Proposal for a Council Decision on measures applying to the processing of certain animal waste to protect against transmissible spongiform encephalopathies and amending Commission Decision 97/735/EC
Date: 1999-07-06
Institutions: European Commission
Subjects: agricultural waste, animal disease, animal nutrition, animal protein, waste recycling

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 06.07.1999
COM(1999) 341 final

Proposal for a

COUNCIL DECISION

on measures applying to the processing of certain animal waste to protect
against transmissible spongiform encephalopathies
and amending Commission Decision 97/735/EC

(presented by the Commission)

EXPLANATORY MEMORANDUM

Decision 96/449/EC on the approval of alternative heat
treatment systems for
spongiform
processing animal waste with a view to the
encephalopathy agents, establishes that from 1 April 1997 all mammalian animal
waste to which this Decision applies has to be processed in accordance with the
standards set out in the Annex to the Decision.

inactivation of

During recent community inspections,
implementation of this Decision due to difficulties of legal interpretation.

it appeared that

there are problems of

Furthermore, on 26-27 March 1998, the Scientific Steering Committee adopted the
following opinions:

-

-

experimentally susceptible

opinion on the safety of meat and bone meal from mammalian animals,
naturally or
to Transmissible Spongiform
Encephalopathies which has been up-dated by a scientific report on the safety
of meat-and-bone meal derived from mammalian animals fed to non-ruminant
food-producing farm animals adopted by the Scientific Steering Committee on
24-25 September 1998,

opinion on the safety of tallow derived from ruminant tissues.

In order to clarify the above mentioned problems of interpretation and to take into
account these scientific opinions, it is necessary to amend Decision 96/449/EC.

the validation of

On 12 December 1994 the Scientific Veterinary Committee recommended detailed
procedures for
rendering processes laid down in Decision
94/382/EC; Pending a scientific review of these procedures, it is necessary to lay
indicators based, where appropriate, on the above scientific
down a list of
recommendation, to be used for the validation of rendering processes in order to
ensure that the parameters laid down in this Decision are achieved on a plant-by-plant
basis.

The foregoing entails a fundamental reworking of Decision 96/449/EC. Therefore, in
the interests of clarity, this Decision repeals Decision 96/449/EC.

Decision 97/735/EC concerning certain protection measures with regard to trade in
certain types of mammalian animal waste need to be amended to be in line with the
provision of this Decision.

The adoption of this Decision is without prejudice to the adoption of rules for the
organisation
spongiform
of
encephalopathies.

transmissible

prevention

control

and

the

of

This proposal has no impact on the Community budget.

2

On 31 May 1999, the College of Commissioners agreed to submit the proposal to the
Standing Veterinary Committee for an opinion. On 2 June 1999 the SVC gave a
negative opinion.

Germany opposed for the issue of ‘bones fit for human consumption’ Germany is
claimed that there is not scientific justification for submitting this material to the
pressure standards is it is destined to animal consumption.

Germany, Spain and Ireland opposed for the requirements of ’20 minutes without
interruption’ in Annex I.

Germany, Austria, Spain and Ireland opposed on the double treatment of tallow
derived from high risk material. These delegation stated that the recommendation that
tallow derived from material not fit for human consumption must be purified such that
the maximum level of impurities does not exceed 0.15% and treated to 133°C
20 Minutes 3 bar is scientifically unjustified.

Italy opposed to the proposal because of the requirement that material fit for human
consumption derived from non-ruminant animals must be treated under pressure.

The result of the vote was:

In favour: 52 (B, DK, GR, FR, L, NL, P, FIN, SW, UK)

Against: 31 (DE, SP, IRL, IT)

Abstention: 4 (AT).

