Amended proposal for a Regulation of the European Parliament and of the Council laying down the health rules concerning animal by-products not intended for human consumption (presented by the Commission pursuant to Article 250 (2) of the EC-Treaty)
Date: 2001-12-12
Institutions: European Commission
Subjects: agricultural waste, animal product, by-product, health legislation

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Official Journal of the European Communities

30.4.2002

Amended proposal for a Regulation of the European Parliament and of the Council laying down
the health rules concerning animal by-products not intended for human consumption (1)

(2002/C 103 E/10)

(Text with EEA relevance)

COM(2001) 748 final — 2000/0259(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 12 December 2001)

(1) OJ C 96 E, 27.3.2001, p. 40.

INITIAL PROPOSAL

AMENDED PROPOSAL

THE EUROPEAN PARLIAMENT AND THE COUNCIL
OF THE EUROPEAN UNION,

Unchanged

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,

Having regard to the opinion of the Economic and Social
Committee,

Having regard to the opinion of the Committee of the Regions,

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

Whereas:

(1) Council Directive 90/667/EC 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 feedstuffs
of
fish origin and amending Directive
90/425/EEC (1) established the principle that all animal
its source, may be used for the
waste, regardless of
production of
appropriate
following
treatment.

feed material

animal or

for

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

that

is

___________
(1) OJ L 363, 27.12.1990, p. 51. Directive as last amended by the Act

of Accession of Austria, Finland and Sweden.

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AMENDED PROPOSAL

(3) In the light of

those scientific opinions, a distinction
should be drawn between the measures to be imple-
mented on the basis of the nature of animal by-products
used. The possibility of using certain animal materials
should be limited. Alternative methods to the production
of
feed material should be laid down for the use or
disposal of animal by-products.

(3) In the light of

those scientific opinions, a distinction
should be drawn between the measures to be imple-
mented on the basis of the nature of animal by-products
used. The possibility of using certain animal materials
should be limited, so as to apply only to products
deemed suitable for human consumption. Moreover, the
existing possibility of recycling within a species for the
feeding animals must cease. Alternative
purpose of
methods to the production of feed material should be
laid down for the use or disposal of animal by-products.

in order

(4) In the light of the experience gained in recent years, it is
appropriate to clarify the relationship between Directive
90/667/EEC and Council Directive 75/442/EEC of 15 July
1975 on waste (1),
to avoid confusion and
conflict of interest among the competent authorities of
In particular, when an animal
the Member States.
by-product
recovery
operation,
it should be treated as waste in order to
ensure that it is disposed of or recovered in such a way
that the objectives of Article 4 of Directive 75/442/EEC
are achieved and the human health and environment are
protected.

is consigned to a disposal or

in order

(4) In the light of the experience gained in recent years, it is
appropriate to clarify the relationship between Directive
90/667/EEC and Council Directive 75/442/EEC of 15 July
1975 on waste (1),
to avoid confusion and
conflict of interest among the competent authorities of
In particular, when an animal
the Member States.
by-product
recovery
operation,
it should be treated as waste in order to
ensure that it is disposed of or recovered in such a way
that the objectives of Article 4 of Directive 75/442/EEC
are achieved and the human health and environment are
protected. Furthermore, this Regulation should not affect
the application of existing environmental
legislation or
hinder the development of new rules on environmental
protection, particularly as regards biodegradable waste.

is consigned to a disposal or

Unchanged

(5) The International Scientific Conference on Meat-and-Bone
Meal organised by the Commission and the European
Parliament, held in Brussels on 1-2 July 1997, has
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, in order to launch the widest possible public debate
about the future of the Community's feed legislation, 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 in order to bring it in line with the
new scientific information.

(5a) The European Parliament,

in its

resolution of 16
November 2000 (2), called for a ban on the production
of animal feed and on feeding practices involving the
recycling of animal waste in the case of cattle, sheep
and goats and all other species of animal,
including
poultry and fish, until Member States could guarantee
application of existing European legislation on the
treatment at 133 °C for 20
prevention of BSE (heat
minutes at a pressure of 3 bar; guaranteed separation
of SRM)
fallen stock
proposed by this Regulation enters into force.

exclusion of

and until

the

___________
(1) OJ L 194, 25.7.1975, p. 39. Directive as

last amended by

___________
(1) OJ L 194, 25.7.1975, p. 39. Directive as

last amended by

Commission Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32).

Commission Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32).

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

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INITIAL PROPOSAL

AMENDED PROPOSAL

(5b) The European Parliament,

in its

resolution of 16
November 2000, stressed ‘that the open declaration of
feed
ingredients which form part of any animal
all
produced and marketed in the European Union needs
to be delivered by the animal feed industry’.

(5c) The source and the spread of the BSE epidemic are due
to the contamination of animal meal, which could have
been avoided if Member States had applied the decisions
taken at Community level.

Unchanged

(6) From October 1996, the Food and Veterinary Office of
the Commission (FVO) carried out a number of rounds of
inspections to 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.

(7) In order to avoid any risk of dispersal of pathogens
and/or residues, animal by-products should be processed
and stored in an approved and supervised plant
designated by the Member State concerned or else be
disposed of in another suitable manner. In certain circum-
stances, especially when it is justified by distance, time of
or
transport,
designated
processing,
incineration or co-incineration plant could
be located in another Member State.

problems,

capacity

the

(7) In order to avoid any risk of dispersal of pathogens
and/or residues, animal by-products should be separated,
processed and stored in an approved and supervised plant
designated by the Member State concerned or else be
disposed of in another suitable manner. In certain circum-
stances, especially when it is justified by distance, time of
or
transport,
designated
processing,
incineration or co-incineration plant could
be located in another Member State.

problems,

capacity

the

(7a) The animal by-products whose use in animal feed is
authorised must be separated by animal category at
every stage of processing, storage and transport.

(8) Specific rules

should be laid down on controls for
processing plants, with particular reference to detailed
procedures for the validation of processing methods and
self-supervision of production.

Unchanged

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(9) In order to take into account certain practices, it should
be possible to derogate from the processing laid down for
controlled uses.

(10) Community inspections should be carried out

in the
Member States in order to ensure uniform implemen-
tation of
the health requirements. Such inspections
should also include audit procedures.

(11) The basis for Community legislation on health issues is
scientific
Decisions
should be consulted

sound science. To this
committees
set
97/404/EC (1) and 97/579/EC (2)
wherever necessary.

Commission

end,
by

relevant

the

up

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

to ensure that

if necessary,

In order

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

Community rules
appears to be necessary.

(14) Animal by-products not destined to 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. In
order to ensure rational development in this sector and
increase productivity, animal health and public health
rules for the products in question should be laid down
at Community level. Given the significant risks of the
spread of diseases
exposed,
particular requirements should apply to the placing on
the market of certain animal by-products, particularly in
regions with a high health status.

to which animals

are

(14) Animal by-products not destined to 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. In
order
in this sector,
animal health and public health rules for the products
in question should be laid down at Community level.
Given the significant risks of the spread of diseases to
which animals
requirements
should apply to the placing on the market of certain
animal by-products, particularly in regions with a high
health status.

to ensure rational development

exposed, particular

are

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

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

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

2000/443/EC.

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INITIAL PROPOSAL

AMENDED PROPOSAL

Unchanged

a

for

the

that

approval

conditions

(15) In order to ensure that products imported from third
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 third countries and their establishments,
together with a Community inspection procedure to
ensure
are
importation from third countries of
observed. The
petfood and raw material
for petfood can take place
subject to conditions different from those applicable to
such material produced in the Community, in particular
as regards the guarantees required concerning the residues
of substances prohibited in accordance with Council
Directive 96/22/EEC (1).
In order to ensure that such
petfood and raw material are only used for
their
intended purpose, it is necessary to lay down appropriate
control measures on importation of material covered by
such derogations.

such approval

(16) The accompanying document

the best way of

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

(17) The abovementioned objectives are pursued by 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).

regards pathogens,

(18) Several Decisions implementing Directives 90/667/EEC
and 92/118/EEC have been adopted by the Council and
by the Commission. Furthermore, Directive 92/118/EEC
has been substantially amended and further amendments
are to be made. Consequently, at present the sector of
products of animal origin not destined to human
consumption is regulated by a great number of different
Community legislative acts. Therefore, there is a need for
a simplification of the Community legislation dealing with
these products.

(19) Such a simplification will also lead to more transparency
with regard to specific health rules for products of animal
origin not destined to human consumption. Simplification
of the specific health legislation must not lead to deregu-
lation. It is therefore necessary to maintain and, where
required to ensure public and animal health protection,
tighten the detailed health rules for products of animal
origin not destined to human consumption.

(19) Such a simplification will also lead to more transparency
with regard to specific health rules for products of animal
origin not destined to human consumption. Simplification
of the specific health legislation must not lead to deregu-
lation. It is therefore necessary to maintain and ensure
public and animal health protection, and to tighten the
detailed health rules for products of animal origin not
destined to human consumption.

___________
(1) OJ L 125, 23.5.1996, p. 3 (amendment proposed by COM(2000)

320).

(2) OJ L 62, 15.3.1993, p. 49. Directive as

last amended by
Commission Decision 1999/724/EC (OJ L 290, 12.11.1999, p. 32).

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INITIAL PROPOSAL

AMENDED PROPOSAL

(20) The products concerned should be subject to the rules for
veterinary checks 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 (1).

(20) The products concerned should be subject

to precise
monitoring,
including by Community's inspection, and
to the rules for veterinary checks 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 (1).

(21) 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 third countries (2).

Unchanged

(22) 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
certain animal
feedstuffs
marketed
categories (3) 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 (4) should therefore be repealed.

locally

for

as

(23) The implementation of

the new health requirements
established by this Regulation will require adjustments
by the industry. Therefore, a period of time should be
provided for the implementation of those requirements.
Furthermore, Member
inform the
States
Commission of the measures taken to ensure compliance
in
with this Regulation following its entry into force,
order to enable the Commission on the basis of
the
information received, to prepare and submit a report to
the European Parliament and to the Council accompanied,
if appropriate, by legislative proposals.

should

(24) In order

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 (5).

Unchanged

(25) Since the measures necessary for the implementation of
this Regulation are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of
28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission (6),
they should be adopted by use of
regulatory
procedure provided for in Article 5 of that Decision,

the

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

92/118/EEC.

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

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

92/118/EEC.

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INITIAL PROPOSAL

AMENDED PROPOSAL

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1.

This Regulation lays down:

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

(b) the animal and public health rules for the placing on the
market, trade and importation of animal by-products and
products derived therefrom,
intended for purposes other
than human consumption.

2. Without prejudice to the relevant animal and public
health rules, this Regulation shall not apply to:

(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) carcases or parts of wild animals not suspected of being
infected with diseases communicable to man or animals;

(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.

(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,

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

and

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

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AMENDED PROPOSAL

3.
This Regulation shall not affect national veterinary legis-
lation applicable to the eradication and control of certain
diseases and to the use of catering waste.

3.
This Regulation shall not affect national veterinary legis-
lation applicable to the eradication and control of certain
diseases.

Article 2

Definitions

Unchanged

For the purpose of this Regulation, the following definitions
and the definitions laid down in Annex I shall apply:

1. Animal by-products: carcases or parts of animal or products
of animal origin referred to in Articles 4, 5 and 6 not
intended for human consumption, with the exception of
ova, embryos, semen and catering waste;

1. Animal by-products: whole carcases or parts of animal or
products of animal origin referred to in Articles 4, 5 and 6
including ova,
not
embryos, semen and catering waste;

intended for human consumption,

2. Category 1 material: animal by-products referred to in

Unchanged

Article 4;

3. Category 2 material: animal by-products referred to in

Article 5;

4. Category 3 material: animal by-products referred to in

Article 6;

5. Animals: any vertebrate or invertebrate animal (including

fish, reptiles or amphibians);

6. Farmed animals: any animal which is kept, fattened or bred
for the production of food (meat, milk, eggs), wool, fur,
feathers, skins, or any other product of animal origin;

7. Wild animals: animals not kept by man, excluding fish;

8. Pet

animals:

animals belonging to species normally
nourished and kept, but not consumed, by man for
purposes other than farming;

9. Competent authority: the central authority of a Member State
competent to ensure compliance with the requirements of
this Regulation or any authority to which it has delegated
that competence;

10. Placing on the market: any operation the purpose of which
is to supply animal by-products, or products derived
therefrom covered by this Regulation, to a third party
for sale, or any other form of transfer against payment
or free of charge to a third party and storage with a
view to supply to a third party, regardless of whether
the operation takes place within a Member State,
between Member States or between a Member State and
a third country or vice versa;

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INITIAL PROPOSAL

AMENDED PROPOSAL

11. Trade: trade between Member States in goods within the

meaning of Article 23(2) of the Treaty;

12. Producer: any person whose activity produces animal

by-products;

13. Processing plant: an animal by-products processing plant;

14. Category 1 processing plant: a plant in which Category 1
is processed before its final disposal or further

material
transformation;

15. Category 2 processing plant: a plant in which Category 2
is processed before its final disposal or further

material
transformation;

16. Category 3 processing plant: a plant in which Category 3

materials are processed into feed material;

17. Processing methods: methods listed in Annex III, Chapter III;

18. oleochemical plant: a plant processing rendered fats derived
from Category 2 material or Category 3 material under
conditions set out in Annex IV, Chapter III;

18. Category 2 oleochemical plant: a plant processing rendered
fats derived from Category 2 material under conditions set
out in Annex IV, Chapter III;

18a. Category 3 oleochemical plant: a plant processing rendered

fats derived from Category 3 material;

19. Incineration: the disposal of animal by-products or products

Unchanged

derived therefrom in an incineration plant;

20. Co-incineration:

the disposal of animal by-products or

products derived therefrom in a co-incineration plant;

21. Incineration plant: disposal site as defined in Article 3(4) of
Directive 2000/. . ./EC of the European Parliament and of
the Council [on the incineration of waste] (1);

21. Incineration plant: disposal site as defined in Article 3(4) of

Directive 2000/76/EC (1);

21a. high-capacity incineration plant: an incineration plant with a
animal

throughput of 50 kilograms or more of
by-products per hour;

___________
(1) COM(1998) 558 final.

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

21b. low-capacity incineration plant: an incineration plant with a
animal

that 50 kilograms of

less
throughput of
by-products per hour;

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22. Co-incineration plant: disposal site as defined in Article 3(5)

22. Co-incineration plant: disposal site as defined in Article 3(5)

of Directive 2000/. . ./EC;

of Directive 2000/76/EC;

23. Landfill: disposal site as defined by Council Directive

Unchanged

1999/31/EC (1);

24. Biogas plant: a plant in which biological degradation of
organic material is undertaken under anaerobic conditions
for the production and collections of biogas;

25. Composting plant: a plant in which biological degradation
of organic material is undertaken under aerobic conditions;

26. Technical products: products 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, apiculture products, serum
of equidae, blood products, pharmaceutical, bone products
for china, gelatine and glue, processed manure;

27. Technical plant: a plant producing technical products;

28. Category 1 or Category 2 intermediate plant: a plant in which
unprocessed Category 1 or Category 2 material is handled
and/or temporarily stored for the purpose of further trans-
portation to its final destination; it may be used for certain
preliminary processing activities,
removal of
ruminant hides and skins, performing of post-mortem
examination;

such as

29. Category 3 intermediate plant: 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;

30. Collection centres: premises collecting and treating certain
animal by-products intended to be used as feed for
categories of animals referred to in Article 21(1)(c);

31. Storage plant: a plant, other than establishments and inter-
mediaries covered by Council Directive 95/69/EC (2),
in
which processed animal by-products are
temporarily
stored before their final use or disposal;

32. Unprocessed animal by-products: animal by-products which
have only undergone refrigeration or other treatment not
resulting in sufficiently safe destruction of pathogenic
agents;

___________
(1) OJ L 182, 16.7.1999, p. 1.
(2) OJ L 332, 30.12.1995, p. 15.

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33. Processed animal protein: animal proteins derived entirely
from Category 3 material, which have been treated so as
to render them suitable for direct use as feed material or
organic fertilisers or soil improvers or in a feedingstuff for
animals or in petfood;
includes fishmeal, meatmeal,
bonemeal, meat-and-bone meal, bloodmeal, dry greaves,
feathermeal, hoofmeal, hornmeal
similar
products, including mixture or products containing these
products;

and other

it

34. Feed material: feed of animal origin for farmed animals,
including processed animal proteins, rendered fats,
fish
oil, gelatine and hydrolysed proteins, dicalcium phosphate,
milk and milk products;

35. Organic fertilisers and soil

improvers: materials of animal
origin that are 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 compost or digestion residues from
biogas production;

36. Batch: a quantity of a product produced, manufactured or

packaged under practically the same conditions;

37. Rendered fats: fats derived from processing of Category 2

material or Category 3 material;

38. Greaves: the protein-containing residue of rendering, after

partial separation of fat and water;

39. Petfood:

food for pet animals containing Category 3

39. Petfood: food for pet animals which may contain Category

material;

3 material;

40. Dogchews: untanned edible products

for pet animals
produced from hides and skins of ungulates or other
animal material;

Unchanged

41. Petfood plant: a plant producing petfood or petfood
ingredients or dogchews and in which certain animal
by-products are used in the preparation of such petfood
or petfood ingredients or dogchews;

42. Manure: any excrement and/or urine of cloven-hoofed
animals, equidae and/or poultry, with or without litter,
and guano;

43. TSEs: all transmissible spongiform encephalopathies with

the exception of those occurring in humans;

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44. Specified Risk material: Material referred to in Annex II,
Chapter B,
the European
to Regulation (EC) No of
Parliament and of the Council laying down rules for the
prevention and control of certain transmissible spongiform
encephalopathies.

