98/653/EC: Commission Decision of 18 November 1998 concerning emergency measures made necessary by the occurrence of bovine spongiform encephalopathy in Portugal (notified under document number C(1998) 3544) (Text with EEA relevance)
Date: 1998-11-18
Institutions: European Commission
Subjects: Portugal, animal disease, animal product, cattle, veterinary inspection, veterinary legislation

20. 11. 98

EN

Official Journal of the European Communities

L 311/23

COMMISSION DECISION

of 18 November 1998

concerning emergency measures made necessary by the occurrence of bovine
spongiform encephalopathy in Portugal

(notified under document number C(1998) 3544)

(Text with EEA relevance)

(98/653/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

indicates potential recycling and accumulation of
the BSE agent in the Portuguese cattle population;

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), as last amended by Directive 92/
118/EEC (2), and in particular Article 10(4) thereof,

Having regard to Council Directive 89/662/EEC of 11
December 1989 concerning veterinary checks in intra-
Community trade with a view to the completion of the
internal market (3), as last amended by Directive 92/
118/EEC, and in particular Article 9(4) thereof,

(1) Whereas several distinct transmissible spongiform
encephalopathies (TSEs) have been recognised for
many years as occurring separately in humans and
animals; whereas bovine spongiform encephalo-
pathy (BSE) was first recognised in cattle in 1986
and in following years was recognised as occurring
in other species of animals; whereas a new variant
of Creutzfeldt-Jakob Disease
(nv-CJD) was
described in 1996; whereas evidence is accumu-
lating that the agent causing BSE is identical to
that causing nv-CJD;

(2) Whereas 66 cases of BSE have been notified in
Portugal between 1 January 1998 and 14 October
1998; whereas this leads to a BSE incidence rate
calculated over the past 12 months of 105,6 cases
per million animals over two years of age; whereas
two cases have been identified in animals born
after implementation of the prohibition on feeding
mammalian derived protein to ruminants; whereas
the development of the incidence of the disease

(1) OJ L 224, 18. 8. 1990, p. 29.
(2) OJ L 62, 15. 3. 1993, p. 49.
(3) OJ L 395, 30. 12. 1989, p. 13.

(3) Whereas missions on BSE-related issues have been
carried out in Portugal by the Commission Office
for Veterinary and Phytosanitary Inspection and
Control from 7 to 12 July 1996 and by the Food
and Veterinary Office of the Commission from 15
to 21 June 1997 and from 11 to 15 May 1998;
whereas those missions contributed to the assess-
ment of the application and effectiveness of meas-
ures to protect against BSE; whereas those missions
concluded that, despite important improvements,
not all
risk factors were adequately managed;
whereas a follow-up mission was conducted by the
food and Veterinary Office from 28 September to 2
October 1998; whereas that mission confirmed
most of the findings of the previous missions and
observed, despite an overall improvement, certain
continued shortcomings in the enforcement of the
measures to control the risk factors; whereas the
sharp increase in the incidence of BSE, in partic-
ular since June 1998, raises serious concerns with
regard to the development of the disease in the
near future; whereas on the basis of that mission it
is concluded that due to deficiencies existing until
very recently in the implementation of Community
legislation on identification and registration of
animals, and of measures on TSE surveillance and
BSE eradication, no adequate guarantees can be
provided regarding the BSE history of the herds of
origin and herds through which bovine animals
pass and regarding the dams of bovine animals;

(4) Whereas the Scientific Steering Committee (SSC)
adopted an opinion on BSE risk on 27 March 1998;
whereas in that opinion the SSC recognised three
major issues in considering the risk of BSE: first,
the risk of human exposure arising from the direct
consumption of potentially infective material,
secondly, the risk to man from ingesting or being
exposed to processed, potentially infective material,

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Official Journal of the European Communities

