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 Ataíde 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

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

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

1.1.2. A directive amending Council Directive 91/68/EEC as regards scrapie.

1.2. The proposed measures are pursuant to the undertakings 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 development of the human variant of the disease.

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

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. 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 competition, 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).

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

1.5. The proposed horizontal regulation on TSE, based on 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.

1.5.1. 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.

1.6. The proposal 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.

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

1.7.1. Some of the received wisdom regarding the temperatures needed to eliminate the "prion" is now being called into question(3), 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.

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

1.8. Similar rules apply to importing and exporting third 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(4), 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.

1.11.1. 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.

1.11.2. 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.

1.12. The Committee - which recently called for a "universal ban on mammalian meat and bonemeal in animal feedstuffs"(5) - 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 safeguard measures in cases where the competent national authority 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.

2.2.1. This is an essential instrument for health protection 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 concerned that the mechanisms for apportioning responsibilities are not sufficiently operative.

2.3. Chapter II deals with determination of BSE status. This is a vital part of the future system.

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, Chapter 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 satisfactory. 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.

2.5. Since the IOE will shortly adopt status rules to which the EU Member States have contributed, the Committee 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 Commission, in its proposals concerning health, the environment and consumer protection, to take a high level of protection as its base.

2.5.3. The system proposed by the Commission is based 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.

2.5.4. The regulation seeks to protect ruminant health by 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 consumption 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(6), 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.

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 considered 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.

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:

2.7.1. Removal of the distal ileum (category 2b, 3b and 4c) 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(7).

2.7.3. Only post mortem tests (histopathological, immunocytochemical 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 procedures 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 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. Article 9 (animal feeding) prohibits the feeding to ruminants of protein derived from mammals.

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

- 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.

2.10.1. The ESC interprets the Commission's term "farmed animal" as referring to breeding stock.

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. The reason why carnivorous animals bred for their fur are not excluded should also be given.

2.10.4. The proposal does not address the fact that there is 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(8).

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

- 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.

2.12.1. The regulation should state explicitly - at least in the recitals - that payment of compensation and, if appropriate, 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

3.1. The proposal is designed to adjust Directive 91/68/EEC to the provisions of the new regulation.

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

4. Conclusions

4.1. The Committee supports the Commission proposals 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(9) on the Commission's bi-annual BSE follow-up report.

4.1.2. The text of the proposed regulation should be amended to address the doubts raised above in this opinion.

4.1.3. The deadline for transposing the proposed directive should be aligned on that of the regulation.

Brussels, 7 July 1999.

The President

of the Economic and Social Committee

Beatrice RANGONI MACHIAVELLI

(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.

(3) Symposium on prion and lentiviral diseases, August 1998, Reykjavik, Iceland.

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

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

(6) See The Lancet, vol. 353 - 20.3.1999 (p. 979).

(7) Commission spokesman's service - IP 99/42, 25.6.1999.

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

(9) Resolution A4-0083/99, adopted by the European Parliament's Agriculture and Environment Committees in March 1999.

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.