44. Specified Risk material: Material referred to in Annex V to
Regulation (EC) No 999/2001 of the European Parliament
and of the Council laying down rules for the prevention
and control of certain transmissible spongiform encepha-
lopathies (1);

45. Catering waste: all waste food originating in restaurants,
catering facilities and kitchens, including central kitchens
and household kitchens;

46. Remote areas: areas where the concentration of livestock is
so low, and where facilities are so far away,
the
arrangements necessary for the collection and transport
would be unacceptably onerous
compared to local
disposal;

that

47. Pasture land:

land covered with grass or other herbage

which may be grazed by farmed animals.

Article 3

General obligations

Unchanged

Animal by-products, and products derived therefrom, shall be
collected, transported, stored, handled, processed, disposed of,
placed on the market, imported from third countries and used
in accordance with this Regulation.

CHAPTER II

CATEGORISATION, COLLECTION, TRANSPORTATION 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 parts of the body,
following animals:

including hides and skins, of the

(i) animals suspected of being infected by a TSE or in
which the presence of a TSE has been officially
including animals which were killed in
confirmed,
the context of TSE eradication measures,

(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,
including animals which were killed in
the context of TSE eradication measures,

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

Unchanged

___________
(1) OJ L 147, 31.5.2001, p. 1.

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(iii) experimental animals as defined by Article 2 of Council

Directive 86/609/EEC (1),

(iv) wild animals not kept by man when suspected of being
to man or

communicable

infected with diseases
animals;

(b)

(i) specified risk material, including dead ruminant animals

(b)

(i) specified risk material; and

containing such material;

(ii) where, at the point 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 have been admin-
istrated substances prohibited under Directive 96/22/EC
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 (2),
if such residues exceed the permitted level
laid down by Community legislation or,
in the absence
thereof, by national legislation;

Unchanged

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

is
removed,
from desanding, grease

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

removed,
is
from desanding, grease

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

nationally,

(e) mixtures of Category 1 material with either Category 2

(f) mixtures of Category 1 material with either Category 2

material or Category 3 material or both.

material or Category 3 material or both.

Category 1 material shall be collected and transported
2.
without undue delay in accordance with Article 7 and, shall be:

Category 1 material shall be collected and transported
2.
without undue delay in accordance with Article 7 and,
except as otherwise provided in Articles 21 and 21a, shall
be, after being permanently marked in case of specified risk
material in accordance with Regulation 999/2001:

(a) directly disposed of as waste by incineration in an incin-
eration plant approved under Directive . . ./. . ./EC [on the
incineration of waste];

(a) directly disposed of as waste by incineration in an incin-
eration plant approved in accordance with Article 9a;

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

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(b) processed in a processing plant approved under Article 10
the resulting material shall be finally disposed of as waste
by incineration or by co-incineration in an incineration or
co-incineration plant under Directive . . ./. . ./EC [on the
incineration of waste];

(c) with the exclusion of material

listed in paragraph 1(a)(i),
processed in a processing plant approved in accordance
with Article 10 following processing method 1, and the
resulting material shall be finally disposed of as waste in
a landfill approved under Directive 1999/31/EC;

(d) disposed of by other means

approved in
accordance with the procedure referred to in Article
33(2), after consultation of
the appropriate Scientific
Committee.

that

are

(b) processed in a processing plant approved under Article 10
following the application of any processing methods 1 to 5
III or, where the
referred to in Annex III, Chapter
competent authority so requires, of processing method 1,
in which case the resulting material shall be permanently
marked, where
in
accordance with Annex IV, Chapter I, and finally disposed
of as waste by incineration or by co-incineration in an
incineration or co-incineration plant in accordance with
Article 9a;

possible with smell,

technically

(c) with the exclusion of material as referred to in paragraph
1(a)(i), processed in a processing plant approved in
accordance with Article 10 following processing method
1 referred to in Annex III, Chapter III, and the resulting
material shall be permanently marked, where technically
possible with smell,
in accordance with Annex IV,
Chapter I, and finally disposed of as waste by means of
burial in a landfill approved under Directive 1999/31/EC;

Unchanged

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

3.
shall
accordance with Article 9.

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

3.
shall
approved in accordance with Article 9.

4.
By way of derogation from paragraph 2, dead pet animals
may be directly disposed of as waste by burial in accordance
with Article 4 of Directive 75/442/EEC.

4.
The methods of disposal referred to under points (a) to
(d) of paragraph 2 above shall be revised in the light of devel-
opments
in scientific knowledge in accordance with the
procedure referred to in Article 33 (2), after consultation of
the appropriate Scientific Committee.

Category 1 material, other

than products derived
5.
therefrom referred to in Annex VI, shall not be exported to
third countries.

Article 5

Category 2 material

Unchanged

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

(a) manure from all animal species and the digestive tract

content from mammalian species;

(b) all animal materials collected when treating waste water
from slaughterhouses other than slaughterhouses referred
from Category 2 processing
to in Article 4(1)(d) or
from desanding,
plants,
grease
and materials
and sludge,
removed from drains from these premises;

including screenings, materials
and oil mixture,

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(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 the
permitted level laid down by Community legislation;

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

their

(d) mixtures of Category 2 material with Category 3 material;

(e) mixtures of Category 2 material with Category 3 material;

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

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

Category 3 material.

Category 3 material.

2.
Category 2 material shall be collected and transported
without undue delay in accordance with Article 7 and, shall be:

2.
Category 2 material shall be collected and transported
without undue delay in accordance with Article 7 and,
except as otherwise provided in Articles 21 and 21a, shall be:

(a) disposed of as waste by incineration or by co-incineration
in an incineration or co-incineration plant approved under
Directive . . ./. . ./EC [on the incineration of waste];

(a) directly disposed of as waste by incineration or by co-incin-
eration in an incineration or co-incineration plant approved
in accordance with Article 9a;

(b) processed in a processing plant approved in accordance

with Article 10 and:

(i) the resulting material shall be disposed of as waste
either by incineration or by co-incineration in an incin-
approved under
eration or
Directive . . ./. . ./EC [on the incineration of waste] or
in a landfill approved under Directive 1999/31/EC, or

co-incineration plant

(b) processed in a processing plant approved in accordance
with Article 10 following the application of any processing
methods 1 to 5 referred to in Annex III, Chapter III or,
where the competent authority so requires, of processing
in which case the resulting material shall be
method 1,
permanently marked, where
technically possible with
smell, in accordance with Annex IV, Chapter I, and:

(i) disposed of as waste either by incineration or by
co-incineration in an incineration or co-incineration
plant approved in accordance with Article 9a, or

(ii) the rendered fats, shall be further processed into fat
derivatives
soil
in organic
improvers or other technical use in an oleo-chemical
plant approved in accordance with Article 11,

fertilisers or

for use

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, pharmaceutical and medical devices,
in a
Category 2 oleo-chemical plant approved in accordance
with Article 11,

fertilisers or

(c) processed in a processing plant approved in accordance
with Article 10 following processing method 1 referred
to in Annex III, Chapter III, and:

(c) processed in a processing plant approved in accordance
with Article 10 following the application of processing
method 1 referred to in Annex III, Chapter III, in which
case the resulting material shall be permanently marked,
where technically possible with smell, in accordance with
Annex IV, Chapter I, and:

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(i) the resulting proteinaceous material, shall be used as

organic fertiliser or soil improver, or

(i) in the case of resulting proteinaceous material, used as
organic fertiliser or soil improver in compliance with
if any, adopted in accordance with the
requirements,
procedure referred to in Article 33(2), after consultation
of the appropriate Scientific Committee, or

(ii) the resulting material shall be treated in a biogas plant
or in a composting plant approved by the Member State
in accordance with Article 12;

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

approved in accordance with Article 12, or

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

Directive 1999/31/EC;

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

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

(e) in the case of manure and digestive tract content and
referred to in

material collected from slaughterhouses
paragraph 1(b):

Unchanged

(i) used without processing as raw material

plant or
technical plant approved for this purpose,

in a composting plant or

in a biogas
treated in a

(ii) if not suspected of being capable of spreading a serious
transmissible diseases, spread on land in accordance
with this Regulation;

(f) disposed of by other means

approved in
accordance with the procedure referred to in Article
33(2), after consultation of
the appropriate Scientific
Committee.

that

are

Intermediate handling or storage of Category 2 material,
take place only in intermediate plants approved in

3.
shall
accordance with Article 9.

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 9.

The methods of disposal referred to under points (a) to (f)
4.
of paragraph 2 above shall be revised in the light of devel-
opments
in scientific knowledge in accordance with the
procedure referred to in Article 33 (2), after consultation of
the appropriate Scientific Committee.

By way of derogation from paragraph 2, the competent
4.
authority may, where necessary, decide that Category 2
material may be disposed of as waste by burial on site where:

(i) a widespread epizootic disease leads to a lack of capacity at

the processing plant or incineration plant, or

(ii) the animal by-products concerned originate from a place
with difficult access and, therefore, the quantity and the
justify collecting the
distance to be covered does not
animal by-products.

Burial shall be carried out in accordance with Article 4 of
Directive 75/442/EEC.

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Category 2 material, other

5.
than products derived
therefrom referred to in Annex VI, shall not be exported to
third countries.

Article 6

Category 3 material

Unchanged

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

(a) all parts of slaughtered animals, which are declared fit for
human consumption in accordance with Community legis-
lation, but are not intended for human consumption for
commercial reason;

(b) all slaughtered animal parts, which have been rejected as
unfit for human consumption but are not affected by any
signs of diseases communicable to man or animals and
have been derived from carcases passed fit
for human
consumption in accordance with Community legislation;

(b) all parts of slaughtered animal, which have been rejected as
unfit for human consumption but are not affected by any
signs of diseases communicable to man or animals and
have been derived from carcases passed fit
for human
consumption in accordance with Community legislation;

(c) hides and skins, hooves and horns, pig bristles and feathers
originating from animals which have been slaughtered in a
slaughterhouse, have undergone an ante-mortem inspection
for
and been passed fit, as a result of such inspection,
slaughter in accordance with Community legislation;

(c) hides and skins, hooves and horns, pig bristles and feathers
originating from animals which have been slaughtered in a
slaughterhouse, have undergone an ante-mortem inspection
and been passed fit, as a result of such inspection, for
slaughter
for human consumption in accordance with
Community legislation;

(d) blood obtained from animals which have been slaughtered
in a slaughterhouse, have undergone an ante-mortem
inspection and been passed fit, as a result of
that
inspection, for slaughter in accordance with Community
legislation;

(d) blood obtained from animals which have been slaughtered
in a slaughterhouse, have undergone an ante-mortem
inspection and been passed fit, as a result of
that
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;

Unchanged

(f)

foodstuffs of animal origin, or
foodstuffs containing
products of animal origin, which were originally intended
for human consumption but are destined for animal
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,
which are destined for farmed animals and have not been
processed in accordance with animal health legislation for
the production of swill;

(f)

foodstuffs containing
foodstuffs of animal origin, or
products of animal origin, other
than catering waste,
which were originally intended for human consumption
but are destined for animal 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;

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

Unchanged

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

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(i)

fresh fish offal from plants manufacturing fish products for
human consumption;

(j) 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 man
or animals;

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

2.
Animal by-products shall be collected and transported
without undue delay in accordance with Article 7 and, shall be:

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

2.
Category 3 material shall be collected and transported
refrigerated in accordance with Annex II, without undue
delay in accordance with Article 7 and, except as otherwise
provided in Articles 21 and 21a, shall be:

(a) disposed of as waste by incineration or by co-incineration
in an incineration or co-incineration plant approved under
Directive . . ./. . ./EC [on the incineration of waste];

(a) directly disposed of as waste by incineration or by co-incin-
eration in an incineration or co-incineration plant
in
accordance with Article 9a;

(b) processed in a processing plant approved in accordance

Unchanged

with Article 15;

(c) transformed in a technical plant approved in accordance

(c) processed in a technical plant approved in accordance with

with Article 16;

Article 16;

(d) used as raw material

in a petfood plant approved in

Unchanged

accordance with Article 16;

(e) processed in a processing plant approved in accordance
with Article 10 or in a processing plant approved in
accordance with Article 15 and the resulting material
is
finally disposed of as waste either by incineration or by
co-incineration in an incineration or co-incineration plant
approved under Directive . . ./. . ./EC [on the incineration of
waste] or in landfill approved under Directive 1999/31/EC;
or

(e) processed in a processing plant approved in accordance
with Article 10 or in a processing plant approved in
accordance with Article 15 and the resulting material
is
finally disposed of as waste either by incineration or by
co-incineration in an incineration or co-incineration plant
approved in accordance with Article 9a or in landfill
approved under Directive 1999/31/EC;

(f)

transformed in a biogas plant or in a composting plant
approved in accordance with Article 12

(f)

transformed in a biogas plant or in a composting plant
approved in accordance with Article 12, or

(g) in case of catering waste referred to in paragraph 1(l),
transformed in a biogas plant or composted in compliance
with rules to be adopted in accordance with the procedure
referred to in Article 33(2), or, pending the adoption of
such rules, in accordance with national law.

Intermediate handling and/or

3.
storage of Category 3
material shall take place only in intermediate plants approved
in accordance with Article 9.

Intermediate handling and/or

3.
material shall
plants approved in accordance with Article 9.

storage of Category 3
take place only in Category 3 intermediate

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Article 7

Unchanged

Collection and transportation

Unprocessed and Animal by-products and processed animal
by-products shall be collected, transported and identified in
accordance with Annex II.