20. 11. 98

and, thirdly, the risk of propagating the infection
by recycling the infective material through animal
feed; whereas the Code Commission of the Inter-
national Office of Epizootics (OIE) also proposes
the risk to human and
that
animal health in countries, or regions within coun-
tries, be based on a combination of the spread of
BSE and the application of measures to control the
risk;

the assessment of

it

(5) Whereas, in those circumstances and as an emer-
gency measure,
appropriate to prohibit
is
temporarily the dispatch from Portugal to the other
Member States of all bovine animals and of all
products obtained from, or incorporating materials
derived from, bovine animals which are liable to
enter the human food or animal feed chains or are
destined for use in cosmetic or medicinal products
or medical devices; whereas in order to prevent
deflections of trade, the same prohibitions should
also apply to exports to third countries; whereas it
is necessary to prohibit temporarily the dispatch
from Portugal of mammalian meat-and-bone meal
and
containing
and
mammalian meat-and-bone meal, which by their
nature could enter the animal feed chain;

fertilisers

animal

feed

(6) Whereas the level of risk of propagating or intro-
ducing the disease from live cattle to unaffected
animal populations is considered to be consider-
able; whereas additional measures proposed by
Portugal to address the risk of exposing humans
and animals to infected material are considered to
be adequate; whereas account should be taken of
the effective implementation and assessment of
effective enforcement of those measures; whereas,
therefore, the prohibition on the dispatch of bovine
products can be limited in time, provided that a
risk assessment conducted on the basis of the find-
ings of a mission of
the Food and Veterinary
Office, taking into account the evolution of the
disease, demonstrates that appropriate measures
have been taken to manage any risk, and that the
relevant Community and national measures are
complied with and effectively enforced; whereas
the period foreseen for the prohibition on the
export of meat and certain other products could be

reduced in the event of a favourable outcome of
such risk assessment;

(7) Whereas Council Regulation (EC) No 820/97 of 21
April 1997 establishing a system for the identifica-
tion and registration of bovine animals
and
regarding the labelling of beef and beef products (1)
provides for a system enabling animals to be traced
back to the dam and herd of origin; whereas such a
system is a prerequisite for effective eradication of
BSE and it is necessary for Portugal to ensure that
those Community
effectively
complied with;

provisions

are

(8) Whereas Commission Decision 98/272/EC of 23
trans-
April 1998 on epidemio-surveillance for
and
spongiform encephalopathies
missible
amending Decision 94/474/EC (2) provides for an
on-going education programme
to encourage
reporting of TSEs,
the compulsory notification,
movement restriction, possible killing, examination
and destruction of suspect animals, the conducting
of a sampling and monitoring programme and the
annual
reporting to the Commission and the
Member States of the results of this programme
and in particular of the information concerning the
number and outcome of clinical and epidemiolog-
ical investigations of suspect animals; whereas it is
justified, in view of the seriousness of the situation,
to require Portugal to increase the frequency of
reporting to the Commission and the Member
States to once every four weeks;

(9) Whereas Commission Decision 96/381/EC of 20
June 1996 approving the measures to be imple-
mented as regards bovine spongiform encephalo-
pathy in Portugal (3) refers to the principle, laid
down in point 6 of the conclusions of the Council
meeting of 1 to 3 April 1996, that a programme to
control BSE and reduce the number of future cases
should concentrate on removal of animals, or as
appropriate herds, most
likely to have been
exposed to infected meat-and-bone meal; whereas
the main principles of the plan are:

(a) compulsory slaughter of animals identified as
imported from the United Kingdom,
all
animals in herds where cases of BSE have
occurred and all animals in other herds identi-
fied as belonging to the same birth cohort as
affected animals;

(b) and improved system of health monitoring of
holdings with bovine animals and intensified
surveillance of the feed manufacturing industry
to prevent the possible use of meat-and-bone
meal;

(1) OJ L 117, 7. 5. 1997, p. 1.
(2) OJ L 122, 24. 4. 1998, p. 59.
(3) OJ L 149, 22. 6. 1996, p. 25.

