(d) The plant must have adequate lavatories, changing rooms and washbasins for staff.

(e) The plant must have appropriate arrangements for protection against pests, such as insects, rodents and birds.

(f) The plant must have a waste-water disposal system which meets hygiene requirements.

(g) Where it is necessary for the purpose of achieving the objectives of this Regulation, plants must have suitable
temperature-controlled storage facilities of sufficient capacity for maintaining animal by-products at appropriate
temperatures and designed to allow the monitoring and recording of those temperatures.

2. The plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which animal
by-products are received and the vehicles, other than ships, in which they are transported. Adequate facilities must be
provided for the disinfecting of vehicle wheels.

CHAPTER II

General hygiene requirements

A. Category 3 intermediate plants

1. The plant must not engage in activities other than the importation, collection, sorting, cutting, chilling, freezing into

blocks, temporary storage and dispatching of Category 3 material.

2. The sorting of Category 3 material must be carried out in such a way as to avoid any risk of the propagation of

animal diseases.

3. All the time during sorting or storage, Category 3 material must be handled and stored separately from goods other
than other Category 3 material and in such a way as to prevent any propagation of pathogens and to ensure
compliance with Article 22.

4. Category 3 material must be stored properly, and, where appropriate, chilled or frozen, until re-dispatched.

5. Packaging material must be incinerated or disposed of by some other means in accordance with instructions from

the competent authority.

B. Category 1 or Category 2 intermediate plants

6. The plant must not engage in activities other than the collection, handling, temporary storage and dispatching of

Category 1 or Category 2 material.

7. The sorting of the Category 1 or Category 2 material must be carried out in such a way as to avoid any risk of the

propagation of animal diseases.

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8. All the time during storage, the Category 1 or Category 2 material must be handled and stored separately from

other goods and in such a way as to prevent any propagation of pathogens.

9. Category 1 or Category 2 material must be stored properly, including under appropriate temperature conditions,

until re-dispatched.

10. Packaging material must be incinerated or disposed of by some other means in accordance with instructions from

the competent authority.

11. Waste water must be treated to ensure, as far as is reasonably practicable, that no pathogens remain. Specific
requirements for the treatment of waste water from Category 1 and Category 2 intermediate plants may be laid
down in accordance with the procedure referred to in Article 33(2).

CHAPTER III

Requirements for the approval of storage plants

Premises and facilities must meet at least the following requirements.

1. Premises storing processed products derived from Category 3 material must not be at the same site as premises
storing processed products derived from Category 1 or Category 2 material, unless in a completely separate building.

2. The plant must:

(a) have a covered space to receive the products;

(b) be constructed in such a way that it is easy to clean and disinfect. Floors must be laid down in such a way as to

facilitate the draining of liquids;

(c) have adequate lavatories, changing rooms and washbasins for staff; and

(d) have appropriate arrangements for protection against pests, such as insects, rodents and birds.

3. The plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which the
products are received and the vehicles, other than ships, in which they are transported. Adequate facilities must be
provided for the disinfecting of vehicle wheels.

4. Products must be stored properly until re-dispatched.

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REQUIREMENTS FOR INCINERATION AND COINCINERATION PLANTS TO WHICH DIRECTIVE 2000/76/EC
DOES NOT APPLY

ANNEX IV

CHAPTER I

General conditions

1.

Incineration or coincineration plants must be designed, equipped and operated in such a manner as to fulfil the
requirements of this Regulation.

2. The operator of an incineration or coincineration plant must take all necessary precautions concerning the
reception of animal by-products to prevent, or limit as far as practicable, direct risks to human or animal health.

CHAPTER II

Operating conditions

3. Incineration or coincineration plants must be designed, equipped, built and operated in such a way that the gas
resulting from the process is raised in a controlled and homogeneous fashion, even under the most unfavourable
conditions, to a temperature of 850 (cid:176)C, as measured near the inner wall or at another representative point of the
combustion chamber as authorised by the competent authority, for two seconds.

4. Each line of high-capacity incineration plants must be equipped with at least one auxiliary burner. This burner must
be switched on automatically when the temperature of the combustion gases after the last injection of combustion
air falls below 850 (cid:176)C. It must also be used during plant start-up and shut-down operations to ensure that the
temperature of 850 (cid:176)C is maintained at all times during these operations and as long as unburned material is in the
combustion chamber.

5. High-capacity incineration or coincineration plants must have and operate an automatic system to prevent feed with

animal by-products:

(a) at start-up, until the temperature of 850 (cid:176)C has been reached; and

(b) whenever the temperature of 850 (cid:176)C is not maintained.

6. Animal by-products should, where practicable, be placed straight in the furnace without direct handling.

CHAPTER III

Water discharges

7.

Incineration or coincineration plant sites,
including associated storage areas for animal by-products, must be
designed in such a way as to prevent unauthorised and accidental release of any polluting substances into soil,
surface water and groundwater in accordance with the provisions provided for in relevant Community legislation.
Moreover, storage capacity must be provided for contaminated rainwater run-off from the incineration plant site or
for contaminated water arising from spillage or fire-fighting operations.

8. The storage capacity must be adequate to ensure that such waters can be tested and treated before discharge where

necessary.

CHAPTER IV

Residues

9. For the purposes of this Chapter,

(cid:145)residues(cid:146) means any liquid or solid material generated by the incineration or
coincineration process, the waste-water treatment or other processes within the incineration or coincineration plant.
They include bottom ash and slag, fly ash and boiler dust.

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10. Residues resulting from the operation of the incineration or coincineration plant must be minimised in their
amount and harmfulness. Residues must be recycled, where appropriate, directly in the plant or outside in
accordance with relevant Community legislation.

11. Transport and intermediate storage of dry residues in the form of dust must take place in such a way as to prevent

dispersal in the environment (e.g., in closed containers).

CHAPTER V

Temperature measurement

12. Techniques must be used to monitor the parameters and conditions relevant to the incineration or coincineration
process. High-capacity incineration and coincineration plants must have and use temperature measurement
equipment.

13. The approval

issued by the competent authority, or conditions attached to it, must

lay down temperature

measurement requirements.

14. The appropriate installation and the functioning of any automated monitoring equipment must be subject to
control and to an annual surveillance test. Calibration must be carried out by means of parallel measurements
with the reference methods at least every three years.

15. Temperature measurement results must be recorded and presented in an appropriate fashion to enable the
competent authority to verify compliance with the permitted operating conditions laid down in this Regulation
in accordance with procedures to be decided upon by that authority.

CHAPTER VI

Abnormal operating

16.

In the case of a breakdown, or abnormal operating conditions, the operator must reduce or close down operations
as soon as practicable until normal operations can be resumed.

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GENERAL HYGIENE REQUIREMENTS FOR THE PROCESSING OF CATEGORY 1, 2 AND 3 MATERIAL

ANNEX V

General requirements for the approval of Category 1, 2 and 3 processing plants

CHAPTER I

1. Premises and facilities must meet at least the following requirements:

(a) premises for the processing of animal by-products must not be at the same site as slaughterhouses, unless in a
completely separate building or part of a building. Unauthorised persons and animals must not have access to the
plant;

(b) the processing plant must have a clean and unclean sector, adequately separated. The unclean sector must have a
covered place to receive animal by-products and must be constructed in such a way that it is easy to clean and
disinfect. Floors must be laid in such a way as to facilitate the draining of liquids. The processing plant must have
adequate lavatories, changing rooms and washbasins for staff;

(c)

the processing plant must have sufficient production capacity for hot water and steam for the processing of
animal by-products;

(d) the unclean sector must,

if appropriate, contain equipment to reduce the size of animal by-products and

equipment for loading the crushed animal by-products into the processing unit;

(e) all installations in which animal by-products are processed must operate in accordance with the requirements of

Chapter II. Where heat treatment is required, all installations must be equipped with:

(i) measuring equipment to monitor temperature against time and,

if necessary, pressure at critical points;

(ii) recording devices to record continuously the results of these measurements; and

(iii) an adequate safety system to prevent insufficient heating;

(f)

to prevent recontamination of the finished product by incoming animal by-products, there must be a clear
separation between the area of the plant where incoming material for processing is unloaded and the areas set
aside for the processing of that product and the storage of the processed product.

2. The processing plant must have adequate facilities for cleaning and disinfecting the containers or receptacles in which

animal by-products are received and the vehicles, other than ships, in which they are transported.

3. Adequate facilities must be provided for the disinfecting of vehicle wheels, on leaving the unclean sector of the

processing plant.

4. All processing plants must have a waste-water disposal system meeting the competent authority’s requirements.

5. The processing plant must have its own laboratory or make use of the services of an external

laboratory. The

laboratory must be equipped to carry out necessary analyses and be approved by the competent authority.

CHAPTER II

General hygiene requirements

1. Animal by-products must be processed as soon as possible after arrival. They must be stored properly until

processed.

2. Containers, receptacles and vehicles used for transporting unprocessed material must be cleaned in a designated area.

That area must be situated or designed to prevent the risk of contamination of processed products.

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3. Persons working in the unclean sector must not enter the clean sector without changing their working clothes and
footwear or without disinfecting the latter. Equipment and utensils must not be taken from the unclean sector into
the clean sector, unless first cleaned and disinfected. Personnel movement procedures must be established to control
the movement of personnel between areas and to prescribe the proper use of foot baths and wheel baths.

4. Waste water originating in the unclean sector must be treated to ensure, as far as is reasonably practicable, that no
pathogens remain. Specific requirements for the treatment of waste water from processing plants may be laid down
under the procedure referred to in Article 33(2).

5. Preventive measures against birds, rodents, insects or other vermin must be taken systematically. A documented pest

control programme must be used for that purpose.

6. Cleaning procedures must be established and documented for all parts of the premises. Suitable equipment and

cleaning agents must be provided for cleaning.

7. Hygiene control must include regular inspections of the environment and equipment. Inspection schedules and

results must be documented and maintained for at least two years.

8. Installations and equipment must be kept in a good state of repair and measuring equipment must be calibrated at

regular intervals.

9. Processed products must be handled and stored at the processing plant in such a way as to preclude recontamination.

CHAPTER III

Processing methods

Method 1

R e d u c t i o n

1. If the particle size of the animal by-products to be processed is more than 50 millimetres, the animal by-products
must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than
50 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks
disclose the existence of particles larger than 50 millimetres, the process must be stopped and repairs made before
the process is resumed.

T i m e , t e m p e r a t u r e a n d p r e s s u r e

2. After reduction the animal by-products must be heated to a core temperature of more than 133 (cid:176)C for at least 20
minutes without interruption at a pressure (absolute) of at least 3 bars produced by saturated steam (1); the heat
treatment may be applied as the sole process or as a pre- or post-process sterilisation phase.

3. The processing may be carried out in batch or continuous systems.

R e d u c t i o n

Method 2

1. If the particle size of the animal by-products to be processed is more than 150 millimetres, the animal by-products
must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than
150 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks
disclose the existence of particles larger than 150 millimetres, the process must be stopped and repairs made before
the process is resumed.