Animal by-products and processed products derived
transported and identified in

1.
therefrom shall be collected,
accordance with Annex II.

The three categories of animal by-products shall be kept strictly
and completely separate throughout their handling, collection
and transport, and they shall

(a) in case of Category 1 and Category 2 material and products
derived therefrom referred to in Articles 4 and 5, be
permanently marked, where
technically possible with
smell, in accordance with Annex IV, Chapter I;

(b) in case of Category 3 material always be stored and trans-
ported refrigerated or frozen in accordance with Annexes II
and VIII, and be kept separate by animal species.

this Regulation,

During transport, a commercial document or, when
2.
required by
shall
accompany animal by-products and processed products. The
commercial document and health certificate shall meet
the
requirements, and be kept for the period, specified in Annex II.

a health certificate

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

Article 8

Records

Unchanged

Producers

1.
premises shall keep a record of each consignment showing:

consigning animal by-products

from any

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

premises;

(b) the quantity and description of the material;

(b) the quantity and description of the material and of the

marker, if appropriate;

(c) the destination to which it was consigned; and

Unchanged

(d) the name of the haulier transporting it.

Any person transporting animal by-products shall, at the

2.
time of collection, record:

(a) the address of the premises from which the material was

collected;

(b) the date on which the material was collected;

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(c) the quantity and description of the material;

(c) the quantity and description of the material and of the

marker, if appropriate;

(d) the destination to which it is to be taken.

Unchanged

Any person receiving animal by-products shall keep a

3.
record of incoming consignments showing:

(a) the date on which the material arrived;

(b) the address of the premises from which the material was

consigned;

(c) the quantity and description of the material;

(c) the quantity and description of the material and of the

marker, if appropriate;

(d) the name and address of the haulier who transported it.

Unchanged

4.
The records referred to in paragraphs 1, 2 and 3 shall be
kept for a period of at least two years for presentation to the
competent authorities.

Article 9

Intermediate plants and storage plants

Animal by-products

1.
intermediate plants and storage
plants shall be subject to approval by the competent authority.

1.
Category 1, 2 and 3 intermediate plants and storage
plants shall be subject to approval by the competent authority.

In order to be approved, the Category 1 or Category 2

2.
intermediate plant must:

Unchanged

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

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

in

accordance with Annex VIII, Chapter II, Part B;

(c) have undergone the establishment's own checks provided

for in Article 22;

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

Article 23.

In order to be approved, the Category 3 intermediate

3.
plant must:

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

(a) be physically separated from plants for Category 1 and 2
requirements of Annex VIII,

and meet

the

material
Chapter I;

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

Unchanged

Annex VIII, Chapter II, Part A;

(c) have undergone the establishment's own checks provided

for in Article 22;

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

Article 23.

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4.

In order to be approved, storage plants must:

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

(b) store processed animal by-products in accordance with

Annex VIII, Chapter III, point 3;

(c) be supervised by the competent authority.

Article 9a

Approval of incineration and co-incineration plants

The

incineration and co-incineration of processed
1.
products shall take place in accordance with the provisions
of Directive 2000/76/EC. The incineration and co-incineration
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 co-incineration plants
shall be approved under that Directive or in accordance with
paragraph 2 and 3.

this Regulation.

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

co-incineration plant

(a) fulfil

the general conditions laid down in Annex XII,

Chapter I;

(b) fulfil the operating conditions laid down in Annex XII,

Chapter II;

(c) fulfil the requirements laid down in Annex XII, Chapter III,

concerning water discharges;

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

concerning residues;

(e) fulfil the temperature measurement requirements laid down

in Annex XII, Chapter V; and

(f)

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

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

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

Category 2 and 3 material;

(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 XII,

Chapter I;

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(d) fulfil

the applicable operating conditions laid down in

Annex XII, Chapter II;

(e) fulfil the requirements laid down in Annex XII, Chapter IV,

concerning residues;

(f)

the temperature measurement

fuilfil
down in Annex XII, Chapter V; and

requirements

laid

(g) fulfil the conditions concerning abnormal operating laid

down in Annex XII, 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.

CHAPTER III

Unchanged

APPROVAL OF CATEGORY 1 AND 2 PROCESSING PLANTS,
BIOGAS PLANTS, COMPOSTING PLANTS AND OLEO-
CHEMICAL PLANTS

Article 10

Approval of Category 1 and Category 2 processing plants

1. Member States shall approve for all or part of
their
territory one or more Category 1 and Category 2 processing
plants for the collection and processing of Category 1 or
to
Category 2 material. A Member State may decide
designate a Category 1 or Category 2 processing plant
in
another Member State after agreement with that State.

In order to be approved by the competent authority,

2.
Category 1 and Category 2 processing plants must:

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

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

material
Annex IV, Chapter I;

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

Annex III, Chapter V;

(d) have undergone the establishment's own checks provided

for in Article 22;

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

Article 23;

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

(g) ensure that

the products after processing satisfy the

requirements of Annex IV, Chapter I.

Approval

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

immediately

suspended

shall be

if

Article 11

Approval of oleo-chemical plants

Oleo-chemical plants shall be subject to approval by the

1.
competent authority.

2.

In order to be approved, a oleo-chemical plant must:

In order to be approved, a Category 2 oleo-chemical

2.
plant must:

(a) process the rendered fats in accordance with the standards

laid down in Annex IV, Chapter III;

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

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

Unchanged

(c) keep a record of the information obtained pursuant
point (b) for presentation to the competent authority;

to

(d) be under the supervision of the competent authority to
ensure that the operator or manager of the establishment
complies with the requirements of this Regulation.

3.
for
In order to be approved, an oleo-chemical plant
Category 3 shall process rendered fat derived only from
Category 3 material and shall meet the requirements for oleo-
chemical plants for Category 2 material
in accordance with
paragraph 2.

Approval

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

immediately

suspended

shall be

if

Approval

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

immediately

suspended

shall be

if

Article 12

Unchanged

Approval of biogas plants and composting plants

Biogas plants and composting plants which transform
to approval by the

shall be subject

1.
animal by-products
competent authority.

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In order to be approved, a biogas plant and composting

2.
plant must:

(a) meet the requirements of Annex IV, Chapter II, section A;

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

with Annex IV, Chapter II, sections B and C;

(c) be checked by the competent authority;

(d) establish and implement methods of monitoring and

checking the critical control points;

(e) ensure that digestion residues comply with the microbi-
ological standards laid down in Annex IV, Chapter II,
section D.

Approval

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

immediately

suspended

shall be

if

Article 13

Dispatch of processed animal by-products to incineration
or co-incineration plants or to landfill

1.
Processed animal by-products may be sent for disposal by
incineration or co-incineration or landfill only subject to the
following conditions:

(a) processed animal by-products must be:

(i) transported in sealed covered containers or vehicles
animal
which bear
consumption — for incineration/co-incineration/landfill
only', as appropriate,’

indication ‘not

clear

the

for

(ii) consigned only to incineration or co-incineration plants
approved under Directive . . ./. . ./EC [on the incin-
eration of waste] or
approved under
Directive 1999/31/EC;

to landfill

(b) the competent authority of the place of origin must inform
the competent authority of the place of destination of the
dispatch of each consignment;

(c) the competent authority of the place of destination must
inform the competent authority of the place of origin of
the arrival of each consignment;

(d) the competent authority of the place of destination must
ensure that
the
the designated plant or
consignment only for the authorised purposes and keeps
full records demonstrating compliance with this Regulation.

landfill uses

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2.
Processed animal by-products may be sent for disposal by
incineration or co-incineration to other Member States only
subject to the following conditions:

(a) the Member State of destination must have authorised the

receipt of the material;

(b) the processed animal by-products must:

(i) be accompanied by an official certificate as laid down in

Annex VII,

(ii) be transported in sealed covered containers or vehicles
animal
incineration or co-incineration
if appropriate in the language of the Member

which bear
consumption — for
only’,
States of origin, destination and transit,

indication ‘not

clear

the

for

(iii) be conveyed directly to the incineration or co-incin-

eration plant;

(c) Member States which send processed animal by-products to
other Member States must inform the competent authority
of the place of destination of each consignment by means
of
for animal
consumption — For incineration or co-incineration only’
must be contained in the ANIMO message;

the ANIMO system and the words ‘Not

(d) Member States of destination must inform the competent
the arrival of each

authority of
consignment by means of the ANIMO system;

the place of origin of

(e) Member States of destination must

the
designated plants on their territory use the consignment
only for the authorised purposes and keep full records
demonstrating compliance with this Regulation.

ensure

that

CHAPTER IV

PLACING ON THE MARKET OF PROCESSED ANIMAL
PROTEINS AND OTHER FEED MATERIAL, PETFOOD,
DOGCHEW AND TECHNICAL PRODUCTS

Article 14

General animal health provisions

shall

take all necessary measures

to
1. Member States
guarantee
that animal by-products and products derived
therefrom, referred to in Annex V and Annex VI, are not
dispatched from any holding, situated in zone subject
to
restrictions because of the occurrence of a disease to which
the species from which the product is derived is susceptible or
from any plants 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.

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The measures referred to in paragraph 1 shall guarantee

2.
that the products are obtained from animals which:

subject

(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
disease-control measures
particular
imposed by Community legislation or by virtue of a
serious transmissible disease listed in Council Directive
92/119/EC (1);

restrictions under

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

3.
Subject to compliance with the disease-control measures
referred to in paragraph 2(a), the marketing of unprocessed
animal by-products which come from a territory or part of a
to animal health restriction but are not
territory subject
infected or suspected of being infected shall be permitted
provided that, as appropriate, the products:

Subject to compliance with the disease-control measures
3.
referred to in paragraph 2(a),
the marketing of animal
by-products, and products derived therefrom referred to in
Annex V and VI, which come from a territory or part of a
territory subject
to animal health restriction but are not
infected or suspected of being infected shall be permitted
provided that, as appropriate, the products:

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

from or at different
animal health conditions;

Unchanged

(b) have undergone a treatment sufficient

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

(c) are properly identified;

(d) comply with the special conditions laid down in Annexes V
and VI, or with detailed rules to be adopted 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.

Article 15

Approval of Category 3 processing plants

Category 3 processing plants shall be subject to approval

1.
by the competent authority.

___________
(1) OJ L 62, 15.3.1993, p. 69.

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In order to be approved, Category 3 processing plants

2.
must:

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

Annex V;

(a) be physically separated from plants for Category 1 and 2
material and meet the requirements of Annex III, Chapter I
and II and Annex V;

(b) handle, process and store Category 3 material in accordance

(b) handle, process and store only Category 3 material

in

with Annex V;

accordance with Annex V;

(c) have been validated by the

competent

authority in

Unchanged

accordance with Annex III, Chapter V;

(d) have undergone the establishment's own checks provided
for in Article 22 and be supervised by the competent
authority in accordance with Article 23;

(e) ensure that after processing the products

satisfy the

requirements of Annex V, Chapter I.

Approval

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

immediately

suspended

shall be

if

Article 16

Approval of petfood plants and technical plants

Petfood plants and technical plants shall be subject to

1.
approval by the competent authority.

In order
2.
technical plant must:

to be approved,

the petfood plant or

the

(a) undertake,

in the light of the specific requirements laid
down in Annex VI for the products the plant produces, to:

(i) comply with the specific production requirements set

out in this Regulation;

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

(iii) depending on the products, take samples for analyses in
a laboratory recognised by the competent authority for
the purposes of checking compliance with the standards
established by this Regulation;

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

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

(vi) consign only products accompanied by a commercial
document
the
name and the veterinary approval number of the estab-
lishment of production;

indicating the nature of

the product,

(b) be under the supervision of the competent authority to
ensure that the operator or manager of the establishment
complies with the requirements of this Regulation.

Approval

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

immediately

suspended

shall be

if

Article 17

Placing on the market of processed animal protein and
other feed material

Placing on the market and export of processed animal
protein and other feed material

Member States shall ensure that processed animal proteins and
other feed material are placed on the market only if they:

Member States shall ensure that processed animal proteins and
other feed material are placed on the market or exported only
if they:

(a) have been prepared in a Category 3 processing plant
approved and supervised in accordance with Article 15;

(a) have been prepared in a Category 3 processing plant
approved and supervised in accordance with Article 15
and in such a way that recycling within the species can
be avoided;

(b) have been prepared exclusively with Category 3 material

Unchanged

listed in points (a) to (j) of Article 6(1);

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

accordance with Annex V;

(d) comply with the standards laid down in Annex V.

Article 18

Placing on the market of petfood, dogchews and technical
products

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

Member States
technical products, are placed on the market only if they:

that petfood, dogchew and

shall ensure

1. Member States shall ensure that petfood, dogchew and
technical products, except as referred to in paragraphs 2 and
3, are placed on the market or exported only if they:

(a) meet the specific requirements laid down in Annex VI;

Unchanged

(b) come from establishments approved and supervised in

accordance with Article 16.

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2. Member States shall ensure that organic fertilizers or soil
improvers produced from processed products, other than those
produced from manure and digestive tract contents, 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 appopriate 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 oleo-chemical plant
from rendered
approved in accordance with Article 11,
fats derived from processing of Category 2 material
in a
Category 2 processing plant approved in accordance with
Article 10 following the application of any processing
methods 1 to 5,

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

accordance with Annex IV, and

(c) meet the specific requirements in Annex IV.

Article 19

Safeguard measures

Unchanged

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

Article 20

Organic fertilisers and soil improvers

Limits on use

The following uses of animal by-products and products

1.
derived therefrom 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;

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

the spreading on pasture land of organic fertilizers and soil
improvers, other than manure, is prohibited.

(c) the spreading on pasture land of organic fertilizers and soil

improvers, other than manure, is prohibited.

Rules for the implementation of this Article,
concerning control measures,

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

including
shall be adopted in

Derogations from paragraph 1(a) may be granted in relation to
fish and fur animals by the same procedure, after consultation
of the appropriate Scientific Committee.

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Unchanged

INITIAL PROPOSAL

CHAPTER V

DEROGATIONS

Article 21

Derogations

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;

(b) the use of animal by-products for taxidermy purposes in
technical plants approved for this purpose in accordance
with Article 16;

(c) in accordance with the rules laid down in Annex IX, the
use of Category 2 material, provided that it comes from
animals which were not killed or did not die as a result of
a
the
disease
presence
and Category 3
communicable
the
material
feeding of:

referred to in Article 6(1)(a)

or
to man or

suspected

presence

animals,

to (j),

for

of

(i) zoo animals,

(ii) circus animals,

(iii) reptiles other than zoo or circus animals,

(iv) fur animals,

(v) wild animals of endangered species,

(vi) wild animals of any species where this is necessary
for

conditions or

because of
severe nutritional
preparing documentary reports,

(vii) recognised kennels or packs of hounds,

(viii) maggots for fishing bait.

2. Member States shall inform the Commission where they
make use of the derogations referred to in paragraph 1 and
shall notify it of the verification arrangements they introduce
to prevent the animal by-products concerned from being used
for unauthorised purposes.

authorised and registered pursuant

Each Member State shall draw up a list of users and
3.
collection centres
to
paragraph 1(c) within its own territory. Each user and
collection centre shall be assigned an official number for
inspection purposes and in order to be able to trace the
origin of the products concerned.

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The premises of users and collection centres shall be supervised
by the competent authority, which shall at all time have free
to ensure
access
compliance with the requirements referred to in paragraph
1(c).

to all parts of

the premises,

in order

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

4.
Detailed rules concerning verification measures may be
adopted in accordance with the procedure referred to in Article
33(2).