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whereas the Commission accepted under circum-
stances particular
and to restore
to Portugal
consumer confidence that a whole herd slaughter
policy be adopted in Portugal; whereas the plan
approved by Decision 96/381/EC provides for the
slaughter of all animals belonging to the same birth
cohort as affected animals; whereas,
therefore,
Portugal must identify all animals belonging to the
same birth cohort
the
affected animals were born or reared in the same
herd as that to which they belonged at the moment
of confirmation of BSE or in another herd;

regardless of whether

(10) Whereas the provisions of Council Directive 82/
894/EEC of 21 December 1982 on the notification
of animal diseases within the Community (1), as last
amended by Commission Decision 98/12/EC (2),
require each Member State to notify directly to the
Commission, at least on the first working day of
each week,
the secondary outbreaks of BSE
confirmed in its territory;

(11) Whereas, in order to protect animal and human
health in the Community,
the Commission
adopted Decision 94/381/EC of 27 June 1994
concerning certain protection measures with regard
to bovine spongiform encephalopathy and the
as
feeding of mammalian derived protein (3),
amended by Decision 95/60/EC (4), which prohib-
ited the feeding of mammalian protein to rumi-
nants throughout the Community, Decision 96/
449/EC of 18 July 1996 on the approval of altern-
ative heat treatment systems for processing animal
waste with a view to the inactivation of spongiform
encephalopathy agents (5), which lays down the best
available method for processing animal waste as
regards spongiform encephalopathy agents, and
Decision
1997
concerning certain protection measures with regard
to trade in certain types of mammalian animal
waste (6);

97/735/EC of

21 October

to

prohibit

(12) Whereas Portugal has taken measures as notified to
the Commission on 12 October 1998, including
measures
of
meat-and-bone meal in any animal feed and to
require the destruction of meat-and-bone meal;
whereas subsequently commitments were given to
recall and destroy any stocks of meat-and-bone
meal, and of animal feed that contains meat-and-

incorporation

the

(1) OJ L 378, 31. 12. 1982, p. 58.
(2) OJ L 4, 8. 1. 1998, p. 63.
(3) OJ L 172, 7. 7. 1994, p. 23.
(4) OJ L 55, 11. 3. 1995, p. 43.
(5) OJ L 184, 24. 7. 1996, p. 43.
(6) OJ L 294, 28. 10. 1997, p. 7.

in animal waste processing
bone meal, present
establishments, feedingstuff producing plants, agri-
cultural establishments or any other place; whereas
those measures are considered to reduce the risk of
propagating the disease through animal feed;

(13) Whereas Portugal has taken measures to destroy
certain risk materials as notified to the Commis-
sion on 12 October 1998, including the bovine,
ovine, and caprine tissues defined as specified risk
materials in Commission Decision 97/534/EC of
30 July 1997 on the prohibition of the use of
material presenting risks as regards transmissible
spongiform encephalopathies (7), as last amended
by Council Decision 98/248/EC (8); whereas those
measures are considered to reduce the risk of
exposing humans or animals directly or indirectly
to the BSE agent present in risk materials;

(14) Whereas, in those circumstances and as an emer-
gency measure, it is appropriate to require Portugal
to implement programmes to demonstrate effective
compliance with all relevant Community legisla-
tion, this Decision and relevant national legislation,
and to report in detail to the Commission every
four weeks on the outcome of those programmes;

(15) Whereas strict conditions should apply to deroga-
tions from the prohibition for certain products and
for products derived from bovine animals slaugh-
tered outside Portugal;

(16) Whereas, in view of the epidemiological situation
live cattle to the auto-
and the movements of
nomous region of the Azores, this Decision should
not apply to that region;

(17) Whereas, with a view to giving financial support to
the efforts made by Portugal, the Commission will,
as soon as possible, propose appropriate measures;

(18) Whereas the Commission should continue to carry
out Community inspections in Portugal to verify
the application of the measures provided for in this
Decision;

(19) Whereas, pending an overall examination of the
situation, this Decision should be reviewed in the
light of new scientific information;

(20) Whereas

in this
the measures provided for
Decision are in accordance with the opinion of the
Standing Veterinary Committee,

(7) OJ L 216, 8. 8. 1997, p. 95.
(8) OJ L 102, 2. 4. 1998, p. 26.