T i m e , t e m p e r a t u r e a n d p r e s s u r e

2. After reduction the animal by-products must be heated to a core temperature greater than 100 (cid:176)C for at least 125
minutes, a core temperature greater than 110 (cid:176)C for at least 120 minutes and a core temperature greater that 120 (cid:176)C
for at least 50 minutes.

3. The processing must be carried out in a batch system.

4. The animal by-products must be cooked in such a manner that the time-temperature requirements are achieved at

the same time.

(1) (cid:145)Saturated steam(cid:146) means that all air is evacuated and replaced by steam in the whole sterilisation chamber.

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R e d u c t i o n

Method 3

1. If the particle size of the animal by-products to be processed is more than 30 millimetres, the animal by-products
must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than
30 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks
disclose the existence of particles larger than 30 millimetres, the process must be stopped and repairs made before
the process is resumed.

T i m e , t e m p e r a t u r e a n d p r e s s u r e

2. After reduction the animal by-products must be heated to a core temperature greater than 100 (cid:176)C for at least 95
minutes, a core temperature greater than 110 (cid:176)C for at least 55 minutes and a core temperature greater that 120 (cid:176)C
for at least 13 minutes.

3. The processing may be carried out in batch or continuous systems.

4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the

same time.

R e d u c t i o n

Method 4

1. If the particle size of the animal by-products to be processed is more than 30 millimetres, the animal by-products
must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than
30 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks
disclose the existence of particles larger than 30 millimetres, the process must be stopped and repairs made before
the process is resumed.

T i m e , t e m p e r a t u r e a n d p r e s s u r e

2. After reduction the animal by-products must be placed in a vessel with added fat and heated to a core temperature
greater than 100 (cid:176)C for at least 16 minutes, a core temperature greater than 110 (cid:176)C for at least 13 minutes, a core
temperature greater that 120 (cid:176)C for at least eight minutes and a core temperature greater that 130 (cid:176)C for at least
three minutes.

3. The processing may be carried out in batch or continuous systems.

4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the

same time.

R e d u c t i o n

Method 5

1. If the particle size of the animal by-products to be processed is more than 20 millimetres, the animal by-products
must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than
20 millimetres. The effectiveness of the equipment must be checked daily and its condition recorded. If checks
disclose the existence of particles larger than 20 millimetres, the process must be stopped and repairs made before
the process is resumed.

T i m e , t e m p e r a t u r e a n d p r e s s u r e

2. After reduction the animal by-products must heated until they coagulate and then pressed so that fat and water are
removed from the proteinaceous material. The proteinaceous material must then be heated to a core temperature
greater than 80 (cid:176)C for at least 120 minutes and a core temperature greater than 100 (cid:176)C for at least 60 minutes.

3. The processing may be carried out in batch or continuous systems.

4. The animal by-products may be cooked in such a manner that the time-temperature requirements are achieved at the

same time.

R e d u c t i o n

Method 6
(for animal by-products of fish origin only)

1. The animal by-products must be reduced to . . . millimetres. They must then be mixed with formic acid to reduce the

pH to . . .. The mixture must be stored for . . . hours pending further treatment.

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2. The mixture must then be introduced into a heat converter and be heated to a core temperature of . . . (cid:176)C for at least
. . . minutes. The progression of the product through the heat converter must be controlled by means of mechanical
commands limiting its displacement in such a way that at the end of the heat treatment operation the product has
undergone a cycle which is sufficient in both time and temperature.

3. After heat treatment, the product must be separated into liquid, fat and greaves by mechanical means. To obtain
processed animal protein concentrate, the liquid phase must be pumped into two heat-exchanger which are steam-
heated and equipped with vacuum chambers in order for its humidity to be removed therein in the form of water
vapour. The greaves must be reincorporated into the protein concentrate before storage.

1. Any processing method approved by the competent authority where it has been demonstrated to that authority that
the final product has been sampled on a daily basis over a period of one month in compliance with the following
microbiological standards:

Method 7

(a) Samples of material taken directly after heat treatment:

Clostridium perfringens absent in 1 g of the products

(b) Samples of material taken during or upon withdrawal from storage at the processing plant:

Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0

Enterobacteriaceae:

n = 5, c = 2, m = 10, M = 300 in 1 g

where:

n = number of samples to be tested;

m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in

all samples does not exceed m;

M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria

in one or more samples is M or more; and

c = number of samples the bacterial count of which may be between m and M, the sample still being

considered acceptable if the bacterial count of the other samples is m or less.

2. Details of the critical control points under which each processing plant satisfactorily complies with the microbi-
ological standards must be recorded and maintained so that the owner, operator or their representative and the
competent authority can monitor the operation of the processing plant. The information to be recorded and
monitored must include the particle size, critical temperature and, as appropriate, the absolute time, pressure
profile, raw material feed-rate and fat recycling rate.

3. This information must be made available to the Commission on request.

CHAPTER IV

Supervision of production

1. The competent authority must supervise processing plants to ensure compliance with the requirements of this

Regulation. It must in particular:

(a) check:

(i) the general conditions of hygiene of the premises, equipment and staff;

(ii) the efficacy of the own checks carried out by the plant, in accordance with Article 25, particularly by

examining the results and taking samples;

(iii) the standards of the products after processing. The analyses and tests must be carried out in accordance with
scientifically- recognised methods (in particular, those laid down in Community legislation or, where none
exist, recognised international standards or, in their absence, national standards); and

(iv) the storage conditions;

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(b) take any samples required for laboratory tests; and

(c) make any other checks it considers necessary to ensure compliance with this Regulation.

2. To allow it to carry out its responsibilities under paragraph 1, the competent authority must have free access at all

times to all parts of the processing plant and to records, commercial documents and health certificates.

CHAPTER V

Validation procedures

1. The competent authority must validate the processing plant in accordance with the following procedures and

indicators:

(a) description of the process (by a process flow diagram);

(b) identification of critical control points (CCPs) including the material process rate for continuous systems;

(c) compliance with the specific process requirements laid down by this Regulation; and

(d) achievement of the following requirements:

(i) particle size for batch-pressure and continuous processes (cid:151) defined by the mincer hole or the anvil gap size,

and

(ii) temperature, pressure, processing time and material processing rate (for continuous system only) as specified

in paragraphs 2 and 3.

2. In the case of a batch pressure system:

(a) the temperature must be monitored with a permanent thermocouple and it must be plotted against real time;

(b) the pressure stage must be monitored with a permanent pressure gauge. Pressure must be plotted against real

time;

(c)

the processing time must be shown by time/temperature and time/pressure diagrams.

At least once a year the thermocouple and the pressure gauge must be calibrated.

3. In the case of a continuous pressure system:

(a) the temperature and the pressure must be monitored with thermocouples, or an infrared temperature gun, and
pressure gauges used at defined positions throughout the process system in such a way that temperature and
pressure comply with the required conditions inside the whole continuous system or in a section of it. The
temperature and pressure must be plotted against real time;

(b) measurement of the minimum transit time inside the whole relevant part of the continuous system where the
temperature and pressure comply with the required conditions, must be provided to the competent authorities,
using insoluble markers (for example, manganese dioxide) or a method which offers equivalent guarantees.
Accurate measurement and control of the material process rate is essential and must be measured during the
validation test in relation to a CCP that can be continuously monitored such as:

(i) feed screw revolutions per minute (rev./min.),

(ii) electric power (amps at given voltage),

(iii) evaporation/condensation rate, or

(iv) number of pump strokes per unit time.

All measuring and monitoring equipment must be calibrated at least once a year.

4. The competent authority must repeat the validation procedures periodically, when it considers it necessary, and in
any case each time any significant alterations are made to the process (for example, modification of the machinery or
a change of raw materials).

5. Validation procedures based on testing methods may be laid down under the procedure referred to in Article 33(2).

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SPECIFIC REQUIREMENTS FOR THE PROCESSING OF CATEGORY 1 AND 2 MATERIAL AND FOR BIOGAS
AND COMPOSTING PLANTS

ANNEX VI

Specific requirements for the processing of Category 1 and Category 2 material

The following requirements apply in addition to the general requirements laid down in Annex V.

CHAPTER I

A. Premises

1. The layout of Category 1 and Category 2 processing plants must ensure the total separation of Category 1 material
from Category 2 material from reception of the raw material until dispatch of the resulting processed product.

2. However, the competent authority may authorise the temporary use of a Category 2 processing plant for the
processing of Category 1 material when a widespread outbreak of an epizootic disease or other extraordinary and
unforeseeable circumstances leads to a lack of capacity at a Category 1 processing plant.

The competent authority must re-approve the Category 2 processing plant in accordance with Article 13 before it
processes Category 2 material again.

B. Processing standards

3. The critical control points that determine the extent of the heat treatments applied in processing must be identified

for each processing method as specified in Annex V, Chapter III. The critical control points may include:

(a) raw material particle size;

(b) temperature achieved in the heat treatment process;

(c) pressure applied to the raw material; and

(d) duration of the heat treatment process or feed rate to a continuous system.

Minimum process standards must be specified for each applicable critical control point.

4. Records must be maintained for at least two years to show that the minimum process values for each critical control

point are applied.

5. Accurately calibrated gauges/recorders must be used to monitor continuously the processing conditions. Records

must be kept to show the date of calibration of gauges/recorders.

6. Material that may not have received the specified heat treatment (e.g., material discharged at start up, or leakage from

cookers) must be recirculated through the heat treatment or collected and reprocessed.

7. Animal by-products must be processed in accordance with the following processing standards.

(a) Processing method 1 must be applied to:

(i) Category 2 material, other than manure and digestive tract content, destined for biogas or composting plants

or intended to be used as organic fertilisers or soil improvers, and

(ii) Category 1 and Category 2 material destined for landfill.

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(b) Any of processing methods 1 to 5 must be applied to:

(i) Category 2 material from which the resulting protein is destined for incineration or coincineration,

(ii) Category 2 material from which the rendered fat is destined for a Category 2 oleochemical plant, and

(iii) Category 1 or Category 2 material destined for incineration or coincineration.

However, the competent authority may require processing method 1 to be applied to Category 1 material
destined for incineration or coincineration.

C. Processed products

8. Processed products derived from Category 1 or 2 materials, with the exception of liquid products destined for biogas
or composting plants, must be permanently marked, where technically possibly with smell, using a system approved
by the competent authority. Detailed rules for such marking may be laid down under the procedure referred to in
Article 33(2).

9. Samples of processed products destined for bio-gas or composting plants or landfill, taken directly after heat
treatment, must be free from heat-resistant pathogenic bacteria spores (Clostridium perfringens absent in 1 g of the
products).

Specific requirements for the approval of biogas and composting plants

CHAPTER II

A. Premises

1. Biogas plants must be equipped with:

(a) a pasteurisation/hygienisation unit, which cannot be bypassed, with:

(i) installations for monitoring temperature against time;

(ii) recording devices to record the results of these measurements continuously; and

(iii) an adequate safety system to prevent insufficient heating; and

(b) adequate facilities for the cleaning and disinfecting vehicles and containers on leaving the biogas plant.