Article 21a

Derogations regarding the disposal of animal by-products

The competent authority may, where necessary, decide

1.
that:

(a) dead pet animals, other than animals referred to in Article
4(1)(a)(i), 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;

(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, if the competent authority rejects transport to the
nearest
the
dangers of propagation of health risks or because a wide-
spread disease outbreak leads to a lack of capacity at such
plants.

incineration or processing plant because of

No derogation may be granted in respect of Category 1

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

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

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4. Member States shall inform the Commission of:

(a) the use they make of

the possibilities provided for in
in respect of Category I and Category 2

paragraph 1(b)
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.

The
5.
measures:

competent

authority

shall

take

the necessary

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

Unchanged

CHAPTER VI

CONTROLS AND INSPECTIONS TO BE CARRIED OUT ON
INTERMEDIATE AND PROCESSING PLANTS

Article 22

Plants' own-checks

and
Operators
1.
processing plants or
shall adopt all
measures necessary to comply with the requirements of this
Regulation and shall in particular:

and owners of
their

intermediate plants

representatives

representatives

intermediate plants

and owners of
their

and
Operators
1.
processing plants or
shall adopt all
measures 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 prin-
ciples of the system of hazard analysis and critical control
points (HACCP). They shall in particular:

(a) identify and control the critical points in the plants;

Unchanged

(b) establish and implement methods

for monitoring and

checking such critical points;

(c) in the case of processing plants,

take representatives
samples from each processed batch in order to check
compliance with the standards for the products established
by this Regulation and the maximum permitted levels of
physico-chemical residues laid down in Community legis-
lation;

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

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(e) introduce a system that makes it possible to link each batch

dispatched and the time when it was produced.

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

(a) notify the competent authority immediately;

(b) establish the causes of failures of compliance;

(c) ensure that no material

suspected or known to be
contaminated is moved from the plant before being repro-
cessed under
the competent
authority and re-sampled officially in order to comply
with the standards laid down in this Regulation.

supervision of

the direct

3.
Detailed arrangements for implementing this Article may
be adopted in accordance with the procedure referred to in
Article 33(2).

Article 23

Official controls

1.
The competent authorities shall at regular intervals carry
out inspections and supervision at the intermediate plants and
processing plants in accordance with Annex III, 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 Hazard Analysis Critical Control Points implementation.

3.
If the inspection carried out by the competent authority
reveals that not all of the requirements of this Regulation are
being met,
take appropriate
action. In the case of non-compliance with the provisions of
this Article in relation to microbiological standards, and the
types of microbiological controls, the manufacturer shall:

the competent authority 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) process and reprocess the contaminated batch under the

supervision of the competent authority;

(c) increase

the

intensity of

sampling

and

testing of

production;

(d) investigate unprocessed animal by-products records appro-

priate to the finished sample;

(e) instigate

appropriate

decontamination

and

cleaning

procedures within the plant.

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4.
Detailed arrangements for implementing this Article may
be adopted in accordance with the procedure referred to in
Article 33(2).

Article 24

Frequency of checks and microbiological analyses

1.
the
The detailed arrangements for and frequency of
checks provided for in Articles 22 and 23 shall be established
in accordance with the procedure referred to in Article 33(2).

2.
The reference methods for the microbiological analyses
shall be established in accordance with the procedure referred
to in Article 33(2).

Article 25

List of approved plants

Each Member State shall draw up a list of plants approved
pursuant to Articles 9 to 12 and Articles 15 and 16 within
its own territory. Each plant shall be assigned an official
number which identifies the plant with respect to the nature
of its activities.

The Member States shall forward the list and its up-dates to the
other Member States and to the Commission.

CHAPTER VII

COMMUNITY CONTROLS

COMMUNITY CONTROLS IN MEMBER STATES

Article 26

Community controls

Unchanged

the Member States,

in cooperation with

The Commission shall,

1.
the
carry out
competent authorities of
on-the-spot inspections and audits of all levels of production
and placing on the market and disposal of animals by-products,
and products derived therefrom and of the organisation and
functioning of the competent authorities in the Member States,
in order to ensure that the provisions of this Regulation, rules
adopted pursuant
thereto and any safeguard measures are
applied uniformly.

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

inform the competent authorities of

carrying out

2.
Rules for the implementation of this Article, shall be
adopted in accordance with the procedure referred to in
Article 33(2).

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

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CHAPTER VIII

AMENDED PROPOSAL

Unchanged

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

Article 27

General provisions

The provisions applicable to the importation of feed material
referred to in Annex V and petfood, dogchews and technical
products referred to in Annex VI from third countries shall be
no more favourable or less favourable that those applicable to
the production and marketing of
in the
Community.

those products

The provisions applicable to the importation of products
referred to in Annex V and petfood, dogchews and technical
products referred to in Annex VI from third countries shall be
no more favourable or less favourable that those applicable to
the production and marketing of
in the
Community.

those products

However, the importation from third countries of 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 permitted
under specific conditions to be laid down in accordance with
the procedure referred to in Article 33(2).

However, the importation from third countries of 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 permitted
provided that such raw material is marked and under specific
conditions to be laid down in accordance with the procedure
referred to in Article 33(2).

Article 28

Prohibitions

Unchanged

Import of animal by-products and derived products into the
Community shall be prohibited, except in accordance with this
Regulation.

Article 29

Compliance with Community rules

Products referred to in Annexes V and VI may be
they satisfy the

1.
imported into the Community only if
requirements set out in paragraphs 2 to 5.

2.
Products referred to in Annexes V and VI must, save as
otherwise specified in those Annexes, come from a third
country or parts of third countries on a list to be drawn up
and updated in accordance with the procedure referred to in
Article 33(2).

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 third country;

(b) the organisation of

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

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(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 third country can give
compliance with the relevant health conditions;

regarding

(e) experience of marketing the product from the third country

and the results of import checks carried out;

(f)

the result of any Community inspections on the third
country;

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

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

(i)

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

Products referred in Annex V must come from estab-
3.
lishments on a Community list to be drawn up in accordance
with the procedure referred to in Article 33(2) on the basis of a
communication from the competent authorities of the third
country to the Commission declaring that the plant complies
with the Community requirements and is subject to supervision
by an official inspection service in the third country.

Approved lists shall be amended as follows:

(a) the Commission shall

inform the Member States of the
modifications proposed by the third country concerned to
the lists of establishments 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 establishments
referred to in (a) to send any written comments to the
Commission;

the Commission shall

(c) where written comments are made by at least one Member
inform the Member States
State,
within five working days and include the point on the
next meeting of the Standing Veterinary Committee for
decision in accordance with the procedure referred to in
Article 33(2);

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(d) where no comments are received from the Member States
within the time limit referred to in (b), the modifications to
the list shall be considered to have been accepted by the
Member States. The Commission shall inform the Member
States within five working days, and imports shall be auth-
orised from such establishments five working days after
receipt of this information by the Member States.

4.
Products referred to in Annex VI must come from estab-
lishments that have been approved and registered by the
competent authority of the third countries.

Consignments of products referred to in Annexes V and
5.
VI, must, save as otherwise specified in those Annexes, be
accompanied by a health certificate corresponding to the
specimen laid down in Annex X, certifying that the products
meet the conditions referred to in those annexes and come
from establishments offering such conditions.

Article 30

Equivalence

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

The decision shall
the conditions governing the
importation 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 which must

accompany the product;

(b) specific health requirements applicable to importation into

the Community;

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

The detailed rules for the application of this Article shall
3.
be adopted in accordance with the procedure referred to in
Article 33(2).

Article 31

Community inspections and audits

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

(a) drawing up the list of third countries or parts thereof and

determining conditions for importation;

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(b) verifying compliance with:

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

third countries,

(ii) import conditions,

(iii) the conditions for recognising equivalence of measures,

(iv) any emergency measures applied under Community

legislation.

The experts from the Member States responsible for these
checks shall be appointed by the Commission.

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

2.
on behalf of
incurred.

3.
The frequency of and the procedure for 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 request
the third 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

the Annexes may be amended or supplemented and any appro-
priate transitional measures may be adopted in accordance
with the procedure referred to in Article 33(2).

After consultation of the appropriate Scientific Committee on
any questions 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

Article 33

Regulatory procedure

Unchanged

The Commission shall be assisted by the Standing
1.
Veterinary Committee instituted by Article 1 of Decision
68/361/EEC.

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

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

3.
1999/468/EC shall be 15 days.

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Article 34

Consultation of scientific committees

AMENDED PROPOSAL

The appropriate Scientific Committees may be consulted on
any matter falling within the scope of this Regulation which
is likely to have an effect on animal or public health.

The appropriate Scientific Committees shall be consulted on
any matter falling within the scope of this Regulation which
could have an effect on animal or public health.

Article 35

Unchanged

Communication of national provisions

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

The Member

1.
the
Commission the text of the provisions of national law which
they adopt in the field covered by this Regulation.

communicate

States

shall

to

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 to the Council accompanied, if
appropriate, by legislative proposals.

Article 36

Financing rules

Unchanged

The Commission shall prepare a report on the financial
support in Member States for the processing and disposal of
the animal by-products, with particular reference to Category 1
and Category 2 material,
appropriate
proposals.

accompanied by

Article 37

Repeal

Directive
1999/534/EC are repealed.

90/667/EEC

and Decisions

95/348/EC

and

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

Article 38

Entry into force

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

It shall apply from 1 February 2003 (1).

It shall apply six months after the date of its entry into force.

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

Unchanged

___________
(1) This date has been indicated to provide a period of 18 months for

the implementation of the new provisions.

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ANNEX I

DEFINITIONS

Gelatine: 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);

Unchanged

Hydrolysed proteins: mixtures of polypeptides, peptides and aminoacids
obtained by the hydrolysis of collagen;

Hides and skins: all cutaneous and subcutaneous tissues;

the hardening of hides, using vegetable tanning agents,
Tanning:
chromium salts or other substances such as aluminium salts, ferric
synthetic
silicic
salts,
hardening agents;

and quinones, or other

aldehydes

salts,

Processed petfood: petfood, other than raw petfood, which has undergone
a treatment which ensure its stability;

Canned petfood: heat processed petfood contained within a hermetically
sealed container;

Hermetically sealed container: container that is designed and intended to
be secure against the entry of micro-organism;

Raw petfood: petfood which has not undergone any preserving process
other than chilling, freezing or quick freezing or equivalent processes
to ensure preservation;

Fishmeal: processed animal protein derived from sea animals, except sea
mammals

Blood: fresh whole blood;

Blood products: 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 fraction thereof and
mixtures;

Bloodmeal: Blood products derived from the heat-treatment of blood in
accordance with Annex V, Chapter
II and intended for animal
consumption or fertilizers;

Blood products
intended for technical of pharmaceutical purposes;

technical and pharmaceutical use: Blood products

for

Products used for in vitro diagnosis: a packaged product, ready for use by
the end user, containing a blood product, and used as 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;

Laboratory reagents: 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;

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Unprocessed wool, hair and bristles: sheep's wool, ruminant hair and pig
bristles which have not undergone factory washing or been obtained
from tanning;

Unprocessed feathers and parts of feathers: feathers and part of feathers
which have not been treated with a steam current or by some other
method ensuring that no pathogens are transmitted;

Apiculture products: honey, beswax, royal jelly, propolis or pollen, not
intended for human consumption or industrial use.

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

ANNEX II

1. All the necessary measures shall be taken to assure that Category 1,
Category 2 and Category 3 materials are identifiable and kept identi-
fiable during collection and transportation.

1. All the necessary measures shall be taken to assure that Category 1,
Category 2 and Category 3 materials and products derived
therefrom are identifiable and kept strictly separated and identifiable
during collection and transportation.

2. Animal by-products must be collected and transported in suitable
containers or vehicles in such a way as to prevent leakage. The
containers or vehicles must be adequately covered. Vehicles for
refrigerated transport must have been designed in such a way that
the temperature required can be maintained throughout the period
of transport.

Unchanged

3. Vehicles, tarpaulin covers and reusable containers must be cleaned
and disinfected after each use and must be maintained in a clean
conditions.

4. Where animal by-products are not transported directly in bulk, the
the animal
information on the origin, name and nature of
by-products and the words
for
human consumption’ must also be indicated on a label attached
to the container, cartons or other packaging material in letters at
least 2 cm high.

‘Animal by-products — Not

5. During transportation,

(a) Unprocessed and processed animal by-products, and products

derived therefrom must be accompanied either

(i) by a commercial document, specifying:

— the date on which the material was taken from the

premises

— the description of the material including its classification

in accordance with this Regulation,

— the description of the material including its category in
accordance with this Regulation, the animal species for
Category 3 material and to processed products derived
therefrom destined for use as feed material and,
if
applicable, the ear tag number

— with the exception of manure,
indicated by means of

material,
by-products — not fit for human consumption’

the nature of
the
the words ‘Animal

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— the quantity of the material

Unchanged

— the place origin of the material

— the name and the address of the carrier

— the name and the address of the receiver and the regis-

tration number

— if appropriate,

I. the approval or registration number of the plant of

origin

II. the nature and the methods of the treatment.

The commercial document must be produced in triplicate (1
original and two copies). The original shall accompany the
consignment to its final destination and shall be retained by
the receiver, one copy shall be retained by the producer,
another shall be retained by the carrier.

or

(ii) when specifically requested by this Regulation, by a health
certificate issued and signed by the competent authority.

The commercial document and the health certificate referred to
in (i) and (ii) shall be kept for a period of at least two years for
presentation to the competent authorities.

A model for the commercial document referred to in (i) or for
the health certificate referred to in (ii) may be laid down in
accordance with the procedure referred to in Article 33(2).

6. The competent authority shall

take the necessary measures to
control
the movements of unprocessed and processed animal
by-products and products derived therefrom by checking the
keeping of
documents, which shall
accompany those products during their transport to the place of
destination, and, if necessary, by sealing.

required

records

and

7. The transport of animal by-products must take place at an appro-
priate temperature, to avoid any risk to animal or human health.

8. Unprocessed Category 3 material destined for the production of
feed material or petfood must be transported chilled or frozen,
unless processed within 24 hours of departure.

9. The design of vehicles used for refrigerated transport must ensure
throughout
an appropriate

temperature

the maintenance of
transport.

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GENERAL HYGIENE REQUIREMENTS FOR ANIMAL BY-PRODUCTS PROCESSING PLANTS

ANNEX III

CHAPTER I

Unchanged

General conditions for the approval of animal by-products
processing plants

1. Premises

and
requirements:

facilities must meet

at

least

the

following

(a) The premises of

the processing plant must be adequately
separated from the public highway and other premises such as
slaughterhouses.
animal
for
by-products must not be at the same site as slaughterhouses,
unless in a completely separate part of a building. Unauthorised
persons and animals shall have no access to the plant.

the processing of

Premises

(a) The premises of

the processing plant must be adequately
separated from the public highway and other premises such as
slaughterhouses.
animal
for
by-products of Category 1 and 2 must not be at the same site
as slaughterhouses, unless in a completely separate part of a
building. Unauthorised persons and animals shall have no
access to the plant.

the processing of

Premises

Unchanged

(b) The processing plant must have a clean and unclean section,
adequately separated. The unclean section must have a covered
place to receive the animal by-products and must be constructed
in such a way that 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 capacity and hot
the processing of animal

water and steam production for
by-products.

(d) The unclean section 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
installations must be
is required, all
equipped with:

treatment

— measuring equipment to monitor temperature against time

and, if necessary, pressure at critical points,

— recording devices to record continuously the results of these

measurements,

— an adequate safety system to prevent insufficient heating.