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Official Journal of the European Communities

20. 11. 98

HAS ADOPTED THIS DECISION:

Member States or to third countries, when derived from
bovine animals slaughtered in Portugal:

CHAPTER I

SCOPE

Article 1

1. Notwithstanding Community provisions adopted to
protect against bovine spongiform encephalopathy (BSE),
this Decision lays down emergency measures made neces-
sary by the occurrence of BSE in Portugal.

The provisions of this Decision shall not apply to

2.
the autonomous region of the Azores.

the provisions of
However, Portugal shall ensure that
Articles 2 to 12 are applied to the dispatch of consign-
ments from the other parts of Portugal to the Azores.

CHAPTER II

LIVE BOVINE ANIMALS, BOVINE
EMBRYOS,
MEAT-AND-BONE MEAL AND RELATED PRODUCTS

Article 2

shall

following are not
that
Portugal
dispatched from its territory to other Member States or to
third countries:

ensure

the

(a)

live bovine animals and bovine embryos;

(b) meat meal, bone meal, and meat-and-bone meal of

mammalian origin;

(c) animal feed and fertilisers containing material referred

to in (b).

Article 3

By way of derogation from Article 2, food destined for
domestic carnivores containing material referred to in
Article 2(b) may be dispatched to other Member States or
to third countries provided that those materials did not
originate from Portugal and that the conditions laid down
in Articles 8 and 9 are complied with.

CHAPTER III

(a) meat;

(b) products which are liable to enter the human food or

animal feed chains;

(c) materials which are destined for use in cosmetic or

medicinal products or medical devices.

Article 5

1.
By way of derogation from Article 4, Portugal may
authorise the production and the dispatch from its ter-
ritory to other Member States or to third countries of:

(a) amino acids, peptides and tallow, which have been
produced in establishments under official veterinary
supervision which have been shown to be operating in
accordance with the conditions set out in the Annex;

(b) tallow products and products derived from tallow by
saponification, transesterification or hydrolysis, where
these are manufactured from tallow produced in
accordance with this Article;

(c) samples, dispatched from the national veterinary la-
boratories in Lisbon and Porto to officially approved
institutes, obtained from bovine animals slaughtered
in Portugal and which are destined for use for the
purpose of laboratory examination or research into
BSE and BSE diagnostic tests.

2.
Portugal shall ensure that the products referred to in
paragraph 1(a) and (b) are labelled or otherwise identified
to show the establishment of production and to indicate
that they are suitable for use in human food, animal feed,
cosmetics, medicinal products or medical devices.

3.
Portugal shall ensure that products referred to in
paragraph 1(a) which are dispatched to other Member
States in accordance with this Article are accompanied by
a health certificate issued by an official veterinarian
stating that they conform to the conditions laid down in
this Decision and attesting to the frequency of official
controls carried out.

MATERIALS DERIVED FROM BOVINE ANIMALS
SLAUGHTERED IN PORTUGAL

Article 4

Portugal shall ensure that until 1 August 1999 the
following are not dispatched from its territory to other

4.
Before an establishment may commence or recom-
mence the dispatch of products pursuant to this Article,
Portugal shall forward to the Commission and the other
Member States the list of the establishments referred to in
the
paragraph 1(a),
purpose for which it has been approved. It shall notify the
Commission and the other Member States immediately of
any amendments to that list.

identifying for each establishment

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Article 6

tallow,

Portugal shall ensure that gelatin, di-calcium phosphate,
tallow products and products derived
collagen,
transesterification or
from tallow by saponification,
hydrolysis which are produced for technical use from raw
materials derived from bovine animals slaughtered in
Portugal are labelled or otherwise identified to show the
establishment of production and their unsuitability for
use in human food, animal feed, cosmetics, medicinal
products or medical devices.