However, a pasteurisation/hygienisation unit
by-products that have undergone processing method 1.

is not mandatory for biogas plants that

transform only animal

2. Composting plants must be equipped with:

(a) a closed composting reactor, which cannot be bypassed, with:

(i) installations for monitoring temperature against time;

(ii) recording devices to record the results of these measurements continuously; and

(iii) an adequate safety system to prevent insufficient heating; and

(b) adequate facilities
by-products.

for cleaning and disinfecting vehicles and containers

transporting untreated animal

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3. Each biogas plant and composting plant must have its own laboratory or make use of an external laboratory. The

laboratory must be equipped to carry out the necessary analyses and approved by the competent authority.

B. Hygiene requirements

4. Only the following animal by-products may be transformed in a biogas or composting plant:

(a) Category 2 material, when using processing method 1 in a Category 2 processing plant;

(b) manure and digestive tract content; and

(c) Category 3 material.

5. Animal by-products referred to in paragraph 4 must be transformed as soon as possible after arrival. They must be

stored properly until treated.

6. Containers, receptacles and vehicles used for transporting untreated material must be cleaned in a designated area.

This area must be situated or designed to prevent risk of contamination of treated products.

7. Preventive measures against birds, rodents, insects or other vermin must be taken systematically. A documented

pest-control programme must be used for that purpose.

8. Cleaning procedures must be documented and established for all parts of the premises. Suitable equipment and

cleaning agents must be provided for cleaning.

9. Hygiene control must include regular inspections of the environment and equipment. Inspection schedules and

results must be documented.

10. Installations and equipment must be kept in a good state of repair and measuring equipment must be calibrated at

regular intervals.

11. Digestion residues must be handled and stored at the plant in such a way as to preclude recontamination.

C. Processing standards

12. Category 3 material used as raw material in a biogas plant equipped with a pasteurisation/hygienisation unit must

be submitted to the following minimum requirements:

(a) maximum particle size before entering the unit: 12 mm;

(b) minimum temperature in all material in the unit: 70 (cid:176)C; and

(c) minimum time in the unit without interruption: 60 minutes.

13. Category 3 material used as raw material in a composting plant must be submitted to the following minimum

requirements:

(a) maximum particle size before entering the composting reactor: 12 mm,

(b) minimum temperature in all material in the reactor: 70 (cid:176)C; and

(c) minimum time in the reactor at 70 (cid:176)C (all material): 60 minutes.

14. However, pending the adoption of rules in accordance with Article 6(2)(g), the competent authority may, when
catering waste is the only animal by-product used as raw material in a biogas or composting plant, authorise the
use of processing standards other than those laid down in paragraphs 12 and 13 provided that they guarantee an
equivalent effect regarding the reduction of pathogens.

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D. Digestion residues and compost

15. Samples of the digestion residues or compost taken during or on withdrawal from storage at the biogas or

composting plant must comply with the following standards:

Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0

Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g

where:

n = number of samples to be tested;

m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all

samples does not exceed m;

M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in

one or more samples is M or more; and

c = number of samples the bacterial count of which may be between m and M, the sample still being considered

acceptable if the bacterial count of the other samples is m or less.

CHAPTER III

Treatment standards for the further processing of rendered fats

The following processes may be used to produce fat derivatives from rendered fats derived from Category 2 material:

1. transesterification or hydrolysis at least 200 (cid:176)C, under corresponding appropriate pressure, for 20 minutes (glycerol,

fatty acids and esters); or

2. saponification with NaOH 12M (glycerol and soap):

(a)

in a batch process at 95 (cid:176)C for three hours; or

(b) in a continuous process at 140 (cid:176)C 2 bars (2 000 hPa) for eight minutes, or under equivalent conditions laid down

in accordance with the procedure referred to in Article 33(2).

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SPECIFIC HYGIENE REQUIREMENTS FOR THE PROCESSING AND PLACING ON THE MARKET OF
PROCESSED ANIMAL PROTEIN AND OTHER PROCESSED PRODUCTS THAT COULD BE USED AS FEED
MATERIAL

ANNEX VII

Specific requirements for the approval of Category 3 processing plants

The following requirements apply in addition to the general requirements laid down in Annex V.

CHAPTER I

A. Premises

1. Premises for the processing of Category 3 material must not be at the same site as premises processing Category 1

or Category 2 material, unless in a completely separate building.

2. However, the competent authority may authorise the temporary use of a Category 3 processing plant for the
processing of Category 1 or Category 2 material when a widespread outbreak of an epizootic disease or other
extraordinary and unforeseeable circumstances lead to a lack of capacity at a Category 1 or Category 2 processing
plant.

The competent authority must re-approve the Category 3 processing plant in accordance with Article 17 before it
processes Category 3 material again.

3. Category 3 processing plants must have:

(a) an installation to check the presence of extraneous matter, such as packaging material, metallic pieces, etc. in the

animal by-products; and

(b)

if the volume of products treated requires regular or permanent presence of the competent authority, an
adequately equipped lockable room for the exclusive use of the inspection service.

B. Raw material

4. Only Category 3 material listed in paragraph 1(a) to (j) of Article 6 that has been handled, stored and transported in
accordance with Article 22 may be used for the production of processed animal proteins and other feed material.

5. Before processing, animal-by products must be checked for the presence of extraneous matter. When present, it

must be removed immediately.

C. Processing standards

6. The critical control points that determine the extent of the heat treatments applied in processing must be identified
for each processing method as specified in Annex V, Chapter III. The critical control points must at least include:

(cid:151) raw material particle size,

(cid:151) temperature achieved in the heat treatment process,

(cid:151) pressure applied to the raw material, if applicable, and

(cid:151) duration of the heat treatment process or feed rate to a continuous system.

Minimum process standards must be specified for each applicable critical control point.

7. Records must be maintained for at least two years to show that the minimum process values for each critical control

point are applied.

8. Accurately calibrated gauges/recorders must be used to monitor continuously the processing conditions. Records

must be kept for at least two years to show the date of calibration of gauges/recorders.

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9. Material that may not have received the specified heat treatment (for example, material discharged at start up, or

leakage from cookers) must be re-circulated through the heat treatment or collected and reprocessed.

D. Processed products

10. Samples of the final products taken during or on withdrawal from storage at the processing plant must comply with

the following standards:

Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0

Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g

where:

n = number of samples to be tested;

m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all

samples does not exceed m;

M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in

one or more samples is M or more; and

c = number of samples the bacterial count of which may be between m and M, the sample still being considered

acceptable if the bacterial count of the other samples is m or less.

CHAPTER II

Specific requirements for processed animal protein

The following conditions apply in addition to the general conditions laid down in Chapter I.

A. Processing standards

1. Mammalian processed animal protein must have been submitted to processing method 1.

2. Non-mammalian processed animal protein, with the exclusion of fishmeal, must have been submitted to any of

processing methods 1 to 5 or 7.

3. Fishmeal must have been submitted:

(a) to any of the processing methods; or

(b) to a method and parameters which ensure that the product complies with the microbiological standards set in

Chapter I, paragraph 10.

B. Storage

4. Processed animal protein must be packed and stored in new or sterilised bags or stored in properly constructed bulk

bins.

5. Sufficient measures must be taken to minimise condensation inside bins, conveyors or elevators.

6. Products in conveyors, elevators and bins must be protected from casual contamination.

7. Processed animal protein handling equipment must be maintained in a clean and dry condition and should have
adequate inspection points so that equipment can be examined for cleanliness. All storage facilities must be emptied
and cleaned regularly, as production requirements require.

8. Processed animal protein must be kept dry. Leakages and condensation in the storage area must be prevented.

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C. Importation

9. Member States must authorise the importation of processed animal protein:

(a)

if it comes from non-member countries that appear on the list in Part II of Annex XI or, in the case of fishmeal,
that appear on the list in Part III of Annex XI;

(b) if it comes from a processing plant that appears on the list referred to in Article 29(4);

(c)

if it has been produced in accordance with this Regulation; and

d)

if it is accompanied by a health certificate as provided for in Article 29(6).

10. Before consignments are released for free circulation within the Community, the competent authority must sample
imports of processed animal protein at the border inspection post to ensure compliance with the requirements of
Chapter I, paragraph 10. The competent authority must:

(a) sample each consignment of products carried in bulk; and

(b) carry out random sampling of consignments of products packaged in the manufacturing plant of origin.

11. However, when six consecutive tests on bulk consignments originating in a given non-member country prove
negative, the competent authority may carry out random sampling of subsequent bulk consignments from that
non-member country. If one of these random samples proves positive, the competent authority carrying out the
sampling must inform the competent authority of the country of origin so that it can take appropriate measures to
remedy the situation. The competent authority of the country of origin must bring these measures to the attention
of the competent authority carrying out the sampling. In the event of a further positive result from the same source,
the competent authority must sample each consignment from the same source until six consecutive tests again
prove negative.

12. Competent authorities must keep a record for at least two years of the results of sampling carried out on all

consignments that have undergone sampling.

13. Where a consignment proves to be positive for salmonella, it must either:

(a) be dealt with in accordance with the procedure laid down by Article 17(2)(a) of Directive 97/78/EC (1); or

(b) reprocessed in a processing plant approved pursuant this Regulation or decontaminated by a treatment auth-
orised by the competent authority. A list of permitted treatments may be established in accordance with the
procedure referred to in Article 33(2). The consignment must not be released until it has been treated, tested for
salmonella by the competent authority in accordance with Chapter I, paragraph 10, and a negative result
obtained.

CHAPTER III

Specific requirements for blood products

The following conditions apply in addition to the general conditions laid down in Chapter I.

A. Raw material

1. Only blood coming under paragraph 1(a) and (b) of Article 6 may be used for the production of blood products.

B. Processing standards

2. Blood products must have been submitted:

(a) to any of processing methods 1 to 5 or 7; or

(b) to a method and parameters which ensure that the product complies with the microbiological standards set in

Chapter I, paragraph 10.

(1) Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on

products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9).

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C. Importation

3. Member States must authorise the importation of blood products if they:

(a) come from non-member countries that appear on the list in Part V of Annex XI;

(b) come from a processing plant that appears on the list referred to in Article 29(4);

(c) have been produced in accordance with this Regulation; and

d) are accompanied by a health certificate as provided for in Article 29(6).

CHAPTER IV

Specific requirements for rendered fats and fish oil

The following conditions apply in addition to the general conditions laid down in Chapter I.

A. Processing standards

1. Rendered fats derived from ruminant animals must be purified in such a way that the maximum levels of remaining

total insoluble impurities does not exceed 0,15 % in weight.