(f) To prevent recontamination of the finished product by incoming
unprocessed animal by-product, 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 process
of that product and the storage of the processed product.

2. The processing plant must have adequate facilities for cleaning and
disinfecting the vehicles or containers and recipients in which
animal by-products are received — other than ships — or in
which it is transported.

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3. Adequate facilities must be provided for the disinfecting of vehicle
wheels, upon leaving the unclean section of the processing plant.

4. A waste-water disposal system meeting the Competent Authority's

requirements is required for all processing plants.

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 make the essential analysis and must be approved by
the competent authority.

CHAPTER II

General conditions of hygiene

1. Animal by-products must be processed as soon as possible after

arrival. They must be stored properly until processed.

2. Containers, recipients and vehicles used for the transport of animal
by-products must be cleaned, washed and disinfected after each use.
Containers, recipients and vehicles used for transporting unpro-
cessed material shall be cleaned in a designated area. This area
shall be situated or designed to prevent the risk of contamination
of processed products.

3. Persons working in the unclean section must not enter the clean
section without changing their working clothes and footwear or
without disinfecting the latter. Equipment and utensils shall not
be taken from the unclean section into clean section. Personnel
movement procedure
the
be
movement of personnel between areas and to prescribe the
proper use of foot baths and wheel baths.

established

control

shall

to

4. Waste water originating in the unclean section must be treated to

ensure that no pathogens remain.

The Commission shall lay down requirements for the treatment of
waste water
in accordance with the
from processing plants
procedure referred to in Article 33(2).

5. Preventive measures against birds, rodents, insects or other vermin
control

taken systematically. A documented pest

must be
programme shall be used for that purpose.

6. Cleaning procedures shall be documented and established for all
the premises. Suitable equipment and cleaning agents

parts of
must be provided for cleaning.

7. Hygiene

control

the
environment and equipment. Inspection schedules and results shall
be documented.

should include

inspections of

regular

7. Hygiene

control

the
environment and equipment. Inspection schedules and results shall
be documented and maintained for at least two years.

should include

inspections of

regular

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

Unchanged

9. The processed animal by-products must be handled and stored at
the processing plant in such a way as to preclude recontamination.

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CHAPTER III

Processing methods

AMENDED PROPOSAL

M e t h o d 1

Continuous or batch pressure

Reduction

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

Time, temperature and pressure

2. After reduction the animal by-products shall be heated to a core
temperature of more than 133 °C eor 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 pre or post-process sterilisation phase.

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

M e t h o d 2

Natural fat batch

Reduction

the animal by-products

1. If the particle size of the animal by-products to be processed is
shall be
more than 150 millimetres,
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 shall be checked daily and its
If checks disclose the existence of particles
condition recorded.
the process shall be stopped and
larger than 150 millimetres,
repairs made before the process is resumed.

Time, temperature and pressure

2. After reduction the animal by-products shall be heated to a core
temperature greater than 100 °C for at least 125 minutes, a core
temperature greater than 110 °C for at least 120 minutes and a core
temperature greater that 120 °C for at least 50 minutes.

3. The processing shall be carried out in batch system.

4. The animal by-products may be cooked such that

the time-

temperature requirements are achieved at the same time.

___________
(1) ‘Saturated steam’ means that all air is evacuated and replaced by steam in the

whole sterilisation chamber.

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M e t h o d 3

Natural fat batch — Continuous or batch

Reduction

AMENDED PROPOSAL

the animal by-products

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

than 30 millimetres,

Time, temperature and pressure

2. After reduction the animal by-products shall be heated to a core
temperature greater than 100 °C for at least 95 minutes, a core
temperature greater than 110 °C for at least 55 minutes and a
core temperature greater that 120 °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 such that

the time-

temperature requirements are achieved at the same time.

M e t h o d 4

Added fat — Continuous or batch

Reduction

the animal by-products

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

than 30 millimetres,

Time, temperature and pressure

2. After reduction the animal by-products shall be placed in a vessel
with added fat and heated to a core temperature greater than 100 °C
for at least 16 minutes, a core temperature greater than 110 °C for
at least 13 minutes and a core temperature greater that 120 °C for
at least 8 minutes and a core temperature greater that 130 °C for at
least 3 minutes.

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

4. The animal by-products may be cooked such that

the time-

temperature requirements are achieved at the same time.

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M e t h o d 5

Defatted — Continuous or batch

Reduction

AMENDED PROPOSAL

the animal by-products

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

than 20 millimetres,

Time, temperature and pressure

2. After reduction the animal by-products shall be heated until they
coagulate and then pressed so that fat and water are removed from
the proteinaceous material. The proteinaceous material shall be then
heated to a core temperature greater than 80 °C for at least 120
minutes, a core temperature greater than 100 °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 such that

the time-

temperature requirements are achieved at the same time.

M e t h o d 6

(For animal by-products of fish origin only) Combined acidification
and heat treatment

1. The animal by-products shall be reduced to . . . millimetres. They
shall then be mixed with formic acid to reduce the pH to . . . The
mixture shall be stored for . . . hours pending new treatment.

2. The mixture shall then be introduced into a heat converter and shall
be heated to a core temperature of . . . °C for at least . . . minutes.
The progression of
through the heat converter is
limiting its
controlled by means of mechanical
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.

the product

commands

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

M e t h o d 7

Any processing method approved by the competent authority where it
has been demonstrated to the competent 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:

1. Samples of material taken directly after heat treatment:

— Clostridium perfringens absent in 1 g of the products.

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2. 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 = 3 × 102 in 1 g

Where

n = number of units comprising the sample;

m = threshold value for the number of bacteria;

is
the number of bacteria in all

the result

considered satisfactory if
sample units 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 sample units is M or more;

c = number of sample units the bacterial count of which may be
between m and M,
sample still being considered
acceptable if the bacterial count of the other sample units is
m or less.

the

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

This information shall be made available to the Commission on
request.

CHAPTER IV

Supervision of production

1. Processing plants shall be subject to supervision by the competent
authority, which must ensure that the requirements of this Regu-
lation are met and 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 22, notably by examining the results
and taking samples;

(iii) the standards of the products after processing. The analyses
and tests shall be carried out in accordance with methods
which are scientifically recognised, and in particular those
laid down in Community provisions or, where none exist, in
recognised international standards;

(iv) the storage and transport conditions;

(b) take any samples required for laboratory tests;

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(c) make any other checks

it considers necessary to ensure

compliance with this Regulation.

2. The competent authority must have free access at all times to all
parts of the processing plant and to the records and commercial
documents or health certificate in order to ensure that this Regu-
lation is being strictly complied with.

CHAPTER V

Validation procedures

The processing plant must be validated by the competent authority in
accordance with the following procedures which shall
take into
account at least the following 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 system;

(c) Compliance with the specific process requirements laid down by

this Regulation;

(d) Achievement of the following requirements:

— Particle size for batch-pressure and continuous processes. The
particle size is defined by the mincer hole or the anvil gap size;

— Temperature, pressure, processing time and material processing

rate (for continuous system only):

I. batch pressure system:

— the temperature must be monitored with a permanent
thermocouple and it must be plotted against real time,

— the pressure

stage must be monitored with a
permanent pressure gauge. Pressure must be plotted
against real time,

— the processing time must be

shown by time/

temperature and time/pressure diagrams.

least once a year

At
pressure gauge must be calibrated.

the thermocouple and the

II. continuous pressure system:

— The temperature and the pressure must be monitored
with thermocouples, or an infrared temperature gun,
gauges used at defined positions
and pressure
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;

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temperature

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

can be

that

— feed screw revolutions per minute (rev/min), or

— electric power (amps at given voltage), or

— evaporation/condensation rate, or

— number of pump strokes per unit time

All measuring and monitoring equipment must be cali-
brated at least once a year.

The validation procedures shall be repeated periodically or when it is
considered necessary by the competent authority and in any case each
time any significant alterations are made to the process (i.e. modifi-
cation of the machinery, change of raw materials etc.).

The Commission shall lay down validation procedures based on testing
method in accordance with the procedure referred to in Article 33(2).

HYGIENE REQUIREMENTS FOR PROCESSING AND DISPOSAL OF ANIMAL BY-PRODUCTS DESTINED TO
BIOGAS OR COMPOSTING PLANT OR TO AN OLEO-CHEMICAL PLANT

ANNEX IV

CHAPTER I

Unchanged

Special conditions for the processing of Category 1 or Category 2
material

Requirement for the approval of Category 1 or Category 2
processing plants

In addition to the general requirements laid down in Annex III,

1. Premises for the processing of Category 1 material must not be at
the same site as premises processing Category 2 material, unless in
a completely separate part of a building.

2. By way of derogation from the above paragraph, Member States
may allow that the premises of a Category 2 processing plant are

(i) temporary used for the processing of Category 1 material
where a widespread epizootic diseases leads to a lack of
capacity at the category 1 processing plant; or

(ii) permanently used for the processing of Category 1 material
where the additional capacity necessary in order to authorise
plant for specific purposes does not exist.

2. However, the competent authority may authorise the temporary
use of a Category 2 processing plant
the processing of
Category 1 material when a widespread epizootic disease or
other extraordinary and unforeseeable circumstances lead to a
lack of capacity at a Category 1 processing plant. The competent
authority must re-approve the Category 2 processing plant before it
processes Category 2 material again.

for

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only under the following conditions:

— the plant must be under a permanent official supervision;

— all unloading, processing, storage or other handling of
Category 1 material must take place under official super-
vision;

— Category 1 material must be stored in a completely

separate room or separate reception area;

— Category 1 material must be processed in separate rooms
using separate installations and equipment, except where

(i) the processing takes place in completely enclosed
installation or equipment used exclusively for
this
purpose; or

(ii) the batch of Category 2 material processed immediately
following the processing of Category 1 material, shall
be deemed as Category 1 material;

— the processed Category 1 material must be stored in a
different room or separate tanks which are labelled appro-
priately. The room or the separate tanks must be kept
locked under seal of the competent authority when the
latter is not present;

— Category 2 processing plants which have been temporarily
or permanently processing Category 1 must undergo a
thorough regime of cleansing and disinfection as agreed
by the competent authority before processing material of
a higher health category.

Processing standards

Unchanged

3. Animal by-products, other than rendered fats derived from Category
2 material and destined to an oleo-chemical plant, must be
processed in accordance with

— Processing method 1, in case of Category 2 material, other than
manure and digestive tract content from mammalian species,
destined to a biogas or composting plants or intended to be
used as organic fertilisers or soil improvers and Category 1 and
Category 2 material destined to landfill

— Any of the processing methods listed in Annex III, Chapter III,
in case of Category 1 or Category 2 material destined to incin-
eration or co-incineration.

Requirements of the products after processing

4. After processing, the products must be permanently coloured or
marked, using a system approved by the competent authority.
the system
The Commission shall establish detailed rules of
referred to in the above paragraph in accordance with the
procedure referred to in in Article 33(2).

if

4. After processing, the products must be permanently coloured or
marked,
technically possible with a smell, using a system
approved by the competent authority. The Commission shall
establish detailed rules of
the system referred to in the above
paragraph in accordance with the procedure referred to in in
Article 33(2).

5. Samples of processed animal by-products destined to bio-gas or
composting plant or to landfill or intended to be used as organic
fertilisers or soil improvers, taken directly after heat treatment, must
be free from heat-resistant pathogenic bacteria spores (Clostridium
perfringens absent in 1 g of the products).

Unchanged

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AMENDED PROPOSAL

Special requirements for biogas and composting plant

A. Requirements for approval of biogas and composting plant handling

animal by-products

1. Biogas plant must be equipped with:

(a) a pasteuration/hygienisation unit, which cannot be by-passed,
in which the processed Category 2 material or the unpro-
cessed Category 3 material are heat treated before entering
the biogas reactor. This unit must have:

— installations for monitoring temperature against time,

— recording devices to record continuously the results of

these measurements,

— an adequate safety system to prevent insufficient heating,

(b) adequate facilities for cleaning and disinfecting of vehicles

and containers upon leaving the biogas plant.

2. Composting plant must be equipped with:

(a) a closed composting reactor which must have:

— installations for monitoring temperature against time,

— recording devices to record continuously the results of

these measurements,

— an adequate safety system to prevent insufficient heating

(b) adequate facilities for cleaning and disinfecting of vehicles
and containers transporting untreated animal by-products.

3. Biogas plants and composting plants must have its own
the services of a laboratory

laboratory or make use of
equipped to make the essential analyses.

B. Special conditions of hygiene

1. Only Category 2 material which has undergone processing
method 1 in a Category 2 processing plant and Category 3
material may be transformed in a biogas plant or
in a
composting plant.

2. Animal by-products referred in paragraph 1, must be trans-
formed as soon as possible after arrival. They must be stored
properly until treated.

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3. Containers, recipients and vehicles used for the transport of
animal by-products must be cleaned, washed and disinfected
after each use. Containers, recipients and vehicles used for trans-
porting untreated material shall be cleaned in a designated area.
This area shall be situated or designed to prevent risk of
contamination of treated products.

4. Preventive measures against birds, rodents,

insects or other
vermin must be taken systematically. A documented pest
control programme shall be used for that purpose.

5. Cleaning procedures shall be documented and established for all
parts of the premises. Suitable equipment and cleaning agents
must be provided for cleaning.

6. Hygiene control

the
environment and equipment. Inspection schedules and results
shall be documented.

should include regular

inspections of

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

8. Digestion residues must be handled and stored at the plant in

such a way as to preclude recontamination.

C. Heat treatment conditions

1. Animal by-products used as raw material in a biogas plant must

be submitted to the following minimum requirements:

(a) maximum particle size before entering the pasteurisation

unit: 12 mm

(b) minimum temperature in all material in the pasteurisation

unit: 70 °C

(c) minimum time in the pasteurisation unit without

inter-

ruption: 60 minutes

2. Animal by-products 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 °C

(c) minimum time in the reactor at 70 °C (all material): 60

minutes

D. Requirements concerning the digestion residues and compost

Samples of the digestion residues or compost taken during or upon
withdrawal from storage at the biogas or composting plant must be
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 = 3 × 102 in 1 g

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Where

n = number of units comprising the sample

m = threshold value for the number of bacteria;

is
the number of bacteria in all

the result

considered satisfactory if
sample units 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 sample units is M or more;

c = number of sample units the bacterial count of which may be
the sample still being considered
between m and M,
acceptable if the bacterial count of the other sample units
is m or less.

CHAPTER III

Treatment standards for further processing of ruminant rendered
fats

1. Transesterification or hydrolysis at at least: 200 °C, under corre-
sponding appropriate pressure for 20 minutes (glycerol, fatty acids
and esters);

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

— in a batch process: at 95 °C for three hours;

or

— in a continuous process: at 140 °C, 2 bars (2 000 hPa) for eight

minutes or equivalent conditions.

SPECIFIC CONDITIONS FOR PLACING ON THE MARKET AND IMPORTATION OF PROCESSED ANIMAL
PROTEIN AND OTHER FEED MATERIAL

ANNEX V

CHAPTER I

Unchanged

General requirements

Requirements for approval of processing plants

In addition to the general requirements laid down in Annex III:

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 part of a building.

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.

2. By way of derogation from the above paragraph, Member States
may allow that the premises of a Category 3 processing plant are

(i) temporary used for the processing of Category 1 or Category 2
material where a wide-spread epizootic diseases leads to a lack
of capacity at the Category 1 or Category 2 processing plant; or

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 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 before it processes Category 3 material again.