CHAPTER IV

MATERIALS DERIVED FROM BOVINE ANIMALS NOT
SLAUGHTERED IN PORTUGAL

Article 7

Portugal shall ensure that the provisions of Articles 8 to
12 are complied with when the following products
derived from bovine animals not slaughtered in Portugal
are dispatched from its territory to other Member States or
to third countries:

(a)

(b)

(c)

‘fresh meat' as defined by Council Directive 64/
433/EEC (1);

‘minced meat' and ‘meat preparations' as defined by
Council Directive 94/65/EC (2);

‘meat products' and ‘other products of animal origin'
as defined by Council Directive 77/99/EEC (3);

(d) food which is destined for domestic carnivores;

(e) gelatin and di-calcium phosphate, tallow, tallow prod-
ucts, and products derived from tallow by saponifica-
tion,
transesterification or hydrolysis, amino acids,
peptides and collagen which are liable to enter the
human food or animal feed chains, or are destined for
use in cosmetic or medicinal products or medical
devices.

Article 8

1.
The products referred to in Article 7 shall come from
and, as appropriate, have passed through, establishments
in Portugal:

(a) which have been approved by

the

competent

authority;

(b) which are under official veterinary supervision or, in
the case of products derived from tallow by saponifi-
cation,
the
supervision of the competent authority;

transesterification or hydrolysis, under

(c) which have put in place a system of tracing of the raw
material which will guarantee the origin of
the
material throughout the whole production chain;

(d) which have put

in place a registration system of
amounts of incoming and outgoing materials to allow
for cross-checking consignments entering or leaving;

(e)

in which the products are unloaded, processed, stored,
handled, loaded and transported separately from, or at
different times from, products which do not comply
with the conditions laid down in this Article and
Articles 9, 10 and 11.

2.
Portugal shall forward to the Commission and the
other Member States the list of establishments which
meet the conditions referred to in paragraph 1, identi-
fying for each establishment the purpose for which it has
been approved. It shall notify the Commission and the
Member States immediately of any amendments to that
list.

Article 9

1.
Products referred to in Article 7(a) to (d) shall come
from and, as appropriate, have passed through establish-
ments in Portugal:

(a)

in which all unloading, processing, storage or other
handling and loading of products takes place under
official supervision;

(b) in which the products are stored in cold stores in
chambers which are not used at the same time for
storing any bovine products which do not comply
with the conditions laid down in this Article and in
Articles 8, 10, 11 and 12 and are kept locked under
the seal of the competent authority when the latter is
not present;

(c)

in which the products are marked or labelled with an
additional distinct mark which cannot be confused
with the Community health mark;

(d) in which the products eligible for dispatch from
Portugal under this Article and Articles 8, 10, 11 and
12, but destined for placing on the market in Portugal
do not bear the additional mark referred to in point
(c). Where such a mark is present, it shall be cancelled
or removed from the meat or cancelled from the label
at the time that meat or those products leave the
establishment.

(1) OJ 121, 29. 7. 1964, p. 2012/64.
(2) OJ L 368, 31. 12. 1994, p. 10.
(3) OJ L 26, 31. 1. 1977, p. 85.

Portugal shall forward to the Commission and the other
Member States the model of the additional mark.

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For the purposes of the health marking and applica-
2.
tion of additional marks provided for in Community
legislation, the competent authority shall keep and main-
tain under its responsibility:

indicate that they have been produced in accordance with
this Decision and, as appropriate, that they are suitable for
use in human food, animal feed, cosmetics, medicinal
products or medical devices.

(a)

the instruments intended for meat health marking
and application of additional marks, which may be
handed over to auxiliaries only at the time of marking
and for the length of time required for that purpose;

(b) any labels bearing a health mark or an additional
mark. Those labels shall be serially numbered and the
requisite quantity may be given to auxiliaries at the
time when they are to be used.

3.
The products referred to in paragraph 1 shall be
transported in means of transport that are sealed by the
competent authority.

When those products are dispatched to other Member
States, they shall be accompanied by a health certificate
issued by an official veterinarian stating that the condi-
tions referred to in this Article and Articles 8, 10, 11 and
12 are met, identifying all establishments where they were
obtained, processed, handled or stored and identifying all
labels and their serial numbers in the consignment.

Meat shall be accompanied by the health certificate
referred to in Annex IV to Directive 64/433/EEC identi-
fying in the ‘Identification of meat' section of the certi-
ficate all labels and their serial numbers in the consign-
ment.