B. Importation of rendered fats

2. Member States must authorise the importation of rendered fats if they:

(a) come from non-member countries appearing on the list in Part IV of Annex XI;

(b) come from a processing plant that appears on the list referred to in Article 29(4);

(c) have been produced in accordance with this Regulation;

(d) either:

(i) are entirely or partly derived from swine raw material and come from a country or a part of the territory of
a country free from foot-and-mouth disease for the previous 24 months and free from classical swine fever,
African swine fever for the previous 12 months,

(ii) are entirely or partly derived from poultry raw material and come from a country or a part of the territory

of a country free from Newcastle disease and avian influenza for the previous six months,

(iii) are entirely or partly derived from ruminant raw material and come from a country or a part of the territory
of a country free from foot-and-mouth disease for the previous 24 months and free from Rinderpest for the
previous 12 months, or

(iv) where there has been an outbreak of one of the abovementioned diseases during the relevant period

mentioned above, have been subjected to one of the following heat treatment processes:

(cid:151) at least 70 (cid:176)C for at least 30 minutes, or

(cid:151) at least 90 (cid:176)C for at least 15 minutes,

and details of the critical control points are recorded and maintained so that the owner, operator or their
representative and, as necessary, the competent authority can monitor the operation of the plant. The
information must include the particle size, critical temperature and, as appropriate, the absolute time,
pressure profile, raw material feed-rate and fat recycling rate; and

(e) are accompanied by a health certificate as provided for in Article 29(6).

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C. Importation of fish oil

3. Member States must authorise the importation of fish oil if it:

(a) comes from non-member countries appearing on the list in Part III of Annex XI;

(b) comes from a processing plant that appears on the list referred to in Article 29(4);

(c) has been produced in accordance with this Regulation; and

(d) is accompanied by a health certificate as provided for in Article 29(6).

D. Hygiene requirements

4. Where rendered fat or fish oil is packaged, it must be packaged in new containers or in containers that have been
cleaned, and all precautions must be taken to prevent its recontamination. Where bulk transport of the products is
intended, the pipe, pumps and bulk tanks and any other bulk container or bulk road tanker used in the trans-
portation of the products from the manufacturing plant either directly on to the ship or into shore tanks or direct to
plants must have been inspected and found to be clean before use.

Specific requirements for milk, milk-based products and colostrum

The following conditions apply in addition to the general conditions laid down in Chapter I.

CHAPTER V

A. Processing standards

1. Raw milk and colostrum must be produced under conditions offering adequate guarantees as regards animal health.

Such conditions may be established in accordance with the procedure referred to in Article 33(2).

2. Milk or treated or processed milk products must be subjected to a heat treatment of at least 2 (cid:176)C for at least 15
seconds or any combination of temperature and time having at least an equivalent heat effect and producing a
negative reaction to the phosphatase test, followed by:

(a)

in the case of dried milk or dried milk products, a drying process; or

(b) in the case of an acidified milk product, a process by which the pH is reduced and kept for at least one hour at a

level below 6.

3. In addition to the requirements laid down in paragraph 2, dried milk or dried milk products must meet the following

requirements:

(a) after completion of the drying process, every precaution must be taken to prevent contamination of the products;

and

(b) the final product must be:

(i) packed in new containers, or

(ii) in the case of bulk transport, transported in vehicles or containers that have been disinfected using a product
approved by the competent authority before loading with the milk, milk-based product or colostrum.

B. Importation

4. Member States must authorise imports of milk and milk-based products if:

(a) they come from non-member countries appearing on the list in Part I of Annex XI;

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(b) in the case of milk and milk-based products from non-member countries or parts of non-member countries listed
in column B of the Annex to Decision 95/340/EC (1), they have undergone a pasteurisation treatment sufficient
to produce a negative phosphatase test and a health certificate conforming to the model laid down in Chapter
2(A) of Annex X accompanies them;

(c)

in the case of milk-based products with a pH reduced to less than 6 from non-member countries or parts of
non-member countries listed in column C of the Annex to Decision 95/340/EC, they have first undergone a
pasteurisation treatment sufficient to produce a negative phosphatase test and a health certificate conforming to
the model laid down in Chapter 2(B) of Annex X accompanies them;

(d) in the case of milk and milk-based products from non-member countries or parts of non-member countries listed
in column C of the Annex to Decision 95/340/EC, they have first undergone a sterilisation process or a double
heat treatment where each treatment was sufficient to produce a negative phosphatase test on its own and a
laid down in Chapter 2(C) of Annex X accompanies them; and
health certificate conforming to the model

(e)

they come from a processing plant which appears on the list referred to in Article 29(4).

5. Milk and milk-based products from non-member countries or parts of non-member countries listed in column C of
the Annex to Decision 95/340/EC where there has been an outbreak of foot-and-mouth disease in the last 12 months
or where vaccination against foot-and-mouth disease has been carried out in the last 12 months must, before
introduction on to Community territory, have undergone either:

(a) a sterilisation process whereby an Fc value equal to or greater than 3 is achieved; or

(b) an initial heat treatment with a heating effect at least equal to that achieved by a pasteurisation process of at least
72 (cid:176)C for at least 15 seconds and sufficient to produce a negative reaction to a phosphatase test, followed by:

(i) a second heat treatment with a heating effect at least equal to that achieved by the initial heat treatment, and
which would be sufficient to produce a negative reaction to a phosphatase test, followed, in the case of dried
milk, or dried milk-based products, by a drying process, or

(ii) an acidification process such that the pH has been maintained at less than 6 for at least one hour.

6. Where a risk of introduction of an exotic disease or any other risk to animal health is identified, additional conditions
for the protection of animal health may be established in accordance with the procedure referred to in Article 33(2).

CHAPTER VI

Specific requirements for gelatin and hydrolysed protein

The following conditions apply in addition to the general conditions laid down in Chapter I.

A. Processing standards for gelatin

1. (a) Gelatin must be produced by a process that ensures that unprocessed Category 3 material is subjected to a
treatment with acid or alkali, followed by one or more rinses. The pH must be adjusted subsequently. Gelatin must
be extracted by heating one or several times in succession, followed by purification by means of filtration and
sterilisation.

(b) After having been subjected to the processes referred to in subparagraph (a), gelatin may undergo a drying process

and, where appropriate, a process of pulverisation or lamination.

(c) The use of preservatives, other than sulphur dioxide and hydrogen peroxide, is prohibited.

2. Gelatin must be wrapped, packaged, stored and transported under satisfactory hygiene conditions. In particular:

(a) a room must be provided for storing materials for wrapping and packaging;

(b) wrapping and packaging must take place in a room or in a place intended for that purpose; and

(c) wrappings and packages containing gelatin must carry the words (cid:145)gelatin suitable for animal consumption(cid:146).

(1) Commission Decision 95/340/EC of 27 July 1995 drawing up a provisional

list of third countries from which Member States
authorise imports of milk and milk-based products and revoking Decision 94/70/EC (OJ L 200, 24.8.1995, p. 38). Decision as
last amended by Decision 96/584/EC (OJ L 255, 9.10.1996, p. 20).

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B. Processing standards for hydrolysed protein

3. Hydrolysed protein must be produced by a production process which involves appropriate measures to minimise
liming and

contamination of raw Category 3 material. Preparation of the raw Category 3 material by brining,
intensive washing must be followed by:

(a) exposure of the material to a pH of more than 11 for more than three hours at a temperature of more than

80 (cid:176)C and subsequently by heat treatment at more than 140 (cid:176)C for 30 minutes at more than 3,6 bar;

(b) exposure of the material to a pH of 1 to 2, followed by a pH of more than 11, followed by heat treatment at

140 (cid:176)C for 30 minutes at 3 bar; or

(c) an equivalent production process approved in accordance with the procedure referred to in Article 33(2).

C. Importation

4. Member States must authorise the importation of gelatin and hydrolysed proteins if they:

(a) come from non-member countries that appear on the list in Part XI of Annex X;

(b) come from a processing plant that appears on the list referred to in Article 29(4);

(c) have been produced in accordance with this Regulation; and

(d) are accompanied by a health certificate as provided for in Article 29(6).

CHAPTER VII

Specific requirements for dicalcium phosphate

The following conditions apply in addition to the general conditions laid down in Chapter I.

A. Processing standards

1. Dicalcium phosphate must be produced by a process that:

(a) ensures that all Category 3 bone-material is finely crushed and degreased with hot water and treated with dilute
hydrochloric acid (at a minimum concentration of 4 % and a pH of less than 1,5) over a period of at least two
days;

(b) follows this with treatment of the obtained phosphoric liquor with lime, resulting in a precipitate of dicalcium

phosphate at pH 4 to 7; and

(c)

finally air dries this precipitate for 15 minutes, with inlet temperature of 270 (cid:176)C to 325 (cid:176)C and end temperature
between 60 (cid:176)C and 65 (cid:176)C,

or by an equivalent process approved in accordance with the procedure referred to in Article 33(2).

B. Importation

2. Member States must authorise the importation of dicalcium phosphate if it:

(a) comes from non-member countries that appear on the list in Part XI of Annex X;

(b) comes from a processing plant that appears on the list referred to in Article 29(4);

(c) has been produced in accordance with this Regulation; and

(d) is accompanied by a health certificate as provided for in Article 29(6).

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REQUIREMENTS FOR THE PLACING ON THE MARKET OF PETFOOD, DOGCHEWS AND TECHNICAL
PRODUCTS

ANNEX VIII

CHAPTER I

Requirements for the approval of petfood and technical plants

Plants producing petfood, dogchews and technical products, other than organic fertilisers, soil
derivatives derived from Category 2 material, must fulfil the following requirements:

improvers and fat

1. they must have adequate facilities for storing and treating incoming material in complete safety; and

2. they must have adequate facilities for disposing of unused animal by-products remaining after the production of the
products in accordance with this Regulation, or this material must be sent to a processing plant or to an incineration
or coincineration plant in accordance with this Regulation.

CHAPTER II

Requirements for petfood and dogchews

A. Raw material

1. The only animal by-products that may be used to produce petfood and dogchews are those referred to in Article
6(1)(a) to (j). However, raw petfood may be manufactured only from animal by-products referred to in Article 6(1)(a).

B. Processing standards

2. Canned petfood must be subjected to heat treatment to a minimum Fc value of 3.

3. Processed petfood other than canned petfood must be subjected to a heat treatment of at least 90 (cid:176)C throughout its
substance. After treatment, every precaution must be taken to ensure that the product is not exposed to contami-
nation. The product must be packed in new packaging.

4. Dogchews must be subjected to a heat treatment during processing sufficient to destroy pathogenic organisms
(including salmonella). After treatment, every precaution must be taken to ensure that the product is not exposed
to contamination. The product must be packed in new packaging.

5. Raw petfood must be packed in new packaging preventing any leakage. Effective steps must be taken to ensure that
the product is not exposed to contamination throughout the production chain and up to the point of sale. The
wording (cid:145)petfood only(cid:146) must be visibly and legibly displayed on the packaging.

6. Random samples must be taken during production and/or during storage (before dispatching) to verify compliance

with the following standards:

Salmonella absence in 25 g: n = 5, c = 0, m = 0, M = 0

where:

n = number of samples to be tested;

m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all

samples does not exceed m;

M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in

one or more samples is M or more; and

c = number of samples the bacterial count of which may be between m and M, the sample still being considered

acceptable if the bacterial count of the other samples is m or less.