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(ii) permanently used for the processing of Category 1 or Category
2 material where the additional capacity necessary in order to
authorise plant for specific purposes does not exist.

Only under the following conditions:

— the plant must be under a permanent official supervision;

— all unloading, processing, storage or other handling of Category
1 or Category 2 material must take place under official super-
vision;

— Category 1 or Category 2 material must be stored in a

completely separate room or separate reception area;

— Category 1 or Category 2 material must be processed in
separate rooms using separate installations and equipment,
except where
in completely
the processing takes place
enclosed installation or equipment used exclusively for this
purpose;

— the processed Category 1 or Category 2 material must be stored
in a different room or separate tanks which are labelled appro-
priately and must not go for animal consumption. The room or
the separate tanks must be kept
the
competent authority when the latter is not present;

locked under seal of

— Category 3 processing plants which have been temporarily or
permanently processing Category 1 or Category 2 material must
undergo a thorough regime of cleansing and disinfection as
agreed by the competent authority before processing material
of a higher health category.

2a. Category 3 processing plants shall carry out strict sorting of
material deriving from cattle, pigs and poultry prior to, during
and following processing.

3. Category 3 processing plants shall have:

Unchanged

(a) an installation to check the presence of extraneous matter, such
as packaging material, metallic pieces, etc., in the unprocessed
animal by-products;

(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.

Special conditions of hygiene for processing plants

R a w m a t e r i a l r e c e p t i o n

4. Only Category 3 material listed in points (a) to (l) of Article 6 can
be used for the production of processed animal proteins and other
feed material;

4. Only Category 3 material

listed in points (a) to (l) of Article 6
which has been kept separate as regards animal species, can be
used for the production of processed animal proteins and other
feed material;

5. Before processing, animal by-products shall be checked for the
these must be

presence of extraneous matter. When present
removed.

5. Before processing, animal by-products shall be checked for the
it must be

presence of extraneous matter. When present,
removed immediately.

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H e a t t r e a t m e n t s t a n d a r d s

Unchanged

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 III Chapter III. The
critical control points may, include:

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 III Chapter III. The
critical control points must, at least, include:

— Raw material particle size

Unchanged

— Temperature achieved in the heat treatment process

— Pressure applied to the raw material

— Duration of

the heat

treatment process or feed rate to a

continuous system

— Minimum process values shall be specified for each applicable

critical control point

7. Records shall be maintained to show that the minimum process

values for each critical control point are applied.

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

8. Accurately calibrated temperatures gauges/recorders shall be used
to monitor continuously the processing conditions. Records shall
be kept to show the date of calibration of temperatures gauges/
recorders.

8. Accurately calibrated temperatures gauges/recorders shall be used
to monitor continuously the processing conditions. Records shall
be kept for at least two years to show the date of calibration of
temperatures gauges/recorders.

9. Material that may not have received the specified heat treatment
(i.e. material discharged at start up, or leakage from cookers), shall
be re-circulated through the heat treatment or shall be collected
and reprocessed.

Unchanged

Requirements concerning the products after processing

10. Samples of the final products taken during or upon withdrawal
the processing plant must comply with the

from storage at
following standards:

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

Enterobacteriaceae: n = 5, c = 2, m = 10, M = 3 × 102 in 1 g

Where

n = number of units comprising the sample

m = threshold value for the number of bacteria;

the result is
the number of bacteria in all

considered satisfactory if
sample units 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 sample units is M or more;

c = number of sample units the bacterial count of which may be
between m and M,
the sample still being considered
acceptable if the bacterial count of the other sample units
is m or less.

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CHAPTER II

Special conditions for processed animal protein

In addition to the conditions of Chapter I the following conditions
apply:

Processing standards

1. Mammalian processed animal protein with the exclusion of blood
meal, must have been submitted to the processing method 1.

2. Blood meal and non-mammalian processed animal protein with
the exclusion of fishmeal, must have been submitted to any of
the processing methods listed in Annex III, Chapter III.

3. Fishmeal must have been submitted to

(i) any of the processing methods listed in Annex III, Chapter III;

or

(ii) a method and parameters which ensure that the processed
product comply with the microbiological standards set
in
Chapter I (10) of this Annex.

Storage and dispatch of processed animal proteins

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

5. Adequate measures shall be taken to minimise condensation inside

bins, conveyors or elevators;

6. Products in conveyors, elevators and bins shall be protected from

casual contamination;

7. Processed animal protein handling equipment shall 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
shall be emptied and cleaned regularly, as
production requirements require;

8. Processed animal protein must be kept dry. Leakages and conden-

sation in the storage area shall be prevented;

9. Processed animal protein shall be dispatched in sealed new bags or

in covered bulk containers or vehicles;

10. Every vehicle must be checked and must be clean and dry before it

is loaded.

Importation of processed animal protein

11. Member States shall authorise the importation of processed animal

protein only if:

— It comes from third countries which appear on the list of Part
II of Annex XI or, in case of fishmeal, which appear on the list
of Part III of Annex XI;

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— It comes from a processing plant which appears on the list

referred to in Article 29(3);

— It has been produced in accordance with this Regulation;

— It

is accompanied by a health certificate as laid down in

Chapter 1 of Annex X.

12. For

for

release

free circulation in Community territory of
consignments of processed animal protein, imports of processed
animal protein are subject to sampling by the competent authority
at the border inspection post of

(i) each consignment of products submitted in bulk;

(ii) at random of consignments of products packaged in the

manufacturing plant of origin.

13. Member

states may carry out

random sampling of bulk
consignments origination from a third country from which the
last six consecutive tests have proved negative. Where during
one of these checks a result has proved positive, the competent
authority of the country of origin must be informed so that it can
take appropriate measures to remedy the situation. These measures
must be brought to the attention of the competent authority for
the import checks. In the event of a further positive result from
the same source,
tests must be carried out on all
consignments from the same source until the requirements laid
down in the first sentence are again satisfied.

further

14. Member States must keep, a record of the results of sampling
carried out on all consignments which have undergone sampling.

14. Competent authorities must keep, for at least two years, a record
of the results of sampling carried out on all consignments which
have undergone sampling.

15. Where a consignment proves to be positive for salmonella, it is

Unchanged

either:

(a) re-exported from the Community;

(a) be dealt with in accordance with the procedure laid down in

Article 17(2)(a) of Directive 97/78/EC, or;

(b) reprocessed in a processing plant approved pursuant to this
Regulation or decontaminated by treatments permitted under
Community legislation. The consignment shall not be released
salmonella by the
until
competent authority in accordance with Chapter I
(10) of
this Annex and a negative result obtained.

it has been treated,

tested for

(b) reprocessed in a processing plant approved pursuant to this
Regulation or decontaminated by a treatment authorised 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 shall not be released until it
tested for salmonella by the competent
has been treated,
(10) of this Annex
authority in accordance with Chapter I
and a negative result obtained.

CHAPTER III

Unchanged

Special conditions for blood products

In addition to the conditions of Chapter I, the following conditions
apply:

1. Only blood referred to in points (a) and (b) of Article 6 can be used

for the production of blood products;

2. Blood products must have been submitted to

(i) any of the processing methods listed in Annex III, Chapter III;

or

(ii) a method and parameters which ensure that

products comply with the microbiological standards set
Chapter I (10) of this Annex.

the processed
in

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Importation of processed blood products

3. Member States shall authorise the importation of blood products

only if:

— they come from third countries which appear on the list of Part

V of Annex X,

— they come from a processing plant which appears on the list

referred to in Article 29(3),

— they have been produced in accordance with this Regulation,

— they are accompanied by a health certificate as provided for in

Article 29(5).

CHAPTER IV

Special conditions for rendered fats and fish oil

In addition to the conditions of Chapter I, the following conditions
apply:

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.

Importation of rendered fats

2. Member States shall authorise the importation into the Community

of rendered fats only if:

— they come from third countries appearing on the list of Part IV

of Annex XI;

— they come from a processing plant which appears on the list

referred to in Article 29(3);

— they have been produced in accordance with this Regulation,

and:

(a) where it

is entirely or partly derived from swine raw
material, comes from a country or a part of the territory
of a country free of
foot-and-mouth disease from the
previous twenty-four months and free of classical swine
fever, African swine fever for the previous twelve months,

(b) where it is entirely or partly derived from poultry raw
material, comes from a country or a part of the territory
of a country free of Newcastle disease and avian influenza
for the previous six months,

(c) where it is entirely or partly derived from ruminant raw
material, comes from a country or a part of the territory of
a country free of foot-and-mouth disease from the previous
twenty-four months and free of Rinderpest for the previous
twelve months,

or

(d) where there has been an outbreak of one of the above-
mentioned diseases during the relevant period mentioned
above, has been subjected to one of the following heat
treatment processes:

(i) at least 70 °C for at least 30 minutes, or

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(ii) at least 90 °C for at least 15 minutes,

and details of the critical control points are recorded and
maintained so that the owner, operator or his represen-
tative and, as necessary,
the competent authority can
monitor the operation of the plant. The information shall
include the particle size, critical temperature and, as appro-
priate,
the absolute time, pressure profile, raw material
feed-rate and fat recycling rate.

— they are accompanied by a health certificate as provided for in

Article 29(5).

Importation of fish oil

3. Member States shall authorise the importation into the Community

of fish oil only if:

— it comes from third countries appearing on the list of Part III of

Annex XI,

— it comes from a processing plant which appears on the list

referred to in Article 29(3),

— it has been produced in accordance with this Regulation,

— it is accompanied by a health certificate as provided for in

Article 29(5).

4. Where the rendered fat or the fish oil are packaged, they have been
packed in new containers or in containers that have been cleaned,
and all precautions have been taken to prevent their recontami-
the
nation. Where bulk transport of
pipe, pumps and bulk tanks and any other bulk container or bulk
road tanker used in the transportation of the products from the
manufacturing plant either directly on to the ship or into shore
tanks or direct to establishments have been inspected and found
to be clean before use.

the products is intended,

4. Where the rendered fat or the fish oil are packaged, they shall be
packaged in new containers or in containers that have been cleaned,
and all precautions shall be taken to prevent their 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 transportation of the products from the manufacturing
plant either directly on to the ship or into shore tanks or direct to
establishments must be inspected and found to be clean before use.

CHAPTER V

Unchanged

Special conditions for milk, milk-based products and colostrum

In addition to the conditions of Chapter I, the following conditions
apply:

1. raw milk and colostrum must be produced under conditions
offering adequate guarantees
regard animal health. Such
as
conditions must 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 72 °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:

(i) in case of dried milk or dried milk products, a drying process;

(ii) 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
6,0;

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3.

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

(i) after completion of the drying process, every precaution must

be taken to prevent contamination of the products;

(ii) the final products must be packed in new containers;

4.

in the case of bulk containers, before the milk, milk product or
colostrum is loaded into any vehicles or container for conveyance to
its destination, the said vehicle or container must be disinfected
using a product approved by the competent authority.

Importation of milk and milk-based products

5. Member States shall authorise the imports of milk and milk-based

products only if:

— they come from third countries appearing on the list of Part I of

Annex XI, and

third countries listed in column B of

(a) milk and milk-based products from third countries or parts
the Annex to
of
Decision 95/340/EC if they have undergone a pasteurisation
treatment sufficient to produce a negative phosphatase test
and are accompanied by a copy of the health certificate laid
down in Chapter 2(A) of Annex X;

the Annex to Decision 95/340/EC if

(b) milk-based products with a pH reduced to less that 6 from
third countries or parts of third countries listed in column C
of
they have first
undergone a pasteurisation treatment sufficient to produce
a negative phosphatase test and are accompanied by a copy
of the health certificate laid down in Chapter 2(B) of Annex
X;

third countries listed in column C of

(c) milk and milk-based products from third countries or parts
of
the Annex to
Decision 95/340/EC if they have first undergone a sterili-
sation process or a double heat
treatment where each
treatment was sufficient to produce a negative phosphatase
test on its own and are accompanied by a copy of the health
certificate laid down in Chapter 2(C) of Annex X;

— they come from a processing plant which appears on the list

referred to in Article 29(3);

6. Milk and milk based products from third countries or parts of third
countries listed in column C of the Annex to Decision 95/304/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 practised in the last 12 months must, before introduction
onto Community territory, have undergone

either:

(i) a sterilisation process whereby a F° value equal to or greater

that 3 is achieved; or

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

— 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

— an acidification process such that the pH has been main-

tained at less that 6 for at least one hour.

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

identified, additional conditions

for

CHAPTER VI

Special conditions for gelatine and hydrolysed protein

In addition to the conditions of Chapter I, the following conditions
apply:

A. Gelatine

1. Gelatine must be produced by a process which 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. Gelatine must be extracted by
heating one or several times in succession, followed by purifi-
cation by means of filtration and sterilisation,

— After having been subjected to the processes referred to in
paragraph 1, gelatine may undergo a drying process and,
where appropriate, a process of pulverisation or lamination,

— The use of preservatives, other
hydrogen peroxide, is prohibited.

than sulphur dioxide and

2. Gelatine must be wrapped, packaged, stored and transported

under satisfactory hygiene conditions, in particular:

— a room must be provided for

storing, wrapping and

packaging materials,

— wrapping and packaging must take place in a room or in a

place intended for that purpose,

— wrappings and packages containing gelatine must carry the

words ‘Gelatine for animal consumption’.

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B. Hydrolysed protein

3. Hydrolysed protein must be produced by a production process
which involves appropriate measures to minimise contamination
of raw Category 3 material, preparation of the raw Category 3
material by brining, liming and intensive washing followed by

— exposure of the material to a pH of > 11 for > 3 hours at
treatment at

temperature > 80 °C and followed by heat
> 140 °C for 30 minutes at > 3,6 bar; or

— exposure of the material to a pH of 1 to 2, followed by a pH of
>11, followed by heat treatment at 140 °C for 30 minutes at 3
bar; or

— a by an equivalent production process approved in accordance

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

Importation of gelatine and hydrolysed protein

4. Member States shall authorise the importation of gelatine only if:

— it comes from third countries which appear on the list of Part

XI of Annex X,

— it comes from a processing plant which appears on the list

referred to in Article 29(3),

— it has been produced in accordance with this Regulation,

— it is accompanied by a health certificate as provided for in

Article 29(5).

5. Member States
proteins only if:

shall authorise the importation of hydrolysed

— they come from third countries which appear on the list of Part

XI of Annex X,

— they come from a processing plant which appears on the list

referred to in Article 29(3),

— they have been produced in accordance with this Regulation,

— they are accompanied by a health certificate as provided for in

Article 29(5).

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CHAPTER VII

Special conditions for dicalcium phosphate

1. Dicalcium phosphate must be produced by a process which 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 pH < 1,5) over a period of
at least two days followed by a treatment of the obtained phos-
phoric liquor with lime, resulting in a precipitate of dicalcium
phosphate at pH 4 to 7, which is finally air dried for 15 minutes
with inlet temperature of 270-325 °C and end temperature between
60-65 °C or by an equivalent process approved in accordance with
the procedure referred to in Article 33(2).

Importation of dicalcium phosphate

2. Member States

shall authorise

the

importation of dicalcium

phosphate only if:

— it comes from third countries which appear on the list of Part

XI of Annex X,

— it comes from a processing plant which appears on the list

referred to in Article 29(3),

— it has been produced in accordance with this Regulation,

— it is accompanied by a health certificate as provided for in

Article 29(5).