The following words shall be added to all certificates:

‘produced in accordance with Commission Decision
98/653/EC'.

4.
Portugal shall inform the competent authority of the
place of destination of each consignment by means of the
ANIMO system as referred to in Commission Decision
91/398/EEC (1), or by fax.

Article 12

1. A Member State which dispatches meat as referred to
in Article 7(a)
from an establishment or Community
approved border inspection post in its territory through
the territory of Portugal or to an establishment approved
in accordance with Article 8 shall ensure that the meat is
accompanied by a veterinary certificate issued by an offi-
cial veterinarian or the certificate issued by the competent
authority of the border inspection post.

The originals of all certificates shall accompany the
consignment to the establishment of its destination.

The meat as referred to in Article 7(a) shall be trans-

2.
ported in an officially sealed vehicle.

The seal may be broken only for official
purposes.

inspection

3. A Member State which dispatches products referred
to in Article 7(e) or any raw materials for use in the
production of
to an establishment
approved in accordance with Article 8 shall ensure that
they are labelled or otherwise identified to show the
establishment and Member State in which they were
produced.

those products

CHAPTER V

MONITORING, REPORTS AND INSPECTIONS

Article 10

Article 13

Without prejudice to Article 9(1)(d), where products
referred to in Article 7(a) come from and, as appropriate,
the
have passed through establishments in Portugal,
health marks shall not be removed except where that is
unavoidable in the cutting process.

Article 11

The products
referred to in Article 7(e) which are
dispatched to other Member States shall be labelled in
order to identify the establishment of production and to

(1) OJ L 221, 9. 8. 1991, p. 30.

1.
Portugal shall complete the efforts undertaken, and
implement a programme to demonstrate effective compli-
ance with all relevant Community legislation on identi-
fication and registration of animals, the notification of
animal diseases, epidemio-surveillance for transmissible
spongiform encephalopathy (TSE) and with all other
Community legislation to protect against BSE.

Portugal shall adopt a programme to demonstrate

2.
effective compliance with:

(a)

the provisions of this Decision;

(b) the relevant national measures to protect against BSE,
in particular those on the eradication of BSE.

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The programmes referred to in paragraphs 1 and 2
3.
shall include a permanent monitoring of the application
of the provisions and where appropriate physical exam-
ination by
the products
an approved method of
concerned.

Article 14

Portugal shall send the Commission every four weeks a
report on the application of the protective measures taken
against TSEs in accordance with Community and national
provisions and on the results of the programmes referred
to in Article 13.

enforcement of the relevant measures, and in the light of
new scientific information.

2. At the request of Portugal, this Decision shall be
amended to take account of different control systems that
provide equivalent guarantees to the measures provided
for in Articles 5 to 12.

3.
This Decision shall be amended, where appropriate,
after consultation of the appropriate scientific committee,
in accordance with the procedure laid down in Article 17
of Directive 89/662/EEC.

Article 15

The Commission shall carry out Community inspections
on-the-spot in Portugal to:
(a) verify the application of

this
Decision, in particular in relation to the implementa-
tion of official controls;

the provisions of

Article 17

Member States shall adopt
comply with this Decision. They shall
inform the Commission thereof.

the necessary measures to
immediately

(b) to examine the development of the incidence of the
disease,
the relevant
the effective enforcement of
national measures and to conduct a risk assessment
demonstrating whether
to
manage any risk have been taken.

appropriate measures

Article 18

This Decision is addressed to the Member States.

CHAPTER VI

FINAL PROVISIONS

Article 16

Done at Brussels, 18 November 1998.

This Decision shall be reviewed within 18 months
1.
after its adoption at the latest, pending an overall exam-
ination of the situation, in particular in view of the devel-
opment of the incidence of the disease and the effective

For the Commission

Franz FISCHLER

Member of the Commission

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20. 11. 98

ANNEX

CHAPTER 1

1. The following products may be exported from Portugal in application of the provisions of Article 5:

(a) amino acids and peptides produced from hides and skins by a process which involves exposure of the
material to a pH of 1 to 2, followed by a ph of ;11, followed by heat treatment of 140 (cid:190)C for 30
minutes at 3 bar;

(b) tallow and tallow products produced from material from animals fit for human consumption which

have been subjected to one of the processes described in Chapter 2;

(c) products derived from tallow by one of the processes described in Chapter 3.