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C. Importation

7. Member States must authorise importation of petfood and dogchews if they:

(a) come from non-member countries that appear on the list in Part X of Annex XI;

(b) come from petfood plants approved by the competent authority of the non-member country meeting the specific

conditions laid down in this Regulation;

(c) have been produced in accordance with this Regulation;

(d) are accompanied:

(i) in the case of canned petfood, by a certificate that conforms to the model laid down in Chapter 3(A) of

Annex X,

(ii) in the case of processed petfood other than canned petfood, by a certificate that conforms to the model laid

down in Chapter 3(B) of Annex X,

(iii) in the case of dogchews, by a certificate that conforms to the model laid down in Chapter 3(C) of Annex X,

or

(iv) in the case of raw petfood, by a certificate that conforms to the model laid down in Chapter 3(D) of Annex

X.

Requirements for manure, processed manure and processed manure products

CHAPTER III

I. Unprocessed manure

A. T r a d e

1.

(a) Trade in unprocessed manure of species other than poultry or equidae is prohibited, except for manure:

(i) from an area which is not subject to restrictions by virtue of a serious transmissible disease, and

(ii) intended for application, under the supervision of the competent authorities, to land forming part of a single

holding located on both sides of the border of two Member States.

(b) However, the competent authority may grant specific approval for the introduction on to its territory of:

(i) manure intended for processing in a technical plant or a biogas plant or in a composting plant approved by
the competent authority in accordance with this Regulation with a view to the manufacture of the products
referred to under Section II below. The competent authority must take account of the origin of the manure
when approving such plants; or

(ii) manure intended for applying to land on a holding. Such trade can only occur with the consent of the
competent authorities of both the Member States of origin and destination. When considering giving consent,
the competent authorities must have particular regard to the origin of the manure, its destination and animal
health and safety considerations.

A health certificate conforming to a model laid down under the procedure referred to in Article 33(2) must
accompany the manure in such cases.

2. Trade in unprocessed poultry manure is subject to the following conditions:

(a) the manure must originate in an area which is not subject to restrictions by virtue of Newcastle disease or avian

influenza;

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(b) in addition, unprocessed manure from poultry flocks vaccinated against Newcastle disease must not be dispatched
to a region which has obtained Newcastle disease non-vaccinating status pursuant to Article 15(2) of Directive
90/539/EEC (1); and

(c) a health certificate conforming to a model laid down under the procedure referred to in Article 33(2) must

accompany the manure.

3. Trade in unprocessed manure of equidae is not subject to any animal health conditions.

B. I m p o r t a t i o n

4. Member States must authorise the importation of unprocessed manure if it:

(a) comes from non-member countries that appear on the list in Part IX of Annex XI;

(b) satisfies, according to the species concerned, the requirements of paragraph 1(a);

(c)

is accompanied by a health certificate as provided for in Article 29(6).

II. Processed manure and processed manure products

A. P l a c i n g o n t h e m a r k e t

5. The placing on the market of processed manure and processed manure products is subject to the following

conditions:

(a) they must come from a technical plant, a biogas plant or a composting plant approved by the competent

authority in accordance with this Regulation;

(b) they must have been subjected to a heat treatment process of at least 70 (cid:176)C for at least 60 minutes or to an
equivalent treatment in accordance with rules laid down under the procedure referred to in Article 33(2);

(c)

they must:

(i) be free from salmonella (no salmonella in 25 g treated product),

(ii) be free from enterobacteriaceae (based on the aerobic bacteria count: < 1 000 cfu per gram of

treated

products), and

(iii) have been subjected to reduction in spore-forming bacteria and toxic formation; and

(d) they must be stored in such a way that, once processed, contamination or secondary infection and dampness is

impossible. They must therefore be stored in:

(i) well-sealed and insulated silos, or

(ii) properly sealed packs (plastic bags or (cid:145)big bags(cid:146)).

B. I m p o r t a t i o n

6. Member States must authorise importation of processed manure and processed manure products if they:

(a) come from non-member countries that appear on the list in Part IX of Annex XI;

(b) come from a plant approved by the competent authority of the non-member country meeting the specific

conditions laid down in this Regulation;

(c) satisfy the requirements of paragraph 5 above; and

(d) are accompanied by a health certificate as provided for in Article 29(6).

(1) Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports
from third countries of poultry and hatching eggs (OJ L 303, 31.10.1990, p. 6). Directive as last amended by Commission Decision
2000/505/EC (OJ L 201, 9.8.2000, p. 8).

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III. Guano

7. The placing on the market of (cid:145)guano(cid:146) is not subject to any animal health conditions.

CHAPTER IV

Requirements for blood and blood products used for technical purposes, including pharmaceuticals, in vitro
diagnosis and laboratory agents, but excluding serum of equidae

A. Placing on the market

1. The placing on the market of blood products covered by this Chapter is subject to the requirements laid down in

Article 20.

B. Importation

2. Imports of blood are subject to the requirements laid down in Chapter XI.

3. Member States must authorise importation of blood products if they:

(a) come from non-member countries that appear on the list in Part VI of Annex XI;

(b) come from a plant approved by the competent authority of the non-member country meeting the specific

conditions laid down in this Regulation; and

(c) are accompanied by a health certificate as provided for in Article 29(6); and either

(d) originate in a non-member country in which no case of foot-and-mouth disease has been recorded within at least
24 months and no case of vescicular stomatitis, swine vesicular disease, rinderpest, peste des petits ruminants,
Rift Valley Fever, blue tongue, African horse sickness, classical swine fever, African swine fever, Newcastle disease
or avian influenza has been recorded for 12 months in the susceptible species and in which vaccination has not
been carried out against those diseases for at least 12 months. The health certificate may be made out according
to the species of animal from which the blood products are derived; or

(e)

in the case of blood products derived from bovine animals:

(i) originate in an area of a non-member country fulfilling the requirements of subparagraph (d) from which
imports of bovine animals, their fresh meat or their sperm are authorised pursuant to Community legis-
lation. The blood from which such products are manufactured must be from bovine animals from that area
of the non-member country and must have been collected:

(cid:151) in slaughterhouses approved in accordance with Community legislation,

or

(cid:151) in slaughterhouses approved and supervised by the competent authority of the non-member country.
The Commission and Member States must be notified of the address and approval number of such
slaughterhouse or the certificate must indicate them;

(ii) have undergone one of the following treatments guaranteeing the absence of pathogens of the bovine

diseases referred to in subparagraph (d):

(cid:151) heat treatment at a temperature of 65 (cid:176)C for at least three hours, followed by an effectiveness check,

(cid:151) irradiation at 2,5 megarads or by gamma rays, followed by an effectiveness check,

(cid:151) change in pH to pH 5 for two hours, followed by an effectiveness check,

(cid:151) heat treatment of at least 90 (cid:176)C throughout their substance, followed by an effectiveness check, or

(cid:151) any other treatment provided for in accordance with the procedure referred to in Article 33(2); or

(iii) fulfil the requirements laid down in Chapter X. In this case, the packaging may not be opened during storage

and the technical plant must carry out one of the treatments listed in point (ii).

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4. The specific conditions relating to imports of products for use in in vitro diagnosis and laboratory reagents may be

laid down, where necessary, under the procedure referred to in Article 33(2).

CHAPTER V

Requirements for serum of equidae

A. Raw material

1. Serum must:

(a) come from equidae which show no signs of

the serious transmissible diseases referred to in Directive

90/426/EEC (1) or of any other serious transmissible disease to which equidae are susceptible; and

(b) have been obtained in bodies or centres not subject to health restrictions pursuant to that Directive.

B. Importation

2. Member States must authorise the import of serum of equidae if:

(a)

it comes from equidae born and raised in a non-member country from which the importation of horses for
slaughter is authorised;

(b) it was obtained, processed and dispatched in conformity with the following conditions:

(i) it comes from a country where the following diseases are compulsorily notifiable: African horse sickness,
dourine, glanders, equine encephalomyelitis (all types including VEE), equine infectious anaemia, vesicular
stomatitis, rabies, anthrax;

(ii) it was obtained, under the supervision of a veterinarian, from equidae which, at the time of collection, were

free from clinical signs of infectious disease;

(iii) it was obtained from equidae that have remained since birth in the territory or, in case of official regional-
isation according to Community legislation, in parts of the territory of a non-member country in which:

(cid:151) Venezuelan equine encephalomyelitis had not occurred during the last two years,

(cid:151) dourine had not occurred during the last six months, and

(cid:151) glanders had not occurred during the last six months;

(iv) it was obtained from equidae that had never been present on a holding that had been subject to prohibition

for animal health reasons or where:

(cid:151) in the case of equine encephalomyelitis, the date on which all the equidae suffering from the disease were

slaughtered was at least six months before the date of collection,

(cid:151) in the case of infectious anaemia, all the infected animals had been slaughtered and the remaining

animals showed a negative reaction to two Coggins tests carried out three months apart,

(cid:151) in the case of vesicular stomatitis, the prohibition was lifted at least six months before the date of

collection,

(cid:151) in the case of rabies, the last recorded case was at least a month before the date of collection,

(cid:151) in the case of anthrax, the last recorded case was at least 15 days before the date of collection, or

(1) Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third
countries of equidae (OJ L 224, 18.8.1990, p. 42). Directive as last amended by Commission Decision 2001/298/EC (OJ L 102,
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(cid:151) all the animals of species susceptible to the disease located on the holding were slaughtered and the
premises disinfected, at least 30 days before the date of collection (or, in the case of anthrax, at least 15
days before);

(v) it has undergone all precautions to avoid contamination with pathogenic agents during production, handling

and packaging;

vi) it was packed in sealed impermeable containers clearly labelled (cid:145)serum from equidae(cid:146) and bearing the

registration number of the establishment of collection;

(c)

it comes from a plant approved by the competent authority of the non-member country meeting the specific
conditions laid down in this Regulation; and

(d) a certificate conforming to the model laid down in Chapter 4 of Annex X accompanies it.

CHAPTER VI

Requirements for hides and skins of ungulates

A. Scope

1. The provisions of this Chapter do not apply:

(a) to hides and skins of ungulates fulfilling the requirements of Council Directive 64/433/EEC of 26 June 1964 on

health problems affecting intra-Community trade in fresh meat (2);

(b) to hides and skins of ungulates having undergone the complete process of tanning;

(c)

to (cid:145)wet blue(cid:146);

(d) to (cid:145)pickled pelts(cid:146); and

(e)

to limed hides (treated with lime and in brine at a pH of 12 to 13 for at least eight hours).

2. Within the scope defined in paragraph 1, the provisions of this Chapter apply to fresh, chilled and treated hides and

skins. For the purpose of this Chapter, (cid:145)treated hides and skins(cid:146) means hides and skins that have been:

(a) dried;

(b) dry-salted or wet-salted for at least 14 days prior to dispatch;

(c) salted for seven days in sea salt with the addition of 2 % of sodium carbonate;

(d) dried for 42 days at a temperature of at least 20 (cid:176)C; or

(e) preserved by a process other than tanning specified in accordance with the procedure referred to in Article 33(2).

B. Trade

3. Trade in fresh or chilled hides and skins is subject to the same health conditions as those applicable to fresh meat
pursuant to Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade
in fresh meat (3).

4. Trade in treated hides and skins is authorised on condition that the commercial document provided for in Annex II

accompanies each consignment and attests that:

(a) the hides and skins have been treated in accordance with paragraph 2; and

(b) the consignment has not been in contact with other animal products or live animals presenting a risk of

spreading a serious transmissible disease.

