the 'Proposal for a European Parliament and Council Regulation laying down rules for the prevention and control of certain transmissible spongiform encephalopathies' and the 'Proposal for a European Parliament and Council Directive amending Council Directive 91/68/EEC as regards scrapie'
Date: 1999-07-07
Institutions: European Economic and Social Committee
Subjects: animal disease, cattle, disease prevention, goat, health control, sheep

10.9.1999

EN

Official Journal of the European Communities

C 258/19

Opinion of the Economic and Social Committee on

— the ‘Proposal for a European Parliament and Council Regulation laying down rules for the

prevention and control of certain transmissible spongiform encephalopathies’ and

— the ‘Proposal for a European Parliament and Council Directive amending Council Directive

91/68/EEC as regards scrapie’

(1999/C 258/06)

On 22 June 1999 the Council decided to consult the Economic and Social Committee, under Article 262
of the Treaty establishing the European Community, on the above-mentioned proposals.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 1 June 1999. The rapporteur was
Mr Ataı´de Ferreira.

At its 365th plenary session (meeting of 7 July 1999), the Economic and Social Committee adopted the
following opinion by 82 votes to 13, with 14 abstentions.

1.

Introduction

The Commission, on the basis of Article 95 of the
1.1.
Treaty, proposes that the European Parliament and the Council
adopt the following legislative measures:

A regulation laying down rules for the prevention
1.1.1.
and control of certain transmissible spongiform encephalopa-
thies (TSE);

1.1.2.
as regards scrapie.

A directive amending Council Directive 91/68/EEC

1.2.
The proposed measures are pursuant to the undertak-
ings made by the Commission in its report to the European
Parliament committee on follow-up of the recommendations
on BSE.

1.2.1.
As the EU has failed to become a full member of the
International Office for Epizootics (IOE) and the Council has
sadly not shown appropriate respect for consumer interests
and public health with regard to the removal of specified risk
material from the human and animal food chain, sufficient
steps are still not being taken to prevent the risk of develop-
ment of the human variant of the disease.

The proposed regulation is thus undoubtedly to be welcomed
as it provides the legal instrument best guaranteed to ensure
uniform action throughout
the Community and in third
countries. It should also ensure, without distorting compe-
tition, that concerted action is taken to safeguard public health.
The rapid updating and fine-tuning of its provisions may
nonetheless be necessary when more research findings are
available.

1.4.
Studies have shown that the appearance of the BSE
agent (1) in sheep and goats is no longer just a theoretical
possibility. The manifestations of bovine spongiform disease
in these ruminants are very similar to scrapie, and vertical or
horizontal transmission within these species cannot be ruled
out (2).

It now seems that transmission is possible not only
1.4.1.
via beef products but also via the products of other ruminants.
The time has therefore come to consider further measures.

The proposed horizontal regulation on TSE, based on
1.5.
Treaty Article 95, is a welcome step forward, although it is a
pity that it was not issued earlier. The Committee regrets that
the Commission continues to treat BSE in a rather lax
manner; it was very slow to draw up the abovementioned
recommendation, and was equally slow in responding to the
Council’s failure to adopt it. The fact remains that in the case
of preventive action, it is always better to err on the side of
excessive zeal.

1.3.
The Scientific Steering Committee (SSC) adopted an
opinion on the geographical risk in January 1998. The Com-
mission adopted a recommendation on the matter
in
July 1998, but some Member States failed to respond.

1.5.1.
The Committee questions some of the proposed
provisions in the light of the need for maximum prevention
and the fact that disease prevention and health promotion
should prevail over selfish interests.

1.3.1.
Important studies are still under way at various levels
but, by reason of their intrinsic nature and complexity, these
are not yet available. The need for preventive action dictates,
however, that fundamental measures be taken immediately.

(1) See The Lancet, vol. 353 — 13.2.1999.
(2) See the second bi-annual BSE follow-up report, COM (1998) 598

final, p. 27.

C 258/20

EN

Official Journal of the European Communities

10.9.1999

The proposal

1.6.
is an attempt at codification, while
leaving the way open to further fine-tuning during the
legislative stage or by subsequent revision thanks to the
introduction of a simpler procedure. This prevention and
control framework covers the main TSEs with respect to food
and feed but excludes industrial products, cosmetics, medicinal
products and medical devices.

1.11.1.
It has to be said that the late launch of the legislative
process makes it unlikely that this will be possible. Before
then, EU and national administrative machinery will have to
be put in place, and the arrangements needed to apply the
regulation properly will have to be tested.