2. Products referred to in point 1 must be filtered after production.

3. Bovine animals which are showing signs of BSE may not be used as source material for production of the

products referred to in point 1.

4. The following tissues may not be used for production of products referred to in point 1: skull, vertebral

column, brain, spinal cord, eye, tonsil, thymus, intestine or spleen.

CHAPTER 2

A. Production standards for tallow produced in Portugal from material derived from bovine
animals slaughtered in Portugal

1. Tallow may be produced only in systems described in Chapters I to IV, VI and VII of the Annex to
Commission Decision 92/562/EEC (1), in which the following minimum conditions are achieved:

CHAPTER I

(batch/atmospheric/natural fat) 150 mm particle size maximum

Temperature

;100 (cid:190)C ;110 (cid:190)C ;120 (cid:190)C

Time

125 min.

120 min.

50 min.

CHAPTER II

(batch/pressure/natural fat) 50 mm particle size maximum

Temperature

;100 (cid:190)C ;133 (cid:190)C

Time

25 min.

20 min.

Pressure (absolute)

3 bar

CHAPTER III

(continuous/atmospheric/natural fat) 30 mm particle size maximum

Temperature

;100 (cid:190)C ;110 (cid:190)C ;120 (cid:190)C

Time

95 min.

55 min.

13 min.

CHAPTERS IV and VI

(continuous/atmospheric/added fat and continuous/pressure/added fat) 30 mm
particle size maximum

Temperature

;100 (cid:190)C ;110 (cid:190)C ;120 (cid:190)C ;130 (cid:190)C

Time

16 min.

13 min.

8 min.

3 min.

(1) OJ L 359, 9. 12. 1992, p. 23.

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CHAPTER VII

(continuous/atmospheric/defatted) 20 mm particle size maximum

Temperature

;80 (cid:190)C ;100 (cid:190)C

Time

120 min.

60 min.

The above temperature/time requirements may run concurrently.

2. Portugal may authorize plants only if they have been shown by methods laid down in Section B to be

operating in accordance with the conditions set out in point 1.

3. Batch systems which achieve the parameters laid down in point 2 for continuous systems operating in

accordance with Chapters III, IV, VI or VII may also be authorised.

B. Procedures for the validation of plants for the processing of animal waste of ruminant origin
for the production of tallow in Portugal, using methods described in the Annex to Decision
92/562/EEC

1. Temperature — continuous and batch systems

Temperature monitoring devices must be situated regularly throughout the equipment in order to record
temperature at different stages in the process. Records should be kept and calibrations completed at regular
intervals.

2. Pressure (Chapter II only)

Pressure monitoring devices must be installed in order to record pressure at stages in the process. Records
must be kept and calibrations completed at regular intervals.

3. Particle size — all systems

CHAPTER 3

Human food, animal feed, medicinal products or medical devices, their starting materials or
intermediate products

Tallow derivatives may be used provided that they are produced by an appropriate, validated and strictly
certified method such as:

1. transesterification or hydrolysis at not less than 200 (cid:190)C for not less than 20 minutes under pressure

(glycerol, fatty acids and fatty acid esters production); or,

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

— in a batch process: at not less than 95 (cid:190)C for not less than 3 hours, or
— in a continuous process: at not less than 140 (cid:190)C, 2 bars for not less than 8 minutes, or equivalent.

Cosmetic products, starting materials or intermediate products

Tallow derivatives may be used provided that the following methods have been used and strictly certified by
the producer:

1. transesterification or hydrolysis at at least 200 (cid:190)C, 40 bars for 20 minutes (glycerol and fatty acids and

esters); or,

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

— in a batch process: at 95 (cid:190)C for 3 hours, or
— in a continuous process: at 140 (cid:190)C, 2 bars for 8 minutes or equivalent.