(2) OJ 121, 29.7.1964, p. 2012. Directive as last amended by Directive 95/23/EC (OJ L 243, 11.10.1995, p. 7).
(3) OJ L 302, 31.12.1972, p. 24. Directive last amended by the 1994 Act of Accession.

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C. Importation

5. Member States must authorise the import of fresh or chilled hides and skins if:

(a) they have been obtained from animals referred to in Article 6(1)(b) or (c);

(b) they originate from a non-member country or, in the case of regionalisation in accordance with Community
legislation, from a part of a non-member country from which imports of all categories of fresh meat of the
corresponding species are authorised and which:

(i) for at least 12 months before dispatch, has been free from the following diseases:

(cid:151) classical swine fever,

(cid:151) African swine fever, and

(cid:151) rinderpest, and

(ii) has been free for at least 24 months before dispatch from foot-and-mouth disease and where, for 12 months

before dispatch, no vaccination has been carried out against foot-and-mouth disease;

(c)

they have been obtained from:

(i) animals that have remained in the territory of the country of origin for at least three months before being

slaughtered or since birth in the case of animals less that three months old,

(ii) in the case of hides and skins from biungulates, animals that come from holdings in which there has been no
outbreak of foot-and-mouth disease in the previous 30 days, and around which within a radius of 10 km
there has been no case of foot-and-mouth disease for 30 days,

(iii) in the case of hides and skins from swine, animals that come from holdings in which there has been no
outbreak of swine vesicular disease in the previous 30 days, or of classical or African swine fever in the
previous 40 days, and around which within a radius of 10 km there has been no case of these diseases for 30
days, or

(iv) animals that have passed the ante-mortem health inspection at the slaughterhouse during the 24 hours
before slaughter and have shown no evidence of foot-and-mouth disease, rinderpest, classical swine fever,
African swine fever or swine vesicular disease;

(d) they have undergone all precautions to avoid recontamination with pathogenic agents; and

(e) a certificate conforming to the model laid down in Chapter 5(A) of Annex X accompanies them.

6. Member States must authorise the import of treated hides and skins if:

(a) they have been obtained from animals referred to in Article 6(1)(b), (c) or (k);

(b) a certificate conforming to the model laid down in Chapter 5(B) of Annex X accompanies them;

(c)

they come either:

(i) from animals originating in a region of a non-member country or in a non-member country not subject,
pursuant to Community legislation, to restrictions as a result of an outbreak of a serious transmissible disease
to which the animals of the species concerned are susceptible and they have been treated in accordance with
paragraph 2, or

(ii) from animals originating from other regions of a non-member country or other non-member countries and

they have been treated in accordance with paragraph 2(c) or (d), or

(iii) from ruminant animals and have been treated in accordance with paragraph 2 and have been kept separate
for 21 days or have undergone transport for 21 uninterrupted days. In this case, the certificate referred to in
subparagraph (b) is replaced by a declaration conforming to the model laid down in Chapter 5(C) of Annex
X, to the effect that or proving that those requirements have been met;

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(d) in the case of salted hides and skins transported by ship, the hides have been salted before importation for the

duration stated in the certificate accompanying the consignment; and

(e)

the consignment has not been in contact with other animal products or with live animals presenting a risk of
spreading a serious transmissible disease.

7. Fresh, chilled or treated hides and skins of ungulates must be imported in containers, road vehicles, railway wagons

or bales sealed by the competent authority of the non-member country of dispatch.

CHAPTER VII

Requirements for game trophies

A. Raw material

1. Without prejudice to the measures adopted pursuant to Council Regulation (EC) No 338/97 of 9 December 1996 on

the protection of species of wild fauna and flora by regulating trade therein (1), game trophies:

(a) of ungulates and birds having undergone a complete taxidermy treatment ensuring their preservation at ambient

temperatures; and

(b) of species other than ungulates and birds,

are not subject to any ban or restriction for reasons of animal health.

2. Without prejudice to the measures adopted pursuant to Regulation (EC) No 338/97, game trophies of ungulates and
birds not having undergone the treatment mentioned in paragraph 1(a) are subject to the following conditions. They
must:

(a) come from animals originating in an area not subject to restrictions as a result of the presence of serious

transmissible diseases to which animals of the species concerned are susceptible; or

(b) comply with the conditions laid down in paragraphs 3 or 4 if they come from animals originating in an area
subject to restrictions as a result of the presence of serious transmissible diseases to which animals of the species
concerned are susceptible.

3. In respect of game trophies consisting solely of bone, horns, hooves, claws, antlers or teeth, the trophies must:

(a) have been immersed in boiling water for an appropriate time so as to ensure that any matter other than bone,

horns, hooves, claws, antlers or teeth is removed;

(b) have been disinfected with a product authorised by the competent authority,

in particular with hydrogen

peroxide where parts consisting of bone are concerned;

(c) be packaged, immediately after treatment, without being in contact with other products of animal origin likely to
contaminate them, in individual, transparent and closed packages so as to avoid any subsequent contamination;
and

(d) be accompanied by a document or certificate certifying that the above conditions have been met.

4. In respect of game trophies consisting solely of hides or skin, the trophies must:

(a) have been either:

(i) dried, or

(ii) dry or wet-salted for a minimum of 14 days before dispatch, or

(iii) preserved by a treatment other that tanning approved in accordance with the procedure referred to in Article

33(2);

(1) OJ L 61, 3.3.1997, p. 1. Regulation as last amended by Commission Regulation (EC) No 1579/2001 (OJ L 209, 2.8.2001, p. 14)

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(b) be packaged, immediately after treatment, without being in contact with other products of animal origin likely to
contaminate them, in individual, transparent and closed packages so as to avoid any subsequent contamination;
and

(c) be accompanied by a document or certificate certifying that the above conditions have been met.

B. Importation

5. Member States must authorise the importation of treated game trophies from birds and ungulates, being solely bones,

horns, hooves, claws, antlers, teeth, hides or skins, from non-member countries if:

(a) a certificate that conforms to the model laid down in Chapter 6(A) of Annex X accompanies them; and

(b) they comply with the requirements of paragraphs 3 and 4. However, in the case of dry-salted or wet-salted skins
transported by ship, the skins need not be salted 14 days before dispatch, provided that they are salted for 14
days before importation.

6. Member States must,

in accordance with the requirements of paragraph 7, authorise the importation of game
trophies from birds and ungulates consisting of entire anatomical parts, not having been treated in any way, from
non-member countries:

(a) that appear in one of the lists in the Annex to Commission Decision 94/86/EC of 16 February 1994 drawing up
a provisional list of non-member countries from which Member States authorise imports of wild game meat (1);
and

(b) from which the importation of all categories of fresh meat of the corresponding species is authorised.

7. Member States must authorise importation of the game trophies referred to in paragraph 6 if:

(a) they come from animals originating in an area not subject to restrictions as a result of the presence of serious

transmissible diseases to which animals of the species concerned are susceptible;

(b) they were packaged, immediately after treatment, without being in contact with other products of animal origin
in individual, transparent and closed packages so as to avoid any subsequent

likely to contaminate them,
contamination; and

(c) a certificate conforming to the model laid down in Chapter 6(B) of Annex X accompanies them.

Requirements for wool, hair, pig bristles, feathers and parts of feathers

CHAPTER VIII

A. Raw material

1. Unprocessed wool, unprocessed hair, unprocessed pig bristles and unprocessed feathers and parts of feathers must
have been obtained from animals referred to in Article 6(1)(c) or (k). They must be securely enclosed in packaging
and dry. However, movements of pig bristles from regions in which African swine fever is endemic are prohibited
except for pig bristles that have:

(a) been boiled, dyed or bleached; or

(b) undergone some other form of treatment which is certain to kill pathogenic agents, provided that evidence to this
effect is submitted in the form of a certificate from the veterinarian responsible for the place of origin. Factory
washing may not be regarded as a form of treatment for the purposes of this provision.

2. The provisions of paragraph 1 do not apply to decorative feathers or feathers:

(a) carried by travellers for their private use; or

(b) in the form of consignments sent to private individuals for non-industrial purposes.

(1) OJ L 44, 17.2.1994, p. 33.

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B. Importation

3. Member States must authorise the importation of pig bristles from non-member countries or, in case of regional-

isation according to Community legislation, regions thereof, if:

(a) the pig bristles were obtained from animals originating, and slaughtered in a slaughterhouse, in the country of

origin; and

(b) either:

(i) where no case of African swine fever has occurred during the previous 12 months, a certificate conforming

to the model laid down in Chapter 7(A) of Annex X accompanies the consignment; or

(ii) where one or more case of African swine fever has occurred during the previous 12 months, a certificate

conforming to the model laid down in Chapter 7(B) of Annex X accompanies the consignment.

4. Member States must authorise the importation of unprocessed wool, hair, feathers and parts of feathers if they are:

(a) securely enclosed in packaging and dry; and

(b) sent directly to the technical plant or to an intermediate plant in conditions such that any spread of pathogenic

agents is avoided.

CHAPTER IX

Requirements for apiculture products

A. Raw material

1. Apiculture products intended exclusively for use in apiculture must:

(a) not come from an area which is subject of a prohibition order associated with an occurrence of American
foulbrood or acariosis if, in the case of acariosis, the area of destination has obtained additional guarantees in
accordance with Article 14(2) of Directive 92/65/EEC (1); and

(b) meet the requirements imposed by Article 8(a) of Directive 92/65/EEC.

Any derogation must be established, as necessary, in accordance with the procedure referred to in Article 33(2).

B. Importation

2. Member States must authorise the importation of apiculture products intended for use in apiculture if:

(a) the commercial document accompanying the consignment includes the following information:

(i) the country of origin,

(ii) the name of the establishment of production,

(iii) the registration number of the establishment of production,

(iv) the nature of the products, and

(v) the indication: (cid:145)Apiculture products intended exclusively for use in apiculture originating from a holding not
subject to restrictions because of occurrence of bee diseases and collected in the centre of a region with a
radius of 3 kilometres which is not subjected to restrictions because of American foulbrood, which is a
notifiable disease, for at least 30 days(cid:146) and

(1) Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the
Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules
referred to in Annex A(I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54). Directive as last amended by Commission Decision
2001/298/EC (OJ L 102, 12.4.2001, p. 63).

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(b) the competent authority supervising the registered establishment of production has stamped the commercial

document.

CHAPTER X

Requirements for bones and bone products (excluding bone meal), horns and horn products (excluding horn
meal) and hooves and hoof products (excluding hoof meal) intended for use other than as feed material,
organic fertilisers or soil improvers

1. Member States must authorise the importation of bones and bone products (excluding bone meal), horns and horn
products (excluding horn meal) and hooves and hoof products (excluding hoof meal) to produce technical products
if:

(a) the products are dried before export and not chilled or frozen;

(b) the products are conveyed only by land and sea from their country of origin direct to a border inspection post in

the Community and are not transhipped at any port or place outside the Community;

(c)

following the document checks provided for in Directive 97/78/EC, the products are conveyed directly to the
technical plant.