3

Proposal for a

COUNCIL DECISION

on measures applying to the processing of certain animal waste to protect
against transmissible spongiform encephalopathies
and amending Commission Decision 97/735/EC

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to 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 market1, as last
amended by Directive 92/118/EEC2, and in particular Article 10(4) thereof,

Having regard to the proposal of the Commission,

(1) Whereas Council Directive 90/667/EEC3, as last amended by the Act of
Accession of Austria, Finland and Sweden, lays down the veterinary rules for
the disposal and processing of animal waste, for its placing on the market and
for the prevention of pathogens in feedstuffs of animal or fish origin;

(2) Whereas Commission Decision 92/562/EEC4, as amended by the Act of
Accession of Austria, Finland and Sweden, defined alternative systems of heat
treatment as provided for in paragraph 6(c) of Chapter II of Annex II to
Directive 90/667/EEC;

(3) Whereas in 1994, phase 1 of a scientific study into the physical parameters
which must be applied in order to inactivate the agents of bovine spongiform
encephalopathy (BSE) and scrapie identified the minimum parameters
necessary for inactivation of the BSE agent; whereas it also identified certain
processes which were not effective;

(4) Whereas the results of phase 2 of that study showed that only one system
tested was capable of fully inactivating the scrapie agent in meat-and-bone
meal;

1 OJ L 224, 18.8.1990, p. 29.
2 OJ L 62, 15.3.1993, p. 49.
3 OJ L 363, 27.12.1990, p. 51.
4 OJ L 359, 9.12.1992, p. 23

4

(5) Whereas, therefore, it is necessary to ensure that systems which have been
shown to be ineffective are not used for the processing of mammalian animal
waste in order
spongiform
encephalopathy agents in animal feed, unless an effective sterilisation phase is
added to the process;

from the hazard of

to protect animals

(6) Whereas, at its meeting on 1 to 3 April 1996, the Council concluded that a
Commission Decision should be adopted under the Standing Veterinary
Committee procedure in order to require all animal waste of mammalian origin
in the Community to be processed by a method that has been demonstrated as
being de facto effective for the inactivation of the agents of scrapie and BSE;
in a
whereas the only such method at present
rendering system which achieves a minimum 133°C at 3 bar for a minimum
period of 20 minutes; whereas that may be applied as the sole process or as a
pre- or post-process sterilisation phase;

is the application of heat

(7) Whereas the Scientific Steering Committee adopted an opinion on the safety
of meat-and-bone meal from mammalian animals, naturally or experimentally
susceptible to transmissible spongiform encephalopathies (TSEs) on 26 and
27 March 1998; whereas that opinion has been up-dated by a scientific report
on the safety of meat-and-bone meal derived from mammalian animals fed to
non-ruminant food-producing farm animals adopted by the Scientific Steering
Committee on 24 and 25 September 1998;

(8) Whereas it is necessary to define the maximum particle size and the minimum
time and temperature to be applied in approved systems, in order to ensure that
such systems are running in accordance with procedures which have been
shown to be effective;

(9) Whereas specific rules should be laid down on controls on establishments;

(10) Whereas on 12 December 1994 the Scientific Veterinary Committee
recommended detailed procedures for the validation of rendering processes;
whereas, pending a scientific review of those procedures, it is necessary to lay
down a list of
indicators based, where appropriate, on that scientific
recommendation, to be used for the validation of rendering processes in order
to ensure that the parameters laid down in this Decision are achieved on a
plant-by-plant basis;

(11) Whereas Commission Decision 96/449/EC of 18 July 1996 on the approval of
alternative heat treatment systems for processing animal waste with a view to
the inactivation of spongiform encephalopathy agents5 provided that, from 1
April 1997, certain mammalian animal waste which had not been processed in
accordance with the standards set out therein should not be fed to animals;
whereas recent Community inspections have revealed that there are problems
of implementation of that Decision due to difficulties of legal interpretation;

5 OJ L 184, 24.7.1996, p. 43.

5

(12) Whereas the Scientific Steering Committee adopted an opinion on the safety
of tallow derived from ruminant tissues on 26 and 27 March 1998; whereas, in
order to take account of that scientific opinion, it is necessary to lay down
requirements for the production of rendered fats derived from ruminant tissue;
whereas a period of time should be provided for the implementation of those
requirements;

(13) Whereas a revision of the Animal Health Code of the Office International
des Epizooties (OIE) on BSE was adopted in the general assembly of the OIE
in Paris on 29 May 1998; whereas Article 3.2.13.3 of that Code recommends
that if protein-free tallow (maximum level of impurities of 0.15% in weight) is
derived from healthy animals, veterinary administrations should be able to
authorise, without restriction, its import and transit through their territories,
regardless of the status of the exporting countries; whereas Article 3.12.13.16
of that Code recommends sourcing and processing conditions under which
tallow (other than protein-free tallow) and tallow derivatives (other than
protein-free tallow derivatives) can be traded;