1.7.
The legislation will be rounded off by rules on animal
waste (the elimination of which is a major problem) and on
gelatin and fats.

1.11.2.
All this will call for a strong political commitment
from all the parties concerned, and vigorous action by all tiers
of authority, given that serious organizational shortcomings
remain within the EU, both as regards monitoring and
evaluation and in the punishment of infringements.

Some of the received wisdom regarding the tempera-
1.7.1.
tures needed to eliminate the ‘prion’
is now being called
into question (1), and the environmental problems caused by
inadequate storage and disposal of the waste generated by
the treatment of risk materials have been overlooked. The
Committee therefore hopes that the Commission will put
forward a regulation providing an effective legal framework to
guarantee the protection of human and animal health and the
quality of the environment.

The Committee also hopes that the legal framework
1.7.2.
regarding gelatin and fats will be consolidated and updated,
and that human health protection will be strengthened.

Similar rules apply to importing and exporting third

1.8.
countries. This is fair and logical.

1.9.
In its July 1996 opinion on the BSE crisis and its
wide-ranging consequences for the EU (2), the Committee
called for a ban on the production and sale of all bonemeal
based feed for ruminants and asked that the case be considered
for extending the ban to non-ruminants; this was to be backed
by reliable systems for the manufacture of petfoods and
feed for other animals kept in captivity and for human
consumption. The Committee also called for a ban on the
circulation and sale of beef products considered as high-risk
by the WHO.

1.10. With the adoption of this regulation, the European
Union will have formal powers of rapid response.

1.11.
The regulation has eight chapters and ten annexes. It
will apply from 1 July 2000 (according to oral information
from the Commission; the dates cited in the various language
versions differ), and will enter into force on the twentieth day
following that of its publication in the Official Journal. It
would be helpful if the Community authorities could agree to
bring forward the implementing deadline.

1.12.
The Committee — which recently called for a ‘univer-
sal ban on mammalian meat and bonemeal in animal feed-
stuffs’ (3) — asks for the draft regulation to be rewritten in the
light of the following.

2. Detailed analysis of the draft regulation

2.1.
Article 3 and Annex I contain a variety of definitions
and clarifications to facilitate interpretation. Some definitions
should be amplified or their translations reworded more
carefully, while others need to be spelt out and cross-checked
(e.g. geographical area and geographical intervention area).

2.2.
Article 4 empowers the Commission to adopt safe-
guard measures in cases where the competent national auth-
ority has underestimated or overlooked a TSE transmission
risk which constitutes a hazard to human or animal health.
The Commission may act either on its own initiative or at the
request of another Member State.

This is an essential instrument for health protection
2.2.1.
and for the proper operation of the single market.
It is
therefore valid to question whether this provision will be
effective; there also appears to be inadequate linkage between
DG XXIV and DG VI and between the Commission and the
Member States. Sound provisions will be to no avail if they are
not applied correctly and promptly. Without ignoring the
responsibility of the Veterinary Committee, the ESC is con-
cerned that the mechanisms for apportioning responsibilities
are not sufficiently operative.

Chapter II deals with determination of BSE status. This

2.3.
is a vital part of the future system.

(1) Symposium on prion and lentiviral diseases, August 1998,

Reykjavik, Iceland.

(2) OJ C 295, 7.10.1996, p. 55.

(3) OJ C 101, 12.4.1999, p. 89.

10.9.1999

EN

Official Journal of the European Communities

C 258/21

2.3.1.
The Member State or third country concerned must
submit an application for the classification of the whole of its
area, or of the various parts of it, on the basis of the data set
out in Annex II (Chapter A) of the regulation. Failure to submit
an application will result in an unofficial classification based
on the information available to the Commission and following
consultation of the relevant committee. Several questions arise
in connection with the data which countries are to send to the
Commission:

2.3.1.1.
The concept of ‘geographical area’ (Annex II, Chap-
ter A, point 2b) is not defined in the relevant annex and needs
clarification in the light of point 7d. It must be remembered
that the concept of ‘health intervention area’ is also used in
this field (ADNS) in relation to the ANIMO animal movement
system. The existence of overlapping definitions encourages
fraud and creates unnecessary difficulties for farmers.

2.3.1.2.
Point 6g mentions ‘strains of BSE and scrapie
agents’. There are various known strains of scrapie, but
the Commission should explain the scientific basis of this
requirement in the case of BSE, as this is important for
regulatory purposes.