2. Each consignment must be accompanied by:

(a) a commercial document stamped by the competent authority supervising the establishment of origin, including

the following information:

(i) the country of origin,

(ii) the name of the establishment of production,

(iii) the nature of

the product

(dried bone/dried bone product/dried horns/dried horn products/dried

hooves/dried hoof products), and

(iv) the fact that the product was:

(cid:151) derived from healthy animals slaughtered in a slaughterhouse, or

(cid:151) dried for 42 days at an average temperature of at least 20 (cid:176)C, or

(cid:151) heated for one hour to at least 80 (cid:176)C to the core before drying, or

(cid:151) ashed for one hour to at least 80 (cid:176)C to the core before drying, or

(cid:151) underwent an acidification process such that the pH was maintained at less than 6 to the core for at least

one hour before drying, and

is not intended at any stage to be diverted for any use in food, feed material, organic fertilisers or soil
improvers; and

(b) the following declaration of the importer which must be in at least one official language of the Member State
through which the consignment first enters the Community and in at least one official language of the Member
State of destination:

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3. On dispatch to the Community territory, the material must be enclosed in sealed containers or vehicles or carried in
bulk in a ship. If transported in containers, the containers, and in all cases all the accompanying documents, must
bear the name and the address of the technical plant.

4. Following the border check provided for in Directive 97/78/EC, and in accordance with the rules laid down in Article

9(4) of that Directive, the material must be transported direct to the technical plant.

5. Records must be kept of the quantity and nature of the material, during manufacture, in such a way as to ensure that

the material has actually been used for the intended purposes.

CHAPTER XI

Animal by-products for the manufacture of petfood and pharmaceutical and other technical products

Member States must authorise the importation of animal by-products intended for the manufacture of petfood, phar-
maceutical products and other technical products if:

1. they come from non-member countries which appear on the list in Part VII of Annex XI;

2. they consist only of animal by-products referred to in Article 6(1)(a);

3. they have been deep frozen at the plant of origin;

4. they have undergone all precautions to avoid recontamination with pathogenic agents;

5. they were packed in new packaging preventing any leakage;

6. a certificate conforming to the model laid down in Chapter 8 of Annex X accompanies them; and

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7. following the border check provided for in Directive 97/78/EC, and in accordance with the rules laid down in Article

9(4) of that Directive, they are transported either:

(a) directly to a petfood or technical plant, which has given the guarantee that the animal by-products will be used

only for the permitted purpose and will not leave the plant untreated; or

(b) to an intermediate plant.

CHAPTER XII

Rendered fats for oleochemical purposes

Member States must authorise the importation of rendered fat intended to be processed by a method that at least meets
the standards of one of the processes described in Annex VI, Chapter III, if:

1. the product is conveyed only by land and sea from the country of origin direct to a border inspection post in the

Community;

2. following the document checks provided for in Directive 97/78/EC, and in accordance with the rules laid down in
Article 9(4) of that Directive, the products are conveyed to the oleochemical plant where they will be processed;

3. a declaration made by the importer accompanies each consignment. This declaration must state that products
imported in accordance with this Chapter will not be diverted for any use other than further processing by a
method which at least meets the standards of one of the processes described in Annex VI, Chapter III. This
declaration must be presented to, and annotated by, the competent authority at the border inspection post at the
first point of entry of the goods into the Community, and thereafter accompany the consignment up to the
oleochemical plant.

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ANNEX IX

RULES APPLICABLE TO THE USE OF CERTAIN CATEGORY 2 AND CATEGORY 3 MATERIAL FOR THE
FEEDING OF CERTAIN ANIMALS IN ACCORDANCE WITH ARTICLE 23(2)

1. This Annex applies only to users and collection centres authorised and registered pursuant to Article 23(2)(c)(iv), (vi)
(cid:145)relevant material(cid:146) means the animal by-products specified in Article

and (vii). For the purposes of this Annex,
23(2)(b) and products derived therefrom.

2. Relevant material must be transported to the users or to collection centres in accordance with Annex II.

3. Collection centres must:

(a) comply at least with the following requirements of Annex V:

(i) Chapter I, paragraphs 1(a), (b), (c), (d) and (f), 2, 3 and 4, and

(ii) Chapter II, paragraphs 1, 2, 4, 5 and 9; and

(b) have adequate facilities for destroying unused unprocessed relevant material, or send it to a processing plant or to

an incineration or coincineration plant in accordance with this Regulation.

Member States may authorise the use of a Category 2 processing plant as a collection centre.

4. In addition to the records required in accordance with Annex II, the following records must be kept in relation to

relevant material:

(a)

in the case of final users, the quantity used and the date of use; and

(b) in the case of collection centres:

(i) the quantity treated in accordance with paragraph 5;

(ii) the name and address of each final user buying the material;

(iii) the premises to which the material is taken for use;

(iv) the quantity dispatched; and

(v) the date on which the material was dispatched.

5. Operators of collection centres supplying relevant material other than fish offal to final users, must ensure that:

(a)

it undergoes one of the following treatments (either in the collection centre or in a slaughterhouse approved by
the competent authority in accordance with Community legislation):

(i) denaturing with a solution of a colouring agent approved by the competent authority. The solution must be
of such a strength that the colouring on the stained material is clearly visible, and the whole surface of all
pieces of material have been covered with a solution as aforesaid either by immersing the material in, or
spraying or otherwise applying the solution;

(ii) sterilisation, that is to say boiling or steaming under pressure until every piece of material

is cooked

throughout; or

(iii) any other treatment approved by the competent authority; and

(b) it is packaged after treatment and before distribution in packaging that is clearly and legibly marked with the

name and the address of the collection centre and the indication (cid:145)not for human consumption(cid:146).

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MODEL HEALTH CERTIFICATES FOR THE IMPORTATION FROM NON-MEMBER COUNTRIES OF CERTAIN
ANIMAL BY-PRODUCTS AND PRODUCTS DERIVED THEREFROM

ANNEX X

CHAPTER 1

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CHAPTER 2(A)

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CHAPTER 2(B)

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CHAPTER 2(C)

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CHAPTER 3(A)

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CHAPTER 3(B)

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CHAPTER 3(C)

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CHAPTER 3(D)

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CHAPTER 4

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CHAPTER 5(A)

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CHAPTER 5(B)

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CHAPTER 5(C)

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CHAPTER 6(A)

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CHAPTER 6(B)

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CHAPTER 7(A)

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CHAPTER 7(B)

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CHAPTER 8

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ANNEX XI

LISTS OF NON-MEMBER COUNTRIES FROM WHICH MEMBER STATES MAY AUTHORISE IMPORTS OF
ANIMAL BY-PRODUCTS NOT INTENDED FOR HUMAN CONSUMPTION

The inclusion of a country on one of the following lists is a necessary, but not sufficient, condition for the importation
of relevant products from that country.
the relevant animal health and public health
requirements.

Imports must also fulfil

List of non-member countries from which Member States may authorise imports of milk and milk-based
products

Non-member countries listed in column B or column C of the Annex to Decision 95/340/EC.

PART I

PART II

List of non-member countries from which Member States may authorise imports of processed animal proteins
(excluding fishmeal)

Non-member countries listed in Part I of the Annex to Decision 79/542/EEC.

List of non-member countries from which Member States may authorise imports of fishmeal and fishoil

Non-member countries listed in the Annex to Decision 97/296/EC.

PART III

PART IV

List of non-member countries from which Member States may authorise imports of rendered fats (excluding
fishoil)

Non-member countries listed in Part I of the Annex to Decision 79/542/EEC.

PART V

List of non-member countries from which Member States may authorise imports of blood products for feed
material

A. Blood products from ungulates

Non-member countries or parts of countries listed in Part I of the Annex to Decision 79/542/EEC from which imports
of all categories of fresh meat of the respective species are authorised.

B. Blood products from other species

Non-member countries listed in Part I of the Annex to Decision 79/542/EEC.

PART VI

List of non-member countries from which Member States may authorise imports of blood products (with the
exception of equidae) intended for technical and pharmaceutical uses

A. Blood products from ungulates

Non-member countries or parts of countries listed in Part I of the Annex to Decision 79/542/EEC from which imports
of all categories of fresh meat of the respective species are authorised.

B. Blood products from other species

Non-member countries listed in Part I of the Annex to Decision 79/542/EEC.

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PART VII

List of non-member countries from which Member States may authorise imports of unprocessed material for
the manufacture of petfood and technical products

A. Unprocessed material from bovine, ovine, caprine, porcine and equine animals

Non-member countries or parts of countries listed in Part I of the Annex to Decision 79/542/EEC from which imports
of all categories of fresh meat of the respective species are authorised.

B. Unprocessed material from poultry

Non-member countries from which Member States authorise imports of fresh poultrymeat.

C. Unprocessed material from other species

Non-member countries listed in Part I of the Annex to Decision 79/542/EEC.

List of non-member countries from which Member States may authorise imports of untreated pig bristles

Non-member countries listed in Part I of the Annex to Decision 79/542/EEC.

PART VIII

List of non-member countries from which Member States may authorise imports of manure for treatment of
the soil

PART IX

A. Processed manure products

Non-member countries listed in Part I of the Annex to Decision 79/542/EEC.

B. Processed manure from equidae

Non-member countries listed in Part I of the Annex to Decision 79/542/EEC for live equidae.

C. Unprocessed manure from poultry

Non-member countries from which Member States authorise imports of fresh poultrymeat.

List of non-member countries from which Member States may authorise imports of petfood and dogchews

Non-member countries listed in Part I of the Annex to Decision 79/542/EEC, and the following countries:

PART X

(LK) Sri Lanka (1)
(JP) Japan (2)
(TW) Taiwan (2).

PART XI

List of non-member countries from which Member States may authorise imports of gelatin, hydrolysed protein
and dicalcium phosphate

Non-member countries listed in Part I of the Annex to Decision 79/542/EEC, and the following countries:

(KR) The Republic of Korea (3)
(MY) Malaysia (3)
(PK) Pakistan (3)
(TW) Taiwan (3).

(1) Dogchews made from hides and skins of ungulates only.
(2) Processed petfood for ornamental fish only.
(3) Gelatin only.

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STATEMENT OF THE COUNCIL’S REASONS

I.

INTRODUCTION

The Commission proposed a Regulation laying down health rules concerning animal by-products not
intended for human consumption in October 2000.

The European Parliament adopted an opinion on the proposed Regulation at first reading on 12 June
2001. The Economic and Social Committee adopted an opinion on 26 April 2001 (1).

After considering these opinions, the Council adopted a Common Position on 20 November 2001.

II. OBJECTIVE OF THE PROPOSED REGULATION

The aim of the proposed Regulation is to establish a single legal framework for animal by-products,
which better protects animal and public health and is clearer, simpler and more flexible than the
current rules.

It would, together with the recently adopted Regulation on transmissible spongiform encephalopathies
(TSEs) (2), provide a comprehensive legal framework for feed containing animal proteins. It would lay
down strict rules governing the production of such feed and set limits on its use (which the TSEs
Regulation would supplement in respect of TSEs).