(14) Whereas special uses of animal waste may be exempted from the requirements
of this Decision; whereas, furthermore, products which will be used for
industrial purposes, where it can be assured that they will not be used in any
animal
feed chain or as fertilisers, may also be exempted from the
requirements of this Decision;

(15) Whereas in view of the foregoing a fundamental reworking of Decision
96/449/EC is necessary; whereas, in the interests of clarity, that Decision
should be replaced;

(16) Whereas Commission Decision 97/735/EC of 21 October 1997 concerning
certain protection measures with regard to trade in certain types of mammalian
animal waste6 should be amended to take account of the provisions of this
Decision;

(17) Whereas this Decision should be without prejudice to Council Decision
98/256/EC7, as last amended by Commission Decision 98/692/EC8 and
Commission Decision 98/653/EC9, which lay down specific conditions for the
production of amino acids, peptides, tallow and products derived from tallow
in the United Kingdom and Portugal;

(18) Whereas this Decision should be without prejudice to the adoption of rules for

the organisation of the prevention and control of TSEs;

(19) Whereas the Commission has, by Decision 97/534/EC10, as last amended by
Council Decision 98/745/EC11, prohibited the use of material presenting risks
as regards TSEs;

6 OJ L 294, 28.10.1997, p. 7.
7 OJ L 113, 15.4.1998, p. 32.
8 OJ L 328, 4.12.1998, p. 28.
9 OJ L 311, 20.11.1998, p. 23.
10 OJ L 216, 8.8.1997, p. 95.

6

(20) Whereas the Commission has, by Decision 98/272/EC12, laid down measures

to be applied in cases of animals suspected of having a TSE;

(21) Whereas the Standing Veterinary Committee has not given a favourable

opinion,

HAS ADOPTED THIS DECISION:

Article 1

1.

2.

3.

This Decision applies to the processing of high-risk and low-risk mammalian
animal waste within the scope of Directive 90/667/EEC,
including
mammalian by-products not intended for human consumption derived from
the production of products intended for human consumption.

Member States shall ensure that all waste to which this Decision applies is
processed in accordance with the requirements laid down in Annex I.

Paragraph 2 shall not apply to the processing of the following:

(a)

(b)

low-risk material within the meaning of Directive 90/667/EEC for the
production of petfood;

animal waste referred to in Article 7(ii) of Directive 90/667/EEC for
the feeding of zoo, circus or fur animals, recognised packs of hounds
and maggot farming for fishing bait;

(c)

degreased bones for the production of gelatine;

(d)

hides and skins for the production of gelatine, collagen and hydrolysed
proteins, hooves, horns, hair;

(e)

glands, tissues and organs for pharmaceutical use;

(f)

blood and blood products;

(g) milk and milk products;

(h)

(i)

(j)

non-ruminant waste for the production of rendered fats, excluding
greaves derived from such production;

low-risk ruminant waste for the production of rendered fats excluding
greaves derived from such production;

animal waste for the production of products for which it can be assured
that they will not enter any human food or animal feed chain and will
not be used as fertilisers;

11 OJ L 358,31.12.1998, p. 113.
12 OJ L 122, 24.4.1998, p. 59.

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and, until 1 July 2000,

(k)

high-risk ruminant waste for the production of rendered fats, excluding
greaves derived from such production;

(l)

bones fit for human consumption.

Member States which already impose requirements for the processing of
waste to which this Decision applies which are more stringent than those
provided for in Annex I may maintain their existing requirements.

Article 2

Member States shall ensure that all rendered fats derived from ruminant
waste are purified in such a way that the maximum levels of remaining total
insoluble impurities does not exceed 0.15% in weight.

Article 1(2) and paragraph 1 of this Article shall not apply to the production
of rendered fats derived from ruminant waste if they are to be processed by a
method which at least meets the standards of one of the processes described
in Annex II or it can be assured that they will not enter any human food or
animal feed chain.

4.

1.

2.