2.3.2.
The procedural aspects of the system appear satisfac-
tory. Provision is made for involvement of the veterinary
committee, and the system is to be adversarial
in nature,
guaranteeing that appropriate account is taken of the various
positions. The Commission proposes to present criteria, during
the legislative process, for assessing the risk of BSE spreading
to humans.

2.4.
Annex II (Chapter B) provides for four categories of
BSE status, as regards Member States and their regions and
third countries; a category I area is one that is considered safe
or risk-free.

Since the IOE will shortly adopt status rules to which
2.5.
the Committee
the EU Member States have contributed,
recommends that the European Union take over the IOE
categories of countries or regions when determining BSE status
under Chapter II(5) in conjunction with Annex II (Chapter B).

2.5.1.
The Commission and IOE approach of differentiating
specified risk materials in accordance with the geographical
risk is welcomed by the Committee. This approach takes
account of the differing BSE risk in the Member States and
geographical regions.

2.5.1.1.
The categories of countries or regions should be as
follows, in accordance with the BSE chapter of the international
animal health provisions:

— BSE-free country or area

— provisionally BSE-free country or area

— country or area with small incidence of BSE

— country or area with high incidence of BSE.

2.5.2.
The EC Treaty (Article 95(3)) requires the Com-
mission, in its proposals concerning health, the environment
and consumer protection, to take a high level of protection as
its base.

The system proposed by the Commission is based
2.5.3.
on information on BSE levels over a seven-year period. There
is every reason for believing that such information will not be
available. Moreover, as noted above, the seven-year period is
an average, and some studies consider that it is not long
enough in view of the data available. The legislator should bear
this in mind.

The regulation seeks to protect ruminant health by
2.5.4.
banning the use of meat and bone meal in ruminant feed. The
Committee feels that human health is more important than
ruminant health. Accordingly, throughout the EU or in all the
areas referred to in the Annex — if this is the preferred option
— there should be a ban on the marketing of all products that
are considered to pose a potential BSE transmission risk to
humans. The WHO recommendations in this field should be
followed, as the WHO has shown a more appropriate attitude
and has proved more independent in its assessment of the
risks.

2.5.5.
As the ESC recommended in 1996, human consump-
tion of all potential risk material in food must be banned until
the whole EU (and the EEA and Switzerland) has freed itself of
the perverse effects of the mistakes engendered by a thirst for
easy profits, which have caused the deaths of a number of EU
citizens (1), harmed farmers enormously, and imposed as yet
unquantified burdens on the EU and national budgets.

2.5.6.
Despite the efforts made, EU rules on the operation
of slaughterhouses are applied very laxly, and the effective
inability to carry out intra-EU checks in only too well known;
action will clearly be principally a matter for the Member
States. Details of movements of
live animals, meat and
meat-based products will be a source of concern because there
are no guarantees that the available monitoring systems are
effective, bearing in mind that border checks and systematic
checks on products from other Member States are not
permitted.

(1) See The Lancet, vol. 353 — 20.3.1999 (p. 979).

C 258/22

EN

Official Journal of the European Communities

10.9.1999

2.6.
The proposal (Article 6) provides for the launch of a
vast education programme for all parties involved in its
application. This should go some way towards remedying the
abovementioned lack of resources. However, it will not suffice
unless the Member States, backed by effective EU support,
address the structural aspects. This should certainly be con-
sidered in the assessment of the annual reports which the
Member States are to submit (Annex III-B). Uniformity of
information campaigns in the EU and in third countries is
vital.

about which techniques are acceptable, so as to prevent any
practices which could have undesired effects, the aim being to
prevent the entry into circulation of brain fragments.

2.10.
ruminants of protein derived from mammals.

Article 9 (animal feeding) prohibits the feeding to

Under Article 9, the following are also banned in category 4
countries and regions:

2.7.
Specified risk materials (listed in Annex IV) must be
removed and disposed of. They may not be sold for human
consumption, animal feed or fertilisers unless the animal has
been subjected to a test. However, without prejudice to the
points made in 2.5 above, it should be noted that:

— the feeding to any farmed animal of protein derived from

mammals;

— the feeding to any mammal — except dogs, cf. Annex V

— of protein derived from ruminants.

Removal of the distal ileum (category 2b, 3b and 4c)
2.7.1.
seems unrealistic and certainly not safe, however well trained
the person carrying out the operation may be. It would be
safer to remove the whole of the small intestine.