SPECIAL CONDITIONS FOR PLACING ON THE MARKET, TRADE AND IMPORTATION OF PETFOOD,
DOGCHEW AND TECHNICAL PRODUCTS

ANNEX VI

CHAPTER I

Unchanged

General conditions for approval of petfood and technical plants

Establishment producing petfood, dogchews and technical products
must fulfil the following requirements:

(a) they must have adequate facilities for storing and treating incoming

material in complete safety;

(b) they must have adequate facilities for disposing of in accordance
with this Regulation unused unprocessed animal by-products
remaining after the production of the products, or must send it
to a processing plant or to an incinerator or co-incineration plant
in accordance with this Regulation.

CHAPTER II

Petfood and dogchews

Petfood and dogchews must satisfy the following requirements:

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(a) the ingredients of animal origin from which the petfood is manu-
factured are animal by-products referred to in points (a) to (l) of
Article 6 only;

(b) canned petfood shall be subjected to heat treatment to a minimum

Fc value of 3,0;

(c) processed petfood

— must be subjected to a heat

treatment of at

least 90 °C

throughout its substance,

— 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;

(d) dogchews

— must be subjected to a heat

sufficient
salmonella),

to

destroy

treatment during processing
(including

organisms

pathogenic

— 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;

(e) raw petfood

— must be manufactured only from animal by-products listed in
point (a) of Article 6 derived from animals slaughtered in an EC
approved slaughterhouse,

— the final product was packed in new packaging preventing any

leakage,

— effective steps must be taken to ensure that the product is not
exposed to contamination through all the production chain up
to the point of sale,

— the wording ‘petfood only’ must be visibly and legibly displayed

on the packaging;

(f) must be examined by random samples taken along production
and/or during storage (before dispatching) to verify its compliance
with the following standards:

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

Importation of petfood and dogchews

Member States shall authorise importation of petfood and dogchew
only if:

— they come from third countries which appear on the list of Part X

of Annex XI;

— they come from petfood plants approved by the competent
authority of the third country meeting the specific conditions laid
down in this Regulation;

— they has been produced in accordance with this Regulation;

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— they are accompanied

(a)

in case of canned petfood, by the certificate that conforms to
the model laid down in Chapter 3(A) of Annex X;

(b)

in case of processed petfood, by the certificate that conforms
to the model laid down in Chapter 3(B) of Annex X;

(c)

in case of dogchews, by the certificate that conforms to the
model laid down in Chapter 3(C) of Annex X;

(d)

in case of raw petfood, by the certificate that conforms to the
model laid down in Chapter 3(D) of Annex X.

CHAPTER III

Manure, processed manure and processed manure products

I. Unprocessed manure

T r a d e i n u n p r o c e s s e d m a n u r e

1. (a) The trade of unprocessed manure of species other than
poultry or equidae is prohibited, except for manure:

— from an area which is not subjected to restrictions by

virtue of a serious transmissible disease, and

— intended for spreading, under the supervision of

the
competent authorities, on land forming part of a single
holding located on both sides of the frontier of two
Member States.

(b) However,

in derogation to (a), Member States may grant
specific approval for the introduction onto its territory of:

— manure intended for processing in a technical plant or a
biogas plant or in a composting plant approved by the
competent authorities in accordance with this Regulation
with a view to manufacture of the products referred to
under II below. When such plants are being approved,
account is to be taken of the origin of the manure, or

— manure intended for spreading on a holding. Such trade
can only occur with the consent of the competent auth-
orities of both the Member States of origin and desti-
nation. When giving consent, account is to be taken in
particular of the origin of the manure, its destination and
animal health and safety considerations.

In such cases the manure is to be accompanied by a health
certificate that conform to the model laid down in accordance
with the procedure referred to in Article 33(2).

A health cerificate conforming to a model laid down in accordance
with the procedure referred to in Article 33(2) must accompany the
manure in such cases.

2. Trade of unprocessed poultry manure is subject to the following

Unchanged

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-vacci-
to Article 12(2) of Directive
nating status pursuant
90/539/EEC;

(c) the manure is to be accompanied by a health certificate that
laid down in accordance with the

conform to the model
procedure referred to in Article 33(2).

(c) A health cerificate conforming to a model

laid down in
accordance with 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.

I m p o r t s o f u n p r o c e s s e d m a n u r e

4. Member States
manure only if:

shall authorise importation of unprocessed

— it comes from third countries which appear on the list of

Part IX of Annex XI,

— it

satisfies,

according to the
requirements under (1)(a) above,

species

concerned,

the

— it is accompanied by a health certificate as provided for in

Article 29(c).

II. Processed manure and processed manure products

5. 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 or a biogas plant or
a composting plant approved by the competent authorities
in accordance with this Regulation;

(b) they must have been subjected to a heat treatment processes

of at least 70 °C for at least 60 minutes

(b) they must have been subjected to a heat treatment processes
of at least 70 °C for at least 60 minutes or to an equivalent
treatment in compliance with rules laid down in accordance
with the procedure referred to in Article 33(2);

(c)

they must:

Unchanged

— be free from salmonella (no salmonella in 25 g treated

product),

— be free from enterobacteriaceae (based on the aerobic
treated

count: < 1 000 cfu per

gram of

bacteria
products),

— have been subjected to reduction in spore-forming

bacteria and toxic formation;

(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:

— well-sealed and insulated silos, or

— properly sealed packs (plastic bags or ‘big bags’).

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I m p o r t a t i o n o f p r o c e s s e d m a n u r e
m a n u r e p r o d u c t s

a n d p r o c e s s e d

6. Member States shall authorise importation of processed manure

and processed manure products only if:

— they come from third countries which appear on the list of

Part IX of Annex XI,

— they come from a plant approved by the competent
specific

third country meeting the

authority of
conditions laid down in this Regulation,

the

— they satisfy the requirements under 5 above,

— they are accompanied by a health certificate as provided for

in Article 29(5).

III. Guano

7. Marketing of
conditions.

‘guano’

is not subject

to any animal health

CHAPTER IV

Blood and blood products used for technical or pharmaceutical
purpose, in vitro diagnosis or laboratory agents, 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 conditions laid down in Article 18 of
this Regulation.

B. Importation of blood and blood products used for technical or phar-
in vitro diagnosis or laboratory agents, excluding

maceutical purpose,
serum of equidae

2. Imports of blood are subject to the conditions laid down in

Chapter XI to this Annex.

3. Member States shall authorise importation of blood products

only if:

— they come from third countries which appear on the list of

Part VI of Annex XI;

vescicular

stomatitis,

and no case of

— they originate in a third country in which no case of foot-
least 24
and-mouth disease has been recorded within at
swine
months
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

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— in the case of blood products derived from bovine animals,
they originate in an area of a third country fulfilling the
conditions set out in the first indent from which imports
of bovine animals, their fresh meat or their sperm are auth-
orised pursuant to Community legislation. The blood from
which such products are manufactured must be from bovine
animals from that area of the third country and must have
been collected:

(i) in

slaughterhouses
Community legislation,

approved

in

accordance with

or

authorities of

(ii) in slaughterhouses approved and supervised by the
competent
third country. The
Commission and Member States must be notified of
the address and approval number of such slaughterhouse
or it must be indicated in the certificate.

the

or

— in the case of blood products derived from bovine animals,
they have undergone one of the following treatments guar-
anteeing the absence of pathogens of the bovine diseases
referred to in the first indent:

(i) heat treatment at a temperature of 65 °C for at least

three hours, followed by an effectiveness check,

(ii) irradiation at 2,5 magarads or by gamma rays, followed

by an effectiveness check,

(iii) change in pH to pH 5 for two hours, followed by an

effectiveness check,

(iv) heat

treatment of at

least 90 °C throughout

their

substance, followed by an effectiveness check,

(v) any other treatment provided for in accordance with the

procedure referred to in Article 33(2),

or

— in the case of blood products derived from bovine animals,
they fulfil the conditions laid down in Chapter X of this
Annex.
In such cases, the packaging may not be opened
during storage and the processing undertaking must carry
out one of the treatments listed in the above indent;

and

— they comes

from a plant approved by the competent
authority of the third country meeting the specific conditions
laid down in this Regulation; and

— they are accompanied by a health certificate as provided for

in Article 29(5).

4. The specific conditions relating to imports of products for use in
in vitro diagnosis and laboratory reagents shall be established,
where necessary, in accordance with the procedure referred to
in Article 33(2).

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CHAPTER V

Serum of equidae

1. Serum must come from equidae which show none of the serious
transmissible disease referred to in Directive 90/426/EEC or if the
serious transmissible diseases to which equidae are susceptible and
have been obtained in bodies or centres not subject
to health
restrictions pursuant to that Directive.

Importation of serum of equidae

2. Member States shall authorise the import of serum of equidae only

if:

— it comes from equidae born and raised in a third country from
which the importation of horses for slaughter is authorised;

— it was obtained, processed and dispatched in conformity with

the following conditions:

(a) it comes from a country where the following diseases are
compulsory notifiable: African horse sickness, dourine,
glanders, equine
including
VEE), equine infectious anemia, vesicular stomatitis, rabies,
anthrax;

encephalomyelitis

types

(all

(b) 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;

(c) it was obtained from equidae, which have remained since
birth in the territory or, in case of official regionalisation
according to Community legislation, in parts of the territory
of a third country in which:

(i) venezuelan equine encephalomyelitis has not occurred

during the last two years;

(ii) dourine has not occurred during the last six months;

(iii) glanders has not occurred during the last six months;

(d) it was obtained from equidae, which, at the moment of
collection, did not come from a holding and have been
not present on a holding which was subject to prohibition
for animal health reasons:

(i) within the previous six months in the case of equine
encephalomyelitis, beginning on the date on which the
equidae suffering from the disease are slaughtered;

(ii) in the case of infectious anaemia, until the date on
which, the infected animals having been slaughtered,
the remaining animal have shown a negative reaction
to two Coggins tests carried out three months apart;

(iii) within the previous six months in the case of vesicular

stomatitis;

(iv) within the previous 15 days of the last recorderd case,

in the case of anthrax.

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If all the animals of species susceptible to the disease located
on the holding have been slaughtered and premises disin-
fected, the period of prohibition shall be 30 days, beginning
on the day on which the animal were destroyed and the
premises disinfected, except in the case of anthrax, where
the period of prohibition is 15 days;

(e) it has undergone all precautions to avoid contamination
with pathogenic agents during production, handling and
packaging;

(f)

it was packed in sealed impermeable containers clearly
labelled ‘serum from equidae’ and bearing the registration
number of the establishment of collection.

— they come from a plant approved by the competent authority
of the third country meeting the specific conditions laid down
in this Regulation;

— It

is accompanied by a health certificate as laid down in

Chapter 4 of Annex X.

CHAPTER VI

Hides and skins of ungulates

1. The provisions of this chapter shall not apply to:

— Hides and skins of ungulates fulfilling the requirements of

Directive 64/433/EEC,

— Hides and skins of ungulates having undergone the complete

process of tanning,

— ‘wet blue’,

— ‘pickled pelts’,

— 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 1, the provisions of this chapter apply

to fresh, chilled and treated hides and skins.

For the purpose of this chapter,
hides and skins which have been:

‘treated hides and skins’ means

— dried, or

— dry-salted or wet-salted for at least 14 days prior to dispatch, or

— salted for seven days in sea salt with the addition of sodium

carbonate to 2 %, or

— drying for 42 days at a temperature of at least 20 °C, or

— preserved by a process other than tanning, to be determined in
accordance with the procedure referred to in Article 33(2).

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Trade

3. Trade in fresh or chilled hides and skins are subjected to the same
those applicable to fresh meat pursuant

health conditions as
Directive 72/461/EEC.

4. Trade in treated hides and skins is authorised on conditions that
each consignment is accompanied by the commercial document as
provided for in Annex II attesting that:

(i) the hides and skins have been treated in accordance with point

2, and

(ii) the consignments has not been in contact with other animal
live animals presenting a risk of spreading a

products or
serious transmissible disease.

Importation of hides and skins

5. Member States shall authorise the import of fresh or chilled hides

and skins if:

(a) they have been obtained from animals which have been

slaughtered in a slaughterhouse and

(b) they originate from third countries or in case of regionalisation
in accordance with Community legislation from a part of a third
country from which imports of all categories of fresh meat of
the corresponding species are authorised and which for at least
12 months before dispatch have been free from the following
diseases:

— classical swine fever

— African swine fever

— rinderpest

and which have 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) have been obtained from:

— animals which 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,

— in the case of hides and skins from bi-ungulates, animals
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,

— in the case of hides and skins from swine, animals which
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 disease for 30 days,

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— animals which have passed the

ante-mortem health
the slaughterhouse during the 24 hours
inspection at
before slaughter and have shown no evidence of
foot-
and-mouth disease, rinderpest, classical swine fever, African
swine fever or swine vesicular disease;

(d) have undergone all precautions to avoid recontamination with

pathogenic agents;

(e) are accompanied by an animal health certificate as laid down in

Chapter 5(A) of Annex X.

6. Member States shall authorise the import of treated hides and skins

if:

(a) they are accompanied by an animal health certificate as laid

down in Chapter 5(B) of Annex X;

(b) either the hides and skins come from animals originating in a
region of a third country or in a third country not subject,
pursuant to Community regulations, 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 point 2

or

the hides and skins come from animals originating from other
regions of a third country or other third countries and they have
been treated in accordance with point 2,
third and fourth
indents

or

the hides and skins come from ruminant animals and have been
treated in accordance with point 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 point 6(a)
is
replaced by a declaration laid down in Chapter 5(C) of Annex
X, to the effect that or proving that those requirements have
been met;

(c) 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;

(d) the consignment has not been in contact with other animal
product 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, trucks, trainwagons or bales sealed by the
competent authority of third country of dispatch.

CHAPTER VII

Game trophies

1. Without prejudice to the measures adopted pursuant to Regulation

(EEC) 3626/82, game trophies:

(i) of ungulates and birds having undergone a complete taxidermy
treatment ensuring their preservation at ambient temperatures;

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(ii) of species other than ungulates and birds;

shall not be subject to any ban or restriction for reasons of animal
health.

2. Without prejudice to the measures adopted pursuant to Regulation
(EEC) 3626/82, game trophies of ungulates and birds not having
undergone the treatment mentioned in (i) shall be subject to the
following conditions:

— come from animals originating in an area not subject

to
restrictions as a result of the presence of serious transmissible
diseases
concerned are
susceptible, or

to which animals of

the species

— comply with the conditions laid down in (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:

— 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 are removed,

— have been disinfected with a product authorised by the
in particular with hydrogen peroxide

competent authority,
where parts consisting of bone are concerned,

— be packaged,

immediately after treatment, without being in
animal origin likely to
and closed
transparent

contact with other products of
contaminate
in individual,
them,
packages so as to avoid any subsequent contamination,

— be accompanied by a document or certificate certifying that the

above conditions have been met.

4. In respect of game trophies consisting solely of hide or skin, the

trophies must

— 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 to be fixed
according to the procedure referred to in Article 33(2);

— be packaged,

immediately after treatment, without being in
animal origin likely to
and closed
transparent

contact with other products of
contaminate
in individual,
them,
packages so as to avoid any subsequent contamination,

— be accompanied by a document or certificate certifying that the

above conditions have been met.

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Importation of game trophies

5. Member States shall authorise the importation of

treated game
trophies from birds and ungulates, being solely bones, horns,
hooves, claws, antlers, teeth, hides or skins, from third countries
only if:

— they are accompanied by a certificate/document as laid down in

Chapter 6(A) of Annex X, and

— in the case of dry-salted or wet-salted skins transported by ship,
the skins have been salted a minimum of 14 days before
importation.