Article 3

By way of derogation from Article 1(2) and Article 2, Member States may authorise:

(a)

(b)

the processing of waste to which this Decision applies by a method which
does not meet the requirements set out in Annex I if such processing is
followed by a process which meets those requirements or if the resulting
proteinaceous material is destroyed by burial, incineration, burning as fuel or
a similar method which ensures safe disposal;

the production of rendered animal fat derived from high-risk ruminant waste
by a method which does not meet the requirements set out in Annex I or the
standards set out in Annex II, if such processing is followed by a process
which meets those requirements or standards, or if the resulting rendered fat
is destroyed by burial, incineration, burning as fuel or a similar method
which ensures safe disposal.

Member States which authorise a method provided for in the first paragraph shall put
in place a system of control to ensure that waste to which this Decision applies which
has not been processed in accordance with the requirements set out in Annex I or the
standards set out in Annex II cannot enter the animal feed chain and is not used as
fertiliser.

8

Article 4

1.

2.

Member States shall ensure that establishments, which are approved in
accordance with Directive 90/667/EEC and process waste referred to in
Article 1(2), other than those establishments which process waste pursuant to
Article 1(3) and Article 3(a), operate in accordance with the requirements set
out in Annex I and are validated according to the procedures laid down in
Annex III.

Member States
those
establishments at regular intervals. Records of the temperature, pressure and
particle size for the approved establishments must be maintained.

shall carry out checks on the operation of

In accordance with Article 11 of Directive 90/667/EEC, Member States shall
ensure that the list of approved establishments processing animal waste
indicates the establishments which operate in accordance with the conditions
laid down in this Decision.

Article 5

In Annex II to Decision 97/735/EC, the words "defined by the Scientific Veterinary
Committee" are replaced by "laid down in Annex III to Decision 1999/.../EC".

1.

2.

Article 6

Decision 96/449/EC is repealed.

References to the repealed Decision shall be construed as references to this
Decision. In particular, references to Article 1(2) of the repealed Decision
shall be construed as references to Article 1(3) of this Decision and
references to the Annex to the repealed Decision shall be construed as
references to Annex I to this Decision.

Article 7

This Decision shall apply from 1 July 1999.

However, Article 2(1) shall apply from 1 July 2000.

Article 8

This Decision is addressed to the Member States.

Done at Brussels,

For the Council
The President

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ANNEX I

PROCESSING REQUIREMENTS REFERRED TO IN ARTICLE 1(2)

Minimum requirements for the processing of mammalian animal waste:

Maximum particle size

Temperature

50 mm

>133°C

Time
Pressure (Absolute) produced by saturated steam13 ≥

3 bar

20 minutes without interruption

Processing may be carried out in a batch or a continuous system.

13 ‘saturated steam’ means that all air is evacuated and replaced by steam in the whole sterilisation

chamber.

10

ANNEX II

STANDARDS REFERRED TO IN ARTICLE 2(2)

1.

2.

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

saponification with NaOH 12M (glycerol and soap):

–

or

–

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

in a continuous process: at 140°C, 2 bars (2000 hPa) for eight minutes
or equivalent conditions

11

ANNEX III

VALIDATION PROCEDURES FOR PLANTS PROCESSING
MAMMALIAN ANIMAL WASTE

Validation procedures shall take into accounts at least the following indicators:

1.

2.

3.

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

Identification of Critical Control Points (CCPs)
process rate for continuous system:

including the material

Compliance with the following process requirements:

(a) Maximum particle size

50 mm maximum

(b) Temperature

> 133°C

(c)

Time

at least 20 minutes without interruption

(d)

Pressure (Absolute) produced by saturated steam at least 3 bar

4.

Achievement of the requirements laid down in Annex I

(a)

Particle size for batch-pressure and continuous processes:

the particle size is defined by the mincer hole or the anvil gap size

(b) 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.

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

12

(II)

continuous pressure system:

–

–

The temperature and the pressure must be monitored with
thermocouples, or an infrared temperature gun, and
pressure gauges used at defined positions throughout the
process system in such a way that temperature and pressure
comply with the conditions set out in Annex I inside the
it. The
whole continuous system or
temperature and pressure must be plotted against real time,

in a section of

the

continuous

system where

Measurement of the minimum transit time inside the whole
the
relevant part of
temperature and pressure comply with the conditions set
out in the Annex I, must be provided to the 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 must be measured during the validation
test in relation to a CCP that can be continuously monitored
such as:

–

–

–

–

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
calibrated 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. modification of the machinery, change of raw
materials etc.).

13