2.7.2.
The reliability of the test has not yet been established,
and this is very important. It is not yet known when these tests
will be available, let alone when they will be operative in the
EU and in third countries, although recent news on this matter
has been very encouraging (1).

2.7.3.
Only post mortem tests (histopathological, immuno-
cytochemical and some immuno-enzymatic) have proved safe.

2.7.4.
The Commission should take more account of the
work undertaken by European TSE research networks to
underpin its regulatory proposals. This would eliminate some
of the present proposal’s inconsistencies and some of the
devices which can only be justified on sectoral policy grounds
or because of the benefits they offer to certain trade interests.

2.8.
The regulation is rather vague about sampling pro-
cedures for suspect animals (Annex III — Chapter A) and
about the scientific parameters of the tests, their detailed
implementation and reliability, the methodological checks and
the interpretation of results.

2.9. Member States and regions which are not placed
in category 1 are not to use certain slaughter techniques
(Article 8(3)). The regulation should give strict specifications

2.10.1.
animal’ as referring to breeding stock.

The ESC interprets the Commission’s term ‘farmed

2.10.2.
The exclusion of dogs needs to be justified, as there
is no guaranteeing the effectiveness of such a measure, not
least because the feed available on the market could be diverted
for other uses.

2.10.3.
fur are not excluded should also be given.

The reason why carnivorous animals bred for their

The proposal does not address the fact that there is
2.10.4.
no reliable analysis for detecting ruminant-derived protein in
feed. Such protein can easily be confused with that from other
mammals. The proposal does not draw the full consequences of
this. Here the Committee would reiterate the recommendation
made in its opinion of 28 January 1999 (2).

Article 12 states that any suspect animal must be
2.11.
slaughtered
under
placed
(Article 12(2)).

restrictions

and may

be

— Reference should be made here to Annex III, and this
annex should be more clearly worded and aligned with the
prevention system laid down in Article 12. As currently
worded,
the annex contains contradictory guidelines
regarding the sampling of the sub-population.

2.12.
Article 13(4) states that owners will be compensated
the market value of the animals slaughtered and the products
(e.g. semen) destroyed.

— As this is only fair, it is important that the payment is
made promptly and that interest is paid to compensate for
any delay.

(1) Commission spokesman’s service — IP 99/42, 25.6.1999.

(2) OJ C 101, 12.4.1999, p. 89.

10.9.1999

EN

Official Journal of the European Communities

C 258/23

2.12.1.
The regulation should state explicitly — at least in
the recitals — that payment of compensation and, if appropri-
ate, interest is to be the joint responsibility of the Community
and the Member State involved.

2.13.
Animals in category 2, 3 and 4 countries or regions
(if this is the chosen option) must be identified by a permanent
identification system enabling them to be traced back to the
dam and herd of origin. It should be noted (see 2.6 above)
that the Community provisions on this are not yet applied
everywhere. The Committee reiterates that the proposal to
differentiate between categories 3 and 4 is motivated solely by
commercial interests, and encourages non-reporting of suspect
cases, with all the aforementioned consequences this has for
public health.

3. Detailed analysis of the draft directive

The proposal is designed to adjust Directive 91/68/EEC

3.1.
to the provisions of the new regulation.

The Committee supports the proposal, and stresses
3.2.
that the proposed amendment should be transposed into
national law so that it is in force by the time the regulation
enters into force.

Brussels, 7 July 1999.

4. Conclusions

The Committee supports the Commission proposals

4.1.
subject to the following reservations:

4.1.1.
Chapters II and III of the proposed regulation and
the relevant annexes should be revised in the light of the clear
requirement of EC Treaty Article 95(3) which, under the terms
of Article 211, cannot be ignored by the Commission. The
Commission should also take account of
the Parliament
resolution on the matter, which has been recently referred to
in the resolution (1) on the Commission’s bi-annual BSE
follow-up report.

4.1.2.
amended to address the doubts raised above in this opinion.

the proposed regulation should be

The text of

4.1.3.
should be aligned on that of the regulation.

The deadline for transposing the proposed directive

(1) Resolution A4-0083/99, adopted by the European Parliament’s

Agriculture and Environment Committees in March 1999.

The President

of the Economic and Social Committee

Beatrice RANGONI MACHIAVELLI

APPENDIX

to the opinion of the Economic and Social Committee

Defeated amendment

The following amendment was defeated during the debate:

Point 2.10.3

Delete.

Result of the vote

For: 29, against: 45, abstentions: 26.