6. Member States shall authorise the importation of game trophies
from birds and ungulates consisting of entire anatomical parts,
not having been treated in any way,
from third countries
appearing on the list of Commission Decision 94/86/EC from
which the importation of all categories of fresh meat of the corre-
sponding species is authorised if
they are accompanied by a
veterinary certificate as laid down in Chapter 6(B) of Annex X.

Chapter VIII

Unprocessed wool, hair, pig bristles, feathers and parts
of feathers

1. Unprocessed wool, hair, pig bristles, feathers and parts of feathers
(the goods) must be securely enclosed in packaging and dry.
in which
However, movements of pig bristles
African swine fever
for pig
bristles which:

is endemic are prohibited except

from regions

(a) have been boiled, dyed or bleached; or

(b) have 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 shall not
be regarded as a form of treatment for the purposes of this
provision.

2. The provisions of the above paragraph shall 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.

Importation of pig bristles

3. Member States shall authorise the importation of pig bristles from
third countries or,
regionalisation according to
Community legislation, regions thereof, where no cases of African
swine fever has occurred during the previous 12 months,
if the
consignment
is accompanied by an animal health certificate as
laid down in Chapter 7(A) of Annex X.

in case of

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4. Member States shall authorise the importation of pig bristles from
third countries or,
regionalisation according to
Community legislation, regions thereof, where one or more cases
of African swine fever has occurred during the previous 12 months,
if the consignment is accompanied by an animal health certificate as
laid down in Chapter 7(B) of Annex X.

in case of

5. Member States shall authorise the importation of unprocessed wool,
feathers and parts of feathers only if securely enclosed in

hair,
packaging and dry.

6. Unprocessed wool, hair, bristles, feathers and parts of feathers must
be sent directly to the plant of destination or to the intermediate
storage plant in conditions such that any spread of pathogenic
agents is avoided.

CHAPTER IX

Apiculture products

1. Apiculture products intended exclusively for use in apiculture:

(a) must 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 92/68/EEC;

(b) must meet the requirements imposed by Article 8(a) of Directive

92/65/EEC;

Any derogation must be established, as necessary, under
procedure referred to in Article 33(2).

the

Importation of apiculture products

2. Member States shall only authorise the importation of apiculture
products intended for use in apiculture if the commercial document
accompanying the consignment includes the following information
and it is stamped by the competent authorities supervising the
registered establishment of production:

— country of origin

— name of the establishment of production

— registration number of the establishment of production

— nature of the products:

‘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.’

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CHAPTER X

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 different from animal
consumption or fertilizers

1. Member States shall 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)
intended for further processing but not for any use in human or
animal food or as fertilizers provided that:

(i) the products are dried before export and not chilled or frozen;

(ii) 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;

(iii) following the document checks provided for

in Directive
97/78/EC, the products are conveyed directly to the manu-
factured plant.

2. Each consignment must be accompanied by

(i) A commercial document stamped by the competent authority
supervising the establishment of origin, including the following
information:

Country of origin,

Name of the establishment of production,

Nature of the product (dried bone/dried bone product/dried
horns/dried horn products/dried hooves/dried hoof products)
which:

— Were derived from healthy animals

slaughtered in a

slaughterhouse; or

— Were dried for 42 days at an average temperature of at least

20 °C; or

— Were heated for one hour to at least 80 °C to the core

before drying; or

— Were washed for one hour to at least 80 °C to the core

before drying; or

— Have undergone an acidification process such that the pH
has been maintained at less that six to the core for at least
one hour before drying;

and are not intended at any stage to be diverted for any use in
human food or animal feed or fertilizers

and

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(ii) by 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:

3. On dispatch to the Community territory,

the material shall be
enclosed in lead-sealed container units or trucks or in bulk in a
vessel. If transported in containers the containers and in all case all
the accompanying documents shall bear the name and the address
of the processing establishments.

4. The material shall be transported direct to the processing estab-
in Community territory in

lishment
containers or means of transport which are sealed.

from the point of arrival

5. On arrival in the territory of the Community and before dispatch of
the material
intended
dispatch shall be made as quickly as possible to the local official
veterinarian or competent authority by Animo message or, when
this is not possible, by telex or telefax.

to the processing plant, notification of

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6. Records shall 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

Unprocessed animal by-products for the manufacture of petfood
and pharmaceutical or technical products

Member States shall authorise the importation of unprocessed animal
by-products intended for the manufacture of petfood, pharmaceutical
or technical products only if:

— they come from third countries which appear on the list of Part VII

of Annex XI;

— They are accompanied by a health certificate as laid down in

Chapter 8 of Annex X;

— Following the border check provided for in Directive 97/78/EC and
in accordance with the rules laid down in Article 8(4) of that
Directive, they are transported either

(i) directly to a petfood or technical plant which has given the
guarantee that the unprocessed animal by-products will be
used only for the permitted purpose and that they will not
leave the plant untreated, or

(ii) to an intermediate animal by-products plant.

CHAPTER XII

Rendered fats for oleo-chemical purpose

Member States shall authorise the importation of rendered fat intended
to be processed by a method which at least meets the standards of one
of the processes described in Annex IV, Chapter III only if:

— The product is conveyed only by land and sea from their country
of origin direct to a border inspection post in the Community;

— Following the document checks provided for in Directive 97/78/EC
and in accordance with the rules laid down in Article 8(4) of that
Directive, the products are conveyed to the oleo-chemical plants
where they will be processed;

— each consignment must be accompanied by a declaration from the
importer that products imported under this paragraph will not be
diverted for any other use than further processing by a method
the processes
which at
described in Annex IV, Chapter III.

least meets the standards of one of

This declaration must be presented to the official veterinarian at the
border inspection post, at first point of entry of the goods into the
Community and be annotated by him, and thereafter shall accompany
the consignment up to the manufacturing plant.

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ANNEX VII

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ANNEX VIII

HYGIENE REQUIREMENTS FOR INTERMEDIATE AND STORAGE PLANTS

CHAPTER I

Unchanged

Requirements for the approval of intermediate plants

1. Premises

and
requirements:

facilities must meet

at

least

the

following

(a) the premises must be adequately separated from the public

highway and other premises such as slaughterhouses;

(b) the plant must have a covered space to receive the 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, birds, etc.;

(f)

the plant must have a waste water disposal system which meets
hygiene requirements.

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

suitable

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

Unchanged

CHAPTER II

General conditions of hygiene

A. Category 3 intermediate plant

1. The plant must have not other activities

collecting,
temporary storing and dispatching of Category 3 material;

chilling,

cutting,

sorting,

than importing,
freezing into blocks,

1. The plant must not be at the same site as a plant for Category 1
or 2 material and must not have any other activities than
importing, collecting, sorting, cutting, chilling,
freezing into
blocks,
temporary storing and dispatching of Category 3
material;

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2. the sorting of the Category 3 material must be done in way that
any risk of introduction of animal diseases can be avoided;

2. the sorting of the Category 3 material must be done in way that
any risk of introduction of animal diseases can be avoided; raw
material destined to the production of animal proteins destined
to farmed animal feed must be kept separate as regards animal
species;

3. All the time during sorting or storage, the Category 3 material
must be handled and stored separately from other goods and in
such a way as to prevent any propagation of epizootic diseases;

3. All the time during sorting or storage, the Category 3 material
must be handled and stored separately from other goods and in
such a way as to prevent any propagation of animal diseases;

4. Category 3 material must be stored properly until re-dispatched;

4. Category 3 material must be stored properly and, where appro-

priate, chilled or frozen until re-dispatched;

5. The vehicles and containers used for the transport of unpro-
cessed Category 3 material,
items of
equipment or appliances which have come into contact with
the unprocessed Category 3 material must be cleaned, washed
and disinfected after each use. Packaging material must be incin-
erated or disposed of by some other means in accordance with
instructions from the official veterinarian.

together with all

Unchanged

B. Category 1 or Category 2 intermediate plant

1. The plant must not have other activities

than collecting,
handling, temporary storing and dispatching of Category 1 or
Category 2 material;

2. The sorting of the Category 1 or Category 2 material must be
done in way that any risk of introduction of animal diseases can
be avoided;

3. 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
epizootic diseases;

4. Category 1 or Category 2 material must be stored properly until

re-dispatched;

4. Category 1 or Category 2 material must be stored properly,
conditions, until

temperature

appropriate

including under
re-dispatched;

5. The vehicles and containers used for the transport of Category 1
or Category 2 material, together with all items of equipment or
appliances which have come into contact with the Category 1 or
Category 2 material must be cleaned, washed and disinfected
after each use. Packaging material must be incinerated or
disposed of by some other means
in accordance with
instructions from the official veterinarian.

Unchanged

CHAPTER III

Requirements for the approval of storage plants

1. Premises

and
requirements:

facilities must meet

at

least

the

following

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

(b) the plant must have a covered space to receive the products;

(a) premises for storage of Category 3 material must not be located
in the same place as premises for storage of Category 1 or
Category 2 material;

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(b) 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;

(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;

(c) the plant must have adequate lavatories, changing rooms and

(d) the plant must have adequate lavatories, changing rooms and

washbasins for staff;

washbasins for staff;

(d) the plant must have appropriate arrangements for protection

(e) the plant must have appropriate arrangements for protection

against pests such as insects, rodents, birds, etc.

against pests such as insects, rodents, birds, etc.;

2. The plant must have adequate facilities for cleaning and disinfecting
the containers or recipients 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.

Unchanged

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

RULES APPLICABLE TO THE TREATMENT OF CERTAIN CATEGORY 2 AND CATEGORY 3 MATERIALS
INTENDED TO BE USED AS FEEDSTUFFS FOR CATEGORIES OF ANIMALS LISTED IN ARTICLE 21

ANNEX IX

1. Category 2 or Category 3 material must be transported to the users

Unchanged

or to the collection centres in accordance with Annex II;

2. The premises must comply at least with the requirements of Annex
III Chapter I points 1(a) (b) (c) (d) and (f), 2, 3, 4 and Chapter II
points 1, 2, 4, 5, 9 and they must have adequate facilities for
destroying unused unprocessed Category 2 or Category 3
material, or must send it to a processing plant or to an incinerator
in accordance with this Regulation.

3. In addition to the records required in accordance to Article 8, the

following records shall be kept:

(i) In the case of final users, the quantity of Category 2 or Category

3 material used and the date of use

(ii) In the case of centres of collection supplying Category 2 or

Category 3 material to final users:

(a) the quantity of Category 2 or Category 3 material treated in

accordance with point 4 below;

(b) the name and address of each final user buying the

processed Category 2 or Category 3 material;

(c) the premises to which the Category 2 or Category 3

material are to be taken for use;

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(d) the quantity dispatched; and

(e) the date on which the material was dispatched.

4. In the case of centres of collection supplying Category 2 or
to final users, Category 2 or Category 3

Category 3 material
material, other than fish offals, must:

(i) undergo one of the following treatments:

(a) denaturing with the solution of a colouring agent approved
by the competent authority; the solution to be of such a
strength that the colouring on the stained meat is clearly
visible, and the whole surface of all pieces of meat have
been covered with a solution as aforesaid either by
immersing the meat in, or spraying or otherwise applying
the solution;

(b) sterilisation,

to say, boiling or steaming under
pressure until every piece of meat is cooked throughout;

that

it

(c) any other treatment approved by the competent authority

(ii) after treatment the Category 2 or Category 3 material must be
packaged before distribution and the packaging must include
the name and the address of the collection centre and be clear
and legibly marked ‘not for human consumption’.

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ANNEX X

MODELS OF HEALTH CERTIFICATES FOR THE IMPORTATION FROM THIRD COUNTRIES OF CERTAIN
ANIMAL BY-PRODUCTS, AND PRODUCTS DERIVED THEREFROM

CHAPTER 1

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ANNEX X

MODELS OF HEALTH CERTIFICATES FOR THE IMPORTATION FROM THIRD COUNTRIES OF CERTAIN
ANIMAL BY-PRODUCTS, AND PRODUCTS DERIVED THEREFROM

CHAPTER 1

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CHAPTER 2

(A)

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(B)

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(C)

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(A)

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(B)

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(C)

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(D)

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(A)

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(B)

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(C)

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(A)

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(B)

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(A)

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(B)

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LISTS OF THIRD COUNTRIES FROM WHICH MEMBER STATES AUTHORISE IMPORTS OF ANIMAL
BY-PRODUCTS NOT INTENDED FOR HUMAN CONSUMPTION

ANNEX XI

The following lists are lists in principle and importation shall fulfil the relevant animal health and public health
requirements.

List of third countries from which Member States authorise imports of milk, milk-based products

PART I

Third countries listed in column B or column C of the Annex to Decision 95/340/EC.

List of third countries from which Member States authorise imports of processed animal proteins (excluding
fishmeal)

PART II

Third countries listed in Part I of the Annex to Decision 79/542/EEC.

List of third countries from which Member States authorise imports of fishmeal and fishoil

PART III

Third countries listed in the Annex to Decision 97/296/EC, and the following countries:

(EE) Estonia

(PR) Puerto Rico

(UA) Ukraine

List of third countries from which Member States authorise imports of rendered fats (excluding fishoil)

PART IV

Third countries listed in Part I of the Annex to Decision 79/542/EEC.

List of third countries from which Member States authorise imports of blood products

PART V

A. Blood products from ungulates

Third 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

Third countries listed in Part I of the Annex to Decision 79/542/EEC.

PART VI

List of third countries from which Member States authorise imports of blood products (with the exception of
equidae) intended for technical and pharmaceutical use

A. Blood products from ungulates

Third 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

Third countries listed in Part I of the Annex to Decision 79/542/EEC.

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PART VII

List of third countries from which Member States authorise imports of unprocessed material for the manu-
facture of petfood and technical products

A. Unprocessed material from animals of bovine, ovine, caprine, porcine and equine species

Third 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

Third countries from which Member States authorise imports of fresh poultrymeat.

C. Unprocessed material from other species

Third countries listed in Part I of the Annex to Decision 79/542/EEC.

List of third countries from which Member States authorise imports of untreated pig bristles

Third countries listed in Part I of the Annex to Decision 79/542/EEC.

PART VIII

List of third countries from which Member States authorise imports of manure for treatment of the soil

PART IX

A. Processed manure products

Third countries listed in Part I of the Annex to Decision 79/542/EEC.

B. Processed manure from equidae

Third countries listed in Part I of the Annex to Decision 79/542/EEC for live equidae.

C. Unprocessed manure from poultry

Third countries from which Member States authorise imports of fresh poultrymeat.

List of third countries from which Member States authorise imports of petfood and dogchews

Third 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 third countries from which Member States authorise imports of gelatine, hydrolysed protein and
dicalcium phosphate intended for animal consumption

Third 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 fishes only.
(3) Gelatine only.

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ANNEX XII

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

CHAPTER I

General conditions

1. The incineration or co-incineration plant must be designed, equipped and operated in such a manner as to fulfil the

requirements of this Regulation.

2. The operator of the incineration or co-incineration 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 co-incineration 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 °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 °C. It must also be used during plant start-up and shut down operations to ensure that the
temperature of 850 °C is maintained at all times during this operations and as long as unburned material is in the
combustion chamber.

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

with animal by-products:

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

(b) whenever the temperature of 850 °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 co-incineration 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,

‘residues’ means any liquid or solid material generated by the incineration or
co-incineration process, the waste water treatment or other processes within the incineration or co-incineration
plant. They include bottom ash and slag, fly ash and boiler dust.

10. Residues resulting from the operation of the incineration or co-incineration 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).

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CHAPTER V

Temperature measurement

12. Techniques must be used to monitor the parameters and conditions relevant to the incineration or co-incineration
process. High-capacity incineration and co-incineration 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