However, its scope is wider than feed alone. It would lay down rules covering the fate of virtually all
products of animal origin that are not destined for human consumption. These include rules to ensure
that the destruction of such products and a wide range of uses in or as products other than in feed take
place in a manner that minimises the risks for animal and human health. Examples of other uses of
animal by-products include the production of pet food and technical products and as a raw material for
biogas and composting plants.

III. ANALYSIS OF THE COMMON POSITION

A. Introduction

There is no difference of opinion between the Council,
the European Parliament and the
Commission regarding the basic principles that the Regulation should establish. In particular, the
three institutions agree:

(cid:151) that only by-products from animals fit for human consumption should be used in feed,

(cid:151) that intra-species recycling (or animal cannibalism) should be prohibited, and

(cid:151) that the legal framework that the Regulation establishes should be flexible enough to be able to

adapt to technical developments and advances in scientific knowledge.

As a consequence, the Common Position adopted by the Council encompasses the bulk of the
amendments that Parliament adopted at first reading. The Commission accepts these amendments
and the other modifications made to its proposal.

(1) The Committee of the Regions decided not to provide an opinion.
(2) Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention,

control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).

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B. Animal feed

As mentioned above, the Council agrees with the European Parliament and the Commission that the
Regulation should prohibit intra-species recycling. Scientific advice justifies the introduction of such
a precautionary measure to prevent the spread of disease. The Common Position incorporates the
principles of Parliamentary amendments 1, 2, 9, 18, 60, 62, 79, 80 and 94 (1).

The Common Position provides scope to grant derogations in respect of fish and fur animals, if
scientific advice justifies them (2).
In the case of fish, strict application of the prohibition on
intra-species recycling would prevent the practice of using wild fish to prepare feed for farmed
fish. Fishmeal is generally produced from wild fish that are not used for human consumption.
However, it would not be possible to guarantee that fishmeal fed to farmed fish did not contain a
small amount of material derived from wild fish of the same species (for example, it would be
impossible to prove that feed for farmed salmon contained no material derived from wild salmon).
A derogation might therefore be appropriate to allow the practice to continue. Fur animals are also
a special case. Unlike other farmed animals, they are not used for the production of food. Moreover,
by-products from fur animals could not be used to prepare feed for other animals.

that swill

The Common Position would also prohibit the use of catering waste to prepare feed (3). In part, this
is a corollary to the prohibition on intraspecies recycling. It would be virtually impossible to prove,
for pigs included no leftovers from dishes containing pork or ham.
for example,
The prohibition is also an indispensable precautionary measure to prevent
the spread of
epizootic diseases. Recent outbreaks of animal diseases appear to be due to the use of catering
waste
ineffective.
Consequently, the Council does not accept Parliamentary amendments 102/rev and 103/rev (4).

containing infected meat, demonstrating that

controls are

current

the

C. Handling, processing, transport and identification

The Council agrees on the need to ensure the separation of animal by-products and processed
products so as to prevent cross-contamination. The Common Position therefore incorporates the
principle of Parliamentary amendments 8, 9, 28, 37, 44, 45, 46, 47, 51, 54, 55, 57, 58, 70, 73, 75,
77, 78, 93, 95 and 97 (5).

The Council shares the view that processed products derived from Category 1 and 2 material
should contain a visual and, if practicable, an olfactory marker. However, it does not believe the
marking and denaturing of unprocessed products (such as the whole bodies of dead animals and
manure) to be either necessary or practicable. The Common Position therefore incorporates the
relevant elements of Parliamentary amendments 26, 27, 35, 45, 46, 47 and 76 (6), but none of
amendments 24 and 31 (7).

The Council does not agree that Category 1 and 2 material ought always to undergo processing
method 1 (133 oC, 20 minutes, 3 bar). It believes that the Regulation should follow the advice of
the Scientific Steering Committee and allow the use of other processing methods prior to the
destruction or use of animal by-products when this does not present a risk for animal or
human health.

(1) Recitals 6 and 7, Articles 19(c) and 22 and Annexes III(II)(3) and VII(I)(4).
(2) Article 22(2).
(3) Article 22(1)(b).
(4) The Commission was similarly unable to accept these amendments.
(5) Recitals 7 and 10, Articles 4(3), 5(3), 6(3), 7, 14, 17(2)(b) and Annexes II(I)(1), II(II)(3), III(I)(1)(a), III(II)(3), III(III)(1),

V(I)(1)(a), VI(I)(1), VI(I)(2), VII(I)(1) and VII(I)(2).

(6) Articles 4(2), 5(2) and 7 and Annex VI(I)(8).
(7) The Commission was also not able to accept amendment 31 and could accept amendments 24, 26, 35 and 45 only

in part or under certain conditions.

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Consequently, the Common Position does not incorporate Parliamentary amendment 53 (1).
It
would, however, provide each Member State with the option of requiring the application of
processing method 1 to material destined for an incineration or coincineration plant
in its
territory (2).

D. Catering waste

The Council agrees that the Regulation should lay down rules on the use and disposal of catering
waste. The Common Position therefore incorporates the principle of Parliamentary amendments 15,
16 and 17 (3).

In addition to the rules on the use of catering waste in feed discussed under B, the Common
Position:

(cid:151) clarifies that catering waste from international means of transport must be disposed of safely (4),

and

(cid:151) provides for the adoption of appropriate rules for the use of catering waste in biogas plants or

for composting (5).

E.

Incineration and coincineration

The Council agrees that the Regulation should lay down animal and public health rules for
incineration and coincineration to the extent necessary to fill
the gap left by Directive
2000/76/EC (6). The Common Position therefore incorporates the relevant elements of Parliamentary
amendments 25, 26, 35, 43, 52 and 99 (7).

F. Disposal (cid:151) special cases

The Council agrees that all the rules providing for the disposal of animal by-products in special
circumstances should appear in a single provision. It also agrees that it is appropriate, on strict
conditions, to provide more flexibility than envisaged in the Commission’s proposal, to cater for
exceptional circumstances. The Common Position therefore incorporates Parliamentary amendments
29, 38, 63 and 69 (8).

G. Exports and transit

The Council agrees that the Regulation should lay down rules on the export of animal by-products
and processed products. It shares the European Parliament’s view that the same rules should apply
to processed products whether they are placed on the Community market or exported. The
Common Position therefore incorporates Parliamentary amendments 59 and 61 (9).

However, rather than prohibiting all exports of unprocessed animal by-products,
the Council
believes that the Regulation should allow them only to take place in special circumstances (for
example, in relation to pet animals). The Common Position therefore incorporates the principle of
Parliamentary amendments 30 and 39, but envisages that it would be possible for exemptions to be
granted under the comitology procedure if this proves necessary to cater for such special circum-
stances (10).

(1) The Commission could accept this amendment only under certain conditions.
(2) Articles 4(2)(b), 5(2)(b) and 8(2).
(3) Articles 1(3) and 2(1) and Annex I(15).
(4) Article 4.
(5) Article 6(2)(g).
(6) Directive 2000/76/EC on the incineration of waste (OJ L 332, 28.12.2000, p. 91) does not apply to incineration and

coincineration plants used to dispose of no waste other than (cid:145)animal carcases(cid:146).

(7) Articles 4(2), 5(2), 6(2) and 12 and Annex IV.
(8) Articles 4, 5 and 24 and Annex I(49).
(9) Articles 19 and 20(1).
(10) Articles 4(4) and 5(4).

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In addition, the Council believes that the Regulation should lay down minimum standards for
transit through the Community. Products carried in transit should meet the requirements for
imports and the relevant rules applying to transport within the Community (1).

H. Fat derivatives and fertilisers

The Council agrees that the Regulation should lay down specific rules for the placing on the market
and export of organic fertilisers, soil
improvers and fat derivatives produced from Category 2
material. The Common Position therefore incorporates the principle of Parliamentary amendment
61. However, pending the adoption of Community rules in the light of new scientific advice, it
would enable Member States to regulate the use of these products under national law (2).

I. Date of application

The Council fully accepts the principle of Parliamentary amendment 68: that the Regulation should
take effect as soon as practicable. The Common Position envisages that the Regulation would apply
six months after its entry into force (3).

J. Other

The Common Position also incorporates the Parliamentary amendments:

(cid:151) requiring a minimum two-year retention period for records (amendments 74, 83, 84 and 86) (4),

(cid:151) providing for appropriate regulation of the temperature of animal by-products (amendments 72

and 96) (5),

(cid:151) relating to Community controls and reports from Member States on the implementation of the

Regulation (amendments 14 and 64) (6),

(cid:151) requiring the marking of imported petfood ingredients derived from hormone-treated animals

(amendment 65) (7),

(cid:151) providing for the use of alternative treatments for manure (amendment 92) (8), and

(cid:151) adding clarification (amendments 13, 21, 34, 56, 66, 71, 81, 82, 87, 89, 90 and 91) (9).

The Common Position does not incorporate a small number of amendments that the Council could
not accept:

(cid:151) amendments 3, 4, 6, 10, 11 and 12, because they propose changes to the recitals that are not in

line with the provisions in the body of the Regulation (10),

(1) Articles 29, 30 and 31 and Annex II(VII).
(2) Articles 20(1), 20(2) and 35(3).
(3) Article 38.
(4) Annexes V(II)(7), VII(I)(7), VII(I)(8) and VII(II)(14).
(5) Annexes II(VI), III(I)(1)(g) and III(II)(4).
(6) Recital 26 and Articles 27 and 35(2).
(7) Article 28.
(8) Annex VIII(III)(5)(b).
(9) Recital 25, Articles 4(1)(a), 5(1)(d), 16(3) and 32 and Annexes II(I)(2), II(III)(2), VII(I)(5), VII(I)(6), VII(II)(15), VII(IV)(4),

VIII(III)(1) and VIII(III)(2).

(10) The Commission was similarly unable to accept amendments 4, 10 and 12 and could accept amendment 11 only in

part.

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(cid:151) amendments 40, 41, 48, 49, 50 and 98, because they are impracticable and not necessary to

achieve the intended objective, and

(cid:151) amendment 88, because it seeks to regulate a matter that falls within the scope of another

instrument (Regulation (EC) No 999/2001) (1).

Finally, compared to the Commission’s proposal, the Common Position also:

(cid:151) clarifies that Member States can regulate under national law the importation and placing on the

market of products for which Annexes VII and VIII do not lay down rules (2),

(cid:151) provides more flexibility in relation to manure (3),

(cid:151) makes possible the use of whole bodies of dead animals to feed endangered species of necro-

phagous birds, under strict conditions to be laid down through comitology (4), and

(cid:151) comprises a number of editorial changes to improve the clarity of the Regulation.

IV. CONCLUSION

The Council welcomes the fact
the European
Parliament’s amendments in its Common Position and that the Commission accepts these and the
other changes to its proposal. It hopes that this will enable the rapid adoption of the Regulation.

it has been able to incorporate the bulk of

that

(1) The Commission was also unable to accept this amendment.
(2) Article 3(2).
(3) Articles 5(2)(e)(iii) and 7(5).
(4) Article 23(2)(d).