1999/534/EC: Council Decision 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
Date: 1999-07-19
Institutions: Council of the European Union
Subjects: agricultural waste, animal protein, exchange of information, intra-EU trade, waste recycling

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Official Journal of the European Communities

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II

(Acts whose publication is not obligatory)

COUNCIL

COUNCIL DECISION

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

(1999/534/EC)

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 market (1), and in
particular Article 10(4) thereof,

Having regard to the proposal of the Commission,

Whereas:

(1)

(2)

(3)

Council Directive 90/667/EEC (2), lays down the veter-
inary rules for the disposal and processing of animal
waste, for its placing on the market and for the preven-
tion of pathogens in feedstuffs of animal or fish origin;

Commission Decision 92/562/EEC (3), defined alternative
systems of heat treatment as provided for in paragraph
6(c) of Chapter II of Annex II to Directive 90/667/EEC;

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 neces-
sary for inactivation of the BSE agent; it also identified
certain processes which were not effective;

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

92/118/EEC (OJ L 62, 15.3.1993, p.49).

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

(3) OJ L 359, 9.12.1992, p. 23. Directive as last amended by the 1994

Act of Accession.

Act of Accession.

(4)

(5)

(6)

(7)

The result 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;

It is therefore necessary to ensure that systems which
have been shown to be ineffective are not used for the
processing of mammalian animal waste in order to
protect animals from the hazard of spongiform ence-
phalopathy agents in animal feed, unless an effective
sterilisation phase is added to the process;

At its meeting from 1 to 3 April 1996, the Council
concluded that a Commission Decision should be
the Standing Veterinary Committee
adopted under
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; the only such method at present is the
application of heat in a rendering system which achieves
a minimum 133 (cid:176)C at 3 bar for a minimum period of
20 minutes; that method may be applied as the sole
process or as a pre- or post-process sterilisation phase;

The Scientific Steering Committee adopted an opinion
on the safety of meat-and-bone meal from mammalian
animals, naturally or experimentally susceptible to trans-
missible spongiform encephalopathies (TSEs) on 26 and
27 March 1998; that opinion has been updated 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;

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(8)

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)

Specific rules should be laid down on controls on estab-
lishments;

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

(11)

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 agents (1) 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;
recent Community inspections have revealed that there
are problems of implementation of that Decision due to
interpretation;
difficulties of legal

(12)

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

(13) 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; 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, veter-
inary administrations
should be able to authorise,
without restriction, its import and transit through their
territories, regardless of the status of the exporting coun-
tries; Article 3.12.13.16 of
that Code recommends
sourcing and processing conditions which are to be
complied with before tallow (other than protein-free

(1) OJ L 184, 24.7.1996, p. 43.

tallow) and tallow derivatives (other than protein-free
tallow derivatives) can be traded;

(14)

this Decision;

Special uses of animal waste may be exempted from the
requirements of
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) A fundamental reworking of Decision 96/449/EC there-
fore appears necessary; in the interests of clarity, that
Decision should be replaced;

(16)

(17)

(18)

(19)

(20)

Commission Decision 97/735/EC of 21 October 1997
concerning certain protection measures with regard to
trade in certain types of mammalian animal waste (2)
should be amended to take account of the provisions of
this Decision;

This Decision should apply without prejudice to Council
Decision 98/256/EC (3),
and Commission Decision
98/653/EC (4), which lay down specific conditions for
the production of amino acids, peptides,
tallow and
products derived from tallow in the United Kingdom
and Portugal;

This Decision should be without prejudice to the adop-
tion of rules for the organisation of the prevention and
control of TSEs;

The Commission has, by Decision 97/534/EC (5),
prohibited the use of material presenting risks as regards
TSEs;

The Commission has, by Decision 98/272/EC (6),
laid
down measures to be applied in cases of animals
suspected of having a TSE;

(21)

The Standing Veterinary Committee has not given a
favourable opinion,

HAS ADOPTED THIS DECISION:

Article 1

1.
This Decision shall apply to the processing of low-risk
and high-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.

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

Paragraph 2 shall not apply to the processing of the

3.
following:

(a) low-risk material within the meaning of Directive

90/667/EEC for the production of petfood;

(2) OJ L 294, 28.10.1997, p. 7.
(3) OJ L 113, 15.4.1998, p.32. Decision as last amended by Decision

98/692/EC (OJ L 328, 4.12.1998, p. 28).

(4) OJ L 311, 20.11.1998, p. 23.
(5) OJ L 216, 8.8.1997, p. 95. Decision as last amended by Decision

98/745/EC (OJ L 358, 31.12.1998, p. 113).

(6) OJ L 122, 24.4.1998, p. 59.

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(b) 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) non-ruminant waste for the production of rendered fats,

excluding greaves derived from such production;

(i) low-risk ruminant waste for the production of rendered fats

excluding greaves derived from such production;

(j) 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;

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.

material is destroyed by burial, incineration, burning as fuel
or a similar method which ensures safe disposal;

the requirements set out

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

the resulting rendered fat

Member States which authorise a method provided for in the
first subparagraph 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.

Article 4

1. 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 proced-
ures laid down in Annex III.

4. 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.

Member States shall carry out checks on the operation of those
establishments at regular intervals. Records of the temperature,
pressure and particle size for the establishments must be main-
tained.

Article 2

1. 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.

2.
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.

2.
In accordance with Article 11 of Directive 90/667/EEC,
Member States shall ensure that the list of approved establish-
ments 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' shall be replaced by ‘laid down
in Annex III to Decision 1999/534/EC'.

Article 3

1.

Decision 96/449/EC shall be repealed.

Article 6

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

(a) 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

References to Decision 96/449/EC shall be construed as
2.
references to this Decision. In particular, references to Article
1(2) of the said Decision shall be construed as references to
Article 1(3) of this Decision and references to the Annex to
Decision 96/449/EC shall be construed as references to Annex
I to this Decision.

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This Decision shall apply from 1 July 1999.

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

Article 7

This Decision is addressed to the Member States.

Article 8

Done at Brussels, 19 July 1999.

For the Council

The President

K. HEMIL(cid:142)

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ANNEX I

REQUIREMENTS REFERRED TO IN ARTICLE 1(2)

Minimum requirements for the processing of mammalian animal waste:

(a) Maximum particle size
(b) Temperature
(c) Time
Pressure (absolute) produced by saturated steam (1)

50 mm
; 133 (cid:176)C
20 minutes without interruption
A3 bar

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

ANNEX II

STANDARDS REFERRED TO IN ARTICLE 2 (2)

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

fatty acids and esters);

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

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

— in a continuous process: at 140 (cid:176)C, 2 bars (2 000 hPa) for eight minutes or equivalent conditions.

(1) ‘Saturated steam' means that all air is evacuated and replaced by steam in the whole sterilisation chamber.

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ANNEX III

VALIDATION PROCEDURES FOR PLANTS PROCESSING MAMMALIAN ANIMAL WASTE

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

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

2. Identification of critical control points (CCPs) including the material process rate for continuous system:

3. Compliance with the following process requirements:

(a) Maximum particle size
(b) Temperature
(c) Time
(d) Pressure (absolute) produced by saturated steam

4. Achievement of the requirements laid down in Annex I

50 mm maximum
; 133 (cid:176)C
at least 20 minutes without interruption
at least 3 bar

(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.

(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 whole continuous
system or in a section of it; the temperature and pressure must be plotted against real time,

— measurement of the minimum transit time inside the whole relevant part of the continuous system where
the 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 equiva-
lent 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 must 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.).